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{
"NCT_ID" : "NCT03395574",
"Brief_Title" : "Effect of Terlipressin on Cerebral Oxygen Saturation During Liver Transplantation",
"Official_title" : "Effect of Terlipressin on Cerebral Oxygen Saturation and Cerebral Blood Flow During Living Donor Liver Transplantation",
"Conditions" : ["Terlipressin Adverse Reaction", "Liver Transplantation"],
"Interventions" : ["Drug: Terlipressin", "Drug: Normal saline"],
"Location_Countries" : ["Egypt"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-01-25",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-11-25",
"Study_Completion_Date(Actual)" : "2018-11-25},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-12-25",
"First_Posted(Estimated)" : 2018-01-10"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-01-04",
"Last_Update_Posted(Estimated)" : 2018-12-24",
"Last_Verified" : 2018-12"
}
}} | #Study Description
Brief Summary
in our study the investigators aim to assess the effect of terlipressin on cerebral oxygenation monitored by cerebral oxymetry and cerebral blood flow measured by transcranial doppler.
Detailed Description
All patients will receive 6ml /kg/h Ringer acetate solution as a maintenance intraoperative fluid. If pulse pressure variations (PPV) is more than 15%, the patient will be considered as fluid responder and will receive a 250-ml bolus of albumin 5% to maintain PPV ≤15%. Blood transfusion will be given based on a hemoglobin level (\< 7 g/dl) in both (control group) and (terlipressin group). Other blood products will be transfused guided by lab result; Fresh frozen plasma will be given when INR \> 2 and platelets will be given when platelets \<30.000/mm3. The patients will be randomly allocated into 2 groups; Group T (Terlipressin group) and group S (Normal saline 0.9%).
For (terlipressin group) all patients will receive loading dose of terlipressin (1mg diluted with 50 ml of normal saline 0.9% solution over 30 min) and it will be maintained by continuous infusion at rate of 160 μg per hour (8 ml/h).
For (control group) all patient will receive 50 ml of normal saline 0.9% solution over 30 min and will be maintained continuous infusion at rate of 8 ml/h.
Drugs will be prepared by the nurse and the investigator will be blinded to the drug given.
#Intervention
- DRUG : Terlipressin
- drug will be given after 30 minutes of induction of anesthesia
- DRUG : Normal saline
- drug will be given after 30 minutes as placebo in control group | #Eligibility Criteria:
Inclusion Criteria:
* ASA II-IV undergoing orthotopic liver transplantation.
* Age above 18 years.
Exclusion Criteria:
* Age below 18 years.
* Patients on Terlipressin preoperative.
* Patients known allergic to Terlipressin.
* Portal vein thrombosis.
* Ischemic heart disease.
* Patients with T. bilirubin level above 7 mg/dl
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03395574 | 16,364 |
{
"NCT_ID" : "NCT00532831",
"Brief_Title" : "Characterisation of Asthma in Obese Subjects",
"Official_title" : "Characterisation of Asthma in Obese Subjects. Relationships Between Asthma and Obesity, Potential Mechanisms by Which Obesity Can Contribute to Asthma and Modify Treatment Responses",
"Conditions" : ["Asthma", "Obesity"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2005-08",
"Study_Completion_Date(Actual)" : "2010-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2007-09-18",
"First_Posted(Estimated)" : 2007-09-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2007-09-18",
"Last_Update_Posted(Estimated)" : 2012-02-22",
"Last_Verified" : 2012-02"
}
}} | #Study Description
Brief Summary
Our hypothesis:
Obese subjects with a physician's made diagnosis of asthma have a poorer asthma control than asthmatics with normal weight, less variability of peak expiratory flows (PEF) and bronchodilator response,increased induced sputum and systemic markers of inflammation and an increased prevalence of atopy.
Obese subjects have an increased incidence of co-morbidities such as rhinosinusitis, gastroesophageal reflux and sleep apnea syndrome.
This study aims to determine if, in comparison with asthmatics with a normal weight, paired for age and sex, obese subjects with asthma (all not using anti-inflammatory agents) show:
* A more uncontrolled asthma, increased health care use and poorer quality of life
* A reduced response to bronchodilators and diurnal variability of expiratory flows
* More marked airway inflammation and evidences of a systemic inflammatory response
* An increased prevalence of co-morbidities which can influence the report of respiratory symptoms or the severity of the disease, such as esophageal reflux symptoms, upper airway disease (rhinitis) and sleep apnea syndrome or other sleep disorder.
Detailed Description
Questionnaires on respiratory symptoms, health care use, quality of life, medication and asthma control will be administered and a thoracic examination performed.
Spirometry and bronchodilator response, blood tests for inflammatory parameters, pH measurements in exhaled air condensate and sputum induction will be performed. Peak expiratory flows will be measured and recorded on a diary card during one week.
On the second visit, measures of lung volumes and a methacholine challenge will be performed.
| #Eligibility Criteria:
Inclusion Criteria:
* aged 18 and over.
* in good health apart from asthma or obesity as determined by history and physical examination (no other condition which could influence the proposed tests).
* All will be non smokers or ex- smokers for more than six months with a smoking history of no more than 10 pack- years (i.e., one pack per day or its equivalent for 10 years.)
* Subjects will have a physician's made diagnosis of asthma and have received a bronchodilator prescription in the last year.
Exclusion Criteria:
* Use of asthma medications other than bronchodilators
* Subjects who are, in the opinion of the investigator, mentally or legally
* incapacitated thus preventing informed consent from being obtained.
* Subjects having a co-existing illness that precludes them from the trial.
* Pregnancy or lactation
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00532831 | 9,540 |
{
"NCT_ID" : "NCT00810615",
"Brief_Title" : "Treatment of Traumatic Brain Injury With Hyperbaric Oxygen Therapy",
"Official_title" : "Treatment of Moderate to Mild Cognitive Dysfunction Caused by Traumatic Brain Injury (TBI) With Hyperbaric Oxygen Therapy (HBOT)",
"Conditions" : ["Brain Injury, Chronic"],
"Interventions" : ["Other: Sham treatment", "Other: Hyperbaric oxygen @ 2.4 ATA"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2009-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-01",
"Study_Completion_Date(Actual)" : "2011-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-12-17",
"First_Submitted_that_Met_QC_Criteria" : 2017-11-22",
"First_Posted(Estimated)" : 2008-12-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-12-17",
"Last_Update_Posted(Estimated)" : 2018-08-13",
"Last_Verified" : 2017-11"
}
}} | #Study Description
Brief Summary
The purpose of this study is to determine if hyperbaric oxygen therapy (HBOT) improves the cognitive function of OIF/OEF individuals who have chronic mild to moderate traumatic brain injury (TBI). Cognitive function includes such things as thinking, remembering, recognition, concentration ability and perception. Traumatic brain injury is common with head injuries caused by blows to the head, nearby explosions, or concussion. Subjects will be assigned to an intervention or sham arm. Computer based cognitive tests will be used as outcome measures. Subjects are enrolled by invitation only.
Detailed Description
The Agency for Healthcare Research and Quality (AHRQ) did a comprehensive review of the literature focusing on TBI, stroke and cerebral palsy in Sep 2003. The study design and goals were based on the AHRQ recommendations for future hyperbaric oxygen for TBI research. This report stated, 'The most important gap in the evidence is a lack of a good quality time-series study or controlled trial of the effects of HBOT on cognition, memory, and functional status in patients with deficits due to mild and moderate chronic TBI.' The AHRQ Evidence Report further stated, 'Lack of agreement on the dosage of HBOT and the duration of treatment is an important barrier to conducting good-quality clinical studies...Good-quality dose-ranging studies of HBOT for brain injury can be done, based on the model used by pharmaceutical manufacturers and the FDA. It is likely that the dosage of HBOT needs to be individualized based on the patient's age, clinical condition, and other factors'. Although there are many anecdotal cases of TBI improvement with HBO, this case is backed with non-subjective data. The biological basis for why breathing 100% oxygen under pressurized conditions improves chronic neurological trauma remains unclear. There is some evidence that chronic TBI effects are related to the demyelization effect linked to the expression of a specific protease, calpain. This protease is also seen in demyelination delayed effects of carbon monoxide poisoning which is slowed by treatment with HBO. The 'idling neuron' theory advocated in neurological studies suggest that HBO may increase metabolic performance of chronically impaired neurons that were marginally capable, enabling restoration of full function leading in turn to increased integrative plasticity. HBO has been shown to increase recruitment of stem cells from the bone marrow, suggesting that HBO may increase the rate at which damaged neuronal tissue can be reconstituted de novo. The proposed research will treat 25 subjects using HBO (2.4 ATA breathing 100% oxygen) and 25 subjects in a sham HBO treatment (1.3 ATA breathing air). Computer-based cognitive testing and the Post-traumatic Stress Disorder Checklist for Military (PCL-M) will be administered pre- and post-HBOT as well as at intervals throughout the treatment. The cognitive test results and stem cell results will be analyzed within each subject at the various treatment points as well as cohort groups between each treatment leg. Cognitive test scores will also be compared to cognitive test population reference bases matched for gender and age. The Agency for Healthcare Research and Quality 2003 report also stated, 'If there is a 1 percent chance that the treatment works, a rational decision maker would try it-there is a potential gain and no potential loss. On the other hand, if there are proven harms, and their severity and frequency are well described, the probability that the treatment works would have to be higher before most people would try it'
#Intervention
- OTHER : Hyperbaric oxygen @ 2.4 ATA
- Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
- Other Names :
- hyperbaric oxygen, HBOT, HBO
- OTHER : Sham treatment
- Other Names :
- sham exposure; 1.3 ATA air | #Eligibility Criteria:
Inclusion Criteria:
* neurology diagnosis of mild to moderate TBI
* injury sustained during OIF/OEF military activities
* perception of cognitive dysfunction following their injury
* stable mental status for at least two months
* stable psychotropic medication history for at least one month
* ability to perform computer based cognitive testing (must be capable using a mouse and PDA pointer and readily view the displays)
* TBI occurrence since 7 October 2001
* ability to consent
Exclusion Criteria:
* medical conditions that prevent subject from participating in hyperbaric environments
* previous hyperbaric oxygen treatments since being diagnosed with TBI
* history of alcohol abuse
* history of drug abuse
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
| NCT00810615 | 191,232 |
{
"NCT_ID" : "NCT00511940",
"Brief_Title" : "Acamprosate in the Treatment of Binge-Eating Disorder",
"Conditions" : ["Binge Eating Disorder"],
"Interventions" : ["Drug: acamprosate", "Other: placebo"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2", "PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2007-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-01",
"Study_Completion_Date(Actual)" : "2011-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2007-08-03",
"First_Posted(Estimated)" : 2007-08-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2007-08-03",
"Last_Update_Posted(Estimated)" : 2011-06-22",
"Last_Verified" : 2011-06"
}
}} | #Study Description
Brief Summary
The purpose of this research study is to determine the efficacy (how well it works), tolerability and safety of acomprosate compared with placebo in patients with binge eating disorder.
#Intervention
- DRUG : acamprosate
- 999 mg/day - 2997 mg/day, oral
- Other Names :
- Campral
- OTHER : placebo
- oral, placebo | #Eligibility Criteria:
Inclusion Criteria:
* Subjects will meet the DSM-IV (1) criteria for a diagnosis of binge eating disorder (BED) for at least the last 6 months. The DSM-IV criteria are as follows:
* Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following: eating, in a discrete period of time (eg, within any two hour period), an amount of food that is definitely larger than most people would eat in a similar period of time under similar conditions; and a sense of lack of control over eating during the episode (eg, a feeling that one cannot stop eating or control what or how much one is eating).
* The binge eating episodes are associated with at least three of the following: eating much more rapidly than normal; eating until uncomfortably full; eating large amounts of food when not feeling physically hungry; eating alone because of being embarrassed by how much one is eating; feeling disgusted with oneself, depressed, or feeling very guilty after overeating.
* Marked distress regarding binge eating.
* The binge eating occurs, on average, at least two days a week for six months.
* The episodes of binge eating do not occur exclusively during the course of bulimia nervosa or anorexia nervosa.
* In addition, subjects will report at least 3 binge eating episodes per week for the last 6 months prior to randomization
* Weight > 85% of the midpoint of ideal body weight for their height. (According to the Metropolitan Height/Weight table.) The subject population is expected to include both normal weight and obese individuals (although the majority of subjects are expected to be overweight).
* Men or women, between the ages of 18 and 65. The subject population is expected to be predominantly made up of women.
Exclusion Criteria:
* Have concurrent symptoms of bulimia nervosa or anorexia nervosa, including weight loss to at least 15% below the Metropolitan Height/Weight tables.
* Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures. (All women of childbearing potential will have a negative pregnancy test before entering the study).
* Patients who are displaying clinically significant suicidality or homicidality.
* Patients who have received psychotherapy or behavioral therapy from a mental health professional as a part of previous treatment for BED for at least 3 months prior to randomization.
* A DSM-IV diagnosis of substance abuse or dependence (except nicotine abuse or dependence) within the 6 months prior to randomization.
* A lifetime DSM-IV history of psychosis, mania or hypomania, or dementia.
* History of any psychiatric and personality disorder (eg, schizotypal and borderline) which might interfere with a diagnostic assessment, treatment, or compliance.
* Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease which could interfere with diagnosis, treatment, or assessment of BED. Patients should be biochemically euthyroid to enter the study.
* History of seizures, including febrile seizures in childhood.
* Patients requiring treatment with any drug which might interact adversely with or obscure the action of the study medication.
* Clinically relevant abnormal laboratory results, specifically including hypokalemia.
* Patients who have received monoamine oxidase inhibitors, antipsychotics, lithium, or fluoxetine within four weeks prior to randomization.
* Patients who have received other psychoactive medications (other than hypnotics) within one week prior to randomization.
* Patients who have received investigational medications or depot neuroleptics within three months prior to randomization.
* Patients previously enrolled in this study or have previously been treated with acamprosate.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00511940 | 23,289 |
{
"NCT_ID" : "NCT03087552",
"Brief_Title" : "Mini-invasive Balloon Aortic Valvuloplasty",
"Official_title" : "Safety and Feasibility of Transradial Mini-invasive Balloon Aortic Valvuloplasty",
"Conditions" : ["Aortic Valve Stenosis"],
"Interventions" : ["Procedure: Transradial balloon aortic valvuloplasty"],
"Location_Countries" : ["Italy"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-03-11",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-01-07",
"Study_Completion_Date(Actual)" : "2021-04-20},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-03-11",
"First_Posted(Estimated)" : 2017-03-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-03-16",
"Last_Update_Posted(Estimated)" : 2021-04-29",
"Last_Verified" : 2021-04"
}
}} | #Study Description
Brief Summary
The spreading of transcatheter aortic valve implantation has paradoxically increased the spectrum of indications for balloon aortic valvuloplasty. Balloon aortic valvuloplasty is currently used as destination therapy for patients excluded from transcatheter aortic valve implantation, as bridge to transcatheter aortic valve implantation or to surgical aortic valve replacement, or as a stratification tool for selected high-risk patients who cannot be immediate candidates for transcatheter aortic valve implantation. Moreover, it has been recently showed that transcatheter aortic valve implantation without balloon aortic valvuloplasty is encumbered by an increased risk of cerebral embolization. However, balloon aortic valvuloplasty has a complication rate comparable to transcatheter aortic valve implantation, mainly related to access site or temporary pacemaker implantation. Thus, a transradial mini-invasive approach with rapid pacing through the 0,035 inch left ventricular support wire could be extremely appealing.
Detailed Description
Consecutive patients with severe aortic stenosis with indication to aortic balloon valvuloplasty will be enrolled. An ad hoc informed consent for the procedure will be obtained from all patients.
This is a prospective observational study. The Investigators will include patients where aortic ballloon valvuloplasty is attempted by radial access and without temporary pacemaker implantation. The aim is to register and monitor the effectiveness and safety of this approach. Details regarding management of radial access and pacing with 0.035 wire can be found in the references reported below. The primary endpoint will be the 30-day occurence of minor and major vascular complications according VARC 2 classification. The safety endpoint will be the absence of intra- or periprocedural major complications in transradial balloon aortic valvuloplasty, namely balloon entrapment or compartment syndrome requiring surgical intervention.
The feasibility endpoint will be a procedural success rate ≥90%. The efficacy endpoint will be a reduction of the mean invasive gradient \>30%. At baseline, Handgrip strength test will be performed and angiography of the instrumented arm will be performed at the beginning and at the end of the procedure. All patients will be prospectively followed-up for at least 30 days and all adverse events will be recorded. All patients will be assessed also for frailty according the clinical frailty scale (CFS). During the 30-day follow-up visit two independent blinded operators will evaluate radial artery patency by ultrasonography and perform handgrip strength test in in both arms in all patients.
#Intervention
- PROCEDURE : Transradial balloon aortic valvuloplasty
- Mini-invasive balloon aortic valvuloplasty consisting in transradial access
- PROCEDURE : Transradial balloon aortic valvuloplasty
- Rapid pacing using the 0.035-in. retrograde left ventricular support wire | #Eligibility Criteria:
Inclusion Criteria:
* severe symptomatic aortic stenosis requiring balloon aortic valvuloplasty
Exclusion Criteria:
* cardiogenic shock
* bilateral absence of radial pulse
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03087552 | 196,489 |
{
"NCT_ID" : "NCT04021758",
"Brief_Title" : "Peer to Peer Programs for Military Suicide Prevention",
"Official_title" : "Peer to Peer Programs for Military Suicide Prevention",
"Conditions" : ["Suicide"],
"Interventions" : ["Behavioral: Peer to peer program intervention"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-01-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-03-30",
"Study_Completion_Date(Actual)" : "2022-03-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-05-02",
"First_Posted(Estimated)" : 2019-07-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-07-15",
"Last_Update_Posted(Estimated)" : 2022-10-06",
"Last_Verified" : 2022-10"
}
}} | #Study Description
Brief Summary
In the present project the investigators propose to test the efficacy of a peer to peer program entitled Airman's Edge. The Airman's Edge program plans to utilize peer mentors that will be trained in specialized skills designed to impact suicide risk at multiple levels of the military community without creating 'extra duties' that increase workload and interfere with mission demands. Peer mentors will introduce primary prevention strategies to their units that target broad-based risk factors across the entire population (i.e., sleep disturbance, social support, meaning in life, firearm safety) with secondary prevention strategies that target individual-level risk factors (i.e., crisis response planning, firearm safety counseling). Peer mentors will complete a structured training process using existing curriculum and procedures that have been tested and refined within military groups. Peers mentors will also participate in monthly consultation calls with the investigative team to receive ongoing support, share resources and lessons learned, and address challenges and barriers to program implementation.
The purpose of the Airman's Edge peer to peer program is to influence indicators of suicide risk among military personnel at two levels, group and individual, consistent with the program's hybrid design that combines group-based education and individual-level suicide prevention skills training. The hypotheses are therefore designed to examine outcomes and effects at multiple levels of the community, which could inform subsequent implementation and translational efforts. The following aims are proposed:
Aim 1: To test the efficacy of a peer to peer program for the reduction of suicidal behavior among military personnel.
Aim 2: To identify moderators and mediators of the peer to peer program's effects on suicidal behavior.
Detailed Description
Suicides among military personnel doubled from 2001 to 2015 and have remained elevated. Although new treatments and interventions have been shown to reduce the occurrence of suicidal behavior, they are predominantly available only in mental health clinics. Data indicates that the large majority of military personnel who die by suicide do not access mental healthcare services in the months preceding their deaths. New strategies that are based on these empirically-supported interventions but can be delivered outside the mental healthcare system, thereby reaching a larger proportion of the military community, are therefore needed. Peer to peer (P2P) support programs hold promise as a method for achieving these aims, but the evidence supporting this intervention model remains limited or, in the case of suicide prevention, absent. In light of this gap, the proposed project aims to test the efficacy of a P2P program for the reduction of suicidal behaviors among military personnel. The proposed P2P program, called Airman's Edge, is a hybrid model that includes both group-based peer educator and individual-based peer support components; these P2P program models have demonstrated the strongest outcomes with respect to changing attitudes, perspectives, and behaviors, all of which are key targets for reducing suicidal thoughts and behaviors. The Airman's Edge program is comprised of several skills-based strategies that have been shown to directly reduce suicidal thoughts and behaviors (i.e., sleep habits, firearm safety procedures, crisis response planning), and targets population-level contextual variables known to reduce suicide risk (i.e., purpose and meaning in life, social support). The mechanisms by which these strategies reduce suicidal behavior align with an empirically-supported conceptual model, the suicidal mode, which has guided recent advances in military suicide prevention. The delivery platform for the skills-based strategies employed in the Airman's Edge program have demonstrated very good acceptability and feasibility when used with military personnel.
#Intervention
- BEHAVIORAL : Peer to peer program intervention
- Peer to peer suicide prevention program aimed at reducing suicide in a military population.
- Other Names :
- Airman's Edge | #Eligibility Criteria:
Inclusion Criteria:
* 18 years or older; and
* able to understand and speak the English language.
Exclusion Criteria:
* an inability to understand and speak the English language and
* an inability to complete the informed consent process.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT04021758 | 126,131 |
{
"NCT_ID" : "NCT02014324",
"Brief_Title" : "Single Scope Staging of Lung Cancer With Endosonography",
"Official_title" : "Complete Endosonographic Staging of Lung Cancer: a Systematic Single Scope Approach",
"Conditions" : ["Non Small Cell Lung Cancer (NSCLC)", "Indication Mediastinal Staging", "Complete Endosonography"],
"Interventions" : ["Procedure: Endosonography"],
"Location_Countries" : ["Belgium", "Netherlands"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-10",
"Study_Completion_Date(Actual)" : "2014-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-05-30",
"First_Posted(Estimated)" : 2013-12-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-12-12",
"Last_Update_Posted(Estimated)" : 2014-10-20",
"Last_Verified" : 2014-10"
}
}} | #Study Description
Brief Summary
Rationale: Lung cancer is the most commonly diagnosed cancer worldwide and is the most frequent cause of cancer death. Accurate staging is important because it directs treatment and prognosis. Mediastinal staging can be done by both EBUS-TBNA and EUS-FNA. These two techniques have a complementary diagnostic range and the combined procedure is suited for assessment of almost the entire mediastinum. In practice, when mediastinal tissue staging is indicated, endoscopists often perform either an EBUS or an EUS investigation (instead of the combined procedure). Second, frequently only one or two, by imaging suspected lymph node stations, are sampled (ie. targeted approach).
Objectives: main and secondary:
1. Complete endosonographic (combined endobronchial and esophageal) staging using a single EBUS scope improves locoregional staging (N2, N3, T4) versus EBUS staging alone.
2. Systematic mediastinal staging results in improved locoregional staging compared to PET-CT directed assessment of the mediastinum (ie targeted approach).
Study population: Patients with potentially operable and resectable NSCLC are eligible if there is an indication for mediastinal nodal sampling. Patients have an indication for EBUS-TBNA.
Intervention: Patients will undergo an EBUS investigation followed by EUS-B in the same session. During this single scope procedure, lymph nodes that are suspected on prior CT-PET imaging and on subsequent ultrasound are sampled.
Main study endpoint: The main study parameter is the sensitivity for locoregional disease (N2, N3, T4 disease) of complete endosonographic staging (by EBUS-TBNA and EUS-B-FNA) in comparison with EBUS staging alone.
#Intervention
- PROCEDURE : Endosonography
- Complete endosonographic mediastinal staging is performed in 2 steps:
1. Systematic EBUS (airways)
2. Systematic EUS-B (esophagus)
- Other Names :
- EBUS, EUS-B | #Eligibility Criteria:
Inclusion Criteria:
* (Suspected) NSCLC;
* Indication for mediastinal nodal assessment;
* Suspected mediastinal lymph nodes within reach of EBUS;
* Age >= 18 years;
* Clinically fit to undergo surgical resection of the lung tumor;
* Provision of a written informed consent;
Exclusion Criteria:
* Mediastinal re-staging after neo-adjuvant treatment;
* Indication for EUS other than mediastinal staging, eg a for malignancy
* suspected left adrenal;
* Active malignancy with a life expectancy of less than two years;
* Former therapy for lung cancer (chemotherapy, radiotherapy or surgery);
* Technical contraindication for EBUS or EUS (eg, esophagus stenosis);
* Pregnancy;
* Inability to consent;
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02014324 | 68,385 |
{
"NCT_ID" : "NCT06191211",
"Brief_Title" : "Can Doctors Reduce COVID-19 Misinformation and Increase Vaccine Uptake in Ghana? A Cluster-randomised Controlled Trial",
"Official_title" : "Can Routine Consultations be Used to Reduce COVID-19 Misinformation and Increase Vaccine Uptake? An Experimental Study in Ghana",
"Conditions" : ["COVID-19"],
"Interventions" : ["Behavioral: Facility engagement", "Behavioral: Motivational Interviewing, AIMS"],
"Location_Countries" : ["Ghana"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "HEALTH_SERVICES_RESEARCH",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2024-02-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-05-15",
"Study_Completion_Date(Actual)" : "2024-05-15},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-12-29",
"First_Posted(Estimated)" : 2024-01-05"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2024-01-03",
"Last_Update_Posted(Estimated)" : 2024-08-13",
"Last_Verified" : 2024-08"
}
}} | #Study Description
Brief Summary
Whilst Ghana was one of the first countries to start vaccinating its population against COVID-19, less than 30% of the population was fully vaccinated at the end of 2022. To improve COVID-19 vaccine uptake, the government has so far relied on two strategies: sensitization in communities and specific national vaccination days. Against the backdrop of strict budget constraints and the return to normalcy in health-seeking behaviours, the investigators aim to test the effectiveness of leveraging interactions of patients with the healthcare system to reduce misinformation and increase vaccination. The investigators collaborate with the Ghana Health Service to offer vaccination as a default option during routine consultations. To dispel information and encourage vaccination uptake effectively, the investigators test two interventions designed to encourage and equip front-line providers with skills to discuss COVID-19 vaccination with patients. The study evaluates the effect of the two interventions in a cluster-randomised trial where the investigators allocate 120 facilities to one of three groups: a control group where providers are not asked to offer COVID-19 vaccines; a light engagement group, where providers receive information about COVID-19 and vaccines and a light-touch vaccine monitoring device is deployed in their facility, and a communication skills building group, where providers receive all the elements of the light intervention, plus training in motivational engagement techniques to encourage vaccination. The primary outcome will be vaccination uptake and intentions. The study will also evaluate the impact of the intervention on patients' knowledge, beliefs and satisfaction. The investigators will track the effectiveness of the training on providers as well as the extent to which they apply their training to actual practice. Results will contribute to a nascent evidence base on potential ways to encourage adult vaccination during routine consultations.
#Intervention
- BEHAVIORAL : Motivational Interviewing, AIMS
- Motivational interviewing (MI). MI is an approach to patient engagement which promotes a collaborative conversation style for strengthening a person's own motivation and commitment to change. With MI, the doctor facilitates patient exploration of potential reasons for behaviour change in the context of what is important to the patient, rather than the physician directly telling the patient what to do. MI has been found more effective than other approaches to patient engagement and health behaviour change and can be effectively taught to primary care providers.
- BEHAVIORAL : Facility engagement
- A letter to the facility from the local health officials; a meeting with the facility manager and health staff to formally announce that we would like providers to encourage COVID-19 vaccinations; deploying a tracking sheet for vaccinations. | #Eligibility Criteria:
Inclusion Criteria:
* Mentally sound adults who are aged 16 years and above
* Presenting at the health centre on the day of surveys
Exclusion Criteria:
* Received a COVID-19 vaccination dose within last 6 months, or received 2 or more doses
* Have fever, chills, or are experiencing severe pain
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
| NCT06191211 | 210,677 |
{
"NCT_ID" : "NCT02529527",
"Brief_Title" : "Web-based Preconception Health Education Tool",
"Official_title" : "MyFamilyPlan: A Patient-Centered Web-based Preconception Health Education Tool",
"Conditions" : ["Reproductive Health"],
"Interventions" : ["Behavioral: MyFamilyPlan"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "HEALTH_SERVICES_RESEARCH",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-06-01",
"Study_Completion_Date(Actual)" : "2016-06-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-05-19",
"First_Posted(Estimated)" : 2015-08-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-08-18",
"Last_Update_Posted(Estimated)" : 2017-04-10",
"Last_Verified" : 2017-04"
}
}} | #Study Description
Brief Summary
Strong evidence supports that preconception care, or care to optimize a woman's health health prior to pregnancy, can improve birth outcomes. Preconception health counseling covers a broad range of topics, including: desire for pregnancy, obstetric history, nutrition, vaccinations, sexual health, chronic disease, substance abuse, mental health and contraception. Despite calls from public health organizations and experts in the field for universal access to preconception care, most US women do not receive any health counseling to prepare for pregnancy. Given that approximately half of US pregnancies are unintended, it is critical that routine primary care serve as a venue for the provision of this important service. From a patient's perspective, improving preconception health involves many health behavior changes. As such, patient engagement and education regarding preconception health must be a primary focus. Several preconception health promotion tools have been developed for patients to date; few are truly patient-centered and even fewer have been rigorously evaluated.
This study presents MyFamilyPlan - a novel, web-based, patient centered preconception health education tool designed for women of reproductive age receiving primary care. MyFamilyPlan is truly innovative in two key ways:
* MyFamilyPlan is a web-based preconception health self-assessment. This will allow for the employment of skip logic to individualize the questionnaire and subsequent health recommendations for each patient.
* Recognizing that preconception care is relevant to all women 'at risk' of pregnancy, MyFamilyPlan has been designed for utilization in a primary care setting.
This preconception health education tool will be tested using a randomized controlled design. This study will measure whether or not exposure to MyFamilyPlan promotes the discussion of preconception health issues in primary care encounters (primary outcome). It will also evaluate whether the intervention affects participant self-efficacy in planning a healthy pregnancy, and relevant health behaviors (secondary outcome). The study proposed here will improve the quality of evidence for preconception health education tools. Should it demonstrate effectiveness, it will also result in a new tool that could be made more widely available to promote preconception health.
#Intervention
- BEHAVIORAL : MyFamilyPlan
- Web-based preconception health education tool (interactive self-assessment) - to be completed by patient | #Eligibility Criteria:
Inclusion Criteria:
* 18 <= age <= 45 years
* English-speaking
* Non-pregnant
* Capable of pregnancy (i.e., no previous hysterectomy or sterilization procedure)
* Scheduled primary care visit in health system in the upcoming 7 <= age <= 10 days
* Active email address
Exclusion Criteria;
* Currently pregnant
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT02529527 | 23,049 |
{
"NCT_ID" : "NCT05875701",
"Brief_Title" : "Phase 3 Study of Novavax Vaccine(s) as Booster Dose After mRNA Vaccines",
"Official_title" : "A Phase 3 Study to Evaluate the Immunogenicity and Safety of Novavax COVID-19 Vaccine(s) as Second or Subsequent Booster After mRNA Vaccines in Individuals 18 to 49 Years of Age",
"Conditions" : ["COVID-19"],
"Interventions" : ["Biological: SARS-CoV-2 rS antigen/Matrix-M Adjuvant", "Biological: NVX-CoV2373"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2023-03-28",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-11-11",
"Study_Completion_Date(Actual)" : "2023-11-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-05-16",
"First_Posted(Estimated)" : 2023-05-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-05-16",
"Last_Update_Posted(Estimated)" : 2024-03-05",
"Last_Verified" : 2024-03"
}
}} | #Study Description
Brief Summary
This is an open-label Phase 3 study evaluating the immunogenicity and safety of Novavax vaccine(s) with Matrix-M™ adjuvant (ancestral strain NVX-CoV2373 and an alternative strain and/or multivalent Novavax vaccine) as booster doses following a series of primary and booster doses of authorized/approved mRNA vaccines followed by a single booster dose of NVX-CoV2373 in the Novavax 2019nCoV-307 study (NCT05463068).
Detailed Description
This Phase 3 study investigates the immunogenicity and safety of Novavax's NVX-CoV2373 vaccine (including its Matrix-M adjuvant) as an additional booster dose for adults aged 18 to 49. Participants must have already received both their primary mRNA vaccine series and at least one booster dose of the same type. All participants were previously enrolled in Study 307 (NCT05463068), where they received either their primary mRNA vaccines with or without an additional mRNA booster, followed by a single NVX-CoV2373 booster.
The study involves up to 300 volunteers who will receive a single dose of the Novavax vaccine (5 micrograms of recombinant spike protein antigen and 50 micrograms of Matrix-M adjuvant) on Day 1.
#Intervention
- BIOLOGICAL : NVX-CoV2373
- 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
- Other Names :
- SARS-CoV-2 rS/Matrix-M Adjuvant
- BIOLOGICAL : SARS-CoV-2 rS antigen/Matrix-M Adjuvant
- 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS antigen+ 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
- Other Names :
- Updated Novavax COVID-19 vaccine | #Eligibility Criteria:
Inclusion Criteria:
To be included in this study, each individual must satisfy all the following criteria:
* Adults 18 <= age <= 49 (inclusive) of age at the time of vaccination in Study 307 who received two or three doses of mRNA prior to enrollment in Study 307, then one dose of ancestral strain NVX-CoV2373 in Study 307.
* Willing and able to give informed consent prior to study enrollment and to comply with study procedures.
* Participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of study (EOS) visit OR agree to consistently use a medically acceptable method of contraception from at least 28 days prior to enrollment and through the EOS visit.
* Is medically stable, as determined by the investigator (based on review of health status, vital signs [to include body temperature], medical history, and physical examination [to include body weight]). Vital signs must be within medically acceptable ranges prior to the study vaccination.
* Agree to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study. Note: For participants who become hospitalized with COVID-19, participation in investigational treatment studies is permitted.
* Documented receipt of COVID-19 vaccines. The most recent dose of NVX-CoV2373 must have been administered at least 180 days prior to vaccination in this study.
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded from the study.
* Received any additional COVID-19 vaccine booster after the Day 1 dose of NVX-CoV2373 administered during participation in Study 307.
* History of laboratory-confirmed (by polymerase chain reaction [PCR] or rapid antigen test) COVID-19 infection <= 4 months prior to Day 1.
* Current participation in research involving receipt of an investigational product (drug/biologic/device).
* Any known allergies or history of anaphylaxis to the active substance or any of the other ingredients contained in the investigational product.
* Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) or therapy that causes clinically significant immunosuppression.
* Received any vaccine <= 90 days prior to study vaccination, except for influenza vaccine which may be received > 4 days prior to study vaccine, or rabies vaccine, which may be received at any time if medically indicated.
* Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to study vaccination, except for rabies immunoglobulin which may be given if medically indicated.
* Active cancer (malignancy) on chemotherapy that is judged to cause significant immunocompromise within 1 year prior to first study vaccination (with the exception of malignancy cured via excision, at the discretion of the investigator).
* Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the EOS visit.
* Suspected or known history of alcohol abuse or drug addiction within 3 months prior to the study vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance.
* Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the trial vaccine or interpretation of study results (including neurologic or psychiatric conditions likely to impair the quality of safety reporting).
* Study team member or immediate family member of any study team member (inclusive of Sponsor, clinical research organization [CRO], and study site personnel involved in the conduct or planning of the study).
* Participants with a history of myocarditis or pericarditis.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 49 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT05875701 | 59,101 |
{
"NCT_ID" : "NCT00001095",
"Brief_Title" : "A Study of Three Anti-HIV Drug Combinations in Patients Who Have Taken Amprenavir",
"Official_title" : "A Phase II Study of 1) Amprenavir (141W94/VX478) Plus 3TC Plus ZDV (or d4T) or 2) IDV Plus NVP Plus 3TC Plus d4T in Subjects Previously Treated With Amprenavir and 3) Other Treatment Regimens (Observational ARM) in Subjects Previously Treated With Amprenavir",
"Conditions" : ["HIV Infections"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
},
"Recruitment_Information" : {
"Study_Completion_Date(Actual)" : "1999-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 1999-11-02",
"First_Posted(Estimated)" : 2001-08-31"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2001-08-30",
"Last_Update_Posted(Estimated)" : 2021-11-04",
"Last_Verified" : 2021-10"
}
}} | #Study Description
Brief Summary
To determine the proportion of patients treated with amprenavir, zidovudine (ZDV), stavudine (D4T) and lamivudine (3TC) whose HIV-1 RNA level remains below the level of detection during 96 weeks of therapy. To determine the proportion of patients treated with indinavir (IDV), nevirapine (NVP), 3TC, and d4T whose HIV-1 RNA level decreases and then remains below the level of detection, during the 96-week therapy period. To determine the viral effects, safety, tolerability, and pharmacokinetics of amprenavir in combination with zidovudine, stavudine, and lamivudine. \[AS PER AMENDMENT 2/27/98: To determine the proportion of patients with undetectable plasma HIV RNA, by treatment and baseline RNA cohort (either detectable or undetectable). To determine the durability of these regimens by estimating the distribution of time to loss of virologic suppression (or equivalently, time to virologic failure), by treatment and baseline RNA cohort.\] This study allows patients who have successfully participated in ACTG 347 or other trials involving amprenavir to continue treatment with amprenavir, ZDV, d4T, and 3TC. Additionally, this study provides patients whose HIV-1 RNA was not reduced to undetectable levels or who had a significant increase in plasma levels ('treatment failures') the opportunity to change to a potentially more active regimen that includes indinavir, nevirapine, lamivudine, and stavudine.
Detailed Description
This study allows patients who have successfully participated in ACTG 347 or other trials involving amprenavir to continue treatment with amprenavir, ZDV, d4T, and 3TC. Additionally, this study provides patients whose HIV-1 RNA was not reduced to undetectable levels or who had a significant increase in plasma levels ('treatment failures') the opportunity to change to a potentially more active regimen that includes indinavir, nevirapine, lamivudine, and stavudine.
Patients with HIV RNA less than 500 copies/ml on a regimen containing amprenavir are treated on Arm A; those with greater than or equal to 500 copies while on or intolerant to a regimen containing amprenavir are treated on Arm B.
Arm A: Amprenavir + ZDV + d4T + 3TC. Arm B: IND + NVP + 3TC + d4T. Patients enrolled in Arm A who fail therapy may roll over to Arm B. Patients in Arm B who fail therapy discontinue study medications and seek best available treatment.
\[AS PER AMENDMENT 2/27/98: Patients with HIV RNA less than 500 copies/ml currently on triple therapy with amprenavir + 3TC + ZDV (or d4T if ZDV-intolerant) are treated on ARM A. Patients with HIV RNA greater than or equal to 500 copies/ml, who have been intolerant to a regimen containing amprenavir or who were previously enrolled on ACTG 347 who elected to receive a treatment regimen other than amprenavir + ZDV (or d4T) + 3TC or IDV + NVP + 3TC + d4T or other regimens are assigned to Arm C.
Arm A: Amprenavir + ZDV\* plus 3TC. Arm B: IDV\*\* + NVP + 3TC + d4T\*\*\*. Arm C: Observation only. Patients are followed for the duration of the study.
* Patients intolerant of ZDV may elect to receive d4T. \*\*Patients intolerant of IDV may take study-provided nelfinavir. \*\*\*Patients who switched to open-label IDV/NVP/3TC/d4T prior to enrollment on this study and who were intolerant to any of the study medications may enroll into Arm B with appropriate substitution of the intolerant study drug(s).
Patients initially assigned to Arm A who are intolerant of amprenavir or who fail therapy have the option of receiving Arm B therapy. Patients initially assigned to Arm B who are intolerant of any of the assigned study drugs may make an appropriate antiretroviral substitution (with approval of the protocol chair).\]
#Intervention
- DRUG : Indinavir sulfate
- DRUG : Amprenavir
- DRUG : Nevirapine
- DRUG : Lamivudine
- DRUG : Stavudine
- DRUG : Zidovudine | #Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Required:
* Chemoprophylaxis for Pneumocystis carinii pneumonia (for patients with a CD4+ cell count less than or equal to 200 cells/mm3.
Allowed:
* Topical and/or oral antifungal agents.
* Treatment, maintenance or chemoprophylaxis with approved agents for opportunistic infections.
* Antibiotics.
* Systemic corticosteroid use for 21 days or less.
* Recombinant erythropoietin (rEPO) and granulocyte-colony stimulating factor (G-CSF, filgrastim).
* Regularly prescribed medications such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives (not as a sole form of contraception), megestrol acetate, and testosterone.
* Alternative therapies such as vitamins, acupuncture, and visualization techniques.
[AS PER AMENDMENT 2/27/98:
* Current use of triple therapy with amprenavir/3TC/ZDV (or d4T) for Arm A patients.
* Current use of quadruple therapy with IDV/NVP/3TC/d4T for Arm B patients.]
Patients must have:
* HIV-positive status.
* Successful response to treatment in ACTG 347 as measured by HIV RNA less than 500 copies/ml (Arm A) OR unsuccessful response to treatment in ACTG 347 or another regimen containing amprenavir OR an increase in plasma HIV RNA above the nadir value to greater than 5,000 copies/ml or by at least one log10 at any time (Arm B) OR intolerance to a regimen containing amprenavir.
* Consent for patients less than 18 years.
[AS PER AMENDMENT 2/27/98:
Arm A patients must have:
* HIV RNA less than 500 copies/ml on at least one occasion within 60 days of entry while previously enrolled in ACTG 347 and in one of the following categories: currently receiving amprenavir/3TC/ZDV (or d4T) or randomized to monotherapy arm of ACTG 347 and received open-label amprenavir/3TC/ZDV (or d4T).
Arm B patients must have:
* Failed prior amprenavir therapy, whether on ACTG 347 or not, i.e., HIV RNA greater than or equal to 500 copies/ml after at least 16 weeks of amprenavir and confirmed within 1 <= age <= 6 weeks OR treatment failure that mandated early permanent discontinuation of randomized ACTG 347 study drugs and defined as HIV RNA of at least one log 10 above the nadir (to at least 5,000 copies/ml) or HIV RNA level above the baseline value before 16 weeks of amprenavir and confirmed within 1 <= age <= 6 weeks.
* Initially randomized to triple therapy arm of ACTG 347 with two plasma HIV-1 RNA values of at least 500 copies/ml taken within 60 days prior to study entry and at least 1 <= age <= 6 weeks apart or initially receive open-label amprenavir/3TC/ZDV (or d4T) and with two HIV RNA levels of at least 500 copies/ml, regardless of duration of treatment with amprenavir/3TC/ZDV (or d4T).
* Documented intolerance to any of the reverse transcriptase inhibitors or attempted nevirapine therapy allowed. Arm C patients must have:
* Previously enrolled on ACTG 347 and elected to receive a treatment regimen other than amprenavir/3TC/ZDV (or d4T) or IDV/NVP/3TC/d4T.]
Prior Medication: Required:
Amprenavir therapy [AS PER AMENDMENT 2/27/98:
* amprenavir therapy (Arm A and B patients only)].
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Arm A:
* Inability to tolerate amprenavir, ZDV, or 3TC.
Arm B:
* Inability to tolerate d4T, NVP, or 3TC.
* Active infection requiring acute treatment within 14 days prior to study entry.
* Malignancy that requires systemic therapy (patients with minimal Kaposi's sarcoma are not excluded provided they do not require systemic therapy).
[AS PER AMENDMENT 2/27/98:
Patients with the following conditions or symptoms are excluded: Arm A:
* Any detection of plasma HIV RNA greater than 500 copies/ml after subject has switched to triple therapy for at least 16 weeks.
* Inability to tolerate amprenavir, ZDV (or d4T), or 3TC.
* Malignancy that requires systemic therapy (minimal Kaposi's sarcoma allowed provided systemic therapy is not required) Arm A and B patients only.]
Concurrent Medication:
Excluded:
* Non-protocol-specified antiretroviral agents.
* Immunomodulators that affect immunologic or virologic indices, such as systemic corticosteroids (more than 21 days), thalidomide, or cytokines.
* Concomitant use of rifabutin and/or rifampin.
* Investigational drugs without specific approval.
* Systemic cytotoxic chemotherapy.
* Oral astemizole, carbamazepine, dexamethasone, ketoconazole, itraconazole, phenobarbital, phenytoin, terfenadine, cisapride, triazolam, terfenadine, astemizole, and midazolam.
Prior Medication:
[AS PER AMENDMENT 2/27/98: Excluded:
* Prior protease inhibitor therapy except amprenavir (Arm A patients).
* Prior protease inhibitor therapy except amprenavir and IDV (Arm B patients).
Excluded within 14 days prior to entry:
* Investigational drugs or immunomodulators (except amprenavir) without specific consent of protocol chair(s) (Arm A patients).
* Immunomodulators that affect immunologic or virologic indices, such as systemic corticosteroids, thalidomide or cytokines, unless approved by protocol chair(s) (Arm B patients).
