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## Protocol Section ### Identification Module **NCT ID:** NCT02615379 **Brief Title:** Transdermal Continuous Oxygen Therapy for Infection Prophylaxis in High- Risk Patients Undergoing Instrumented Fusion **Official Title:** A Prospective, Randomized, Parallel Pilot Study of Transdermal, Continuous Oxygen Therapy for Infection Prophylaxis in High- Risk Patients Undergoing Instrumented Fusion #### Organization Study ID Info **ID:** EPF-515 #### Organization **Class:** INDUSTRY **Full Name:** Neogenix, LLC dba Ogenix ### Status Module #### Completion Date **Date:** 2019-03-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2017-08-14 **Type:** ACTUAL **Last Update Submit Date:** 2017-08-10 **Overall Status:** WITHDRAWN #### Primary Completion Date **Date:** 2017-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2017-07-01 **Type:** ESTIMATED **Status Verified Date:** 2017-08 #### Study First Post Date **Date:** 2015-11-26 **Type:** ESTIMATED **Study First Submit Date:** 2015-11-18 **Study First Submit QC Date:** 2015-11-24 **Why Stopped:** Administrative reasons ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Neogenix, LLC dba Ogenix #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** EPIFLO® unit along with standard wound care vs only standard wound care for Surgical site infections (SSI). **Detailed Description:** Surgical site infections (SSI) after instrumented spinal fusions are not rare, and patients with SSI after instrumented spinal surgery often require repeat operations and prolonged intravenous antibiotic therapy. Wound hypoxia has been identified as a pathogenic mechanism behind wound infection and poor healing. Transdermal oxygen delivery (EPIFLO) has recently become a novel strategy to facilitate wound healing. The study doctor will give an EPIFLO® unit along with standard wound care to some subjects in this study to see if it is safe and can help them. Another purpose of this study is to find out if using EPIFLO® is better than getting only standard wound care for Surgical site infections (SSI). The sponsor also wants to compare the cost of using the study device and standard wound care to the cost of standard wound care alone. The U.S. Food and Drug Administration (FDA) has approved EPIFLO® to treat skin ulcers (including diabetic skin ulcers), bedsores, amputations, skin grafts, burns, and frostbite. ### Conditions Module **Conditions:** - Instrumented Spinal Fusion **Keywords:** - instrumented spinal fusion - infection - topical oxygen ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Masking Description:** The outcomes assessor will be given blinded data and pictures to enable unbiased assessment. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** EPIFLO® working study unit, all day, every day for 2 weeks + standard wound care **Intervention Names:** - Device: EPIFLO **Label:** Transdermal Continuous Oxygen Therapy **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** standard wound care for 2 weeks **Label:** Standard of care **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Transdermal Continuous Oxygen Therapy **Description:** Transdermal continuous oxygen therapy is oxygen delivery to the wound site directly. Ogenix makes a small portable oxygen concentrator (Trade Name: EPIFLO) that makes continuous transdermal delivery of oxygen possible. It is a 3 ounce oxygen generator that continuously delivers 3 ml of pure oxygen to the wound site. **Name:** EPIFLO **Other Names:** - TCOT, Transdermal Continuous Oxygen Therapy **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The primary objective of this study is to assess surgical site infection within 3 months of surgery for "high risk" patients undergoing posterior cervical, posterior thoracic, or posterior lumbar instrumented spinal fusions in patients receiving adjunct Transdermal Continuous Oxygen therapy vs. standard of care control. Surgical site infection will be clinically assessed by the PI according to CDC criteria. Independent blinded assessment by a clinician blinded to the allocation arm will also be obtained. The number of patients with infection (and the severity of infection) in the treated arm will be compared to the number in the control arm. **Measure:** Incidence of surgical site infection **Time Frame:** 3 months #### Secondary Outcomes **Description:** Resource utilization- the sum total of cost of treatments, hospital stays, bandages, nursing care and anything else related to treatment all measured in dollar amounts and then summed **Measure:** Resource utilization **Time Frame:** 3 months **Description:** Severity of infection - Superficial or deep as per CDC classification as assessed by investigator **Measure:** Severity of infection **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Elective spinal fusion - posterior cervical, posterior thoracic, or posterior lumbar instrumented spinal fusions * Patient Age 18-80 * Patients must be considered high risk for infection, meeting one or more of the following criteria: * Anticipated Surgical duration ≥ 3 hours * Diabetes Mellitus type I or II * Anesthesiology ASA score of 3 or above * BMI ≥35 * Patients with malnutrition as indicated by Pre-albumin value of \<20 * Chronic corticosteroid use * Smokers * Patients on immune modulators Exclusion Criteria: Major Study Exclusion Criteria include: * Pregnancy * Active infection at the time of surgery * Persons with decubitus or diabetic ulcers * Patients undergoing \>5 level fusion (Level is defined as crossing a disk space; e.g.,an L3-5 fusion is a 2 level fusion) * Disseminated Cancer Patients **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Pittsburgh **Country:** United States **Facility:** Department of Neurological Surgery Allegheny General Hospital **State:** Pennsylvania **Zip:** 15212 #### Overall Officials **Official 1:** **Affiliation:** Department of Neurosurgery **Name:** Nestor Tomycz, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05604079 **Acronym:** EECCHO **Brief Title:** Electrolarynx for Enabling Communication in the CHrOnically Critically Ill (EECCHO) **Official Title:** Feasibility Assessment of the Electrolarynx for Enabling Communication in the #### Organization Study ID Info **ID:** TorontoEGH #### Organization **Class:** OTHER **Full Name:** Michael Garron Hospital ### Status Module #### Completion Date **Date:** 2017-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-11-03 **Type:** ACTUAL **Last Update Submit Date:** 2022-10-27 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-12 **Type:** ACTUAL #### Start Date **Date:** 2014-11 **Status Verified Date:** 2021-05 #### Study First Post Date **Date:** 2022-11-03 **Type:** ACTUAL **Study First Submit Date:** 2015-01-05 **Study First Submit QC Date:** 2022-10-27 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Sunnybrook Health Sciences Centre **Class:** OTHER **Name:** Unity Health Toronto #### Lead Sponsor **Class:** OTHER **Name:** Michael Garron Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** All critically ill patients receiving mechanical ventilation experience a period of inability to speak due to the need for cuffed endotracheal or tracheostomy tubes. Consequences of the inability to speak include: significant emotional distress; unrecognized pain; sleeplessness; increased use of restraints, self-extubation and line removal, as well as injury to self and healthcare professionals. Communication methods such as word mouthing, gesticulating, and writing may be ineffective and result in frustration. Recent technological innovations include communication boards and electronic speech generating devices however these require fine motor skills and coordination which may not be intact in the chronically critically ill. The Electrolarynx was recently shown to be effective in establishing communication in a case study of an intubated patient. Despite the well-recognized deleterious consequences of speech incapacity, few studies have evaluated communication strategies in the critically ill and no published study has evaluated the Electrolarynx in this patient population. In this study, the investigators aim to assess the feasibility and patient acceptability of establishing speech with an Electrolarynx for intubated or tracheostomized patients experiencing difficult weaning and unable to tolerate cuff deflation. Feasibility will be determined by the proportion of participants able to produce intelligible and comprehensible speech. The investigators will also collect data on consent rates, reasons for refusal, the proportion of eligible patients and the time required for research procedures to inform future studies. The investigators will provide participants with a maximum of five Electrolarynx training sessions. On completion the investigators will measure speech intelligibility, comprehensibility, and patient acceptability using the Assessment of Intelligibility of Dysarthric Speech and the Ease of Communication scale. Satisfaction with communication and anxiety will be measured before and after Electrolarynx training. To the investigators' knowledge, this study will be the first to rigorously evaluate, using previously validated measures, the feasibility of the Electrolarynx for establishing communication for mechanically ventilated patients. **Detailed Description:** Despite the well-recognized deleterious consequences of speech incapacity, few studies have evaluated communication strategies for patients unable to tolerate cuff deflation. Despite the aforementioned case reports, no studies report the feasibility of the Electrolarynx in restoring communication. Communication impairment during hospitalization has implications for the quality and safety of care as it is a modifiable risk factor for adverse events. This has led to accreditation organizations mandating reasonable efforts to establish alternative communication strategies for patients unable to speak. For chronically critically ill (CCI) patients, inability to speak increases anxiety, decreases a sense of control, and impairs meaningful patient involvement in decision making. Anxiety can exacerbate pain, which is known to impede ventilator weaning. Therefore it is likely that the inability to speak can impact negatively on weaning outcomes. To the investigators' knowledge, this study will be the first to rigorously evaluate, using previously validated measures, the feasibility of the Electrolarynx for establishing communication for mechanically ventilated patients. Overall Program of Research Hypothesis The investigators hypothesize that restoration of communication using the Electrolarynx can reduce patient anxiety resulting in improvement in weaning outcomes (weaning success and duration) and reduced adverse events associated with inability to communicate such as agitation, delirium, restraint use, and tube/line/device removal. Before being able to test this hypothesis, the feasibility of use of the Electrolarynx needs to be confirmed. Study Aim The aim of this study is to assess the feasibility of establishing speech with an Electrolarynx for patients receiving ventilation via an endotracheal tube or tracheostomy experiencing difficult weaning and unable to tolerate cuff deflation. Feasibility will be determined in terms of the proportion of participants able to produce intelligible and comprehensible speech as well as ease of, and satisfaction with communication. ### Conditions Module **Conditions:** - Communication **Keywords:** - communication - mechanical ventilation - weaning ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 24 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In this single arm study, all participants will receive training in the Electrolarynx **Intervention Names:** - Device: Electrolarynx **Label:** Electrolarynx **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Electrolarynx **Description:** The device transmits electronic sound source vibrations through soft tissue, either the neck at the level of the glottis, or less commonly the check. Speech is created through movements of articulators including the lips, tongue and jaw. **Name:** Electrolarynx **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** We determined speech intelligibility and comprehensibility using the Assessment of Intelligibility of Dysarthric Speech (AIDS), a validated objective tool for quantifying single-word and sentence intelligibility. Intelligible speech was arbitrarily defined as ≥70% of words identified correctly by raters. Ability to establish comprehensible speech was defined as a difficulty score of ≤ 5 averaged over the five sentences. **Measure:** Feasibility of the Electrolarynx for establishing successful communication defined as the ability to generate speech that is intelligible and comprehensible **Time Frame:** Within 5 days of training #### Secondary Outcomes **Description:** The investigators will use a simplified form of the Ease of Communication scale developed by Menzel that has been adapted and used in studies assessing communication in non-vocal ICU patients. We will use a 5-point Likert type scale to measure satisfaction with 1 indicating very satisfied and 5 indicating not at all satisfied. **Measure:** Perceived ease and satisfaction with use **Time Frame:** Within 5 days of training **Description:** The investigators will record the total time spent to train each participant to use the Electrolarynx **Measure:** Training time **Time Frame:** Commencement and completion of training - training is a maximum of five days **Description:** The investigators will measure anxiety using the Faces Anxiety Scale **Measure:** Anxiety **Time Frame:** Within 5 days of training **Description:** The investigators will document the number of participants that consent and decline **Measure:** Consent rate **Time Frame:** One month after completion of study recruitment **Description:** The investigators will record the time to complete all research procedures **Measure:** Time to complete research measures **Time Frame:** One month after completion of study recruitment **Description:** The investigators will measure the effectiveness of the Electrolarynx for communication using the Electrolarynx Effectiveness Score **Measure:** Effectiveness of the Electrolarynx **Time Frame:** Within 5 days of training ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. endotracheal tube or tracheostomy in situ and unable to tolerate cuff deflation for \> one hour 2. alert, awake and able to follow simple commands demonstrated by a Glasgow Coma Score of 15 with the verbal score assigned for the ability to communicate words using non-vocal methods 3. able to read and understand English 4. ≥ 18 years old 5. unimpaired oral-motor capabilities (functional speech structures) assessed by standard oral-peripheral examination by a speech language pathologist and capable of mouthing words in response to orientation questions 6. meets all the above criteria and is anticipated to require mechanical ventilation for a further 5 days 7. consent to participate.. Exclusion Criteria: 1. pre-existing hearing or speech impairment that seriously interferes with communication before hospitalization (as documented in chart or reported by family members) 2. previous diagnosis of dementia identified in the patient's medical history. **Maximum Age:** 100 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Toronto **Country:** Canada **Facility:** Toronto East General Hospital **State:** Ontario **Zip:** M4C 3E7 **Location 2:** **City:** Toronto **Country:** Canada **Facility:** Saint Michael's Hospital **State:** Ontario **Location 3:** **City:** Toronto **Country:** Canada **Facility:** Sunnybrook Health Care Centre **State:** Ontario ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M19010 - Name: Critical Illness - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00016679 **Brief Title:** 1-Octanol to Treat Essential Tremor **Official Title:** Dose Finding Study of 1-Octanol in Essential Tremor #### Organization Study ID Info **ID:** 010178 #### Organization **Class:** NIH **Full Name:** National Institutes of Health Clinical Center (CC) #### Secondary ID Infos **ID:** 01-N-0178 ### Status Module #### Completion Date **Date:** 2004-03 #### Expanded Access Info #### Last Update Post Date **Date:** 2008-03-04 **Type:** ESTIMATED **Last Update Submit Date:** 2008-03-03 **Overall Status:** COMPLETED #### Start Date **Date:** 2001-05 **Status Verified Date:** 2004-03 #### Study First Post Date **Date:** 2001-05-25 **Type:** ESTIMATED **Study First Submit Date:** 2001-05-24 **Study First Submit QC Date:** 2001-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** NIH **Name:** National Institute of Neurological Disorders and Stroke (NINDS) ### Description Module **Brief Summary:** This study will determine the optimal dose of 1-octanol that will safely reduce tremors in patients with essential tremor-a disorder in which the hands, and sometimes the head, shake involuntarily. Current treatments may be ineffective or produce unwanted side effects. Ethanol (the chemical in beer and wine that causes intoxication) reduces tremor in many patients, but patients generally don't use it regularly because it interferes with daily activities. Laboratory studies show that 1-octanol, a drug that is similar to ethanol, may have the same beneficial effect on tremors with less likelihood of intoxication. Patients 21 years of age and older with essential tremor may be eligible for this 10-day study. Candidates will be evaluated with a neurological examination, blood tests, urinalysis and electrocardiogram (EKG). Those enrolled will be admitted to the hospital for 4 days for 1-octanol administration and monitoring. On day 1, patients will have a medical history and physical examination. A catheter (a thin plastic tube) will be placed in a vein of the forearm for sampling blood. Patients will take one 1-octanol capsule (at one of seven doses) by mouth and will be monitored for tremors and drug side effects. Blood will be sampled periodically in the first 3 hours to determine 1-octanol blood levels. On days 2 and 3, patients will be monitored for additional side effects. On days 3 and 4, laboratory tests (blood and urine) will be done to evaluate liver and kidney function. On day 4, the catheter will be removed and the patient will be discharged from the hospital. A follow-up visit will be scheduled 1 week after discharge for a physical examination and blood, urine and EKG tests. **Detailed Description:** Essential tremor is a very common movement disorder affecting approximately 1.4% of the population. Response to medications such as beta blockers and mysoline may be only partial or be accompanied by intolerable side effects. Roughly 80% of patients have significant tremor reduction to ethanol although daily use of this as a treatment has potentially serious social and legal consequences. The leading hypothesis for the pathophysiology of essential tremor is unmasking of spontaneous oscillation of neurons in the inferior olive. Both ethanol and 1-octanol have been shown to reduce these spontaneous oscillations in an animal model of essential tremor; however, 1-octanol dose this at a dose much lower than an intoxicating dose suggesting that it may be useful in the treatment of essential tremor. Our initial study with 1-octanol at a low, single dose in patients with essential tremor suggested it was both efficacious and safe. This present study is planned to identify a maximum tolerated dose and broaden the safety and efficacy data in humans. Additionally, we hope to collect further information about the pharmacokinetics of 1-octanol. This study is designed as a phase Ia, unblinded, inpatient study of adults with essential tremor receiving escalating doses of 1-octanol. Cohorts of three will begin dose escalation at the dose previously studied. Each cohort will be followed in inpatient setting for 72 hours ( and outpatient for 1 additional week) during which adverse events, pharmacokinetics and efficacy will be assessed. If no subject achieves dose-limiting toxicity, 3 additional subjects will be recruited to receive the next higher dose. If 1/3 subjects achieves dose-limiting toxicity, the next cohort will receive the same dose. Dose limiting toxicity is defined as the dose that produces dose-limiting toxicity in at least 2 subjects. Maximum tolerated dose will be defined as the next lower dose. With this study, we hope to identify a range of doses that may useful in the treatment of essential tremor and combined with the pharmacokinetic and efficacy data, design a protocol to study multiple dose regimens over longer time periods. ### Conditions Module **Conditions:** - Essential Tremor **Keywords:** - Pharmacokinetics - Metabolism - Toxicity - Side Effects - Essential Tremor - Tremor - Movement Disorder ### Design Module #### Design Info **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 42 **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** 1-Octanol **Type:** DRUG ### Eligibility Module **Eligibility Criteria:** INCLUSION CRITERIA: Patients with essential tremor with a history or ethanol responsiveness. Patients must be off any medications used to treat essential tremor such as mysoline or propranalol for at least 2 weeks. Patients must withhold ethanol and caffeine from 24 hours prior to starting the study until study termination (10 days). EXCLUSION CRITERIA: Patients with abnormalities on neurologic exam other than tremor. Patients with a history of chronic alcohol dependence. Patients with chronic medical conditions such as renal failure, hepatic failure and chronic lung disease. Patients on other chronic medications that cannot be temporarily discontinued for the length of the study (10 days). Patients, who for moral or religious reasons do not wish to take a potentially intoxicating drug. Patients with abnormalities on their baseline screening laboratory tests. Women who are pregnant or lactating. People of Asian decent who may differ pharmocogenetically with respect to alcohol and aldehyde dehydrogenase and may have increased sensitivity to alcohols and their metabolites **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bethesda **Country:** United States **Facility:** National Institute of Neurological Disorders and Stroke (NINDS) **State:** Maryland **Zip:** 20892 ### References Module #### References **Citation:** Lyon RC, McComb JA, Schreurs J, Goldstein DB. A relationship between alcohol intoxication and the disordering of brain membranes by a series of short-chain alcohols. J Pharmacol Exp Ther. 1981 Sep;218(3):669-75. **PMID:** 7264950 **Citation:** Hellwig J, Jackh R. Differential prenatal toxicity of one straight-chain and five branched-chain primary alcohols in rats. Food Chem Toxicol. 1997 May;35(5):489-500. doi: 10.1016/s0278-6915(97)00007-0. **PMID:** 9216748 **Citation:** Bal T, McCormick DA. Synchronized oscillations in the inferior olive are controlled by the hyperpolarization-activated cation current I(h). J Neurophysiol. 1997 Jun;77(6):3145-56. doi: 10.1152/jn.1997.77.6.3145. **PMID:** 9212264 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020820 - Term: Dyskinesias - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000009069 - Term: Movement Disorders - ID: D000002493 - Term: Central Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M16956 - Name: Tremor - Relevance: HIGH - As Found: Tremor - ID: M22137 - Name: Essential Tremor - Relevance: HIGH - As Found: Essential Tremor - ID: M12029 - Name: Movement Disorders - Relevance: LOW - As Found: Unknown - ID: M22574 - Name: Dyskinesias - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014202 - Term: Tremor - ID: D000020329 - Term: Essential Tremor ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02783079 **Brief Title:** Insomnia Interventions in Cancer Survivors **Official Title:** Insomnia Interventions in Cancer Survivors #### Organization Study ID Info **ID:** 15-146EX #### Organization **Class:** OTHER **Full Name:** The Cooper Health System ### Status Module #### Expanded Access Info **Last Known Status:** NOT_YET_RECRUITING #### Last Update Post Date **Date:** 2016-05-26 **Type:** ESTIMATED **Last Update Submit Date:** 2016-05-25 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2018-05 **Type:** ESTIMATED #### Start Date **Date:** 2016-05 **Status Verified Date:** 2016-05 #### Study First Post Date **Date:** 2016-05-26 **Type:** ESTIMATED **Study First Submit Date:** 2016-02-12 **Study First Submit QC Date:** 2016-05-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The Cooper Health System #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study looks at two different interventions used for the treatment of insomnia in survivors of breast, colon, lung, prostate and gynecologic cancer. **Detailed Description:** The purpose of this study is to evaluate two validated interventions for the treatment of insomnia in cancer survivors of breast, colon, lung and prostate cancer. Moreover, it will provide an opportunity to assess the efficacy of both of these interventions in a group setting in patients of varied ethnic backgrounds including African-Americans, Latinos and Caucasians. The results of this study will help clinicians provide future interventions specific to cancer type and ethnicity in order to better serve the needs of our cancer survivors and improve their quality of life. ### Conditions Module **Conditions:** - Insomnia **Keywords:** - Breast Cancer - Prostate Cancer - Colon Cancer - Lung Cancer - Gynecologic Cancer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 210 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Cognitive Behavioral Therapy (CBT) **Intervention Names:** - Behavioral: CBT **Label:** Arm 1 **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Mindfulness Based Stress Reduction (MBSR) **Intervention Names:** - Behavioral: MBSR **Label:** Arm 2 **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm 1 **Name:** CBT **Other Names:** - cognitive behavioral therapy **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Arm 2 **Name:** MBSR **Other Names:** - mindfulness based stress reduction **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Change in Insomnia Severity Index (ISI) rating ratings in cancer survivors receiving CBT vs. MBSR interventions. **Measure:** Change in Insomnia Severity Index **Time Frame:** Baseline to 6 weeks and 6 weeks to 12 weeks #### Secondary Outcomes **Description:** Change in Fatigue rating using the BFI in cancer survivors receiving CBT vs. MBSR interventions. **Measure:** Change in Brief Fatigue Inventory (BFI) **Time Frame:** Baseline to 6 weeks and 6 weeks to 12 weeks **Description:** Change in Depression and Anxiety rating using the DASS21 in cancer survivors receiving CBT vs. MBSR interventions **Measure:** Change in Depression, Anxiety and Stress Scale 21 (DASS21) **Time Frame:** Baseline to 6 weeks and 6 weeks to 12 weeks **Description:** Variations in efficacy outcomes based on ethnicity **Measure:** Number of patients who respond to CBT vs MBSR based on Ethnicity **Time Frame:** 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * signed informed consent * age 18 and over * diagnosis of breast, colon, lung, prostate or gynecologic cancer that is non metastatic * receiving treatment at one of the outpatient offices of the MD Anderson Cancer Center at Cooper * Self reported insomnia * Not currently taking any medications to treat insomnia * No medical or psychological condition that would prevent successful protocol completion in the opinion of investigator. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Camden **Contacts:** ***Contact 1:*** - **Phone:** 856-735-6100 - **Role:** CONTACT **Country:** United States **Facility:** MD Anderson Cancer Center at Cooper **State:** New Jersey **Zip:** 08103 **Location 2:** **City:** Voorhees **Contacts:** ***Contact 1:*** - **Phone:** 856-325-6750 - **Role:** CONTACT **Country:** United States **Facility:** MD Anderson Cancer Center at Cooper **State:** New Jersey **Zip:** 08043 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020919 - Term: Sleep Disorders, Intrinsic - ID: D000020920 - Term: Dyssomnias - ID: D000012893 - Term: Sleep Wake Disorders - ID: D000009422 - Term: Nervous System Diseases - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: LOW - As Found: Unknown - ID: M14335 - Name: Prostatic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M10356 - Name: Sleep Initiation and Maintenance Disorders - Relevance: HIGH - As Found: Insomnia - ID: M22242 - Name: Parasomnias - Relevance: LOW - As Found: Unknown - ID: M22654 - Name: Sleep Disorders, Intrinsic - Relevance: LOW - As Found: Unknown - ID: M22655 - Name: Dyssomnias - Relevance: LOW - As Found: Unknown - ID: M15696 - Name: Sleep Wake Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007319 - Term: Sleep Initiation and Maintenance Disorders ### Intervention Browse Module - Browse Branches - Abbrev: HB - Name: Herbal and Botanical - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T120 - Name: Cola - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01987479 **Acronym:** OSCAR **Brief Title:** A Study on Safety and Efficacy of Tocilizumab (RoActemra/Actemra) Alone or in Combination With Non-Biologic Antirheumatics in Participants With Rheumatoid Arthritis **Official Title:** Multi-Center, Open Label, Single Arm Phase IIIB Study on Safety and Efficacy of Subcutaneous Tocilizumab in Monotherapy or in Combination With Methotrexate or Other Non-Biologic Disease Modifying Antirheumatic Drugs in Rheumatoid Arthritis Patients With an Inadequate Response to Non-Biologic DMARDs - OSCAR #### Organization Study ID Info **ID:** ML28702 #### Organization **Class:** INDUSTRY **Full Name:** Hoffmann-La Roche #### Secondary ID Infos **ID:** 2013-000342-19 **Type:** EUDRACT_NUMBER ### Status Module #### Completion Date **Date:** 2016-05-26 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-06-19 **Type:** ACTUAL **Last Update Submit Date:** 2017-05-19 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2016-05-26 **Type:** ACTUAL #### Results First Post Date **Date:** 2017-06-19 **Type:** ACTUAL **Results First Submit Date:** 2017-05-19 **Results First Submit QC Date:** 2017-05-19 #### Start Date **Date:** 2014-01-30 **Type:** ACTUAL **Status Verified Date:** 2017-05 #### Study First Post Date **Date:** 2013-11-19 **Type:** ESTIMATED **Study First Submit Date:** 2013-11-08 **Study First Submit QC Date:** 2013-11-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Hoffmann-La Roche #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This multi-center, open-label single arm Phase IIIb study will evaluate the safety and efficacy of subcutaneous (SC) tocilizumab administered as monotherapy and/or in combination with methotrexate or other non-biologic disease modifying antirheumatic drugs (DMARDs) in participants with rheumatoid arthritis (RA) with an inadequate response to non-biologic DMARDs. ### Conditions Module **Conditions:** - Rheumatoid Arthritis ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 150 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive a weekly SC injection of tocilizumab 162 milligrams (mg) as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. **Intervention Names:** - Drug: Non-Biologic DMARDs - Drug: Tocilizumab - Drug: Methotrexate **Label:** Tocilizumab Alone or in Combination with Methotrexate or DMARD **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Tocilizumab Alone or in Combination with Methotrexate or DMARD **Description:** Treatment with non-biologic DMARDs, at a stable dose that was initiated at least 4 weeks prior to baseline, is permitted during the study and is at the investigator's discretion. **Name:** Non-Biologic DMARDs **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Tocilizumab Alone or in Combination with Methotrexate or DMARD **Description:** Tocilizumab 162 mg will be administered once a week by SC injection and as a single fixed dose, irrespective of body weight, for the treatment duration of 24 weeks. **Name:** Tocilizumab **Other Names:** - RoActemra, Actemra **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Tocilizumab Alone or in Combination with Methotrexate or DMARD **Description:** Methotrexate will be administered per investigator's discretion. **Name:** Methotrexate **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Adverse events included serious as well as non-serious adverse events. **Measure:** Percentage of Participants With Adverse Events **Time Frame:** Baseline up to Week 32 #### Secondary Outcomes **Description:** DAS28 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR; millimeters per hour \[mm/hour\]), and patient's global assessment of disease activity (measured on a 0 to 100 mm Visual Analog Scale \[VAS\] where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR less than or equal to (≤) 3.2 implied low disease activity and greater than (\>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-ESR less than (\<) 2.6 implied clinical remission. **Measure:** Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24) **Description:** A participant had an ACR20 response if there was at least a 20 percent (%) improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0 mm=no pain to 100 mm=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (either C-reactive protein \[CRP\] or ESR). **Measure:** Percentage of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24) **Description:** A participant had an ACR50 response if there was at least a 50% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0 mm=no pain to 100 mm=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (either CRP or ESR). **Measure:** Percentage of Participants Achieving an ACR50 Response **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24) **Description:** A participant had an ACR70 response if there was at least a 70% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0 mm=no pain to 100 mm=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (either CRP or ESR). **Measure:** Percentage of Participants Achieving an ACR70 Response **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24) **Description:** A participant had an ACR90 response if there was at least a 90% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0 mm=no pain to 100 mm=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (either CRP or ESR). **Measure:** Percentage of Participants Achieving an ACR90 Response **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24) **Description:** DAS28-ESR was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). DAS28-ESR scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. The DAS28-ESR based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline \>1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline \>1.2 with a DAS28 score \>3.2 or a change from baseline \>0.6 to ≤1.2 with a DAS28 score ≤5.1. Participants with change from baseline \>0.6 to ≤1.2 with a DAS28 score \>5.1, or any score with change from baseline ≤0.6, were assessed as non-responders. **Measure:** Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24) **Description:** The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient and physician global assessment of disease activity assessed on 0-10 centimeter (cm) VAS (0 cm= no disease activity and 10 cm= worst disease activity), and CRP in milligrams per liter (mg/L). SDAI total score = 0-86. SDAI \<=3.3 indicates clinical remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high (or severe) disease activity . **Measure:** Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24) **Description:** The CDAI is the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, patient and physician's global assessment of disease activity assessed on 0-10 cm VAS (0 cm= no disease activity and 10 cm= worst disease activity). CDAI total score = 0-76. CDAI \<= 2.8 indicates clinical remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high (or severe) disease activity. **Measure:** Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 16, 20, 24, and Early Withdrawal **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24) **Description:** Number of tender joints was determined by examining 28 joints for TJC28 and 68 joints for TJC68, and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28 for a TJC28 and 68 for a TJC68. A reduction in number of tender joints compared to baseline indicates improvement. **Measure:** Change From Baseline in Total TJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24) **Description:** Number of swollen joints was determined by examination of 28 joints for SJC28 and 66 joints for SJC66 and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28 for a SJC28 and 66 for a SJC66. A reduction in number of swollen joints compared to baseline indicates improvement. **Measure:** Change From Baseline in Total SJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24) **Description:** Results are reported for percentage of participants who had NSAIDs dose reductions or discontinuation by reasons for dose reductions or discontinuation (unknown reasons, safety reasons, other reasons, lack of efficacy, and discomfort). **Measure:** Percentage of Participants With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Dose Reductions or Discontinuation Categorized by Reasons **Time Frame:** From Week 16 and before Week 20; From Week 20 and before Week 24 **Description:** Results are reported for percentage of participants who had corticosteroid dose reductions or discontinuation by reasons for dose reductions or discontinuation (unknown reasons, safety reasons, other reasons, lack of efficacy, and discomfort). **Measure:** Percentage of Participants With Corticosteroid Dose Reductions or Discontinuation Categorized by Reasons **Time Frame:** From Week 16 and before Week 20; From Week 20 and before Week 24 **Description:** Time to discontinuation or first dose reduction of corticosteroids or NSAIDs (weeks) = (Date of the first dose reduction or end date of corticosteroids or NSAIDs treatment - date of first drug intake of this study) + 1. Time to discontinuation or first dose reduction was based on the first occurring event (corticosteroid discontinuation or corticosteroid first dose reduction or NSAIDs discontinuation or NSAIDs first dose reduction, whichever occurred first). **Measure:** Time to Discontinuation or First Dose Reduction of Corticosteroids or NSAIDs **Time Frame:** Baseline up to Week 32 **Measure:** Percentage of Participants With Anti-Tocilizumab Antibodies **Time Frame:** Baseline, Weeks 12 and 24, early withdrawal (up to Week 24), follow-up visit (8 weeks after last dose of tocilizumab, up to 32 weeks) **Measure:** Serum Levels of Tocilizumab **Time Frame:** Baseline, Weeks 12 and 24, Early Withdrawal (up to Week 24), Follow-up Visit (8 weeks after last dose of tocilizumab, up to 32 weeks) **Measure:** Serum Levels of Soluble Interleukin-6 Receptors (sIL-6Rs) **Time Frame:** Baseline, Weeks 12 and 24, Early Withdrawal (up to Week 24), Follow-up Visit (8 weeks after last dose of tocilizumab, up to 32 weeks) **Description:** Patient global assessment of disease activity was measured on a 0 to 100 mm horizontal VAS where 0 mm=no disease activity and 100 mm=maximum disease activity. **Measure:** Patient Global Assessment of Disease Activity VAS Scores **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and Early withdrawal (up to Week 24) **Description:** This assessment represents the participant's assessment of his/her current level of pain on a 100 mm horizontal VAS where 0 mm= no pain to 100 mm= unbearable pain. **Measure:** Patient Pain VAS Scores **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and Early withdrawal (up to Week 24) **Description:** The HAQ-DI questionnaire measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI was the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do. **Measure:** Health Assessment Questionnaire-Disability Index (HAQ-DI) Score **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and early withdrawal (up to Week 24) **Description:** A diary card was provided to participants to record home injections. Participants were asked to return all empty drug supply boxes, unused pre-filled syringe, and diary cards to the clinic at each visit as a measure of drug accountability and participant compliance. A participant was considered compliant if the participant correctly administered all scheduled doses of SC tocilizumab during the assessment period. **Measure:** Percentage of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records **Time Frame:** Weeks 2, 4, 8, 12, 16, 20, 24, and early withdrawal (up to Week 24) **Description:** The FACIT-F score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). **Measure:** Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and early withdrawal (up to Week 24) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participants with a diagnosis of active RA according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria. * Oral corticosteroids (≤10 mg/day prednisone or equivalent), nonsteroidal anti-inflammatory drugs (NSAIDs) and non-biologic DMARDs are permitted if on a stable dose regimen for greater than or equal to (≥\]) 4 weeks prior to Baseline. * Use of effective contraception throughout the study as defined by protocol; female participants of childbearing potential cannot be pregnant. Exclusion Criteria: * Presence of clinically significant medical conditions. * History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower gastrointestinal disease that might predispose to perforation. * Current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections. * Any infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening. * Clinically significant findings on laboratory tests. * Positive hepatitis B surface antigen or hepatitis C antibody. * Active tuberculosis requiring treatment within the previous 3 years. * Evidence of active malignant disease, malignancies diagnosed within the previous 10 years, or breast cancer diagnosed within the previous 20 years. * History of alcohol, drug, or chemical abuse within 1 year prior to Screening. * Neuropathies or other conditions that might interfere with pain evaluation. * Major surgery (including joint surgery) within 8 weeks prior to Screening or planned major surgery within 6 months following Baseline. * Rheumatic autoimmune disease other than RA, including systemic lupus erythematosis, mixed connective tissue disorder, scleroderma, polymyositis, or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis or Felty's syndrome). Secondary Sjögren's syndrome with RA is permitted. * Functional Class IV as defined by the ACR Classification of Functional Status in RA. * Diagnosis of juvenile idiopathic arthritis or juvenile RA, and/or RA before the age of 16 years. * Prior history of or current inflammatory joint disease other than RA. * Exposure to tocilizumab (either intravenous or SC) at any time prior to Baseline. * Treatment with any investigational agent within 4 weeks (or five half-lives of the investigational drug, whichever is longer) of Screening. * Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies, with alkylating agents such as chlorambucil, or with total lymphoid irradiation. * Treatment with IV gamma globulin, plasmapheresis within 6 months of Baseline. * Immunization with a live/attenuated vaccine within 4 weeks prior to Baseline. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Almelo **Country:** Netherlands **Facility:** ZGT Almelo; Reumatologie **Zip:** 7609 PP **Location 2:** **City:** Amsterdam **Country:** Netherlands **Facility:** Jan Van Breemen Instituut **Zip:** 1056 AB **Location 3:** **City:** Apeldoorn **Country:** Netherlands **Facility:** Gelre Ziekenhuizen; Reumatologie **Zip:** 7334 DZ **Location 4:** **City:** Breda **Country:** Netherlands **Facility:** Amphia ziekenhuis, locatie langendijk **Zip:** 4819 EV **Location 5:** **City:** Dordrecht **Country:** Netherlands **Facility:** Albert Schweitzer Ziekenhuis ; Dordwijk **Zip:** 3318AT **Location 6:** **City:** Groningen **Country:** Netherlands **Facility:** Universitair Medisch Centrum Groningen; Department of Rheumatology **Zip:** 9700RB **Location 7:** **City:** Groningen **Country:** Netherlands **Facility:** Martini Ziekenhuis **Zip:** 9728 MG **Location 8:** **City:** Haarlem **Country:** Netherlands **Facility:** Kennemer Gasthuis **Zip:** 2035 RC **Location 9:** **City:** Heerlen **Country:** Netherlands **Facility:** Atrium Medisch Centrum **Zip:** 6419 PC **Location 10:** **City:** Hoofddorp **Country:** Netherlands **Facility:** Spaarne Ziekenhuis; Inwendige Geneeskunde **Zip:** 2134 TM **Location 11:** **City:** Leeuwarden **Country:** Netherlands **Facility:** Medisch Centrum Leeuwarden; Reumatology **Zip:** 8934 AD **Location 12:** **City:** Leiden **Country:** Netherlands **Facility:** Academisch Ziekenhuis Leiden; Dept of Rheumatology **Zip:** 2333 ZA **Location 13:** **City:** Maastricht **Country:** Netherlands **Facility:** Maastricht University Medical Centre; Rheumatology **Zip:** 6202 ZA **Location 14:** **City:** Rotterdam **Country:** Netherlands **Facility:** Erasmus Medisch Centrum; Reumatologie **Zip:** 3015 CE **Location 15:** **City:** Rotterdam **Country:** Netherlands **Facility:** Maasstadziekenhuis; Reumatologie **Zip:** 3079 DZ **Location 16:** **City:** Schiedam **Country:** Netherlands **Facility:** Vlietland Hospital **Zip:** 3118 JH **Location 17:** **City:** Sneek **Country:** Netherlands **Facility:** Antonius Ziekenhuis Sneek; Department of Rheumatology **Zip:** 8601 ZK **Location 18:** **City:** The Hague **Country:** Netherlands **Facility:** Leyenburg Ziekenhuis; Internal Medecine **Zip:** 2545 CH **Location 19:** **City:** The Hague **Country:** Netherlands **Facility:** St. Bronovo-Nebo **Zip:** 2597 AX **Location 20:** **City:** Utrecht **Country:** Netherlands **Facility:** University Medical Centre Utrecht; Reumatologie en Klinische Immunologie **Zip:** 3584 GA #### Overall Officials **Official 1:** **Affiliation:** Hoffmann-La Roche **Name:** Clinical Trials **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Choy E, Caporali R, Xavier R, Fautrel B, Sanmarti R, Bao M, Devenport J, Petho-Schramm A. Effects of concomitant glucocorticoids in TOZURA, a common-framework study programme of subcutaneous tocilizumab in rheumatoid arthritis. Rheumatology (Oxford). 2019 Jun 1;58(6):1056-1064. doi: 10.1093/rheumatology/key393. **PMID:** 30649524 **Citation:** Choy E, Caporali R, Xavier R, Fautrel B, Sanmarti R, Bao M, Bernasconi C, Petho-Schramm A. Subcutaneous tocilizumab in rheumatoid arthritis: findings from the common-framework phase 4 study programme TOZURA conducted in 22 countries. Rheumatology (Oxford). 2018 Mar 1;57(3):499-507. doi: 10.1093/rheumatology/kex443. Erratum In: Rheumatology (Oxford). 2018 Jun 1;57(6):1129. **PMID:** 29244149 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M4476 - Name: Arthritis - Relevance: HIGH - As Found: Arthritis - ID: M4480 - Name: Arthritis, Rheumatoid - Relevance: HIGH - As Found: Rheumatoid Arthritis - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001168 - Term: Arthritis - ID: D000001172 - Term: Arthritis, Rheumatoid ### Intervention Browse Module - Ancestors - ID: D000000020 - Term: Abortifacient Agents, Nonsteroidal - ID: D000000019 - Term: Abortifacient Agents - ID: D000012102 - Term: Reproductive Control Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents - ID: D000003879 - Term: Dermatologic Agents - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000005493 - Term: Folic Acid Antagonists - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000018501 - Term: Antirheumatic Agents - ID: D000019384 - Term: Nucleic Acid Synthesis Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Micro - Name: Micronutrients - Abbrev: Hemat - Name: Hematinics - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M11703 - Name: Methotrexate - Relevance: HIGH - As Found: Breast Cancer - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown - ID: M7074 - Name: Dermatologic Agents - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M8618 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: M17546 - Name: Vitamin B Complex - Relevance: LOW - As Found: Unknown - ID: M8619 - Name: Folic Acid Antagonists - Relevance: LOW - As Found: Unknown - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: T447 - Name: Folinic Acid - Relevance: LOW - As Found: Unknown - ID: T446 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: T448 - Name: Folate - Relevance: LOW - As Found: Unknown - ID: T475 - Name: Vitamin B9 - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000008727 - Term: Methotrexate ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module **Description:** FAS population #### Event Groups **Group ID:** EG000 **Title:** Tocilizumab Alone or in Combination With Methotrexate or DMARD **Description:** Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. **ID:** EG000 **Other Num Affected:** 77 **Other Num at Risk:** 150 **Serious Number Affected:** 14 **Serious Number At Risk:** 150 **Title:** Tocilizumab Alone or in Combination With Methotrexate or DMARD **Frequency Threshold:** 5 #### Other Events **Term:** Nasopharyngitis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA v19.0 **Term:** Nausea **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA v19.0 **Term:** Diarrhoea **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA v19.0 **Term:** Fatigue **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA v19.0 **Term:** Dizziness **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Nervous system disorders **Source Vocabulary:** MedDRA v19.0 **Term:** Rash **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA v19.0 **Term:** Leukopenia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders **Source Vocabulary:** MedDRA v19.0 **Term:** Oropharyngeal pain **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA v19.0 #### Serious Events **Term:** Appendicitis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA v19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 150 **Term:** Arthritis bacterial **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA v19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 150 **Term:** Skin infection **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** MedDRA v19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 150 **Term:** Scapula fracture **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA v19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 150 **Term:** Tibia fracture **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA v19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 150 **Term:** Arthralgia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA v19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 150 **Term:** Joint range of motion decreased **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA v19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 150 **Term:** B-cell lymphoma **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA v19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 150 **Term:** Bowen's disease **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA v19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 150 **Term:** Psoriasis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA v19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 150 **Term:** Toxic skin eruption **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Skin and subcutaneous tissue disorders **Source Vocabulary:** MedDRA v19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 150 **Term:** Hip arthroplasty **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Surgical and medical procedures **Source Vocabulary:** MedDRA v19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 150 **Term:** Prophylaxis **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Surgical and medical procedures **Source Vocabulary:** MedDRA v19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 150 **Term:** Diverticular perforation **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA v19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 150 **Term:** Aortic aneurysm **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA v19.0 ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 150 **Time Frame:** Baseline up to Week 32 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 150 **Units:** Participants ### Group **ID:** BG000 **Title:** Tocilizumab Alone or in Combination With Methotrexate or DMARD **Description:** Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. ### Measure #### Measurement **Group ID:** BG000 **Spread:** 11.20 **Value:** 55.85 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 110 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 40 **Category Title:** Male **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants **Population Description:** Full Analysis Set (FAS) population included all participants who received at least one dose of SC tocilizumab. ## Results Section - More Information Module ### Certain Agreement **Other Details:** The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights. **Restriction Type:** OTHER **Restrictive Agreement:** True ### Point of Contact **Email:** [email protected] **Organization:** Hoffmann-La Roche **Phone:** 800-821-8590 **Title:** Medical Communications ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ### Outcome Measure 5 ### Outcome Measure 6 ### Outcome Measure 7 ### Outcome Measure 8 ### Outcome Measure 9 ### Outcome Measure 10 ### Outcome Measure 11 ### Outcome Measure 12 ### Outcome Measure 13 ### Outcome Measure 14 ### Outcome Measure 15 ### Outcome Measure 16 ### Outcome Measure 17 ### Outcome Measure 18 ### Outcome Measure 19 ### Outcome Measure 20 ### Outcome Measure 21 ### Outcome Measure 22 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 91.3 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.3 - **Upper Limit:** - **Value:** 4.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.989 - **Upper Limit:** - **Value:** 1.337 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.991 - **Upper Limit:** - **Value:** 2.037 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.098 - **Upper Limit:** - **Value:** 2.635 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.135 - **Upper Limit:** - **Value:** 2.908 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.240 - **Upper Limit:** - **Value:** 3.014 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.170 - **Upper Limit:** - **Value:** 3.169 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.247 - **Upper Limit:** - **Value:** 3.232 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.562 - **Upper Limit:** - **Value:** 1.653 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.989 - **Upper Limit:** - **Value:** 20.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.991 - **Upper Limit:** - **Value:** 40.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.098 - **Upper Limit:** - **Value:** 58.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.135 - **Upper Limit:** - **Value:** 69.9 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.240 - **Upper Limit:** - **Value:** 71.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.170 - **Upper Limit:** - **Value:** 78.9 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.247 - **Upper Limit:** - **Value:** 82.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.562 - **Upper Limit:** - **Value:** 37.0 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.989 - **Upper Limit:** - **Value:** 6.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.991 - **Upper Limit:** - **Value:** 18.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.098 - **Upper Limit:** - **Value:** 33.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.135 - **Upper Limit:** - **Value:** 43.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.240 - **Upper Limit:** - **Value:** 52.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.170 - **Upper Limit:** - **Value:** 54.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.247 - **Upper Limit:** - **Value:** 62.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.562 - **Upper Limit:** - **Value:** 18.5 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.989 - **Upper Limit:** - **Value:** 1.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.991 - **Upper Limit:** - **Value:** 6.9 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.098 - **Upper Limit:** - **Value:** 14.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.135 - **Upper Limit:** - **Value:** 21.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.240 - **Upper Limit:** - **Value:** 29.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.170 - **Upper Limit:** - **Value:** 38.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.247 - **Upper Limit:** - **Value:** 35.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.562 - **Upper Limit:** - **Value:** 14.8 **Title:** #### Outcome Measure 6 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.989 - **Upper Limit:** - **Value:** 0.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.991 - **Upper Limit:** - **Value:** 1.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.098 - **Upper Limit:** - **Value:** 2.9 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.135 - **Upper Limit:** - **Value:** 6.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.240 - **Upper Limit:** - **Value:** 9.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.170 - **Upper Limit:** - **Value:** 11.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.247 - **Upper Limit:** - **Value:** 15.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.562 - **Upper Limit:** - **Value:** 3.7 **Title:** #### Outcome Measure 7 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.989 - **Upper Limit:** - **Value:** 34.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.991 - **Upper Limit:** - **Value:** 41.9 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.098 - **Upper Limit:** - **Value:** 23.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.135 - **Upper Limit:** - **Value:** 59.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.240 - **Upper Limit:** - **Value:** 34.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.170 - **Upper Limit:** - **Value:** 6.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.247 - **Upper Limit:** - **Value:** 78.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 1.562 - **Upper Limit:** - **Value:** 17.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 85.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 12.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 89.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 7.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3.9 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 91.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 92.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 44.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 29.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 25.9 **Title:** #### Outcome Measure 8 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 12.55 - **Upper Limit:** - **Value:** 26.03 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7.4 - **Upper Limit:** - **Value:** -6.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 8.0 - **Upper Limit:** - **Value:** -11.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 9.2 - **Upper Limit:** - **Value:** -14.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 10.8 - **Upper Limit:** - **Value:** -17.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 11.1 - **Upper Limit:** - **Value:** -18.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 11.2 - **Upper Limit:** - **Value:** -19.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 11.8 - **Upper Limit:** - **Value:** -19.9 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 10.7 - **Upper Limit:** - **Value:** -8.0 **Title:** #### Outcome Measure 9 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 11.84 - **Upper Limit:** - **Value:** 24.32 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7.3 - **Upper Limit:** - **Value:** -4.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7.2 - **Upper Limit:** - **Value:** -9.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 8.7 - **Upper Limit:** - **Value:** -13.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 9.2 - **Upper Limit:** - **Value:** -15.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 10.1 - **Upper Limit:** - **Value:** -16.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 10.2 - **Upper Limit:** - **Value:** -17.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 11.1 - **Upper Limit:** - **Value:** -18.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 10.3 - **Upper Limit:** - **Value:** -6.4 **Title:** #### Outcome Measure 10 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 6.5 - **Upper Limit:** - **Value:** 7.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 3.71 - **Upper Limit:** - **Value:** -1.38 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 3.89 - **Upper Limit:** - **Value:** -2.94 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 4.82 - **Upper Limit:** - **Value:** -4.33 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 5.05 - **Upper Limit:** - **Value:** -4.68 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 5.55 - **Upper Limit:** - **Value:** -5.36 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 5.24 - **Upper Limit:** - **Value:** -5.79 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 5.67 - **Upper Limit:** - **Value:** -5.96 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 4.59 - **Upper Limit:** - **Value:** -1.07 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 10.0 - **Upper Limit:** - **Value:** 13.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 5.84 - **Upper Limit:** - **Value:** -2.40 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 6.25 - **Upper Limit:** - **Value:** -5.15 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7.57 - **Upper Limit:** - **Value:** -7.19 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 8.46 - **Upper Limit:** - **Value:** -7.98 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 9.07 - **Upper Limit:** - **Value:** -9.45 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 9.04 - **Upper Limit:** - **Value:** -9.86 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 8.94 - **Upper Limit:** - **Value:** -10.02 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 8.53 - **Upper Limit:** - **Value:** -1.93 **Title:** #### Outcome Measure 11 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 5.4 - **Upper Limit:** - **Value:** 6.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 3.04 - **Upper Limit:** - **Value:** -1.18 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 3.33 - **Upper Limit:** - **Value:** -2.44 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 3.86 - **Upper Limit:** - **Value:** -3.62 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 4.17 - **Upper Limit:** - **Value:** -4.24 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 4.14 - **Upper Limit:** - **Value:** -4.61 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 4.24 - **Upper Limit:** - **Value:** -4.92 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 4.63 - **Upper Limit:** - **Value:** -5.23 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 4.18 - **Upper Limit:** - **Value:** -1.33 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7.3 - **Upper Limit:** - **Value:** 9.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 4.16 - **Upper Limit:** - **Value:** -1.84 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 4.35 - **Upper Limit:** - **Value:** -3.94 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 4.74 - **Upper Limit:** - **Value:** -5.61 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 5.79 - **Upper Limit:** - **Value:** -6.50 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 5.95 - **Upper Limit:** - **Value:** -6.78 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 6.44 - **Upper Limit:** - **Value:** -7.52 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 6.86 - **Upper Limit:** - **Value:** -7.80 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 4.89 - **Upper Limit:** - **Value:** -2.33 **Title:** #### Outcome Measure 12 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.0 **Title:** #### Outcome Measure 13 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 0.0 **Title:** #### Outcome Measure 14 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 25.0 - **Spread:** - **Upper Limit:** 28.0 - **Value:** 25.3 **Title:** #### Outcome Measure 15 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.5906 - **Upper Limit:** - **Value:** 6.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.5734 - **Upper Limit:** - **Value:** 40.0 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.5587 - **Upper Limit:** - **Value:** 7.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.5330 - **Upper Limit:** - **Value:** 9.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.5682 - **Upper Limit:** - **Value:** 11.5 **Title:** #### Outcome Measure 16 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.3 - **Upper Limit:** - **Value:** 0.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 25.2 - **Upper Limit:** - **Value:** 42.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 29.2 - **Upper Limit:** - **Value:** 46.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 19.3 - **Upper Limit:** - **Value:** 16.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 29.7 - **Upper Limit:** - **Value:** 60.9 **Title:** #### Outcome Measure 17 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 10.4 - **Upper Limit:** - **Value:** 38.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 137.7 - **Upper Limit:** - **Value:** 516.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 161.6 - **Upper Limit:** - **Value:** 536.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 215.2 - **Upper Limit:** - **Value:** 380.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 194.3 - **Upper Limit:** - **Value:** 117.5 **Title:** #### Outcome Measure 18 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 22.3 - **Upper Limit:** - **Value:** 54.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 23.0 - **Upper Limit:** - **Value:** 43.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 23.0 - **Upper Limit:** - **Value:** 35.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 21.8 - **Upper Limit:** - **Value:** 27.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 20.3 - **Upper Limit:** - **Value:** 22.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 21.0 - **Upper Limit:** - **Value:** 21.3 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 18.6 - **Upper Limit:** - **Value:** 19.2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 19.5 - **Upper Limit:** - **Value:** 18.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 30.9 - **Upper Limit:** - **Value:** 40.4 **Title:** #### Outcome Measure 19 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 22.1 - **Upper Limit:** - **Value:** 52.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 21.9 - **Upper Limit:** - **Value:** 44.4 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 22.3 - **Upper Limit:** - **Value:** 35.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 21.3 - **Upper Limit:** - **Value:** 27.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 19.0 - **Upper Limit:** - **Value:** 21.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 20.2 - **Upper Limit:** - **Value:** 20.9 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 18.0 - **Upper Limit:** - **Value:** 19.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 18.8 - **Upper Limit:** - **Value:** 19.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 30.4 - **Upper Limit:** - **Value:** 42.8 **Title:** #### Outcome Measure 20 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.5708 - **Upper Limit:** - **Value:** 1.2329 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.5906 - **Upper Limit:** - **Value:** 1.0978 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.5734 - **Upper Limit:** - **Value:** 0.9673 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.5587 - **Upper Limit:** - **Value:** 0.8249 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.5330 - **Upper Limit:** - **Value:** 0.7460 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.5682 - **Upper Limit:** - **Value:** 0.6996 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.5333 - **Upper Limit:** - **Value:** 0.6620 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.5745 - **Upper Limit:** - **Value:** 0.6681 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.6853 - **Upper Limit:** - **Value:** 1.2315 **Title:** #### Outcome Measure 21 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.5906 - **Upper Limit:** - **Value:** 90.5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.5734 - **Upper Limit:** - **Value:** 95.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.5587 - **Upper Limit:** - **Value:** 91.9 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.5330 - **Upper Limit:** - **Value:** 97.7 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.5682 - **Upper Limit:** - **Value:** 93.8 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.5333 - **Upper Limit:** - **Value:** 95.1 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.5745 - **Upper Limit:** - **Value:** 92.6 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.6853 - **Upper Limit:** - **Value:** 88.9 **Title:** #### Outcome Measure 22 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 9.43 - **Upper Limit:** - **Value:** 29.84 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 9.34 - **Upper Limit:** - **Value:** 33.07 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 10.37 - **Upper Limit:** - **Value:** 35.10 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 9.25 - **Upper Limit:** - **Value:** 37.34 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 8.52 - **Upper Limit:** - **Value:** 37.89 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 9.11 - **Upper Limit:** - **Value:** 37.93 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 8.87 - **Upper Limit:** - **Value:** 39.65 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 8.65 - **Upper Limit:** - **Value:** 39.93 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 12.06 - **Upper Limit:** - **Value:** 33.48 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Adverse events included serious as well as non-serious adverse events. **Parameter Type:** NUMBER **Population Description:** FAS population **Reporting Status:** POSTED **Time Frame:** Baseline up to Week 32 **Title:** Percentage of Participants With Adverse Events **Type:** PRIMARY **Unit of Measure:** percentage of participants ##### Group **Description:** Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. **ID:** OG000 **Title:** Tocilizumab Alone or in Combination With Methotrexate or DMARD #### Outcome Measure 2 **Description:** DAS28 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR; millimeters per hour \[mm/hour\]), and patient's global assessment of disease activity (measured on a 0 to 100 mm Visual Analog Scale \[VAS\] where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR less than or equal to (≤) 3.2 implied low disease activity and greater than (\>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-ESR less than (\<) 2.6 implied clinical remission. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** FAS population. Here, "n" = participants who were evaluable at the specified timepoint. **Reporting Status:** POSTED **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24) **Title:** Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal **Type:** SECONDARY **Unit of Measure:** units on a scale ##### Group **Description:** Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. **ID:** OG000 **Title:** Tocilizumab Alone or in Combination With Methotrexate or DMARD #### Outcome Measure 3 **Description:** A participant had an ACR20 response if there was at least a 20 percent (%) improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0 mm=no pain to 100 mm=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (either C-reactive protein \[CRP\] or ESR). **Parameter Type:** NUMBER **Population Description:** FAS population. "n" = participants who were evaluable at specified timepoint. **Reporting Status:** POSTED **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24) **Title:** Percentage of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. **ID:** OG000 **Title:** Tocilizumab Alone or in Combination With Methotrexate or DMARD #### Outcome Measure 4 **Description:** A participant had an ACR50 response if there was at least a 50% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0 mm=no pain to 100 mm=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (either CRP or ESR). **Parameter Type:** NUMBER **Population Description:** FAS population. "n" = participants who were evaluable at specified timepoint. **Reporting Status:** POSTED **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24) **Title:** Percentage of Participants Achieving an ACR50 Response **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. **ID:** OG000 **Title:** Tocilizumab Alone or in Combination With Methotrexate or DMARD #### Outcome Measure 5 **Description:** A participant had an ACR70 response if there was at least a 70% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0 mm=no pain to 100 mm=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (either CRP or ESR). **Parameter Type:** NUMBER **Population Description:** FAS population. "n" = participants who were evaluable at specified timepoint. **Reporting Status:** POSTED **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24) **Title:** Percentage of Participants Achieving an ACR70 Response **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. **ID:** OG000 **Title:** Tocilizumab Alone or in Combination With Methotrexate or DMARD #### Outcome Measure 6 **Description:** A participant had an ACR90 response if there was at least a 90% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0 mm=no pain to 100 mm=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (either CRP or ESR). **Parameter Type:** NUMBER **Population Description:** FAS population. "n" = participants who were evaluable at specified timepoint. **Reporting Status:** POSTED **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24) **Title:** Percentage of Participants Achieving an ACR90 Response **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. **ID:** OG000 **Title:** Tocilizumab Alone or in Combination With Methotrexate or DMARD #### Outcome Measure 7 **Description:** DAS28-ESR was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). DAS28-ESR scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. The DAS28-ESR based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline \>1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline \>1.2 with a DAS28 score \>3.2 or a change from baseline \>0.6 to ≤1.2 with a DAS28 score ≤5.1. Participants with change from baseline \>0.6 to ≤1.2 with a DAS28 score \>5.1, or any score with change from baseline ≤0.6, were assessed as non-responders. **Parameter Type:** NUMBER **Population Description:** FAS population. "n" = participants who were evaluable at specified timepoint. **Reporting Status:** POSTED **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24) **Title:** Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. **ID:** OG000 **Title:** Tocilizumab Alone or in Combination With Methotrexate or DMARD #### Outcome Measure 8 **Description:** The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient and physician global assessment of disease activity assessed on 0-10 centimeter (cm) VAS (0 cm= no disease activity and 10 cm= worst disease activity), and CRP in milligrams per liter (mg/L). SDAI total score = 0-86. SDAI \<=3.3 indicates clinical remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high (or severe) disease activity . **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** FAS population. Here, "Overall Number of Participants Analyzed" = participants who were evaluable for this outcome. "n" = participants who were evaluable at specified timepoint. **Reporting Status:** POSTED **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24) **Title:** Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal **Type:** SECONDARY **Unit of Measure:** units on a scale ##### Group **Description:** Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. **ID:** OG000 **Title:** Tocilizumab Alone or in Combination With Methotrexate or DMARD #### Outcome Measure 9 **Description:** The CDAI is the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, patient and physician's global assessment of disease activity assessed on 0-10 cm VAS (0 cm= no disease activity and 10 cm= worst disease activity). CDAI total score = 0-76. CDAI \<= 2.8 indicates clinical remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high (or severe) disease activity. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** FAS population. Here, "n" = participants who were evaluable at specified timepoint. **Reporting Status:** POSTED **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24) **Title:** Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 16, 20, 24, and Early Withdrawal **Type:** SECONDARY **Unit of Measure:** units on a scale ##### Group **Description:** Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. **ID:** OG000 **Title:** Tocilizumab Alone or in Combination With Methotrexate or DMARD #### Outcome Measure 10 **Description:** Number of tender joints was determined by examining 28 joints for TJC28 and 68 joints for TJC68, and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28 for a TJC28 and 68 for a TJC68. A reduction in number of tender joints compared to baseline indicates improvement. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** FAS population. Here, "n" = participants who were evaluable at specified timepoint. **Reporting Status:** POSTED **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24) **Title:** Change From Baseline in Total TJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal **Type:** SECONDARY **Unit of Measure:** tender joints ##### Group **Description:** Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. **ID:** OG000 **Title:** Tocilizumab Alone or in Combination With Methotrexate or DMARD #### Outcome Measure 11 **Description:** Number of swollen joints was determined by examination of 28 joints for SJC28 and 66 joints for SJC66 and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28 for a SJC28 and 66 for a SJC66. A reduction in number of swollen joints compared to baseline indicates improvement. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** FAS population. Here, "n" = participants who were evaluable at specified timepoint. **Reporting Status:** POSTED **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24) **Title:** Change From Baseline in Total SJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal **Type:** SECONDARY **Unit of Measure:** swollen joints ##### Group **Description:** Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. **ID:** OG000 **Title:** Tocilizumab Alone or in Combination With Methotrexate or DMARD #### Outcome Measure 12 **Description:** Results are reported for percentage of participants who had NSAIDs dose reductions or discontinuation by reasons for dose reductions or discontinuation (unknown reasons, safety reasons, other reasons, lack of efficacy, and discomfort). **Parameter Type:** NUMBER **Population Description:** FAS population **Reporting Status:** POSTED **Time Frame:** From Week 16 and before Week 20; From Week 20 and before Week 24 **Title:** Percentage of Participants With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Dose Reductions or Discontinuation Categorized by Reasons **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. **ID:** OG000 **Title:** Tocilizumab Alone or in Combination With Methotrexate or DMARD #### Outcome Measure 13 **Description:** Results are reported for percentage of participants who had corticosteroid dose reductions or discontinuation by reasons for dose reductions or discontinuation (unknown reasons, safety reasons, other reasons, lack of efficacy, and discomfort). **Parameter Type:** NUMBER **Population Description:** FAS population **Reporting Status:** POSTED **Time Frame:** From Week 16 and before Week 20; From Week 20 and before Week 24 **Title:** Percentage of Participants With Corticosteroid Dose Reductions or Discontinuation Categorized by Reasons **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. **ID:** OG000 **Title:** Tocilizumab Alone or in Combination With Methotrexate or DMARD #### Outcome Measure 14 **Description:** Time to discontinuation or first dose reduction of corticosteroids or NSAIDs (weeks) = (Date of the first dose reduction or end date of corticosteroids or NSAIDs treatment - date of first drug intake of this study) + 1. Time to discontinuation or first dose reduction was based on the first occurring event (corticosteroid discontinuation or corticosteroid first dose reduction or NSAIDs discontinuation or NSAIDs first dose reduction, whichever occurred first). **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEDIAN **Population Description:** FAS population **Reporting Status:** POSTED **Time Frame:** Baseline up to Week 32 **Title:** Time to Discontinuation or First Dose Reduction of Corticosteroids or NSAIDs **Type:** SECONDARY **Unit of Measure:** weeks ##### Group **Description:** Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. **ID:** OG000 **Title:** Tocilizumab Alone or in Combination With Methotrexate or DMARD #### Outcome Measure 15 **Parameter Type:** NUMBER **Population Description:** FAS population. Here, "n" = participants who were evaluable at specified timepoint. **Reporting Status:** POSTED **Time Frame:** Baseline, Weeks 12 and 24, early withdrawal (up to Week 24), follow-up visit (8 weeks after last dose of tocilizumab, up to 32 weeks) **Title:** Percentage of Participants With Anti-Tocilizumab Antibodies **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. **ID:** OG000 **Title:** Tocilizumab Alone or in Combination With Methotrexate or DMARD #### Outcome Measure 16 **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** FAS population. "n" = participants who were evaluable at specified timepoint. **Reporting Status:** POSTED **Time Frame:** Baseline, Weeks 12 and 24, Early Withdrawal (up to Week 24), Follow-up Visit (8 weeks after last dose of tocilizumab, up to 32 weeks) **Title:** Serum Levels of Tocilizumab **Type:** SECONDARY **Unit of Measure:** micrograms per milliliter (mcg/mL) ##### Group **Description:** Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. **ID:** OG000 **Title:** Tocilizumab Alone or in Combination With Methotrexate or DMARD #### Outcome Measure 17 **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** FAS population. "n" = participants who were evaluable at specified timepoint. **Reporting Status:** POSTED **Time Frame:** Baseline, Weeks 12 and 24, Early Withdrawal (up to Week 24), Follow-up Visit (8 weeks after last dose of tocilizumab, up to 32 weeks) **Title:** Serum Levels of Soluble Interleukin-6 Receptors (sIL-6Rs) **Type:** SECONDARY **Unit of Measure:** nanograms per milliliter (ng/mL) ##### Group **Description:** Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. **ID:** OG000 **Title:** Tocilizumab Alone or in Combination With Methotrexate or DMARD #### Outcome Measure 18 **Description:** Patient global assessment of disease activity was measured on a 0 to 100 mm horizontal VAS where 0 mm=no disease activity and 100 mm=maximum disease activity. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** FAS population. Here, "n" = participants who were evaluable at specified timepoint. **Reporting Status:** POSTED **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and Early withdrawal (up to Week 24) **Title:** Patient Global Assessment of Disease Activity VAS Scores **Type:** SECONDARY **Unit of Measure:** mm ##### Group **Description:** Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. **ID:** OG000 **Title:** Tocilizumab Alone or in Combination With Methotrexate or DMARD #### Outcome Measure 19 **Description:** This assessment represents the participant's assessment of his/her current level of pain on a 100 mm horizontal VAS where 0 mm= no pain to 100 mm= unbearable pain. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** FAS population. Here, "n" = participants who were evaluable at specified timepoint. **Reporting Status:** POSTED **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and Early withdrawal (up to Week 24) **Title:** Patient Pain VAS Scores **Type:** SECONDARY **Unit of Measure:** mm ##### Group **Description:** Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. **ID:** OG000 **Title:** Tocilizumab Alone or in Combination With Methotrexate or DMARD #### Outcome Measure 20 **Description:** The HAQ-DI questionnaire measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI was the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** FAS population. Here, "n" = participants who were evaluable at specified timepoint. **Reporting Status:** POSTED **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and early withdrawal (up to Week 24) **Title:** Health Assessment Questionnaire-Disability Index (HAQ-DI) Score **Type:** SECONDARY **Unit of Measure:** units on a scale ##### Group **Description:** Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. **ID:** OG000 **Title:** Tocilizumab Alone or in Combination With Methotrexate or DMARD #### Outcome Measure 21 **Description:** A diary card was provided to participants to record home injections. Participants were asked to return all empty drug supply boxes, unused pre-filled syringe, and diary cards to the clinic at each visit as a measure of drug accountability and participant compliance. A participant was considered compliant if the participant correctly administered all scheduled doses of SC tocilizumab during the assessment period. **Parameter Type:** NUMBER **Population Description:** FAS population. "n" = participants who were evaluable at specified timepoint. **Reporting Status:** POSTED **Time Frame:** Weeks 2, 4, 8, 12, 16, 20, 24, and early withdrawal (up to Week 24) **Title:** Percentage of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records **Type:** SECONDARY **Unit of Measure:** percentage of participants ##### Group **Description:** Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. **ID:** OG000 **Title:** Tocilizumab Alone or in Combination With Methotrexate or DMARD #### Outcome Measure 22 **Description:** The FACIT-F score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** FAS population. Here, "n" = participants who were evaluable at specified timepoint. **Reporting Status:** POSTED **Time Frame:** Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and early withdrawal (up to Week 24) **Title:** Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score **Type:** SECONDARY **Unit of Measure:** units on a scale ##### Group **Description:** Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. **ID:** OG000 **Title:** Tocilizumab Alone or in Combination With Methotrexate or DMARD ### Participant Flow Module #### Group **Description:** Participants received a weekly subcutaneous (SC) injection of tocilizumab 162 milligrams (mg) as monotherapy or in combination with methotrexate or other non-biologic disease modifying antirheumatic drugs (DMARDs) for 24 weeks. **ID:** FG000 **Title:** Tocilizumab Alone or in Combination With Methotrexate or DMARD #### Period **Title:** Overall Study ##### Withdraw **Type:** Protocol Violation ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ##### Withdraw **Type:** Physician Decision ###### Reason **Group ID:** FG000 **Number of Subjects:** 2 ##### Withdraw **Type:** Participant/legal guardian decision ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ##### Withdraw **Type:** Other ###### Reason **Group ID:** FG000 **Number of Subjects:** 5 ##### Withdraw **Type:** Lost to Follow-up ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ##### Withdraw **Type:** Adverse Event ###### Reason **Group ID:** FG000 **Number of Subjects:** 7 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 150 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 133 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 17 **Pre-Assignment Details:** A total of 174 participants were screened, out of which 150 participants met eligibility criteria and were enrolled into the study. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT01674179 **Acronym:** FMQEEG-10-26 **Brief Title:** Quantitative EEG During PSG in Patients With and Without Fibromyalgia **Official Title:** Quantitative EEG During PSG in Patients With and Without Fibromyalgia #### Organization Study ID Info **ID:** SM 10-26 #### Organization **Class:** OTHER **Full Name:** SouthCoast Medical Group ### Status Module #### Completion Date **Date:** 2012-10 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2016-10-13 **Type:** ESTIMATED **Last Update Submit Date:** 2016-10-12 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2012-10 **Type:** ACTUAL #### Start Date **Date:** 2010-07 **Status Verified Date:** 2016-10 #### Study First Post Date **Date:** 2012-08-28 **Type:** ESTIMATED **Study First Submit Date:** 2010-09-10 **Study First Submit QC Date:** 2012-08-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** SouthCoast Medical Group #### Responsible Party **Investigator Affiliation:** SouthCoast Medical Group **Investigator Full Name:** Victor Rosenfeld MD **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to retrospectively analyze Clinical and Nocturnal Polysomnographic Data (Overnight Sleep Studies) in patients with and without Fibromyalgia. Fibromyalgia is a pain syndrome associated with dysfunctional sleep, fatigue, frequent awakenings, non-refreshing sleep, and alpha frequency intrusions. Quantitative EEG during routine Nocturnal Polysomnography can be used to assess Alpha/Delta sleep. Hypothesis: Alpha intrusions may be an objective marker for Fibromyalgia and may correlate with current clinical American College of Rheumatology Criteria for the diagnosis of Fibromyalgia. **Detailed Description:** This is a Retrospective Study of patients with and without Fibromyalgia seen in private practice from Aug 2007-July 2010 who underwent Overnight Sleep Studies (PSG) The polysomnographic and clinical data from research subjects with a diagnosis of Fibromyalgia will be compared to other subjects' PSG and Clinical data who were also referred for Sleep Studies including those with Sleep Apnea, Narcolepsy, Periodic Limb Movement, Fatigue, and Insomnia which are standard indications for Overnight Sleep Studies. Clinical Data: Clinical Data points will include the following: 1. Research Study Number, 2. Age, 3. Gender, 4. Body Mass Index, 5. Epworth Sleepiness Scale (self reported scale on Sleepiness), 6. Fatigue Severity Scale (self reported scale on Fatigue, 7. American College of Rheumatology (ACR) Criteria for Fibromyalgia, 8. Manual Tender Point Exam (# of anatomically specific tender points/18), 9. Medications: Benzodiazepines (Bnz, Bnz ), Tricyclic Antidepressants (TCA) and Serotonin Reuptake Inhibitors (SSRIs SNRIs). Sleep Study Data Points: The following data points will be captured from Overnight Sleep Studies: 1. Total Sleep Time, 2. Sleep Efficiency, 3. Wake After Sleep Onset, 4.Apnea/Hypopnea Index, 5. Respiratory Distress Index, 6. Periodic Limb Movement Index, 7. Periodic Limb Movement Arousal Index, and 8. Quantitative EEG: Delta Event/Alpha Event Ratio. ### Conditions Module **Conditions:** - Fibromyalgia **Keywords:** - Fibromyalgia - qEEG - Sleep - Pain ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 560 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Label:** ACR diagnosis of Fibromyalgia #### Arm Group 2 **Label:** Patients without Fibromyalgia ### Outcomes Module #### Primary Outcomes **Description:** Assess the sensitivity and specificity of Delta Event/Alpha Event Ratios in Non-REM sleep in patients with and without Fibromyalgia **Measure:** Delta Event/Alpha Event Ratios in Non-REM sleep **Time Frame:** up to 24 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Completed a polysomnogram * Complaints of disordered sleep * Age 18 to 80 inclusive * Men and women Exclusion Criteria: * History of seizure * use of benzodiazepines * use of AEDs * any significant medical condition other than disorder sleep or fibromyalgia that would influence qEEG measures **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Private Sleep Practice ### Contacts Locations Module #### Locations **Location 1:** **City:** Savannah **Country:** United States **Facility:** SouthCoast Medical Group **State:** Georgia **Zip:** 31406 #### Overall Officials **Official 1:** **Affiliation:** SouthCoast Medical Group **Name:** Victor Rosenfeld, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Rosenfeld VW, Rutledge DN, Stern JM. Polysomnography with quantitative EEG in patients with and without fibromyalgia. J Clin Neurophysiol. 2015 Apr;32(2):164-70. doi: 10.1097/WNP.0000000000000134. **PMID:** 25233248 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M8486 - Name: Fibromyalgia - Relevance: HIGH - As Found: Fibromyalgia - ID: M12161 - Name: Myofascial Pain Syndromes - Relevance: HIGH - As Found: Fibromyalgia - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005356 - Term: Fibromyalgia - ID: D000009209 - Term: Myofascial Pain Syndromes ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00563979 **Acronym:** EMPOLS **Brief Title:** Enhancement of Macular Pigment Density by Oral Lutein Supplementation **Official Title:** Enhancement of Macular Pigment Density by Oral Lutein Supplementation #### Organization Study ID Info **ID:** KEK 152/07 #### Organization **Class:** OTHER **Full Name:** Insel Gruppe AG, University Hospital Bern ### Status Module #### Completion Date **Date:** 2009-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2015-06-12 **Type:** ESTIMATED **Last Update Submit Date:** 2015-06-10 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2009-12 **Type:** ACTUAL #### Start Date **Date:** 2007-07 **Status Verified Date:** 2015-06 #### Study First Post Date **Date:** 2007-11-27 **Type:** ESTIMATED **Study First Submit Date:** 2007-11-26 **Study First Submit QC Date:** 2007-11-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Insel Gruppe AG, University Hospital Bern #### Responsible Party **Investigator Affiliation:** Insel Gruppe AG, University Hospital Bern **Investigator Full Name:** Sebastian Wolf **Investigator Title:** Director **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The primary objective of EMPOLS is an increase in macular pigment density (MPD) and contrast sensitivity (CS) after six months supplementation of oral non-compound ester Lutein 10 mg daily, contained in VitaluxPlus®. **Detailed Description:** The primary objective of EMPOLS is an increase in macular pigment density (MPD) and contrast sensitivity (CS) after six months supplementation of oral non-compound ester Lutein 10 mg daily, contained in VitaluxPlus®. Primary variable for a significant change will be 10% increase compared to baseline MPD. The measurement will be carried out by means of a modified confocal scanning laser ophthalmoscope (HRA) recording autofluorescence images at 488 nm and 514 nm 6. MPD is determined on MPD maps within 0.5 degrees around the center of the fovea. All MPD measurements and photographs will by performed by the Bern Photographic Reading Center (BPRC). Complete examination of study patients comprises testing of standardized visual acuity (ETDRS-VA), visual contrast sensitivity (CS), biomicroscopy, fundus photography, and a blood sample. Participating patients also have to fill out a food frequency questionnaire (FFQ-Bern) allowing for correction of additional lutein intake by regular diet. Moreover possible confounding factors e.g. as sunlight exposure or smoking habits will be assessed. Secondary objective of EMPOLS is the effect of oral non-compound ester lutein supplementation on CS and ETDRS-VA during one year. The variable for a significant change in ETDRS-VA is loss or gain of 7 letters on the ETDRS chart, for a change in CS: loss or gain of at least four letters on the Pelli-Robson CS Chart. Additionally, serum carotenoid levels of lutein will be determined by high performance liquid chromatography (HPLC) for each visit 1. ### Conditions Module **Conditions:** - Age-Related Maculopathies **Keywords:** - age related macular degeneration - supplementation - macular pigment ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 80 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** VitaluxPlus® **Intervention Names:** - Dietary Supplement: VitaluxPlus® **Label:** 1 **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Omega 3 **Intervention Names:** - Dietary Supplement: Omega 3 **Label:** 2 **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - 1 **Description:** 1 tablet daily **Name:** VitaluxPlus® **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - 2 **Description:** 1 tablet daily **Name:** Omega 3 **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Measure:** Macular pigment density **Time Frame:** 6 months #### Secondary Outcomes **Measure:** contrast sensitivity **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * age related maculopathy Exclusion Criteria: * exudative age related degeneration **Minimum Age:** 50 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bern **Country:** Switzerland **Facility:** Klinik und Poliklinik für Augenheilkunde, University Bern #### Overall Officials **Official 1:** **Affiliation:** University of Bern **Name:** Sebastian Wolf, MD **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** University of Bern **Name:** Ute Wolf-Schnurrbusch, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Wolf-Schnurrbusch UE, Zinkernagel MS, Munk MR, Ebneter A, Wolf S. Oral Lutein Supplementation Enhances Macular Pigment Density and Contrast Sensitivity but Not in Combination With Polyunsaturated Fatty Acids. Invest Ophthalmol Vis Sci. 2015 Dec;56(13):8069-74. doi: 10.1167/iovs.15-17586. **PMID:** 26720458 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012162 - Term: Retinal Degeneration - ID: D000012164 - Term: Retinal Diseases - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M11260 - Name: Macular Degeneration - Relevance: HIGH - As Found: Age-Related Maculopathy - ID: M14997 - Name: Retinal Degeneration - Relevance: LOW - As Found: Unknown - ID: M14999 - Name: Retinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008268 - Term: Macular Degeneration ### Intervention Browse Module - Browse Branches - Abbrev: Ot - Name: Other Dietary Supplements - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T415 - Name: Omega 3 Fatty Acid - Relevance: LOW - As Found: Unknown - ID: T407 - Name: Lutein - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00127179 **Brief Title:** A Study of an Investigational Study Drug for Benign Prostatic Hyperplasia (0906-140) **Official Title:** MK0906 Phase III Double-Blind Comparative Study - Benign Prostate Hyperplasia #### Organization Study ID Info **ID:** 0906-140 #### Organization **Class:** INDUSTRY **Full Name:** Organon and Co #### Secondary ID Infos **ID:** MK0906-140 **ID:** 2005_042 ### Status Module #### Completion Date **Date:** 2005-07-25 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-02-16 **Type:** ACTUAL **Last Update Submit Date:** 2022-02-04 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2005-07-01 **Type:** ACTUAL #### Start Date **Date:** 2004-01-01 **Type:** ACTUAL **Status Verified Date:** 2022-02 #### Study First Post Date **Date:** 2005-08-05 **Type:** ESTIMATED **Study First Submit Date:** 2005-08-03 **Study First Submit QC Date:** 2005-08-04 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Organon and Co #### Responsible Party **Type:** SPONSOR ### Description Module **Brief Summary:** The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with benign prostatic hyperplasia. ### Conditions Module **Conditions:** - Benign Prostatic Hyperplasia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 600 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** MK0906, finasteride / Duration of Treatment: 48 weeks **Type:** DRUG #### Intervention 2 **Name:** Comparator: placebo / Duration of Treatment: 48 weeks **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Change from baseline in the International Prostate Symptom Score #### Secondary Outcomes **Measure:** Change from baseline in QOL - index **Measure:** Change from baseline in maximum urinary flow rate, % **Measure:** Change from baseline in Prostate volume ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with benign prostatic hyperplasia Exclusion Criteria: * Patients who are suspected to be suffering from prostatic cancer **Maximum Age:** 79 Years **Minimum Age:** 50 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Merck Sharp & Dohme LLC **Name:** Medical Monitor **Role:** STUDY_DIRECTOR ### References Module #### Available IPDs **Type:** CSR Synopsis **URL:** http://www.merck.com/clinical-trials/policies-perspectives.html ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000011469 - Term: Prostatic Diseases - ID: D000005832 - Term: Genital Diseases, Male - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M14334 - Name: Prostatic Hyperplasia - Relevance: HIGH - As Found: Prostatic Hyperplasia - ID: M10016 - Name: Hyperplasia - Relevance: HIGH - As Found: Hyperplasia - ID: M14333 - Name: Prostatic Diseases - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M8944 - Name: Genital Diseases, Male - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011470 - Term: Prostatic Hyperplasia - ID: D000006965 - Term: Hyperplasia ### Intervention Browse Module - Ancestors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000058891 - Term: 5-alpha Reductase Inhibitors - ID: D000065088 - Term: Steroid Synthesis Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000006727 - Term: Hormone Antagonists - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000064804 - Term: Urological Agents ### Intervention Browse Module - Browse Branches - Abbrev: Urol - Name: Urological Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M20273 - Name: Finasteride - Relevance: HIGH - As Found: Gemcitabine 1000 mg - ID: M29274 - Name: 5-alpha Reductase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000018120 - Term: Finasteride ### Misc Info Module #### Removed Countries - Country: Japan - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05290779 **Brief Title:** Ultrasound Versus Fluoroscopy-guided Selective Lumbar Nerve Root Injection **Official Title:** Ultrasound Versus Fluoroscopy-guided Selective Lumbar Nerve Root Injection for Treatment of Radicular Pain #### Organization Study ID Info **ID:** US vs. FL SNRB injection #### Organization **Class:** OTHER **Full Name:** Minia University ### Status Module #### Completion Date **Date:** 2022-05-16 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-09-27 **Type:** ACTUAL **Last Update Submit Date:** 2022-09-26 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-04-12 **Type:** ACTUAL #### Start Date **Date:** 2021-04-06 **Type:** ACTUAL **Status Verified Date:** 2022-09 #### Study First Post Date **Date:** 2022-03-22 **Type:** ACTUAL **Study First Submit Date:** 2022-02-25 **Study First Submit QC Date:** 2022-03-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Minia University #### Responsible Party **Investigator Affiliation:** Minia University **Investigator Full Name:** Islam Ahmed Bakr Mohammed **Investigator Title:** Director **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The study is conducted to compare pain relief, accuracy and safety and radiation exposure of selective lumbar nerve root injection for lumbar radicular pain using ultrasound guidance versus fluoroscopy guidance **Detailed Description:** Radicular pain is believed to be induced by irritation or inflammation of a nerve root caused by mechanical pressure or chemical irritation from degeneration herniation or rupture of intervertebral disc .Nerve root steroid injection is the most commonly performed minimally invasive technique for treatment of radicular pain in lumbar spine.The mechanism of action of steroids is to reduce inflammation by reduction in proinflammatory mediators around the nerve root, causing reduction in pain levels . Although Fluoroscopy guided technique is the most widely accepted method in lumbar selective nerve root injection, but recently ultrasound technique has gained acceptance among physicians due its reliability, efficacy, real-time guidance of injection and reduction of radiation exposure. Real-time guidance of injection provided by ultrasonography allows for good identification of the spinous process and adjacent structures such as lamina, zygapophyseal articulations and transverse process allowing for safer and potentially equally effective injection technique. The patients are randomly allocated into two groups; one group will receive injection under fluoroscopy guidance and the other group will receive injection under ultrasound guidance. The two groups are compared in terms of pain relief, accuracy and safety and radiation exposure. ### Conditions Module **Conditions:** - Lumbar Radiculopathy **Keywords:** - lumbar radicular pain - selective nerve root injection - ultrasound selective lumbar nerve root injection ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 74 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** selective lumbar nerve root steroid injection under ultrasound guidance. **Intervention Names:** - Procedure: selective lumbar nerve root injection **Label:** ultrasound **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** selective lumbar nerve root steroid injection under fluoroscopy guidance. **Intervention Names:** - Procedure: selective lumbar nerve root injection **Label:** fluoroscopy **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - fluoroscopy - ultrasound **Description:** selective lumbar nerve root steroid injection for treatment of radicular pain. **Name:** selective lumbar nerve root injection **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** evaluation of pain relief using visual analogue score on a scale from 0 to 10 with higher scores mean worse outcome **Measure:** improvement of visual analogue score of pain **Time Frame:** 3 months **Description:** evaluation of pain relief using Oswestry disability index score on a scale from 0% to 100% with the higher scores mean worse outcome. **Measure:** improvement of Oswestry disability index score for back pain **Time Frame:** 3 months #### Secondary Outcomes **Description:** comparing rate of complications **Measure:** safety of technique **Time Frame:** 3 months **Description:** time of x-ray radiation exposure during procedure. **Measure:** radiation exposure **Time Frame:** 1 hour ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * adult patients aged 18-60 years . * Both sexes . * With unilateral chronic lumbar radicular pain for more than 3 months. * Cooperative and oriented patients. * All patients are diagnosed by a neurologist for radicular low back pain through clinical presentation, medical examinations, computed tomography (CT), or magnetic resonance imaging (MRI). Exclusion Criteria: * Uncontrolled diabetes. * Infection at the site of injection. * Spine fractures. * Previous back surgery. * Progressive neurologic disorders. * Fever. * Peripheral neuropathy. * Presence of motor or sphencteric disturbance. * Bilateral radicular pain. * Allergy to substance of injection. * Patients with body mass index (BMI) more than 35. **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Minya **Country:** Egypt **Facility:** Faculty of medicine **Zip:** 61111 #### Overall Officials **Official 1:** **Affiliation:** Professor of Anesthesia and intensive care, MiniaU. **Name:** Amany K Abu Elhusein, PhD **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** Assistant professor of Anesthesia and intensive care, AsuitU.. **Name:** Abd ELraheem M Mohamed, MD **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010523 - Term: Peripheral Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M14689 - Name: Radiculopathy - Relevance: HIGH - As Found: Radiculopathy - ID: M13432 - Name: Peripheral Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011843 - Term: Radiculopathy ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06364579 **Acronym:** PROACT **Brief Title:** Patient Reported Outcomes (PROs) in Anal Cancer Patient Treated by Intensity Modulated Radiotherapy (IMRT). **Official Title:** Patient Reported Outcomes (PROs) in Anal Cancer Patient Treated by Intensity Modulated Radiotherapy (IMRT). #### Organization Study ID Info **ID:** 6533 #### Organization **Class:** OTHER **Full Name:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Status Module #### Completion Date **Date:** 2031-01-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-04-15 **Type:** ACTUAL **Last Update Submit Date:** 2024-04-09 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-01-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-28 **Type:** ACTUAL **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-04-15 **Type:** ACTUAL **Study First Submit Date:** 2024-03-28 **Study First Submit QC Date:** 2024-04-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Radiochemotherapy is the standard treatment for neoplasms of the anal canal with excellent rates of local control and preservation of the anal sphincter. However, patients may experience a deterioration of quality of life related to sequelae of the treatment particularly at intestinal, anal sphincter and sexual level. Few studies to date have documented patient-reported outcomes (PROs) in this area. The aim of this observational study is to verify the quality of life (QOL) of the patients by means of self-completed questionnaires. **Detailed Description:** In recent times, the focus on collecting patient-reported outcomes (PROs) has increased in healthcare. The Food and Drug Administration defines PROs as a -measurement of any aspect of a health status of the patient that comes directly from the patient-. These includes disease symptoms, functional aspects and quality of life (QOL). The collection of PROs, combined with physician-assessed toxicity, is constantly being incorporated into clinical practice and studies to provide a more holistic picture of the impact of treatment on patients and prove useful for planning future interventions. Although the use of PROs has now become the standard for measuring quality of life of patients there are still few studies on the self-reported long-term QOL of anal cancer patients and on disease or therapy related symptoms that affect QOL. Therefore, the EORTC (European Organisation for Research and Treatment of Cancer) has recently developed the specific Quality of Life Questionnaire for anal cancer (QLQ-AN27) module to explore typical symptoms of anal cancer and its therapy. In this study, the QLQ-AN27 questionnaire will be administered together with the EORTC Quality of Life 30 (QLQ 30) in patients with anal cancer who have undergone radio-chemotherapy. The questionnaire may be administered before treatment, after treatment and during follow-ups until completion of the fifth year. This is an observational study both retrospective and prospective. ### Conditions Module **Conditions:** - Anal Cancer Patients **Keywords:** - PROs - QOL - EORTC - anal cancer - radiotherapy - radiation therapy - follow up ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** OTHER #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Analysis of quality of life (QOL) by administration of PRO questionnaires to patients with cancer of the anus treated with IMRT radiochemotherapy. **Measure:** QOL analysis **Time Frame:** 60 months from the last enrolled patient (january 2026) #### Secondary Outcomes **Description:** Absence of death from any cause. **Measure:** Overall survival (OS) **Time Frame:** time 0, end of treatment, 6 month post treatment, 1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up **Description:** Being alive without a temporary or permanent ileostomy or colostomy **Measure:** Colostomy Free Survival (CFS) **Time Frame:** time 0, end of treatment, 6 month post treatment, 1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up **Description:** Presence of disease progression inside the target volume of radiation therapy **Measure:** Loco-Regional Recurrence (LRR) **Time Frame:** time 0, end of treatment, 6 month post treatment, 1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up **Description:** The time from last treatment to cancer recurrence or death from any cause **Measure:** Disease-Free Survival (DFS) **Time Frame:** time 0, end of treatment, 6 month post treatment, 1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up **Description:** Acute toxicity caused by chemoradiation according to CTCAE v. 5.0 **Measure:** Acute toxicity **Time Frame:** during treatment, end of treatment **Description:** Late toxicity caused by chemoradiation according to CTCAE v. 5.0 **Measure:** Late toxicity **Time Frame:** 6 month post treatment ,1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) 0-3 * minimum 18 years old * squamous cell carcinoma of the anal canal * low burden of metastatic disease at diagnosis * indication for radiochemotherapy treatment * informed consent Exclusion Criteria: * age under 18 years * Eastern Cooperative Oncology Group (ECOG) higher than 3 * metastatic disease at diagnosis not amenable to radiochemotherapy treatment **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with anal cancer treated with radiochemotherapy at the Fondazione Policlinico Gemelli from 2010 to the present. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Stefania Manfrida, MD **Phone:** 0039 0630154434 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Stefania Manfrida **Phone:** +390630155701 **Role:** CONTACT #### Locations **Location 1:** **City:** Rome **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Stefania Manfrida, MD - **Phone:** +3900630154434 - **Role:** CONTACT ***Contact 2:*** - **Name:** Stefania Mandrida - **Phone:** +390630155701 - **Role:** CONTACT ***Contact 3:*** - **Name:** Stefania Manfrida, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Italy **Facility:** Fondazione Policlinico Universitario A. Gemelli IRCCS **State:** Lazio **Status:** RECRUITING **Zip:** 00168 #### Overall Officials **Official 1:** **Affiliation:** Fondazione Policlinico Universitario A. Gemelli, IRCCS **Name:** Stefania Manfrida **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012004 - Term: Rectal Neoplasms - ID: D000015179 - Term: Colorectal Neoplasms - ID: D000007414 - Term: Intestinal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000001004 - Term: Anus Diseases - ID: D000012002 - Term: Rectal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4321 - Name: Anus Neoplasms - Relevance: HIGH - As Found: Anal Cancer - ID: M14846 - Name: Rectal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17890 - Name: Colorectal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M10448 - Name: Intestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M4320 - Name: Anus Diseases - Relevance: LOW - As Found: Unknown - ID: M14844 - Name: Rectal Diseases - Relevance: LOW - As Found: Unknown - ID: T362 - Name: Anal Cancer - Relevance: HIGH - As Found: Anal Cancer ### Condition Browse Module - Meshes - ID: D000001005 - Term: Anus Neoplasms ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04380779 **Acronym:** BLEEDING **Brief Title:** Prevalence of Severe Bleeding in COVID-19 Patients Treated With Higher Than Recommended Thromboprophylaxis Doses **Official Title:** Prevalence of Severe Bleeding in COVID-19 Patients Treated With Higher Than Recommended Thromboprophylaxis Doses (BLEEDING Study) #### Organization Study ID Info **ID:** BLEEDING042020 #### Organization **Class:** OTHER **Full Name:** Foundation for the study of VTE diseases. (FUENTE) ### Status Module #### Completion Date **Date:** 2020-10-13 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-12-14 **Type:** ACTUAL **Last Update Submit Date:** 2020-12-11 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-10-13 **Type:** ACTUAL #### Start Date **Date:** 2020-04-13 **Type:** ACTUAL **Status Verified Date:** 2020-12 #### Study First Post Date **Date:** 2020-05-08 **Type:** ACTUAL **Study First Submit Date:** 2020-05-07 **Study First Submit QC Date:** 2020-05-07 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Manuel Monreal #### Responsible Party **Investigator Affiliation:** Foundation for the study of VTE diseases. (FUENTE) **Investigator Full Name:** Manuel Monreal **Investigator Title:** Professor of Internal Medicine **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The main objectives are: * To establish the prevalence of major bleeding in patients treated with higher than recommended thromboprophylaxis doses. * To identify variables associated to higher risk of bleeding. ### Conditions Module **Conditions:** - COVID-19 ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 2430 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Study endpoints are clinically recognized (and objectively confirmed) major and minor bleeding complications, and death. **Measure:** Bleeding events and complications **Time Frame:** 30 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients infected with COVID-19 treated with higher than recommended thromboprophylaxis doses. * Admission to hospital. Exclusion Criteria: * Patients treated with ECMO (Extracorporeal membrane oxygenation). **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Patients infected with COVID-19 treated with higher than recommended thromboprophylaxis doses and admitted to hospital ### Contacts Locations Module #### Locations **Location 1:** **City:** Badalona **Country:** Spain **Facility:** Manuel Monreal **State:** Barcelona **Zip:** 08916 #### Overall Officials **Official 1:** **Affiliation:** Germans Trias i Pujol Hospital **Name:** Manuel Monreal **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011024 - Term: Pneumonia, Viral - ID: D000011014 - Term: Pneumonia - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000014777 - Term: Virus Diseases - ID: D000018352 - Term: Coronavirus Infections - ID: D000003333 - Term: Coronaviridae Infections - ID: D000030341 - Term: Nidovirales Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases ### Condition Browse Module - Browse Leaves - ID: M9556 - Name: Hemorrhage - Relevance: LOW - As Found: Unknown - ID: M2561 - Name: COVID-19 - Relevance: HIGH - As Found: COVID-19 - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M13914 - Name: Pneumonia, Viral - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M20490 - Name: Coronavirus Infections - Relevance: LOW - As Found: Unknown - ID: M6555 - Name: Coronaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M23685 - Name: Nidovirales Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000086382 - Term: COVID-19 ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00002679 **Brief Title:** Adjuvant High-Dose, Sequential Chemotherapy in Treating Patients With Resected Breast Cancer **Official Title:** Sequential Adjuvant Chemotherapy With Doxorubicin, Taxol, and Cyclophosphamide for Stage II or III Resectable Breast Cancer With Four or More Involved Axillary Lymph Nodes #### Organization Study ID Info **ID:** CDR0000064337 #### Organization **Class:** OTHER **Full Name:** Yale University #### Secondary ID Infos **ID:** YALE-HIC-7374 **ID:** NCI-V95-0720 ### Status Module #### Completion Date **Date:** 2002-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2009-08-26 **Type:** ESTIMATED **Last Update Submit Date:** 2009-08-24 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2002-01 **Type:** ACTUAL #### Start Date **Date:** 1994-02 **Status Verified Date:** 2009-08 #### Study First Post Date **Date:** 2004-02-06 **Type:** ESTIMATED **Study First Submit Date:** 1999-11-01 **Study First Submit QC Date:** 2004-02-05 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Yale University #### Responsible Party **Old Name Title:** Maysa Abu-Khalaf, MD, Principal Investigator **Old Organization:** Yale University School of Medicine ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of high-dose sequential chemotherapy as adjuvant therapy in treating patients with stage II or stage III breast cancer who have four or more positive axillary lymph nodes. **Detailed Description:** OBJECTIVES: I. Evaluate the efficacy of dose intensive, sequential adjuvant chemotherapy with doxorubicin, paclitaxel, and cyclophosphamide in patients with stage II/III resected breast cancer. II. Evaluate the toxicity of this regimen in these patients. OUTLINE: All patients receive sequential chemotherapy regimens consisting of 3 courses each of doxorubicin, paclitaxel, and cyclophosphamide on a schedule of one course every 14 days. Following completion of chemotherapy, patients who underwent breast conservation surgery receive radiotherapy. Mastectomy patients with 10 or more positive nodes or with T3-4 tumors are also eligible for delayed radiotherapy. Patients who are hormone receptor positive (or whose receptor status is unknown) are treated with oral tamoxifen for 5 years, beginning after completion of all other therapy. Patients are followed every 3 months for 2 years, every 6 months for 3 years, then yearly. PROJECTED ACCRUAL: At total of 90 patients will be entered. ### Conditions Module **Conditions:** - Breast Cancer **Keywords:** - stage II breast cancer - stage IIIA breast cancer - male breast cancer ### Design Module #### Design Info **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 89 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** filgrastim **Type:** BIOLOGICAL #### Intervention 2 **Name:** cyclophosphamide **Type:** DRUG #### Intervention 3 **Name:** doxorubicin hydrochloride **Type:** DRUG #### Intervention 4 **Name:** paclitaxel **Type:** DRUG #### Intervention 5 **Name:** tamoxifen citrate **Type:** DRUG #### Intervention 6 **Name:** radiation therapy **Type:** RADIATION ### Eligibility Module **Eligibility Criteria:** DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the breast with involvement of 4 or more axillary nodes, including any T N1 M0 Concurrent bilateral breast cancer allowed Complete resection required Total mastectomy or breast conserving surgery Adjuvant radiotherapy planned after protocol chemotherapy Clear surgical margins Axillary dissection yielding at least 9 lymph nodes Entry required within 8 weeks of definitive surgery Hormone receptor status: Any status PATIENT CHARACTERISTICS: Age: Over 18 Sex: Not specified Menopausal status: Not specified Performance status: Karnofsky 80%-100% ECOG 0 or 1 Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 times normal AST no greater than 2 times normal Alkaline phosphatase no greater than 2 times normal Renal: Creatinine no greater than 1.8 mg/dL OR Creatinine clearance at least 60 mL/min Urinalysis normal Cardiovascular: Left ventricular ejection fraction normal on MUGA or echocardiogram No congestive heart failure requiring medical therapy No serious arrhythmia No first-, second-, or third-degree heart block Other: No abnormal CT of chest or abdomen No uncontrolled infection No serious medical condition that would prevent treatment No second malignancy except curatively treated: Nonmelanomatous skin cancer Carcinoma in situ of the cervix Not pregnant Negative pregnancy test Barrier contraception required of fertile patients before, during, and for 6 months after protocol therapy PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy Endocrine Therapy: No concurrent hormonal therapy unless unrelated to cancer Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: No concurrent medication affecting conduction unless cleared by a cardiologist, e.g.: Beta blockers Digoxin Antiarrhythmia agents Calcium channel blockers **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** New Haven **Country:** United States **Facility:** Yale Comprehensive Cancer Center **State:** Connecticut **Zip:** 06520-8028 #### Overall Officials **Official 1:** **Affiliation:** Yale University **Name:** Maysa Abu-Khalaf, MD **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M20665 - Name: Breast Neoplasms, Male - Relevance: LOW - As Found: Unknown - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: T861 - Name: Breast Cancer, Male - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### Intervention Browse Module - Ancestors - ID: D000000972 - Term: Antineoplastic Agents, Phytogenic - ID: D000000970 - Term: Antineoplastic Agents - ID: D000050257 - Term: Tubulin Modulators - ID: D000050256 - Term: Antimitotic Agents - ID: D000050258 - Term: Mitosis Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018501 - Term: Antirheumatic Agents - ID: D000018906 - Term: Antineoplastic Agents, Alkylating - ID: D000000477 - Term: Alkylating Agents - ID: D000019653 - Term: Myeloablative Agonists - ID: D000000903 - Term: Antibiotics, Antineoplastic - ID: D000059005 - Term: Topoisomerase II Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000004965 - Term: Estrogen Antagonists - ID: D000006727 - Term: Hormone Antagonists - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000018931 - Term: Antineoplastic Agents, Hormonal - ID: D000020845 - Term: Selective Estrogen Receptor Modulators - ID: D000020847 - Term: Estrogen Receptor Modulators - ID: D000050071 - Term: Bone Density Conservation Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: BDCA - Name: Bone Density Conservation Agents - Abbrev: AnCoag - Name: Anticoagulants - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M19537 - Name: Paclitaxel - Relevance: HIGH - As Found: Surgery - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M6727 - Name: Cyclophosphamide - Relevance: HIGH - As Found: Cycle - ID: M7492 - Name: Doxorubicin - Relevance: HIGH - As Found: Influenza - ID: M227339 - Name: Liposomal doxorubicin - Relevance: HIGH - As Found: Influenza - ID: M1945 - Name: Lenograstim - Relevance: LOW - As Found: Unknown - ID: M16403 - Name: Tamoxifen - Relevance: HIGH - As Found: Castration-Resistant Prostate Cancer - ID: M21320 - Name: Citric Acid - Relevance: LOW - As Found: Unknown - ID: M1837 - Name: Sodium Citrate - Relevance: LOW - As Found: Unknown - ID: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M20942 - Name: Antineoplastic Agents, Alkylating - Relevance: LOW - As Found: Unknown - ID: M3820 - Name: Alkylating Agents - Relevance: LOW - As Found: Unknown - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M8116 - Name: Estrogens - Relevance: LOW - As Found: Unknown - ID: M8114 - Name: Estrogen Antagonists - Relevance: LOW - As Found: Unknown - ID: M30483 - Name: Estrogen Receptor Antagonists - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M20966 - Name: Antineoplastic Agents, Hormonal - Relevance: LOW - As Found: Unknown - ID: M22599 - Name: Estrogen Receptor Modulators - Relevance: LOW - As Found: Unknown - ID: M22597 - Name: Selective Estrogen Receptor Modulators - Relevance: LOW - As Found: Unknown - ID: T382 - Name: Citrate - Relevance: HIGH - As Found: Free ### Intervention Browse Module - Meshes - ID: D000013629 - Term: Tamoxifen - ID: D000017239 - Term: Paclitaxel - ID: D000003520 - Term: Cyclophosphamide - ID: D000004317 - Term: Doxorubicin - ID: C000506643 - Term: Liposomal doxorubicin ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03898479 **Brief Title:** Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata **Official Title:** A Multicenter, Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata #### Organization Study ID Info **ID:** CP543.5001 #### Organization **Class:** INDUSTRY **Full Name:** Concert Pharmaceuticals ### Status Module #### Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-04-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-04-02 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2024-06 **Type:** ESTIMATED #### Start Date **Date:** 2019-04-04 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2019-04-02 **Type:** ACTUAL **Study First Submit Date:** 2019-03-29 **Study First Submit QC Date:** 2019-03-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Concert Pharmaceuticals #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** The overall objectives of the study are to evaluate long-term safety of CTP-543 and to assess long-term effects of CTP-543 on treating hair loss in adult patients with chronic, moderate to severe alopecia areata. ### Conditions Module **Conditions:** - Alopecia Areata ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 1000 **Type:** ESTIMATED **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients who previously completed a qualifying CTP-543 clinical trial **Intervention Names:** - Drug: CTP-543 **Label:** CTP-543 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - CTP-543 **Description:** Twice daily dosing **Name:** CTP-543 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Number of Participants with Adverse Events as a Measure of Safety **Time Frame:** 276 weeks **Measure:** Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT) **Time Frame:** 276 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Have completed 24 weeks of treatment in a previous qualifying CTP-543 clinical trial Exclusion Criteria: * Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis * Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study medication * Donation of blood at any point throughout the study and for 30 days after last dose of study medication **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Birmingham **Country:** United States **Facility:** Total Skin and Beauty Dermatology Center **State:** Alabama **Zip:** 35203 **Location 2:** **City:** Phoenix **Country:** United States **Facility:** Alliance Dermatology & MOHS Center **State:** Arizona **Zip:** 85032 **Location 3:** **City:** Scottsdale **Country:** United States **Facility:** Center for Dermatology and Plastic Surgery/CCT Research **State:** Arizona **Zip:** 85260 **Location 4:** **City:** Fort Smith **Country:** United States **Facility:** Johnson Dermatology **State:** Arkansas **Zip:** 72916 **Location 5:** **City:** Rogers **Country:** United States **Facility:** Northwest Arkansas Clinical Trials Center, PLLC **State:** Arkansas **Zip:** 72758 **Location 6:** **City:** Bakersfield **Country:** United States **Facility:** Kern Research Inc. **State:** California **Zip:** 93301 **Location 7:** **City:** Canoga Park **Country:** United States **Facility:** Hope Clinical Research **State:** California **Zip:** 91303 **Location 8:** **City:** Encinitas **Country:** United States **Facility:** California Dermatology & Clinical Research Institute **State:** California **Zip:** 92024 **Location 9:** **City:** Irvine **Country:** United States **Facility:** University of California, Irvine **State:** California **Zip:** 92697 **Location 10:** **City:** Los Angeles **Country:** United States **Facility:** Dermatology Research Associates **State:** California **Zip:** 90045 **Location 11:** **City:** Northridge **Country:** United States **Facility:** Quest Dermatology Research **State:** California **Zip:** 91324 **Location 12:** **City:** Oakland **Country:** United States **Facility:** Kaiser Permanente Northern California - Oakland **State:** California **Zip:** 94611 **Location 13:** **City:** Palm Springs **Country:** United States **Facility:** Palmtree Clinical Research, Inc. **State:** California **Zip:** 92262 **Location 14:** **City:** Redwood City **Country:** United States **Facility:** Stanford University School of Medicine - Medical Dermatology Clinic **State:** California **Zip:** 94063 **Location 15:** **City:** Sacramento **Country:** United States **Facility:** Kaiser Permanente South Sacramento **State:** California **Zip:** 95823 **Location 16:** **City:** San Francisco **Country:** United States **Facility:** Kaiser Permanente Clinical Trials Unit **State:** California **Zip:** 94118 **Location 17:** **City:** Centennial **Country:** United States **Facility:** Colorado Center for Dermatology, PLLC d/b/a CODerm Research **State:** Colorado **Zip:** 80111 **Location 18:** **City:** Denver **Country:** United States **Facility:** Colorado Medical Research Center **State:** Colorado **Zip:** 80210 **Location 19:** **City:** New Haven **Country:** United States **Facility:** Yale University Church Street Research Unit **State:** Connecticut **Zip:** 06519 **Location 20:** **City:** Boca Raton **Country:** United States **Facility:** Skin Care Research, LLC **State:** Florida **Zip:** 33486 **Location 21:** **City:** Hollywood **Country:** United States **Facility:** Skin Care Research, LLC **State:** Florida **Zip:** 33021 **Location 22:** **City:** Miami **Country:** United States **Facility:** University of Miami Hospital **State:** Florida **Zip:** 33125 **Location 23:** **City:** Miami **Country:** United States **Facility:** Floridian Research Institute, LLC **State:** Florida **Zip:** 33179 **Location 24:** **City:** Sweetwater **Country:** United States **Facility:** Lenus Research & Medical Group, LLC **State:** Florida **Zip:** 33172 **Location 25:** **City:** Tampa **Country:** United States **Facility:** Clinical Research Trials of Florida, Inc. **State:** Florida **Zip:** 33607 **Location 26:** **City:** Tampa **Country:** United States **Facility:** ForCare Clinical Research **State:** Florida **Zip:** 33613 **Location 27:** **City:** Boise **Country:** United States **Facility:** ASR, LLC **State:** Idaho **Zip:** 83702 **Location 28:** **City:** Chicago **Country:** United States **Facility:** Denova Research **State:** Illinois **Zip:** 60611 **Location 29:** **City:** Indianapolis **Country:** United States **Facility:** Dawes Fretzin Clinical Research Group, LLC **State:** Indiana **Zip:** 46250 **Location 30:** **City:** New Albany **Country:** United States **Facility:** DS Research **State:** Indiana **Zip:** 47150 **Location 31:** **City:** Plainfield **Country:** United States **Facility:** The Indiana Clinical Trials Center, PC **State:** Indiana **Zip:** 46168 **Location 32:** **City:** Louisville **Country:** United States **Facility:** DS Research **State:** Kentucky **Zip:** 40241 **Location 33:** **City:** Owensboro **Country:** United States **Facility:** Qualmedica Research **State:** Kentucky **Zip:** 42301 **Location 34:** **City:** Boston **Country:** United States **Facility:** Massachusetts General Hospital **State:** Massachusetts **Zip:** 02114 **Location 35:** **City:** Boston **Country:** United States **Facility:** Brigham and Women's Hospital **State:** Massachusetts **Zip:** 02115 **Location 36:** **City:** Clarkston **Country:** United States **Facility:** Clarkston Skin Research **State:** Michigan **Zip:** 48346 **Location 37:** **City:** Fridley **Country:** United States **Facility:** Minnesota Clinical Study Center **State:** Minnesota **Zip:** 55432 **Location 38:** **City:** Minneapolis **Country:** United States **Facility:** University of Minnesota Department of Dermatology **State:** Minnesota **Zip:** 55417 **Location 39:** **City:** Las Vegas **Country:** United States **Facility:** Vivida Dermatology **State:** Nevada **Zip:** 89119 **Location 40:** **City:** Hackensack **Country:** United States **Facility:** Skin Laser and Surgery Specialists of NJ **State:** New Jersey **Zip:** 07601 **Location 41:** **City:** Verona **Country:** United States **Facility:** Schweiger Dermatology, P.C. **State:** New Jersey **Zip:** 07044 **Location 42:** **City:** New York **Country:** United States **Facility:** Icahn School of Medicine at Mount Sinai **State:** New York **Zip:** 10029 **Location 43:** **City:** New York **Country:** United States **Facility:** Sadick Research Group **State:** New York **Zip:** 10075 **Location 44:** **City:** Rochester **Country:** United States **Facility:** UR Dermatology at College Town **State:** New York **Zip:** 14620 **Location 45:** **City:** Charlotte **Country:** United States **Facility:** Darst Dermatology **State:** North Carolina **Zip:** 28277 **Location 46:** **City:** Charlotte **Country:** United States **Facility:** Dermatology Specialists of Charlotte **State:** North Carolina **Zip:** 28277 **Location 47:** **City:** Raleigh **Country:** United States **Facility:** North Carolina Dermatology Associates, PLLC **State:** North Carolina **Zip:** 27617 **Location 48:** **City:** Winston-Salem **Country:** United States **Facility:** Wake Forest University Health Sciences, Department of Dermatology **State:** North Carolina **Zip:** 27104 **Location 49:** **City:** Bexley **Country:** United States **Facility:** Bexley Dermatology Research **State:** Ohio **Zip:** 43209 **Location 50:** **City:** Columbus **Country:** United States **Facility:** Remington-Davis, Inc. **State:** Ohio **Zip:** 43215 **Location 51:** **City:** Tulsa **Country:** United States **Facility:** Vital Prospects Clinical Research Institute, P.C. **State:** Oklahoma **Zip:** 74136 **Location 52:** **City:** Portland **Country:** United States **Facility:** Oregon Medical Research Center **State:** Oregon **Zip:** 97201 **Location 53:** **City:** Portland **Country:** United States **Facility:** NW Dermatology Institute **State:** Oregon **Zip:** 97210 **Location 54:** **City:** Philadelphia **Country:** United States **Facility:** Hospital of the University of Pennsylvania Dept of Dermatology **State:** Pennsylvania **Zip:** 19104 **Location 55:** **City:** Plymouth Meeting **Country:** United States **Facility:** Dermatology Associates of Plymouth Meeting **State:** Pennsylvania **Zip:** 19462 **Location 56:** **City:** Upper Saint Clair **Country:** United States **Facility:** Peak Research - Pennsylvania **State:** Pennsylvania **Zip:** 15241 **Location 57:** **City:** East Greenwich **Country:** United States **Facility:** Velocity Clinical Research-Providence **State:** Rhode Island **Zip:** 02818 **Location 58:** **City:** Providence **Country:** United States **Facility:** Rhode Island Hospital **State:** Rhode Island **Zip:** 02903 **Location 59:** **City:** Charleston **Country:** United States **Facility:** Clinical Research Center of the Carolinas **State:** South Carolina **Zip:** 29407 **Location 60:** **City:** Fountain Inn **Country:** United States **Facility:** Palmetto Clinical Trial Services **State:** South Carolina **Zip:** 29644 **Location 61:** **City:** Dallas **Country:** United States **Facility:** Dermatology Treatment and Research Center - Dallas **State:** Texas **Zip:** 75230 **Location 62:** **City:** Frisco **Country:** United States **Facility:** North Texas Center for Clinical Research **State:** Texas **Zip:** 75034 **Location 63:** **City:** Houston **Country:** United States **Facility:** Suzanne Bruce and Associates, PA **State:** Texas **Zip:** 77056 **Location 64:** **City:** Pflugerville **Country:** United States **Facility:** Austin Institute for Clinical Research, Inc. **State:** Texas **Zip:** 78660 **Location 65:** **City:** San Antonio **Country:** United States **Facility:** Progressive Clinical Research **State:** Texas **Zip:** 78213 **Location 66:** **City:** San Antonio **Country:** United States **Facility:** Texas Dermatology and Laser Specialists **State:** Texas **Zip:** 78218 **Location 67:** **City:** San Antonio **Country:** United States **Facility:** Dermatology Clinical Research Center of San Antonio **State:** Texas **Zip:** 78229 **Location 68:** **City:** West Jordan **Country:** United States **Facility:** Jordan Valley Dermatology **State:** Utah **Zip:** 84088 **Location 69:** **City:** Charlottesville **Country:** United States **Facility:** University of Virginia Health System **State:** Virginia **Zip:** 22903 **Location 70:** **City:** Richmond **Country:** United States **Facility:** West End Dermatology Associates **State:** Virginia **Zip:** 23233 **Location 71:** **City:** Kenosha **Country:** United States **Facility:** Clinical Investigation Specialists, Inc. **State:** Wisconsin **Zip:** 53144 **Location 72:** **City:** Calgary **Country:** Canada **Facility:** Dermatology Research Institute **State:** Alberta **Zip:** T1Y 0B4 **Location 73:** **City:** Calgary **Country:** Canada **Facility:** Kirk Barber Research **State:** Alberta **Zip:** T2G 1B1 **Location 74:** **City:** Red Deer **Country:** Canada **Facility:** Care Clinic **State:** Alberta **Zip:** T4P 1K4 **Location 75:** **City:** Kelowna **Country:** Canada **Facility:** Medical Arts Health Research Group **State:** British Columbia **Zip:** V1Y 4N7 **Location 76:** **City:** Surrey **Country:** Canada **Facility:** Enverus Medical Research **State:** British Columbia **Zip:** V3V 0C6 **Location 77:** **City:** Winnipeg **Country:** Canada **Facility:** Wiseman Dermatology Research Inc. **State:** Manitoba **Zip:** R3M 3Z4 **Location 78:** **City:** Barrie **Country:** Canada **Facility:** SimcoDerm Medical and Surgical Dermatology Center **State:** Ontario **Zip:** L4M 7G1 **Location 79:** **City:** Etobicoke **Country:** Canada **Facility:** Kingsway Clinical Research **State:** Ontario **Zip:** M8X 1Y9 **Location 80:** **City:** Guelph **Country:** Canada **Facility:** Guelph Dermatology Research **State:** Ontario **Zip:** N1L 0B7 **Location 81:** **City:** London **Country:** Canada **Facility:** DermEffects **State:** Ontario **Zip:** N6H 5L5 **Location 82:** **City:** Markham **Country:** Canada **Facility:** Lynderm Research Inc. **State:** Ontario **Zip:** L3P 1X3 **Location 83:** **City:** Newmarket **Country:** Canada **Facility:** Dr. S. K. Siddha Medicine Professional Corporation **State:** Ontario **Zip:** L3Y 5G8 **Location 84:** **City:** Oakville **Country:** Canada **Facility:** The Centre for Clinical Trials **State:** Ontario **Zip:** L6J 7W5 **Location 85:** **City:** Ottawa **Country:** Canada **Facility:** JRB research Inc. **State:** Ontario **Zip:** K1H 7X3 **Location 86:** **City:** Richmond Hill **Country:** Canada **Facility:** Centre for Dermatology **State:** Ontario **Zip:** L4B 1A5 **Location 87:** **City:** Toronto **Country:** Canada **Facility:** Research Toronto **State:** Ontario **Zip:** M4W 2N4 **Location 88:** **City:** Waterloo **Country:** Canada **Facility:** Alliance Clinical Trials **State:** Ontario **Zip:** N2J 1C4 **Location 89:** **City:** Montreal **Country:** Canada **Facility:** Innovaderm Research Inc. **State:** Quebec **Zip:** H2X 2V1 **Location 90:** **City:** Québec **Country:** Canada **Facility:** Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ) **Zip:** G1V 4X7 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007039 - Term: Hypotrichosis - ID: D000006201 - Term: Hair Diseases - ID: D000012871 - Term: Skin Diseases - ID: D000020763 - Term: Pathological Conditions, Anatomical ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M3846 - Name: Alopecia - Relevance: HIGH - As Found: Alopecia - ID: M3847 - Name: Alopecia Areata - Relevance: HIGH - As Found: Alopecia Areata - ID: M10089 - Name: Hypotrichosis - Relevance: LOW - As Found: Unknown - ID: M9293 - Name: Hair Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000505 - Term: Alopecia - ID: D000000506 - Term: Alopecia Areata ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04148079 **Brief Title:** Safety of Electrotherapy in Patients With Knee Osteoarthritis and Cardiac Diseases **Official Title:** Frequency of Arrhythmias During Physiotherapy #### Organization Study ID Info **ID:** UniversitateaMFH #### Organization **Class:** OTHER **Full Name:** Universitatea de Medicina si Farmacie Iuliu Hatieganu ### Status Module #### Completion Date **Date:** 2017-08 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-11-04 **Type:** ACTUAL **Last Update Submit Date:** 2019-10-31 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-08 **Type:** ACTUAL #### Start Date **Date:** 2013-03 **Type:** ACTUAL **Status Verified Date:** 2019-10 #### Study First Post Date **Date:** 2019-11-01 **Type:** ACTUAL **Study First Submit Date:** 2019-10-29 **Study First Submit QC Date:** 2019-10-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universitatea de Medicina si Farmacie Iuliu Hatieganu #### Responsible Party **Investigator Affiliation:** Universitatea de Medicina si Farmacie Iuliu Hatieganu **Investigator Full Name:** Ciubean Alina Deniza **Investigator Title:** Principal investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study aimed to asses whether physyical therapy (e.g. electrotherapy in the form of low, medium or high frequency currents, massage and kinetotherapy) for treatment of knee osteoarthritis can induce or aggravate certain cardiac diseases during or immediately after therapy. The physyical treatment described is not a new method, is currently used and recommended in all guidelines for non-pharmacological and non-surgical therapy of knee osteoarthritis. What is not clear is whether application of electrotherapy in the knee area can alter the preexisting cardiac condition. **Detailed Description:** An analytical and transversal study was carried out between March 2013 and August 2017. The study included a total of 46 patients previously diagnosed with degenerative knee OA. All the patients included in the study were recruited during inpatient visit in the Clinical Rehabilitation Hospital in Cluj-Napoca, Romania. Each patient was clinically evaluated and was furthermore prescribed a PT program (ET, massage and kinesiotherapy). They were monitored by 24 hour-Holter ECG in 2 separate days, at the beginning of treatment, before applying the PT methods (day 1), and after completing a 10-day PT program (day 2). PT modalities prescribed for each patient after clinical evaluation included different types of ET, all currently used and included in the national and international treatment guidelines, as in low frequency currents (galvanic or TENS), medium frequency currents (interferential) and high frequency currents (short wave diathermy), all combined with an individualized exercise program and massage therapy. The program was performed on a daily basis, for 10 days. The aim of the PT program was to decrease pain and increase range of motion in the affected joints and did not lead to increases in cardiac frequencies. No hydrotherapy was applied, given that that the Holter ECG was not waterproof. No technical incidents were reported during the study. No alternate positioning of the patient wearing a Holter ECG for ET procedures was necessary, as the region of interest was the knee. No change in current drug therapy was allowed for the whole duration of the study. ### Conditions Module **Conditions:** - Knee Osteoarthritis ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 46 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** low frequency currents (galvanic or TENS), medium frequency currents (interferential) and high frequency currents (short wave diathermy), all combined with an individualized exercise program and massage therapy **Name:** physical therapy **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Minimal, average, maximum heart rate evaluated by 24 hour Holter EKG monitoring **Measure:** Heart rate **Time Frame:** Change from Baseline after 10 days **Description:** supraventricular, ventricular, total extraystoles evaluated by 24 hour Holter EKG monitoring **Measure:** Supraventricular, ventricular and total Extrasystoles **Time Frame:** Change from Baseline after 10 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * clinical diagnosis and imaging diagnosis of knee osteoarthrtitis based on ACR 2000 diagnostic criteria Exclusion Criteria: * known cardiac arrhythmias (atrial fibrillation, atrial flutter) * congestive heart failure class NYHA II, III or IV * any other general contraindications for PT (infections, psychiatric disorders etc) **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** 46 patients, 33 female, 13 male 20 patients had a history of arrythmias (e.g.premature atrial contractions) 19 patients had a history of ischemic heart disease ### IPD Sharing Statement Module **Description:** If asked for the data from someone who needs it, we will be happy to share **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M12926 - Name: Osteoarthritis - Relevance: HIGH - As Found: Osteoarthritis - ID: M22168 - Name: Osteoarthritis, Knee - Relevance: HIGH - As Found: Knee Osteoarthritis - ID: M4453 - Name: Arrhythmias, Cardiac - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010003 - Term: Osteoarthritis - ID: D000020370 - Term: Osteoarthritis, Knee ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01129479 **Brief Title:** Galantamine Treatment for Nonfluent Aphasia in Stroke Patients **Official Title:** Galantamine Treatment for Nonfluent Aphasia in Stroke Patients #### Organization Study ID Info **ID:** GAL-EMR-4008 #### Organization **Class:** OTHER **Full Name:** University of North Carolina, Chapel Hill ### Status Module #### Completion Date **Date:** 2007-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2010-05-24 **Type:** ESTIMATED **Last Update Submit Date:** 2010-05-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2007-12 **Type:** ACTUAL #### Start Date **Date:** 2004-10 **Status Verified Date:** 2010-05 #### Study First Post Date **Date:** 2010-05-24 **Type:** ESTIMATED **Study First Submit Date:** 2010-05-21 **Study First Submit QC Date:** 2010-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Ortho-McNeil Neurologics, Inc. #### Lead Sponsor **Class:** OTHER **Name:** University of North Carolina, Chapel Hill #### Responsible Party **Old Name Title:** Heidi Roth **Old Organization:** University of North Carolina ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Cognitive impairment after stroke is common and has a major effect on morbidity and quality of life. Acetylcholinesterase inhibitors have demonstrated benefit in vascular dementia, but efficacy in treating more circumscribed cognitive deficits following stroke, such as aphasia, has not been systematically investigated. This study evaluated the efficacy of Galantamine (Reminyl) in subjects with chronic, stable non-fluent aphasia secondary to stroke. Subjects enrolled in a double-blind placebo- controlled cross-over study that employed a comprehensive battery of language tests and measures of general cognitive and behavioral status that will be used to control for factors that may influence language functioning. The primary study outcome was a within-subject comparison of changes in language function and behavioral scores between placebo and active-treatment phases (12 weeks each). Our hypothesis was that by increasing acetylcholine levels, and facilitating activity of other neurotransmitters affecting attentional systems, Galantamine would produce gains in both language and behavioral scores in patients suffering chronic effects in cognitive systems due to injury following stroke. ### Conditions Module **Conditions:** - Aphasia - Stroke **Keywords:** - Aphasia - treatment - cholinesterase inhibitor - stroke ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 8 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Galantamine **Label:** Galantamine **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Drug: Placebo pill **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Galantamine **Description:** Galantamine XL 8 mg for 4 weeks, followed by Galantamine XL 16 mg for subsequent 12 weeks. Taken in the morning with food for total of 12 weeks. **Name:** Galantamine **Other Names:** - Razadyne - Reminyl **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Placebo pill each morning with food for 12 weeks. **Name:** Placebo pill **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Analysis of spontaneous speech production with picture description (cookie theft picture): content units and lexical efficiency; as well as Boston Naming Test naming latency. **Measure:** Spontaneous Speech **Time Frame:** Every 4 weeks #### Secondary Outcomes **Description:** Aphasia Diagnostic Profile: lexical Retrieval, phrase length, phonemic fluency, and category fluency. **Measure:** ADP **Time Frame:** Every 4 weeks **Description:** Subject communication change log scores Caregiver communication change log score **Measure:** Communication Log scores **Time Frame:** Every 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosis of aphasia with relatively spared comprehension. * Onset 6 months or greater prior to enrollment. * Native English speaker * Right-handed. * Adults (18 years of age or older). Exclusion Criteria: * Patients receiving ongoing individual speech therapy. (Most patients are no longer eligible for individualized speech therapy after 6 months from stroke onset, thus this should not eliminate many patients). * Extremely mild or extremely severe aphasia. (Boston Naming Test Score \<3 or \>45 items named from 60 items). * Global dementia (and any other patient with reduced decisional capacity requiring a legally authorized representative for consent). * Presence of major cognitive deficit other than aphasia caused by stroke related disease. * Contraindications to cholinomimetic agents: History of active peptic ulcer disease within 1 year, Severe asthma, unstable angina, bradyarrhythmia with resting pulse less than 50, sick sinus syndrome, or seizures. * Major psychiatric disorders that affect cognition including: psychosis, major depression, bipolar disorder, alcohol or substance abuse. * Major medical conditions that alter cognition (e.g., heart failure, dialysis dependent renal failure, hepatic failure, active cancer). * Impairments that affect metabolism of the medication including: Severe renal impairment (Creatinine clearance equal to or greater than 9), and moderate or severe hepatic impairment (Child-Pugh score \>7) * Patients using medications that have major effects on brain neurotransmitter systems or cognition within 2 months of enrollment. Exclusionary medications are: medications with significant anti-cholinergic activity (tricyclic antidepressants, diphenhydramine), anti-Parkinsonian medications (including Sinemet, amantadine, bromocriptine, pergolide, selegiline), and narcotic analgesics (\> 2 doses per week). **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** University of North Carolina **Name:** Heidi L Roth, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000013064 - Term: Speech Disorders - ID: D000007806 - Term: Language Disorders - ID: D000003147 - Term: Communication Disorders - ID: D000019954 - Term: Neurobehavioral Manifestations - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M22306 - Name: Stroke - Relevance: HIGH - As Found: Stroke - ID: M4352 - Name: Aphasia - Relevance: HIGH - As Found: Aphasia - ID: M4353 - Name: Aphasia, Broca - Relevance: HIGH - As Found: Nonfluent Aphasia - ID: M5810 - Name: Cerebrovascular Disorders - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M15864 - Name: Speech Disorders - Relevance: LOW - As Found: Unknown - ID: M10823 - Name: Language Disorders - Relevance: LOW - As Found: Unknown - ID: M6374 - Name: Communication Disorders - Relevance: LOW - As Found: Unknown - ID: M21826 - Name: Neurobehavioral Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020521 - Term: Stroke - ID: D000001037 - Term: Aphasia - ID: D000001039 - Term: Aphasia, Broca ### Intervention Browse Module - Ancestors - ID: D000002800 - Term: Cholinesterase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000018678 - Term: Cholinergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000010277 - Term: Parasympathomimetics - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000018697 - Term: Nootropic Agents ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: NootAg - Name: Nootropic Agents ### Intervention Browse Module - Browse Leaves - ID: M6040 - Name: Cholinesterase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M8820 - Name: Galantamine - Relevance: HIGH - As Found: Aortic Valve Replacement - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M20758 - Name: Cholinergic Agents - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M20774 - Name: Nootropic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000005702 - Term: Galantamine ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05407779 **Brief Title:** Study of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of Single Escalating Doses of BCD-180 in Healthy Volunteers **Official Title:** An Open-Label, Non-controlled Study of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of Single Escalating Doses of BCD-180 (JSC BIOCAD, Russia) in Healthy Volunteers #### Organization Study ID Info **ID:** BCD-180-1 #### Organization **Class:** INDUSTRY **Full Name:** Biocad ### Status Module #### Completion Date **Date:** 2023-09-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-01-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-01-30 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-09-30 **Type:** ACTUAL #### Start Date **Date:** 2021-01-22 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2022-06-07 **Type:** ACTUAL **Study First Submit Date:** 2022-06-02 **Study First Submit QC Date:** 2022-06-02 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Biocad #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of the study is to investigate the pharmacodynamics, pharmacokinetics, safety, and immunogenicity of BCD-180 after a single intravenous administration in escalating doses to healthy volunteers. **Detailed Description:** The study will be carried out in 2 stages. Stage 1 involves administration of escalating doses of study drug (BCD-180) in 7 cohorts of healthy subjects. The first cohort will include one subject ("sentinel volunteer"). Each of the subsequent cohorts will include 3 subjects, each of whom will receive a preset cohort dose of BCD-180 as a single intravenous infusion. Stage 2: additionally two cohorts of healthy Asian volunteers (Cohorts 8 and 9) will be included: subjects will receive a single infusion of BCD-180 at selected doses (planned for further clinical development) based on the results of the main period of Stage 1. ### Conditions Module **Conditions:** - Healthy ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL **Intervention Model Description:** Stage 1. The first cohort will include one subject ("sentinel volunteer") who will receive BCD-180 at a dose 1. Starting from the 2nd cohort, the study will have a classic "3 + 3" design. Subjects will be monitored for 14 days following drug administration to assess the presence of dose limiting toxicity (DLT). In the absence of DLT, another cohort with a higher dose level will be formed. After all subjects have completed the main study period (Days 1-57), the safe dose range of BCD-180 will be determined based on assessed PD, PK, safety and immunogenicity endpoints. Further follow-up of the subjects included in stage 1 will continue up to a year. Stage 2. Two cohorts of healthy Asian volunteers (Cohorts 8 and 9) will be included. Subjects will receive a single infusion of BCD-180 at selected doses planned for further clinical development based on the results of the main period of stage 1. ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 39 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The Cohort 1 include one subject ("sentinel volunteer") to receive BCD-180 at a dose 1 **Intervention Names:** - Biological: BCD-180, dose 1 **Label:** Cohort 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The Cohort 2 include 3 subjects to receive BCD-180 at a dose 2 **Intervention Names:** - Biological: BCD-180, dose 2 **Label:** Cohort 2 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** The Cohort 3 include 3 subjects to receive BCD-180 at a dose 3 **Intervention Names:** - Biological: BCD-180, dose 3 **Label:** Cohort 3 **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** The Cohort 4 include 3 subjects to receive BCD-180 at a dose 4 **Intervention Names:** - Biological: BCD-180, dose 4 **Label:** Cohort 4 **Type:** EXPERIMENTAL #### Arm Group 5 **Description:** The Cohort 5 include 3 subjects to receive BCD-180 at a dose 5 **Intervention Names:** - Biological: BCD-180, dose 5 **Label:** Cohort 5 **Type:** EXPERIMENTAL #### Arm Group 6 **Description:** The Cohort 6 include 3 subjects to receive BCD-180 at a dose 6 **Intervention Names:** - Biological: BCD-180, dose 6 **Label:** Cohort 6 **Type:** EXPERIMENTAL #### Arm Group 7 **Description:** The Cohort 7 include 3 subjects to receive BCD-180 at a dose 7 **Intervention Names:** - Biological: BCD-180, dose 7 **Label:** Cohort 7 **Type:** EXPERIMENTAL #### Arm Group 8 **Description:** The Cohort 8 include 3 subjects to receive BCD-180 at one of two selected for the further development doses **Intervention Names:** - Biological: BCD-180, dose 6 **Label:** Cohort 8 **Type:** EXPERIMENTAL #### Arm Group 9 **Description:** The Cohort 9 include 3 subjects to receive BCD-180 at one of two selected for the further development doses **Intervention Names:** - Biological: BCD-180, dose 7 **Label:** Cohort 9 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Cohort 1 **Description:** anti-TRBV9 monoclonal antibody single infusion at dose 1 **Name:** BCD-180, dose 1 **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Cohort 2 **Description:** anti-TRBV9 monoclonal antibody, single infusion at dose 2 **Name:** BCD-180, dose 2 **Type:** BIOLOGICAL #### Intervention 3 **Arm Group Labels:** - Cohort 3 **Description:** anti-TRBV9 monoclonal antibody, single infusion at dose 3 **Name:** BCD-180, dose 3 **Type:** BIOLOGICAL #### Intervention 4 **Arm Group Labels:** - Cohort 4 **Description:** anti-TRBV9 monoclonal antibody, single infusion at dose 4 **Name:** BCD-180, dose 4 **Type:** BIOLOGICAL #### Intervention 5 **Arm Group Labels:** - Cohort 5 **Description:** anti-TRBV9 monoclonal antibody, single infusion at dose 5 **Name:** BCD-180, dose 5 **Type:** BIOLOGICAL #### Intervention 6 **Arm Group Labels:** - Cohort 6 - Cohort 8 **Description:** anti-TRBV9 monoclonal antibody, single infusion at dose 6 **Name:** BCD-180, dose 6 **Type:** BIOLOGICAL #### Intervention 7 **Arm Group Labels:** - Cohort 7 - Cohort 9 **Description:** anti-TRBV9 monoclonal antibody, single infusion at dose 7 **Name:** BCD-180, dose 7 **Type:** BIOLOGICAL ### Outcomes Module #### Other Outcomes **Measure:** Proportion of subjects with serious adverse reactions **Time Frame:** 361 days after the study drug administration for stage 1 **Measure:** Proportion of subjects with serious adverse reactions **Time Frame:** 57 days after the study drug administration for stage 2 **Measure:** Proportion of subjects with adverse reactions of grade 3 or higher according to CTCAE 5.0 **Time Frame:** 361 days after the study drug administration for stage 1 **Measure:** Proportion of subjects with adverse reactions of grade 3 or higher according to CTCAE 5.0 **Time Frame:** 361 days after the study drug administration for stage 2 **Measure:** Proportion of subjects who prematurely withdrew from the study due to adverse reactions **Time Frame:** 361 days after the study drug administration fo stage 1 **Measure:** Proportion of subjects who prematurely withdrew from the study due to adverse reactions **Time Frame:** 57 days after the study drug administration fo stage 2 **Measure:** Proportion of Binding antibodies (BAb) and neutrolizing antibodies (NAb) positive subjects **Time Frame:** 361 days after the study drug administration **Measure:** Proportion of Binding antibodies (BAb) and neutrolizing antibodies (NAb) positive subjects **Time Frame:** 361 days after the study drug administration fo stage 1 **Measure:** Titer of BAb and/or NAb **Time Frame:** 361 days after the study drug administration for stage 1 **Measure:** Titer of BAb and/or NAb antibodies **Time Frame:** 57 days after the study drug administration for stage 2 **Description:** Area under the concentration-time curve from administration to Day 57 (1344 hours) **Measure:** AUC 0-1344 **Time Frame:** day 57 **Description:** Area under the concentration-time curve from administration to Day 85 (2016 hours) (for stage 1) **Measure:** AUC0-2016 **Time Frame:** day 85 #### Primary Outcomes **Measure:** Proportion of subjects with adverse reactions **Time Frame:** 361 days after the study drug administration for stage 1 **Measure:** Proportion of subjects with adverse reactions **Time Frame:** 57 days after the study drug administration for stage 2 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Signed Informed consent form (ICF) for participation in the study. 2. Men aged 18 to 45 inclusive at the time of ICF signing. 3. For stage 2: Asian race. 4. The ability of the subject to follow the Protocol procedures, according to the investigator. 5. A diagnosis of "health" established using standard clinical, laboratory tests and investigations carried out at screening, according to the investigator, as well as medical history data (no acute or chronic respiratory, gastrointestinal, cardiovascular, nervous system diseases, hepatic or renal impairment). 6. Hemodynamic parameters within normal limits: systolic blood pressure (SBP) within 100-130 mm Hg, diastolic blood pressure (DBP) within 60-90 mm Hg, pulse rate within 60-90 bpm. 7. Willingness of subjects and their female sexual partners of childbearing potential to use reliable contraception from the ICF signing throughout the main period of the study and during Day 57 of the main period of the study. This requirement does not apply to subjects who have had surgical sterilization. Reliable methods of contraception involve the use of one barrier method in combination with one of the following in the female partner: spermicides, intrauterine device/oral contraceptives. 8. Willingness to refrain from participating in any other clinical trials, starting from the ICF signing, throughout the main study period and during Day 57 of the main study period, and in other clinical trials involving the administration of any drugs that affect the human immune system, including other monoclonal antibody products with immunosuppressive action, during the current study, i.e., until the end of participation in it. Exclusion Criteria: 1. Any medical or social condition that, in the opinion of the investigator, precludes participation in this study. 2. Any confirmed or suspected immunosuppressive or immunodeficient condition. 3. Any acute infectious or non-infectious disease, including convalescence, less than 4 weeks from clinical recovery, as well as during the screening. 4. A diagnosis of infectious mononucleosis (either documented or reported by the subject) made within 2 months prior to the ICF signing or during the screening. 5. BCG (Bacillus Calmette-Guérin vaccine) vaccination (within 12 weeks), administration of live vaccines (within 8 weeks) or any other vaccines (within 4 weeks) before signing the ICF or during the screening. 6. Medical history of allergic reactions and evidence of other significant adverse reactions after administration of any medicinal products. 7. Hypersensitivity to any of the BCD-180 ingredients or premedication drugs. 8. Body mass index (BMI) outside of the normal range (18.0-30.0 kg/m2). 9. Results of standard laboratory and imaging tests that fall beyond the reference intervals adopted at the study center. 10. Positive screening tests for HIV infection, hepatitis B and C, syphilis, tuberculosis. 11. Positive urine test for psychotropic, narcotic, psychoactive drugs or saliva alcohol test at screening. 12. Impossibility of venipuncture to collect blood samples (for example, due to skin disease at venipuncture sites). 13. Long-term (more than 14 days) use of drugs that have a pronounced effect on hemodynamics, liver function, etc. (barbiturates, omeprazole, cimetidine, etc.) less than 30 days before the ICF signing; prior use of drugs that affect the immune system, including other monoclonal antibody products, with immunosuppressive action. 14. Regular oral or parenteral administration of any medicinal products, including over-the-counter drugs, vitamins and dietary supplements, less than 14 days before the ICF signing. 15. Smoking more than 10 cigarettes a day. 16. Consumption of more than 10 units of alcohol per week (1 unit of alcohol is equivalent to ½ L of beer, 200 mL of wine or 20 mL of spirits) or a history of alcoholism, drug addiction or drug abuse. 17. Surgical interventions performed less than 90 days before the ICF signing. 18. Donation of 450 mL or more of blood or plasma within 60 days prior to the ICF signing. 19. Participation in any clinical studies of medicinal products less than 90 days prior to the ICF signing; previous participation in this study in case of administration of the investigational product . 20. For stage 2: a history of coronavirus infection (positive polymerase chain reaction (PCR) test for SARC-CoV2-RNA) within 8 weeks prior to the ICF signing. **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Saint Petersburg **Country:** Russian Federation **Facility:** X7 Clinical Research ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M4230 - Name: Antibodies, Monoclonal - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05163379 **Brief Title:** EARLY MOBILIZATION OF INTUBETED PATIENTS IN THE INTENSİVE CARE UNİT AND THE EFFECTS OF EARLY MOBILIZATION ON RESPIRATORY PATTERN AND PATIENT HEMODYNAMICS **Official Title:** EARLY MOBILIZATION OF INTUBETED PATIENTS IN THE INTENSİVE CARE UNİT AND THE EFFECTS OF EARLY MOBILIZATION ON RESPIRATORY PATTERN AND PATIENT HEMODYNAMICS #### Organization Study ID Info **ID:** GURKANCAMOK #### Organization **Class:** OTHER **Full Name:** Okan University ### Status Module #### Completion Date **Date:** 2022-03-01 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** NOT_YET_RECRUITING #### Last Update Post Date **Date:** 2021-12-20 **Type:** ACTUAL **Last Update Submit Date:** 2021-12-06 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2022-02-01 **Type:** ESTIMATED #### Start Date **Date:** 2021-12-10 **Type:** ESTIMATED **Status Verified Date:** 2021-12 #### Study First Post Date **Date:** 2021-12-20 **Type:** ACTUAL **Study First Submit Date:** 2021-12-06 **Study First Submit QC Date:** 2021-12-06 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Okan University #### Responsible Party **Investigator Affiliation:** Okan University **Investigator Full Name:** Gürkan ÇAMOK **Investigator Title:** Nursing Graduate Student **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The present study was carried out as a quasi-experimental study in order to examine the effects of early mobilization of intubated patients in the intensive care unit and the effects of early mobilization on respiratory pattern and patient hemodynamics. The sample of the study consisted of 25 intubated patients monitored in the intensive care unit at in a private hospital between May 2020 and July 2021. Ethics committee approval and study permission were obtained from the hospital before starting the data collection process. Research data, descriptive data collection form, Richmond- Agitation Sedation Scale (RASS) scale, Muscle Strength Testing (Oxford Scale) and with the mobilization of the patients 45 minute in 30-60 minute including the preparation process, (1st Stage Semi Fowler position, 2nd Stage bedside sitting position, 3rd Stage in the bedside sitting position after mobilization) were registered in the Early Mobilization Follow-up Form and collected. Number and percentage calculations, repeated measurement ANOVA and Post Hoc Sheffe, LSD test analyzes were utilized in the evaluation of the data. ### Conditions Module **Conditions:** - Intensive Care Unit Acquired Weakness - Intensive Care, Intubated Patient, Early Mobilization, Mobilization, Respiratory Pattern ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 25 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Day ### Arms Interventions Module #### Arm Group 1 **Description:** EARLY MOBILIZATION OF INTUBE PATIENTS **Intervention Names:** - Other: MOBILIZATION **Label:** INTENSIVE CARE PATIENTS ### Interventions #### Intervention 1 **Arm Group Labels:** - INTENSIVE CARE PATIENTS **Description:** EARLY MOBILIZATION OF INTUBE PATIENTS AND ITS EFFECTS OF MOBILIZATION **Name:** MOBILIZATION **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** HEMODYNAMIC EFFECTSRESPIRATORY PATTERN, BLOOD GAS ANALYSISZ **Measure:** EARLY MOBILIZATION OF INTUBE PATIENTS AND THE EFFECTS OF EARLY MOBLIZATION ON RESPIRATORY PATTERN AND PATIENT HEMODYNAMICS **Time Frame:** ONE DAY ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18 years and over, * Hemodiamic stability (OCD \>60, OCD \<120, respiratory rate \<35, SpO2 \>90), * Areas of \>3/5 (Oxford scale) and above on the lower limbs with areas of secure support, * The patient scores 0 (awake and calm) on the Richmond Agitation Sedation Scale (RASS), * PaO2 / FiO2 ≥300, * Body temperature below 38 degrees, * Platelet count ≥20,000 cells / mm3, * Having blood sugar of 60-360 mg/dl, * Having arterial monitoring, * Patient with 30% FiO2 due to mechanical ventilator, * Those with mechanical ventilator-dependent ventilation method (mode) PASB, * Patient with a PEEP value of 5 due to mechanical ventilator, * Patient with a PASB value of 10 connected to a mechanical ventilator, * A sample accepted by the patient who voluntarily agreed to participate in the study was approximated from the patient. Exclusion Criteria: * Patients under the age of 18, * Those with hemodynamic instability (OCD \<60 mmHg, OCD \>120 mmHg, breath rate \>35, SpO2 \<90), * Those who do not have secure unsupported sitting balance and have a score of \>3/5 (Oxford scale) in the lower limbs, * Patients whose Richmond agitation sedation scale (RASS) is between +1 and +4 points, and patients with a score between -1 and -5, * Those with arrhythmia, * Patients without arterial monitoring, * Patients whose FiO2 percentage is not 30% in patients on mechanical ventilator, * Patients who do not have ventilation method (mod) PASB in patients on mechanical ventilator, * Patients who do not have a PEEP value of 5 in patients on mechanical ventilators, * Patients who do not have a PASB value of 10 in patients on mechanical ventilators, * Those with neurological and orthopedic contraindications, * Patients who could not get approval from the relatives of the patients who did not accept to participate in the study were excluded from the study. **Healthy Volunteers:** True **Maximum Age:** 90 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** INTUBE PATIENTS IN ICU ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** GÜRKAN ÇAMOK - **Phone:** +905380301709 - **Role:** CONTACT **Country:** Turkey **Facility:** Gürkan ÇAMOK **State:** İ̇stanbul **Zip:** 34959 ### IPD Sharing Statement Module **Description:** all of **IPD Sharing:** UNDECIDED ### References Module #### Available IPDs **Type:** Study Protocol **URL:** https://khgmekodemedb.saglik.gov.tr/Eklenti/23273/0/fizik-tedavi-ve-rehabilitasyon-islemleri-degerlendirme-olcekleripdf.pdf #### References **Citation:** Green M, Marzano V, Leditschke IA, Mitchell I, Bissett B. Mobilization of intensive care patients: a multidisciplinary practical guide for clinicians. J Multidiscip Healthc. 2016 May 25;9:247-56. doi: 10.2147/JMDH.S99811. eCollection 2016. **PMID:** 27307746 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4554 - Name: Asthenia - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05275179 **Brief Title:** Pharmacokinetic of Posaconazole in Critically Ill Patients **Official Title:** Pharmacokinetic of Intravenous Posaconazole in Critically Ill Patients #### Organization Study ID Info **ID:** PV7263 #### Organization **Class:** OTHER **Full Name:** Universitätsklinikum Hamburg-Eppendorf ### Status Module #### Completion Date **Date:** 2022-11-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-11-08 **Type:** ACTUAL **Last Update Submit Date:** 2022-11-06 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-03-30 **Type:** ACTUAL #### Start Date **Date:** 2021-02-11 **Type:** ACTUAL **Status Verified Date:** 2022-11 #### Study First Post Date **Date:** 2022-03-11 **Type:** ACTUAL **Study First Submit Date:** 2022-01-21 **Study First Submit QC Date:** 2022-03-01 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universitätsklinikum Hamburg-Eppendorf #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** The posaconazole pharmacokinetic in critically ill patients will be studied in a prospective, non-interventional, monocentric observational trial. **Detailed Description:** The posaconazole pharmacokinetic in critically ill patients will be studied in a prospective, non-interventional, monocentric observational trial. Plasma specimens will be retrieved on consecutive days (max. 7 days) in order to measure posaconazole levels during the treatment episode. ### Conditions Module **Conditions:** - Therapeutic Drug Monitoring - Critical Illness ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 10 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Therapeutic Drug Monitoring of posaconzole is performed by measuring posaconazole concentrations in serum **Intervention Names:** - Other: Posaconazole Therapeutic Drug Monitoring **Label:** Posaconazole Therapeutic Drug Monitoring ### Interventions #### Intervention 1 **Arm Group Labels:** - Posaconazole Therapeutic Drug Monitoring **Description:** Therapeutic Drug Monitoring is performed by measuring posaconazole concentrations in serum on seven consecutive days (anticipated). **Name:** Posaconazole Therapeutic Drug Monitoring **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Measurement of posaconazole concentration in serum **Measure:** Posaconazole Drug Exposure **Time Frame:** seven days from therapystart #### Secondary Outcomes **Description:** Analysis of Peak Plasma Concentration (Cmax) for posaconazole in the given cohort. **Measure:** population-pharmacokinetic analysis 1 **Time Frame:** 12 months after close out **Description:** Analysis of Area under the plasma concentration versus time curve (AUC) for posaconazole in the given cohort. **Measure:** population-pharmacokinetic analysis 2 **Time Frame:** 12 months after close out **Description:** Analysis of Monte-Carlo-Simulations in order to asses novel dosing regimens for posaconazole. **Measure:** Evaluation of probability of target attainment of posaconazole **Time Frame:** 12 months after close out ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * treatment with intravenous posaconazole * critically ill patient * written declaration of consent Exclusion Criteria: - no declaration of consent **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Critically ill patients treated with posaconazole intravenously. ### Contacts Locations Module #### Locations **Location 1:** **City:** Hamburg **Country:** Germany **Facility:** University Medical Center Hamburg-Eppendorf **Zip:** 20246 #### Overall Officials **Official 1:** **Affiliation:** Universitätsklinikum Hamburg-Eppendorf **Name:** Dominic Wichmann, Prof **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M19010 - Name: Critical Illness - Relevance: HIGH - As Found: Critical Illness - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016638 - Term: Critical Illness ### Intervention Browse Module - Ancestors - ID: D000000935 - Term: Antifungal Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000014344 - Term: Trypanocidal Agents - ID: D000000981 - Term: Antiprotozoal Agents - ID: D000000977 - Term: Antiparasitic Agents - ID: D000058888 - Term: 14-alpha Demethylase Inhibitors - ID: D000065607 - Term: Cytochrome P-450 Enzyme Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000065088 - Term: Steroid Synthesis Inhibitors - ID: D000006727 - Term: Hormone Antagonists - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M219015 - Name: Posaconazole - Relevance: HIGH - As Found: Venous Thromboembolism - ID: M6252 - Name: Clotrimazole - Relevance: LOW - As Found: Unknown - ID: M11796 - Name: Miconazole - Relevance: LOW - As Found: Unknown - ID: M4254 - Name: Antifungal Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M4298 - Name: Antiprotozoal Agents - Relevance: LOW - As Found: Unknown - ID: M4294 - Name: Antiparasitic Agents - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M30537 - Name: Cytochrome P-450 Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000101425 - Term: Posaconazole ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03370679 **Acronym:** PULSE **Brief Title:** The Prognostic Significance of Premature Ventricular Complexes in Patients Without Structural Heart Disease **Official Title:** The Prognostic Significance of Premature Ventricular Complexes in Patients Without Structural Heart Disease #### Organization Study ID Info **ID:** PULSE #### Organization **Class:** OTHER **Full Name:** Danderyd Hospital ### Status Module #### Completion Date **Date:** 2018-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-02-05 **Type:** ACTUAL **Last Update Submit Date:** 2018-02-01 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-12 **Type:** ACTUAL #### Start Date **Date:** 2013-09 **Type:** ACTUAL **Status Verified Date:** 2018-02 #### Study First Post Date **Date:** 2017-12-12 **Type:** ACTUAL **Study First Submit Date:** 2017-11-30 **Study First Submit QC Date:** 2017-12-06 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Danderyd Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** With this project the investigators aim to investigate whether premature ventricular complexes (PVC) have a prognostic significance in persons without structural heart disease. Further the investigators look at the possible connection between PVC-morphology and clinical outcome and investigate whether advanced cardiac imaging-methods may identify subtle signs of heart disease in PVC-patients with normal findings at echocardiography. **Detailed Description:** The PULSE project consists of four different studies: * in study one the investigators include patients who are evaluated because of PVCs and have no signs of structural heart disease at echocardiography and exercise test. The investigators follow them (average follow-up time 3,5 years) to investigate if they have a higher mortality och cardiovascular morbidity than standard population * in study two the investigators carry out a sub-group analysis of the population in study one to assess whether PVC:s different sites of origin (morphology) are related to the clinical outcome * in study three the investigators include persons with a high PVC-burden (at least 10 000 PVC:s/day) and normal echocardiography. The included subjects undergo magnetic resonance (MR) to investigate whether it can identify signs of heart disease where standard echocardiography cannot ### Conditions Module **Conditions:** - Premature Ventricular Complexes Multiple - Premature Ventricular Contraction **Keywords:** - Premature - Ventricular - Complexes - Beats - Prognosis ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 1000 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Mortality compared with sex and age-matched control population. Data for Control population obtained via Socialstyrelsen (The Swedish Health Board) **Measure:** Mortality **Time Frame:** Average follow-up time 3,5 years #### Secondary Outcomes **Description:** Incidence of heart failure and myocardial infarction in the study population compared with age and sex-matched Controls. Control data obtained via Socialstyrelsen (The Swedish Health Board) **Measure:** Cardiovascular morbidity **Time Frame:** Average follow-up time 3,5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: - Diagnosed with Premature Ventricular Complexes at Three major Hospitals in Stockholm, Sweden Exclusion Criteria: * History of Myocardial Infarction * Undergone coronary arterty bypass grafting (CABG) * Finding of Heart Failure at echocardiography * Direct or indirect findings of coronary ischaemia at exercise test, coronary angiography or other equivalent examination **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with Premature Ventricular Complexes treated at Three major hospitals in the Stockholm area (Danderyd Hospital, Karolinska Hospital and Södersjukhuset Hospital) ### Contacts Locations Module #### Locations **Location 1:** **City:** Stockholm **Country:** Sweden **Facility:** Hjärtkliniken Danderyds Sjukhus #### Overall Officials **Official 1:** **Affiliation:** Karolinska Institutet - Danderyd Hospital **Name:** Raffaele Scorza, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000007752 - Term: Obstetric Labor, Premature - ID: D000007744 - Term: Obstetric Labor Complications - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000005117 - Term: Cardiac Complexes, Premature - ID: D000001145 - Term: Arrhythmias, Cardiac - ID: D000075224 - Term: Cardiac Conduction System Disease - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M25869 - Name: Premature Birth - Relevance: HIGH - As Found: Premature - ID: M9419 - Name: Heart Diseases - Relevance: HIGH - As Found: Heart Disease - ID: M20921 - Name: Ventricular Premature Complexes - Relevance: HIGH - As Found: Premature Ventricular Complex - ID: M10772 - Name: Obstetric Labor, Premature - Relevance: LOW - As Found: Unknown - ID: M10764 - Name: Obstetric Labor Complications - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8260 - Name: Cardiac Complexes, Premature - Relevance: LOW - As Found: Unknown - ID: M4453 - Name: Arrhythmias, Cardiac - Relevance: LOW - As Found: Unknown - ID: M1472 - Name: Cardiac Conduction System Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000047928 - Term: Premature Birth - ID: D000006331 - Term: Heart Diseases - ID: D000018879 - Term: Ventricular Premature Complexes ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03875079 **Brief Title:** A Study To Evaluate Safety And Therapeutic Activity Of RO6874281 In Combination With Pembrolizumab, In Participants With Advanced Or Metastatic Melanoma **Official Title:** An Open-Label, Multicenter, Phase Ib Study To Evaluate Safety And Therapeutic Activity Of RO6874281, An Immunocytokine, Consisting Of Interleukin-2 Variant (IL-2v) Targeting Fibroblast Activation Protein-Α (FAP), In Combination With Pembrolizumab (Anti-PD-1), In Participants With Advanced Or Metastatic Melanoma #### Organization Study ID Info **ID:** BP41054 #### Organization **Class:** INDUSTRY **Full Name:** Hoffmann-La Roche #### Secondary ID Infos **ID:** 2018-003872-11 **Type:** EUDRACT_NUMBER ### Status Module #### Completion Date **Date:** 2022-07-14 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-03-29 **Type:** ACTUAL **Last Update Submit Date:** 2023-03-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-07-14 **Type:** ACTUAL #### Start Date **Date:** 2019-06-24 **Type:** ACTUAL **Status Verified Date:** 2023-03 #### Study First Post Date **Date:** 2019-03-14 **Type:** ACTUAL **Study First Submit Date:** 2019-03-13 **Study First Submit QC Date:** 2019-03-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Hoffmann-La Roche #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** This is an open-label, multicenter, Phase Ib study to evaluate the safety and therapeutic activity of RO6874281 in combination with pembrolizumab. The study will consist of 3 parts: a safety run-in (Part I: Cohorts 1.1. and 1.2) and two expansion parts (Parts II and III). Part II will start once all participants in Cohort 1.1 have completed the observation period. Part III will start once all participants in Cohorts 1.1 and 1.2 have completed the observation period. ### Conditions Module **Conditions:** - Metastatic Melanoma ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 83 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Cohort 1.1 (CPI naive and experienced melanoma participants): Participants will receive RO6874281 in combination with Pembrolizumab every 3 weeks (Q3W) and will be observed for 2 cycles (ie: 6 weeks) in order to confirm the safety of the proposed dose and schedule that will be used in Part II of this study. Cohort 1.2 (CPI experienced melanoma participants only): Participants will receive RO6874281 in combination with Pembrolizumab via an induction and maintenance schedule for RO6874281: QW three times (D1, D8, D15) followed by Q3W dosing (D22 and subsequent). Pembrolizumab is to be administered Q3W, starting on Day 1. Participants will be observed for 2 pembrolizumab cycles (ie: 6 weeks) in order to confirm the safety of the proposed dose and schedule that will be used in Part III of this study. **Intervention Names:** - Drug: RO6874281 - Drug: Pembrolizumab **Label:** Part I Safety Run in: RO6874281 + Pembrolizumab **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Part II will start once all participants in Part I Cohort 1.1 have completed the observation period. Approximately 34 participants will receive RO6874281 in combination with Pembrolizumab every 3 weeks (Q3W) and will be observed for 2 cycles (ie: 6 weeks). **Intervention Names:** - Drug: RO6874281 - Drug: Pembrolizumab **Label:** Part II Expansion: RO6874281 + Pembrolizumab **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Part III will start once all participants in Part I Cohorts 1.1 and 1.2 have completed the observation period. Approximately 80 participants will be randomised to receive RO6874281 in combination with Pembrolizumab in either a Q3W or QW/Q3W schedule. **Intervention Names:** - Drug: RO6874281 - Drug: Pembrolizumab **Label:** Part III Expansion: RO6874281 + Pembrolizumab **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Part I Safety Run in: RO6874281 + Pembrolizumab - Part II Expansion: RO6874281 + Pembrolizumab - Part III Expansion: RO6874281 + Pembrolizumab **Description:** Part I Safety Run in: Cohort 1.1: RO6874281 will be administered by intravenous (IV) infusion; 10 mg (Q3W) every 3 weeks and will be observed over 2 administration cycles (i.e. 6 weeks) in order to confirm the safety of the proposed dose and schedule that will be used in Part II of this study. Cohort 1.2: RO6874281 will be administered by IV infusion via an induction and maintenance phase; 10 mg (QW) every week for 3 weeks followed by 10 mg (Q3W) every 3 weeks and will be observed over 2 administration cycles (6 weeks) to confirm safety of the proposed dose and schedule to be used in Part III of this study. Part II Expansion: RO6874281 will be administered by IV infusion; 10 mg (Q3W) every 3 weeks (or lower dose level depending on Part I Cohort 1.1 outcome). Part III Expansion: RO6874281 will be administered by IV infusion; 10 mg (QW) every week or 10mg (Q3W) every 3 weeks (or lower dose level depending on Part I Cohorts 1.1 and 1.2 outcomes) in either a Q3W or QW/Q3W schedule. **Name:** RO6874281 **Other Names:** - simlukafusp alfa **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Part I Safety Run in: RO6874281 + Pembrolizumab - Part II Expansion: RO6874281 + Pembrolizumab - Part III Expansion: RO6874281 + Pembrolizumab **Description:** Part I Safety Run in (Cohorts 1.1 and 1.2): Pembrolizumab will be administered by IV; 200 mg Q3W and will be observed over 2 administration cycles (i.e. 6 weeks). Part II Expansion: Pembrolizumab will be administered by IV; 200 mg Q3W (or lower dose level depending on Part I Cohort 1.1 outcome) Part III Expansion: Pembrolizumab will be administered by IV; 200 mg Q3W (or lower dose level depending on Part I Cohorts 1.1 and 1.2 outcomes) **Name:** Pembrolizumab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Percentage of participants with adverse events **Time Frame:** Baseline to end of study (approximately 24 months) #### Secondary Outcomes **Measure:** Objective Response Rate (ORR) **Time Frame:** Time from first occurrence of a documented objective response until the time of documented disease progression or death from any cause during treatment (whichever occurs first) until the end of study (approximately 24 months) **Measure:** Complete Response Rate (CRR) **Time Frame:** Baseline to end of study (approximately 24 months) **Measure:** Disease Control Rate (DCR) **Time Frame:** Baseline to end of study (approximately 24 months) **Measure:** Duration of Response **Time Frame:** Time from first occurrence of a documented objective response until the time of documented disease progression or death from any cause during treatment (whichever occurs first) until the end of study (approximately 24 months) **Measure:** Progression Free Survival (PFS) **Time Frame:** Time from study treatment initiation to the first occurrence of documented disease progression (based on Investigator's assessment) or death from any cause during treatment (whichever occurs first) until the end of study (approximately 24 months) **Measure:** Baseline PD-L1 **Time Frame:** Baseline to end of study (approximately 24 months) **Measure:** Fibroblast Activation Protein-a (FAP) **Time Frame:** Baseline to end of study (approximately 24 months) **Measure:** Change from baseline in density (cell/mm2) of immune cells including CD8+, FOXP3, and PD-L1 **Time Frame:** Baseline to end of study (approximately 24 months) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Histologically confirmed unresectable stage III or stage IV cutaneous or mucosal melanoma (AJCC v8.0). 2. Participants need to have known BRAF status. 3. CPI naïve melanoma population: Participants with unresectable stage III or stage IV cutaneous or mucosal melanoma who have not received prior treatment for advanced disease. BRAF mutation-positive patients are eligible without prior treatment or after failure of BRAF directed inhibitor therapy. 4. CPI experienced melanoma population: Participants with unresectable stage III or stage IV cutaneous melanoma. Participants must have progressed during or after treatment with anti PD-1 antibody therapy, either as monotherapy or in combination with other agent(s). 5. Participants should have adequate cardiovascular, hematological, liver, and renal function. 6. Participants with unilateral pleural effusion are eligible if they fulfill both of the following: NYHA Class 1; Forced expiratory volume 1 (FEV1) \>70% and forced vital capacity (FVC) \>70% of predicted value; participants with lung metastases should present with DLCO \>60% of predicted value. Exclusion criteria: Medical Conditions 1. Rapid disease progression or suspected hyperprogression (as determined by the Investigator) or threat to vital organs or critical anatomical sites requiring urgent alternative medical intervention. 2. Known active CNS metastases and/or carcinomatous meningitis/leptomeningeal disease: Participants with previously treated brain metastases may participate. 3. History of treated asymptomatic CNS metastases. 4. An active second malignancy (exceptions are non-melanoma skin cancer, cervical carcinoma in situ, or prostate carcinoma that is in remission under androgen deprivation therapy for ≥ 2 years, or participants who have a history of malignancy and have been treated with curative intent and the participant is expected to be cured as per Investigator's assessment). 5. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, and known autoimmune diseases or other disease with ongoing fibrosis (such as scleroderma, pulmonary fibrosis. and emphysema). 6. Episode of significant cardiovascular/cerebrovascular acute disease within 6 months before study treatment administration. 7. Active or uncontrolled infections, including latent tuberculosis. 8. Known HIV infection. 9. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 10. Severe infection within 4 weeks before study treatment administration, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia. 11. History of chronic liver disease or evidence of hepatic cirrhosis. 12. Dementia or altered mental status that would prohibit informed consent. 13. History of autoimmune disease. 14. Adverse events related to any previous radiotherapy, chemotherapy, targeted therapy, CPI therapy or surgical procedure that have not resolved to Grade =\< 1, except alopecia (any grade) and Grade 2 peripheral neuropathy. 15. History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. 16. Bilateral pleural effusion. 17. Severe dyspnea at rest or requiring supplementary oxygen therapy. 18. Concurrent therapy with any other investigational drug (defined as a treatment for which there is currently no regulatory authority approved indication). 19. Immunomodulating agents: Last dose with any of the following agents, for example, etanercept, infliximab, tacrolimus, cyclosporine, mycophenolic acid, alefacept, or efalizumab (or similar agents) \< 28 days before study treatment administration. Regular immunosuppressive therapy (i.e., for organ transplantation, chronic rheumatologic disease) 20. Treatment with systemic immunosuppressive medications including, but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents within 2 weeks prior to Cycle 1 Day 1. 21. Radiotherapy within the last 4 weeks before start of study treatment administration, with the exception of limited field palliative radiotherapy. 22. Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1. 23. Major surgery or significant traumatic injury \< 28 days before study treatment administration (excluding fine needle biopsies) or anticipation of the need for major surgery during study treatment. 24. Known hypersensitivity to any of the components of the RO6874281 drug product or pembrolizumab drug product, including but not limited to hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies. 25. No prior cytotoxic therapy for unresectable stage III or stage IV disease is permitted. 26. Toxicity from prior anti-PD-1 antibody therapy (including adjuvant treatment). **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** New Haven **Country:** United States **Facility:** Yale University **State:** Connecticut **Zip:** 06510 **Location 2:** **City:** Iowa City **Country:** United States **Facility:** University of Iowa **State:** Iowa **Zip:** 52242 **Location 3:** **City:** Boston **Country:** United States **Facility:** Beth Israel Deaconess Med Ctr **State:** Massachusetts **Zip:** 02215 **Location 4:** **City:** Boston **Country:** United States **Facility:** Dana Farber Cancer Institute **State:** Massachusetts **Zip:** 02215 **Location 5:** **City:** North Sydney **Country:** Australia **Facility:** Melanoma Institute Australia **State:** New South Wales **Zip:** 2060 **Location 6:** **City:** Melbourne **Country:** Australia **Facility:** Peter Maccallum Cancer Institute; Clinical Trial Unit **State:** Victoria **Zip:** 3000 **Location 7:** **City:** Edegem **Country:** Belgium **Facility:** UZ Antwerpen **Zip:** 2650 **Location 8:** **City:** Leuven **Country:** Belgium **Facility:** UZ Leuven Gasthuisberg **Zip:** 3000 **Location 9:** **City:** Toronto **Country:** Canada **Facility:** Princess Margaret Cancer Centre **State:** Ontario **Zip:** M5G 1Z5 **Location 10:** **City:** Montreal **Country:** Canada **Facility:** Jewish General Hospital **State:** Quebec **Zip:** H3T 1E2 **Location 11:** **City:** Lille **Country:** France **Facility:** Hopital Claude Huriez; Sce Dermatologie **Zip:** 59037 **Location 12:** **City:** Marseille **Country:** France **Facility:** Hôpital de la Timone; Dermatologie **Zip:** 13005 **Location 13:** **City:** Rennes **Country:** France **Facility:** Centre Eugene Marquis; Service d'oncologie **Zip:** 35042 **Location 14:** **City:** Villejuif **Country:** France **Facility:** Institut Gustave Roussy; Dermatologie **Zip:** 94805 **Location 15:** **City:** Moscow **Country:** Russian Federation **Facility:** Main Military Clinical Hospital named after N.N. Burdenko **State:** Moskovskaja Oblast **Zip:** 105229 **Location 16:** **City:** Moscow **Country:** Russian Federation **Facility:** Russian Oncology Research Center n.a. N.N. Blokhin **Zip:** 115478 **Location 17:** **City:** Moscow **Country:** Russian Federation **Facility:** P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept **Zip:** 125284 **Location 18:** **City:** Saint-Petersburg **Country:** Russian Federation **Facility:** FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov" **Location 19:** **City:** Pamplona **Country:** Spain **Facility:** Clinica Universitaria de Navarra; Servicio de Oncologia **State:** Navarra **Zip:** 31008 **Location 20:** **City:** Barcelona **Country:** Spain **Facility:** Hospital Universitari Vall d'Hebron; Oncology **Zip:** 08035 **Location 21:** **City:** Barcelona **Country:** Spain **Facility:** Hospital Clínic i Provincial; Servicio de Oncología **Zip:** 08036 **Location 22:** **City:** Madrid **Country:** Spain **Facility:** Clinica Universidad de Navarra Madrid; Servicio de Oncología **Zip:** 28027 **Location 23:** **City:** Madrid **Country:** Spain **Facility:** Hospital Ramon y Cajal; Servicio de Oncologia **Zip:** 28034 #### Overall Officials **Official 1:** **Affiliation:** Hoffmann-La Roche **Name:** Clinical Trials **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** "Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)." **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000018358 - Term: Neuroendocrine Tumors - ID: D000017599 - Term: Neuroectodermal Tumors - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009380 - Term: Neoplasms, Nerve Tissue - ID: D000018326 - Term: Nevi and Melanomas - ID: D000012878 - Term: Skin Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11528 - Name: Melanoma - Relevance: HIGH - As Found: Melanoma - ID: M20495 - Name: Neuroendocrine Tumors - Relevance: LOW - As Found: Unknown - ID: M19845 - Name: Neuroectodermal Tumors - Relevance: LOW - As Found: Unknown - ID: M20388 - Name: Neuroectodermal Tumors, Primitive - Relevance: LOW - As Found: Unknown - ID: M12318 - Name: Neoplasms, Germ Cell and Embryonal - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M12325 - Name: Neoplasms, Nerve Tissue - Relevance: LOW - As Found: Unknown - ID: M12448 - Name: Nevus, Pigmented - Relevance: LOW - As Found: Unknown - ID: M12446 - Name: Nevus - Relevance: LOW - As Found: Unknown - ID: M20470 - Name: Nevi and Melanomas - Relevance: LOW - As Found: Unknown - ID: M15681 - Name: Skin Neoplasms - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: T4091 - Name: Neuroendocrine Tumor - Relevance: LOW - As Found: Unknown - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008545 - Term: Melanoma ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000082082 - Term: Immune Checkpoint Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M349416 - Name: Pembrolizumab - Relevance: HIGH - As Found: Blind - ID: M10411 - Name: Interleukin-2 - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000582435 - Term: Pembrolizumab ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02468479 **Brief Title:** Prognostic Values of Chest/Abdominal Wall Varices and Spider Nevi in Patients With Liver Cirrhosis **Official Title:** Prognostic Values of Chest/Abdominal Wall Varices and Spider Nevi in Patients #### Organization Study ID Info **ID:** CAWV-LC #### Organization **Class:** OTHER **Full Name:** General Hospital of Shenyang Military Region ### Status Module #### Completion Date **Date:** 2016-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-04-19 **Type:** ACTUAL **Last Update Submit Date:** 2017-04-18 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2016-12 **Type:** ACTUAL #### Start Date **Date:** 2015-06 **Status Verified Date:** 2017-04 #### Study First Post Date **Date:** 2015-06-10 **Type:** ESTIMATED **Study First Submit Date:** 2015-06-04 **Study First Submit QC Date:** 2015-06-06 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** General Hospital of Shenyang Military Region #### Responsible Party **Investigator Affiliation:** General Hospital of Shenyang Military Region **Investigator Full Name:** Xingshun Qi **Investigator Title:** Doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Chest/abdominal wall varices and spider nevi are two common presenting signs of liver cirrhosis. Their prognostic values remain unclear. ### Conditions Module **Conditions:** - Liver Cirrhosis **Keywords:** - Liver cirrhosis ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 200 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** No relevant intervention. **Name:** No relevant intervention. **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Baseline data **Measure:** Prevalence and type of chest/abdominal wall varices and spider nevi **Time Frame:** 1.5 years **Description:** Baseline data **Measure:** Association between etiology of liver cirrhosis and type of chest/abdominal wall varices and spider nevi **Time Frame:** 1.5 years **Description:** Baseline data **Measure:** Association between degree of liver function and type of chest/abdominal wall varices and spider nevi **Time Frame:** 1.5 years **Description:** Follow-up data **Measure:** Effect of chest/abdominal wall varices and spider nevi on survival **Time Frame:** 2.5 years or more ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Liver cirrhosis. 2. Consecutive admission. 3. Permitted to physical examinations. 4. Informed consents. Exclusion Criteria: 1. Non-cirrhotic portal hypertension. 2. Malignancy. 3. Uncontrolled infection. 4. Severe chronic diseases. 5. Poor patient compliance. **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Patients with a diagnosis of liver cirrhosis who are consecutively admitted to our department. ### Contacts Locations Module #### Locations **Location 1:** **City:** Shenyang **Country:** China **Facility:** Department of Gastroenterology, General Hospital of Shenyang Military Area **State:** Liaoning **Zip:** 110840 #### Overall Officials **Official 1:** **Affiliation:** Department of Gastroenterology, General Hospital of Shenyang Military Area **Name:** Xiaozhong Guo, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Li H, Wang R, Mendez-Sanchez N, Peng Y, Guo X, Qi X. Impact of spider nevus and subcutaneous collateral vessel of chest/abdominal wall on outcomes of liver cirrhosis. Arch Med Sci. 2019 Mar;15(2):434-448. doi: 10.5114/aoms.2018.74788. Epub 2018 Mar 28. **PMID:** 30899297 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000008107 - Term: Liver Diseases - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC04 - Name: Neoplasms ### Condition Browse Module - Browse Leaves - ID: M11103 - Name: Liver Cirrhosis - Relevance: HIGH - As Found: Liver Cirrhosis - ID: M17396 - Name: Varicose Veins - Relevance: LOW - As Found: Unknown - ID: M12448 - Name: Nevus, Pigmented - Relevance: LOW - As Found: Unknown - ID: M12446 - Name: Nevus - Relevance: LOW - As Found: Unknown - ID: M8485 - Name: Fibrosis - Relevance: HIGH - As Found: Cirrhosis - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008103 - Term: Liver Cirrhosis - ID: D000005355 - Term: Fibrosis ### Intervention Browse Module - Browse Branches - Abbrev: Hemat - Name: Hematinics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05467579 **Brief Title:** Mandibular Advancement Clear Aligner Treatment in Juvenile Idiopathic Arthritis Subjects **Official Title:** Short-term and Long-term Evaluation of Three-dimensional Morphological Condylar and Mandibular Changes in Patients Affected by Juvenile Idiopathic Arthritis Treated With Mandibular Advancement Clear Aligner. A Prospective Controlled Study #### Organization Study ID Info **ID:** 072022 #### Organization **Class:** OTHER **Full Name:** University of Genova ### Status Module #### Completion Date **Date:** 2025-01-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2022-07-20 **Type:** ACTUAL **Last Update Submit Date:** 2022-07-19 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-01-01 **Type:** ESTIMATED #### Start Date **Date:** 2022-10-01 **Type:** ESTIMATED **Status Verified Date:** 2022-07 #### Study First Post Date **Date:** 2022-07-20 **Type:** ACTUAL **Study First Submit Date:** 2022-07-14 **Study First Submit QC Date:** 2022-07-19 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** University of Milan - Prof. Maspero Cinzia **Class:** UNKNOWN **Name:** University of Milan - Dr. Abate Andrea #### Lead Sponsor **Class:** OTHER **Name:** University of Genova #### Responsible Party **Investigator Affiliation:** University of Genova **Investigator Full Name:** ALESSANDRO UGOLINI **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** There is currently no information on how mandibular advancement therapy could influence three-dimensionally the condylar and mandibular morphology in growing patients affected by Juvenile Idiopathic Arthritis (JIA). Therefore, the aim is to assess the three-dimensional morphological mandibular changes produced by the Invisalign® Mandibular Advancement (MA) (Align Technology, San José, CA, USA) in growing subjects affected by juvenile idiopathic arthritis with unilateral and bilateral JIA and to compare them with not-JIA control subjects **Detailed Description:** A wide range of functional appliances have been designed across the years to obtain a supplementary growth of the mandible by its forward posturing to correct mandibular retrusion. In a review published by Cozza et al., the efficiency of functional appliances used in healthy humans in terms of supplementary growth of the mandible per month of treatment, was measured. The Herbst appliance had the highest coefficient of efficiency (0.28 mm per month) followed by the Twin-block device (0.23 mm per month). Different authors claimed that functional treatment by removable appliances may be effective in treating Class II malocclusion with clinically relevant skeletal effects if performed during the pubertal growth phase. However, the growth pattern in JIA patients is more complicated and difficult compared to the treatment groups in the above-mentioned studies. The pattern is not only characterized by a decrease in mandibular length, but also by a decreased ratio between the posterior and the anterior face height, due to a failure in the vertical growth of the condyles The favorable effect of functional orthopedic appliances in JIA cases is therefore, besides advancing the mandible, an anterior (counter clockwise) rotation with a possible increase of the posterior face height, if possible. The efficacy of the functional orthopedic appliance in the correction of open bite has been demonstrated by Ibitayo et al. To date, different types of removable orthopedic appliances have been proposed into the scientific literature for management of deformities in skeletally immature patients with JIA, in particular the activator and the distraction splint. Although functional orthopedic treatment is recommended, literature is still lacking studies on this important topic. Recently a mandibular advancement device (MA) was implemented by Align TechnologyTM (San José, CA, USA) on clear aligners, for the treatment of skeletal Class II in growing patients. Similarly, to the principle applied in Twin Block, MA is composed by two pairs of lateral inclined planes (precision wings), positioned buccally in the posterior area of aligners, which come into contact each time the patient closes his mouth determining a mandibular forward position. Regarding the above-mentioned novel therapeutic approach, accurate bibliographic research performed on June 2022 showed that, the scientific literature needs further studies evaluating the skeletal effects produced by the Mandibular advancement with clear aligner since there is limited literature on its efficiency, consisting mostly of case studies. Recent longitudinal studies reported very promising results, when used in the pubertal growth phase. The short-term effects of Mandibular Advancement feature are dento-skeletal with additional growth of the mandible and improvement in facial convexity. The MA clear aligner treatment in JIA patients could bring countless benefits. The main ones are the possibility of performing a class II functional therapy with the same ability of a distraction splint or activators in promoting mandibular growth and at the same time controlling the vertical dimension with a programmed intrusion/extrusion of the teeth. Moreover, these therapeutic approaches should be more aesthetic, less bulky, and annoying appliances which can therefore guarantee greater collaboration from the patient. The latter would be reinforced by the fact that during functional therapy there would be a concomitant dental alignment with positive implications in patients whose facial aesthetics are already partially compromised, the face is one of the most salient and relevant social stimuli humans encounter and automatically evokes neural responses, facial deformity must not be underestimated. Moreover, clear aligner therapy is associated with minimal adverse events related to the periodontal structures compared to fixed appliances, this is of relevant interest in JIA subjects who often suffer from moderate or severe periodontitis. ### Conditions Module **Conditions:** - Juvenile Idiopathic Arthritis - Malocclusion, Angle Class II ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Healthy patients that will serve as controls will recruited having the same demographic characteristics of the experimental group i.e., age, sex, vertebral maturation stage and the same cranio-facial features, skeletal class II, class II division 1 malocclusion, mandibular retrognathia, normal/hyperdivergent growth pattern. **Intervention Names:** - Device: Device: orthodontic - mandibular advancement clear aligner **Label:** Healthy subjects **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Young people aged from 10 to 14 years old with skeletal class II, class II division 1 malocclusion, mandibular retrognathia, normal/hyperdivergent growth pattern, and affected by juvenile idiopathic arthritis **Intervention Names:** - Device: Device: orthodontic - mandibular advancement clear aligner **Label:** JIA subjects **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Healthy subjects - JIA subjects **Description:** Intervention orthodontic - mandibular advancement: mandibular retrognathia correction with a mandibular advancement using a step-wise approach with clear aligner. **Name:** Device: orthodontic - mandibular advancement clear aligner **Other Names:** - MA clear aligner; activator appliances **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Clinical evaluation in vivo (binary outcome yes/no) **Measure:** Improvement of the facial profile **Time Frame:** 12 months **Description:** Measured on CBCT scans (increase in mm of the mandibular length, superimposition of the 3D reconstruction of the condyles) **Measure:** Mandibular growth achievement **Time Frame:** 12 months **Description:** To monitoring TMJ inflammation during the active phase of treatment comparing the MRI taken before the beginning of therapy with those taken as controls every six months until the end of treatment and to evaluate patient's reported outcomes regarding treatment with mandibular advancement both in JIA and in the healthy control group **Measure:** Presence of inflammation during active phase of mandibular advancement **Time Frame:** 12 months **Description:** Discomfort reported on a questionnaire during all the active phase of treatment recorded every 6 month (VAS scale, pain min-max 0-100) **Measure:** Discomfort during active phase **Time Frame:** 6 months **Description:** Discomfort reported on a questionnaire during all the active phase of treatment recorded every 6 month (VAS scale, pain min-max 0-100) **Measure:** Discomfort during active phase **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** 1. Aged from 10 to 14 years old and attending the Department of Biomedical Surgical and Dental Sciences, University of Milan at the peak of the pubertal spurt assessed using vertebral analysis. 2. Features of a class II, division 1 malocclusion with mandibular retrusion and ANB according to Riedel \>4°. 3. Convex profile and minimum overjet of 4 mm in permanent dentition, without missing teeth 4. moderate crowding in the upper arch (≤4 mm) 5. Parental informed consent Exclusion Criteria: 1. Previous orthodontic or orthopedic treatment with any type of intervention (to avoid confounding factors related to previous treatment) 2. Patients with severe transverse dental or skeletal discrepancies 3. Syndromes, orofacial cleft, or other special needs, except for Juvenile idiopathic arthritis 4. Missing teeth (to avoid confounding factors related to anchorage loss due to the absence or early extraction of permanent teeth) 5. Poor oral health that precludes orthodontic treatment (presence of caries, active white spots or periodontal diseases) **Maximum Age:** 14 Years **Minimum Age:** 8 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Alessandro Ugolini, DDS **Phone:** 3475971340 **Role:** CONTACT #### Locations **Location 1:** **City:** Milan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Andrea Abate, DDS - **Role:** CONTACT **Country:** Italy **Facility:** Università di Milano, Ospedale maggiore Policlincio, IRCCS Cà Granda **State:** Itali **Zip:** 20100 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases - ID: D000014076 - Term: Tooth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M4476 - Name: Arthritis - Relevance: HIGH - As Found: Arthritis - ID: M11301 - Name: Malocclusion - Relevance: HIGH - As Found: Malocclusion - ID: M4479 - Name: Arthritis, Juvenile - Relevance: HIGH - As Found: Juvenile Idiopathic Arthritis - ID: M11303 - Name: Malocclusion, Angle Class II - Relevance: HIGH - As Found: Malocclusion, Angle Class II - ID: M28896 - Name: Overbite - Relevance: HIGH - As Found: Malocclusion, Angle Class II - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M16831 - Name: Tooth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001168 - Term: Arthritis - ID: D000001171 - Term: Arthritis, Juvenile - ID: D000008310 - Term: Malocclusion - ID: D000008312 - Term: Malocclusion, Angle Class II - ID: D000057887 - Term: Overbite ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00677079 **Brief Title:** Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer **Official Title:** A Phase 2, Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer #### Organization Study ID Info **ID:** ARD11489 #### Organization **Class:** INDUSTRY **Full Name:** Sanofi #### Secondary ID Infos **Domain:** BiPar **ID:** 20080105 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2008-12 **Type:** ACTUAL #### Disp First Post Date **Date:** 2012-12-28 **Type:** ESTIMATED **Disp First Submit Date:** 2012-12-21 **Disp First Submit QC Date:** 2012-12-21 #### Expanded Access Info **Has Expanded Access:** True **Status For NCT ID:** NO_LONGER_AVAILABLE #### Last Update Post Date **Date:** 2013-10-01 **Type:** ESTIMATED **Last Update Submit Date:** 2013-09-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2008-12 **Type:** ACTUAL #### Start Date **Date:** 2008-06 **Status Verified Date:** 2013-09 #### Study First Post Date **Date:** 2008-05-13 **Type:** ESTIMATED **Study First Submit Date:** 2008-05-09 **Study First Submit QC Date:** 2008-05-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Sanofi #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this study was to determine the efficacy of iniparib (BSI-201/SAR240550) in patients with breast cancer gene-associated (BRCA) ovarian cancer. Up to 35 patients were to be treated using a Simon 2-stage optimal design, i.e. twelve were to be treated in a first stage, then if 2/12 patients responded to treatment as defined by Response Evaluation Criteria in Solid Tumor (RECIST), 23 additional patients were be treated in the second stage. **Detailed Description:** Participants were treated for at least one 8-week cycle, with additional cycles as long as they had stable or responding disease (per RECIST criteria) and wished to remain on study. Participants had a final follow-up visit within 4 weeks following the last dose of iniparib, after which time they were contacted by study staff every 3 months for the first year and every 6 months thereafter to assess disease status and survival. ### Conditions Module **Conditions:** - Primary Peritoneal Cancer - Advanced Epithelial Ovarian Cancer **Keywords:** - BRCA-1 or BRCA-2 associated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer - BRCA-1 - BRCA-2 ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 12 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Iniparib, twice weekly on Days 1 and 4 of each week during 8-week cycles **Intervention Names:** - Drug: Iniparib **Label:** Iniparib **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Iniparib **Description:** Body weight adjusted dose 1 hour intravenous infusion **Name:** Iniparib **Other Names:** - BSI-201 - SAR240550 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Best overall response was defined as the best evaluation observed through the entire treatment period based on Response Evaluation Criteria in Solid Tumor (RECIST) criteria. **Measure:** Best overall response **Time Frame:** until treatment discontinuation (assessment at the at the end of each 8-week cycle) **Description:** Objective response rate was defined as the percentage of participants with confirmed partial response or complete response according to RECIST criteria. **Measure:** Objective response rate **Time Frame:** until treatment discontinuation (assessment at the at the end of each 8-week cycle) #### Secondary Outcomes **Description:** Clinical benefit rate was defined as the percentage of participants with complete response, partial response or stable disease according to RECIST criteria. **Measure:** Clinical benefit rate **Time Frame:** until treatment discontinuation (assessment at the at the end of each 8-week cycle) **Description:** Progression-free survival was defined as the time interval from study entry until disease progression or death due to any cause, whichever came first. In the absence disease progression or death, progression-free survival was censored at the last date the participant was known to be alive. **Measure:** Progression-Free Survival **Time Frame:** until death or study end **Description:** Overall Survival was defined as the time interval from study entry until death due to any cause. In the absence of confirmation of death, progression-free survival was censored at the last date the participant was known to be alive. **Measure:** Overall Survival **Time Frame:** until death or study end **Description:** Objective response rate was defined as the percentage of participants with confirmed partial response or complete response according to CA125 levels. **Measure:** Cancer antigen 125 response (participants with elevated CA125) **Time Frame:** until treatment discontinuation (assessment at the at the end of each 8-week cycle) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Female, age 18 or older; * Histologically or cytologically confirmed advanced epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (stage III or IV); * At least one previous regimen with platinum/taxane combination therapy and no curative options as determined by their physician (no limit on the number of prior therapies); * Confirmed BRCA1 or BRCA2 status; * One or more measurable lesions, at least 10mm in longest diameter by spiral computed tomography (CT) scan or 20mm in longest diameter when measured with conventional techniques (palpation, plain x-ray, CT or magnetic resonance imaging (MRI)); * Karnofsky performance status ≥70%; * Estimated life expectancy of at least 16 weeks. Exclusion Criteria: * Normal clinical laboratory values; * Any anti-cancer therapy within 21 days prior to study start; * Any other malignancy within 3 years of study start, except adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of the breast, or basal or squamous cell skin cancer; * Active viral infection including HIV/AIDS, Hepatitis B or Hepatitis C infection; * Active central nervous system or brain metastases; * History of seizures or current treatment with anti-epileptic medication; * Persistent grade 2 or greater toxicities from prior therapy, excluding alopecia. **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** New York **Country:** United States **State:** New York **Zip:** 10021 #### Overall Officials **Official 1:** **Affiliation:** Sanofi **Name:** Clinical Sciences & Operations **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Bell-McGuinn KM, Konner JA, Tew WP, Hensley ML, Iasonos A, Charpentier E, Mironov S, Sabbatini P, Aghajanian C. A Phase 2, Single Arm Study of Iniparib in Patients With BRCA1 or BRCA2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Int J Gynecol Cancer. 2016 Feb;26(2):255-60. doi: 10.1097/IGC.0000000000000591. **PMID:** 26745694 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010051 - Term: Ovarian Neoplasms - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000010049 - Term: Ovarian Diseases - ID: D000000291 - Term: Adnexal Diseases - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000005833 - Term: Genital Neoplasms, Female - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000091662 - Term: Genital Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000006058 - Term: Gonadal Disorders - ID: D000000008 - Term: Abdominal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000010532 - Term: Peritoneal Diseases - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12974 - Name: Ovarian Neoplasms - Relevance: LOW - As Found: Unknown - ID: M1704 - Name: Carcinoma, Ovarian Epithelial - Relevance: HIGH - As Found: Epithelial Ovarian Cancer - ID: M13443 - Name: Peritoneal Neoplasms - Relevance: HIGH - As Found: Peritoneal Cancer - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12972 - Name: Ovarian Diseases - Relevance: LOW - As Found: Unknown - ID: M3643 - Name: Adnexal Diseases - Relevance: LOW - As Found: Unknown - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8945 - Name: Genital Neoplasms, Female - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M9163 - Name: Gonadal Disorders - Relevance: LOW - As Found: Unknown - ID: M7 - Name: Abdominal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M13441 - Name: Peritoneal Diseases - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: T4352 - Name: Ovarian Cancer - Relevance: HIGH - As Found: Epithelial Ovarian Cancer - ID: T4354 - Name: Ovarian Epithelial Cancer - Relevance: HIGH - As Found: Epithelial Ovarian Cancer ### Condition Browse Module - Meshes - ID: D000010534 - Term: Peritoneal Neoplasms - ID: D000077216 - Term: Carcinoma, Ovarian Epithelial ### Intervention Browse Module - Ancestors - ID: D000067856 - Term: Poly(ADP-ribose) Polymerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M233006 - Name: Iniparib - Relevance: HIGH - As Found: Vaccine administration - ID: M205 - Name: Poly(ADP-ribose) Polymerase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000090712 - Term: Iniparib ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00925379 **Acronym:** HDR **Brief Title:** Renal HYPODYSPLASIA : Genetic and Familial Assessment **Official Title:** Renal HYPODYSPLASIA;Study of Familial Cases and Search for Predisposing Genes #### Organization Study ID Info **ID:** P070151 #### Organization **Class:** OTHER **Full Name:** Assistance Publique - Hôpitaux de Paris ### Status Module #### Completion Date **Date:** 2014-07 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2014-07-28 **Type:** ESTIMATED **Last Update Submit Date:** 2014-07-25 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2013-04 **Type:** ACTUAL #### Start Date **Date:** 2009-04 **Status Verified Date:** 2014-07 #### Study First Post Date **Date:** 2009-06-22 **Type:** ESTIMATED **Study First Submit Date:** 2009-06-19 **Study First Submit QC Date:** 2009-06-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assistance Publique - Hôpitaux de Paris #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** Evaluation of the frequency of familial cases of renal HYPODYSPLASIA **Detailed Description:** DNA collection from the propositus and its family. A questionnaire will be filled by the parents to seek other affected individual in the family.With another affected member, DNA collection will be collected from the whole family. A renal ultrasound will be prescribed for the parents, brothers and sisters. ### Conditions Module **Conditions:** - Renal HYPODYSPLASIA, Nonsyndromic, 1 ### Design Module #### Bio Spec **Description:** DNA collection from the propositus and its parents and in case of families with more than one affected member, collection of DNA from the all family. **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT #### Enrollment Info **Count:** 342 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Measure:** Evaluation of the heritability of renal HYPODYSPLASIA (on the renal ultra sound) and DNA collection to make possible identification of predisposing genes **Time Frame:** the same day ### Eligibility Module **Eligibility Criteria:** Inclusion criteria : - Children aged more than 3 months and less than 18 years old with a renal bilateral HYPODYSPLASIA set by renal ultrasound examination : * renal size \< -2DS * with/or hyperechogenicity or lack of cortical-medullary differentiation * with/or renal cysts Exclusion criteria : * Bladder uropathy or sus-bladder uropathy * Recessive or dominant renal polycystic disease * Bardet-Biedl syndrome and other malformative syndromes except renal coloboma syndrome, Renal cysts and diabetes syndrome RCAD * Lack of written informed consent **Maximum Age:** 18 Years **Minimum Age:** 3 Months **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT **Study Population:** Children with a bilateral renal hypodysplasia ### Contacts Locations Module #### Locations **Location 1:** **City:** Paris **Country:** France **Facility:** Necker Hospital **Zip:** 75015 #### Overall Officials **Official 1:** **Affiliation:** Assistance Publique - Hôpitaux de Paris **Name:** Remi Salomon, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** University Hospital, Limoges **Name:** Vincent Guigonis, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: HIGH - As Found: Renal Hypodysplasia, Nonsyndromic, 1 - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007674 - Term: Kidney Diseases ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01939379 **Brief Title:** Adductor Canal Nerve Block Following Total Knee Arthroplasty **Official Title:** Adductor Canal Nerve Block Following Total Knee Arthroplasty: A Randomized, Prospective Study Comparing High vs. Low Volume Bolus of 0.33% Ropivacaine #### Organization Study ID Info **ID:** 5130183 #### Organization **Class:** OTHER **Full Name:** Loma Linda University ### Status Module #### Completion Date **Date:** 2017-07-25 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-04-20 **Type:** ACTUAL **Last Update Submit Date:** 2021-04-19 **Overall Status:** WITHDRAWN #### Primary Completion Date **Date:** 2017-07-25 **Type:** ACTUAL #### Start Date **Date:** 2013-09 **Status Verified Date:** 2021-04 #### Study First Post Date **Date:** 2013-09-11 **Type:** ESTIMATED **Study First Submit Date:** 2013-09-03 **Study First Submit QC Date:** 2013-09-05 **Why Stopped:** PI left institution. Efforts made to contact PI unsuccessful. No study data available. ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Loma Linda University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is that an adductor canal nerve block (putting numbing medicine near the nerve) has been shown to produce excellent pain relief with less pain medication use after knee replacement surgery.The investigators will be comparing the amount of pain relief following knee replacement surgery when you have a nerve block in place. There will be approximately 66 subjects participating in this study. After surgery subjects will receive numbing medication every 6 hours for 48 hours. Subjects will also receive a morphine PCA (patient controlled analgesia) after surgery and pain medication by mouth every 4 hours around the clock with the option to receive more pain medication if needed. Subjects will participate in the study up to 3 days. ### Conditions Module **Conditions:** - Post-op Pain **Keywords:** - Total knee arthroplasty - nerve block - Pain control after surgery ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Depending on what dose of ropivacaine the subject is randomized to he/she could receive the 15ml dose injected into the catheter every 6 hours **Intervention Names:** - Drug: Morphine PCA started at the end of surgery, 1 Percocet 1/325mg every 4 hours; may receive a second Percocet if needed. **Label:** 15ml ropivacaine **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** If the subject is randomized to 30ml ropivacaine he/she will be injected through the catheter every 6 hours. **Intervention Names:** - Drug: For the 30ml ropivacaine the intervention would be the subject can request extra pain medication which would be Percocet and/or morphine PCA. **Label:** 30ml ropivacaine **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - 15ml ropivacaine **Name:** Morphine PCA started at the end of surgery, 1 Percocet 1/325mg every 4 hours; may receive a second Percocet if needed. **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - 30ml ropivacaine **Name:** For the 30ml ropivacaine the intervention would be the subject can request extra pain medication which would be Percocet and/or morphine PCA. **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** At the end of the 48 hours period the total opiate pain medication taken will be collected and used for comparison as our primary outcome **Measure:** Total Opiate pain medication **Time Frame:** The total amount of opiate pain medication will be recorded at 6 hour intervals for 48 hours after surgery. #### Secondary Outcomes **Description:** Secondary outcome measures will include demographic characteristics, pain scores, medication administration,patient satisfaction with pain control and any complications that may have arisen. We will also record the location of the adductor canal catheter on the final bolus dose. **Measure:** Patient satisfaction with pain control **Time Frame:** We will look at the secondary outcome measure beginning every six hours for 48 hours after surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Is the subject undergoing primary unilateral total knee arthroplasty? 2. Is the subject 18 to 99 years of age? 3. Is the subject ASA class 1, 2, or 3? 4. Does the subject have a BMI less than 35? 5. Can the subject consent in the English language? Exclusion Criteria: 1. Does subject have an allergy to drugs used in this study; 2. Does subject have a daily intake of opiate medications that are considered stronger than hydrocodone? 3. Does subject have a history of alcohol or drug abuse 4. Has subject had a previous total knee arthroplasty? 5. Has subject had any neurologic deficits in the lower extremity being studied? **Maximum Age:** 99 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Loma Linda **Country:** United States **Facility:** Loma Linda University Medical Center East Campus Hospital **State:** California **Zip:** 92354 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: HIGH - As Found: Post-op Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010149 - Term: Pain, Postoperative ### Intervention Browse Module - Ancestors - ID: D000000701 - Term: Analgesics, Opioid - ID: D000009294 - Term: Narcotics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000000779 - Term: Anesthetics, Local - ID: D000000777 - Term: Anesthetics - ID: D000000894 - Term: Anti-Inflammatory Agents, Non-Steroidal - ID: D000018712 - Term: Analgesics, Non-Narcotic - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000018501 - Term: Antirheumatic Agents - ID: D000058633 - Term: Antipyretics ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Analg - Name: Analgesics - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Antipy - Name: Antipyretics - Abbrev: AnTuAg - Name: Antitussive Agents - Abbrev: Resp - Name: Respiratory System Agents ### Intervention Browse Module - Browse Leaves - ID: M1700 - Name: Ropivacaine - Relevance: HIGH - As Found: Eye - ID: M11982 - Name: Morphine - Relevance: HIGH - As Found: 400 - ID: M4032 - Name: Analgesics - Relevance: HIGH - As Found: Pregnancy Loss - ID: M225501 - Name: Acetaminophen, hydrocodone drug combination - Relevance: HIGH - As Found: Flight - ID: M2340 - Name: Acetaminophen - Relevance: HIGH - As Found: Flight - ID: M9911 - Name: Hydrocodone - Relevance: LOW - As Found: Unknown - ID: M13020 - Name: Oxycodone - Relevance: HIGH - As Found: Flight - ID: M4033 - Name: Analgesics, Opioid - Relevance: LOW - As Found: Unknown - ID: M12245 - Name: Narcotics - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M4218 - Name: Anti-Inflammatory Agents, Non-Steroidal - Relevance: LOW - As Found: Unknown - ID: M20786 - Name: Analgesics, Non-Narcotic - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M29176 - Name: Antipyretics - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000082 - Term: Acetaminophen - ID: C000083640 - Term: Acetaminophen, hydrocodone drug combination - ID: D000009020 - Term: Morphine - ID: D000010098 - Term: Oxycodone - ID: D000000700 - Term: Analgesics - ID: D000077212 - Term: Ropivacaine ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03356379 **Acronym:** PETRUS **Brief Title:** Popliteal Artery Entrapment Syndrome & TRanscutaneoUS Oxymetry **Official Title:** Application de l'oxymétrie Dynamique Pour le Diagnostic Des pièges artériels poplités #### Organization Study ID Info **ID:** 2017-AO1887-46 #### Organization **Class:** OTHER_GOV **Full Name:** University Hospital, Angers ### Status Module #### Completion Date **Date:** 2019-11-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-12-02 **Type:** ACTUAL **Last Update Submit Date:** 2019-11-29 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-11-15 **Type:** ACTUAL #### Start Date **Date:** 2017-11-22 **Type:** ACTUAL **Status Verified Date:** 2019-11 #### Study First Post Date **Date:** 2017-11-29 **Type:** ACTUAL **Study First Submit Date:** 2017-11-22 **Study First Submit QC Date:** 2017-11-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** University Hospital, Angers #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Aim of the study is to test the feasibility of transcutaneous oxygen pressure (TcPO2) recording in the diagnosis of popliteal entrapment syndrome (PES) in 30 patients with suspected PES and 30 asymptomatic control heathy subjects **Detailed Description:** Patients suspected of PES and healthy cpontrols after detailled explanation of the protocol will have a recording of tcpO2 on both calves and will perform a series of elevation on foot in the standing position. ### Conditions Module **Conditions:** - Popliteal Entrapment Syndrome **Keywords:** - Diagnosis - Peripheral artery disease - sports ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** transcutaneous oximetry ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 60 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients suspected of PES will have a transcutaneous oximetry test during tiptoeing **Intervention Names:** - Diagnostic Test: Transcutaneous oximetry **Label:** Patients **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Healthy asymptomatic athletes will have a transcutaneous oximetry test during tiptoeing **Intervention Names:** - Diagnostic Test: Transcutaneous oximetry **Label:** Controls **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Controls - Patients **Description:** Measurement of TcpO2 on calves and chests. Calculation of the DROP index (decrease from rest of oxygen pressure)on both calves **Name:** Transcutaneous oximetry **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Comparison of DROP value between PES patients and controls **Measure:** Presence of a significant DROP decrease **Time Frame:** 1 hour ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age over 18 years * Insurance company alffiliation Symptoms consistent with PES (patients) or absence of symptoms (controls) Exclusion Criteria: * Refuse to participate Exclusion period from another protocole **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Angers **Country:** France **Facility:** CHU Angers **Zip:** 49933 #### Overall Officials **Official 1:** **Affiliation:** University Hospital in Angers **Name:** Pierre ABRAHAM, MD; PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000001157 - Term: Arterial Occlusive Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M29213 - Name: Peripheral Arterial Disease - Relevance: LOW - As Found: Unknown - ID: M2391 - Name: Popliteal Artery Entrapment Syndrome - Relevance: HIGH - As Found: Popliteal Entrapment Syndrome - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000083082 - Term: Popliteal Artery Entrapment Syndrome - ID: D000013577 - Term: Syndrome ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05496179 **Brief Title:** The Effect of Prucalopride on Gastric Emptying in Intensive Care Unit Patients **Official Title:** The Effect of Prucalopride on Gastric Emptying in Intensive Care Unit Patients #### Organization Study ID Info **ID:** Future University in Egypt #### Organization **Class:** OTHER **Full Name:** Ain Shams University ### Status Module #### Completion Date **Date:** 2023-07-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-04-12 **Type:** ACTUAL **Last Update Submit Date:** 2024-04-11 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-06-10 **Type:** ACTUAL #### Start Date **Date:** 2022-08-30 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2022-08-11 **Type:** ACTUAL **Study First Submit Date:** 2022-08-09 **Study First Submit QC Date:** 2022-08-09 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Future University in Egypt #### Lead Sponsor **Class:** OTHER **Name:** Ain Shams University #### Responsible Party **Investigator Affiliation:** Ain Shams University **Investigator Full Name:** Eman Mohamed El Mokadem **Investigator Title:** Lecturer of Clinical Pharmacy **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** to compare the effectiveness as well as the safety of prucalopride against metoclopramide as the first line treatment for feeding intolerance in critically ill patients. **Detailed Description:** Provision of nutrition support to the critically ill is now established as an essential part of patient care where aiming toward 100% of the predicted target may have resulted in reduced mortality and increased ventilator-free days in those who are premorbidly malnourished. Despite these reported benefits, clinicians continue to deliver little more than half of the enteral nutrition (EN) they plan to provide, due to gastric motility disorders, patient intolerance and clinical interruptions. Also despite the availability of numerous clinical practice guidelines (CPGs) focused on feeding critically ill patients, observational studies have consistently demonstrated persistent and significant gaps between guideline recommendations and actual nutrition practice. Consequently, underfeeding is prevalent in the intensive care unit (ICU), with patients on average receiving only 60 % of the calories that are prescribed. Moreover, Among the barriers to adequate nutritional supply in the ICU which contributes to nutritional status deterioration, gastrointestinal disorders causing enteral feed intolerance are the most important and the most often mentioned in the literature. when gastric emptying was measured in critically ill patients, 46 % of them had evidence of delayed gastric emptying. Untreated slow gastric emptying has a plethora of clinical consequences such as vomiting, aspiration of gastric contents, pneumonia, and contributes significantly to the frequent interruptions and cessation of EN in the ICU, which results in inadequate nutritional delivery. Studies have shown an association between feeding intolerance, prolonged intensive care unit (ICU) stay, and increased risk of death. ### Conditions Module **Conditions:** - Enteral Feeding Intolerance ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 70 **Type:** ACTUAL **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will receive prucalopride (2 mg) once daily for 7 days. **Intervention Names:** - Drug: Prucalopride **Label:** Prucalopride **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Patients will receive metoclopramide (10 mg) three times daily for 7 days. **Intervention Names:** - Drug: Metoclopramide **Label:** Metoclopramide **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Prucalopride **Description:** Prokinetic **Name:** Prucalopride **Other Names:** - Resolor **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Metoclopramide **Description:** Prokinetic **Name:** Metoclopramide **Other Names:** - Primperan **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Gastric residual volume as a surrogate to gastric emptying by means of gastric residual volume **Measure:** Gastric residual volume **Time Frame:** 7 days #### Secondary Outcomes **Description:** Enteral nutrition volume ratio **Measure:** Determining the adequacy of enteral nutrition: **Time Frame:** 7 days **Description:** C reactive protein **Measure:** Incidence of infectious complications. **Time Frame:** one month **Description:** duration of stay in intensive care unit **Measure:** Length of ICU stay **Time Frame:** 3 months **Description:** occurence of adverse drug events **Measure:** Adverse drug events **Time Frame:** 7 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients aging between 18 and 60 years (of both sexes) who are admitted to the ICU and are expected to stay in the ICU for not less than 7 days and are prescribed enteral feeding through naso- or oro-gastric tube whose modified nutritional risk in the critically ill (mNUTRIC) score is of more than or equal Exclusion Criteria: * Patients who met the following criteria were excluded: * Age less than 18 years or more than 60 years. * Previous upper gastrointestinal tract surgery, obstruction, hemorrhage or history of GI disease. * Clinically significant hepatic dysfunction. (\>3 times above the upper end of normal range of bilirubin, γ-glutamyl transferase, aspartate transaminase, or lactate dehydrogenase) * Regular use of H2 blockers, prokinetic, proton pump inhibitor or anticholinergic agents for previous 4 weeks. * Patients with arrhythmia or atrioventricular blocks. * Any condition or comorbid disease that might interfere with gastric emptying such as diabetes. * Patients with head injuries. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Kasr Al Ainy Hospital **Zip:** 11865 #### Overall Officials **Official 1:** **Affiliation:** Future University in Egypt **Name:** Eman Elmokadem, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000000932 - Term: Antiemetics - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000005765 - Term: Gastrointestinal Agents - ID: D000065127 - Term: Dopamine D2 Receptor Antagonists - ID: D000018492 - Term: Dopamine Antagonists - ID: D000015259 - Term: Dopamine Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000054368 - Term: Laxatives - ID: D000058828 - Term: Serotonin 5-HT4 Receptor Agonists - ID: D000017366 - Term: Serotonin Receptor Agonists - ID: D000018490 - Term: Serotonin Agents ### Intervention Browse Module - Browse Branches - Abbrev: AnEm - Name: Antiemetics - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CaAg - Name: Cardiotonic Agents ### Intervention Browse Module - Browse Leaves - ID: M11760 - Name: Metoclopramide - Relevance: HIGH - As Found: At 10 - ID: M275353 - Name: Prucalopride - Relevance: HIGH - As Found: Polymerase chain reaction - ID: M4251 - Name: Antiemetics - Relevance: LOW - As Found: Unknown - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown - ID: M7473 - Name: Dopamine - Relevance: LOW - As Found: Unknown - ID: M20596 - Name: Dopamine Antagonists - Relevance: LOW - As Found: Unknown - ID: M17962 - Name: Dopamine Agents - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M27664 - Name: Laxatives - Relevance: LOW - As Found: Unknown - ID: M5651 - Name: Cathartics - Relevance: LOW - As Found: Unknown - ID: M15512 - Name: Serotonin - Relevance: LOW - As Found: Unknown - ID: M19648 - Name: Serotonin Receptor Agonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000008787 - Term: Metoclopramide - ID: C000406662 - Term: Prucalopride ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01450579 **Brief Title:** A Study to Evaluate the Immune Response to the ASP7373 and Its Safety in Healthy Adult Volunteers **Official Title:** Phase II Study of ASP7373 Evaluation of Immunogenicity and Safety of ASP7373 in Healthy Adults #### Organization Study ID Info **ID:** 7373-CL-0106 #### Organization **Class:** INDUSTRY **Full Name:** UMN Pharma Inc. ### Status Module #### Completion Date **Date:** 2011-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-09-29 **Type:** ACTUAL **Last Update Submit Date:** 2017-09-27 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2011-12 **Type:** ACTUAL #### Start Date **Date:** 2011-07 **Status Verified Date:** 2017-09 #### Study First Post Date **Date:** 2011-10-12 **Type:** ESTIMATED **Study First Submit Date:** 2011-09-22 **Study First Submit QC Date:** 2011-10-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** UMN Pharma Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** This trial is to investigate the clinically recommended dosage for ASP7373 based on the comparison of the immunogenicity and safety among the three doses of ASP7373 in healthy adults. ### Conditions Module **Conditions:** - Healthy **Keywords:** - Recombinant Influenza HA vaccine - Immunogenicity of ASP7373 ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 180 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Saline **Intervention Names:** - Biological: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** ASP7373 **Intervention Names:** - Biological: ASP7373 **Label:** Dose -1 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** ASP7373 **Intervention Names:** - Biological: ASP7373 **Label:** Dose -2 **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** ASP7373 **Intervention Names:** - Biological: ASP7373 **Label:** Dose -3 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Dose -1 - Dose -2 - Dose -3 **Description:** Intermuscular administration **Name:** ASP7373 **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Intramuscular administration **Name:** Placebo **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Measure:** Safety assessed by the incidence of adverse events, vital signs, laboratory tests and 12-lead ECGs **Time Frame:** up to 43 days **Measure:** Immunogenicity (HI antibody titer)- first vaccine **Time Frame:** on Day 21 **Description:** second vaccination on Day 22 **Measure:** Immunogenicity (HI antibody titer)- second vaccine **Time Frame:** on Day 43 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Body weight: Female: ≥40.0 kg, \<70.0 kg, Male: ≥50.0 kg, \<80.0 kg * BMI: ≥17.6, \<26.4 * Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations (subjective symptoms and objective findings) and all tests obtained Exclusion Criteria: * Scheduled to receive another vaccine during study period * History of H5 influenza infection or received H5 influenza vaccine * Past history of anaphylactic shock or an allergic reaction such as generalized eruption due to food or drug (including vaccines) allergies, fever ≥ 39.0°C within 2 days after the previous vaccination (influenza vaccine and others) * Diagnosis of immune deficit in the past, has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome * Received or scheduled to receive a live vaccine within 28 days prior to vaccination of the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination of the study vaccine * History of seizures * Female subjects who are breastfeeding, pregnant, possibly pregnant, and planning to become pregnant during the study period **Healthy Volunteers:** True **Maximum Age:** 40 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Kyushu **Country:** Japan #### Overall Officials **Official 1:** **Affiliation:** Astellas Pharma Inc **Name:** Use Central Contact **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10295 - Name: Influenza, Human - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M17360 - Name: Vaccines - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04229979 **Acronym:** REGAL **Brief Title:** Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2 **Official Title:** A Randomized, Open-Label Study of the Efficacy and Safety of Galinpepimut-S (GPS) Maintenance Monotherapy Compared to Investigator's Choice of Best Available Therapy in Subjects With Acute Myeloid Leukemia Who Have Achieved Complete Remission After Second-Line Salvage Therapy #### Organization Study ID Info **ID:** SLSG18-301 #### Organization **Class:** INDUSTRY **Full Name:** Sellas Life Sciences Group ### Status Module #### Completion Date **Date:** 2025-03 **Type:** ESTIMATED #### Expanded Access Info **Has Expanded Access:** True **Status For NCT ID:** AVAILABLE #### Last Update Post Date **Date:** 2024-04-09 **Type:** ACTUAL **Last Update Submit Date:** 2024-04-08 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2021-02-08 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2020-01-18 **Type:** ACTUAL **Study First Submit Date:** 2020-01-12 **Study First Submit QC Date:** 2020-01-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Sellas Life Sciences Group #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** To assess the safety and efficacy of galinpepimut-S (GPS) compared with investigator's choice of best available therapy (BAT) on overall survival (OS) in subjects with acute myeloid leukemia (AML) who are in second or later complete remission (CR2) or second or later complete remission with incomplete platelet recovery (CRp2). **Detailed Description:** This is an open-label, multicenter, randomized, parallel groups study of galinpepimut-S (GPS) vs. best available treatment (BAT) in patients with AML in second complete remission (CR2) or in second complete remission with incomplete platelet recovery (CRp2). All patients will have their historical bone marrow samples and/or peripheral blood drawn during screening stained for WT1 via IHC and/or analyzed via PCR by central pathology review. The primary goal of the study will be to demonstrate an advantage for GPS in overall survival in these patient populations. The study will enroll approximately 140 patients and will be conducted at about 110 investigational sites. Patients will be randomized 1:1 to GPS or BAT stratified by whether they are in CR2 or CRp2, their cytogenetic risk at diagnosis (poor vs all other), whether they harbor minimal residual disease (MRD), and the duration of CR1 of less than one year or one year or more. Patients on the BAT arm may be treated with 1. observation (whereby palliative management with hydroxyurea is allowed), 2. a hypomethylating agent (decitabine or azacitidine), 3. venetoclax and/or 4. low-dose ara-C. Patients whose remission in CR2 can be maintained with molecularly targeted agents (e.g. FLT-3 or IDH inhibitors) per investigator's determination will not be eligible. However, there are no restrictions on prior use of any agents in the CR1 setting. Patients cannot receive GPS as an adjunct therapy to any other agents. Patients on the GPS arm will receive 70 μg of sargramostim (GM-CSF) on Day -2 and Day 1 before each injection of GPS. The first two administrations of GM-CSF will take place at the same anatomical site as the planned administration of GPS within each treatment cycle. GPS will be administered as an immunization induction every 2 weeks for 6 administrations (Weeks 0 - 10); this will be followed by a 4-week period of no treatment. Treatment will then resume for 6 administrations as an initial booster phase every 4 weeks (Weeks 14 - 34) which will again be followed by a period of no treatment lasting 6 weeks. GPS will be resumed after this period as a second booster phase and will be administered every 6 weeks for 3 administrations (Weeks 40 - 52). Following each administration of GM-CSF or GPS, patients will be observed for approximately 30 minutes. An End of Treatment visit will be conducted 30 days following the last dose of GPS. Patients will then enter the long-term follow-up portion of the trial where they will be followed for recurrence of leukemia and overall survival. To ensure a comparable level of observation, patients randomized to the BAT arm will be seen every 4 weeks through Week 52. All patients will undergo bone marrow aspirates and biopsies at screening, Week 12 and end of treatment. Bone marrow examinations will then be repeated as clinically indicated. Patients will be assessed for safety at each clinic encounter. The primary endpoint will be overall survival. ### Conditions Module **Conditions:** - Acute Myeloid Leukemia **Keywords:** - maintenance - complete remission - overall survival - galinpepimut-S - randomized - Wilms Tumor-1 protein ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Open-label, multicenter, randomized, parallel group study ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 128 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A maximum of 15 total injections will be administered as follows: 1. First 6 galinpepimut-S injections: every 2 weeks (Weeks 0 - 10) followed by a 4-week period of no treatment. The first series of 6 injections of galinpepimut-S define the initial immunization induction phase. 2. Injections 7 to 12: every 4 weeks (between Weeks 14 and 34) followed by a 6-week period of no treatment. The second series of injections of galinpepimut-S define the early immune booster phase. 3. Injections 13 to 15: every 6 weeks (between Weeks 40 and 52). The third series of injections of galinpepimut-S define the late immune booster phase. Note: Galinpepimut-S is admixed with Montanide adjuvant before administered as a subcutaneous injection. GM-CSF is administered one day before and on the same day as the galinpepimut-S + Montanide injection. **Intervention Names:** - Biological: Galinpepimut-S - Biological: GM-CSF - Other: Montanide **Label:** Galinpepimut-S + Montanide + GM-CSF **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Four options, as monotherapy or as combination of agents listed below, (per treating investigator's choice): 1. Observation (whereby palliative management with hydroxyurea is allowed), or 2. HMA (decitabine or azacitidine), and/or 3. Venetoclax, and/or 4. Low-dose ara-C **Intervention Names:** - Drug: Azacitidine - Drug: Venetoclax - Drug: Decitabine - Drug: Cytarabine - Other: Observation **Label:** Best Available Therapy **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Galinpepimut-S + Montanide + GM-CSF **Description:** Galinpepimut-S admixed with the adjuvant Montanide following specified schedule **Name:** Galinpepimut-S **Other Names:** - SLS-001 - GPS **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Best Available Therapy **Description:** injection **Name:** Azacitidine **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Best Available Therapy **Description:** tablet **Name:** Venetoclax **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Best Available Therapy **Description:** injection **Name:** Decitabine **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - Best Available Therapy **Description:** injection **Name:** Cytarabine **Other Names:** - Ara-C **Type:** DRUG #### Intervention 6 **Arm Group Labels:** - Best Available Therapy **Description:** palliative management **Name:** Observation **Type:** OTHER #### Intervention 7 **Arm Group Labels:** - Galinpepimut-S + Montanide + GM-CSF **Description:** subcutaneous injection **Name:** GM-CSF **Other Names:** - sargramostim **Type:** BIOLOGICAL #### Intervention 8 **Arm Group Labels:** - Galinpepimut-S + Montanide + GM-CSF **Description:** adjuvant **Name:** Montanide **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The primary objective of the trial is to compare the efficacy of GPS to Investigator's choice of BAT on OS in subjects with AML who are in CR2/CRp2. **Measure:** Overall survival **Time Frame:** Up to 156 weeks #### Secondary Outcomes **Description:** Leukemia free survival **Measure:** LFS **Time Frame:** Up to 156 weeks **Description:** Percentage of patients surviving **Measure:** OS rate (%) **Time Frame:** At 6, 9 and 12 months **Description:** Percentage of patients surviving and being free of leukemic relapse **Measure:** LFS rate (%) **Time Frame:** At 6, 9, and 12 months **Description:** Minimum residual disease **Measure:** MRD **Time Frame:** Up to 91 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Willing and able to understand and provide signed informed consent for the study that fulfills Institution Review Board (IRB) guidelines. 2. Male or female patients ≥18 years of age on the day of signing informed consent. 3. Must have a diagnosis of AML according to the WHO criteria (primary/de novo or secondary, including treatment-related \[e.g., due to prior anthracycline use\], as well as cases due to progression of antecedent hematological disorder \[e.g., MDS, MPN, or MDS/MPN 'overlap' syndrome). 4. Must be in second morphological complete remission (with or without platelet recovery; CR2/CRp2) for relapsed AML based upon the CRp criteria as follows: 1. \<5% myeloblasts in bone marrow 2. Absence of Auer rods 3. Absence of circulating peripheral blasts 4. Peripheral blood absolute neutrophil count (ANC) \>1000 cells/µL 5. Peripheral blood platelet count \>20,000/µL 6. Absence of extramedullary disease 5. Patients must have \> 300 lymphocytes/ μL. 6. Must not be candidates at the time of study entry for allogeneic stem cell transplant (Allo-SCT) due to intercurrent medical conditions, patient's preference or lack of an available donor. 7. Must have received the last dose of re-induction antileukemic therapy at least 4 weeks or ten half-lives of induction therapy (whichever is shorter) prior to receiving study treatment. 8. Must be consented within 6 months of having achieved CR2/CRp2 or later. 9. Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3. 10. Must have an estimated life expectancy \>6 months. 11. If female, is postmenopausal (at least 12 sequential months of amenorrhea) or surgically sterile. Females of childbearing potential must have a negative pregnancy test 12. Female patients of childbearing potential who are heterosexually active and male patients with female sexual partners of childbearing potential must agree to use an effective method of contraception (e.g., oral contraceptives, double-barrier methods such as a condom and a diaphragm, intrauterine device) during the study and for 4 months following the last dose of study medication, or to abstain from sexual intercourse for this time; a woman not of childbearing potential is one who has undergone bilateral oophorectomies or who is post- menopausal, defined as the absence of menstrual periods for 12 consecutive months. 13. Must have recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5 Grade 0 or 1 after completion of prior AML therapy with the exception of the platelet count requirements (i.e., as long as peripheral blood platelet count is \>20,000/µL). 14. Must not have end stage renal disease. 15. Must have adequate hepatic function defined as a serum total bilirubin \<2 × ULN (except for Gilbert's syndrome, which will allow bilirubin ≤3.0 mg/dL), and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN. 16. Must be willing and able to return to the clinical site for adequate follow-up and to comply with the protocol as required. Exclusion Criteria: 1. For subjects randomized to GPS maintenance monotherapy: 1. Continuation of any agents administered as part of induction of CR2/CRp2 or later 2. Receiving any concurrent anti-AML systemic therapy 3. Prior clinically significant allergic reaction to Montanide, sargramostim (GM-CSF) or filgrastim (granulocyte colony stimulating factor \[G-CSF\]). 4. Received any consolidation and/or maintenance antileukemic therapy, investigational agent, systemic corticosteroid therapy, or other immunosuppressive therapy within 4 weeks prior or 10 half lives, whichever is shorter prior to receiving study treatment. Systemic corticosteroids for chronic conditions (at doses ≤10 mg/day of prednisone or equivalent) or permitted, as are inhalational, intra-ocular, intra-articular and topical corticosteroids as well as any corticosteroids or other immunosuppressive therapies that do not act systemically (e.g. budesonide) at any dose level. 2. Imminently planned hematopoietic stem cell transplant (autologous or allogeneic, with any degree of match donor). 3. Acute promyelocytic leukemia or any morphologic and molecular variants, inclusive. 4. Serious concurrent illness that in the opinion of the Investigator would pose an undue risk to the subject being participating in the clinical study. 5. Currently have, central nervous system leukemia. 6. Received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Vaccines for Covid-19 used under an EUA, are considered an authorized (though not an approved or cleared) medical product for use in clinical care. Vaccines used for the prevention of Covid-19 are allowed to be used. 7. Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks, or in the case of drugs 10 half lives, whichever is shorter, prior to the first dose of study treatment. 8. Patients who had an SCT after their most recent re-induction that resulted in CR2 or CRp2 or later are not eligible. Patients with prior SCT are allowed only if they had SCT prior to their latest re-induction or achieved CR by means of transplant ("hot transplant"). 9. Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy exceeding 10 mg daily of prednisone equivalent within 7 days prior the first dose of study drug. The use of physiologic doses of corticosteroids and/or immunosuppressive agents may be approved after consultation with the Sponsor. Steroids taken as short-term therapy (≤ 7 days) for antiemesis are permissible. 10. Known additional malignancy that is progressing or has required active treatment within the past 5 years, even if currently inactive or unapparent. 11. Known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment. 12. Known hypersensitivity to Montanide or vaccine adjuvants. 13. Previous clinically significant systemic allergic reaction to Montanide, sargramostim (GM-CSF), or filgrastim (G-CSF). 14. Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. 15. Active life threatening infection requiring systemic therapy. 16. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. This includes any serious, intercurrent, chronic, or acute illness, such as cardiac disease (New York Heart Association \[NYHA\] class III or IV), hepatic disease, or other illness considered by the investigator as an unwarranted high risk for investigational drug treatment. 17. Known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study. 18. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 30 days after the last dose of study treatment. 19. Has had an allogeneic tissue/solid organ transplant. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Birmingham **Country:** United States **Facility:** O'Neal Comprehensive Cancer Center **State:** Alabama **Zip:** 35205 **Location 2:** **City:** Los Angeles **Country:** United States **Facility:** UCLA Medical Hematology and Oncology **State:** California **Zip:** 90095 **Location 3:** **City:** Whittier **Country:** United States **Facility:** The Oncology Institute of Hope and Innovation **State:** California **Zip:** 90603 **Location 4:** **City:** Denver **Country:** United States **Facility:** Colorado Blood Cancer Institute - SCRI - PPDS **State:** Colorado **Zip:** 80218 **Location 5:** **City:** Jacksonville **Country:** United States **Facility:** Mayo Clinic Jacksonville Florida **State:** Florida **Zip:** 32224 **Location 6:** **City:** Augusta **Country:** United States **Facility:** Augusta University **State:** Georgia **Zip:** 30912 **Location 7:** **City:** Chicago **Country:** United States **Facility:** Rush University Cancer Center **State:** Illinois **Zip:** 60612 **Location 8:** **City:** New Orleans **Country:** United States **Facility:** Tulane Cancer Center - Liberty **State:** Louisiana **Zip:** 70112 **Location 9:** **City:** Lake Success **Country:** United States **Facility:** Northwell Health Cancer Institute **State:** New York **Zip:** 11042 **Location 10:** **City:** Valhalla **Country:** United States **Facility:** New York Medical College **State:** New York **Zip:** 10532 **Location 11:** **City:** Cleveland **Country:** United States **Facility:** University Hospitals Cleveland Medical Center **State:** Ohio **Zip:** 44106 **Location 12:** **City:** Portland **Country:** United States **Facility:** Oregon Health and Science University **State:** Oregon **Zip:** 97239 **Location 13:** **City:** Greenville **Country:** United States **Facility:** Bon Secours St. Francis Cancer Center **State:** South Carolina **Zip:** 29607 **Location 14:** **City:** Dallas **Country:** United States **Facility:** Baylor Scott and White Research Institute **State:** Texas **Zip:** 75246 **Location 15:** **City:** Houston **Country:** United States **Facility:** University of Texas - MD Anderson Cancer Center **State:** Texas **Zip:** 77030 **Location 16:** **City:** Gainesville **Country:** United States **Facility:** Virginia Cancer Specialists **State:** Virginia **Zip:** 20155 **Location 17:** **City:** Seattle **Country:** United States **Facility:** Swedish Cancer Institute **State:** Washington **Zip:** 98109 **Location 18:** **City:** Amiens **Country:** France **Facility:** CHU Amiens-Picardie - Hopital Sud **Zip:** 80000 **Location 19:** **City:** Angers **Country:** France **Facility:** CHU Angers **Zip:** 49000 **Location 20:** **City:** Caen **Country:** France **Facility:** CHU de Caen **Zip:** 14000 **Location 21:** **City:** Grenoble **Country:** France **Facility:** CHU de Grenoble **Zip:** 38043 **Location 22:** **City:** Nantes **Country:** France **Facility:** Hôtel Dieu - Nantes **Zip:** 44000 **Location 23:** **City:** Paris **Country:** France **Facility:** Hôpital Saint Antoine **Zip:** 75571 **Location 24:** **City:** Pierre-Bénite **Country:** France **Facility:** Centre Hospitalier Lyon Sud **Zip:** 69310 **Location 25:** **City:** Poitiers **Country:** France **Facility:** CHU de Poitiers **Zip:** 86000 **Location 26:** **City:** Villejuif **Country:** France **Facility:** Institut Gustave Roussy **Zip:** 94805 **Location 27:** **City:** Chemnitz **Country:** Germany **Facility:** Klinikum Chemnitz gGmbH **Zip:** 09116 **Location 28:** **City:** Leipzig **Country:** Germany **Facility:** Universitatsklinikum Leipzig **Zip:** 04103 **Location 29:** **City:** Rostock **Country:** Germany **Facility:** Universitätsklinik Rostock **Zip:** 18057 **Location 30:** **City:** Alexandroupolis **Country:** Greece **Facility:** University General Hospital of Alexandroupoli **Zip:** 68100 **Location 31:** **City:** Athens **Country:** Greece **Facility:** General Hospital of Athens "Evaggelismos" **Zip:** 10676 **Location 32:** **City:** Athens **Country:** Greece **Facility:** General Hospital of Athens "Laiko" **Zip:** 11526 **Location 33:** **City:** Athens **Country:** Greece **Facility:** General Hospital of Athens "G. Gennimatas" **Zip:** 11527 **Location 34:** **City:** Athens **Country:** Greece **Facility:** General Hospital of Athens "Ηippokration" **Zip:** 11527 **Location 35:** **City:** Chaïdári **Country:** Greece **Facility:** University General Hospital "Attikon" **Zip:** 12462 **Location 36:** **City:** Chortiátis **Country:** Greece **Facility:** General Hospital of Thessaloniki "G. Papanikolaou" **Zip:** 57010 **Location 37:** **City:** Ioánnina **Country:** Greece **Facility:** University General Hospital of Ioannina **Zip:** 45500 **Location 38:** **City:** Río **Country:** Greece **Facility:** University General Hospital of Patras **Zip:** 26504 **Location 39:** **City:** Thessaloníki **Country:** Greece **Facility:** University General Hospital of Thessaloniki "Ahepa" **Zip:** 54636 **Location 40:** **City:** Budapest **Country:** Hungary **Facility:** Semmelweis Egyetem **Zip:** 1088 **Location 41:** **City:** Győr **Country:** Hungary **Facility:** Petz Aladár Egyetemi Oktató Kórház **Zip:** 9028 **Location 42:** **City:** Pécs **Country:** Hungary **Facility:** Pécsi Tudományegyetem **Zip:** 7624 **Location 43:** **City:** Kannur **Country:** India **Facility:** Malabar Cancer Centre **State:** Kerala **Zip:** 670103 **Location 44:** **City:** Hyderabad **Country:** India **Facility:** Yashoda Hospital **Zip:** 500084 **Location 45:** **City:** Ludhiāna **Country:** India **Facility:** Fortis Hospital **Zip:** 141015 **Location 46:** **City:** New Delhi **Country:** India **Facility:** All India Institute of Medical Sciences **Zip:** 110029 **Location 47:** **City:** Patna **Country:** India **Facility:** State Cancer Institute, Indira Gandhi Institute of Medical Sciences **Zip:** 800014 **Location 48:** **City:** Bydgoszcz **Country:** Poland **Facility:** Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy **Zip:** 85-168 **Location 49:** **City:** Gdańsk **Country:** Poland **Facility:** Uniwersyteckie Centrum Kliniczne Klinika Hematologii i Transplantologii **Zip:** 80-952 **Location 50:** **City:** Gdynia **Country:** Poland **Facility:** Szpitale Pomorskie Sp. z o.o. **Zip:** 81-519 **Location 51:** **City:** Kielce **Country:** Poland **Facility:** Swietokrzyskie Centrum Onkologii **Zip:** 25-734 **Location 52:** **City:** Legnica **Country:** Poland **Facility:** Wojewodzki Szpital Specjalistyczny w Legnicy **Zip:** 59-220 **Location 53:** **City:** Olsztyn **Country:** Poland **Facility:** Zaklad Opieki Zdrowotnej MSW z Warminsko-Mazurskim Centrum Onkologii **Zip:** 10-228 **Location 54:** **City:** Opole **Country:** Poland **Facility:** Szpital Wojewodzki w Opolu **Zip:** 45-372 **Location 55:** **City:** Slomniki **Country:** Poland **Facility:** SP ZOZ Szpital Uniwersytecki w Krakowie **Zip:** 32-090 **Location 56:** **City:** Warsaw **Country:** Poland **Facility:** Instytut Hematologii i Transfuzjologii **Zip:** 02-776 **Location 57:** **City:** Wrocław **Country:** Poland **Facility:** Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu **Zip:** 50-367 **Location 58:** **City:** Belgrade **Country:** Serbia **Facility:** University Clinical Center of Serbia **Zip:** 11000 **Location 59:** **City:** Novi Sad **Country:** Serbia **Facility:** Clinical Centre of Vojvodina **Zip:** 402007 **Location 60:** **City:** Cáceres **Country:** Spain **Facility:** Hospital de San Pedro de Alcantara **Zip:** 10003 **Location 61:** **City:** Córdoba **Country:** Spain **Facility:** C.H. Regional Reina Sofia **Zip:** 14004 **Location 62:** **City:** Madrid **Country:** Spain **Facility:** Hospital General Universitario Gregorio Marañon **Zip:** 28007 **Location 63:** **City:** Madrid **Country:** Spain **Facility:** Hospital Universitario La Paz **Zip:** 28046 **Location 64:** **City:** Oviedo **Country:** Spain **Facility:** Hospital Universitario Central de Asturias **Zip:** 33011 **Location 65:** **City:** Pamplona **Country:** Spain **Facility:** Clinica Universidad Navarra **Zip:** 31008 **Location 66:** **City:** Salamanca **Country:** Spain **Facility:** Complejo Asistencial Universitario de Salamanca **Zip:** 37007 **Location 67:** **City:** Sevilla **Country:** Spain **Facility:** Hospital Universitario Virgen del Rocio **Zip:** 41013 **Location 68:** **City:** Valencia **Country:** Spain **Facility:** Hospital Universitari i Politecnic La Fe de Valencia **Zip:** 46026 **Location 69:** **City:** Chang Hua **Country:** Taiwan **Facility:** Changhua Christian Hospital **Zip:** 50006 **Location 70:** **City:** Kaohsiung **Country:** Taiwan **Facility:** Kaohsiung Medical University Hospital **Zip:** 807 **Location 71:** **City:** Taichung **Country:** Taiwan **Facility:** Taichung Veterans General Hospital **Zip:** 40705 **Location 72:** **City:** Tainan **Country:** Taiwan **Facility:** National Cheng Kung University Hospital **Zip:** 704 **Location 73:** **City:** Taipei **Country:** Taiwan **Facility:** National Taiwan University Hospital **Zip:** 100 #### Overall Officials **Official 1:** **Affiliation:** Sellas Life Sciences Group **Name:** Dragan Cicic Chief Development Officer, MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000006402 - Term: Hematologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10945 - Name: Leukemia - Relevance: HIGH - As Found: Leukemia - ID: M10955 - Name: Leukemia, Myeloid - Relevance: HIGH - As Found: Myeloid Leukemia - ID: M18127 - Name: Leukemia, Myeloid, Acute - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: M12341 - Name: Wilms Tumor - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: T3995 - Name: Myeloid Leukemia - Relevance: HIGH - As Found: Myeloid Leukemia - ID: T182 - Name: Acute Myeloid Leukemia - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: T188 - Name: Acute Non Lymphoblastic Leukemia - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T5932 - Name: Wilms' Tumor - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007938 - Term: Leukemia - ID: D000007951 - Term: Leukemia, Myeloid - ID: D000015470 - Term: Leukemia, Myeloid, Acute ### Intervention Browse Module - Ancestors - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents - ID: D000000998 - Term: Antiviral Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000000276 - Term: Adjuvants, Immunologic ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AnSickAg - Name: Antisickling Agents ### Intervention Browse Module - Browse Leaves - ID: M6766 - Name: Cytarabine - Relevance: HIGH - As Found: Infants - ID: M4673 - Name: Azacitidine - Relevance: HIGH - As Found: Side - ID: M1697 - Name: Decitabine - Relevance: HIGH - As Found: Above - ID: M249656 - Name: Venetoclax - Relevance: HIGH - As Found: Third - ID: M257633 - Name: Molgramostim - Relevance: LOW - As Found: Unknown - ID: M219218 - Name: Sargramostim - Relevance: HIGH - As Found: Irradiation - ID: M9969 - Name: Hydroxyurea - Relevance: LOW - As Found: Unknown - ID: M254598 - Name: Monatide (IMS 3015) - Relevance: HIGH - As Found: 11C - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown - ID: M4314 - Name: Antiviral Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M3628 - Name: Adjuvants, Immunologic - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000003561 - Term: Cytarabine - ID: D000001374 - Term: Azacitidine - ID: D000077209 - Term: Decitabine - ID: C000579720 - Term: Venetoclax - ID: C000081222 - Term: Sargramostim - ID: C000712049 - Term: Monatide (IMS 3015) ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04717479 **Brief Title:** A Scalable Model for Promoting Functioning and Well-Being Among Older Adults With Mild Cognitive Impairment Via Meaningful Social Interactions: Project SPEAK! **Official Title:** A Scalable Model for Promoting Functioning and Well-Being Among Older Adults With Mild Cognitive Impairment Via Meaningful Social Interactions: Project SPEAK! #### Organization Study ID Info **ID:** 1R21AG066644 **Link:** https://reporter.nih.gov/quickSearch/1R21AG066644 **Type:** NIH #### Organization **Class:** OTHER **Full Name:** University of Michigan #### Secondary ID Infos **ID:** 5R21AG066644-02 **Link:** https://reporter.nih.gov/quickSearch/5R21AG066644-02 **Type:** NIH ### Status Module #### Completion Date **Date:** 2022-04-08 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-07-20 **Type:** ACTUAL **Last Update Submit Date:** 2023-06-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-04-08 **Type:** ACTUAL #### Results First Post Date **Date:** 2023-07-20 **Type:** ACTUAL **Results First Submit Date:** 2023-04-11 **Results First Submit QC Date:** 2023-06-28 #### Start Date **Date:** 2021-03-19 **Type:** ACTUAL **Status Verified Date:** 2023-06 #### Study First Post Date **Date:** 2021-01-22 **Type:** ACTUAL **Study First Submit Date:** 2021-01-15 **Study First Submit QC Date:** 2021-01-20 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute on Aging (NIA) #### Lead Sponsor **Class:** OTHER **Name:** University of Michigan #### Responsible Party **Investigator Affiliation:** University of Michigan **Investigator Full Name:** John Piette **Investigator Title:** Professor of Health Behavior and Health Education, and of Internal Medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this study is to refine and test a strategy for engaging older adults with symptoms of SCD/MCI (subjective cognitive decline/mild cognitive impairment) as volunteers to help English language learners (ELLs) who live in the US improve their speaking skills via structured conversations using videoconferencing. **Detailed Description:** Aim 1: Conduct a user-centered design process to refine the SPEAK! training protocols for older adults with symptoms of SCD/MCI and ELLs, and the materials that will support productive engaging English conversation practice. Aim 2: Conduct a randomized, wait-list controlled trial of 8 weeks of SPEAK! participation, using a variety of recruitment sources, in order to evaluate our capacity to recruit, implement the intervention, and retain older adults with symptoms of SCD/MCI in sufficient numbers for a subsequent randomized-controlled trial evaluating the intervention's impact on participants' psychological well-being, mood, and cognitive functioning. Aim 3: Using mixed methods, evaluate the communication process between older adults with symptoms of SCD/MCI and ELLs including factors that contribute to satisfaction of both parties, engagement in planned contacts, possible contributors to stress or dissatisfaction, and perceptions among older adults of being appreciated and effective. The investigators will also estimate variances for key outcome variables and conduct exploratory analyses of intervention-control differences in participants' perceptions of their wellbeing, mood, and cognitive functioning. ### Conditions Module **Conditions:** - Mild Cognitive Impairment ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 80 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will be paired with an English language learner and engage in 8 weeks, 1 hour videoconferencing sessions. **Intervention Names:** - Other: Intervention (videoconferencing) **Label:** Intervention **Type:** OTHER #### Arm Group 2 **Description:** Participants will wait 8 weeks and then they will be paired with an English language learner and engage in 8 weeks, 1 hour videoconferencing sessions. **Intervention Names:** - Other: Intervention (videoconferencing) **Label:** Wait-list Control **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention - Wait-list Control **Description:** 1 hour videoconferencing sessions over 8 weeks with an English language learner partner. **Name:** Intervention (videoconferencing) **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** The Psychological Wellbeing Scale (PWB) is a validated measure shown to be sensitive to intervention effects. This is a 6 point scale where the minimum is 1 (strongly disagree) and maximum is 6 (strongly agree). Higher scores reflect higher wellbeing. **Measure:** Psychological Wellbeing Scale (PWB) **Time Frame:** Baseline and follow-up collected after the 8-week intervention time period. **Description:** This is a validated measure of loneliness with an alpha reliability of .94. This is a 4 point scale from 1=never to 4=always (minimum is 1 maximum is 4). Positively worded questions will be reverse-coded so that higher scores mean more loneliness. **Measure:** UCLA Revised Loneliness Scale **Time Frame:** Baseline and follow-up collected after the 8-week intervention time period. **Description:** The Geriatric Depression Scale is a measure of depressive symptoms specifically designed for older adults. The 30 point scale has a minimum of 0 points to maximum 30 points. Higher scores reflect greater depression. **Measure:** Geriatric Depression Scale **Time Frame:** Baseline and follow-up collected after the 8-week intervention time period. #### Primary Outcomes **Description:** The primary aim for Phase 2 of the study was to demonstrate the feasibility of recruiting and consenting a minimum of 35 older adults with MCI/SCD (mild cognitive impairment/subjective cognitive decline) within the first six months. **Measure:** Number of MCI/SCD (Mild Cognitive Impairment/Subjective Cognitive Decline) Participants Recruited Within the First Six Months **Time Frame:** Baseline (Up to approximately 1 hour and 15 minutes over the course of two meetings). ### Eligibility Module **Eligibility Criteria:** Mild Cognitive Impairment participant -- Inclusion Criteria: * 55+ years of age, fluent speakers of English of any race/ethnicity, and be able to participate in a videoconference via a smartphone, tablet laptop, or desktop computer in their home or referring organization using a widely accessible, no cost videoconferencing platform. Exclusion Criteria: * Participants will be ineligible if they have a history of stroke or traumatic brain injury, bipolar disorder, schizophrenia, or current alcohol or drug abuse/dependence, that would affect their ability to participate in the study; MoCA score \<12. **Healthy Volunteers:** True **Minimum Age:** 55 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Ann Arbor **Country:** United States **Facility:** University of Michigan, North Campus Research Complex **State:** Michigan **Zip:** 48109 #### Overall Officials **Official 1:** **Affiliation:** University of Michigan **Name:** John D Piette, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Document Section ### Large Document Module #### Large Docs - Date: 2021-06-25 - Filename: Prot_SAP_001.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 342861 - Type Abbrev: Prot_SAP - Upload Date: 2023-04-06T12:44 - Date: 2022-01-06 - Filename: ICF_000.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 257542 - Type Abbrev: ICF - Upload Date: 2022-07-20T10:29 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003072 - Term: Cognition Disorders - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M29705 - Name: Cognitive Dysfunction - Relevance: HIGH - As Found: Mild Cognitive Impairment - ID: M6301 - Name: Cognition Disorders - Relevance: LOW - As Found: Unknown - ID: M21836 - Name: Neurocognitive Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000060825 - Term: Cognitive Dysfunction ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module **Description:** Reviewed by staff during our weekly meetings. Same definition as in clinicaltrials.gov. All serious events were unrelated to the study. #### Event Groups **Group ID:** EG000 **Title:** Intervention **Deaths Num At Risk:** 41 **Description:** Participants will be paired with an English language learner and engage in 8 weeks, 1 hour videoconferencing sessions. Intervention (videoconferencing): 1 hour videoconferencing sessions over 8 weeks with an English language learner partner. **ID:** EG000 **Other Num at Risk:** 41 **Serious Number Affected:** 2 **Serious Number At Risk:** 41 **Title:** Intervention **Group ID:** EG001 **Title:** Wait-list Control **Deaths Num At Risk:** 39 **Description:** Participants will wait 8 weeks and then they will be paired with an English language learner and engage in 8 weeks, 1 hour videoconferencing sessions. Intervention (videoconferencing): 1 hour videoconferencing sessions over 8 weeks with an English language learner partner. **ID:** EG001 **Other Num at Risk:** 39 **Serious Number Affected:** 1 **Serious Number At Risk:** 39 **Title:** Wait-list Control **Frequency Threshold:** 0 #### Serious Events **Term:** Surgery **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Surgical and medical procedures ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 39 **Term:** Stroke **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 41 **Num Events:** 1 **Group ID:** EG001 **Num At Risk:** 39 **Term:** Car accident injury **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications ##### Stats **Group ID:** EG000 **Num At Risk:** 41 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 39 **Num Events:** 1 **Time Frame:** 2 months during recruitment and delivery of the intervention. ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 41 **Group ID:** BG001 **Value:** 39 **Group ID:** BG002 **Value:** 80 **Units:** Participants ### Group **ID:** BG000 **Title:** Intervention **Description:** Participants will be paired with an English language learner and engage in 8 weeks, 1 hour videoconferencing sessions. Intervention (videoconferencing): 1 hour videoconferencing sessions over 8 weeks with an English language learner partner. ### Group **ID:** BG001 **Title:** Wait-list Control **Description:** Participants will wait 8 weeks and then they will be paired with an English language learner and engage in 8 weeks, 1 hour videoconferencing sessions. Intervention (videoconferencing): 1 hour videoconferencing sessions over 8 weeks with an English language learner partner. ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 9.49 **Value:** 70 #### Measurement **Group ID:** BG001 **Spread:** 8.06 **Value:** 71 #### Measurement **Group ID:** BG002 **Spread:** 8.82 **Value:** 71 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 22 **Group ID:** BG001 **Value:** 22 **Group ID:** BG002 **Value:** 44 **Class Title:** MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) #### Measurement **Group ID:** BG000 **Spread:** 9.73 **Value:** 41 #### Measurement **Group ID:** BG001 **Spread:** 9.07 **Value:** 43 #### Measurement **Group ID:** BG002 **Spread:** 9.32 **Value:** 42 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 19 **Group ID:** BG001 **Value:** 17 **Group ID:** BG002 **Value:** 36 **Class Title:** ELL (English Language Learner) ### Measure #### Measurement **Group ID:** BG000 **Value:** 12 #### Measurement **Group ID:** BG001 **Value:** 16 #### Measurement **Group ID:** BG002 **Value:** 28 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 10 #### Measurement **Group ID:** BG001 **Value:** 6 #### Measurement **Group ID:** BG002 **Value:** 16 **Category Title:** Male #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 22 **Group ID:** BG001 **Value:** 22 **Group ID:** BG002 **Value:** 44 **Class Title:** MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) #### Measurement **Group ID:** BG000 **Value:** 15 #### Measurement **Group ID:** BG001 **Value:** 13 #### Measurement **Group ID:** BG002 **Value:** 28 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 4 #### Measurement **Group ID:** BG001 **Value:** 4 #### Measurement **Group ID:** BG002 **Value:** 8 **Category Title:** Male #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 19 **Group ID:** BG001 **Value:** 17 **Group ID:** BG002 **Value:** 36 **Class Title:** ELL (English Language Learner) ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 22 #### Measurement **Group ID:** BG001 **Value:** 22 #### Measurement **Group ID:** BG002 **Value:** 44 **Category Title:** Not Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Unknown or Not Reported #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 22 **Group ID:** BG001 **Value:** 22 **Group ID:** BG002 **Value:** 44 **Class Title:** MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) #### Measurement **Group ID:** BG000 **Value:** 11 #### Measurement **Group ID:** BG001 **Value:** 12 #### Measurement **Group ID:** BG002 **Value:** 23 **Category Title:** Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 8 #### Measurement **Group ID:** BG001 **Value:** 5 #### Measurement **Group ID:** BG002 **Value:** 13 **Category Title:** Not Hispanic or Latino #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Unknown or Not Reported #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 19 **Group ID:** BG001 **Value:** 17 **Group ID:** BG002 **Value:** 36 **Class Title:** ELL (English Language Learner) ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 2 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 2 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 4 #### Measurement **Group ID:** BG001 **Value:** 7 #### Measurement **Group ID:** BG002 **Value:** 11 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 16 #### Measurement **Group ID:** BG001 **Value:** 15 #### Measurement **Group ID:** BG002 **Value:** 31 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Unknown or Not Reported #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 22 **Group ID:** BG001 **Value:** 22 **Group ID:** BG002 **Value:** 44 **Class Title:** MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 4 #### Measurement **Group ID:** BG001 **Value:** 4 #### Measurement **Group ID:** BG002 **Value:** 8 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 2 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 9 #### Measurement **Group ID:** BG001 **Value:** 10 #### Measurement **Group ID:** BG002 **Value:** 19 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 3 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 3 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 2 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 4 **Category Title:** Unknown or Not Reported #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 19 **Group ID:** BG001 **Value:** 17 **Group ID:** BG002 **Value:** 36 **Class Title:** ELL (English Language Learner) ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** 8th grade or less #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Some high school,but did not graduate #### Measurement **Group ID:** BG000 **Value:** 1 #### Measurement **Group ID:** BG001 **Value:** 2 #### Measurement **Group ID:** BG002 **Value:** 3 **Category Title:** High school graduate or GED #### Measurement **Group ID:** BG000 **Value:** 5 #### Measurement **Group ID:** BG001 **Value:** 3 #### Measurement **Group ID:** BG002 **Value:** 8 **Category Title:** Some college or two-year college degree #### Measurement **Group ID:** BG000 **Value:** 6 #### Measurement **Group ID:** BG001 **Value:** 9 #### Measurement **Group ID:** BG002 **Value:** 15 **Category Title:** Four-year college graduate #### Measurement **Group ID:** BG000 **Value:** 10 #### Measurement **Group ID:** BG001 **Value:** 8 #### Measurement **Group ID:** BG002 **Value:** 18 **Category Title:** More than four-year college degree #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 22 **Group ID:** BG001 **Value:** 22 **Group ID:** BG002 **Value:** 44 **Class Title:** MCI/SCD (Older adults with mild cognitive impairment/subjective cognitive decline) #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** 8th grade or less #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Some high school,but did not graduate #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** High school graduate or GED #### Measurement **Group ID:** BG000 **Value:** 2 #### Measurement **Group ID:** BG001 **Value:** 1 #### Measurement **Group ID:** BG002 **Value:** 3 **Category Title:** Some college or two-year college degree #### Measurement **Group ID:** BG000 **Value:** 7 #### Measurement **Group ID:** BG001 **Value:** 4 #### Measurement **Group ID:** BG002 **Value:** 11 **Category Title:** Four-year college graduate #### Measurement **Group ID:** BG000 **Value:** 10 #### Measurement **Group ID:** BG001 **Value:** 12 #### Measurement **Group ID:** BG002 **Value:** 22 **Category Title:** More than four-year college degree #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 19 **Group ID:** BG001 **Value:** 17 **Group ID:** BG002 **Value:** 36 **Class Title:** ELL (English Language Learner) **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Population Description:** Information was not obtained for one ELL participant **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** Overall population described in two groups: MCI/SCD participants and ELL participants **Title:** Sex/Gender, Customized **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** Overall population described in two groups: MCI/SCD participants and ELL participants **Title:** Ethnicity (NIH/OMB) **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ### Measure 5 **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** Overall population analyzed in 2 groups: MCI/SCD participants and ELL participants **Title:** Highest Degree of Completed Education **Unit of Measure:** Participants ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** [email protected] **Organization:** University of Michigan **Phone:** 734-763-0412 **Title:** Sarah Yon ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 35 **Title:** #### Outcome Measure 2 #### Outcome Measure 3 #### Outcome Measure 4 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** The primary aim for Phase 2 of the study was to demonstrate the feasibility of recruiting and consenting a minimum of 35 older adults with MCI/SCD (mild cognitive impairment/subjective cognitive decline) within the first six months. **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** The overall number of participants analyzed refers to the 50 participants that were screened in the first 6 months, from which 35 participants were enrolled in the first 6 months. **Reporting Status:** POSTED **Time Frame:** Baseline (Up to approximately 1 hour and 15 minutes over the course of two meetings). **Title:** Number of MCI/SCD (Mild Cognitive Impairment/Subjective Cognitive Decline) Participants Recruited Within the First Six Months **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** Overall participant recruitment of MCI/SCD (older adults with mild cognitive impairment/subjective cognitive decline) arm of the study within the first six months. **ID:** OG000 **Title:** Overall #### Outcome Measure 2 **Description:** The Psychological Wellbeing Scale (PWB) is a validated measure shown to be sensitive to intervention effects. This is a 6 point scale where the minimum is 1 (strongly disagree) and maximum is 6 (strongly agree). Higher scores reflect higher wellbeing. **Reporting Status:** NOT_POSTED **Time Frame:** Baseline and follow-up collected after the 8-week intervention time period. **Title:** Psychological Wellbeing Scale (PWB) **Type:** OTHER_PRE_SPECIFIED #### Outcome Measure 3 **Description:** This is a validated measure of loneliness with an alpha reliability of .94. This is a 4 point scale from 1=never to 4=always (minimum is 1 maximum is 4). Positively worded questions will be reverse-coded so that higher scores mean more loneliness. **Reporting Status:** NOT_POSTED **Time Frame:** Baseline and follow-up collected after the 8-week intervention time period. **Title:** UCLA Revised Loneliness Scale **Type:** OTHER_PRE_SPECIFIED #### Outcome Measure 4 **Description:** The Geriatric Depression Scale is a measure of depressive symptoms specifically designed for older adults. The 30 point scale has a minimum of 0 points to maximum 30 points. Higher scores reflect greater depression. **Reporting Status:** NOT_POSTED **Time Frame:** Baseline and follow-up collected after the 8-week intervention time period. **Title:** Geriatric Depression Scale **Type:** OTHER_PRE_SPECIFIED ### Participant Flow Module #### Group **Description:** Participants will be paired with an English language learner and engage in 8 weeks, 1 hour videoconferencing sessions. Intervention (videoconferencing): 1 hour videoconferencing sessions over 8 weeks with an English language learner partner. **ID:** FG000 **Title:** Intervention #### Group **Description:** Participants will wait 8 weeks and then they will be paired with an English language learner and engage in 8 weeks, 1 hour videoconferencing sessions. Intervention (videoconferencing): 1 hour videoconferencing sessions over 8 weeks with an English language learner partner. **ID:** FG001 **Title:** Wait-list Control #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 41 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 39 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 34 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 35 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 7 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 4 **Recruitment Details:** Goal of recruiting 44 pairs into the waitlist trial for AIMS 2-3. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT04967079 **Brief Title:** Trametinib Plus Anlotinib in Non-G12C KRAS-Mutant NSCLC Patients **Official Title:** Combined MEK Inhibitor Trametinib and RTK Inhibitor Anlotinib Therapy in Non-G12C KRAS-Mutant Non-Small Cell Lung Cancer Patients #### Organization Study ID Info **ID:** ATRAS-LC #### Organization **Class:** OTHER **Full Name:** Shanghai Chest Hospital ### Status Module #### Completion Date **Date:** 2024-03-26 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-04-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-04-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-07-01 **Type:** ACTUAL #### Start Date **Date:** 2021-08-01 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2021-07-19 **Type:** ACTUAL **Study First Submit Date:** 2021-07-05 **Study First Submit QC Date:** 2021-07-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Shanghai Chest Hospital #### Responsible Party **Investigator Affiliation:** Shanghai Chest Hospital **Investigator Full Name:** Baohui Han **Investigator Title:** Director of department **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is a Phase I exploratory study. The study is divided into two parts (A/B).In part A, the primary endpoint is the determination of the recommended phase 2 dose (RP2D). Secondary endpoint for phase Ia includes evaluating the objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and adverse events (AEs). Following the establishment of the RP2D, the expansion cohort will be initiated. Transitioning to part B, 20 patients will be enrolled to further evaluate the ORR. All patients will receive the trametinib plus anlotinib regimen based on the RP2D determined in part A. The primary endpoint for part B is to assess the ORR, while secondary endpoint includes evaluating PFS, overall survival (OS), DCR, AEs, and duration of overall response (DoR). In part A, the study plans to enroll eligible patients to receive the MEK inhibitor trametinib (2 mg) in combination with anlotinib (6mg, 8 mg, 10 mg, 12 mg). The number of subjects is determined according to the actual situation of dose climbing. In part B, another 20 eligible patients will be enrolled and treated with trametinib (2mg) + anlotinib (RP2D), until the disease progression (PD) or unacceptable toxicity occurs to further evaluate the safety, tolerability and efficacy. Patients participated in safety follow-up after the first course of treatment until 3 months after discontinuation due to PD or toxicity. Dose-limiting toxicities from the first cycle were collected. Therapeutic efficacy evaluation was scheduled according to RECIST version 1.1 every 4-8 weeks. After the investigators' evaluation, the assessment cycle could extend to 12 weeks or longer due to the uncontrollable factors during the treatment period. Blood samples will be collected for pharmacokinetic analysis and biomarker discovery at baseline and at each periodic assessment. ### Conditions Module **Conditions:** - Non Small Cell Lung Cancer **Keywords:** - non-G12C KRAS Mutations - Advanced NSCLC - MEK inhibitor-trametinib - RTKs inhibitor-Anlotinib ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 33 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Anlotinib given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) plus trametinib 2 milligrams (mg) given orally, once daily. **Intervention Names:** - Drug: Trametinib - Drug: Anlotinib **Label:** Trametinib + Anlotinib **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Trametinib + Anlotinib **Description:** Trametinib 2 mg given orally, once daily **Name:** Trametinib **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Trametinib + Anlotinib **Description:** Anlotinib given orally, every two weeks followed by a one-week discontinuation cycle **Name:** Anlotinib **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The determination of RP2D relied on several priority indexes: firstly, the MTD, followed by ORR, and mean tumor shrinkage rate. If the highest dose of anlotinib (12 mg) did not reach MTD, ORR would be the main index for defining the RP2D. Subsequently, if 2 or more dosage groups had same ORR, the average tumor shrinkage rate would replace MTD and ORR in determining RP2D. **Measure:** Part A: Recommended phase 2 dose (RP2D) **Time Frame:** 1 year **Description:** Percentage of participants achieving CR and PR. **Measure:** Part B: Objective response rate (ORR) **Time Frame:** 1.5 year #### Secondary Outcomes **Description:** The time from the start of systemic treatment date to the date of first documented disease progression (event: disease progression - DP, based on RECIST, death, adverse events, which provide to disqualification from further therapy). **Measure:** Progression Free Survival (PFS) **Time Frame:** 2 years **Description:** Percentage of participants achieving CR and PR and SD. **Measure:** Disease control rate (DCR) **Time Frame:** 2 years **Description:** OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. **Measure:** Overall survival (OS) **Time Frame:** 2 years **Description:** Adverse event caused by the combination treatments. **Measure:** Adverse Event (AE) **Time Frame:** 2 years **Description:** The time from date of the first documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. **Measure:** Duration of overall response (DoR) **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * For inclusion in the study subjects should fulfill the following criteria: 1. According to the 8th edition of the American Journal of Critical Care (AJCC)/Union for International Cancer Control (UICC) Tumor Node Metastasis (TNM) NSCLC staging system, locally advanced (stage III B/III C), metastatic or recurrent (stage IV) NSCLC patients confirmed by histology or cytology. The NSCLC patient cannot receive surgery and radical radiotherapy, and at least one measurable lesion is confirmed according to RECIST 1.1. 2. KRAS mutation positive excluded KRASG12C mutation. 3. No active brain metastases. 4. Age ≥18 years old and ≤75 years old. 5. ECOG PS score: 0-1. 6. Patients who had previously received at least 1st-line standard therapy. Note: the treatment naïve patients who refused immunotherapy/chemotherapy at 1st-line, and willingly enrolled in the clinical trial are also eligible. Part A: advanced NSCLC patients with non-G12C mutations who have previously received standard treatment or treatment naïve. Part B: advanced NSCLC patients with non-G12C mutations who have previously received standard 1st or more treatment. 7. Palliative radiotherapy must be completed 7 days before the first dose of study drug is administered. 8. The main organs are functioning normally, that is, they meet the following standards: Good hematopoietic function, defined as absolute neutrophil count ≥1.5 billion /L, platelet count ≥100 billion/L, hemoglobin ≥90 g/L \[no blood transfusion or no erythropoietin (EPO) within 7 days before enrollment dependence\]; The biochemical test results should meet the following standards: BIL \<1.25 times the upper limit of normal (ULN); ALT and AST \<2.5×ULN; if liver metastasis occurs, ALT and AST \<5×ULN; Cr ≤1.5×ULN or creatinine clearance Rate (CCr) ≥60 ml/min; good coagulation function, International Normalized Ratio (INR) and PT ≤1.5 times of ULN; if the subject is receiving anticoagulation therapy, PT should be within the prescribed range of anticoagulation drugs; Women of childbearing age should agree to take contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study and within 6 months after the study; the serum or urine pregnancy test of non-breastfeeding patients should be negative; male patients should agree to take contraceptive measures during the study period and within 6 months after the study. 9. The patients voluntarily participated in the study, signed an informed consent form and had good compliance. 10. The expected survive time is longer than 3 months. Exclusion Criteria: * Subjects must not enter the study if any of the following exclusion criteria are fulfilled: 1. Patients with active central nervous system metastasis are excluded. If a subject has received adequate treatment for central nervous system (CNS) metastasis at least 2 weeks before enrollment, and is neurologically restored to baseline levels (except for residual signs or symptoms related to CNS treatment), the subject is eligible. In addition, subjects must stop corticosteroids, or the daily dose of prednisone must be stabilized orgradually reduced to ≤10 mg (or equivalent dose). 2. Small cell lung cancer (including mixed small cell and non-small cell lung cancer) or hollow central squamous cell carcinoma. 3. There are obvious bleeding symptoms. 4. Patients who have previously received MEK inhibitors, anlotinib or other multi-targeted anti-angiogenic therapy. 5. Patients with dysphagia, gastrointestinal resection, chronic diarrhea, intestinal obstruction and other factors that affect oral medication. 6. Patients who are known to have active brain metastases, spinal cord compression, cancerous meningitis, brain or soft tissue diseases diagnosed by computed tomography (CT) or magnetic resonance imaging (MRI) at the time of screening. 7. Patients with severe and/or uncontrollable diseases, such as: unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months, severe uncontrollable arrhythmia; uncontrolled blood pressure (BP, constriction BP \> 140 mmHg, diastolic BP \> 90 mmHg). 8. Active or uncontrolled serious infections. 9. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis. 10. Incomplete control of eye inflammation or eye infection, or any condition that may cause the above eye diseases. 11. Poor diabetes control (fasting blood glucose (FBG) \> 10 mmol/L). 12. Routine urine test results show that urine protein is ≥++, and the 24-hour urine protein quantitative is\> 1.0 g. 13. Active tuberculosis. 14. Uncontrollable hypercalcemia (calcium ion\> 1.5 mmol/L or calcium\> 12 mg/dL or corrected serum calcium \>ULN), or symptomatic hypercalcemia that requires continued bisphosphonate therapy. 15. Long-term unhealed wounds or fractures. 16. Those who have a history of psychotropic drug abuse and cannot be quit or have mental disorders. 17. Patients with known severe allergies (≥Grade 3) to active ingredients and excipients. 18. Patients who also suffer from other malignant tumors (except radical cervical carcinoma in situ, non-melanoma skin cancer, etc.); patients who have been assessed by the investigator as having concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study. 19. During the clinical trial, the subjects or their sexual partners cannot or refuse to take effective contraceptive measures. 20. Pregnant or breastfeeding women. 21. Previous treatment including Chinese medicine treatment. 22. Patients who are allergic to any medicine or any ingredient. 23. In other cases, patients who are not eligible for inclusion as assessed by the investigator. 24. The expected survive time is shorter than 3 months. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Shanghai **Country:** China **Facility:** Shanghai Chest Hospital **State:** Shanghai **Zip:** 200000 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000002283 - Term: Carcinoma, Bronchogenic - ID: D000001984 - Term: Bronchial Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M11172 - Name: Lung Neoplasms - Relevance: HIGH - As Found: Lung Cancer - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: HIGH - As Found: Non-Small Cell Lung Cancer - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M5540 - Name: Carcinoma, Bronchogenic - Relevance: LOW - As Found: Unknown - ID: M5260 - Name: Bronchial Neoplasms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008175 - Term: Lung Neoplasms - ID: D000002289 - Term: Carcinoma, Non-Small-Cell Lung ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000047428 - Term: Protein Kinase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M218495 - Name: Trametinib - Relevance: HIGH - As Found: 24 months - ID: M25820 - Name: Protein Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000560077 - Term: Trametinib ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04076579 **Brief Title:** Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma **Official Title:** Phase II Multi-Center Trial of Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma #### Organization Study ID Info **ID:** UMCC 2018.132 #### Organization **Class:** OTHER **Full Name:** University of Michigan Rogel Cancer Center #### Secondary ID Infos **Domain:** University of Michigan **ID:** HUM00161251 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2025-01 **Type:** ESTIMATED #### Last Update Post Date **Date:** 2023-08-31 **Type:** ACTUAL **Last Update Submit Date:** 2023-08-30 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2023-01-30 **Type:** ACTUAL #### Start Date **Date:** 2020-03-17 **Type:** ACTUAL **Status Verified Date:** 2023-08 #### Study First Post Date **Date:** 2019-09-03 **Type:** ACTUAL **Study First Submit Date:** 2019-08-29 **Study First Submit QC Date:** 2019-08-29 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Janssen Scientific Affairs, LLC **Class:** INDUSTRY **Name:** AstraZeneca #### Lead Sponsor **Class:** OTHER **Name:** University of Michigan Rogel Cancer Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** This phase II trial studies how well trabectedin and olaparib work in treating patients with sarcoma that cannot be removed by surgery or has spread to other places in the body. Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing cells, stopping them from dividing or stopping them from spreading. Olaparib may stop the growth of tumor cells by blocking pathways responsible for repairing damaged cells. Giving trabectedin and olaparib may shrink or stop the tumor from growing. ### Conditions Module **Conditions:** - Sarcoma - Sarcoma Metastatic ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 29 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** There are 2 cohorts. Both cohorts receive the same treatment: * Cohort 1: Leiomyosarcoma and liposarcoma * Cohort 2: Other bone or soft tissue sarcoma histologies Treatment consists of 21-day cycles for a maximum of 18 months. **Intervention Names:** - Drug: Olaparib - Drug: Trabectedin **Label:** Olaparib + Trabectedin **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Olaparib + Trabectedin **Description:** Olaparib taken by mouth twice daily **Name:** Olaparib **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Olaparib + Trabectedin **Description:** Trabectedin administered intravenously (IV) every 21 days **Name:** Trabectedin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Percentage of participants with complete or partial response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, within each cohort. **Measure:** Overall response rate **Time Frame:** Up to 2 years #### Secondary Outcomes **Description:** Defined as the duration of time from start of treatment to time of progression. Calculated by the Kaplan-Meier method with errors according to Peto, within each cohort. Median and 6-month PFS will be estimated along with their 95% confidence intervals. **Measure:** Progression free survival **Time Frame:** At 6 months **Description:** Defined as the duration of time from start of treatment to time of progression. Calculated by the Kaplan-Meier method with errors according to Peto, within each cohort. Median and 6-month PFS will be estimated along with their 95% confidence intervals. **Measure:** Progression free survival **Time Frame:** At approximately 2 years after enrollment **Description:** Calculated by the Kaplan-Meier method with errors according to Peto, within each cohort. Median, 1- and 2-year OS will be estimated along with their 95% confidence intervals. **Measure:** Overall survival **Time Frame:** At approximately 2 years after enrollment **Description:** The frequency and rates of adverse events occurring in at least 5% of participants and rates of grade 3-5 adverse events will be tabulated by system organ class and preferred term using Common Terminology Criteria of Adverse Events (CTCAE), within each cohort. **Measure:** Incidence of adverse events **Time Frame:** Up to 30 days after end of treatment ### Eligibility Module **Eligibility Criteria:** Key Inclusion Criteria * Age ≥ 16 years * Advanced unresectable or metastatic sarcoma * Cohort 1: Leiomyosarcoma (LMS)/Liposarcoma (LPS) * Cohort 2: Other sarcoma histologies (excluding gastrointestinal stromal tumors) * Received at least 1 prior standard chemotherapy. For cohort 1 patients, this must have included a prior anthracycline. * Measurable disease by RECIST 1.1 * Adequate hematologic, renal, hepatic function * Adequate creatine phosphokinase * ECOG performance status ≤ 1 * Left ventricular ejection fraction (LVEF) \>= institutional lower limit of normal (LLN) * Women of childbearing potential and men must agree to use adequate contraception from signing informed consent to at least 6 months (females) and 5 months (men) after study drug treatment Key Exclusion Criteria * Prior therapy with PARP inhibitor, including olaparib * Prior therapy with trabectedin * Additional active malignancy or treatment for alternative cancer (excluding non-melanoma skin cancer) requiring treatment within the past two years * Pregnant or breastfeeding women * Known hypersensitivity to trabectedin or olaparib * Other exclusions per protocol **Minimum Age:** 16 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Ann Arbor **Country:** United States **Facility:** University of Michigan Rogel Cancer Center **State:** Michigan **Zip:** 48109 #### Overall Officials **Official 1:** **Affiliation:** University of Michigan Rogel Cancer Center **Name:** Rashmi Chugh, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000018204 - Term: Neoplasms, Connective and Soft Tissue - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15327 - Name: Sarcoma - Relevance: HIGH - As Found: Sarcoma - ID: M20350 - Name: Neoplasms, Connective and Soft Tissue - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: T5284 - Name: Soft Tissue Sarcoma - Relevance: HIGH - As Found: Sarcoma ### Condition Browse Module - Meshes - ID: D000012509 - Term: Sarcoma ### Intervention Browse Module - Ancestors - ID: D000067856 - Term: Poly(ADP-ribose) Polymerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents - ID: D000018906 - Term: Antineoplastic Agents, Alkylating - ID: D000000477 - Term: Alkylating Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M233003 - Name: Olaparib - Relevance: HIGH - As Found: Fentanyl - ID: M1862 - Name: Trabectedin - Relevance: HIGH - As Found: Excluded - ID: M205 - Name: Poly(ADP-ribose) Polymerase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M20942 - Name: Antineoplastic Agents, Alkylating - Relevance: LOW - As Found: Unknown - ID: M3820 - Name: Alkylating Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000531550 - Term: Olaparib - ID: D000077606 - Term: Trabectedin ### Misc Info Module #### Submission Tracking - Estimated Results First Submit Date: 2024-03-18 ##### Submission Infos - MCP Release N: 10 - Release Date: 2024-03-18 - Reset Date: 2024-04-12 - Unrelease Date: Unknown - Unrelease Date Unknown: Unknown - MCP Release N: 11 - Release Date: 2024-05-06 - Reset Date: 2024-05-15 - Unrelease Date: Unknown - Unrelease Date Unknown: Unknown - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03603379 **Acronym:** GBM-LIPO **Brief Title:** Doxorubicin-loaded Anti-EGFR-immunoliposomes (C225-ILs-dox) in High-grade Gliomas **Official Title:** A Pharmacokinetic Phase 1 Study of Anti-epidermal Growth Factor Receptor (EGFR) -Immunoliposomes Loaded With Doxorubicin in Patients With Relapsed or Refractory High-grade Gliomas #### Organization Study ID Info **ID:** 2018-01160; me17Kasenda2 #### Organization **Class:** OTHER **Full Name:** University Hospital, Basel, Switzerland ### Status Module #### Completion Date **Date:** 2020-11-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-12-08 **Type:** ACTUAL **Last Update Submit Date:** 2020-12-07 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-11-01 **Type:** ACTUAL #### Start Date **Date:** 2018-11-16 **Type:** ACTUAL **Status Verified Date:** 2020-12 #### Study First Post Date **Date:** 2018-07-27 **Type:** ACTUAL **Study First Submit Date:** 2018-07-17 **Study First Submit QC Date:** 2018-07-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Basel, Switzerland #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Anti-EGFR-immunoliposomes loaded with doxorubicin (C225-ILs-dox) are given intravenously in patients with relapsed or refractory high-grade gliomas. The pharmacokinetics of C225-ILs-dox in peripheral blood (PB), cerebro-spinal fluid (CSF) and resected tumour tissue will be assessed. ### Conditions Module **Conditions:** - Glioblastoma **Keywords:** - anti- EGFR- immunoliposomes ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 9 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** C225-ILs-dox administered intravenously **Intervention Names:** - Drug: C225-ILs-dox **Label:** C225-ILs-dox i.v. **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - C225-ILs-dox i.v. **Description:** C225-ILs-dox will be administered at a dose of 50 mg/m2. i.v., on day 1 of each cycle, cycle length is 28 days. In total, 4 cycles are planned to be applied. **Name:** C225-ILs-dox **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Ratio of C225-ILs-dox concentration in cerebro-spinal fluid over the C225-ILs-dox concentration in peripheral blood. **Measure:** Ratio of C225-ILs-dox concentration **Time Frame:** 24 hours after first C225-ILs-dox application #### Secondary Outcomes **Description:** Tumour response according to RANO criteria; RANO criteria: divides response into four types of response based on imaging (MRI) and clinical features: complete response partial response stable disease progression **Measure:** Tumour response according to RANO criteria on the final MRI scan **Time Frame:** At the end of 4 treatment cycle 4 (each cycle is 28 days) **Description:** 1st or second MRI scan during treatment phase according to RANO criteria. RANO criteria: divides response into four types of response based on imaging (MRI) and clinical features: complete response partial response stable disease progression **Measure:** Best achieved tumour response (1st or second MRI scan) during treatment phase according to RANO criteria ( **Time Frame:** between day 28 and day 104 **Description:** Defined as the time between registration to progression, termination of therapy for toxicity, or death whichever occurs first. **Measure:** Event free survival **Time Frame:** 12 months **Description:** Defined as the time between registration to progression or death whichever occurs first **Measure:** Progression free survival **Time Frame:** 12 months **Description:** Defined as the time between registration to death due to any cause **Measure:** Overall survival **Time Frame:** 12 months **Description:** CTCAE grade 4 Life-threatening consequences; urgent intervention indicated; Neutrophils \< 0.5 x 109/l or Platelets \< 25 x 109/l; febrile neutropenia **Measure:** Toxicity as graded by the CTCAE Version 4.0 **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Written informed consent according to International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) regulations before registration and prior to any trial specific procedures 2. Patients with relapsed histologically proven glioblastoma ≥ 18 years of age. 3. Patients need to have at least one line of treatment with combined radio-chemotherapy 4. EGFR amplification. EGFR amplification will be tested by comparative genomic hybridization (CGH) method. EGFR will be considered amplified if the value is 0.15 above the average signal of chromosome 7. 5. Evaluable disease on MRI brain scan 6. Adequate bone marrow function: neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L 7. Adequate hepatic function: bilirubin ≤ 1.5 x upper limit of normal (ULN), aspartate aminotransferase (AST), Alanin-Aminotransferase (ALT) and alkaline phosphatase (AP) ≤ 2.5 x ULN 8. Adequate renal function: serum creatinine ≤ 1.5 x ULN and calculated creatinine clearance \> 30 mL/min, according to the formula of Cockcroft-Gault 9. Adequate cardiac function: Left ventricular Ejection Fraction (LVEF) ≥ 50% as determined by either echocardiography (ECHO) or radionuclide angiocardiography (MUGA) in addition to pre- (brain-type natriuretic Peptide) BNP from peripheral blood 10. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (0=Fully active, able to carry on all pre-disease performance without restriction, 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work, 2=Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours). 11. No contraindications for lumbar puncture 12. Women with child-bearing potential have to use effective contraception, are not allowed to be pregnant and have to agree not to become pregnant during trial treatment and during the 6 months thereafter. A negative pregnancy test before inclusion into the trial is required for all women with child-bearing potential. Exclusion Criteria: 1. History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years from registration except for adequately treated cervical carcinoma in situ and localized non-melanoma skin cancer. 2. Lack to provide written informed consent 3. Previous therapy with more than 240 mg/m2 of doxorubicin or more than 450 mg/m2 of epirubicin 4. Any serious underlying medical condition (at the judgement of the investigator) which could impair the ability of the patient to participate in the trial (e.g. active autoimmune disease, uncontrolled diabetes, etc.) 5. Breastfeeding and pregnancy 6. Participation in any investigational drug trial within 4 weeks preceding treatment start 7. Any concomitant drugs contraindicated when administering Erbitux™ or Caelyx™ according to the Swissmedic-approved product information 8. Known hypersensitivity to trial drug(s) or to any component of the trial drug(s) 9. Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Aarau **Country:** Switzerland **Facility:** Kantonsspital Aarau (KSA), Oncology **Zip:** 5001 **Location 2:** **City:** Basel **Country:** Switzerland **Facility:** Department of Oncology University Hospital Basel **Zip:** 4031 #### Overall Officials **Official 1:** **Affiliation:** Dep. Oncology University Hospital Basel **Name:** Heinz Laeubli, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Kasenda B, Konig D, Manni M, Ritschard R, Duthaler U, Bartoszek E, Barenwaldt A, Deuster S, Hutter G, Cordier D, Mariani L, Hench J, Frank S, Krahenbuhl S, Zippelius A, Rochlitz C, Mamot C, Wicki A, Laubli H. Targeting immunoliposomes to EGFR-positive glioblastoma. ESMO Open. 2022 Feb;7(1):100365. doi: 10.1016/j.esmoop.2021.100365. Epub 2022 Jan 5. **PMID:** 34998092 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001254 - Term: Astrocytoma - ID: D000005910 - Term: Glioma - ID: D000018302 - Term: Neoplasms, Neuroepithelial - ID: D000017599 - Term: Neuroectodermal Tumors - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009380 - Term: Neoplasms, Nerve Tissue ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9020 - Name: Glioma - Relevance: LOW - As Found: Unknown - ID: M9019 - Name: Glioblastoma - Relevance: HIGH - As Found: Glioblastoma - ID: M4561 - Name: Astrocytoma - Relevance: LOW - As Found: Unknown - ID: M20446 - Name: Neoplasms, Neuroepithelial - Relevance: LOW - As Found: Unknown - ID: M19845 - Name: Neuroectodermal Tumors - Relevance: LOW - As Found: Unknown - ID: M20388 - Name: Neuroectodermal Tumors, Primitive - Relevance: LOW - As Found: Unknown - ID: M12318 - Name: Neoplasms, Germ Cell and Embryonal - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12325 - Name: Neoplasms, Nerve Tissue - Relevance: LOW - As Found: Unknown - ID: T2519 - Name: Glioma - Relevance: LOW - As Found: Unknown - ID: T2518 - Name: Glioblastoma - Relevance: HIGH - As Found: Glioblastoma - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005909 - Term: Glioblastoma ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M315 - Name: Cetuximab - Relevance: LOW - As Found: Unknown - ID: M7492 - Name: Doxorubicin - Relevance: LOW - As Found: Unknown - ID: M227339 - Name: Liposomal doxorubicin - Relevance: LOW - As Found: Unknown - ID: M11900 - Name: Mitogens - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04645979 **Brief Title:** A Study to Learn What Participants Think of Treatment With Betamethasone Plus Loratadine to Treat Their Acute Allergic Rhinitis, Also Known as Hay Fever in Mexico **Official Title:** The Perception of Celestamine Treatment in Mexico: a Retrospective Assessment of Consumer Perception of Prior Celestamine Use #### Organization Study ID Info **ID:** 21614 #### Organization **Class:** INDUSTRY **Full Name:** Bayer ### Status Module #### Completion Date **Date:** 2020-11-27 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-06-01 **Type:** ACTUAL **Last Update Submit Date:** 2023-05-31 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-11-27 **Type:** ACTUAL #### Start Date **Date:** 2020-11-11 **Type:** ACTUAL **Status Verified Date:** 2023-05 #### Study First Post Date **Date:** 2020-11-27 **Type:** ACTUAL **Study First Submit Date:** 2020-11-23 **Study First Submit QC Date:** 2020-11-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Bayer #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Acute allergic rhinitis is a common allergic reaction to things like pollen or dust. It causes inflammation inside the nose, resulting in symptoms similar to the common cold. Allergic rhinitis is also known as hay fever. In this study, the researchers want to learn what participants think of betamethasone plus loratadine as a treatment for their acute allergic rhinitis. These participants will have used betamethasone plus loratadine as a treatment for their acute allergic rhinitis within the past two months. During the study, participants will complete an online questionnaire about their experience with betamethasone plus loratadine. ### Conditions Module **Conditions:** - Rhinitis, Allergic ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 153 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants who used betamethasone plus loratadine to treat allergic rhinitis within the previous two months. **Intervention Names:** - Other: Online survey **Label:** Participants ### Interventions #### Intervention 1 **Arm Group Labels:** - Participants **Description:** Participants will be invited to complete an online questionnaire about their experience of product use. **Name:** Online survey **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Participants' experiences with betamethasone plus loratadine used under real life conditions. **Measure:** Experience with betamethasone plus loratadine via an online questionnaire **Time Frame:** 2 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participants who used betamethasone plus loratadine within the previous 2 months for the treatment of acute episodes of allergic rhinitis * Participants allowing to use the data for research and marketing purposes as well as talking to authorities * Participants allowing us to use the pseudo-randomized individual data for further data analysis * Able to read and understand the language of the online questionnaire Exclusion Criteria: - None **Maximum Age:** 50 Years **Minimum Age:** 20 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** The study population are participants who used betamethasone plus loratadine within the previous 2 months for the treatment of acute episodes of allergic rhinitis. ### Contacts Locations Module #### Locations **Location 1:** **City:** Multiple Locations **Country:** Mexico **Facility:** Many locations ### IPD Sharing Statement Module **Description:** Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal. **IPD Sharing:** NO ### References Module #### See Also Links **Label:** Click here to find results for studies related to Bayer products **URL:** http://clinicaltrials.bayer.com/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000009668 - Term: Nose Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000010038 - Term: Otorhinolaryngologic Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15049 - Name: Rhinitis - Relevance: HIGH - As Found: Rhinitis - ID: M30545 - Name: Rhinitis, Allergic - Relevance: HIGH - As Found: Rhinitis, Allergic - ID: M2454 - Name: Hyperthermia - Relevance: LOW - As Found: Unknown - ID: M8464 - Name: Fever - Relevance: LOW - As Found: Unknown - ID: M9345 - Name: Rhinitis, Allergic, Seasonal - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M12604 - Name: Nose Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M12961 - Name: Otorhinolaryngologic Diseases - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012220 - Term: Rhinitis - ID: D000065631 - Term: Rhinitis, Allergic ### Intervention Browse Module - Browse Branches - Abbrev: AAll - Name: Anti-Allergic Agents - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: Resp - Name: Respiratory System Agents ### Intervention Browse Module - Browse Leaves - ID: M19623 - Name: Loratadine - Relevance: LOW - As Found: Unknown - ID: M4909 - Name: Betamethasone - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00848679 **Brief Title:** Investigating the Novel Observation of Right-left Difference in Uterine Artery Vascular Resistance in Pre-eclampsia **Official Title:** Investigating the Novel Observation of Right-left Difference in Uterine Artery Vascular Resistance in Pre-eclampsia: A Double-blinded, Randomized, Placebo-controlled Study to Assess the Dose-dependent Effect of Epidural Lidocaine on Right-left Uterine Artery Blood Flow Differences in Pre-eclampsia, With Healthy Term Pregnant and Non-pregnant Controls #### Organization Study ID Info **ID:** ACET3-ginosar-HMO-CTIL #### Organization **Class:** OTHER **Full Name:** Hadassah Medical Organization ### Status Module #### Completion Date **Date:** 2009-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2019-09-12 **Type:** ACTUAL **Last Update Submit Date:** 2019-09-10 **Overall Status:** WITHDRAWN #### Primary Completion Date **Date:** 2009-10 **Type:** ESTIMATED #### Start Date **Date:** 2009-03 **Status Verified Date:** 2009-02 #### Study First Post Date **Date:** 2009-02-20 **Type:** ESTIMATED **Study First Submit Date:** 2009-02-19 **Study First Submit QC Date:** 2009-02-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hadassah Medical Organization #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The investigators previously demonstrated that epidural ropivacaine reduces uterine artery vascular resistance in a dose dependent manner in pre-eclampsia. The investigators also noted a marked right-left difference in vascular resistance between paired uterine arteries, which was almost completely abolished following epidural ropivacaine. However, this novel observation was not a stated outcome variable before the study began. This study assesses right-left difference in vascular resistance between paired uterine arteries as a primary end-point, assesses the dose-response effect of epidural lidocaine and compares the effect observed in pre-eclampsia with that in two control populations (term normal pregnancy and non-pregnant controls). ### Conditions Module **Conditions:** - Pre-eclampsia **Keywords:** - Pre-eclampsia - Pregnancy - Uteroplacental blood flow - Epidural - Anesthesia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 30 women to receive 5 x 5mL boluses of epidural lidocaine 2%. 10 pre-eclampsia, 10 term pregnancy, 10 non-pregnant. **Intervention Names:** - Drug: Epidural lidocaine - Drug: Epidural lidocaine 2% **Label:** Epidural lidocaine **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** 30 women to receive 5 x 5 mL boluses of epidural saline. 10 pre-eclamptics, 10 normal term pregnancy, 10 non-pregnant **Intervention Names:** - Drug: Epidural lidocaine - Drug: Epidural lidocaine 2% **Label:** Epidural saline **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Epidural lidocaine - Epidural saline **Description:** Epidural 2% lidocaine, administered in 5mL incremental boluses. Looking at dose-response effect. **Name:** Epidural lidocaine **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Epidural lidocaine - Epidural saline **Description:** 5 x 5ml boluses of either epidural lidocaine 2% or epidural saline **Name:** Epidural lidocaine 2% **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Uterine artery pulsatility index (by Doppler ultrasound). Specifically the right-left uterine artery difference. **Time Frame:** 15min after each dose - on a dose--response curve #### Secondary Outcomes **Measure:** Uterine artery pulsatility index (worse vessel) **Time Frame:** 15 min after dose ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Pre-eclampsia patients and normal pregnancy controls scheduled to receive epidural catheterization for induction of labor or Cesarean delivery. Non-pregnant controls receiving epidural catheterization for elective surgery. Pre-eclampsia group: 1. gestational age between 35 to 40 completed weeks 2. uterine artery notching OR evidence of reduced uterine artery blood flow 3. resting systolic pressure \> 140mmHg or diastolic pressure \> 90mmHg measured twice at least 6 hours apart 4. proteinuria (at least 0•1 g/l in two random samples at least 6 hours apart or at least 0•3g in a 24 hour collection). * Normal pregnancy control group: 1. gestational age between 35 to 40 completed weeks 2. absence of other inclusion factors for the pre-eclampsia group. Non-pregnant control group: Non-pregnant women of reproductive age. Exclusion Criteria: * Active labor, resting blood pressure ≥ 160/110 (recorded on at least two occasions 6 hours apart), coagulopathy or other contraindications for epidural catheterization, abnormal fetal heart tracing, known fetal anomaly, intrauterine infection, placental anomalies, twins, and refusal of consent. **Maximum Age:** 40 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Jerusalem **Country:** Israel **Facility:** Hadassah Hebrew University Medical Center **Zip:** 91120 ### References Module #### References **Citation:** Ginosar Y, Nadjari M, Hoffman A, Firman N, Davidson EM, Weiniger CF, Rosen L, Weissman C, Elchalal U; ACET study group. Antepartum continuous epidural ropivacaine therapy reduces uterine artery vascular resistance in pre-eclampsia: a randomized, dose-ranging, placebo-controlled study. Br J Anaesth. 2009 Mar;102(3):369-78. doi: 10.1093/bja/aen402. Epub 2009 Jan 27. **PMID:** 19176534 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000046110 - Term: Hypertension, Pregnancy-Induced - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14106 - Name: Pre-Eclampsia - Relevance: HIGH - As Found: Pre-Eclampsia - ID: M7633 - Name: Eclampsia - Relevance: HIGH - As Found: Eclampsia - ID: M10024 - Name: Hypertension - Relevance: LOW - As Found: Unknown - ID: M25635 - Name: Hypertension, Pregnancy-Induced - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: T2019 - Name: Eclampsia - Relevance: HIGH - As Found: Eclampsia ### Condition Browse Module - Meshes - ID: D000004461 - Term: Eclampsia - ID: D000011225 - Term: Pre-Eclampsia ### Intervention Browse Module - Ancestors - ID: D000000779 - Term: Anesthetics, Local - ID: D000000777 - Term: Anesthetics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000000889 - Term: Anti-Arrhythmia Agents - ID: D000061567 - Term: Voltage-Gated Sodium Channel Blockers - ID: D000026941 - Term: Sodium Channel Blockers - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: ChanBlk - Name: Channel Blockers - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11014 - Name: Lidocaine - Relevance: HIGH - As Found: Solution - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown - ID: M4213 - Name: Anti-Arrhythmia Agents - Relevance: LOW - As Found: Unknown - ID: M23177 - Name: Sodium Channel Blockers - Relevance: LOW - As Found: Unknown - ID: M30025 - Name: Diuretics, Potassium Sparing - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000008012 - Term: Lidocaine ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02376179 **Brief Title:** Endotracheal Tube Intracuff Pressure and Leak **Official Title:** Endotracheal Tube Intracuff Pressure and Leak Around the Cuff During Retractor Placement for Tonsillectomy and/or Adenoidectomy #### Organization Study ID Info **ID:** IRB13-00613 #### Organization **Class:** OTHER **Full Name:** Nationwide Children's Hospital ### Status Module #### Completion Date **Date:** 2016-06-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-12-11 **Type:** ACTUAL **Last Update Submit Date:** 2019-12-01 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2016-06-01 **Type:** ACTUAL #### Results First Post Date **Date:** 2019-01-16 **Type:** ACTUAL **Results First Submit Date:** 2018-07-24 **Results First Submit QC Date:** 2018-07-24 #### Start Date **Date:** 2014-08 **Status Verified Date:** 2019-12 #### Study First Post Date **Date:** 2015-03-03 **Type:** ESTIMATED **Study First Submit Date:** 2015-02-24 **Study First Submit QC Date:** 2015-02-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Kris Jatana #### Responsible Party **Investigator Affiliation:** Nationwide Children's Hospital **Investigator Full Name:** Kris Jatana **Investigator Title:** ENT Surgeon **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** We have devised a simple method to continuously measure the endotracheal tube cuff pressure (CP) using an invasive pressure monitoring setup (IPMS), which is used routinely in the operating room to monitor arterial or central venous pressures. We have previously confirmed both in vitro and in vivo (previous IRB approved protocol), a clinically applicable agreement of the IPMS readings with the values obtained from a standard manometer (gold standard). In the current study, we will prospectively evaluate the relationship between the patient's head position and CP in patients undergoing otolaryngological surgery. A secondary outcome measure is the oxygen or nitrous oxygen concentration in the oropharynx. ### Conditions Module **Conditions:** - Otolaryngological Surgery ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 84 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy. **Intervention Names:** - Device: Cuffed ETT **Label:** Cuffed ETT ### Interventions #### Intervention 1 **Arm Group Labels:** - Cuffed ETT **Name:** Cuffed ETT **Other Names:** - Kimberly Clark Microcuff ETT **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Changes in the intracuff pressure from baseline of cuffed ETT's after positioning of the patient's head and retractor placement. **Measure:** Changes in the Intracuff Pressure **Time Frame:** during time of surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Less than 18 years of age, undergoing otolaryngological surgery with endotracheal intubation. Exclusion Criteria: * Patient who is intubated with an uncuffed endotracheal tube. * Patients who have a limitation for movement of the neck or concerns of the stability of the cervical spine. **Maximum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT **Study Population:** Less than 18 years of age, undergoing otolaryngological surgery with endotracheal intubation. ### Contacts Locations Module #### Locations **Location 1:** **City:** Columbus **Country:** United States **Facility:** Nationwide Children's Hospital **State:** Ohio **Zip:** 43205 ### References Module #### References **Citation:** Olsen GH, Krishna SG, Jatana KR, Elmaraghy CA, Ruda JM, Tobias JD. Changes in intracuff pressure of cuffed endotracheal tubes while positioning for adenotonsillectomy in children. Paediatr Anaesth. 2016 May;26(5):500-3. doi: 10.1111/pan.12873. Epub 2016 Mar 9. **PMID:** 26956620 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Cuffed ETT **Description:** Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy. **ID:** EG000 **Other Num at Risk:** 84 **Serious Number At Risk:** 84 **Title:** Cuffed ETT **Frequency Threshold:** 0 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 84 **Units:** Participants ### Group **ID:** BG000 **Title:** Cuffed ETT **Description:** Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy. Cuffed ETT ### Measure #### Measurement **Group ID:** BG000 **Value:** 84 **Category Title:** <=18 years #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Between 18 and 65 years #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** >=65 years **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Spread:** 3.9 **Value:** 5.7 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 46 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 38 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 84 **Class Title:** United States **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Categorical **Unit of Measure:** Participants ### Measure 2 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ## Results Section - More Information Module ### Certain Agreement **PI Sponsor Employee:** True ### Point of Contact **Email:** [email protected] **Organization:** Nationwide Children's Hospital **Phone:** 614-722-6032 **Title:** Kris Jatana, MD ## Results Section - Outcome Measures Module ### Outcome Measure 1 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7 - **Upper Limit:** - **Value:** 3 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Changes in the intracuff pressure from baseline of cuffed ETT's after positioning of the patient's head and retractor placement. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** during time of surgery **Title:** Changes in the Intracuff Pressure **Type:** PRIMARY **Unit of Measure:** cmH2O ##### Group **Description:** Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy. Cuffed ETT **ID:** OG000 **Title:** Cuffed ETT ### Participant Flow Module #### Group **Description:** Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy. **ID:** FG000 **Title:** Cuffed ETT #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 84 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 84 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT04790279 **Brief Title:** Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension **Official Title:** Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension: A Randomized Controlled Noninferiority Trial #### Organization Study ID Info **ID:** Pro00106643 #### Organization **Class:** OTHER **Full Name:** Prisma Health-Upstate ### Status Module #### Completion Date **Date:** 2023-01-25 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-01-27 **Type:** ACTUAL **Last Update Submit Date:** 2023-01-25 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-12-13 **Type:** ACTUAL #### Start Date **Date:** 2021-04-09 **Type:** ACTUAL **Status Verified Date:** 2022-12 #### Study First Post Date **Date:** 2021-03-10 **Type:** ACTUAL **Study First Submit Date:** 2021-03-03 **Study First Submit QC Date:** 2021-03-05 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Prisma Health-Upstate #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True ### Description Module **Brief Summary:** A significant number of pregnancies are complicated by hypertensive disorders. Hypertension often worsens in the postpartum period and many women need started on medications. Currently, recommended medications for blood pressure management in pregnant and postpartum women are limited, with labetalol and nifedipine ER being the most commonly used medications. While these medications are both effective, they are not without limitations. Amlodipine is a medication in the same class as nifedipine ER. It is a first-line antihypertensive in the general population. It tends to have less side effects than nifedipine ER. It has not been studied specifically in postpartum women. The purpose of this study is to determine if amlodipine is noninferior to nifedipine ER in managing hypertension in the postpartum period. ### Conditions Module **Conditions:** - Hypertension in Pregnancy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 132 **Type:** ACTUAL **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Amlodipine **Label:** Amlodipine **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: NIFEdipine ER **Label:** Nifedipine ER **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Amlodipine **Description:** Initiation of amlodipine 2.5 mg **Name:** Amlodipine **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Nifedipine ER **Description:** Initiation of nifedipine ER 30 mg **Name:** NIFEdipine ER **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** length of stay from delivery until discharge **Measure:** Length of stay **Time Frame:** Through hospital stay, on average 2-5 days #### Secondary Outcomes **Measure:** Number of additional antihypertensives needed **Time Frame:** Through hospital stay, on average 2-5 days **Measure:** Number of side effects reported by patient **Time Frame:** Through hospital stay, on average 2-5 days **Measure:** Number of patients discontinuing medication due to side effects **Time Frame:** Through hospital stay, on average 2-5 days **Measure:** Number of patients requiring hospital readmission **Time Frame:** until 6 weeks postpartum **Measure:** Breastfeeding duration **Time Frame:** until 6 weeks postpartum **Measure:** Number of patients reporting satisfaction with breastfeeding experience on patient-completed questionnaire **Time Frame:** until 6 weeks postpartum ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Postpartum women with a diagnosis of chronic hypertension, gestational hypertension, or preeclampsia * Delivery at or beyond 20 weeks' gestation * Need for antihypertensive therapy, defined as blood pressure \>/= 150 mmHg systolic and/or 100 mmHg diastolic on two occasions four hours apart or isolated blood pressure \>160/110 mmHg * English or Spanish-speaking * Age 18 years or older Exclusion Criteria: * Use of antihypertensive prior to delivery (for any indication) * Allergy to nifedipine ER or amlodipine * Persistent tachycardia (as defined by the treatment team) **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Greenville **Country:** United States **Facility:** Greenville Memorial Hospital **State:** South Carolina **Zip:** 29605 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available. **PMID:** 24150027 **Citation:** ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003018. **PMID:** 30575675 **Citation:** American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 203: Chronic Hypertension in Pregnancy. Obstet Gynecol. 2019 Jan;133(1):e26-e50. doi: 10.1097/AOG.0000000000003020. **PMID:** 30575676 **Citation:** Ainuddin J, Javed F, Kazi S. Oral labetalol versus oral nifedipine for the management of postpartum hypertension a randomized control trial. Pak J Med Sci. 2019 Sep-Oct;35(5):1428-1433. doi: 10.12669/pjms.35.5.812. **PMID:** 31489020 **Citation:** Magee L, von Dadelszen P. Prevention and treatment of postpartum hypertension. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD004351. doi: 10.1002/14651858.CD004351.pub3. **PMID:** 23633317 **Citation:** Cairns AE, Pealing L, Duffy JMN, Roberts N, Tucker KL, Leeson P, MacKillop LH, McManus RJ. Postpartum management of hypertensive disorders of pregnancy: a systematic review. BMJ Open. 2017 Nov 28;7(11):e018696. doi: 10.1136/bmjopen-2017-018696. **PMID:** 29187414 **Citation:** Sharma KJ, Greene N, Kilpatrick SJ. Oral labetalol compared to oral nifedipine for postpartum hypertension: A randomized controlled trial. Hypertens Pregnancy. 2017 Feb;36(1):44-47. doi: 10.1080/10641955.2016.1231317. Epub 2016 Oct 27. **PMID:** 27786578 **Citation:** 8. Bloch, M. (2020). In Basile J. (Ed.), Major side effects and safety of calcium channel blockers. UpToDate. **Citation:** Hosie J, Bremner AD, Fell PJ, James IG, Saul PA, Taylor SH. Comparison of early side effects with amlodipine and nifedipine retard in hypertension. Cardiology. 1992;80 Suppl 1:54-9. doi: 10.1159/000175048. **PMID:** 1534716 **Citation:** Naito T, Kubono N, Deguchi S, Sugihara M, Itoh H, Kanayama N, Kawakami J. Amlodipine passage into breast milk in lactating women with pregnancy-induced hypertension and its estimation of infant risk for breastfeeding. J Hum Lact. 2015 May;31(2):301-6. doi: 10.1177/0890334414560195. Epub 2014 Dec 1. **PMID:** 25447596 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions ### Condition Browse Module - Browse Leaves - ID: M10024 - Name: Hypertension - Relevance: HIGH - As Found: Hypertension - ID: M25635 - Name: Hypertension, Pregnancy-Induced - Relevance: HIGH - As Found: Hypertension in Pregnancy - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000046110 - Term: Hypertension, Pregnancy-Induced - ID: D000006973 - Term: Hypertension ### Intervention Browse Module - Ancestors - ID: D000000959 - Term: Antihypertensive Agents - ID: D000002121 - Term: Calcium Channel Blockers - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000077264 - Term: Calcium-Regulating Hormones and Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000014665 - Term: Vasodilator Agents - ID: D000015149 - Term: Tocolytic Agents - ID: D000012102 - Term: Reproductive Control Agents ### Intervention Browse Module - Browse Branches - Abbrev: AnAg - Name: Antihypertensive Agents - Abbrev: ChanBlk - Name: Channel Blockers - Abbrev: VaDiAg - Name: Vasodilator Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: BDCA - Name: Bone Density Conservation Agents ### Intervention Browse Module - Browse Leaves - ID: M19600 - Name: Amlodipine - Relevance: HIGH - As Found: Energy - ID: M12483 - Name: Nifedipine - Relevance: HIGH - As Found: Elevated - ID: M4277 - Name: Antihypertensive Agents - Relevance: LOW - As Found: Unknown - ID: M5381 - Name: Calcium - Relevance: LOW - As Found: Unknown - ID: M5384 - Name: Calcium Channel Blockers - Relevance: LOW - As Found: Unknown - ID: M5398 - Name: Calcium, Dietary - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M17412 - Name: Vasodilator Agents - Relevance: LOW - As Found: Unknown - ID: M17869 - Name: Tocolytic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017311 - Term: Amlodipine - ID: D000009543 - Term: Nifedipine ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03829579 **Brief Title:** Pre-Approval Access to Esketamine Nasal Spray for the Treatment of Treatment-Resistant Depression (TRD) **Official Title:** Esketamine Single Patient Request #### Organization Study ID Info **ID:** CR108572 #### Organization **Class:** INDUSTRY **Full Name:** Janssen Research & Development, LLC #### Secondary ID Infos **Domain:** Janssen Research & Development, LLC **ID:** 54135419TRD3012 **Type:** OTHER ### Status Module #### Last Update Post Date **Date:** 2020-02-10 **Type:** ACTUAL **Last Update Submit Date:** 2020-02-06 **Overall Status:** APPROVED_FOR_MARKETING **Status Verified Date:** 2020-02 #### Study First Post Date **Date:** 2019-02-04 **Type:** ACTUAL **Study First Submit Date:** 2019-02-01 **Study First Submit QC Date:** 2019-02-01 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Janssen Research & Development, LLC #### Responsible Party **Type:** SPONSOR ### Description Module **Brief Summary:** This is a pre-approval access program (PAAP) for eligible participants. The main purpose of this program is to provide access to esketamine nasal spray to eligible participant with treatment-resistant depression (TRD), who have exhausted all other treatment options, including all alternative treatment options with marketed therapies. ### Conditions Module **Conditions:** - Depressive Disorder, Treatment-Resistant ### Design Module #### Expanded Access Types **Individual:** True **nPtrsToThisExpAccNctId:** 3 **Study Type:** EXPANDED_ACCESS ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Participants will self-administer esketamine nasal spray, under the supervision of the healthcare professional at the site of care. A starting dose of 56 milligram (mg) will be administered intranasally into each nostril on Day 1 with subsequent doses of 56 mg or 84 mg administered during Weeks 1-4 (2 treatment sessions per week). For participants who respond, treatment is continued as follows: 56 mg or 84 mg of esketamine nasal spray during Weeks 5-8 (once weekly), and Week 9 onwards (every 2 weeks or once weekly), with period re-evaluation to determine the need for continued treatment. Doses will be adjusted based on efficacy and tolerability to the previous dosing. **Name:** Esketamine **Type:** DRUG ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Must have an unmet medical need to treat treatment-resistant depression (TRD) with esketamine nasal spray, an investigational compound, that has not been approved by any health authority. This means no other treatment options are available and the participant must be unable to participate in a clinical trial; for example, because they do not fulfill the eligibility criteria of the protocol or there are no trial sites within a reasonable distance of where they reside * Must not participate in a clinical trial or be concurrently treated with an investigational drug when being treated with esketamine nasal spray * Participants must have TRD with the diagnosis verified by a psychiatrist, and have exhausted all other options including all alternative treatment options with marketed therapies, specifically: 1. Participant must meet the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnostic criteria for single-episode major depressive episode (major depressive disorder \[MDD\]) (if single-episode MDD, the duration must be greater than \[\>\]2 years) or recurrent MDD, without psychotic features. 2. Participant must have had nonresponse to 2 or more oral antidepressant treatments in the current episode of depression confirmed by documented medical history and/or pharmacy/prescription records to meet criteria for TRD and have failed at least one augmentation strategy (for example, atypical antipsychotics such as aripiprazole or quetiapine, lithium, thyroid hormones, bupropion, etc) and have failed an adequate course (greater than or equal to \[\>=\] 7 unilateral \[UL\] sessions) of, or have a contraindication to electro-convulsive therapy (ECT) and transcranial magnetic stimulation (TMS) * Participants must have exhausted clinical trials, early access programs or named patient programs that may be available in their region * Participants must have moderate to severe depression per clinical judgment Exclusion Criteria: * The participant's depressive symptoms have previously demonstrated nonresponse to Esketamine Nasal Spray or ketamine in the current major depressive episode per clinical judgment * Participant has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychosis, bipolar or related disorders, comorbid obsessive- compulsive disorder, intellectual disability (only DSM-5 diagnostic code 319), borderline personality disorder, antisocial personality disorder, histrionic personality disorder, or narcissistic personality disorder * Participant has homicidal ideation/intent or has suicidal ideation with some intent to act within 6 months or a history of suicidal behavior within the past year, per the requesting psychiatrist's clinical judgment * Participant has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria, except nicotine or caffeine, within 6 months before the start of the first dose. a) A history (lifetime) of ketamine, phencyclidine (PCP), lysergic acid diethylamide (LSD), or 3, 4-methylenedioxy-methamphetamine (MDMA) hallucinogen-related use disorder is exclusionary * Participants with a current or past history of seizures (uncomplicated childhood febrile seizures with no sequelae are not exclusionary) **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Janssen Research & Development, LLC **Name:** Janssen Research & Development, LLC Clinical Trial **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depressive Disorder - ID: M29783 - Name: Depressive Disorder, Treatment-Resistant - Relevance: HIGH - As Found: Depressive Disorder, Treatment-Resistant - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003866 - Term: Depressive Disorder - ID: D000061218 - Term: Depressive Disorder, Treatment-Resistant ### Intervention Browse Module - Ancestors - ID: D000000928 - Term: Antidepressive Agents - ID: D000011619 - Term: Psychotropic Drugs ### Intervention Browse Module - Browse Branches - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M271980 - Name: Esketamine - Relevance: HIGH - As Found: Auditory - ID: M4247 - Name: Antidepressive Agents - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000629870 - Term: Esketamine ### Misc Info Module #### Removed Countries - Country: France - Country: Italy - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05026879 **Brief Title:** Adverse Events Report of Inactivated COVID-19 Vaccine **Official Title:** Adverse Events Report of Inactivated COVID-19 Vaccine From 4040 Healthcare Workers #### Organization Study ID Info **ID:** 24.02.2021-29 #### Organization **Class:** OTHER **Full Name:** Bozyaka Training and Research Hospital ### Status Module #### Completion Date **Date:** 2021-03-14 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-09-02 **Type:** ACTUAL **Last Update Submit Date:** 2021-08-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-02-28 **Type:** ACTUAL #### Start Date **Date:** 2021-02-14 **Type:** ACTUAL **Status Verified Date:** 2021-08 #### Study First Post Date **Date:** 2021-08-30 **Type:** ACTUAL **Study First Submit Date:** 2021-08-27 **Study First Submit QC Date:** 2021-08-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Bozyaka Training and Research Hospital #### Responsible Party **Investigator Affiliation:** Bozyaka Training and Research Hospital **Investigator Full Name:** Şeniz Akçay **Investigator Title:** Physical Medicine and Rehabilitation, Study Chair, Assoc. Prof. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Numerous vaccination studies are conducted to protect against COVID-19 infection, and preclinical and clinical studies are still ongoing worldwide. During this extraordinary period, the necessity to perform COVID-19 vaccine studies and immunization programs together has emerged. Many manufacturing companies have started mass production of vaccines accepting the risk of failure of vaccines during trials. Vaccine Adverse Effects (VAEs) need to be documented quickly. We aimed to determine the VAEs and to compare the frequency of VAEs between groups according to socio-demographic characteristics after the inactivated vaccine (Corona Vac®) was administered to healthcare workers (HCWs) in Turkey. In this study, an online questionnaire was delivered to volunteer healthcare workers across the whole country. Sociodemographic characteristics, medical history, history of COVID-19 infection, and VAEs occurring after the first and second doses of inactivated vaccine were evaluated. **Detailed Description:** A new coronavirus, severe acute respiratory syncytial coronavirus 2 (SARS-CoV-2) first appeared in China at the end of 2019 and attracted attention with clusters of pneumonia-like cases, which were later defined as coronavirus disease 2019 (COVID-19). Vaccine development is usually achieved over decades and therefore it is unprecedented to have access to such a large number of approved vaccines for COVID-19. In this process, great efforts were made by many organizations to cope with this pandemic that affected the whole world. COVID-19 vaccines with different features in the form of vector-mediated, messenger RNA (mRNA) or inactivated vaccines are being produced worldwide. CoronaVac® is an inactivated vaccine against severe acute respiratory syncytial coronavirus 2 (SARS-CoV-2) developed by Sinovac Biotech, China which was approved by World Health Organization (WHO) in June 2021. Vaccine Adverse Effect (VAE) is defined as "any adverse medical event that occurs after vaccination, which is thought to be due to a vaccine. The primary endpoint of our study was to evaluate the VAEs reported after the first dose and the second doses following the inactivated vaccine (CoronaVac®), which was administered to HCWs in our country as a dose of 3 µg twice, 28 days apart. The secondary endpoint was the comparison of the frequency of VAE development between groups according to socio-demographic characteristics. ### Conditions Module **Conditions:** - COVID-19 - Vaccine Adverse Reaction **Keywords:** - COVID-19 - Vaccine - Vaccination - Adverse effect ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 4040 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** The adverse events due to an inactivated COVID-19 vaccine. **Name:** Inactivated COVID-19 vaccine (CoronaVac) **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** An online questionnaire was delivered to obtain Vaccine Adverse Effects to volunteer Healthcare Workers in Turkey. **Measure:** Adverse events detection **Time Frame:** 20 minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1)The HCWs vaccinated with two doses of CoronaVac. Exclusion Criteria: 1. The HCWs under 18 years old 2. The HCWs those couldn't be able to complete the questionnaire accurately. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The healthcare workers ### Contacts Locations Module #### Locations **Location 1:** **City:** Izmir **Country:** Turkey **Facility:** University of Health Sciences Izmir Bozyaka Training and Research Hospital **State:** Karabaglar #### Overall Officials **Official 1:** **Affiliation:** Izmir Bozyaka Education and Research Hospital **Name:** Selma Tosun, Prof. **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Izmir Bozyaka Education and Research Hospital **Name:** Hulya Ozkan Ozdemir, MD **Role:** STUDY_CHAIR **Official 3:** **Affiliation:** University of Health Sciences, Izmir Bozyaka Education and Research Hospital **Name:** Esin Erdogan, Assoc. Prof. **Role:** STUDY_CHAIR **Official 4:** **Affiliation:** University of Health Sciences, Izmir Bozyaka Education and Research Hospital **Name:** Seniz Akcay, Assoc. Prof. **Role:** STUDY_CHAIR **Official 5:** **Affiliation:** Izmir Katip Celebi University, Faculty of Medicine **Name:** Murat Aysin, Assis. Prof. **Role:** STUDY_CHAIR **Official 6:** **Affiliation:** University of Health Sciences, Izmir Bozyaka Education and Research Hospital **Name:** Neslihan Eskut, MD **Role:** STUDY_CHAIR **Official 7:** **Affiliation:** University of Health Sciences, Izmir Bozyaka Education and Research Hospital **Name:** Pinar Ortan, Prof. **Role:** STUDY_CHAIR **Official 8:** **Affiliation:** University of Izmir Katip Celebi, Ataturk Education and Research Hospital **Name:** Burak Eskut, MD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Li J, Huang DQ, Zou B, Yang H, Hui WZ, Rui F, Yee NTS, Liu C, Nerurkar SN, Kai JCY, Teng MLP, Li X, Zeng H, Borghi JA, Henry L, Cheung R, Nguyen MH. Epidemiology of COVID-19: A systematic review and meta-analysis of clinical characteristics, risk factors, and outcomes. J Med Virol. 2021 Mar;93(3):1449-1458. doi: 10.1002/jmv.26424. Epub 2020 Aug 25. **PMID:** 32790106 **Citation:** Gao Q, Bao L, Mao H, Wang L, Xu K, Yang M, Li Y, Zhu L, Wang N, Lv Z, Gao H, Ge X, Kan B, Hu Y, Liu J, Cai F, Jiang D, Yin Y, Qin C, Li J, Gong X, Lou X, Shi W, Wu D, Zhang H, Zhu L, Deng W, Li Y, Lu J, Li C, Wang X, Yin W, Zhang Y, Qin C. Development of an inactivated vaccine candidate for SARS-CoV-2. Science. 2020 Jul 3;369(6499):77-81. doi: 10.1126/science.abc1932. Epub 2020 May 6. **PMID:** 32376603 **Citation:** Xia S, Duan K, Zhang Y, Zhao D, Zhang H, Xie Z, Li X, Peng C, Zhang Y, Zhang W, Yang Y, Chen W, Gao X, You W, Wang X, Wang Z, Shi Z, Wang Y, Yang X, Zhang L, Huang L, Wang Q, Lu J, Yang Y, Guo J, Zhou W, Wan X, Wu C, Wang W, Huang S, Du J, Meng Z, Pan A, Yuan Z, Shen S, Guo W, Yang X. Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes: Interim Analysis of 2 Randomized Clinical Trials. JAMA. 2020 Sep 8;324(10):951-960. doi: 10.1001/jama.2020.15543. **PMID:** 32789505 **Citation:** Che Y, Liu X, Pu Y, Zhou M, Zhao Z, Jiang R, Yin Z, Xu M, Yin Q, Wang J, Pu J, Zhao H, Zhang Y, Wang L, Jiang Y, Lei J, Zheng Y, Liao Y, Long R, Yu L, Cui P, Yang H, Zhang Y, Li J, Chen W, He Z, Ma K, Hong C, Li D, Jiang G, Liu D, Xu X, Fan S, Cheng C, Zhao H, Yang J, Li Y, Zou Y, Zhu Y, Zhou Y, Guo Y, Yang T, Chen H, Xie Z, Li C, Li Q. Randomized, Double-Blinded, Placebo-Controlled Phase 2 Trial of an Inactivated Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine in Healthy Adults. Clin Infect Dis. 2021 Dec 6;73(11):e3949-e3955. doi: 10.1093/cid/ciaa1703. **PMID:** 33165503 **Citation:** Xia S, Zhang Y, Wang Y, Wang H, Yang Y, Gao GF, Tan W, Wu G, Xu M, Lou Z, Huang W, Xu W, Huang B, Wang H, Wang W, Zhang W, Li N, Xie Z, Ding L, You W, Zhao Y, Yang X, Liu Y, Wang Q, Huang L, Yang Y, Xu G, Luo B, Wang W, Liu P, Guo W, Yang X. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial. Lancet Infect Dis. 2021 Jan;21(1):39-51. doi: 10.1016/S1473-3099(20)30831-8. Epub 2020 Oct 15. **PMID:** 33069281 **Citation:** Zhang Y, Zeng G, Pan H, Li C, Hu Y, Chu K, Han W, Chen Z, Tang R, Yin W, Chen X, Hu Y, Liu X, Jiang C, Li J, Yang M, Song Y, Wang X, Gao Q, Zhu F. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021 Feb;21(2):181-192. doi: 10.1016/S1473-3099(20)30843-4. Epub 2020 Nov 17. **PMID:** 33217362 **Citation:** Wu Z, Hu Y, Xu M, Chen Z, Yang W, Jiang Z, Li M, Jin H, Cui G, Chen P, Wang L, Zhao G, Ding Y, Zhao Y, Yin W. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021 Jun;21(6):803-812. doi: 10.1016/S1473-3099(20)30987-7. Epub 2021 Feb 3. **PMID:** 33548194 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011024 - Term: Pneumonia, Viral - ID: D000011014 - Term: Pneumonia - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000014777 - Term: Virus Diseases - ID: D000018352 - Term: Coronavirus Infections - ID: D000003333 - Term: Coronaviridae Infections - ID: D000030341 - Term: Nidovirales Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M2561 - Name: COVID-19 - Relevance: HIGH - As Found: COVID-19 - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M13914 - Name: Pneumonia, Viral - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M20490 - Name: Coronavirus Infections - Relevance: LOW - As Found: Unknown - ID: M6555 - Name: Coronaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M23685 - Name: Nidovirales Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000086382 - Term: COVID-19 ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M17360 - Name: Vaccines - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03122379 **Brief Title:** [Trial of device that is not approved or cleared by the U.S. FDA] **Official Title:** [Trial of device that is not approved or cleared by the U.S. FDA] #### Organization Study ID Info **ID:** CINC0002 #### Organization **Full Name:** [Redacted] ### Status Module **Delayed Posting:** True #### Expanded Access Info #### Last Update Post Date **Date:** 2017-04-20 **Type:** ACTUAL **Last Update Submit Date:** 2017-04-19 **Overall Status:** WITHHELD #### Study First Post Date **Date:** 2017-04-20 **Type:** ACTUAL **Study First Submit Date:** 2017-04-14 **Study First Submit QC Date:** 2017-04-19 ### Sponsor Collaborators Module #### Lead Sponsor **Name:** [Redacted] #### Responsible Party **Old Name Title:** [Redacted] **Old Organization:** [Redacted] ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00866879 **Brief Title:** Randomized Conversion of Calcineurin-Inhibitors in Renal Allograft Recipients **Official Title:** Randomized Conversion of Calcineurin-Inhibitors(Tacrolimus to Sirolimus),6-24 Months Post Transplant Prednisone-Free Immunosuppression Regimen: Impact of Incidence of Acute Cellular Rejection,Renal Allograft Function & Lymphocytes Function #### Organization Study ID Info **ID:** STU8308 0773-017 #### Organization **Class:** OTHER **Full Name:** Northwestern University #### Secondary ID Infos **Domain:** Pfizer (Wyeth) **ID:** 0468H1-4472 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2019-03 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-06-28 **Type:** ACTUAL **Last Update Submit Date:** 2019-06-18 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-12 **Type:** ACTUAL #### Results First Post Date **Date:** 2019-05-31 **Type:** ACTUAL **Results First Submit Date:** 2019-04-09 **Results First Submit QC Date:** 2019-05-08 #### Start Date **Date:** 2007-06 **Type:** ACTUAL **Status Verified Date:** 2019-06 #### Study First Post Date **Date:** 2009-03-23 **Type:** ESTIMATED **Study First Submit Date:** 2009-03-19 **Study First Submit QC Date:** 2009-03-20 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Wyeth is now a wholly owned subsidiary of Pfizer #### Lead Sponsor **Class:** OTHER **Name:** Northwestern University #### Responsible Party **Investigator Affiliation:** Northwestern University **Investigator Full Name:** Lorenzo Gallon **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is being done to investigate the impact of changing immunosuppressive medications from tacrolimus (Prograf®) to sirolimus (Rapamune®) between 6 and 24 months post transplant. The primary purpose of this research study is to evaluate whether the use of mycophenolate mofetil(MMF)/Cellcept® and tacrolimus(TAC)/Prograf® (Group 1) or mycophenolate mofetil(MMF)/Cellcept® and sirolimus/Rapamune® (Group 2) impacts the incidence of acute cellular rejection in post kidney transplant patients. This study will examine whether switching from tacrolimus to sirolimus will better preserve long-term kidney function. **Detailed Description:** For this research study, between 6 and 24 Months post-transplant, we plan to prospectively randomize 2:1 renal transplant patients to either: * Substitute tacrolimus (TAC) with sirolimus and continue mycophenolate mofetil (MMF) or * Continue with tacrolimus (TAC) and mycophenolate mofetil (MMF) A total of 400 patients are expected to be screened for the randomization. We expect to randomize 275 renal transplant patients into this protocol (275 donors to be recruited). The following data will be collected at the time of randomization: Recipient demographics: (i) age at transplantation, (ii) sex, and (iii) race. Clinical history: (i) causes of end-stage renal disease, and (ii) past medical history. Transplant related information: (i) donor age, (ii) cadaveric versus living kidney transplant, (iii) histocompatibility and cross match data, (iv) viral serology, (v) history of acute rejection and delayed graft function, (vi) use of induction therapy and immunosuppressants, (vii) use of ACEI and/or ARB, and (viii) level of renal allograft function-estimated GFR (e-GFR(12) using MDRD formula, proteinuria. Peripheral blood leukocytes will be obtained from renal transplant recipients for baseline (prior to randomization) lymphocytes functional activity and characterization of lymphocytes subpopulations by flow cytometry analysis. Peripheral donor leukocytes (from living donor patients) will also be obtained at the time of randomization. These donor leukocytes will be used as stimulator cells to study the functional activity of the recipient's lymphocytes function. The recipients assigned to continue with tacrolimus and MMF will be routinely followed at the outpatient Comprehensive Transplant Center (CTC) with monthly labs. In addition to labs at baseline pre-randomization, 6, 12 and 24 Months post-randomization, peripheral blood leukocytes will be obtained to study lymphocytes functional activity and to characterize lymphocytes subpopulations by flow cytometry analysis. Post randomization: The recipients assigned to switch from tacrolimus to sirolimus and continue with MMF will be routinely followed at the CTC with monthly labs. During the period of conversion from tacrolimus to sirolimus, weekly labs will be obtained to monitor renal function and bone marrow function. In addition to labs at baseline pre-randomization, 6, 12 and 24 Months post-randomization, peripheral blood leukocytes will be obtained to study lymphocytes functional activity to characterize lymphocytes subpopulations by flow cytometry analysis. Urine will be collected to assess tubular toxicity by evaluating urinary biomarkers. Both groups of patients will be followed for 2 years post-randomization. In addition to monitoring renal allograft function, we will evaluate the incidence of acute rejection, patient and graft survival, impact of CI conversion on the lipid profile, incidence of hypertension, malignancies, opportunistic infections, and post-transplant diabetes mellitus (DM). For those willing to undergo an optional kidney biopsy, one will be performed at the end of the second year in order to evaluate renal allograft pathology and renal allograft tissue gene expression profiles of the two groups. With the peripheral leukocytes obtained at baseline prior to randomization and at 6, 12 and 24 Months post-randomization, we will investigate possible modifications of lymphocytes function and the lymphocytes subpopulations that might have occurred as a consequence of the switch from tacrolimus to sirolimus. Obtaining renal allograft tissue samples at 24 months post randomization can have potential important ramifications to help explain the mechanisms of fibrosis and tubular atrophy typically associated with CI and the role of CI elimination with the substitution of sirolimus (SRL). All data will then be analyzed comparing gene expression profiles of peripheral blood (Pax gene tubes are routinely collected at the different time points as part of the original study). Based on power analysis, we will perform 24 months post randomization biopsies in 70% of the total subjects enrolled in the study (approximately 46 subjects from the tacrolimus/MMF group and approximately 93 subjects from the sirolimus/MMF group). We plan to obtain renal allograft biopsies at 24 Months for those that consent for this additional biopsy. This will be compared to the standard of care 12 months post-transplant biopsy to allow us to address the effect of immunosuppressive modifications on renal allograft pathology at 24 months post randomization. Renal allograft biopsies will also be stored in RNA later to further extend our knowledge on the effect of CI free immunosuppression on gene expression profiles. ### Conditions Module **Conditions:** - Renal Transplant Rejection **Keywords:** - Sirolimus - Rapamune - Immunosuppression - Renal allograft function - Lymphocytes function ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 275 **Type:** ACTUAL **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Group 1 will continue immunosuppression medication per standard of care (SOC) at Northwestern by taking mycophenolate mofetil and tacrolimus. **Intervention Names:** - Other: Demographic Data, Medical History, and Donor Data - Procedure: Blood Draws for Control Group - Procedure: Kidney Biopsy **Label:** Control **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Group 2 will switch immunosuppression medication to taking mycophenolate mofetil and sirolimus **Intervention Names:** - Drug: Sirolimus - Other: Demographic Data, Medical History, and Donor Data - Procedure: Blood Draws for Experimental Group - Procedure: Kidney Biopsy **Label:** Transition to Sirolimus Group **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Data and blood samples from the donors are collected in this study to contribute to the general knowledge to be used in assessing the two donor recipient groups, which are the target of this study. **Intervention Names:** - Procedure: Donor Blood Draws - Other: Donor Information **Label:** Donors **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Transition to Sirolimus Group **Description:** Sirolimus will initially be given at a dose of 2-4 mg orally (PO) daily. The dose will be modified to achieve 24 hours trough concentrations of 6-10 ng/ml by high-performance liquid chromatography (HPLC) assay. This medication will be given in an open label fashion. The first dose of sirolimus will be given at the time of randomization to those patients assigned to have tacrolimus switched to sirolimus. **Name:** Sirolimus **Other Names:** - Rapamune **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Control - Transition to Sirolimus Group **Description:** Age at transplant, sex, race, cause of end-stage renal disease, medical history, donor age, cadaveric vs. living kidney transplant, histocompatibility/cross match data, viral serology, history of acute rejection and delayed graft function, use of induction therapy and immunosuppressants, use of Angiotensin Converting Enzyme Inhibitor (ACEI) and/or Angiotensin Receptor Blockers (ARB) level of renal allograft function-estimated GFR (e-GFR(12) using Modification of Diet in Renal Disease (MDRD) formula, proteinuria. **Name:** Demographic Data, Medical History, and Donor Data **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Control **Description:** Subjects maintaining standard of care drug treatment of TAC and MMF will have monthly labs in addition to the baseline pre-randomization labs, at 6, 12, and 24 Months post-randomization. Peripheral blood leukocytes will be obtained. **Name:** Blood Draws for Control Group **Type:** PROCEDURE #### Intervention 4 **Arm Group Labels:** - Transition to Sirolimus Group **Description:** This group will have monthly labs taken but will also have weekly labs during the period of conversion to monitor renal function and bone marrow function. In addition to the baseline pre-randomization labs, and labs collected at 6, 12, and 24 Months post-randomization, peripheral blood leukocytes will be obtained. **Name:** Blood Draws for Experimental Group **Type:** PROCEDURE #### Intervention 5 **Arm Group Labels:** - Donors **Description:** Peripheral blood leukocytes from living donors obtained at the time of randomization. These donor leukocytes will be used as stimulator cells to study the functional activity of the recipient's lymphocytes function. **Name:** Donor Blood Draws **Type:** PROCEDURE #### Intervention 6 **Arm Group Labels:** - Donors **Description:** Donor age, cadaveric vs. living donor, and histocompatibility and cross match to recipient **Name:** Donor Information **Type:** OTHER #### Intervention 7 **Arm Group Labels:** - Control - Transition to Sirolimus Group **Description:** Kidney biopsy at 24 Months to compare to the standard of care biopsy taken at 12 Months. This information will help evaluate renal allograft pathology and renal allograft tissue gene expression profiles of the two groups. Renal allograft biopsies will be stored in RNA later (preservative) to further extend knowledge on the effect of calcineurin-inhibitors (CI) free immunosuppression on gene expression profiles. **Name:** Kidney Biopsy **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The primary purpose of this research study is to evaluate whether the use of mycophenolate mofetil/Cellcept ® and either tacrolimus/Prograf ® (Group #1) or mycophenolate mofetil/Cellcept ® and sirolimus/Rapamune® (Group #2) impacts the incidence of acute cellular rejection in post-kidney transplant patients. This study will examine whether switching from tacrolimus to sirolimus will better preserve long-term kidney function. **Measure:** Incidence of Acute Cellular Rejection **Time Frame:** Assessed at 6 Months, 12 Months, 24 Months, months 24 reported #### Secondary Outcomes **Description:** Evaluate whether CI conversion (tacrolimus→sirolimus) contributes positively or negatively on the renal allograft function calculated with e-GFR and proteinuria **Measure:** Renal Allograft Function Calculated With e-GFR and Proteinuria **Time Frame:** Assessed at 6 Months, 12 Months, 24 Months, months 24 reported **Description:** In addition to monitoring renal allograft function, evaluation will be conducted on the incidence of acute rejection, patient and graft survival, the impact of CI conversion on the lipid profile, the incidence of hypertension, malignancies, opportunistic infections and post-transplant DM (de novo diabetes mellitus). **Measure:** Evaluate if CI Conversion Impacts on Lipid Profile, Incidence of Hypertension, Malignancies, and Opportunistic Infections and Post-transplant DM **Time Frame:** Assessed at 6 Months, 12 Months, 24 Months, months 24 reported **Description:** This study also reviews the impact of the immunosuppressive medications on patient and graft survival. **Measure:** Patient and Graft Survival **Time Frame:** Assessed at 6 Months, 12 Months, 24 Months, months 24 reported **Description:** Specifically we reported here the percentage of regulatory T cells that were present in the two groups at 24 months post randomization. With peripheral leukocytes taken at baseline (first visit) prior to randomization and at 6, 12 and 24 Months post-randomization, researchers will also review possible modifications of lymphocytes function and of the lymphocytes subpopulations that might have occurred as a consequence of the switch from tacrolimus to sirolimus (randomization). **Measure:** Percentage of Regulatory T Cells **Time Frame:** Assessed at 6 Months, 12 Months, 24 Months, months 24 reported ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Subjects should be adults ≥ 18- ≤ 70 years of age 2. Subjects can be either gender or of any ethnic background 3. Subjects should be single organ recipients (kidney only) 4. Subjects must be able to understand the protocol and provide informed consent. Exclusion Criteria: 1. Subjects with end-stage renal disease (ESRD) secondary to primary focal segmental glomerulonephritis (FSGS). 2. Inability to comply with study procedures 3. Inability to sign the informed consent 4. Subjects with a significant or active infection 5. Subjects who are pregnant or nursing females 6. Subjects with a history of severe hyperlipidemia not controlled with statins, patients with at total cholesterol of \> 400 mg/dl 7. Subjects with a platelet count \<100,000mm3 white blood cell (WBC)\< 2,000mm3 8. Subjects with severe proteinuria at the time of randomization (\>2gm/day) 9. Subjects with more then 2 episodes of acute cellular rejection post transplantation will be excluded from this study 10. An estimated GFR\<40 cc/min 11. A history of malignancy during the post-transplant period (other than treated basal cell cancer and/or squamous cell cancer) 12. Subjects, who, due to the existence of a surgical, medical or psychiatric condition, other than the current transplant, which in the opinion of the investigator, precludes enrollment into this trial 13. A history of albumin-creatinine ratio (ACR) during the most recent previous 3 months prior to randomization **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Chicago **Country:** United States **Facility:** Northwestern Memorial Hospital **State:** Illinois **Zip:** 60611 #### Overall Officials **Official 1:** **Affiliation:** Northwestern Univesity, Northwestern Memorial Hospital, Northwestern Medical Faculty Foundation **Name:** Lorenzo Gallon, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Ojo AO, Held PJ, Port FK, Wolfe RA, Leichtman AB, Young EW, Arndorfer J, Christensen L, Merion RM. Chronic renal failure after transplantation of a nonrenal organ. N Engl J Med. 2003 Sep 4;349(10):931-40. doi: 10.1056/NEJMoa021744. **PMID:** 12954741 **Citation:** Stoves J, Lindley EJ, Barnfield MC, Burniston MT, Newstead CG. MDRD equation estimates of glomerular filtration rate in potential living kidney donors and renal transplant recipients with impaired graft function. Nephrol Dial Transplant. 2002 Nov;17(11):2036-7. doi: 10.1093/ndt/17.11.2036. No abstract available. **PMID:** 12401874 **Citation:** Gonwa TA, Mai ML, Melton LB, Hays SR, Goldstein RM, Levy MF, Klintmalm GB. End-stage renal disease (ESRD) after orthotopic liver transplantation (OLTX) using calcineurin-based immunotherapy: risk of development and treatment. Transplantation. 2001 Dec 27;72(12):1934-9. doi: 10.1097/00007890-200112270-00012. **PMID:** 11773892 **Citation:** Fisher NC, Nightingale PG, Gunson BK, Lipkin GW, Neuberger JM. Chronic renal failure following liver transplantation: a retrospective analysis. Transplantation. 1998 Jul 15;66(1):59-66. doi: 10.1097/00007890-199807150-00010. **PMID:** 9679823 **Citation:** Hornberger J, Best J, Geppert J, McClellan M. Risks and costs of end-stage renal disease after heart transplantation. Transplantation. 1998 Dec 27;66(12):1763-70. doi: 10.1097/00007890-199812270-00034. **PMID:** 9884274 **Citation:** Goldstein DJ, Zuech N, Sehgal V, Weinberg AD, Drusin R, Cohen D. Cyclosporine-associated end-stage nephropathy after cardiac transplantation: incidence and progression. Transplantation. 1997 Mar 15;63(5):664-8. doi: 10.1097/00007890-199703150-00009. **PMID:** 9075835 **Citation:** Myers BD, Ross J, Newton L, Luetscher J, Perlroth M. Cyclosporine-associated chronic nephropathy. N Engl J Med. 1984 Sep 13;311(11):699-705. doi: 10.1056/NEJM198409133111103. **PMID:** 6382005 **Citation:** Bennett WM, DeMattos A, Meyer MM, Andoh T, Barry JM. Chronic cyclosporine nephropathy: the Achilles' heel of immunosuppressive therapy. Kidney Int. 1996 Oct;50(4):1089-100. doi: 10.1038/ki.1996.415. No abstract available. **PMID:** 8887265 **Citation:** Bennett WM. Insights into chronic cyclosporine nephrotoxicity. Int J Clin Pharmacol Ther. 1996 Nov;34(11):515-9. **PMID:** 8937936 **Citation:** Myers BD. Cyclosporine nephrotoxicity. Kidney Int. 1986 Dec;30(6):964-74. doi: 10.1038/ki.1986.280. No abstract available. **PMID:** 3546916 **Citation:** Puschett JB, Greenberg A, Holley J, McCauley J. The spectrum of ciclosporin nephrotoxicity. Am J Nephrol. 1990;10(4):296-309. doi: 10.1159/000168123. No abstract available. **PMID:** 2240057 **Citation:** Young EW, Ellis CN, Messana JM, Johnson KJ, Leichtman AB, Mihatsch MJ, Hamilton TA, Groisser DS, Fradin MS, Voorhees JJ. A prospective study of renal structure and function in psoriasis patients treated with cyclosporin. Kidney Int. 1994 Oct;46(4):1216-22. doi: 10.1038/ki.1994.387. **PMID:** 7861719 ## Document Section ### Large Document Module #### Large Docs - Date: 2012-11-01 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 210385 - Type Abbrev: Prot_SAP - Upload Date: 2019-04-08T16:17 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: Rare - Name: Rare Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000000903 - Term: Antibiotics, Antineoplastic - ID: D000000970 - Term: Antineoplastic Agents - ID: D000000935 - Term: Antifungal Agents - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M14121 - Name: Prednisone - Relevance: LOW - As Found: Unknown - ID: M16975 - Name: Triamcinolone Acetonide - Relevance: LOW - As Found: Unknown - ID: M16974 - Name: Triamcinolone - Relevance: LOW - As Found: Unknown - ID: M237966 - Name: Triamcinolone hexacetonide - Relevance: LOW - As Found: Unknown - ID: M209573 - Name: Triamcinolone diacetate - Relevance: LOW - As Found: Unknown - ID: M12128 - Name: Mycophenolic Acid - Relevance: LOW - As Found: Unknown - ID: M18950 - Name: Tacrolimus - Relevance: LOW - As Found: Unknown - ID: M21960 - Name: Sirolimus - Relevance: HIGH - As Found: Included - ID: M28916 - Name: Angiotensin Receptor Antagonists - Relevance: LOW - As Found: Unknown - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M30452 - Name: Calcineurin Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4134 - Name: Angiotensin-Converting Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M353695 - Name: Temsirolimus - Relevance: LOW - As Found: Unknown - ID: M2827 - Name: MTOR Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M6252 - Name: Clotrimazole - Relevance: LOW - As Found: Unknown - ID: M11796 - Name: Miconazole - Relevance: LOW - As Found: Unknown - ID: M4254 - Name: Antifungal Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000020123 - Term: Sirolimus ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module **Description:** Donor participants were no part of our outcome analysis because their participation was only on the basis of providing blood for testing the immune system of the recipients. The analysis of the recipients was intention to treat therefore all recipient participants completed the study period #### Event Groups **Group ID:** EG000 **Title:** Control **Deaths Num Affected:** 3 **Deaths Num At Risk:** 90 **Description:** Group 1 will continue immunosuppression medication per standard of care (SOC) at Northwestern by taking mycophenolate mofetil and tacrolimus. Patients were followed for 24 months post randomization **ID:** EG000 **Other Num Affected:** 58 **Other Num at Risk:** 90 **Serious Number Affected:** 42 **Serious Number At Risk:** 90 **Title:** Control **Group ID:** EG001 **Title:** Transition to Sirolimus **Deaths Num Affected:** 10 **Deaths Num At Risk:** 185 **Description:** Group 2 will switch immunosuppression medication to taking mycophenolate mofetil and sirolimus. Patients were followed for 24 months post randomization **ID:** EG001 **Other Num Affected:** 135 **Other Num at Risk:** 185 **Serious Number Affected:** 117 **Serious Number At Risk:** 185 **Title:** Transition to Sirolimus **Frequency Threshold:** 0 #### Other Events **Term:** Infections **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Infections and infestations **Source Vocabulary:** **Term:** Hyperlipidemia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** **Term:** Diabetes **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Endocrine disorders **Source Vocabulary:** **Term:** BK viremia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** **Term:** BK nephropathy **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** #### Serious Events **Term:** Renal allograft loss **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 90 **Num Events:** 4 **Group ID:** EG001 **Num Affected:** 12 **Num At Risk:** 185 **Num Events:** 12 **Term:** Proteinuria **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders ##### Stats **Group ID:** EG000 **Num Affected:** 12 **Num At Risk:** 90 **Num Events:** 12 **Group ID:** EG001 **Num Affected:** 61 **Num At Risk:** 185 **Num Events:** 61 **Term:** Neutropenia **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Blood and lymphatic system disorders ##### Stats **Group ID:** EG000 **Num Affected:** 22 **Num At Risk:** 90 **Num Events:** 22 **Group ID:** EG001 **Num Affected:** 35 **Num At Risk:** 185 **Num Events:** 35 **Term:** Malignancies **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) ##### Stats **Group ID:** EG000 **Num Affected:** 4 **Num At Risk:** 90 **Num Events:** 4 **Group ID:** EG001 **Num Affected:** 9 **Num At Risk:** 185 **Num Events:** 9 **Time Frame:** 24 months ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 90 **Group ID:** BG001 **Value:** 185 **Group ID:** BG002 **Value:** 275 **Units:** Participants ### Group **ID:** BG000 **Title:** Control **Description:** Group 1 will continue immunosuppression medication per standard of care (SOC) at Northwestern by taking mycophenolate mofetil and tacrolimus. ### Group **ID:** BG001 **Title:** Transition to Sirolimus Group **Description:** Group 2 will switch immunosuppression medication to taking mycophenolate mofetil and sirolimus ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 12.6 **Value:** 39.2 #### Measurement **Group ID:** BG001 **Spread:** 12.5 **Value:** 38.8 #### Measurement **Group ID:** BG002 **Spread:** 12.6 **Value:** 38.9 **Class Title:** Age in years ### Measure #### Measurement **Group ID:** BG000 **Value:** 55 #### Measurement **Group ID:** BG001 **Value:** 106 #### Measurement **Group ID:** BG002 **Value:** 161 **Class Title:** Sex male #### Measurement **Group ID:** BG000 **Value:** 35 #### Measurement **Group ID:** BG001 **Value:** 79 #### Measurement **Group ID:** BG002 **Value:** 114 **Class Title:** Sex female ### Measure #### Measurement **Group ID:** BG000 **Value:** 44 #### Measurement **Group ID:** BG001 **Value:** 83 #### Measurement **Group ID:** BG002 **Value:** 127 **Class Title:** white #### Measurement **Group ID:** BG000 **Value:** 24 #### Measurement **Group ID:** BG001 **Value:** 37 #### Measurement **Group ID:** BG002 **Value:** 61 **Class Title:** AA #### Measurement **Group ID:** BG000 **Value:** 17 #### Measurement **Group ID:** BG001 **Value:** 45 #### Measurement **Group ID:** BG002 **Value:** 62 **Class Title:** Hispanic #### Measurement **Group ID:** BG000 **Value:** 5 #### Measurement **Group ID:** BG001 **Value:** 20 #### Measurement **Group ID:** BG002 **Value:** 25 **Class Title:** other ### Measure #### Measurement **Group ID:** BG000 **Value:** 90 #### Measurement **Group ID:** BG001 **Value:** 185 #### Measurement **Group ID:** BG002 **Value:** 275 **Class Title:** United States ### Measure #### Measurement **Group ID:** BG000 **Spread:** 1.7 **Value:** 3.9 #### Measurement **Group ID:** BG001 **Spread:** 1.82 **Value:** 3.61 #### Measurement **Group ID:** BG002 **Spread:** 1.8 **Value:** 3.8 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 63 #### Measurement **Group ID:** BG001 **Value:** 130 #### Measurement **Group ID:** BG002 **Value:** 193 **Category Title:** Living donors #### Measurement **Group ID:** BG000 **Value:** 27 #### Measurement **Group ID:** BG001 **Value:** 55 #### Measurement **Group ID:** BG002 **Value:** 82 **Category Title:** Cadaveric kidneys **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 14 #### Measurement **Group ID:** BG001 **Value:** 24 #### Measurement **Group ID:** BG002 **Value:** 38 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 26 #### Measurement **Group ID:** BG001 **Value:** 69 #### Measurement **Group ID:** BG002 **Value:** 95 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 76 #### Measurement **Group ID:** BG001 **Value:** 158 #### Measurement **Group ID:** BG002 **Value:** 234 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 10 #### Measurement **Group ID:** BG001 **Value:** 31 #### Measurement **Group ID:** BG002 **Value:** 41 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 9 #### Measurement **Group ID:** BG001 **Value:** 29 #### Measurement **Group ID:** BG002 **Value:** 38 **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Customized **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex/Gender, Customized **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race/Ethnicity, Customized **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ### Measure 5 **Description:** The number of human leukocyte antigens (HLAs) found on the cells of a donor organ but not found on the cells of the organ recipient **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** HLA mismatch **Unit of Measure:** HLA antigens ### Measure 6 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Donor type **Unit of Measure:** Participants ### Measure 7 **Description:** A panel-reactive antibody (PRA) is a group of antibodies in a test serum that are reactive against any of several known specific antigens in a panel of test cells or purified HLA antigens from cells. A panel-reactive antibody test (PRA test) is an immunologic test routinely performed by clinical laboratories on the blood of people awaiting organ transplantation. This result is the number of participants on the study that had PRA \> 20% at the time of Transplantation **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** PRA >20% **Unit of Measure:** Participants ### Measure 8 **Description:** Number of participants that were diagnosed with Diabetes at the time of Transplantation **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Diabetis mellitus **Unit of Measure:** Participants ### Measure 9 **Description:** Number of participant with elevated blood pressure at the time of Transplantation **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Elevated blood pressure **Unit of Measure:** Participants ### Measure 10 **Description:** Coronary artery disease (CAD) occurs when the arteries that supply blood to the heart become hardened and narrowed due to the buildup of cholesterol and other substances, known as plaque **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Coronary artery disease (CAD) **Unit of Measure:** Participants ### Measure 11 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Smoking **Unit of Measure:** Participants **Population Description:** Donor participants were no part of our outcome analysis because their participation was only on the basis of providing blood for testing the immune system of the recipients. The analysis of the recipients was intention to treat therefore all recipient participants completed the study period ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** [email protected] **Organization:** Northwestern University **Phone:** 3126954457 **Title:** Lorenzo Gallon, MD ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ### Outcome Measure 5 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 31 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 20.4 - **Upper Limit:** - **Value:** 57.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 25.2 - **Upper Limit:** - **Value:** 58.4 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 33 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 83 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 9 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 12 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 61 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 9 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 19 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 2 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 15 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 28 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 1 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 5 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 22 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 35 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 12 **Title:** **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 10 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 7.1 - **Upper Limit:** - **Value:** 75 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 10.8 - **Upper Limit:** - **Value:** 98 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** The primary purpose of this research study is to evaluate whether the use of mycophenolate mofetil/Cellcept ® and either tacrolimus/Prograf ® (Group #1) or mycophenolate mofetil/Cellcept ® and sirolimus/Rapamune® (Group #2) impacts the incidence of acute cellular rejection in post-kidney transplant patients. This study will examine whether switching from tacrolimus to sirolimus will better preserve long-term kidney function. **Parameter Type:** COUNT_OF_PARTICIPANTS **Reporting Status:** POSTED **Time Frame:** Assessed at 6 Months, 12 Months, 24 Months, months 24 reported **Title:** Incidence of Acute Cellular Rejection **Type:** PRIMARY **Unit of Measure:** Participants ##### Group **Description:** Group 1 will continue immunosuppression medication per standard of care (SOC) at Northwestern by taking mycophenolate mofetil and tacrolimus. **ID:** OG000 **Title:** Control ##### Group **Description:** Group 2 will switch immunosuppression medication to taking mycophenolate mofetil and sirolimus **ID:** OG001 **Title:** Transition to Sirolimus Group #### Outcome Measure 2 **Description:** Evaluate whether CI conversion (tacrolimus→sirolimus) contributes positively or negatively on the renal allograft function calculated with e-GFR and proteinuria **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Assessed at 6 Months, 12 Months, 24 Months, months 24 reported **Title:** Renal Allograft Function Calculated With e-GFR and Proteinuria **Type:** SECONDARY **Unit of Measure:** mL/min ##### Group **Description:** Group 1 will continue immunosuppression medication per standard of care (SOC) at Northwestern by taking mycophenolate mofetil and tacrolimus. **ID:** OG000 **Title:** Control ##### Group **Description:** Group 2 will switch immunosuppression medication to taking mycophenolate mofetil and sirolimus **ID:** OG001 **Title:** Transition to Sirolimus Group #### Outcome Measure 3 **Description:** In addition to monitoring renal allograft function, evaluation will be conducted on the incidence of acute rejection, patient and graft survival, the impact of CI conversion on the lipid profile, the incidence of hypertension, malignancies, opportunistic infections and post-transplant DM (de novo diabetes mellitus). **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Assessed at 6 Months, 12 Months, 24 Months, months 24 reported **Title:** Evaluate if CI Conversion Impacts on Lipid Profile, Incidence of Hypertension, Malignancies, and Opportunistic Infections and Post-transplant DM **Type:** SECONDARY **Unit of Measure:** number of incidents ##### Group **Description:** Group 1 will continue immunosuppression medication per standard of care (SOC) at Northwestern by taking mycophenolate mofetil and tacrolimus. **ID:** OG000 **Title:** Control ##### Group **Description:** Group 2 will switch immunosuppression medication to taking mycophenolate mofetil and sirolimus **ID:** OG001 **Title:** Transition to Sirolimus Group #### Outcome Measure 4 **Description:** This study also reviews the impact of the immunosuppressive medications on patient and graft survival. **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** Assessed at 6 Months, 12 Months, 24 Months, months 24 reported **Title:** Patient and Graft Survival **Type:** SECONDARY **Unit of Measure:** number of incidents ##### Group **Description:** Group 1 will continue immunosuppression medication per standard of care (SOC) at Northwestern by taking mycophenolate mofetil and tacrolimus. **ID:** OG000 **Title:** Control ##### Group **Description:** Group 2 will switch immunosuppression medication to taking mycophenolate mofetil and sirolimus **ID:** OG001 **Title:** Transition to Sirolimus Group #### Outcome Measure 5 **Description:** Specifically we reported here the percentage of regulatory T cells that were present in the two groups at 24 months post randomization. With peripheral leukocytes taken at baseline (first visit) prior to randomization and at 6, 12 and 24 Months post-randomization, researchers will also review possible modifications of lymphocytes function and of the lymphocytes subpopulations that might have occurred as a consequence of the switch from tacrolimus to sirolimus (randomization). **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Assessed at 6 Months, 12 Months, 24 Months, months 24 reported **Title:** Percentage of Regulatory T Cells **Type:** SECONDARY **Unit of Measure:** % of Treg Cells ##### Group **Description:** Group 1 will continue immunosuppression medication per standard of care (SOC) at Northwestern by taking mycophenolate mofetil and tacrolimus. **ID:** OG000 **Title:** Control ##### Group **Description:** Group 2 will switch immunosuppression medication to taking mycophenolate mofetil and sirolimus **ID:** OG001 **Title:** Transition to Sirolimus Group ### Participant Flow Module #### Group **Description:** Group 1 will continue immunosuppression medication per standard of care (SOC) at Northwestern by taking mycophenolate mofetil and tacrolimus. **ID:** FG000 **Title:** Control #### Group **Description:** Group 2 will switch immunosuppression medication to taking mycophenolate mofetil and sirolimus **ID:** FG001 **Title:** Transition to Sirolimus Group #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 90 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 185 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 90 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 185 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 0 **Pre-Assignment Details:** Donor participants were no part of our outcome analysis because their participation was only on the basis of providing blood for testing the immune system of the recipients. The analysis of the recipients was intention to treat therefore all recipient participants completed the study period **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT05572879 **Brief Title:** A Phase III Study of COVID-19 Vaccine EuCorVac-19 in Healthy Adults **Official Title:** A Phase III, Randomized, Observer-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate Immunogenicity and Safety of a Preventive COVID-19 Vaccine EuCorVac-19 in Healthy Adults Aged 18 Years and Older #### Organization Study ID Info **ID:** EuSNAP_COV301 #### Organization **Class:** INDUSTRY **Full Name:** EuBiologics Co.,Ltd ### Status Module #### Completion Date **Date:** 2024-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-12-01 **Type:** ACTUAL **Last Update Submit Date:** 2023-11-30 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2023-06-23 **Type:** ACTUAL #### Start Date **Date:** 2022-10-01 **Type:** ACTUAL **Status Verified Date:** 2023-11 #### Study First Post Date **Date:** 2022-10-10 **Type:** ACTUAL **Study First Submit Date:** 2022-10-06 **Study First Submit QC Date:** 2022-10-06 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** EuBiologics Co.,Ltd #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is a phase III, randomized, observer-blind, active-controlled, parallel group, multi-center study to compare the immunogenicity and safety of a preventive COVID-19 vaccine EuCorVac-19 to ChAdOx1 in healthy adults aged 18 years and older ### Conditions Module **Conditions:** - COVID-19 ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 2600 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Cohort A - Immunogenicity cohort **Intervention Names:** - Biological: EuCorVac-19 **Label:** Test group(EuCorVac-19) - Cohort A **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Cohort A - Immunogenicity cohort **Intervention Names:** - Biological: ChAdOx1 nCoV-19 **Label:** Comparator group(ChAdOx1) - Cohort A **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Cohort B - Safety cohort **Intervention Names:** - Biological: EuCorVac-19 **Label:** Test group(EuCorVac-19) - Cohort B **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Cohort B - Safety cohort **Intervention Names:** - Biological: ChAdOx1 nCoV-19 **Label:** Comparator group(ChAdOx1) - Cohort B **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Test group(EuCorVac-19) - Cohort A - Test group(EuCorVac-19) - Cohort B **Description:** COVID-19 vaccine **Name:** EuCorVac-19 **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Comparator group(ChAdOx1) - Cohort A - Comparator group(ChAdOx1) - Cohort B **Description:** COVID-19 vaccine **Name:** ChAdOx1 nCoV-19 **Other Names:** - COVISHIELD **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Measure:** The proportion of GMT of neutralizing antibody of EuCorVac-19 and ChAdOx1 **Time Frame:** 14 days after the 2nd vaccination **Measure:** The difference in neutralizing antibody SRR of EuCorVac-19 and ChAdOx1 **Time Frame:** 14 days after the 2nd vaccination #### Secondary Outcomes **Measure:** Occurrence of solicited Adverse Events (AEs) **Time Frame:** Through 7 days after each vaccination **Measure:** Occurrence of unsolicited Adverse Events (AEs) **Time Frame:** Through 28 days after the 2nd vaccination ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Individuals aged 18 years and older who voluntarily decide to participate in this study and provide written informed consent * Female of childbearing potential who agree to use medically allowed methods of contraception during the study period * Individuals who agrees not to perform blood donation and transfusion during the study period Exclusion Criteria: * Individual being considered to be confirmed COVID-19 * Direct contact with COVID-19 infected person within 14 days prior to the 1st dose of the IP * Individuals at high risk of exposure to SARS-CoV-2 * Individuals with clinically significant abnormalities in clinical laboratory tests, ECGs, and chest X-ray during screening * Individuals with fever within 72 hours prior to the 1st dose of the IP or suspected other infectious disease or symptoms associated with other infectious disease * Individuals with serious medical or psychiatric disease * History of SARS-CoV or MERS-CoV infection * History of allergic reaction or hypersensitivity reactions to any of components of the IP * History of serious adverse events, serious allergic reaction or serious hypersensitivity reactions to vaccination * History of receiving organ or bone marrow transplant * Suspected or history of drug abuse or alcohol abuse within 6 months prior to vaccination * History of vaccination against SARS-CoV, MERS-CoV, or SARS-CoV-2 * History of vaccination with test vaccine substance * Treatment with immunosuppressants or immune modifying drugs * History of treatment with antipsychotics or opioid dependence * Pregnant or lactating women * Other reasons based on which the individual is considered to be ineligible for this study in the opinion of the investigator **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Manila **Country:** Philippines **Facility:** Trial site ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011024 - Term: Pneumonia, Viral - ID: D000011014 - Term: Pneumonia - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000014777 - Term: Virus Diseases - ID: D000018352 - Term: Coronavirus Infections - ID: D000003333 - Term: Coronaviridae Infections - ID: D000030341 - Term: Nidovirales Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M2561 - Name: COVID-19 - Relevance: HIGH - As Found: COVID-19 - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M13914 - Name: Pneumonia, Viral - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M20490 - Name: Coronavirus Infections - Relevance: LOW - As Found: Unknown - ID: M6555 - Name: Coronaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M23685 - Name: Nidovirales Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000086382 - Term: COVID-19 ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M17360 - Name: Vaccines - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01717079 **Acronym:** STIMOREX **Brief Title:** rTMS and Body Shape Perception **Official Title:** Effect of Transcranial Magnetic Stimulation on Disturbance of Body Shape Perception in Patients With Anorexia Nervosa #### Organization Study ID Info **ID:** 2011/122/HP #### Organization **Class:** OTHER **Full Name:** University Hospital, Rouen ### Status Module #### Completion Date **Date:** 2017-12-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2018-05-25 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2017-12-15 **Type:** ACTUAL #### Start Date **Date:** 2013-05 **Type:** ACTUAL **Status Verified Date:** 2018-05 #### Study First Post Date **Date:** 2012-10-30 **Type:** ESTIMATED **Study First Submit Date:** 2012-09-24 **Study First Submit QC Date:** 2012-10-29 **Why Stopped:** Protocol stopped for safety reason ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Rouen #### Responsible Party **Type:** SPONSOR ### Description Module **Brief Summary:** Anorexia nervosa (AN) is a frequent, potentially life-threatening eating disorder characterized by a resistance to maintaining body weight at or above a minimally normal weight for age and height, an intense fear of weight gain or being "fat" even though underweight, a loss of menstrual periods in girls and women post-puberty and a disturbance in the experience of body weight or shape. Body weight and shape dissatisfaction is linked to the development, maintenance and relapse of AN. Neuroimaging studies have shown that the inferior parietal cortex is involved in body image perception and less activated in patients with AN compared with healthy subjects. Repetitive transcranial magnetic stimulation (rTMS) is used to modulate cortical excitability, and particularly to increase excitability with high-frequency rTMS. The aim of this study was to investigate the effect of "excitatory" high-frequency rTMS over the "hypoactive" inferior parietal cortex of 54 patients with AN. This randomized, double-blind, placebo-controlled study will compare effective rTMS (2000 ten-Hz stimulations per session, applied at 90% of the resting motor threshold, with 10 sessions in two weeks) versus placebo rTMS. Assessments will be performed before rTMS and after the last rTMS session (immediately after, at 15 days and three months). The principal criteria for judgement is a body image satisfaction scale (Boby Shape Questionnaire, BSQ-34). The secondary criteria for judgement are eating behaviour scales (Eating Attitude Test, EAT-40; Bulimia test, BULIT and Eating Disorders Inventory, EDI-2), the Hamilton depression rating scale and Hamilton anxiety rating scale, a quality of life scale (Short-Form Health Survey, SF-36), a body composition analysis using a Dual-energy X-ray absorptiometry and the alpha-MSH autoantibodies levels (biomarker for eating disorders recently described). Inferior parietal cortex rTMS could not only improve body image perception, but also help in the treatment of eating disorders, allowing weight gain with a decreased anxiety and improving patients' quality of life. Also positive results could have direct therapeutic implications with the possibility to complete regular rTMS sessions, or to implant extradural electrodes for chronic parietal cortex stimulation. ### Conditions Module **Conditions:** - Anorexia Nervosa ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 22 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Effective coil **Intervention Names:** - Procedure: rTMS **Label:** Effective arm **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Placebo coil **Intervention Names:** - Procedure: Sham rTMS **Label:** Placebo arm **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Placebo arm **Description:** 120 pulses 0.2Hz **Name:** Sham rTMS **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Effective arm **Description:** 120 pulses 0.2Hz **Name:** rTMS **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** BSQ-34 scale (Body Shape Questionnaire) **Time Frame:** Just after rTMS #### Secondary Outcomes **Measure:** EAT-40 scale (eating attitude test) **Time Frame:** Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS **Measure:** BULIT scale (bulimia test) **Time Frame:** Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS **Measure:** EDI-2 scale (eating disorder inventory) **Time Frame:** Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS **Measure:** Hamilton scale **Time Frame:** Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMSBefore rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS **Measure:** Quality of Life Scale, MOS 36 Item Short-Form Health Survey or SF-36 **Time Frame:** Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS **Measure:** The body mass index **Time Frame:** Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS **Measure:** body composition analysis using dual energy X-ray absorptiometry **Time Frame:** Before rTMS and 3 months after rTMS **Measure:** autoantibodies against alpha-melanocyte stimulating hormone **Time Frame:** Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS **Measure:** The adverse effects **Time Frame:** After rTMS **Measure:** Weight **Time Frame:** Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS **Measure:** BSQ-34 scale (Body Shape Questionnaire) **Time Frame:** Before rTMS, 15 days after rTMS and 3 months after rTMS ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Female * Age above 18 * Restrictive anorexia nervosa with a disease duration more than one year and less than three years. * Body Mass Index below 16 * Patient receiving or having received optimal treatment for anorexia nervosa * Right-handed * Normal blood ionogramme * Previous stable antidepressor treatment for one month and no expected modification in the three following months * Patients arriving by car with someone else or by public transportation Exclusion Criteria: * Pregnancy * Contraindication to transcranial magnetic stimulation i.e. pace-maker, cardiac valve protheses, metallic protheses etc. * History of epileptic seizure * Cerebral lesion of any etiology (post-traumatic, tumoral, vascular etc.) * History of previous rTMS **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Rouen **Country:** France **Facility:** Rouen University Hospital **Zip:** 76031 #### Overall Officials **Official 1:** **Affiliation:** UH Rouen **Name:** Nathalie CHASTAN, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012817 - Term: Signs and Symptoms, Digestive - ID: D000001068 - Term: Feeding and Eating Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M4181 - Name: Anorexia - Relevance: HIGH - As Found: Anorexia - ID: M4182 - Name: Anorexia Nervosa - Relevance: HIGH - As Found: Anorexia Nervosa - ID: M15622 - Name: Signs and Symptoms, Digestive - Relevance: LOW - As Found: Unknown - ID: M4380 - Name: Feeding and Eating Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000855 - Term: Anorexia - ID: D000000856 - Term: Anorexia Nervosa ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00006079 **Brief Title:** Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia **Official Title:** A Randomized Double-Blind Study of Alpha-Difluromethylornithine (DFMO) Versus Placebo in Patients With Cervical Intraepithelial Neoplasia (CIN) Grade 2-3 #### Organization Study ID Info **ID:** ID92-026 #### Organization **Class:** OTHER **Full Name:** M.D. Anderson Cancer Center #### Secondary ID Infos **ID:** P30CA016672 **Link:** https://reporter.nih.gov/quickSearch/P30CA016672 **Type:** NIH **Domain:** UT MD Anderson Cancer Center **ID:** MDA-ID-92026 **Type:** OTHER **ID:** NCI-P00-0149 **Domain:** NCI PDQ **ID:** CDR0000067921 **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2004-04-27 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-10-25 **Type:** ACTUAL **Last Update Submit Date:** 2018-10-24 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2004-04-27 **Type:** ACTUAL #### Start Date **Date:** 1998-06-19 **Type:** ACTUAL **Status Verified Date:** 2018-10 #### Study First Post Date **Date:** 2004-05-26 **Type:** ESTIMATED **Study First Submit Date:** 2000-08-03 **Study First Submit QC Date:** 2004-05-25 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Cancer Institute (NCI) #### Lead Sponsor **Class:** OTHER **Name:** M.D. Anderson Cancer Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of eflornithine may be an effective way to prevent the recurrence of or further development of cervical cancer. PURPOSE: Randomized phase II trial to determine the effectiveness of eflornithine in preventing cervical cancer in patients who have cervical intraepithelial neoplasia. **Detailed Description:** OBJECTIVES: I. Compare the efficacy of eflornithine versus placebo in causing regression in patients with cervical intraepithelial neoplasia. II. Compare the qualitative and quantitative toxicities of these treatment regimens in these patients. III. Establish the biochemical tissue markers of DNA content, PCNA, the ras oncogene, EGFR, and keratin and involucrin as intermediate biomarker end points for squamous carcinogenesis in these patients. OUTLINE: This is a randomized, double blind, multicenter study. Patients are randomized to one of three treatment arms. Arm I-II: Patients receive one of two different doses of oral eflornithine daily. Arm III: Patients receive oral placebo daily. Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed at 28 days, and then at 6, 12, 18, and 24 months. PROJECTED ACCRUAL: A total of 180 patients (60 per treatment arm) will be accrued for this study. ### Conditions Module **Conditions:** - Cervical Cancer - Precancerous Condition **Keywords:** - cervical cancer - cervical intraepithelial neoplasia grade 2 - cervical intraepithelial neoplasia grade 3 - Eflornithine ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 150 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Arm I-II: Patients receive one of two different doses of oral eflornithine daily. Treatment continues for 28 days. **Intervention Names:** - Drug: Eflornithine **Label:** Arm I **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Arm I-II: Patients receive one of two different doses of oral eflornithine daily. Treatment continues for 28 days. **Intervention Names:** - Drug: Eflornithine **Label:** Arm II **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Arm III: Patients receive oral placebo daily. Treatment continues for 28 days. **Intervention Names:** - Other: Placebo **Label:** Arm III **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm I - Arm II **Description:** Arm I-II: Patients receive one of two different doses of oral eflornithine daily for 28 days. **Name:** Eflornithine **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Arm III **Description:** Patients receive oral placebo daily for 28 days. **Name:** Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Efficacy in causing regression in patients with cervical intraepithelial neoplasia measured by absence of disease progression or unacceptable toxicity. Patients are followed at 28 days, and then at 6, 12, 18, and 24 months. **Measure:** Efficacy Comparison of Eflornithine versus Placebo **Time Frame:** 28 Days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1) Women with newly diagnosed or recurrent CIN grade 2-3, involving an area 3times larger than the biopsy site. Patients must be \> 18 years old, with a performance status less than or equal to 2 (Zubrod Scale) and a predicted life expectancy of greater than or equal to 12 months. Patients must have a medically safe form of contraception for the duration of the study. All patients must complete the of pretreatment evaluation, consent to colposcopy and cervical biopsy for histologic evaluation Exclusion Criteria: 1) Patients may not have had a prior malignancy. **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Houston **Country:** United States **Facility:** University of Texas - MD Anderson Cancer Center **State:** Texas **Zip:** 77030 #### Overall Officials **Official 1:** **Affiliation:** M.D. Anderson Cancer Center **Name:** Michele Follen, MD, PhD **Role:** STUDY_CHAIR ### References Module #### See Also Links **Label:** UT MD Anderson Cancer Center Website **URL:** http://www.mdanderson.org ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014594 - Term: Uterine Neoplasms - ID: D000005833 - Term: Genital Neoplasms, Female - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000002577 - Term: Uterine Cervical Diseases - ID: D000014591 - Term: Uterine Diseases - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000091662 - Term: Genital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5830 - Name: Uterine Cervical Neoplasms - Relevance: HIGH - As Found: Cervical Cancer - ID: M14111 - Name: Precancerous Conditions - Relevance: HIGH - As Found: Precancerous Condition - ID: M5826 - Name: Uterine Cervical Dysplasia - Relevance: HIGH - As Found: Cervical Intraepithelial Neoplasia - ID: M17342 - Name: Uterine Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8945 - Name: Genital Neoplasms, Female - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5825 - Name: Uterine Cervical Diseases - Relevance: LOW - As Found: Unknown - ID: M17339 - Name: Uterine Diseases - Relevance: LOW - As Found: Unknown - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: T1074 - Name: Cervical Intraepithelial Neoplasia - Relevance: HIGH - As Found: Cervical Intraepithelial Neoplasia ### Condition Browse Module - Meshes - ID: D000002583 - Term: Uterine Cervical Neoplasms - ID: D000009369 - Term: Neoplasms - ID: D000002578 - Term: Uterine Cervical Dysplasia - ID: D000011230 - Term: Precancerous Conditions ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000014344 - Term: Trypanocidal Agents - ID: D000000981 - Term: Antiprotozoal Agents - ID: D000000977 - Term: Antiparasitic Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000065108 - Term: Ornithine Decarboxylase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M3859 - Name: Eflornithine - Relevance: HIGH - As Found: SPI - ID: M4298 - Name: Antiprotozoal Agents - Relevance: LOW - As Found: Unknown - ID: M4294 - Name: Antiparasitic Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: T13 - Name: Ornithine - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000518 - Term: Eflornithine ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04610879 **Acronym:** CASTLE **Brief Title:** Changing Agendas on Sleep, Treatment and Learning in Epilepsy **Official Title:** Randomised Factorial Design Controlled Trial Comparing Carbamazepine, Levetiracetam or Active Monitoring Combined With or Without Sleep Behaviour Intervention in Treatment Naive Children With Rolandic Epilepsy #### Organization Study ID Info **ID:** CASTLE #### Organization **Class:** OTHER **Full Name:** King's College London #### Secondary ID Infos **ID:** 2018-003893-29 **Type:** EUDRACT_NUMBER **Domain:** NIHR **ID:** RP-PG-0615-20007 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2020-09-23 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-11-02 **Type:** ACTUAL **Last Update Submit Date:** 2020-10-26 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2020-09-23 **Type:** ACTUAL #### Start Date **Date:** 2019-08-02 **Type:** ACTUAL **Status Verified Date:** 2020-10 #### Study First Post Date **Date:** 2020-11-02 **Type:** ACTUAL **Study First Submit Date:** 2019-07-09 **Study First Submit QC Date:** 2020-10-26 **Why Stopped:** Following the internal pilot, the study did not meet prespecified stop/go criteria for continuation. ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** King's College Hospital NHS Trust **Class:** OTHER **Name:** University of Liverpool **Class:** OTHER **Name:** Bangor University **Class:** OTHER **Name:** Edge Hill University **Class:** OTHER **Name:** Oxford Brookes University #### Lead Sponsor **Class:** OTHER **Name:** King's College London #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Rolandic epilepsy (RE) is the most common type of epilepsy. Children with RE have seizures and can often find that their learning, sleep, behaviour, self-esteem and mood are affected. As part of standard NHS care, children diagnosed with RE may be treated with standard anti-epileptic medicines, like carbamazepine, or no medicine at all. The medicines used to treat epilepsy often slow down a child's thinking and learning. In the past, doctors believed this was an acceptable price to pay to reduce seizures. However, with RE, where the seizures usually stop in teenage years, investigators do not know if it is better to treat these children with medicines or not, especially if the medicines might have a negative effect on their learning. A newer medicine called levetiracetam has also been found to work in children with RE and has shown less problems with thinking and learning in adults. However, it is still no known if this is also the case for children and it has not been proven which of the three options (carbamazepine, levetiracetam or no treatment) would be best for RE patients. The CASTLE study aims to find this out. In addition, it has been found that seizures often happen when a child has had poor sleep and they often come at night or early in the morning. It has been shown that sleep can be improved through practice without the need of medicines. There are established guidelines to help toddlers go to sleep, but nothing available that helps young people with epilepsy and their parents improve their sleep quality. In the CASTLE study, a sleep training plan has been developed for children with epilepsy and the trial aims to find out whether following this sleep training plan results in less seizures than using no sleep training at all. **Detailed Description:** The trial is a phase IV randomised factorial design controlled trial comparing carbamazepine, levetiracetam or active monitoring combined with or without sleep behaviour intervention. A factorial trial design has been used as this approach enables the efficient simultaneous investigation of AED (carbamazepine; levetiracetam; no AED) and sleep behaviour intervention (vs standard care) by including all participants in both analyses. In a factorial trial it is also possible to consider both the separate effects of each intervention and the benefits of receiving both interventions together (for example levetiracetam and sleep intervention). The CASTLE trial will take place in NHS out-patient paediatric epilepsy and general paediatric clinics in the United Kingdom (UK). Once consent has been obtained from the appropriate adult, and assent from the child if appropriate, by the delegated member of the research team the eligibility assessments will be completed, full eligibility confirmed (confirmation must be by a medically qualified doctor) and baseline data will be collected prior to randomisation. Randomisation will be performed via a web based tool accessed by research team at site. This system is generated centrally by the Clinical Trial Research Centre (CTRC) using a computer algorithm concealed from the investigators and research teams/trial management group. In order to balance the groups, minimisation for variables believed to influence disease outcome and end points will be built into the randomisation algorithm. Participants will be randomised to treatment with carbamazepine, levetiracetam or active monitoring. Where randomised to drug treatment, the randomised treatment should ideally begin on the day of randomisation or within 14 days of randomisation at the latest. Randomised treatment will continue for a minimum of 12 months and a maximum of 48 months. All treatments will be procured, prescribed and issued as per routine NHS practice. Clinical data capture will be in the form of paper copies of Case Report Forms (CRFs) that will be returned as an on-going process from each centre to the CTRC. Patient/parent reported data will be collected directly on paper at each outpatient visit with the exception of CANTAB, which will be collected on iPads at the centre. All trial documents (except raw Hospital Episode Statistics (HES) from NHS digital that will only be retained for 1 year) will be retained for 25 years from the End of Trial. The PI at each investigational centre must make arrangements to store the essential trial documents, (as defined in Essential Documents for the Conduct of a Clinical Trial (ICH E6, Guideline for Good Clinical Practice)) including the ISF, until the CTRC informs the investigator that the documents are no longer to be retained ### Conditions Module **Conditions:** - Rolandic Epilepsy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** FACTORIAL **Intervention Model Description:** The trial is a phase IV randomised factorial design controlled trial comparing carbamazepine, levetiracetam or active monitoring combined with or without sleep behaviour intervention. We have used a factorial trial design as this approach enables the efficient simultaneous investigation of anti-epileptic drug (AED) (carbamazepine; levetiracetam; no AED) and sleep behaviour intervention (vs standard care) by including all participants in both analyses. In a factorial trial it is also possible to consider both the separate effects of each intervention and the benefits of receiving both interventions together (for example levetiracetam and sleep intervention). ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 5 **Type:** ACTUAL **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Carbamazepine - Behavioral: Parent based sleep (PBS) intervention **Label:** Carbamazepine plus sleep intervention **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Drug: Carbamazepine **Label:** Carbamazepine plus standard care **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Intervention Names:** - Drug: Levetiracetam - Behavioral: Parent based sleep (PBS) intervention **Label:** Levetiracetam plus sleep intervention **Type:** ACTIVE_COMPARATOR #### Arm Group 4 **Intervention Names:** - Drug: Levetiracetam **Label:** Levetiracetam plus standard care **Type:** ACTIVE_COMPARATOR #### Arm Group 5 **Intervention Names:** - Behavioral: Parent based sleep (PBS) intervention **Label:** No AED plus sleep intervention **Type:** ACTIVE_COMPARATOR #### Arm Group 6 **Label:** No AED plus standard care **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Carbamazepine plus sleep intervention - Carbamazepine plus standard care **Description:** Treatment will be procured, prescribed and issued as per routine NHS practice. Generics can be prescribed. **Name:** Carbamazepine **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Levetiracetam plus sleep intervention - Levetiracetam plus standard care **Description:** Treatment will be procured, prescribed and issued as per routine NHS practice. Generics can be prescribed. **Name:** Levetiracetam **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Carbamazepine plus sleep intervention - Levetiracetam plus sleep intervention - No AED plus sleep intervention **Description:** The PBS intervention is an e-learning package for parents/primary carers and children with epilepsy. The PBS intervention offers parents education about normal sleep, advice about sleep-promoting practices and targeted strategies parents can employ to help their children to ''learn'' an appropriate set of sleep behaviours/habits and/or to unlearn inappropriate sleep behaviours. **Name:** Parent based sleep (PBS) intervention **Other Names:** - CASTLE Online Sleep Intervention (COSI) **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** To determine which sleep parameters change in primary carer and child dyads in different treatment groups **Measure:** Summary of actigraphy variables (total sleep time/sleep latency/sleep efficiency) averaged over a 1-week period **Time Frame:** 1 week actigraphy (arranged centrally via Oxford unit) at baseline, 3 and 12 months #### Primary Outcomes **Description:** To determine if carbamazepine or levetiracetam are superior to no anti-epileptic drugs **Measure:** Time to 6-month seizure remission **Time Frame:** Up to 48 months **Description:** To determine if a Parent-Based Sleep intervention is superior to standard care **Measure:** Change from baseline to total sleep problem score as measured by the Children's Sleep Habits Questionnaire (CSHQ) **Time Frame:** At 3 months #### Secondary Outcomes **Description:** To estimate the cost-utility of carbamazepine, levetiracetam and PBS **Measure:** Total costs measured in Quality-Adjusted Life Years (QALYs) **Time Frame:** At 0, 3, 12, 24, 36 and 48 months **Description:** To compare time to treatment failure due to inadequate seizure control or unacceptable adverse reactions **Measure:** Time taken from randomisation to decision by child, parent or treating physician to be withdrawn from treatment due to inadequate seizure control or unacceptable adverse reactions **Time Frame:** At 3, 6,12, 24, 36 and 48 months **Description:** To compare time to treatment failure due to inadequate seizure control **Measure:** Time taken from randomisation to decision by child, parent or treating physician to be withdrawn from treatment due to inadequate seizure control **Time Frame:** At 3, 6,12, 24, 36 and 48 months **Description:** To compare time to treatment failure due to unacceptable adverse reactions **Measure:** Time taken from recruitment to decision by child, parent or treating physician to be withdrawn from trial due to unacceptable adverse reactions **Time Frame:** At 3, 6,12, 24, 36 and 48 months **Description:** To compare time to first seizure **Measure:** Time to first seizure based on seizure report **Time Frame:** At 3, 6,12, 24, 36 and 48 months **Description:** To compare time to 12-month remission from seizures **Measure:** Time to 12-month seizure remission based on seizure report **Time Frame:** At 3, 6,12, 24, 36 and 48 months **Description:** To determine if a Parent-Based Sleep intervention is superior to standard care **Measure:** Total sleep problem score as measured by the Children's Sleep Habits Questionnaire (CSHQ) **Time Frame:** At 12, 24, 36 and 48 months **Description:** To compare measures of cognition across the different treatment groups **Measure:** Total score in three chosen assessments delivered by the Cambridge Neuropsychological Test Automated Battery (CANTAB) **Time Frame:** At 0, 3, 6,12, 24, 36 and 48 months **Description:** To compare Health Related Quality of Life across the different treatment groups **Measure:** Score change in Health Related Quality of Life in Children with Epilepsy - Child self-report scale (CHEQOL) **Time Frame:** At 0, 12, 24, 36 and 48 months **Description:** To compare measures of children's behaviour across the different treatment groups **Measure:** Total score on Strengths and Difficulties Questionnaire (SDQ) **Time Frame:** At 0, 12, 24, 36 and 48 months **Description:** To identify any adverse reactions and their rate **Measure:** Records of adverse reactions **Time Frame:** At 3, 6, 12, 24, 36 and 48 months **Description:** To estimate child health utilities and Quality-Adjusted Life Years (QALYs) across the different treatment groups **Measure:** Score changes in Child Health Utility instrument (CHU9D) **Time Frame:** At 0, 3, 12, 24, 36 and 48 months **Description:** To estimate child health utilities and Quality-Adjusted Life Years (QALYs) across the different treatment groups **Measure:** Score changes in EQ-5D-Y **Time Frame:** At 0, 3, 12, 24, 36 and 48 months **Description:** To estimate health utilities and Quality-Adjusted Life Years (QALYs) across parents in the different treatment groups **Measure:** EQ-5D-5L score change **Time Frame:** At 0, 3, 12, 24, 36 and 48 months **Description:** To compare parenting self-efficacy across the different treatment groups **Measure:** Score changes in Parental Self-Efficacy Measure (PSAM) **Time Frame:** At 0, 3, 12, 24, 36 and 48 months **Description:** To compare sickness related school absences across the different treatment groups **Measure:** Total sickness related school absences (days) **Time Frame:** At 0, 3, 6, 12, 24, 36 and 48 months **Description:** To determine the costs to the National Health Service (NHS) **Measure:** Resource Use Questionnaire **Time Frame:** At 3, 12, 24, 36 and 48 months **Description:** To determine the costs to the National Health Service (NHS) **Measure:** Hospital Episode Statistics (HES) Data **Time Frame:** 48 months, measured for the participant's study duration **Description:** To determine the costs to the National Health Service (NHS) **Measure:** Patient Level Information and Costing System (PLICS) Data **Time Frame:** 48 months, measured for the participant's study duration ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Children diagnosed with RE (see International League Against Epilepsy Diagnostic Manual at https://www.epilepsydiagnosis.org/syndrome/ects-overview.html) 2. EEG showing focal sharp waves with normal background (see International League Against Epilepsy Diagnostic Manual at https://www.epilepsydiagnosis.org/syndrome/ects-eeg.html) 3. Aged ≥5 years and \<13 years at the time of randomisation 4. Currently untreated with antiepileptic drugs 5. Written informed consent received from person with parental responsibility/legal representative. 6. Family have an email address and regular internet access (for online sleep intervention) 7. Parent and child are to have a good understanding of the English language Exclusion Criteria: 1. Known contraindication to any of the trial drugs 2. Previously treated for epilepsy with antiepileptic drugs **Maximum Age:** 12 Years **Minimum Age:** 5 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** London **Country:** United Kingdom **Facility:** King's College Hospital NHS Foundation Trust **Zip:** SE5 8EF **Location 2:** **City:** Manchester **Country:** United Kingdom **Facility:** Tameside Hospital **Location 3:** **City:** Whiston **Country:** United Kingdom **Facility:** Whiston Hospital ### IPD Sharing Statement Module **Description:** The current data sharing plans for this study are unknown and will be available at a later date **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000004828 - Term: Epilepsies, Partial - ID: D000073376 - Term: Epileptic Syndromes ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M7983 - Name: Epilepsy - Relevance: HIGH - As Found: Epilepsy - ID: M21286 - Name: Epilepsy, Rolandic - Relevance: HIGH - As Found: Rolandic Epilepsy - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M7984 - Name: Epilepsies, Partial - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M1165 - Name: Epileptic Syndromes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004827 - Term: Epilepsy - ID: D000019305 - Term: Epilepsy, Rolandic ### Intervention Browse Module - Ancestors - ID: D000000927 - Term: Anticonvulsants - ID: D000018697 - Term: Nootropic Agents - ID: D000018692 - Term: Antimanic Agents - ID: D000014149 - Term: Tranquilizing Agents - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000011619 - Term: Psychotropic Drugs - ID: D000018712 - Term: Analgesics, Non-Narcotic - ID: D000000700 - Term: Analgesics - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000026941 - Term: Sodium Channel Blockers - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000065701 - Term: Cytochrome P-450 CYP3A Inducers - ID: D000065693 - Term: Cytochrome P-450 Enzyme Inducers ### Intervention Browse Module - Browse Branches - Abbrev: AntiConv - Name: Anticonvulsants - Abbrev: NootAg - Name: Nootropic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ChanBlk - Name: Channel Blockers - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: PsychDr - Name: Psychotropic Drugs ### Intervention Browse Module - Browse Leaves - ID: M1741 - Name: Levetiracetam - Relevance: HIGH - As Found: Heat - ID: M5480 - Name: Carbamazepine - Relevance: HIGH - As Found: PPI - ID: M4246 - Name: Anticonvulsants - Relevance: LOW - As Found: Unknown - ID: M20774 - Name: Nootropic Agents - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M20786 - Name: Analgesics, Non-Narcotic - Relevance: LOW - As Found: Unknown - ID: M23177 - Name: Sodium Channel Blockers - Relevance: LOW - As Found: Unknown - ID: M30025 - Name: Diuretics, Potassium Sparing - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000002220 - Term: Carbamazepine - ID: D000077287 - Term: Levetiracetam ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02428179 **Acronym:** StOP **Brief Title:** Impact of Structured Communication in the OR on Surgical Site Infections: Prospective Observational Clinical Trial **Official Title:** StOP?-Trial: Impact of Structured Communication in the OR on Surgical Site Infections: Prospective Observational Clinical Trial #### Organization Study ID Info **ID:** 161/14 #### Organization **Class:** OTHER **Full Name:** Insel Gruppe AG, University Hospital Bern ### Status Module #### Completion Date **Date:** 2017-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-03-15 **Type:** ACTUAL **Last Update Submit Date:** 2017-03-14 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2016-12 **Type:** ACTUAL #### Start Date **Date:** 2015-04 **Status Verified Date:** 2017-03 #### Study First Post Date **Date:** 2015-04-28 **Type:** ESTIMATED **Study First Submit Date:** 2015-04-23 **Study First Submit QC Date:** 2015-04-23 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Lausanne Hospitals **Class:** OTHER **Name:** Triemli Hospital **Class:** UNKNOWN **Name:** Kantonsspital Chur, Switzerland #### Lead Sponsor **Class:** OTHER **Name:** Insel Gruppe AG, University Hospital Bern #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** Surgical site infection (SSI) is the most frequent complication in patients that undergo abdominal surgery. A previous prospective observational study in 167 patients undergoing elective open abdominal procedures showed that case-relevant communication protects from organ/space SSI whereas case-irrelevant communication during the last 20 minutes of the procedure is a risk factor for incisional SSI. Therefore, the introduction of a clinical applicable intervention "structured briefing using the StOP protocol" has been developed and was tested in pilot experiments. This intervention aims at improving case-relevant communication during the procedure and to reduce excess case-irrelevant communication at the end of an operation. The hypothesis is: structured briefings during an operation reduce the incidence of SSI after surgery. **Detailed Description:** Background A number of publications has shown a relatively high rate of complications that are related to the treatment and not to the disease. Such iatrogenic incidents are an important influence on patient morbidity and increase healthcare costs. Therefore, patient safety and minimizing the risk of iatrogenic harm has become a major concern in healthcare. Surgical site infection (SSI) is one of the most frequent complication in patients that undergo surgery, leading to considerable costs. In a previous study, the investigators established an empirical relationship between communication during surgery and SSI was shown in a prospective observational study in 167 patients undergoing major elective open abdominal procedures. An analysis of 11383 communication events observed by a team of trained work psychologists showed a relationship between intraoperative communication and SSI. Adjusted logistic regression analysis revealed that more case-relevant communication during the entire procedure was associated with a significant reduction in organ/space SSI (odds ratio 0.861, 95% confidence interval 0.750-0.987; P=0.034). Interestingly, case-irrelevant communication during the last 20 minutes of the procedure was associated with a significant increase of incisional SSI (odds ratio 1.1153, 95% confidence interval 1.040-1.196; P=0.002). Distractors such as noise and traffic were also assessed but had no effect on SSI. The current study is based on these observations, which reveal that case-relevant communication protects from organ/space SSI and case-irrelevant communication during the last 20 minutes of the procedure is a risk factor for SSI. These findings can be interpreted in light of previous studies assessing communication in surgery and similar collaborative tasks which showed that explicit task-relevant communication fosters the development of a shared mental model of the task within the team. This facilitates coordination, because all team members are informed about the state of task progress, and can better anticipate their contribution. This is particularly important in critical phases of the procedure, as well as in OR teams composed of members with different levels of knowledge and expertise. Explicit task-related communication may be particularly useful to inform non-sterile team members (anesthetists, scrub nurses) that do not have full sight of the operative field at all times. Although case-irrelevant communication in surgical teams has been found to foster a positive team-climate, it can be seen as a distractor if it diverts the attention away from the main task. This is more likely during the closing phase (last 20 minutes), because for most of the team members, the central task is already finished, and clearing and cleaning are routine tasks. If during routine tasks the team engages in too much non-patient relevant communication, attention to the closure may be diverted. Given the previously found results, the introduction of a clinically applicable intervention (described below) has been tested in pilot studies. This intervention aims to assure a short discussion of case-relevant aspects at specific moments of the procedure, draw the attention of the on case-relevant communication during the main phase and to prevent a high increase in case-irrelevant communication at the end of an operation. Objective To perform a prospective clinical trial to test the impact of structured intraoperative briefings on SSI. The incidence of SSIs will be compared before and after the introduction of this intervention. Methods - Intraoperative briefings: First briefing: after exposure of the organ of interest, Second briefing: Intraoperative briefing before closure of the operative field. * Trainings and Retrainings * Optional Interventions: Transparent drape between anesthesia and sterile team; Controlling noise and potential distractors during wound closure; Nutritional support during the operation ### Conditions Module **Conditions:** - Incidence of Surgical Site Infection - Short Intraoperative Briefings - Mortality - Shared Mental Model **Keywords:** - Surgical site infection - Intraoperative briefings - Mortality - Wound closure - Surgical procedure ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 3003 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Control group without Study intervention **Intervention Names:** - Procedure: StOP? - Control group **Label:** Control group without Study intervention #### Arm Group 2 **Description:** Group with Study intervention **Intervention Names:** - Procedure: StOP? - Intervention group **Label:** Group with Study intervention ### Interventions #### Intervention 1 **Arm Group Labels:** - Control group without Study intervention **Description:** Control group - Surgical procedure without Study Intervention **Name:** StOP? - Control group **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Group with Study intervention **Description:** Intervention group - Surgical procedure with intraoperative briefings, optional interventions: Transparent drape between anesthesia and sterile team, Controlling noise and potential distractors during wound closure, Nutritional support during the operation **Name:** StOP? - Intervention group **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** Incidence of surgical Site infections **Time Frame:** 30 days postoperative #### Secondary Outcomes **Measure:** Postoperative mortality **Time Frame:** 30 days postoperative **Measure:** Type of Operation / Laparoscopic procedure **Time Frame:** 30 days postoperative **Measure:** Grade of contamination **Time Frame:** 30 days postoperative ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients undergoing elective or emergency surgery Exclusion Criteria * Preexisting surgical site infection **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Patients undergoing abdominal surgery ### Contacts Locations Module #### Locations **Location 1:** **City:** Bern **Country:** Switzerland **Facility:** University Hospital Inselspital **Zip:** 3010 #### Overall Officials **Official 1:** **Affiliation:** Visceral and transplant surgery, University hospital, Berne **Name:** Guido Beldi, Prof. Dr. med. **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Sax H, Uckay I, Balmelli C, Bernasconi E, Boubaker K, Muhlemann K, Ruef C, Troillet N, Widmer A, Zanetti G, Pittet D. Overall burden of healthcare-associated infections among surgical patients. Results of a national study. Ann Surg. 2011 Feb;253(2):365-70. doi: 10.1097/SLA.0b013e318202fda9. **PMID:** 21217517 **Citation:** Weber WP, Zwahlen M, Reck S, Feder-Mengus C, Misteli H, Rosenthal R, Brandenberger D, Oertli D, Widmer AF, Marti WR. Economic burden of surgical site infections at a European university hospital. Infect Control Hosp Epidemiol. 2008 Jul;29(7):623-9. doi: 10.1086/589331. **PMID:** 18564917 **Citation:** Mazzocco K, Petitti DB, Fong KT, Bonacum D, Brookey J, Graham S, Lasky RE, Sexton JB, Thomas EJ. Surgical team behaviors and patient outcomes. Am J Surg. 2009 May;197(5):678-85. doi: 10.1016/j.amjsurg.2008.03.002. Epub 2008 Sep 11. **PMID:** 18789425 **Citation:** Nurok M, Sundt TM 3rd, Frankel A. Teamwork and communication in the operating room: relationship to discrete outcomes and research challenges. Anesthesiol Clin. 2011 Mar;29(1):1-11. doi: 10.1016/j.anclin.2010.11.012. **PMID:** 21295749 **Citation:** Catchpole K, Mishra A, Handa A, McCulloch P. Teamwork and error in the operating room: analysis of skills and roles. Ann Surg. 2008 Apr;247(4):699-706. doi: 10.1097/SLA.0b013e3181642ec8. **PMID:** 18362635 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000014946 - Term: Wound Infection - ID: D000011183 - Term: Postoperative Complications ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infection - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M16310 - Name: Surgical Wound Infection - Relevance: HIGH - As Found: Surgical Site Infection - ID: M1112 - Name: Surgical Wound - Relevance: LOW - As Found: Unknown - ID: M17684 - Name: Wound Infection - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000013530 - Term: Surgical Wound Infection ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00366379 **Brief Title:** A Dose-Titration Study of GK Activator (2) in Patients With Type 2 Diabetes. **Official Title:** An Open Label Study to Determine the Effect on Fasting Glucose Levels, and Safety, of Increasing Doses of GK Activator (2) in Patients With Type 2 Diabetes Not Optimally Controlled With One Previous Oral Antihyperglycemic Agent. #### Organization Study ID Info **ID:** BC19800 #### Organization **Class:** INDUSTRY **Full Name:** Hoffmann-La Roche ### Status Module #### Completion Date **Date:** 2007-06 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2016-11-02 **Type:** ESTIMATED **Last Update Submit Date:** 2016-11-01 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2007-06 **Type:** ACTUAL #### Start Date **Date:** 2006-07 **Status Verified Date:** 2016-11 #### Study First Post Date **Date:** 2006-08-21 **Type:** ESTIMATED **Study First Submit Date:** 2006-08-16 **Study First Submit QC Date:** 2006-08-18 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Hoffmann-La Roche #### Responsible Party **Type:** SPONSOR ### Description Module **Brief Summary:** This study will assess the efficacy, safety and tolerability of increasing doses of GK Activator (2) in patients with type 2 diabetes whose condition has not been optimally controlled with one previous oral antihyperglycemic agent. After a 2 week washout from their previous antidiabetic therapy, patients will receive GK Activator (2) orally, twice a day for 12 weeks, at increasing doses of 25mg bid to 200mg bid; doses will be titrated to achieve a target fasting glucose level (FPG) of \<100mg/dL. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals. ### Conditions Module **Conditions:** - Diabetes Mellitus Type 2 ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 127 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: GK Activator (2) **Label:** 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: GK Activator (2) **Label:** 2 **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Drug: GK Activator (2) **Label:** 3 **Type:** EXPERIMENTAL #### Arm Group 4 **Intervention Names:** - Drug: GK Activator (2) **Label:** 4 **Type:** EXPERIMENTAL #### Arm Group 5 **Intervention Names:** - Drug: GK Activator (2) **Label:** 5 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 1 - 2 - 3 - 4 - 5 **Description:** 25-200mg po bid for 20 weeks **Name:** GK Activator (2) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Percentage of patients at each dose who achieve FPG <100mg/dL. **Time Frame:** Throughout study #### Secondary Outcomes **Measure:** Mean change in HbA1c and FPG from baseline to endpoint; absolute/relative changes in lipid profile. **Time Frame:** At intervals throughout study **Measure:** AEs, laboratory parameters. **Time Frame:** Throughout study ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * adult patients, 18-75 years of age; * type 2 diabetes mellitus treated with one oral antihyperglycemic agent for \>=3 months prior to screening. Exclusion Criteria: * type 1 diabetes mellitus; * treatment with insulin, PPAR agonists or systemic corticosteroids during the 3 months prior to screening; * women who are pregnant, breast-feeding or not using adequate contraceptive methods. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Chandler **Country:** United States **State:** Arizona **Zip:** 85225 **Location 2:** **City:** Oviedo **Country:** United States **State:** Florida **Zip:** 32765 **Location 3:** **City:** Nampa **Country:** United States **State:** Idaho **Zip:** 83687 **Location 4:** **City:** Evansville **Country:** United States **State:** Indiana **Zip:** 47714 **Location 5:** **City:** Butte **Country:** United States **State:** Montana **Zip:** 59701 **Location 6:** **City:** Canton **Country:** United States **State:** Ohio **Zip:** 44718 **Location 7:** **City:** Portland **Country:** United States **State:** Oregon **Zip:** 97239 **Location 8:** **City:** Greer **Country:** United States **State:** South Carolina **Zip:** 29651 **Location 9:** **City:** Midland **Country:** United States **State:** Texas **Zip:** 79707 **Location 10:** **City:** Richmond **Country:** United States **State:** Virginia **Zip:** 23249 **Location 11:** **City:** Tallinn **Country:** Estonia **Zip:** 10138 **Location 12:** **City:** Tartu **Country:** Estonia **Zip:** 50406 **Location 13:** **City:** Tartu **Country:** Estonia **Zip:** 50708 **Location 14:** **City:** Tartu **Country:** Estonia **Zip:** 51014 **Location 15:** **City:** Jelgava **Country:** Latvia **Zip:** 3001 **Location 16:** **City:** Riga **Country:** Latvia **Zip:** 1002 **Location 17:** **City:** Riga **Country:** Latvia **Zip:** 1038 **Location 18:** **City:** Chihuahua **Country:** Mexico **Zip:** 31238 **Location 19:** **City:** Guadalajara **Country:** Mexico **Zip:** 44340 **Location 20:** **City:** Guadalajara **Country:** Mexico **Zip:** 44650 **Location 21:** **City:** Pachuca **Country:** Mexico **Zip:** 42086 #### Overall Officials **Official 1:** **Affiliation:** Hoffmann-La Roche **Name:** Clinical Trials **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: HIGH - As Found: Diabetes Mellitus Type 2 - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003924 - Term: Diabetes Mellitus, Type 2 ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01563679 **Brief Title:** Analysis of Percutaneous Ablations for Cancer Treatment **Official Title:** Prospective Analysis of Percutaneous Ablations for Cancer Treatment #### Organization Study ID Info **ID:** IRB00054905 #### Organization **Class:** OTHER **Full Name:** Emory University #### Secondary ID Infos **Domain:** Other **ID:** RAD2160-11 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2014-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2014-05-28 **Type:** ESTIMATED **Last Update Submit Date:** 2014-05-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2014-01 **Type:** ACTUAL #### Start Date **Date:** 2012-02 **Status Verified Date:** 2014-05 #### Study First Post Date **Date:** 2012-03-27 **Type:** ESTIMATED **Study First Submit Date:** 2012-03-12 **Study First Submit QC Date:** 2012-03-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Emory University #### Responsible Party **Investigator Affiliation:** Emory University **Investigator Full Name:** Hyun Kevin Kim **Investigator Title:** Director of Interventional Radiology and Image-guided Medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a study involving patients with cancer who are referred by their treating physician for percutaneous locoregional therapies. Patient's clinical and radiology findings, pathology findings, survival, treatment responses, and complications after their locoregional therapy will be studied. **Detailed Description:** The efficacy of the percutaneous and transarterial treatments for solid tumors will be studied. Prospective study on patients who receive percutaneous locoregional therapies, including radiofrequency ablation (RFA), cryoablation, microwave ablation, IRE and chemical ablation for treatment of cancer will be performed. Preoperative clinic chart, procedure note, postoperative chart, pre- and post-operative CT, MRI or Ultrasound, angiographic findings, biopsy results and pathologic findings, will be reviewed. Patient survival, treatment responses, complications after the therapy will be collected from clinic visits and clinical encounters. Patient overall performance status before and after procedures will be assessed using the Quality of Life questionnaire (SF-36™ Health Survey). ### Conditions Module **Conditions:** - Cancer **Keywords:** - cancer - locoregional therapies - RFA - Cryoablation - Microwave ablation - chemical ablation - Irreversible electroporation ### Design Module #### Design Info **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 26 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Patients will complete the QOL questionnare during their follow up visits after procedure. 1 month, 3 months, 6 months and 1 year. **Measure:** Effect of percutaneous and transarterial treatments for cancer in quality of life **Time Frame:** 1 year #### Secondary Outcomes **Description:** Patients will be followed up 1, 3, 6 and 1year intervals after procedure. **Measure:** response rate to percutaneous and transarterial treatment for cancer **Time Frame:** 1 month, 3 months, 6 months, 1 year. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18yrs of age * Cancer diagnosis * Candidate for Locoregional therapy * Willingness to sign informed consent Exclusion Criteria: * Unable to sign informed consent * Patients not eligible for locoregional therapies **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients who undergo ablative therapy procedures, in the Interventional Radiology department as part of a clinical treatment for cancer. ### Contacts Locations Module #### Locations **Location 1:** **City:** Altanta **Country:** United States **Facility:** Emory University Hospital **State:** Georgia **Zip:** 30322 #### Overall Officials **Official 1:** **Affiliation:** Emory University **Name:** Hyun S Kim, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00073879 **Brief Title:** Fludarabine, Cyclophosphamide, and Alemtuzumab in Treating Patients With Recurrent or Metastatic Renal Cell Carcinoma (Kidney Cancer) Undergoing Allogeneic Stem Cell Transplantation **Official Title:** Allogeneic Adoptive Immunochemotherapy For Treatment Of Renal Cell Carcinoma #### Organization Study ID Info **ID:** CDR0000328247 #### Organization **Class:** OTHER **Full Name:** Baylor College of Medicine #### Secondary ID Infos **ID:** BCM-H-8447 ### Status Module #### Completion Date **Date:** 2004-04 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2015-01-29 **Type:** ESTIMATED **Last Update Submit Date:** 2015-01-27 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2004-04 **Type:** ACTUAL #### Start Date **Date:** 2003-04 **Status Verified Date:** 2015-01 #### Study First Post Date **Date:** 2003-12-11 **Type:** ESTIMATED **Study First Submit Date:** 2003-12-10 **Study First Submit QC Date:** 2003-12-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Baylor College of Medicine #### Responsible Party **Investigator Affiliation:** Baylor College of Medicine **Investigator Full Name:** Helen Heslop **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Description Module **Brief Summary:** RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells can reject the body's normal tissues. Alemtuzumab and tacrolimus may prevent this from happening. PURPOSE: Phase II trial to study the effectiveness of combining fludarabine and cyclophosphamide with alemtuzumab in treating patients who are undergoing allogeneic stem cell transplantation for recurrent or metastatic renal cell carcinoma (kidney cancer). **Detailed Description:** OBJECTIVES: * Determine the safety and feasibility of fludarabine, cyclophosphamide, and alemtuzumab in patients with recurrent or metastatic renal cell carcinoma undergoing HLA-matched allogeneic stem cell transplantation. OUTLINE: This is a pilot, multicenter study. * Conditioning: Patients receive fludarabine IV over 30 minutes on days -6 to -2, cyclophosphamide IV over 2 hours on days -6 and -5, and alemtuzumab IV on days -4 to -2. * Allogeneic transplantation: Allogeneic stem cells are infused on day 0. Patients receive graft-vs-host disease prophylaxis with tacrolimus IV or orally for approximately 30 days. Patients are followed weekly for 100 days and then at 6, 12, 18, 24, 36, 48, and 60 months after transplantation. PROJECTED ACCRUAL: A total of 20 patients (10 with HLA-identical related donors and 10 with matched unrelated donors) will be accrued for this study. ### Conditions Module **Conditions:** - Kidney Cancer **Keywords:** - stage IV renal cell cancer - recurrent renal cell cancer ### Design Module #### Design Info **Primary Purpose:** TREATMENT **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** alemtuzumab **Type:** BIOLOGICAL #### Intervention 2 **Name:** graft-versus-tumor induction therapy **Type:** BIOLOGICAL #### Intervention 3 **Name:** cyclophosphamide **Type:** DRUG #### Intervention 4 **Name:** fludarabine phosphate **Type:** DRUG #### Intervention 5 **Name:** allogeneic bone marrow transplantation **Type:** PROCEDURE #### Intervention 6 **Name:** peripheral blood stem cell transplantation **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** Number of patients with treatment related mortality **Time Frame:** 100 ### Eligibility Module **Eligibility Criteria:** DISEASE CHARACTERISTICS: * Diagnosis of recurrent or metastatic renal cell carcinoma * Failed interleukin-2 (IL-2)-based therapy OR intolerant to IL-2 * Clinically evident and followable disease * Availability of 1 of the following compatible donors: * Related HLA-identical or 1-Ag mismatched donor * Unrelated HLA-A, B, DRB1-matched donor PATIENT CHARACTERISTICS: Age * Any age Performance status * Karnofsky 70-100% Life expectancy * No concurrent illness that severely limits life expectancy Hematopoietic * Not specified Hepatic * No episode of hepatitis within the past month * No evidence of chronic active hepatitis or cirrhosis Renal * Creatinine no greater than 2 mg/dL Cardiovascular * LVEF at least 40% * No uncontrolled arrhythmias * No symptomatic cardiac disease Pulmonary * FEV_1, FVC, and DLCO at least 50% of predicted (unless due to metastatic disease) Other * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * No active infection * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Houston **Country:** United States **Facility:** Baylor College of Medicine **State:** Texas **Zip:** 77030 #### Overall Officials **Official 1:** **Affiliation:** Baylor College of Medicine **Name:** Uday Popat, MD **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000000230 - Term: Adenocarcinoma - ID: D000014571 - Term: Urologic Neoplasms - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000007674 - Term: Kidney Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M5548 - Name: Carcinoma, Renal Cell - Relevance: HIGH - As Found: Kidney Cancer - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M10703 - Name: Kidney Neoplasms - Relevance: HIGH - As Found: Kidney Cancer - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M17320 - Name: Urologic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: T4906 - Name: Renal Cell Carcinoma - Relevance: HIGH - As Found: Renal Cell Carcinoma - ID: T1341 - Name: Clear Cell Renal Cell Carcinoma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002292 - Term: Carcinoma, Renal Cell - ID: D000007680 - Term: Kidney Neoplasms ### Intervention Browse Module - Ancestors - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018501 - Term: Antirheumatic Agents - ID: D000018906 - Term: Antineoplastic Agents, Alkylating - ID: D000000477 - Term: Alkylating Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents - ID: D000019653 - Term: Myeloablative Agonists - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000963 - Term: Antimetabolites - ID: D000074322 - Term: Antineoplastic Agents, Immunological ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M6727 - Name: Cyclophosphamide - Relevance: HIGH - As Found: Cycle - ID: M283230 - Name: Fludarabine - Relevance: HIGH - As Found: Comparison - ID: M225513 - Name: Fludarabine phosphate - Relevance: HIGH - As Found: Intubation - ID: M1347 - Name: Alemtuzumab - Relevance: HIGH - As Found: SOC - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M20942 - Name: Antineoplastic Agents, Alkylating - Relevance: LOW - As Found: Unknown - ID: M3820 - Name: Alkylating Agents - Relevance: LOW - As Found: Unknown - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000003520 - Term: Cyclophosphamide - ID: C000024352 - Term: Fludarabine - ID: C000042382 - Term: Fludarabine phosphate - ID: D000074323 - Term: Alemtuzumab ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01843179 **Brief Title:** Sulindac for Patients With AML **Official Title:** A Phase II Study of Sulindac, a COX Inhibitor, in Older Patients With Acute Myeloid Leukemia in First Complete Remission #### Organization Study ID Info **ID:** 12-302 #### Organization **Class:** OTHER **Full Name:** Massachusetts General Hospital ### Status Module #### Completion Date **Date:** 2014-01 #### Expanded Access Info #### Last Update Post Date **Date:** 2017-02-17 **Type:** ACTUAL **Last Update Submit Date:** 2017-02-15 **Overall Status:** WITHDRAWN #### Primary Completion Date **Date:** 2014-01 **Type:** ESTIMATED #### Start Date **Date:** 2014-01 **Status Verified Date:** 2017-02 #### Study First Post Date **Date:** 2013-04-30 **Type:** ESTIMATED **Study First Submit Date:** 2013-04-22 **Study First Submit QC Date:** 2013-04-25 **Why Stopped:** Lack of Funding ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Massachusetts General Hospital #### Responsible Party **Investigator Affiliation:** Massachusetts General Hospital **Investigator Full Name:** Amir Fathi **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug is effective in treating a specific cancer. "Investigational" means that sulindac is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not yet approved the use of sulindac for your type of cancer. Participants in this study must have undergone previous chemotherapy and achieved complete remission, which is the absence of disease activity in people with a chronic illness, in this case AML. Unfortunately, a significant number of patients with AML who achieve a complete remission with initial chemotherapy eventually experience a relapse, often within a few months. Previous research studies have demonstrated that a type of medication frequently used to treat inflammation, called a COX inhibitor, may suppress and kill leukemia cells. COX inhibitors work by blocking a class of proteins called COX proteins. Other commonly used COX inhibitors are ibuprofen and naproxen. For this study, the investigators are using a COX inhibitor called sulindac, which has been FDA approved and used to treat pain and inflammation for many years, and has also been studied in suppressing certain tumors of the gastrointestinal system. The main goal of this study is to determine whether sulindac can help participants remain in a state of complete remission following the initial course of chemotherapy for AML, and two cycles of chemotherapy that is standard of care for your cancer, called consolidation chemotherapy. During the course of this study, the investigators will also attempt to learn more about how COX inhibition suppresses the emergence of leukemia, at the molecular and cellular level, by studying the participants on this trial. **Detailed Description:** To determine if you are eligible to participate in this study you will be asked to undergo some screening tests or procedures. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. These procedures include a medical history, performance status, medical record review, routine blood tests, electrocardiogram, echocardiogram and research blood samples. If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study. You will begin the study with up to two cycles of chemotherapy that is an accepted approach treatment of your type of leukemia. This is called consolidation chemotherapy. If you experience severe side effects, you may only be given one cycle. You will begin to take sulindac after you complete consolidation therapy. The consolidation therapy that is commonly used for your type of cancer is a chemotherapy drug called cytarabine. Each cycle of consolidation chemotherapy will be 28 days, or four weeks. You will receive cytarabine via IV infusion on Days 1-5 of each cycle, over a period of 3 hours. You will be admitted to MGH for approximately a week during each cycle of consolidation chemotherapy with cytarabine. Before starting sulindac, the same tests and procedures done at the screening visit listed above will be repeated. This visit is "Day 0", meaning it takes place prior to study treatment with sulindac. In addition, you will also have a sample of your bone marrow taken for research purposes. This sample is related to the study and will help us understand better the activity of the study drug, sulindac, on leukemia cells and the effect of the body on the sulindac. You will take sulindac twice a day. Sulindac comes in the form of tablets and can be taken at home by mouth. Your first day of taking sulindac will be called day 1. The following tests and procedures will be one in the outpatient clinic on Day 1 of the study: Blood samples will be taken at 3 points on day 1. These will occur before the first dose of sulindac, 1 hour after the first dose of sulindac, and 4 hours after the first dose of sulindac. Approximately 3 teaspoons of blood will be drawn each time. These samples are related to the study and will help us understand better the activity of the study drug, sulindac, on leukemia cells and the effect of the body on sulindac. You will come into the clinic for dosing on day 2 (Visit 3) of the study. Approximately 3 teaspoons of blood will be drawn before dosing. 3 teaspoons of blood will also be drawn prior to dosing on days 8, 15 and 28 of study treatment with sulindac. These samples will be stored for as long as research is ongoing with currently no end date. You will continue sulindac twice daily for the duration of the study, which will be 12 months. You will be monitored for bleeding, since COX inhibitors can also decrease platelet function and affect clotting abilities, and for gastritis or ulcer disease, as COX inhibitors can damage the lining of the stomach. These occur in the minority of participants, but you will be monitored closely on this study for these unexpected effects. If you develop toxicities on therapy, your dose of sulindac may be reduced or if your symptoms are severe enough, you may be taken off sulindac. If for whatever reason you are unable to participate in the study or adhere to the schedules and study treatments, you will be taken off the study treatment and discontinued from the study. You may choose to stop treatment and come off the study at any time. We would like to keep track of your medical condition and overall health following the 12 months of study treatment on study with sulindac. This will not involve any communication, but only occasional review of your medical record in regards to medical condition and overall health. ### Conditions Module **Conditions:** - Acute Myeloid Leukemia **Keywords:** - Newly diagnosed - Complete Remission ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Induction Chemotherapy followed by treatment with sulindac **Intervention Names:** - Drug: Cytarabine - Drug: Sulindac **Label:** Sulindac Treatment Arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Sulindac Treatment Arm **Description:** Up to two cycles. Administered via IV infusion on Days 1-5 of each 28 day cycle **Name:** Cytarabine **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Sulindac Treatment Arm **Description:** Taken orally twice per day at home for 12 months **Name:** Sulindac **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** To define the efficacy of the COX inhibitor sulindac in maintaining complete remission in older patients with AML who achieve remission after induction chemotherapy **Measure:** Efficacy of sulindac in maintaining complete remission **Time Frame:** 2 years #### Secondary Outcomes **Description:** To assess for safety and tolerability of sulindac in the post-induction setting for this patient population through recording and grading of related toxicity **Measure:** Assess and grade toxicity of sulindac treatment **Time Frame:** 2 years **Description:** To assess for relapse free survival, time to relapse and overall survival **Measure:** Assessment of survival **Time Frame:** 2 years **Description:** To perform correlative pharmacodynamic studies including B-catenin protein levels and expression levels of B-catenin downstream genes **Measure:** Correlative pharmacodynamic studies including B-catenin protein levels and expression levels of B-catenin downstream genes **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Pathologically confirmed newly diagnosed acute myelogenous leukemia in complete remission following induction chemotherapy Exclusion Criteria: * Plan for consolidative stem cell transplant in CR1 at the time of enrollment * Previous history of coronary artery disease or heart failure * Previous history of major allergic reaction to aspirin or other non-steroidal anti-inflammatory drugs * Previous history of gastric or duodenal ulceration * Diagnosis of acute promyelocytic leukemia * Diagnosis of acute bilineal/biphenotypic leukemia * History of a different malignancy unless disease free for at least 5 years or diagnosed and treated for cervical cancer in situ, basal or squamous cell carcinoma of the skin * Uncontrolled intercurrent illness that would limit compliance with study requirements * Disseminated intravascular coagulation * HIV positive on combination anti-retroviral therapy * Known active hepatitis B or C * History of coronary artery disease * Current or history of congestive heart failure * History of ventricular arrhythmia * Patients with mental deficits or psychiatric conditions that preclude them form giving informed consent and following protocol * Pregnant **Minimum Age:** 60 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Boston **Country:** United States **Facility:** Massachusetts General Hospital **State:** Massachusetts **Zip:** 02115 #### Overall Officials **Official 1:** **Affiliation:** Massachusetts General Hospital **Name:** Amir Fathi, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000006402 - Term: Hematologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10945 - Name: Leukemia - Relevance: HIGH - As Found: Leukemia - ID: M10955 - Name: Leukemia, Myeloid - Relevance: HIGH - As Found: Myeloid Leukemia - ID: M18127 - Name: Leukemia, Myeloid, Acute - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: T3995 - Name: Myeloid Leukemia - Relevance: HIGH - As Found: Myeloid Leukemia - ID: T182 - Name: Acute Myeloid Leukemia - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: T188 - Name: Acute Non Lymphoblastic Leukemia - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007938 - Term: Leukemia - ID: D000007951 - Term: Leukemia, Myeloid - ID: D000015470 - Term: Leukemia, Myeloid, Acute ### Intervention Browse Module - Ancestors - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents - ID: D000000998 - Term: Antiviral Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000894 - Term: Anti-Inflammatory Agents, Non-Steroidal - ID: D000018712 - Term: Analgesics, Non-Narcotic - ID: D000000700 - Term: Analgesics - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000018501 - Term: Antirheumatic Agents - ID: D000016861 - Term: Cyclooxygenase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M6766 - Name: Cytarabine - Relevance: HIGH - As Found: Infants - ID: M16250 - Name: Sulindac - Relevance: HIGH - As Found: Isometric contraction - ID: M19209 - Name: Cyclooxygenase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown - ID: M4314 - Name: Antiviral Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M4218 - Name: Anti-Inflammatory Agents, Non-Steroidal - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M20786 - Name: Analgesics, Non-Narcotic - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000003561 - Term: Cytarabine - ID: D000013467 - Term: Sulindac ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06163079 **Acronym:** PMAPT **Brief Title:** Assisted Reproductive Techniques (ART) With Sperm Donation : an Inclusive Model of ART for All Women **Official Title:** Assisted Reproductive Techniques (ART) With Sperm Donation : an Inclusive Model of ART for All Women #### Organization Study ID Info **ID:** 2023PI128 #### Organization **Class:** OTHER **Full Name:** Central Hospital, Nancy, France ### Status Module #### Completion Date **Date:** 2024-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-04-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-04-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-01-01 **Type:** ACTUAL #### Start Date **Date:** 2023-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2023-12-08 **Type:** ACTUAL **Study First Submit Date:** 2023-11-30 **Study First Submit QC Date:** 2023-11-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Central Hospital, Nancy, France #### Responsible Party **Investigator Affiliation:** Central Hospital, Nancy, France **Investigator Full Name:** Mikael AGOPIANTZ **Investigator Title:** MCU-PH - ART Center coordinator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a monocentric, retrospective, non-interventional study. The main objective is to describe the populations requesting assisted reproductive techniques (ART) with sperm donation ; and compare them between groups depending on their parental project.. The secondary objectives are to describe the center support process in the context of ART with sperm donation, to determine the initial/final orientation of support and the time to care The statistical analysis will be carried out to compare these parameters between groups depending on their parental project The study is taking place in the reproductive medicine department of the regional university hospital centre in Nancy. **Detailed Description:** Descriptive analysis of a new MAP population since the update of bioethics legislation in August 2021 This study is a descriptive analysis of the population requesting assisted reproductive techniques (ART) with sperm donation since update of bioethics legislation in August 2021 ; and compare them in groups depending on their parental project. The main objective is to describe the different populations requesting ART with sperm donation (number and evolution of requests, age, history, geographical origin, infertility delay, parenthood context). The secondary objectives are to describe the center support process in the context of ART with sperm donation, to determine the initial/final orientation of support and the time to care and compare them between groups depending on their parental project The statistical analysis will be carried out to compare these parameters between groups depending on their parental project This research contributes to our knowledge of patients with a parental project. It may lead to improve their medical care The study is monocentric, retrospective, non-interventional and does not involve human subjects. This research is based on existing data, extracted from patient files in the médifirst software. This is taking place in the reproductive medicine department of the regional university hospital centre in Nancy. ### Conditions Module **Conditions:** - Fertility Issues **Keywords:** - parenthood - Assisted reproductive techniques ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 675 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Inclusion of all single women consulting the Reproductive Medicine Service for a parenthood project by sperm donation between January 2021 and June 2023. Exclusion : * Minors * Person under guardianship **Intervention Names:** - Behavioral: No intervention **Label:** Single women applying for sperm donation #### Arm Group 2 **Description:** Inclusion of all women in relationship with a women consulting the Reproductive Medicine Service for a parenthood project by sperm donation between January 2021 and June 2023. Exclusion : * Minors * Person under guardianship **Intervention Names:** - Behavioral: No intervention **Label:** women in relationship with a women applying for sperm donation #### Arm Group 3 **Description:** Inclusion of all heterosexual couples consulting the Reproductive Medicine Service for a parenthood project by sperm donation between January 2021 and June 2023. Exclusion : * Minors * Person under guardianship **Label:** Heterosexuel couples applying for sperm donation ### Interventions #### Intervention 1 **Arm Group Labels:** - Single women applying for sperm donation - women in relationship with a women applying for sperm donation **Description:** No intervention. This is a retrospective study. Data will be collected from routine consultations Will be collectad the following datas : Number and evolution of requests, age, background, infertility timing, parenthood context, Appointment time, ART timing, Type of ART, ART outcome, Outcome time **Name:** No intervention **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The significance of statistical tests (significant result p \< 0.05) will show if a difference exists among people applying for sperm donation between single women, women in relationship with a women, compared with heterosexual couples. Qualitative data are available in the medical files created during the usual appointments in the Reproductive Medicine Department. **Measure:** significant result p < 0.05 of qualitative and quantitative data **Time Frame:** Statistical analysis will be performed by January 2024 #### Secondary Outcomes **Description:** Describe the support process in the context of ART with sperm donation Determine the initial/final orientation of support and the different timeframes for care. **Measure:** ART process **Time Frame:** Statistical analysis will be performed by January 2024 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * single women consulting the Reproductive Medicine Service for a parenthood project by sperm donation between January 2021 and June 2023. * women in relationship with women consulting the Reproductive Medicine Service for a parenthood project by sperm donation between January 2021 and June 2023 Exclusion Criteria: * Minors * Person under guardianship **Gender Based:** True **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** single women and women in relationship with women consulting the Reproductive Medicine Service for a parenthood project through sperm donation between January 2021 and June 2023. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Agopiantz Mikael, PhD **Phone:** 0033383344426 **Role:** CONTACT #### Locations **Location 1:** **City:** Nancy **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** AGOPIANTZ Mikael, PHD - **Phone:** 0033383344426 - **Role:** CONTACT ***Contact 2:*** - **Name:** AGOPIANTZ Mikael, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** Centre AMP Maternité Régionale de Nancy **Status:** RECRUITING **Zip:** 54000 #### Overall Officials **Official 1:** **Affiliation:** Central HNF Nancy Regional University Hospital **Name:** AGOPIANTZ Mikael, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10290 - Name: Infertility - Relevance: HIGH - As Found: Fertility Issues - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007246 - Term: Infertility ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00231179 **Acronym:** MOM Program **Brief Title:** The MOM Program: 5 Year Follow-up Study of a Home Visiting Program at The Children's Hospital of Philadelphia **Official Title:** The MOM Program Continuation - 5 Year Follow-up #### Organization Study ID Info **ID:** 2003-10-3495 #### Organization **Class:** OTHER **Full Name:** Children's Hospital of Philadelphia ### Status Module #### Completion Date **Date:** 2007-02 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2015-11-23 **Type:** ESTIMATED **Last Update Submit Date:** 2015-10-26 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2007-02 **Type:** ACTUAL #### Results First Post Date **Date:** 2010-07-02 **Type:** ESTIMATED **Results First Submit Date:** 2010-03-01 **Results First Submit QC Date:** 2010-06-01 #### Start Date **Date:** 2004-02 **Status Verified Date:** 2015-10 #### Study First Post Date **Date:** 2005-10-04 **Type:** ESTIMATED **Study First Submit Date:** 2005-09-30 **Study First Submit QC Date:** 2005-09-30 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** William Penn Foundation **Class:** OTHER **Name:** Claneil Foundation, Inc. **Class:** OTHER **Name:** Robert Wood Johnson Foundation #### Lead Sponsor **Class:** OTHER **Name:** Children's Hospital of Philadelphia #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of the MOM Program Continuation is to promote child development by helping families become more competent in accessing and using available health, developmental and educational resources. The program focuses are childhood immunizations, Early Intervention services, lead screening, Early Head Start and Head Start enrollment. The Intervention consists of frequent phone calls and home visits to encourage mothers to have their babies immunized on schedule and to participate in needed developmental and educational services. The program seeks to fill the gap between children's need for services and mothers' ability to assure their children's participation in those services. **Detailed Description:** The MOM Program Continuation builds on the work of The MOM Program, a 3 year randomized intervention. The premise of the MOM Program was that professional support through home visits and frequent phone contacts would improve children's cognitive and behavioral development, ultimately improving their early educational success. The children were enrolled in the MOM Program at birth. The MOM Program Continuation provides continued intervention for the children and mothers of the original cohort to assure that the children are prepared for kindergarten entry at 5 years of age and to evaluate the children's cognitive and behavioral outcomes at age 5 years. The program will also create a longitudinal database to study the linkages between maternal cognitive ability and child cognitive, educational, and behavioral outcomes through entry into school. ### Conditions Module **Conditions:** - Child Development **Keywords:** - child, preschool - intelligence - environment - home visiting ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 302 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Home visiting intervention group. **Intervention Names:** - Behavioral: Home visiting professional support model **Label:** Home visiting Intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Control condition did not receive any services. **Intervention Names:** - Other: Control **Label:** Control **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Home visiting Intervention **Description:** Home visits and telephone calls keyed to well child visits. **Name:** Home visiting professional support model **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Control **Description:** The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information **Name:** Control **Other Names:** - No intervention, informational booklet only **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Cognitive ability was assessed through the Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III). The WPPSI-III has been developed and standardized for children ages 2 years, 6 months through 7 years, 3 months of age. The WPPSI-III yields a Verbal Score, a Performance Score, a General Language Score, and a Full Scale Score. These scores have a mean of 100 and a standard deviation of 15. The range of possible values is 50 (worst value) to 150 (best value). **Measure:** Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III) **Time Frame:** 5 years of age (plus or minus 1 month) **Description:** Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child" based on the past two months. The range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal). **Measure:** Child Behavior Checklist Internalizing Scale at 5 Years of Age, Percentage of Participants **Time Frame:** at child age of 5 years (plus or minus 1 month) **Description:** Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child" based on the past two months. The range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal). **Measure:** Child Behavior Checklist Externalizing Scale, Percentage of Abnormality in Participants **Time Frame:** at child age of 5 years (plus or minus 1 month) **Description:** Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child" based on the past two months. The range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal). **Measure:** Child Behavior Checklist Aggressive Subscale, Percentage of Abnormality in Participants **Time Frame:** at child age of 5 years (plus or minus 1 month) **Description:** Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child" based on the past two months. The range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal). **Measure:** Child Behavior Checklist Attention Subscale, Percentage of Abnormality in Participants **Time Frame:** child age 5 years (plus or minus 1 month) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Previous enrollment in The MOM Program; child age of 5 years (plus or minus 3 months); willingness to come to office for follow-up assessment visit; parental consent and child assent. Exclusion Criteria: None. **Healthy Volunteers:** True **Maximum Age:** 5 Years **Minimum Age:** 4 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Philadelphia **Country:** United States **Facility:** The Children's Hospital of Philadelphia **State:** Pennsylvania **Zip:** 19104 #### Overall Officials **Official 1:** **Affiliation:** Children's Hospital of Philadelphia **Name:** Jerilynn Radcliffe, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M4854 - Name: Benzocaine - Relevance: LOW - As Found: Unknown - ID: T433 - Name: Tannic Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Home Visiting Intervention **Description:** The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made. **ID:** EG000 **Other Num at Risk:** 152 **Serious Number At Risk:** 152 **Title:** Home Visiting Intervention **Group ID:** EG001 **Title:** Control **Description:** The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information. **ID:** EG001 **Other Num at Risk:** 150 **Serious Number At Risk:** 150 **Title:** Control **Frequency Threshold:** 0 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 152 **Group ID:** BG001 **Value:** 150 **Group ID:** BG002 **Value:** 302 **Units:** Participants ### Group **ID:** BG000 **Title:** Home Visiting Intervention **Description:** The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made. ### Group **ID:** BG001 **Title:** Control **Description:** The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information. ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Value:** 152 #### Measurement **Group ID:** BG001 **Value:** 150 #### Measurement **Group ID:** BG002 **Value:** 302 **Class Title:** 4-5 years ### Measure #### Measurement **Group ID:** BG000 **Value:** 81 #### Measurement **Group ID:** BG001 **Value:** 82 #### Measurement **Group ID:** BG002 **Value:** 163 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 71 #### Measurement **Group ID:** BG001 **Value:** 68 #### Measurement **Group ID:** BG002 **Value:** 139 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 152 #### Measurement **Group ID:** BG001 **Value:** 150 #### Measurement **Group ID:** BG002 **Value:** 302 **Class Title:** United States **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** NUMBER **Title:** Age, Customized **Unit of Measure:** participants ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ## Results Section - More Information Module ### Certain Agreement ### Limitations and Caveats **Description:** The initial high rate of refusal to participate in the study may affect the generalizability of our results. Those who refused study participation were older and did not elaborate on their lack of interest. ### Point of Contact **Email:** [email protected] **Organization:** Children's Hospital of Philadelphia **Phone:** 215-590-7446 **Title:** Jerilynn Radcliffe, PhD ## Results Section - Outcome Measures Module ### Outcome Measure 1 #### Analysis **CI Lower Limit:** 0.31 **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** 2.13 **CI Upper Limit Comment:** **Dispersion Type:** STANDARD_DEVIATION **Dispersion Value:** 15.0 **Estimate Comment:** **Group Description:** We compared scores for verbal, performance, and full scale Intelligence Quotient (IQ). **Non-Inferiority Comment:** Sample sizes were established when the trial was first developed. For all power calculations, we set alpha = .05 and beta = .20 and specified 2-tailed tests. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.59 **P-Value Comment:** Bonferroni corrections were made for multiple comparisons. **Parameter Type:** Mean Difference (Final Values) **Parameter Value:** 0.81 **Statistical Comment:** **Statistical Method:** t-test, 2 sided **Tested Non-Inferiority:** True ### Outcome Measure 2 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** STANDARD_ERROR_OF_MEAN **Dispersion Value:** 5 **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** Please see earlier power calculation. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.72 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 10 **Statistical Comment:** **Statistical Method:** Chi-squared **Tested Non-Inferiority:** True ### Outcome Measure 3 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** STANDARD_ERROR_OF_MEAN **Dispersion Value:** 5 **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** See previous. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** <0.01 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 10 **Statistical Comment:** **Statistical Method:** Chi-squared **Tested Non-Inferiority:** True ### Outcome Measure 4 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** STANDARD_ERROR_OF_MEAN **Dispersion Value:** 3 **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** See previous. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** <0.05 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 3 **Statistical Comment:** **Statistical Method:** Chi-squared **Tested Non-Inferiority:** True ### Outcome Measure 5 #### Analysis **CI Lower Limit:** **CI Number of Sides:** TWO_SIDED **CI Percentage Value:** 95 **CI Upper Limit:** **CI Upper Limit Comment:** **Dispersion Type:** STANDARD_ERROR_OF_MEAN **Dispersion Value:** 3 **Estimate Comment:** **Group Description:** **Non-Inferiority Comment:** See previous. **Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE **Other Analysis Description:** **P-Value:** 0.64 **P-Value Comment:** **Parameter Type:** Hazard Ratio (HR) **Parameter Value:** 3 **Statistical Comment:** **Statistical Method:** Chi-squared **Tested Non-Inferiority:** True ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 12.6 - **Upper Limit:** - **Value:** 86.5 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 12.2 - **Upper Limit:** - **Value:** 87.4 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 8.9 - **Upper Limit:** - **Value:** 8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 11.2 - **Upper Limit:** - **Value:** 11 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 12 **Title:** #### Outcome Measure 4 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 12 **Title:** #### Outcome Measure 5 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 7 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 8 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Cognitive ability was assessed through the Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III). The WPPSI-III has been developed and standardized for children ages 2 years, 6 months through 7 years, 3 months of age. The WPPSI-III yields a Verbal Score, a Performance Score, a General Language Score, and a Full Scale Score. These scores have a mean of 100 and a standard deviation of 15. The range of possible values is 50 (worst value) to 150 (best value). **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Number of children evaluated at 60 month visit. **Reporting Status:** POSTED **Time Frame:** 5 years of age (plus or minus 1 month) **Title:** Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III) **Type:** PRIMARY **Unit of Measure:** Scores on a scale ##### Group **Description:** The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made. **ID:** OG000 **Title:** Home Visiting Intervention ##### Group **Description:** The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information. **ID:** OG001 **Title:** Control #### Outcome Measure 2 **Description:** Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child" based on the past two months. The range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal). **Parameter Type:** NUMBER **Population Description:** Number of mothers/caregivers evaluated at 60 month visit. **Reporting Status:** POSTED **Time Frame:** at child age of 5 years (plus or minus 1 month) **Title:** Child Behavior Checklist Internalizing Scale at 5 Years of Age, Percentage of Participants **Type:** PRIMARY **Unit of Measure:** percentage of participants ##### Group **Description:** The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made. **ID:** OG000 **Title:** Home Visiting Intervention ##### Group **Description:** The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information. **ID:** OG001 **Title:** Control #### Outcome Measure 3 **Description:** Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child" based on the past two months. The range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal). **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** at child age of 5 years (plus or minus 1 month) **Title:** Child Behavior Checklist Externalizing Scale, Percentage of Abnormality in Participants **Type:** PRIMARY **Unit of Measure:** percentage of participants ##### Group **Description:** The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made. **ID:** OG000 **Title:** Home Visiting Intervention ##### Group **Description:** The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information. **ID:** OG001 **Title:** Control #### Outcome Measure 4 **Description:** Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child" based on the past two months. The range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal). **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** at child age of 5 years (plus or minus 1 month) **Title:** Child Behavior Checklist Aggressive Subscale, Percentage of Abnormality in Participants **Type:** PRIMARY **Unit of Measure:** Percentage of participants ##### Group **Description:** The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made. **ID:** OG000 **Title:** Home Visiting Intervention ##### Group **Description:** The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information. **ID:** OG001 **Title:** Control #### Outcome Measure 5 **Description:** Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child" based on the past two months. The range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal). **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** child age 5 years (plus or minus 1 month) **Title:** Child Behavior Checklist Attention Subscale, Percentage of Abnormality in Participants **Type:** PRIMARY **Unit of Measure:** Percentage of participants ##### Group **Description:** The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made. **ID:** OG000 **Title:** Home Visiting Intervention ##### Group **Description:** The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information. **ID:** OG001 **Title:** Control ### Participant Flow Module #### Group **Description:** The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made. **ID:** FG000 **Title:** Home Visiting Intervention #### Group **Description:** The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information. **ID:** FG001 **Title:** Control #### Period **Title:** Overall Study ##### Withdraw **Type:** Lost to Follow-up ###### Reason **Group ID:** FG000 **Number of Subjects:** 21 ###### Reason **Group ID:** FG001 **Number of Subjects:** 21 ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 3 ###### Reason **Group ID:** FG001 **Number of Subjects:** 3 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 152 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 150 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 128 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 126 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 24 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 24 **Pre-Assignment Details:** Randomization occurred at enrollment. At the time of follow-up, participants continued to remain in the originally assigned group of either control or intervention. **Recruitment Details:** Participants were recruited from the Hospital of the University of Pennsylvania after giving birth to a healthy singleton newborn infant, if they lived in pre-identified ZIP Code areas of Philadelphia. Participants were recruited from July 6, 2001 through January 7, 2002. 302 mothers were enrolled and 254 completed the 5-year follow-up visit. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT00167479 **Brief Title:** A Study of Risperidone Monotherapy in Bipolar Anxiety **Official Title:** A Randomized, Double-Blind, Placebo-Controlled Study of Risperidone Monotherapy in Ambulatory Bipolar Disorder With Current at Least Moderately Severe Anxiety and Lifetime Panic Disorder or Generalized Anxiety Disorder #### Organization Study ID Info **ID:** 101541d #### Organization **Class:** OTHER **Full Name:** University of South Florida #### Secondary ID Infos **ID:** RIS-BIP-408 ### Status Module #### Completion Date **Date:** 2006-09 #### Expanded Access Info #### Last Update Post Date **Date:** 2006-09-11 **Type:** ESTIMATED **Last Update Submit Date:** 2006-09-08 **Overall Status:** COMPLETED #### Start Date **Date:** 2003-09 **Status Verified Date:** 2006-09 #### Study First Post Date **Date:** 2005-09-14 **Type:** ESTIMATED **Study First Submit Date:** 2005-09-10 **Study First Submit QC Date:** 2005-09-12 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Janssen, LP #### Lead Sponsor **Class:** OTHER **Name:** University of South Florida ### Description Module **Brief Summary:** The specific aim of this study is to evaluate the efficacy, tolerability, and safety of risperidone monotherapy in the treatment of ambulatory bipolar disorder with comorbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety. **Detailed Description:** This is a randomized, double-blind, placebo controlled, parallel-group, 8-week trial of risperidone monotherapy in outpatient subjects with a lifetime bipolar I, II, or NOS disorder, a lifetime panic or generalized anxiety disorder, and current at least moderately severe anxiety symptoms. Approximately 90 subjects will be enrolled to obtain 60 subjects who complete the 8-week trial. Subjects will be randomized to risperidone or placebo in a 1:1 ratio. No concomitant psychotropic medication will be allowed except for prn lorazepam during the first two weeks for the management of affective and anxiety symptoms, and prn zolpidem and zaleplon throughout the study for the management of insomnia. Throughout the study, psychiatric scales will be used to assess psychiatric symptoms and the presence of treatment-emergent adverse events will be monitored and recorded. ### Conditions Module **Conditions:** - Bipolar Disorder - Panic Disorder - Generalized Anxiety Disorder **Keywords:** - Bipolar Anxiety - Bipolar Disorder - Anxiety - Panic Disorder - Generalized Anxiety Disorder - GAD - Risperidone - Double-Blind - Placebo Controlled ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** risperidone (Risperdal) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Clinician Global Improvement Scale (CGI-21) #### Secondary Outcomes **Measure:** Sheehan Panic Disorder Scale (SPS) **Measure:** The Psychic and Somatic factors of the HAM-A **Measure:** Young Mania Rating Scale, Total Score **Measure:** Inventory of Depressive Symptoms, Total Score **Measure:** Patient Global Improvement Scale (PGI-21) **Measure:** The Clinician Global Improvement-Bipolar (CGI-BP) **Measure:** The Family Impact Scale (FIS) **Measure:** The Sheehan Disability Scale - Total Disability Score, Work Disability Score, Social Disability Score, Family Disability Score ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Subjects must be 18 years of age or older. 2. Subjects must have lifetime bipolar I, II, or NOS disorder as defined by DSM-IV criteria. 3. Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV criteria (except clause "does not occur exclusively during a mood disorder" of Criterion F for GAD) . 4. Subjects' bipolar symptoms must be no more than moderately severe, defined as a CGI-BP \< 4. 5. Subjects' anxiety symptoms must be at least moderately severe, defined as a CGI-S \> 4. 6. Subjects must not be receiving mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for \> one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for \> four weeks prior to baseline. 7. Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained. 8. If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, double barrier methods, intrauterine device) for at least one month prior to study entry and throughout the study. Exclusion Criteria: 1. Subjects who do not have lifetime bipolar disorder by DSM-IV-TR criteria. 2. Subjects who do not have lifetime panic disorder or generalized anxiety disorder by DSM-IV-TR criteria. 3. Subjects who are receiving treatment with an antimanic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication. 4. Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP \> 5). 5. Subjects whose anxiety symptoms are presently less than moderately severe (CGI \< 3). 6. Subjects with clinically significant suicidal or homicidal ideation. 7. Subjects with current psychotic symptoms. 8. Subjects with a current DSM-IV Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV diagnosis of a substance dependence disorder within the past six months; a lifetime DSM-IV psychotic disorder (e.g., schizophrenia or schizoaffective disorder). 9. Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo- or hyperthyroidism unless stabilized on thyroid replacement \> 3 months. 10. Subjects with a clinically significant abnormality in their prestudy physical exam, vital signs, EKG, or laboratory tests. 11. Subjects who are allergic to or who have demonstrated hypersensitivity to risperidone. 12. Women who are pregnant or nursing. 13. Subjects who have received an experimental drug or used an experimental device within 30 days. 14. Subjects who have a history of neuroleptic malignant syndrome. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Tampa **Country:** United States **Facility:** University of South Florida Psychiatry Center **State:** Florida **Zip:** 33613-4788 **Location 2:** **City:** Cincinatti **Country:** United States **Facility:** University of Cincinatti **State:** Ohio **Location 3:** **City:** Dallas **Country:** United States **Facility:** University of Texas Southwestern Medical Center **State:** Texas #### Overall Officials **Official 1:** **Affiliation:** University of South Florida College of Medicine **Name:** David V. Sheehan, MD, MBA **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** University of Cincinatti, Department of Psychiatry **Name:** Susan L. McElroy, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** University of Texas Southwestern Medical Center **Name:** Trisha - Suppes, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 4:** **Affiliation:** University of Cincinatti, Department of Psychiatry **Name:** Paul E. Keck, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders - ID: D000068105 - Term: Bipolar and Related Disorders - ID: D000019964 - Term: Mood Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: HIGH - As Found: Anxiety Disorder - ID: M4996 - Name: Bipolar Disorder - Relevance: HIGH - As Found: Bipolar Disorder - ID: M18970 - Name: Panic Disorder - Relevance: HIGH - As Found: Panic Disorder - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M226 - Name: Bipolar and Related Disorders - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001008 - Term: Anxiety Disorders - ID: D000001714 - Term: Bipolar Disorder - ID: D000016584 - Term: Panic Disorder ### Intervention Browse Module - Ancestors - ID: D000012702 - Term: Serotonin Antagonists - ID: D000018490 - Term: Serotonin Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000014150 - Term: Antipsychotic Agents - ID: D000014149 - Term: Tranquilizing Agents - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000011619 - Term: Psychotropic Drugs - ID: D000018492 - Term: Dopamine Antagonists - ID: D000015259 - Term: Dopamine Agents ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CaAg - Name: Cardiotonic Agents ### Intervention Browse Module - Browse Leaves - ID: M20999 - Name: Risperidone - Relevance: HIGH - As Found: Evening - ID: M15512 - Name: Serotonin - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M16904 - Name: Antipsychotic Agents - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown - ID: M7473 - Name: Dopamine - Relevance: LOW - As Found: Unknown - ID: M20596 - Name: Dopamine Antagonists - Relevance: LOW - As Found: Unknown - ID: M17962 - Name: Dopamine Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000018967 - Term: Risperidone ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01358279 **Brief Title:** Transcranial Direct Current Stimulation for Migraine Attack **Official Title:** Manho Kim, MD, PhD Professor, Neurology Seoul National University Hospital, #### Organization Study ID Info **ID:** 2009-4615-A #### Organization **Class:** OTHER **Full Name:** Seoul National University Hospital ### Status Module #### Completion Date **Date:** 2011-03 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2016-10-25 **Type:** ESTIMATED **Last Update Submit Date:** 2016-10-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2009-10 **Type:** ACTUAL #### Start Date **Date:** 2009-01 **Status Verified Date:** 2016-10 #### Study First Post Date **Date:** 2011-05-23 **Type:** ESTIMATED **Study First Submit Date:** 2011-05-18 **Study First Submit QC Date:** 2011-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Seoul National University Hospital #### Responsible Party **Investigator Affiliation:** Seoul National University Hospital **Investigator Full Name:** Manho Kim **Investigator Title:** Manho Kim, MD, PhD Professor, Neurology Seoul National University Hospital **Type:** PRINCIPAL_INVESTIGATOR ### Description Module **Brief Summary:** This study is conducted to investigate the therapeutic efficacy and safety of transcranial direct current stimulation (tDCS) over the primary motor cortex of patients with acute migraine attack. ### Conditions Module **Conditions:** - Acute Migraine ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 32 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Procedure: transcranial direct current stimulation **Label:** migraine **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - migraine **Description:** A constant current of 2 mA intensity applied for 20 min over C3 or C4 **Name:** transcranial direct current stimulation **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** Number of participants who experienced pain relief of one level or more **Time Frame:** at 2h post-treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged 17-70 years * Migraine * With or without aura * The first attack of migraine was earlier than 50 years of age * One to 8 moderate to severe migraine attacks per month in the 2 months preceding the screening * Willing and able to give written informed consent * Able to read, comprehend and complete the diary form Exclusion Criteria: * Not able to distinguish between migraine and non-migraine headache * Combined headache, including the tension type headache and medication overuse headache * Pregnant, actively trying to become pregnant or breast-feeding women * Uncontrolled and significant medical illness * Vertebrobasilar or hemiplegic migraine according to the International Headache Society diagnostic criteria * Having intracranial metal implants or a cardiac pacemaker * A history of epilepsy or other organic brain disorders * A history of psychological diseases * Having changed medications for migraine within 1 month before giving us informed consent * Drug abuser or alcoholics **Maximum Age:** 70 Years **Minimum Age:** 17 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Seoul **Country:** Korea, Republic of **Facility:** Seoul National University Hospital **Zip:** 110-744 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000051270 - Term: Headache Disorders, Primary - ID: D000020773 - Term: Headache Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11852 - Name: Migraine Disorders - Relevance: HIGH - As Found: Migraine - ID: M9351 - Name: Headache - Relevance: LOW - As Found: Unknown - ID: M22529 - Name: Headache Disorders - Relevance: LOW - As Found: Unknown - ID: M26657 - Name: Headache Disorders, Primary - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008881 - Term: Migraine Disorders ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05149079 **Acronym:** MARPEP **Brief Title:** Effects of a Marine Protein Hydrolysate in Healthy Adults **Official Title:** Randomized, Double Blind, Placebo Controlled Clinical Study to Investigate the Effect of a Marine Protein Hydrolysate in Healthy Adults #### Organization Study ID Info **ID:** FHF-Study #### Organization **Class:** OTHER **Full Name:** University of Bergen ### Status Module #### Completion Date **Date:** 2021-05-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-12-08 **Type:** ACTUAL **Last Update Submit Date:** 2021-11-25 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-05-15 **Type:** ACTUAL #### Start Date **Date:** 2021-02-01 **Type:** ACTUAL **Status Verified Date:** 2021-11 #### Study First Post Date **Date:** 2021-12-08 **Type:** ACTUAL **Study First Submit Date:** 2021-03-09 **Study First Submit QC Date:** 2021-11-25 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Haukeland University Hospital **Class:** OTHER **Name:** Alesund Hospital **Class:** OTHER **Name:** Norwegian University of Science and Technology #### Lead Sponsor **Class:** OTHER **Name:** University of Bergen #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This randomized, double blind, controlled trial investigates changes in the cardiovascular index (triacylglycerol/HDL-cholesterol × waist/hip ratio) after 12 weeks of marine protein hydrolysate (MPH) or whey protein powder (placebo) supplementation in adult healthy persons. Additionally, the study investigates potential effects on plasma parameters of metabolic health including lipids, glucose, inflammatory parameters and redox state, as well as associations between dietary MPH and body weight, abdominal obesity, body composition, and gut microbiota composition. Finally, putative end-products of diet-microbial interactions (TMAO and short-chain fatty acids) with CVD risk factors and biomarkers of mitochondrial function are examined. **Detailed Description:** Marine protein sources, including fish and fish protein hydrolysates, may have particular health benefits. Health benefits from fish consumption have been attributed to the n-3 polyunsaturated fatty acids, in particular eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Proteins from marine sources may contain valuable bioactive components, with amino acid composition and protein profiles that differ from terrestrial sources. Generally, the dietary source of protein can affect cellular energy metabolism, and hydrolyzed peptides can have potent and specific bioactive potential. Rest raw materials (RRM) from cod (Fjordlaks AS, Norway) are used for the hydrolysis production (Food Grade). Freshly minced RRM were treated with enzymes optimized to generate bioactive hydrolysates using facilities and techniques approved for human consumption. The investigational products are given in a dose of 18 g protein per day, corresponding to the protein content of a standard meal, and similar to doses recommended in a range of protein supplements. The study enrolls around 70 men and women age of 20-80 years with waist circumference of \< 102 cm for men and \< 88 cm for women. Prospective study participants were informed of the study and invited to participate through advertising primarily in social media (Facebook advertisement, geographically limited to 12 km surrounding the city centers of Bergen and Ålesund). Participants provided written informed consent, and were screened via self-reporting in an online form in EasyTrial hosted by the Research Unit for Clinical Trials at the University of Bergen. Data collection by the study staff at baseline verifies inclusion and exclusion criteria and participant eligibility prior to randomization. The potential participants are informed about practical details at a digital or physical meeting 1-2 weeks prior to baseline. Groups of participants (40-60% males/females) are block randomized to the two treatments using randomly selected block sizes, and stratified according to sex. The participants are given a container with the powder sufficient for the entire study period, and a spoon to measure the intake at breakfast (6 g), lunch (6 g) and supper (6 g), or morning (9 g) and evening (9 g) according to individual preference. The patients will mix the powder products in water or mineral water. Flavours have been masked by supplementation with beet powder, and mixing 0.5 g fish hydrolysate per serving in the placebo, to minimize differences in taste of the placebo and active product. ### Conditions Module **Conditions:** - Healthy Diet **Keywords:** - Cardiovascular disease risk - Protein supplementation - Metabolic health ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized, double blind, placebo controlled clinical study ##### Masking Info **Masking:** TRIPLE **Masking Description:** The groups will be randomly labelled A or B. Neither participants, care providers or statistician will know the treatments of the groups before the statistical analyses for the primary outcome have been completed. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 67 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will consume 18 g of the placebo whey protein supplement each day for 12 weeks. **Intervention Names:** - Dietary Supplement: Placebo **Label:** Placebo (whey protein supplement) **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** Participants will consume 18 g of the cod protein supplement each day for 12 weeks. **Intervention Names:** - Dietary Supplement: Cod protein hydrolysate **Label:** Cod protein hydrolysate supplement **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Cod protein hydrolysate supplement **Description:** Rest raw materials (RRM) from cod (Fjordlaks AS, Norway) are used for the hydrolysis production (Food Grade). Freshly minced RRM is treated wth enzymes optimized to generate bioactive hydrolysates using facilities and techniques approved for human consumption. **Name:** Cod protein hydrolysate **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Placebo (whey protein supplement) **Description:** Whey protein powder, commercially available **Name:** Placebo **Other Names:** - Whey protein powder **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Triacylclygerol and HDL-cholesterol concentrations will be measured in serum. Waist and hip circumference will be measured using anthropometric tape over light clothing. For waist circumference, the minimum circumference between the iliac crest and the rib cage will be used. For waist circumference the circumference at the level of the greatest protrusion of the buttocks is used. **Measure:** Changes in the cardiovascular index (triacylglycerol/high density lipoprotein (HDL)-cholesterol × waist/hip ratio) **Time Frame:** Baseline to 12 weeks #### Secondary Outcomes **Description:** Measured in serum and calculated as 1 / (log(fasting insulin μU/mL) + log(fasting glucose mg/dL) **Measure:** Changes in the Quick1 index, a surrogate marker of insulin sensitivity **Time Frame:** Baseline to 12 weeks **Description:** Measured in serum **Measure:** Changes in fasting insulin **Time Frame:** Baseline to 12 weeks **Description:** Measured in serum **Measure:** Changes in fasting insulin C-peptide **Time Frame:** Baseline to 12 weeks **Description:** Measured in serum **Measure:** Changes in fasting glucose **Time Frame:** Baseline to 12 weeks **Description:** Measured in serum **Measure:** Changes in total cholesterol **Time Frame:** Baseline to 12 weeks **Description:** Measured in serum **Measure:** Changes in non-high density lipoprotein (HDL) cholesterol **Time Frame:** Baseline to 12 weeks **Description:** Measured in serum **Measure:** Changes in non-esterified fatty acids (NEFA) **Time Frame:** Baseline to 12 weeks **Description:** Measured in serum **Measure:** Changes in triacylglycerol (TAG) **Time Frame:** Baseline to 12 weeks **Description:** Measured by 16S sequencing **Measure:** Changes in gut microbiota composition **Time Frame:** Baseline to 12 weeks **Description:** Faecal SCFA concentrations calculated as (mmol/L) × wet faecal weight x faecal moisture content (g/100 g) × 10 **Measure:** Changes in short chained fatty acids (SCFA) **Time Frame:** Baseline to 12 weeks **Description:** Body composition measured by bioimpedance analysis **Measure:** Changes in fat mass/fat free mass ratio **Time Frame:** Baseline to 12 weeks **Description:** Waist and hip circumference will be measured using anthropometric tape over light clothing. For waist circumference, the minimum circumference between the iliac crest and the rib cage will be used. For waist circumference the circumference at the level of the greatest protrusion of the buttocks is used **Measure:** Changes in waist-hip ratio **Time Frame:** Baseline to 12 weeks **Description:** Waist circumference will be measured using anthropometric tape over light clothing. Hight will be measured using a stadiometer. For waist circumference, the minimum circumference between the iliac crest and the rib cage will be used. **Measure:** Changes in waist-to-height ratio (WHtR) **Time Frame:** Baseline to 12 weeks **Description:** Blood pressure measurement will be performed manually by a trained nurse using standard equipment **Measure:** Changes in blood pressure **Time Frame:** Baseline to 12 weeks **Description:** Heart rate will be determined manually by a trained nurse **Measure:** Changes in heart rate **Time Frame:** Baseline to 12 weeks **Description:** Measured in plasma by ELISA (enzyme-linked immunosorbent assay) **Measure:** Changes in glucagon-like peptide 1 (GLP-1, hormone involved in appetite and metabolism regulation) **Time Frame:** Baseline to 12 weeks **Description:** Measured in plasma by ELISA (enzyme-linked immunosorbent assay) **Measure:** Changes in gastric inhibitory polypeptide (GIP, hormone involved in metabolism regulation) **Time Frame:** Baseline to 12 weeks **Description:** Measured in plasma by ELISA (enzyme-linked immunosorbent assay) **Measure:** Changes in ghrelin (hormone involved in appetite regulation) **Time Frame:** Baseline to 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy female and male subjects at age 20-80 years old understanding Norwegian oral and written information * Waist circumference for males \< 102 cm and females \< 88 cm Exclusion Criteria: * Pregnancy or lactation * Having used high-dose omega-3 PUFA supplements (\>2 g/day) less than 28 days prior to randomization * Use of corticosteroids that will influence protein metabolism * Antibiotic treatment previous 3 months * Alcohol or drug abuse or any conditions associated with poor compliance * Medical diagnosis of malabsorption disorders, Crohn's disease, or lactose intolerance * Scheduled hospitalization during the course of the study that could compromise the study * Diabetes type I or II, serious high blood pressure at screening, serious infections, diseases requiring medication that can influence the study * Known or suspected sensitivity or allergic reactions to the IMP or excipients * Presence of other major medical or psychiatric illness that would affect the ability to participate in the study or put the subject at increased risk * Intake of statins. If needed to obtain the recruitment goals, we will accept people using a low dose of statin **Healthy Volunteers:** True **Maximum Age:** 80 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bergen **Country:** Norway **Facility:** Research Unit for Health Trials **Zip:** 5009 #### Overall Officials **Official 1:** **Affiliation:** University of Bergen, Norway **Name:** Rolf K Berge, PhD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Kim SK, Ngo DH, Vo TS. Marine fish-derived bioactive peptides as potential antihypertensive agents. Adv Food Nutr Res. 2012;65:249-60. doi: 10.1016/B978-0-12-416003-3.00016-0. **PMID:** 22361192 **Citation:** Erdmann K, Cheung BW, Schroder H. The possible roles of food-derived bioactive peptides in reducing the risk of cardiovascular disease. J Nutr Biochem. 2008 Oct;19(10):643-54. doi: 10.1016/j.jnutbio.2007.11.010. Epub 2008 May 20. **PMID:** 18495464 ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Ot - Name: Other Dietary Supplements - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T435 - Name: Whey Protein - Relevance: HIGH - As Found: Ingredients ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05875779 **Brief Title:** Peer Education as a Strategy to Promote Vaccine Acceptance **Official Title:** Developing Vaccine Educators Within Practices of Community Healthcare Providers: a Pragmatic, Randomized Controlled Trial of Peer Education to Promote Vaccine Acceptance #### Organization Study ID Info **ID:** 21-01526 #### Organization **Class:** OTHER **Full Name:** NYU Langone Health ### Status Module #### Completion Date **Date:** 2023-08-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-08-07 **Type:** ACTUAL **Last Update Submit Date:** 2023-08-03 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-05-27 **Type:** ACTUAL #### Start Date **Date:** 2022-03-06 **Type:** ACTUAL **Status Verified Date:** 2023-08 #### Study First Post Date **Date:** 2023-05-25 **Type:** ACTUAL **Study First Submit Date:** 2023-05-16 **Study First Submit QC Date:** 2023-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** NYU Langone Health #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Effective interventions to improve uptake of vaccines among hesitant groups are urgently needed. Peer education is an effective intervention in modifying health behaviors in other conditions and may be effective in promoting vaccine confidence but has not been studied. To fill this knowledge gap, we will enroll approximately 152 parents of children age 0-18 months who are eligible for pneumococcal conjugate (PCV-13) vaccine and randomize them 1:1 to a peer-led vaccine education intervention or usual care. ### Conditions Module **Conditions:** - Vaccine Acceptance **Keywords:** - Vaccine confidence ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 154 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Parents randomized to peer-led vaccine education intervention. **Intervention Names:** - Behavioral: Peer-led vaccine education intervention **Label:** Peer-led vaccine education intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Parents randomized to usual care. **Label:** Usual Care **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Peer-led vaccine education intervention **Description:** The intervention will be delivered face-to-face by a trained peer-educator and will consist of one session of 10-20 minutes. Peer vaccine educators will receive written vaccine materials for distribution. These materials will present content that accurately represents the risks and benefits of vaccination. Responsibilities of the vaccine educators will be to: provide motivational interviewing with patients, provide vaccine counseling, address questions and concerns regarding available vaccines, brief clinical provider on hesitant patients and areas of their vaccine-related concerns, and provide follow-up with participants at day 30, day 60 and day 90 for additional engagement. **Name:** Peer-led vaccine education intervention **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Outcome will be determined via review of patient medical chart. **Measure:** Number of Participants Ages 0 Months to 18 Months at Enrollment who Receive at least One Dose of PCV-13 Vaccine by 3 Months Post-Enrollment **Time Frame:** Month 3 Post-Enrollment #### Secondary Outcomes **Description:** Outcome will be determined via review of patient medical chart. **Measure:** Number of Participants Ages 1 Month to 18 Months at Enrollment who Receive at least One Dose of PCV-13 Vaccine by 1 Month Post-Enrollment **Time Frame:** Month 1 Post-Enrollment **Description:** To obtain the percentage of days underimmunized, investigators will sum the days late across all 4 doses of PCV-13 doses and will divide this by the maximum cumulative number of days a child could be late if they had received no vaccine doses by their age one month post study enrollment. If a dose was never received, the maximum number of days late a child could be for dose will be: age at enrollment in days+31 days minus the latest age in days in which that dose should have been received. **Measure:** Percentage of Days Under-immunized at 3 Months among Participants Ages 0 Months to 18 Months at Enrollment **Time Frame:** Month 1 Post-Enrollment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. A parent of a child aged 0 to 18 months born at ≥35 weeks' gestation who is eligible for a dose of PCV-13. Eligibility by age defined as follows: 1. Age 0-6 months: never received first dose or is \>8 weeks from last dose (3 doses scheduled in this age group at 2, 4, and 6 months) 2. Age 7-11 months: never received first dose or is \> 8 weeks from last dose (2 doses scheduled in this age group if started at 7 months) 3. 12-18 months: never received first dose, is \>8 weeks from last dose (2 doses scheduled in this age group if started at 12 months) or is due for booster at 12-18 months having received primary series between age 2-11 months. 2. Self-identifies as Orthodox Jewish. 3. Is able to provide informed consent. Exclusion Criteria: 1. Unable to communicate verbally in English or Yiddish 2. Unwilling or unable to utilize a Yiddish in-person or telephone interpreter 3. Has already participated in this study as an eligible adult or parent. A parent will only be able to participate in this study once (i.e. for only one child in the family that is eligible) 4. Has an appointment at clinic that day to specifically receive vaccines. **Healthy Volunteers:** True **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** New York **Country:** United States **Facility:** NYU Grossman School of Medicine, Division of Infectious Diseases **State:** New York **Zip:** 10016 #### Overall Officials **Official 1:** **Affiliation:** NYU Langone Health **Name:** Ellie Carmody, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to [email protected]. To gain access, data requestors will need to sign a data access agreement. **Description:** The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Ellie Carmody, MD, [email protected]. **IPD Sharing:** YES **Time Frame:** Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research. ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M17360 - Name: Vaccines - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00809679 **Brief Title:** Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia **Official Title:** A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled, Pilot Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia #### Organization Study ID Info **ID:** K862-08-2002 #### Organization **Class:** INDUSTRY **Full Name:** Pfizer ### Status Module #### Completion Date **Date:** 2009-06 **Type:** ACTUAL #### Disp First Post Date **Date:** 2010-06-30 **Type:** ESTIMATED **Disp First Submit Date:** 2010-06-25 **Disp First Submit QC Date:** 2010-06-25 #### Expanded Access Info #### Last Update Post Date **Date:** 2012-06-08 **Type:** ESTIMATED **Last Update Submit Date:** 2012-06-06 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2009-06 **Type:** ACTUAL #### Start Date **Date:** 2008-12 **Status Verified Date:** 2012-06 #### Study First Post Date **Date:** 2008-12-17 **Type:** ESTIMATED **Study First Submit Date:** 2008-12-15 **Study First Submit QC Date:** 2008-12-16 **Why Stopped:** Some patients experienced asymptomatic, transient elevations in liver transaminases ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Pfizer #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to evaluate the safety and efficacy of T-62 in subjects with postherpetic neuralgia. **Detailed Description:** Study K862-08-2002 is a multicenter, randomized, double-blind, placebo-controlled study assessing the analgesic efficacy and safety of T-62 in subjects with postherpetic neuralgia (PHN) and its associated pain. Up to 20 centers in the United States will participate in the trial. Two doses of T-62 and placebo will be evaluated in parallel design. Approximately 130 subjects will be enrolled to complete approximately 100 subjects. Each subject will complete a 7-day Screening Period , a 28-day Treatment Period, and a 14-day Post-Treatment Period. Each subject will complete 8 clinic visits over the course of the study during which procedures and assessments of safety, efficacy, and protocol compliance will be performed. ### Conditions Module **Conditions:** - Postherpetic Neuralgia **Keywords:** - Postherpetic neuralgia - Varicella Zoster - Shingles - Neuropathic pain - Analgesia - Pain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 19 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: T-62 Dose 1 **Label:** T-62 100 mg bid **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: T-62 Dose 2 **Label:** T-62 200 mg bid **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Other: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - T-62 100 mg bid **Description:** Capsule dosage form 100 mg bid **Name:** T-62 Dose 1 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - T-62 200 mg bid **Description:** Capsule dosage form 200 mg bid **Name:** T-62 Dose 2 **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Placebo **Description:** Capsule dosage form placebo bid **Name:** Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Change in pain scores from baseline to following treatment. **Time Frame:** weekly #### Secondary Outcomes **Measure:** General safety monitoring (adverse reactions, vital signs, electrocardiograms, clinical laboratories) **Time Frame:** weekly **Measure:** Pharmacokinetics **Time Frame:** weekly ### Eligibility Module **Eligibility Criteria:** Inclusion criteria (additional criteria apply): 1. Diagnosis of PHN made by primary treating physician and is experiencing pain for at least 3 months after the healing of a herpes zoster rash. 2. Subject is in general good health. 3. Females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control or be surgically sterile or post-menopausal. Double barrier methods and abstinence are the only acceptable birth control methods for this study. Exclusion Criteria (additional criteria apply): 1. Subject has a current acute disease or unstable chronic disease other than post herpetic neuralgia. 2. Subject has a clinically important history of a medical disorder (particularly cardiovascular, neurological \[e.g., diabetic neuropathy\], respiratory, or hepato-biliary systems \[e.g., Gilbert Syndrome\]) that would confound and/or interfere with the safety and efficacy evaluations defined in the protocol. 3. Subject is being treated for a medical condition that affects cardiac conduction. 4. Subject's plasma alanine aminotransferase (ALT) aspartate aminotransferase (AST), total bilirubin, and alkaline phosphatase (AP) values are not within the normal reference ranges. 5. Subject has a history of asthma requiring management for reactive airway disease in the last year. 6. Subject uses and is unwilling/unable to discontinue use of (A) Lyrica® (pregabalin), Cymbalta® (duloxetine), Neurontin® (gabapentin), topical lidocaine, topical capsaicin, or other medication specifically indicated (i.e., labeled) for the treatment of neuropathic pain, or (B) anticonvulsant medications to control post herpetic neuralgia. 7. Subject currently requires anticonvulsant medications to control seizures. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Tucson **Country:** United States **State:** Arizona **Location 2:** **City:** Westlake Village **Country:** United States **State:** California **Location 3:** **City:** Bradenton **Country:** United States **State:** Florida **Location 4:** **City:** Naples **Country:** United States **State:** Florida **Location 5:** **City:** New Port Richey **Country:** United States **State:** Florida **Location 6:** **City:** Sunrise **Country:** United States **State:** Florida **Location 7:** **City:** Tampa **Country:** United States **State:** Florida **Location 8:** **City:** Lexington **Country:** United States **State:** Kentucky **Location 9:** **City:** Albuquerque **Country:** United States **State:** New Mexico **Location 10:** **City:** Winston-Salem **Country:** United States **State:** North Carolina **Location 11:** **City:** Oklahoma City **Country:** United States **State:** Oklahoma **Location 12:** **City:** San Antonio **Country:** United States **State:** Texas **Location 13:** **City:** Spokane **Country:** United States **State:** Washington #### Overall Officials **Official 1:** **Affiliation:** King Pharmaceuticals is now a wholly owned subsidiary of Pfizer **Name:** Robert L. Rolleri, Pharm. D. **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010523 - Term: Peripheral Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections ### Condition Browse Module - Browse Leaves - ID: M12381 - Name: Neuralgia - Relevance: HIGH - As Found: Neuralgia - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M26725 - Name: Neuralgia, Postherpetic - Relevance: HIGH - As Found: Postherpetic Neuralgia - ID: M9640 - Name: Herpes Zoster - Relevance: LOW - As Found: Unknown - ID: M5888 - Name: Chickenpox - Relevance: LOW - As Found: Unknown - ID: M13432 - Name: Peripheral Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009437 - Term: Neuralgia - ID: D000051474 - Term: Neuralgia, Postherpetic ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03608579 **Brief Title:** Autologous Culture Expanded Adipose Derived MSCs for Treatment of Painful Hip OA **Official Title:** ASCLEPIOS Autologous Stem CelL Expansion and Prospective Injection for Osteoarthritic Hip Symptoms #### Organization Study ID Info **ID:** 18-000015 #### Organization **Class:** OTHER **Full Name:** Mayo Clinic ### Status Module #### Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-03-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-03-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Start Date **Date:** 2018-11-05 **Type:** ACTUAL **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2018-08-01 **Type:** ACTUAL **Study First Submit Date:** 2018-07-10 **Study First Submit QC Date:** 2018-07-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mayo Clinic #### Responsible Party **Investigator Affiliation:** Mayo Clinic **Investigator Full Name:** Aaron Krych **Investigator Title:** Professor of Orthopedics **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Will injection(s) of autologous culture-expanded AMSCs be safe and efficacious for treatment of painful Hip OA, and if so, which dosing regimen is most effective? **Detailed Description:** This phase I study will enroll 24 subjects with mild to moderate osteoarthritis of the hip. Subjects will receive either a single dose of 30 million autologous culture-expanded adipose-derived mesenchymal stromal cells (AMSCs), or two doses of AMSCs (with one month interval between doses) via ultrasound guided intra-articular hip injection. Patients will be followed for 24 months past their last injection to determine the local and systemic safety of single and two-dose injections of AMSCs in the treatment of symptomatic hip OA. ### Conditions Module **Conditions:** - Osteoarthritis, Hip ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 24 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Single administration of Autologous Adipose Derived Mesenchymal Stromal Cells into the hip by single ultrasound guided injection **Intervention Names:** - Drug: Autologous Adipose Derived Mesenchymal Stromal Cells **Label:** Single Injection **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Two-dose administration (2 x ultrasound guided injections) of Autologous Adipose Derived Mesenchymal Stromal Cells into the hip with one month interval between doses **Intervention Names:** - Drug: Autologous Adipose Derived Mesenchymal Stromal Cells **Label:** Two Injections **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Single Injection - Two Injections **Description:** Human, autologous, culture expanded, adipose derived, mesenchymal stromal cells (AMSCs) produced on site in the Mayo Clinic Human Cellular Therapy Laboratory using current good manufacturing practices **Name:** Autologous Adipose Derived Mesenchymal Stromal Cells **Other Names:** - ASCLEPIOS **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Defined as any untoward or undesirable medical occurrence in the form of signs, symptoms, abnormal findings, or diseases that emerge or worsen relative to baseline (i.e., if present upon study entry) during the study regardless of causal relationship. Methods i. Spontaneous subject reports ii. Subject interview by study personnel iii. Clinical examination during face-to-face clinic follow-ups **Measure:** Nature, incidence and severity of adverse events (AEs) **Time Frame:** For a period of 2 years following last injection #### Secondary Outcomes **Description:** 100 mm Visual Analog Scale. Range: 0 to 100 mm. Lower is better, higher is worse. **Measure:** Change in Visual Analog Scale (VAS) for pain in the target hip following completion of treatment cycles **Time Frame:** Baseline, 6 weeks, 6 months, 12 months post-treatment cycle **Description:** Tegner activity scale (Level 0 to Level 10). Higher is better, lower is worse. **Measure:** Change in Tegner activity scale in the target hip following completion of treatment cycles **Time Frame:** Baseline, 6 weeks, 6 months, 12 months post-treatment cycle **Description:** modified Harris Hip Score (mHHS). Score 0 to 100. Higher is better, lower is worse. **Measure:** Change in modified Harris Hip Score (mHHS) in the target hip following completion of treatment cycles **Time Frame:** Baseline, 6 weeks, 6 months, 12 months post-treatment cycle **Description:** Hip disability and osteoarthritis Outcome Score (HOS). Score 0 to 100. Higher is better, lower is worse. **Measure:** Change in Hip disability and osteoarthritis Outcome Score (HOS) in the target hip following completion of treatment cycles **Time Frame:** Baseline, 6 weeks, 6 months, 12 months post-treatment cycle **Description:** Evaluation of joint morphology on hip X-rays, including standing antero-posterior, lateral, and false profile **Measure:** Change in radiographic joint morphology **Time Frame:** Baseline, 6 months, and 12 months post-treatment cycle **Description:** Cartilage thickness on MRI **Measure:** Change in cartilage thickness **Time Frame:** Baseline, 6 months, and 12 months post-treatment cycle **Description:** Cartilage volume on MRI **Measure:** Change in cartilage volume **Time Frame:** Baseline, 6 months, and 12 months post-treatment cycle **Description:** Cartilage morphology on MRI **Measure:** Change in cartilage morphology **Time Frame:** Baseline, 6 months, and 12 months post-treatment cycle **Description:** Subchondral bone morphology (i.e. edema) on MRI **Measure:** Change in subchondral bone morphology **Time Frame:** Baseline, 6 months, and 12 months post-treatment cycle **Description:** Evaluate periarticular tissues on MRI (i.e. visible synovitis) **Measure:** Change periarticular soft-tissues **Time Frame:** Baseline, 6 months, and 12 months post-treatment cycle **Description:** Synovial fluid from attempted aspiration at the time of injection (and re-injection for the two injection cohort) will be analyzed for cells, cytokines, growth factors, and other similar biomarkers. **Measure:** Change in synovial fluid biomarkers within the target hip **Time Frame:** Baseline at the time of AMSC injection, At time of second injection (1 month status post first injection) in 2-injection group ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria To be eligible for inclusion into this study, the subjects must fulfill all of the following criteria: 1. Male or female ages 18-65 years • Persons of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening to a period of 1 year following completion of the drug treatment cycle. Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. A urine pregnancy test will be performed prior to the administration of the study drug to confirm negative results. If the urine pregnancy test is positive, the study drug will not be administered and the result will be confirmed by a serum pregnancy test. Serum pregnancy tests will be performed at a central clinical laboratory, whereas urine pregnancy tests will be performed by qualified personnel using kit 2. Persons becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer. Monitoring will include perinatal and neonatal outcome. Any SAEs associated with pregnancy will be recorded. 3. Chronic (\> 3 months), unilaterally symptomatic, primary hip OA. Patients with episodes of contralateral hip pain that is asymptomatic at the time of enrollment will be eligible for inclusion. However, as outlined in the primary study endpoints, patients with previous episodes of contralateral hip pain who experience a repeat episode of contralateral pain similar to their established pattern of pain during the course of the trial will not be considered as having experienced an adverse event. 4. Radiographic hip OA of Tönnis Grade 1 - 2, accompanied by at least mild sclerosis and joint space narrowing, as agreed upon by two study co-investigators without underlying structural hip abnormalities 5. Previous 6 week or longer trial of one of the following conservative treatments: activity modification, weight loss, physical therapy, anti-inflammatory medications or injection therapy (e.g. cortisone) 6. Able to routinely walk without assistance (e.g. cane, walker) 7. Clinically stable target hip 8. No surgery planned in the target hip for at least 12 months following the last injection 9. Completed general physical and well-being evaluation with primary care provider within 12 months of enrollment 10. Fully understanding of the requirements of the study and willingness to comply with the treatment plan, including fat harvesting, laboratory tests, diagnostic imaging, and follow-up visits and assessments 11. Can provide written informed consent and complete HIPAA documentation after the nature of the study is fully explained and prior to any study-related procedure Exclusion Criteria To be eligible for inclusion in this study, the subjects must not meet any of the following criteria: 1. Pregnant or nursing, or planning on becoming pregnant during the study period 2. Congenital or acquired malformation of the target hip resulting in significant deformity or leading to problems with the study treatment or analysis of the results 3. Significant structural deformity, including large cam lesion (alpha angle greater than 55 degrees) or moderate dysplasia (defined as lateral center edge angle less than 18 degrees). 4. Injections of any kind into the target hip within 3 months prior to study enrollment 5. Locking, catching, give-away or another major mechanical symptoms of the target hip 6. History of intra-articular infection in the target hip 7. History of superficial infection in the target hip within 6 months of study enrollment, or evidence of current superficial infection affecting the target hip 8. History of falls requiring medical attention, or gait instability 9. Clinically significant abnormal hematology (complete blood count with differential), blood chemistry, or urinalysis screening laboratory results. 10. Body mass index (BMI) \> 35 kg/m2 11. Taking anticoagulant medications (e.g. warfarin, heparin or clopidogrel) which may pose a clinically-significant contraindication to intra-articular injection. 12. Taking herbal therapies or supplements within 4 weeks of enrollment or unwilling to avoid use of herbal therapies or supplements until at least 30 days following completion of the study drug treatment cycle (includes, but not limited to chondroitin sulfate, diacerein, n-glucosamine and capsaicin) 13. Taking non-steroidal anti-inflammatory medications (e.g. COX-2 inhibitors) without a stable dosing regimen for at least 4 weeks before baseline evaluation, or anticipating not remaining on a stable dose until at least 30 days following completion of the study drug treatment cycle 14. Use of electrotherapy or acupuncture for OA, unless there is a stable regimen for at least 4 weeks before baseline assessment 15. Taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment 16. On chronic, immunosuppressive transplant therapy or having a chronic, immunosuppressive state, including use of systemic steroids/corticosteroids 17. Current tobacco product use, including nicotine patch or other nicotine products 18. Clinically significant systemic inflammatory, rheumatological or connective tissue disorder including but not limited to rheumatoid arthritis, systemic sclerosis, system lupus erythematosus, and Ehlers-Danlos Syndrome 19. Clinically significant rheumatological or inflammatory disease of the hip or chondrocalcinosis/calcium pyrophosphate disease (CPPD), hemochromatosis, inflammatory arthritis, arthropathy of the hip associated with juxta-articular Paget's disease of the femur or pelvis, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's hip joint, villonodular synovitis, and synovial chondromatosis 20. Ongoing infectious disease, including but not limited to tuberculosis, HIV, hepatitis, and syphilis 21. Clinically significant cardiovascular (e.g. history of myocardial infarction, congestive heart failure or uncontrolled hypertension \> 90 mmHg diastolic and/or 180 mmHg systolic), neurologic (e.g. stroke, TIA) renal, hepatic, orthopedic (e.g. surgery on other weight bearing joints that will interfere with study, osteoporosis, acute lower body fractures), or endocrine disease (e.g. diabetes). 22. Vascular or neurological disorder affecting the either lower limb which poses clinical significance to the safe delivery of intra-articular therapy. 23. History of cancer/malignancy with the exception of adequately treated basal cell or squamous cell carcinoma of the skin not associated with the target hip 24. History of clinically significant blood dyscrasia, including but not limited to anemia, thrombocytopenia, and monoclonal gammopathy 25. Participation in a study of an experimental drug or medical device within 3 months of study enrollment 26. Known allergy to local anesthetics of other components of the study drug 27. Any contraindication to MRI scan according to MRI guidelines, or unwillingness to undergo MRI procedures 28. History of or current evidence of alcohol or drug abuse or dependence, recreational use of illicit drug or prescription medications, or have use of medical marijuana within 30 days of study entry 29. Any illness or condition which, in the investigators' judgement will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Rochester **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sejal Dave - **Phone:** 507-266-9085 - **Role:** CONTACT ***Contact 2:*** - **Name:** Aaron J Krych - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Mayo Clinic in Rochester **State:** Minnesota **Status:** RECRUITING **Zip:** 55905 #### Overall Officials **Official 1:** **Affiliation:** Mayo Clinic **Name:** Aaron J Krych **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### See Also Links **Label:** Mayo Clinic Clinical Trials **URL:** https://www.mayo.edu/research/clinical-trials ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010003 - Term: Osteoarthritis - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M12926 - Name: Osteoarthritis - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M17912 - Name: Osteoarthritis, Hip - Relevance: HIGH - As Found: Osteoarthritis, Hip - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015207 - Term: Osteoarthritis, Hip ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02513979 **Acronym:** PP&ARA **Brief Title:** Postoperative Pain and Angiotensin II Receptor Antagonists **Official Title:** The Effect of Angiotensin II Receptor Antagonists on Acute and Chronic Postoperative Pain in Patients Treated for Hypertension. #### Organization Study ID Info **ID:** AHSTSA-102 #### Organization **Class:** OTHER **Full Name:** University of Athens ### Status Module #### Completion Date **Date:** 2018-01 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2015-10-08 **Type:** ESTIMATED **Last Update Submit Date:** 2015-10-07 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2017-10 **Type:** ESTIMATED #### Start Date **Date:** 2015-08 **Status Verified Date:** 2015-07 #### Study First Post Date **Date:** 2015-08-03 **Type:** ESTIMATED **Study First Submit Date:** 2015-07-28 **Study First Submit QC Date:** 2015-07-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Athens #### Responsible Party **Investigator Affiliation:** University of Athens **Investigator Full Name:** Argyro Fassoulaki **Investigator Title:** Professor Emeritus **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** An angiotensin II type 2 receptor (AT2R) antagonist has been assessed for its efficacy in neuropathic pain with promising results. A considerable number of patients undergoing surgery under general anesthesia are hypertensive and receive drugs to control high blood pressure, including angiotensin II receptor antagonists. These drugs may attenuate the acute and/or chronic postoperative pain or decrease the analgesic requirements after surgery. The aim of the present study is to assess the early postoperative pain and analgesic requirements in patients treated with antagonists of the angiotensin II receptors for at least three months before surgery compared to normotensive patients. **Detailed Description:** Patients ASA I-III, aged between 35 and 79 years old, with BMI ≤ 35, scheduled for abdominal surgery, thus gynecological, urological and general surgery procedures will be recruited for the study. All patients will be scheduled in the morning list, informed for the study and will be asked to give written informed consent. Exclusion Criteria will be patients on analgesic, antidepressive, or sedative consumption during the previous one month, mental impairment, not speaking Greek or refusing to give written informed consent, diabetics, patients receiving antihypertensive treatment other than angiotensin type II receptor (AT2R) antagonists. Two groups of patients will be stydied: Patients hypertensive (the hypertensive group) receiving treatment for blood pressure control with angiotensin II receptor antagonists for at least three months preoperatively and a normotensive group. Measurements * Pain intensity (visual analogue scale: VAS) from 0 to 100 will be reported 2, 4, 8, and 24 hours postoperatively with 0 representing no pain and 100 excruciate worst pain. Pain will be recorded at rest and subsequently patients will be asked to cough for three times. * Analgesics consumed at the same time points will be recorded. * Patient satisfaction (VAS 0-100) 24 h postoperatively (with special reference to pain) * Three months postoperatively patients will be contacted by phone and will be asked if they experience pain related to surgery or not. If yes pain characteristics, thus burning, pricking etc. will be recorded. * Three months postoperatively patients will be asked whether they used analgesics after discharge from the hospital for the postoperative pain. Statistics Primary outcome of the study: Pain intensity 24 hours postoperatively after cough in patients receiving angiotensin II receptor antagonists, or no antihypertensive therapy. Secondary outcomes of the study are pain intensity 2, 4, 8 and 24 hours postoperatively at rest, 2, 4 and 8 hours after cough, analgesic consumption , 2, 4, 8 and 24 hours postoperatively, patient satisfaction regarding pain, presence of pain three months after surgery and if present its characteristics. Also, analgesic consumption during the first three months postoperatively due to surgery. Statistics Power analysis: A 30% difference in pain intensity after cough 24 hours postoperatively between the angiotensin II receptor antagonists treated group compared and the treated group. Acute pain at rest and after cough all the time points as defined by the study design will be compared between patients receiving antihypertensive treatment (angiotensin II receptors antagonists) and the controls. Cumulative analgesics consumed 2, 4, 8 and 24 hours after surgery will be compared between the two groups. The presence of chronic postsurgical pain and the need or not of analgesic intake due to chronic pain three months after surgery will be also compared between the hypertensive treated and normotensive patients. Parametric or non-parametric tests will be used for normal and no normal distributions respectively. ### Conditions Module **Conditions:** - Hypertension **Keywords:** - Angiotensin type II receptor (AT2R) antagonists - Acute postoperative pain - Chronic postoperative pain - Abdominal surgery ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Hypertensive patients treated with angiotensin type II receptor antagonists **Intervention Names:** - Drug: Angiotensin type II receptor antagonists **Label:** angiotensin type II receptor antagonists **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Normotensive patients **Label:** No treatment **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - angiotensin type II receptor antagonists **Description:** Angiotensin type II receptor antagonists given to hypertensive patients treated with high blood pressure **Name:** Angiotensin type II receptor antagonists **Other Names:** - AT2R antagonists **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Patient satisfaction measured in a 0-100 mm scale with special reference to postoperative pain management **Measure:** Patient satisfaction **Time Frame:** 24 hours postoperatively #### Primary Outcomes **Description:** Intensity of pain after cough measured with the Visual Analogue Scale (VAS 0-100 mm) **Measure:** Acute pain after cough **Time Frame:** 24 hours postoperatively #### Secondary Outcomes **Description:** Intensity of pain at rest measured with the Visual Analogue Scale (VAS 0-100 mm) **Measure:** Acute pain at rest **Time Frame:** 2, 4, 8 and 24 hours postoperatively **Description:** Intensity of pain after cough measured with the Visual Analogue Scale (VAS 0-100 mm) **Measure:** Acute pain after cough **Time Frame:** 2, 4 and 8 hours postoperatively **Description:** All analgesics converted to morphine equivalent (mg) **Measure:** Analgesic consumption **Time Frame:** 2, 4, 8 and 24 hours postoperatively **Description:** Present or absent, if present characteristics (pricking, burning, throbbing) **Measure:** Chronic pain **Time Frame:** Three months postoperatively **Description:** Yes or not, number of pills **Measure:** Analgesic consumption for chronic pain **Time Frame:** Three months postoperatively ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients aged between 35 and 79 years * ASA II or III * BMI ≤ 35 * Elective abdominal surgery Exclusion Criteria:- * Patients on analgesic, antidepressive, or sedative consumption during the last month * Mental impairment * Not speaking fluently Greek language * Refuse to give written informed consent * Diabetics * Patients receiving antihypertensive treatment other than angiotensin type II receptor (AT2R) antagonists **Maximum Age:** 79 Years **Minimum Age:** 35 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Argyro Fassoulaki, MD, PhD **Phone:** +30210 9024530 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Maria Valta, MD **Phone:** +30210 8062133 **Role:** CONTACT #### Locations **Location 1:** **City:** Athens **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Argyro Fassoulaki, MD, PhD - **Phone:** +30 6936701333 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Maria Valta, MD - **Phone:** +30 6971554146 - **Role:** CONTACT **Country:** Greece **Facility:** Argyro Fassoulaki **Status:** RECRUITING **Zip:** 11528 #### Overall Officials **Official 1:** **Affiliation:** Aretaieio University Hospital **Name:** Argyro Fassoulaki, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** St Savas Hospital **Name:** Marianna Zotou, MD **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: HIGH - As Found: Postoperative Pain - ID: M10024 - Name: Hypertension - Relevance: HIGH - As Found: Hypertension - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006973 - Term: Hypertension - ID: D000010149 - Term: Pain, Postoperative ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: VaCoAg - Name: Vasoconstrictor Agents ### Intervention Browse Module - Browse Leaves - ID: M28916 - Name: Angiotensin Receptor Antagonists - Relevance: LOW - As Found: Unknown - ID: M4132 - Name: Angiotensin II - Relevance: LOW - As Found: Unknown - ID: M289354 - Name: Giapreza - Relevance: LOW - As Found: Unknown - ID: M4135 - Name: Angiotensinogen - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05953779 **Brief Title:** Personalized Need-focused Single Session Intervention **Official Title:** Randomized Controlled Trial for Personalized Need-focused Single-Session Interventions #### Organization Study ID Info **ID:** ER13323 #### Organization **Class:** OTHER **Full Name:** Bar-Ilan University, Israel ### Status Module #### Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-07-20 **Type:** ACTUAL **Last Update Submit Date:** 2023-07-18 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-01-08 **Type:** ACTUAL **Status Verified Date:** 2023-07 #### Study First Post Date **Date:** 2023-07-20 **Type:** ACTUAL **Study First Submit Date:** 2023-03-18 **Study First Submit QC Date:** 2023-07-18 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of California, Berkeley **Class:** OTHER **Name:** United States - Israel Binational Science Foundation #### Lead Sponsor **Class:** OTHER **Name:** Bar-Ilan University, Israel #### Responsible Party **Investigator Affiliation:** Bar-Ilan University, Israel **Investigator Full Name:** Prof. Eshkol Rafaeli **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a two-site randomized controlled trial, with two goals. First, the investigators aim to demonstrate that single-session interventions for mild-to-moderate anxiety and depression can generate statistically significant symptom change as a main effect across control and experimental (i.e. personalized) conditions. Second, the investigators hope to establish the additional incremental efficacy of personalization via person-specific intensive longitudinal data collection and analysis. **Detailed Description:** This is a two-site randomized controlled trial, with two goals. First, the investigators aim to demonstrate that single-session interventions for mild-to-moderate anxiety and depression can generate statistically significant symptom change as a main effect across control and experimental (i.e. personalized) conditions. Second, the investigators hope to establish the additional incremental efficacy of personalization via person-specific intensive longitudinal data collection and analysis. All single-session interventions will be 90-minutes in length. At the conclusion of the intervention session, participants will receive suggestions for daily homework practice to complete and a flash drive with a copy of their session audio to review at their discretion. Participants will also meet with the therapist for a 10-minute remote check-in two weeks following the single session. All interventions include standard psychoeducational components. Participants randomized to the personalization arm of the study will be given an intervention matched to their most pressing psychosocial need. Participants randomized to the control condition will receive a standard intervention (at the UCB site) or a randomly selected one (at the BIU site). Both the standard intervention and the specific ones were designed to be broadly efficacious for depression and anxiety symptomatology. The psychosocial needs which serve as the focus of the interventions are derived from motivation and affect regulation models and include emotional stability, predictability, acceptance, competence, self-esteem, autonomy, and pleasure. The primary unmet need for each individual will be determined by a conditional entropy algorithm. Simply, the presence versus absence of subjective distress will be measured eight times per day for 30 days. Concurrently, the presence versus absence of need frustration will also be measured eight times per day for 30 days. Utilizing a k-fold cross-validated estimation, conditional entropy will be used to determine the need that best reduces the uncertainty in subjective distress (that is, best explains its presentation probabilistically). ### Conditions Module **Conditions:** - Depression and/or Anxiety in the Mild-to-moderate Range ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized Control Trial with 2 conditions: Experimental condition (personalized-selected intervention) and control condition (randomly-selected or standard intervention focused on emotion-regulation). ##### Masking Info **Masking:** TRIPLE **Masking Description:** The participants and any care provider and study personnel who interact with them will be blind to condition. The PI will utilize a randomization table to allocate participants to condition, and will inform the front-line study personnel and through them, the care provider, regarding which intervention to use without specifying whether it was personalized or randomly-chosen. The outcomes assessor will be blind even to the type of intervention utilized. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 240 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The intervention approach taken in this RCT is focused on unmet psychological needs (predictability, belonging, competence, self-worth, autonomy, and playfulness). For each need, a specific 90-minute intervention has been developed. The primary unmet need for each individual will be determined by a conditional entropy algorithm. Simply, the presence versus absence of subjective distress will be measured eight times per day for 30 days. Concurrently, the presence versus absence of need frustration will also be measured eight times per day for 30 days. Utilizing a k-fold cross-validated estimation, conditional entropy will be used to determine the need that best reduces the uncertainty in subjective distress (that is, best explains its presentation probabilistically). At both sites, the experimental condition will consist of an algorithmically-chosen intervention. The choice will be made based on data collected during thirty days of ecological momentary assessment. **Intervention Names:** - Behavioral: Clinician-administered Need-focused Single Session Intervention **Label:** Personalized Intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The intervention approach taken in this RCT is focused on unmet psychological needs (predictability, belonging, competence, self-worth, autonomy, and playfulness). For each need, a specific 90-minute intervention has been developed. At the BIU site, the active control condition will consist of an intervention chosen randomly (out of the six mentioned above). At the UCB site, the active control condition will consist of a standard intervention addressing emotion regulation difficulties. **Intervention Names:** - Behavioral: Clinician-administered Need-focused Single Session Intervention **Label:** Non-personalized Intervention **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Non-personalized Intervention - Personalized Intervention **Description:** All single-session interventions will be 90-minutes in length. At the conclusion of the intervention session, participants will receive suggestions for daily homework practice to complete and a flash drive with a copy of their session audio to review at their discretion. They will also meet with the therapist for a 10-minute remote check-in two weeks following the single session. All interventions include standard psychoeducational components. Both the standard intervention and the specific ones were designed to be broadly efficacious for depression and anxiety symptomatology. The psychosocial needs which serve as the focus of the interventions are derived from motivation and affect regulation models. **Name:** Clinician-administered Need-focused Single Session Intervention **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** Positive and negative affect schedule (20 items) **Measure:** PANAS **Time Frame:** Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention **Description:** Emotion Regulation Questionnaire **Measure:** ERQ **Time Frame:** Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention **Description:** Difficulties in Emotion Regulation **Measure:** DERS-18 **Time Frame:** Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention **Description:** Pittsburgh Sleep Quality Index **Measure:** PSQI **Time Frame:** Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention **Description:** Inventory of Interpersonal Problems **Measure:** IIP-32 **Time Frame:** Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention #### Primary Outcomes **Description:** (Range 0-52, higher scores denote greater depression) **Measure:** Hamilton-Depression Rating Scale **Time Frame:** Change between pre-intervention and 1 month post-intervention **Description:** (Range 0-60, higher scores denote greater depression) **Measure:** Montgomery-Asberg Depression Rating Scale **Time Frame:** Change between pre-intervention and 1 month post-intervention **Description:** (Range 0-56, higher scores denote greater anxiety); will be used in lieu of Hamilton-Depression ratings for individuals whose Hamilton-Anxiety scores are higher than their Hamilton-Depression scores. **Measure:** Hamilton-Anxiety Rating Scale **Time Frame:** Change between pre-intervention and 1 month post-intervention #### Secondary Outcomes **Description:** (Range 0-24, higher scores denote greater depression) **Measure:** PHQ-8 **Time Frame:** Immediately prior to intervention, and again at 1 and 3 months post-intervention **Description:** (Range 0-21, higher scores denote greater anxiety) **Measure:** GAD-7 **Time Frame:** Immediately prior to intervention, and again at 1 and 3 months post-intervention **Description:** (Range 0-63, higher scores denote greater depression, anxiety, and stress) **Measure:** DASS **Time Frame:** Immediately prior to intervention, and again at 1 and 3 months post-intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criterion. \* a score of 5 or above on the Hamilton Rating Scale for Depression (HRSD). Exclusion Criteria based on Diagnostic Interview for DSM-5 Anxiety, Mood, and Obsessive-Compulsive and Related Disorders (DIAMOND). * Psychotic Disorders (hallucinations or delusions) * Past or current mania, current hypo-mania. * Anorexia Disorder * Current Obsessive-Compulsive and related Disorders rated as moderate and above. * Alcohol or drug abuse rated as moderate and above. * Panic Disorder rated as moderate and above. * Agoraphobia rated as moderate and above. * Premenstrual dysphoric disorder rated as moderate and above. * Current Post-Traumatic Stress Disorder rated as moderate and above. * binge eating rated as moderate and above. * Phobia rated as severe and above. * Somatic symptom disorder rated as severe and above. * Illness Anxiety Disorder rated as severe and above. * MDD rated as severe and above. * GAD rated as severe and above. * Social Anxiety rated as severe and above. * Separation anxiety rated as severe and above. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Eshkol Rafaeli, PhD **Phone:** +972-3-7384660 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Gal Lazarus, PhD **Role:** CONTACT #### Locations **Location 1:** **City:** Berkeley **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Aaron J. Fisher, PhD - **Phone:** 510-642-8615 - **Role:** CONTACT **Country:** United States **Facility:** University of California, Berkeley **State:** California **Status:** RECRUITING **Zip:** 94720 **Location 2:** **City:** Ramat Gan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Eshkol Rafaeli, PhD - **Phone:** +972-3-7384660 - **Role:** CONTACT **Country:** Israel **Facility:** Bar-Ilan University **Status:** RECRUITING **Zip:** 52900 ### IPD Sharing Statement Module **Description:** De-identified data will be made available through the osf.io platform or similar platforms. **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00444379 **Acronym:** ARKS **Brief Title:** Anti-Retrovirals for Kaposi's Sarcoma **Official Title:** A Randomized Comparison of Protease Inhibitor-based Versus Non-nucleoside Reverse Transcriptase Inhibitor-based Antiretroviral Therapy for Initial Treatment of Individuals With AIDS-related Kaposi's Sarcoma in Sub-Saharan Africa #### Organization Study ID Info **ID:** NIH/NCI Grant #: R01 CA119903 #### Organization **Class:** OTHER **Full Name:** University of California, San Francisco ### Status Module #### Completion Date **Date:** 2012-07 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2014-08-20 **Type:** ESTIMATED **Last Update Submit Date:** 2014-08-19 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2012-02 **Type:** ACTUAL #### Start Date **Date:** 2007-04 **Status Verified Date:** 2014-08 #### Study First Post Date **Date:** 2007-03-07 **Type:** ESTIMATED **Study First Submit Date:** 2007-03-06 **Study First Submit QC Date:** 2007-03-06 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institutes of Health (NIH) **Class:** INDUSTRY **Name:** Gilead Sciences **Class:** INDUSTRY **Name:** Abbott **Class:** INDUSTRY **Name:** Merck Sharp & Dohme LLC #### Lead Sponsor **Class:** OTHER **Name:** University of California, San Francisco #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The primary purpose of this study is to determine whether a protease inhibitor-based antiretroviral regimen is more efficacious than a non-nucleoside reverse transcriptase inhibitor-based antiretroviral regimen in promoting the regression of KS tumor burden in persons with AIDS-related KS in Africa. **Detailed Description:** With the advent of the HIV epidemic, Kaposi's sarcoma (KS) is now the most common adult cancer in many parts of sub-Saharan Africa. In HIV-infected patients with KS in developed settings, the initiation of highly active anti-retroviral therapy (HAART) has been associated with regression of the tumor, in many but not all cases, even in the absence of conventional chemotherapy. However, it is not known which specific antiretroviral drugs or regimens are critical to convey HAART's anti-KS effect. In particular, it is not known whether the anti-KS effects of protease inhibitors (PI) in vitro and in animal models translate into improved clinical outcomes as compared to non-PI-based HAART regimens. To address this, we will determine whether a PI-based HAART regimen (lopinavir/ritonavir plus emtricitabine/tenofovir) is superior to a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based HAART regimen (efavirenz plus emtricitabine/tenofovir) in promoting the regression of KS tumor burden in persons with AIDS-related KS in sub-Saharan Africa. We will enroll 224 patients with AIDS-related KS in Kampala, Uganda, randomly assign them to either a PI-based HAART or an NNRTI-based HAART regimen, and observe them for one year to determine the response in their KS to therapy. ### Conditions Module **Conditions:** - Kaposi's Sarcoma - HIV Infections **Keywords:** - Kaposi's sarcoma - KSHV - AIDS - HHV-8 - treatment naive ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 224 **Type:** ACTUAL **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** PI-based HAART regimen (lopinavir/ritonavir plus emtricitabine/tenofovir) **Intervention Names:** - Drug: Lopinavir/ritonavir plus Emtricitabine/Tenofovir versus Efavirenz plus Emtricitabine/Tenofovir **Label:** PI-based HAART regimen **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** non-nucleoside reverse transcriptase inhibitor (NNRTI)-based HAART regimen (efavirenz plus emtricitabine/tenofovir) **Intervention Names:** - Drug: Lopinavir/ritonavir plus Emtricitabine/Tenofovir versus Efavirenz plus Emtricitabine/Tenofovir **Label:** non-nucleoside reverse transcriptase inhibitor **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - PI-based HAART regimen - non-nucleoside reverse transcriptase inhibitor **Description:** Lopinavir/ritonavir 200/50mg plus Emtricitabine/Tenofovir 200/300mg versus Efavirenz 600mg plus Emtricitabine/Tenofovir 200/300mg **Name:** Lopinavir/ritonavir plus Emtricitabine/Tenofovir versus Efavirenz plus Emtricitabine/Tenofovir **Other Names:** - Lopinavir/ritonavir Aluvia (ALUABT) - Efavirenz Stocrin (EFVBMM) - Emtricitabine/Tenofovir Truvada (TRUGLD) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** survival **Measure:** Blinded assessment of the change in the burden of KS lesions #### Secondary Outcomes **Measure:** CD4+ T cell count and HIV plasma HIV RNA levels **Measure:** KSHV DNA levels in saliva and blood **Measure:** Humoral and cellular KSHV immune response markers **Measure:** Quality-of-life assessment **Measure:** Incidence of Kaposi's sarcoma-associated Immune Reconstitution Inflammatory Syndrome (KS-IRIS) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 18 years or older * HIV-1 infection * No prior antiretroviral therapy of any duration, including prior use to prevent perinatal transmission within prior six months. * No prior chemotherapy or radiotherapy for KS * Presence of Kaposi's sarcoma, documented by biopsy by the Pathology Department at Mulago Hospital, with at least one mucocutaneous lesion (including oral or genital mucosal lesions), each at least 0.6 x 0.6 cm in perpendicular diameters. * Laboratory values obtained within 21 days prior to randomization: absolute neutrophil count equal to or more than 1000/mm3; hemoglobin \> 9.0 g/dL; platelet count \> 50,000/mm3; creatinine \< 2 times upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5 times ULN; and alkaline phosphatase and total bilirubin \< 2 times ULN. * In women, negative urine pregnancy test within 28 days of randomization and just before randomization. * If a woman of child-bearing potential (i.e., not yet reached menopause or undergone hysterectomy, bilateral oophorectomy, or tubal ligation), must be willing to use at least two of the following methods of contraception, to be provided by the study: condoms (male or female), IUD, or hormone-based therapy, e.g., contraceptive pills, Norplant or Depo-Provera. * Candidate currently resides within Uganda and does not intend to relocate away from current geographical area of residence for the duration of study participation. * Karnofsky performance score of 70 or more Exclusion Criteria: * Extensive degree of mucocutaneous KS, which would typically require chemotherapy or radiotherapy. This is defined by any of the following: * One or more bulky cutaneous lesions, defined as at least 5.0 cm in greatest diameter across the surface of the skin and at least 3 cm in height * One or more mucocutaneous lesions exhibiting ulceration * One or more oral lesions that interfere with swallowing * Suggestion of pulmonary or gastrointestinal visceral KS, as evidenced by any of the following: * Abnormal chest x-ray within 21 days prior to randomization which is otherwise unexplained, unless the x-ray is unchanged compared with at least 60 days earlier * Positive occult blood stool testing within 21 days prior to randomization or history of overt bleeding from the mouth or rectum in the 21 days prior to randomization * Facial lymphedema or lymphedema in any other body region which causes symptoms (e.g., pain) or functional disability (e.g., any less than 85% active range of motion in a large joint) * Evidence of currently active, untreated opportunistic infection or malignancy (not including Kaposi's sarcoma); or unexplained temperature which is \> 38.5 degrees C * Use of drugs, within the prior 28 days, contraindicated while taking lopinavir/ritonavir or efavirenz because of effects on the cytochrome P450 system. These include propafenone, astemizole, terfenadine, rifampin, rifapentine, ergot derivatives, cisapride, lovastatin, simvastatin, pimozide, midazolam, and triazolam. * Active drug or alcohol use that, in the investigators' opinion, would interfere with study participation * Breastfeeding **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Kampala **Country:** Uganda **Facility:** Infectious Diseases Institute, Mulago Hospital #### Overall Officials **Official 1:** **Affiliation:** University of California, San Francisco **Name:** Dr. Jeffrey N Martin, MD, MPH **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** MRC/UVRI and LSHTM Uganda Research Unit **Name:** Dr. Edward K Mbidde, MBChB, MMed **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### See Also Links **Label:** Medline Plus- Health Information **URL:** http://www.nlm.nih.gov/medlineplus/kaposissarcoma.html ## Derived Section ### Condition Browse Module - Ancestors - ID: D000018204 - Term: Neoplasms, Connective and Soft Tissue - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000007239 - Term: Infections - ID: D000014777 - Term: Virus Diseases - ID: D000006566 - Term: Herpesviridae Infections - ID: D000004266 - Term: DNA Virus Infections - ID: D000009383 - Term: Neoplasms, Vascular Tissue ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC04 - Name: Neoplasms - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M3522 - Name: Acquired Immunodeficiency Syndrome - Relevance: LOW - As Found: Unknown - ID: M18250 - Name: HIV Infections - Relevance: LOW - As Found: Unknown - ID: M15327 - Name: Sarcoma - Relevance: HIGH - As Found: Sarcoma - ID: M15332 - Name: Sarcoma, Kaposi - Relevance: HIGH - As Found: Kaposi's Sarcoma - ID: M20350 - Name: Neoplasms, Connective and Soft Tissue - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M9643 - Name: Herpesviridae Infections - Relevance: LOW - As Found: Unknown - ID: M7442 - Name: DNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M12328 - Name: Neoplasms, Vascular Tissue - Relevance: LOW - As Found: Unknown - ID: T5284 - Name: Soft Tissue Sarcoma - Relevance: HIGH - As Found: Sarcoma - ID: T3199 - Name: Kaposi Sarcoma - Relevance: HIGH - As Found: Kaposi's Sarcoma ### Condition Browse Module - Meshes - ID: D000012514 - Term: Sarcoma, Kaposi - ID: D000012509 - Term: Sarcoma ### Intervention Browse Module - Ancestors - ID: D000017320 - Term: HIV Protease Inhibitors - ID: D000084762 - Term: Viral Protease Inhibitors - ID: D000011480 - Term: Protease Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000019380 - Term: Anti-HIV Agents - ID: D000044966 - Term: Anti-Retroviral Agents - ID: D000000998 - Term: Antiviral Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000065692 - Term: Cytochrome P-450 CYP3A Inhibitors - ID: D000065607 - Term: Cytochrome P-450 Enzyme Inhibitors - ID: D000018894 - Term: Reverse Transcriptase Inhibitors - ID: D000019384 - Term: Nucleic Acid Synthesis Inhibitors - ID: D000065688 - Term: Cytochrome P-450 CYP2C9 Inhibitors - ID: D000065689 - Term: Cytochrome P-450 CYP2C19 Inhibitors - ID: D000065695 - Term: Cytochrome P-450 CYP2B6 Inducers - ID: D000065693 - Term: Cytochrome P-450 Enzyme Inducers - ID: D000065701 - Term: Cytochrome P-450 CYP3A Inducers ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21394 - Name: Ritonavir - Relevance: HIGH - As Found: Left - ID: M296 - Name: Tenofovir - Relevance: HIGH - As Found: 1000 - ID: M294 - Name: Emtricitabine - Relevance: HIGH - As Found: Sampling - ID: M29837 - Name: Lopinavir - Relevance: HIGH - As Found: Mg/kg/day - ID: M20935 - Name: Reverse Transcriptase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M340137 - Name: Efavirenz - Relevance: HIGH - As Found: See - ID: M19609 - Name: HIV Protease Inhibitors - Relevance: LOW - As Found: Unknown - ID: M14343 - Name: Protease Inhibitors - Relevance: LOW - As Found: Unknown - ID: M25428 - Name: Anti-Retroviral Agents - Relevance: LOW - As Found: Unknown - ID: M448 - Name: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination - Relevance: HIGH - As Found: Scaling - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M21350 - Name: Anti-HIV Agents - Relevance: LOW - As Found: Unknown - ID: M4314 - Name: Antiviral Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M30564 - Name: Cytochrome P-450 CYP3A Inhibitors - Relevance: LOW - As Found: Unknown - ID: M30537 - Name: Cytochrome P-450 Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000019438 - Term: Ritonavir - ID: D000061466 - Term: Lopinavir - ID: D000068698 - Term: Tenofovir - ID: D000068679 - Term: Emtricitabine - ID: D000069480 - Term: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination - ID: C000098320 - Term: Efavirenz ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04630379 **Brief Title:** Early Integration of Palliative Care Using the BEACON PROQOL in Patients With High Grade Glioma and Their Caregivers **Official Title:** Pilot Study of Early Integration of Palliative Care Using the BEACON PROQOL in Patients With High Grade Glioma and Their Caregivers #### Organization Study ID Info **ID:** 17-011342 #### Organization **Class:** OTHER **Full Name:** Mayo Clinic #### Secondary ID Infos **Domain:** CTRP (Clinical Trial Reporting Program) **ID:** NCI-2020-07998 **Type:** REGISTRY **Domain:** Mayo Clinic in Arizona **ID:** 17-011342 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2020-08-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-03-20 **Type:** ACTUAL **Last Update Submit Date:** 2023-03-16 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-06-13 **Type:** ACTUAL #### Start Date **Date:** 2018-06-13 **Type:** ACTUAL **Status Verified Date:** 2023-03 #### Study First Post Date **Date:** 2020-11-16 **Type:** ACTUAL **Study First Submit Date:** 2020-11-10 **Study First Submit QC Date:** 2020-11-10 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Cancer Institute (NCI) #### Lead Sponsor **Class:** OTHER **Name:** Mayo Clinic #### Responsible Party **Investigator Affiliation:** Mayo Clinic **Investigator Full Name:** Alyx Porter, M.D. **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This trial assesses the quality of life in patients with high grade glioma and their caregivers using a questionnaire called the Beacon Patient Related Outcomes Quality of Life (PROQOL). Knowledge gained from this trial may help researchers find out if early integration of palliative care will lead to improvement in quality of life for both patients and caregivers. **Detailed Description:** PRIMARY OBJECTIVES: I. Assess feasibility of intra-office Beacon Patient Related Outcomes Quality of Life Scale (PROQOL) assessment of patient and caregiver. II. Assess feasibility of routine (monthly) visits with palliative care specialists. III. Evaluate if overall quality of life of patients with high grade glioma and their caregivers improves with identifying and addressing symptoms and psychosocial concerns identified through the PROQOL tool. IV. Evaluate if overall quality of life of patients with high grade glioma improves further with early integration of palliative care. V. Evaluate if overall quality of life of primary caregivers improves with early integration of palliative care. VI. Compare patient's perception and understanding of disease severity and prognosis with that of the caregivers, and with that of the clinicians. VII. Evaluate variance in prognosis between the neurooncologist and palliative care specialist. OUTLINE: Patients are randomized to 1 of 3 groups. GROUP A: Patients and primary caregiver complete the Beacon PROQOL survey before each visit. Patients then receive standard of care for high grade glioma consisting of visits with neuro-oncologist monthly for 6 months to address concerns that are identified via the survey and the domain of concern identified by patient and caregiver. GROUP B: Patients and primary caregiver complete the Beacon PROQOL survey before each visit. Patients then receive standard of care for high grade glioma consisting of visits with neuro-oncologist and palliative care team monthly for 6 months to address concerns that are identified by the survey and domains of concerns. Caregivers also attend support sessions led by a social worker monthly for 6 months. GROUP C: Patients and primary caregiver complete quality of life portion of the Beacon PROQOL survey before each visit. Patients then receive standard of care for high grade glioma consisting of visits with neuro-oncologist monthly for 6 months and address important concerns that come up on the survey. Patients may also receive palliative care consultation as deemed appropriate by the neuro-oncologist. ### Conditions Module **Conditions:** - Glioblastoma - Malignant Glioma - WHO Grade III Glioma ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 16 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients and primary caregiver complete the BEACON PROQOL survey before each visit. Patients then receive standard of care for high grade glioma consisting of visits with neuro-oncologist monthly for 6 months to address concerns that are identified via the survey and the domain of concern identified by patient and caregiver. **Intervention Names:** - Other: Quality-of-Life Assessment - Other: Supportive Care - Other: Survey Administration **Label:** Group A (visit with neuro-oncologist) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients and primary caregiver complete the BEACON PROQOL survey before each visit. Patients then receive standard of care for high grade glioma consisting of visits with neuro-oncologist and palliative care team monthly for 6 months to address concerns that are identified by the survey and domains of concerns. Caregivers also attend support sessions led by a social worker monthly for 6 months. **Intervention Names:** - Other: Palliative Therapy - Other: Quality-of-Life Assessment - Other: Supportive Care - Other: Survey Administration **Label:** Group B (visit with neuro-oncologist and palliative care team) **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Patients and primary caregiver complete quality of life portion of the BEACON PROQOL survey before each visit. Patients then receive standard of care for high grade glioma consisting of visits with neuro-oncologist monthly for 6 months and address important concerns that come up on the survey. Patients may also receive palliative care consultation as deemed appropriate by the neuro-oncologist. **Intervention Names:** - Other: Palliative Therapy - Other: Quality-of-Life Assessment - Other: Supportive Care - Other: Survey Administration **Label:** Group C (visit with neuro-oncologist, palliative care team) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group B (visit with neuro-oncologist and palliative care team) - Group C (visit with neuro-oncologist, palliative care team) **Description:** Visit with palliative care team **Name:** Palliative Therapy **Other Names:** - Comfort Care - PA-Palliative Therapy - palliation - Palliative - Palliative Care - Palliative Treatment - Symptom Management - Symptoms Management **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Group A (visit with neuro-oncologist) - Group B (visit with neuro-oncologist and palliative care team) - Group C (visit with neuro-oncologist, palliative care team) **Description:** Ancillary studies **Name:** Quality-of-Life Assessment **Other Names:** - Quality of Life Assessment **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Group A (visit with neuro-oncologist) - Group B (visit with neuro-oncologist and palliative care team) - Group C (visit with neuro-oncologist, palliative care team) **Description:** Visit with neuro-oncologist **Name:** Supportive Care **Other Names:** - Supportive Therapy - Symptom Management - Therapy, Supportive **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - Group A (visit with neuro-oncologist) - Group B (visit with neuro-oncologist and palliative care team) - Group C (visit with neuro-oncologist, palliative care team) **Description:** Complete survey **Name:** Survey Administration **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Patients will be randomized to 3 groups - Control (standard of care); Arm A (PROQOL + standard of care); Arm B (early palliative care + Arm A). Feasibility of conducting the assessment at monthly visits for each patient/caregiver cluster, along with early involvement of palliative care, will be assessed. **Measure:** Change in feasibility of using the Beacon Patient Reported Outcomes Quality of Life Scale (PROQOL) **Time Frame:** monthly for six months **Description:** At each visit, patients, their caregivers, and the clinicians will be asked to estimate survival time left with options being weeks, weeks to months, several months to years, indefinite number of years, or they may choose not to answer. **Measure:** Change in feasibility of using a single question to assess prognostic understanding in patients, caregivers, and clinicians **Time Frame:** monthly for 6 months #### Secondary Outcomes **Description:** Quality of life is being assessed with a 10 question survey that inquires about overall well being, physical and emotional health, stressors, interaction, and mood. Depending on the question, a higher score may be worse (for example - how would you score your anxiety where 10 is worst; versus how would you score your emotional well being where 10 is worst). The minimum value for each question is 0 and the maximum is 10. This scale has been used in other studies with Beacon. A summary statistic for each patient will be developed depending on the individual responses. Full survey can be reviewed upon request. **Measure:** Quality of life of patients and caregivers **Time Frame:** Up to 6 months **Description:** We will assess how patients, caregivers, and their clinicians differently understand prognosis of the patient in a longitudinal fashion. **Measure:** Discordance in prognostic understanding over time **Time Frame:** Up to 6 months. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults with pathology confirmed high grade glioma, graded as World Health Organization (WHO) grade III and IV * Ability to use a tablet * Able to adhere to completing surveys at study visits * English speaking * Has a caregiver that has provided oral consent to participate in this study * Insurance accepted at Mayo Clinic Arizona Exclusion Criteria: * Inability to use a tablet * Inability to adhere to completing surveys at monthly visits * Unable to speak English * Lack of a caregiver * Insurance not accepted at Mayo Clinic Arizona **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Scottsdale **Country:** United States **Facility:** Mayo Clinic in Arizona **State:** Arizona **Zip:** 85259 #### Overall Officials **Official 1:** **Affiliation:** Mayo Clinic **Name:** Alyx B Porter Umphrey **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Sharma A, Fruth B, Barrera C, Farfour HN, Mrugala MM, Edwin MK, Sloan JA, Porter AB. How much time do we have? Longitudinal perception of prognosis in newly-diagnosed high grade glioma patients and caregivers compared to clinicians. J Neurooncol. 2021 Apr;152(2):313-323. doi: 10.1007/s11060-021-03700-2. Epub 2021 Jan 23. **PMID:** 33486637 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001254 - Term: Astrocytoma - ID: D000018302 - Term: Neoplasms, Neuroepithelial - ID: D000017599 - Term: Neuroectodermal Tumors - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009380 - Term: Neoplasms, Nerve Tissue ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9020 - Name: Glioma - Relevance: HIGH - As Found: Glioma - ID: M9019 - Name: Glioblastoma - Relevance: HIGH - As Found: Glioblastoma - ID: M4561 - Name: Astrocytoma - Relevance: LOW - As Found: Unknown - ID: M20446 - Name: Neoplasms, Neuroepithelial - Relevance: LOW - As Found: Unknown - ID: M19845 - Name: Neuroectodermal Tumors - Relevance: LOW - As Found: Unknown - ID: M20388 - Name: Neuroectodermal Tumors, Primitive - Relevance: LOW - As Found: Unknown - ID: M12318 - Name: Neoplasms, Germ Cell and Embryonal - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12325 - Name: Neoplasms, Nerve Tissue - Relevance: LOW - As Found: Unknown - ID: T2519 - Name: Glioma - Relevance: HIGH - As Found: Glioma - ID: T2518 - Name: Glioblastoma - Relevance: HIGH - As Found: Glioblastoma - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005909 - Term: Glioblastoma - ID: D000005910 - Term: Glioma ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01641679 **Acronym:** THYROPET **Brief Title:** PET Evaluation of Recurrent Differentiated Thyroid Cancer **Official Title:** Recurrent Differentiated Thyroid Cancer: Towards Personalized Treatment Based on Evaluation of Tumor Characteristics With PET (THYROPET #### Organization Study ID Info **ID:** NL37266.031.11 #### Organization **Class:** OTHER **Full Name:** The Netherlands Cancer Institute #### Secondary ID Infos **Domain:** PTC NKI-AVL **ID:** M11TRP **Type:** OTHER ### Status Module #### Completion Date **Date:** 2016-01 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** NOT_YET_RECRUITING #### Last Update Post Date **Date:** 2014-06-17 **Type:** ESTIMATED **Last Update Submit Date:** 2014-06-16 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2015-08 **Type:** ESTIMATED #### Start Date **Date:** 2012-08 **Status Verified Date:** 2014-06 #### Study First Post Date **Date:** 2012-07-17 **Type:** ESTIMATED **Study First Submit Date:** 2012-07-12 **Study First Submit QC Date:** 2012-07-16 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Amsterdam UMC, location VUmc **Class:** OTHER **Name:** UMC Utrecht #### Lead Sponsor **Class:** OTHER **Name:** The Netherlands Cancer Institute #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** After initial treatment of differentiated thyroid cancer patients (DTC) are followed by a blood test, a biomarker called thyroglobulin, in order to detect a possible recurrence. Nowadays patients are treated 'blindly' with high dose radioactive iodine to treat a suspected recurrence. However, the scan made after therapy to verify the effect of the treatment shows that in up to 50% the treatment could be considered as futile. 124I - a radioactive isotope - in combination with whole body PET became recently available for use in the follow-up of DTC. This could make it possible before the therapy with high dose radioactive iodine to determine the extensiveness of the disease and whether effect of the therapy could be expected. Additionally, recurrent DTC lesions that do not accumulate iodine can be found without the futile treatment with 131I. FDG-PET (another PET modality) is able to detect these lesions. The value of FDG-PET before 131I treatment however has not been tested. The combination of these two diagnostic tools, 124I-PET and FDG-PET, has a potential to allow earlier and better restaging and selection for treatment **Detailed Description:** Differentiated thyroid cancer (DTC) is the most frequent endocrine tumor, with an annual incidence per 100.000 individuals of 1 - 3 in men and 2 - 4 in women. In general DTC has a good prognosis, and only 6% of patients will die of their disease, but the prognosis is less favourable when the disease recurs after primary treatment. Measurement of the tumor marker Thyroglobulin (Tg) in serum plays a pivotal role in the follow-up of differentiated thyroid cancer. Serum Tg should be undetectable in DTC patients following thyroid remnant ablation with radioactive iodine-131 (131I), and any detectable level signals the persistence of (neoplastic) thyroid tissue. A serum Tg cut-off level of ≥ 2 ng/ml following rhTSH is highly sensitive for identifying patients in whom persistent tumor may be found. Historically the follow-up of patients with DTC included diagnostic planar scintigraphy with a low dose of 131I, but nowadays this is no longer recommended because of poor sensitivity. Instead, whole body scintigraphy after blind administration of high dose, 'therapeutic', 131I is recommended, both to diagnose and stage the potential recurrence, and to initiate its treatment. This strategy can be effective, but an estimated 38% - 50% of patients will have a negative post-therapeutic whole body scan and/or no objective therapy effect. These patients will have received a total body irradiation of 450 mSv and potentially will have suffered from side effects such as nausea, sialoadenitis, loss of taste, or reduced spermatogenesis. Also, the prolonged thyroid hormone withdrawal and subsequent hypothyroidism necessary for 131I therapy has major impact on quality of life with a majority of patients suffering from significant changes in physical, psychological, and social well-being. The high frequency of high dose 131I therapies from which patients do not derive any benefit but are exposed to its toxicity and potential adverse oncological effects, has led to a search for new diagnostic tools to improve the selection of patients before such treatment. Historically, ultrasound of the neck is applied to detect local recurrence or regional lymph node metastases, and it allows direct biopsy to confirm the diagnosis. But ultrasound is limited to the neck only, and when it is negative in the presence of detectable Tg, a form of whole body evaluation is required. Recently Iodine-124 (124I) became available as a novel radionuclide for whole body PET imaging in the follow-up of DTC, with a promising diagnostic accuracy and a considerably lower radiation exposure as compared to planar whole body scintigraphy after high dose 131I. Furthermore, recent experience has shown that 124I-PET images may be representative for the biodistribution and radiation dosimetry of subsequent treatment with high dose 131I. Thus, with the availability of 124I-PET, it might become possible to more accurately re-stage patients in a whole body procedure, perform dosimetry for subsequent 131I therapy and predict the outcome of the treatment. At the same time, some recurrent DTC lesions do not accumulate iodine, which is correlated with tumor dedifferentiation and poor prognosis. Patients suspected of non-iodine accumulating DTC, so far only evident after futile blind 131I therapy, require restaging before local or systemic therapy may be installed. Metabolic PET imaging with the glucose analogon 18F-fluorodeoxyglucose (FDG), stimulated with rhTSH, has a high sensitivity for recurrent DTC in patients with detectable Tg and negative iodine scintigraphy, may correlate with a more aggressive tumor behaviour and poor prognosis, and is able to select patients for additional surgery or external beam radiotherapy. This technique is currently applied only when prior treatment and imaging with high dose 131I has proven to be ineffective. The value of FDG-PET before 131I treatment has not been tested. The uptake of 124iodine and FDG are related to histopathological characteristics of tumor tissue, such as the resected primary tumor or metastases. 