* Oral astemizole, carbamazepine, dexamethasone, ketoconazole, itraconazole, phenobarbital, phenytoin, terfenadine, cisapride, triazolam, midazolam, ergot alkaloids, or drugs containing derivatives of ergot alkaloids.]
Sex :
ALL
Ages :
- Minimum Age : 13 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT00001095 | 121,172 |
{
"NCT_ID" : "NCT00214500",
"Brief_Title" : "A Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease",
"Official_title" : "A Phase 2, Open-Label, Multicenter, 12-Week Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AT1001 in Patients With Fabry Disease",
"Conditions" : ["Fabry Disease"],
"Interventions" : ["Drug: migalastat HCl"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2006-01-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-01-29",
"Study_Completion_Date(Actual)" : "2008-01-29},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-09-13",
"First_Submitted_that_Met_QC_Criteria" : 2018-08-10",
"First_Posted(Estimated)" : 2005-09-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-09-14",
"Last_Update_Posted(Estimated)" : 2018-10-30",
"Last_Verified" : 2018-10"
}
}} | #Study Description
Brief Summary
Study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease.
Detailed Description
This was a Phase 2, open-label study in male participants with Fabry disease. All participants who met initial eligibility criteria underwent a 28-day screening period, including a 14-day run-in with migalastat (150 milligrams \[mg\] migalastat once a day \[QD\] from Days -28 to -15) to assess eligibility for entering the treatment period of the study. Participants who entered the treatment period were required to have α-galactosidase A (α-Gal A) activity responsive to migalastat.
Fifteen participants received at least 1 dose of study drug, however, 6 of these participants did not demonstrate α-Gal A activity responsive to migalastat and were thus screen failures (these participants are hereafter referred to as 'dosed screen failures') due to not meeting all inclusion criteria for treatment. Therefore, 9 participants were enrolled into the treatment period (these participants are hereafter referred to as 'eligible-enrolled').
Eligible-enrolled participants (those who satisfied the criteria for inclusion in the study) received escalating doses of migalastat twice a day (BID) for 6 weeks (Days 1 to 42), followed by 6 weeks at 1 dose level BID (Days 43 to 84) during the treatment period. Participants could then opt to participate in the extension period. The study consisted of 2 optional extension periods, the first through Week 48 and the second through Week 96. For participants who did not continue into the optional treatment extension, the study included a 2-week follow-up period.
#Intervention
- DRUG : migalastat HCl
- Other Names :
- AT1001, Galafold, migalastat | #Eligibility Criteria:
Inclusion Criteria:
* Males between 18 and 55 years (inclusive)
* Hemizygous for Fabry disease
* Had a confirmed diagnosis of Fabry disease with a documented missense gene mutation (individual or familial)
* Had enhanceable enzyme activity
* In the judgment of the investigator, were either able to safely suspend ERT throughout the study, or be ERT naive
* Agreed to be sexually abstinent or use a condom with spermicide when engaging in sexual activity during the course of the study and for a period of 30 days following completion of the study
* Were willing and able to sign an informed consent form
Exclusion Criteria:
* History of significant disease other than Fabry disease (for example, end-stage renal disease; Class III or IV heart disease [per the New York Heart Association classification]; current diagnosis of cancer, except for basal cell carcinoma of the skin; diabetes [unless hemoglobin A1c <=8]; or neurological disease that would have impaired the participant's ability to participate in the study)
* History of organ transplant
* Serum creatinine >2 mg per deciliter on Day -2
* Screening 12-lead electrocardiogram demonstrating corrected QT interval >450 milliseconds prior to dosing
* Taking a medication prohibited by the protocol: Fabrazyme® (agalsidase beta), Replagal™ (agalsidase alfa), Glyset® (miglitol), Zavesca® (miglustat), or any experimental therapy for any indication
* Participated in a previous clinical trial in the last 30 days
* Any other condition, which, in the opinion of the investigator, would jeopardize the safety of the participant or impact the validity of the study results
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
| NCT00214500 | 166,319 |
{
"NCT_ID" : "NCT00750451",
"Brief_Title" : "Low Molecular Weight Heparin in Recurrent Implantation Failure",
"Official_title" : "Empirical Low Molecular Weight Heparin Administration in the Luteal Phase in Patients With Recurrent Implantation Failures: a Randomized Open Labeled Trial",
"Conditions" : ["Infertility", "Fertilization in Vitro", "Recurrent Implantation Failure"],
"Interventions" : ["Drug: crinone 8% gel", "Drug: low molecular weight heparin (enoxaparine sodium)"],
"Location_Countries" : ["Turkey"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2006-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-05",
"Study_Completion_Date(Actual)" : "2008-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-09-09",
"First_Posted(Estimated)" : 2008-09-10"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-09-09",
"Last_Update_Posted(Estimated)" : 2009-03-20",
"Last_Verified" : 2009-03"
}
}} | #Study Description
Brief Summary
Recurrent implantation failure is the failure to achieve a pregnancy after multiple attempts with in vitro fertilization treatment. The reason is usually obscure. Many empirical treatments have been offered without substantial evaluation. Heparin is thought to play a role in the embryo implantation process beyond its anticoagulation effects. The proposed study aims to assess the effectiveness and safety of empirical administration of low molecular weight heparin in patients undergoing a new IVF treatment cycle after multiple failed attempts.
#Intervention
- DRUG : low molecular weight heparin (enoxaparine sodium)
- 1 mg/kg/day subcutaneously in the luteal phase after IVF treatment
- DRUG : crinone 8% gel
- routine luteal phase support with progesterone gel | #Eligibility Criteria:
Inclusion Criteria:
* History of at least two previously failed fresh embryo transfer cycles
* All previously failed cycles to be performed in the American Hospital of Istanbul
* Female age <= 38 years
* Fresh ejaculate sperms to be used for ICSI
* No hormonal, coagulation, or immunological disorders detected
* Normal uterine cavity, as assessed by diagnostic office hysteroscopy or saline infusion sonography
* Normal female and male peripheral karyotype
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 38 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
| NCT00750451 | 252,377 |
{
"NCT_ID" : "NCT05784233",
"Brief_Title" : "Relevance and Salience During Attention Task",
"Official_title" : "Relevance and Salience During Attention Task",
"Conditions" : ["Healthy"],
"Interventions" : ["Behavioral: Relevance (Likelihood Salient Item is Target)"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-09-15",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-10-28",
"Study_Completion_Date(Actual)" : "2022-10-28},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-03-13",
"First_Posted(Estimated)" : 2023-03-24"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-03-13",
"Last_Update_Posted(Estimated)" : 2024-02-02",
"Last_Verified" : 2024-02"
}
}} | #Study Description
Brief Summary
In this line of research, the researchers are examining the influence of relevance of a salient item on task performance, depending on overall task set.
Detailed Description
When finding a target item during visual search (looking for a pencil), a salient item can capture attention (your phone flashing from a message). Typical attention studies only examine salient items when shown as distractor during search, to ensure any attention to the items are driven by salience alone. However, the impact of salience may interact with the relevance of the item for the search task (e.g. how likely the salient item is to be the target). Here, the researchers investigate these interactions in a basic science study when participants perform an easy task or a difficult search task.
#Intervention
- BEHAVIORAL : Relevance (Likelihood Salient Item is Target)
- The proportion of trials, when the salient visual item is present in the array, where the salient item is the search target. | #Eligibility Criteria:
Inclusion Criteria:
* normal or corrected to normal visual acuity, normal color vision
Exclusion Criteria:
*
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT05784233 | 239,833 |
{
"NCT_ID" : "NCT04886557",
"Brief_Title" : "Retrospective Image Analysis of Degenerative Lumbar Disease Patients",
"Official_title" : "Retrospective Image Analysis of Degenerative Lumbar Disease Patients",
"Conditions" : ["Lumbar Spondylolisthesis"],
"Interventions" : ["Procedure: L4-L5 decompression and dynamic instrumentation"],
"Location_Countries" : ["Taiwan"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2007-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-12",
"Study_Completion_Date(Actual)" : "2018-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-05-12",
"First_Posted(Estimated)" : 2021-05-14"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-05-12",
"Last_Update_Posted(Estimated)" : 2021-05-14",
"Last_Verified" : 2021-05"
}
}} | #Study Description
Brief Summary
The Dynesys dynamic stabilization (DDS) system is considered a motion-preserving device. However, studies addressing the change in the range of motion (ROM) are limited. Therefore, this study aimed to investigate the factors influencing ROM change at the index surgical level, supra-index level, and whole lumbar spine, in addition to the association between ROM preservation and the incidence of screw-loosening.
Detailed Description
Decompression with instrumented fusion is an effective surgical intervention for lumbar degenerative spondylolisthesis with spinal stenosis. However, the range of motion (ROM) decreased at the index surgical level may lead to an increased ROM at the non-surgical level, increase biomechanical stress at the transitional adjacent segment, and lead to adjacent segment degeneration (ASD) .
The Dynesys dynamic stabilization (DDS) system is a pedicle screw-based, motion-preserving, and non-fusion stabilization developed as an alternative to the rigid instrumented fusion for degenerative spondylolisthesis. The aim of the DDS is to maintain segmental motion at index levels and to reduce the incidence of ASD. However, the actual impact of ROM has remained elusive. Prior studies have reported an average ROM loss of 1.1º to 17.3º 7 at index surgical level at an average of 24 months follow-up.
The change of ROM at index surgical, supra-index, and whole lumbar spine following DDS remains unclear. This study aims to investigate the factors influencing the ROM change at index surgical level, supra-index level, and whole lumbar spine, and the association between ROM preservation and the incidence of screw-loosening.
#Intervention
- PROCEDURE : L4-L5 decompression and dynamic instrumentation
- All surgeries were performed by a senior surgeon using a traditional midline approach. Stability-preserving lumbar decompression with facet joint undercutting was performed to preserve the facet joints as much as possible. In cases of severe stenosis, a bilateral partial facetectomy (\< 25%) was performed for adequate decompression. Posterior tension of the supra- and inter-spinous ligaments was preserved at the most cranial level. Patients were encouraged to ambulate after drain removal and wear a soft lumbar orthosis for at least 3 months after the operation. | #Eligibility Criteria:
Inclusion Criteria:
* Adult patients
* Diagnosed with degenerative spondylolisthesis over L4-L5
* Received DDS
* Received a minimum of 2-year follow-up were reviewed.
Exclusion Criteria:
* presence of degenerative scoliosis or spinal deformity,
* prior spine surgery,
* lost to follow-up, or
* failure to complete the questionnaires or radiographic examinations.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04886557 | 226,507 |
{
"NCT_ID" : "NCT02267070",
"Brief_Title" : "Enhancing Cognitive Training Through Exercise After a First Schizophrenia Episode",
"Official_title" : "Enhancing Cognitive Training Through Exercise After a First Schizophrenia Episode",
"Conditions" : ["Schizophrenia", "Schizophreniform Disorder", "Schizoaffective Disorder"],
"Interventions" : ["Behavioral: Case management and supportive psychotherapy", "Behavioral: Family psychoeducation", "Behavioral: Aerobic exercise", "Behavioral: Cognitive training"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-11",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-11",
"Study_Completion_Date(Actual)" : "2017-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-11-19",
"First_Posted(Estimated)" : 2014-10-17"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-10-16",
"Last_Update_Posted(Estimated)" : 2017-12-07",
"Last_Verified" : 2017-12"
}
}} | #Study Description
Brief Summary
This is a randomized controlled 6-month trial of the efficacy of a novel intervention combining neuroplasticity-based cognitive training with aerobic exercise, compared to the same systematic cognitive training alone. The primary treatment targets are overall cognitive deficit level and independent living skills. The investigators hypothesize that combining neuroplasticity-based computerized cognitive training and neurotrophin-enhancing physical exercise will produce large cognitive and functional improvements, even relative to cognitive training alone. Adding aerobic exercise to a cognitive training program will have the additional benefit of helping to ameliorate medication side effects, reduce the risk for developing metabolic syndrome, and help to prevent the deterioration in physical health that usually follows the onset of schizophrenia and its pharmacologic treatment. The investigators target the period shortly after a first episode of schizophrenia to maximize the generalization of cognitive improvement to functional outcome, before chronic disability is established.
Detailed Description
The Cognitive Training and Exercise intervention involves 24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, four 30 minute sessions per week. The first 12 weeks involves neurocognitive training, using auditory training exercises from Posit Science Brain HQ. The second 12 weeks involves social cognitive training, using the Posit Science SocialVille modules. Aerobic exercise occurs as two 30-minute sessions at the clinic and two at home weekly. Intensity of aerobic exercise is tailored to maintain an individualized target heart rate zone and is monitored by a heart rate recorder. A weekly one-hour Bridging Skills Group with other members of the treatment condition is designed to aid generalization of training to everyday life situations.
#Intervention
- BEHAVIORAL : Case management and supportive psychotherapy
- An individual therapist will provide weekly case management and therapy targeting the individual psychological problems and everyday functioning needs of the patient
- BEHAVIORAL : Family psychoeducation
- All immediate family members will be invited to family psychoeducation sessions.
- BEHAVIORAL : Cognitive training
- The Cognitive Training and Exercise intervention involves 24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, four 30 minute sessions per week. The first 12 weeks involves neurocognitive training, using auditory training exercises from Posit Science Brain HQ. The second 12 weeks involves social cognitive training, using the Posit Science SocialVille modules. A weekly one-hour Bridging Skills Group with other members of the treatment condition is designed to aid generalization of training to everyday life situations.
- Other Names :
- cognitive remediation
- BEHAVIORAL : Aerobic exercise
- Aerobic exercise occurs as two 30-minute sessions at the clinic and two at home weekly. Intensity of aerobic exercise is tailored to maintain an individualized target heart rate zone and is monitored by a heart rate recorder.
- Other Names :
- physical exercise | #Eligibility Criteria:
Inclusion Criteria:
* a first episode of a psychotic illness that began within the past two years;
* a diagnosis by Diagnostic and Statistical Manual of Mental Disorders of schizophrenia, schizoaffective disorder, mainly depressed type, or schizophreniform disorder;
* between 18 and 45 years;
* sufficient acculturation and fluency in the English language to avoid invalidating research measures of thought, language, and speech disorder or of verbal cognitive abilities; and
* residence within commuting distance of the Aftercare Research Program at the University of California, Los Angeles.
Exclusion Criteria:
* evidence of a known neurological disorder (e.g., epilepsy) or significant head injury;
* evidence of alcohol or substance use disorder within the six months prior to the first episode and evidence that substance abuse triggered the psychotic episode or makes the schizophrenia diagnosis ambiguous;
* mental retardation, i.e. premorbid intelligence quotient less than 70.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT02267070 | 160,196 |
{
"NCT_ID" : "NCT04948385",
"Brief_Title" : "Driving Performance After Deep Sedation for Outpatient Endoscopy",
"Official_title" : "Can Patients Who Have Undergone a Digestive Endoscopy Under Deep Sedation Drive Their Vehicle as Soon as a Post-Anesthetic Discharge Scoring System (PADDS) Equal to 9 is Obtained ?",
"Conditions" : ["Driving Impaired"],
"Interventions" : ["Drug: Propofol", "Procedure: No sedation"],
"Location_Countries" : ["Belgium"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-02-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-05-06",
"Study_Completion_Date(Actual)" : "2019-05-06},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-06-03",
"First_Posted(Estimated)" : 2021-07-02"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-06-23",
"Last_Update_Posted(Estimated)" : 2021-07-02",
"Last_Verified" : 2021-06"
}
}} | #Study Description
Brief Summary
Many drugs used during anesthesia can reduce alertness and therefore present potential risks when driving a vehicle (risk of accident). Some scientific societies recommend not driving for 12 to 24 hours after sedation or general anesthesia. However, there are conflicting data in the literature showing that general anesthesia in healthy volunteers does not impair driving ability as early as 2 hours after the end of anesthesia.
This need not to drive requires the outpatient to have an escort. Unfortunately, some patients find it difficult to benefit from an adult escort, which can lead to last minute cancellations, absences or the need for a classic overnight hospital stay.
The main objective of the study is to compare with a simulator the driving performances of patients who have benefited from deep sedation for an outpatient endoscopic digestive procedure when they have met the discharge criteria to the performances of their escorts in order to determine if the conditions are as safe to let them drive home.
#Intervention
- DRUG : Propofol
- deep sedation with propofol +/- adjuvants such as midazolam, sufentanil, lidocaine and/or dehydrobenperidol
- PROCEDURE : No sedation
- No sedation | #Eligibility Criteria:
Inclusion Criteria:
* Presence of a driver license
Exclusion Criteria:
* Unavailabilty of the escort for the duration of the examination
* No driving for the past 5 years
* Refusal of participation
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT04948385 | 191,475 |
{
"NCT_ID" : "NCT03482492",
"Brief_Title" : "Tramadol vs.Tramadol With Paracetamol",
"Official_title" : "Comparison of Tramadol vs. Tramadol With Paracetamol for Efficacy of Postoperative Pain Management in Lumbar Discectomy: A Randomised Controlled Trial",
"Conditions" : ["Lumbar Disc Herniation"],
"Interventions" : ["Drug: Tramadol", "Drug: Paracetamol"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-03-20",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-01-12",
"Study_Completion_Date(Actual)" : "2015-04-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-03-20",
"First_Posted(Estimated)" : 2018-03-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-03-27",
"Last_Update_Posted(Estimated)" : 2018-03-29",
"Last_Verified" : 2018-03"
}
}} | #Study Description
Brief Summary
This study focused on to determine postoperative analgesic efficacy of tramadol compared to tramadol with addition of paracetamol after a lumbar disc surgery.
Detailed Description
Background:
Despite developments in treatment of pain, the availability of new drugs or increased knowledge of pain management, postoperative pain control after different surgeries still remains inadequate.
Aims:
This study focused on to determine postoperative analgesic efficacy of tramadol compared to tramadol with addition of paracetamol after a lumbar disc surgery.
Study Design:
In this study we have randomized 60 patients into two treatment groups. In Group Tramadol patients received tramadol, In Group TramadolParacetamol patients received paracetamol 1 gr iv in addition to tramadol 30 minutes before the operation ends and 1 g at 6 hour intervals.
Methods:
Severity of the pain, total tramadol consumption, adverse effects, ramsay sedation scale score, nausea/vomiting scores, patient satisfaction score were recorded in the postoperative period.
#Intervention
- DRUG : Tramadol
- Tramadol iv
- DRUG : Paracetamol
- Paracetamol iv | #Eligibility Criteria:
Inclusion Criteria:
American Society of Anesthesiologists (ASA) 1 or 2 status patients with single level lumbar disc herniation.
Exclusion Criteria:
Patients who could not use a patient controlled analgesia (PCA) device, known allergies to any of the drugs used in this study,hepatic and renal dysfunction, herniated disc with neurological deficit or intense pain justifying emergency surgery and the patients whose body mass index is >=30 kg/m2 were excluded from the study.
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
| NCT03482492 | 78,781 |
{
"NCT_ID" : "NCT01549301",
"Brief_Title" : "Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Filgrastim (G-CSF)Produced by Blausiegel Indústria e Comércio Ltda. Compared to Granulokine Produced by Produtos Roche Químicos e Farmacêuticos S/A.",
"Conditions" : ["Healthy Subjects"],
"Interventions" : ["Drug: Filgrastim"],
"Location_Countries" : ["Brazil"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-08",
"Study_Completion_Date(Actual)" : "2013-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-03-06",
"First_Posted(Estimated)" : 2012-03-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-03-06",
"Last_Update_Posted(Estimated)" : 2018-06-20",
"Last_Verified" : 2018-01"
}
}} | #Study Description
Brief Summary
The primary aim of this study is to compare the pharmacokinetic and pharmacodynamic effects of two commercial preparations of filgrastim (T and C), after single dose via subcutaneous or intravenous administration at a concentration of 5 mcg/kg or 10 mcg/kg in healthy subjects through the alteration in the pharmacokinetic and pharmacodynamic parameters (measurement of serum levels of G-CSF and absolute neutrophil count - ANC).
#Intervention
- DRUG : Filgrastim
- filgrastim, single dose, s.c., dosage: 5 mcg/kg
- DRUG : Filgrastim
- filgrastim, single dose, s.c., dosage: 10 mcg/kg
- DRUG : Filgrastim
- Filgrastim, i.v., single dose, dosage: 5 mcg/kg
- DRUG : Filgrastim
- Filgrastim, i.v., single dose, dosage: 10 mcg/kg | #Eligibility Criteria:
Inclusion Criteria:
* Agree with all study procedures, sign and date back by their own free will, the IC;
* Be between 18 and 50 years, of both sexes;
* Present a body mass index (BMI) greater than or equal to 20 and less than or equal to 28;
* are considered healthy, clinical, psychological and laboratory;
* are female, but they have and maintain a safe method of contraception during the study.
Exclusion Criteria:
* Known hypersensitivity to filgrastim;
* Hypersensitivity to products derived from E. coli;
* fever or infectious disease in the 07 days preceding the first administration;
* Positive serology for hepatitis B or C and HIV;
* Prior treatment with CSFs, interleukins and interferons;
* Participation in a clinical study in the last 12 months;
* Donation or loss of blood in the 03 months preceding the study;
* General anesthesia in the 03 months preceding the study;
* Provide a history of alcohol abuse, drug or drugs;
* Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological, psoriasis, gout, acute myocardial infarction, thyroid or psychiatric disease;
* Pregnant or lactating women.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT01549301 | 51,293 |
{
"NCT_ID" : "NCT00318903",
"Brief_Title" : "Irinotecan and Taxotere With Radiotherapy as Preoperative Treatment in Resectable Esophageal Cancer",
"Official_title" : "A Phase II Study of Irinotecan and Taxotere With Concurrent Radiotherapy as a Preoperative Treatment in Resectable Esophageal Cancer",
"Conditions" : ["Esophageal Cancer", "Cancer of the Esophagus", "Esophagus Cancer", "Esophageal Neoplasm", "Cancer of Esophagus"],
"Interventions" : ["Drug: Taxotere (drug)", "Procedure: Radiotherapy (procedure)", "Procedure: Esophagectomy (procedure)", "Drug: Irinotecan (drug)"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2002-01",
"Study_Completion_Date(Actual)" : "2006-04},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2006-04-13",
"First_Posted(Estimated)" : 2006-04-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2006-04-25",
"Last_Update_Posted(Estimated)" : 2023-05-25",
"Last_Verified" : 2023-05"
}
}} | #Study Description
Brief Summary
There is a need for more effective therapy for patients following surgery for esophageal carcinoma. Docetaxel and Irinotecan, independent of each other, have demonstrated activity in this disease. There is interest in the combination of these two active agents plus radiotherapy.
Detailed Description
The high rate of local and distant failure following surgery for esophageal carcinoma necessitates a more effective therapy for these patients. The merit of neoadjuvant chemotherapy is early management of micrometastatic disease and radiosensitization. A longstanding regimen, 5-FU and Cisplatin, have failed to produce a substantial survival benefit, but the approach has resulted in pathologic complete responses prior to surgical eradication of the diseased organ. This raises questions of organ preservation in some patients. Docetaxel and Irinotecan have both demonstrated independent activity in this disease and are radiosensitizers. In this study, Docetaxel and Irinotecan will be given together weekly for 3 consecutive weeks in an attempt to decrease the recurrence of systemic disease, and this will be followed by giving each agent independently with radiation therapy to decrease the local relapse rate and independently measure the toxicity of each with radiation. Following completion of chemoradiotherapy, the patients will undergo resection and be evaluated for the pathologic response rate.
#Intervention
- DRUG : Irinotecan (drug)
- 50 mg/m2 of Irinotecan will be administered intravenously over 60-90 minutes following a Taxotere infusion each week for 3 weeks. After a break, Irinotecan will then be given for 3 consecutive weeks at 45 mg/m2 in conjunction with radiotherapy.
- Other Names :
- Camptosar
- DRUG : Taxotere (drug)
- Taxotere at 35 mg/m2 is given intravenously over 1 hour each week for three consecutive weeks. After a one-week break, patients will receive Taxotere at a 25 mg/m2 dose for the first three weeks of a 5-6 week radiotherapy regimen.
- Other Names :
- Docetaxel
- PROCEDURE : Radiotherapy (procedure)
- Radiotherapy will be given in 28 fractions over 5-6 weeks at 1.8 Gy per fraction for a total of 50.4 Gy. This will begin concurrently with chemotherapy on Day 29 of treatment.
- PROCEDURE : Esophagectomy (procedure)
- After approximately 14 weeks of treatment, the patient will be evaluated for surgery. Only those who have achieved a good response will be eligible. | #Eligibility Criteria:
Inclusion Criteria:
* Histological confirmation of adenocarcinoma/squamous cell carcinoma of the esophagus. Patients should be considered resection candidates, Clinical Stages II- IV (For GE junction tumors 50% of the tumor must be within the esophagus)
* Age 19 years
* Male or female gender (not pregnant or lactating). If the subject is fertile, use of medically acceptable contraception will be required, and women with reproductive potential shall have a negative pregnancy test.
* Patient should be able to understand and offer signed written informed consent prior to study entry.
* No prior receipt of surgery, chemotherapy, radiotherapy or immunotherapy.
* Patients must demonstrate a ECOG P.S. <= 1
* Minimum life expectancy of 12 weeks
* End Organ function must be adequate meeting the below criteria at baseline:
WBC 3000/mm3, ANC 1500/mm3 , Hgb 9.0 g/dL, PLT 100,000mm3 Normal serum creatinine ( 1.5 mg/dL) Total Bilirubin ULN, Transaminases (SGOT and/or SGPT) may be up to 1.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is < ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are < ULN.
PT/PTT below the upper limit of normal (patients may be on 1mg of Coumadin for line patency) Peripheral neuropathy must be < Grade 1
Exclusion Criteria:
* Diagnosis of active, invasive (treated in past 5 years) concomitant malignancy except non-melanotic skin cancer
* Patients must be fully recovered from any reversible side effects of prior intervention
* Presence of an underlying disease state associated with impairment of performance status
* New York Heart Association Class IV congestive heart failure
* Limited mental capacity or language skills to the extent simple instructions cannot be followed or information regarding adverse events cannot be provided
History of non-compliance with prescribed medical care.
* Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80 must be excluded.
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00318903 | 175,150 |
{
"NCT_ID" : "NCT02916082",
"Brief_Title" : "Cervical Length Pre-induction as a Tool to Predict Vaginal Birth",
"Official_title" : "Use of Cervical Length Previous to the Use of Prostaglandins as a Tool to Predict Vaginal Birth in Pregnancies With > 41 Weeks Gestation.",
"Conditions" : ["Cervical Length Measurement", "Pregnancy, Prolonged"],
"Interventions" : ["Procedure: Cervical length measurement"],
"Location_Countries" : ["Panama"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-11",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-06",
"Study_Completion_Date(Actual)" : "2016-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-09-25",
"First_Posted(Estimated)" : 2016-09-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-09-25",
"Last_Update_Posted(Estimated)" : 2016-09-27",
"Last_Verified" : 2016-09"
}
}} | #Study Description
Brief Summary
To evaluate the value of measuring cervical length as a predictor of vaginal birth after induction of labor with prostaglandins in pregnancies with 41 weeks of gestation.
#Intervention
- PROCEDURE : Cervical length measurement
- Vaginal ultrasound to measure cervical length previous to use of prostaglandins. | #Eligibility Criteria:
Inclusion Criteria:
* 41 weeks or more of gestational age
* Cervical length measured by a FMF certified physician
Exclusion Criteria:
* Any condition that could interfere with a possible vaginal birth (previous cesarean section, hypertensive disorders of pregnancies).
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT02916082 | 9,435 |
{
"NCT_ID" : "NCT02482532",
"Brief_Title" : "Vaccine Enriched, Autologous, Activated T-Cells Directed to Tumor in Patients With Relapsed/Refractory Melanoma",
"Official_title" : "Phase I Study of Vaccine Enriched, Autologous, Activated T-Cells Redirected to the Tumor Marker GD2 in Patients With Relapsed/Refractory Melanoma",
"Conditions" : ["Melanoma"],
"Interventions" : ["Biological: tvs-CTL Vaccine"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-10-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-10-10",
"Study_Completion_Date(Actual)" : "2021-09-13},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-06-18",
"First_Posted(Estimated)" : 2015-06-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-06-23",
"Last_Update_Posted(Estimated)" : 2022-02-04",
"Last_Verified" : 2021-11"
}
}} | #Study Description
Brief Summary
The researchers will investigate if modified T-cells from a patients own system can be utilized to find and destroy metastatic melanoma tumor and thus improve patient outcomes.
Detailed Description
The rate of progression free survival at one (1) year is \< 20% for patients with stage IV metastatic melanoma, despite aggressive cytotoxic chemotherapy regimens and newly approved immunomodulatory and targeted therapy. Immunotherapy seems to hold the most promise for achieving prolonged survival or even cure, therefore,efforts have focused on several different approaches. Such approaches have used tumor vaccination, adoptive transfer of tumor infiltrating lymphocytes, and even monoclonal antibodies, unconjugated or conjugated to cytokines, toxins, or radionucleotides.
The tumor-associated antigen GD2 has been noted on the surface of several tumors, most notably neuroblastoma, but is expressed on melanoma as well. Clinical studies have shown activity of a GD2-specific chimeric T-cell receptor expressed on activated, autologous, T-cells in patients with neuroblastoma. It is the investigators intention to enrich peripheral blood mononuclear cells (PBMC) of patients with stage IV metastatic melanoma with vaccine-specific T-cells through pre-harvest/ phlebotomy vaccination with common, well understood vaccines. The investigators will then modify the T-cells to attack the GD2 antigen. These tumor redirected, vaccine specific, activated T-cells will then be infused into the patient following revaccination with the common vaccines. The Investigators will monitor expansion of the modified T-cells through serial polymerase chain reaction (PCR) assays following vaccination.
The Investigators then intend to re-vaccinate with the selected vaccines one month following infusion and monitor for expansion of the modified T-cells.
#Intervention
- BIOLOGICAL : tvs-CTL Vaccine
- autologous, 14g2a.zeta chimeric receptor transduced, activated T-cells, enriched for vaccine specific cytotoxic T-lymphocytes (tvs-CTL) | #Eligibility Criteria:
Inclusion Criteria:
* Metastatic, surgically unresectable melanoma or newly diagnosed melanoma of any stage, where the patient is unable to receive or complete standard therapy
* Life expectancy of at least 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance score of <= 2
* Laboratory Values
* absolute neutrophil count > 500 microliters (mcL)
* platelet > 50,000 mcL
* serum aspartate aminotransferase (AST) < 5 x institutional upper limit of normal (IULN)
* total bilirubin < 3 x IULN
* serum creatinine < 3 x IULN
* Pulse oximetry of > 95% on room air.
* Must have recovered from the toxic effects of all prior chemotherapy
Exclusion Criteria:
* Patients with rapidly progressive disease.
* Patient is currently receiving any investigational drugs
* Current cardiomegaly or bilateral pulmonary infiltrates on chest radiograph, pulmonary metastatic lesions are allowed
* Patients must not have tumor in a location where enlargement could cause airway obstruction
* Patient is pregnant or lactating
* History of hypersensitivity reactions to murine protein-containing products.
* Currently receiving immunosuppressive drugs such as corticosteroids (excluding topical treatment), tacrolimus or cyclosporin
* Received any tumor vaccines within previous six weeks
* Known hypersensitivity to rat monoclonal antibodies
* History of severe allergic reaction to Hepatitis B vaccine, Polio vaccine or Tetanus, Diphtheria, Pertussis vaccine (DTP, Tdap, DT or Td).
* Allergy to baker's yeast or other components of the vaccines.
* History of allergy to the antibiotics Neomycin, Streptomycin or Polymyxin B
* History of coma, long/multiple seizures within 7 days after DTP or Tdap, unless a cause other than the vaccine was indicated.
* Melanoma involvement of the central nervous system
* Chemotherapy given within the last 28 days
* Presence of human anti-mouse antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 66 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02482532 | 203,861 |
{
"NCT_ID" : "NCT05183555",
"Brief_Title" : "Early Feasibility Study of Somatostatin Receptors PET Imaging for the Diagnosis of Infective Endocarditis",
"Official_title" : "Early Feasibility Study of Somatostatin Receptors PET Imaging (68Ga-DOTATOC PET/CT) for the Diagnosis of Infective Endocarditis",
"Conditions" : ["Infective Endocarditis"],
"Interventions" : ["Drug: 68Ga-DOTATOC PET/CT"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "DIAGNOSTIC",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-05-16",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-06-18",
"Study_Completion_Date(Actual)" : "2024-06-18},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-12-21",
"First_Posted(Estimated)" : 2022-01-10"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-12-21",
"Last_Update_Posted(Estimated)" : 2024-09-26",
"Last_Verified" : 2024-09"
}
}} | #Study Description
Brief Summary
Study hypothesis: 68Ga-DOTATOC PET/CT could detect cardiac foci of infective endocarditis regardless of the type of valve (native or prosthetic) and also extracardiac localizations related to this pathology (infection responsible, peripheral emboli, ...). This study is a proof of concept with low population
Detailed Description
The incidence of infective endocarditis (IE) in France is estimated to be around 30 cases per million inhabitants in studies conducted in Western countries and is significantly increased in patients with a valve prosthesis and even more so in cases of a history of endocarditis. The morbi-mortality is significant and the hospital mortality rate is 20%.
The diagnosis of IE remains difficult and according to the modified Duke criteria, the diagnostic sensitivity is 80%.
Currently, the diagnosis of IE is often determined according to the 2015 ESC criteria and the sensitivity increases from 57% to 84% regarding IE on prosthetic valves.
The 18F-FDG PET/CT examination is of major interest in the diagnosis of AR on prosthetic valves with a detection sensitivity of between 70 and 90% (with an accuracy of 70 to 80%). Concerning native valves, the sensitivity of PET/CT remains below 50%.
Indeed, a 'physiological' myocardial fixation in 18F-FDG PET/CT compromises the interpretation of PET exam, so it is important to start a hypoglycemic-hyperlipidic diet the day before the 18F-FDG PET/CT, followed by a 12-hour fasting period.
For several years, a radiopharmaceutical, 68Ga-DOTATOC (68Ga-edotreotide) has been used in PET/CT for the diagnosis and follow-up of neuroendocrine tumours (NETs). 68Ga-DOTATOC binds mainly with high affinity to somatostatin receptor subtype 2 (SSTR2) but also to somatostatin receptor subtype 5 (SSTR5).
Activated monocytes, macrophages, and lymphocytes express somatostatin receptors , thus detection of SSTR2 receptors expressed by inflammatory cells could help for the diagnosis of infective endocarditis.
PET/CT with 68Ga-DOTATOC could thus detect inflammatory cells at infectious sites. This radiopharmaceutical has already shown an ability to identify a myocardial inflammation (inflammatory phase myocarditis and cardiac sarcoidosis).
In current study conducted by our teams (NCT03347760 on ClinicalTrials.gov), early results showed the capacity of the 68Ga-DOTATOC to detect efficiently myocarditis, including myocarditis induced by RNA anti-COVID vaccinations.
In vitro, the 18FDG uptake by inflammatory cells is more important than the 68Ga-DOTATOC uptake, but the contrast between infection focus and healthy tissue should be better since 68Ga-DOTATOC does not cause any physiological myocardial uptake. The 68Ga-DOTATOC does not required any special metabolic preparation or prolonged fasting often poorly supported by patients.
#Intervention
- DRUG : 68Ga-DOTATOC PET/CT
- 68Ga-DOTATOC PET/CT will be recorded the following day of 18F-FDG PET/CT if patient signed the consent
- Other Names :
- 18F-FDG PET/CT | #Eligibility Criteria:
Inclusion Criteria:
* Adult who has received full information about the organisation of the research and has signed informed consent adult
* Participant hospitalised for definite AE according to modified Duke criteria (Li), on native or prosthetic valve, referred for 18F-FDG PET/CT from Cardiology and Infectious Diseases departments
Exclusion Criteria:
* Person with a history of hypersensitivity from previous use of 68Ga-DOTATOC
* Unable to perform a 68Ga-DOTATOC PET scan (agitated, confused patient...).
* Inability to schedule 68Ga-DOTATOC PET/CT the day after 18F-FDG PET/CT.
* Person with severe renal impairment (GFR <30 ml/min/1.73 m2)
* Participant treated with a somatostatin analogue.
* Participant with Cushing's syndrome
* Pregnant, potentially pregnant or breastfeeding women
* Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
* Person of full age who is unable to give consent
* Person deprived of liberty by a judicial or administrative decision
* Person subject to psychiatric care by virtue of Articles L. 3212 <= age <= 1 and L. 3213 <= age <= 1
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT05183555 | 144,356 |
{
"NCT_ID" : "NCT04858022",
"Brief_Title" : "Visual Acoustic Biofeedback for RSE Via Telepractice",
"Official_title" : "Online Assessment and Enhancement of Auditory Perception for Speech Sound Errors: Visual Acoustic Biofeedback for RSE Via Telepractice",
"Conditions" : ["Speech Sound Disorder"],
"Interventions" : ["Behavioral: Visual Acoustic Biofeedback", "Other: No treatment - waitlist"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "FACTORIAL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-01-15",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-04-15",
"Study_Completion_Date(Actual)" : "2024-04-15},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-04-05",
"First_Posted(Estimated)" : 2021-04-23"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-04-22",
"Last_Update_Posted(Estimated)" : 2024-07-29",
"Last_Verified" : 2024-07"
}
}} | #Study Description
Brief Summary
This research will meet a public health need by evaluating the efficacy of speech intervention supplemented with real-time visual-acoustic biofeedback when delivered using remote technologies.
Detailed Description
In a crossover design, participants will be randomly assigned to receive 10 weeks/20 sessions of visual-acoustic biofeedback treatment via telepractice followed by a 10-week period of no treatment, or the same two conditions in the reverse order. Production accuracy will be assessed with standard probes (20 syllables, 30 words, and 10 sentences containing /r/ in various phonetic contexts) administered prior to the beginning of treatment (baseline), after the first 10-week phase, and again at the end of the study.
#Intervention
- BEHAVIORAL : Visual Acoustic Biofeedback
- In visual-acoustic biofeedback treatment, the elements of traditional articulatory treatment (i.e., auditory models and verbal descriptions of articulator placement) are enhanced with a dynamic display of the speech signal in the form of the real-time LPC (Linear Predictive Coding) spectrum. Because correct vs incorrect productions of /r/ contrast acoustically in the frequency of the third formant (F3), participants will be cued to make their real-time LPC spectrum match a visual target characterized by a low F3 frequency. They will be encouraged to attend to the visual display while adjusting the placement of their articulators and observing how those adjustments impact F3.
- OTHER : No treatment - waitlist
- 10-week period of no treatment | #Eligibility Criteria:
Inclusion Criteria:
* Must be between 9;0 and 15;11 years at the time of enrollment.
* Must speak English as the dominant language (i.e., must have begun learning English by age 2, per parent report).
* Must speak a rhotic dialect of English.
* Must pass a pure-tone hearing screening at 20dB hearing level.
* Must pass a brief examination of oral structure and function.
* Must exhibit less than 30% accuracy, based on consensus across 2 trained listeners, on a probe list eliciting rhotics in various phonetic contexts at the word level.
* Must exhibit no more than 3 sounds other than /r/ in error on the Goldman-Fristoe Test of Articulation-3 (GFTA-3).
Exclusion Criteria:
* Must not receive a T score more than 1.3 SD below the mean on the Wechsler Abbreviated Scale of Intelligence-2 (WASI-2) Matrix Reasoning
* Must not receive a scaled score of 7 or higher on the Recalling Sentences and Formulated Sentences subtests of the Clinical Evaluation of Language Fundamentals-5 (CELF-5).
* Must not have an existing diagnosis of developmental disability or major neurobehavioral syndrome such as cerebral palsy, Down Syndrome, or Autism Spectrum Disorder
Sex :
ALL
Ages :
- Minimum Age : 9 Years
- Maximum Age : 15 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
| NCT04858022 | 67,215 |
{
"NCT_ID" : "NCT00726128",
"Brief_Title" : "Patient Outcomes Evaluation of the EBI Vuelock™ Anterior Cervical Plate System",
"Official_title" : "A Multi-Center Prospective Patient Outcomes Evaluation of the EBI Vuelock™ Anterior Cervical Plate System",
"Conditions" : ["Trauma", "Tumor", "Pseudarthrosis", "Scoliosis", "Degenerative Disc Disease"],
"Interventions" : ["Device: VueLock™ Anterior Cervical Plate"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "1998-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-09",
"Study_Completion_Date(Actual)" : "2009-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-07-29",
"First_Posted(Estimated)" : 2008-07-31"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-07-30",
"Last_Update_Posted(Estimated)" : 2020-02-24",
"Last_Verified" : 2020-02"
}
}} | #Study Description
Brief Summary
To prospectively collect radiographic and outcome data on patients who are having cervical spine fusion surgery with the VueLock™ Anterior Cervical Plate System
Detailed Description
The purpose is to prospectively collect radiographic and outcome data on patients who are having cervical spine fusion surgery with the VueLock™ Anterior Cervical Plate System.
#Intervention
- DEVICE : VueLock™ Anterior Cervical Plate
- Implanted in subjects having an ACDF (Anterior cervical discectomy and fusion) | #Eligibility Criteria:
Inclusion Criteria:
* The patient will undergo anterior cervical fusion with the VueLock™ Anterior Cervical Plate System for treatment of degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma, tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusion.
* The patient must be available for follow-up during the study.
* The patient must be skeletally mature (epiphyses closed).
Exclusion Criteria:
* Patients with other pathology at the involved spinal level, e.g., osteomyelitis, Paget's disease, pathologic fracture, etc.
* Patients with a disease entity or condition that totally precludes the possibility of bony fusion such as known active cancer, etc.
* Pregnant or nursing females.
* Patients who in the opinion of the investigator would be psychologically unwilling or unable to understand or complete the protocol, especially those unwilling or unstable to participate in the follow-up.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT00726128 | 216,139 |
{
"NCT_ID" : "NCT05675137",
"Brief_Title" : "Efficacy of a Mobile-based Multidomain Intervention to Improve Cognitive Function and Health-related Outcomes Among Older Korean Adults With a High Risk of Dementia",
"Official_title" : "Efficacy of a Mobile-based Multidomain Intervention to Improve Cognitive Function and Health-related Outcomes Among Older Korean Adults With a High Risk of Dementia",
"Conditions" : ["Cognitive Decline", "Cognitive Impairment, Mild", "Aging", "Dementia"],
"Interventions" : ["Device: mobile-based", "Other: paper-based"],
"Location_Countries" : ["Korea, Republic of"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-04-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-10-28",
"Study_Completion_Date(Actual)" : "2022-10-28},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-12-30",
"First_Posted(Estimated)" : 2023-01-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-01-05",
"Last_Update_Posted(Estimated)" : 2023-01-09",
"Last_Verified" : 2023-01"
}
}} | #Study Description
Brief Summary
This study investigated the efficacy of the Silvia program, a mobile-based multidomain intervention, to improve cognitive function and health-related outcomes of older adults with a high risk of dementia. We compare its effects to a conventional paper-based multidomain program on various health indicators related to risk factors of dementia.
#Intervention
- DEVICE : mobile-based
- Participants who were randomly assigned to the mobile-based intervention group were provided multidomain programs based on scientific evidence of ways to improve brain-health and reduce dementia risk for 10 minutes per day and at least 50 minutes per week.
- OTHER : paper-based
- Participants who were randomly assigned to the paper-based intervention group were provided with the Korean version of the dementia prevention booklet published by the WHO. | #Eligibility Criteria:
Inclusion Criteria:
* experiencing subjective cognitive decline,
* had a smart phone and could use it, and
* understood the purpose and process of this study.
Exclusion Criteria:
* major psychiatric disorders
* dementia,
* degenerative brain diseases
* severe or unstable heart diseases
* neurological or psychological diseases that affected cognitive functioning
* severe vision or hearing impairment,
* current participation in a cognitive training program
* does not know how to use mobile devices.
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT05675137 | 190,710 |
{
"NCT_ID" : "NCT02671851",
"Brief_Title" : "Ultrasound-Guided Thoracic Paravertebral Blocks in Patients Undergoing Reduction Mammoplasty",
"Official_title" : "Ultrasound-Guided Bilateral Thoracic Paravertebral Blocks as an Adjunct to General Anaesthesia in Patients Undergoing Reduction Mammoplasty: A Historical Cohort Study",
"Conditions" : ["Pain, Postoperative"],
"Interventions" : ["Drug: Thoracic paravertebral blocks (TPVBs)", "Drug: IV metamizole sodium, paracetamol"],
"Location_Countries" : ["Turkey"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-01",
"Study_Completion_Date(Actual)" : "2016-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-01-22",
"First_Posted(Estimated)" : 2016-02-02"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-02-01",
"Last_Update_Posted(Estimated)" : 2016-02-10",
"Last_Verified" : 2016-02"
}
}} | #Study Description
Brief Summary
Background: Thoracic paravertebral blocks (TPVBs) have been effective for postoperative analgesia in mastectomy, thoracic and video-assisted thoracic surgeries.
Objective: To assess whether addition of ultrasound-guided TPVBs to general anaesthesia (GA) could postpone time to first pain and improve postoperative analgesia in patients undergoing bilateral reduction mammoplasty.
Design: A historical cohort study. Patients: Of the 70 female patients who underwent bilateral reduction mammoplasty, 64 patients had complete data in the acute pain/regional anaesthesia database.
Intervention: Thirty patients, received only GA, were included in Group GA. Thirty-four patients, received bilateral single injection ultrasound-guided TPVBs with 20 mL bupivacaine 0.375% as an adjunct to GA, were included in Group TPVBs. Patients in both groups were administered intraoperative fentanyl if heart rate or mean arterial pressure increased \>20% above pre-induction values, postoperative tramadol 1mg/kg in the postoperative care unit (PACU) if numeric rating scale (NRS) was ≥4, and rescue analgesics as metamizole sodium 4x1g and/or paracetamol 3x1g on wards (NRS≥4).
Main outcome measures: The primary endpoint was time to first pain after the surgery. Secondary endpoints were intra- and postoperative opioid and other rescue analgesic requirements, length of stay in the PACU, pain scores, incidence of postoperative nausea and vomiting (PONV), and patient and surgeon satisfaction through the postoperative first 2 days.
Detailed Description
Background: Thoracic paravertebral blocks (TPVBs) have been effective for postoperative analgesia in mastectomy, thoracic and video-assisted thoracic surgeries.
Objective: The objective was to assess whether addition of ultrasound-guided TPVBs to general anaesthesia (GA) could postpone time to first pain and improve postoperative analgesia in patients undergoing bilateral reduction mammoplasty.
Design: A historical cohort study. Patients: Of the 70 female patients who underwent bilateral reduction mammaplasty, 64 patients had complete data in the acute pain/regional anaesthesia database.
Intervention: Standard monitoring was applied before any anesthetic techniques were performed. All patients were given sedation in the form of midazolam 1-2 mg and fentanyl 50-100 µg. Patients underwent bilateral reduction mammaplasty were distributed to two groups due to their data: 1) Patients received only general anaesthesia (GA) were included in Group GA, and 2) Patients received preoperative US-guided TPVBs as an adjunct to GA were included in Group TPVBs. Thirty patients were in Group GA. Thirty-four patients who were in Group TPVBs received bilateral single injection ultrasound-guided TPVBs with 20 mL bupivacaine 0.375% (20 mL per injection) at the level of T3-4, as an adjunct to GA. Patients in both groups were administered intraoperative fentanyl if heart rate or mean arterial pressure increased \>20% above pre-induction values. They also received postoperative tramadol 1mg/kg in the postoperative care unit (PACU) and rescue analgesics as metamizole sodium 4x1g and/or paracetamol 3x1g on wards, if numeric rating scale (NRS) was ≥4.
Main outcome measures: The primary endpoint was time to first pain after the surgery. Secondary endpoints were intra- and postoperative opioid and other rescue analgesic requirements, length of stay in the PACU, pain scores, incidence of postoperative nausea and vomiting (PONV), and patient and surgeon satisfaction through the postoperative first 2 days.
#Intervention
- DRUG : Thoracic paravertebral blocks (TPVBs)
- Patients received bilateral single injection ultrasound-guided TPVBs with 20mL bupivacaine 0.375% at the level of T3-T4 as an adjunct to GA, intraoperative fentanyl and postoperative tramadol, metamizole sodium and paracetamol were used.
- Other Names :
- Bupivacaine,fentanyl,tramadol,metamizole sodium,paracetamol
- DRUG : IV metamizole sodium, paracetamol
- Patients received only standardized GA, intraoperative fentanyl and postoperative tramadol, metamizole sodium and paracetamol were used.
- Other Names :
- Fentanyl,tramadol,metamizole sodium,paracetamol | #Eligibility Criteria:
Inclusion Criteria:
* ASA I-III patients who underwent bilateral reduction mammoplasty
Exclusion Criteria:
* Patients with deficient data
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02671851 | 252,764 |
{
"NCT_ID" : "NCT00427804",
"Brief_Title" : "Tumor Necrosis Factor Decreases Vitamin D Dependant Calcium Absorption",
"Official_title" : "Tumor Necrosis Factor-α Induces Vitamin D Resistance in Small Intestinal Calcium Absorption",
"Conditions" : ["Rheumatoid Arthritis", "Crohn's Disease"],
"Interventions" : ["Drug: calcitriol"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2007-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-08",
"Study_Completion_Date(Actual)" : "2009-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2007-01-25",
"First_Submitted_that_Met_QC_Criteria" : 2011-08-03",
"First_Posted(Estimated)" : 2007-01-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2007-01-25",
"Last_Update_Posted(Estimated)" : 2013-02-04",
"Last_Verified" : 2013-01"
}
}} | #Study Description
Brief Summary
This study is a pilot study to determine whether patients with TNFα excess have decreased calcium absorption in response to calcitriol (1,25-dihydroxyvitamin D, the active form of vitamin D) compared to normal controls. This initial pilot study is being done to determine if it is feasible to conduct a study where TNFα could be blocked (e.g., by anti-TNFα therapy such as Enbrel® or Remicade®) to improve vitamin D dependant calcium absorption and thus bone health.
Detailed Description
Vitamin D is important for the maintenance of normal calcium homeostasis by improving the efficacy of calcium absorption from the small intestine. The efficacy of calcium absorption is decreased with aging, menopause, and other inflammatory states. Subjects who have low intestinal absorption of calcium are at risk for developing osteoporosis and fractures. Early data suggests that patients with rheumatoid arthritis (RA) and Crohn's disease appear to have decreased calcium absorption. Patients with RA and Crohn's disease have elevated levels of TNFα in local tissues and systemically which may be causing resistance to vitamin D dependant calcium absorption.
Recently a new vitamin D dependant calcium channel important for calcium absorption has been discovered in the small intestine called Transient Receptor Potential Vallinoid type 6 (TRPV6). We have some pre-clinical data in rats to suggest that TNFα has a role in inhibiting the expression of this protein by decreasing the induction of this protein in response to vitamin D treatment.
HYPOTHESIS:
Subjects with disease conditions that result in elevated TNFα have vitamin D resistance and inability to increase calcium absorption with increasing concentrations of calcitriol.
STUDY DESIGN:
Subjects: The study will be conducted at the Emory GCRC/Emory Clinic and VA clinical research center. Study participants will be recruited from the Atlanta Veterans Administration Medical Center (VAMC) and Emory Clinics for participation in the study according to the following inclusion and exclusion criteria
Inclusion: Males, age 18 to 50, history of Crohn's disease or Rheumatoid Arthritis (cases) or healthy individuals (controls)
Exclusion: Subjects already taking activated vitamin D medications such as calcitriol, Zemplar®, Hectoral®, vitamin D deficiency defined as 25(OH)D ≤ 20 ng/ml, post-menopausal women (absence of menses for greater than 6 months by history or FSH level \>20), history of nephrolithiasis, history of hypercalcemia or hypercalciuria, short bowel disease, glucocorticoid use, use of osteoporosis medication (bisphosphonate, calcitonin or teriparatide), chronic kidney disease (calculated GFR \<60 ml/min/1.73 m2), history of hyperparathyroidism (PTH greater than upper limit of normal) or hypoparathyroidism (PTH below lower limit of normal)
Procedures:
Screening Phase: Case subjects will be identified from Rheumatology and Gastroenterology clinics from the VA or Emory Clinic. The subject's doctors will give the patient a brochure of the study with the study investigator's name and phone number to contact. There will also be advertisements in the Rheumatology and Gastroenterology clinics to recruit subjects for the study. Control subjects will be identified by postings at the VA hospital or at Emory Clinic in designated areas for research postings.
The subject will initiate contact with the study personnel by calling the number on the advertisement or brochure. The study investigator will pre-screen the subject on the phone to see if the subject is eligible for entry into the study. If the subject remains eligible, the subject will be invited to the VA clinical research center or Emory GCRC/Emory Clinic for informed consent.
Screening Visit: The study investigator will review the inclusion and exclusion criteria with each subject. If the subject agrees to participate in the study, the subject will sign the informed consent and undergo baseline laboratory investigations for total calcium, parathyroid hormone (PTH), 25-hydroxyvitamin D, comprehensive panel including renal function, 24-hour urine collection for calcium and creatinine clearance. Subjects will be counseled to take no more than 600 mg of calcium daily and no more than 400 IU a day of vitamin D. The subjects will be instructed on how to complete a three day food diary for future visits.
They will be given a schedule to return for the following visits.
Visit #1 (baseline fractional absorption of calcium (FCA)) Subjects will return to the clinical research center in a fasting state for a baseline FCA test (see specific methods in the following section). Subjects will return their three day food diary record. Subjects will also have blood drawn for comprehensive panel including calcium and renal function, 1,25-dihydroxyvitamin D, PTH level and serum TNFα. The subjects will be given calcitriol 0.25 mcg PO BID to be taken for 7 days.
Visit #2 (FCA on low dose calcitrol, 0.25 mcg PO BID) Subjects will take their morning dose of calcitriol 8 am on the day of visit #2. Subjects will come to the clinic in a fasting state. They will return their 3 day food diary records. A repeat FCA will be performed. Subjects will also have blood drawn for comprehensive panel including calcium and renal function, 1,25-dihydroxyvitamin D, PTH level and serum TNFα. After the test is completed, the subjects will be given calcitriol 0.50 mcg PO BID to be taken for 7 days. They will be scheduled to return to the clinical research center within 20 days after a minimum 7 day washout period.
Visit #3 (FCA on high dose calcitriol, 0.50 mcg PO BID) Subjects will take their morning dose of calcitriol at 8 am on the day of visit #3. Subjects will come to the clinic in a fasting state. They will return their 3 day food diary records. A repeat FCA will be performed. Subjects will also have blood drawn for comprehensive panel including calcium and renal function, 1,25-dihydroxyvitamin D, PTH level and serum TNFα.
Fractional absorption of calcium (FCA) procedure Subjects will come to the clinic after an overnight fast. After voiding the fasting urine, a 24 hour urine collection will begin. Each subject will receive a standard breakfast (see FCA diet section) which will contain approximately 211 mg of calcium and 45 IU of vitamin D. Oral 43Ca will be administered after the patient has drunk the milk. 1.9 ml will be drawn from a sterile 43Ca (calcium chloride) vial with a syringe and will be injected in 4 ounces of distilled water. The subject will drink the glass of water. The glass will be rinsed twice with 4 ounces of distilled water and the subject will drink each rinse.
2.7 ml of 42Ca will be drawn from a sterile 42Ca (calcium chloride) vial with a sterile hypodermic syringe. The solution will be injected into the patient intravenously with an IV catheter and flushed with 5 ml of normal saline. The intravenous calcium will be infused within 30 minutes of ingestion of the oral calcium.
The subject will be discharged from the clinical research center and will continue with their 24 hour urine collection. The following morning, the subject will return the 24 hour urine collection to the research clinic. The subject will be advised to not eat for at least 4 hours after the breakfast meal.
#Intervention
- DRUG : calcitriol
- 0.25 mcg PO BID for 1 week for low dose then 0.25 mcg PO BID for high dose | #Eligibility Criteria:
Inclusion Criteria:
* Males
* Age 18 to 50
* History of Crohn's disease or Rheumatoid Arthritis (cases) or healthy individuals (controls)
Exclusion Criteria:
* Subjects already taking activated vitamin D medications such as calcitriol, Zemplar®, Hectoral®
* Vitamin D deficiency defined as 25(OH)D <= 20 ng/ml
* Post-menopausal women (absence of menses for greater than 6 months by history or FSH level >20)
* History of nephrolithiasis
* History of hypercalcemia or hypercalciuria
* Short bowel disease
* Glucocorticoid use
* Use of osteoporosis medication (bisphosphonate, calcitonin or teriparatide)
* Chronic kidney disease (calculated GFR <60 ml/min/1.73 m2)
* History of hyperparathyroidism (PTH greater than upper limit of normal) or
* Hypoparathyroidism (PTH below lower limit of normal)
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT00427804 | 113,429 |
{
"NCT_ID" : "NCT00633074",
"Brief_Title" : "Non-inferiority Study of GSK Biologicals' Influenza Vaccine GSK576389A Using Different Formulations",
"Official_title" : "Non-inferiority Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK576389A Using Different Formulations.",
"Conditions" : ["Influenza"],
"Interventions" : ["Biological: Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A)", "Biological: Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A)"],
"Location_Countries" : ["Estonia"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2008-03-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-04-11",
"Study_Completion_Date(Actual)" : "2008-04-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-02-29",
"First_Submitted_that_Met_QC_Criteria" : 2012-04-26",
"First_Posted(Estimated)" : 2008-03-11"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-03-10",
"Last_Update_Posted(Estimated)" : 2018-06-08",
"Last_Verified" : 2016-11"
}
}} | #Study Description
Brief Summary
The purpose of this study is to show the non-inferiority of different formulations of GlaxoSmithKline Biologicials' influenza vaccine.
#Intervention
- BIOLOGICAL : Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A)
- Intramuscular administration, 1 dose
- BIOLOGICAL : Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A)
- Intramuscular administration, 1 dose | #Eligibility Criteria:
Inclusion Criteria:
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female 65 years or older at the time of vaccination.
* Written informed consent obtained from the subject.
* Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.
Exclusion Criteria:
* Suspected (based on clinical symptoms) or confirmed (based on laboratory results) influenza infection within the last 6 months.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 21 days after vaccination.
* Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
* Previous vaccination against influenza with any seasonal vaccine since July 2007.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of hypersensitivity to a previous dose of influenza vaccine.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein.
* Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
* Any medical conditions in which IM injections are contraindicated
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
Yes
| NCT00633074 | 16,964 |
{
"NCT_ID" : "NCT02101281",
"Brief_Title" : "Safety and Efficacy of rhNGF Eye Drops at Different Doses in Patients With Dry Eye",
"Official_title" : "An Open-label Study Evaluating Safety and Efficacy of Recombinant Human Nerve Growth Factor (rhNGF) Eye Drops at Different Doses in Patients With Dry Eye",
"Conditions" : ["Dry Eye Syndrome"],
"Interventions" : ["Drug: rhNGF 4 µg/mL", "Drug: rhNGF 20 µg/mL"],
"Location_Countries" : ["Austria"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-01-20",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-01",
"Study_Completion_Date(Actual)" : "2015-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-03-20",
"First_Submitted_that_Met_QC_Criteria" : 2019-07-31",
"First_Posted(Estimated)" : 2014-04-02"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-03-28",
"Last_Update_Posted(Estimated)" : 2024-04-19",
"Last_Verified" : 2022-12"
}
}} | #Study Description
Brief Summary
The primary objective of this study was to assess the efficacy and safety of different doses of rhNGF when administered as eye drops to patients with dry eye.
Detailed Description
This is an open-label study evaluating safety and efficacy of recombinant human nerve growth factor (rhNGF) eye drops at different doses in patients with Dry Eye
#Intervention
- DRUG : rhNGF 20 µg/mL
- 1 drop for each eye, twice daily for 28 day
- Other Names :
- cenegermin, recombinant human Nerve Growth Factor
- DRUG : rhNGF 4 µg/mL
- 1 drop each eye, twice daily for 28 day
- Other Names :
- cenegermin, recombinant human Nerve Growth Factor | #Eligibility Criteria:
Inclusion Criteria:
* Male or female patients, >= 18 years;
* Required use of artificial tears for the treatment of Dry Eye within the 3 months prior to study enrolment;
* Current use or recommended use of artificial tears for the treatment of Dry Eye;
* Average VAS score for typical symptoms of Dry Eye (foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia) >= 25 mm;
* Corneal staining score with lissamine green > 3 using the NEI corneal grading system in the worse eye (study eye);
* Conjunctival staining score > 3 using the NEI conjunctival grading system in the worse eye (study eye);
* Schirmer test without anaesthesia <= 10 mm/5 minutes in the worse eye (study eye);
* Tear film break-up time (TBUT) <= 10 seconds in the worse eye (study eye);
* A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period
Exclusion Criteria:
* Patient not suitable to participate in the study in the opinion of the investigator;
* Patient with a mild or moderate Dry Eye condition (severity level less than 3 according to the Report of the International Dry Eye Workshop -DEWS, 2007) if fourteen (14) patients with mild or moderate dry eye condition have been already enrolled in the current treatment group (Group 1 and Group 2 separately);
* Patient has had a serious adverse reaction or significant hypersensitivity to any drug or chemically related compounds or has a clinically significant allergy to drugs, foods, amide local anaesthetics or other materials including commercial artificial tears containing Hypromellose (in the opinion of the investigator);
* Use of topical cyclosporine, topical corticosteroids or any other topical medication for the treatment of dry eye in either eye within 30 days of study enrolment. Use of own artificial tears is allowed until Visit 2;
* Any ocular disease other than Dry Eye requiring treatment with topical medications in either eye within 30 days of study enrolment;
* Any active ocular infection or active inflammation in either eye unrelated to Dry Eye;
* Presence or history of any systemic or ocular disorder, condition or disease that could possibly interfere with the conduct of the required study procedures or the interpretation of the study results;
* Use of therapeutic or Refractive Contact lenses in either eye within 30 days of study enrolment;
* History of ocular surgery in the study eye, including corneal refractive procedures, within 90 days of study enrolment;
* Participation in another clinical study at the same time as the present and within 30 days of study enrolment;
* History of drug, medication or alcohol abuse or addiction.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02101281 | 140,734 |
{
"NCT_ID" : "NCT02300025",
"Brief_Title" : "A Study to Evaluate the Pharmacokinetics and Safety of Cobimetinib in Volunteers With and Without Liver Damage",
"Conditions" : ["Healthy Volunteer"],
"Interventions" : ["Drug: cobimetinib"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-01",
"Study_Completion_Date(Actual)" : "2015-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-11-20",
"First_Submitted_that_Met_QC_Criteria" : 2016-01-21",
"First_Posted(Estimated)" : 2014-11-24"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-11-21",
"Last_Update_Posted(Estimated)" : 2016-02-19",
"Last_Verified" : 2016-01"
}
}} | #Study Description
Brief Summary
This study is an open-label, multi-center, single-dose, parallel group study to determine the pharmacokinetics, safety, and tolerability of cobimetinib administered at 10 mg to fasted male and female adult subjects with varying degrees of hepatic function. The study will be conducted based on the Child-Pugh classification of hepatic impairment. The anticipated duration of the study is 7.5 weeks. The target sample sizes are: 18 volunteers with varying degrees of hepatic function and up to 12 healthy control volunteers.
#Intervention
- DRUG : cobimetinib
- single oral 10-mg dose of cobimetinib | #Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects between 18 and 74 years, inclusive
* Body weight >=45 kg and body mass index between 17 and 41 kg/m2, inclusive
* Subjects with hepatic impairment must have a Child-Pugh score of 5 to 6 (mild), 7 to 9 (moderate), or 10 to 15 (severe) and have stable hepatic insufficiency within 1 month prior to Screening and a stable medication regimen for at least 1 month prior to Check-in
* Agreement to use highly effective contraceptive methods as defined in the protocol
Exclusion Criteria:
* Significant illness, including infections, or hospitalization within the 2 weeks prior to dosing, except for subjects with hepatic impairment who due to their liver disease may be affected by significant medical problems which require frequent hospitalizations. Invasive systemic fungal infections need to be fully treated prior to study entry
* Significant history or clinical manifestations of any cardiac event that would put the subject at risk in the opinion of the Investigator
* Use of drugs of abuse within 1 month of Screening or during the entire study
* Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 74 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT02300025 | 29,375 |
{
"NCT_ID" : "NCT02405338",
"Brief_Title" : "DC Vaccination for Post-remission Therapy in AML",
"Official_title" : "Dendritic Cell-based Active Immunotherapy of Patients With Acute Myeloid Leukemia Using Autologous Cells Transfected With RNA Encoding Two Different Leukemia-associated Antigens",
"Conditions" : ["Acute Myeloid Leukemia"],
"Interventions" : ["Biological: WT1/PRAME vaccination"],
"Location_Countries" : ["Norway"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-11",
"Study_Completion_Date(Actual)" : "2019-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-03-24",
"First_Posted(Estimated)" : 2015-04-01"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-03-27",
"Last_Update_Posted(Estimated)" : 2020-07-07",
"Last_Verified" : 2019-07"
}
}} | #Study Description
Brief Summary
This is a multi-centre, open label, prospective, non-randomized phase I/II trial in 20 patients including a safety-run in phase I part comprising 6 patients.
Trial subjects will receive repeated immunotherapies with autologous Dendritic Cells (DCs), presenting two leukemia-associated antigens.
Detailed Description
20 patients with AML who are in remission (ELN criteria by Döhner et al 2017) receive WT1/PRAME autologous DC vaccine by intradermal injection once per week during the first 4 weeks and 1 per month thereafter for 23 consecutive months.
Primary objective is to assess the safety and tolerability of the DC vaccine in the aforementioned population and the feasibility.
Secondary objectives include evaluation of clinical response and exploratory immune monitoring assessments.
#Intervention
- BIOLOGICAL : WT1/PRAME vaccination | #Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Acute Myeloid Leukemia (AML)
* Age 18 - 75 years
* Morphologic remission (CR) with or without hematological recovery (CRi) following induction chemotherapy
* WT1 with or without PRAME positivity by qPCR
* Negative pregnancy test in women of childbearing potential (within 7 days before the first vaccination). Women of childbearing potential and sexually active male participants must use reliable methods of contraception during the whole treatment period and 3 months after the last trial drug dose
* Negative HIV 1 and 2 test, Hepatitis B and C test and negative Syphilis test at screening
* Informed consent signed prior to any trial related activities
Exclusion Criteria:
* Patients suitable for allogeneic stem cell transplantation
* AML M3 (acute promyelocytic leukemia)
* Patients not in complete remission (CR or CRi), bone marrow blast count >= 5 %
* Active immunodeficiency syndromes
* Concurrent active second malignancy other than non-melanoma skin cancers
* Clinically relevant autoimmune disease
* Prior immunotherapy
* Severe organ dysfunction precluding the apheresis procedure:
* Creatinine > 200 mmol/l
* Bilirubin, ALAT and ASAT > 3 x upper normal limit
* Respiratory insufficiency with pO2 < 60 mmHg
* Clinically relevant coronary heart disease of ventricular arrhythmia, congestive heart failure > grade II NYHA
* Recent cerebral hemorrhage
* Known allergies to substances used in the generation of DCs
* Other severe acute or chronic medical psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or the administration of the investigational product
* Use of corticosteroids
* Active CMV infection (Antibody-positivity due to previous, now inactive infection is accepted)
* Inability to comply with the trial protocol
* Participation in other clinical trials that, according to the investigator's discretion, may interfere with this trial
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02405338 | 134,415 |
{
"NCT_ID" : "NCT00356668",
"Brief_Title" : "Humidified High Flow Nasal Cannula as Compared to Nasal Continuous Positive Airway Pressure",
"Official_title" : "Observational, Cross-over Study of the Positive Distending Pressure Generated by Humidified High Flow Nasal Cannula as Compared to Nasal Continuous Positive Airway Pressure",
"Conditions" : ["Respiratory Distress Syndrome", "Cronic Lung Disease"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2006-07",
"Study_Completion_Date(Actual)" : "2007-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2006-07-24",
"First_Posted(Estimated)" : 2006-07-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2006-07-24",
"Last_Update_Posted(Estimated)" : 2015-07-14",
"Last_Verified" : 2015-07"
}
}} | #Study Description
Brief Summary
The specific aims of this study are to evaluate the amount of high flow nasal cannula (HFNC) gas flow required to generate an equivalent positive distending pressure as that provided by nasal continuous positive airway pressure (NCPAP) of 6 cm H2O, assess the relationships between positive distending pressure, gas flow, oxygen requirement, and patient weight, and lastly, develop an appropriate protocol to be used in the NICU for transitioning patients from NCPAP to an equivalent amount of HFNC.
Detailed Description
In the face of exogenous surfactant and use of antenatal steroids, respiratory distress syndrome (RDS) remains a leading cause of morbidity and mortality in premature infants. RDS is the result of a series of complex, interrelated events, including atelectasis, ventilation-perfusion mismatching, and lung inflammation/injury (1). The cascade of events which typifies RDS and its long-term counterpart, chronic lung disease (CLD), is rooted in the intrinsic deficits of the premature lung as well as exacerbated by mechanical ventilation, a mainstay of therapy. For this reason, scientists and clinicians alike continue to search for treatment modalities which will not only treat RDS but also decrease the incidence of chronic lung disease.
The use of non-invasive ventilatory strategies, such as nasal continuous positive airway pressure (NCPAP), in the treatment of RDS is thought to provide positive distending pressure while minimize lung inflammation and injury associated with mechanical ventilation (2). Avoidance of intubation and increased use of NCPAP to treat respiratory distress syndrome has been shown to decrease the incidence of chronic lung disease (3,4). However, NCPAP does have some common clinical limitations. First, the administration of NCPAP has inherent mechanical difficulties in appropriately maintaining the nasal prong apparatus within the small neonatal nose. Secondly, the nasal prongs used to deliver NCPAP can cause nasal septal trauma. Lastly, some premature infants do not tolerate the NCPAP apparatus which must be tightly affixed to their nose and face. This intolerance is often demonstrated by increased patient movement, and subsequently, the risk of mechanical difficulties and septal trauma increase during these times. Although NCPAP continues to be used in most neonatal intensive care units (NICUs), due to its aforementioned drawbacks, we continue to look for other effective, non-invasive modes of ventilation to provide support to premature infants with respiratory distress.
Humidified high flow nasal cannula (HFNC) has recently been introduced into neonatal respiratory care as a means of providing positive distending pressure to the neonate with respiratory distress. HFNC aims to maximize patient tolerance by employing heated, humidified gas flow through the standard neonatal nasal cannula that is used routinely in neonatal intensive care units. HFNC provides positive distending pressure by using high gas flow (\>1 liter per minute) (5). Although numerous neonatal intensive care units are using HFNC, including both NICUs at Children's Hospitals of Minnesota, there are very few studies regarding its use in this population. Anecdotally, the premature babies tolerate the administration of HFNC quite well. However, like any new therapy, there are many unknowns.
There is only one study to date which investigates HFNC versus NCPAP in the preterm neonate (6). Sreenan and colleagues found HFNC to be as effective as NCPAP in the management of apnea of prematurity and also demonstrated that the positive distending pressure provided by HFNC varied with the patient's weight. Sreenan's study as well as preliminary data presented in abstract form cite HFNC use with various amounts of gas flow, ranging from 1 liter per minute up to 6 liters per minute (6,7,8). The choice of how much gas flow to use with the HFNC system is unclear. This decision is actually a three-fold question: 1) the initial amount of liter flow to use, 2) what does a particular liter flow provide for positive distending pressure to that patient, and 3) are these values system-specific? We aim to evaluate these questions in our study. Until recently, NCPAP has been the mainstay of non-invasive ventilatory support for premature babies. However, as HFNC is better tolerated and uses a nasal cannula that is less prone to mechanical mishaps than NCPAP, it is clear that we need more information to accurately treat babies with HFNC. The results of this study will help guide the use of HFNC in preterm babies with respiratory insufficiency, as knowledge of the positive distending pressures derived from the HFNC system are crucial in minimizing barotrauma to the fragile, premature lung.
#Intervention
- DEVICE : High Flow Nasal Cannula
- 30 minute blocks on varying flows of high flow nasal cannula | #Eligibility Criteria:
Inclusion Criteria:
* 1) receiving NCPAP ventilatory support at > 72 hrs. of age and 2) requiring FiO2 21 <= age <= 50% on NCPAP.
Exclusion Criteria:
* FiO2 >50%, presence of pneumothorax or pleural effusion, anatomical abnormalities of the airway, lungs, or esophagus, or cyanotic congenital heart defect.
Sex :
ALL
Ages :
- Minimum Age : 72 Hours
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT00356668 | 114,548 |
{
"NCT_ID" : "NCT01431521",
"Brief_Title" : "Study of Changes in Hepatic Fat Following Administration of MK-4074 and Pioglitazone Hydrochloride (MK-4074-008)",
"Official_title" : "An Exploratory Study to Evaluate Changes in Hepatic Fat Following Multiple-Dose Administration of MK-4074 and Pioglitazone Hydrochloride",
"Conditions" : ["Non-alcoholic Fatty Liver Disease"],
"Interventions" : ["Drug: Placebo for MK-4074", "Drug: Placebo for pioglitazone hydrochloride", "Drug: Pioglitazone hydrochloride 30 mg", "Drug: MK-4074 200 mg"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-10-26",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-09-18",
"Study_Completion_Date(Actual)" : "2012-10-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2011-09-07",
"First_Submitted_that_Met_QC_Criteria" : 2016-02-24",
"First_Posted(Estimated)" : 2011-09-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-09-07",
"Last_Update_Posted(Estimated)" : 2018-09-10",
"Last_Verified" : 2018-08"
}
}} | #Study Description
Brief Summary
This study will evaluate changes in liver fat content following multiple oral doses of MK-4074 and Pioglitazone Hydrochloride in adult males and females with fatty liver disease. The primary hypothesis of the study is that a multiple-dose administration of MK-4074 200 mg twice daily for 4 weeks results in a decrease in hepatic fat content with respect to placebo in adult male and female participants with hepatic steatosis (i.e., on order of 50% reduction in hepatic fat with respect to placebo is expected).
#Intervention
- DRUG : MK-4074 200 mg
- 2 x 100-mg capsules, orally, twice-daily (BID) for 4 weeks
- DRUG : Placebo for MK-4074
- 2 x 100-mg capsules, orally, BID for 4 weeks.
- DRUG : Pioglitazone hydrochloride 30 mg
- 1 x 30-mg tablet, orally, once daily for 4 weeks
- DRUG : Placebo for pioglitazone hydrochloride
- 1 x 30-mg tablet, orally, once daily for 4 weeks | #Eligibility Criteria:
Inclusion Criteria:
* Females must be of non-childbearing potential
* Body mass index (BMI) >=32.0 kg/m^2
* In good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests
* No clinically significant abnormality on electrocardiogram
* Has documented hepatic fat content >=10% within 6 months of enrollment
* Maintained stable weight (by history) for at least 4 weeks
* Agrees not to initiate a weight loss program and agrees to maintain consistent dietary habits and exercise routines for the duration of the study
* Has a rating of 'moderate' or 'severe' steatosis on ultrasound at the prestudy (screening) visit
Exclusion Criteria:
* Change in weight greater than 4% between prestudy visit and randomization into the study
* History of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant
* Liver disease other than fatty liver or non-alcoholic steatohepatitis (NASH)
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >=3x the upper limit of normal range
* Serum triglyceride level >600 mg/dL
* History of stroke, chronic seizures, or major neurological disorder
* History of clinically significant endocrine, gastrointestinal, cardiovascular (including congestive heart failure), hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
* Had abdominal surgery, gastric bypass, bowel resection, recent liver biopsy, or any other procedure within a minimum of 4 weeks
* History of neoplastic disease
* Claustrophobia or other contraindication to magnetic resonance imaging (MRI)
* Have not washed off agents associated with changes in hepatic fat or used for treatment of Non-alcoholic fatty liver disease (NAFLD) or NASH for a minimum of 3 months prior
* Consumes excessive amounts of alcohol, coffee, tea, cola, or other caffeinated beverages
* Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks
* Significant multiple and/or severe allergies
* Intolerance or hypersensitivity to pioglitazone hydrochloride or any inactive ingredients
* Regular user of any illicit drugs or has a history of drug (including alcohol) abuse.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
| NCT01431521 | 187,628 |
{
"NCT_ID" : "NCT03082664",
"Brief_Title" : "Negative Pressure Wound Therapy to Prevent Wound Complications Following Cesarean Section in High Risk Patients",
"Official_title" : "Topical Negative Pressure Wound Therapy to Prevent Wound Complications Following Cesarean Section in High Risk Obstetric Patients",
"Conditions" : ["High Risk Pregnancy", "Cesarean Wound Disruption With Postnatal Complication"],
"Interventions" : ["Device: PICO Single Use Negative Pressure Wound Therapy"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-03",
"Study_Completion_Date(Actual)" : "2019-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-03-13",
"First_Submitted_that_Met_QC_Criteria" : 2022-09-05",
"First_Posted(Estimated)" : 2017-03-17"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-03-13",
"Last_Update_Posted(Estimated)" : 2022-09-26",
"Last_Verified" : 2022-09"
}
}} | #Study Description
Brief Summary
This is a randomized controlled trial. Patients with a condition that increases their risk of a wound complication will be approached for inclusion in the trial. Each participant agreeing to study inclusion will be randomized to either suture alone or to closure of their skin incision with suture and then with prophylactic placement of a wound vac (PICO).
Detailed Description
Once consent has been obtained from patients, an envelope containing the study allocation will be retrieved from the Pyxis.
* Non-wound vac patients will undergo wound closure with subcutaneous fat closure with Vicryl in all cases that this is practicable (in extremely thin patients, this may not be possible), followed by subcuticular skin closure also using Vicryl. A compression dressing will then be applied. This dressing is usually removed by the clinician the following day.
* Wound vac (PICO) patients will undergo wound closure with subcutaneous fat closure with Vicryl in all cases that this is practicable (in extremely thin patients, this may not be possible), followed by subcuticular skin closure also using Vicryl. The wound vac system will then be applied over the closed incision. This vac dressing will then be removed on the day of hospital discharge and replaced with a second bandage and the wound vacuum will be re-activated. The patient will remove the bandage and discard on POD#7. This is per the manufacturer's guidelines for length of use.
* If the patient fails the wound vac therapy- ie the wound separates and requires traditional wound care (packing, wet to dry dressing, etc), then the PICO system is no longer used as part of their care.
It would be unrealistic to try to standardize the entire operative approach (closure of the uterus, closure of the fascia) as the different providers working at the hospital may choose not to participate if the approach specified deviated too much from their usual technique. Different providers may typically use different kinds or sutures (made of different material, and of different sizes) or staples to close the subcutaneous fat and the skin. However, for this study all patients will have the subcutaneous fat and skin closed in the same manner (with Vicryl suture). To participate in the trial patients will have to agree to these closure materials. For this study a standard closure with suture was chosen as there is evidence suggesting a lower rate of wound complications with suture as compared to staples.
The wound will be re-assessed at their 2 week and 6 week post-op follow up visits. The patients will be assessed by a physician at their post-operative clinic visits. The physician/investigator will ask the patient if they have had any postoperative complications since their surgery and will be asked to detail any complications if they answer yes to this question. The investigators will also obtain permission to call the participants for a patient satisfaction questionnaire at 1 week post-op, and possibly 2 and 6 weeks if they have not presented for their post op/partum appointments or the questionnaire could not be obtained at their visit.
#Intervention
- DEVICE : PICO Single Use Negative Pressure Wound Therapy
- The PICO device will be placed over the closed cesarean section incision.
- Other Names :
- Smith & Nephew PICO patch | #Eligibility Criteria:
Inclusion Criteria:
* Maternal Age 18 or above
* Cesarean delivery
* Maternal condition which increases the risk of wound complication. These conditions include: Obesity (BMI >30), diabetes, HIV/AIDS, chorioamnionitis, rheumatologic disease, history of wound complication, anticoagulant therapy.
* Patient able to read and speak English or Spanish.
Exclusion Criteria:
* Minors (<18 years)
* Non-cesarean wound (ie tubal ligation wound)
* No high risk maternal condition
* Patient unable to read and speak English or Spanish.
* Prisoners
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03082664 | 176,615 |
{
"NCT_ID" : "NCT02412020",
"Brief_Title" : "Treatment of Refractory Chronic Cough With PA101",
"Official_title" : "Treatment of Chronic Idiopathic Cough and Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis With PA101",
"Conditions" : ["Refractory Chronic Cough"],
"Interventions" : ["Drug: Placebo", "Drug: PA101"],
"Location_Countries" : ["Netherlands", "United Kingdom"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-01",
"Study_Completion_Date(Actual)" : "2016-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-04-03",
"First_Posted(Estimated)" : 2015-04-08"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-04-03",
"Last_Update_Posted(Estimated)" : 2016-02-22",
"Last_Verified" : 2016-02"
}
}} | #Study Description
Brief Summary
This is a double-blind, randomized, placebo-controlled, 2-period crossover, 2-cohort study in adult patients with refractory chronic cough.
The purpose of the study is to assess the efficacy and safety of inhaled PA101 delivered via eFlow high efficiency nebulizer for treating refractory chronic cough.
Detailed Description
The study consists of 2 treatment cohorts with refractory chronic cough: Idiopathic Pulmonary Fibrosis (IPF, Cohort 1) and Chronic Idiopathic Cough (CIC, Cohort 2). In each cohort, the study will include two treatment periods of 14 days each separated by a Washout Period of 14 days between Period 1 and Period 2. The two periods will be identical except that in Period 2, patients will crossover to the alternate treatment from that received in Period 1, according to a 1:1 randomization scheme.
During each period, patients will self-administer study drug (i.e., 40 mg PA101 or Placebo PA101 via eFlow) three times daily for 14 consecutive days of each period. Objective cough count will be recorded over 24-hour period using a cough count device (Leicester Cough Monitor) at the Baseline, Day 7 and Day 14 of each treatment period.
In the IPF cohort, patients will be allowed to use antifibrotic therapy (i.e., pirfenidone, nintedanib, and N-acetylcysteine) during the course of the study provided that the dose is stabilized at least 3 months prior to Screening and throughout the study period.
Clinical safety assessments will be performed at the start and end of each treatment period.
#Intervention
- DRUG : PA101
- DRUG : Placebo | #Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Idiopathic Pulmonary Fibrosis (based on presence of definitive or possible usual interstitial pneumonia UIP pattern on high-resolution computed tomography and after excluding lung diseases associated with environmental and occupational exposure, with connective tissue disease and with drugs; transfer capacity for carbon monoxide corrected for hemoglobin [TLCOc] >25% predicted within 12 months of Screening; and forced vital capacity [FRC] >50% predicted within 1 month of Screening) or Chronic Idiopathic Cough (that is unresponsive to targeted treatment for identified underlying triggers including post-nasal drip, asthmatic/non-asthmatic eosinophilic bronchitis, and gastro-esophageal reflux disease)
* Refractory chronic cough for at least 8 weeks
* Daytime cough severity score >40 mm on Cough Severity VAS at Screening
* Daytime average cough count >=15 per hour at Screening
* Willing and able to provide written informed consent
Exclusion Criteria:
* Current or recent history of clinically significant medical condition, laboratory abnormality or illness that could put the patient at risk or compromise the quality of the study data as determined by the investigator
* Upper or lower respiratory tract infection within 4 weeks of Screening
* History of malignancy treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma or cervix carcinoma in situ
* Current or recent history (within 12 months) of excessive use or abuse of alcohol
* Current or recent history (within 12 months) of abusing legal drugs or use of illegal drugs or substances
* Participation in any other investigational drug study within 4 weeks of Screening
* Use of prednisone, narcotic antitussives, baclofen, gabapentin, inhaled corticosteroids, benzonatate, dextromethorphan, carbetapentane, H1 antihistamines, leukotriene modifiers, and cromolyn sodium within 2 weeks of Screening
* Pregnant or breastfeeding females, or if of child-bearing potential unwilling to practice acceptable means of birth control or abstinence during the study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02412020 | 20,056 |
{
"NCT_ID" : "NCT01779076",
"Brief_Title" : "Oxygen Level and Safe Emergence From Anesthesia",
"Official_title" : "Emergence From General Anesthesia With Laryngeal Mask Airway and Increased End-expiratory Pressure Using 30% Oxygen is as Safe as With 100% Oxygen But Reduces the Area of Post Operative Atelectasis.",
"Conditions" : ["Focus of Study is Postoperative Pulmonary Atelectacis"],
"Interventions" : ["Procedure: 100% oxygen", "Procedure: 30% oxygen"],
"Location_Countries" : ["Sweden"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-06",
"Study_Completion_Date(Actual)" : "2013-06-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-01-28",
"First_Posted(Estimated)" : 2013-01-30"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-01-28",
"Last_Update_Posted(Estimated)" : 2018-01-17",
"Last_Verified" : 2018-01"
}
}} | #Study Description
Brief Summary
Using a protective ventilation strategy during general anesthesia from pre-oxygenation to emergence and selecting patients without risk of a difficult airway or intubation, a lower fraction of inspiratory oxygen (FIO2) can be used during extubation. This might reduce the postoperative area of atelectasis without desaturations becoming more common.
#Intervention
- PROCEDURE : 30% oxygen
- PROCEDURE : 100% oxygen | #Eligibility Criteria:
Inclusion Criteria:
* No sign of difficult airway or intubation
* Day case surgery in total intravenous anesthesia with laryngeal mask airway without adding regional anesthesia of plexus brachialis or muscle relaxant.
* Body mass index less than 35.
* American Society of Anesthesiologists physical status (ASA) class I-III
Exclusion Criteria:
* Body mass index 35 or higher
* Increased risk of aspiration
* Obstructive sleep apnea syndrome
* Procedures during surgery making a former easy airway a difficult airway
* Need for opioids after extubation
* Hypothermia
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01779076 | 5,237 |
{
"NCT_ID" : "NCT04478981",
"Brief_Title" : "The Natural History of Patients With Mutations in SEPN1 (SELENON) or LAMA2",
"Official_title" : "The Natural History of Patients With Congenital Muscular Dystrophies Due to Mutations in the SELENON or LAMA2 Genes: Working Towards Trial-readiness in Two Mitochondrial Myopathy Mimics",
"Conditions" : ["MDC1A", "SELENON-related Myopathy"],
"Interventions" : ["Other: No intervention"],
"Location_Countries" : ["Netherlands"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-08-26",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-05-23",
"Study_Completion_Date(Actual)" : "2023-03-24},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-07-09",
"First_Posted(Estimated)" : 2020-07-21"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-07-16",
"Last_Update_Posted(Estimated)" : 2023-11-18",
"Last_Verified" : 2022-04"
}
}} | #Study Description
Brief Summary
SEPN1 (SELENON) is a rare congenital myopathy due to mutations in the SELENON gene. MDC1A is a rare congenital muscle dystrophy due to mutations in the LAMA2 gene. Currently, not much is known about the natural history of these two muscle diseases and no (curative) treatment options exist. The investigators aim to study the natural history of SELENON- and LAMA2-related myopathy/congenital muscular dystrophy patients and prepare for future trials by selection of the most appropriate outcome measures. To this end, a standard medical history, neurological examination, functional measures, questionnaires, cardiac examination, respiratory function tests, radiological examination and accelerometry will be performed over an one and-a-half year period.
Detailed Description
Rationale: Patients with mutations in the SELENON gene suffer from slowly progressive congenital muscular dystrophy with early onset rigidity of the spine and potentially life-threatening respiratory insufficiency. The protein encoded by SELENON, selenoprotein-1, functions as an endogeneous antioxidant and executes a role in cellular redox metabolism. The first results of an intervention study using KH176, currently under development for mitochondrial disease, in an animal model (Sepn1 knock out zebrafish) showed improved muscular function. Patients with mutations in LAMA2 gene causing merosin-deficient congenital muscular dystrophy (MDC1A) have a similar phenotype as those with mutations in SELENON gene. Key characteristics include congenital hypotonia, delayed motor development and contractures. For them no treatment is available either. Since not much is known about the clinical progression of these two congenital muscle diseases, there is an urgent need for natural history-outcome measure studies to reach trial-readiness enabling smooth transition towards clinical trials.
Objective: The primary objective is to identify and follow (i.e. describe the natural history of) patients with congenital myopathy/muscular dystrophy due to mutations in SELENON- or LAMA2 genes. The secondary objectives are: 1. to select appropriate outcome measures based on the natural history data. 2. to determine the necessity for routine cardiological and respiratory screening.
Study design: This is an observational study. A standard medical history, neurological examination, functional measures, questionnaires, cardiac examination, respiratory function tests, radiological examination (qualitative and quantitative full body MRI, muscle ultrasound, DEXA scan, X-ray of the spine) and accelerometry will be performed. For each participant, the investigators will perform four six-monthly measurements over an one-and-a-half year period. If more than 20 patients are willing to participate in this study, the investigators will select per muscle disease 10 participants that are representative of the entire patient population (based on age, gender, disease severity etc.). Patients that are not included in this study and patients that are not able to or do not wish to visit the Radboudumc will be retrospectively analyzed through medical records. Additionally, they will receive questionnaires, which can be completed at home.
Study population: all patients with congenital myopathy/muscular dystrophy due to mutations in the SELENON or LAMA2 genes.