124I uptake is related to expression of the sodium iodine symporter (NIS), while FDG uptake is related to hexokinase-I (HKI) activity. The power of combined 124I-PET and FDG-PET for detection and characterization of DTC lesions has been suggested in proof of concept studies. The relation of these imaging findings and histopathological parameters (such as thyroglobulin, TTF1, Ki-67 and Cytokeratine-19 staining) and response to 131I treatment has not been elucidated in sufficiently large series. Based on the characteristics of 124I-PET and FDG-PET, it is reasonable to assume that a combined strategy of imaging and histopathological evaluation at the time of suspected recurrence will yield adequate information on the disease stage prior to treatment with 131I, regardless of tumor dedifferentiation, with a potential impact on clinical decision making. This hypothesis needs proper testing, to increase fundamental knowledge about DTC and further improve treatment. The multi-center design of this study requires a standard acquisition of the 124I-PET scans. Previously this was done for FDG-PET in the Netherlands, the so-called NEDPAS protocol. In order to compare the scans between the centers calibration and standardization of the 124I-PET scans prior to the start of the study will be done. Additional to this objective the study aims to answer whether thyroid hormone withdrawal and rhTSH preparation for the 124I-PET results in different scan results. In summary, high dose 131I treatment for recurrent DTC is effective in many cases, but the current blind approach also leads to overtreatment, delay, and unnecessary decrease in quality of life in a significant number of cases. As we have shown, a combination of diagnostic tests has a potential to allow earlier and better restaging and selection for treatment. The proposed trial aims to test the value and optimal implementation of these new tests, standalone and in combination, to derive parameters for a new personalised strategy for diagnosis and treatment of patients with (suspected) recurrent DTC. ### Conditions Module **Conditions:** - Thyroid Neoplasms - Differentiated Thyroid Cancer **Keywords:** - Recurrent differentiated thyroid cancer - I124-PET/CT - FDG-PET/CT ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 100 patients with biochemically suspected recurrent DTC **Label:** Suspected recurrent DTC ### Outcomes Module #### Primary Outcomes **Description:** In order to dertermine wheter a treatment could be considered futile a comparison between de I124-PET en post-therapy scan will be made and when the results are consistent we determine how many futile treatments could have been avoided when the I124 will be implemented in the future. **Measure:** The number of futile high-dose 131I treatments that could have been avoided by implementation of pre-therapy imaging based on result of post-therapy scintigraphy **Time Frame:** Baseline and post-therapy #### Secondary Outcomes **Description:** In order to make the scans quantifiable and comparable 124I-PET scans in this multicenter study a phantom study will be performed. The mean and median measured activity (Bq) in the different vials in the phantom will be assessed and compared to the known activity in the vial. In this way we will be able to create a calibration curve for each scanner. **Measure:** Synchronised QA/QC of 124I-PET in the Netherlands **Time Frame:** Before start study **Description:** - The outcome of the treatment is defined as a positive or negative post-therapy scan. This scan and both 124I-PET and FDG-PET will be correlated with histopathological features. The expression of different markers will be quantified in the samples. These results will also be compared with the results of the different scan modalities. In this way we aim to determine which histopathological features can predict outcome of the scans. **Measure:** - Translational correlation of 124I-PET and FDG-PET with histopathology (where available) and treatment outcome, in an explorative setting. **Time Frame:** At follow-up **Description:** Because 124I-PET will be performed both after stimulation with rhTSH and after withdrawal from levothyroxine it is possible to determine any differences in outcome from the two scan preparation strategies. Both visual assessment as the quantifiable data will be compared. **Measure:** - To investigate whether 124I-PET has the same diagnostic, dosimetric and prognostic yield during stimulation with rhTSH and hormone withdrawal combined with low-iodine diet. **Time Frame:** Baseline and during therapy ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with a history of differentiated thyroid cancer * After complete thyroidectomy and ablation of functional remnants with 131I. * Planned for blind high dose 131I treatment based on biochemically suspected recurrence, defined as a Tg-level above 2.0 ng/ml. * Ultrasonography of the neck performed \< 2 months prior to inclusion. Exclusion Criteria: * Age \< 18 years * Pregnancy * Incapacitated subjects * Contrast enhanced CT performed \< 4 months prior to inclusion * I-131 therapy performed \< 12 months prior to inclusion * Indication for other therapy modality (ie. surgery in case of a positive ultrasonography, radiotherapy, embolization or chemotherapy) **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** 100 patients with a history of DTC treated with total thyroidectomy and ablation who now have a suspicion of recurrence outside the neck based on a raised Tg and a negative neck ultrasound ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jakob W Kist, MD **Phone:** +31641853004 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Marcel PM Stokkel, MD PhD **Phone:** +31205122283 **Role:** CONTACT #### Locations **Location 1:** **City:** Arnhem **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Vanessa JR Schelfhout, MD - **Phone:** +31 88 005 8888 - **Role:** CONTACT ***Contact 2:*** - **Name:** Vanessa JR Schelfhout, MD PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Netherlands **Facility:** Rijnstate Hospital **State:** Gelderland **Zip:** 6815 AD **Location 2:** **City:** Nijmegen **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Martin Gotthardt, MD PhD - **Phone:** +31243611111 - **Role:** CONTACT ***Contact 2:*** - **Name:** Martin Gotthardt, MD PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Rick Hermsen, MD - **Role:** SUB_INVESTIGATOR **Country:** Netherlands **Facility:** UMC St. Radboud Nijmegen **State:** Gelderland **Zip:** 6525 GA **Location 3:** **City:** Tilburg **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Arjen B van Dijk, MD - **Phone:** +31 13 5947715 - **Role:** CONTACT ***Contact 2:*** - **Name:** Arjen B van Dijk, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Netherlands **Facility:** Bernard Verbeeten Institute **State:** Noord-Braband **Zip:** 5000 LA **Location 4:** **City:** Den Bosch **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Corneline J Hoekstra, MD PhD - **Phone:** +31 73 553 2690 - **Role:** CONTACT ***Contact 2:*** - **Name:** Corneline J Hoekstra, MD PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Netherlands **Facility:** Jeroen Bosch Hospital **State:** Noord-Brabant **Zip:** 5223 GZ **Location 5:** **City:** Eindhoven **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Dyde Huysmans, MD PhD - **Phone:** +31 40 239 9111 - **Role:** CONTACT ***Contact 2:*** - **Name:** Dyde Huysmans, MD PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Netherlands **Facility:** Catharina Hospital **State:** Noord-Brabant **Zip:** 5623 EJ **Location 6:** **City:** Alkmaar **Country:** Netherlands **Facility:** Medical Center Alkmaar **State:** Noord-Holland **Zip:** 1815JD **Location 7:** **City:** Amsterdam **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Farida Sivro, MD - **Phone:** +31 20 510 8877 - **Role:** CONTACT ***Contact 2:*** - **Name:** Ferida Sivro, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Netherlands **Facility:** St. Lucas Andreas Hospital **State:** Noord-Holland **Zip:** 1061 AE **Location 8:** **City:** Amsterdam **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Otto S Hoekstra, MD PhD - **Phone:** +31 20 4444214 - **Role:** CONTACT ***Contact 2:*** - **Name:** Otto S Hoekstra, MD PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Netherlands **Facility:** VUmc Medical Center **State:** Noord-Holland **Zip:** 1081HV **Location 9:** **City:** Enschede **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Wieger I de Bruin, MD - **Phone:** +31 53 4872088 - **Role:** CONTACT ***Contact 2:*** - **Name:** Wieger I de Bruin, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Netherlands **Facility:** Medical spectrum Twente **State:** Overijssel **Zip:** 7500 KA **Location 10:** **City:** Zwolle **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Piet L Jager, MD PhD - **Phone:** +31 38 424 7909 - **Role:** CONTACT ***Contact 2:*** - **Name:** Piet L Jager, MD PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Netherlands **Facility:** Isala Clinics **State:** Overijssel **Zip:** 8025 AB **Location 11:** **City:** Amersfoort **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** John MH de Klerk, MD PhD - **Phone:** +31338505050 - **Phone Ext:** 2876 - **Role:** CONTACT ***Contact 2:*** - **Name:** John MH de Klerk, MD PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Netherlands **Facility:** Meander Medical Center **State:** Utrecht **Zip:** 3818 ES **Location 12:** **City:** Nieuwegein **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jules Lavalaye, MD PhD - **Phone:** +31 88 320 3000 - **Role:** CONTACT ***Contact 2:*** - **Name:** Jules Lavalaye, MD PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Netherlands **Facility:** St. Antonius hospital **State:** Utrecht **Zip:** 3435 CM **Location 13:** **City:** Leiden **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Bernies van der Hiel, MD PhD - **Phone:** +31715263475 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Daphne DD Rietbergen, MD - **Phone:** +31715263466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Bernies van der Hiel, MD PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Netherlands **Facility:** Leiden University Medical Center **State:** Zuid-Holland **Zip:** 2333ZA **Location 14:** **City:** Groningen **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Adrienne H Brouwers, MD PhD - **Phone:** +31503611319 - **Role:** CONTACT ***Contact 2:*** - **Name:** Adrienne H Brouwers, MD PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Netherlands **Facility:** University Medical Center Groningen **Zip:** 9700 RB **Location 15:** **City:** Utrecht **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Bart de Keizer, MD PhD - **Phone:** +31 88 755 5555 - **Phone Ext:** 1794 - **Role:** CONTACT ***Contact 2:*** - **Name:** Bart de Keizer, MD PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Netherlands **Facility:** University Medical Center Utrecht **Zip:** 3584 CX #### Overall Officials **Official 1:** **Affiliation:** The Netherlands Cancer Institute **Name:** Marcel PM Stokkel, MD PhD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Kist JW, de Keizer B, Stokkel MP, Hoekstra OS, Vogel WV; THYROPET study group. Recurrent differentiated thyroid cancer: towards personalized treatment based on evaluation of tumor characteristics with PET (THYROPET Study): study protocol of a multicenter observational cohort study. BMC Cancer. 2014 Jun 5;14:405. doi: 10.1186/1471-2407-14-405. **PMID:** 24906384 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004700 - Term: Endocrine System Diseases - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000006258 - Term: Head and Neck Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M16718 - Name: Thyroid Diseases - Relevance: HIGH - As Found: Thyroid - ID: M16723 - Name: Thyroid Neoplasms - Relevance: HIGH - As Found: Thyroid Cancer - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013964 - Term: Thyroid Neoplasms - ID: D000013959 - Term: Thyroid Diseases ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03820479 **Brief Title:** A Study to Investigate Quality of Recovery up to Day 7 in Females Undergoing Laparoscopic Abdominal Surgery Provided Apfel-score Based PONV Care and Prophylaxis **Official Title:** An Observational Study to Investigate Quality of Recovery, the Incidence and Impact of Post-Operative Nausea and Vomiting (PONV)/Post-Discharge Nausea and Vomiting (PDNV) up to Day 7 in Females Undergoing Laparoscopic Abdominal Surgery Provided Apfel-score Based PONV Care and Prophylaxis #### Organization Study ID Info **ID:** DanderydH #### Organization **Class:** OTHER **Full Name:** Danderyd Hospital ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-12-07 **Type:** ACTUAL **Last Update Submit Date:** 2023-12-06 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2024-02-28 **Type:** ESTIMATED #### Start Date **Date:** 2019-02-11 **Type:** ACTUAL **Status Verified Date:** 2023-12 #### Study First Post Date **Date:** 2019-01-29 **Type:** ACTUAL **Study First Submit Date:** 2019-01-23 **Study First Submit QC Date:** 2019-01-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Danderyd Hospital #### Responsible Party **Investigator Affiliation:** Danderyd Hospital **Investigator Full Name:** EmmaObrink **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** SYNOPSIS Title: An observational study to investigate Quality of Recovery and the incidence and impact of Post-Operative Nausea and Vomiting (PONV)/Post-Discharge Nausea and Vomiting (PDNV) and up to 7 days in females undergoing laparoscopic abdominal surgery provided Apfel-score based PONV care and prophylaxis. Study period: September 2018- September 2019 Hypothesis: When a high risk patient, Apfel-score 3 or 4, is given Apfel-score based PONV care with strict adherence to PONV guidelines there should be no difference in Quality of Recovery between a high-risk patient and a low-risk patient. Aim: The aim of the study is to investigate if it is possible to reach no difference in Quality of Recovery (QoR) between a high-risk patient and a low risk patient using Apfel-score based PONV care. Primary objective: Assessing Quality of Recovery, using QoR15 at 24h, 48h, 72h and after 7 days. Secondary objectives: Assessing the incidence and severity of PONV and PDNV in females undergoing laparoscopic surgery up to 72h. Assessing PONV and PDNV severity and duration. Nicotine habits and impact on PONV. Study outline: Females scheduled for elective abdominal laparoscopic surgery will be provided PONV care based on Apfel risk-score. All patients will fill in the QoR15 form before surgery (base line). PONV and PDNV will be assessed in the PACU postoperatively, after 24h, 48h and 72h. Quality of Recovery will be assessed up to 7 days after surgery. Treatment: The females will be given ordinary care after local routines, with strict adherence to PONV guidelines. Study population: 100 females aged 18-65, ASA 1-2, undergoing laparoscopic abdominal surgery in Danderyds Hospital. Primary outcome variables and examinations: When the QoR 15 reaches base line or better after surgery. Number of times the females experience nausea, retching or vomiting and the impact of emetic symptoms on the QoR. ### Conditions Module **Conditions:** - Quality of Recovery **Keywords:** - Quality of recovery - PONV - PDNV ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 7 Days ### Arms Interventions Module #### Arm Group 1 **Description:** Female **Intervention Names:** - Other: Protocol **Label:** Apfel score 1 #### Arm Group 2 **Description:** Female, non smoker **Intervention Names:** - Other: Protocol **Label:** Apfel score 2 #### Arm Group 3 **Description:** Female, non smoker, under 40 years old **Intervention Names:** - Other: Protocol **Label:** Apfel score 3 #### Arm Group 4 **Description:** Female, non smoker, under 40 years old, previous history of PONV **Intervention Names:** - Other: Protocol **Label:** Apfel score 4 ### Interventions #### Intervention 1 **Arm Group Labels:** - Apfel score 1 - Apfel score 2 - Apfel score 3 - Apfel score 4 **Description:** Best practice of protocol **Name:** Protocol **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Score, a valid questionnaire to measure quality of recovery, 15 questions, maximum score 150p. VAS scales for each items; 0 bad score, 10 optimal score. Mean values for group, sum score will be compared with parametric tests. **Measure:** Quality of recovery, QoR15 (Quality of Recovery 15) **Time Frame:** 7 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ASA class 1-2 Exclusion Criteria: * ASA 4, obese **Gender Based:** True **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Female undergoing laparoscopic surgery ### Contacts Locations Module #### Locations **Location 1:** **City:** Stockholm **Country:** Sweden **Facility:** Danderyds Sjukhus ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12273 - Name: Nausea - Relevance: LOW - As Found: Unknown - ID: M17582 - Name: Vomiting - Relevance: LOW - As Found: Unknown - ID: M22074 - Name: Postoperative Nausea and Vomiting - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06218979 **Acronym:** KF2022#3 **Brief Title:** KF2022#3-trial: Effect of Tea and Cola Beverage on Absorption of Risperidone Oral Solution **Official Title:** KF2022#3-tutkimus: Teen ja Kolajuoman Vaikutus Risperidoni-oraaliliuoksen Imeytymiseen #### Organization Study ID Info **ID:** KF2022#3 #### Organization **Class:** OTHER **Full Name:** Helsinki University Central Hospital ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-01-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-01-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-12-04 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2024-01-23 **Type:** ACTUAL **Study First Submit Date:** 2023-12-04 **Study First Submit QC Date:** 2024-01-22 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Helsinki #### Lead Sponsor **Class:** OTHER **Name:** Helsinki University Central Hospital #### Responsible Party **Investigator Affiliation:** Helsinki University Central Hospital **Investigator Full Name:** Janne Backman **Investigator Title:** Professor, head physician **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Risperidone is widely used in the treatment of schizophrenia, bipolar disorder, and aggression associated with moderate or severe Alzheimer's dementia. In vitro studies have shown that constituents of tea and cola beverages can result in insoluble complex formation with risperidone, potentially reducing risperidone oral absorption. The purpose of this study is to investigate the effect of tea and cola beverage on the pharmacokinetics of risperidone oral solution. In an open three-phase, randomized, crossover study with 12 healthy volunteers, the subjects will receive a 1 mg dose of risperidone oral solution with either water, tea or cola beverage. Blood samples will be collected and risperidone's pharmacokinetics will be monitored up to 48 hours postdose. Primary endpoint is area under the plasma concentration-time curve of risperidone. Recruitment starting date is December 4, 2023. ### Conditions Module **Conditions:** - Psychosis - Food-drug Interaction ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 12 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Study drug dose (1 mg risperidone) and 250 ml of water at 8:00 a.m., and 250 ml of water at 8:30 a.m. **Intervention Names:** - Drug: Risperidone oral solution **Label:** Control phase **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** Study drug dose (1 mg risperidone) and 250 ml of tea at 8:00 a.m., and 250 ml of tea at 8:30 a.m. **Intervention Names:** - Drug: Risperidone oral solution **Label:** Tea phase **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Study drug dose (1 mg risperidone) and 250 ml cola drink at 8:00 a.m., and 250 ml cola beverage at 8:30 a.m. **Intervention Names:** - Drug: Risperidone oral solution **Label:** Cola beverage phase **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Cola beverage phase - Control phase - Tea phase **Description:** See arm/group descriptions **Name:** Risperidone oral solution **Other Names:** - Twinings English Breakfast tea - Pepsi Max beverage **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Area under the plasma concentration - time curve of risperidone **Time Frame:** Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone #### Secondary Outcomes **Measure:** Peak plasma concentration for both risperidone and its metabolites **Time Frame:** Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone **Measure:** Half-life for both risperidone and its metabolites **Time Frame:** Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone **Measure:** Time to peak plasma concentration for both risperidone and its metabolites **Time Frame:** Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone **Measure:** Fractional areas under concentration-time curve (AUC) for both risperidone and its metabolites **Time Frame:** Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone **Measure:** Areas under concentration-time curve (AUC) for risperidone metabolites **Time Frame:** Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone **Measure:** CYP2D6 activity biomarkers (solanidine and its metabolites) **Time Frame:** Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Written informed consent * Age 18-45 * Healthy * Systolic blood pressure ≥110 mmHg * Heart rate ≥ 50/min * Normal ECG * Accepted results from laboratory tests (blood haemoglobin, basic blood count and blood platelets, alanine aminotransferase, alkaline phosphatase, glutamyl transferase, creatinine, plasma potassium and sodium). Negative pregnancy test result (serum human chorionic gonadotropin) for women. Exclusion Criteria: * Significant disease * Mood disorder or suicidality * Smoking * Using oral contraception pills or other regular medication * Pregnancy (current or planned) or nursing * Participation in any other studies involving investigational or marketed drug products within three months prior to the entry into this study * Donation of blood within three months prior to the entry into this study * Significant overweight / small or hard-to-find veins * BMI \< 18.5 kg/m2 * Insufficient Finnish language skills **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Janne T Backman, MD, PhD **Phone:** +35894711 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Laura Tervala **Phone:** +35894711 **Role:** CONTACT #### Locations **Location 1:** **City:** Helsinki **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Janne Backman, MD, PhD - **Phone:** +35894711 - **Role:** CONTACT **Country:** Finland **Facility:** Department of Clinical Pharmacology **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Professor, Head physician **Name:** Janne Backman, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019967 - Term: Schizophrenia Spectrum and Other Psychotic Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: HIGH - As Found: Psychosis - ID: M15376 - Name: Schizophrenia - Relevance: LOW - As Found: Unknown - ID: M21838 - Name: Schizophrenia Spectrum and Other Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011618 - Term: Psychotic Disorders ### Intervention Browse Module - Ancestors - ID: D000012702 - Term: Serotonin Antagonists - ID: D000018490 - Term: Serotonin Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000014150 - Term: Antipsychotic Agents - ID: D000014149 - Term: Tranquilizing Agents - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000011619 - Term: Psychotropic Drugs - ID: D000018492 - Term: Dopamine Antagonists - ID: D000015259 - Term: Dopamine Agents ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: CaAg - Name: Cardiotonic Agents - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M20999 - Name: Risperidone - Relevance: HIGH - As Found: Evening - ID: M15512 - Name: Serotonin - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M16904 - Name: Antipsychotic Agents - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown - ID: M7473 - Name: Dopamine - Relevance: LOW - As Found: Unknown - ID: M20596 - Name: Dopamine Antagonists - Relevance: LOW - As Found: Unknown - ID: M17962 - Name: Dopamine Agents - Relevance: LOW - As Found: Unknown - ID: T312 - Name: Tea - Relevance: LOW - As Found: Unknown - ID: T120 - Name: Cola - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000018967 - Term: Risperidone ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06137079 **Brief Title:** "Iron Overload and Endocrinological Diseases" **Official Title:** "Iron Overload and Endocrinological Diseases" #### Organization Study ID Info **ID:** 24/13 #### Organization **Class:** OTHER **Full Name:** Azienda Ospedaliero-Universitaria di Modena ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-11-18 **Type:** ACTUAL **Last Update Submit Date:** 2023-11-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2013-06-20 **Status Verified Date:** 2023-11 #### Study First Post Date **Date:** 2023-11-18 **Type:** ACTUAL **Study First Submit Date:** 2023-11-08 **Study First Submit QC Date:** 2023-11-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Azienda Ospedaliero-Universitaria di Modena #### Responsible Party **Investigator Affiliation:** Azienda Ospedaliero-Universitaria di Modena **Investigator Full Name:** Vincenzo Rochira **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Patients with hemochromatosis or Thalassemia develop progressive tissue and organs damages secondary to iron overload. Iron overload can result both from transfusional hemosiderosis and excess gastrointestinal iron absorption. Iron deposition in the heart, liver, and multiple endocrine glands results in severe damage to these organs, with variable degrees of endocrine and organ failure. Although patients with iron overload often present endocrine disorders, the pathogenetic mechanisms underlying endocrinopathies are not completely clear. In particular it is not elucidated if the spectrum of endocrinopathies could change with advancing age. All endocrinological comorbidities can develop from a primary damage of the target gland, from pituitary secondary failure or from both. The aim of this study is to investigate the prevalence of endocrinological diseases in adult patients with iron overload due to β-thalassemia or hemochromatosis and their impact on well-being and quality of life. The study design is a prospective cross-sectional clinical study. All subjects enrolled will be evaluated for the endocrine diseases. The study protocol will include data collection from family and patients' history of diseases, physical examination, hormonal assessment for all endocrine axes and instrumental examinations. The results will provide evidence on the prevalence of endocrine diseases in patients with iron overload and will add information to characterize the type and the degree of endocrine deficiencies, and on the pathogenic mechanisms involved, in order to individualize diagnostic and therapeutic approaches. ### Conditions Module **Conditions:** - Iron Overload - Thalassemia Major - Thalassemia Intermedia - Hemochromatosis - Endocrinopathy ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 62 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Measure:** Estimate prevalence of endocrine comorbidities of β-thalassemia in adulthood **Time Frame:** 12 years #### Secondary Outcomes **Measure:** Evaluate prevalence of endocrine diseases to characterize the type and the degree of endocrine deficiencies **Time Frame:** 12 years **Measure:** Evaluate incidence of endocrine diseases to characterize the type and the degree of endocrine deficiencies **Time Frame:** 12 years **Measure:** To investigate the relationships among iron status and endocrine alterations in these group of patients **Time Frame:** 12 years **Measure:** To investigate the relationships among iron status and cardiac disease in these group of patients **Time Frame:** 12 years **Measure:** To investigate the relationships among iron status and liver disease in these group of patients **Time Frame:** 12 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Certain diagnosis of β-thalassemia major or intermedia * Certain diagnosis of Hereditary Hemochromatosis * Adult patients with an age between 18 and 65 years Exclusion Criteria: * Subjects with an age \< 18 and \> 65 years **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adult patients with a confirmed diagnosis of β-thalassemia (major or intermedia) or with a diagnosis of hemochromatosis enrolled at the "Unit of Endocrinology, Department of Medical Specialties, Azienda Ospedaliero-Universitaria di Modena Policlinico di Modena, Ospedale Civile di Baggiovara, Modena, Italy". Since thalassemia is a rare pathology and considering that the involvement of the endocrine glands in thalassemic patients is extremely common (it is expected to find at least one impaired endocrinological axis in each patient), the number of patients the investigators will enroll is appropriate to make an estimation of the prevalence of endocrine deficiency. Patients will be considered eligible according to the inclusion and exclusion criteria, independently from the presence/absence of known endocrine diseases and after providing their informed signed consent. ### Contacts Locations Module #### Locations **Location 1:** **City:** Modena **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Vincenzo Rochira, Professor - **Phone:** +390593962453 - **Role:** CONTACT **Country:** Italy **Facility:** Unit of Endocrinology of Azienza Ospedaliero-Universitaria di Modena **Status:** RECRUITING ## Derived Section ### Condition Browse Module - Ancestors - ID: D000000745 - Term: Anemia, Hemolytic, Congenital - ID: D000000743 - Term: Anemia, Hemolytic - ID: D000000740 - Term: Anemia - ID: D000006402 - Term: Hematologic Diseases - ID: D000006453 - Term: Hemoglobinopathies - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000019189 - Term: Iron Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000008664 - Term: Metal Metabolism, Inborn Errors - ID: D000008661 - Term: Metabolism, Inborn Errors ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16557 - Name: Thalassemia - Relevance: HIGH - As Found: Thalassemia - ID: M19408 - Name: beta-Thalassemia - Relevance: HIGH - As Found: Thalassemia Intermedia - ID: M21178 - Name: Iron Overload - Relevance: HIGH - As Found: Iron Overload - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M9518 - Name: Hemochromatosis - Relevance: HIGH - As Found: Hemochromatosis - ID: M9572 - Name: Hemosiderosis - Relevance: HIGH - As Found: Hemochromatosis - ID: M4070 - Name: Anemia - Relevance: LOW - As Found: Unknown - ID: M9547 - Name: Hemolysis - Relevance: LOW - As Found: Unknown - ID: M4073 - Name: Anemia, Hemolytic - Relevance: LOW - As Found: Unknown - ID: M4075 - Name: Anemia, Hemolytic, Congenital - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M9539 - Name: Hemoglobinopathies - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M21177 - Name: Iron Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M11641 - Name: Metabolism, Inborn Errors - Relevance: LOW - As Found: Unknown - ID: M11644 - Name: Metal Metabolism, Inborn Errors - Relevance: LOW - As Found: Unknown - ID: T5622 - Name: Thalassemia - Relevance: HIGH - As Found: Thalassemia - ID: T737 - Name: Beta-thalassemia - Relevance: HIGH - As Found: Thalassemia Intermedia - ID: T2699 - Name: Hemochromatosis Type 3 - Relevance: HIGH - As Found: Hemochromatosis - ID: T2716 - Name: Hemosiderosis - Relevance: HIGH - As Found: Hemochromatosis ### Condition Browse Module - Meshes - ID: D000013789 - Term: Thalassemia - ID: D000017086 - Term: beta-Thalassemia - ID: D000006432 - Term: Hemochromatosis - ID: D000019190 - Term: Iron Overload - ID: D000006486 - Term: Hemosiderosis ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M10533 - Name: Iron - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03579979 **Brief Title:** Sentinel Lymph Node Biopsy in Breast Cancer Surgery Using ICG **Official Title:** To Evaluate the Safety and Efficacy of Near-infarred Fluorescence Molecular Imaging in the Prospective, Multi-center and Self-controlled Clinical Trial of Sentinel Lymph Node Biopsy in Breast Cancer Surgery #### Organization Study ID Info **ID:** CIP-DPM-02 #### Organization **Class:** OTHER_GOV **Full Name:** Chinese Academy of Sciences ### Status Module #### Completion Date **Date:** 2020-08-19 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2021-08-04 **Type:** ACTUAL **Last Update Submit Date:** 2021-08-03 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-08-30 **Type:** ACTUAL #### Start Date **Date:** 2017-08-24 **Type:** ACTUAL **Status Verified Date:** 2021-08 #### Study First Post Date **Date:** 2018-07-09 **Type:** ACTUAL **Study First Submit Date:** 2018-06-08 **Study First Submit QC Date:** 2018-07-05 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Beijing Digital Precesion Medicine Company **Class:** OTHER **Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences **Class:** OTHER **Name:** Beijing Friendship Hospital **Class:** OTHER **Name:** Tangshan People's Hospital **Class:** OTHER **Name:** The Second Hospital of Hebei Medical University #### Lead Sponsor **Class:** OTHER_GOV **Name:** Chinese Academy of Sciences #### Responsible Party **Investigator Affiliation:** Chinese Academy of Sciences **Investigator Full Name:** Chongwei Chi, Ph.D **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This clinical trial is a prospective, multicenter, self-controlled clinical study. In order to meet the requirements of this plan, 130 breast cancer patients need the sentinel lymph node biopsy with novel near-infarred fluorescence imaging system produced by Beijing digital precision medical technology co., LTD. The fluorescence molecular imaging of indocyanine green (ICG) on imaging detection and the control group, routine medical using methylene blue test .The safety and efficacy of fluorescence and staining in sentinel lymph node biopsy of breast cancer were compared. **Detailed Description:** This trial was a prospective, multicenter, and self controlled clinical trial. The subjects who were in line with this scheme were detected by fluorimetry and staining, and the primary effectiveness evaluation index, secondary effectiveness evaluation index and safety evaluation index were established during the operation. Record evaluation. At present, in the clinic for sentinel lymph node biopsy of breast cancer, routine medical treatment is a blue staining method. A large number of clinical data show that the number of blue staining methods was 1-2.4, and the number of fluorescence detection is 2-3.7. Therefore, choosing a self controlled clinical trial can increase the number of sentinel lymph node detection. ### Conditions Module **Conditions:** - Sentinel Lymph Node - Breast Cancer **Keywords:** - Near-infrared fluorescence - Image guided surgery - Sentinel lymph node biopsy - Indocyanine green - Methylene blue ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 130 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** During the operation, with the fluorescent molecular imaging instrument, the imaging agent (indocyanine green) is illuminated by the probe distance to the tissue surface 10-30cm, and is excited to produce the near infrared fluorescence of the specific wavelength (the human eye is not visible). The system uses a photoelectric coupler to collect the light of the specific spectrum, and the image is collected by the method of correction. The operation was performed to achieve real-time display of lesions. The injection points were selected subcutaneously around the areola or the periphery of the tumor. 1% methylene blue 0.5ml was injected at each point, with a total of 2-3 points. Within 5 minutes, 2.5mg/ml ICG 0.5ml was injected at each point, with a total of 2-3 points. **Intervention Names:** - Drug: Methylene Blue - Drug: Indocyanine Green **Label:** Self control **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Self control **Description:** Subcutaneous injection of injection point at the periphery of the areola or tumor, injecting 1% methylene blue 0.5ml at each point, a total of 2-3 points. **Name:** Methylene Blue **Other Names:** - MB **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Self control **Description:** Within 5 minutes after MB injection, 2.5mg/ml ICG 0.5ml was injected at each point, a total of 2-3 points. Methylene blue and ICG injection points do not coincide **Name:** Indocyanine Green **Other Names:** - ICG **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Participants will be followed for the duration of hospital stay, an expected average of 1 year **Measure:** Sentinel lymph node detection number **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. the age of 18-75 years, female patients; 2. the diagnosis of breast cancer by biopsy; 3. participants voluntarily participated in the clinical trial and signed informed consent. Exclusion Criteria: 1. had received SLNB or axillary surgery; 2. breast area radiotherapy or neoadjuvant chemotherapy has been accepted. 3. clinical hints of axillary lymph node metastasis; 4. discovery of distant metastasis; 5. inflammatory breast cancer; 6. women in pregnancy; 7. people with iodine allergy; 8. the serum creatinine was \> 1.5 times as high as the upper limit of the normal value. 9. to participate in clinical trials of other devices or drugs within one month; 10. the researchers consider it inappropriate to participate in this clinical trial. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Beijing **Country:** China **Facility:** Key Laboratory of Molecular Imaging, Chinese Academy of Sciences **State:** Beijing **Zip:** 100190 ### References Module #### References **Citation:** He K, Chi C, Kou D, Huang W, Wu J, Wang Y, He L, Ye J, Mao Y, Zhang GJ, Wang J, Tian J. Comparison between the indocyanine green fluorescence and blue dye methods for sentinel lymph node biopsy using novel fluorescence image-guided resection equipment in different types of hospitals. Transl Res. 2016 Dec;178:74-80. doi: 10.1016/j.trsl.2016.07.010. Epub 2016 Jul 18. **PMID:** 27497181 **Citation:** Chi C, Ye J, Ding H, He D, Huang W, Zhang GJ, Tian J. Use of indocyanine green for detecting the sentinel lymph node in breast cancer patients: from preclinical evaluation to clinical validation. PLoS One. 2013 Dec 16;8(12):e83927. doi: 10.1371/journal.pone.0083927. eCollection 2013. **PMID:** 24358319 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### Intervention Browse Module - Ancestors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11726 - Name: Methylene Blue - Relevance: HIGH - As Found: Hyperactivity Disorder - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000008751 - Term: Methylene Blue ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06376279 **Brief Title:** Genetic Diagnosis in Inborn Errors of Metabolism **Official Title:** Genetisk Diagnostik Vid medfödda Metabola Sjukdomar #### Organization Study ID Info **ID:** 2008/351-31 #### Organization **Class:** OTHER_GOV **Full Name:** Region Stockholm ### Status Module #### Completion Date **Date:** 2030-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-04-19 **Type:** ACTUAL **Last Update Submit Date:** 2024-04-16 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2030-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2008-04-29 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2024-04-19 **Type:** ACTUAL **Study First Submit Date:** 2024-01-29 **Study First Submit QC Date:** 2024-04-16 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Karolinska Institutet #### Lead Sponsor **Class:** OTHER_GOV **Name:** Region Stockholm #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Inborn Errors of metabolism comprise a large number of rare conditions with a collective incidence of around 1/2000 newborns. Many disorders are treatable provided that a correct diagnosis can be established in time, and for many diseases novel therapies are being developed. Without treatment, many of the conditions result in early death or severe irreversible handicaps. The Centre for Inherited Metabolic Diseases, CMMS at Karolinska university hospital, is an integrated expert center where clinical specialists work closely together with experts in laboratory medicine, combining clinical genetics, clinical chemistry, pediatrics, neurology, and endocrinology. The center serves the whole Swedish population with diagnostics and expert advice on IEM and has a broad arsenal of biochemical investigations designed to detect defects in intermediary metabolism. **Detailed Description:** Approximately one in two thousand infants is born with a metabolic disorder that often leads to brain damage. By means of high-tech genetic mapping using whole genome sequencing (WGS), we have discovered the molecular foundations for several of these diseases. For investigation of mitochondrial diseases, mitochondria are isolated from muscle biopsies for analysis of ATP production using a range of substrate combinations, determination of activities of respiratory chain complexes, and analysis of nuclear and mitochondrial DNA. The center also performs the national neonatal screening program, currently comprising 26 treatable diseases. Dried blood spot samples (DBS) are stored in the phenylketonuria (PKU) biobank, currently (2024 january) holding around 4.9 million of Sweden's 10.6 million inhabitants. Many metabolic disorders, however, lack effective counter-measures. ### Conditions Module **Conditions:** - Metabolic Disease - Mitochondrial Diseases - Epilepsy in Children - Epilepsy - LHON - Motor Neuron Disease ### Design Module #### Bio Spec **Description:** Blood, Muscle biopsy, skin biopsy, fibroblasts, urine **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 1000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Data from IEM-inborn error of metabolism cohort of individuals **Name:** IEM-EP **Type:** GENETIC ### Outcomes Module #### Primary Outcomes **Description:** Variant identification in patients investigated at our clinic, Centre for inherited metabolic diseases, is an ongoing clinical activity. In many cases, if no variant is identified with NGS (Next Genenation Sequencing) using WGS, additional methods are used such as transcriptomics, proteomics and different cellmodels. More than 400 patients are investigated yearly with NGS/WGS in our clinic. **Measure:** Genetic variant identification using NGS for diagnosis **Time Frame:** Through study completion, an average of 1 year. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Medical inferral, suspicion metabolic disease incl epilepsy and their relatives Exclusion Criteria: * Disease other than metabolic **Healthy Volunteers:** True **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Inborn errors of metabolism, a group of around one thousand different monogenic diseases with a wide spectrum of presentation. ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Karolinska University Hospital, Karolinska Institutet **Name:** Anna Wedell **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000013118 - Term: Spinal Cord Diseases - ID: D000057177 - Term: TDP-43 Proteinopathies - ID: D000057165 - Term: Proteostasis Deficiencies ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M18879 - Name: Motor Neuron Disease - Relevance: HIGH - As Found: Motor Neuron Disease - ID: M4024 - Name: Amyotrophic Lateral Sclerosis - Relevance: HIGH - As Found: Motor Neuron Disease - ID: M7983 - Name: Epilepsy - Relevance: HIGH - As Found: Epilepsy - ID: M11639 - Name: Metabolic Diseases - Relevance: HIGH - As Found: Metabolic Diseases - ID: M23341 - Name: Mitochondrial Diseases - Relevance: HIGH - As Found: Mitochondrial Disease - ID: M11641 - Name: Metabolism, Inborn Errors - Relevance: LOW - As Found: Unknown - ID: M15415 - Name: Sclerosis - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M15915 - Name: Spinal Cord Diseases - Relevance: LOW - As Found: Unknown - ID: M28759 - Name: TDP-43 Proteinopathies - Relevance: LOW - As Found: Unknown - ID: M28747 - Name: Proteostasis Deficiencies - Relevance: LOW - As Found: Unknown - ID: T349 - Name: Amyotrophic Lateral Sclerosis - Relevance: HIGH - As Found: Motor Neuron Disease - ID: T4699 - Name: Primary Lateral Sclerosis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004827 - Term: Epilepsy - ID: D000016472 - Term: Motor Neuron Disease - ID: D000000690 - Term: Amyotrophic Lateral Sclerosis - ID: D000008659 - Term: Metabolic Diseases - ID: D000028361 - Term: Mitochondrial Diseases ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06298279 **Brief Title:** Assessing Social Learning and Course Delivery Timing in Internet-delivered Cognitive Behaviour Therapy for Public Safety Personnel **Official Title:** A Randomized Factorial Trial of Internet-delivered Cognitive Behaviour Therapy for Public Safety Personnel: Examining the Impact of Content Delivery Method #### Organization Study ID Info **ID:** 2023-436 #### Organization **Class:** OTHER **Full Name:** University of Regina ### Status Module #### Completion Date **Date:** 2025-04-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-03-07 **Type:** ACTUAL **Last Update Submit Date:** 2024-03-04 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-04-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-12 **Type:** ESTIMATED **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2024-03-07 **Type:** ACTUAL **Study First Submit Date:** 2024-02-14 **Study First Submit QC Date:** 2024-03-04 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Government of Canada #### Lead Sponsor **Class:** OTHER **Name:** University of Regina #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is a randomized factorial trial designed to evaluate unguided (i.e., purely self-help), transdiagnostic internet delivered cognitive behaviour therapy tailored for public safety personnel with tunneled of personalized course delivery and with or without the incorporation of social learning resources. **Detailed Description:** Background---- Public Safety Personnel (PSP) are at an increased risk of developing mental disorders. PSP also face many barriers to accessing mental health services (e.g., stigma, location, time). The PSP Wellbeing Course is a transdiagnostic internet-delivered cognitive behaviour therapy (ICBT) course that has been specifically tailored to PSP. The effectiveness of the therapist-guided course and a self-guided course have both been supported. Consistent with the larger literature on self-guided ICBT, engagement with and outcomes of the self-guided PSP Wellbeing Course could be strengthened. Persuasive design describes using technology to influence human behaviour. The current study is designed to assess the impact of different timing options (i.e., tunneled vs. personalized) and increased social learning (i.e., standard versus enhanced social learning) on user experience, adherence, and outcomes in ICBT. Methods--- Participants will be recruited via posts on the PSPNET social media platforms (i.e., Twitter and Facebook) and emails distributed by PSP organizations. Members of the PSPNET team will also reach out to contacts within PSP organizations to ask them to tell their colleagues about the proposed research. All interested participants will be directed to the study website (www.pspnet.ca) to complete an online screening questionnaire. As part of this questionnaire, they will be presented with a consent form explaining the screening. After consent is given, clients will be assessed for eligibility using an online screening questionnaire. The online screening questionnaire captures demographic information (e.g., sex, ethnicity, location), information about depression and other mental health issues, and background information (e.g., medical history, mental health history, symptoms). After completing the questionnaires, participant responses will be reviewed by PSP staff for eligibility. Clients who are eligible will be randomized into one of four conditions. Participants who do not meet criteria, but are over the age of 18, will not be randomized and will instead be enrolled into the "treatment-as-usual" version of the course, which consists of a tunneled delivery and standard resources. Ineligible participants' data will not be included in analyses. Individuals under the age of 18 will not be eligible for any services.The two factors in the trial are: Factor 1: Tunneled course delivery or personalized course delivery Factor 2: Standard or enhanced social learning resources. As this is a factorial trial with two factors, each client will be randomized to one of four conditions: Condition 1: Tunneled Delivery and Standard Resources Condition 2: Tunneled Delivery and Enhanced Social Learning Resources Condition 3: Personalized Delivery and Standard Resources Condition 4: Personalized Delivery and Enhanced Social Learning Resources Randomization will occur within 2 business-days of completion of the screening questionnaires. All participants will receive the Self-Guided PSP Wellbeing Course, a transdiagnostic internet intervention. The program is an adaptation of a previous Australian course, the Wellbeing Course. The course involved 5 lessons that are typically completed over an 8 week period, though participants will have access to the course materials for up to 26 weeks. The content is focused on cognitive behavior therapy and relapse prevention. Materials are presented in a didactic (i.e., text-based with visual images) and case-enhanced learning format (i.e., educational stories demonstrate the application of skills). All participants are presented with worksheets at the end of each lesson that contain exercises that facilitate skill acquisition. Participants will be sent automatic emails reminding them to stay engaged with the lessons and to complete questionnaires. Participants will complete questionnaires at screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment). ### Conditions Module **Conditions:** - Depression - Anxiety - Stress Disorders, Post-Traumatic ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** FACTORIAL **Intervention Model Description:** Factor 1: Tunneled or Personalized Course Delivery Factor 2: Standard or Enhanced Social Learning Resources Participants will be randomly assigned to one of four treatment conditions (tunneled delivery of ICBT with standard resources, tunneled delivery of ICBT with enhanced social learning resources, personalized delivery ICBT with standard resources, personalized delivery of ICBT with enhanced social learning resources) ##### Masking Info **Masking:** NONE **Masking Description:** Participants cannot be blinded to condition because ICBT (like other psychotherapies) cannot be both provided to and concealed from a participant. However, the difference between the four conditions (i.e., presence or absence of social learning resources, tunneled versus personalized course navigation) will be concealed from all participants. Because outcomes will be assessed via self-report questionnaire measures, outcomes assessor masking is not applicable. **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 164 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In this arm, participants will be guided through the Self-Guided PSP Wellbeing Course in a predetermined order and using predetermined timing. Future lessons will "unlock" as previous lessons are completed. Participants receiving the standard resources will be presented with resources that are typically presented in PSPNET courses. This includes lesson slides case stories, do-it yourself guides, and frequently asked questions pages. **Intervention Names:** - Behavioral: Tunneled Delivery - Behavioral: Standard Resources - Behavioral: Transdiagnostic Self-Guided ICBT **Label:** Tunneled Delivery/Standard Resources **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** In this arm, participants will be guided through the Self-Guided PSP Wellbeing Course in a predetermined order and using predetermined timing. Future lessons will "unlock" as previous lessons are completed. Participants receiving the enhanced social learning resources will receive the same resources offered in the standard conditions (i.e., lesson slides, case stories, do-it-yourself guides, and frequently asked questions pages) and will also receive additional resources. Additional resources will include homework records to accompany the case stories, de-identified quotations from previous clients for each lesson, and a motivational video encouraging them to engage with the course. **Intervention Names:** - Behavioral: Tunneled Delivery - Behavioral: Enhanced Social Learning Resources - Behavioral: Transdiagnostic Self-Guided ICBT **Label:** Tunneled Delivery/Enhanced Social Learning Resources **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** In this arm, participants will be able to navigate through the course modules in whichever order and at whatever pace they like. Participants will not have to complete one lesson in order to gain access to the following lesson. Participants receiving the standard resources will be presented with resources that are typically presented in the course. This includes lesson slides, case stories, do-it yourself guides, and frequently asked questions pages. **Intervention Names:** - Behavioral: Personalized Delivery - Behavioral: Standard Resources - Behavioral: Transdiagnostic Self-Guided ICBT **Label:** Personalized Delivery/Standard Resources **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** In this arm, participants will be able to navigate through the course modules in whichever order and at whatever pace they like. Participants will not have to complete one lesson in order to gain access to the following lesson. Participants receiving the enhanced social learning resources will receive the same resources offered in the standard conditions (i.e., lesson slides, case stories, do-it-yourself guides, and frequently asked questions pages) and will also receive additional resources. Additional resources will include homework records to accompany the case stories, de-identified quotations from previous clients for each lesson, and a motivational video encouraging them to engage with the course. **Intervention Names:** - Behavioral: Personalized Delivery - Behavioral: Enhanced Social Learning Resources - Behavioral: Transdiagnostic Self-Guided ICBT **Label:** Personalized Delivery/Enhanced Social Learning Resources **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Tunneled Delivery/Enhanced Social Learning Resources - Tunneled Delivery/Standard Resources **Description:** Participants will be offered a pre-determined pathway to completing the 8-week course **Name:** Tunneled Delivery **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Personalized Delivery/Enhanced Social Learning Resources - Personalized Delivery/Standard Resources **Description:** Participants will be able to complete course modules at their own pace and in the order that most interests them. **Name:** Personalized Delivery **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Personalized Delivery/Standard Resources - Tunneled Delivery/Standard Resources **Description:** Participants will receive the resources as typically included in the Self-Guided PSP Wellbeing Course. **Name:** Standard Resources **Type:** BEHAVIORAL #### Intervention 4 **Arm Group Labels:** - Personalized Delivery/Enhanced Social Learning Resources - Tunneled Delivery/Enhanced Social Learning Resources **Description:** Participants will receive additional intervention content. **Name:** Enhanced Social Learning Resources **Type:** BEHAVIORAL #### Intervention 5 **Arm Group Labels:** - Personalized Delivery/Enhanced Social Learning Resources - Personalized Delivery/Standard Resources - Tunneled Delivery/Enhanced Social Learning Resources - Tunneled Delivery/Standard Resources **Description:** An ICBT course that is completed without the guidance of a therapist. **Name:** Transdiagnostic Self-Guided ICBT **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** A semi-structured interview developed to assess for clients experiences within the course. **Measure:** Post-treatment Semi-structured interview **Time Frame:** 8-10 weeks (post-treatment) #### Primary Outcomes **Description:** Change in total GAD-7 anxiety score which can range from 0 to 21. Higher scores indicate greater anxiety (worse outcome) **Measure:** Generalized Anxiety Disorder 7-item (GAD-7) **Time Frame:** Screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment) **Description:** Change in total PHQ-9 score which can range from 0 to 27. Higher scores indicate greater depression (worse outcome) **Measure:** Patient Health Questionnaire-9 (PHQ-9) **Time Frame:** Screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment) **Description:** Change in total PCL-5 score which can range from 0 to 80. Higher scores indicate greater posttraumatic stress symptoms (worse outcome) **Measure:** PTSD Checklist for the DSM-5 (PCL-5) **Time Frame:** Screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment) **Description:** Internal portal recordings of participant how many lessons participants accessed, how many additional resources were accessed, and the dates of access. Greater course access is indicative of greater engagement within the course. **Measure:** Engagement **Time Frame:** From date of enrollment to 26 weeks (post-treatment) #### Secondary Outcomes **Description:** Change in total WSAS score which can range from 0 to 40. Higher scores indicate greater levels of distress related to functional impairment (worse outcome) **Measure:** Work and Social Adjustment Scale (WSAS) **Time Frame:** Screening, 8 weeks (post-treatment), and 20 weeks (post-treatment) **Description:** Change in total BRS score which can range from 0 to 30. Higher scores indicate greater resilience (better outcome) **Measure:** Brief Resilience Scale (BRS) **Time Frame:** Screening, 8 weeks (post-treatment), and 20 weeks (post-treatment) **Description:** Bespoke questionnaire regarding access to healthcare resources **Measure:** Healthcare Use Questionnaire **Time Frame:** Screening, 8 weeks (post-treatment), and 20 weeks (post-treatment) **Description:** Bespoke questionnaire inquiring about participants' experiences with the case stories. Participants receiving enhanced social learning resources will be asked additional questions about the enhanced social learning resources. **Measure:** Case Story Questionnaire **Time Frame:** 8-weeks (post-treatment) **Description:** Bespoke 7-item questionnaire assessing participants' treatment satisfaction. **Measure:** Treatment Satisfaction Questionnaire **Time Frame:** 8-weeks (post-treatment) **Description:** The DBCI is a questionnaire where participants are asked to rate their feelings of engagement with online interventions, which can range from 0-56. Higher scores are indicative of more positive feelings about engagement. **Measure:** Digital Behavior Change Interventions Engagement Scale (DCBI) **Time Frame:** 8-weeks (post-treatment) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * At least 18 years of age * Current or former public safety personnel (or public safety personnel trainee) * Residing in Canada at time of enrollment * Has regular access to the internet * Confirms intent to participate in study Exclusion Criteria: * Not 18 years of age or older * Not a current or former public safety personnel (or public safety personnel trainee) * Not residing in Canada at time of enrollment * Does not have regular access to the internet **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Heather D Hadjistavropoulos, PhD **Phone:** (306)585-5133 **Role:** CONTACT #### Locations **Location 1:** **City:** Regina **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Heather D Hadjistavropoulos, PhD - **Phone:** 306-585-5133 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Caeleigh A Landry, MSc - **Phone:** 306-337-2473 - **Role:** CONTACT ***Contact 3:*** - **Name:** Heather D Hadjistavropoulos, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Canada **Facility:** Department of Psychology, University of Regina **State:** Saskatchewan **Zip:** S4S 0A2 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000040921 - Term: Stress Disorders, Traumatic - ID: D000068099 - Term: Trauma and Stressor Related Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M16103 - Name: Stress Disorders, Post-Traumatic - Relevance: HIGH - As Found: Stress Disorders, Post-Traumatic - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M24916 - Name: Stress Disorders, Traumatic - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M222 - Name: Trauma and Stressor Related Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013313 - Term: Stress Disorders, Post-Traumatic ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00311779 **Brief Title:** A Dose Ranging Study of Different Strengths of Spinosad Topical Creme in Subjects With Pediculosis Capitis **Official Title:** Phase 2 Study of Efficacy and Safety of Different Strengths of Spinosad Topical Creme Rinse (0%, 0.5% or 1.0%) in Subjects 2 Years of Age or Older With Pediculosis Capitis - A Dose Ranging Study #### Organization Study ID Info **ID:** SPN-202-06 #### Organization **Class:** INDUSTRY **Full Name:** ParaPRO LLC ### Status Module #### Completion Date **Date:** 2006-07 #### Last Update Post Date **Date:** 2006-07-12 **Type:** ESTIMATED **Last Update Submit Date:** 2006-07-11 **Overall Status:** COMPLETED #### Start Date **Date:** 2006-03 **Status Verified Date:** 2006-07 #### Study First Post Date **Date:** 2006-04-06 **Type:** ESTIMATED **Study First Submit Date:** 2006-04-04 **Study First Submit QC Date:** 2006-04-04 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** ParaPRO LLC ### Description Module **Brief Summary:** The primary objective of the study is to determine the safety and efficacy of different strengths of Spinosad topical creme, as compared to a vehicle control, in subjects who have been infested with at least a mild case of Pediculosis capitis (head lice). **Detailed Description:** There are millions of children and adults affected with head lice each year in the United States. It has become a major nuisance in school children resulting in many lost school days and frustrated parents. Lice and nit (ova) resistance to current OTC products has been reported. Compliance with product instructions is thought to be low. Therefore a safe and effective alternative to these products is desirable. Spinosad and its formulations have been approved by the Environmental Protection Agency as crop protection products in the US, Canada and Australia, and has received provisional approval in the UK, Spain and several other European Union countries. Spinosad is being formulated as a creme rinse using excipients that are widely used and are "generally regarded as safe" (GRAS). This study is intended to show the safety and efficacy of Spinosad 0.5% and 1.0%, as compared to the vehicle control in subjects 2 years of age and older with at least a mild infestation of pediculosis capitis. ### Conditions Module **Conditions:** - Pediculosis Capitis (Head Lice) **Keywords:** - Pediculosis capitis - Head Lice - Crawlers - Ova ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** FACTORIAL ##### Masking Info **Masking:** SINGLE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 120 **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** Spinosad Creme Rinse **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Efficacy variable: The presence/absence of live lice and/or nits at Day 7 and Day 14. **Measure:** Safety Analyses: The assessment of safety will be based on frequency of adverse events and on the scalp evaluations for irritation. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Subject must have head lice infestation of at least a mild severity present at baseline of at least 3 live lice and the presence of nits; 2. Subject can be either male or female, 2 years or older 3. Subject must be in good general health, based on medical history. 4. Each subject must have a appropriately signed informed consent. 5. The parent or guardian of a child subject must be willing to allow other household members to be screened for head lice. If other household members are found to have a head lice infestation, they should also be enrolled in the study. If other household members are not willing to enroll in the study or do not qualify for enrollment, they must be willing to use the standard course of OTC lice treatment at home. 6. Subjects must agree to not use any other form of lice treatment during the course of the study. Subjects must also agree not to use a lice comb during the course of the study. 7. Subjects must agree not to cut or chemically treat their hair in the period between the Baseline treatment and the Day 14 visit. Exclusion Criteria: 1. Individuals with history of irritation or sensitivity to pediculicides or hair care products. 2. Individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel, will interfere with the evaluation. 3. Individuals previously treated with a pediculicide within the 4 weeks prior to the study. 4. Individuals who have used hair dyes, bleaches, permanent wave or relaxing solutions within the past 2 weeks or during the study. 5. Individuals with a condition or illness that, in the opinion of the investigator, may compromise the objective of the protocol. 6. Individuals receiving systemic or topical drugs or medications, including systemic antibiotics, which in the opinion of the investigative personnel may interfere with the study results. 7. Individuals who have participated in a clinical trial within the past 30 days. 8. Individuals who, in the opinion of the investigator, do not understand the subject requirements for study participation and/or may be likely to exhibit poor compliance. 9. Individuals with family members who are infested with lice but are unwilling or unable to enroll in the study or to ouse the standard course of lice treatment. 10. Females who are pregnant or nursing. 11. Sexually active females not using effective contraception. 12. Individuals who have a history of drug abuse in the past year. **Healthy Volunteers:** True **Minimum Age:** 2 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Scottsdale **Country:** United States **Facility:** Hill Top Resesarch **State:** Arizona **Zip:** 85251 **Location 2:** **City:** West Palm Beach **Country:** United States **Facility:** Hill Top Research **State:** Florida **Zip:** 33409 **Location 3:** **City:** Miamiville **Country:** United States **Facility:** Hill Top Research **State:** Ohio **Zip:** 45147 #### Overall Officials **Official 1:** **Affiliation:** Hill Top Research **Name:** Dyal Garg, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Hill Top Research **Name:** Robert Lewine, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** Hill Top Research **Name:** Michael Noss, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004478 - Term: Ectoparasitic Infestations - ID: D000012876 - Term: Skin Diseases, Parasitic - ID: D000010272 - Term: Parasitic Diseases - ID: D000007239 - Term: Infections - ID: D000012874 - Term: Skin Diseases, Infectious - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M13284 - Name: Lice Infestations - Relevance: HIGH - As Found: Pediculosis - ID: M13185 - Name: Parasitic Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M15679 - Name: Skin Diseases, Parasitic - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M15677 - Name: Skin Diseases, Infectious - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010373 - Term: Lice Infestations ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03033979 **Brief Title:** Prolonged Laryngeal Mask Airway ProSealTM Use **Official Title:** Prolonged Use of the Laryngeal Mask Airway ProSealTM: a Report of Seven Cases Lasting 5-11 Hours #### Organization Study ID Info **ID:** Schulthess_Anä_9 #### Organization **Class:** OTHER **Full Name:** Schulthess Klinik ### Status Module #### Completion Date **Date:** 2015-12-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-01-27 **Type:** ESTIMATED **Last Update Submit Date:** 2017-01-26 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2015-12-31 **Type:** ACTUAL #### Start Date **Date:** 2015-01-01 **Type:** ACTUAL **Status Verified Date:** 2017-01 #### Study First Post Date **Date:** 2017-01-27 **Type:** ESTIMATED **Study First Submit Date:** 2017-01-25 **Study First Submit QC Date:** 2017-01-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Schulthess Klinik #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The investigators conclude that use of the LMA ProSealTM for prolonged procedures is feasible. In principle, it should be safer and more effective than the LMA ClassicTM provided basic guidelines are followed. **Detailed Description:** There is controversy concerning use of the classic laryngeal mask airway (LMA ClassicTM) for prolonged procedures, particularly over 2 hours, as some clinicians consider it unsuitable for positive pressure ventilation (needed to counter the alleged progressive respiratory fatigue with time) and/or unsuitable for airway protection (needed to counter the alleged progressive increase in aspiration risk with time). The LMA ProSealTM is a laryngeal mask device with a modified cuff to facilitate ventilation and a drain tube to provide airway protection. In principle, the LMA ProSealTM should be more suitable than the LMA ClassicTM for prolonged procedures; however, there are only four reports and one case series. ### Conditions Module **Conditions:** - Airway Management ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 7 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Oropharyngeal leak pressure **Measure:** Feasibility of the LMA ProSealTM for prolonged use **Time Frame:** 30 Minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ASA 1 - 3 * Age 19-85 yr * Written informed consent Exclusion Criteria: * Difficult airway * Non fasted * BMI \> 35 **Maximum Age:** 85 Years **Minimum Age:** 19 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** We describe the use of the LMA ProSealTM in seven patients in a variety of clinical situations for procedures lasting more than 5 hours. ### Contacts Locations Module #### Locations **Location 1:** **City:** Zürich **Country:** Switzerland **Facility:** Christian Keller MD, M.Sc. **Zip:** 8008 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03670979 **Brief Title:** Periodontal Osseous Wall Piezosplitting and EDTA Root Surface Etching **Official Title:** A Novel Approach of Periodontal Osseous Wall Piezosplitting and EDTA Root Surface Etching in Management of Localized Intrabony Defects With Wide Angulation. Controlled Clinical Trial #### Organization Study ID Info **ID:** 839/2757 #### Organization **Class:** OTHER **Full Name:** Al-Azhar University ### Status Module #### Completion Date **Date:** 2017-01-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-02-14 **Type:** ACTUAL **Last Update Submit Date:** 2023-02-13 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-01-05 **Type:** ACTUAL #### Start Date **Date:** 2016-01-05 **Type:** ACTUAL **Status Verified Date:** 2023-02 #### Study First Post Date **Date:** 2018-09-14 **Type:** ACTUAL **Study First Submit Date:** 2018-08-01 **Study First Submit QC Date:** 2018-09-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Al-Azhar University #### Responsible Party **Investigator Affiliation:** Al-Azhar University **Investigator Full Name:** mahmoud eldestawy **Investigator Title:** lecturer, periodontology department **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study was designed to investigate the use of minimally invasive Piezo knife to harvest vascularized interceptal bone pedicle in treating intrabony defects. **Detailed Description:** Sixteen non-smoking patients with severe chronic periodontitis participated in this prospective, randomized clinical study. Patients were randomly assigned into one of a 2 groups (8 patients each): bone substitute grafting of the intrabony defect, control group (Gr1), intrabony defect osseous wall swaging (OWS) combined xenograft (Gr2). In both groups root surfaces where treated with a neutral 24% EDTA gel and saline irrigation. Clinical and radiographic measurements were reassessed at 6 months after surgery. ### Conditions Module **Conditions:** - Periodontitis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 16 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** xenograft alone **Intervention Names:** - Procedure: bone swaging **Label:** bone swaging alone **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** bone swaging with EDTA **Intervention Names:** - Procedure: bone swaging **Label:** bone swaging plus EDTA **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - bone swaging alone - bone swaging plus EDTA **Description:** osseous wall pedicle was placed to treat the infrabony defect by autogrnous bone **Name:** bone swaging **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** removing the defect as seen in radiograph defect filling with bone swaging with edta and bone substitute **Measure:** Radiographic evaluation **Time Frame:** 3 months #### Secondary Outcomes **Description:** By periodontal prob to measure the clinical parameter **Measure:** Clinical pocket depth **Time Frame:** 3month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. good compliance with plaque control instructions following initial therapy 2. teeth involved were all vital with no mobility ; 3. each subject contributed a single predominately 2 or 3-wall intrabony interproximal defect around premolar or molar teeth without furcation involvement; Exclusion Criteria: 1. no systemic diseases which could influence the outcome of therapy; 2. absence of periodontal treatment during the previous year. **Maximum Age:** 60 Years **Minimum Age:** 25 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Ain Shams University **Name:** ahmed y gamal, professor **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** institutional review board, egypt **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010510 - Term: Periodontal Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M13427 - Name: Periodontitis - Relevance: HIGH - As Found: Periodontitis - ID: M13419 - Name: Periodontal Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010518 - Term: Periodontitis ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00647179 **Brief Title:** Substrate Metabolism and Insulin Sensitivity in Acromegalic Patients Before and After Treatment **Official Title:** Substrate Metabolism and Insulin Sensitivity in Acromegalic Patients Before and After Treatment #### Organization Study ID Info **ID:** MM-ISA-20070130 #### Organization **Class:** OTHER **Full Name:** University of Aarhus #### Secondary ID Infos **ID:** M-20070130 ### Status Module #### Completion Date **Date:** 2016-12-07 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-12-26 **Type:** ACTUAL **Last Update Submit Date:** 2017-12-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2016-12-07 **Type:** ACTUAL #### Start Date **Date:** 2008-02 **Status Verified Date:** 2017-12 #### Study First Post Date **Date:** 2008-03-31 **Type:** ESTIMATED **Study First Submit Date:** 2008-03-26 **Study First Submit QC Date:** 2008-03-28 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Aarhus University Hospital #### Lead Sponsor **Class:** OTHER **Name:** University of Aarhus #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to investigate the effects of chronic elevated growth hormone on metabolism and insulin sensitivity by studying acromegalic patients before and after treatment. ### Conditions Module **Conditions:** - Acromegaly - Excessive Growth Hormone Secretion - Insulin Resistance **Keywords:** - Acromegaly - Growth Hormone - Insulin resistance - Glucose tolerance - Body Composition - Substrate metabolism ### Design Module #### Bio Spec **Description:** Whole blood, serum, muscle samples, fat samples **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 27 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients recently diagnosed with acromegaly **Intervention Names:** - Procedure: Transsphenoidal adenomectomy **Label:** 1 ### Interventions #### Intervention 1 **Arm Group Labels:** - 1 **Description:** Surgery **Name:** Transsphenoidal adenomectomy **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** Insulin sensitivity **Time Frame:** Before and after treatment #### Secondary Outcomes **Measure:** QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism, Glucose tolerance **Time Frame:** Before and after treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Written consent * Age between 18 and 70 * Recently diagnosed with acromegaly Exclusion Criteria: * NYHA 3 * Uncontrolled hypertension * Known cerebrovascular disease * Proliferative retinopatia **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patiens recently diagnoses with acromegaly, recruited from the clinic ### Contacts Locations Module #### Locations **Location 1:** **City:** Aarhus C **Country:** Denmark **Facility:** Department of Endocrinology, Aarhus University Hospital **State:** Aarhus **Zip:** DK-8000 #### Overall Officials **Official 1:** **Affiliation:** Aarhus University Hospital, Department of Endocrinology **Name:** Jens Otto L. Jørgensen, Professor MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Arlien-Soborg MC, Grondahl C, Baek A, Dal J, Madsen M, Hogild ML, Pedersen SB, Bjerre M, Jorgensen JOL. Fibroblast Activation Protein is a GH Target: A Prospective Study of Patients with Acromegaly Before and After Treatment. J Clin Endocrinol Metab. 2020 Jan 1;105(1):dgz033. doi: 10.1210/clinem/dgz033. **PMID:** 31544947 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006946 - Term: Hyperinsulinism - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000001849 - Term: Bone Diseases, Endocrine - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000006964 - Term: Hyperpituitarism - ID: D000010900 - Term: Pituitary Diseases - ID: D000007027 - Term: Hypothalamic Diseases - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10370 - Name: Insulin Resistance - Relevance: HIGH - As Found: Insulin Resistance - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M3531 - Name: Acromegaly - Relevance: HIGH - As Found: Acromegaly - ID: M9997 - Name: Hyperinsulinism - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M5128 - Name: Bone Diseases, Endocrine - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M13791 - Name: Pituitary Diseases - Relevance: LOW - As Found: Unknown - ID: M10077 - Name: Hypothalamic Diseases - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: T139 - Name: Acromegaly - Relevance: HIGH - As Found: Acromegaly ### Condition Browse Module - Meshes - ID: D000000172 - Term: Acromegaly - ID: D000007333 - Term: Insulin Resistance ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M10365 - Name: Insulin - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03135379 **Acronym:** HUGS **Brief Title:** Comparison of Patient Satisfaction Using Heated Versus Room Temperature Ultrasound Gel **Official Title:** Comparison of Patient Satisfaction Using Heated Versus Room Temperature Ultrasound Gel: a Single-blind Randomized Controlled Trial #### Organization Study ID Info **ID:** C.2016.046d #### Organization **Class:** FED **Full Name:** Brooke Army Medical Center ### Status Module #### Completion Date **Date:** 2017-04 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-08-06 **Type:** ACTUAL **Last Update Submit Date:** 2017-11-09 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-04 **Type:** ACTUAL #### Results First Post Date **Date:** 2018-08-06 **Type:** ACTUAL **Results First Submit Date:** 2017-10-06 **Results First Submit QC Date:** 2017-11-09 #### Start Date **Date:** 2016-04 **Type:** ACTUAL **Status Verified Date:** 2017-11 #### Study First Post Date **Date:** 2017-05-01 **Type:** ACTUAL **Study First Submit Date:** 2017-04-27 **Study First Submit QC Date:** 2017-04-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** FED **Name:** Brooke Army Medical Center #### Responsible Party **Investigator Affiliation:** Brooke Army Medical Center **Investigator Full Name:** Michael D. April **Investigator Title:** Assistant Program Director for Research, Emergency Medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this single-blind, randomized control trial will be to investigate whether simply having warmed gel, as compared to room-temperature gel, during a bedside ultrasound significantly improves patient satisfaction scores. **Detailed Description:** ED physicians who identify that a patient will require an ultrasound will page the ultrasound team as part of standard of care. At that time, an investigator will obtain verbal consent from the patient and provide an information sheet to help explain study details/answer any questions. The patient will then be randomized to either warmed gel or room temperature gel. Investigators will handle the gel using a heat-resistant glove (ULine Terry Cloth Glove) to maintain blinding to the gel temperature. A bedside ultrasound study will then be performed by emergency physicians not otherwise involved in the study using the study gel. Immediately upon ultrasound completion, the patients will complete a satisfaction survey. The images from the study will be saved and subsequently reviewed by an emergency physician with fellowship training in ultrasound to score image quality from 1 (low) to 5 (high). ### Conditions Module **Conditions:** - Ultrasound ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Masking Description:** A heat-resistant glove, ULine Terry Cloth Glove (Appendix F), will be used by the investigators to handle the ultrasound gels. **Who Masked:** - INVESTIGATOR **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 124 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patient undergoes ultrasound study using the intervention of heated ultrasound gel. **Intervention Names:** - Device: Heated ultrasound gel **Label:** Heated gel **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patient undergoes ultrasound study using the intervention of room temperature gel. **Intervention Names:** - Device: Room temperature gel **Label:** Room temperature gel **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Heated gel **Description:** Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) set to "medium" setting (102 degree fahrenheit). **Name:** Heated ultrasound gel **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Room temperature gel **Description:** Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) turned off. **Name:** Room temperature gel **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Measured on 100-mm visual analogue scale. This scale is a horizontal line on a sheet of paper measuring 100 mm. The scale ranges from 0 on the left (representing "completely unsatisfied") to 100 on the right (representing "completely satisfied"). We instructed subjects to draw a single vertical mark through the horizontal line to represent how satisfied they were with their overall emergency department visit. **Measure:** Patient Satisfaction **Time Frame:** Immediately upon completion of ultrasound examination #### Secondary Outcomes **Description:** Measured 1 (low) to 5 (high) by an attending emergency physician who has completed ultrasound fellowship. **Measure:** Ultrasound Image Quality **Time Frame:** Within 1 week of completion of ultrasound examination ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults aged 18-89 years * Patients require bedside ultrasound Exclusion Criteria: * Patients under age 18 * Patients over age 89 * Pregnant women * Altered mental status * Incarcerated * Military basic trainees * Primary language other than English * Patients with open or broken skin over areas requiring ultrasound gel application **Healthy Volunteers:** True **Maximum Age:** 89 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** [email protected] **Name:** Benjamin M Krainin, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Cydulka RK, Tamayo-Sarver J, Gage A, Bagnoli D. Association of patient satisfaction with complaints and risk management among emergency physicians. J Emerg Med. 2011 Oct;41(4):405-11. doi: 10.1016/j.jemermed.2010.10.021. Epub 2011 Jan 7. **PMID:** 21215554 **Citation:** Levin DC, Rao VM, Parker L, Frangos AJ. Continued growth in emergency department imaging is bucking the overall trends. J Am Coll Radiol. 2014 Nov;11(11):1044-7. doi: 10.1016/j.jacr.2014.07.008. Epub 2014 Nov 3. **PMID:** 25439619 **Citation:** Singer AJ, Thode HC Jr. Determination of the minimal clinically significant difference on a patient visual analog satisfaction scale. Acad Emerg Med. 1998 Oct;5(10):1007-11. doi: 10.1111/j.1553-2712.1998.tb02781.x. **PMID:** 9862594 ## Document Section ### Large Document Module #### Large Docs - Date: 2016-04-22 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 155750 - Type Abbrev: Prot_SAP - Upload Date: 2017-10-06T14:56 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Heated Gel **Deaths Num At Risk:** 62 **Description:** Patient undergoes ultrasound study using the intervention of heated ultrasound gel. Heated ultrasound gel: Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) set to "medium" setting (102 degree fahrenheit). **ID:** EG000 **Other Num at Risk:** 62 **Serious Number At Risk:** 62 **Title:** Heated Gel **Group ID:** EG001 **Title:** Room Temperature Gel **Deaths Num At Risk:** 62 **Description:** Patient undergoes ultrasound study using the intervention of room temperature gel. Room temperature gel: Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) turned off. **ID:** EG001 **Other Num at Risk:** 62 **Serious Number At Risk:** 62 **Title:** Room Temperature Gel **Frequency Threshold:** 0 **Time Frame:** 30 minutes ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 61 **Group ID:** BG001 **Value:** 59 **Group ID:** BG002 **Value:** 120 **Units:** Participants ### Group **ID:** BG000 **Title:** Heated Gel **Description:** Patient undergoes ultrasound study using the intervention of heated ultrasound gel. Heated ultrasound gel: Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) set to "medium" setting (102 degree fahrenheit). ### Group **ID:** BG001 **Title:** Room Temperature Gel **Description:** Patient undergoes ultrasound study using the intervention of room temperature gel. Room temperature gel: Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) turned off. ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Spread:** 17.6 **Value:** 41.5 #### Measurement **Group ID:** BG001 **Spread:** 18.5 **Value:** 42.0 #### Measurement **Group ID:** BG002 **Spread:** 18.0 **Value:** 41.7 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 61 **Group ID:** BG001 **Value:** 59 **Group ID:** BG002 **Value:** 120 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 19 #### Measurement **Group ID:** BG001 **Value:** 32 #### Measurement **Group ID:** BG002 **Value:** 51 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 42 #### Measurement **Group ID:** BG001 **Value:** 27 #### Measurement **Group ID:** BG002 **Value:** 69 **Category Title:** Male #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 61 **Group ID:** BG001 **Value:** 59 **Group ID:** BG002 **Value:** 120 **Class Title:** ### Measure #### Measurement **Group ID:** BG002 **Value:** 0 #### Denomination **Units:** Participants ##### Denomination Counts **Group ID:** BG000 **Value:** 0 **Group ID:** BG001 **Value:** 0 **Group ID:** BG002 **Value:** 0 **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** STANDARD_DEVIATION **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Population Description:** Race and Ethnicity were not collected from any participant. **Title:** Race and Ethnicity Not Collected **Unit of Measure:** Participants ## Results Section - More Information Module ### Certain Agreement **PI Sponsor Employee:** True ### Point of Contact **Email:** [email protected] **Organization:** Brooke Army Medical Center **Phone:** 210-916-0808 **Title:** Benjamin M. Krainin ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 84.8 - **Spread:** - **Upper Limit:** 90.1 - **Value:** 87.6 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 79.4 - **Spread:** - **Upper Limit:** 87.6 - **Value:** 83.9 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 3 - **Spread:** - **Upper Limit:** 4 - **Value:** 4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** 4 - **Spread:** - **Upper Limit:** 4 - **Value:** 4 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Measured on 100-mm visual analogue scale. This scale is a horizontal line on a sheet of paper measuring 100 mm. The scale ranges from 0 on the left (representing "completely unsatisfied") to 100 on the right (representing "completely satisfied"). We instructed subjects to draw a single vertical mark through the horizontal line to represent how satisfied they were with their overall emergency department visit. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** Immediately upon completion of ultrasound examination **Title:** Patient Satisfaction **Type:** PRIMARY **Unit of Measure:** units on a scale ##### Group **Description:** Patient undergoes ultrasound study using the intervention of heated ultrasound gel. Heated ultrasound gel: Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) set to "medium" setting (102 degree fahrenheit). **ID:** OG000 **Title:** Heated Gel ##### Group **Description:** Patient undergoes ultrasound study using the intervention of room temperature gel. Room temperature gel: Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) turned off. **ID:** OG001 **Title:** Room Temperature Gel #### Outcome Measure 2 **Description:** Measured 1 (low) to 5 (high) by an attending emergency physician who has completed ultrasound fellowship. **Dispersion Type:** Inter-Quartile Range **Parameter Type:** MEDIAN **Reporting Status:** POSTED **Time Frame:** Within 1 week of completion of ultrasound examination **Title:** Ultrasound Image Quality **Type:** SECONDARY **Unit of Measure:** units on a scale ##### Group **Description:** Patient undergoes ultrasound study using the intervention of heated ultrasound gel. Heated ultrasound gel: Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) set to "medium" setting (102 degree fahrenheit). **ID:** OG000 **Title:** Heated Gel ##### Group **Description:** Patient undergoes ultrasound study using the intervention of room temperature gel. Room temperature gel: Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) turned off. **ID:** OG001 **Title:** Room Temperature Gel ### Participant Flow Module #### Group **Description:** Patient undergoes ultrasound study using the intervention of heated ultrasound gel. Heated ultrasound gel: Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) set to "medium" setting (102 degree fahrenheit). **ID:** FG000 **Title:** Heated Gel #### Group **Description:** Patient undergoes ultrasound study using the intervention of room temperature gel. Room temperature gel: Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) turned off. **ID:** FG001 **Title:** Room Temperature Gel #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 62 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 62 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 61 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 59 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 1 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 3 **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT04115579 **Brief Title:** The Impact of Low Glycaemic Index (GI) Biscuits on Postprandial Glycaemia Using the Continuous Glucose Monitoring System (CGMS™) (Biscuit Study (BIS) Study) **Official Title:** The Impact of Low Glycaemic Index (GI) Biscuits on Postprandial Glycaemia Using the Continuous Glucose Monitoring System (CGMS™) (Biscuit Study (BIS) Study) #### Organization Study ID Info **ID:** 2018/01066 #### Organization **Class:** OTHER_GOV **Full Name:** Clinical Nutrition Research Centre, Singapore ### Status Module #### Completion Date **Date:** 2020-06-22 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-07-17 **Type:** ACTUAL **Last Update Submit Date:** 2020-07-16 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-06-22 **Type:** ACTUAL #### Start Date **Date:** 2019-02-20 **Type:** ACTUAL **Status Verified Date:** 2020-01 #### Study First Post Date **Date:** 2019-10-04 **Type:** ACTUAL **Study First Submit Date:** 2019-10-03 **Study First Submit QC Date:** 2019-10-03 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Clinical Nutrition Research Centre, Singapore #### Responsible Party **Investigator Affiliation:** Clinical Nutrition Research Centre, Singapore **Investigator Full Name:** JeyaKumar Henry **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** To investigate whether low glycaemic index (GI) biscuits have the greatest impact on the post-meal glucose response and on the overall 24 hour blood glucose control, using the continuous glucose monitoring system (CGMS™) **Detailed Description:** The study was a randomized, non-blinded, crossover design. Randomization conducted using www.randomizer.org. Each participant came for two test sessions (each of 3 days- Days 0, 1 and 2) with each session separated by at least three days (to avoid crossover effects). Test foods: The foods were Control and Test \[Low glycemic index (GI)\] biscuits. The foods will vary in macronutrient, micronutrients and fibre contents. Screening session: Potential participants attend a first session for consenting and screening procedures. Subjects will be at the centre for the study between 8:00-9:00am, with screening session lasting approximately 1 hour. Subjects will have to come following a 10-12 hour overnight fast each day. Fingerprick blood sample (5μl) is required for the screening session (to establish fasting glucose concentration). Screening questionnaire: The screening questionnaire will include contact information, demographic, general health details, and physical activity level. This information will be used to determine whether the participant is eligible for the study, as well as to check for any possible confounders that may influence the study outcomes. Anthropometric measurements: Body weight and body composition will be measured using bioelectrical impedance analysis (Tanita scale). Height will be measured using a stadiometer in order to calculate participants' BMI. Waist circumference will be measured at the minimum circumference between the iliac crest and the rib cage. Hip circumference will be measured at the maximum protuberance of the buttocks. Biceps and triceps skinfold measurements will also be taken. Blood pressure will also be measured. Blood pressure: Blood pressure will be measured using an Omron blood pressure monitor (Model HEM-907) at baseline. Participants will be seated for five minutes before blood pressure is measured. Measurements will be taken in duplicate and the averaged results will be recorded. (approximately 1 teaspoon or 5 ml) will be collected from subject via passive drooling (only once during). Start of test session (Day 0-Day 2) Day 0 If subject is eligible, subjects will be enrolled into the study. Subject will undergo the insertion of the Continuous Glucose Monitoring System (CGMS™) sensor the day before the test day (Day 0) to allow for the monitor to stabilize overnight. Medtronic's iPro2 Professional CGMS, designed to gain more complete insights into the glycaemic profiles of a person. The CGMS sensor will be inserted into the adipose tissue in the abdominal area by trained researchers and nurses. Subjects will have to wait in the laboratory for 1 hour after insertion for the sensor to be stabilized. After 1 hour the inserted CGMS sensor will be calibrated against a manual finger-prick blood glucose sample (5 μL, a small drop). Manual calibration using finger-prick blood samples will need to be carried out before every meal and before bed in the night (5 μL each for before dinner and before sleeping). The calibrations before dinner and bed will have to be carried out the subjects at home. Therefore, the subjects will be provided with a finger-prick blood glucose test kit to take home and instructed on how to correctly use it and measure blood glucose values. Calibration finger pricks will be made using disposable individual lancets. This may cause minimal discomfort. The volume of blood taken each time will be 5 μL (a small drop). For Day 0, subjects will be provided a standard dinner meal to be consumed at home at 7pm. Afterwhich, they will be asked to not eat and drink anything except water after 10:30 pm. They will also be instructed to arrive at the CNRC the following morning in an overnight fasted state. On the evenings before the test sessions, subject will be reminded to have no strenuous physical activities and no consumption of alcoholic beverages. Day 1 On the test Day 1, participants will be asked to attend the testing sessions after an overnight fast of ten to twelve hours, and arrive between 8:00-9:00am, with each session lasting approximately 4 hours. One fasting blood sample will be collected by fingerprick for calibration of the CGMS glucose meter (5 μL, a small drop). Then, an indwelling catheter will be inserted into a vein in the forearm. Subsequently, a blood sample will be taken from a cannula to measure baseline values. Immediately after that, participants will be served a test breakfast, where they will be asked to consume within 15 minutes. Following the test breakfast meal, further blood samples will be taken (from the cannula) for the next 15, 30, 45, 60, 90, 120, 150, 180 minutes. The blood samples collected at each timepoint will be measured for insulin and metabolic biomarkers related to the intake of the test meal ingredients. The amount of blood that will be collected at every time point will be about 1.2 teaspoon of blood (approximately 6 ml), the accumulative amount per test session will not be more than 11 teaspoons of blood (approximately 55 ml), and the accumulative amount for the entire study duration will not be more than 22 teaspoons of blood (approximately 110 ml), by cannula. For the fingerprick calibration, 5 μL is taken after insertion of sensor, before each meal and before sleeping. So a total of 9 fingerpricks will be taken for one test session. Therefore, a total of 18 fingerpricks for the entire two sessions. (approximately 90 μL equivalent to approximately 1/5 of a teaspoon). A standard lunch will then be served and afterwhich the cannula is removed. Subjects will take a fingerprick blood glucose (5 μL, a small drop) for calibration of the CGMS before their standard lunch meal. Subjects are to consume the entire lunch meal in 15 minutes. After lunch, participants will be provided with their snack and dinner meal to be consumed at home and they will leave the research facility. Before snack, dinner and before sleeping, participants are to take their own fingerprick blood glucose for calibration of the CGMS.Day 2 Participants will return the following day, Day 2, between 8:00-9:00am. Participants will have the CGMS sensor removed. A final fingerprick (5 μL, a small drop) for calibration purposes will be done 15 minutes before removal of the sensor. This marks the end of one session and participant will return for the next session after 3 days of washout period. Participants attend a total of about 15 hours for two sessions (including one screening visit lasting around 1 hour). Participants will spend approximately 1 hour for screening session, 1 hour for Day 0, 4 hours for Day 1 and about half hour on Day 2. This will repeat for the next session. All test and standard meals in the research facility will be served with 250ml of water. All the study diets will be prepared in the CNRC food preparation kitchen and will use locally sourced ingredients and food purchased from local supermarkets and food distributors. ### Conditions Module **Conditions:** - Diabetes Mellitus, Type 2 - Diabetes ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 14 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Consumption of control biscuit for breakfast and afternoon snack and impact on postprandial glucose and insulin **Intervention Names:** - Other: Biscuit 1 Control **Label:** Biscuit 1 Control **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Consumption of test biscuit for breakfast and afternoon snack on postprandial glucose and insulin **Intervention Names:** - Other: Biscuit 2 Test **Label:** Biscuit 2 Test **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Biscuit 1 Control **Description:** Consumption of control biscuit of a higher glycaemic index at one session during breakfast and afternoon snack **Name:** Biscuit 1 Control **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Biscuit 2 Test **Description:** Consumption of test biscuit of a lower glycaemic index at one session during breakfast and afternoon snack **Name:** Biscuit 2 Test **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Glucose measurements taken using the Continuous Glucose Monitoring System **Measure:** Postprandial glucose **Time Frame:** Up to 24 hours #### Secondary Outcomes **Description:** Plasma blood will be analyzed using COBAS **Measure:** Postprandial insulin **Time Frame:** up to 180 minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Males * Healthy Asian Chinese * Aged between 21 - 40 years * Body mass index between 18.5 to 25.0 kg/m2 * Normal blood pressure \<140/90 mmHg * Fasting blood glucose \<6.0 mmol/L Exclusion Criteria: * Smoking * Allergic/intolerant to any of the test foods to be administered, or any of the following common food and ingredients: eggs, fish, milk, peanuts, and tree nuts, shellfish, soya, wheat, gluten, cereal, fruits, dairy products, meat, vegetable, sugar and sweetener, natural food colourings or flavourings, etc. * Anyone with intentional food restrictions * People with known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency) * Having metabolic or cardiovascular diseases (such as diabetes, hypertension, heart condition, etc), Having any other diseases involving the small intestine or the colon (e.g., irritable bowel syndrome, inflammatory bowel disease, gastric reflux) or having any liver or kidney disorders or any family history of kidney stones * Having medical conditions and/or taking medications known to affect glycemia (glucocorticoids, thyroid hormones, thiazide diuretics) * Taking any prescribed medication or dietary supplements which may interfere with the study measurements * Excessive alcohol consumption: consuming ≥ 6 alcoholic drinks per week * Individuals who have donated blood or taken part in other studies within 4 weeks of study participation. * Have poor veins impeding venous access * Have history of severe vasovagal syncope (blackouts or near faints) following blood draws * Have known Chronic infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV) * Have active Tuberculosis (TB) or currently receiving treatment for TB * Individuals who partake in sports at the competitive and/or endurance levels. * A team member of the study or is an immediate family member (Immediate family defined as a spouse, parent, child, or sibling, whether biological or legally adopted **Gender Based:** True **Gender Description:** Healthy male volunteers **Healthy Volunteers:** True **Maximum Age:** 40 Years **Minimum Age:** 21 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Singapore **Country:** Singapore **Facility:** Clinical Nutrition Research Centre **Zip:** 117599 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: HIGH - As Found: Diabetes Mellitus, Type 2 - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003924 - Term: Diabetes Mellitus, Type 2 ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M10365 - Name: Insulin - Relevance: LOW - As Found: Unknown - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00966979 **Acronym:** PKR **Brief Title:** Triathlon® Partial Knee Replacement (PKR) Outcomes Study **Official Title:** A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Partial Knee Resurfacing (PKR) Unicondylar Knee System #### Organization Study ID Info **ID:** 66 #### Organization **Class:** INDUSTRY **Full Name:** Stryker Orthopaedics ### Status Module #### Completion Date **Date:** 2023-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-09-13 **Type:** ACTUAL **Last Update Submit Date:** 2023-08-16 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2022-09 **Type:** ACTUAL #### Results First Post Date **Date:** 2023-09-13 **Type:** ACTUAL **Results First Submit Date:** 2023-07-10 **Results First Submit QC Date:** 2023-08-16 #### Start Date **Date:** 2010-01 **Type:** ACTUAL **Status Verified Date:** 2023-08 #### Study First Post Date **Date:** 2009-08-27 **Type:** ESTIMATED **Study First Submit Date:** 2009-08-25 **Study First Submit QC Date:** 2009-08-25 **Why Stopped:** Enrollment goals not being met. ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Stryker Orthopaedics #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to compare the 10-year Knee Society Score (KSS) functional results of the Triathlon PKR Unicondylar Knee to the 10-year Knee Society Score (KSS) functional results of the Triathlon Cruciate Retaining (CR) Total Knee. ### Conditions Module **Conditions:** - Arthroplasty, Replacement, Knee **Keywords:** - Osteoarthritis, Post-traumatic arthritis ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 111 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All subjects enrolled will receive the Triathlon PKR device. **Intervention Names:** - Device: Triathlon PKR **Label:** Triathlon PKR **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Triathlon PKR **Description:** Triathlon PKR is a unicondylar knee resurfacing system designed to replace a single osteoarthritic compartment of a patient's natural knee. **Name:** Triathlon PKR **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The Knee Society Score (KSS) consists of two distinct sub-scores: one for pain, range of motion, joint stability and alignment (Pain/Motion KSS) and one for distance walked, stair climbing and walking aids (Functional KSS). This outcome measure was only for the KSS Function Score at 10-years. The KSS Function score subscale is 0-100, with 100 representing a better outcome. Although the specific scores are not distinguished as "excellent", "good", "fair", or "poor", a higher value represents a better outcome. **Measure:** Investigation of Clinical Performance and Patient Outcome With the Functional Knee Society Score (KSS). **Time Frame:** 10 years #### Secondary Outcomes **Description:** For the purpose of this study the Kaplan-Meier survival curves are a statistical method to estimate the survival function from lifetime data of a knee replacement after treatment. Survivorship is defined as a percentage of knees free of any component revision for any reason. **Measure:** 10-years Kaplan Meier Survival Analysis **Time Frame:** 10-years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * The subject is a male or non-pregnant female 21-75 years of age at the time of enrollment. * The subject requires a primary cemented unicompartmental knee replacement. * The subject has a diagnosis of osteoarthritis (OA) or posttraumatic arthritis (TA). * The subject has clinically intact cruciate and collateral ligaments and no ligamentous instability is present. * The subject has less than 10 degrees of flexion contracture and greater than 90 degrees of flexion. * The subject's preoperative mechanical alignment is less than 15 degrees of varus and 15 degrees of valgus. * The subject has signed the Institutional Review Board (IRB) approved study specific Informed Patient Consent Form. * The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation. Exclusion Criteria: * The subject has inflammatory arthritis or avascular necrosis(AVN). * The subject is obese, BMI \> 35. * The subject has a history of total or unicompartmental (contralateral compartment and/or patellofemoral joint) reconstruction of the affected joint. * The subject has a history of anterior cruciate ligament (ACL) reconstruction. * The subject has had a high distal femoral, or proximal tibial osteotomy. * The subject has a mental, neuromuscular or neurosensory disorder, which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in post-operative care and/or limit the ability to assess the performance of the device. * The subject has a systemic or metabolic disorder leading to progressive bone deterioration that the surgeon feels would affect the overall outcome of the study. * The subject is immunologically suppressed, or is receiving chronic steroids (\>30 days duration). * The subject has a known sensitivity to device materials. * The subject's bone stock is compromised by disease and/or infection which cannot provide adequate support and/or fixation to the prosthesis. * The subject's bone stock is compromised by a prior implantation which cannot provide adequate support and/or fixation to the prosthesis. * The subject has an active or suspected latent infection in or about the knee joint. * The subject is a prisoner. **Maximum Age:** 75 Years **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Jacksonville **Country:** United States **Facility:** Heekin Orthopaedic Institute for Research, Inc. **State:** Florida **Zip:** 32204 **Location 2:** **City:** Egg Harbor Township **Country:** United States **Facility:** Rothman Institute **State:** New Jersey **Zip:** 08234 **Location 3:** **City:** Buffalo **Country:** United States **Facility:** Department of Orthopaedic Surgery, Kaleida Health, Buffalo General Hospital **State:** New York **Zip:** 14203 **Location 4:** **City:** Syracuse **Country:** United States **Facility:** Syracuse Orthopedic Specialists **State:** New York **Zip:** 13214 **Location 5:** **City:** Media **Country:** United States **Facility:** Rothman Institute **State:** Pennsylvania **Zip:** 19063 **Location 6:** **City:** Morrisville **Country:** United States **Facility:** Mansfield Orthopaedics **State:** Vermont **Zip:** 05661 **Location 7:** **City:** Stollberg **Country:** Germany **Facility:** Praxisklinik Stollberg und Arthro. Zentrum GmbH **Zip:** 09366 **Location 8:** **City:** Alessandria **Country:** Italy **Facility:** Presidlo Ospedaliero Civile Santi Antonio e Biagio **Zip:** 15100 **Location 9:** **City:** Hässleholm **Country:** Sweden **Facility:** Hassleholm Sygehus Ortopaedkirurgisk afd. Esplanadgatan #### Overall Officials **Official 1:** **Affiliation:** St. Vincent's Medical Center **Name:** R. David Heekin, M.D. **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Praxisklinik Stollberg **Name:** Marco Tinius, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** Presidlo Ospedaliero Civile Santi Antonio e Biagio **Name:** Marco Schiraldi, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 4:** **Affiliation:** Mansfield Orthopaedics **Name:** Brian Aros, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 5:** **Affiliation:** Rothman Institute **Name:** Fabio Orozco, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 6:** **Affiliation:** Department of Orthopaedic Surgery, Kaleida Health, Buffalo General Hospital **Name:** Matthew Phillips, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 7:** **Affiliation:** Bonutti Clinic **Name:** Peter Bonutti, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 8:** **Affiliation:** Hassleholm Sygehus Ortopaedkirurgisk afd. **Name:** Soren Toksvig-Larsen, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 9:** **Affiliation:** Syracuse Orthopedic Specialists **Name:** Brett Greenky, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 10:** **Affiliation:** Oklahoma Sports Science and Orthopaedics **Name:** Paul Jacob, MD **Role:** PRINCIPAL_INVESTIGATOR ## Document Section ### Large Document Module #### Large Docs - Date: 2019-09-26 - Filename: Prot_SAP_ICF_000.pdf - Has ICF: True - Has Protocol: True - Has SAP: True - Label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Size: 15048969 - Type Abbrev: Prot_SAP_ICF - Upload Date: 2023-06-06T13:49 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12926 - Name: Osteoarthritis - Relevance: LOW - As Found: Unknown - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module **Description:** The date of occurrence, date diagnosed, type of complication/adverse event and treatment were collected. #### Event Groups **Group ID:** EG000 **Title:** Operative Adverse Events **Deaths Num At Risk:** 89 **Description:** Operative site adverse events are reported by knee because in the case of bilateral participants (this is when one participant has both knees enrolled in the study), an event can occur in one knee, both knees or the same knee at different times and are counted separately for this reason. **ID:** EG000 **Other Num Affected:** 26 **Other Num at Risk:** 89 **Serious Number Affected:** 11 **Serious Number At Risk:** 89 **Title:** Operative Adverse Events **Group ID:** EG001 **Title:** Non-Operative Adverse Events **Deaths Num Affected:** 1 **Deaths Num At Risk:** 88 **Description:** Non-operative site adverse events are reported by participant. **ID:** EG001 **Other Num at Risk:** 88 **Serious Number Affected:** 20 **Serious Number At Risk:** 88 **Title:** Non-Operative Adverse Events **Frequency Threshold:** 5 #### Other Events **Term:** Operative **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA #### Serious Events **Term:** Non-operative **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Cardiac disorders **Source Vocabulary:** MedDRA ##### Stats **Group ID:** EG000 **Group ID:** EG001 **Num Affected:** 6 **Num At Risk:** 88 **Num Events:** 6 **Term:** Non-operative **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Gastrointestinal disorders **Source Vocabulary:** MedDRA ##### Stats **Group ID:** EG000 **Group ID:** EG001 **Num Affected:** 3 **Num At Risk:** 88 **Num Events:** 3 **Term:** Non-operative **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** General disorders **Source Vocabulary:** MedDRA ##### Stats **Group ID:** EG000 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 88 **Num Events:** 2 **Term:** Operative site **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Injury, poisoning and procedural complications **Source Vocabulary:** MedDRA ##### Stats **Group ID:** EG000 **Num Affected:** 1 **Num At Risk:** 89 **Num Events:** 1 **Group ID:** EG001 **Term:** Operative site **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Musculoskeletal and connective tissue disorders **Source Vocabulary:** MedDRA ##### Stats **Group ID:** EG000 **Num Affected:** 10 **Num At Risk:** 89 **Num Events:** 10 **Group ID:** EG001 **Term:** Non-operative **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps) **Source Vocabulary:** MedDRA ##### Stats **Group ID:** EG000 **Group ID:** EG001 **Num Affected:** 4 **Num At Risk:** 88 **Num Events:** 4 **Term:** Non-operative site **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Psychiatric disorders **Source Vocabulary:** MedDRA ##### Stats **Group ID:** EG000 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 88 **Num Events:** 1 **Term:** Non-operative **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Renal and urinary disorders **Source Vocabulary:** MedDRA ##### Stats **Group ID:** EG000 **Group ID:** EG001 **Num Affected:** 2 **Num At Risk:** 88 **Num Events:** 2 **Term:** Non-operative **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Respiratory, thoracic and mediastinal disorders **Source Vocabulary:** MedDRA ##### Stats **Group ID:** EG000 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 88 **Num Events:** 1 **Term:** Non-operative **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Organ System:** Vascular disorders **Source Vocabulary:** MedDRA ##### Stats **Group ID:** EG000 **Group ID:** EG001 **Num Affected:** 1 **Num At Risk:** 88 **Num Events:** 1 **Time Frame:** This study required that all operative site adverse events, regardless of seriousness, and serious systemic events, be reported from enrollment to the 10-year postoperative time interval. ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 88 **Units:** Participants ### Group **ID:** BG000 **Title:** Triathlon PKR **Description:** All subjects enrolled will receive the Triathlon PKR device. Triathlon PKR: Triathlon PKR is a unicondylar knee resurfacing system designed to replace a single osteoarthritic compartment of a patient's natural knee. ### Measure #### Measurement **Group ID:** BG000 **Lower Limit:** 44 **Upper Limit:** 76 **Value:** 61.83 **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 39 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 49 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 1 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 1 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 86 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 0 **Category Title:** Unknown or Not Reported **Class Title:** **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Dispersion Type:** FULL_RANGE **Parameter Type:** MEAN **Title:** Age, Continuous **Unit of Measure:** years ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ## Results Section - More Information Module ### Certain Agreement **Other Details:** There is an agreement between Principal Investigators and the Sponsor (or its agents) that requires Investigators to allow Sponsor at least 60 days to review material intended for publications to ensure that confidential information is not disclosed and that the data is accurately represented. The investigators can submit publication proposals prior to the study completion date for Sponsor consideration and for up to 7 years after study completion. **Restriction Type:** OTHER **Restrictive Agreement:** True ### Limitations and Caveats **Description:** After 13-years the enrollment goal was not met. This led to a protocol amendment to include retrospective cases. These cases were combined with the initial prospective cases and followed prospectively for the planned observation time. This study does not compare prospective to retrospective cases. The retrospectively enrolled cases were followed prospectively and there were no retrospective cases that reached the 10-year time point, only 12 prospective cases had 10-year data. ### Point of Contact **Email:** [email protected] **Organization:** Stryker Orthopaedics **Phone:** 201-831-5000 **Title:** Stryker JR Clinical Research ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 5.77 - **Upper Limit:** - **Value:** 98.33 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** 80.12 - **Spread:** - **Upper Limit:** 96.37 - **Value:** 91.35 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** The Knee Society Score (KSS) consists of two distinct sub-scores: one for pain, range of motion, joint stability and alignment (Pain/Motion KSS) and one for distance walked, stair climbing and walking aids (Functional KSS). This outcome measure was only for the KSS Function Score at 10-years. The KSS Function score subscale is 0-100, with 100 representing a better outcome. Although the specific scores are not distinguished as "excellent", "good", "fair", or "poor", a higher value represents a better outcome. **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Population Description:** Due to early study termination the primary outcome was only reached for a minimal number of participants (12) reaching 10 years. These only included prospective cases. No retrospective cases reached the 10-year time interval. **Reporting Status:** POSTED **Time Frame:** 10 years **Title:** Investigation of Clinical Performance and Patient Outcome With the Functional Knee Society Score (KSS). **Type:** PRIMARY **Type Units Analyzed:** Knees **Unit of Measure:** units on a scale ##### Group **Description:** All subjects enrolled will receive the Triathlon PKR device. Triathlon PKR: Triathlon PKR is a unicondylar knee resurfacing system designed to replace a single osteoarthritic compartment of a patient's natural knee for a primary replacement indication. **ID:** OG000 **Title:** Triathlon PKR Unicompartmental Knee #### Outcome Measure 2 **Description:** For the purpose of this study the Kaplan-Meier survival curves are a statistical method to estimate the survival function from lifetime data of a knee replacement after treatment. Survivorship is defined as a percentage of knees free of any component revision for any reason. **Dispersion Type:** 95% Confidence Interval **Parameter Type:** NUMBER **Population Description:** This primary outcome measure at 10 years is a statistical estimation based on 80 prospective knees as per the protocol. **Reporting Status:** POSTED **Time Frame:** 10-years **Title:** 10-years Kaplan Meier Survival Analysis **Type:** SECONDARY **Type Units Analyzed:** Knees **Unit of Measure:** percentage of knees ##### Group **Description:** All subjects enrolled will receive the Triathlon PKR device. Triathlon PKR: Triathlon PKR is a unicondylar knee resurfacing system designed to replace a single osteoarthritic compartment of a patient's natural knee for a primary replacement indication. **ID:** OG000 **Title:** Triathlon PKR Unicompartmental Knee ### Participant Flow Module #### Group **Description:** All subjects enrolled will receive the Triathlon PKR device. Triathlon PKR: Triathlon PKR is a unicondylar knee resurfacing system designed to replace a single osteoarthritic compartment of a patient's natural knee for a primary replacement indication. **ID:** FG000 **Title:** Triathlon PKR Unicompartmental Knee #### Period **Title:** Overall Study ##### Withdraw **Type:** Death ###### Reason **Group ID:** FG000 **Number of Subjects:** 1 ##### Withdraw **Type:** Lost to Follow-up ###### Reason **Group ID:** FG000 **Number of Subjects:** 6 ##### Withdraw **Type:** Withdrawal by Subject ###### Reason **Group ID:** FG000 **Number of Subjects:** 14 ##### Withdraw **Type:** Adverse Event ###### Reason **Group ID:** FG000 **Number of Subjects:** 5 ##### Withdraw **Type:** Sponsor terminated early ###### Reason **Group ID:** FG000 **Number of Subjects:** 49 ##### Withdraw **Type:** Censored because surgery not done ###### Reason **Group ID:** FG000 **Number of Subjects:** 2 ##### Withdraw **Type:** Censored because study device was not implanted ###### Reason **Group ID:** FG000 **Number of Subjects:** 14 ##### Withdraw **Type:** Censored because of Inclusion/exclusion violation ###### Reason **Group ID:** FG000 **Number of Subjects:** 7 ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 111 **Number of Units:** 112 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 13 **Number of Units:** 13 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 98 **Number of Units:** 99 **Pre-Assignment Details:** Of the 111 participants enrolled, there were 23 cases that were censored due to not having the study device, surgery canceled or an inclusion exclusion violation. Therefore, 89 knees in 88 participants are followed who did receive the study device and met protocol criteria. Those applicable data are reflected in this record. **Recruitment Details:** There were 112 knees in 111 patients that were enrolled in the study (one bilateral case). **Type Units Analyzed:** Knees **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT04434079 **Brief Title:** Fluid Balance and Body Weight Changes in Critically Ill Adult Patients **Official Title:** Fluid Balance and Body Weight Changes in Critically Ill Adult Patients #### Organization Study ID Info **ID:** 2018-0486 #### Organization **Class:** OTHER **Full Name:** Hospital de Clinicas de Porto Alegre ### Status Module #### Completion Date **Date:** 2018-12-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2020-06-16 **Type:** ACTUAL **Last Update Submit Date:** 2020-06-12 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2018-10-01 **Type:** ACTUAL #### Start Date **Date:** 2018-06-01 **Type:** ACTUAL **Status Verified Date:** 2020-06 #### Study First Post Date **Date:** 2020-06-16 **Type:** ACTUAL **Study First Submit Date:** 2020-06-05 **Study First Submit QC Date:** 2020-06-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hospital de Clinicas de Porto Alegre #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Positive fluid status has been consistently associated with worse prognosis in critically ill adult patients.However, observational studies showed poor agreement between fluid balance and body weight changes. The objective of the study is to compare the measurements of FB and BW over time and to assess correlation with ICU mortality. **Detailed Description:** Positive fluid status has been consistently associated with worse prognosis in critically ill adult patients. Daily and cumulative fluid balance (FB) is a routine nursing activity in intensive care unit (ICU). In view of the potential for errors in the calculation of FB totals and the problem of accounting for insensible fluid losses, measurement of body weight (BW) changes is an alternative non-invasive method commonly used for estimating body fluid status. Its accuracy over FB assumes a one kilogram change in BW equates to a one liter gain or loss in body fluid volume. However, observational studies showed poor agreement between those measurements, particularly among individuals staying more than a week in ICU possibly due to muscle and fat loss as well as bone demineralization. The objective of the study is to compare the measurements of FB and BW over time and to assess correlation with ICU mortality. ### Conditions Module **Conditions:** - Critical Illness - Fluid Overload **Keywords:** - Fluid Balance - Body Weight Change - Critical Illness ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 98 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Adult patients consecutively admitted to the ICU from June to October 2018 are eligible if expected length of stay is superior to 24 hours and no oral nutritional has been offered. **Intervention Names:** - Other: Regular critical care **Label:** Included individuals ### Interventions #### Intervention 1 **Arm Group Labels:** - Included individuals **Description:** Clinical demographic data, daily and cumulative FB (input minus output) with and without insensible fluid losses, and daily and total BW changes are recorded, as well as survival outcome. **Name:** Regular critical care **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Correlation between daily fluid balance and weight change (Bland-Altman agreement test) **Measure:** Correlation between daily fluid balance (difference between fluid input and output during 24 hours) and the change on daily weight **Time Frame:** At midnight every 24 hours up to patient's ICU discharge or up to 6 months, whichever comes first. #### Secondary Outcomes **Description:** Correlation between cumulative fluid balance and total weight change (Bland-Altman) **Measure:** Correlation between cumulative fluid balance and total weight change **Time Frame:** Last day of each patient's ICU hospitalization, up to 6 months **Description:** Area under ROC curve for fluid balance (L). ICU mortality as reference variable. **Measure:** Discriminative power of fluid balance in predicting ICU mortality **Time Frame:** Through study completion, up to 6 months **Description:** Area under ROC curve for body weight change (kg). ICU mortality as reference variable. **Measure:** Discriminative power of body weight changes in predicting ICU mortality **Time Frame:** Through study completion, up to 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Individuals aged \>18 years-old admitted to ICU; * Expected length of ICU stay superior to 24 hours. Exclusion Criteria: * Individuals receiving oral diet; * Actual body weight superior to 227kgs or 501lb. **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** All adult patients consecutively admitted to the ICU from June to October 2018 are eligible if expected length of ICU stay is superior to 24 hours and no oral nutritional is being offered. ### Contacts Locations Module #### Locations **Location 1:** **City:** Porto Alegre **Country:** Brazil **Facility:** Hospital de Clínicas de Porto Alegre **State:** RS #### Overall Officials **Official 1:** **Affiliation:** Hospital de Clínicas de Porto Alegre **Name:** Ana Carolina P Antonio, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5114 - Name: Body Weight - Relevance: HIGH - As Found: Body Weight - ID: M5115 - Name: Body Weight Changes - Relevance: HIGH - As Found: Body Weight Changes - ID: M19010 - Name: Critical Illness - Relevance: HIGH - As Found: Critical Illness - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016638 - Term: Critical Illness - ID: D000001835 - Term: Body Weight - ID: D000001836 - Term: Body Weight Changes ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00125879 **Brief Title:** Extension Study of Patients With Infantile-Onset Pompe Disease Who Were Previously Enrolled in Protocol AGLU01602 **Official Title:** A Long-Term Continuation Study of Patients With Infantile-Onset Pompe Disease Who Were Previously Enrolled in Protocol AGLU01602 #### Organization Study ID Info **ID:** AGLU02403 #### Organization **Class:** INDUSTRY **Full Name:** Sanofi ### Status Module #### Completion Date **Date:** 2006-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2014-02-06 **Type:** ESTIMATED **Last Update Submit Date:** 2014-02-04 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2006-06 **Type:** ACTUAL #### Start Date **Date:** 2005-06 **Status Verified Date:** 2014-02 #### Study First Post Date **Date:** 2005-08-02 **Type:** ESTIMATED **Study First Submit Date:** 2005-08-01 **Study First Submit QC Date:** 2005-08-01 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Genzyme, a Sanofi Company #### Responsible Party **Old Name Title:** Medical Monitor **Old Organization:** Genzyme Corporation ### Description Module **Brief Summary:** Pompe disease (also known as glycogen storage disease type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. The overall objective of this study is to evaluate the long-term safety and efficacy of Myozyme treatment in patients with infantile-onset Pompe disease. ### Conditions Module **Conditions:** - Glycogen Storage Disease Type II **Keywords:** - Glycogen Storage Disease Type II - GSD-II - Pompe Disease - Pompe Disease (Late-onset) - Acid Maltase Deficiency Disease - Glycogenosis 2 - Glycogen Storage Disease Type II (GSD-II) ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 16 **Type:** ACTUAL **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Biological: Myozyme **Label:** 1 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 1 **Description:** 20 mg/kg qow or 40 mg/kg qow **Name:** Myozyme **Other Names:** - alglucosidase alfa **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Measure:** Long-term Safety and Efficacy **Time Frame:** 52 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * The patient's legal guardian(s) must provide written informed consent prior to any study-related procedures being performed * The patient and his/her legal guardian(s) must have the ability to comply with the clinical protocol * The patient must have completed Protocol AGLU01602. Exclusion Criteria: * Patient has experienced any unmanageable adverse event (AE) in Protocol AGLU01602 due to Myozyme that would preclude continuing treatment with Myozyme **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Birmingham **Country:** United States **Facility:** University of Alabama **State:** Alabama **Zip:** 35233 **Location 2:** **City:** Gainesville **Country:** United States **Facility:** Shands Hospital at the University of Florida **State:** Florida **Zip:** 32610 **Location 3:** **City:** Miami **Country:** United States **Facility:** Miami Children's Hospital **State:** Florida **Zip:** 33155 **Location 4:** **City:** Decatur **Country:** United States **Facility:** Emory University Medical Genetics **State:** Georgia **Zip:** 30033 **Location 5:** **City:** Durham **Country:** United States **Facility:** Duke University Medical Center **State:** North Carolina **Zip:** 27710 **Location 6:** **City:** Cincinnati **Country:** United States **Facility:** Children's Hospital Medical Center **State:** Ohio **Zip:** 45229 **Location 7:** **City:** Amiens **Country:** France **Facility:** CHU Amiens **Zip:** 80054 **Location 8:** **City:** Caen **Country:** France **Facility:** CHU Cote de Nacre **Zip:** 14033 **Location 9:** **City:** Mainz **Country:** Germany **Facility:** Universitats-Kinderklinik Mainz **Zip:** 55131 **Location 10:** **City:** Haifa **Country:** Israel **Facility:** Rambam Medical Center **Zip:** 35254 **Location 11:** **City:** Monza **Country:** Italy **Facility:** San Gerardo Hospital **Zip:** 20052 **Location 12:** **City:** Rotterdam **Country:** Netherlands **Facility:** Erasmus MC University **Zip:** 3015 GJ **Location 13:** **City:** Hua-lien **Country:** Taiwan **Facility:** Tzu-Chi General Hospital **Zip:** 970 **Location 14:** **City:** Tainan **Country:** Taiwan **Facility:** Chi-Mei Medical Center Dept of Pediatrics **Zip:** 710 #### Overall Officials **Official 1:** **Affiliation:** Genzyme, a Sanofi Company **Name:** Medical Monitor **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Kishnani PS, Goldenberg PC, DeArmey SL, Heller J, Benjamin D, Young S, Bali D, Smith SA, Li JS, Mandel H, Koeberl D, Rosenberg A, Chen YT. Cross-reactive immunologic material status affects treatment outcomes in Pompe disease infants. Mol Genet Metab. 