Risk and benefit assessment: This study does not concern any product (medicinal product, food product, or medical device). There is a small risk for minor injury, e.g. when a participant falls. However, since the investigators use all functional test using movements to which most participants are familiar (i.e. walking, transfers, etc), the participant will be able to estimate his/her own risk. The investigators don't include tests in which they push participants to their physical limits. The investigators conclude that this study has a negligible risk. A benefit includes the possibility for participants to get a detailed analysis on their own health. Additionally, participants will contribute to the design of future clinical trials on possible treatment options.
#Intervention
- OTHER : No intervention
- This concerns a natural history study; no interventions will be used | #Eligibility Criteria:
Inclusion Criteria:
* Willing and able to complete (part of the) measurement protocol
* Willing and able to travel to Nijmegen (The Netherlands)
* Dutch-speaking
* Genetically-confirmed muscle disease caused by mutations in SELENON (SEPN1): congenital muscular dystrophy with early spine rigidity or congenital myopathy (multicore/minicore disease, congenital fiber type size disproportion)
* Genetically confirmed muscular dystrophy caused by mutations in LAMA2: merosin-deficient muscular dystrophy 1A (early-onset LAMA2-related muscular dystrophy) or childhood-onset limb-girdle type muscular dystrophy (late-onset LAMA2-related muscular dystrophy)
Exclusion Criteria:
* None
Sex :
ALL
Ages :
- Minimum Age : 1 Day
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT04478981 | 138,877 |
{
"NCT_ID" : "NCT02068703",
"Brief_Title" : "Sleep Enhancing Tools: Pilot Study",
"Official_title" : "Use of Sleep Enhancing Tools Impact on Self-Reported Sleep Survey",
"Conditions" : ["Sleep", "Pain"],
"Interventions" : ["Behavioral: Sleep Education Presentation", "Behavioral: Sleep Tool Demonstration"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "HEALTH_SERVICES_RESEARCH",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-09",
"Study_Completion_Date(Actual)" : "2015-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-02-19",
"First_Posted(Estimated)" : 2014-02-21"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-02-19",
"Last_Update_Posted(Estimated)" : 2016-06-28",
"Last_Verified" : 2016-06"
}
}} | #Study Description
Brief Summary
To demonstrate whether use of sleep enhancing aids (face mask, ear plugs or white noise machine) in hospitalized patients can positively affect subjective symptoms of sleep quality, fatigue and pain.
Detailed Description
A randomized, clinical pilot to trial the effect of sleep tools on patients' perception of sleep within the hospital setting.
We propose to conduct this pilot study to improve subjective symptoms of sleep deprivation in non-ICU hospitalized subjects by performing a brief intervention, easily performed at the point of care. Given the heterogeneity of hospitalized patients with varying ages, co-morbidities and other factors (such as pain and fatigue), we felt that an initial pilot study should focus on acceptability of three sleep aids (ear plugs, eye masks and white noise machine) among hospitalized non-ICU patients. Patients will be able to choose which aid they use and will be allowed to change aids during their hospital stay.
The primary outcomes of this study will be 1) improvement in perceived sleep quality as measured by PROMIS, a validated patient-reported outcome information system and 2) quality of care measures (length of stay, medication use and participation in therapy sessions).
PROMIS (Patient Reported Outcomes Measurement Information System) is an NIH sponsored health survey tool.
Information on characteristics (both patient and environment) including demographics, illness severity, number of medications, specific medications (such as sedatives and pain medications) will be collected to examine which predictors of improved perception of sleep quality correlate with use of sleep aids. This study is intended to focus on modifying the environment at the patient level rather than addressing the sources of environmental hospital noise.
Our study has the potential to impact this field with a preventative education based intervention, using simple tools in the non-ICU setting. It is important to understand this is not a study measuring sleep objectively but whether hospitalized patients perceive they sleep better if sleep aids are used.
#Intervention
- BEHAVIORAL : Sleep Education Presentation
- Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep WITHOUT a demonstration of tools to improve sleep.
- BEHAVIORAL : Sleep Tool Demonstration
- Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep PLUS a demonstration of tools to improve sleep. | #Eligibility Criteria:
Inclusion Criteria:
* Admitted to a private room in the hospital
* Speak and read english
* expected length of stay > 2 days
Exclusion Criteria:
* Hearing aids
* sleep apnea using positive airway pressure therapy
* medically or behaviorally unstable
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02068703 | 177,247 |
{
"NCT_ID" : "NCT02335866",
"Brief_Title" : "Platelet-Rich Fibrin in the Treatment of Multiple Gingival Recessions",
"Official_title" : "Platelet Rich Fibrin Against Connective Tissue Graft in Treatment of Gingival Recessions",
"Conditions" : ["Gingival Recessions"],
"Interventions" : ["Procedure: Control groups", "Procedure: test groups"],
"Location_Countries" : ["Turkey"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["EARLY_PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-01",
"Study_Completion_Date(Actual)" : "2014-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-12-13",
"First_Posted(Estimated)" : 2015-01-12"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-01-07",
"Last_Update_Posted(Estimated)" : 2015-01-12",
"Last_Verified" : 2015-01"
}
}} | #Study Description
Brief Summary
The main objective of this study was to evaluate the clinical effectiveness of platelet-rich fibrin membrane used in combination with a coronally advanced flap and to compare it with the use of a subepitelial connective tissue graft in combination with a coronally advanced flap in Miller class I-II bilateral gingival recession treatment
Detailed Description
Purpose
The main objective of this study was to evaluate the clinical effectiveness of platelet-rich fibrin (PRF) in combination with modified coronally advanced flap (MCAF) in the treatment of multiple gingival recessions. Furthermore the second aim of the present study was to compare plastic periodontal surgical procedure, with PRF membrane and connective tissue graft, by a randomized splitmouth controlled study.
Clinical effectiveness of platelet-rich fibrin (PRF) in combination with modified coronally advanced flap (MCAF) as measured by Clinical measurements.
Material and Methods
Twenty patients with multiple gingival recession defects (Miller I, II) participated in this split-mouth trial. Sixty defects received either MCAF+PRF (test) or MCAF with subepithelial connective tissue graft (SCTG) (control). Gingival recession depth (RD), gingival recession width (RW), keratinized tissue width (KTW), recession area (RA), probing depth (PD), clinical attachment level (CAL) and gingival thickness (GT) were evaluated at baseline and 6 months. Additionally post-surgery patient satisfaction and pain status were measured by comparing visual analogue scale (VAS) scores.
Clinical measurements were taken at starting point and 6 months postoperatively. The measurements comprised an assessment of probing depth (PD),clinical attachment level (CAL) and gingival recession parameters including recession depth (RD), recession width (RW), keratinized tissue width (KTW) and gingival thickness (GT) were assessed by a calibrated examiner (E. Ö.). PD, CAL, RD, RW and KTW values were recorded by a Williams probe graduated in 1-mm increments and rounded up to the nearest millimeter (Hu Friedy, Chicago, IL, USA). To standardize the clinical measurements acrylic stents were prepared on patients' casts. The following measurements were recorded at the mid-buccal point of the teeth at baseline and6 months after surgery. GT was evaluated using endodontic reamer attached to a rubber stopper inserted perpendicularly into the gingival tissue 3 mm below the gingival margin under local anesthesia, and then the thickness was measured to the nearest 0.1 mm using a caliper.RD was measured from the CEJ to the gingival margin, RW was measured tangentially at the mid-facial CEJ and RA was calculated as the area within the contour of denuded root. KTW recorded as the distance from the mucogingival junction to the gingival margin. Duplicate measurements were made for RD, RW, RA and KTW with an interval of 24 hours and the average value of two measurements was used for the assessment. The postoperative pain was evaluated with a visual analog score (VAS).
#Intervention
- PROCEDURE : test groups
- At the test sites, the previously prepared PRF was positioned over the recession defects, the coronal margin of the PRF was placed at the CEJ
- Other Names :
- PRF groups
- PROCEDURE : Control groups
- Split-full-split thickness flap incisions were performed in a coronal-apical direction. The papillae adjacent to the involved tooth were de-epithelialized to create a connective tissue bed. The gingival flap was repositioned without tension, with its margin located on the enamel, on the test and control sides. It was held in that position with 5-0 resoble sutures
- Other Names :
- Connective tissue graft groups | #Eligibility Criteria:
Inclusion Criteria:
* non smoking,
* similar bilateral Miller Class I or II20 localized gingival recessions at least >=3 mm, located on incisors, canines or premolars on both jaws,
* identifiable cemento-enamel junction (CEJ),
* age >=18 years,
* presence of tooth vitality and absence of restorations and superficial caries in the area to be treated,
* no periodontal surgical treatment on the involved sites,
* sufficient palatal donor tissue at least >=2.5 mm thickness for the indicated SCTG
Exclusion Criteria:
* Patients in a pregnancy or lactation period or with self-reported history of antibiotic medication within 6 months
* Molar, mobile or fully restorated teeth
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT02335866 | 225,913 |
{
"NCT_ID" : "NCT00417404",
"Brief_Title" : "Vitamin A and Very Low Birthweight Babies (VitAL)",
"Official_title" : "Does Additional Vitamin A Supplementation Improve Retinal Function and Conjunctival Health in Very Low Birthweight Infants?",
"Conditions" : ["Preterm Birth", "Retinopathy of Prematurity"],
"Interventions" : ["Drug: Aquasol A", "Other: sham injection"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2007-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-12",
"Study_Completion_Date(Actual)" : "2009-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2006-12-29",
"First_Posted(Estimated)" : 2007-01-01"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2006-12-29",
"Last_Update_Posted(Estimated)" : 2010-06-25",
"Last_Verified" : 2010-06"
}
}} | #Study Description
Brief Summary
Vitamin A is important for the development of healthy eyes and lungs. Very low birth weight premature babies have low body stores of vitamin A and are prone to diseases of the eye and lungs. Previous work has shown that intramuscular (IM) vitamin A reduces the number of babies who require prolonged oxygen therapy, and may also reduce the number of babies affected by retinopathy of prematurity (ROP)). There is also some evidence that the conjunctiva shows signs of deficiency of vitamin A in premature infants, particularly those who develop ROP. Our own work here in Glasgow suggests that, compared to babies born at full term, premature babies' eyes are less sensitive to light and we believe that this may reflect shortage of vitamin A in the eye. This study will examine the effects upon the eye of giving extra intramuscular vitamin A to very low birth weight, premature infants. We will also measure blood levels of vitamin A and calculate liver stores of this nutrient.
Detailed Description
Eligible infant will be those infants born at \< 32 completed weeks gestation and/or weighing \< 1501 grams birth weight who have been admitted to either Princess Royal Maternity or Queen Mother's Hospital within the first 24 hours of life. If informed, written consent is obtained within 48-72 hours of birth, the infant will be randomised into either control or intervention group.
The intervention group will receive IM vitamin A (Aquasol A)10,000IU three times weekly; control infants will receive mock injections. Injections will be continued for 4 weeks (maximum 12 injections). If enteral feeds are tolerated (defined as more than 75% of predicted intake via the enteral route)after the 14th day, oral vitamin A (as part of a multivitamin preparation) will be commenced and IM vitamin A discontinued. The dose of oral vitamin A will be 5000IU daily (= 0.6ml Dalivit), continued through discharge from the neonatal unit until the first birthday. The same oral vitamin supplement will be given to all VLBW babies, whether or not enrolled in this study. For infants receiving parenteral nutrition, Vitlipid N infant (4ml/kg/day) will be commenced on day 2, or at the discretion of the attending neonatologist. This will be given in addition to IM vitamin A.
The study design is partially blinded whereby control infants will have mock injections (as described by Tyson et al.), rather than placebo injections. Infants randomised to placebo will simply have a sticking plaster applied to a leg prior to the screens being withdrawn. The research nurse will therefore be blinded to the infant's randomisation.
Blood samples will be collected from enrolled infants at birth (or immediately after randomisation), on day 7, day 28 and at 36 corrected weeks. Samples will be separated, frozen and plasma retinol subsequently analysed by high pressure liquid chromatography.
The RDR test will be performed as close as practicable to 36 corrected weeks, and whenever possible in conjunction with routine blood sampling. The baby will be given oral vitamin A, 2000IU/kg, and a second specimen of blood obtained 3 hours after administration of vitamin A. As well as measurement of plasma retinol concentration, red blood cells will be analysed for the DHA content of the cell membrane.
Retinal function will be assessed using the electroretinogram (ERG), in conjunction with routine ROP screening and as close as possible to 36 corrected weeks. The ERG luminance-response function will be recorded using different filters and background lighting to distinguish rod and cone responses. Conjunctival impression cytology (CIC) will be performed coincident with the ERG by taking a single sample from the bulbar conjunctiva, using a Millicell® filter.
All infants will be examined weekly for signs of vitamin A toxicity, including mucocutaneous lesions, bone and joint abnormalities and fullness of the anterior fontanelle. Weekly blood tests during the period of IM injections will include full blood count and liver function.
#Intervention
- DRUG : Aquasol A
- IM Aquasol A 10,000IU three times weekly
- Other Names :
- vitamin A
- DRUG : aquasol A
- 10,000 IU three times weeks, by intramuscular injection
- Other Names :
- vitamin A
- OTHER : sham injection
- sham injection | #Eligibility Criteria:
Inclusion Criteria:
* Infants born at < 32 completed weeks gestation and/or weighing < 1501 grams birth weight who have been admitted to either Princess Royal Maternity or Queen Mother's Hospital within the first 24 hours of life.
Exclusion Criteria:
* Congenital ocular abnormality
Sex :
ALL
Ages :
- Minimum Age : 24 Hours
- Maximum Age : 72 Hours
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
| NCT00417404 | 74,740 |
{
"NCT_ID" : "NCT05671523",
"Brief_Title" : "Effect Of Dry Needling On Quality Of Life In Patients With Trigger Fingers",
"Official_title" : "Effect Of Dry Needling On Quality Of Life In Patients With Trigger Fingers. Randomized Controlled Trail",
"Conditions" : ["Trigger Finger Disorder"],
"Interventions" : ["Procedure: Dry needling", "Other: conventional treatment"],
"Location_Countries" : ["Egypt"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2023-01-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-06-10",
"Study_Completion_Date(Actual)" : "2023-06-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-12-14",
"First_Posted(Estimated)" : 2023-01-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-12-26",
"Last_Update_Posted(Estimated)" : 2023-09-13",
"Last_Verified" : 2023-09"
}
}} | #Study Description
Brief Summary
This study will be conducted to investigate the effect of dry needling on quality of life in patients with trigger finger
Detailed Description
Trigger finger (TF) is one of the most prevalent causes of hand disability and is a common cause of referral to orthopedic clinics. Trigger finger is tenosynovitis of the flexor sheaths that typically occurs in the 4th finger and thumb as a result of repetitive use. The incidence of TF is 28:100,000 per year or lifetime risk of 2.6% in the general population. It has the highest incidence being between 52 and 62 years more in women (75%). Thumb and fourth digit (ring finger) are the most commonly affected fingers.
Dry needling (DN) is a relatively new technique used by physical therapists to treat myofascial trigger points (MTrPs) and various pain syndromes. Dry needling is defined as a 'skilled intervention using a thin filiform needle to penetrate the skin that stimulates myofascial TrPs, muscles, and connective tissue for the treatment of musculoskeletal pain disorders. DN has analgesic and anti-inflammatory effects, it is commonly used to relieve pain and reduce inflammation.
#Intervention
- PROCEDURE : Dry needling
- Firstly the skin is cleaned with a piece of cotton immersed in alcohol. Then sterilized disposable thin, stainless steel needles (25 × 0.30 mm) will be inserted into the skin over the nodule in A1 pulley anatomic location. The duration of needling will be 1 minute. The needle will be inserted deeply at 45° to the level of metacarpophalangeal level to the nodule. The needle may be inserted into the tendon. This is confirmed by needle movement when the patient flexes and extends the distal phalanx. The needle is withdrawn slowly until this motion ceases, and the needle tip is in the A1 pulley. This will be repeated 2 times per week for 5 weeks.
- OTHER : conventional treatment
- Finger splint is designed to stabilize and immobilize a small finger joint. A wide, flat band offers comfortable pressure distribution and control. Contoured finger splint with a comfortable, close fit. The patient will use the splint at night. Can easily be adjusted to accommodate swollen digits. Suitable for a number of finger conditions.
Therapeutic ultrasound is often used by physiotherapists to reduce pain, increase circulation and increase mobility of soft tissues. Additionally, the application of ultrasound can be helpful in the reduction of inflammation, reducing pain and the healing. | #Eligibility Criteria:
Inclusion Criteria:
* 40 patients all have trigger fingers lasting at least 4 weeks.
* Both gender will be included
* Age of patients will be 45 <= age <= 75 years
* Pain and tenderness at the position of A1 pulley.
* Nodule palpation, pain, and discomfort when flexing and extending the finger, presence of a clicking sound at the time of flexion or extension of the finger, snapping or locking of the finger.
* Willing and able to complete study procedures.
Exclusion Criteria:
* Participants with diabetes mellitus.
* History of trauma, and rheumatoid arthritis.
* Dialysis treatment.
* fingers with a history of local gouty/pyogenic disease.
* Major hand trauma and fear of needles.
* Any contraindication for deep dry needling such as anticoagulants, infections, bleeding, or psychotic conditions tumors, calcium deposits, or severe osteoarthritis.
Sex :
ALL
Ages :
- Minimum Age : 45 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT05671523 | 100,235 |
{
"NCT_ID" : "NCT02168933",
"Brief_Title" : "308nm Excimer Laser for Treatment of Fingernail Psoriasis",
"Official_title" : "Randomized Controlled Trial of 308 nm Excimer Laser for Treatment of Nail Psoriasis",
"Conditions" : ["Nail Psoriasis"],
"Interventions" : ["Device: Sham laser", "Device: 308 nm excimer laser"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-12",
"Study_Completion_Date(Actual)" : "2015-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-06-18",
"First_Submitted_that_Met_QC_Criteria" : 2019-07-31",
"First_Posted(Estimated)" : 2014-06-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-06-19",
"Last_Update_Posted(Estimated)" : 2019-09-18",
"Last_Verified" : 2019-09"
}
}} | #Study Description
Brief Summary
Psoriasis is a common skin disease, which affects 2-3% of the population. Up to two third of patients with psoriasis develop nail changes. These visible changes can be painful and disabling and are associated with social stigma. Most topical treatments are only partially effective. Systemic treatments can have serious side effects. Excimer laser is a form of targeted ultraviolet light therapy that has been successfully used to treat isolated psoriatic plaques on difficult to treat areas such as scalp or palms. The purpose of this study is to investigate efficacy of excimer laser for treatment of fingernail psoriasis. Sixteen patients with stable fairly symmetric fingernail psoriasis will be enrolled. After obtaining informed consent, an investigator will evaluate the severity of nail psoriasis in each hand using an objective score, called Modified Nail Psoriasis Severity Index (mNAPSI). In a random fashion, one hand will be treated with excimer laser and the other hand will receive sham treatment. During the treatments, patients will wear protective eyewear that does not permit them to see which hand receives active treatment and which hand receives sham treatment. Patients will be treated twice a week for 8 weeks. At weeks 8, 12, and16 the investigator who is blinded to the treatment assignments will re-evaluate the fingernails using mNAPSI score. Mean change from baseline mNAPSI score at weeks 8, 12, and 16 in hands treated with excimer compared to hands treated with sham will be measured. We will also measure patient's assessment of severity of nail disease and the pain or any adverse events associated with laser treatments. Given the slow growth rate of fingernails, the final evaluations will be performed at week 16. In summary, this is the first controlled study to evaluate efficacy of excimer laser in fingernail psoriasis. If found to be effective, excimer laser could be used as a safe, locally administered treatment for recalcitrant nail psoriasis.
#Intervention
- DEVICE : 308 nm excimer laser
- Biweekly treatments with 308 nm excimer laser for a total of 8 weeks
- DEVICE : Sham laser
- Sham laser treatment to the control side biweekly for a total of 8 weeks. | #Eligibility Criteria:
Inclusion Criteria:
* Must give written informed consent.
* Must be at least 18 years.
* Must have been diagnosed with stable fingernail psoriasis.
* Must have fairly symmetric fingernail psoriasis in right and left hand with similar modified NAPSI scores in right and left hand target nails. Target nail is defined as the fingernail with highest modified NAPSI score.
* Must have active fingernail psoriasis, defined as a target fingernail matrix NAPSI score of at least 2 and modified NAPSI score from a combination of crumbling, onycholysis and pitting at least 2.
*
* No changes in the systemic therapy or nail directed topical therapy during the 16 week study period.
Exclusion criteria:
* Subjects unable to tolerate frequency of visits.
* History of intolerance to or worsening of psoriasis with ultraviolet light.
* Current use of known photosensitizing medications.
* History of Fitzpatrick Type I skin, photosensitivity, or keloid formation.
* Any new systemic psoriasis therapy including biologics, conventional systemic immunomodulators, phototherapy, or nail directed topical therapy for the last 3 months prior to enrollment.
* Any other condition that in the eyes of the investigator will disqualify patient from the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02168933 | 220,552 |
{
"NCT_ID" : "NCT03297502",
"Brief_Title" : "Safety and Bioequivalence of Pimecrolimus Cream 1% and Elidel R in Treatment of Mild to Moderate Atopic Dermatitis",
"Official_title" : "Multicenter Study of the Safety and Bioequivalence of Par's Pimecrolimus Cream, 1% and RLD Elidel® (Pimecrolimus Cream, 1%) and Compare Both Active Treatments to a Vehicle Control in Treatment of Mild to Moderate Atopic Dermatitis",
"Conditions" : ["Atopic Dermatitis"],
"Interventions" : ["Drug: pimecrolimus cream 1%", "Drug: placebo", "Drug: Elidel (pimecrolimus) cream 1%"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-06",
"Study_Completion_Date(Actual)" : "2017-06},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-09-22",
"First_Posted(Estimated)" : 2017-09-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-09-28",
"Last_Update_Posted(Estimated)" : 2017-09-29",
"Last_Verified" : 2017-09"
}
}} | #Study Description
Brief Summary
A phase 3, double-blind, randomized, parallel-group, placebo-controlled, multicenter study to evaluate the safety and bioequivalence of Par Pharmaceutical Inc.'s Pimecrolimus Cream, 1% and Reference Listed Elidel® (Pimecrolimus Cream, 1%). The study compares both active treatments to a placebo control in the treatment of mild to moderate atopic dermatitis.
#Intervention
- DRUG : pimecrolimus cream 1%
- DRUG : Elidel (pimecrolimus) cream 1%
- DRUG : placebo | #Eligibility Criteria:
Inclusion Criteria:
* Willing and able to provide written informed consent/assent for the study.
* Non-immunocompromised male or female aged >= 12 years.
* A clinical diagnosis of mild to moderate atopic dermatitis that has failed to respond adequately to other topical prescription treatments for atopic dermatitis, or subjects for whom the use of those other treatments is deemed inadvisable.
* A diagnosis of atopic dermatitis for at least 3 months.
* A baseline Investigator's Global Assessment (IGA) of disease severity of mild or moderate (score of 2 or 3). (See Section 9.6.10 for the scale.)
* An affected area of atopic dermatitis involvement of at least 5% of the body surface area (BSA) at Visit 2/Day 1 (Baseline), as defined by the criteria of Hanifin and Rajka (1980).
* Treatment with a bland emollient for at least 7 days prior to Visit 2/Day 1 (Baseline).
* Agree to adhere to protocol-specified requirements and concomitant therapy restrictions.
* Willing to avoid constant sun exposure and the use of tanning booths or other UV light sources during participation in the study.
* In general good health, non-immunocompromised, and free from any clinically significant disease, other than atopic dermatitis, that might interfere with the study evaluations.
* Willing and able to understand and comply with the requirements of the study, apply the study medication as instructed, return for the required study visits, comply with therapy prohibitions, and complete the study.
* Female subjects of childbearing potential (excluding women who are surgically sterilized [hysterectomy, bilateral tubal ligation, or bilateral ovariectomy] or have been postmenopausal for at least 1 year) must have a negative urine pregnancy test and must be willing to use a medically accepted method of contraception during the study. The following are considered acceptable methods of birth control for the purpose of this study: oral contraceptives, contraceptive patches, contraceptive implant, vaginal contraceptive, double barrier methods (e.g., condom and spermicide), contraceptive injection (Depo-Provera®), intrauterine device (IUD), hormonal IUD (Mirena®), Essure® permanent birth control, and abstinence with a documented second acceptable method of birth control if the subject becomes sexually active.
Exclusion Criteria:
* Females who are pregnant, breastfeeding, intending to become pregnant during the study, or who do not agree to use an acceptable form of birth control during the study.
* Active cutaneous bacterial or viral infection in any proposed treatment area at Visit 2/Baseline (e.g., clinically infected atopic dermatitis).
* Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at Visit 2/Baseline that would interfere with the study evaluations.
* History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, or ichthyosis.
* History or presence of Netherton's Syndrome, immunological deficiencies or diseases, HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency, or severe hepatic disorders.
* Use of any treatment listed in Table 9.1 more recently than the indicated washout period prior to Visit 2/Baseline.
* Need or intent to continue to use any treatment listed in Table 9.1 during the current study.
Table 9.1 Medications, Supplements, and Other Substances Prohibited for Study Entry Prohibited Medications, Supplements, and Other Substances Washout Period Prior to Randomization Visit 2/Baseline
* Systemic corticosteroids (oral and injectable [intravenous and intramuscular]) (Intranasal and Inhalational steroids are allowed if use is kept constant during the study)
* UVA/UVB therapy
* PUVA (psoralen plus ultraviolet A) therapy
* Tanning booths
* Nonprescription UV light sources
* Immunomodulators or immunosuppressive therapies
* Interferon
* Cytotoxic drugs (e.g., methotrexate, cyclophosphamide, azathioprine)
* Oral retinoids
* Systemic anti-fungals
* Tacrolimus
* Pimecrolimus 30 days (1 month)
* Systemic antibiotics
* Topical calcipotriene or other topical vitamin D preparations
* Topical retinoids 14 days (2 weeks)
* Topical and oral antihistamines
* Topical antibiotics
* Topical corticosteroids
* Topical antifungals
* Other topical drug products 7 days (1 week)
* Any topical product (e.g., sunscreens, lotions, creams) in areas to be treated except for bland emollient (moisturizer)
* Grapefruit or grapefruit juice which is considered a CYP3A inhibitor 24 hours
* Current use of calcium channel blockers (e.g, amlodipine, nifedipine, verapamil, diltiazem, felodipine, isradipine, nisoldipine, etc) and/or cimetidine (e.g., Tagamet) which are CPY3A inhibitors.
* Known allergy or hypersensitivity to pimecrolimus or any other component of the Test or Reference product.
* Unwilling to minimize or avoid natural and artificial sunlight exposure during treatment.
* Consumption of excessive alcohol, abuse of drugs, or a condition that could compromise the subject's ability to comply with study requirements.
* Any clinically significant condition or situation other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
* Use of any investigational drug or investigational device within 30 days prior to Visit 2/Baseline.
* Previous participation in this study.
* Employees of the research center or investigator.
* Family members of employees of the research center or investigator.
* Family members living in the same household participating at the same time.
Table 9.2 Medications (Prescription and Over-the-Counter), Supplements, and Other Substances Prohibited During the Study Prohibited Medications, Supplements, and Other Substances Treatment for atopic dermatitis other than assigned study medication or bland emollient.
Topical or systemic (oral and injectable) corticosteroid (Intranasal and inhalational steroids are allowed if kept constant during the study) Topical or systemic antibiotic Topical or systemic antifungal Topical or oral antihistamine (e.g., diphenhydramine, hydroxyzine) Immunosuppressive drugs Immunomodulator (e.g., tacrolimus) Calcipotriene or other topical vitamin D preparations Topical or oral retinoids Interferon Cyclosporine Methotrexate Azathioprine CPY3A inhibitor (e.g., erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers, cimetidine, grapefruit or grapefruit juice) Topical product other than assigned study medication or bland emollient (e.g., sunscreen, new brand of cosmetic or cleanser, cream, lotion, ointment, or powder) applied on or near the treatment area(s) Phototherapy (e.g., PUVA, UVA or UVB therapy)
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT03297502 | 183,062 |
{
"NCT_ID" : "NCT04370080",
"Brief_Title" : "Silver Diamine Fluoride Treatment of Active Root Caries Lesions in Older Adults: A Case Series",
"Official_title" : "Silver Diamine Fluoride Treatment of Active Root Caries Lesions in Older Adults: A Case Series",
"Conditions" : ["Root Caries"],
"Interventions" : ["Device: Silver Diamine Fluoride 38%"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-01-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-11-21",
"Study_Completion_Date(Actual)" : "2019-11-21},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-04-23",
"First_Posted(Estimated)" : 2020-04-30"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-04-29",
"Last_Update_Posted(Estimated)" : 2020-04-30",
"Last_Verified" : 2020-04"
}
}} | #Study Description
Brief Summary
The authors conducted a case series to determine the outcomes of treatment of root surface caries lesions when the teeth were treated topically with 38% silver diamine fluoride.
Detailed Description
The study is a prospective, single center case series. The cases were consecutive. Participation was offered to every patient who qualified based on age and the presence of an active lesion in a root surfaces, in a furcation, or under an individual crown or crown abutment for a fixed prosthesis. The study was conducted at the dental clinic of the Roseman College of Dental Medicine in South Jordan, Utah. The University of California, San Francisco protocol for applying topical silver diamine fluoride was adapted for use with these patients. Lesions were flushed with water and then dried with compressed air, isolated with cotton rolls, and then 38% silver diamine fluoride (Advantage Arrest, Elevate Oral Care, West Palm Beach, FL) was applied repeatedly for two minutes with the manufacturer supplied dental applicator. The silver diamine fluoride was stored under the manufacturer's recommended conditions. If the patient complained about the taste, the lesion was coated with sodium fluoride varnish. All of the lesions were reevaluated for dental caries lesion activity about every six months and retreated regardless of their arrest status. Follow-up was for 30 months or until loss to follow-up.
#Intervention
- DEVICE : Silver Diamine Fluoride 38%
- Dental caries arrest medication
- Other Names :
- Advantage Silver Arrest | #Eligibility Criteria:
Inclusion Criteria:
* At least 1 active root surface caries lesion by Nyvad criteria
Exclusion Criteria:
* None
Sex :
ALL
Ages :
- Minimum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT04370080 | 8,308 |
{
"NCT_ID" : "NCT05814926",
"Brief_Title" : "GP681 in Volunteers With Hepatic Impairment Compared With Healthy Volunteers",
"Official_title" : "Pharmacokinetics, Safety and Tolerability of GP681 Single Oral Dose in Male and Female Patients With Different Degrees of Hepatic Impairment (Child-Pugh Classification A and B) as Compared With GP681 Administration to Male and Female Healthy Subjects",
"Conditions" : ["Healthy Volunteers", "Hepatic Impairment"],
"Interventions" : ["Drug: GP681"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2023-04-26",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-08-03",
"Study_Completion_Date(Actual)" : "2023-10-20},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-04-04",
"First_Posted(Estimated)" : 2023-04-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-04-04",
"Last_Update_Posted(Estimated)" : 2023-11-15",
"Last_Verified" : 2023-11"
}
}} | #Study Description
Brief Summary
The primary objective of this study is to test whether mild (Child-Pugh A, score 5-6) and moderate (Child-Pugh B, score 7-9) hepatic impairment affects pharmacokinetics, safety and tolerability of GP681, compared with a control group with normal hepatic function following oral administration of GP681 as single dose.
Detailed Description
This is a multicenter, open-label, parallel group, single-dose study to compare pharmacokinetics of GP681 after a single 40mg oral dose in eight healthy subjects and eight mild or eight moderate hepatic impairment subjects. Subjects with hepatic impairment will be enrolled into either mild (Child-Pugh A, score 5-6) or moderate (Child-Pugh B, score 7-9) hepatic impairment groups. The healthy subjects will match with impaired hepatic function patients on ethnic group, sex(+/- 1 subject), age (+/- 10 years) and weight (+/- 25%).
Participants will be admitted into the Clinical Research Units(CRU) on Day-1. On the morning of Day 1, subjects will receive a single 40 mg oral dose of GP681 following an overnight fast (i.e., at least 10 hours). Participants will be confined to the CRU until discharge on Day 12, with PK blood sample draws for measurement of GP681 and its main metabolites being taken throughout the confinement.
Safety assessments will include physical examinations, ECGs, vital signs, standard clinical laboratory evaluations (hematology, blood chemistry, urinalysis, coagulation), AE and serious adverse event (SAE) monitoring.
All participants will have a post-study safety follow-up contact conducted approximately 12 days after administration of study treatment. The study will be considered complete once all the participants have finished the required assessments, dropped out, or been lost to follow-up before completing the required assessments.
#Intervention
- DRUG : GP681
- GP681, tablet, oral | #Eligibility Criteria:
Inclusion Criteria:
* Male or female participants，between the ages of 18 and 68 years (inclusive) at the time of Screening;
* Body weight >=50 kg for males, >=45kg for females, and body mass index (BMI) between18 <= age <= 30 kg/m^2(inclusive);
* Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions.
Participants with Hepatic Impairment Only:
Participants must satisfy the criteria for primary liver disease as evidenced by a Child-Pugh A (score 5 <= age <= 6), B (score 7 <= age <= 9). Treatment-naïve participants for at least 4 weeks before screening can be entered into the study. Unless otherwise stated, participants must have been on stable doses and regimens of the concomitant medication for at least 4 weeks before screening.
Participants with Normal Hepatic Function Only:
* Healthy participants, between the ages of 18 and 68 years (inclusive) at the time of Screening, matched to participants with hepatic impairment with regard to age (+/-10 years), and gender(+/-1 subject);
* Body weight >=50 kg for males, >=45kg for females, and body mass index (BMI) between18 <= age <= 30 kg/m^2(inclusive), matched to participants with hepatic impairment with regard to body weight (+/-25% kg);
* In good health, determined by no clinically significant findings from vital signs, physical examination, 12-lead electrocardiogram (ECG), clinical laboratory evaluations, and other safety examinations at screening, as assessed by the investigator.
* Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for at least 3 months after the final dose of study drug
* Adequate hepatic function within 14 days before drug administration defined as: AST or ALT <= 1.5 times the upper limit of normal values, total bilirubin within normal limits.
Exclusion Criteria:
* History of allergic conditions or allergic diseases, or a history of allergic reactions attributed to drugs. Those who cannot follow a uniform diet for special dietary requirements.
* History of seizure，including any febrile seizure, or transient ischemic attack, or any condition that may pre-dispose to seizure (such as prior stroke, brain arteriovenous malformation, brain trauma with requiring hospitalization, and lacunar cerebral infarction).
* Have a malignant tumor or a history of malignant tumor in the 5 years prior to screening (except for patients with non-melanoma skin cancers with no evidence of recurrence, or patients with excised cervical intraepithelial neoplasia).
* Subjects with severe infection, trauma, gastrointestinal surgery or other major surgical operations within 4 weeks before screening;
* Abnormal blood pressure response, or clinically significant abnormal blood pressure assessed by the investigator.
* Having a history of clinically significant ECG abnormalities (history of tachycardia/bradycardia requiring medical therapy, II-III degree atrioventricular block, or QTcF>450ms for males，>460ms for females(corrected by Fridericia's formula), or other clinically significant abnormals assessed by the investigator.
* Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2, according to the modification of diet in renal disease equation.
* Those who plan to undergo surgery, or intent to intent to be hospitalized during the trial.
* A positive test for HIV antibody at screening.
* Received any drugs that inhibit or induce the CYP450 enzyme (i.e., phenytoin, rifampin, carbamazepine, fluvoxamine, enoxacin, ticlopidine, gemfibrozil, clopidogrel, clarithromycin, itraconazole, ketoconazole, ritonavir) 4 weeks prior to screening period.
* Received any drugs (including Chinese herbal medicine, vitamins and supplements) within 14 days or 5-half-lives (which is longer) prior to dosing;
* Participation in another clinical trial within 3 months before dosing.
* Those who have lost blood or donated up to 200 mL within 3 months before dosing, or those who plan to donate blood within 1 month after the end of this study.
* Smoking more than 5 cigarettes per day within 3 months prior to screening，or who cannot stop using any tobacco products during the study period.
* Average weekly intake of alcohol is more than 14 units alcohol (1 units ≈ 360 mL beer, or 45 mL spirits with 40% content, or 150 mL wine) within the 6 months prior to dosing, or a positive ethanol breath test at screening.
* Substance abuse or use of soft drugs (e.g., marijuana) or use of hard drugs (e.g., cocaine, amphetamines, phenylcyclohexidine, etc.); Or screening for positive urine drug abuse (drug) tests.
* Habitual or excessive consumption (more than 8 cups, 1cup=250mL) of grapefruit juice, tea, coffee and/or caffeinated beverages.
* Subjects who are intolerant to venipuncture or have a history of fainting blood or acupuncture.
* Those who have received vaccine within 1 month before screening.
* Pregnant or lactating women, or those with positive blood pregnancy tests.
* Male or female subjects of childbearing age agreed to take effective and safe contraception during treatment and 3 months after treatment.
* Subjects with poor compliance, or not suitable for this study as judged by the investigator.
Participants with Hepatic Impairment Only:
* Have received liver transplant at any time in the past.
* Patients complicated with drug-induced liver injury.
* Other causes of acute liver injury.
* Patients with liver failure, or combined with hepatic encephalopathy, hepatocellular carcinoma, and esophageal and gastric variceal bleeding and other complications considered by the investigator as unsuitable for the clinical study.
* Any history of clinically serious illness or disease or condition except for primary liver disease that the investigator believes may affect the results of the trial, including but not limited to a history of circulatory, endocrine, nervous, digestive, urinary, or hematological, immune, psychiatric, and metabolic disorders.
Participants with Normal Hepatic Function Only:
* Any history of clinically serious illness or disease or condition except for primary liver disease that the investigator believes may affect the results of the trial, including but not limited to a history of circulatory, endocrine, nervous, digestive, urinary, or hematological, immune, psychiatric, and metabolic disorders.
* Any history of hepatic impairment, or potential presence of liver function impairment by physical examination and laboratory examination at screening.
* Positive result of any indicators of hepatitis B surface antigen, hepatitis C antibody within 1 week prior to screening or at screening.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 68 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT05814926 | 32,217 |
{
"NCT_ID" : "NCT03416946",
"Brief_Title" : "Custom Cutting Block Instrument vs Regular Instrumentation Total Knee Replacement (TKR)",
"Official_title" : "A Double-blinded, Randomized, Controlled Trial of Total Knee Replacement Using Custom Cutting Block Instrument vs Regular Instrumentation",
"Conditions" : ["Osteoarthritis, Knee"],
"Interventions" : ["Other: Traditional", "Device: Visionaire"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-12-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-05-01",
"Study_Completion_Date(Actual)" : "2017-05-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-12-13",
"First_Submitted_that_Met_QC_Criteria" : 2021-09-30",
"First_Posted(Estimated)" : 2018-01-31"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-01-24",
"Last_Update_Posted(Estimated)" : 2021-10-04",
"Last_Verified" : 2021-09"
}
}} | #Study Description
Brief Summary
To determine if the use of patient-specific custom cutting blocks for implantation of total knee components results in improved limb alignment and component positioning compared to regular instrumentation.
Detailed Description
This is a randomized controlled trial. Patients will be randomized to have their knee implanted using either the patient-specific custom cutting blocks or the regular instrumentation system. Functional and radiographic outcomes will be assessed in a blinded fashion. The Smith and Nephew Legion Primary® total knee system will be used in both groups; this is an implant with a good long term track record based on the Genesis II design. All surgeons have used and are familiar with the regular instrumentation. They will be instructed in the use of the patient-specific custom cutting blocks prior to study initiation.
#Intervention
- DEVICE : Visionaire
- Custom cutting block using MRI to create patient specific instrumentations
- OTHER : Traditional
- Traditional cutting method | #Eligibility Criteria:
Inclusion Criteria:
* Patient is male or female ages 18 and over.
* Patient is having primary total knee replacement
* Patient is willing to sign the informed consent and to come for all study visits.
Exclusion Criteria:
* Deformity of the femur preventing use of the intra-medullary guide utilized in the regular instrumentation set.
* Necessity for the use of constrained implants. These types of implants have intra-medullary stems, therefore all bone cuts need to be referenced off intramedullary guides, making image guided bone cuts inappropriate.
* Patients undergoing knee replacement revision surgery. Theses types of implants also have stems, making the use of image guided bone cuts inappropriate for the same reasons.
* Patients scheduled for bilateral knee surgery (simultaneous or staged)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT03416946 | 25,945 |
{
"NCT_ID" : "NCT03890510",
"Brief_Title" : "The Effect of High vs. Low Fluid Volume on Ocular Parameters in Prone Spine Surgery",
"Official_title" : "Effect of Different Fluid Volume on Ocular Parameters in Patients Undergoing Spine Surgery in Prone Position",
"Conditions" : ["Prone Position", "Blood Volume", "Intraocular Pressure"],
"Interventions" : ["Other: Ringer's Lactate solution", "Procedure: Spine surgery under general Anesthesia in the prone position"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-05-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-08-31",
"Study_Completion_Date(Actual)" : "2020-09-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-02-21",
"First_Posted(Estimated)" : 2019-03-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-03-24",
"Last_Update_Posted(Estimated)" : 2020-12-17",
"Last_Verified" : 2020-12"
}
}} | #Study Description
Brief Summary
The purpose of this trial is to compare the effect of different fluid volume infusion on ocular parameters in patients undergoing spine surgery in prone position.
Detailed Description
In the prone position, the intraocular pressure and optic nerve sheath diameter increase progressively with time as compared with those in the supine position. Excessive fluid infusion may further increase intraocular pressure and optic nerve sheath diameter. Pulse pressure variation (PPV) is a dynamic index which can effectively assess fluid responsiveness during general anesthesia.Therefore,the investigators have designed a study to compare the effect of different fluid volume infusion guided by low and high PPV indices on intraocular pressure and optic nerve sheath of patients undergoing prone spine surgery with general anesthesia. One group of the patients will receive relatively loose fluid infusion (target value of PPV: 6%-9%),while the other group of the patients will receive limited fluid infusion (target value of PPV: 13%-16%).
#Intervention
- OTHER : Ringer's Lactate solution
- Patients in both groups will receive Ringer's lactate solution continuously during operation with different infusion volume.
- PROCEDURE : Spine surgery under general Anesthesia in the prone position
- The surgery, general anesthesia, and the placement of the prone position will be performed according to the standard procedures. | #Eligibility Criteria:
Inclusion Criteria:
* Scheduled for elective spine surgery in prone position under general anesthesia
* American Society of Anesthesiologists (ASA) physical status I or II
* Have signed consent form
Exclusion Criteria:
* History of eye disease or eye surgery
* Pregnancy or breast feeding
* Known Allergy to latex or Ringer's lactate solution
* Hyperlactacidemia，uncontrolled hypertension, diabetes mellitus, arrhythmia, cardiovascular disease，chronic pulmonary disease, swelling of any body part, abnormal of liver or renal function, anemia, etc.
* Body mass index（BMI）>30
* Expected operation time >6 hours
* Estimated Intraoperative hemorrhage >1000ml
* Taking part in other clinical trials in the last 3 months or at present
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
| NCT03890510 | 103,481 |
{
"NCT_ID" : "NCT04571866",
"Brief_Title" : "Gastric Emptying After Bread Consumption",
"Official_title" : "The Effect of Dietary Fiber-enriched Bread on Gastric Emptying and Postprandial Glucose Levels",
"Conditions" : ["Gastric Emptying"],
"Interventions" : ["Other: Beta-glucan bread"],
"Location_Countries" : ["Norway"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-10-20",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-01-15",
"Study_Completion_Date(Actual)" : "2021-02-15},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-09-21",
"First_Posted(Estimated)" : 2020-10-01"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-09-25",
"Last_Update_Posted(Estimated)" : 2021-07-13",
"Last_Verified" : 2021-07"
}
}} | #Study Description
Brief Summary
The rate of gastric emptying is proposed to be one of the major determinants of postprandial glycemia. A slower gastric emptying will thus result in a less pronounced rise in blood glucose, which is especially desirable in diabetes care as it will highly influence the overall glycemic control. The present study aims to investigate the rate of gastric emptying and postprandial blood glucose levels in response to the intake of bread with different dietary fiber-content. Though bread is one of the major sources of dietary carbohydrates in Central- and Northern Europe, the mechanism and the metabolic effects of bread consumption, however, is investigated in a limited number of studies.
Detailed Description
The rate of gastric emptying is related to small intestinal motility and absorption of carbohydrates, and it is one of the major determinants of postprandial glycemia. A slower rate of gastric emptying will thus result in a less pronounced rise in blood glucose. Especially in diabetes care, reduced gastric emptying is desirable because of its effect on the rise of postprandial blood glucose, which again highly influences the overall glycemic control.
Bread is one of the most eaten food items in Central- and Northern Europe, being one of the major sources of dietary carbohydrate intake. In addition, bread often contains a diverse range of dietary fiber. The effect on gastric emptying and the amount of dietary carbohydrates absorbed in the small intestine depends on the overall meal composition, the degree of processing, and the type of dietary fiber, e.g., viscous or non-viscous. The oat-derived dietary fiber beta-glucan may have favorable properties in this regard as adding beta-glucan to a meal has been shown to slow down the rate of gastric emptying. However, studies investigating the effect of beta-glucan on gastric emptying are scarce.
For assessment of gastric emptying, scintigraphy is seen as the 'gold standard' as the method readily can discriminate between gastric emptying and absorption of glucose in the small intestine. However, this method is not often used due to its invasive nature and radiation. High-resolution real-time ultrasonography is now the most preferred method and regarded as a new 'gold standard', proving good inter- and intra-observer agreement. Compared to scintigraphy, ultrasound is a safe and non-invasive procedure widely available in clinical settings.
Objectives
To establish whether a wheat bread with an optimized content of beta-glucan has a different effect on gastric emptying, satiety, and postprandial glycemia compared to control bread.
Study procedures
Recruitment
Healthy adults (age range 18 to 40 years) with normal to overweight body mass index (BMI: 18.5-30 kg/m2) and no gastrointestinal diseases or other issues that can affect gastric motility, are eligible and will be asked to participate. Health status will be briefly checked during a screening examination.
Participants will be recruited through flyers, announcements, and advertisements in social media, such as Facebook. The eligibility of participants will be addressed during a screening visit. Participants will answer questionnaires including questions on general health status, lifestyle habits, current medications, allergies, and gastrointestinal symptoms (using the ROMA-IV questionnaire).
Study design: randomized cross-over design
The study will be conducted at the Research Unit for Health Surveys, University of Bergen, on non-consecutive days, with at least 3 days (wash-out period) in between two study days. Participants will consume bread with either beta-glucan or no additive at a quantity of 25 g available carbohydrates within 10 minutes together with 250 ml water. Gastric emptying will then be measured by ultrasound during the next 2 hours in 15 minute-intervals the first hour, and then every 30th minute (15, 30, 45, 60, 90, and 120 minutes). Blood samples will be taken for measurement of postprandial glucose and satiety hormones, and the participants will fill in a Visual Analogue Scale (VAS) for satiety. Blood pressure, body weight, waist circumference, and height will be measured during the study visit. The participants must be fasting for at least 12 hours (overnight, usually from 8 pm the evening before the study visit).
Study bread will be blinded to both the investigators and the participants, although it cannot be excluded that participants may recognize the type of bread. Consumption of bread occurs in a randomized order, according to a randomization scheme.
Gastric emptying by ultrasound
Measurement: The participant is to be placed in a standardized sitting position. The cross-sectional area of the antrum of the stomach will be measured using 2D ultrasonography. The outer profile of the antrum will be measured using a built-in caliper and a calculation program available in the ultrasound apparatus. The gastric antrum, the mesenteric vein, and the aorta have to be visualized in this section. A minimal amount of force must be applied during each reading to prevent compression of the antrum. The measurement will be performed when the participants are suspending their breathing in expiration, between antral contractions. The average of the two measurements will be used.
The antral area will be measured at the fasting state (baseline), immediately following bread and water intake, and during the next 2 hours at regular intervals.
Blood glucose and satiety hormones
The effect of gastric emptying on postprandial blood glucose will be measured by collecting venous and capillary blood samples. Venous blood samples, sampled via a catheter inserted into an arm vein, will be collected at baseline, and 15, 30, 45, 60, 90, and 120 minutes after the participant starts to ingest the test meal. In addition, the venous blood samples will be used for the determination of insulin, Glucagon-like peptide-1 (GLP-1), peptide YY (PYY), ghrelin, and leptin. The capillary blood samples, collected at the same time intervals as the venous blood samples, will be used to measure postprandial blood glucose levels.
Satiety
The participants will be asked to report satiety sensations by filling in a VAS at baseline, and 15, 30, 45, 60, 90, and 120 minutes after consumption of the standardized meals, without having the previous scale available.
Statistics
The primary outcome variable is the difference in gastric emptying (antral area, cm2) at different time points and the calculated area under the curve for the entire study duration. The comparison of the antral area following the different bread-options will be done at each time point using a Tukey's multiple comparisons test. Each subject serves as her/his control when comparing antral areas at different time points.
Secondary outcomes are the postprandial blood glucose concentrations at different time points, subjectively reported satiety, insulin, and satiety hormones at different time points.
Ethics
Participants will be provided with written and oral information about the study. Before inclusion, the participants have to sign a consent form. The participants can withdraw from the study at any time without explanation. The study will be performed following the Declaration of Helsinki.
Overall, participation in the study implies very little risk. Some discomfort may occur when drawing blood and bruising can occur. However, blood sample collection will be performed by authorized personnel in a standardized matter. Participants will be covered by the Patient Injury Act.
All study procedures will be conducted in accordance with Good Clinical Practice. All study procedures will be described in standard operating procedures (SOPs).
#Intervention
- OTHER : Beta-glucan bread
- Beta-glucan is a dietary fiber with beneficial health effects, both on cholesterol levels and potentially blood glucose levels. | #Eligibility Criteria:
Inclusion Criteria:
* Adults 18 <= age <= 40 years
* BMI: 18.5 <= age <= 30 kg/m2
* Healthy
Exclusion Criteria:
* Celiac disease, non-celiac gluten sensitivity or wheat allergy and intolerance
* Use of medication that can affect gastric emptying
* Gastroparesis
* Gastrointestinal diseases
* Gastrointestinal surgery including bariatric surgery
* Chronic alcohol abuse
* Current smoker
* Pregnant or lactating women
* Diabetes mellitus type 1 and 2
* Anorexia nervosa or bulimia nervosa
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT04571866 | 28,251 |
{
"NCT_ID" : "NCT02982811",
"Brief_Title" : "Intelligent Activity-based Client-centred Training",
"Official_title" : "Intelligent Activity-based Client-centred Training",
"Conditions" : ["Central Nervous System Diseases", "Aged"],
"Interventions" : ["Device: i-ACT"],
"Location_Countries" : ["Belgium"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-03-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-05-31",
"Study_Completion_Date(Actual)" : "2020-06-26},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-11-29",
"First_Posted(Estimated)" : 2016-12-05"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-12-01",
"Last_Update_Posted(Estimated)" : 2020-07-27",
"Last_Verified" : 2020-07"
}
}} | #Study Description
Brief Summary
The purpose of this study is to determine whether additional therapy with i-ACT system is effective in the training of functional skills in persons with central neurological diseases (e.g. multiple sclerosis, stroke, spinal cord injury, etc.).
#Intervention
- DEVICE : i-ACT
- 3x 45 min training with i-ACT system (analytical and functional training) during 6 weeks, additional to therapy as usual (i.e. occupational therapy, physiotherapy, etc.) | #Eligibility Criteria:
Inclusion Criteria:
* Medical diagnosis of central nervous system disease (e.g. multiple sclerosis, stroke, spinal cord, etc.)
* Be able to understand and respond to questions in Dutch
* Actively involved in a rehabilitation programme in the participating rehabilitation centres
* Have a dysfunction in upper and/or lower limb and/or core stability
* Specifically for multiple sclerosis: min. of one month without corticosteroids
* Specifically for stroke and spinal cord: min. 3 months post injury
Exclusion Criteria:
* Severe spasticity which prevent performing basic functional exercises
* Severe cognitive and communicative impairment which prevent the person to understand and respond to Dutch instructions
* Severe visual impairment, e.g. blindness, cataract, etc.
* Pregnancy
* Persons who use an electrical wheelchair, who can not transfer safely into a normal chair and perform the exercises
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02982811 | 210,706 |
{
"NCT_ID" : "NCT02022046",
"Brief_Title" : "Methylation Biosignature in Childhood Chronic Kidney Disease",
"Official_title" : "Methylation Biosignature in Childhood Chronic Kidney Disease: the Link Among Asymmetric Dimethylarginine, Homocysteine, and Cardiovascular Disease",
"Conditions" : ["Chronic Kidney Disease", "Cardiovascular Disease"],
"Interventions" : ["Other: Methylation biosignature"],
"Location_Countries" : ["Taiwan"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-11",
"Study_Completion_Date(Actual)" : "2016-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-12-11",
"First_Posted(Estimated)" : 2013-12-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-12-20",
"Last_Update_Posted(Estimated)" : 2017-07-21",
"Last_Verified" : 2017-07"
}
}} | #Study Description
Brief Summary
Chronic kidney disease (CKD) and end-stage renal disease are highly prevalent in Taiwan. Cardiovascular disease (CVD) is the most common cause of death in children with CKD. Nitric oxide (NO) deficiency links CKD and CVD. Asymmetric dimethylarginine (ADMA), a NO synthase inhibitor, its level is increased in kidney disease and cardiovascular disease and serves as a methylation biomarker.
In addition to ADMA, uremic environment, hyperhomocysteinemia (Hcy) and oxidative stress may affect DNA methylation. S-adenosylmethionine (SAM) is an important human methyl donor. S-adenosylhomocysteine (SAH) is demethylated product. Methylenetetrahydrofolate reductase (MTHFR), a folate metabolism enzyme can regulate methylation pathway.
The investigators intend to examine whether ADMA, SAM/SAH ratio, Hcy, and MTHFR gene methylation can serve as biosignature to predict CVD in children with CKD children.
#Intervention
- OTHER : Methylation biosignature
- Methylation biosignature, CKD staging, assessment of cardiovascular function, and traditional/uremia-related risk factors will be performed. | #Eligibility Criteria:
Inclusion Criteria:
* chronic kidney disease stage 1 <= age <= 4
* Volunteer
Exclusion Criteria:
* pregnancy
* renal transplant
* congenital heart disease
* not able to be adherent/complaint with study procedure
* not volunteer
Sex :
ALL
Ages :
- Minimum Age : 3 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
| NCT02022046 | 73,847 |
{
"NCT_ID" : "NCT01158625",
"Brief_Title" : "Nighttime Dosing of Antihypertensive Drugs in Type 2 Diabetes",
"Official_title" : "Nighttime Dosing of Antihypertensive Drugs in Type 2 Diabetes",
"Conditions" : ["Diabetes Mellitus, Type 2", "Hypertension"],
"Interventions" : ["Other: Change of time of administration"],
"Location_Countries" : ["Denmark"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-11",
"Study_Completion_Date(Actual)" : "2012-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-06-25",
"First_Posted(Estimated)" : 2010-07-08"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2010-07-07",
"Last_Update_Posted(Estimated)" : 2013-04-04",
"Last_Verified" : 2013-04"
}
}} | #Study Description
Brief Summary
The purpose of this study is to investigate if it is possible to lower the nighttime blood pressure in patients with type 2 diabetes mellitus by shifting the administration of antihypertensive drugs from morning to nighttime.
Detailed Description
In recent years several studies have shown that high nighttime blood pressure is associated with increased cardiovascular risk independently of the average 24 hour blood pressure. As a consequence there has been increasing focus on nighttime blood pressure and how to lower it. One way of addressing the problem is to shift the administration of antihypertensive drugs from morning to nighttime. Studies on non-diabetic patients show that by doing this the nighttime blood pressure can be lowered with 3-5 mm Hg without negative effect on the 24 hour blood pressure.
Only recently a study was made on diabetic patients. This showed similar results as for non-diabetic patients.However this study was based on diabetic patients who did not receive any antihypertensive drugs before.
This study will investigate the effects on nighttime blood pressure when shifting administration of antihypertensive drugs from morning to nighttime. The population is diabetic patients who are already in antihypertensive treatment.
#Intervention
- OTHER : Change of time of administration
- Change of time of administration | #Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes
* Systolic nighttime blood pressure above 120 mm Hg
* Systolic daytime blood pressure not exceeding 150 mm Hg
* Antihypertensive treatment which must include
* once-daily drugs
* at least one drug must be a Angiotensin-Converting Enzyme Inhibitor, Angiotensin II Receptor Blocker or Renin Inhibitor.
Exclusion Criteria:
* MI or stroke within 6 months
* heart failure (EF < 45 %)
* atrial fibrillation
* eGFR < 30 ml/min
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01158625 | 86,672 |
{
"NCT_ID" : "NCT02955342",
"Brief_Title" : "Back and Neck Pain in Adolescence",
"Official_title" : "Back and Neck Pain in Adolescence: A Prospective Cohort Study Using a German Version of the Young Spine Questionnaire",
"Conditions" : ["Back Pain"],
"Location_Countries" : ["Switzerland"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-12-07",
"Study_Completion_Date(Actual)" : "2019-12-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-10-06",
"First_Posted(Estimated)" : 2016-11-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-11-03",
"Last_Update_Posted(Estimated)" : 2020-04-30",
"Last_Verified" : 2020-04"
}
}} | #Study Description
Brief Summary
To validate the German version of the Young Spine Questionnaire (G-YSQ) and to study back and neck pain in adolescents between 10 and 16 years during one year by means of G-YSQ.
Detailed Description
In two settings (school, clinics) back and neck pain of 10 to 16 years old adolescents will be assessed by the German Version of the Young Spine Questionnaire at 6 points in time during one year.
Validity, reliability and responsiveness of the G-YSQ will be determined and the development of back and neck pain within a year will be described.
#Intervention
- OTHER : no intervention
- no intervention | #Eligibility Criteria:
Inclusion Criteria:
* 10 <= age <= 16 old
Exclusion Criteria:
* younger than 10, older than 16
Sex :
ALL
Ages :
- Minimum Age : 10 Years
- Maximum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
| NCT02955342 | 222,866 |
{
"NCT_ID" : "NCT05676307",
"Brief_Title" : "Vestibular Rehabilitaion in Bilateral Vestibular Hypofunction",
"Official_title" : "ETIOLOGICAL FACTORS AND EFFECT OF VESTIBULAR REHABILITATION ON BILATERAL VESTIBULAR HYPOFUNCTION",
"Conditions" : ["Bilateral Vestibular Loss", "Vestibular Rehabilitation"],
"Interventions" : ["Behavioral: Vestibular Rehabilitation"],
"Location_Countries" : ["Turkey"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-01-15",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-10-23",
"Study_Completion_Date(Actual)" : "2022-11-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-12-02",
"First_Posted(Estimated)" : 2023-01-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-12-22",
"Last_Update_Posted(Estimated)" : 2023-01-09",
"Last_Verified" : 2022-12"
}
}} | #Study Description
Brief Summary
The purpose of this study is to determine the etiological factors that constitute bilateral vestibular hypofunction and to investigate the effect of vestibular rehabilitation in these patients.
The Caloric test and Video Head Impulse test were applied to evaluate the vestibular hypofunction picture of the patients who applied to Clinic with complaints of vertigo, dizziness and imbalance. Among these patients with BVH, those with vestibular symptoms, imbalance complaints and limited daily living activities were included in rehabilitation. In order to investigate the effectiveness of rehabilitation, oculomotor functions were evaluated using Simulation Of Vestibulo-ocular Reflex Exercises (SVORE) System, balance assessment was done with timed balance tests and quality of life assessment was performed with Dizziness Handicap Inventory.
#Intervention
- BEHAVIORAL : Vestibular Rehabilitation
- Cawthorne Cooksey Based Vestibular Rehabilitation Exercises (Oculomotor exercise, Vestibulo-ocular Exercise, posture exercise, balance training, etc) | #Eligibility Criteria:
Inclusion Criteria:
* Patients between 18 <= age <= 70 years with bilateral vestibular hypofunction and peripheral vestibulopathy
Exclusion Criteria:
* Patients with unilateral vestibular hypofunction, cerebellar lesion, and cognitive problems were excluded from the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT05676307 | 233,841 |
{
"NCT_ID" : "NCT06141824",
"Brief_Title" : "Performance Evaluation of the Lucira COVID-19 & Flu Test",
"Official_title" : "Performance Evaluation of the Lucira COVID-19 & Flu Test Versus FDA Authorized SARS-CoV-2 and Influenza A&B Assays",
"Conditions" : ["COVID-19", "Influenza"],
"Interventions" : ["Device: Lucira COVID-19 & Flu Test"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "DIAGNOSTIC",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-10-11",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-02-16",
"Study_Completion_Date(Actual)" : "2023-02-16},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-08-03",
"First_Submitted_that_Met_QC_Criteria" : 2024-03-13",
"First_Posted(Estimated)" : 2023-11-21"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-11-16",
"Last_Update_Posted(Estimated)" : 2024-03-15",
"Last_Verified" : 2024-03"
}
}} | #Study Description
Brief Summary
The Lucira COVID-19\& Flu Test is a single use (disposable) RT-LAMP test kit intended for the simultaneous rapid in vitro qualitative detection and differentiation of SARS-CoV-2, Influenza A, and Influenza B viral RNA in anterior nasal swab specimens.
The test consists of a nasal swab, a sample vial the nasal swab sample is placed in the sample vial, containing the sample buffer, and the test unit, which detects whether SARS-CoV-2, Influenza A, and Influenza B virus is present within the specimen during an acute infection. The Lucira test uses a proprietary, molecular based process to detect the presence of SARS-CoV-2, Influenza A, or Influenza B virus. The purpose of this study is to investigate the Lucira COVID-19 \& Flu Test for the in vitro qualitative detection and differentiation of RNA from SARS-CoV-2, Influenza A, and Influenza B in nasal swab specimens from patients suspected of COVID-19 or Influenza A or Influenza B. The primary objective is to test at least 1000 self-collected nasal swab samples and to confirm the Lucira COVID-19 \& Flu Test provides similar accuracy to a high complexity lab molecular diagnostic RT-PCR assay(s) with known high sensitivity for detecting SARS-CoV-2, Influenza A, and Influenza B virus.
Detailed Description
The study is a prospective study with seven (7) sites in the U.S. participating in the study. The Investigational device was tested on-site, and the comparator samples were sent to reference laboratories in the U.S. Reference testing was performed by trained laboratory personnel. This investigational device testing was performed in a simulated-home environment with medical staff on site and included nasal swabs self-collected by study subjects per the quick reference instructions (QRI).
A qualified research person was designated as the Investigator at each site with the responsibility for oversight of the study in accordance with Good Clinical Practice (GCP) and regulatory requirements.
The protocol and subject informed consent were reviewed by an Institutional Review Board (IRB) and written IRB approval was issued prior to enrollment of subjects into the study at that site.
A subject's participation in this study consisted of a single visit. Following completion of the informed consent process and a review of Inclusion/Exclusion criteria to determine eligibility, each subject then received a unique study identification number. Subject demographics including age, sex, race, ethnicity, education level, employment status, and income was also collected at that time.
Two (2) swabs were collected for this study: One (1) nasal swab for the Lucira COVID-19 \& Flu Test and one (1) nasal swab for reference testing. These two study swabs were both collected similarly as directed in the Lucira COVID-19 \& Flu Test QRI. Any swab specimens required for routine standard of care testing were collected prior to the specimens collected for this investigation.
Subjects aged 14 years or older self-collected a nasal swab sample and ran the Lucira COVID-19 Test according to QRI in the test kit. Nasal swab sample collection and testing for Subjects ≥ 2 years but \<14 years of age was assisted by a subject meeting the requirement for self-collection. The subject was observed during the swabbing collection by the HCP and HCP documented collection details and any collection issues. Nasal swabs obtained from self-collection were discarded after having been used for testing per QRI. HCP interpreted and documented results.
Following the Lucira COVID-19 Test self-collection an additional swab was collected for reference method testing. One (1) additional NS specimen was collected by the health care professional, prepared in Transport Medium, and sent for reference laboratory testing. Each collection, the Lucira swab and reference swab, had a potential maximum of two swabs, including retests, for a maximum of four swabs per visit.
Reference labs received study sample aliquots and tested samples against FDA emergency use authorized SARS-CoV-2 and FDA cleared Influenza A\&B Assays. Reference testing characterized specimens as negative or positive for SARS-CoV-2 and Influenza A\&B. Therefore, positive percent agreement (PPA) and negative percent agreement (NPA) of the Lucira COVID-19 \& Flu Test was calculated by comparison with the respective reference methods.
Additional testing on remaining remnant aliquots may be performed to investigate any discrepant and discordant results as needed by other FDA cleared/authorized molecular methods.
At the end of the study, and at the Sponsor's discretion, residual remnant aliquots shall remain at the reference laboratory, be destroyed/discarded, or returned to the Sponsor.
#Intervention
- DEVICE : Lucira COVID-19 & Flu Test
- The Lucira COVID-19 \& Flu Test is a rapid, single-use, molecular test for the qualitative detection and discrimination of SARS-CoV-2, Influenza A, and Influenza B viral RNA in nasal swab samples. | #Eligibility Criteria:
Inclusion Criteria:
* Individuals aged 14 years and older (self-collected) or individuals less than 14 years but >= 2 years (collected by an adult)
* Human subjects suspected of respiratory viral infection consistent with COVID-19 or Influenza by their healthcare provider within 4 days of symptom onset
* Must be willing to try Lucira COVID-19 & Flu test with an anterior nasal (nasal) swab specimen collected from both nostrils
* Subject information shall include: gender, age, collection date, collection time, race, ethnicity, temperature, signs/symptoms, date of symptom onset, symptom severity, vaccination status, household income, education status, employment status, routine test data (results, methodology, date of collection, if available)
Exclusion Criteria:
* Currently suffering from nasal trauma such as a nosebleed
* Received a nasal rinse/wash/aspirates for standard of care testing
* The subject is undergoing treatment for COVID-19 or Flu currently and/or within the past 14 days of the study visit, including but not limited to: inhaled influenza vaccine (FluMist®) or flu antiviral medication, which may include but is not limited to Amantadine (Symmetrel®), Rimantadine (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), or Baloxavir marboxil (Xofluza®).
* The subject is currently receiving or has received within the past 30 days of the study visit an experimental biologic, drug, or device including either treatment or therapy.
* The subject has previously participated in this research study
* Incorrect comparator swab type or transport media
* Incorrect specimen handling
* Subjects not consented
Sex :
ALL
Ages :
- Minimum Age : 2 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT06141824 | 94,476 |
{
"NCT_ID" : "NCT01590628",
"Brief_Title" : "Allogeneic SCT of NiCord®, UCB-Derived Ex Vivo Expanded Stem and Progenitor Cells, in Patients With Hemoglobinopathies",
"Official_title" : "Allogeneic Stem Cell Transplantation of NiCord®, Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells, in Patients With Hemoglobinopathies",
"Conditions" : ["Sickle Cell Disease & Thalassemia"],
"Interventions" : ["Drug: NiCord"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-09",
"Study_Completion_Date(Actual)" : "2019-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-04-15",
"First_Submitted_that_Met_QC_Criteria" : 2022-03-31",
"First_Posted(Estimated)" : 2012-05-03"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-05-02",
"Last_Update_Posted(Estimated)" : 2022-05-20",
"Last_Verified" : 2022-04"
}
}} | #Study Description
Brief Summary
Allogeneic Stem Cell Transplantation of NiCord®, Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells, in Patients with Hemoglobinopathies
Detailed Description
Umbilical cord blood (UCB) is an alternative stem cell source for hematopoietic stem cell transplantations (HSCT) and can be used for the treatment of various life-threatening diseases, such as hematological malignancies or genetic blood disorders, in such cases where a matched related stem cell donor is not available. However, the major drawback of using this valuable stem cells source is the limited cell dose in a single cord blood unit (CBU), which was shown to be associated with inadequate hematopoietic reconstitution and high risk of transplant-related mortality. To improve outcomes and extend applicability of UCB transplantation, one potential solution is ex vivo expansion of UCB-derived stem and progenitor cells. NiCord® is a stem/progenitor cell based product composed of ex vivo expanded allogeneic UCB cells. NiCord® is based on a novel technology for the ex vivo cell expansion of cord blood derived hematopoietic progenitor cells. By increasing the number of the short and long-term reconstitution progenitor cells transplanted, NiCord® has the potential to enable the broader application of UCB transplantation, and improve the clinical outcomes of UCB transplantation.
In Part 1 of this study, NiCord® will be administered to the patient in conjunction with a second, unmanipulated CBU. In Part 2 of this study, NiCord® will be administered to the patient without a second, unmanipulated CBU. The study duration per patient is approximately 270 days from signing of informed consent to last visit on day 180 post-transplant.
The overall study objectives of part 1 of this study are to evaluate the safety and efficacy of co-transplantation of NiCord® and an unmanipulated CBU in patients with Hemoglobinopathies (Sickle Cell Disease (SCD), or thalassemia major) following myeloablative therapy. The overall study objectives of part 2 of this study are to evaluate the safety and efficacy of transplantation of NiCord® in patients with Hemoglobinopathies (Sickle Cell Disease (SCD), or thalassemia major) following myeloablative therapy.
The study hypothesis for part 1 of this study is that the co-transplantation of NiCord® and an unmanipulated unrelated cord blood graft in patients with hemoglobinopathies (SCD, or thalassemia major) following myeloablative preparative therapy will be safe and will enable cord blood engraftment. The study hypothesis for part 2 of this study is that transplantation of NiCord® in patients with hemoglobinopathies (SCD, or thalassemia major) following myeloablative preparative therapy will be safe and will enable cord blood engraftment.
Up to fifteen (15) evaluable patients recruited for part 1 of the study and up to five (5) patients for part 2 of the study should be 2-45 years of age, at least 10 kg in weight, have symptomatic SCD or thalassemia major and should be considered as candidates for allogeneic myeloablative HSCT for the treatment of SCD.
#Intervention
- DRUG : NiCord
- NiCord® is a cell-based product composed of umbilical cord-derived ex vivo expanded stem and progenitor cells | #Eligibility Criteria:
Inclusion Criteria:
* Must be 2 - 45 years and at least 10 kg
* Must have clinically severe SCD (SS, SC or SBeta0 Thal) or thalassemia major and be eligible for myeloablative SCT
* Must have two partially HLA-matched CBUs for part 1; and one partially HLA-matched CBU for part 2
* Back-up autologous stem cells harvested from bone marrow
* Adequate Karnofsky Performance score or Lansky Play-Performance scale
* Sufficient physiological reserves
* Signed written informed consent
Exclusion Criteria:
* HLA-matched related donor able to donate
* Severe alloimmunization with inability to guarantee a supply of adequate PRBC donors
* Prior allogeneic hematopoietic SCT within the last 12 months or reduced-intensity transplant within the past 6 months
* Human immunodeficiency virus (HIV) infection
* Active or uncontrolled infection
* Pregnancy or lactation
Sex :
ALL
Ages :
- Minimum Age : 2 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT01590628 | 236,175 |
{
"NCT_ID" : "NCT05653895",
"Brief_Title" : "Independent and Additive Effects Of Micronutrients With Metformin In Patients With PCOS",
"Official_title" : "Independent and Additive Effects Of Micronutrients With Metformin In Patients With PCOS:A Double Blind Randomized Placebo Controlled Trial",
"Conditions" : ["PCOS"],
"Interventions" : ["Combination Product: Acetyl-L-Carnitin, L Arginine, Co-Q10", "Dietary Supplement: Resveratrol", "Drug: Metformin"],
"Location_Countries" : ["Pakistan"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-12-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-12-30",
"Study_Completion_Date(Actual)" : "2024-02-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-03-01",
"First_Posted(Estimated)" : 2022-12-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-12-15",
"Last_Update_Posted(Estimated)" : 2024-02-23",
"Last_Verified" : 2024-02"
}
}} | #Study Description
Brief Summary
The investigators aim to conduct a double blind randomized clinical trial to study the independent and additive effects of micronutrients (Resveratrol, Acetyl-L Carnitine, L Arginine and COQ10 ) with Metformin in patients with PCOS .Women diagnosed with PCOS according to National Institute of Health( NIH) 2012 extension of European Society of Human Reproduction and Embryology /American Society of Reproductive Medicine ESHRE /ASRM 2003 criteria will be included according to a specific phenotype including Hyperandrogenism, Ovulatory dysfunction and Polycystic Ovarian Morphology. The investigators propose that by using combination therapy with micro supplements like Resveratrol, Acetyl-L Carnitine, L Arginine and COQ10 will produce greater improvement better than or at least comparable to Metformin in metabolic and endocrine profile of patients with PCOS.
Detailed Description
Polycystic ovary syndrome is a condition which is manifested by certain polycystic ovarian morphologic features, hyperandrogenism and ovulatory dysfunction. As per the revised diagnostic criteria by National Institute of Health 2012, about 6 to 10% women of the reproductive age are affected by the classic polycystic ovarian syndrome, the prevalence of which is twice as more according to the broader Rotterdam standards . One important cause of distress in patients with this syndrome is the excessive expression of androgens (e.g., hirsutism) which leads to infertility. A number of reports based on PCOS suggest that genetic anomalies of follicular maturation and ovarian steroidogenesis also have a crucial role in the development and occurrence of PCOS. This disorder is polygenic in nature and contributes towards metabolic diseases like obesity . About 50 to 80% women having PCOS are obese . Not only has this but PCOS also had a connection with an elevated risk of cardiovascular disease . Type-2 diabetes amongst women with this syndrome is reported to be 8 to 10%, and the compromised glucose tolerance cases are reported as high as 30 to 35% of US. Moreover, the chances of occurrence of this disease is highly associated with changes in age, history of diabetes in family and obesity . PCOS is a multifaceted health issue having several short and long term effects on woman's health. These include cardiovascular diseases, metabolic and sexual dysfunction, depression and anxiety that effects the overall quality of life. The present study documents the impact of PCOS and its complications on overall quality of life and how new treatment options can help minimize the signs and symptoms associated with the disease condition. Some of the recent focused therapeutic compounds reported in this context are Resveratrol, L-Carnitine, Co-Q10, L-Arginine and Decanoic acid as naturally occurring nutraceuticals and metformin as standard therapeutic drug against PCOS.
Resveratrol (3,5,4-trihydroxystilbene)-A naturally occurring polyphenol, found in grapes, peanuts, red wine and many medicinal plants . According to studies, this compound may have many antidiabetic, anti-inflammatory and antioxidant actions . Kong et al. highlighted that resveratrol decreases the atretic follicles which significantly increase the number of oocytes . This leads to an inhibition of both, apoptosis and primordial to the developing follicle in rats of different age groups . Resveratrol has been reported to interact with multiple cell targets, but its major effects are brought about by the activation of SIRT1 (silent information regulator 1) . SIRT1, which is a key player in energy metabolism and homeostasis, is a mammalian homologue of Sir2 (yeast) which deacetylates many mammalian cell targets. The SIRT1 is basically expressed in oocytes and human granulosa nuclei cells at multiple developmental stages of the follicles. It is also responsible for suppressing inflammation. Moreover, SIRT1 is also involved in protecting the oocytes from age dependent insufficiencies through oxidative stress . Resveratrol has a tendency to suppress inflammation by activating SIRT1 and as a result the symptoms of inflammation are reduced in many autoimmune disease models like rheumatoid arthritis, colitis, encephalomyelitis and type I diabetes L-Carnitine is involved in fatty acid oxidation by long chain fatty acids transport inside the mitochondria for oxidation to produce metabolic energy and have effects on glucose metabolism in tissues. L-Carnitine is known to regulate energy production . Studies have shown that patients treated with L-Carnitine have improved ovulation and pregnancy rates and is very well tolerated by the patients .
Coenzyme Q10 (CoQ10) a lipid soluble coenzyme which is an important component of the inner membrane of mitochondria. It is a key regulator of oxidative phosphorylation in the electron transport chain for ATP synthesis. A number of studies have reported a protective role of CoQ10 in ovaries by restoring aging of ovaries and improving mitochondrial function . According to a recent finding, administration of 20 mg/kg of CoQ10 in a rat model led to increased insulin sensitivity, suggesting its antidiabetic potential .
Decanoic acid- is naturally occurring fatty acid present in palm and coconut oils . Lee et al suggested that decanoic acid along with metformin altered cAMP signaling and normalized the androgen synthesis. Moreover, in a diabetic mouse model, treatment with decanoic acid led to improved glucose sensitivity. In another study, letrozole-induced rat PCOS model, the administration of decanoic acid reduced the levels of androgen and 3-HSD which led to restoration of the estrous cycle . These studies suggest a positive role of decanoic acid in management and treatment of insulin resistance and hyperandrogenism in PCOS patients.
L-Arginine is an amino acid that plays a role in a number of metabolic pathways and serves as a substrate for NOS (Nitric Oxide synthase) enzyme which is essentially involved in normal insulin signaling and endothelial function . In other findings, it is proposed that L-Arginine also enhances metabolic profile, β-cell function and has anti-oxidant potential . The ovarian health was also improved along with follicular growth, luteal function and oocyte development by the administration of L-Arginine. According to a previous study, PCOS patients had lowered levels of NO (nitric oxide) due to reduced expression of NOS which consequently led to a decline in arginine bioavailability. Therefore, L-arginine supplementation can have a therapeutic potential .
Metformin a biguanide which is used in type 2 diabetes and is mostly used as a gold standard drug for PCOS therapy . The mechanism of action is such that it helps in inhibition of hepatic gluconeogenesis and intestinal glucose absorption which ultimately improves insulin signaling .
Metformin has a direct and important role in human ovarian steroidogenesis. It inhibits insulin stimulated progesterone and gonadotrophin dose dependently in granulosa cells . According to a recent research report, it was reported that metformin treatment in infertile, anovulatory PCOS women, resulted in pregnancy, higher ovulation and live birth rates as compared to placebo . PCOS is a systemic condition, an endocrinopathy whose etiology is still not understood, correct treatment regimens of PCOS will not only improve menstrual cycle irregularities of the patients but will also improve the metabolic or endocrinological parameters . PCOS sufferers are also known to have increased levels of perceived stress which will be considered in the study. Very little evidence is available on combination therapy for treatment of PCOS patients. In this study the investigators goal will be to come up with a better treatment option to treat the disease effectively.
#Intervention
- DIETARY_SUPPLEMENT : Resveratrol
- Resveratrol
- DRUG : Metformin
- Metformin
- COMBINATION_PRODUCT : Acetyl-L-Carnitin, L Arginine, Co-Q10
- Treatment of PCOS with combination of Acetyl-L-Carnitin, L Arginine, Co-Q10 | #Eligibility Criteria:
Inclusion Criteria:
* PCOS women aged 16 -45 years.Diagnosis of PCOS will be made according to NIH 2012 extension of ESHRE/ASRM 2003 criteria Identification of specific phenotype will be included
1. HA+OD+PCOM (Hyperandrogenism, Ovulatory dysfunctions, Polycystic ovarian morphology)
2. HA+OD
3. HA+PCOM
4. PCOM+OD
Exclusion Criteria:
* Women with hyperprolactenemia
* Diabetes Mellitus
* Cushing syndrome
* Androgen secreting tumours
* Non classical congenital adrenal hyperplasia
* History of seizures
* Patients on anti coagulants, anti platelets ,isoproterenol ,antidepressants, potassium sparing diuretics
* Pregnancy or use of contraceptives
* Patients with thyroid disease
* Patients on hormonal therapy -
Sex :
FEMALE
Ages :
- Minimum Age : 16 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT05653895 | 73,523 |
{
"NCT_ID" : "NCT00906256",
"Brief_Title" : "Clinical Pharmacology Study of AZD7295 in Healthy Subjects",
"Official_title" : "A Clinical Pharmacology Study to Determine the Pharmacokinetic, Safety and Tolerability Profile of Oral Doses of AZD7295 in Healthy Subjects",
"Conditions" : ["Healthy"],
"Interventions" : ["Drug: Placebo", "Drug: AZD7295"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2009-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-07",
"Study_Completion_Date(Actual)" : "2009-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-05-11",
"First_Posted(Estimated)" : 2009-05-21"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-05-20",
"Last_Update_Posted(Estimated)" : 2010-02-12",
"Last_Verified" : 2010-02"
}
}} | #Study Description
Brief Summary
The purpose of this study is to determine the pharmacokinetic profile of oral doses of AZD7295 capsules in healthy subjects, and also to assess the effects of food as well as safety and tolerability.
Detailed Description
OBJECTIVES: Primary
* To determine the pharmacokinetic profiles of oral doses of AZD7295 capsules administered to healthy subjects
* To study the effect of food on the pharmacokinetic profiles of oral doses of AZD7295 capsules in healthy subjects
* To assess the safety and tolerability profiles of oral daily doses of AZD7295 capsules in healthy subjects TYPE AND DESIGN: Part A A phase I, single-centre, double-blind, randomised, placebo-controlled, crossover, food effect study in healthy subjects
Part B A phase I, single-centre, double-blind, randomised, placebo-controlled, ascending dose study in healthy subjects
NUMBER OF SUBJECTS: 16 subjects will take part in a total of 4 treatment periods.
SUBJECT CHARACTERISTICS: Healthy males and females of non-child bearing potential aged 18 to 65 years.
Recruitment will not be balanced for gender or any other variable.
TREATMENT: Part A
Subjects will be randomised to receive AZD7295 or placebo (14 active; 2 placebo) in either the fed or fasted state according to the treatment allocation:
Treatment A: 260 mg (4 x 65 mg) AZD7295 capsules or placebo dosed in the fed state
Treatment B: 260 mg (4 x 65 mg) AZD7295 capsules or placebo dosed in the fasted state
Following dosing of the first two periods there will be a period of interim analysis, during which the pharmacokinetic data will be reviewed in order to determine whether the remaining treatments will be dosed either in the fed or fasted state.
Subjects from Part A will continue into Part B of the study.
Part B
Subjects will be allocated to two groups of n=8 (Group 1 and Group 2) and randomised to receive AZD7295 or placebo (6 active; 2 placebo). Subjects will receive two of the ascending dose treatments in the following order according to group allocation:
Group 1:
Treatment C: 455 mg (7 x 65 mg) AZD7295 or placebo dosed either in the fed or fasted state;
Group 2:
Treatment D: 650 mg (10 x 65 mg) AZD7295 or placebo dosed either in the fed or fasted state;
Group 1:
Treatment E: 650 mg (10 x 65 mg) AZD7295 or placebo, twice a day (q12h) dosed either in the fed or fasted state (total administered dose: 1300 mg);
Group 2:
Treatment F: 650 mg (10 x 65 mg) AZD7295 or placebo, three times a day (q8h) dosed either in the fed or fasted state (total administered dose: 1950 mg).
Safety data and limited PK data will be reviewed by the data review group prior to proceeding to the next dose level.
During the dose escalation phase a maximum of 4 subjects will be dosed per day.
MAIN OUTCOME MEASURES: The primary outcome will be to determine the pharmacokinetic profiles of AZD7295 when dosed in the fed and fasted state and to assess the safety and tolerability of higher daily doses of AZD7295.
GENERAL SCHEDULE: Screening is planned to start in April 2009, with the clinical phase due to be completed by the end of July 2009
#Intervention
- DRUG : AZD7295
- Capsules 260mg, 455mg, 650mg (single doses), 650mg q12h, 650mg q8h.
- DRUG : Placebo
- Placebo | #Eligibility Criteria:
Inclusion Criteria:
* Healthy males or healthy females of non-child bearing potential
* Aged 18 <= age <= 65 years;
* Body Mass Index (BMI) of 18 <= age <= 32kg/m2;
* Normal electrocardiograms (ECGs) or with clinically insignificant abnormalities in the opinion of the Investigator;
* Normal vital signs or with clinically insignificant abnormalities in the opinion of the Investigator;
* Clinically normal physical findings and safety laboratory values at the time of the screening visit, as judged by the Investigator;
* Must be willing and able to participate in the whole study and must provide written informed consent.
Exclusion Criteria:
* Participation in a clinical research study involving investigational drugs or dosage forms within the previous 3 months;
* Subjects who have previously been enrolled in this study;
* A past or current disease, which as judged by the Investigator, could affect the subject's participation in or the outcome of the study. These diseases include, but are not limited to cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease and endocrine disease;
* Subjects who have ever sought advice from or been referred to a GP or counsellor for abuse or misuse of alcohol, non medical drugs, medicinal drugs or other substance abuse e.g. solvents;
* Subjects who admit to any current or previous use of Class A drugs such as opiates, cocaine, ecstasy, lysergic acid diethylamide (LSD) and intravenous amphetamines (Subjects who admit to occasional past use of cannabis will not be excluded as long as they have a negative drugs of abuse test and have been abstinent for at least 12 months;);
* Positive drugs of abuse test result (Appendix 1, Section 20);
* Regular alcohol consumption in males >21 units per week and females >14 units per week (1 Unit = ½ pint beer, a 25 mL shot of 40% spirit or a 125 mL glass of wine);
* Smoking of more than 10 cigarettes per day and the inability to refrain from smoking during confinement;
* Females of child bearing potential, as detailed in Section 9.4;
* Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the PI (Appendix 1, Section 20);
* History of adverse reaction or allergy to study drug or its excipients. If the subject suffers from hayfever they must not have or be expecting to have symptoms during the study period;
* Subjects with known present or past medical history, or family history (as far as known by the subject) of any of the following cardiovascular findings:
* 2nd degree AV-block (type II) or 3rd degree AV-block and/or other relevant arrhythmias
* Prolonged QT-interval syndrome or other cardiac conduction disorder QTc > 450 ms
* PR interval outside range of 120 - 220 ms
* Evidence of clinically significant T wave abnormalities
* Donation of blood within the previous three months;
* Subjects will be excluded from the study if they are considered by the PI to be at risk of transmitting, thorough blood or other body fluids, the agents responsible for acquired immunodeficiency syndrome (AIDS) or other sexually transmitted disease or hepatitis;
* Positive HBV, HCV or HIV results;
* Excessive use of caffeine (more than five cups of coffee or equivalent per day);
* Subjects receiving prohibited medication as described in Section 9.5;
* Subjects with planned surgery, dental procedure or hospitalisation during the study;
* Failure to satisfy the PI of fitness to participate for any other reason.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT00906256 | 203,687 |
{
"NCT_ID" : "NCT02956707",
"Brief_Title" : "Impact of Pre-operative Steroids on Adrenal Insufficiency",
"Official_title" : "Impact of Pre-operative Steroids on Adrenal Insufficiency and Clinical Outcomes After Neonatal Cardiac Surgery With Cardiopulmonary Bypass",
"Conditions" : ["Adrenal Insufficiency Neonatal"],
"Interventions" : ["Other: No pre-operative steroids"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-01-12",
"Study_Completion_Date(Actual)" : "2019-01-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-10-14",
"First_Posted(Estimated)" : 2016-11-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-11-03",
"Last_Update_Posted(Estimated)" : 2019-01-15",
"Last_Verified" : 2019-01"
}
}} | #Study Description
Brief Summary
Little is known regarding the incidence and clinical impact of AI in neonates during the acute postoperative period following separation from CPB. In a randomized control pilot study performed by the UAB CVICU research team, prophylactic post-CPB hydrocortisone infusions improved some postoperative outcomes, especially in those that acquired AI7. In an attempt to further explore post-CPB AI, a retrospective analysis of data from this study was performed. Of the 40 neonates included in the study, one-third (32.5%) developed AI following CPB (as determined by low-dose, 1 µg, cosyntropin stimulation test). Almost all of these subjects had normal response to cosyntropin stimulation pre-CPB. Subjects that developed AI demonstrated more hemodynamic instability, increased serum lactate and required more colloid resuscitation in the immediate post-CPB period in the operating room. Recent evidence has begun to highlight potential morbidity associated with perioperative steroid administration. Our cardiac surgery program is changing clinical practice and ceasing to give preoperative steroids to all patients (previously only neonatal CPB patients received preoperative methylprednisolone). With the possibility that preoperative steroid administration, and not CPB, primarily causes the high incidence of AI, it is prudent to further investigate the benefit and/or harm of perioperative steroid administration
Detailed Description
Cardiopulmonary bypass (CPB) induces systemic inflammatory response syndrome (SIRS), which may contribute to postoperative morbidity. Neonates experience an exaggerated inflammatory response and may be at a higher risk for the deleterious effects of CPB. SIRS may disrupt the hypothalamic-pituitary-adrenal (HPA) axis leading to a relative adrenal insufficiency (AI) after neonatal CPB. There is some emerging evidence supporting an association of AI with morbidity in neonates after cardiac surgery. Postoperative steroids may offer hemodynamic benefits to neonates suffering from low cardiac output syndrome (LCOS) following CPB. Benefit of postoperative steroids is multifactorial including: suppression of inflammatory cytokines, direct actions on the heart and vascular smooth muscle, and treatment of AI in a subset of patients.