2010 Jan;99(1):26-33. doi: 10.1016/j.ymgme.2009.08.003. **PMID:** 19775921 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020140 - Term: Lysosomal Storage Diseases, Nervous System - ID: D000020739 - Term: Brain Diseases, Metabolic, Inborn - ID: D000001928 - Term: Brain Diseases, Metabolic - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000008661 - Term: Metabolism, Inborn Errors - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000002239 - Term: Carbohydrate Metabolism, Inborn Errors - ID: D000016464 - Term: Lysosomal Storage Diseases - ID: D000008659 - Term: Metabolic Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9114 - Name: Glycogen Storage Disease - Relevance: HIGH - As Found: Glycogen Storage Disease - ID: M9115 - Name: Glycogen Storage Disease Type II - Relevance: HIGH - As Found: Glycogen Storage Disease Type II - ID: M6879 - Name: Deficiency Diseases - Relevance: LOW - As Found: Unknown - ID: M18871 - Name: Lysosomal Storage Diseases - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5205 - Name: Brain Diseases, Metabolic - Relevance: LOW - As Found: Unknown - ID: M22498 - Name: Brain Diseases, Metabolic, Inborn - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M11641 - Name: Metabolism, Inborn Errors - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M5498 - Name: Carbohydrate Metabolism, Inborn Errors - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: T2562 - Name: Glycogen Storage Disease Type 2 - Relevance: HIGH - As Found: Glycogen Storage Disease Type II ### Condition Browse Module - Meshes - ID: D000006009 - Term: Glycogen Storage Disease Type II - ID: D000006008 - Term: Glycogen Storage Disease - ID: D000004194 - Term: Disease ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05453279 **Brief Title:** A Dose Escalation Phase 1 Study Evaluating the Safety and Pharmacokinetics of an Inhaled COVID-19 Inhibitor Delcetravir in Healthy Subjects **Official Title:** A Single and Multiple Dose Escalation First-In-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Delcetravir Administered Via Inhalation in Healthy Subjects #### Organization Study ID Info **ID:** COV0001 #### Organization **Class:** INDUSTRY **Full Name:** Esfam Biotech Pty Ltd ### Status Module #### Completion Date **Date:** 2023-01-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2022-07-12 **Type:** ACTUAL **Last Update Submit Date:** 2022-07-10 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2022-11-01 **Type:** ESTIMATED #### Start Date **Date:** 2022-09-01 **Type:** ESTIMATED **Status Verified Date:** 2022-07 #### Study First Post Date **Date:** 2022-07-12 **Type:** ACTUAL **Study First Submit Date:** 2022-06-01 **Study First Submit QC Date:** 2022-07-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Esfam Biotech Pty Ltd #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study will be a single center, Phase I, randomized, double-blind, placebo controlled, single and multiple ascending dose (SAD/MAD) study evaluating the safety, tolerability, and PK of Delcetravir after administration via oral inhalation in healthy subjects. **Detailed Description:** Primary objectives: * To evaluate the safety and tolerability of single and multiple doses of Delcetravir in healthy subjects (18-50 years of age). * To evaluate the safety and tolerability of single and multiple doses of Delcetravir in healthy subjects (50-80 years of age). * To evaluate the pharmacokinetics (PK) of Delcetravir after single and multiple doses of ESFAM289 in healthy subjects (18-50 years of age). * To evaluate the PK of Delcetravir after single and multiple doses of Delcetravir in healthy subjects (50-80 years of age) Secondary objectives: * To compare the PK of Delcetravir after single and multiple doses of Delcetravir in age stratified subjects (18-50 vs. 50-80 years of age). * To compare the safety and tolerability after single and multiple doses of Delcetravir in age stratified subjects (18-50 vs. 50-80 years of age). ### Conditions Module **Conditions:** - COVID-19 ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This study will be a single center, Phase I, randomized, double-blind, placebo controlled, single and multiple ascending dose (SAD/MAD) study evaluating safety, tolerability, and PK after administration via oral inhalation in healthy subjects. ##### Masking Info **Masking:** TRIPLE **Masking Description:** Double-blind allocation to inhalation formulation (active or placebo) **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 8 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Delcetravir inhalation via dry powder inhaler device administered up to 4 single ascending doses. According to tolerability of single ascending doses, delcetravir is then given as inhalation via dry powder device in multiple ascending doses, once daily for 7 days. **Intervention Names:** - Combination Product: Delcetravir dry powder inhaler **Label:** Active (experimental) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Placebo inhaler, identical in appearance to the active comparator, administered doses up to 4 single ascending doses. According to tolerability of single ascending doses, placebo doses are then given as inhalation via dry powder device in multiple ascending doses, once daily for 7 days. **Intervention Names:** - Combination Product: Delcetravir dry powder inhaler **Label:** Placebo comparator **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Active (experimental) - Placebo comparator **Description:** Placebo dry powder inhaler **Name:** Delcetravir dry powder inhaler **Type:** COMBINATION_PRODUCT ### Outcomes Module #### Primary Outcomes **Description:** Symptoms of chest pain **Measure:** Number of subjects with chest pain after single and multiple ascending doses of active and placebo comparator **Time Frame:** 22 days **Description:** Symptoms of shortness of breath **Measure:** Number of subjects with shortness of breath after single and multiple ascending doses of active and placebo comparator **Time Frame:** 22 days **Description:** Symptoms of cough **Measure:** Number of subjects with cough after single and multiple ascending doses of active and placebo comparator **Time Frame:** 22 days **Description:** Symptoms of sputum production **Measure:** Number of subjects with sputum production after single and multiple ascending doses of active and placebo comparator **Time Frame:** 22 days **Description:** Hemoglobin in g/L **Measure:** Hemoglobin assessment after active comparator and placebo. **Time Frame:** 22 days **Description:** White cell count differential in 109/L **Measure:** White cell count assessment after active comparator and placebo. **Time Frame:** 22 days **Description:** Platelet count in 109/L **Measure:** Platelet count assessment after active comparator and placebo. **Time Frame:** 22 days **Description:** Serum sodium in mmol/L **Measure:** Laboratory meaurement of sodium concentration after active comparator and placebo. **Time Frame:** 22 days **Description:** Serum potassium in mmol/L **Measure:** Laboratory measurement of potassium concentration after active comparator and placebo. **Time Frame:** 22 days **Description:** Serum bicarbonate in mmol/L **Measure:** Laboratory measurement of bicarbonate concentration after active comparator and placebo. **Time Frame:** 22 days **Description:** Serum urea in mmol/L **Measure:** Laboratory measurement of urea concentration after active comparator and placebo. **Time Frame:** 22 days **Description:** Serum creatinine in umol/L **Measure:** Laboratory measurement of creatinine concentration after active comparator and placebo. **Time Frame:** 22 days **Description:** Serum ALT in U/L **Measure:** Laboratory measurement of ALT concentration after active comparator and placebo. **Time Frame:** 22 days **Description:** Serum AST in U/L **Measure:** Laboratory measurement of AST concentration after active comparator and placebo. **Time Frame:** 22 days **Description:** Serum alkaline phosphatase in U/L **Measure:** Laboratory measurement of alkaline phosphatase concentration after active comparator and placebo. **Time Frame:** 22 days **Description:** Heart rate in beats per minute **Measure:** Heart rate after active comparator and placebo. **Time Frame:** 22 days **Description:** Systolic and diastolic blood pressure in mmHg **Measure:** Blood pressure after active comparator and placebo. **Time Frame:** 22 days **Description:** Respiratory rate in breaths per minute **Measure:** Respiratory rate after active comparator and placebo. **Time Frame:** 22 days **Description:** Pulse oximetry in blood oxygen saturation **Measure:** Pulse oximetry measurement after active comparator and placebo. **Time Frame:** 22 days **Description:** PR interval, QRS complex, QTc interval **Measure:** ECG after active comparator and placebo. **Time Frame:** 22 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Subjects must meet all of the following criteria to be included in the study: 1. Male or female, non-smokers or casual smokers (defined as smoking the equivalent of less than an average of 5 cigarettes per week, and willing to abstain from smoking during involvement in the study), ≥18 and \<50 (For Parts A and B) or ≥50 and ≤80 (for Parts C and D) years of age, with BMI \>18.0 and \<32.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females. 2. Healthy as defined by: 1. the absence of clinically significant illness and surgery within 4 weeks prior to dosing. 2. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease. 3. Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive methods throughout the study and for 30 days after the last study drug administration: 1. Simultaneous use of intra-uterine device placed at least 4 weeks prior to study drug administration, and condom for the male partner; 2. Simultaneous use of hormonal contraceptives started at least 4 weeks prior to study drug administration and condom for the male partner. 3. Sterile male partner (vasectomized since at least 6 months). 4. Females of non-childbearing potential must be: 1. Post-menopausal (defined as absence of menses for at least 12 months prior to the first study drug administration) with confirmation of the post menopausal status by documented FSH level greater than 40 mIU/mL; or 2. Surgically sterile (complete hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or tubal ligation at least 6 months prior to the first study drug administration). 5. Male subjects who are not vasectomized for at least 6 months, and who are sexually active with a female partner of childbearing potential (childbearing potential females are defined as women that are neither post-menopausal nor surgically sterile) must be willing to use one of the following acceptable contraceptive methods from the first study drug administration until at least 90 days after the last study drug administration: a) Simultaneous use of a male condom and, for the female partner, hormonal contraceptives used since at least 4 weeks, or intra-uterine contraceptive device placed since at least 4 weeks; 6. Male subjects who are sexually active with a same-sex partner must be willing to use a condom until study exit. 7. Male and female subjects who practice abstinence from sexual intercourse as a usual and preferred lifestyle. 8. Male subjects must be willing not to donate sperm until 90 days following the last study drug administration. 9. Subjects with normal lung function defined as ≥80% predicted forced expiratory volume in one second (FEV1) at screening. 10. Capable of consent. Exclusion criteria: 1) Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for HIV, hepatitis B, or hepatitis C found during medical screening. 2) Any clinically significant illness, infection, medical/surgical procedure, or trauma within 4 weeks of check-in, or planned inpatient surgery or hospitalization during the study period. 3) Any history of malignancy or neoplastic disease 1. Positive urine drug screen, urine cotinine test, or alcohol breath test at screening. 2. History of significant allergic reactions (e.g., drug reaction, anaphylactic reaction, hypersensitivity, angioedema) to any drug. 3. Positive pregnancy test at screening. 4. Clinically significant ECG abnormalities (QTc greater than 450 ms) or vital sign abnormalities (systolic blood pressure less than 90 or greater than140 mmHg, diastolic blood pressure less than 40 or greater than 90 mmHg, or heart rate less than 40 or greater than100 bpm, oxygen saturation less than 95% O2) at screening. 5. History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit. Regular use of alcohol is defined as greater than 14 units of alcohol per week, where 1 unit is defined as 375 mL of beer at 3.5% a/v, 100 mL of wine at 13.5% a/v, or 30 mL of spirit at 40% a/v. 6. History of drug abuse within 1 year prior to screening, recreational use of soft drugs (such as tetrahydrocannabinol \[THC\]) within 1 month prior to the screening visit, or hard drugs (amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines, cocaine, opiates, methyledioxymethamphetamine \[MDMA\], and phencyclidine \[PCP\]) within 3 months prior to screening. 7. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration. 8. Use of medications for the timeframes specified below, with the exception of medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or subject safety (e.g., topical drug products without significant systemic absorption): 1. Prescription medications (except for hormonal contraceptives) within 14 days prior to the first dosing; 2. Over-the-counter products and natural health products (including herbal remedies, such as St. John's wort, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 7 days prior to the first dosing, with the exception of the occasional use of acetaminophen/paracetamol (up to 2 g/day), ibuprofen (up to 800 mg/day), and topical formulations without significant systemic absorption; 3. Depot injection or implant (except for hormonal contraceptives) of any drug within 3 months prior to the first dosing. 9. Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing. 10. Breast-feeding subject. 11. History of latent or active tuberculosis, or exposure to endemic areas within 8 weeks prior to QuantiFERON®-TB testing performed at screening. 12. Positive QuantiFERON®-TB test indicating possible tuberculosis infection. 13. Immunization with a live attenuated vaccine within 1 month prior to dosing or planned vaccination during the course of the study. 14. Presence of fever (body temperature greater than 37.6 °C) e.g. a fever associated with a symptomatic viral or bacterial infection, within 2 weeks prior to the first dosing. 15. Any reason that, in the opinion of the Investigator, would prevent the subject from participating in the study. **Healthy Volunteers:** True **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Albert G Frauman, MD **Phone:** +61 416198042 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Esfam Biotech Pty Ltd **Name:** Albert G Frauman, MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011024 - Term: Pneumonia, Viral - ID: D000011014 - Term: Pneumonia - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000014777 - Term: Virus Diseases - ID: D000018352 - Term: Coronavirus Infections - ID: D000003333 - Term: Coronaviridae Infections - ID: D000030341 - Term: Nidovirales Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M2561 - Name: COVID-19 - Relevance: HIGH - As Found: COVID-19 - ID: M27137 - Name: Respiratory Aspiration - Relevance: LOW - As Found: Unknown - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M13914 - Name: Pneumonia, Viral - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M20490 - Name: Coronavirus Infections - Relevance: LOW - As Found: Unknown - ID: M6555 - Name: Coronaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M23685 - Name: Nidovirales Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000086382 - Term: COVID-19 ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03026179 **Brief Title:** Education of Parents About Discipline in a Way That is Culturally Sensitive **Official Title:** Education of Parents About Discipline in a Way That is Culturally Sensitive #### Organization Study ID Info **ID:** PN_CultSen #### Organization **Class:** OTHER **Full Name:** Vanderbilt University Medical Center ### Status Module #### Completion Date **Date:** 2013-08 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-11-08 **Type:** ACTUAL **Last Update Submit Date:** 2019-11-07 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2013-08 **Type:** ACTUAL #### Start Date **Date:** 2013-07 **Status Verified Date:** 2019-11 #### Study First Post Date **Date:** 2017-01-20 **Type:** ESTIMATED **Study First Submit Date:** 2015-12-09 **Study First Submit QC Date:** 2017-01-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Vanderbilt University #### Responsible Party **Investigator Affiliation:** Vanderbilt University **Investigator Full Name:** Seth Scholer **Investigator Title:** Associate Professor of Pediatrics **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** To determine if a brief primary care intervention can educate under-resourced and minority parents about discipline in a way that is culturally sensitive. ### Conditions Module **Conditions:** - Violence - Parenting ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 108 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Parents were asked to view 5-10 minutes of a program designed to educate about discipline. **Intervention Names:** - Behavioral: Play Nicely **Label:** Intervention parents **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention parents **Description:** Play Nicely is a multimedia program that teaches parents about appropriate methods to discipline. **Name:** Play Nicely **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** If parent stated that they planned to use less spanking at home, a follow up question was asked about what caused them to decide to spank less. **Measure:** Spanking questionnaire **Time Frame:** baseline #### Primary Outcomes **Description:** Parents were asked to view 5-10 minutes of an educational program. Following the clinic visit, parents were asked several questions about whether the program was culturally sensitive. **Measure:** Cultural Sensitivity **Time Frame:** baseline #### Secondary Outcomes **Description:** Parents were asked if they planned to make any changes in how they discipline at home. **Measure:** Changes in discipline questionnaire **Time Frame:** baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Parents presenting with their children to a pediatric clinic. Exclusion Criteria: - **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Vanderbilt University **Name:** Seth Scholer, MD, MPH **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10018 - Name: Hypersensitivity - Relevance: HIGH - As Found: Sensitive - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006967 - Term: Hypersensitivity ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05519579 **Brief Title:** Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia **Official Title:** Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia #### Organization Study ID Info **ID:** NSH 1354 #### Organization **Class:** OTHER **Full Name:** Northside Hospital, Inc. ### Status Module #### Completion Date **Date:** 2025-08-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-04-15 **Type:** ACTUAL **Last Update Submit Date:** 2024-04-12 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-11-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-06-30 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2022-08-29 **Type:** ACTUAL **Study First Submit Date:** 2022-08-25 **Study First Submit QC Date:** 2022-08-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Northside Hospital, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True ### Description Module **Brief Summary:** Changing the schedule of intrathecal chemotherapy to be given before and during blinatumomab will maintain the anti-leukemic effects of this drug while at the same time adding the benefit of limiting the neurotoxicity associated with cytokine release. ### Conditions Module **Conditions:** - Acute Lymphoblastic Leukemia ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Methotrexate - Drug: Blinatumomab **Label:** Intrathecal chemotherapy before blinatumomab **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intrathecal chemotherapy before blinatumomab **Description:** Methotrexate 12mg given intrathecally within 24 hours prior to blinatumomab administration **Name:** Methotrexate **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Intrathecal chemotherapy before blinatumomab **Description:** Blinatumomab 28ug/day continuous infusion for 4 weeks **Name:** Blinatumomab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Record occurrence and severity of neurotoxicity based on CTCAE criteria **Measure:** Number of participants that experienced neurotoxicity during the first cycle of blinatumomab therapy **Time Frame:** 28 days after first infusion #### Secondary Outcomes **Description:** Record occurrence and severity of cytokine release syndrome based on CTCAE criteria **Measure:** Number of participants that experienced cytokine release syndrome during the first cycle of blinatumomab therapy **Time Frame:** 28 days after first infusion **Description:** Conduct disease restaging assessments, such as bone marrow biopsies and lumbar punctures, to determine response to treatment **Measure:** Number of participants with a response of complete remission and MRD negativity at the end of cycle 1 **Time Frame:** 28 days after first infusion ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults receiving first cycle of blinatumomab for relapse/refractory or MRD-positive B-cell Acute Lymphoblastic Leukemia * Adequate renal and hepatic function * Negative for HIV * Negative serum pregnancy test, if applicable * ECOG 0-2 Exclusion Criteria: * Active CNS involvement by ALL * Relative CNS disorders (seizure, paresis, aphasia, Cerebrovascular ischemia/hemorrhage, severe brain injury, dementia, Parkinson's, cerebellar disease, psychosis, coordination or movement disorder) * Contraindication to receive intrathecal methotrexate * Prior treatment with blinatumomab * Active malignancy other than ALL * Active infection or any other concurrent disease or medical condition that was deemed to interfere with the conduct of the study as judged by the investigator **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Caitlin Guzowski **Phone:** 404-851-8523 **Role:** CONTACT #### Locations **Location 1:** **City:** Atlanta **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Caitlin Guzowski, MBA, MHA - **Phone:** 404-851-8523 - **Role:** CONTACT ***Contact 2:*** - **Name:** H. Kent Holland, MD - **Role:** SUB_INVESTIGATOR ***Contact 3:*** - **Name:** Asad Bashey, MD - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Lawrence E Morris, MD - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** Scott Solomon, MD - **Role:** SUB_INVESTIGATOR ***Contact 6:*** - **Name:** Melhem Solh, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 7:*** - **Name:** Lizamarie Bachier-Rodriguez, MD - **Role:** SUB_INVESTIGATOR **Country:** United States **Facility:** Northside Hospital **State:** Georgia **Status:** RECRUITING **Zip:** 30342 #### Overall Officials **Official 1:** **Affiliation:** Blood and Marrow Transplant Group of Georgia **Name:** Melhem Solh, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Kantarjian H, Stein A, Gokbuget N, Fielding AK, Schuh AC, Ribera JM, Wei A, Dombret H, Foa R, Bassan R, Arslan O, Sanz MA, Bergeron J, Demirkan F, Lech-Maranda E, Rambaldi A, Thomas X, Horst HA, Bruggemann M, Klapper W, Wood BL, Fleishman A, Nagorsen D, Holland C, Zimmerman Z, Topp MS. Blinatumomab versus Chemotherapy for Advanced Acute Lymphoblastic Leukemia. N Engl J Med. 2017 Mar 2;376(9):836-847. doi: 10.1056/NEJMoa1609783. **PMID:** 28249141 **Citation:** Gokbuget N, Dombret H, Bonifacio M, Reichle A, Graux C, Faul C, Diedrich H, Topp MS, Bruggemann M, Horst HA, Havelange V, Stieglmaier J, Wessels H, Haddad V, Benjamin JE, Zugmaier G, Nagorsen D, Bargou RC. Blinatumomab for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukemia. Blood. 2018 Apr 5;131(14):1522-1531. doi: 10.1182/blood-2017-08-798322. Epub 2018 Jan 22. Erratum In: Blood. 2019 Jun 13;133(24):2625. **PMID:** 29358182 **Citation:** Topp MS, Gokbuget N, Zugmaier G, Klappers P, Stelljes M, Neumann S, Viardot A, Marks R, Diedrich H, Faul C, Reichle A, Horst HA, Bruggemann M, Wessiepe D, Holland C, Alekar S, Mergen N, Einsele H, Hoelzer D, Bargou RC. Phase II trial of the anti-CD19 bispecific T cell-engager blinatumomab shows hematologic and molecular remissions in patients with relapsed or refractory B-precursor acute lymphoblastic leukemia. J Clin Oncol. 2014 Dec 20;32(36):4134-40. doi: 10.1200/JCO.2014.56.3247. Epub 2014 Nov 10. **PMID:** 25385737 **Citation:** Topp MS, Gokbuget N, Stein AS, Zugmaier G, O'Brien S, Bargou RC, Dombret H, Fielding AK, Heffner L, Larson RA, Neumann S, Foa R, Litzow M, Ribera JM, Rambaldi A, Schiller G, Bruggemann M, Horst HA, Holland C, Jia C, Maniar T, Huber B, Nagorsen D, Forman SJ, Kantarjian HM. Safety and activity of blinatumomab for adult patients with relapsed or refractory B-precursor acute lymphoblastic leukaemia: a multicentre, single-arm, phase 2 study. Lancet Oncol. 2015 Jan;16(1):57-66. doi: 10.1016/S1470-2045(14)71170-2. Epub 2014 Dec 16. Erratum In: Lancet Oncol. 2015 Apr;16(4):e158. **PMID:** 25524800 **Citation:** Bargou R, Leo E, Zugmaier G, Klinger M, Goebeler M, Knop S, Noppeney R, Viardot A, Hess G, Schuler M, Einsele H, Brandl C, Wolf A, Kirchinger P, Klappers P, Schmidt M, Riethmuller G, Reinhardt C, Baeuerle PA, Kufer P. Tumor regression in cancer patients by very low doses of a T cell-engaging antibody. Science. 2008 Aug 15;321(5891):974-7. doi: 10.1126/science.1158545. **PMID:** 18703743 **Citation:** Topp MS, Kufer P, Gokbuget N, Goebeler M, Klinger M, Neumann S, Horst HA, Raff T, Viardot A, Schmid M, Stelljes M, Schaich M, Degenhard E, Kohne-Volland R, Bruggemann M, Ottmann O, Pfeifer H, Burmeister T, Nagorsen D, Schmidt M, Lutterbuese R, Reinhardt C, Baeuerle PA, Kneba M, Einsele H, Riethmuller G, Hoelzer D, Zugmaier G, Bargou RC. Targeted therapy with the T-cell-engaging antibody blinatumomab of chemotherapy-refractory minimal residual disease in B-lineage acute lymphoblastic leukemia patients results in high response rate and prolonged leukemia-free survival. J Clin Oncol. 2011 Jun 20;29(18):2493-8. doi: 10.1200/JCO.2010.32.7270. Epub 2011 May 16. **PMID:** 21576633 **Citation:** Martinelli G, Boissel N, Chevallier P, Ottmann O, Gokbuget N, Topp MS, Fielding AK, Rambaldi A, Ritchie EK, Papayannidis C, Sterling LR, Benjamin J, Stein A. Complete Hematologic and Molecular Response in Adult Patients With Relapsed/Refractory Philadelphia Chromosome-Positive B-Precursor Acute Lymphoblastic Leukemia Following Treatment With Blinatumomab: Results From a Phase II, Single-Arm, Multicenter Study. J Clin Oncol. 2017 Jun 1;35(16):1795-1802. doi: 10.1200/JCO.2016.69.3531. Epub 2017 Mar 29. Erratum In: J Clin Oncol. 2017 Aug 10;35(23):2722. J Clin Oncol. 2017 Aug 20;35(24):2856. **PMID:** 28355115 **Citation:** Jain T, Litzow MR. No free rides: management of toxicities of novel immunotherapies in ALL, including financial. Blood Adv. 2018 Nov 27;2(22):3393-3403. doi: 10.1182/bloodadvances.2018020198. **PMID:** 30482769 **Citation:** Shah NN, Johnson BD, Fenske TS, Raj RV, Hari P. Intrathecal chemotherapy for management of steroid-refractory CAR T-cell-associated neurotoxicity syndrome. Blood Adv. 2020 May 26;4(10):2119-2122. doi: 10.1182/bloodadvances.2020001626. No abstract available. **PMID:** 32407473 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000006402 - Term: Hematologic Diseases - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000011041 - Term: Poisoning - ID: D000064419 - Term: Chemically-Induced Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC25 - Name: Substance Related Disorders - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10945 - Name: Leukemia - Relevance: HIGH - As Found: Leukemia - ID: M10951 - Name: Leukemia, Lymphoid - Relevance: HIGH - As Found: Lymphoblastic Leukemia - ID: M27585 - Name: Precursor Cell Lymphoblastic Leukemia-Lymphoma - Relevance: HIGH - As Found: Acute Lymphoblastic Leukemia - ID: M22080 - Name: Neurotoxicity Syndromes - Relevance: HIGH - As Found: Neurotoxicity - ID: M11220 - Name: Lymphoma - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M13931 - Name: Poisoning - Relevance: LOW - As Found: Unknown - ID: M30302 - Name: Chemically-Induced Disorders - Relevance: LOW - As Found: Unknown - ID: T175 - Name: Acute Lymphoblastic Leukemia - Relevance: HIGH - As Found: Acute Lymphoblastic Leukemia - ID: T3533 - Name: Lymphoblastic Lymphoma - Relevance: HIGH - As Found: Acute Lymphoblastic Leukemia - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T4120 - Name: Neurotoxicity Syndromes - Relevance: HIGH - As Found: Neurotoxicity - ID: T3543 - Name: Lymphosarcoma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007938 - Term: Leukemia - ID: D000054198 - Term: Precursor Cell Lymphoblastic Leukemia-Lymphoma - ID: D000007945 - Term: Leukemia, Lymphoid - ID: D000020258 - Term: Neurotoxicity Syndromes ### Intervention Browse Module - Ancestors - ID: D000000020 - Term: Abortifacient Agents, Nonsteroidal - ID: D000000019 - Term: Abortifacient Agents - ID: D000012102 - Term: Reproductive Control Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents - ID: D000003879 - Term: Dermatologic Agents - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000005493 - Term: Folic Acid Antagonists - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000018501 - Term: Antirheumatic Agents - ID: D000019384 - Term: Nucleic Acid Synthesis Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Micro - Name: Micronutrients - Abbrev: Hemat - Name: Hematinics - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M11703 - Name: Methotrexate - Relevance: HIGH - As Found: Breast Cancer - ID: M287547 - Name: Blinatumomab - Relevance: HIGH - As Found: Inguinal Hernia - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown - ID: M7074 - Name: Dermatologic Agents - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M8618 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: M17546 - Name: Vitamin B Complex - Relevance: LOW - As Found: Unknown - ID: M8619 - Name: Folic Acid Antagonists - Relevance: LOW - As Found: Unknown - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: T447 - Name: Folinic Acid - Relevance: LOW - As Found: Unknown - ID: T446 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: T448 - Name: Folate - Relevance: LOW - As Found: Unknown - ID: T475 - Name: Vitamin B9 - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000008727 - Term: Methotrexate - ID: C000510808 - Term: Blinatumomab ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05682079 **Brief Title:** The Relationship Between Functional Exercise Capacity, Respiratory Muscle Strength, Trunk Control, Balance and Activities of Daily Living in Individuals With Cerebral Palsi **Official Title:** Investigation of the Relationship Between Functional Exercise Capacity, Respiratory Muscle Strength, Trunk Control, Balance and Activities of Daily Living in Individuals With Spastic Cerebral Palsy. #### Organization Study ID Info **ID:** KirikkaleUni2 #### Organization **Class:** OTHER **Full Name:** Kırıkkale University ### Status Module #### Completion Date **Date:** 2022-11-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-09-01 **Type:** ACTUAL **Last Update Submit Date:** 2023-08-31 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-10-15 **Type:** ACTUAL #### Start Date **Date:** 2022-08-15 **Type:** ACTUAL **Status Verified Date:** 2023-08 #### Study First Post Date **Date:** 2023-01-12 **Type:** ACTUAL **Study First Submit Date:** 2022-12-23 **Study First Submit QC Date:** 2023-01-10 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** yeni kurtuluş özel eğitim ve rehabilitasyon merkezi **Class:** UNKNOWN **Name:** Özel Gelişim Akademi Özel Eğitim ve Rehabilitasyon Merkezi #### Lead Sponsor **Class:** OTHER **Name:** Nursena Güçlü #### Responsible Party **Investigator Affiliation:** Kırıkkale University **Investigator Full Name:** Nursena Güçlü **Investigator Title:** fizyoterapist **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Cerebral palsy (CP) causes problems in posture, movement, breathing, postural control and balance in individuals. This work; This study was conducted to examine the relationship between functional exercise capacity, respiratory muscle strength, trunk control, balance and activities of daily living in individuals with spastic cerebral palsy. **Detailed Description:** Cerebral palsy (CP) causes problems in posture, movement, breathing, postural control and balance in individuals. This work; This study was conducted to examine the relationship between functional exercise capacity, respiratory muscle strength, trunk control, balance and activities of daily living in individuals with spastic cerebral palsy. 23 children with spastic type CP and 22 typically developing children aged 6-18 years were included in the study. After recording the demographic data, the trunk control "Trunk control measurement scale" (TCMS), the activities of daily living "Pediatric Disability Assessment Inventory" (PDI), the balance "Pediatric Berg Balance Scale" (PBDI), functional exercise capacity "2 Minute Walking Test" and respiratory muscle strength was evaluated with maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) measurements. Compared to individuals with typical development, individuals with CP had lower TCMS, PPI, PBRS, 2-minute walking test and respiratory muscle strength values (p\<0.01). At the same time, it was observed that individuals with hemiparetic CP had better TCMS, PPI, PBRS scores, functional exercise capacities and respiratory muscle strength compared to individuals with diparetic disease and individuals with CP at GMFCS I level compared to individuals with other levels. It was found that there was a high correlation between trunk control, balance and functional capacity of individuals with CP. It was concluded that the influence on trunk control affects balance and functional capacity. There was also a correlation between the scales. ### Conditions Module **Conditions:** - Cerebral Palsy, Spastic **Keywords:** - Trunk Control - Respiratory Muscle Strength - Balance ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 45 **Type:** ACTUAL **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 14 Days ### Arms Interventions Module #### Arm Group 1 **Description:** After recording demographic data, "Trunk control measurement scale" (TCMS) to evaluate trunk control, "Gorge motor function classification system" (GMFCS) to measure gross motor functions, "Pediatric Disability Assessment Inventory" (PDI) to evaluate activities of daily living, balance 'Pediatric Berg Balance Scale' was used to evaluate functional capacities and '2-minute walking test' was used to evaluate functional capacities. In addition, respiratory muscle strength was evaluated with maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) measurements. **Intervention Names:** - Other: TCMS, PEDİ, respiration, GMFCS,PBS,functional capacity **Label:** children with cerebral palsy #### Arm Group 2 **Description:** After recording demographic data, "Trunk control measurement scale" (TCMS) to evaluate trunk control, "Gorge motor function classification system" (GMFCS) to measure gross motor functions, "Pediatric Disability Assessment Inventory" (PDI) to evaluate activities of daily living, balance 'Pediatric Berg Balance Scale' was used to evaluate functional capacities and '2-minute walking test' was used to evaluate functional capacities. In addition, respiratory muscle strength was evaluated with maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) measurements. **Intervention Names:** - Other: TCMS, PEDİ, respiration, GMFCS,PBS,functional capacity **Label:** typical kids ### Interventions #### Intervention 1 **Arm Group Labels:** - children with cerebral palsy - typical kids **Description:** The Trunk Control Measurement Scale evaluates the two main components of trunk control, static sitting balance and dynamic sitting balance. The scale includes a total of 15 items. The Pediatric Disability Assessment Inventory evaluates ADLs in individuals between the ages of 6 months and 7.5 years. It is a detailed clinical assessment scale that evaluates the functional skills and performance of individuals. Items in this section are scored as "0=cannot" and "1=can". The Pediatric Berg Balance Scale is an adapted version of the Berg Balance test for adults, which consists of 14 questions. It is a scale that consists of 14 questions and evaluates balance functionally. For the 2-minute walking test; They were asked to walk at their own pace without running for 2 minutes on a quiet, concrete walkway 15 m long. It was repeated 2 times with a 10-minute rest between each trial. Respiratory muscle strength was measured using a portable, electronic mouth pressure measuring device. **Name:** TCMS, PEDİ, respiration, GMFCS,PBS,functional capacity **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Level I: Walks without restraint. Level II: Walks with restrictions. Level III: Walks using hand-held mobility devices. Level IV: Self-movement is restricted. Can use a motorized mobility vehicle. Level V: Transported in a manual wheelchair. **Measure:** Gross Motor Function Classification System (GMFCS) **Time Frame:** 2 week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Being between 6-18 years old, * Having been diagnosed with spastic hemiplegic or spastic diplegic cerebral palsy, * No communication problem, * GMFCS level was determined to be between I-III. Exclusion Criteria: * The parent who will answer the form does not know Turkish, * Orthopedic surgical treatment and botulinum toxin injection in the 6 months before the study, * It was determined as having other orthopedic, neurological and cardiopulmonary diseases that may affect balance and gait. **Healthy Volunteers:** True **Maximum Age:** 18 Years **Minimum Age:** 6 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT **Study Population:** Individuals aged 6-18 years ### Contacts Locations Module #### Locations **Location 1:** **City:** Ankara **Country:** Turkey **Facility:** Fzt. Nur Sena Güçlü **State:** Çankaya **Zip:** 06510 #### Overall Officials **Official 1:** **Affiliation:** kırıkkale üniversitesi **Name:** saniye aydoğan arslan **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001925 - Term: Brain Damage, Chronic - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000009122 - Term: Muscle Hypertonia - ID: D000020879 - Term: Neuromuscular Manifestations - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5796 - Name: Cerebral Palsy - Relevance: HIGH - As Found: Cerebral Palsy - ID: M12085 - Name: Muscle Spasticity - Relevance: HIGH - As Found: Spastic - ID: M13157 - Name: Paralysis - Relevance: LOW - As Found: Unknown - ID: M5207 - Name: Brain Injuries - Relevance: LOW - As Found: Unknown - ID: M5202 - Name: Brain Damage, Chronic - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M12079 - Name: Muscle Hypertonia - Relevance: LOW - As Found: Unknown - ID: M22619 - Name: Neuromuscular Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009128 - Term: Muscle Spasticity - ID: D000002547 - Term: Cerebral Palsy ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03353779 **Brief Title:** The Impact Of Platelet Function on 1-year Outcome in Complex PCI Patients **Official Title:** The Impact Of Platelet Function on 1-year Outcome in Complex PCI Patients #### Organization Study ID Info **ID:** 2017-901 #### Organization **Class:** OTHER **Full Name:** Chinese Academy of Medical Sciences, Fuwai Hospital ### Status Module #### Completion Date **Date:** 2021-07-29 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2018-01-25 **Type:** ACTUAL **Last Update Submit Date:** 2018-01-24 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2021-07-29 **Type:** ESTIMATED #### Start Date **Date:** 2017-11-29 **Type:** ACTUAL **Status Verified Date:** 2018-01 #### Study First Post Date **Date:** 2017-11-27 **Type:** ACTUAL **Study First Submit Date:** 2017-11-20 **Study First Submit QC Date:** 2017-11-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Chinese Academy of Medical Sciences, Fuwai Hospital #### Responsible Party **Investigator Affiliation:** Chinese Academy of Medical Sciences, Fuwai Hospital **Investigator Full Name:** Yi-Da Tang **Investigator Title:** Professor, Chief Physician **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** To identify the optimal cut-off values in different platelet function testing to predict MACCE at 12-months in complex PCI patients of China **Detailed Description:** This study will observe the relationship between platelet function testing and clinical outcomes. Meanwhile we aim to identify optimal cut-off values in different platelet function testing, including IPF, TEG and VerifyNow, to predict MACCE during12-months in complex PCI patients. ### Conditions Module **Conditions:** - Percutaneous Coronary Intervention - Coronary Artery Disease **Keywords:** - Percutaneous coronary intervention - antiplatelet - platelet function - prognosis ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 1440 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Measure:** Optimal cut-off values in different platelet function testing to predict MACCE at 12-months in complex PCI patients of China **Time Frame:** Within 12 months of patient enrolled #### Secondary Outcomes **Measure:** Effectiveness and sensitivity of predicting between different platelet function testing **Time Frame:** Within 12 months of patient enrolled ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Documented undergoing complex PCI in 1 year prior to enrollment. Exclusion Criteria: * Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language where interpreter services are not reliably available, psychiatric disturbances, alcohol or drug abuse). * Presence of serious/severe co-morbidities in the opinion of the investigator which may limit life expectancy (\<1 year). * Current participation in a blinded randomized clinical trial. **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Patients with complex PCI were defined as having at least 1of the following features :3 vessels treated,≥3 stents implanted, ≥3 lesions treated,bifurcation with 2stents implanted ,total stent length \>60 mm or chronic total occlusion. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Chunli Shao, MD **Phone:** +861088396171 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Name:** Chunli Shao, MD, PhD - **Phone:** +861088396171 - **Role:** CONTACT **Country:** China **Facility:** Chinese Academy of Medical Sciences Fuwai Hospital **State:** Beijing **Status:** RECRUITING **Zip:** 100037 #### Overall Officials **Official 1:** **Affiliation:** Chinese Academy of Medical Sciences, Fuwai Hospital **Name:** Yida Tang, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003327 - Term: Coronary Disease - ID: D000017202 - Term: Myocardial Ischemia - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000001161 - Term: Arteriosclerosis - ID: D000001157 - Term: Arterial Occlusive Diseases - ID: D000014652 - Term: Vascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M6549 - Name: Coronary Disease - Relevance: LOW - As Found: Unknown - ID: M6546 - Name: Coronary Artery Disease - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M4469 - Name: Arteriosclerosis - Relevance: LOW - As Found: Unknown - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003324 - Term: Coronary Artery Disease ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04869579 **Acronym:** SeCOVID **Brief Title:** Selenium as a Potential Treatment for Moderately-ill, Severely-ill, and Critically-ill COVID-19 Patients. **Official Title:** Selenium as a Potential Treatment for Moderately-ill, Severely-ill, and Critically-ill COVID-19 Patients #### Organization Study ID Info **ID:** 2020-190 #### Organization **Class:** OTHER **Full Name:** CHRISTUS Health ### Status Module #### Completion Date **Date:** 2021-12-15 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** NOT_YET_RECRUITING #### Last Update Post Date **Date:** 2021-08-03 **Type:** ACTUAL **Last Update Submit Date:** 2021-07-30 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2021-11-15 **Type:** ESTIMATED #### Start Date **Date:** 2021-08-15 **Type:** ESTIMATED **Status Verified Date:** 2021-07 #### Study First Post Date **Date:** 2021-05-03 **Type:** ACTUAL **Study First Submit Date:** 2021-04-29 **Study First Submit QC Date:** 2021-04-29 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Pharco Pharmaceuticals #### Lead Sponsor **Class:** OTHER **Name:** CHRISTUS Health #### Responsible Party **Investigator Affiliation:** CHRISTUS Health **Investigator Full Name:** Mohamed Ghoweba, MD **Investigator Title:** Internal Medicine Resident Physician **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** Given its anti-viral, anti-oxidative, immune-enhancing, cytokine-modulating, and anticoagulant properties, the investigators hypothesize that Selenium infusion at supranutritional doses for moderately-ill, severely-ill, and critically-ill COVID-19 patients will prevent further clinical deterioration thus decreasing overall mortality and improving survival. To test this hypothesis, a prospective, single-center, phase II trial is proposed to assess the efficacy of Selenium in hospitalized adult patients with moderate, severe, and critical COVID-19 infections. **Detailed Description:** COVID-19 is a respiratory illness that is caused by the novel SARS-CoV-2. Illness severity can widely range from mild, moderate, severe featuring pneumonia, to critical. Despite ongoing extensive research to find a cure for COVID-19, there had been no proven, efficacious, and widely-available treatment for the disease. With the death toll rising in various parts of the US and the world, it is imperative that investigators work on determining new therapeutic modalities. This study relates to inpatient and critical care for COVID-19 patients. The role of Selenium (Se) as a trace element involved in many biological processes and reactions is well established in various organisms. Particularly, Selenium is known to have anti-viral, anti-oxidative, cytokine-modulating, immune-enhancing, and anticoagulant properties that might be beneficial in COVID-19 infections given the pathophysiological processes involved in the disease. Multiple preclinical and clinical studies have shed the light on the various effects exerted by Selenium in multiple inflammatory conditions including acute lung injury and acute respiratory distress syndrome, as well as viral infections including HIV and Influenza. The study team aims to explore the possible role of Selenium in mitigating the inflammatory processes involved in COVID-19 infections and hence its effect on disease progression and mortality. Patients with COVID-19 who exhibit the signs and symptoms of moderate or severe infection or are critically ill will receive Selenium infusion for 14 days. The working hypothesis of this trial is that selenium treatment would decrease the death rates and increase the rate of hospital discharges among hospitalized patients. ### Conditions Module **Conditions:** - Covid19 **Keywords:** - COVID-19 Pneumonia - Cytokine Storm - ARDS - Moderate COVID-19 Infections - Severe COVID-19 Infections - Critical COVID-19 Infections - Selenium ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This is a randomized double-blinded, placebo-controlled Phase 2 clinical trial to assess the efficacy of Selenium in the treatment of moderately-ill, severely-ill, and critically ill COVID-19 patients. The patients will be randomized in a 1:1 ratio to receive standard of care plus a loading dose of Selenium followed by continuous infusion for a total of 14 days, or standard of care plus a Saline-based placebo. ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants who are moderately-ill, severely-ill, or critically ill will receive a Selenious Acid infusion of 2000µg on day 1 as a loading dose infusion, followed by a continuous infusion of Selenious Acid at a maintenance dose of 1000µg daily on days 2-14 together with continued Standard Of Care therapy. **Intervention Names:** - Drug: Selenium (as Selenious Acid) **Label:** Selenious Acid + Standard Of Care (SOC) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive a Saline-based placebo infusion of 2000µg on day 1 as a loading dose, followed by continuous infusion of a Saline-based placebo at a maintenance dose of 1000µg daily on days 2-14. Standard Of Care is to be determined according to patients' clinical picture and may include Dexamethasone, Azithromycin, Ceftriaxone, Remdesivir, Convalescent Plasma. **Intervention Names:** - Other: Placebo **Label:** Standard Of Care (SOC) + Placebo **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Selenious Acid + Standard Of Care (SOC) **Description:** Interventional arm participants will receive Selenium as Selenious Acid infusion plus the standard of care therapy. **Name:** Selenium (as Selenious Acid) **Other Names:** - Selenious Acid (AMERICAN REGENT) **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Standard Of Care (SOC) + Placebo **Description:** Active comparator arm participants will receive the standard of care therapy plus a Saline-based placebo. **Name:** Placebo **Other Names:** - Saline-based Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. **Measure:** Mean change in the ordinal scale **Time Frame:** Day 1 through Day 29 **Description:** Rate of patient discharge to home or other long-term care facilities, or death. **Measure:** Rate of hospital discharges or deaths **Time Frame:** Study duration #### Secondary Outcomes **Description:** The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. **Measure:** Clinical status using ordinal scale **Time Frame:** Day 1 through Day 29 **Description:** The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. **Measure:** Mean change in the ordinal scale **Time Frame:** Day 1 though Day 29 **Description:** The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. **Measure:** Time to an improvement of one category using an ordinal scale **Time Frame:** Day 1 though Day 29 **Description:** The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. **Measure:** Change in National Early Warning Score (NEWS) from baseline **Time Frame:** Day 1 through Day 29 **Description:** An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. **Measure:** Cumulative incidence of serious adverse events (SAEs) **Time Frame:** Day 1 through Day 29 **Description:** Measured in days. **Measure:** Duration of hospitalization **Time Frame:** Day 1 though Day 29 **Description:** Incidence of new oxygen use. **Measure:** Incidence of new oxygen use **Time Frame:** Day 1 though Day 29 **Description:** Measured in days. **Measure:** Duration of new oxygen use **Time Frame:** Day 1 though Day 29 **Description:** Incidence of new non-invasive ventilation or high flow oxygen use. **Measure:** Incidence of new non-invasive ventilation or high flow oxygen use **Time Frame:** Day 1 though Day 29 **Description:** Measured in days. **Measure:** Duration of new non-invasive ventilation or high flow oxygen use **Time Frame:** Day 1 though Day 29 **Description:** Incidence of new ventilator use. **Measure:** Incidence of new ventilator use **Time Frame:** Day 1 though Day 29 **Description:** Measured in days. **Measure:** Duration of new ventilator use **Time Frame:** Day 1 though Day 29 **Description:** For any reason. **Measure:** Discontinuation or temporary suspension of investigational therapeutics **Time Frame:** Day 1 through Day 14 **Description:** Change from baseline in alanine transaminase (ALT). **Measure:** Change from baseline in alanine transaminase (ALT) **Time Frame:** Day 1 through Day 29 **Description:** Change from baseline in aspartate transaminase (AST). **Measure:** Change from baseline in aspartate transaminase (AST) **Time Frame:** Day 1 through Day 29 **Description:** Change from baseline in creatinine (Cr). **Measure:** Change from baseline in creatinine (Cr) **Time Frame:** Day 1 through Day 29 **Description:** Change from baseline in glucose. **Measure:** Change from baseline in glucose **Time Frame:** Day 1 through Day 29 **Description:** Change from baseline in hemoglobin. **Measure:** Change from baseline in hemoglobin **Time Frame:** Day 1 through Day 29 **Description:** Change from baseline in platelets. **Measure:** Change from baseline in platelets **Time Frame:** Day 1 through Day 29 **Description:** Change from baseline in prothrombin time. **Measure:** Change from baseline in prothrombin time **Time Frame:** Day 1 through Day 29 **Description:** Change from baseline in total bilirubin. **Measure:** Change from baseline in total bilirubin **Time Frame:** Day 1 through Day 29 **Description:** Change from baseline in white blood cell count (WBC) with differential. **Measure:** Change from baseline in white blood cell count (WBC) with differential **Time Frame:** Day 1 through Day 29 **Description:** Change from baseline in interleukin-1 (IL-1). **Measure:** Change from baseline in interleukin-1 (IL-1) **Time Frame:** Day 1 through Day 29 **Description:** Change from baseline in interleukin-6 (IL-6). **Measure:** Change from baseline in interleukin-6 (IL-6) **Time Frame:** Day 1 through Day 29 **Description:** Change from baseline in tumor necrosis factor alpha (TNF-α). **Measure:** Change from baseline in tumor necrosis factor alpha (TNF-α) **Time Frame:** Day 1 through Day 29 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age ≥18) prior to performing study procedure. 2. Aged ≥ 18 years. 3. Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization. 4. Currently hospitalized. 5. Peripheral capillary oxygen saturation (SpO2) ≤ 94% or requiring supplemental oxygen on screening. Exclusion Criteria: 1. Participation in any other clinical trial of an experimental treatment for COVID-19. 2. Evidence of multiorgan failure. 3. Mechanically ventilated for \> 5 days. 4. Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 X upper limit of normal (ULN). 5. Creatinine clearance \< 50 mL/min. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Mohamed S Ghoweba, MD **Phone:** 318-219-6701 **Role:** CONTACT #### Locations **Location 1:** **City:** Longview **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Mohamed Ghoweba, MD - **Phone:** 318-219-6701 - **Role:** CONTACT **Country:** United States **Facility:** CHRISTUS Good Shepherd Medical Center **State:** Texas **Zip:** 75601 #### Overall Officials **Official 1:** **Affiliation:** CHRISTUS Health **Name:** Mohamed S Ghoweba, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Researchers who provide a methodologically sound proposal. **Description:** Individual participant data that underlie the results reported in the publication(s) after deidentification (text, tables, figures, and appendices). Proposals should be directed to [email protected]. To gain access, data requestors will need to sign a data access agreement. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** Immediately following publication. No end date. ### References Module #### References **Citation:** Perona G, Schiavon R, Guidi GC, Veneri D, Minuz P. Selenium dependent glutathione peroxidase: a physiological regulatory system for platelet function. Thromb Haemost. 1990 Oct 22;64(2):312-8. **PMID:** 2270539 **Citation:** Steinbrenner H, Sies H. Protection against reactive oxygen species by selenoproteins. Biochim Biophys Acta. 2009 Nov;1790(11):1478-85. doi: 10.1016/j.bbagen.2009.02.014. Epub 2009 Mar 5. **PMID:** 19268692 **Citation:** Steinbrenner H, Speckmann B, Klotz LO. Selenoproteins: Antioxidant selenoenzymes and beyond. Arch Biochem Biophys. 2016 Apr 1;595:113-9. doi: 10.1016/j.abb.2015.06.024. **PMID:** 27095226 **Citation:** Avery JC, Hoffmann PR. 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Epub 2007 Feb 11. **PMID:** 17346688 **Citation:** Hoffmann PR, Berry MJ. The influence of selenium on immune responses. Mol Nutr Food Res. 2008 Nov;52(11):1273-80. doi: 10.1002/mnfr.200700330. **PMID:** 18384097 **Citation:** Steinbrenner H, Al-Quraishy S, Dkhil MA, Wunderlich F, Sies H. Dietary selenium in adjuvant therapy of viral and bacterial infections. Adv Nutr. 2015 Jan 15;6(1):73-82. doi: 10.3945/an.114.007575. Print 2015 Jan. **PMID:** 25593145 **Citation:** Beck MA, Levander OA, Handy J. Selenium deficiency and viral infection. J Nutr. 2003 May;133(5 Suppl 1):1463S-7S. doi: 10.1093/jn/133.5.1463S. **PMID:** 12730444 **Citation:** Beck MA. Selenium and host defence towards viruses. Proc Nutr Soc. 1999 Aug;58(3):707-11. doi: 10.1017/s0029665199000920. **PMID:** 10604206 **Citation:** Beck MA. Antioxidants and viral infections: host immune response and viral pathogenicity. 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Ann Clin Lab Sci. 2006 Autumn;36(4):409-20. **PMID:** 17127727 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011024 - Term: Pneumonia, Viral - ID: D000011014 - Term: Pneumonia - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000014777 - Term: Virus Diseases - ID: D000018352 - Term: Coronavirus Infections - ID: D000003333 - Term: Coronaviridae Infections - ID: D000030341 - Term: Nidovirales Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M2561 - Name: COVID-19 - Relevance: HIGH - As Found: COVID-19 - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M19010 - Name: Critical Illness - Relevance: LOW - As Found: Unknown - ID: M13914 - Name: Pneumonia, Viral - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M20490 - Name: Coronavirus Infections - Relevance: LOW - As Found: Unknown - ID: M6555 - Name: Coronaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M23685 - Name: Nidovirales Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000086382 - Term: COVID-19 ### Intervention Browse Module - Ancestors - ID: D000000975 - Term: Antioxidants - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000020011 - Term: Protective Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000014131 - Term: Trace Elements - ID: D000018977 - Term: Micronutrients ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: AnEm - Name: Antiemetics - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Micro - Name: Micronutrients - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M7102 - Name: Dexamethasone - Relevance: LOW - As Found: Unknown - ID: M15455 - Name: Selenium - Relevance: HIGH - As Found: Antiplatelet - ID: M235549 - Name: Dexamethasone acetate - Relevance: LOW - As Found: Unknown - ID: M20132 - Name: Azithromycin - Relevance: LOW - As Found: Unknown - ID: M5693 - Name: Ceftriaxone - Relevance: LOW - As Found: Unknown - ID: M341627 - Name: Remdesivir - Relevance: LOW - As Found: Unknown - ID: M22626 - Name: Selenious Acid - Relevance: HIGH - As Found: Food and Nutrition - ID: M4292 - Name: Antioxidants - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: M21009 - Name: Micronutrients - Relevance: LOW - As Found: Unknown - ID: M16885 - Name: Trace Elements - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000012643 - Term: Selenium - ID: D000020887 - Term: Selenious Acid ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04786379 **Brief Title:** Surgical Management of Knee Septic Arthritis **Official Title:** Open vs Arthroscopic Treatment of Septic Arthritis in the Adult Native Knee: A Prospective Trial #### Organization Study ID Info **ID:** IRB #E21085 #### Organization **Class:** OTHER **Full Name:** Texas Tech University Health Sciences Center, El Paso ### Status Module #### Completion Date **Date:** 2022-04-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-12-08 **Type:** ACTUAL **Last Update Submit Date:** 2023-12-01 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2022-04-30 **Type:** ACTUAL #### Start Date **Date:** 2021-04-01 **Type:** ACTUAL **Status Verified Date:** 2023-12 #### Study First Post Date **Date:** 2021-03-08 **Type:** ACTUAL **Study First Submit Date:** 2021-02-24 **Study First Submit QC Date:** 2021-03-03 **Why Stopped:** Due to lack of adequate patient sample size in a reasonable time period and lack of research support staff ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Texas Tech University Health Sciences Center, El Paso #### Responsible Party **Investigator Affiliation:** Texas Tech University Health Sciences Center, El Paso **Investigator Full Name:** Matthew Wells **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Surgical excisional debridement is the mainstay of management in septic arthritis with necessary decompression, lavage, debridement, and partial synovectomy. However, there has been considerable debate over the optimal modality. Most surgeons perform an open arthrotomy or arthroscopic debridement, although serial aspiration can be considered as an option in very limited circumstances with patients who cannot tolerate surgery. While open arthrotomy has been often utilized, there has been an increasing number of proponents for arthroscopic treatment citing lower re-infection rates and better functional outcomes. However, there has been a lack of well-designed prospective studies comparing surgical treatment modalities for native knee septic arthritis. The goals of this present study are to determine if arthroscopic management of septic arthritis in the native knee resulted in a lower number of surgeries and a shorter length of stay compared to open arthrotomy. Secondary outcomes included differences in postoperative pain and improvements in Lysholm knee scores. ### Conditions Module **Conditions:** - Septic Arthritis **Keywords:** - orthopedic - septic arthritis - synovectomy ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Patients who are diagnosed with septic arthritis of the native knee will be randomized to either arthroscopic or open treatment. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 10 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Procedure: Arthroscopic Irrigation and Debridement - Procedure: Open Arthrotomy with irrigation and debridement **Label:** Patients with confirmed septic arthritis of the native knee **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients with confirmed septic arthritis of the native knee **Description:** Patients with confirmed septic arthritis treated with multiple small incisions to perform irrigation and debridement with partial synovectomy. **Name:** Arthroscopic Irrigation and Debridement **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Patients with confirmed septic arthritis of the native knee **Description:** Patients with confirmed septic arthritis treated with a single large incision, open arthrotomy to perform irrigation and debridement with partial synovectomy. **Name:** Open Arthrotomy with irrigation and debridement **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The total number of surgeries performed during initial admission in order to obtain appropriate clinical response and resultant discharge on outpatient antibiotics. **Measure:** Number of surgeries to obtain lasting clinical resolution **Time Frame:** Through time period of initial admission (days; expected under 14 days) **Description:** The total number of days in which the patient is initially admitted in order to obtain appropriate clinical response and resultant discharge on outpatient antibiotics. **Measure:** Hospital length of stay **Time Frame:** Through time period of initial admission (days; expected under 14 days) #### Secondary Outcomes **Description:** Daily morning and afternoon visual analogue scale reported by nursing staff. This value is reported on a scale of 0-10; a score of 0 indicates no pain while 10 indicates unbearable pain **Measure:** Post Operative Pain Scores **Time Frame:** Through time period of initial admission (days; expected under 14 days) **Description:** All patients will have post operative pain medications which are to be utilized in a step wise manner for treating their pain. For example, if they are in minimal pain they will be given tylenol whereas unbearable pain will be treated with opioid analgesics. The average total post-operative opioid usage during initial admission will be reported as total morphine milligram equivalent. **Measure:** Post Operative Opioid Use **Time Frame:** Through time period of initial admission (days; expected under 14 days) **Description:** The Lysholm score is a 100-point scoring system for examining a patient's knee-specific symptoms including mechanical locking, instability, pain, swelling, stair climbing, and squatting. The scoring is between 0-100 points. A score of \<65 indicates poor knee function, 65-83 indicates fair knee function, 84-94 indicates a fair outcome, and 95-100 indicates excellent knee function. This scoring system will be obtained at 2 week, 6 week, and 3 months. **Measure:** Lysholm Knee Scale **Time Frame:** Through anticipated follow up period of 3 month post operative appointment. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults (\>18 years old) * Have a diagnosis of septic arthritis of the native knee (synovial WBC \>50k or acrystalline elevated synovial WBC \>25,000 with high clinical suspicion) * Willingness to participate in the study Exclusion Criteria: * Unwilling to participate in the study * Acrystalline elevated synovial WBC \< 25,000 * Crystalline arthropathy with elevated synovial WBC but \< 50,000 * Have a history of a prior knee prosthesis (hemiarthroplasty, total knee arthroplasty) **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** El Paso **Country:** United States **Facility:** University Medical Center of El Paso **State:** Texas **Zip:** 79905 #### Overall Officials **Official 1:** **Affiliation:** Texas Tech University Health Sciences Center of El Paso **Name:** Adam Adler, MD **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Hunter JG, Gross JM, Dahl JD, Amsdell SL, Gorczyca JT. Risk factors for failure of a single surgical debridement in adults with acute septic arthritis. J Bone Joint Surg Am. 2015 Apr 1;97(7):558-64. doi: 10.2106/JBJS.N.00593. **PMID:** 25834080 **Citation:** Bohler C, Dragana M, Puchner S, Windhager R, Holinka J. Treatment of septic arthritis of the knee: a comparison between arthroscopy and arthrotomy. Knee Surg Sports Traumatol Arthrosc. 2016 Oct;24(10):3147-3154. doi: 10.1007/s00167-015-3659-8. Epub 2015 May 28. **PMID:** 26017744 **Citation:** Wirtz DC, Marth M, Miltner O, Schneider U, Zilkens KW. Septic arthritis of the knee in adults: treatment by arthroscopy or arthrotomy. Int Orthop. 2001;25(4):239-41. doi: 10.1007/s002640100226. **PMID:** 11561499 **Citation:** Aim F, Delambre J, Bauer T, Hardy P. Efficacy of arthroscopic treatment for resolving infection in septic arthritis of native joints. Orthop Traumatol Surg Res. 2015 Feb;101(1):61-4. doi: 10.1016/j.otsr.2014.11.010. Epub 2015 Jan 23. **PMID:** 25623272 ## Document Section ### Large Document Module #### Large Docs - Date: 2021-02-19 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 158806 - Type Abbrev: Prot_SAP - Upload Date: 2021-02-27T05:59 - Date: 2021-02-19 - Filename: ICF_001.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 161059 - Type Abbrev: ICF - Upload Date: 2021-02-27T06:00 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000007239 - Term: Infections ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4476 - Name: Arthritis - Relevance: HIGH - As Found: Arthritis - ID: M4478 - Name: Arthritis, Infectious - Relevance: HIGH - As Found: Septic Arthritis - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: T3063 - Name: Infectious Arthritis - Relevance: HIGH - As Found: Septic Arthritis ### Condition Browse Module - Meshes - ID: D000001170 - Term: Arthritis, Infectious - ID: D000001168 - Term: Arthritis ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05004779 **Brief Title:** Regenerative Effects of Human Stem Cell Media After Laser Therapy in Hypertrophic Scar **Official Title:** Regenerative Effects of Human Stem Cell Media After Laser Therapy in Hypertrophic Scar Caused by Burns #### Organization Study ID Info **ID:** HangangSHH-13 #### Organization **Class:** OTHER **Full Name:** Hangang Sacred Heart Hospital ### Status Module #### Completion Date **Date:** 2022-04-20 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** NOT_YET_RECRUITING #### Last Update Post Date **Date:** 2021-08-13 **Type:** ACTUAL **Last Update Submit Date:** 2021-08-09 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2021-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2021-08-10 **Type:** ESTIMATED **Status Verified Date:** 2021-07 #### Study First Post Date **Date:** 2021-08-13 **Type:** ACTUAL **Study First Submit Date:** 2021-07-29 **Study First Submit QC Date:** 2021-08-09 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** National Research Foundation of Korea #### Lead Sponsor **Class:** OTHER **Name:** Hangang Sacred Heart Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study was to determine the effect of combined treatment using nonablative laser and human stem cell media (HSCM) on the regeneration of hypertrophic scars that occurred after burns. **Detailed Description:** The purpose of this study was to determine the effect of combined treatment using nonablative laser and human stem cell media (HSCM) on the regeneration of hypertrophic scars that occurred after burns. Nonablative laser treatment was performed on 30 patients with hypertrophic scars on both sides of the same part of the body. Immediately after the laser treatment, the hypertrophic scars of right side to which HSCM was applied and the left side with the same body position were defined as a control scar, and normal saline was applied. Over the next 6 days, HSCM and moisturizer were applied on the scars of right side, and only moisturizer was applied on the control scar of left side. Laser treatment was performed three times on the hypertrophic scar at 4 weeks intervals. The skin test on hypertrophic scar was evaluated before laser treatment and re-evaluated on the 7the day after the 3rd laser treatment. The thickness was measured with a ultrasonic wave equipment (128 BW1 Medison, Korea). Mexameter® (MX18, Courage-Khazaka Electronics GmbH, Germany) was used to measure melanin levels and the severity of erythema. The higher values indicating a darker and redder skin. Transepidermal water loss (TEWL) was measured with a Tewameter® (Courage-Khazaka Electronic GmbH, Germany), which is used for evaluating water evaporation. Sebum in the scars was measured with the Sebumeter® (Courage-Khazaka Electronic GmbH, Germany). The measurement is based on the principle of grease-spot photometry using a cassette with its special tape. A microprocessor calculates the result, which is shown on the display in μg/cm2. Elasticity was measured using Cutometer SEM 580® (Courage-Khazaka Electronic GmbH, Cologne, Germany), which applies negative pressure (450 mbar) on the skin. The numeric values (mm) of the skin's distortion is presented as the elasticity (Table 1). Two seconds of negative pressure of 450 mbar is followed by 2 s of recess, and this consists of a complete cycle. Three measurement cycles were conducted, and the average values were obtained. To evaluate the effect of HSCM, investigators compared the skin test results (thickness, melanin, erythema, TEWL, sebum, and skin elasticity levels) between the right side and control side, from baseline measures immediately before the laser treatment and measures on the 7the day after the 3rd laser treatment. Outcome measurements and data analyses were performed by a trained and blinded outcome assessor who was not involved in the intervention. Possible complications (pain, ecchymosis, skin abrasion, and swelling) were observed. ### Conditions Module **Conditions:** - Stem Cell Media - Hypertrophic Scar - Regeneration **Keywords:** - stem cell media - non ablative laser - hypertrophic scar - burns - regeneration ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** After laser treatment on hypertrophic scars, human stem cell conditioned media was applied to one side and physiological saline was applied to the other side. ##### Masking Info **Masking:** SINGLE **Masking Description:** After laser treatment on hypertrophic scars, human stem cell media was applied to one side and physiological saline was applied to the other side. **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** human media apply after non ablative laser treatment **Intervention Names:** - Procedure: human stem cell conditioned media was applied after non-ablative laser therapy **Label:** human stem cell media apply lesion **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** normal saline apply after non ablative laser treatment **Intervention Names:** - Procedure: normal saline was applied after non ablative laser therapy **Label:** control condition lesion **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - human stem cell media apply lesion **Description:** After laser treatment on hypertrophic scars, human stem cell media was applied to one side **Name:** human stem cell conditioned media was applied after non-ablative laser therapy **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - control condition lesion **Description:** physiological saline was applied to the other side. **Name:** normal saline was applied after non ablative laser therapy **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The thickness was measured with a ultrasonic wave equipment **Measure:** scar thickness (cm) **Time Frame:** baseline **Description:** the change of scar thickness was measured with a ultrasonic wave equipment **Measure:** change from baseline scar thickness at 3 months (cm) **Time Frame:** after 3 months intervention #### Secondary Outcomes **Description:** the higher values indicating a darker **Measure:** melanin levels (arbitraty units; AU) **Time Frame:** baseline **Description:** the higher values indicating a darker **Measure:** change from baseline melanin level at 3 months (arbitraty units; AU) **Time Frame:** after 3 months intervention **Description:** the higher values indicating a redder skin **Measure:** erythema level (arbitraty units; AU) **Time Frame:** baseline **Description:** the higher values indicating a redder skin **Measure:** change from baseline erythema level at 3 months (arbitraty units; AU) **Time Frame:** after 3 months intervention **Description:** the higher the number, the more dry the skin is. **Measure:** transepidermal water loss (g/h/m2) **Time Frame:** baseline **Description:** the higher the number, the more dry the skin is. **Measure:** change from baseline transepidermal water loss at 3 months (g/h/m2) **Time Frame:** after 3 months intervention **Description:** A microprocessor calculates the result, which is shown on the display in μg/cm2. The higher the number, the more oily the skin is. **Measure:** Sebum level (μg sebum/cm2) **Time Frame:** baseline **Description:** A microprocessor calculates the result, which is shown on the display in μg/cm2. The higher the number, the more oily the skin is. **Measure:** change from baseline sebum level at 3 months (μg sebum/cm2) **Time Frame:** after 3 months intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * partial or full-thickness burns that healed spontaneously or required skin grafting * with hypertrophic scars on the right and left sides of the same body part Exclusion Criteria: * Patients with open wounds or infection on the burn scars * those taking steroids for the scars * with allergies to topical anesthetic cream * those who were pregnant * undergoing any other medical treatment or condition affecting wound healing (e.g., diabetes) **Maximum Age:** 75 Years **Minimum Age:** 19 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Cheong Hoon Seo, M.D. **Phone:** +82 2 2639 5738 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Onur Erol O, Agaoglu G, Jawad MA. Combined Non-Ablative Laser and Microfat Grafting for Burn Scar Treatment. Aesthet Surg J. 2019 Mar 14;39(4):NP55-NP67. doi: 10.1093/asj/sjy291. **PMID:** 30403775 **Citation:** Jayaraman P, Nathan P, Vasanthan P, Musa S, Govindasamy V. Stem cells conditioned medium: a new approach to skin wound healing management. Cell Biol Int. 2013 Oct;37(10):1122-8. doi: 10.1002/cbin.10138. Epub 2013 Jun 24. **PMID:** 23716460 **Citation:** Park IS. Enhancement of Wound Healing by Conditioned Medium of Adipose-Derived Stromal Cell with Photobiomodulation in Skin Wound. Int J Stem Cells. 2021 May 30;14(2):212-220. doi: 10.15283/ijsc20175. **PMID:** 33632992 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002921 - Term: Cicatrix - ID: D000005355 - Term: Fibrosis - ID: D000010335 - Term: Pathologic Processes - ID: D000020763 - Term: Pathological Conditions, Anatomical ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M10035 - Name: Hypertrophy - Relevance: HIGH - As Found: Hypertrophic - ID: M5326 - Name: Burns - Relevance: LOW - As Found: Unknown - ID: M19708 - Name: Cicatrix, Hypertrophic - Relevance: HIGH - As Found: Hypertrophic Scar - ID: M6160 - Name: Cicatrix - Relevance: LOW - As Found: Unknown - ID: M8485 - Name: Fibrosis - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006984 - Term: Hypertrophy - ID: D000017439 - Term: Cicatrix, Hypertrophic ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04727879 **Acronym:** BAOBAB **Brief Title:** Immunopathology of Polymyalgia Rheumatica on Shoulder Bursae's Biopsies **Official Title:** Beyond Analysis Of Blood Sample, to Approach Immunopathology of Polymyalgia Rheumatica on Shoulder Bursae's Biopsies: the BAOBAB Study #### Organization Study ID Info **ID:** 29BRC20.0158 #### Organization **Class:** OTHER **Full Name:** University Hospital, Brest ### Status Module #### Completion Date **Date:** 2022-08-13 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2023-08-01 **Type:** ACTUAL **Last Update Submit Date:** 2023-07-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-07-13 **Type:** ACTUAL #### Start Date **Date:** 2021-04-07 **Type:** ACTUAL **Status Verified Date:** 2023-07 #### Study First Post Date **Date:** 2021-01-27 **Type:** ACTUAL **Study First Submit Date:** 2021-01-07 **Study First Submit QC Date:** 2021-01-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Brest #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The work carried out at the Brest University Hospital on serum immunological changes in patients with polymyalgia rheumatica (PMR) (based on clinical protocols TENOR, SEMAPHORE, THEN) made it possible to describe the changes in the distribution of lymphocyte subpopulations and cytokine levels during PPR, before and then under treatment compared to controls. However, in systemic autoimmune or inflammatory pathologies, serum immunological mechanisms are rarely a reflection of intra-tissue mechanisms. In the specific case of PMR, there are few data concerning muscular or joint immunological modifications. The investigators now wish to study the immunological modifications occurring at the tissue sites of interest, in particular in the shoulder bursae ### Conditions Module **Conditions:** - Polymyalgia Rheumatica ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 20 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with PMR will be offered biopsy of the synovial membrane with puncture of synovial fluid during cortisone infiltration for analgesic purposes. In case of associated peripheric arthritis, the patient will also be offered a joint fluid sample during a cortisonic infiltration for analgesic purposes, performed as part of routine care The study-specific examination that is not part of current practice is the synovial biopsy performed during the cortisonic infiltration procedure. **Intervention Names:** - Procedure: Synovial membrane biopsy with puncture of synovial fluid - Procedure: Joint fluid sampling - Procedure: Blood sample **Label:** PMR **Type:** OTHER #### Arm Group 2 **Description:** Witnesses recruited into the orthopedic surgery department will be offered a synovial membrane biopsy during a shoulder surgery in the context of mechanical pathology. **Intervention Names:** - Procedure: Synovial membrane biopsy with puncture of synovial fluid - Procedure: Blood sample **Label:** Control **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Control - PMR **Description:** The biopsy of the shoulder bursae will be carried out thanks to a device Tru-cut (Tru-Cut Biopsy Needle), minimally invasive, introduced, as during an infiltration, within the bursa serosa. **Name:** Synovial membrane biopsy with puncture of synovial fluid **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - PMR **Description:** In case of associated peripheric arthritis, the patient will also be offered a sample of joint fluid during a cortisonic infiltration for analgesic purposes, performed as part of routine care. **Name:** Joint fluid sampling **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Control - PMR **Description:** A blood sample taken during routine care and unused will also be collected from patients and controls for immunoassays. **Name:** Blood sample **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The main evaluation criterion is the intensity of the tissue IL-6 marking on the subacromio-deltoid bursa sections using the Hyperion technique. **Measure:** IL-6 marking **Time Frame:** Day 0 #### Secondary Outcomes **Measure:** Cytokinic (other than IL-6) infiltration of tissues **Time Frame:** Day 0 **Measure:** Serum cytokine levels **Time Frame:** Day 0 **Measure:** Cytokine levels in joint or synovial fluid **Time Frame:** Day 0 **Description:** Fragments of the synovial membrane taken from patients and controls will be sent to the pathology laboratory. They will be fixed and slides covering the inflammatory region of interest will be prepared. These slides will be marked with antibodies directed against: - CD20, CD27, CD38, CD24, CD21, CD95, CD23, IgM, Tbet for B lymphocytes; - CD3, CD4, CD8, CD25, CD45RA, CD62L, CD28, FoxP3, CCR7, CD45RO and Bcl-2 for T lymphocytes; - CD14, CD11b and CD11c for monocytes; - CD66b for granulocytes and coupled to heavy metals and analyzed by the Hyperion mass cytometer. The intensity of the markings will be analyzed using the usual Hyperion analysis techniques. **Measure:** Tissue distribution of lymphocyte subpopulations by using the Hyperion mass cytometer (analysis of the intensity of the markings) **Time Frame:** Day 0 **Description:** Whole blood will be centrifuged and serum will be collected. Antibodies directed against: - CD20, CD27, CD38, CD24, CD21, CD95, CD23, IgM, Tbet for B lymphocytes; - CD3, CD4, CD8, CD25, CD45RA, CD62L, CD28, FoxP3, CCR7, CD45RO and Bcl-2 for T lymphocytes; - CD14, CD11b and CD11c for monocytes; - CD66b for granulocytes, aand Hnd coupled with heavy metals will be added to it before analysis by the HELIOS mass cytometer. The intensity of the markings will be analyzed using the usual HELIOS analysis techniques. **Measure:** Serum distribution of lymphocyte subpopulations by using the HELIOS mass cytometer (analysis of the intensity of the markings) **Time Frame:** Day 0 **Description:** Analysis of membrane markers related to immunosenescence in percent of cells expressing the marker and in MFI (Mean fluorescence intensity) by hyperion technology. **Measure:** Analysis of immunosenescence markers in tissues by HYPERION technology **Time Frame:** Day 0 **Description:** The target molecules of treatments under study in PPR (CTLA-4 for abatacept, janus kinases 1 and 2 for baricitinib) will be analyzed by ELISA techniques (concentration). **Measure:** Analysis of target molecules of treatments under study in PPR by ELISA technique **Time Frame:** Day 0 **Description:** The target molecules of treatments under study in PPR (CTLA-4 for abatacept, janus kinases 1 and 2 for baricitinib) will be analyzed by protéomic techniques (cytometry, % of cells expressing the marker, MFI) **Measure:** Analysis of target molecules of treatments under study in PPR by proteomic techniques **Time Frame:** Day 0 **Description:** The expected complications related to the synovial biopsy are: Pain at the biopsy site, Hematoma at the biopsy site, Functional impotence of the shoulder, on the biopsy side, greater than 72h, Hypoesthesia, dysesthesia at the biopsy site, Skin rash within 72h following the infiltration, Hypertensive surge documented within 72 hours of the infiltration, In case of pre-existing diabetes, diabetes imbalance within 72 hours of the infiltration. **Measure:** Complications of subacromio-deltoid purse in the 72h after biopsies : M1 phone call **Time Frame:** Month 1 ### Eligibility Module **Eligibility Criteria:** For everyone : * Signed consent * Patients over 50 Inclusion criteria : For case patients: * Addressed for PMR (diagnosis OR relapse) * Score greater than or equal to 4 (without ultrasound criteria) or greater than or equal to 6 (with ultrasound criteria), according to the ACR / EULAR 2012 criteria for polymyalgia rheumatica, and suffering from bilateral scapular pain as well as an increased CRP level . * Thickening of more than 2mm at least one shoulder bursae in ultrasound * DAS-PPR\> = 10 For witnesses: - Shoulder surgery scheduled for mechanical pathology Exclusion criteria : For everyone : * MRI with Gadolinium injection in the previous month- Clinical or paraclinical signs of giant cell arteritis * Patient under protective measure or unable to consent * Active cancer * Active infection For the cases: - History of biotherapy treatment For witnesses: * History of inflammatory rheumatism * Active inflammatory rheumatism **Minimum Age:** 50 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Brest **Country:** France **Facility:** CHU de Brest - Service de rhumatologie **Zip:** 29200 ### IPD Sharing Statement Module **Access Criteria:** Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement. **Description:** All collected data that underlie results in a publication **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** Data will be available beginning three years and ending fifteen years following the final study report completion ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000020293 - Term: Vasculitis, Central Nervous System - ID: D000020274 - Term: Autoimmune Diseases of the Nervous System - ID: D000009422 - Term: Nervous System Diseases - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000001167 - Term: Arteritis - ID: D000014657 - Term: Vasculitis - ID: D000017445 - Term: Skin Diseases, Vascular - ID: D000012871 - Term: Skin Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13995 - Name: Polymyalgia Rheumatica - Relevance: HIGH - As Found: Polymyalgia Rheumatica - ID: M16472 - Name: Giant Cell Arteritis - Relevance: HIGH - As Found: Polymyalgia Rheumatica - ID: M4475 - Name: Arteritis - Relevance: LOW - As Found: Unknown - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M17405 - Name: Vasculitis - Relevance: LOW - As Found: Unknown - ID: M22106 - Name: Vasculitis, Central Nervous System - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M22094 - Name: Autoimmune Diseases of the Nervous System - Relevance: LOW - As Found: Unknown - ID: M5810 - Name: Cerebrovascular Disorders - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M19714 - Name: Skin Diseases, Vascular - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T2487 - Name: Giant Cell Arteritis - Relevance: HIGH - As Found: Polymyalgia Rheumatica ### Condition Browse Module - Meshes - ID: D000011111 - Term: Polymyalgia Rheumatica - ID: D000013700 - Term: Giant Cell Arteritis ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infl - Name: Anti-Inflammatory Agents ### Intervention Browse Module - Browse Leaves - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M6569 - Name: Cortisone - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01086579 **Acronym:** BELLO **Brief Title:** Balloon Elution and Late Loss Optimization (BELLO) Study **Official Title:** Balloon Elution and Late Loss Optimization (BELLO) Study: A Multicentre Randomized Study of the IN.PACT Falcon™ Paclitaxel Drug-eluting Balloon to Reduce Restenosis in Small Coronary Vessels #### Organization Study ID Info **ID:** BELLO #### Organization **Class:** OTHER **Full Name:** Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS ### Status Module #### Completion Date **Date:** 2014-05 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** ACTIVE_NOT_RECRUITING #### Last Update Post Date **Date:** 2013-08-14 **Type:** ESTIMATED **Last Update Submit Date:** 2013-08-13 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2012-03 **Type:** ACTUAL #### Start Date **Date:** 2010-03 **Status Verified Date:** 2013-08 #### Study First Post Date **Date:** 2010-03-15 **Type:** ESTIMATED **Study First Submit Date:** 2010-03-11 **Study First Submit QC Date:** 2010-03-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** Prospective multicentre randomized (1:1) investigator initiated study, in which consecutive patients undergoing percutaneous revascularization of small coronary vessels will be assigned to one of the two study arms: 1. Treatment Arm: IN.PACT Falcon™ paclitaxel drug-eluting balloon (DEB) dilatation and provisional spot bare-metal stenting (BMS). 2. Control Arm: paclitaxel-eluting stent (PES) implantation as per standard practice. Eligible subjects with coronary artery disease in a small vessel (reference diameter\<2.8mm) will be consecutively screened and enrolled based on the inclusion and exclusion criteria The objective of the study is to assess the non-inferiority of the DEB to the PES as regards to primary endpoint of mean late lumen loss (LLL) at 6 months, defined as the difference between postprocedural minimum luminal (MLD) diameter and follow-up MLD, as assessed by quantitative coronary angiography and is based on the following assumptions: 1. The means of LLL in the 2 groups are precisely equal 2. A standard deviation in LLL of 0.5mm in both groups as demonstrated in the ISAR-SMART 3 and PEPCAD II trials 3. A non-inferiority margin of 0.25mm between groups is clinically unimportant Based on these assumptions: 1. Null hypothesis (N0): mean LLL in DEB group is ≥0.25mm than that in the PES group (i.e. PES is superior to DEB) 2. Alternative hypothesis 1 (H1): mean LLL between DEB and PES is \<0.25mm (i.e. DEB is non-inferior to PES) 3. Alternative hypothesis 2 (H2): mean LLL between DEB and PES \<0 (i.e. DEB is superior to PES) Based on the above calculations, a sample size of 77 patients will be required in each group to show non-inferiority of DEB vs. PES with an α error of 0.025 (one-sided Z test) and a power of 80%. To account for a 20% rate of withdrawal, lost to follow-up or not presenting for follow-up angiography, a total of 182 patients (91 in each group) will be randomized. ### Conditions Module **Conditions:** - Coronary Artery Disease **Keywords:** - paclitaxel PTCA drug-eluting balloon - provisional spot stenting - coronary artery disease - Late Lumen Loss - Minimal lumen diameter - coronary artery disease in a small vessel ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 182 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** IN.PACT Falcon™ paclitaxel drug-eluting balloon (DEB) dilatation and provisional spot bare metal stenting (Bare Metal Stent). **Intervention Names:** - Device: IN.PACT Falcon paclitaxel eluting balloon (Drug eluting balloon) **Label:** Treatment Arm (IN.PACT Falcon Drug Eluting Balloon) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Control Arm: paclitaxel-eluting stent (PES) implantation as per standard practice. **Intervention Names:** - Device: Taxus (Paclitaxel eluting stent) **Label:** Control Arm PES **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment Arm (IN.PACT Falcon Drug Eluting Balloon) **Description:** Coronary Artery Bypass Graft (CABG) **Name:** IN.PACT Falcon paclitaxel eluting balloon (Drug eluting balloon) **Other Names:** - IN.PACT Falcon paclitaxel eluting balloon **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Control Arm PES **Description:** Percutaneous transluminal coronary angioplasty (PTCA) with stent **Name:** Taxus (Paclitaxel eluting stent) **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Measure:** Late Lumen Loss (LLL) at 6 months follow-up defined as the difference between postprocedural minimum luminal diameter and follow-up minimum luminal diameter, as assessed by quantitative coronary angiography **Time Frame:** 6 Month #### Secondary Outcomes **Measure:** Device Success: ability of the Investigational Device to be delivered, dilate, and be retrieved from the target lesion. **Time Frame:** day 1 **Measure:** Procedural Success: defined as Device Success without the occurrence of Major Adverse Cardiac Events (MACE) during the index hospitalization **Time Frame:** day 1 **Measure:** MACE rate through 30 days, 6 months,1, 2, 3 years post index procedure **Time Frame:** 30 days, 6 months,1, 2, 3 years **Measure:** Target Lesion Revascularization (TLR) at 6 months,1, 2, 3 years post index procedure **Time Frame:** 6 months,1, 2, 3 years **Measure:** Target Vessel Revascularization (TVR) at 6 months,1, 2, 3 years post index procedure **Time Frame:** 6 months,1, 2, 3 years **Measure:** Target vessel failure (TVF), defined as cardiac death, Myocardial Infarction (MI) or TVR at 1 year **Time Frame:** 1 Year **Measure:** Binary Restenosis rate at 6 months follow-up **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age \> 18 years. * Patient providing written informed consent. * Patients with stable angina pectoris (Canadian Cardiovascular Society \[CCS\] 1, 2 3) or unstable angina pectoris with documented ischemia (CCS 4, Braunwald Class IB-C, IIB-C or IIIB-C), or patients with documented silent ischemia. * Patients who are eligible for coronary revascularization (angioplasty and/or CABG). * Female patients with child bearing potential must have a negative pregnancy test within one week before treatment and must use adequate contraception. Angiographic Inclusion Criteria: * Native coronary artery. * De novo lesion. * Reference vessel diameter \< 2.8mm by visual estimate. * Target lesion with a visually estimated stenosis \>50%. * Target lesion length \< 25mm by visual estimate. * A maximum of 2 epicardial vessels requiring revascularization. * A maximum of 2 target lesions can be included (In the case of treatment of more than one lesion, the treatment selected will remain the same). Exclusion Criteria: * Patients unable to give informed consent. * Patients enrolled in another study with any investigational drug or device within the past 30 days. * Patients scheduled for a major surgical intervention within 6 months of enrolment in the study. * Patients with acute (\< 24h) or recent (≤ 48 hours) myocardial infarction. * Patients with a contraindication to an emergency coronary bypass surgery. * Any individual who may refuse a blood transfusion. * Patients with serum creatinine \>2.0mg/dL or \>180umol/L. * Patients with severe congestive heart failure. * Patients who had a cerebral stroke \<6 months prior to the Index Procedure. * EF (Ejection Fraction) \< 30%. * Patients with any known allergy, hypersensitivity or intolerance to acetylsalicylic acid (ASA), Clopidogrel or Ticlopidine, Paclitaxel. * Any known allergy to contrast medium that cannot be pre-treated. Angiographic exclusion criteria: * \>2 epicardial vessels requiring revascularization. * Target lesion distance from the ostium of left anterior descending coronary artery (LAD)/left circumflex coronary artery (LCX)/right coronary artery (RCA) is \< 5 mm. * Target lesion is located in either a venous or arterial graft. * Target vessel contains a previously implanted stent. * Angiographic evidence of thrombus at the target site. * Chronic total occlusions. * Restenotic lesions. * Bifurcation lesions which the operator decides a 2-stent technique as intention-to-treat is required OR bifurcations with side branches ≥ 2.5mm. * Failure to successfully treat non-target lesions within the target vessel (non-target lesions must be treated prior the target lesion). * Greater than 2 non-target lesions treated during the index procedure. * Previous Percutaneous Coronary Intervention (PCI) within the last 3 months. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Milan **Country:** Italy **Facility:** Irccs Fondazione Centro S.Raffaele Del Monte Tabor **State:** MI **Zip:** 20100 #### Overall Officials **Official 1:** **Affiliation:** IRCCS Fondazione Centro S.Raffaele del Monte Tabor **Name:** Antonio Colombo, Dr. **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Presidio Ospedaliero Ferrarotto di Catania **Name:** Corrado Tamburino, Prof. **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** Istituto Clinico Humanitas di Rozzano (MI) **Name:** Patrizia Presbitero, Prof **Role:** PRINCIPAL_INVESTIGATOR **Official 4:** **Affiliation:** Azienda Ospedaliera Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi di Ancona **Name:** Alberta Pangrazi, Dr. **Role:** PRINCIPAL_INVESTIGATOR **Official 5:** **Affiliation:** Azienda Ospedaliera San Camillo Forlanini di Roma **Name:** Roberto Violini, Dr. **Role:** PRINCIPAL_INVESTIGATOR **Official 6:** **Affiliation:** Ospedale "C.Poma" di Mantova **Name:** Francesca Buffoli, Dr. **Role:** PRINCIPAL_INVESTIGATOR **Official 7:** **Affiliation:** Azienda Ospedaliera "Bolognini" di Seriate **Name:** Maurizio Tespili, Dr. **Role:** PRINCIPAL_INVESTIGATOR **Official 8:** **Affiliation:** Citta' di Lecce Hospital di Lecce **Name:** Fausto Castriota, Dr. **Role:** PRINCIPAL_INVESTIGATOR **Official 9:** **Affiliation:** Villa Maria Cecilia Hospital di Cotignola **Name:** Alberto Cremonesi, Dr. **Role:** PRINCIPAL_INVESTIGATOR **Official 10:** **Affiliation:** Villa Maria Eleonora Hospital di Palermo **Name:** Antonio Micari, Dr. **Role:** PRINCIPAL_INVESTIGATOR **Official 11:** **Affiliation:** Casa di Cura "AntheaHospital" di Bari **Name:** Alfredo Marchese, Dr. **Role:** PRINCIPAL_INVESTIGATOR **Official 12:** **Affiliation:** European Hospital di Roma **Name:** Fabrizio Tomai, Dr. **Role:** PRINCIPAL_INVESTIGATOR **Official 13:** **Affiliation:** Ospedale S.Maria delle Croci AUSL di Ravenna **Name:** Massimo Margheri, Dr. **Role:** PRINCIPAL_INVESTIGATOR **Official 14:** **Affiliation:** Azienda Ospedaliero-Universitaria di Parma **Name:** Alberto Menozzi, Dr. **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Latib A, Colombo A, Castriota F, Micari A, Cremonesi A, De Felice F, Marchese A, Tespili M, Presbitero P, Sgueglia GA, Buffoli F, Tamburino C, Varbella F, Menozzi A. A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels: the BELLO (Balloon Elution and Late Loss Optimization) study. J Am Coll Cardiol. 2012 Dec 18;60(24):2473-80. doi: 10.1016/j.jacc.2012.09.020. Epub 2012 Nov 14. Erratum In: J Am Coll Cardiol. 2013 Apr 16;61(15):1660. **PMID:** 23158530 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000001161 - Term: Arteriosclerosis - ID: D000001157 - Term: Arterial Occlusive Diseases - ID: D000014652 - Term: Vascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M6549 - Name: Coronary Disease - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M6546 - Name: Coronary Artery Disease - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M19506 - Name: Myocardial Ischemia - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M8219 - Name: Exanthema - Relevance: LOW - As Found: Unknown - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M4469 - Name: Arteriosclerosis - Relevance: LOW - As Found: Unknown - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003324 - Term: Coronary Artery Disease - ID: D000017202 - Term: Myocardial Ischemia - ID: D000003327 - Term: Coronary Disease ### Intervention Browse Module - Ancestors - ID: D000000972 - Term: Antineoplastic Agents, Phytogenic - ID: D000000970 - Term: Antineoplastic Agents - ID: D000050257 - Term: Tubulin Modulators - ID: D000050256 - Term: Antimitotic Agents - ID: D000050258 - Term: Mitosis Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M19537 - Name: Paclitaxel - Relevance: HIGH - As Found: Surgery - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: HIGH - As Found: Surgery - ID: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017239 - Term: Paclitaxel - ID: D000068196 - Term: Albumin-Bound Paclitaxel ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05402579 **Acronym:** DaNGER **Brief Title:** Diabetic Ketoacidosis From New SGLT2i: Can Genomics Estimate Risk **Official Title:** Diabetic Ketoacidosis From New SGLT2i: Can Genomics Estimate Risk (DaNGER) #### Organization Study ID Info **ID:** CTO 3737 #### Organization **Class:** OTHER **Full Name:** Mount Sinai Hospital, Canada ### Status Module #### Completion Date **Date:** 2024-06-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-07-11 **Type:** ACTUAL **Last Update Submit Date:** 2023-07-07 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-06 **Type:** ESTIMATED #### Start Date **Date:** 2022-07-29 **Type:** ACTUAL **Status Verified Date:** 2023-07 #### Study First Post Date **Date:** 2022-06-02 **Type:** ACTUAL **Study First Submit Date:** 2022-05-30 **Study First Submit QC Date:** 2022-05-30 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Unity Health Toronto **Class:** OTHER **Name:** University Health Network, Toronto **Class:** OTHER **Name:** Sault Area Hospital #### Lead Sponsor **Class:** OTHER **Name:** Mount Sinai Hospital, Canada #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Sodium glucose co-transporter 2 (SGLT2) inhibitors have revolutionized care for people living with type 2 diabetes mellitus (T2DM). They reduce a person's risk of heart failure, renal failure, myocardial infarction, stroke, cardiovascular mortality, and potentially all-cause mortality. Remarkably, some of these benefits also extend to people who do not have T2DM. While the benefits of SGLT2 inhibitors are impressive, there is one life-threatening side effect associated with their use: diabetic ketoacidosis (DKA). The ability to predict which patients are at highest risk of DKA is needed to sufficiently mitigate this risk. Moreover, considering the impressive benefits of SGLT2 inhibitors, identifying patients at the lowest risk of SGLT2 inhibitor-associated DKA is also important so that providers do not overestimate risk in those who stand to benefit most. Advances in genomic technologies and related analyses have provided unprecedented opportunities to bring genomics-driven precision medicine initiatives to the forefront of clinical research. Leading these developments has been the progress made by genome-wide association studies (GWAS) due to decreasing genotyping costs, and consequently, the ability to routinely study large numbers of patients. These approaches allow for systematic screening of the genome in an unbiased manner and have accelerated the discovery of genetic variants and novel biological processes that contribute to the development of adverse treatment outcomes. By using innovative approaches, which harness large cohorts of population controls, sample size limitations that are associated with rare adverse drug reactions such as SGLT2 inhibitor-associated DKA can be overcome. The DANGER study represents a highly innovative new direction wherein partnership among basic science researchers and computational biologists will lead to the application of genomic techniques to identify genetic variants that may be associated with SGLT2 inhibitor-associated DKA. ### Conditions Module **Conditions:** - Diabetes Type 2 - DKA - Diabetic Ketoacidosis **Keywords:** - DKA - SGLT2i - Diabetes Type 2 ### Design Module #### Bio Spec **Description:** Genetic samples will be collected using a DNA saliva collection kit (Oragene: OG-510) and will be sent for genome-wide genotyping to The Centre for Applied Genomics in The Hospital for Sick Children (SickKids) **Retention:** NONE_RETAINED #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** OTHER #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with type 2 diabetes mellitus who were hospitalized with SGLT2 inhibitor-associated DKA **Intervention Names:** - Genetic: Genomic analysis **Label:** Cases #### Arm Group 2 **Description:** There are two sources for controls. \[1\] Patients hospitalized at one of the participating hospitals who were on an SGLT2i and do not have DKA. \[2\] Population controls using publicly available data from the Canadian Longitudinal Study on Aging (CLSA) database. **Intervention Names:** - Genetic: Genomic analysis **Label:** Controls ### Interventions #### Intervention 1 **Arm Group Labels:** - Cases - Controls **Description:** Genetic samples will be collected using a DNA saliva collection kit (Oragene: OG-510) and will be sent for genome-wide genotyping to The Centre for Applied Genomics in The Hospital for Sick Children (SickKids) **Name:** Genomic analysis **Type:** GENETIC ### Outcomes Module #### Primary Outcomes **Description:** Genetic ancestry will be calculated using principal component analyses and outliers will be removed. GWAS will be performed with SAIGE, including genetic ancestry and the relevant clinical/demographic variables as covariates, to identify genetic variants associated with SGLT2 inhibitor-associated DKA. **Measure:** Identification of genomic variants associated with an increased risk of SGLT2 inhibitor-associated DKA **Time Frame:** One year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: To be considered eligible for participation in this study, a participant must meet each of the following criteria: 1. Be 18 years or older and have a diagnosis of type 2 diabetes mellitus. 2. Have been admitted to hospital with SGLT2 inhibitor-associated DKA (cases) or admitted to hospital on an SGLT2 inhibitor and not have DKA (controls). 3. Be able to provide written consent (or, if patient is unable, have a substitute decision maker \[SDM\] available). Exclusion Criteria: A participant will be ineligible for participation in this study if he or she satisfies any one or more of the following criteria: 1. Diagnosis of type 1 diabetes mellitus. 2. Unable to spit 10mL into a vial. 3. A first degree relative has already been recruited into the study. Our study will not include children or pregnant women because SGLT2 inhibitors are not approved for use in either patient population. **Maximum Age:** 100 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Cases: Patients with type 2 diabetes mellitus who were hospitalized with SGLT2 inhibitor-associated DKA will be eligible for inclusion in our study. Controls: There are two sources for controls. \[1\] Patients hospitalized at one of the participating hospitals who were on an SGLT2i and do not have DKA. \[2\] Population controls using publicly available data from the Canadian Longitudinal Study on Aging (CLSA) database. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Michael Fralick, MD, PhD **Phone:** 4165864800 **Role:** CONTACT #### Locations **Location 1:** **City:** Toronto **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Michael Fralick - **Role:** CONTACT **Country:** Canada **Facility:** St. Joseph's Health Centre (Unity Health Toronto) **State:** Ontario **Status:** RECRUITING **Location 2:** **City:** Toronto **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Michael Fralick - **Role:** CONTACT **Country:** Canada **Facility:** Toronto General Hospital (University Health Network) **State:** Ontario **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003920 - Term: Diabetes Mellitus - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000000137 - Term: Acid-Base Imbalance - ID: D000048909 - Term: Diabetes Complications ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: HIGH - As Found: Diabetes Type 2 - ID: M10687 - Name: Ketosis - Relevance: HIGH - As Found: Ketoacidosis - ID: M19230 - Name: Diabetic Ketoacidosis - Relevance: HIGH - As Found: Diabetic Ketoacidosis - ID: M3499 - Name: Acidosis - Relevance: HIGH - As Found: Ketoacidosis - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M3498 - Name: Acid-Base Imbalance - Relevance: LOW - As Found: Unknown - ID: M26004 - Name: Diabetes Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003924 - Term: Diabetes Mellitus, Type 2 - ID: D000007662 - Term: Ketosis - ID: D000000138 - Term: Acidosis - ID: D000016883 - Term: Diabetic Ketoacidosis ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1691 - Name: Sodium-Glucose Transporter 2 Inhibitors - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00387179 **Brief Title:** Effectiveness of Combining Light and Non-Light Treatments for Jet Lag and Sleep Disorders **Official Title:** Circadian Integration of Photic and Non-photic Stimuli #### Organization Study ID Info **ID:** 406 #### Organization **Class:** NIH **Full Name:** National Heart, Lung, and Blood Institute (NHLBI) #### Secondary ID Infos **ID:** M01RR000051 **Link:** https://reporter.nih.gov/quickSearch/M01RR000051 **Type:** NIH **ID:** R01HL081761 **Link:** https://reporter.nih.gov/quickSearch/R01HL081761 **Type:** NIH ### Status Module #### Completion Date **Date:** 2010-03 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2009-08-25 **Type:** ESTIMATED **Last Update Submit Date:** 2009-08-24 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2010-03 **Type:** ESTIMATED #### Start Date **Date:** 2006-10 **Status Verified Date:** 2009-08 #### Study First Post Date **Date:** 2006-10-12 **Type:** ESTIMATED **Study First Submit Date:** 2006-10-11 **Study First Submit QC Date:** 2006-10-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** NIH **Name:** National Heart, Lung, and Blood Institute (NHLBI) #### Responsible Party **Old Name Title:** Kenneth P. Wright Jr., Ph.D., Associate Professor **Old Organization:** University of Colorado ### Description Module **Brief Summary:** Jet lag and some sleep disorders are caused by a disruption in an individual's "internal clock." Understanding the most effective way to quickly re-adjust the body's internal clock will be beneficial for treating individuals with these conditions. This study will evaluate the combined effectiveness of light and non-light therapies at regulating sleep cycles and improving sleep quality. **Detailed Description:** Circadian rhythm disorders are disruptions in an individual's circadian rhythm, or "internal body clock." This internal clock regulates the 24-hour cycle of biological processes in the body, including sleep and hormone production. Jet lag, delayed sleep phase syndrome, in which individuals fall asleep and wake up later than desired, and advanced sleep phase syndrome, in which individuals fall asleep and wake up earlier than desired, are all examples of circadian rhythm disorders. Because of the disruptive nature of these conditions, it is important to identify the quickest and most effective method for regulating the body and reestablishing normal sleep patterns. Light therapy, in which individuals are exposed to bright, artificial light, is currently used to treat these disorders. Melatonin, a hormone that regulates circadian rhythms, and methylxanthines, a class of stimulant medications, are other common non-light treatments. While each of these individual treatments has been proven effective, little is known about the combined effect of light and non-light treatments. The purpose of this study is to evaluate the safety and effectiveness of light therapy, melatonin, and methylxanthine, alone and in combination, at regulating circadian rhythms and improving sleep quality and cognitive function. This study will enroll healthy individuals. Participants will first attend two screening visits, which will include a review of medical, psychiatric, and sleep histories; vital sign measurements; blood and urine collection; a physical examination; and an electrocardiogram. For 1 week, participants will record sleep habits in a diary and by telephone. They will also wear a device that monitors activity and light exposure levels. Eligible participants will then attend four 5-day inpatient visits at the Sleep and Chronobiology Laboratory at the University of Colorado at Boulder. During each of the four visits, participants will be randomly assigned to one of the following four treatments: * Dim light therapy and placebo * Bright light therapy and placebo * Dim light therapy, melatonin, and methylxanthines * Bright light therapy, melatonin, and methylxanthines At each visit, participants will receive a different treatment. During these visits, participants will remain awake for up to 40 hours at a time, while their eye movements, and brain, muscle, heart, and breathing activity are monitored. Urine and saliva will be collected, and participants will undergo various cognitive performance testing measures. At 3-week intervals between each visit, participants will record sleep habits and will wear the activity and light exposure monitoring device. A sleep diary will also be maintained by participants for 3 weeks following the end of the last visit. ### Conditions Module **Conditions:** - Sleep Disorders, Circadian Rhythm **Keywords:** - Circadian Rhythm Sleep Disorders ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 48 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Dim Light Melatonin and/or methylxanthine **Intervention Names:** - Drug: Melatonin - Drug: Methylxanthine **Label:** Dim Light Melatonin and/or methylxanthine **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Placebo and Dim Light or bright light **Intervention Names:** - Procedure: Light Therapy **Label:** Placebo and Dim Light or bright light **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Bright light, melatonin, and/or methylxanthine **Intervention Names:** - Drug: Melatonin - Drug: Methylxanthine - Procedure: Light Therapy **Label:** Bright light melatonin and/or methylxanthine **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Bright light melatonin and/or methylxanthine - Dim Light Melatonin and/or methylxanthine **Description:** 5mg, pill, once **Name:** Melatonin **Other Names:** - Life Extension Melatonin 5 mg **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Bright light melatonin and/or methylxanthine - Dim Light Melatonin and/or methylxanthine **Description:** 2.9 mg/kg, pill, once **Name:** Methylxanthine **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Bright light melatonin and/or methylxanthine - Placebo and Dim Light or bright light **Description:** Bright light exposure **Name:** Light Therapy **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** Circadian phase, as measured by the shift of the endogenous melatonin rhythm (measured during each inpatient visit) **Time Frame:** 24 hour #### Secondary Outcomes **Measure:** Circadian phase, as measured by the shift of the endogenous temperature rhythm **Time Frame:** 24 hour **Measure:** Sleep quality, as measured by wakefulness after sleep onset (electroencephalogram [EEG] defined wakefulness after 10 minutes of consecutive sleep) and number of awakenings **Time Frame:** overnight **Measure:** Cognitive function, as measured by daytime sleepiness, reaction time, and mood and well being (all measured during each inpatient visit) **Time Frame:** 24 h and daytime ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * In good general health, as determined by blood chemistries, urine toxicology, physical examination, and medical and psychiatric history Exclusion Criteria: * History of any current or chronic disease, including any of the following: 1. Chronobiologic disorders 2. Sleep disorders 3. Cardiovascular disorders 4. Respiratory disorders 5. Kidney and urinary tract disorders 6. Infectious diseases 7. Gastrointestinal disorders 8. Immune system disorders 9. Connective tissue and joint disorders 10. Hematopoietic disorders 11. Neoplastic diseases 12. Endocrine and metabolic diseases 13. Neurologic disorders * Current or past history of drug abuse * Pregnant or breastfeeding * Current oral contraceptive use **Healthy Volunteers:** True **Maximum Age:** 40 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Gayle Wright, MS **Phone:** 303-735-1923 **Role:** CONTACT #### Locations **Location 1:** **City:** Boulder **Contacts:** ***Contact 1:*** - **Name:** Kenneth P. Wright, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Sleep and Chronobiology Laboratory **State:** Colorado **Status:** RECRUITING **Zip:** 80309 #### Overall Officials **Official 1:** **Affiliation:** University of Colorado at Boulder **Name:** Kenneth P. Wright, PhD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Duffy JF, Wright KP Jr. Entrainment of the human circadian system by light. J Biol Rhythms. 2005 Aug;20(4):326-38. doi: 10.1177/0748730405277983. **PMID:** 16077152 **Citation:** Wright KP Jr, Gronfier C, Duffy JF, Czeisler CA. Intrinsic period and light intensity determine the phase relationship between melatonin and sleep in humans. J Biol Rhythms. 2005 Apr;20(2):168-77. doi: 10.1177/0748730404274265. **PMID:** 15834113 **Citation:** Gronfier C, Wright KP Jr, Kronauer RE, Jewett ME, Czeisler CA. Efficacy of a single sequence of intermittent bright light pulses for delaying circadian phase in humans. Am J Physiol Endocrinol Metab. 2004 Jul;287(1):E174-81. doi: 10.1152/ajpendo.00385.2003. Epub 2004 Mar 23. **PMID:** 15039146 **Citation:** Barger LK, Wright KP Jr, Hughes RJ, Czeisler CA. Daily exercise facilitates phase delays of circadian melatonin rhythm in very dim light. Am J Physiol Regul Integr Comp Physiol. 2004 Jun;286(6):R1077-84. doi: 10.1152/ajpregu.00397.2003. Epub 2004 Mar 18. **PMID:** 15031136 **Citation:** Wright KP Jr, Czeisler CA. Absence of circadian phase resetting in response to bright light behind the knees. Science. 