Little is known regarding the incidence and clinical impact of AI in neonates during the acute postoperative period following separation from CPB. In a randomized control pilot study performed by the UAB CVICU research team, prophylactic post-CPB hydrocortisone infusions improved some postoperative outcomes, especially in those that acquired AI. In an attempt to further explore post-CPB AI, a retrospective analysis of data from this study was performed. Of the 40 neonates included in the study, one-third (32.5%) developed AI following CPB (as determined by low-dose, 1 µg, cosyntropin stimulation test). Almost all of these subjects had normal response to cosyntropin stimulation pre-CPB. Subjects that developed AI demonstrated more hemodynamic instability, increased serum lactate and required more colloid resuscitation in the immediate post-CPB period in the operating room.
In this retrospective analysis by Crawford et al.8 ACTH levels were found to be significantly lower post-CPB compared to preoperative levels. This may be secondary to a blunted HPA axis caused by preoperative methylprednisolone (all patients received), which could result in transient, iatrogenic AI. Serum cytokines were not significantly different in patients exhibiting AI compared to those with a normal adrenal response indicating that increased inflammation was not primarily responsible for the development of AI. Higher methylprednisolone levels result in higher cortisol levels due to cross-reactivity of the assays; patients with higher baseline postoperative cortisol levels demonstrated a blunted response to cosyntropin suggesting that these patients may have higher blood concentrations of methylprednisolone and its metabolites, thereby leading to more inhibition of the HPA axis. Taken together, these two studies demonstrate that AI occurs at high frequency after neonatal CPB and that AI is associated with deleterious outcomes. While postoperative hydrocortisone improves outcomes in neonates with AI, the investigator cannot exclude preoperative methylprednisolone as a cause of iatrogenic AI. Other investigators have shown in children treated with dexamethasone prior to surgery, that higher measured levels of dexamethasone were associated with postoperative AI9.
The majority of congenital heart surgery centers utilize perioperative steroids in neonates undergoing cardiac surgery with the rationale that it modulates post-CPB SIRS and treats/prevents AI; studies have inconsistently demonstrated benefit of this approach. Additionally, recent evidence has begun to highlight potential morbidity associated with perioperative steroid administration. Our cardiac surgery program is changing clinical practice and ceasing to give preoperative steroids to all patients (previously only neonatal CPB patients received preoperative methylprednisolone). With the possibility that preoperative steroid administration, and not CPB, primarily causes the high incidence of AI, it is prudent to further investigate the benefit and/or harm of perioperative steroid administration.
With these facts in mind, the investigator designed this study to determine the impact of preoperative steroid administration on development of AI and other outcomes after neonatal cardiac surgery.
B. Herein the investigator proposes to test the following HYPOTHESES and address these SPECIFIC AIMS:
HYPOTHESES: Preoperative steroid (methylprednisolone) administration is associated with development of iatrogenic AI; AI leads to increased postoperative morbidity. Preoperative steroids do not have important impact on other postoperative clinical outcomes.
SPECIFIC AIM# 1: Determine the incidence of AI (as diagnosed by 1µg cosyntropin stimulation testing) following CPB in neonates who do not receive preoperative steroids; compare to the previous cohort that received preoperative steroids.
SPECIFIC AIM# 2: Compare ACTH and cortisol levels between the two cohorts of neonates (those who do and those who do not receive preoperative steroids).
SPECIFIC AIM# 3: Compare secondary clinical outcomes including volume of crystalloid/colloid administered in the CVOR, hemodynamic parameters, laboratory values, vasoactive-inotrope score (VIS), duration of mechanical ventilation, fluid overload and mortality of the two cohorts of neonates.
#Intervention
- OTHER : No pre-operative steroids
- Due to new information provide from previous studies at our center the investigator instituted a clinical practice change remove steroid administration in the pre-operative period for all neonates undergoing surgery with cardiopulmonary bypass. This study is to evaluate this change. | #Eligibility Criteria:
Inclusion Criteria:40 consecutive neonates (<=30 days of age) with complex congenital heart disease undergoing cardiac surgery with CPB who will not be given preoperative steroids.
* Controls: 40 neonates with complex congenital heart disease undergoing cardiac surgery with CPB who received two doses of preoperative methylprednisolone (10mg/kg at eight hours and one hour prior to their operation). Data from this cohort has already been prospectively collected during the original pilot randomized control trial. Based on our clinical data over the past 8 years, the demographic and risk factors of the two cohorts will be very similar.
Exclusion Criteria: Neonates who do not require CPB during cardiac surgery or fail to separate from CPB in the operating room.
*
Sex :
ALL
Ages :
- Minimum Age : 1 Day
- Maximum Age : 60 Days
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
| NCT02956707 | 211,810 |
{
"NCT_ID" : "NCT02888587",
"Brief_Title" : "The Innervation of Human Gut Sensory Epithelial Cells",
"Official_title" : "The Innervation of Human Gut Sensory Epithelial Cells",
"Conditions" : ["Organoids"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-09-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-12-01",
"Study_Completion_Date(Actual)" : "2022-12-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-08-30",
"First_Posted(Estimated)" : 2016-09-05"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-08-30",
"Last_Update_Posted(Estimated)" : 2023-01-06",
"Last_Verified" : 2023-01"
}
}} | #Study Description
Brief Summary
The study has two objectives:
1. To obtain endoscopic and colonoscopic biopsies to harvest and culture intestinal crypts from human tissue to produce organoids. These organoids will be used to study the biology of innervated sensory epithelial cells.
2. to collect subject data relating to clinical management and demographic characteristics of patients undergoing upper endoscopy or colonoscopy to learn the mechanisms behind visceral hypersensitivity, and neurodegenerative diseases that may arise in the gut.
Detailed Description
Throughout the gastrointestinal tract there are specialized sensory epithelial cells that recognize stimuli from nutrients and bacteria. These cells have been traditionally known for their endocrine function. However, it was recently discovered using mouse models that these cells receive synaptic inputs from enteric and peripheral neurons, such as those with cell bodies in dorsal root ganglia or the vagal nodose.
This finding opened a few possibilities, including the following: 1) sensory function of the gastrointestinal tract is modulated by neural activity; 2) gut bacteria influences brain function through a direct neural circuit; and 3) viruses that preferentially infect neurons access the central nervous system through this neural circuit \[1,2\]. To translate findings in animal models to humans, the investigator must test the hypotheses in which the physiology of gut sensory epithelial cells resembles that of humans.
Visceral hypersensitivity is a core symptom for several gastrointestinal and brain behavior disorders, including irritable bowel syndrome, autism and anorexia. Unfortunately, the basic mechanisms of sensory processing in the wall of the gut are non-existent. This lack of knowledge precludes the development of therapeutic strategies to treat disorders linked to visceral hypersensitivity. The investigator's efforts to translate animal research into human models will be a foundation to develop target therapies for visceral hypersensitivity.
Today, it is possible to derive organoids from intestinal crypts harvested from human intestinal or colonic tissue. The organoids have all epithelial cell types, including gut sensory cells. Here, the investigator's goal is to use de-identified human tissues to culture intestinal organoids in the laboratory, and use it as a platform to study the biology of innervated sensory epithelial cells. This work is significant because it will open the possibility to learn the mechanisms behind visceral sensation and neurodegenerative diseases that may arise in the gut.
| #Eligibility Criteria:
Inclusion Criteria:
* All patients undergoing either endoscopy OR colonoscopy OR both procedures will be eligible for inclusion in this study.
* adult males and females 18 years or older who have been seen by the GI clinic or who have been scheduled for direct-to-procedure appointment in the GI clinic.
Exclusion Criteria:
* Subjects who are not competent to give consent
* Males and females under 18 years
* Women who are pregnant
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT02888587 | 189,407 |
{
"NCT_ID" : "NCT04052737",
"Brief_Title" : "PMZ-1620 (Sovateltide) in Mild to Moderate Alzheimer's Disease",
"Official_title" : "A Prospective, Multicentric, Randomized, Double Blind, Placebo Controlled Phase II Clinical Study to Compare the Safety and Efficacy of PMZ-1620 Therapy Along With Standard Supportive Care in Subjects of Mild to Moderate Alzheimer's Disease",
"Conditions" : ["Alzheimer Disease", "Dementia"],
"Interventions" : ["Drug: PMZ-1620 (sovateltide) along with standard treatment", "Drug: Normal Saline along with standard treatment"],
"Location_Countries" : ["India"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-03-23",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-12-20",
"Study_Completion_Date(Actual)" : "2023-01-06},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-08-08",
"First_Posted(Estimated)" : 2019-08-12"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-08-09",
"Last_Update_Posted(Estimated)" : 2023-01-12",
"Last_Verified" : 2023-01"
}
}} | #Study Description
Brief Summary
This is a prospective, multicentric, randomized, double blind, placebo controlled Phase II clinical study to compare the safety and efficacy of PMZ-1620 therapy along with standard supportive care in subjects with mild to moderate Alzheimer's disease.
Detailed Description
Alzheimer's is not just a disease of old age, approximately 200,000 Americans under the age of 65 having younger-onset Alzheimer's disease (AD). In 2015, there were approximately 29.8 million people worldwide with AD. The person with Alzheimer's disease can live an average of eight years after their symptoms become noticeable to others, but survival range is 4 to 20 years, depending on the age and other health conditions (www.alz.org). The pathophysiology of AD is related to the injury and death of neurons, initiating in the hippocampus brain region that is involved with memory and learning, then atrophy affects the entire brain. The cause of Alzheimer's disease is still poorly understood and about 70% of the risk is associated with genetic. Other risk factors may also associate with this like history of head injuries, depression, or hypertension. Like all types of dementia, Alzheimer's is also caused by brain cell death. Although AD is classified as a neurodegenerative dementia, considerable evidence links vascular dysfunction and vascular risk factors as pathogenesis of AD. However, it is a progressive brain cell death that happens over a course of time and treatments can't stop Alzheimer's from progressing, they can temporarily slow the worsening of dementia symptoms and improve quality of life for those with Alzheimer's and their caregivers (www.alz.org; www.who.int).
Sovateltide is an endothelin B (ETB) receptor agonist (previously used names IRL-1620, SPI-1620 and PMZ-1620; International Non-proprietary Name (INN) approved by WHO is sovateltide). Activation of ETB receptors with PMZ-1620 produces neurovascular repair and remodeling or neuroregeneration. There are hidden stem cells in the brain, which becomes active following injury to the brain. Intravenous administration of PMZ-1620 (sovateltide) augments the activity of neuronal progenitor cells in the brain to repair the damage by formation of new mature neurons and blood vessels. In addition, PMZ-1620 has anti-apoptotic activity and also increases cerebral blood flow.
#Intervention
- DRUG : Normal Saline along with standard treatment
- PMZ-1620 (sovateltide) is an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in Alzheimer's disease patients. In this arm normal saline along with standard treatment will be given for active comparison.
- Other Names :
- Vehicle
- DRUG : PMZ-1620 (sovateltide) along with standard treatment
- PMZ-1620 (sovateltide) is an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in Alzheimer's disease patients.
- Other Names :
- IRL-1620 | #Eligibility Criteria:
Inclusion Criteria:
* Adult males or females Aged 45 years through 85 years (have not had their 86th birthday)
* Men and women with a diagnosis of Alzheimer's disease according to the clinical criteria
* Women must be of non-childbearing potential, surgically sterile, or willing to use adequate birth control; men who are sexually active will also be required to use adequate birth control
* Able to give consent for participation on their own or through their Legally Acceptable Representative
* MRI/CT scan assessment within six months before baseline, corroborating the clinical diagnosis of AD and excluding other potential causes of dementia, especially cerebrovascular lesions
* MMSE score in between 11 to 26 in case of mild to moderate stage of Alzheimer's disease
* Absence of major depressive disease according to Geriatric Depression Scale (GDS) of < 5 7. Previous decline in cognition for more than six months as documented in subject's medical records 8. Subject, who are on stable treatment with any of AD drugs are also eligible to participate in this study 9. Formal education for eight or more years 10. Subjects living at home or nursing home setting, without continuous nursing care 11. General health status acceptable for participation in a 6-months clinical trial 12. A caregiver available and living in the same household or interacting with the subject a sufficient time each week and available if necessary to assure administration of drug 13. Subjects with any other chronic conditions are stable and undergoing appropriate treatment
Exclusion Criteria:
* Subjects who have a Mini Mental State Examination (MMSE) score of < 10
* Subjects who have serious or unstable medical conditions that would exclude completion of all procedures and data collection for the study, or would be likely to preclude participation in a drug development trial
* A current Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnosis of active major depression, schizophrenia or bipolar disorder
* Other infectious, metabolic or systemic diseases affecting the central nervous system
* Subjects who have participated in a clinical trial investigating an anti-amyloid agent
* Subjects who are currently participating in a clinical trial with an investigational drug
* Subjects who, in the opinion of the physician, are otherwise unsuitable for this study
* Clinically significant, advanced or unstable disease that may interfere with outcome measures, and which may bias the assessment of the clinical or mental status of the subject or put the subject at special risk
* History of or screening brain MRI scan indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct > 1 cm3, >3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g. abscess or brain tumor such as meningioma)
* Subject has had a myocardial infarction, unstable angina, stroke, transient ischemic attack or required intervention for any of these conditions within 6 months of Screening
* Clinical or laboratory findings consistent with:
1. Other primary degenerative dementia,
2. Other neurodegenerative condition
3. Seizure disorder
* Subjects, who are already taking sedatives, antidepressants, antipsychotics and antihistaminic medications
Sex :
ALL
Ages :
- Minimum Age : 45 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04052737 | 197,484 |
{
"NCT_ID" : "NCT04365725",
"Brief_Title" : "Multicenter, Retrospective Study of the Effects of Remdesivir in the Treatment of Severe Covid-19 Infections",
"Official_title" : "Multicenter, Retrospective Study of the Effects of Remdesivir in the Treatment of Severe Covid-19 Infections.",
"Conditions" : ["COVID-19"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-05-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-06-12",
"Study_Completion_Date(Actual)" : "2020-06-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-04-25",
"First_Posted(Estimated)" : 2020-04-28"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-04-25",
"Last_Update_Posted(Estimated)" : 2021-04-19",
"Last_Verified" : 2021-04"
}
}} | #Study Description
Brief Summary
This study is a retrospective cohort trial to assess the efficacy of remdesivir in hospitalized adult patients diagnosed with COVID-19. The study is a multicenter trial which will be carried out on different sites in France. This trial is retrospective and will analyze the data collected during treatment.
Detailed Description
COVID-19 is a respiratory disease caused by a new coronavirus (SARS-CoV-2) and causes significant morbidity and mortality. There is currently no approved treatment for the treatment of patients with COVID-19. Global efforts to evaluate new antivirals and therapeutic strategies to treat COVID-19 have intensified. To quickly propose a first line of defense and fight against the virus in hospitalized patients, the World Health Organization (WHO) relies on already existing drugs, 'repositioned', which are immediately available in large quantities and present a good security profile. Remdesivir (GS-5734) is a broad spectrum nucleotide analogue that inhibits RNA-dependent RNA polymerase activity among a diverse group of RNA viruses. Non-clinical and clinical data suggest that remdesivir may be useful for the treatment of COVID-19. WHO has identified remdesivir as a candidate drug of interest to be studied in clinical trials. Compassionate provision of the drug allowed its use before clinical trials began. This retrospective cohort study is designed to analyze the data collected during the routine care of patients who have benefited from this compassionate provision.
The data collected in real life during care will allow a multivariate analysis quickly providing elements of response on a typology of patients and level of progression of the disease for which remdesivir would bring a more or less significant clinical benefit. Multivariate analysis of these data will allow the identification of variables at the initiation of treatment with remdesivir that are potentially predictive of its clinical efficacy.
The period for collecting data collected during treatment for an individual subject is 30 days. The retrospective collection begins on the day before initiation of treatment with remdesivir up to 29 days after. A note of information and of no objection to the collection of data will be sent to the patient. The data collected comes from the patient's medical records. The observations will be entered by investigative doctors and or clinical study technicians.
Statistical analysis will be carried out using SAS 9.3 and / or R software. All the analyzes carried out will follow the recommendations of STROBE for observational studies. A detailed statistical analysis plan will be carried out before basic freezing and data analysis. Quantitative data will be described as the mean and standard deviation or medians and quartiles depending on the distribution of the data. Qualitative data will be described in terms of numbers and percentages. Comparisons of quantitative data will be analyzed using the student or wilcoxon test depending on the test application conditions, and comparisons of categorical variables will be made using the Chi2 or Fisher test, if appropriate. Multivariate models will be produced to explore the factors associated with patient prognosis. The clinical development of patients described on a 7-point ordinal scale will be divided into two in order to create logistic models. The entire process of selecting variables in the models will be described in the analysis plan which will be validated before the database freezes.
#Intervention
- DRUG : Remdesivir
- Compassionate provision | #Eligibility Criteria:
Inclusion Criteria:
* Adult >= 18 years.
* SARS-CoV-2 infection confirmed.
* Hospitalized patients who received at least one administration of remdesivir therapy outside of clinical trials
Exclusion Criteria:
* Patients included in a clinical trial testing remdesivir as an investigational drug.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04365725 | 87,235 |
{
"NCT_ID" : "NCT01675102",
"Brief_Title" : "Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in 17p- Chronic Lymphocytic Leukemia (CLL)",
"Official_title" : "Allogeneic HSCT in 17p- CLL in First or Second Partial or Complete Remission at Transplant: a Non-interventional Prospective Study.",
"Conditions" : ["CLL"],
"Location_Countries" : ["Israel", "Netherlands", "Sweden", "Germany", "United Kingdom", "Finland", "Denmark"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-08-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-09",
"Study_Completion_Date(Actual)" : "2015-12-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-08-27",
"First_Posted(Estimated)" : 2012-08-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-08-28",
"Last_Update_Posted(Estimated)" : 2019-08-16",
"Last_Verified" : 2019-08"
}
}} | #Study Description
Brief Summary
17p-/p53-mutated chronic lymphocytic leukemia (CLL) is an orphan disease, accounting for approximately 5% of newly diagnosed CLL. This subgroup of patients has a very poor outcome after chemoimmunotherapy. Allogeneic HCT may change the poor prognosis. In a retrospective EBMT-analysis on 44 patients with advanced 17p-CLL 2-year progression-free survival was 45% (95% CI, 30% to 60%) after allogeneic HCT (Allogeneic hematopoietic stem-cell transplantation for chronic lymphocytic leukemia with 17p deletion: a retrospective European Group for Blood and Marrow Transplantation analysis. J Clin Oncol, 2008, 26, 5094-5100).
Referring to these favorable results and small additional series, patients with 17p-CLL requiring therapy are considered to have an indication for allogeneic transplantation by many CLL study groups. Several CLL study groups recommend allogeneic HCT in 17p-CLL as part of the first- or second line treatment.
The aim is to collect additional evidence on allogeneic HCT in 17p-/p53-mutated CLL in first or second remission by a non-interventional prospective study. Patients shall be registered prior to HCT at the Leiden Office in order to rule out a reporting bias after transplantation.
Detailed Description
Objective:
The aim is to determine early PFS after allogeneic HCT in first or second remission of 17p-/p53-mutated CLL within an epidemiologic study.
Methods:
Neither the decision for allogeneic transplantation nor specific treatment recommendations for patients with 17p-/p53-mutated CLL are part of the study. Instead, the study protocol refers to EBMT guidelines. Indications for allogeneic stem cell transplantation in chronic lymphocytic leukemia: the EBMT transplant consensus. Leukemia 21, 2007, 12-17). Minimal essential data (MED) A and B, defined by the EBMT, will be collected (www.ebmt.org).
The rate of progression-free survival (PFS) at 1 year after HSCT was selected as primary endpoint. Death, clinical relapse or progression but not immune manipulations (taper of immunosuppression, DLI, rituximab) are considered as treatment failure for PFS. Patients without information on one-year follow up will be considered as having experienced treatment failure. The rate of PFS at 1 year will be calculated by dividing the number of patients without treatment failure by the number of patients who met all selection criteria.
For the calculation of the sample size a fixed sample design was selected. The null hypothesis is that the success-rate for PFS is equal or less than 50%. Referring to the retrospective EBMT survey, PFS at one year after allogeneic HCT is expected to be 70%. According to Fleming-A'Hern (1982) the null hypothesis can be rejected with a power of 80% and an alpha error of 5% if a minimum of 24 out of 37 informative patients did not experience treatment failure during the first year after allogeneic HCT (Machin et al, Sample Size Tables for Clinical Studies, Wiley-Blackwell, 3rd edition, 2009). Taking into account a 10% drop-out rate by violation of inclusion criteria the target number of patients to be included was set at 41 patients.
| #Eligibility Criteria:
Inclusion Criteria:
* 17p-/p53-mutated CLL by FISH or sequencing, confirmed by review by an experienced laboratory
* first or second partial remission or complete remission at HCT according to the updated NCI-criteria (Hallek 2008)
* MRD diagnostic as part of the local standard follow up
* allogeneic HCT from a matched related or unrelated donor with up to one mismatch refering to HLA-A, -B, -C and DRB1
Exclusion Criteria:
* ex vivo T-cell depletion
* in vivo T-cell depletion with alemtuzumab
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 69 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01675102 | 179,819 |
{
"NCT_ID" : "NCT00602420",
"Brief_Title" : "Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)",
"Official_title" : "Prevention of Pegfilgrastim-Induced Bone Pain (PIBP): A Phase III Double-Blind Placebo-Controlled Clinical Trial",
"Conditions" : ["Musculoskeletal Complications", "Pain", "Unspecified Adult Solid Tumor, Protocol Specific"],
"Interventions" : ["Drug: naproxen", "Other: placebo"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2008-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-01",
"Study_Completion_Date(Actual)" : "2012-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-01-22",
"First_Submitted_that_Met_QC_Criteria" : 2015-05-08",
"First_Posted(Estimated)" : 2008-01-28"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-01-22",
"Last_Update_Posted(Estimated)" : 2015-11-09",
"Last_Verified" : 2015-10"
}
}} | #Study Description
Brief Summary
RATIONALE: Naproxen may help prevent or lessen bone pain caused by pegfilgrastim. It is not yet known whether naproxen is more effective than a placebo in preventing bone pain caused by pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy.
PURPOSE: This randomized phase III trial is studying naproxen to see how well it works compared with a placebo in preventing bone pain caused by pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy.
Detailed Description
OBJECTIVES:
Primary
* To compare the efficacy of daily administration of naproxen vs placebo in preventing or reducing the severity and duration of pegfilgrastim-induced bone pain (PIBP) in patients with non-hematologic malignancies undergoing chemotherapy.
Secondary
* To identify potential risk factors for the development of PIBP.
* To identify potential clinical predictors for the response or failure to respond to naproxen in preventing PIBP.
* To assess the toxicity of naproxen when administered in the preventive setting.
OUTLINE: This is a multicenter study. Patients are stratified by Clinical Community Oncology Program (CCOP) site. Patients are randomized to 1 treatment arm vs placebo.
* Arm I: Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
* Arm II: Patients receive matching placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
#Intervention
- DRUG : naproxen
- Oral naproxen twice daily for 5-8 days.
- OTHER : placebo
- Oral placebo twice daily for 5-8 days. | #Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of a non-hematologic (non-myeloid) malignancy
* Scheduled to receive chemotherapy; chemotherapy may be given for adjuvant, neoadjuvant, curative, or palliative intent
* Scheduled to receive the first dose of pegfilgrastim (Neulasta®) to ameliorate chemotherapy-induced neutropenia
* Creatinine <= 1.5 times upper limit of normal
* Able to understand English
* More than 6 months since prior surgery on the heart
Exclusion Criteria:
* Pregnant or nursing
* Clinical evidence of active gastrointestinal bleeding, prior gastrointestinal bleeding, or gastric or duodenal ulcers
* Allergy to naproxen
* Prior development of the triad of asthma, rhinitis, and nasal polyps after taking acetylsalicylic acid (aspirin) or other NSAIDs
* Concurrent nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, or any product containing naproxen (e.g., Naprosyn, EC-Naprosyn, Anaprox, Anaprox-DS, Naprosyn suspension, or Aleve), on a regular basis
* Concurrent steroids on a regular basis
* Concurrent prescription or non-prescription medications for preexisting chronic pain; concurrent cardioprotective doses (<= 325 mg/day) of aspirin allowed
* Concurrent therapeutic doses of warfarin
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 120 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00602420 | 3,051 |
{
"NCT_ID" : "NCT03447054",
"Brief_Title" : "Severe Alcohol-use Disorder: a tDCS and Response Inhibition Training Intervention",
"Official_title" : "Treating Alcohol Dependence : Testing a Combined Treatment Model Using Transcranial Direct Current Stimulation (tDCS) and Inhibitory Control Training (ICT)",
"Conditions" : ["Alcohol Use Disorder"],
"Interventions" : ["Behavioral: Combined TDCS active and ICT active", "Behavioral: Combined TDCS sham and ICT active", "Behavioral: Combined Sham TDCS and inactive ICT", "Behavioral: Combined TDCS active and ICT inactive"],
"Location_Countries" : ["Belgium"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-01-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-03-18",
"Study_Completion_Date(Actual)" : "2020-09-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-11-03",
"First_Posted(Estimated)" : 2018-02-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-02-25",
"Last_Update_Posted(Estimated)" : 2020-11-04",
"Last_Verified" : 2020-11"
}
}} | #Study Description
Brief Summary
Most severe forms of alcohol-use disorder are thought to reflect an abnormal interplay between two neural systems: an overly active impulsive one driven by immediate rewards prospects and a weak reflective one, tuned on long-term prospects. The investigators propose that two non-pharmacological interventions, Transcranial Direct Current Stimulation (tDCS) and Inhibitory Control Techniques (ICT) may act on both systems when combined, which might ultimately result is a reduction of alcohol relapse rate.
Detailed Description
Treating Alcohol dependence remains notoriously difficult despite use of several medications, psychotherapeutic and psychosocial interventions. Alcohol dependence is thought to reflect an abnormal interplay between two neural systems: an overly active impulsive one driven by immediate rewards prospects and a weak reflective one, tuned on long-term prospects. The investigators proposes that two non-pharmacological interventions, Transcranial Direct Current Stimulation (tDCS) and Inhibitory Control Techniques (ICT) may act on both systems when combined. tDCS has been found to improve working memory, which is necessary to evaluate long-term consequences of actions. ICT is able to modify the automatic approach tendencies towards appetitive cues.
The investigators will recruit 160 alcohol-dependent patients and divide them randomly between four treatment conditions : real transcranial Direct Current Stimulation (tDCS) with active or control Inhibitory Control Technique (ICT ); or sham (placebo) tDCS with active or control ICT.
Patients will be evaluated with primary outcome measures (alcohol consumption patterns) and secondary outcome measures (working memory and changes in alcohol-related stimuli affective values).
#Intervention
- BEHAVIORAL : Combined TDCS active and ICT active
- Five 20-minute long sessions including TDCS (2 MicroAmperes during 20 minutes) and ICT, 5 consecutive days
- Other Names :
- Experimental
- BEHAVIORAL : Combined TDCS sham and ICT active
- Five 20-minute long sessions including TDCS sham (non active) and ICT, 5 consecutive days
- Other Names :
- Sham/active
- BEHAVIORAL : Combined TDCS active and ICT inactive
- Five 20-minute long sessions including TDCS sham and no-cue inhibition training, 5 consecutive days
- Other Names :
- Sham/inactive
- BEHAVIORAL : Combined Sham TDCS and inactive ICT
- Five 20-minute long sessions including TDCS and no-cue inhibition training, 5 consecutive days
- Other Names :
- Active/inactive | #Eligibility Criteria:
Inclusion Criteria:
* Patients with severe alcohol-use disorder (DSM-5 criteria), hospitalized for detoxification.
* Severity of alcohol use disorder must be at least moderate (at least 4 DSM-5 criteria)
* Aged between 18 and 65 years
* Comorbidity with anxiety disorders and depressive disorders is allowed
* Patients must be illegal drug free for 3 weeks at beginning of trial
* Pharmacotherapy: patients should be benzodiazepines free at the moment of inclusion. They are allowed to continue other psychotropic medication (antidepressants, antipsychotics, mood stabilizers), providing they are following a stable regimen that will not be changed during the protocol time.
* Patients must be reachable for follow-up
Exclusion Criteria:
* Previous neurological conditions (epilepsy, traumatic brain injury, stroke)
* Present delirium, confusion or severe cognitive disorder
* Schizophrenia, chronic psychotic disorders, bipolar type 1 disorder.
* Any severe, life-threatening disorders
* High suicidal risk
* Specific contraindications for tDCS: metallic plates in the head
* Alcohol medication treatment initiated during the rehab: acamprosate, disulfiram, baclofen, nalmefen.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03447054 | 251,451 |
{
"NCT_ID" : "NCT04079504",
"Brief_Title" : "Comparison of Postoperative Pain After Hernial Sac Ligation Versus Non-ligation in Inguinal Hernioplasty",
"Official_title" : "Comparison of Postoperative Pain After Hernial Sac Ligation Versus Non-ligation in Inguinal Hernioplasty.",
"Conditions" : ["Inguinal Hernia, Indirect", "Postoperative Pain"],
"Interventions" : ["Procedure: Non-ligation of Indirect Inguinal hernia sac", "Procedure: Ligation of indirect hernia sac"],
"Location_Countries" : ["Pakistan"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-10-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-07-31",
"Study_Completion_Date(Actual)" : "2021-07-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-09-03",
"First_Posted(Estimated)" : 2019-09-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-09-03",
"Last_Update_Posted(Estimated)" : 2022-04-26",
"Last_Verified" : 2022-04"
}
}} | #Study Description
Brief Summary
This study is intends to compare mean postoperative pain scores for 48-hours in patients undergoing Inguinal hernioplasty with and without hernia sac ligation in Department of Surgery, Dow University of Health Sciences \& Dr. Ruth K. M. Pfau Civil Hospital Karachi.Half of the patients undergoing inguinal hernioplasty will have their indirect inguinal sacs ligated whereas other half will have non-ligation and inversion of sac.
Detailed Description
Amongst general surgical operations done in elective theaters, Hernioplasty is one of the most common. In the current era of new and developing maneuvers of inguinal hernia repairs, the conventional anterior, tension-free approach is considered a daycare method with minimal morbidities. However, mild to medium early postoperative pain is frequent with reported incidence of 21.6% in literature.
The reasons of postoperative pain after hernia repair are multifactorial. Delikoukos et al mentioned that ilioinguinal nerve entrapment or mesh fixation in the periosteum of the pubic tubercle are major etiological factors in the occurrence of postoperative pain. Later studies highlighted that these factors are major culprits in chronic neuralgias with inconsistent involvement in early postoperative pain after mesh repair.This necessitated the exploration of other offenders causing early postoperative pain. In this context, surgeons focused on the role of hernial sac ligation in mesh repairs of indirect inguinal hernias. The notion behind this operative technique is the generation of pain as a consequence of highly pain sensitive parietal peritoneum trauma during ligation and division of hernia sac, the fact which was highlighted by Schulman et al nearly two decades ago. Despite this imperative reason, there is a noteworthy gap on this aspect of early pain with studies still addressing the chronic pain after mesh repair of inguinal hernias. A research reports that frequency of early postoperative pain at day one was significantly higher in 'hernial sac high ligation group' as compared to 'hernial sac non-ligation group' (mean postoperative pain on VAS; 3.5±1.5, and 2.3±1.2 respectively, p\<0.05), yet other studies report no significant difference in pain when evaluating different operative techniques.However further studies are needed to establish omission of hernia sac ligation as part of the standard procedure.
Early postoperative pain not only results in delayed recovery and return to normal activity but also adds to the financial constraints of patient and health system.Therefore, the aim of this study is to compare the early postoperative pain after hernia sac ligation as compared to non-ligation in order to establish a definitive role of these operative techniques in the development of early postoperative pain after mesh repair of inguinal hernia so the superior of the two techniques will be employed subsequently.
#Intervention
- PROCEDURE : Ligation of indirect hernia sac
- Indirect inguinal hernia sac will be separated from the spermatic cord and contents of the sac will be reduced before ligating it at the deep inguinal ring.
- Other Names :
- Prolene Mesh Placement
- PROCEDURE : Non-ligation of Indirect Inguinal hernia sac
- the indirect inguinal hernia sac will be separated from the spermatic cord and reduced/inverted in to the peritoneal cavity through the deep inguinal ring along with its contents.
- Other Names :
- Prolene Mesh placement | #Eligibility Criteria:
Inclusion Criteria:
* Patients >=15 years, of either gender having Incomplete indirect inguinal hernia with or without direct concurrent hernia as mentioned in operational definition.
Exclusion Criteria:
* Complete inguinal hernias.
* Patients having obstructed and/or strangulated inguinal hernia.
* Recurrent inguinal hernias.
* patients with ipsilateral synchronous inguinoscrotal pathologies e.g. hydrocele, testicular malignancy
Sex :
ALL
Ages :
- Minimum Age : 15 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
| NCT04079504 | 113,632 |
{
"NCT_ID" : "NCT02790138",
"Brief_Title" : "A Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis",
"Official_title" : "A Randomized, Double-Blind, Placebo-Controlled Phase 4 Study to Evaluate the Efficacy and Safety of Entyvio (Vedolizumab IV) in the Treatment of Chronic Pouchitis (EARNEST)",
"Conditions" : ["Pouchitis"],
"Interventions" : ["Drug: Vedolizumab Placebo", "Drug: Vedolizumab", "Drug: Ciprofloxacin"],
"Location_Countries" : ["France", "Netherlands", "United States", "Germany", "Canada", "Spain", "Italy", "Belgium", "United Kingdom"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-10-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-06-11",
"Study_Completion_Date(Actual)" : "2021-02-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-05-26",
"First_Submitted_that_Met_QC_Criteria" : 2021-06-09",
"First_Posted(Estimated)" : 2016-06-03"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-05-31",
"Last_Update_Posted(Estimated)" : 2022-02-24",
"Last_Verified" : 2022-02"
}
}} | #Study Description
Brief Summary
The purpose of this study is to compare the efficacy of vedolizumab intravenous (IV) and placebo in terms of the percentage of participants with chronic or recurrent pouchitis achieving clinically relevant remission.
Detailed Description
Vedolizumab is being tested to treat people who have chronic pouchitis. This study will look at the healing of inflammation of ileal pouch in people who take vedolizumab as compared to those receiving a matching placebo. The study will enroll approximately 110 patients. Participants will be randomly assigned to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
* Vedolizumab 300 mg IV
* Placebo IV
All participants will receive an intravenous infusion at Day 1, Weeks 2, 6, 14, 22, and 30 along with concomitant antibiotic treatment with ciprofloxacin 500 mg twice daily through Week 4.
This multicenter trial will be conducted in North America and Europe. The overall time to participate in treatment and efficacy assessment of this study is 34 weeks. Participants will make multiple visits to the clinic, plus a final visit 18 weeks after the last dose of study drug for a safety follow-up assessment (up to Week 48). Participants will also participate in a long-term follow-up, by phone after the last dose of study drug up to Week 56.
#Intervention
- DRUG : Vedolizumab Placebo
- Vedolizumab placebo-matching IV infusion
- DRUG : Ciprofloxacin
- Ciprofloxacin tablets
- DRUG : Vedolizumab
- Vedolizumab IV infusion
- Other Names :
- Entyvio, MLN0002 IV, Kynteles | #Eligibility Criteria:
Inclusion Criteria:
* In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
* The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
* Has a history of ileal pouch anal anastomosis (IPAA) for ulcerative colitis (UC) completed at least 1 year prior to the Day 1 (Randomization) Visit.
* Has pouchitis that is chronic or recurrent, defined by an modified pouchitis disease activity index (mPDAI) score >=5 assessed as average from 3 days immediately prior to the Baseline endoscopy and a minimum endoscopic subscore of 2 (outside the staple or suture line) with either (a) >=3 recurrent episodes within 1 year prior to the Screening Period treated with >=2 weeks of antibiotic or other prescription therapy, or (b) requiring maintenance antibiotic therapy taken continuously for >=4 weeks immediately prior to the Baseline Endoscopy Visit.
* Agrees to take ciprofloxacin (500 mg twice daily) on Day 1 and through Week 4, regardless of the previous treatment and to stop any previous antibiotic therapy on Day 1 of the study (additional courses of antibiotics will be allowed, as needed, for flares after Week 14).
* A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use a barrier method of contraception (e.g., condom with spermicide) from signing of informed consent throughout the duration of the study and for 18 weeks after last dose. The female partner of a male participant should also be advised to use a highly effective method of contraception.
* A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
Exclusion Criteria:
Gastrointestinal Exclusion Criteria
* Has Crohn's disease (CD), or CD of the pouch.
* Has irritable pouch syndrome (IPS).
* Has isolated or predominant cuffitis.
* Has mechanical complications of the pouch (e.g., pouch stricture or pouch fistula).
* Currently requires or has a planned surgical intervention for UC during the study.
* Has diverting stoma.
Infectious Disease Exclusion Criteria 1. Has evidence of an active infection (e.g., sepsis, cytomegalovirus, or listeriosis) during Screening.
* Has active or latent tuberculosis (TB), regardless of treatment history, as evidenced by any of the following:
* A diagnostic TB test performed within 30 days of Screening or during the Screening Period that is positive, as defined by:
1. A positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests. OR
2. A tuberculin skin test reaction >=10 mm (>=5 mm in participants receiving the equivalent of >15 mg/day prednisone).
OR
* Chest X-ray within 3 months prior to Day 1 that is suspicious for pulmonary TB, and a positive or 2 successive indeterminate QuantiFERON test within 30 days prior to Screening or during the Screening Period.
3. Has chronic hepatitis B virus (HBV) infection* or chronic hepatitis C virus (HCV) infection** or a known history of human immunodeficiency virus (HIV) infection (or is found to be seropositive at Screening) or participant is immunodeficient (e.g., due to organ transplantation, history of common variable immunodeficiency, etc).
* Participants who are positive for hepatitis B virus surface antigen (HBsAg) will be excluded. For participants who are negative for HBsAg but are positive for either surface antibodies and/or core antibodies, HBV Deoxyribonucleic acid (DNA) polymerase chain reaction will be performed and if any test result meets or exceeds detection sensitivity, the participant will be excluded.
* If participant is HCV antibody positive, then a viral load test will be performed. If the viral load test is positive then the participant will be excluded.
4. Has evidence of active infection with Clostridium (C) difficile during Screening (to be confirmed by laboratory test)
General Exclusion Criteria
1. Has any prior exposure to vedolizumab, natalizumab, efalizumab, rituximab, etrolizumab, or anti-mucosal addressin cell adhesion molecule-1 (MAdCAM-1) therapy.
2. Has a history of hypersensitivity or allergies to vedolizumab or its components.
3. Has allergies to and/or contraindications for ciprofloxacin, a history of tendon disorders related to quinolone administration and/or glucose-6-phosphate dehydrogenase (G6PD) deficiency. Further conditions requiring precautions for use of ciprofloxacin have to be considered based on local prescribing information.
4. Is taking, has taken, or is required to take any excluded medications.
5. Has received any investigational or approved biologic or biosimilar agent within 60 days prior to Randomization.
6. Has received an investigational nonbiologic therapy within 30 days prior to Randomization.
7. Has received an approved nonbiologic therapy (including 5-aminosalicylate [5-ASA], corticosteroid, azathioprine, 6-mercaptopurine [6-MP], etc.) in an investigational protocol within 30 days prior to Randomization.
8. Has received any live vaccinations within 30 days prior to randomization.
9. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist at Screening.
10. Has had a kidney, heart, or lung transplant.
11. Has a history of malignancy, except for the following: adequately-treated non-metastatic basal cell skin cancer; squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to the Screening visit; and history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to Screening. Participants with a remote history of malignancy (e.g., >10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received and must be discussed with the sponsor on a case-by-case basis prior to enrollment.
12. Has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease.
13. Has conditions, which in the opinion of the investigator, may interfere with the participant's ability to comply with the study procedures.
14. Has any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal (GI), genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurologic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise participant safety.
15. Has any of the following laboratory abnormalities during the Screening Period:
<!-- -->
1. Hemoglobin level <8 g/dL.
2. White blood cell (WBC) count <3 × 10^9/L.
3. Lymphocyte count <0.5 × 10^9/L.
4. Platelet count <100 × 10^9/L or >1200 × 10^9/L.
5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × the upper limit of normal (ULN).
6. Alkaline phosphatase >3 × ULN.
7. Serum creatinine >2 × ULN.
16. If female, the participant is pregnant or lactating or intending to become pregnant or nurse before, during, or within 18 weeks after the last dose of study medication; or intending to donate ova during such time period.
17. If male, the participant intends to donate sperm or father a child during the course of this study or for 18 weeks after the last dose of study medication.
18. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
19. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to Screening.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02790138 | 184,078 |
{
"NCT_ID" : "NCT03156244",
"Brief_Title" : "Using PROMIS as Part of Routine Clinical Care for Racially Diverse Prostate and Bladder Cancer Patients",
"Official_title" : "LCCC 1636: Using PROMIS as Part of Routine Clinical Care for Racially Diverse Prostate and Bladder Cancer Patients",
"Conditions" : ["Prostate Cancer", "Bladder Cancer"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-05-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-05-05",
"Study_Completion_Date(Actual)" : "2018-05-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-05-15",
"First_Posted(Estimated)" : 2017-05-17"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-05-15",
"Last_Update_Posted(Estimated)" : 2019-11-04",
"Last_Verified" : 2019-09"
}
}} | #Study Description
Brief Summary
In this pilot study, a total of 80 patients with prostate or bladder cancer (40 black, 40 white) will complete 3 patient-reported outcome (PRO) surveys: baseline (pre-treatment), during treatment, and after treatment. The overall goal of this study is to assess whether collecting patient-reported data is feasible as part of clinical care of cancer patients, and whether these data are useful for clinicians and patients. Among these 80 patients, those who agree will also undergo a semi-structured interview to assess value of HRQOL assessment at the end of the study. Of specific interest is an evaluation of whether feasibility and perceived value differ between black and white participants.
Detailed Description
Cancer treatments, including surgery, radiotherapy and chemotherapy, are often linked to acute and late side effects. Historically, these effects were assessed by physicians and scored using standardized scales such as the Common Terminology Criteria for Adverse Events (CTCAE). Thorough and accurate assessment of symptoms facilitates timely and patient-centered symptom management.
Multiple studies have demonstrated that PROs more accurately capture patient symptoms than physician assessment. In a prospective trial, Falchook et al. investigated patient vs. physician report of symptoms in head and neck cancer patients undergoing radiotherapy (N=44). Patients and physicians separately completed weekly symptom assessments during treatment and once during follow-up. Patients tended to report more severe symptoms than physicians. For example, in week six, physicians rated 86% of patients' fatigue as non-existent or mild while 86% of patients rated their own fatigue as moderate to very severe. In a larger study conducted at Memorial Sloan-Kettering Cancer Center of 163 lung cancer patients undergoing chemotherapy, Basch et al. similarly examined patient vs. physician report of symptoms over one year. Compared to patients, physicians reported less severe and lower rates of fatigue, nausea, and pain and higher functional status.
Findings from these prior studies are consistent with evidence from a recent systematic review, which concluded that PRO data were essential for the evaluation of symptoms in cancer survivors. Many researchers have hypothesized the reasons behind this discrepancy in physician/patient ratings of symptoms, including poor communication, inadequate physician time spent per patient, and patients' underreporting of symptoms to physicians. Thus, incorporation of PRO data into routine clinical care can facilitate better detection and management of cancer and treatment-related effects.
Therefore, the goal of this pilot study is to move PRO data collection from a purely research exercise into using this as a tool to improve care for cancer patients. This pilot study will assess the feasibility of collecting PRO data as part of clinical care, and assess its 'value' from the patient and physician perspectives. The investigators will recruit 80 patients with prostate or bladder cancers from the UNC Genitourinary Oncology clinics (including Urology and Radiation Oncology). PRO data that is most relevant to this patient population will be collected, including: gastrointestinal, urinary, sexual function, anxiety/depression, and sleep.
Further, given longstanding racial disparities in symptom experiences (e.g., symptom assessment, severity, frequency) among cancer patients and limited evidence of effective strategies for mitigating such inequities, this pilot study will also examine Black-White differences in terms of the feasibility and perceived value of sharing of patient-reported data to improve communication and decision-making.
| #Eligibility Criteria:
Inclusion Criteria:
* >= 18 years
* Non-Hispanic Black and White patients with a known pathologic diagnosis of prostate or bladder cancer and intent to undergo treatment.
* Signed, IRB approved written informed consent.
Exclusion Criteria:
* Initiation of cancer-directed treatment
* Race/ethnicity other than Non-Hispanic Black or Non-Hispanic White
* Inability to read and speak English
* Inability to comply with study for any other reason than language
* Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03156244 | 70,313 |
{
"NCT_ID" : "NCT04657263",
"Brief_Title" : "Impact of the COVID-19 Pandemic on Vaccination",
"Official_title" : "Impact of the COVID-19 Pandemic on Vaccination in Patients at Risk of Infection",
"Conditions" : ["Covid19"],
"Interventions" : ["Other: Vaccine coverage assessment"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-11-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-05-01",
"Study_Completion_Date(Actual)" : "2021-05-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-12-07",
"First_Posted(Estimated)" : 2020-12-08"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-12-07",
"Last_Update_Posted(Estimated)" : 2021-10-25",
"Last_Verified" : 2021-10"
}
}} | #Study Description
Brief Summary
The vaccination policy is drawn up in France by the French Minister of Health, who makes public the vaccination schedule after the opinion of the High Authority of Health.
Currently according to the 2019 immunization schedule, the dTP vaccine is the only mandatory in the general population with recalls in adults aged 25, 45, 65 and every 10 years. In 2011, the Ministry of Health estimated that only 50.5% of the general population was up to date against dTP.
Two vaccines are recommended for person at risk of infection according to the current vaccine schedule: the flu vaccine and the pneumococcal vaccine. In fact, influenza and pneumococcal disease are more frequent and more serious in patients with chronic diseases (diabetes, cardiac insufficiency..) compared to the general population.
The vaccination coverage rate of at-risk populations is dramatically below the vaccination coverage targets set by the Ministry of Health. Indeed, there are many barriers to vaccination, medical and para-medical barriers, but also individual barriers.
The current COVID-19 pandemic has identified people at risk of severe infection and death risk, particularly those with co-morbidities (diabetes, cardiovascular disease, etc.). Thus, this pandemic may have contributed to change in patients' perceptions regarding both the risk of infection and the potential interest and benefit of vaccination.
#Intervention
- OTHER : Vaccine coverage assessment
- Vaccine coverage assessment | #Eligibility Criteria:
Inclusion criteria:
* Person at risk of infection according to french 2019 immunization schedule
* Patients aged above 18 years
Exclusion criteria:
* Patient < 18 years
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04657263 | 31,024 |
{
"NCT_ID" : "NCT03500978",
"Brief_Title" : "Factors Predicting Ineffective Contraception Use",
"Official_title" : "Factors Predicting Ineffective Contraception Use",
"Conditions" : ["Contraception Behavior"],
"Interventions" : ["Behavioral: Peer CBT Intervention"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-03-19",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-05-31",
"Study_Completion_Date(Actual)" : "2019-05-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-04-02",
"First_Posted(Estimated)" : 2018-04-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-04-09",
"Last_Update_Posted(Estimated)" : 2020-06-26",
"Last_Verified" : 2020-06"
}
}} | #Study Description
Brief Summary
Unintended pregnancy (UP), defined as a mistimed or unwanted pregnancy, is a significant and prevalent public health problem, particularly among low-income women. Over half of all pregnancies are reportedly unintended and UP has been linked to adverse health outcomes in mothers and their children. Correct and consistent use of effective contraception is the primary method to prevent UP. Research has shown that low self-esteem and elevated depressive symptoms increase women's risk for ineffective contraception use and, by extension, for UP. This project examines the feasibility and possible efficacy of reducing ineffective contraception using an intervention that addresses depressive symptoms and self concept among young, low-income, predominantly minority women at risk for UP. Traditional cognitive behavioral therapy (CBT) is effective in reducing depressive symptoms and improving self concept; but limited utilization, poor response, and low adherence to CBT is common among low-income and minority women. A more acceptable method for delivering CBT is needed for the target population. This project will use peer-specialists to deliver a CBT-based intervention to women at risk for UP. Because peer specialists are drawn from the same community as the target population and share some similar life experiences, the intervention may be more acceptable and effective than one offered by trained professionals.
This project will examine the effectiveness of a 9 week (8-session) peer-specialist led CBT-based intervention compared to an observational control condition to reduce depressive symptoms, improve self-esteem, and improve consistent contraceptive use to prevent UP. The weekly intervention sessions are delivered by telephone by a trained peer specialist. The study will evaluate the effectiveness of the intervention to improve consistent contraceptive use (primary outcome) and decrease depressive symptoms and increase self-esteem (secondary outcomes).
Detailed Description
This is a randomized controlled trial with one intervention group (peer-specialist led telephone-based CBT) and an observation only control group. There will be 3 measurement periods: baseline (pre-intervention), 10-week follow-up (post-intervention) and 14-week follow up. The 14-week follow up assesses the primary outcome (consistency of contraception use) and secondary outcomes (psychological symptoms and self-esteem), whereas the 10-week follow up assesses mediating variables (sexual self-efficacy, contraceptive self-efficacy, social support and coping). There is also a 4-week, mid-intervention assessment of outcomes designed to assess if there is a worsening of symptoms that needs to be addressed (e.g. referral for spike in depression or emergence of suicidal intent). This midterm evaluation also allows us to monitor the well-being of the control group, which has significantly less contact with project staff than the intervention group.
We will recruit 132 sexually active women from health care clinics (e.g., family planning, OB/GYN), with the aim of retaining at least 92 (46 per condition). Interested women will be consented and screened for eligibility in a private area of the clinics. They will be contacted by phone after consent to complete a structured, baseline questionnaire. After the baseline questionnaire, women will be randomly allocated to study conditions. Women will be randomized based on the randomization schedule established by the project biostatistician. Women allocated to the CBT intervention group will be mailed an intervention workbook and have their first telephone-based intervention session scheduled. The CBT intervention group will receive 8 telephone-based CBT intervention sessions (over 9 weeks) delivered by peer specialists. Each session will last up to 30 minutes. The control group will be an observation only control group (CTL group). They will not receive any intervention. The post-intervention and 1-month follow up questionnaires will also be collected via structured telephone interviews. Research staff who are collecting data will be blinded to study condition.
In addition to monitoring for worsening of psychological symptoms, procedures are in place for referring participants with worrisome increases in depression (i.e., \>14 on the PHQ9) or suicidal intent to relevant mental health resources, including hospital emergency rooms and suicide hotlines for persons expressing suicidal intent. Further, the DSMB will be alerted so that they can monitor whether one condition appears to have an unusually high increase in symptoms, which might warrant stopping the trial for safety reasons. In addition, the researchers collecting data and the peer-specialists implementing the intervention will be engaged in weekly supervision with a clinical psychologist and have access to the study PI at all times. The project biostatistician will conduct all intention-to-treat (ITT) analyses using appropriate modern statistical approaches.
#Intervention
- BEHAVIORAL : Peer CBT Intervention
- Peer specialist delivery of cognitive behavioral therapy intervention over the phone. | #Eligibility Criteria:
Inclusion Criteria:
* female, aged 18 <= age <= 45, sexually active with a man in past 3 months, report inconsistent or no contraception use in the past 3 months, English speaking, own a smartphone, report subclinical to mild depressive symptoms in past two weeks (score 5 to 14 on PHQ-9)
Exclusion Criteria:
* pregnant, using Long Acting Reversible Contraceptives, sterilized, planning to get pregnant in the next 6 months, report acute suicide risk (assessed via the PHQ Follow-up Suicide Risk Assessment form or self-repot a suicide attempt in the past 6 months)
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT03500978 | 227,897 |
{
"NCT_ID" : "NCT05509062",
"Brief_Title" : "Establishing Guidelines for Manual Lymphatic Drainage",
"Official_title" : "Establishing Guidelines for Manual Lymphatic Drainage",
"Conditions" : ["Lymphedema of Leg"],
"Interventions" : ["Procedure: Pressure"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-07-20",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-04-30",
"Study_Completion_Date(Actual)" : "2023-04-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-07-24",
"First_Posted(Estimated)" : 2022-08-19"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-08-17",
"Last_Update_Posted(Estimated)" : 2024-01-11",
"Last_Verified" : 2024-01"
}
}} | #Study Description
Brief Summary
The purpose of this study is to establish optimal guidelines for Manual Lymphatic Drainage in participants with lower extremity lymphedema.
Detailed Description
To determine if there is a difference in L-Dex Score and Segmental Limb Volume in participants with lower extremity lymphedema as measured in liters by the SOZO machine between participants who receive Manual Lymphatic Drainage (MLD) techniques utilizing light tactile pressure with 5-10 mmHg without skin stretch versus medium tactile pressure of 11-20 mmHg and medium skin stretch with therapist in a stationary position, versus firm tactile pressure (\> 21 mmHg) and maximal skin stretch with therapist weight shift.
#Intervention
- PROCEDURE : Pressure
- Subjects are randomized to one of three treatment groups | #Eligibility Criteria:
Inclusion Criteria:
* All adults between the age of 30 - 75 years
* Lower extremity lymphedema
Exclusion Criteria:
* Pregnant women
* Participants who are unable to stand independently for up to 2 mins
* Participants who cannot make their own decisions
* Participants undergoing cancer treatment
* Participants with an Infection (active cellulitis)
* Participants with a known Iodine Allergy
* Participants who weigh more than 375 lbs
* Participants with cardiac arrhythmias or implanted electronic equipment
* Participants who have undergone joint replacement in involved extremity
* Participants with cardiac insufficiency
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT05509062 | 55,609 |
{
"NCT_ID" : "NCT02060721",
"Brief_Title" : "Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension",
"Official_title" : "MERIT-2 : Long Term, Multicenter, Single-arm, Open-label Extension Study of the MERIT-1 Study, to Assess the Safety, Tolerabilty and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)",
"Conditions" : ["Chronic Thromboembolic Pulmonary Hypertension"],
"Interventions" : ["Drug: Macitentan"],
"Location_Countries" : ["France", "Lithuania", "Ukraine", "Mexico", "China", "Poland", "Germany", "Thailand", "Russian Federation", "Switzerland", "Hungary", "Turkey", "Belgium", "Czechia", "United Kingdom"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-02-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-03-21",
"Study_Completion_Date(Actual)" : "2022-03-21},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-01-02",
"First_Submitted_that_Met_QC_Criteria" : 2023-03-17",
"First_Posted(Estimated)" : 2014-02-12"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-02-11",
"Last_Update_Posted(Estimated)" : 2023-04-11",
"Last_Verified" : 2023-03"
}
}} | #Study Description
Brief Summary
Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
#Intervention
- DRUG : Macitentan
- Macitentan 10mg, oral tablet, once daily
- Other Names :
- ACT-064992 | #Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Subject with CTEPH having completed the double-blind (DB) AC-055E201/ MERIT-1 study as scheduled (i.e., who remained in the DB study up to Week 24).
* Females of childbearing potential must have a negative pre-treatment serum pregnancy test, be advised on appropriate methods of contraception, and agree to use 2 reliable methods of contraception.
Exclusion Criteria:
* Permanent discontinuation of DB study treatment due to an hepatic adverse event or liver aminotransferase abnormalities.
* Any known factor (e.g., drug or substance abuse) or disease (e.g., unstable psychiatric illness) that, in the opinion of the investigator, may interfere with treatment compliance or interpretation of the results, or that may influence the ability to comply with any of the study requirements.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02060721 | 181,372 |
{
"NCT_ID" : "NCT00488358",
"Brief_Title" : "Hemodynamic Changes After Aortic Aneurysm Treatment With Stent-Graft",
"Official_title" : "Hemodynamic Changes After Aortic Aneurysm Treatment With Stent-Graft",
"Conditions" : ["Abdominal Aortic Aneurysm"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2005-11",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-01",
"Study_Completion_Date(Actual)" : "2012-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2007-06-18",
"First_Posted(Estimated)" : 2007-06-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2007-06-19",
"Last_Update_Posted(Estimated)" : 2013-10-09",
"Last_Verified" : 2013-10"
}
}} | #Study Description
Brief Summary
To compare the aortic pulse profile before and after stent-graft implantation to prove that endovascular AAA repair using non-compliant stent-graft changes the aortic pulse profile.
Detailed Description
This study will assess hemodynamic changes in aortas of patients after treatment of their abdominal aortic aneurysm (AAA) with an FDA approved stent-graft (Zenith). This study does not require any change in clinical protocol to the the way the AAA procedures are currently done. Utilizing the catheters already employed in this procedure, intravascular blood pressure measurements will be documented at various times and at various anatomic levels prior to and after deployment of the stent-graft.
As the compliant aortic aneurysm acts as a capacitor, expanding during systole and contracting during diastole, it is our hypothesis that endovascular AAA repair using a non-compliant stent-graft changes the aortic pulse profile.
| #Eligibility Criteria:
Inclusion Criteria:
* Abdominal Aortic Aneurysm with planned treatment using Zenith Endovascular Stent-Graft
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT00488358 | 126,141 |
{
"NCT_ID" : "NCT00597402",
"Brief_Title" : "Avastin in Combination With Radiation (XRT) & Temozolomide, Followed by Avastin, Temozolomide and Irinotecan for Glioblastoma (GBM) and Gliosarcomas",
"Official_title" : "Avastin in Combination With Radiation and Temozolomide, Followed by Avastin, Temozolomide and Irinotecan for Glioblastoma Multiformes and Gliosarcomas",
"Conditions" : ["Glioblastoma", "Gliosarcoma", "Brain Tumor"],
"Interventions" : ["Drug: Avastin", "Drug: Temozolomide", "Drug: Irinotecan", "Radiation: Radiation Therapy (XRT)"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2007-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-08",
"Study_Completion_Date(Actual)" : "2013-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-01-10",
"First_Submitted_that_Met_QC_Criteria" : 2012-12-12",
"First_Posted(Estimated)" : 2008-01-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-01-17",
"Last_Update_Posted(Estimated)" : 2014-05-07",
"Last_Verified" : 2014-04"
}
}} | #Study Description
Brief Summary
Primary objective: To use overall survival to assess the efficacy of the combination of radiation therapy, temozolomide and Avastin followed by Avastin, temozolomide, and irinotecan in the treatment of grade IV malignant glioma patients following surgical resection.
Secondary objective: To determine the progression-free survival following the combination of radiation therapy, temozolomide and Avastin followed by Avastin, temozolomide, and irinotecan.
Exploratory Objective: To explore the relationship between biomarkers and outcome (overall survival and progression-free survival) among patients with grade IV malignant glioma treated with radiation therapy, temozolomide and Avastin followed by Avastin, temozolomide, and irinotecan.
To describe the toxicity of radiation therapy,temozolomide and Avastin followed by Avastin, temozolomide, and irinotecan.
Detailed Description
The standard of care for grade IV gliomas is radiation therapy with daily temozolomide, followed by 6 months of temozolomide. The majority of patients progress and die of their tumor. Many glioma patients are resistant to temozolomide because the tumors have high O(6)-methylguanine-DNA methyltransferase (MGMT), conferring resistance. Irinotecan is synergistic with temozolomide, and the combination may overcome high MGMT. Vascular endothelial growth factor (VEGF) is present on the cell surface and around malignant gliomas. It appears that the presence of vascular endothelial growth factor is a prognostic growth factor with more VEGF expression correlating with a poor prognosis. Monoclonal antibodies to VEGF have inhibited growth of malignant gliomas in a mouse xenograft. Avastin is a humanized monoclonal immunoglobulin G (IGG) 1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor. The combination of Avastin and irinotecan was safe and demonstrated high activity against recurrent malignant gliomas. The combination of Avastin, temozolomide, and irinotecan as the initial therapy may maximize the chance for long-term survival. There are other studies completed or ongoing for newly diagnosed glioblastoma (GBM) patients, including a Radiation Therapy Oncology Group (RTOG) study that added irinotecan to temozolomide following standard radiation therapy and temozolomide, and a University of California, Los Angeles (UCLA) study that added Avastin to standard radiation therapy and temozolomide followed by Avastin and temozolomide.
#Intervention
- DRUG : Avastin
- Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury. Following completion of XRT, patients will receive treatment that includes 6 cycles of Avastin, beginning a minimum of 14 days after last XRT.
- Other Names :
- Bevacizumab
- DRUG : Temozolomide
- Daily temozolomide 75 mg/m2/day for 6.5 weeks of radiation treatment. Following completion of XRT, patients will receive treatment including temozolomide 200 mg/m2/day on the 1st 5 days of each 28-day cycle.
- Other Names :
- Temodar
- RADIATION : Radiation Therapy (XRT)
- Treatment with standard XRT (radiation) for 6.5 weeks.
- DRUG : Irinotecan
- Following completion of XRT, patients will receive 6 cycles of treatment that includes irinotecan. Beginning a minimum of 14 days after last XRT, the irinotecan dose will depend on whether the patient is on enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED: 125 mg/m2.)
- Other Names :
- CPT-11, Camptosar | #Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically confirmed diagnosis of World Health Organization (WHO) grade IV primary malignant glioma (glioblastoma multiforme or gliosarcoma). Patients have to be within 4 weeks of the last major surgical procedure.
* Age > 18 years.
* An interval of at least 2 weeks and not > 6 weeks between prior major surgical procedure and study enrollment.
* No prior radiotherapy or chemotherapy for a brain tumor
* Karnofsky >= 60 percent.
* Hemoglobin >= 9.0 g/deciliter (dl), absolute neutrophil count (ANC) >= 1,500 cells/ microliter, platelets >= 125,000 cells/microliter.
* Serum creatinine <= 1.5 mg/dl, serum serum glutamic-oxaloacetic transaminase (SGOT) and bilirubin <= 1.5 times upper limit of normal (ULN).
* For patients on corticosteroids, they must be on a stable or decreasing dose for 1 week prior to entry, and the dose should not be escalated over entry dose level, if clinically possible.
* Signed informed consent approved by the Institutional Review Board
* No evidence of > grade 1 central nervous system (CNS) hemorrhage on the baseline MRI or CT scan.
* If sexually active, patients will take contraceptive measures for the duration of treatment as stated in the informed consent.
Exclusion Criteria:
* Pregnancy or breast feeding.
* Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids.
* Active infection requiring intravenous (IV) antibiotics.
* Prior treatment with radiotherapy or chemotherapy for a brain tumor, irrespective of the grade of the tumor.
* Evidence of > grade 1 CNS hemorrhage on baseline MRI on CT scan.
Avastin-Specific Concerns:
Subjects meeting any of the following criteria are ineligible for study entry:
* Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
* Blood pressure of 150/100 mmHg
* Unstable angina
* New York Heart Association (NYHA) Grade II or greater congestive heart failure
* History of myocardial infarction within 6 months
* History of stroke within 6 months
* Clinically significant peripheral vascular disease
* Evidence of bleeding diathesis
* Coagulopathy (prothrombin time (PT) or partial thromboplastin time (PTT) >1.5x normal or a history of > three grade 2 or greater hemorrhages)
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to first Avastin infusion during XRT/Temodar or anticipation of need for major surgical procedure during the course of the study
* Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to first Avastin infusion during XRT/Temodar
* Pregnant (positive pregnancy test) or lactating
* Urine protein >1.0 + at screening
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to first Avastin infusion during XRT/Temodar
* Serious, non-healing wound, ulcer, or bone fractures.
* Inability to comply with study and/or follow-up procedures.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00597402 | 180,798 |
{
"NCT_ID" : "NCT04306744",
"Brief_Title" : "The RA PROTECTION Study",
"Official_title" : "Researching the Safety and Efficacy the Vorso PROTECT System for the Treatment of Subjects With Active Rheumatoid Arthritis Who Are naïve to Biologic or Synthetic Disease Modifying Agents",
"Conditions" : ["Rheumatoid Arthritis"],
"Interventions" : ["Device: Vorso PROTECT System", "Device: Vorso PROTECT System - Sham (OFF)"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-09-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-01-21",
"Study_Completion_Date(Actual)" : "2022-01-21},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-03-05",
"First_Posted(Estimated)" : 2020-03-13"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-03-09",
"Last_Update_Posted(Estimated)" : 2023-03-30",
"Last_Verified" : 2023-03"
}
}} | #Study Description
Brief Summary
This is a prospective, multi-center, double-blind, randomized, controlled pilot study to assess safety and efficacy of the Vorso PROTECT System in patients who have moderately to severely active rheumatoid arthritis.
Eligible participants will be randomized in a 1:1 ratio of treatment to control (non- therapeutic) group after it has been determined they meet all of the inclusion criteria and none of the exclusion criteria. Both the treatment and control group participants will be asked to use the VORSO System once a day while maintaining a stable dose of methotrexate throughout the 12-week study. Participants will return to the site at 1, 6 and 12 weeks for follow-up testing.
#Intervention
- DEVICE : Vorso PROTECT System
- The Vorso PROTECT System is designed to deliver targeted, imperceptible, non-invasive stimulation to the ear to treat the signs and symptoms (e.g., tender and swollen joints, pain, synovitis) of patients with rheumatoid arthritis.
- DEVICE : Vorso PROTECT System - Sham (OFF)
- Identical device to experimental arm, but the device will not deliver stimulation | #Eligibility Criteria:
Inclusion Criteria:
* Be between 18 and 80 years at the time of enrollment
* Diagnosis of rheumatoid arthritis based on the 2010 EULAR/ACR criteria
* Diagnosis present for >=3 months
* Have evidence of active disease, as defined by having at least 4 tender and 4 swollen joints in the TJC68 and SJC66, respectively
* Presence of rheumatoid factor or anti-CCP antibody at enrollment
* Must have an inadequate response to the maximum tolerated dose of 15 <= age <= 25 mg/week (unless lower dose is needed to due toxicity or physician discretion) of csDMARD/s for at least 12 weeks with a stable dose for at least 4 weeks prior to Baseline visit and have not been previously treated with a biologic
* Participants receiving a nonsteroidal anti-inflammatory drug (NSAID), prednisone or prednisone equivalent (10mg or less/day) or methotrexate must be on stable doses of these agents for more than 30 days prior to Baseline and remain stable for the duration of the study
* Able to operate the device appropriately and use it as per the protocol requirements
* Be willing and capable of giving informed consent
* Be willing and able to comply with research-related requirements, procedures, assessments and visits
Exclusion Criteria:
* Previously treated with any approved or investigational biologic agent (including TNF-, IL-1, IL-6, T-cell or B-cell targeted therapies) or tsDMARD
* History of any arthritis with onset prior to age 17 years or current diagnosis, inflammatory joint disease other than RA (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, fibromyalgia. Current diagnosis of secondary Sjogren's Syndrome is permitted.
* Participants receiving intraarticular, intramuscular, or intravenous glucocorticoids within 4 weeks prior to Baseline (unless participant is on stable dose of prednisone as per inclusion above) or if it is anticipated that the participant will need glucocorticoids at some point during the expected study duration
* Have active disease involving the auricle or ear canal (e.g. otitis media, tinnitus, infection, perforated tympanic membrane, vestibular and/or balance, excessive cerumen production), unwilling to remove a piercing (e.g. daith or tragus), or use a device (e.g. hearing aid, cochlear implant) that would preclude daily use of the earpiece
* History of any clinically significant (as deemed by PI) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, neurologic, gastrointestinal, immunologic, or other major diseases
* History of unilateral or bilateral vagotomy
* History of recurrent vasovagal syncope episodes
* Any condition, including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the research or confounds the ability to interpret data from the research in the opinion of the Investigator
* Previously implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators)
* Be pregnant or breast feeding (if female and sexually active, participant must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal)
* Have symptomatic osteoarthritic knee issues within 30 days of enrollment
* Diagnosis of cancer (other than non-invasive skin cancer or carcinoma in-situ of the cervix) within the 5 years prior to research initiation
* Significant ECG findings (as determined by the Investigator), defined by:
* Ischemic changes (defined as >1mm of down-sloping ST segment depression in at least two contiguous leads)
* Q-waves in at least two contiguous leads
* Clinically significant intra-ventricular conduction abnormalities (left bundle branch block or Wolf-Parkinson-White syndrome)
* Clinically significant arrhythmias (e.g., current atrial fibrillation)
* Bradyarrhythmias (e.g. Type I or type II block)
* Have been hospitalized for psychiatric disorder or attempted suicide within the last 12 months
* History of concurrent illness that requires hospitalization within 30 days prior to Baseline
* Have skin and vascular problems such as infected areas of skin, skin eruptions, dermatological conditions, open wounds or damaged or broken skin in the area where stimulation is planned
* Have uncontrolled hypertension or hypotension
* History or current abuse of or dependence on alcohol or drugs that would interfere with the results or adherence to research requirements based on the judgement of the Investigator
* Any clinically relevant abnormal findings in the physical exam, vital signs or laboratory tests that, in the opinion of the Investigator, may put the participant at risk
* Any language barrier that, in the opinion of the Investigator, would preclude communication and compliance with the research requirements
* Participation in another investigational trial during the 30 days prior to research initiation or during this study
* Any other household member currently participating in Vorso research or relative of site staff member
* If the investigator believes there is any reason that the participant will not be compliant with the study requirements and completion of evaluations
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04306744 | 52,921 |
{
"NCT_ID" : "NCT01971216",
"Brief_Title" : "Mother-infant Signalling During Breastfeeding",
"Official_title" : "Mother-infant Signalling During Breastfeeding: A Randomised Trial Investigating the Effects of a Relaxation Intervention in Breastfeeding Mothers on Breast Milk Production, Breast Milk Cortisol and Infant Behaviour and Growth.",
"Conditions" : ["Breastfeeding Women"],
"Interventions" : ["Behavioral: Relaxation"],
"Location_Countries" : ["Malaysia"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-03",
"Study_Completion_Date(Actual)" : "2017-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-10-23",
"First_Posted(Estimated)" : 2013-10-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-10-23",
"Last_Update_Posted(Estimated)" : 2018-07-12",
"Last_Verified" : 2018-07"
}
}} | #Study Description
Brief Summary
Primary hypotheses
1. The use of a relaxation tape by breastfeeding mothers that will be given starting at week 2 postpartum, will result in : i) reduced maternal stress and anxiety ii) the production of a higher volume of breast milk iii) lower milk cortisol concentrations iv) favourable effects on infant behaviour (less crying, more sleeping) v) higher milk intake by the infant vi) more optimal growth, specifically higher lean mass and lower fat mass (body composition)
Secondary hypotheses (i) Infant temperament/behaviour and gender influence milk and energy intake and hence early growth and body composition (ii) Non-nutrient factors in breast milk (hormones including ghrelin and leptin) influence infant behaviour and feeding patterns and hence infant growth and body composition.
#Intervention
- BEHAVIORAL : Relaxation
- Other Names :
- Relaxation tape - audio tape with visual imagery and relaxation exercises | #Eligibility Criteria:
Inclusion Criteria:
Primiparous mother with singleton pregnancy Infant is singleton and born at term (37 <= age <= 42 week of gestation) Infant birth weight of >2500 g (5,5 pounds or 5 pounds and 8,2 ounces) Mother and infant are generally healthy (free of serious illness that can affect breastfeeding or nursing infant, or energy balance of the infant).
No current or recent involvement in other research studies that could potentially affect any of outcome measures.
Mother speaks and understands either English only or English and Malay (some questionnaires are in English)
Exclusion Criteria:
Mother or baby has a major illness that affects nursing or breastfeeding, or affects energy balance of the infant.
Mother smokes Mothers who do not exclusively breastfeed their infant
*
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT01971216 | 93,848 |
{
"NCT_ID" : "NCT01721512",
"Brief_Title" : "The Growth and Development of Breast and Formula Fed Term Asian Infants",
"Official_title" : "The Growth and Development of Breast and Formula Fed (Containing Synbiotics and LCPUFA) Term Asian Infants.",
"Conditions" : ["Growth"],
"Interventions" : ["Other: Breastfeeding", "Other: Infant formula"],
"Location_Countries" : ["Indonesia"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-11",
"Study_Completion_Date(Actual)" : "2011-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-11-01",
"First_Posted(Estimated)" : 2012-11-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-11-02",
"Last_Update_Posted(Estimated)" : 2012-11-04",
"Last_Verified" : 2012-11"
}
}} | #Study Description
Brief Summary
Prospective cohort study of breast and formula fed infants in a suburban setting in Jakarta, Indonesia
#Intervention
- OTHER : Breastfeeding
- OTHER : Infant formula | #Eligibility Criteria:
Inclusion Criteria:
* Breast-fed: 1. Mother intends to exclusively breast-feed from birth to at least 4 months; 2. A healthy term infant with gestational age fo 37 <= age <= 42 weeks and birth weight greater than or equal to 2.5 kg and equal or less than 4.75 kg.
* Formula-fed: 1. Mother is exclusively feeding infant formula milk less than or equal to 6 weeks of birth and has no prospect of breastfeeding; 2. A healthy term infant with gestational age fo 37 <= age <= 42 weeks and birth weight greater than or equal to 2.5 kg and equal or less than 4.75 kg; 3. Mother consents to her infant receiving trial infant formula for 12 months.
Exclusion Criteria:
* 1. Severe congenital or metabolic disease likely to affect infant feeding or infant growth.
* 2. Multiple birth
Sex :
ALL
Ages :
- Minimum Age : 2 Weeks
- Maximum Age : 6 Weeks
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
| NCT01721512 | 118,834 |
{
"NCT_ID" : "NCT04787393",
"Brief_Title" : "Lancashire Objective Volume Evaluation of Leg Oedema in Heart Failure Second Pilot",
"Official_title" : "Lancashire Objective Volume Evaluation of Leg Oedema in Heart Failure Second (LOVE-HF-2)",
"Conditions" : ["Heart Failure"],
"Interventions" : ["Device: Heartfelt device", "Device: Connected weighing scales"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-06-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-10-26",
"Study_Completion_Date(Actual)" : "2022-10-26},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-03-03",
"First_Posted(Estimated)" : 2021-03-08"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-03-05",
"Last_Update_Posted(Estimated)" : 2022-10-28",
"Last_Verified" : 2022-10"
}
}} | #Study Description
Brief Summary
Patients with heart failure (HF) who recently received treatment with IV diuretics for worsening congestion or outpatients with HF and peripheral oedema treated with at least 80 mg furosemide (or equivalent)/day will be recruited in the LOVE-HF-2 trial at Blackpool Victoria Hospital. The main objective of the study is to test if the Heartfelt device is sensitive to change across the full range of the individual patient's oedema. The participants will be given the Heartfelt device to use in their home. This device automatically and passively measures patient's foot and lower leg's volume without the patient having to remember to do anything. The patients will be seen face to face with a cardiologist to evaluate peripheral oedema using standard clincial technics as well as overall congestion level. The investigators aim to recruit 30 participants for the observational pilot study.
The study follows its sister pilot trial, LOVE-HF (NCT04787380).
Detailed Description
Heart Failure is the final common pathway of most forms of cardiovascular disease. In the United Kingdom (UK), it affects around 900 000 people, causes or complicates around 5% of adult emergency hospital admissions and consumes up to 2% of total National Health Service (NHS) expenditure. An important part of discharge planning includes measures such as early follow up in order to prevent readmissions. The hallmark of heart failure is fluid retention and between 2009 and 2016, 43% to 50% of hospital admissions were associated with peripheral oedema. Therefore, early recognition of this and treatment of the congestion may prevent hospital admissions. In clinical trials, management strategies have included patient education, telemedicine and remote monitoring. The main non-invasive method for detecting fluid retention has been the use of weight as a surrogate marker.
The Heartfelt device is an invention that uses a system of cameras in a compact device in order to generate 3 dimensional images of the feet and lower legs. The volumes can then be calculated and thus, changes in amount of peripheral oedema can be estimated. In a clinical trial (NCT02993601) performed by the Heart Failure team at the Royal Brompton Hospital, there was good correlation between measurements made by Heartfelt and a water displacement method. The resolution was as good as 20mls.
By positioning the Heartfelt device in the bedroom, automatic measurements can be made whenever the subject gets in and out of bed. Images are only taken of the specified subject. Data is censored so that the part of the body which is 50cm above the floor is not stored. Encrypted, anonymised data is transmitted over the internet to the company's secure servers. Personal identifiable data (participant name, address, age...) is stored on an encrypted hard drive, along with linkage information (device serial numbers) to associate the participant identifiable data with the data captured in the home. Therefore, data collection is not only secure but entirely passive, which is a major advantage compared with previous non-invasive methods and it is applicable to a very wide range of compliant and non-compliant patients.
The LOVE-HF trial (NCT04787380) demonstrated that the number of days with missing data collected by the Heartfelt device was significantly lower than that of the weighing scales, providing a promising tool for home patient monitoring.
Being able to demonstrate that the device can provide a measure of oedema that is clinically relevant over the full range of individual patient's oedema is the main objective of this study as this will further adds to the validation of the device.
#Intervention
- DEVICE : Heartfelt device
- The Heartfelt device uses a system of scanner in a compact device to generate depth images of the feet and lower legs with a view to detecting early volume changes. The device can be installed on the wall or as a free standing unit, For the measurements to take place, the participant walks in the field of view of the device, measurments are only taken when the patients has bare feet and no slippers/shoes, so the location of the device in the home is choosen to match this requirement. Participants are not expected to change anything to their routine. The device can also take measurements in the dark.
- DEVICE : Connected weighing scales
- The participant will be instructed to use those scales for the period of the study, as often as directed by their healthcare professional. The weighing scales display weight so that the participants can record the weight in their own heart failure records if they wish to do so.
The scales will communicate with the Personal Computer (PC) contained in the Heartfelt device and the data will be sent to the Heartfelt server through an encrypted link.
The data from the scales will be reviewed retrospectively, as the comparison in this study is with standard care, not with enhanced provision of care, which would be the case if we were using automatic reporting of weights. | #Eligibility Criteria:
Inclusion criteria:
Patients with HF who recently (< 6 months) received treatment with IV diuretics for worsening congestion or outpatients with HF and peripheral oedema (any degree) who are treated with at least 80 mg furosemide (or equivalent) orally per day Patients with HF older than 18 years Patients who took part in LOVE-HF can also be approached.
The research team will try to include as many patients as possible in the month following discharge, however we will not exclude consideration of a small proportion of patients within 6 months of decompensation. This has the extra advantage of demonstrating the value of the device beyond 1 <= age <= 2 months of decompensation.
Exclusion Criteria:
* Inability to provide informed consent*
* Participant has bandages to lower limbs everyday
* Participant has an amputation of the foot
* Participant is a regular wheelchair user
* Participant is of no fixed abode
* Participant has a potentially reversible cause of decompensated heart failure and is awaiting urgent intervention (revascularisation/ valvular heart disease), which means the patient cannot be discharged for home-based care
* Participant is taking part in a conflicting evaluation/study that could confound the results of this evaluation and/or impact clinical interventions and participant outcomes
* Participant must not be pregnant, and is taking relevant birth control if of child-bearing potential*
Note that a participant not able to comply with weighing, or questionnaires is NOT an exclusion criteria as the Heartfelt device should provide data for these participants despite their lack of ability to adhere to the usual monitoring protocol, and this is seen as one of the long term benefits that the device can provide.
* This exclusion criteria (a) has been added as participants would need to be able to communicate directly with the Heartfelt team, etc.
* This exclusion criteria (h) has been requested by the insurance provider for clinical trial cover.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04787393 | 230,229 |
{
"NCT_ID" : "NCT03594916",
"Brief_Title" : "Efficacy of Transcranial Direct Current Stimulation for Severe Primary Dysmenorrhea",
"Official_title" : "Efficacy of Transcranial Direct Current Stimulation for Severe Refractory Primary Dysmenorrhea: Translational and Genetic Neuroimaging Studies",
"Conditions" : ["Primary Dysmenorrhea"],
"Interventions" : ["Device: Active tDCS", "Device: Sham tDCS"],
"Location_Countries" : ["Taiwan"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-09-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-11-30",
"Study_Completion_Date(Actual)" : "2018-12-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-05-21",
"First_Posted(Estimated)" : 2018-07-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-07-11",
"Last_Update_Posted(Estimated)" : 2019-02-15",
"Last_Verified" : 2019-02"
}
}} | #Study Description
Brief Summary
Primary Dysmenorrhea (PDM), defined as menstrual pain without discernable organic causes, is inexorably common in adolescent women, about 40-90% of women may suffer from it, and 20% of them can be severe in the context of being refractory to medication, daily function impairment, and having pain of severe degree. Novel therapeutic method is in need for pain alleviation for this particular phenotype. We have previously reported that PDM females may engage motor-cortex based descending pain modulation system in our resting-state functional Magnetic Resonance Imaging (rs-fMRI) and thermal pain-activation fMRI studies. Based on the reported analgesic efficacy of transcranial Direct Current Stimulation (tDCS) on the motor cortex for various experimental painful conditions and clinical pain disorders, we reason that tDCS can be effective for the severe and medication-refractory PDM patients. This study aim to investigate the analgesic efficacy of tDCS in severe PDMs and to elucidate the dynamic brain neuroplasticity in the context of functional connectivity (FC) of pain matrix after tDCS intervention. We will recruit 30 severe PDMs and randomly allocate them to either real or sham group in a triple-blind manner. rs-fMRI for functional connectivity analysis will be performed before and after the tDCS intervention. The imaging data will be correlated with behavioral and psychological measurements. This is the first study in the literature investigating the tDCS efficacy for severe PDM. The result can promise a new possibility for clinical application.
#Intervention
- DEVICE : Active tDCS
- The anode and cathode sponge electrode (51 cm2) will be placed over C3 and FP2 (10-20 system) respectively. 2 mA current will be applied continuously for 20 minutes.
- DEVICE : Sham tDCS
- The anode and cathode sponge electrode (51 cm2) will be placed over C3 and FP2 (10-20 system) respectively. 2 mA current will be applied for 30 seconds at the beginning. | #Eligibility Criteria:
Inclusion Criteria:
* 20 <= age <= 35 years PDM patients
* Right-handedness
* A regular menstrual cycle: 27 <= age <= 32 days
* Cramping pain during the menstrual period in the last 6 months , VAS ≧ 7
* Abstinence for daily activities due to PDM
* Need analgesic or Physical therapy despite of no prominent effect
Exclusion Criteria:
* History of head injury
* Pathological pituitary gland disease
* Organic pelvic disease, psychiatric disorder
* Pregnancy, childbirth
* A metal or pacemaker implant.
* Take hormone agents within 6 months
Sex :
FEMALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
| NCT03594916 | 124,862 |
{
"NCT_ID" : "NCT03682523",
"Brief_Title" : "The Breaking 'Bad Rest' Study: Interrupting Sedentary Time to Reverse Frailty Levels in Acute Care",
"Official_title" : "The Breaking 'Bad Rest' Study: Interrupting Sedentary Time to Reverse Frailty Levels in Acute Care",
"Conditions" : ["Sedentary Lifestyle"],
"Interventions" : ["Behavioral: Sedentary behavior reduction intervention"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-04-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-07-20",
"Study_Completion_Date(Actual)" : "2023-07-20},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-09-12",
"First_Posted(Estimated)" : 2018-09-24"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-09-20",
"Last_Update_Posted(Estimated)" : 2023-08-30",
"Last_Verified" : 2023-08"
}
}} | #Study Description
Brief Summary
This study will determine whether an intervention aimed at reducing sedentary time in patients admitted to acute care will result in decreased frailty levels at hospital discharge, compared to the current standard of care. All patients will be fitted with accelerometers then randomised to the control or intervention group. The control group will receive only standard of care while in hospital. Participants in the intervention group will engage in daily goal setting for time out-of-bed and have access to real-time feedback on a bedside monitor. Participants in the intervention group will also received assisted mobilization if they have not met their daily goal by the late afternoon. The main outcome is frailty, assessed by a frailty index.
Detailed Description
The objective of this study is to determine if an intervention designed to reduce sedentary time during a patient's stay in acute care will reduce patient's frailty levels more so than current standard of care. This study will be conducted at a single-centre, but will be a stratified, block randomised control trial. Fifty participants will be recruited within 24 hours of admission to a geriatric acute care unit. Both groups will be fitted with a device that measures sedentary and active time (accelerometer). Participants in the intervention group will have a daily goal for activity and will be provided with real-time feedback on attainment of that goal displayed on a bedside tablet. Participants in the intervention group who do not independently achieve their goal will be assisted in reducing their sedentary time in the afternoon and/or early evening to the maximum level of their ability; this level will be determined in consultation with the healthcare team. The primary outcome is a change in frailty during hospitalization, measured using a 30-item frailty index. The data collection phase is approximately 10 months. Data analysis will take an additional six months (16 months total). Knowledge-users will be involved during all stages of the project. The data generated from this study will enable us to scale up this intervention nationally and internationally. If the intervention is successful, it will warrant a study to implement the intervention as part of standard care. Ultimately, this study will inform guidelines to limit patients' sedentary behaviors in acute care.
#Intervention
- BEHAVIORAL : Sedentary behavior reduction intervention
- Participants will be provided with a device to measure physical activity and sedentary behaviours. A tablet will be in the research office and each afternoon, it will be synced to the device to assess the activity progress of the patient. The research team will deliver an upright time goal and will target a 20% increase in upright time from the previous hospital day. Physiotherapist research assistants will visit the participants every afternoon to monitor progress and safely mobilize participants to their maximum ability if they have not met their daily goal (including weekend). The maximum level of ability will be determined in consultation with the healthcare team. Participants who do not meet their goal will be mobilized in the late afternoon/ early evening. | #Eligibility Criteria:
Inclusion Criteria:
* Anticipated hospital length of stay >1 day
* Patient or care partner able to communicate in English
Exclusion Criteria:
* Patient unable to provide informed consent and care partner not available to provide consent
* Bedridden prior to hospital admission
* Previous participation in our study (i.e. readmission during data collection phase)
* End-of-life or waiting for long-term care facility
* Patient is admitted to a shared room with a current study participant.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT03682523 | 142,038 |
{
"NCT_ID" : "NCT03356457",
"Brief_Title" : "Development of Agents to Diminish the Risk of Hypoglycemia-induced Brain Injury in Type 1 Diabetes",
"Official_title" : "Development of Agents to Diminish the Risk of Hypoglycemia-induced Brain Injury in Type 1 Diabetes",
"Conditions" : ["Hyperglycaemia (Diabetic)"],
"Interventions" : ["Drug: Placebo oral capsule", "Drug: Dichloroacetate"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["EARLY_PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-11-30",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-03-20",
"Study_Completion_Date(Actual)" : "2019-03-20},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-11-09",
"First_Posted(Estimated)" : 2017-11-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-11-22",
"Last_Update_Posted(Estimated)" : 2021-01-22",
"Last_Verified" : 2021-01"
}
}} | #Study Description
Brief Summary
To determine the effect of re-activation of brain glucose metabolism induced by dichloroacetate (DCA) on cognitive function and counterregulatory hormone responses in patients with type 1 diabetes (T1DM) with recurrent hypoglycemia.
Detailed Description
This will be a single center, placebo-controlled, cross-over, randomized clinical pilot study. The screening will take place at the Yale New Haven Hospital Research Unit (HRU) 10th floor, East Pavilion at 20 York St., New Haven, CT. At the screening visit informed consent will be obtained. Medical history and documents will be reviewed to screen potential subjects by inclusion and exclusion criteria. Subjects will receive a physical examination and laboratory blood work (BUN/creatinine, electrolytes, lipid profile, liver function, and HbA1c) as well as urine toxicology screens (to confirm self-report of alcohol, and drug information) to ensure good physical health.
#Intervention
- DRUG : Dichloroacetate
- Dichloroacetate is an isoform-unspecific inhibitor of four regulatory pyruvate dehydrogenase kinases, which are able to reduce entry of substrates into mitochondria by reducing the conversion of pyruvate to acetyl-CoA. Drug will be administered to subjects with sever hypoglycemia as well as healthy non-diabetic subjects.
- Other Names :
- DCA
- DRUG : Placebo oral capsule
- A Placebo oral capsule identical in shape and color to those with active ingredient.
- Other Names :
- Placebo | #Eligibility Criteria:
Inclusion Criteria:
Group 1:
* Diagnosed C-peptide-negative T1DM, > 5 years duration, HbA1c of < 7.5%
* Intensive management, defined by frequent self-monitoring of glucose values and by the administration of 3 or more insulin injections each day (or the use of insulin pump therapy).
* History of severe hypoglycemia and hypoglycemia unawareness as assessed by the Guy's and Thomas' Minimally Modified Clarke Hypoglycemia Survey, the Gold Score and the Edinburgh Hypoglycemia Survey (see Appendix 1)
* Willingness to fast and to reduce insulin therapy for a limited time period
Group 2:
* Age, weight, and gender matched to group 1 subjects
* HbA1c <6%
* Good general health as evidenced by medical history and blood screening
* Willing to fast for a limited time period
Exclusion Criteria:
General criteria:
* Known allergic reactions to components of the study product(s)
* Participants carrying polymorphisms known to slow DCA metabolism (e.g. KGM or EGM allele [10])
* Treatment with another investigational drug or other intervention
* Active infection including hepatitis C, hepatitis B, HIV
* Any past or current history of alcohol or substance abuse
* Psychiatric or neurological disorders, including need for medications, including anxiolytics, and antidepressants
* Baseline Hgb < 10.5 g/dL in females, or < 12.5 g/dL in males. Blood donation within 30 days of the study
* History of coagulopathy or medical condition requiring long-term anticoagulant therapy (low-dose aspirin treatment is allowed)
* Co-existing cardiac, liver, and kidney disease
* Abnormal liver function tests
* GI disorders potentially interfering with the ability to absorb oral medications
* Women that are post-menopausal, pregnant (as assessed by pregnancy test that will be performed on female participants at reproductive age), or lactating.