2002 Jul 26;297(5581):571. doi: 10.1126/science.1071697. No abstract available. **PMID:** 12142528 **Citation:** Wright KP Jr, Hughes RJ, Kronauer RE, Dijk DJ, Czeisler CA. Intrinsic near-24-h pacemaker period determines limits of circadian entrainment to a weak synchronizer in humans. Proc Natl Acad Sci U S A. 2001 Nov 20;98(24):14027-32. doi: 10.1073/pnas.201530198. **PMID:** 11717461 **Citation:** Wright KP Jr, Myers BL, Plenzler SC, Drake CL, Badia P. Acute effects of bright light and caffeine on nighttime melatonin and temperature levels in women taking and not taking oral contraceptives. Brain Res. 2000 Aug 11;873(2):310-7. doi: 10.1016/s0006-8993(00)02557-9. **PMID:** 10930561 **Citation:** Wright KP Jr, Badia P, Myers BL, Plenzler SC, Hakel M. Caffeine and light effects on nighttime melatonin and temperature levels in sleep-deprived humans. Brain Res. 1997 Jan 30;747(1):78-84. doi: 10.1016/s0006-8993(96)01268-1. **PMID:** 9042530 #### See Also Links **Label:** Click here for the University of Colorado at Boulder Sleep and Chronobiology Laboratory web site **URL:** http://www.colorado.edu/intphys/research/sleep.html ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009422 - Term: Nervous System Diseases - ID: D000009461 - Term: Neurologic Manifestations - ID: D000001523 - Term: Mental Disorders - ID: D000021081 - Term: Chronobiology Disorders - ID: D000020920 - Term: Dyssomnias - ID: D000009784 - Term: Occupational Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC24 - Name: Occupational Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M22007 - Name: Sleep Disorders, Circadian Rhythm - Relevance: HIGH - As Found: Sleep Disorders, Circadian Rhythm - ID: M22242 - Name: Parasomnias - Relevance: HIGH - As Found: Sleep Disorders - ID: M22008 - Name: Jet Lag Syndrome - Relevance: LOW - As Found: Unknown - ID: M15696 - Name: Sleep Wake Disorders - Relevance: HIGH - As Found: Sleep Disorders - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M22703 - Name: Chronobiology Disorders - Relevance: LOW - As Found: Unknown - ID: M22655 - Name: Dyssomnias - Relevance: LOW - As Found: Unknown - ID: M12719 - Name: Occupational Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012893 - Term: Sleep Wake Disorders - ID: D000020447 - Term: Parasomnias - ID: D000020178 - Term: Sleep Disorders, Circadian Rhythm ### Intervention Browse Module - Ancestors - ID: D000000975 - Term: Antioxidants - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000020011 - Term: Protective Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000002492 - Term: Central Nervous System Depressants ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M11533 - Name: Melatonin - Relevance: HIGH - As Found: Ketamine - ID: M4292 - Name: Antioxidants - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: T410 - Name: Melatonin - Relevance: HIGH - As Found: Ketamine ### Intervention Browse Module - Meshes - ID: D000008550 - Term: Melatonin ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02902679 **Brief Title:** A Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Participants With End-stage Renal Dysfunction on Chronic Stable Hemodialysis Treatment **Official Title:** An Open-label Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Participants With End-stage Renal Dysfunction on Chronic Stable Hemodialysis Treatment #### Organization Study ID Info **ID:** CV010-012 #### Organization **Class:** INDUSTRY **Full Name:** Bristol-Myers Squibb ### Status Module #### Completion Date **Date:** 2017-06 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-07-27 **Type:** ACTUAL **Last Update Submit Date:** 2017-07-25 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-06 **Type:** ACTUAL #### Start Date **Date:** 2016-11 **Type:** ACTUAL **Status Verified Date:** 2017-07 #### Study First Post Date **Date:** 2016-09-16 **Type:** ESTIMATED **Study First Submit Date:** 2016-08-24 **Study First Submit QC Date:** 2016-09-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Bristol-Myers Squibb #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** An oral dose of BMS-986177 administered in End-stage Renal Dysfunction (ESRD) participants before and after a hemodialysis session to evaluate safety, tolerability, and pharmacokinetics in this patient population. ### Conditions Module **Conditions:** - Thrombosis - Factor XI - Renal Impairment - ESRD (End-Stage Renal Disease) ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 6 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects given a single oral dose of BMS-986177 before (Period 1) and after (Period 2) a hemodialysis session **Intervention Names:** - Drug: BMS-986177 **Label:** End Stage Renal Disease Subjects **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - End Stage Renal Disease Subjects **Name:** BMS-986177 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** To assess the Number of subjects with Adverse events (AEs). **Time Frame:** Day -1 - day 3 **Measure:** To assess the Change from baseline in Physical examination parameters. **Time Frame:** Day -1 - day 3 **Measure:** To assess the change from baseline in Electrocardiogram (ECG) assessment. **Time Frame:** Day -1 - day 3 **Measure:** To assess the change from baseline in clinical laboratory values. **Time Frame:** Day -1 - day 3 **Measure:** To assess the change from baseline in vital signs assessment. **Time Frame:** Day -1 - day 3 #### Secondary Outcomes **Measure:** To assess the change from baseline in activated partial thromboplastin time (aPTT). **Time Frame:** Day -1 - day 3 **Measure:** To assess the change from baseline in Factor XI clotting activity (FX1c ). **Time Frame:** Day -1 - day 3 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Classified at screening as having ESRD requiring hemodialysis at least 3 times per week for 3 months. * Clinical, ECG, and laboratory findings consistent with renal dysfunction * BMI of 18.0 to 38.0 kg/m2 inclusive * Subjects must receive unfractionated heparin during dialysis treatments and are able to withstand a decrease in their established heparin dose (75% of current dose) * Women Not of child bearing potential (WNOCBP). Sexually active fertile men with partners who are WOCBP must use non-hormonal highly effective birth control Exclusion Criteria: * History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening * Evidence or history of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising * Current or recent (within 3 months of study drug administration) clinically significant gastrointestinal disease or gastrointestinal surgery that could interfere with absorption of study drug * Any condition requiring anticoagulation such as, but not limited to, atrial fibrillation, mechanical prosthetic valve, deep venous thrombosis, or pulmonary embolism (other than heparin required during hemodialysis) * Need for aspirin or need for P2Y12 antagonist therapy (for example clopidogrel, prasugrel, or ticagrelor) * Other protocol defined exclusion criteria could apply **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Orlando **Country:** United States **Facility:** Orlando Clinical Research Center **State:** Florida **Zip:** 32809 #### Overall Officials **Official 1:** **Affiliation:** Bristol-Myers Squibb **Name:** Bristol-Myers Squibb **Role:** STUDY_DIRECTOR ### References Module #### See Also Links **Label:** BMS Clinical Trial Education Resource **URL:** http://www.bms.com/studyconnect/pages/home.aspx **Label:** FDA Safety Alerts and Recalls **URL:** http://www.fda.gov/Safety/Recalls/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000016769 - Term: Embolism and Thrombosis - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000007674 - Term: Kidney Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000051436 - Term: Renal Insufficiency, Chronic - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M10699 - Name: Kidney Failure, Chronic - Relevance: HIGH - As Found: ESRD (end stage renal disease) - ID: M16686 - Name: Thrombosis - Relevance: HIGH - As Found: Thrombosis - ID: M26718 - Name: Renal Insufficiency - Relevance: HIGH - As Found: Renal Dysfunction - ID: M7784 - Name: Embolism - Relevance: LOW - As Found: Unknown - ID: M19128 - Name: Embolism and Thrombosis - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M26717 - Name: Renal Insufficiency, Chronic - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007676 - Term: Kidney Failure, Chronic - ID: D000051437 - Term: Renal Insufficiency - ID: D000013927 - Term: Thrombosis ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03912779 **Brief Title:** Evaluation of Self-management Education in First Time Hearing Aid Users **Official Title:** The Role of Interactive Hearing Aid Self-management Education on Self-efficacy for Hearing Aid(s), Readiness for Action and Hearing Aid Knowledge in First Time Hearing Aid Users #### Organization Study ID Info **ID:** 16IH006 #### Organization **Class:** OTHER **Full Name:** Nottingham University Hospitals NHS Trust #### Secondary ID Infos **Domain:** Aston University **ID:** 168-2016-RGM **Type:** OTHER ### Status Module #### Completion Date **Date:** 2017-07-28 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-04-11 **Type:** ACTUAL **Last Update Submit Date:** 2019-04-09 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-02-27 **Type:** ACTUAL #### Start Date **Date:** 2016-11-11 **Type:** ACTUAL **Status Verified Date:** 2019-04 #### Study First Post Date **Date:** 2019-04-11 **Type:** ACTUAL **Study First Submit Date:** 2019-02-22 **Study First Submit QC Date:** 2019-04-09 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Aston University #### Lead Sponsor **Class:** OTHER **Name:** Nottingham University Hospitals NHS Trust #### Responsible Party **Investigator Affiliation:** Nottingham University Hospitals NHS Trust **Investigator Full Name:** Melanie Ferguson **Investigator Title:** Associate Professor, Study Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The study will assess the impact of a hearing aid self-management intervention in first time hearing aid users compared to standard hearing aid self-management. Namely, the C2Hear multimedia videos, or Reusable Learning Objects (RLOs) will be used as the self-management intervention. A departmental hearing aid booklet (standard clinical care) will be used as the control intervention. The study will determine the role of these RLOs in self-efficacy for hearing aid(s), hearing aid knowledge and readiness for action compared with standard hearing aid self-management education (hearing aid booklet) in groups of first time hearing aid users. Both groups will receive the education at the earliest audiology appointment (hearing assessment), helping to distinguish any impact of earlier education delivery. **Detailed Description:** Research question: To assess the role of interactive hearing aid self-management education on self-efficacy for hearing aid(s), readiness for action and hearing aid knowledge in first time hearing aid users. Objectives: Primary research question: - Does the early delivery of interactive hearing aid self-management education improve self-efficacy for hearing aid(s) compared with standard care in first-time hearing aid users? Secondary research questions: i. Does the early delivery of interactive hearing aid self-management education improve readiness for hearing aids (their chosen intervention) compared with standard care in first-time hearing aid users? ii. Does the early delivery of interactive hearing aid education improve hearing aid knowledge compared with standard care in first-time hearing aid users? Study design: A single centre, prospective study with two randomised arms; intervention group (access to RLOs in DVD/ or online format, patients' preference) and control (standard hearing aid education booklet). Prospective first-time hearing aid users will be invited to take part in the study at hearing assessment, where they will be randomised to either the control or intervention group. Following 6-8 weeks of independent use prior to receiving hearing aids, study investigators will assess the impact of each education type on individuals self-efficacy for hearing aids, readiness for action and hearing aid knowledge. Comparisons will be made to previous evaluation of the RLOs to allow exploration of the impact of earlier hearing aid self-management education on self-report measures. ### Conditions Module **Conditions:** - Hearing Loss **Keywords:** - First time hearing aid user ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 56 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** C2Hear RLOs (https://www.youtube.com/C2HearOnline): nine (custom earmould) or eight (open fit hearing aid) multi-media learning clips covering practical and psychosocial components of owning a hearing aid, alongside user testimonials (n= 7). Participants asked to watch all relevant to their prospective hearing aid coupling (custom earmould or open fit), with no limit on number of views. A paper diary documented usage during the study duration. **Intervention Names:** - Behavioral: C2Hear RLOs **Label:** C2Hear RLOs **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** A 32-page printed A5 colour booklet, designed and written by local Audiology staff, supplied to all prospective hearing aid owners at the study centre as standard care. Same booklet supplied irrespective of hearing aid style (custom/open fit). All content conveyed via text and supporting pictures only. Participants assigned to the placebo comparator were asked to read the booklet once. A paper diary documented usage during the study duration. **Intervention Names:** - Behavioral: Printed hearing aid booklet **Label:** Printed hearing aid booklet **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - C2Hear RLOs **Description:** Freely available online RLOs **Name:** C2Hear RLOs **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Printed hearing aid booklet **Description:** Departmental printed hearing aid booklet (standard care) **Name:** Printed hearing aid booklet **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Self-reported self-efficacy for hearing aid(s) measured across four-subscales (Basic/advanced handling, adjustment to hearing aids and aided listening). Participants rank confidence in the tasks/behaviours described using an 11-point scale (0%=cannot do this, to 100%=certain I can do this). **Measure:** Measure of Audiologic Rehabilitation Self-efficacy for Hearing Aids score (West and Smith, 2007) **Time Frame:** Change from Baseline self-efficacy for hearing aids up to 8 weeks #### Secondary Outcomes **Description:** Self-report hearing aid self-efficacy (Ida Line Tool Question 2) determines participants perceived confidence in their ability to use hearing aid(s) using an 11-point visual analogue scale (0 = not at all confident, to 10= very much confident). **Measure:** Hearing aid self-efficacy using Ida Motivational Line Tools (Ida Institute, 2013) **Time Frame:** Change from Baseline self-efficacy for hearing aids up to 8 weeks **Description:** A 20-item open-ended questionnaire that measures free recall of hearing aid knowledge relevant to practical (n = 12) and psychosocial (n = 8) issues on hearing aids and communication. One point is allocated to each correct response, resulting in a percentage correct for each score. Maximum correct scores are 54; 32 points for practical subscale and 22 points for psychosocial subscale. Higher percentage values represent better knowledge. **Measure:** Hearing Aid and Communication Knowledge (HACK: Ferguson et al., 2015) **Time Frame:** Up to 8 weeks **Description:** Self-report readiness for hearing rehabilitation (action) (Ida Line Tool Question 1) determines participants readiness to use hearing aid(s) using an 11-point visual analogue (0 = not at all important, to 10= very much important). **Measure:** Readiness for hearing rehabilitation (action); Ida Motivational Line Tools Question 1 (Ida Institute, 2013) **Time Frame:** Change from Baseline readiness up to 8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults aged \> 18 years * Prospective first-time hearing aid users (defined as no hearing aid use in the last 2 years) * English as their spoken language or good understanding of English Exclusion Criteria: * Those unable to complete study questionnaires due to age-related problems (e.g. cognitive decline) **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Nottingham University Hospitals NHS Trust **Name:** Melanie Ferguson **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006311 - Term: Hearing Disorders - ID: D000004427 - Term: Ear Diseases - ID: D000010038 - Term: Otorhinolaryngologic Diseases - ID: D000012678 - Term: Sensation Disorders - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M24420 - Name: Hearing Loss - Relevance: HIGH - As Found: Hearing Loss - ID: M6840 - Name: Deafness - Relevance: LOW - As Found: Unknown - ID: M9400 - Name: Hearing Disorders - Relevance: LOW - As Found: Unknown - ID: M7601 - Name: Ear Diseases - Relevance: LOW - As Found: Unknown - ID: M12961 - Name: Otorhinolaryngologic Diseases - Relevance: LOW - As Found: Unknown - ID: M15490 - Name: Sensation Disorders - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000034381 - Term: Hearing Loss ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05333679 **Brief Title:** Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study) **Official Title:** Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study) #### Organization Study ID Info **ID:** AI152119 #### Organization **Class:** OTHER **Full Name:** University of California, San Francisco ### Status Module #### Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-06-08 **Type:** ACTUAL **Last Update Submit Date:** 2023-06-07 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-03-01 **Type:** ESTIMATED #### Start Date **Date:** 2022-03-02 **Type:** ACTUAL **Status Verified Date:** 2023-06 #### Study First Post Date **Date:** 2022-04-19 **Type:** ACTUAL **Study First Submit Date:** 2022-04-11 **Study First Submit QC Date:** 2022-04-11 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Cape Town **Class:** OTHER **Name:** University of Stellenbosch #### Lead Sponsor **Class:** OTHER **Name:** University of California, San Francisco #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** ART is given to people living with HIV in order to suppress the virus, resulting in improved health for the individual and decreased transmission of the virus to others. Success of ART is dependent on adherence. Currently, adherence is assessed by asking patients directly and then confirming with a viral load test, which is expensive and is often only done when the viral load is already raised. Therefore there is a need to find a method to detect problems with adherence early before the viral load rises. A urine-based test was recently developed, called UTRA (urine tenofovir rapid assay). This test can give clinic staff immediate results about a person's adherence to the antiretroviral medication Tenofovir (TDF). The study will compare the results of this urine test to drug levels found in blood, self-reported adherence and pharmacy collection records to see if this test can be used as part of routine care in ART clinics. If the test is effective it would allow clinic staff to identify people with adherence difficulties early and give them the necessary support before their viral load rises. **Detailed Description:** This is a randomised study, recruiting 200 people taking TDF-based ART. Participants will be randomised 1:1 to intervention versus standard enhanced adherence counselling. Intervention participants will receive an adherence support package informed by feedback from the urine-based test. The investigators will assess the impact of the adherence test on VL suppression rates in each arm (without necessitating a regimen switch) at 12 months after enrolment. Enrolling participants with adherence challenges increases efficiency and mirrors the population requiring adherence support in our setting. The UTRA device used for this study has received a FDA Non-Significant Risk (NSR) designation and is IDE exempt. FEASIBILITY: The investigators will track retention in the study among participants in each arm, missed visits, and the number of urine assessments performed in the intervention arm. ACCEPTABILITY: All participants enrolled will also complete a standardised questionnaire about the acceptability of the adherence support they received. This measure of acceptability will be assessed as a secondary outcome by arm, along with socio-demographics profiles associated with low/high acceptability described within arm. QUALITATIVE PROCEDURES: 1. Participant in-depth interviews: Qualitative data will include in-depth interviews of participants (n\~20; \~3-4 interviews with each participant over 6-9 months of their treatment) using semi-structured guides conducted by experienced socio-behavioural scientists. The semi-structured interview guide will elicit feelings about the urine adherence metric and counseling messages, concerns regarding privacy, advantages/disadvantages of receiving such results, and the likely impact of this monitoring test on sustained adherence to ART or just on short-term adherence. Interviews will be conducted in participants' preferred language. 2. Health care worker interviews: The investigators will additionally assess the feasibility of the intervention by interviewing health care providers, who will be administering the UTRA test at the clinical point of care in the future. The study will examine provider perceptions of the assay at the end of the study using in-depth interviews (n\~10), assessing perceived usefulness, complexity to use, stigma/social harm, and benefits. These interviews will also elicit barriers and facilitators to delivery of the urine assay-informed counseling messages. ### Conditions Module **Conditions:** - Risk Reduction **Keywords:** - UTRA - Point-of-care - Real-time - PLHIV - Adherence monitoring - ART ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** POC adherence testing by a urine TFV assay with feedback **Intervention Names:** - Device: UTRA - Behavioral: UTRA feedback **Label:** Intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Standard enhanced adherence counselling, SA Department of Health, March 2020 **Label:** Standard of Care **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention **Description:** Collect urine on intervention participants and screen for presence of TFV. **Name:** UTRA **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Intervention **Description:** Feedback will be provided to the participant based on the UTRA results on their adherence with provision of standard adherence counseling. **Name:** UTRA feedback **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Assess suppression rates (VL\< 50 copies/mL) in both study arms using an intention-to-treat analysis. Plasma will be stored an enrolment, month 6 and month 12 for viral load assay completion after the study. Samples are assayed either with the Alinity m HIV-1 assay (Abbott Laboratories. Abbott Park, Illinois, U.S.A.); lower limit of detection (LLD) 10 copies/mL or the COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 (Roche Diagnostics, Basel, Switzerland); LLD 20 copies/mL. Whole blood will be centrifuged and plasma then tested on the automated analyzer according to national standard operating procedures **Measure:** Proportion of participants in each arm achieving viral suppression to <50 copies/ml **Time Frame:** 12 months #### Secondary Outcomes **Description:** Follow up visits will occur in 12-week increments post-enrolment: at month 3, month 6, month 9 and month 12; and will be synchronized wherever possible with routine clinic visits. Visit windows will be continuous, with each window extending to 6 weeks before and 6 weeks after the visit target date. A visit will be considered missed if the participant does not attend during the 12-week visit window **Measure:** Retention in care **Time Frame:** 12 months **Description:** Assess suppression rates (VL\< 50 copies/mL) in both study arms using an intention-to-treat analysis. Samples are assayed either with the Alinity m HIV-1 assay (Abbott Laboratories. Abbott Park, Illinois, U.S.A.); lower limit of detection (LLD) 10 copies/mL or the COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 (Roche Diagnostics, Basel, Switzerland); LLD 20 copies/mL. Whole blood will be centrifuged and plasma then tested on the automated analyzer according to national standard operating procedures **Measure:** Viral suppression (<50 copies/mL) **Time Frame:** 6 months **Description:** The proportion of participants indicating "strongly agree" or "agree" averaged across 10 items, each item using a five-point Likert scale to measure aspects of acceptability of the adherence support intervention (i.e., by arm: UTRA-informed or standard of care), at month 12. Responses to the Likert scale range from "Strongly agree" to "Strongly disagree". Aspects of acceptability include domains on: support from health workers, time given by health workers to discuss the patients' treatment, patient perceptions of feeling informed about their adherence, feelings of surveillance (-vely scored), and self-satisfactions with adherence. **Measure:** The proportion of participants indicating "strongly agree" or "agree" averaged across 10 items, each using a five-point Likert scale to measure aspects of the adherence support intervention (i.e., by arm: UTRA-informed or standard of care) **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ≥18 years old * Willing and able to provide written informed consent * HIV-infected, receiving or (re-)starting a tenofovir-based ART regimen * Current ART regimen includes at least one drug with a high genetic barrier to resistance e.g. dolutegravir, atazanavir/ritonavir, darunavir/ritonavir or lopinavir/ritonavir. * Any previous raised viral load \>50 copies/ml (after ART initiation). * Willing and able to comply with laboratory tests and other study procedures Exclusion Criteria: * Not willing or able to provide informed consent in any of the languages provided * Not receiving a tenofovir-based ART regimen * Any other clinical condition that in the opinion of an investigator puts the patient at increased risk if participating in the study. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Monica Gandhi, MD **Phone:** 415 476 4082 **Phone Ext:** 127 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Purba Chatterjee, MSc **Phone:** 415 476 6714 **Role:** CONTACT #### Locations **Location 1:** **City:** Cape Town **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Catherine Orrell, MBChB, PhD - **Phone:** (021) 406 6958 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Zukiswa Nkantsu - **Phone:** (021) 007 2275/6 - **Role:** CONTACT ***Contact 3:*** - **Name:** Catherine Orrell, MBChB, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Yashna Singh, MBBS - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** Lauren Jennings, MBChB - **Role:** SUB_INVESTIGATOR **Country:** South Africa **Facility:** Desmond Tutu Health Foundation, University of Cape Town **State:** Western Cape **Status:** RECRUITING **Zip:** 7925 #### Overall Officials **Official 1:** **Affiliation:** University of California, San Francisco **Name:** Monica Gandhi, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Investigators conducting PrEP research **Description:** We will share de-identified data in publicly accessible databases once study is complete and study findings disseminated. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** 48 months from start of study ### References Module #### References **Citation:** Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Cottle L, Zhang XC, Makhema J, Mills LA, Panchia R, Faesen S, Eron J, Gallant J, Havlir D, Swindells S, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano DD, Essex M, Hudelson SE, Redd AD, Fleming TR; HPTN 052 Study Team. Antiretroviral Therapy for the Prevention of HIV-1 Transmission. N Engl J Med. 2016 Sep 1;375(9):830-9. doi: 10.1056/NEJMoa1600693. Epub 2016 Jul 18. **PMID:** 27424812 **Citation:** Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Mehendale S, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Wang L, Makhema J, Mills LA, de Bruyn G, Sanne I, Eron J, Gallant J, Havlir D, Swindells S, Ribaudo H, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Fleming TR; HPTN 052 Study Team. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011 Aug 11;365(6):493-505. doi: 10.1056/NEJMoa1105243. Epub 2011 Jul 18. **PMID:** 21767103 **Citation:** Rodger AJ, Cambiano V, Bruun T, Vernazza P, Collins S, Degen O, Corbelli GM, Estrada V, Geretti AM, Beloukas A, Raben D, Coll P, Antinori A, Nwokolo N, Rieger A, Prins JM, Blaxhult A, Weber R, Van Eeden A, Brockmeyer NH, Clarke A, Del Romero Guerrero J, Raffi F, Bogner JR, Wandeler G, Gerstoft J, Gutierrez F, Brinkman K, Kitchen M, Ostergaard L, Leon A, Ristola M, Jessen H, Stellbrink HJ, Phillips AN, Lundgren J; PARTNER Study Group. Risk of HIV transmission through condomless sex in serodifferent gay couples with the HIV-positive partner taking suppressive antiretroviral therapy (PARTNER): final results of a multicentre, prospective, observational study. Lancet. 2019 Jun 15;393(10189):2428-2438. doi: 10.1016/S0140-6736(19)30418-0. 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Clin Child Psychol Psychiatry. 2012 Oct;17(4):505-18. doi: 10.1177/1359104511421103. Epub 2011 Sep 25. **PMID:** 21949048 **Citation:** de Necker M, de Beer JC, Stander MP, Connell CD, Mwai D. Economic and public health impact of decentralized HIV viral load testing: A modelling study in Kenya. PLoS One. 2019 Feb 27;14(2):e0212972. doi: 10.1371/journal.pone.0212972. eCollection 2019. **PMID:** 30811510 **Citation:** van Zyl GU, van Mens TE, McIlleron H, Zeier M, Nachega JB, Decloedt E, Malavazzi C, Smith P, Huang Y, van der Merwe L, Gandhi M, Maartens G. Low lopinavir plasma or hair concentrations explain second-line protease inhibitor failures in a resource-limited setting. J Acquir Immune Defic Syndr. 2011 Apr;56(4):333-9. doi: 10.1097/QAI.0b013e31820dc0cc. **PMID:** 21239995 **Citation:** Prasitsuebsai W, Kerr SJ, Truong KH, Ananworanich J, Do VC, Nguyen LV, Kurniati N, Kosalaraksa P, Sudjaritruk T, Chokephaibulkit K, Thammajaruk N, Singtoroj T, Teeraananchai S, Horng H, Bacchetti P, Gandhi M, Sohn AH. Using Lopinavir Concentrations in Hair Samples to Assess Treatment Outcomes on Second-Line Regimens Among Asian Children. AIDS Res Hum Retroviruses. 2015 Oct;31(10):1009-14. doi: 10.1089/AID.2015.0111. Epub 2015 Aug 26. **PMID:** 26200586 **Citation:** Murnane PM, Bacchetti P, Currier JS, Brummel S, Okochi H, Phung N, Louie A, Kuncze K, Hoffman RM, Nematadzira T, Soko DK, Owor M, Saidi F, Flynn PM, Fowler MG, Gandhi M. Tenofovir concentrations in hair strongly predict virologic suppression in breastfeeding women. AIDS. 2019 Aug 1;33(10):1657-1662. doi: 10.1097/QAD.0000000000002237. **PMID:** 31021852 **Citation:** Gandhi M, Bacchetti P, Ofokotun I, Jin C, Ribaudo HJ, Haas DW, Sheth AN, Horng H, Phung N, Kuncze K, Okochi H, Landovitz RJ, Lennox J, Currier JS; AIDS Clinical Trials Group (ACTG) 5257 Study Team. Antiretroviral Concentrations in Hair Strongly Predict Virologic Response in a Large Human Immunodeficiency Virus Treatment-naive Clinical Trial. Clin Infect Dis. 2019 Mar 5;68(6):1044-1047. doi: 10.1093/cid/ciy764. **PMID:** 30184104 **Citation:** Gandhi M, Ameli N, Bacchetti P, Gange SJ, Anastos K, Levine A, Hyman CL, Cohen M, Young M, Huang Y, Greenblatt RM; Women's Interagency HIV Study (WIHS). Protease inhibitor levels in hair strongly predict virologic response to treatment. AIDS. 2009 Feb 20;23(4):471-8. doi: 10.1097/QAD.0b013e328325a4a9. **PMID:** 19165084 **Citation:** Gandhi M, Ameli N, Bacchetti P, Anastos K, Gange SJ, Minkoff H, Young M, Milam J, Cohen MH, Sharp GB, Huang Y, Greenblatt RM. Atazanavir concentration in hair is the strongest predictor of outcomes on antiretroviral therapy. Clin Infect Dis. 2011 May;52(10):1267-75. doi: 10.1093/cid/cir131. **PMID:** 21507924 **Citation:** Cohan D, Natureeba P, Koss CA, Plenty A, Luwedde F, Mwesigwa J, Ades V, Charlebois ED, Gandhi M, Clark TD, Nzarubara B, Achan J, Ruel T, Kamya MR, Havlir DV. Efficacy and safety of lopinavir/ritonavir versus efavirenz-based antiretroviral therapy in HIV-infected pregnant Ugandan women. AIDS. 2015 Jan 14;29(2):183-91. doi: 10.1097/QAD.0000000000000531. **PMID:** 25426808 **Citation:** Koss CA, Natureeba P, Mwesigwa J, Cohan D, Nzarubara B, Bacchetti P, Horng H, Clark TD, Plenty A, Ruel TD, Achan J, Charlebois ED, Kamya MR, Havlir DV, Gandhi M. Hair concentrations of antiretrovirals predict viral suppression in HIV-infected pregnant and breastfeeding Ugandan women. AIDS. 2015 Apr 24;29(7):825-30. doi: 10.1097/QAD.0000000000000619. Erratum In: AIDS. 2015 Nov;29(17):2369. **PMID:** 25985404 **Citation:** Chawana TD, Gandhi M, Nathoo K, Ngara B, Louie A, Horng H, Katzenstein D, Metcalfe J, Nhachi CFB; Adolescent Treatment Failure (ATF) study team. Defining a Cutoff for Atazanavir in Hair Samples Associated With Virological Failure Among Adolescents Failing Second-Line Antiretroviral Treatment. J Acquir Immune Defic Syndr. 2017 Sep 1;76(1):55-59. doi: 10.1097/QAI.0000000000001452. **PMID:** 28520618 **Citation:** Pintye J, Bacchetti P, Teeraananchai S, Kerr S, Prasitsuebsai W, Singtoroj T, Kuncze K, Louie A, Koss CA, Jin C, Phung N, Horng H, Sohn AH, Gandhi M. Brief Report: Lopinavir Hair Concentrations Are the Strongest Predictor of Viremia in HIV-Infected Asian Children and Adolescents on Second-Line Antiretroviral Therapy. J Acquir Immune Defic Syndr. 2017 Dec 1;76(4):367-371. doi: 10.1097/QAI.0000000000001527. **PMID:** 28825944 **Citation:** Baxi SM, Greenblatt RM, Bacchetti P, Jin C, French AL, Keller MJ, Augenbraun MH, Gange SJ, Liu C, Mack WJ, Gandhi M; Women's Interagency HIV Study (WIHS). Nevirapine Concentration in Hair Samples Is a Strong Predictor of Virologic Suppression in a Prospective Cohort of HIV-Infected Patients. PLoS One. 2015 Jun 8;10(6):e0129100. doi: 10.1371/journal.pone.0129100. eCollection 2015. **PMID:** 26053176 **Citation:** Tabb ZJ, Mmbaga BT, Gandhi M, Louie A, Kuncze K, Okochi H, Shayo AM, Turner EL, Cunningham CK, Dow DE. Antiretroviral drug concentrations in hair are associated with virologic outcomes among young people living with HIV in Tanzania. AIDS. 2018 Jun 1;32(9):1115-1123. doi: 10.1097/QAD.0000000000001788. **PMID:** 29438196 **Citation:** Marrazzo JM, Ramjee G, Richardson BA, Gomez K, Mgodi N, Nair G, Palanee T, Nakabiito C, van der Straten A, Noguchi L, Hendrix CW, Dai JY, Ganesh S, Mkhize B, Taljaard M, Parikh UM, Piper J, Masse B, Grossman C, Rooney J, Schwartz JL, Watts H, Marzinke MA, Hillier SL, McGowan IM, Chirenje ZM; VOICE Study Team. Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2015 Feb 5;372(6):509-18. doi: 10.1056/NEJMoa1402269. **PMID:** 25651245 **Citation:** Gandhi M, Bacchetti P, Rodrigues WC, Spinelli M, Koss CA, Drain PK, Baeten JM, Mugo NR, Ngure K, Benet LZ, Okochi H, Wang G, Vincent M. Development and Validation of an Immunoassay for Tenofovir in Urine as a Real-Time Metric of Antiretroviral Adherence. EClinicalMedicine. 2018 Aug-Sep;2-3:22-28. doi: 10.1016/j.eclinm.2018.08.004. 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A systematic evaluation of immunoassay point-of-care testing to define impact on patients' outcomes. Ann Clin Biochem. 2017 Jul;54(4):420-431. doi: 10.1177/0004563217694377. Epub 2017 May 15. **PMID:** 28135840 **Citation:** Zash R, Makhema J, Shapiro RL. Neural-Tube Defects with Dolutegravir Treatment from the Time of Conception. N Engl J Med. 2018 Sep 6;379(10):979-981. doi: 10.1056/NEJMc1807653. Epub 2018 Jul 24. No abstract available. **PMID:** 30037297 **Citation:** Keene CM, Griesel R, Zhao Y, Gcwabe Z, Sayed K, Hill A, Cassidy T, Ngwenya O, Jackson A, van Zyl G, Schutz C, Goliath R, Flowers T, Goemaere E, Wiesner L, Simmons B, Maartens G, Meintjes G. Virologic efficacy of tenofovir, lamivudine and dolutegravir as second-line antiretroviral therapy in adults failing a tenofovir-based first-line regimen. AIDS. 2021 Jul 15;35(9):1423-1432. doi: 10.1097/QAD.0000000000002936. **PMID:** 33973876 **Citation:** Gandhi M, Bacchetti P, Spinelli MA, Okochi H, Baeten JM, Siriprakaisil O, Klinbuayaem V, Rodrigues WC, Wang G, Vincent M, Cressey TR, Drain PK. Brief Report: Validation of a Urine Tenofovir Immunoassay for Adherence Monitoring to PrEP and ART and Establishing the Cutoff for a Point-of-Care Test. J Acquir Immune Defic Syndr. 2019 May 1;81(1):72-77. doi: 10.1097/QAI.0000000000001971. **PMID:** 30664078 **Citation:** Cressey TR, Siriprakaisil O, Klinbuayaem V, Quame-Amaglo J, Kubiak RW, Sukrakanchana PO, Than-In-At K, Baeten J, Sirirungsi W, Cressey R, Drain PK. A randomized clinical pharmacokinetic trial of Tenofovir in blood, plasma and urine in adults with perfect, moderate and low PrEP adherence: the TARGET study. 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High virological suppression regardless of the genotypic susceptibility score after switching to a dolutegravir-based regimen: week 48 results in an observational cohort. J Antimicrob Chemother. 2018 Jun 1;73(6):1665-1671. doi: 10.1093/jac/dky062. **PMID:** 29528412 **Citation:** Jacobson K, Ogbuagu O. Integrase inhibitor-based regimens result in more rapid virologic suppression rates among treatment-naive human immunodeficiency virus-infected patients compared to non-nucleoside and protease inhibitor-based regimens in a real-world clinical setting: A retrospective cohort study. Medicine (Baltimore). 2018 Oct;97(43):e13016. doi: 10.1097/MD.0000000000013016. **PMID:** 30412140 **Citation:** Rahangdale L, Cates J, Potter J, Badell ML, Seidman D, Miller ES, Coleman JS, Lazenby GB, Levison J, Short WR, Yawetz S, Ciaranello A, Livingston E, Duthely L, Rimawi BH, Anderson JR, Stringer EM; HOPES (HIV OB Pregnancy Education Study) Group. Integrase inhibitors in late pregnancy and rapid HIV viral load reduction. Am J Obstet Gynecol. 2016 Mar;214(3):385.e1-7. doi: 10.1016/j.ajog.2015.12.052. **PMID:** 26928154 **Citation:** Rutherford GW, Horvath H. Dolutegravir Plus Two Nucleoside Reverse Transcriptase Inhibitors versus Efavirenz Plus Two Nucleoside Reverse Transcriptase Inhibitors As Initial Antiretroviral Therapy for People with HIV: A Systematic Review. PLoS One. 2016 Oct 13;11(10):e0162775. doi: 10.1371/journal.pone.0162775. eCollection 2016. **PMID:** 27736859 **Citation:** Phillips AN, Stover J, Cambiano V, Nakagawa F, Jordan MR, Pillay D, Doherty M, Revill P, Bertagnolio S. Impact of HIV Drug Resistance on HIV/AIDS-Associated Mortality, New Infections, and Antiretroviral Therapy Program Costs in Sub-Saharan Africa. J Infect Dis. 2017 May 1;215(9):1362-1365. doi: 10.1093/infdis/jix089. Erratum In: J Infect Dis. 2017 Nov 15;216(8):1048. **PMID:** 28329236 **Citation:** Van Laethem K, Schrooten Y, Covens K, Dekeersmaeker N, De Munter P, Van Wijngaerden E, Van Ranst M, Vandamme AM. A genotypic assay for the amplification and sequencing of integrase from diverse HIV-1 group M subtypes. J Virol Methods. 2008 Nov;153(2):176-81. doi: 10.1016/j.jviromet.2008.07.008. Epub 2008 Sep 2. **PMID:** 18706932 **Citation:** Van Zyl GU, Liu TF, Claassen M, Engelbrecht S, de Oliveira T, Preiser W, Wood NT, Travers S, Shafer RW. Trends in Genotypic HIV-1 Antiretroviral Resistance between 2006 and 2012 in South African Patients Receiving First- and Second-Line Antiretroviral Treatment Regimens. PLoS One. 2013 Jun 26;8(6):e67188. doi: 10.1371/journal.pone.0067188. Print 2013. **PMID:** 23840622 ## Document Section ### Large Document Module #### Large Docs - Date: 2021-10-27 - Filename: Prot_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: False - Label: Study Protocol - Size: 910584 - Type Abbrev: Prot - Upload Date: 2022-03-30T17:43 - Date: 2021-10-27 - Filename: ICF_002.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 226358 - Type Abbrev: ICF - Upload Date: 2022-05-16T12:53 ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M296 - Name: Tenofovir - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03397979 **Brief Title:** Twice Daily Versus Twice Weekly Soak-and-Seal Baths in Pediatric Atopic Dermatitis **Official Title:** Twice Daily Versus Twice Weekly Soak-and-Seal Baths in Pediatric Atopic Dermatitis: A Randomized, Single-blinded, Prospective Crossover Controlled Trial #### Organization Study ID Info **ID:** 3927 #### Organization **Class:** OTHER **Full Name:** MaineHealth ### Status Module #### Completion Date **Date:** 2017-03-21 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-01-12 **Type:** ACTUAL **Last Update Submit Date:** 2018-01-05 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2016-04-07 **Type:** ACTUAL #### Start Date **Date:** 2011-11-14 **Type:** ACTUAL **Status Verified Date:** 2018-01 #### Study First Post Date **Date:** 2018-01-12 **Type:** ACTUAL **Study First Submit Date:** 2017-09-28 **Study First Submit QC Date:** 2018-01-05 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** MaineHealth #### Responsible Party **Investigator Affiliation:** MaineHealth **Investigator Full Name:** Ivan Cardona **Investigator Title:** Clinical Assistant Professor, Tufts University School of Medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** There are few studies evaluating best bathing practices in the management of pediatric atopic dermatitis (AD). Trans-epidermal water loss plays a key role in the pathophysiology of AD. In concert with application of topical corticosteroids (TCS), we sought to investigate whether frequent soaking baths (i.e. twice daily for two weeks), followed immediately by application of an occlusive moisturizer (i.e. soak-and-seal), would be more effective than infrequent soaking baths (i.e. twice weekly for two weeks) in the management of AD. **Detailed Description:** To evaluate the effectiveness of twice daily soak-and-seal baths for improving severity of disease in children with AD, we implemented a randomized clinical trial using a single-blind, crossover-controlled design. Patients received the same moisturizer, cleanser, and class VI topical corticosteroid (TCS), and only bathing varied. After a 1 week run-in, children were randomized 1:1 into 2 groups: Group 1 underwent twice weekly soak-and-seal baths for 2 weeks ("dry method") followed by twice daily soak-and-seal baths for 2 weeks ("wet method"), and group 2 did the converse. A single treating physician assessed outcomes and, along with those analyzing the data, was masked to group assignment. Participants and their caregivers could not be masked. Analyses were based on intention to treat. ### Conditions Module **Conditions:** - Atopic Dermatitis **Keywords:** - atopic dermatitis - bathing - baths ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** Randomized, Single-blinded, Prospective Crossover Controlled Trial ##### Masking Info **Masking:** TRIPLE **Masking Description:** A single treating physician assessed outcomes and, along with those analyzing the data, was masked to group assignment. In other words, the care provider, investigator, and outcomes assessor were blinded to which bathing arm (twice daily or twice weekly) the study participants were in. **Who Masked:** - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 63 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Infrequent soaking baths, in this study, is defined as twice a week soaking baths for 10 minutes or less, over 2 weeks. However, this is a crossover study design with two interventions: 1) Infrequent soaking baths, as defined above, and 2) Frequent soaking baths (defined as twice daily soaking baths for 15-20 minutes, over 2 weeks). All subjects in the study will undergo both interventions, but in different order. Thus, this is a study comparing Infrequent Versus Frequent Soaking Baths. Each subject serves as their own control. **Intervention Names:** - Behavioral: Infrequent versus Frequent Soaking Baths **Label:** Infrequent soaking baths **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Frequent soaking baths, in this study, is defined as twice daily soaking baths for 15-20 minutes, over 2 weeks. However, this is a crossover study design with two interventions: 1) Infrequent soaking baths, as defined in the first arm description above, and 2) Frequent soaking baths, as defined above in this arm description. All subjects in the study will undergo both interventions, but in different order. Thus, this is a study comparing Infrequent Versus Frequent Soaking Baths. Each subject serves as their own control. **Intervention Names:** - Behavioral: Infrequent versus Frequent Soaking Baths **Label:** Frequent soaking baths **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Frequent soaking baths - Infrequent soaking baths **Description:** Submersion of skin, affected by atopic dermatitis, in a bathtub filled with luke-warm water, where the frequency and duration of these baths are varied, to look for any differential effect. **Name:** Infrequent versus Frequent Soaking Baths **Other Names:** - Soak and seal baths - Soak and smear baths **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** SCORAD (which stands for SCORing Atopic Dermatitis eczema severity score) is a validated eczema severity score assessed by the treating physician. The scale ranges from 0-103, with higher numbers correlating with more severe/worse eczema. **Measure:** SCORAD (SCORing Atopic Dermatitis eczema severity score) **Time Frame:** Each subject undergoes 4 visits over 5 weeks. Visit 1 (V1) to establish if subject fulfills inclusion criteria. V2 (baseline) is after a 1 week "run-in". 2 weeks between V2-V3 and V3-V4. Change in SCORAD from baseline (V2), for visits 3 minus visits 4. #### Secondary Outcomes **Description:** ADQ (which stands for Atopic Dermatitis Quickscore) is a validated eczema severity score assessed by the caregivers of a child with AD. The scale ranges from 0-70, with higher numbers correlating with more severe/worse eczema. **Measure:** ADQ (Atopic Dermatitis Quickscore eczema severity score) **Time Frame:** Each subject undergoes 4 visits over 5 weeks. Visit 1 (V1) to establish if subject fulfills inclusion criteria. V2 (baseline) is after a 1 week "run-in". 2 weeks between V2-V3 and V3-V4. Change in ADQ from baseline (V2), for visits 3 minus visits 4. **Description:** IDQOL (Which stands for Infant Dermatitis Quality of life index) is a validated quality of life measuring tool for AD. The scale ranges from 0-44, with higher numbers correlating with more severe/worse eczema. **Measure:** IDQOL (Infant Dermatitis Quality of life index for under 4 years of age) **Time Frame:** Each subject undergoes 4 visits over 5 weeks. Visit 1 (V1) to establish if subject fulfills inclusion criteria. V2 (baseline) is after a 1 week "run-in". 2 weeks between V2-V3 and V3-V4. Change in IDQOL from baseline (V2), for visits 3 minus visits 4. **Description:** CDLQI (Which stands for Children's Dermatology Life Quality Index) is a validated quality of life measuring tool for AD. The scale ranges from 0-40, with higher numbers correlating with more severe/worse eczema. **Measure:** CDLQI (Children's Dermatology Life Quality Index for 4 years of age and older) **Time Frame:** Each subject undergoes 4 visits over 5 weeks. Visit 1 (V1) to establish if subject fulfills inclusion criteria. V2 (baseline) is after a 1 week "run-in". 2 weeks between V2-V3 and V3-V4. Change in CDLQI from baseline (V2), for visits 3 minus visits 4. **Description:** DFI (which stands for Dermatitis Family Impact) is a validated quality of life measuring tool for AD. The scale ranges from 0-40, with higher numbers correlating with more severe/worse eczema. **Measure:** DFI (Dermatitis Family Impact questionnaire for QOL measure for 5 and up) **Time Frame:** Each subject undergoes 4 visits over 5 weeks. Visit 1 (V1) to establish if subject fulfills inclusion criteria. V2 (baseline) is after a 1 week "run-in". 2 weeks between V2-V3 and V3-V4. Change in DFI from baseline (V2), for visits 3 minus visits 4. **Description:** Relative quantities of S. aureus cultured from the skin. The scale ranges from 1+ rare, 2+ few, 3+ moderate, 4+ many, with higher numbers correlating with higher quantities of S. aureus on the skin. **Measure:** Staphylococcal aureus (S. aureus); relative quantities **Time Frame:** Each subject undergoes 4 visits over 5 weeks. Visit 1 (V1) to establish if subject fulfills inclusion. V2 (baseline) is after a 1 week "run-in". 2 weeks between V2-V3 and V3-V4. Change in S. aureus from baseline (V2), for visits 3 minus visits visits 4. **Description:** Skin hydration status as measured by impedance-based capacitance utilizing the DPM 9003 instrument by Nova Tech. Corp. The scale ranges from 90-999, with higher values correlating with greater skin hydration. **Measure:** Skin hydration status **Time Frame:** Each subject undergoes 4 visits over 5 weeks. Visit 1 (V1) to establish if subject fulfills inclusion. V2 (baseline) is after a 1 week "run-in". 2 weeks between V2-V3 and V3-V4. Change in skin hydration from baseline (V2), for visits 3 minus visits 4. **Description:** Amount of Desonide 0.05% Oint. used based on weighing the desonide tube at each visit **Measure:** Amount of topical corticosteroid (Desonide 0.05% Oint.) used **Time Frame:** Each subject undergoes 4 visits over 5 weeks. Visit 1 (V1) to establish if subject fulfills inclusion. V2 (baseline) is after a 1 week "run-in". 2 weeks between V2-V3 and V3-V4. Change in Desonide use from baseline (V2), for visits 3 minus visits 4. **Description:** Amount of Vanicream used based on weighing the Vanicream container at each visit **Measure:** Amount of topical moisturizer (Vanicream) used **Time Frame:** Each subject undergoes 4 visits over 5 weeks. Visit 1 (V1) to establish if subject fulfills inclusion. V2 (baseline) is after a 1 week "run-in". 2 weeks between V2-V3 and V3-V4. Change in Vanicream use from baseline (V2), for visits 3 minus visits 4. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Infants and children ages 6 months to 11 years of age with moderate to severe atopic dermatitis according to the criteria of Hanifin and Rajka. Exclusion Criteria: * Patients with suspected or established primary immune deficiency, patients receiving systemic corticosteroids, ultraviolet light therapy, immuno-therapeutic agents, and/or anti-infective drugs less than 1 month from the onset of the study. **Healthy Volunteers:** True **Maximum Age:** 11 Years **Minimum Age:** 6 Months **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Portland **Country:** United States **Facility:** Allergy and Asthma Associates of Maine **State:** Maine **Zip:** 04102 #### Overall Officials **Official 1:** **Affiliation:** Allergy & Asthma Associates of Maine **Name:** Ivan D Cardona, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Able to share any and all individual participant data with other researchers if asked. **IPD Sharing:** NO ### References Module #### References **Citation:** Bieber T. Atopic dermatitis. N Engl J Med. 2008 Apr 3;358(14):1483-94. doi: 10.1056/NEJMra074081. No abstract available. **PMID:** 18385500 **Citation:** Elias PM, Hatano Y, Williams ML. Basis for the barrier abnormality in atopic dermatitis: outside-inside-outside pathogenic mechanisms. J Allergy Clin Immunol. 2008 Jun;121(6):1337-43. doi: 10.1016/j.jaci.2008.01.022. Epub 2008 Mar 7. **PMID:** 18329087 **Citation:** Akdis CA, Akdis M, Bieber T, Bindslev-Jensen C, Boguniewicz M, Eigenmann P, Hamid Q, Kapp A, Leung DY, Lipozencic J, Luger TA, Muraro A, Novak N, Platts-Mills TA, Rosenwasser L, Scheynius A, Simons FE, Spergel J, Turjanmaa K, Wahn U, Weidinger S, Werfel T, Zuberbier T; European Academy of Allergology and Clinical Immunology/American Academy of Allergy, Asthma and Immunology. Diagnosis and treatment of atopic dermatitis in children and adults: European Academy of Allergology and Clinical Immunology/American Academy of Allergy, Asthma and Immunology/PRACTALL Consensus Report. J Allergy Clin Immunol. 2006 Jul;118(1):152-69. doi: 10.1016/j.jaci.2006.03.045. Erratum In: J Allergy Clin Immunol. 2006 Sep;118(3):724. **PMID:** 16815151 **Citation:** Sator PG, Schmidt JB, Honigsmann H. Comparison of epidermal hydration and skin surface lipids in healthy individuals and in patients with atopic dermatitis. J Am Acad Dermatol. 2003 Mar;48(3):352-8. doi: 10.1067/mjd.2003.105. **PMID:** 12637914 **Citation:** Cork MJ, Robinson DA, Vasilopoulos Y, Ferguson A, Moustafa M, MacGowan A, Duff GW, Ward SJ, Tazi-Ahnini R. New perspectives on epidermal barrier dysfunction in atopic dermatitis: gene-environment interactions. J Allergy Clin Immunol. 2006 Jul;118(1):3-21; quiz 22-3. doi: 10.1016/j.jaci.2006.04.042. Epub 2006 Jun 9. **PMID:** 16815133 **Citation:** Werner Y, Lindberg M. Transepidermal water loss in dry and clinically normal skin in patients with atopic dermatitis. Acta Derm Venereol. 1985;65(2):102-5. **PMID:** 2408409 **Citation:** Chandar P, Nole G, Johnson AW. Understanding natural moisturizing mechanisms: implications for moisturizer technology. Cutis. 2009 Jul;84(1 Suppl):2-15. **PMID:** 19702109 **Citation:** O'Regan GM, Sandilands A, McLean WHI, Irvine AD. Filaggrin in atopic dermatitis. J Allergy Clin Immunol. 2008 Oct;122(4):689-693. doi: 10.1016/j.jaci.2008.08.002. Epub 2008 Sep 5. **PMID:** 18774165 **Citation:** McLean WH, Palmer CN, Henderson J, Kabesch M, Weidinger S, Irvine AD. Filaggrin variants confer susceptibility to asthma. J Allergy Clin Immunol. 2008 May;121(5):1294-5; author reply 1295-6. doi: 10.1016/j.jaci.2008.02.039. Epub 2008 Apr 8. No abstract available. **PMID:** 18395783 **Citation:** Tilles G, Wallach D, Taieb A. Topical therapy of atopic dermatitis: controversies from Hippocrates to topical immunomodulators. J Am Acad Dermatol. 2007 Feb;56(2):295-301. doi: 10.1016/j.jaad.2006.09.030. **PMID:** 17224373 **Citation:** Burkhart CG. Clinical assessment by atopic dermatitis patients of response to reduced soap bathing: pilot study. Int J Dermatol. 2008 Nov;47(11):1216-7. doi: 10.1111/j.1365-4632.2008.03829.x. No abstract available. **PMID:** 18986472 **Citation:** Hanifin JM, Tofte SJ. Update on therapy of atopic dermatitis. J Allergy Clin Immunol. 1999 Sep;104(3 Pt 2):S123-5. doi: 10.1016/s0091-6749(99)70054-0. **PMID:** 10482863 **Citation:** Tarr A, Iheanacho I. Should we use bath emollients for atopic eczema? BMJ. 2009 Nov 13;339:b4273. doi: 10.1136/bmj.b4273. No abstract available. **PMID:** 19914950 **Citation:** Gutman AB, Kligman AM, Sciacca J, James WD. Soak and smear: a standard technique revisited. Arch Dermatol. 2005 Dec;141(12):1556-9. doi: 10.1001/archderm.141.12.1556. **PMID:** 16365257 **Citation:** Chiang C, Eichenfield LF. Quantitative assessment of combination bathing and moisturizing regimens on skin hydration in atopic dermatitis. Pediatr Dermatol. 2009 May-Jun;26(3):273-8. doi: 10.1111/j.1525-1470.2009.00911.x. **PMID:** 19706087 **Citation:** Kameyoshi Y, Tanaka T, Mochizuki M, Koro O, Mihara S, Hiragun T, Tanaka M, Hide M. [Taking showers at school is beneficial for children with severer atopic dermatitis]. Arerugi. 2008 Feb;57(2):130-7. Japanese. **PMID:** 18349587 **Citation:** Mochizuki H, Muramatsu R, Tadaki H, Mizuno T, Arakawa H, Morikawa A. Effects of skin care with shower therapy on children with atopic dermatitis in elementary schools. Pediatr Dermatol. 2009 Mar-Apr;26(2):223-5. doi: 10.1111/j.1525-1470.2009.00887.x. **PMID:** 19419481 **Citation:** Cardona ID, Cho SH, Leung DY. Role of bacterial superantigens in atopic dermatitis : implications for future therapeutic strategies. Am J Clin Dermatol. 2006;7(5):273-9. doi: 10.2165/00128071-200607050-00001. **PMID:** 17007538 **Citation:** Huang JT, Abrams M, Tlougan B, Rademaker A, Paller AS. Treatment of Staphylococcus aureus colonization in atopic dermatitis decreases disease severity. Pediatrics. 2009 May;123(5):e808-14. doi: 10.1542/peds.2008-2217. **PMID:** 19403473 **Citation:** Breneman DL, Hanifin JM, Berge CA, Keswick BH, Neumann PB. The effect of antibacterial soap with 1.5% triclocarban on Staphylococcus aureus in patients with atopic dermatitis. Cutis. 2000 Oct;66(4):296-300. **PMID:** 11109156 **Citation:** Kubota K, Machida I, Tamura K, Take H, Kurabayashi H, Akiba T, Tamura J. Treatment of refractory cases of atopic dermatitis with acidic hot-spring bathing. Acta Derm Venereol. 1997 Nov;77(6):452-4. doi: 10.2340/0001555577452454. **PMID:** 9394980 **Citation:** Murota H, Takahashi A, Nishioka M, Matsui S, Terao M, Kitaba S, Katayama I. Showering reduces atopic dermatitis in elementary school students. Eur J Dermatol. 2010 May-Jun;20(3):410-1. doi: 10.1684/ejd.2010.0928. Epub 2010 Apr 23. No abstract available. **PMID:** 20413368 **Citation:** Schuttelaar ML, Coenraads PJ. A randomized, double-blind study to assess the efficacy of addition of tetracycline to triamcinolone acetonide in the treatment of moderate to severe atopic dermatitis. J Eur Acad Dermatol Venereol. 2008 Sep;22(9):1076-82. doi: 10.1111/j.1468-3083.2008.02716.x. Epub 2008 Apr 1. **PMID:** 18384552 **Citation:** Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology. 1993;186(1):23-31. doi: 10.1159/000247298. **PMID:** 8435513 **Citation:** Carel K, Bratton DL, Miyazawa N, Gyorkos E, Kelsay K, Bender B, Strand M, Atkins D, Gelfand EW, Klinnert MD. The Atopic Dermatitis Quickscore (ADQ): validation of a new parent-administered atopic dermatitis scoring tool. Ann Allergy Asthma Immunol. 2008 Nov;101(5):500-7. doi: 10.1016/S1081-1206(10)60289-X. **PMID:** 19055204 **Citation:** Lewis-Jones MS, Finlay AY, Dykes PJ. The Infants' Dermatitis Quality of Life Index. Br J Dermatol. 2001 Jan;144(1):104-10. doi: 10.1046/j.1365-2133.2001.03960.x. **PMID:** 11167690 **Citation:** 27. Hanifin JM, Rajka G. Diagnostic features of atopic derma titis. Acta Derm Venereol1980;92:44-7. **Citation:** Woo SI, Kim JY, Lee YJ, Kim NS, Hahn YS. Effect of Lactobacillus sakei supplementation in children with atopic eczema-dermatitis syndrome. Ann Allergy Asthma Immunol. 2010 Apr;104(4):343-8. doi: 10.1016/j.anai.2010.01.020. **PMID:** 20408346 **Citation:** Gruber C, Wendt M, Sulser C, Lau S, Kulig M, Wahn U, Werfel T, Niggemann B. Randomized, placebo-controlled trial of Lactobacillus rhamnosus GG as treatment of atopic dermatitis in infancy. Allergy. 2007 Nov;62(11):1270-6. doi: 10.1111/j.1398-9995.2007.01543.x. **PMID:** 17919141 **Citation:** Meggitt SJ, Gray JC, Reynolds NJ. Azathioprine dosed by thiopurine methyltransferase activity for moderate-to-severe atopic eczema: a double-blind, randomised controlled trial. Lancet. 2006 Mar 11;367(9513):839-46. doi: 10.1016/S0140-6736(06)68340-2. **PMID:** 16530578 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012871 - Term: Skin Diseases - ID: D000012873 - Term: Skin Diseases, Genetic - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000017443 - Term: Skin Diseases, Eczematous - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M7067 - Name: Dermatitis - Relevance: HIGH - As Found: Dermatitis - ID: M7655 - Name: Eczema - Relevance: HIGH - As Found: Atopic Dermatitis - ID: M7071 - Name: Dermatitis, Atopic - Relevance: HIGH - As Found: Atopic Dermatitis - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M15676 - Name: Skin Diseases, Genetic - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M19712 - Name: Skin Diseases, Eczematous - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003876 - Term: Dermatitis, Atopic - ID: D000003872 - Term: Dermatitis - ID: D000004485 - Term: Eczema ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01190579 **Acronym:** MEDIC **Brief Title:** Dual Source CT Angiography for Detection of Coronary Artery Stenoses **Official Title:** Multicenter Evaluation of Coronary Dual Source CT Angiography in Patients With Intermediate Risk of Coronary Artery Stenoses #### Organization Study ID Info **ID:** MEDIC #### Organization **Class:** OTHER **Full Name:** University of Erlangen-Nürnberg Medical School ### Status Module #### Completion Date **Date:** 2010-12 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2010-08-27 **Type:** ESTIMATED **Last Update Submit Date:** 2010-08-26 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2010-12 **Type:** ESTIMATED #### Start Date **Date:** 2009-08 **Status Verified Date:** 2010-08 #### Study First Post Date **Date:** 2010-08-27 **Type:** ESTIMATED **Study First Submit Date:** 2010-08-20 **Study First Submit QC Date:** 2010-08-26 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Siemens Medical Solutions **Class:** INDUSTRY **Name:** Bayer #### Lead Sponsor **Class:** OTHER **Name:** University of Erlangen-Nürnberg Medical School #### Responsible Party **Old Name Title:** Stephan Achenbach **Old Organization:** University of Erlangen-Nürnberg Medical School ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The trial will investigate the accuracy of Dual Source CT coronary angiography to detect coronary artery stenoses in patients with chest pain who have, based on clinical criteria, an intermediate likelihood for the presence of coronary artery stenoses. No beta blockers will be used to lower the heart rate for the examination. The hypothesis is that Dual Source CT will allow the detection of vessels with at least one coronary artery stenosis with a sensitivity of more than 90%. ### Conditions Module **Conditions:** - Coronary Artery Disease **Keywords:** - Coronary Artery Disease - Chest Pain - Computed Tomography ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 398 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Invasive coronary angiography will be preformed within 72 hours to verify coronary CT angiography results. **Measure:** Accuracy for the detection of coronary artery stenoses **Time Frame:** 72 hours #### Secondary Outcomes **Description:** Patients will be monitored for one hour after injection of Ultravist 370 and Ultravist 300 intravenously to assess safety and detect side effects. **Measure:** Safety of Ultravist 370 and Ultravist 300 for coronary CT angiography **Time Frame:** 1 hour ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * suspected coronary artery disease * chest Pain * intermediate likelihood of coronary stenoses * planned invasive coronary angiography * age 30 to 80 years Exclusion Criteria: * non sinus rhythm * contrast allergy * renal failure * unstable clinical condition * previous coronary revascularization * calcium score exceeding 800 * inability to perform 10 second breathhold * possible pregnancy * metformin medication that cannot be interrupted * inability to establish antecubital iv access **Maximum Age:** 80 Years **Minimum Age:** 30 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with Chest Pain and an Intermdiate Likelihood for Coronary Artery Stenoses ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Stephan Achenbach, MD **Phone:** ++49 9131 8535000 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Dieter Ropers, MD **Phone:** ++49 9131 8535301 **Role:** CONTACT #### Locations **Location 1:** **City:** Vejle **Contacts:** ***Contact 1:*** - **Name:** Kristian Ovrehus, MD - **Role:** CONTACT **Country:** Denmark **Facility:** Vejle Medical Center **Status:** RECRUITING **Location 2:** **City:** Erlangen **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Stephan Achenbach, MD - **Phone:** ++49 9131 8535000 - **Role:** CONTACT ***Contact 2:*** - **Name:** Stephan Achenbach, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Germany **Facility:** University of Erlangen **Status:** RECRUITING **Location 3:** **City:** Hamburg **Contacts:** ***Contact 1:*** - **Name:** Joern Sandstede - **Role:** CONTACT **Country:** Germany **Facility:** Roentgenpraxis Hamburg **Status:** RECRUITING **Location 4:** **City:** Muenchen **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Joerg Hausleiter, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Joerg Hausleiter, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Germany **Facility:** Deutsches Herzzentrum Muenchen **Status:** RECRUITING **Location 5:** **City:** Munich **Contacts:** ***Contact 1:*** - **Name:** Christoph Becker, MD - **Role:** CONTACT **Country:** Germany **Facility:** Klinikum Grosshadern **Status:** NOT_YET_RECRUITING **Location 6:** **City:** Hyderabad **Contacts:** ***Contact 1:*** - **Name:** Ravi Bathina, MD - **Role:** CONTACT **Country:** India **Facility:** Ravi Bathina **Status:** RECRUITING **Location 7:** **City:** Monterrey **Contacts:** ***Contact 1:*** - **Name:** Erasmo De La Pena, MD - **Role:** CONTACT **Country:** Mexico **Facility:** Cardiovascular Institute **Status:** RECRUITING **Location 8:** **City:** Singapore **Contacts:** ***Contact 1:*** - **Name:** Keng Thye Ho, MD - **Role:** CONTACT **Country:** Singapore **Facility:** Tan Tok Seng Hospital **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** University of Erlangen-Nürnberg **Name:** Stephan Achenbach, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000001161 - Term: Arteriosclerosis - ID: D000001157 - Term: Arterial Occlusive Diseases - ID: D000014652 - Term: Vascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M6549 - Name: Coronary Disease - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M6546 - Name: Coronary Artery Disease - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M19506 - Name: Myocardial Ischemia - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M6475 - Name: Constriction, Pathologic - Relevance: LOW - As Found: Unknown - ID: M22913 - Name: Coronary Stenosis - Relevance: HIGH - As Found: Coronary Artery Stenosis - ID: M5882 - Name: Chest Pain - Relevance: LOW - As Found: Unknown - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M4469 - Name: Arteriosclerosis - Relevance: LOW - As Found: Unknown - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003324 - Term: Coronary Artery Disease - ID: D000017202 - Term: Myocardial Ischemia - ID: D000003327 - Term: Coronary Disease - ID: D000023921 - Term: Coronary Stenosis ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05220579 **Brief Title:** Clinical Trial of a Medical Device "Device for Non-invasive Electromagnetic Therapy "TOR" in the Treatment of COVID-19" **Official Title:** A Randomized Blind Placebo-controlled 3rd Phase Study of the Safety and Efficacy of the Device "Device for Non-invasive Electromagnetic Therapy "TOR" in 236 Patients Diagnosed With Moderate Coronavirus Infection #### Organization Study ID Info **ID:** SamaraTOR1 #### Organization **Class:** INDUSTRY **Full Name:** Concern GRANIT ### Status Module #### Completion Date **Date:** 2021-08-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-02-02 **Type:** ACTUAL **Last Update Submit Date:** 2022-02-01 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-08-12 **Type:** ACTUAL #### Start Date **Date:** 2020-12-29 **Type:** ACTUAL **Status Verified Date:** 2021-09 #### Study First Post Date **Date:** 2022-02-02 **Type:** ACTUAL **Study First Submit Date:** 2022-01-19 **Study First Submit QC Date:** 2022-02-01 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Samara State Medical University #### Lead Sponsor **Class:** INDUSTRY **Name:** Concern GRANIT #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** A clinical trial was conducted with human participation in order to assess the safety and efficacy of the medical device "TOR device for non-invasive electromagnetic therapy" when used as an adjunct in combination with standard COVID-19 treatment methods to accelerate the elimination (elimination) of the SARS-COV-2 virus from the nasopharynx in patients diagnosed with COVID-19. Device principle of operation is based on the use of weak electromagnetic radiation, continuously induced by high-voltage pulses on the launcher of a pulsed electromagnetic field electrodes and causing noise in the SARS-CoV-2 virus. The study included 236 patients who met all of the specified criteria: male and female patients aged ≥ 18 years with a coronavirus infection COVID-19 established diagnosis after specific testing, with a course of moderate disease, who do not require mechanical ventilation at the time of enrollment in the study. Infection with the SARS-CoV-2 virus had to be confirmed by PCR (nasopharyngeal and oropharyngeal swab). Informed consent was obtained from all patients. Results were statistically evaluated for 222 patients due to death and exclusion from the clinical study of 14 patients. Patients of the test group were exposed to the "TOR" device for at least 5 (five) consecutive days for at least 4 hours daily in the 15 + 15 mode (15 minutes exposure + 15 minutes break) in combination with standard therapy. Patients in the placebo group were exposed to the switched off "TOR" device in combination with standard therapy. The control group received standard therapy. Standard therapy was prescribed in accordance with the recommended treatment regimens presented in the current version of the Temporary guidelines of the Ministry of Health of Russia "Prevention, diagnosis and treatment of coronavirus infection (COVID-19) No. 9 dated 26.10. 2020)". The study had the periods of screening (day 1, visit 0 - V0), treatment (days 2-6, visits 1-5 - V1-V5), discharge (day 7-14, visit 6 - V6), follow-up (day 26 -30, visit 7 - V7). As a result of the clinical trial, it was established: "The device of non-invasive electromagnetic therapy "TOR" is safe when used as directed; effective as an adjuvant in combination with standard COVID-19 treatments to accelerate the elimination of the SARS-COV-2 virus from the nasopharynx. **Detailed Description:** This is a research work with the participation of patients to study the effect of low-power electromagnetic radiation with a selected spectrum on infected cells and the SARS-CoV-2 virus itself. In the course of work with wave emitters Research center of JSC "Concern GRANIT" conducted research in the field of the body's response to various wave frequencies and their combinations. In February 2020, the Concern's specialists, based on open information, created a computer model of the SARS-CoV-2 virus (COVID-19). After creating the simulation, work was carried out to isolate the spectrum of the wave emanating from the COVID-19 virus colony and infected cells. The resulting spectrum was modified for the purpose of noise pollution, and as a result the virus should lose activity and the standard line of behavior, which in turn should lead to a pause in its spread and enable the human immune system to cope with the infection on its own. Based on these assumptions, the prepared wave spectrum was recorded into the "TOR" device emitter, acting with an electromagnetic field with an intensity not exceeding that of a household microwave oven. The resulting spectrum is directed by the "TOR" device to human tissues affected by the SARS-CoV-2 virus in order to disrupt its activity. Thus, investigators are talking about a method aimed to changing the SARS-CoV-2 virus behavior, both outside a healthy cell and inside an infected one. The main task of this method is to bring low-power electromagnetic radiation with a selected spectrum as close as possible to infected cells and the virus itself. The safety of the "TOR" device is confirmed by the Institute of the Federal State Budgetary Institution "ALL-RUSSIAN RESEARCH AND TESTING INSTITUTE OF MEDICAL TECHNOLOGY" of Roszdravnadzor (permission to conduct tests No. 876/2020 dated 10.12.2020 was issued by Roszdravnadzor). The clinical study was carried out by the Federal State-Funded Educational Institution "Samara State Medical University" of the Ministry of Health of the Russian Federation. Address: 443099 Samara region, Samara, st. Chapaevskaya, 89 The main objective of the study was: to assess the safety and efficacy of the medical device ""TOR" device for non-invasive electromagnetic therapy" when used as an adjunct in combination with standard COVID-19 treatment methods to accelerate the elimination (elimination) of the SARS-COV-2 virus from the nasopharynx in patients diagnosed with COVID-19. Primary performance parameters were: 1. Dynamics of the SARS-CoV-2 virus replication activity (quantitative measurement of the genetic material of the virus (SARS-CoV-2 RNA) presence by PCR. 2. Dynamics of changes in the number of banded neutrophils. Secondary performance parameters were: 1. Dynamics of saturation, respiratory rate. 2. The dynamics of changes in points on the WHO scale; 3. Dynamics of changes in points on the NEWS scale; Within the framework of the study, three cohorts were formed, in each patients were randomized into control group A, receiving only standard therapy, group B with the exposure to the "TOR" device plus standard therapy, and group C with simulated exposure to the "TOR" device (placebo) in combined with standard therapy. Patients were randomly assigned to groups by randomization at visit 1 (day 1) in a 1: 1 ratio. Group A consisted of 84 people (during the study, 73 patients remained due to the death of 11 patients), group B - 77 people (during the study, 75 patients remained due to the death of 2 patients), group C - 75 people (during the study 74 patients remained due to the death of 1 patient). Before the start of treatment, there were no statistically significant differences in the main clinical and functional parameters between patients of all groups, with the exception of anthropometric data, which was taken into account during the study. Cohort 1, exposure to the "TOR" device: • Patients undergo standard therapy + exposure to the "TOR" device Modes of patients' treatment with the "TOR" device: The exposure is carried out for at least 5 (five) days in a row for at least 4 hours daily in the 15 + 15 mode (15 minutes exposure + 15 minutes break). Longer exposure does not have a negative effect on the human body. Standard therapy was prescribed in accordance with the recommended treatment regimens presented in the guidelines of the the Ministry of Health of Russia "Prevention, diagnosis and treatment of coronavirus infection (COVID-19) No. 9 dated 26.10. 2020)". Cohort 2, placebo: • Patients undergo standard therapy + a switched off "TOR" device was installed in the wards Standard therapy was prescribed in accordance with the recommended treatment regimens presented in the guidelines of the the Ministry of Health of Russia "Prevention, diagnosis and treatment of coronavirus infection (COVID-19) No. 9 dated 26.10. 2020)". Cohort 3, control: • Patients received standard therapy Standard therapy was prescribed in accordance with the recommended treatment regimens presented in the guidelines of the the Ministry of Health of Russia "Prevention, diagnosis and treatment of coronavirus infection (COVID-19) No. 9 dated 26.10. 2020)". The study provides for the following periods: * Screening period / enrollment and initiation of symptomatic therapy - day 1, V0; * Treatment period - 2-6 days, V1-V5; * Discharge period - 7-14 days, V6; * Follow-up period: 26-30th day, V7. Thus, the maximum duration of participation in the study for one patient was 30 days. Visit 0 (screening / enrollment / initiation of symptomatic treatment): Day 1 During the visit, the following procedures were performed: * Signing an informed consent form for participation in the study; * Collection of demographic data (date of birth, gender, age); * Collecting anamnesis; * Documenting a positive result of a PCR swab from the nasopharynx and / or oropharynx for SARS-CoV-2 no more than 72 hours old on the day of screening; * Documenting the results of a previously performed CT scan of the lungs; * Registration of complaints; * Registration of concomitant therapy; * Assessment of basic vital signs (blood pressure, heart rate \[HR\], respiratory rate) daily during hospitalization; * Measurement of axillary body temperature once a day * Physical examination; * Clinical blood test (hemoglobin level, hematocrit, erythrocyte count, leukocyte count, leukocyte count, platelet count, ESR); * Biochemical blood test (total protein, albumin, glucose, creatinine, urea, ALT, AST, total bilirubin, direct bilirubin, alkaline phosphatase, potassium, sodium, chlorine, C-reactive protein); * Coagulogram (activated partial thromboplastin time \[APTT\], PT, fibrinogen); * General urine analysis (color, transparency, relative density, pH, glucose, protein, ketone bodies, urobilinogen); * Assessment of SpO2 daily during hospitalization; * Electrocardiogram (ECG): performed to assess the QT interval; * Assessment of the condition according to the WHO scale; * Assessment of the condition according to the NEWS scale; * Assessment of inclusion / non-inclusion criteria; * Enrollment in the research; * Exposure of the method according to the Protocol; * Assessment of AEs / SAEs related to research procedures; * Assessment of exclusion criteria. Visits 1-5 (treatment period): days 2-6 During the visit, the following procedures were performed: * Exposure of the patient with the "TOR" device; * Assessment of basic vital signs (blood pressure, heart rate, respiratory rate) daily during the period of hospitalization; * Daily measurement of axillary body temperature during hospitalization; * Assessment of SpO2 daily during hospitalization; * Assessment of the condition according to the WHO scale; * Assessment of the condition according to the NEWS scale; * Assessment of AE / SAE; * Assessment of exclusion criteria. Visit 6 (end of treatment period, discharge): Day 7-14 During the visit, the following procedures were performed: * Assessment of basic vital signs (blood pressure, heart rate, respiratory rate); * Measurement of axillary body temperature; * Clinical blood test (hemoglobin level, hematocrit, erythrocyte count, leukocyte count, leukocyte count, platelet count, ESR); * Biochemical blood test (total protein, albumin, glucose, creatinine, urea, ALT, AST, total bilirubin, direct bilirubin, alkaline phosphatase, potassium, sodium, chlorine, C-reactive protein); * SpO2 assessment; * Assessment of the condition according to the WHO scale; * Assessment of the condition according to the NEWS scale; * Assessment of AE / SAE; * Assessment of exclusion criteria. Visit 7 (Follow-up): Day 26-30 During the visit, the following procedures were performed: * Assessment of basic vital signs (blood pressure, heart rate, respiratory rate); * Measurement of axillary body temperature; * Clinical blood test (hemoglobin level, hematocrit, erythrocyte count, leukocyte count, leukocyte count, platelet count, ESR); * Biochemical blood test (total protein, albumin, glucose, creatinine, urea, ALT, AST, total bilirubin, direct bilirubin, alkaline phosphatase, potassium, sodium, chlorine, C-reactive protein); * SpO2 assessment; * Assessment of the condition according to the WHO scale; * Assessment of the condition according to the NEWS scale; * Assessment of AE / SAE. ### Conditions Module **Conditions:** - Coronavirus Infection COVID-19 **Keywords:** - Coronavirus Infection - COVID-19 - electromagnetic therapy - SARS-CoV-2 ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized placebo controlled double-blind trial ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** The "TOR" device was provided by the sponsor to the investigators with screened indicators on the front panel. The device was switched on / off by a medical monitor without the participation of medical personnel and investigators. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 236 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients undergo standard therapy + exposure to the "TOR" device Modes of patients' treatment with the "TOR" device: The exposure is carried out for at least 5 (five) days in a row for at least 4 hours daily in the 15 + 15 mode (15 minutes exposure + 15 minutes break). Standard therapy was prescribed in accordance with the recommended treatment regimens presented in the guidelines of the the Ministry of Health of Russia "Prevention, diagnosis and treatment of coronavirus infection (COVID-19) No. 9 dated 26.10. 2020)". **Intervention Names:** - Device: Exposure to "TOR" device **Label:** Exposure to "TOR" device **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients received standard therapy Standard therapy was prescribed in accordance with the recommended treatment regimens presented in the guidelines of the the Ministry of Health of Russia "Prevention, diagnosis and treatment of coronavirus infection (COVID-19) No. 9 dated 26.10. 2020)". **Label:** Control **Type:** NO_INTERVENTION #### Arm Group 3 **Description:** Patients undergo standard therapy + a switched off "TOR" device was installed in the wards Standard therapy was prescribed in accordance with the recommended treatment regimens presented in the guidelines of the the Ministry of Health of Russia "Prevention, diagnosis and treatment of coronavirus infection (COVID-19) No. 9 dated 26.10. 2020)". **Intervention Names:** - Device: Exposure to switched off "TOR" device **Label:** Placebo (exposure to switched off "TOR" device) **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Exposure to "TOR" device **Description:** Specific wave spectrum is directed by the "TOR" device to human tissues affected by the SARS-CoV-2 virus in order to disrupt its activity. **Name:** Exposure to "TOR" device **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Placebo (exposure to switched off "TOR" device) **Description:** The "TOR" device has screened indicators on the front panel. The device was switched on / off by a medical monitor without the participation of medical personnel and investigators. **Name:** Exposure to switched off "TOR" device **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Dynamics of the SARS-CoV-2 virus replication activity (quantitative measurement of the genetic material of the virus (SARS-CoV-2 RNA) presence by PCR. **Measure:** PCR **Time Frame:** Day 5 **Description:** Dynamics of changes in the number of banded neutrophils.Dynamics of the SARS-CoV-2 virus replication activity (quantitative measurement of the genetic material of the virus (SARS-CoV-2 RNA) presence by PCR. **Measure:** PCR **Time Frame:** Day 14 **Description:** Dynamics of changes in the number of banded neutrophils. **Measure:** Banded neutrophils **Time Frame:** Day 7 **Description:** Dynamics of changes in the number of banded neutrophils. **Measure:** Banded neutrophils **Time Frame:** Day 14 **Description:** Dynamics of changes in the number of banded neutrophils. **Measure:** Banded neutrophils **Time Frame:** Day 28 #### Secondary Outcomes **Description:** Dynamics of saturation. **Measure:** Blood oxygen saturation **Time Frame:** Day 2 **Description:** Dynamics of saturation. **Measure:** Blood oxygen saturation **Time Frame:** Day 3 **Description:** Dynamics of saturation. **Measure:** Blood oxygen saturation **Time Frame:** Day 4 **Description:** Dynamics of saturation. **Measure:** Blood oxygen saturation **Time Frame:** Day 5 **Description:** Dynamics of respiratory rate. **Measure:** Respiratory rate **Time Frame:** Day 2 **Description:** Dynamics of respiratory rate. **Measure:** Respiratory rate **Time Frame:** Day 3 **Description:** Dynamics of respiratory rate. **Measure:** Respiratory rate **Time Frame:** Day 4 **Description:** Dynamics of respiratory rate. **Measure:** Respiratory rate **Time Frame:** Day 5 **Description:** The dynamics of changes in points on the scale (score 0-7, 0 - best outcome, 7 - worst outcome). **Measure:** Ordinal Scale for Clinical Improvement **Time Frame:** Day 2 **Description:** The dynamics of changes in points on the scale (score 0-7, 0 - best outcome, 7 - worst outcome). **Measure:** Ordinal Scale for Clinical Improvement **Time Frame:** Day 3 **Description:** The dynamics of changes in points on the scale (score 0-7, 0 - best outcome, 7 - worst outcome). **Measure:** Ordinal Scale for Clinical Improvement **Time Frame:** Day 4 **Description:** The dynamics of changes in points on the scale (score 0-7, 0 - best outcome, 7 - worst outcome). **Measure:** Ordinal Scale for Clinical Improvement **Time Frame:** Day 5 **Description:** The dynamics of changes in points on the scale (score 0-7, 0 - best outcome, 7 - worst outcome). **Measure:** Ordinal Scale for Clinical Improvement **Time Frame:** Day 7 **Description:** The dynamics of changes in points on the scale (score 0-7, 0 - best outcome, 7 - worst outcome). **Measure:** Ordinal Scale for Clinical Improvement **Time Frame:** Day 14 **Description:** The dynamics of changes in points on the scale (score 0-7, 0 - best outcome, 7 - worst outcome). **Measure:** Ordinal Scale for Clinical Improvement **Time Frame:** Day 28 **Description:** Dynamics of changes in points on the NEWS-2 scale (score 0 - \>/= 7, 0 - best outcome, \>/= 7 - worst outcome). **Measure:** NEWS-2 (National Early Warning Score) scale **Time Frame:** Day 2 **Description:** Dynamics of changes in points on the NEWS-2 scale (score 0 - \>/= 7, 0 - best outcome, \>/= 7 - worst outcome). **Measure:** NEWS-2 (National Early Warning Score) scale **Time Frame:** Day 3 **Description:** Dynamics of changes in points on the NEWS-2 scale (score 0 - \>/= 7, 0 - best outcome, \>/= 7 - worst outcome). **Measure:** NEWS-2 (National Early Warning Score) scale **Time Frame:** Day 4 **Description:** Dynamics of changes in points on the NEWS-2 scale (score 0 - \>/= 7, 0 - best outcome, \>/= 7 - worst outcome). **Measure:** NEWS-2 (National Early Warning Score) scale **Time Frame:** Day 5 **Description:** Dynamics of changes in points on the NEWS-2 scale (score 0 - \>/= 7, 0 - best outcome, \>/= 7 - worst outcome). **Measure:** NEWS-2 (National Early Warning Score) scale **Time Frame:** Day 7 **Description:** Dynamics of changes in points on the NEWS-2 scale (score 0 - \>/= 7, 0 - best outcome, \>/= 7 - worst outcome). **Measure:** NEWS-2 (National Early Warning Score) scale **Time Frame:** Day 14 **Description:** Dynamics of changes in points on the NEWS-2 scale (score 0 - \>/= 7, 0 - best outcome, \>/= 7 - worst outcome). **Measure:** NEWS-2 (National Early Warning Score) scale **Time Frame:** Day 28 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Men and women aged 18 and over, diagnosed with coronavirus infection COVID-19 after specific testing. When the course of the disease progressed to a severe degree, patients were excluded from the study; 2. Signed consent to participate in the trial; 3. Patients hospitalized with COVID-19 disease. Positive result of a PCR test (biomaterial - a swab from the nasopharynx and / or oropharynx) for infection with the SARS-CoV-2 virus within 72 hours on the day of screening. 4. Patients with characteristic computed tomographic signs of the "ground-glass opacity" (one or two-sided spread) in combination with local foci of consolidation or without them; 5. Oxygen therapy is not required, or oxygen therapy is required using a face mask or nasal cannulas; 6. The duration of the disease from the first symptoms to the day of screening is not more than 7 days; 7. The ability to understand the requirements for research participants, to give written consent to participate in the research (including the use and transfer of information about the health of patients, relevant to the research) and to follow the procedures specified in the research protocol. Exclusion Criteria: 1. The patient's desire to discontinue participation in the study (withdrawal of informed consent). 2. The decision of the investigating physician that the patient should be excluded for the benefit of the patient him/herself; 3. The patient refuses to cooperate with the investigator or is not disciplined; 4. Death of the patient; 5. Progressing of the disease to a severe degree. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Moscow **Country:** Russian Federation **Facility:** Concern GRANIT **Zip:** 119019 #### Overall Officials **Official 1:** **Affiliation:** Samara State Medical University **Name:** Oleg V Fatenkov, Ph.D, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Upon request to the administrator's email address [email protected] **Description:** We provide the Clinical Study Protocol upon request to the administrator's email. **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** Until December 31, 2022 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011024 - Term: Pneumonia, Viral - ID: D000011014 - Term: Pneumonia - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000014777 - Term: Virus Diseases - ID: D000003333 - Term: Coronaviridae Infections - ID: D000030341 - Term: Nidovirales Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M2561 - Name: COVID-19 - Relevance: HIGH - As Found: COVID-19 - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M20490 - Name: Coronavirus Infections - Relevance: HIGH - As Found: Coronavirus Infection - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M13914 - Name: Pneumonia, Viral - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M6555 - Name: Coronaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M23685 - Name: Nidovirales Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000086382 - Term: COVID-19 - ID: D000018352 - Term: Coronavirus Infections ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03147079 **Acronym:** Mighty Mums **Brief Title:** Study of Antenatal Care Intervention Directed to Pregnant Women With Obesity **Official Title:** Mighty Mums - a Lifestyle Intervention at Primary Care Level for Pregnant Women With Obesity #### Organization Study ID Info **ID:** FoU-project id 203431 #### Organization **Class:** OTHER **Full Name:** Göteborg University #### Secondary ID Infos **Domain:** Approval number from the ethical review board **ID:** 505-10 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2017-12-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2019-05-02 **Type:** ACTUAL **Last Update Submit Date:** 2019-04-30 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2013-12-31 **Type:** ACTUAL #### Start Date **Date:** 2011-01-01 **Type:** ACTUAL **Status Verified Date:** 2019-04 #### Study First Post Date **Date:** 2017-05-10 **Type:** ACTUAL **Study First Submit Date:** 2017-05-08 **Study First Submit QC Date:** 2017-05-09 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Vastra Gotaland Region #### Lead Sponsor **Class:** OTHER **Name:** Göteborg University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to determine whether a behavioural intervention focusing on diet and physical activity is cost-effective in decreasing weight gain during pregnancy among pregnant women with body mass index above 30, and has effect on the weight of offspring at birth and at 2.5 years of age **Detailed Description:** Obesity in relation to pregnancy is becoming an increasing public health issue and 48% of women assigned to antenatal care in Sweden have overweight (BMI≥25) or obesity (BMI≥30). Obesity is associated with adverse perinatal outcomes, the risks increase with increasing BMI and excessive gestational weight gain (GWG) further increases the risks of adverse pregnancy outcomes. Lifestyle intervention can help pregnant women with obesity to limit their GWG. This study evaluated whether a low-budget antenatal lifestyle intervention programme, with emphasis on nutrition and physical activity, influenced GWG and maternal and perinatal outcomes for pregnant women with obesity. The study also evaluated which specific components of the intervention that had effect. ### Conditions Module **Conditions:** - Obesity Complicating Childbirth **Keywords:** - obesity - pregnancy - lifestyle - gestational weight gain - weight of offspring - antenatal care - health behavior - physical activity - diet - programme evaluation - costs and costs analysis ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Open intervention study with 2 control arms ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 1354 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Lifestyle intervention **Intervention Names:** - Behavioral: Lifestyle intervention **Label:** Intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Behavioral: Lifestyle intervention **Label:** Internal controls **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Behavioral: Lifestyle intervention **Label:** External controls **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - External controls - Internal controls - Intervention **Name:** Lifestyle intervention **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Weight gain measured from enrollment/first antenatal care visit to last visit before partum, measured in kg **Measure:** Gestational weight gain < 7 kg **Time Frame:** 7 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * pregnant * BMI\>30 Exclusion Criteria: * first antenatal care visit after week 20 of the pregnancy * abortion * miscarriage **Healthy Volunteers:** True **Sex:** FEMALE **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Gothenburg **Country:** Sweden **Facility:** Sahlgrenska Academy, Institute of Health Care Sciences #### Overall Officials **Official 1:** **Affiliation:** Göteborg University **Name:** Marie Berg, RN PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Dencker A, Premberg A, Olander EK, McCourt C, Haby K, Dencker S, Glantz A, Berg M. Adopting a healthy lifestyle when pregnant and obese - an interview study three years after childbirth. BMC Pregnancy Childbirth. 2016 Jul 30;16(1):201. doi: 10.1186/s12884-016-0969-x. **PMID:** 27473076 **Citation:** Petrov Fieril K, Fagevik Olsen M, Glantz A, Larsson M. Experiences of exercise during pregnancy among women who perform regular resistance training: a qualitative study. Phys Ther. 2014 Aug;94(8):1135-43. doi: 10.2522/ptj.20120432. Epub 2014 May 1. **PMID:** 24786941 **Citation:** Haby K, Glantz A, Hanas R, Premberg A. Mighty Mums - An antenatal health care intervention can reduce gestational weight gain in women with obesity. Midwifery. 2015 Jul;31(7):685-92. doi: 10.1016/j.midw.2015.03.014. Epub 2015 Apr 9. **PMID:** 25912510 **Citation:** Haby K, Gyllensten H, Hanas R, Berg M, Premberg A. A Lifestyle Intervention During Pregnancy and Its Effects on Child Weight 2.5 Years Later. Matern Child Health J. 2022 Sep;26(9):1881-1890. doi: 10.1007/s10995-022-03395-5. Epub 2022 Mar 6. **PMID:** 35253077 **Citation:** Gyllensten H, Haby K, Berg M, Premberg A. Cost effectiveness of a controlled lifestyle intervention for pregnant women with obesity. BMC Pregnancy Childbirth. 2021 Sep 21;21(1):639. doi: 10.1186/s12884-021-04098-5. **PMID:** 34548038 **Citation:** Haby K, Berg M, Gyllensten H, Hanas R, Premberg A. Mighty Mums - a lifestyle intervention at primary care level reduces gestational weight gain in women with obesity. BMC Obes. 2018 Jun 4;5:16. doi: 10.1186/s40608-018-0194-4. eCollection 2018. **PMID:** 29881627 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000050177 - Term: Overweight - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown - ID: M12701 - Name: Obesity - Relevance: HIGH - As Found: Obesity - ID: M18101 - Name: Weight Gain - Relevance: LOW - As Found: Unknown - ID: M1934 - Name: Gestational Weight Gain - Relevance: LOW - As Found: Unknown - ID: M26186 - Name: Overweight - Relevance: LOW - As Found: Unknown - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009765 - Term: Obesity ### Intervention Browse Module - Browse Branches - Abbrev: HB - Name: Herbal and Botanical - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T114 - Name: Chrysanthemum - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT00510679 **Brief Title:** Study of Post-Training Supports for Health Workers in Benin **Official Title:** A Randomized Controlled Trial of Post-Training Supports for Health Workers Trained in the Use of Integrated Management of Childhood Illness Guidelines in Ouémé Department, Benin #### Organization Study ID Info **ID:** CDC-NCID-3279 #### Organization **Class:** FED **Full Name:** Centers for Disease Control and Prevention ### Status Module #### Completion Date **Date:** 2004-10 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2007-08-02 **Type:** ESTIMATED **Last Update Submit Date:** 2007-08-01 **Overall Status:** COMPLETED #### Start Date **Date:** 1999-07 **Status Verified Date:** 2007-08 #### Study First Post Date **Date:** 2007-08-02 **Type:** ESTIMATED **Study First Submit Date:** 2007-08-01 **Study First Submit QC Date:** 2007-08-01 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Ministry of Health, Benin #### Lead Sponsor **Class:** FED **Name:** Centers for Disease Control and Prevention ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The objective of this study was to determine the effectiveness and cost-effectiveness of a package of interventions to support health workers in Benin (in West Africa) who had been trained to use Integrated Management of Childhood Illness guidelines (i.e., guidelines intended to improve the treatment of childhood illnesses). **Detailed Description:** Integrated Management of Childhood Illness (IMCI) is a child health strategy in developing countries with a goal of improving the treatment of illnesses at first-level health facilities through the use of clinical practice guidelines. The World Health Organization (WHO) recommends implementing the guidelines with an 11-day training course. There is a concern that health workers might not master all aspects of the guidelines and that health worker performance may deteriorate over time. In 1999, Benin (in West Africa) was planning to implement IMCI. In response to concerns about how well health workers would follow IMCI guidelines, interventions were designed to support health workers after IMCI training: 1) regular supervision of health workers; 2) supervision of supervisors; 3) job aids; and 4) non-financial incentives for health workers. These interventions were intended to be used together. The objective of this study was to determine the effectiveness and cost-effectiveness of the package of interventions to support IMCI-trained health workers in Benin. ### Conditions Module **Conditions:** - Malaria - Pneumonia - Diarrhea - Measles - Malnutrition **Keywords:** - Benin - child health - developing country - health services research - health worker performance - Integrated Management of Childhood Illness ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 1577 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Name:** Health worker supports (supervision, job aids, incentives) **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Measure:** Proportion of children with potentially life-threatening illnesses who received recommended treatment, according to Integrated Management of Childhood Illness guidelines. **Time Frame:** 3 years **Measure:** Proportion of children with potentially life-threatening illnesses who received recommended treatment, according to Integrated Management of Childhood Illness guidelines, or adequate treatment. **Time Frame:** 3 years **Measure:** Mean proportion of needed case management tasks that were performed during consultations. **Time Frame:** 3 years #### Secondary Outcomes **Measure:** Proportion of children with pneumonia who received recommended treatment, according to Integrated Management of Childhood Illness guidelines. **Time Frame:** 3 years **Measure:** Proportion of children with malaria who received recommended treatment, according to Integrated Management of Childhood Illness guidelines. **Time Frame:** 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Inclusion criteria for health facilities were: 1) public and licensed private health facilities providing outpatient services, and 2) the level of care was appropriate for use of Integrated Management of Childhood Illness (IMCI) guidelines. * Inclusion criteria for consultations were children 1 week - 59 months old seen for any illness during regular working hours (typically 8am-6pm) on weekdays. Exclusion Criteria: * Health facilities in which the level of care was not appropriate for use of Integrated Management of Childhood Illness (IMCI) guidelines(i.e., one referral hospital and one sub-specialty hospital). **Maximum Age:** 59 Months **Minimum Age:** 1 Week **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Entire department of Oueme and Plateau **Country:** Benin **Facility:** All eligible health facilities **State:** Oueme and Plateau #### Overall Officials **Official 1:** **Affiliation:** Centers for Disease Control and Prevention **Name:** Rowe K Alexander, MD, MPH **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Rowe AK, Onikpo F, Lama M, Deming MS. Risk and protective factors for two types of error in the treatment of children with fever at outpatient health facilities in Benin. Int J Epidemiol. 2003 Apr;32(2):296-303. doi: 10.1093/ije/dyg063. **PMID:** 12714553 **Citation:** Rowe AK, Lama M, Onikpo F, Deming MS. Design effects and intraclass correlation coefficients from a health facility cluster survey in Benin. Int J Qual Health Care. 2002 Dec;14(6):521-3. doi: 10.1093/intqhc/14.6.521. No abstract available. **PMID:** 12515339 **Citation:** Rowe AK, Lama M, Onikpo F, Deming MS. Health worker perceptions of how being observed influences their practices during consultations with ill children. Trop Doct. 2002 Jul;32(3):166-7. doi: 10.1177/004947550203200317. No abstract available. **PMID:** 12139161 **Citation:** Rowe AK, Onikpo F, Lama M, Cokou F, Deming MS. Management of childhood illness at health facilities in Benin: problems and their causes. Am J Public Health. 2001 Oct;91(10):1625-35. doi: 10.2105/ajph.91.10.1625. **PMID:** 11574325 **Citation:** Rowe AK, Onikpo F, Lama M, Deming MS. Evaluating health worker performance in Benin using the simulated client method with real children. Implement Sci. 2012 Oct 8;7:95. doi: 10.1186/1748-5908-7-95. **PMID:** 23043671 **Citation:** Rowe AK, Onikpo F, Lama M, Deming MS. The rise and fall of supervision in a project designed to strengthen supervision of Integrated Management of Childhood Illness in Benin. Health Policy Plan. 2010 Mar;25(2):125-34. doi: 10.1093/heapol/czp054. Epub 2009 Nov 18. **PMID:** 19923206 **Citation:** Osterholt DM, Onikpo F, Lama M, Deming MS, Rowe AK. Improving pneumonia case-management in Benin: a randomized trial of a multi-faceted intervention to support health worker adherence to Integrated Management of Childhood Illness guidelines. Hum Resour Health. 2009 Aug 27;7:77. doi: 10.1186/1478-4491-7-77. **PMID:** 19712484 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012817 - Term: Signs and Symptoms, Digestive - ID: D000009748 - Term: Nutrition Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M25306 - Name: Malnutrition - Relevance: HIGH - As Found: Malnutrition - ID: M11280 - Name: Malaria - Relevance: LOW - As Found: Unknown - ID: M7159 - Name: Diarrhea - Relevance: HIGH - As Found: Diarrhea - ID: M11440 - Name: Measles - Relevance: LOW - As Found: Unknown - ID: M15622 - Name: Signs and Symptoms, Digestive - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: T3571 - Name: Malaria - Relevance: LOW - As Found: Unknown - ID: T3653 - Name: Measles - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000044342 - Term: Malnutrition - ID: D000003967 - Term: Diarrhea ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02894879 **Brief Title:** Effectiveness Of Modified Chest PT Technidue In Pre And Post-Operative Program In Patients Open Heart Surgery **Official Title:** Effectiveness of Modified Chest Physical Therapy Techniques Using New Device in Pre and Post-operative Program in Patients Undergoing Open Heart Surgery. #### Organization Study ID Info **ID:** Effect of modify chest PT #### Organization **Class:** OTHER **Full Name:** Khon Kaen University ### Status Module #### Completion Date **Date:** 2017-04 **Type:** ESTIMATED #### Expanded Access Info **Last Known Status:** RECRUITING #### Last Update Post Date **Date:** 2016-10-14 **Type:** ESTIMATED **Last Update Submit Date:** 2016-10-13 **Overall Status:** UNKNOWN #### Primary Completion Date **Date:** 2017-04 **Type:** ESTIMATED #### Start Date **Date:** 2016-09 **Status Verified Date:** 2016-10 #### Study First Post Date **Date:** 2016-09-09 **Type:** ESTIMATED **Study First Submit Date:** 2016-08-15 **Study First Submit QC Date:** 2016-09-05 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Khon Kaen University #### Responsible Party **Investigator Affiliation:** Khon Kaen University **Investigator Full Name:** Mrs.atidtaya yotwong **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to explore effectiveness of modified chest physical therapy techniques using new device in pre and post-operative program in patients undergoing open heart surgery **Detailed Description:** Postoperative pulmonary complications, PPCs are common after open heart surgery. The causes of PPCs is complex and involve numerous factors in cardiac surgery including general anesthesia, cardiopulmonary bypass technique, median sternotomy, internal mammary artery dissection, topical cooling for myocardial protection, process of surgery, pulmonary risk factor of patients preoperative and on intubation. These factors could lead to pain and change in breathing pattern and induced respiratory muscle dysfunction. Causes of restriction lung volume, reduced lung volume, impaired airway clearance and secretion accumulation lead to poor ventilation and gas exchange. These are major contributing factors of PPCs e.g. atelectasis and pneumonia, which increase the load on cardiac function. The cardio-respiratory dysfunction could result in prolonged intubation and mechanical ventilator dependence in ICU and are an important cause of morbidity and mortality. Also, PPCs increase use of medical resources, extend the length of hospital stays and increase hospital costs . The reducing of PPCs need the chest physical therapy (CPT) to solve this problem. The goals of CPT are to increase lung volume, improve airway secretion clearance, and improve physical ambulation and movement. The CPT techniques are composed of deep breathing exercise, coughing and huffing, force expiratory technique, percussion and vibration, and early mobilization and change of position. However, these complications were still available and high incidence. May be, because CPT techniques are urged pain, not to clear secretion, the patients has not enough time to performed the CPT techniques in preoperative period and the atelectasis occurred immediately after surgery. But CPT in patients after cardiac surgery is mostly training after extubation. So, CPT have develops new technique or breathing device for increase lung volume and improve airway secretion clearance without increasing pain to reduce the incidence of PPCs. Incentive spirometry (IS) device is a widely used for the prophylaxis and treatment of respiratory complications in postsurgical patients. The previous study suggested that IS training could reduce an incidence of PPCs. However, several publications have controversisce results the effectiveness of IS when compared other chest physical therapy in preventing PPCs in patients undergoing cardiac surgery. Recent studies suggested that in patients undergoing cardiac surgery no evidence of benefit from IS to prevent PPCs, improving pulmonary function and oxygenation and reducing the length of a hospital when compared with preoperative education or standard postsurgical physical therapy. The comparison the effectiveness between IS and conventional postoperative chest physical therapy showed that did not difference. This may be caused by IS device in there studied not enough increase lung volume especially lower lung, this is often found atelectasis. Moreover, this device has not a property of airway clearance, which the secretion accumulation is a primary cause of PPCs. Positive expiratory pressure (PEP) device was popular used in patients after cardiac surgery practically and demonstrated to reduce the incidence of PPCs. Due to, the PEP technique can prevent the closure of the trachea during exhalation, resulting the increase of lung volumes and the mobilization of secretions. Earlier study had compared the effect of different deep breathing exercise, on PPCs after CABG surgery. However, in such studies there studies to immediate effects of 30 deep breaths performed with or without a mechanical device on atelectasis after 2 days surgery, and did not perform adequate follow-up. A resulting lack of evidence indicating that PEP technique in clinical practice, the patients undergoing cardiac surgery. Due to, in routine treatment, the breathing exercise is repeated every daytime and for several days. It is not unlikely that repeated practice will have a more substantial effect. Moreover, Westerdahl et al. (2003) found that the aerated lung area was increase in the IS+PEP group, when compared to the PEP with deep breathe group. This data is an interesting point that, if the patients practice breathing exercise with IS+PEP at 30 breathes every daytime and several days maybe the difference between patients practice IS+PEP and chest physical therapy on the incidence of PPCs in patients cardiac surgery. The study of the effect of IS+PEP on reducing the incidence of PPCs compared to respiratory physiotherapy intervention in patients undergoing cardiac surgery was a few studied. Westerdahl et al. (2001) studied on the effectiveness of three deep breathing techniques in male patients after CABG surgery and the results found that the occurrence of atelectasis was no statistical difference between IS+PEP group, compared to deep breath and PEP group. This result is contrastly to the results of Haeffener et al., (2008). In patients undergoing CABG surgery, combinated treatment with IS and EPAP helped to reduction the PPCs significantly. However, the studied has a limitation of methodology due to the patients are not comprehensive. Thus, this study was interested in the effects of practicing IS combine PEP to reduce the incidence of PPCs, especially atelectasis in patients undergoing cardiac surgery by BreatheMAX® v.2. Due to, BreatheMAX has been developed and manufactured in Thailand, breathing device has multiple functions with cheaper price and easy. Moreover, IS of BreatheMAX has a humidified and vibrate mechanisms during inhaling, thus it can reduce the viscosity of secretion and increases the ability to remove secretions without causing a dry mouth. The obstruction of secretions is the primary cause of atelectasis in patients undergoing cardiac surgery. But other devices are manufacture in abroad and single function, make time to use several functions need for multiple devices. In order to prevent PPCs, the patients have to be well trained all the CPT techniques used in postoperative period with a physiotherapist. However, in clinical practice patients are always admitted hospital just 1-2 days before the operation, and there is not enough time to practice the CPT techniques. In addition, the taught of CPT techniques may be challenging and redundant to practice in short time. To solve this problem, the illustrated CPT techniques have to be selected and directed toward airway clearance, and alveolar recruitment effects also need to be fewer and efficient techniques feasible to do easily by the post-operative patients. Consequently, apart from huffing or coughing, using the proper breathing device would be easier and enjoy the way of practice and acceptable by the vulnerable patients during pre-operative period. IS and PEP techniques will be selected because of their therapeutic effects. However, there is no evidence supporting the effectiveness of the IS and PEP techniques in pre-operative and continue in post-operative period in order to prevent PPCs. The hypothesized scope that if the patients can learn and do the techniques well, at before and after operative period, the PPCs can reduced or prevented which could result to prevent or reduce the incidence of PPCs. Therefore, this study aimed to evaluate the effectiveness of preoperative physical therapy program (Oscillated PEP + Oscillated IS) on the PPCs in patients who underwent cardiac surgery. In conclusion, this research proposal has to study the effectiveness of Oscillated PEP and Oscillated IS (OPEP+OIS) techniques compare deep breathing exercise conduct pre-operative and continue post-operative period on the incidence of PPCs, especially atelectasis, the length of a mechanical ventilator, the length of intubation, and length of ICU and hospital stay. ### Conditions Module **Conditions:** - Pulmonary Complications **Keywords:** - Postoperative pulmonary complications ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 48 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** For 2 days pre-surgery and continuous post-surgery repeated for 5 sets a day. The patients in Modify group will be taught 4 modify techniques and receive cardiac rehabilitation phase 1 in postoperative period. **Intervention Names:** - Device: BreatheMAX® **Label:** Modify group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** For 2 days pre-surgery and continuous post-surgery repeated for 5 sets a day. The patients in Modify group will be taught 3 conventional techniques and receive cardiac rehabilitation phase 1 in postoperative period. **Intervention Names:** - Other: Routine treatment **Label:** Conventional group **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Modify group **Description:** Modify chest physical therapy * oscillated incentive spirometry (OIS) with inspiratory load of 5-8 cm H2O 30 times/set * oscillated positive expiratory pressure (OPEP) with expiratory load of 5-8 cm H2O 30 times/set * Coughing with splinting 3 times/set * Chest mobilization with overhead both arms rises 10 times/set total 5 set/day **Name:** BreatheMAX® **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Conventional group **Description:** Routine chest physical therapy * Deep breathing exercise (upper and lower costal and diaphragmatic breathing exercise) as deep as possible for 10 times/set/level * Coughing with splinting 3 times/set * Chest mobilization with overhead both arms raised 10 times/set total 5 set/day **Name:** Routine treatment **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Incidence of PPCs were recorded from atelectasis, pneumonia, and pleural effusion according to clinical (symptoms and examinations) and radiological criteria in postoperative day 1-5 and diagnosed by the physician. **Measure:** Incidence of PPCs, **Time Frame:** postoperative day 1-5 **Description:** Duration of mode of mechanical ventilation and intubation times. Dependent variables, mode and duration of mechanical ventilation, starting records mode of mechanical ventilator when the patients arrive to ICU until extubation **Measure:** The duration of breathing with a mode of mechanical ventilator and duration of intubation time **Time Frame:** postoperative 4 weeks #### Secondary Outcomes **Description:** Length of ICU stay starting record when the patients arrive to ICU until move out. Length of hospital stay were record in postoperative period until discharge. **Measure:** length of ICU and hospital stay **Time Frame:** postoperative 4 weeks **Description:** Pulmonary function test were monitored before starting the training, after training 1 day before surgery and 5 days postoperative surgery. Slow vital capacity (SVC), Inspiratory capacity (IC) and Forced expiratory flow (FEF) measured by spirometer (Spirometer MicroLab ML3500) 3 times and records the best value. Then, the SVC and IC has been calculated by a computer program to find value of slow vital capacity %predict (SVC %predict) and inspiratory capacity (IC %predict). Tidal volume (VT) was monitor before and after training every in pre-operation and post-operative 1-5 days, measured by wright respirometer **Measure:** Pulmonary function test **Time Frame:** pre-operation and post-operative 1-5 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with a leaky septal defect, valvular heart disease and coronary artery disease, both male, and female, scheduled for primary elective open heart surgery age 20-80 years who had the ability to communicate and understand informed consent. Exclusion Criteria: * Unstable angina pectoris at the moment of selection or during the program * Complex ventricular and uncontrolled arrhythmia * Uncontrolled high blood pressure (\> 140/90 mm/Hg) * A history of cerebrovascular accident * Presence of a neuromuscular disorder * Cardiovascular instability or the existence an aneurysm * Ejection fractions were less than 0.40 * Unable to participate because of physical limitations **Maximum Age:** 80 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Atidtaya yotwong, master **Phone:** +66945423887 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Chulee Jones, doctor **Phone:** +66845164169 **Role:** CONTACT #### Locations **Location 1:** **City:** Maung Khon Kaen **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Atidtaya Yotwong, Master - **Phone:** +66043336789 - **Phone Ext:** 1322 - **Role:** CONTACT **Country:** Thailand **Facility:** Khon Kaen hospital **State:** KhonKaen **Status:** RECRUITING **Zip:** 40000 #### Overall Officials **Official 1:** **Affiliation:** Khon Kaen University **Name:** Atidtaya yotwong, master **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT06398379 **Acronym:** VISION **Brief Title:** Virus as Treatment of C. Difficile Infection (VISION) **Official Title:** Virus as Treatment of C. Difficile Infection (VISION) #### Organization Study ID Info **ID:** H-22069168 #### Organization **Class:** OTHER **Full Name:** Copenhagen University Hospital, Hvidovre ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-04-30 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-01-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-01 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-03 **Type:** ACTUAL **Study First Submit Date:** 2024-03-21 **Study First Submit QC Date:** 2024-04-30 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Copenhagen #### Lead Sponsor **Class:** OTHER **Name:** Copenhagen University Hospital, Hvidovre #### Responsible Party **Investigator Affiliation:** Copenhagen University Hospital, Hvidovre **Investigator Full Name:** Frederik Cold **Investigator Title:** MD, PhD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Fecal Virome Transplantation (FVT) has in small studies shown benefit in the treatment of recurrent C. difficile infection. In the VISION study we will treat patients with recurrent C. difficile infection with FVT capsules and compare the treatment with Fecal Microbiota Transplantation (FMT) capsules. Both will be following af standard treatment of antibiotics (Vancomycin) **Detailed Description:** In the VISION study we will treat patients with recurrent C. difficile infection (CDI) with FVT capsules and compare the treatment with Fecal Microbiota Transplantation (FMT) capsules. Patients will be randomised to receive either FMT or FTV capsules. Patients will be followed for one year to investigate the risk of a new recurrence of CDI. Patients and researchers involved in the treatment of the patients will be blinded to the treatment ### Conditions Module **Conditions:** - Clostridium Difficile Infections **Keywords:** - Fecal Virome Transplantation - Fecal Microbiota Transplantation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomised controlled trial comparing study treatment (Fecal Virome Transplantation) to standard treatment (Fecal Microbiota Transplantation) ##### Masking Info **Masking:** TRIPLE **Masking Description:** Fecal Virome Transplantation and Fecal Microbiota Transplantation capsules will look exactly the same. **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Treatment with Fecal Virome Transplantation capsules (one treatment) following standard treatment of antiobiotics (Vancomycin) **Intervention Names:** - Other: Fecal Virome Transplantation **Label:** Fecal Virome Transplantation **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Treatment with Fecal Microbiota Transplantation capsules (one treatment) following standard treatment of antiobiotics (Vancomycin) **Intervention Names:** - Other: Fecal microbiota Transplantation **Label:** Fecal Microbiota Transplantation **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Fecal Virome Transplantation **Description:** The primary steps of the production of fecal virome transplantation capsules is the same as when producing fecal microbiota transplantation capsules. Through an subsequent proces of filtering bacterial parts of the material are removed. The material, now called fecal virome transplanation material, has then been moved to capsules and stored in -80c untill use. **Name:** Fecal Virome Transplantation **Other Names:** - Sterile fecal filtrate **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Fecal Microbiota Transplantation **Description:** Donor fecal material is mixed with cryoprotectant and NaCl. Following processing the material transfered to capsules and is stored at -80c prior to use. **Name:** Fecal microbiota Transplantation **Other Names:** - FMT **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Microbiome changes in fecal virome and bacteriome following FMT and FVT treatment **Measure:** Microbiome changes **Time Frame:** Through samples prior to treatment, one and eight weeks following treatment #### Primary Outcomes **Description:** Number of patients in each group (FMT and FVT) with clinical resolution **Measure:** Clinical resolution (≤ 3 bowel movements) or diarrhoea with a negative stool sample for C. diffiicile) **Time Frame:** 8 weeks following treatment **Description:** Among patients eligible for treatment how many are interesting in participating in study and potentially receiving new virome treatment **Measure:** Participation **Time Frame:** 1 week after given information about the study #### Secondary Outcomes **Description:** Number of patients with diarrhoea and stool sample positive for C. diffiicile needing rescue-FMT **Measure:** Need for rescue Fecal Microbiota Transplantation (FMT) **Time Frame:** Up til eight weeks following treatment **Description:** Number of patients registered with recurrence of C. difficile infection (through a positive stool sample) in the first year following treatment **Measure:** Long term recurrence of C. difficile infection **Time Frame:** Up to one year following treatment **Description:** Registered side effects in the first 8 weeks following treatment **Measure:** Side effects **Time Frame:** Up to eight weeks following treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Recurrent C. difficile infection (first or second recurrence) * Understand danish Exclusion Criteria: * Serious food allergy (anaphylaxis) * Other pathogenic bacteria/virus in stool sample prior to inclusion * Inability to ingest capsules * Gastrointestinal perforation in the 180 days prior to inclusion * Previous treatment with FMT og rectal bacteriotherapy in the 180 days prior to inclusion * Short bowel syndrome * Pregnancy or planning of pregnancy * Participation in other clinical trial in the 30 days prior to inclusion * Stoma * Other condition where FMT is considered contraindicated **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Frederik Cold, MD, PhD **Phone:** 21157167 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Morten Helms, MD, PhD **Role:** CONTACT #### Locations **Location 1:** **City:** Hvidovre **Country:** Denmark **Facility:** Copenhagen University Hospital Hvidovre **Zip:** 2650 #### Overall Officials **Official 1:** **Affiliation:** Copenhagen University Hospital, Hvidovre **Name:** Frederik Cold, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000016908 - Term: Gram-Positive Bacterial Infections - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infection - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M6247 - Name: Clostridium Infections - Relevance: HIGH - As Found: Clostridium Difficile Infection - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M19252 - Name: Gram-Positive Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000003015 - Term: Clostridium Infections ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M17388 - Name: Vancomycin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-24