* Any medical condition that, in the opinion of the investigators, will interfere with the safe completion of the study or study outcomes
* Any medication assumed less than 30 days before the study sessions that, in the opinion of the investigators, will interfere with the safe completion of the study or study outcomes.The list of medications to be avoided includes - but is not limited to - drugs known to influence metabolic and endocrine function (other than insulin in Group 1) and neuroactive medications.
Group 1:
* Detectable C-peptide;
* Untreated proliferative retinopathy;
* Creatinine >=1.5 mg/dl, urinary albumin levels . 300 mg/day
* Autonomic neuropathy; painful peripheral neuropathy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT03356457 | 32,097 |
{
"NCT_ID" : "NCT04499716",
"Brief_Title" : "Quadriblock Versus 'IPACK + Femoral Triangle Block + Obturator Nerve Block' in Total Knee Arthroplasty",
"Official_title" : "Quadriblock Versus 'IPACK + Femoral Triangle Block + Obturator Nerve Block' in Total Knee Arthroplasty: a Randomized Controlled Clinical Trial",
"Conditions" : ["Primary Total Knee Arthroplasty"],
"Interventions" : ["Procedure: Obturator nerve block", "Procedure: Sciatic nerve block", "Procedure: IPACK", "Procedure: Femoral triangle block", "Procedure: Femoral nerve block", "Procedure: Lateral femoral cutaneous nerve block"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-12-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-05-07",
"Study_Completion_Date(Actual)" : "2021-05-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-07-31",
"First_Posted(Estimated)" : 2020-08-05"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-08-04",
"Last_Update_Posted(Estimated)" : 2021-06-07",
"Last_Verified" : 2020-07"
}
}} | #Study Description
Brief Summary
Total knee arthroplasty (TKA) is one of the most common orthopedic surgical procedure and is associated with severe pain in the immediate postoperative period, thus limiting early recovery.
Postoperative pain management requires multimodal analgesia, combining drugs and injection of a local anesthetic (LA). For optimal pain management, several peripheral nerve blocks should be associated. Thus, a recent study shows that the combination of IPACK, femoral triangle and obturator nerve blocks (ITO blocks) provides an effective pain control after TKA.
The hypothesis of this study is that a quadruple nerve block combining femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks (quadri-block) could improve analgesia after TKA.
The main objective of this monocenter, prospective, randomized, open-label, controlled trial is to assess the effect of quadri-block on morphine consumption after TKA compared to ITO blocks.
Detailed Description
In the pre-anaesthesia room, after the implementation of classical monitoring with an oxygen mask and a peripheral venous catheter, all patients will receive an antibioprophylaxis according to SFAR (French Society of Anesthesia \& Intensive Care Medecine) recommendations and injection of 10 mg of IV dexamethasone.
The patients will be then randomized in 2 groups:
* ITO group (usual technique): IPACK combined to femoral triangle and obturator nerve blocks
* Quadriblock group (experimental technique): femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks.
An experienced anesthetist will perform ultrasound-guided blocks 30 minutes before surgery with ropivacaine 0.3%, total volume of 70 ml.
In the operating room, general anesthesia will be induced by intravenous ketamine (0.4 mg/kg) and propofol (3 mg/kg). Anesthesia will be maintained with propofol.
Postoperative analgesia protocol :
* Multimodal analgesia will be instituted from the end of the surgery by the administration of paracetamol (1 g) and ketoprofen (100 mg).
* In post-anesthesia care unit (PACU): oxynorm titration if VRS (pain score) \>3 according to the centre's usual care.
* In ward: systematic per os analgesia with paracetamol (1 g, 4 times a day) and ibuprofen (400 mg, 3 times a day); oxynorm (10 mg, lockout interval: 4 h) if VRS (pain score) \>3.
#Intervention
- PROCEDURE : IPACK
- 25 milliliters of ropivacaine 0.3% will be injected between popliteal artery and femur.
- PROCEDURE : Femoral triangle block
- 25 milliliters of ropivacaine 0.3% will be injected on the lateral side of the femoral artery at the distal part of the femoral triangle.
- PROCEDURE : Obturator nerve block
- 20 milliliters of ropivacaine 0.3% will be injected between the adductor magnus and adductor brevis muscles and between the adductor brevis muscle the pectineus.
- PROCEDURE : Femoral nerve block
- 20 milliliters of ropivacaine 0.3% will be injected in supine position under the fascia iliaca lateral to the femoral artery.
- PROCEDURE : Sciatic nerve block
- 25 milliliters of ropivacaine 0.3% will be injected in prone position in the subgluteal space by lateral approach.
- PROCEDURE : Lateral femoral cutaneous nerve block
- 5 milliliters of ropivacaine 0.3% will be injected laterally to the sartorius muscle. | #Eligibility Criteria:
Inclusion Criteria:
* 18 years and older,
* Primary total knee arthroplasty
* Consent for participation,
* Affiliation to a social security system
Exclusion Criteria:
* Preoperative morphine use
* Chronic pain syndrome
* Contraindication to any drugs used in the protocol (paracetamol, ketoprofen, oxynorm, propofol, ketamine, ropivacaine)
* Valgus > 9°
* Pregnant or breastfeeding women
* Patients under protection of the adults (guardianship, curators or safeguard of justice)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04499716 | 124,046 |
{
"NCT_ID" : "NCT03478696",
"Brief_Title" : "A Randomized Study, Comparing Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC /VI) Single Inhaler Triple Therapy, Versus Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)",
"Official_title" : "A Phase IV, 12-week, Randomised, Double-blind, Triple Dummy Study to Compare Single Inhaler Triple Therapy, Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) With Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) Based on Lung Function and Symptoms in Participants With Chronic Obstructive Pulmonary Disease",
"Conditions" : ["Pulmonary Disease, Chronic Obstructive"],
"Interventions" : ["Drug: Placebo to match FF/UMEC/VI", "Device: ELLIPTA", "Device: HandiHaler", "Drug: placebo to match tiotropium", "Drug: tiotropium", "Drug: FF/UMEC/VI", "Device: MDI", "Drug: Placebo to match budesonide/formoterol", "Drug: budesonide/formoterol", "Drug: albuterol/salbutamol"],
"Location_Countries" : ["Germany", "Czechia", "United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-06-25",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-03-18",
"Study_Completion_Date(Actual)" : "2019-03-18},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-03-23",
"First_Submitted_that_Met_QC_Criteria" : 2020-01-30",
"First_Posted(Estimated)" : 2018-03-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-03-23",
"Last_Update_Posted(Estimated)" : 2020-10-28",
"Last_Verified" : 2020-10"
}
}} | #Study Description
Brief Summary
The primary purpose of this study is to evaluate lung function and health related quality of life (HRQoL) after 84 days of treatment with a single inhaler triple therapy combination of FF/UMEC /VI \[100/62.5/25 microgram (mcg)\] once daily via ELLIPTA® compared with a multiple inhaler combination therapy of Symbicort Metered Dose Inhaler (MDI) (budesonide/formoterol 320/9 mcg) twice daily plus Spiriva HandiHaler (tiotropium 18 mcg) once daily. The study will inform healthcare providers that subjects can be effectively and safely switched to FF/UMEC /VI single inhaler therapy from a multiple inhaler triple therapy regimen of Symbicort MDI and Spiriva Handihaler. Eligible subjects will enter a 4-week run-in period during which they will be administered budesonide/formoterol (320/9 mcg) twice daily plus tiotropium (18 mcg) once daily plus placebo via ELLIPTA. Following the run-in period, subjects will be randomized to receive one of the following study treatments for 84 days: 1) FF/UMEC /VI 100/62.5/25 mcg via ELLIPTA once daily in the morning plus two inhalations of placebo to match budesonide/formoterol via MDI, twice daily plus placebo to match tiotropium via HandiHaler once daily in the morning or 2) Budesonide/formoterol 320/9 mcg via MDI, twice daily plus tiotropium 18 mcg via HandiHaler once daily in the morning plus placebo via ELLIPTA once daily in the morning. Subjects will then enter a one week follow-up period. The total duration for a subject in the study will be approximately 17 weeks. ELLIPTA is a registered trademark of the GlaxoSmithKline group of companies.
#Intervention
- DRUG : budesonide/formoterol
- Subjects will be administered two inhalations of budesonide/formoterol via MDI twice daily
- DRUG : albuterol/salbutamol
- Subjects will be provided short-acting albuterol/salbutamol as-rescue medication to be used on an as-needed basis throughout the study.
- DRUG : FF/UMEC/VI
- Subjects will receive FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning
- DRUG : Placebo to match budesonide/formoterol
- Subjects will be administered two inhalations of matching placebo twice daily via MDI
- DRUG : tiotropium
- Subjects will receive tiotropium (18 mcg) once daily in the morning via HandiHaler device
- DRUG : Placebo to match FF/UMEC/VI
- Matching placebo to FF/UMEC/VI will be administered via ELLIPTA once daily in the morning.
- DRUG : placebo to match tiotropium
- Subjects will receive tiotropium matching placebo via Handihaler once daily in the morning
- DEVICE : ELLIPTA
- Subjects will receive FF/UMEC/VI 100/62.5/25 mcg and matching placebo via ELLIPTA in the treatment period. Budesonide/formoterol plus tiotropium once daily plus placebo will be administered via ELLIPTA during the run-in period.
- DEVICE : MDI
- Subjects will receive budesonide/formoterol and placebo to match budesonide/formoterol via MDI in the treatment period.
- DEVICE : HandiHaler
- Subjects will be administered tiotropium (18 mcg) or placebo to match tiotropium via HandiHaler during the treatment period. | #Eligibility Criteria:
Inclusion Criteria:
* Subjects must be capable of giving signed informed consent prior to study start.
* Only outpatient subjects will be included
* Subjects (male or female) must be 40 years or older at Screening (Visit 1). A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the treatment period and until safety follow-up contact after the last dose of study treatment
* An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society
* Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at Screening (Visit 1) [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
* Subjects with a score of >=10 on the COPD Assessment Test (CAT) at Screening (Visit 1)
* Subjects must demonstrate a post-bronchodilator FEV1 <50 % predicted normal or a post-bronchodilator FEV1 <80 % predicted normal and a documented history of >=2 moderate exacerbations or one severe (hospitalized) exacerbation in the previous 12 months. Subjects must also have a measured post albuterol/salbutamol FEV1/forced vital capacity (FVC) ratio of <0.70 at screening
* Subjects must have been receiving daily maintenance treatment for their COPD for at least 3 months prior to Screening
Exclusion Criteria:
* Women who are pregnant or lactating or are planning on becoming pregnant during the study
* Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD).
* Subjects with alpha 1-antitrypsin deficiency as the underlying cause of COPD
* Subjects with active tuberculosis, lung cancer, and clinically significant: bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease or other active pulmonary diseases
* Subjects who have undergone lung volume reduction surgery within the 12 months prior to Screening
* Immune suppression (e.g. advanced human immunodeficiency virus [HIV] with high viral load and low cluster of differentiation 4 [CD4] count, lupus on immunosuppressants) that in the opinion of the investigator would increase risk of pneumonia or other risk factors for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's Disease, Myasthenia Gravis).
* Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening and at least 30 days following the last dose of oral or systemic corticosteroids (if applicable)
* Respiratory tract infection that has not resolved at least 7 days prior to Screening
* Chest x-ray (posteroanterior and lateral) reveals evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD, or another condition that would hinder the ability to detect an infiltrate on chest X-ray (e.g. significant cardiomegaly, pleural effusion or scarring). All subjects will have a chest X-ray at Screening Visit 1 (or historical radiograph or computerized tomography [CT] scan obtained within 3 months prior to screening). For sites in Germany: If a chest x-ray (or CT scan) within 3 months prior to Screening (Visit 1) is not available, approval to conduct a diagnostic chest x-ray will need to be obtained from the Federal Office for Radiation Protection (BfS).
* Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
* Unstable liver disease: alanine transaminase (ALT) >2 times Upper Limit of Normal (ULN); and bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 %). Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
* Subjects with any of the following at Screening (Visit 1) would be excluded: Myocardial infarction or unstable angina in the last 6 months; Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months; New York Heart Association (NYHA) Class IV Heart failure.
* Abnormal and clinically significant 12-lead electrocardiogram (ECG) finding at Visit 1. The Investigator will determine the clinical significance of each abnormal ECG finding in relation to the subject's medical history and exclude subjects who would be at undue risk by participating in the trial. An abnormal and clinically significant finding that would preclude a subject from entering the trial is defined as a 12-lead ECG tracing that is interpreted at, but not limited to, any of the following: i) Atrial Fibrillation (AF) with rapid ventricular rate >120 beats per minute (BPM); ii) Sustained and non-sustained Ventricular tachycardia (VT); iii). Second degree heart block Mobitz type II and third degree heart block (unless pacemaker or defibrillator had been inserted); iv) QT interval corrected for heart rate by Fridericia's formula (QTcF) >=500 milliseconds (msec) in subjects with QRS <120 msec and QTcF >=530 msec in subjects with QRS >=120 msec.
* A history of allergy or hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the Investigator, contraindicates study participation.
* Subjects with carcinoma that has not been in complete remission for at least 3 years. Subjects who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 3 year waiting period if the subject has been considered cured by treatment.
* Use of long-term oxygen therapy (LTOT) described as resting oxygen therapy >3 liters per minute (L/min) at screening (Oxygen use <=3 L/min flow is not exclusionary)
* Subjects who are medically unable to withhold their albuterol/salbutamol for the 4-hour period required prior to spirometry testing at each study visit
* Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Programme within 4 weeks prior to screening or subjects who plan to enter the acute phase of a Pulmonary Rehabilitation Program during the study. Subjects who are in the maintenance phase of a Pulmonary Rehabilitation Program are not excluded.
* Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years
* Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits
* Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study
* Study Investigators, sub-Investigators, coordinators, employees of a participating Investigator or study site, or immediate family members of the aforementioned that is involved with this study
* In the opinion of the Investigator, any subject who is unable to read and/or would not be able to complete study related materials
* Use of various medication prior to screening.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03478696 | 87,922 |
{
"NCT_ID" : "NCT02483429",
"Brief_Title" : "Acute Video-oculography for Vertigo in Emergency Rooms for Rapid Triage (AVERT)",
"Official_title" : "Acute Video-oculography for Vertigo in Emergency Rooms for Rapid Triage (AVERT)",
"Conditions" : ["Vertigo", "Dizziness"],
"Interventions" : ["Device: VRT Care"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "DIAGNOSTIC",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-12-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-03-17",
"Study_Completion_Date(Actual)" : "2023-03-17},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-03-03",
"First_Posted(Estimated)" : 2015-06-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-06-24",
"Last_Update_Posted(Estimated)" : 2024-12-05",
"Last_Verified" : 2024-11"
}
}} | #Study Description
Brief Summary
AVERT is a randomized controlled trial comparing video-oculography (VOG)-guided care to standard care to assess accuracy of diagnoses and initial management decisions for emergency department (ED) patients with a chief symptom of vertigo or dizziness suspected to be of vestibular cause. The trial will test the hypothesis that VOG-guided rapid triage (VRT) will accurately, safely, and efficiently differentiate peripheral from central vestibular disorders in ED patients presenting acute vertigo or dizziness, and that doing so has the potential to improve post-treatment clinical outcomes for these patients.
Detailed Description
AVERT is a multicenter, Phase II clinical trial comparing a novel diagnostic strategy (VRT) to standard ED diagnostic care at three performance sites. The Specific Aims are to assess diagnostic accuracy, diagnostic workup costs, and estimate the short-term impact of correct diagnosis in anticipation of a larger, definitive Phase III trial. Adult ED patients with a chief symptom of vertigo, dizziness, or unsteadiness, new or clearly worse in the previous 30 days, will undergo on-site vestibular function tests by trained research personnel using a portable, quantitative VOG recording device. Research personnel will also record a focused symptom history and bedside hearing tests. Eligible patients with at least one pathologic vestibular eye movement finding or pathologic ataxia will be randomized to VRT or standard ED care. Patients eligible for pre-randomization testing but excluded from randomization will be slated for the Observational Arm of the study and will undergo limited 1 and 6 month phone follow-up. The VRT arm relies on an automated algorithm to interpret VOG results, thereby determining a patient-specific clinical care pathway. For safety, all VRT-arm study subjects will undergo stroke protocol MRI before release. All randomized subjects will undergo confirmatory testing at one week, including vestibular specialist exam and 1.5 or 3-Tesla research MRI combining stroke and internal auditory canal protocols. All randomized patients will also undergo 1 month and 6 month phone follow-up and medical record review to confirm diagnoses. Clinical findings, ED diagnoses, diagnostic resource utilization, treatments applied, and clinical events during follow-up will be recorded. A multidisciplinary, masked, expert panel will adjudicate final diagnoses.
#Intervention
- DEVICE : VRT Care
- The VOG report includes direct device output (physiologic traces, quantitative measures) plus most likely diagnosis, category, and clinical trial care pathway (peripheral, equivocal, central) instructions. The VOG report becomes part of the patient's emergency department clinical record.
- Other Names :
- GN Otometrics (Instrumentation & Control Systems, Inc) | #Eligibility Criteria:
Inclusion criteria:
Adult (18 years and older) ED patients with all of the following (all determined pre-randomization):
* VESTIBULAR SYMPTOMS: presenting symptom of 'vertigo' OR 'dizziness' OR 'unsteadiness' (as defined by consensus expert definitions in the International Classification of Vestibular Disorders).
* RELEVANT EXAM SIGNS*: pathologic nystagmus (spontaneous, gaze-evoked, or positional) by bedside VOG testing OR pathologic ataxia (gait, trunk, stance, limbs) by bedside ataxia examination.
* RECENT ONSET: symptoms AND signs* appear to be new or markedly worse in the past month. (*Exam signs are required for randomization, but not for the observational arm)
Exclusion Criteria
* Excluded from Pre-Randomization Screening
* Level 1 trauma or critical illness
* Altered mental status (e.g., delirium, dementia) that would preclude active study participation (this includes patients with abnormal mental state due to alcohol intoxication or illicit substance, which are known, easily-recognized causes of dizziness or vertigo presentations to the ED)
* Non-English speaking (enrollment of non-English speakers is not feasible given the logistics of identifying a translator and the need for rapid recruitment and randomization in the AVERT study; furthermore, the terms vertigo, dizziness, and unsteadiness may have different meanings in other languages)
* Known pregnancy (all women of childbearing age who are enrolled will undergo a urine or serum beta-HCG pregnancy test prior to MRI to confirm no pregnancy, per local institutional guidelines)
* Unable or unsafe to participate in screening, including VOG tests (as deemed by specific pre-enrollment risk assessment questions or ED provider and/or Study Coordinator judgment) including, but not limited to:
* visual impairment sufficient to prevent visual fixation during the VOG testing
* clinically-perceived risk to patient of participating in study (ED provider or staff concerns)
* clinically-perceived risk to research staff (e.g., violence, blood/body fluid/respiratory precautions)
* unstable cardiac status (given a single reported case of bradycardia with impulse testing)
* acute cranio-cervical trauma or other condition (e.g., rheumatoid arthritis) that might lead to instability of the cervical spine that would be a contraindication to neck rotation during VOG testing
* Obvious general medical cause (as judged by treating ED provider) including, but not limited to, acute myocardial infarction, pulmonary embolus, pneumonia, urinary tract infection, drug intoxication, etc.
* Excluded from Randomization (Eligible for Observational Arm Follow-up)
* Patient previously randomized in the AVERT Trial (previously screened but not randomized are eligible)
* Unable to participate fully with study follow-up (particularly MRI) including, but not limited to:
* unable to return for follow-up testing within 30 days
* unable to undergo MRI because of contraindications (e.g., pacemaker, metallic foreign body, pregnancy) or other reasons (severe claustrophobia, too large or too heavy for MRI scanner)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02483429 | 70,031 |
{
"NCT_ID" : "NCT01244828",
"Brief_Title" : "Long-term Study of Asenapine in Participants With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (P06238)",
"Official_title" : "Long-term Study of Asenapine in Subjects With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (Protocol P06238)",
"Conditions" : ["Schizophrenia"],
"Interventions" : ["Drug: Asenapine"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-04-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-08-21",
"Study_Completion_Date(Actual)" : "2014-08-21},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-11-18",
"First_Submitted_that_Met_QC_Criteria" : 2015-07-30",
"First_Posted(Estimated)" : 2010-11-19"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2010-11-18",
"Last_Update_Posted(Estimated)" : 2024-05-28",
"Last_Verified" : 2022-02"
}
}} | #Study Description
Brief Summary
This is a multi-site, open-label fixed-flexible dose long-term study of asenapine in participants with schizophrenia. Participants in this study consist of schizophrenia with residual subtype or receiving high dose/multiple antipsychotic drugs, treatment refractory, or elderly participants with schizophrenia. The treatment period is up to 52 weeks.
#Intervention
- DRUG : Asenapine
- 5 mg or 10 mg fast-dissolving sublingual tablets BID for up to 52 weeks | #Eligibility Criteria:
Inclusion Criteria:
* Minimum age of 20 years
* Participants who meet at least one of the following:
* current diagnosis of schizophrenia of residual subtype
* received treatment with 3 or more antipsychotic drugs
* treatment-refractory participants with schizophrenia
* 65 years and over with positive schizophrenia symptoms with score of 3 (mild) or more in 1 or more items in the positive subscale of the Positive and Negative Syndrome Scale (PANSS) at the baseline
* Participants who have a Clinical Global Impressions-Severity (CGI-S) score of at least 4 (moderately ill) at the baseline
Exclusion Criteria:
* Uncontrolled, unstable clinically significant medical condition
* Clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram (ECG) findings at Screening
* Positive pregnancy test at Screening, or the intention to become pregnant during the course of the study
* Seizure disorder beyond childhood (12 years or younger)
* History of neuroleptic malignant syndrome
* Allergy or sensitivity to drugs such as psychotropics and antipsychotics
* Known history of or currently treated for narrow angle glaucoma
* Parkinson's disease
* Diagnosis of schizoaffective disorder; schizophreniform disorder
* Concurrent psychiatric disorder other than schizophrenia coded on Axis I; a primary diagnosis other than schizophrenia
* Diagnosis of borderline personality disorder
* Diagnosis of mental retardation or organic brain disorder
* Current (past 6 months) substance abuse or dependence according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria (excluding nicotine)
* Positive drug/alcohol tests at the Screening visit
* Imminent risk of self-harm or harm to others, in the Investigator's opinion
* Substance induced psychotic disorder or a behavioral disturbance thought to be due to substance abuse
* Currently under involuntary inpatient confinement
* Use of a non-approved drug in Japan within 12 weeks prior to informed consent
* Previously treated in an asenapine study
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01244828 | 237,549 |
{
"NCT_ID" : "NCT02710292",
"Brief_Title" : "Clinical Evaluation of DAILIES TOTAL 1® Performance in a Japanese Population",
"Official_title" : "Clinical Evaluation of DAILIES TOTAL 1® in Japanese Population - Comparison of Lens Centration Between DAILIES TOTAL 1® and 1-DAY ACUVUE® TruEye®",
"Conditions" : ["Refractive Error"],
"Interventions" : ["Device: Delefilcon A contact lenses", "Device: Narafilcon A contact lenses"],
"Location_Countries" : ["Japan"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-04-25",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-09-14",
"Study_Completion_Date(Actual)" : "2016-09-14},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-03-11",
"First_Submitted_that_Met_QC_Criteria" : 2017-05-08",
"First_Posted(Estimated)" : 2016-03-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-03-11",
"Last_Update_Posted(Estimated)" : 2018-07-02",
"Last_Verified" : 2017-05"
}
}} | #Study Description
Brief Summary
The purpose of this study is to compare DAILIES TOTAL1® (DT1) to 1-DAY ACUVUE® TruEye® (TE) for Investigator-rated successful lens centration in Japanese population.
#Intervention
- DEVICE : Delefilcon A contact lenses
- Other Names :
- DAILIES TOTAL 1®, DT1
- DEVICE : Narafilcon A contact lenses
- Other Names :
- 1-DAY ACUVUE® TruEye® | #Eligibility Criteria:
Inclusion Criteria:
* Must sign an informed consent form;
* Habitual current daily disposable soft contact lenses wearer;
* Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
* Lenses within the power range specified in the protocol;
* Vision correctable to 20/25 or 0.1 logMAR (logarithmic minimum angle of resolution) or better in each eye at distance with pre-study contact lenses at Visit1;
* Acceptable lens fit with both study contact lenses;
* Willing to wear lenses every day or at least for a minimum of 10 days, 6 hours per day, every day if possible and attend all study visits;
* Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
* Currently wearing DT1 or TE sphere lenses;
* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
* Use of systemic or ocular medications in which contact lens wear could be contraindicated as determined by the investigator;
* Eye injury or surgery within 12 weeks immediately prior to enrollment;
* History of herpetic keratitis, ocular surgery or irregular cornea;
* Prior refractive surgery;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* Participation in any clinical trial within 30 days of the enrollment visit;
* Other protocol-specified exclusion criteria may apply.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02710292 | 77,575 |
{
"NCT_ID" : "NCT00926653",
"Brief_Title" : "Assessing Anterior Cingulate Brain Activity in People With Late-Life Depression",
"Official_title" : "Anterior Cingulate Activation in Geriatric Depression",
"Conditions" : ["Depression"],
"Interventions" : ["Drug: Escitalopram"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2005-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-05",
"Study_Completion_Date(Actual)" : "2010-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-06-22",
"First_Posted(Estimated)" : 2009-06-23"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-06-22",
"Last_Update_Posted(Estimated)" : 2015-08-11",
"Last_Verified" : 2015-08"
}
}} | #Study Description
Brief Summary
This study will examine differences in activity of the anterior cingulate cortex, a brain area involved in emotion and cognitive regulation, between older adults with and without depression.
Detailed Description
Older adults with depression often also suffer from executive dysfunction-problems with planning, impulse control, and reasoning. Executive dysfunction in older adults predicts poor or delayed response to antidepressant treatment and has been associated with early relapse and recurrence of late-life major depression. Functional magnetic resonance imaging (fMRI) is a scan that can measure the activity of someone's brain while that person performs tasks. So far, no fMRI studies investigating cerebral activation patterns in late-life depression have been published. In this study, people will undergo fMRI while they are performing an executive function task. Older adults with late-life depression and older adults without depression will be tested and compared in order to identify the areas and patterns of brain activity underlying executive dysfunction in late-life depression.
Participation in this study will consist of one study visit, during which participants will undergo an fMRI scan that will last 60 to 90 minutes. While being scanned, participants will perform cognitive tasks that involve pressing buttons in response to words viewed on a screen.
#Intervention
- DRUG : Escitalopram
- 10 to 20 mg daily as part of another study in which participants are enrolled
- Other Names :
- Lexapro | #Eligibility Criteria:
Inclusion Criteria for Depressed Participants:
* Diagnosis of major depression by DSM-IV criteria
* Mini-Mental State Examination (MMSE) score greater than 24
* Severity score of 17 or higher on the 21-item Hamilton Depression Rating Scale score (HDRS) during the index episode
* Residence less than a 45-minute drive from New York Hospital-Westchester Division
Exclusion Criteria for Depressed Participants:
* Presence of psychotic depression, as defined by Research Diagnostic Criteria and DSM-IV
* History of psychiatric disorders other than unipolar major depression (people with bipolar disorder and dysthymia will be excluded)
* Presence of dementing disorders
* Acute or severe medical illness, such as the following: delirium; metastatic cancer; decompensated cardiac, liver, or kidney failure; major surgery; or cerebrovascular accident or myocardial infarction 3 months prior to study entry
* Receiving drugs known to cause depression, including reserpine, alpha-methyl-dopa, and steroids
* Requires concomitant treatment with other psychotropics, including antipsychotic medications, lithium salts, stimulants, valproic acid, carbamazepine, or gabapentin
* Severe aphasia interfering with communication
* Contraindications to magnetic resonance (MR) scanning, such as implanted metal, claustrophobia, or weight greater than or equal to 300 lbs
Inclusion Criteria for Age-Matched Non-Psychiatric Comparison Sample:
* MMSE score greater than 24
Exclusion Criteria for Age-Matched Non-Psychiatric Comparison Sample:
* History of psychiatric disorder
* Presence of dementing disorders
* Acute or severe medical illness, such as the following: delirium; metastatic cancer; decompensated cardiac, liver, or kidney failure; major surgery; or cerebrovascular accident or myocardial infarction 3 months prior to study entry
* Receiving drugs known to cause depression, including reserpine, alpha-methyl-dopa, and steroids
* Current treatment with psychotropics
* Severe aphasia interfering with communication
* Contraindications to MR scanning, such as implanted metal, claustrophobia, or weight greater than or equal to 300 lbs
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT00926653 | 264,512 |
{
"NCT_ID" : "NCT00135798",
"Brief_Title" : "Pre-Transplant Treatment to Prevent Recurrence of Hepatitis C After Liver Transplantation",
"Official_title" : "The Adult-to-adult Living Donor Liver Transplantation Cohort Study (A2ALL) Low Accelerated Dosing Regimen (LADR) Protocol: Pre-Transplant Treatment to Prevent Recurrence of Hepatitis C Virus (HCV) After Liver Transplantation",
"Conditions" : ["Hepatitis C"],
"Interventions" : ["Drug: LADR Treatment"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2005-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-12",
"Study_Completion_Date(Actual)" : "2009-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-08-24",
"First_Submitted_that_Met_QC_Criteria" : 2013-02-22",
"First_Posted(Estimated)" : 2005-08-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-08-25",
"Last_Update_Posted(Estimated)" : 2013-04-23",
"Last_Verified" : 2013-04"
}
}} | #Study Description
Brief Summary
The purpose of this study is to learn if pre-liver transplant treatment, using peginterferon plus ribavirin, will clear hepatitis C virus (HCV) RNA from the blood in HCV-infected recipients and reduce the risk of recurrent HCV and allograft hepatitis following liver transplant.
Detailed Description
Patients awaiting deceased donor liver transplant will be asked to enroll in this protocol at the time of identification of a potential living liver donor (see note note at end of description). Patients randomized to treatment arm will be encouraged to delay living donor liver transplant (LDLT) until they have received 12 weeks of treatment to allow for a treatment response, if any, to occur. The pros and cons of immediate versus delayed LDLT will be discussed with each patient; the timing of LDLT for patients randomized to no treatment will be determined by clinical need. There will be separate treatment strategies depending upon HCV genotype. Preliminary data and experience strongly suggests that interferon-based treatment clears HCV RNA in the majority of patients with genotypes 2 and 3, even at lower than standard doses (79% on-treatment response and 50% SVR). In contrast, clearance rates for genotype 1 patients with advanced cirrhosis may only be 28% on-treatment with an 11% SVR. In addition, treatment may be associated with significant side effects, intolerance, and increased risk of complications of liver disease. The HCV Committee for A2ALL strongly agreed that monitoring safety of pre-transplant antiviral therapy was essential and advised inclusion of an untreated control group. For these reasons, all patients with HCV, genotypes 1, 4, 5, \& 6 infection will be randomized 2:1 to either treatment or control (no treatment). Randomization will be web-based to avoid prior knowledge of treatment assignment at any site. In contrast to the randomized design for patients with genotypes 1, 4, 5, and 6, all patients with genotypes 2 and 3 HCV will receive treatment. All genotypes will be included in the analysis of safety, tolerance, and complications occurring during pre-transplant treatment.
Treatment is continued up to the time of LDLT or deceased donor liver transplant (DDLT), or to a maximum of 48 weeks of continuous treatment. Both peginterferon and ribavirin will be stopped if transplantation is expected to occur within 24 hours. Patients whose liver disease stabilize and are no longer in need of a liver transplant will complete a full 48 weeks of treatment with the aim of achieving SVR. These patients will be followed by measurement of HCV RNA, biochemical tests, hematology, and clinical evaluation at 3, 6, and 12 months post-treatment. If relapse occurs when treatment is discontinued after 48 weeks of therapy, institution of retreatment will be at the discretion of the investigator.
Deferral of LDLT while antiviral therapy is continued will be considered in patients who have undetectable HCV RNA, tolerate treatment well, lack evidence of HCC or ongoing hepatic decompensation, and have had stabilization or improvement in clinical or biochemical measures of liver disease: Child-Turcotte-Pugh (CTP) and Model for End-stage Liver Disease (MELD) scores. These patients should lack uncontrolled or ongoing bleeding from portal hypertension, ascites, systolic blood pressure (SBP), or encephalopathy. The decision to defer transplantation and to continue antiviral therapy will be made at the transplant center by the clinical investigator in consultation with the patient.
Based upon the kinetics of early virologic response in the peginterferon + ribavirin clinical trials, the researchers anticipate that a minimum of 12 weeks treatment is necessary to achieve a virologic response. However, the optimum duration of pre-transplant antiviral therapy that yields the highest rates of prevention of post-transplant HCV recurrence is unknown. Prolongation of antiviral therapy beyond 12 weeks may be advantageous in this regard, but prolonged therapy may also increase the risk of development of intercurrent complications of liver disease or side effects of treatment. In addition, patients with stable liver disease who achieve virologic remission may experience hepatic improvement and avoid transplantation.
All patients, treated and untreated controls will be followed and tested at the same intervals unless specified. Unscheduled visits and additional tests may be performed if clinically indicated, the findings at these visits and results of additional tests will be recorded in the database. The following details the schedule of visits and the tests/procedures to be performed at each visit:
Baseline
* History and Physical Examination
* Vital signs: Weight, blood pressure (BP), heart rate (HR), Temperature
* Fundoscopic exam in all patients. In patients with hypertension or diabetes exam should be performed with pupils dilated
* Quality of Life and Depression Assessment (SF-36V2, Beck Depression Inventory)
* Functional status evaluation
* Symptom assessment
* HCV RNA
* HCV Genotype
* Urinalysis
* Pregnancy Test
* HIV Test
* Other blood tests, including: complete blood count (CBC), International Normalized. Ratio (INR), Liver Panel, Creatine, Sodium Alpha-fetoprotein, triglycerides, iron studies, uric acid, thyroid stimulating hormone (TSH), antinuclear antibody (ANA)
* Ultrasound (US), computed tomography (CT), and/or magnetic resonance imaging (MRI) (some or all are probably done in LDLT evaluation)
Week 0 (Randomization and/or Treatment Start)
* Confirm eligibility
* Initiate treatment for all genotype 2, 3 patients and genotype 1, 4, 5 or 6 patients randomized to treatment group
* Repeat CBC, chemistries, INR
After randomization
* Week 1 and 3: CBC (for treated patients only, may be performed in local labs)
* Every 2 weeks up to 12 weeks: CBC, chemistries
* Weeks 4 and 8: Focused physical exam (signs and symptoms of liver disease) vital signs, urinalysis and symptom assessment
* Every 4 weeks from 12 to 48 weeks: Full physical exam and vital signs, urinalysis and symptom assessment, CBC, chemistries.
* Every 12 weeks up to 48 weeks: INR, TSH, urine or serum pregnancy test female (treated subjects of childbearing capacity only)
* At 12 Weeks: HCV RNA is measured. Patients without a 2-log or more drop in HCV RNA level are declared nonresponders and treatment is discontinued.
* After 12 weeks: HCV RNA is measured every 12 weeks on treatment by quantitative tests.
* At the time of LDLT or DDLT: CBC, INR, chemistries, quantitative and qualitative HCV RNA, Medications, adverse events (AE)
* Blood samples will be collected at Treatment Weeks 4, 8, 12, 24, 48 and at time of transplantation for subsequent HCV RNA testing in a central lab
* Quality of life (QOL) assessment at week 12, 24 and 48: Beck Depression Inventory (BDI) and SF-36V2
* Patients who discontinue treatment early due to adverse events will be followed according to the study schedule until 12 months after transplant or 48 weeks after randomization.
Post-LT (LDLT or DDLT) Follow-up
* Week 12, 24 and 52: CBC, INR, chemistries, HCV RNA by quantitative testing (part of A2ALL prospective study)
* Week 12, 24 and 52: Full physical exam and vital signs, urinalysis and symptom assessment
* Week 12: TSH and urine or serum pregnancy test (treated subjects of childbearing capacity only)
* Week 12, 24 and 52: QOL Assessment (BDI, and SF-36V2)
* Week 12 and 52: Liver Biopsy (part of A2ALL prospective study). Pathologists reading the 3 and 12 month biopsies will be blinded to the patients' clinical course and treatment.
* Blood samples will be collected at Week 12, 24 and 52 for subsequent HCV RNA testing in a central laboratory
Follow-up of Patients completing 48 weeks of Treatment without Transplantation
* Week 12, 24 and 48: CBC, INR, chemistries, HCV RNA by quantitative testing
* Week 12, 24 and 48: Full physical exam and vital signs, urinalysis and symptom assessment
* Week 12: TSH and urine or serum pregnancy test (treated subjects of childbearing capacity only)
* Week 12, 24 and 48: QOL Assessment (BDI, and SF-36V2)
* Blood samples will be collected at Week 12, 24 and 48 for subsequent HCV RNA testing in a central laboratory
NOTE: As a result of LADR Protocol Amendment III, patients with hepatocellular carcinoma (HCC) and tumor stage T2 awaiting DDLT are now eligible to participate in the LADR study. The following inclusion criteria was added:
• Candidates for DDLT who are listed for transplantation and meet United Network for Organ Sharing (UNOS) criteria for MELD upgrade for HCC
HCC DDLT candidates will not have their transplant delayed if a liver becomes available even if they have not completed 12 weeks of Rx.
#Intervention
- DRUG : LADR Treatment
- PEG-Intron (peginterferon alfa-2b (PEGIFN)) Redipen; Rebetol (ribavirin (RBV) United States Pharmacopeia (USP)) Capsules:
Treatment was initiated with PEGIFN 0.75 µg/kg/week and RBV 600 mg/day. Dose escalations were performed at weeks 1 (PEGIFN 1.5 µg/kg/week and RBV 800 mg/day), 2 (RBV 1.0 g/day), and 3 (RBV 1.2 g/day for patients who weighed more then 75 kg) based upon patient tolerance and weekly blood counts. Once a patient reached the target RBV dose of 1-1.2 g/day (approximately 10.6 to 13.2 mg/kg/day), no further increases in RBV dose were made. Subsequent doses of PEGIFN and RBV were adjusted based upon adverse events, patient tolerability, and blood counts. If the highest tolerated dose of PEGIFN was \<0.5 ug/kg, PEGIFN was permanently discontinued.
- Other Names :
- PEG-Intron; Rebetol, Low Accelerated Dosing Regimen | #Eligibility Criteria:
Inclusion Criteria:
* Adult (>= 18 years)
* LDLT candidate
* HCV RNA positive
* Expected time on treatment is at least 12 weeks
* Candidates for DDLT who are listed for transplantation and meet UNOS criteria for MELD upgrade for HCC
Exclusion Criteria:
* Severe cytopenia (polymorphonuclear (PMN) leukocytes < 750, OR hemoglobin [Hgb] < 10 g/dL, OR platelet count < 35,000/mm3)
* Uncontrolled depression or psychiatric disease characterized by current symptoms of major depression or other psychiatric disease or increase in medication for major depression or other psychiatric disease within the past three months.
* Uncontrolled cardiopulmonary disease characterized by myocardial infarction, coronary artery bypass graft surgery, Percutaneous coronary intervention, or unstable angina within the past three months.
* Uncontrolled autoimmune disease characterized by current symptoms of autoimmune disease or increase in medications within the last three months.
* Autoimmune hepatitis
* Active substance abuse within 6 months of initiation of treatment
* Known intolerance or serious adverse event during prior therapy with interferon or ribavirin
* Prior nonresponse after at least 24 weeks of full dose treatment with peginterferon plus ribavirin
* Laboratory Model for End-Stage Liver Disease (MELD) score >20. Patients with laboratory MELD score 21 <= age <= 25 may be enrolled if deemed appropriate by the site investigator
* Serum creatinine >2.2 mg/dL
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00135798 | 258,067 |
{
"NCT_ID" : "NCT04783675",
"Brief_Title" : "Efficacy and Safety of Rituximab in the First Episode of Pediatric Idiopathic Nephrotic Syndrome",
"Official_title" : "Efficacy and Safety of Rituximab in the First Episode of Pediatric Idiopathic Nephrotic Syndrome",
"Conditions" : ["Steroid-Sensitive Nephrotic Syndrome"],
"Interventions" : ["Drug: Rituximab"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-04-13",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-01-17",
"Study_Completion_Date(Actual)" : "2023-01-17},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-02-28",
"First_Posted(Estimated)" : 2021-03-05"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-03-03",
"Last_Update_Posted(Estimated)" : 2023-07-11",
"Last_Verified" : 2023-07"
}
}} | #Study Description
Brief Summary
The main objective is to demonstrate, from the initial episode of nephrotic syndrome (NS) in children with standard prednisolone treatment, once complete remission has occurred, that the use of Rituximab (a single intravenous infusion of 375 mg/m2) may reduce the risk of subsequent relapse during 12-month of follow-up.
Detailed Description
NS is the most frequent glomerular disease in children. Between 80% and 90% of children with steroid-sensitive nephrotic syndrome (SSNS) will relapse following an initial response to corticosteroids. Half of these children will experience frequent relapses (FRNS) or become steroid-dependent (SDNS).
The results of multiple observational studies and randomized control trials have shown that Rituximab, a chimeric monoclonal antibody against the cluster of differentiation antigen 20 (CD20) antigen on B cells, is safe and effective for children with FRNS/SDNS without corticosteroid or immunosuppressive therapy. To the investigators' knowledge, Rituximab has never been investigated for the initial episode of NS with the aim to reduce the subsequent risk of relapse that is a major concern in the management of children with NS.
Children aged 1-18 years with the first episode of the SSNS will be treated with a single intravenous infusion of Rituximab 375 mg/m2. The prednisolone at a dose of 2 mg/kg per day (maximum 60 mg in single or divided doses) for 6 weeks, followed by 1.5 mg/kg (maximum 40 mg) as a single morning dose on alternate days for the next 6 weeks; therapy is then discontinued.
#Intervention
- DRUG : Rituximab
- Rituximab (375 mg/m2) will be given as a single intravenous infusion after remission | #Eligibility Criteria:
Inclusion Criteria:
* 1. Children between 1 and 18 years with Steroid-Sensitive Nephrotic Syndrome
* 2. Estimated glomerular filtration rate (eGFR) >=90 ml/min per 1.73 m2 at study entry.
* 3. Remission at study entry
* 4.CD20 positive cells in peripheral blood >=1% total lymphocytes
* 5.No immunosuppressive agents have been used within 3 months of enrollment, except for the use of corticosteroid to treat nephrotic syndrome.
* 6. Provision of consent by a legal representative (parents or legal guardians) using a document approved by the institutional review board after receiving an adequate explanation regarding the implementation of this clinical trial. For children/youth ages 10 <= age <= 18, written assent is required using age-appropriate and background-appropriate documents.
Exclusion Criteria:
* 1.Diagnosis of secondary NS
* 2.Patients showing one of the following abnormal clinical laboratory values: leukopenia (white blood cell count <=3.0*109/L); moderate and severe anemia (hemoglobin <9.0g/dL); thrombocytopenia (platelet count <100*1012/ L); positivity of autoimmunity tests (ANA, Anti DNA antibody, ANCA) or reduced C3 levels; Positive for hepatitis B surface (HBs) antigen, HBs antibody, hepatitis B core (HBc) antibody, or hepatitis C virus (HCV) antibody ; Positive for HIV antibody; Alanine aminotransferase (ALT) > 2.5× upper limit of normal value. Aspartate aminotransferase (AST) > 2.5× upper limit of normal value.
* 3. Presence or history of severe or opportunistic infections within 6 months before assignment; Presence of active tuberculosis or with a history of tuberculosis or in whom tuberculosis is suspected; Presence or history of chronic active infections such as Epstein-Barr virus and CMV virus; presence or history of active hepatitis B or hepatitis C or hepatitis B virus carrier. Presence of human immunodeficiency virus (HIV) infection or other active viral infections
* 4. Receipt of a live vaccine within 4 weeks before enrollment.
* 5. Prior receipt of monoclonal antibodies of any type
* 6. History of angina pectoris, cardiac failure, myocardial infarction, or serious arrhythmia，or poorly controlled hypertension
* 7. Presence or history of autoimmune diseases or vascular purpura.
* 8. Presence or history of malignant tumor
* 9. History of organ transplantation (excluding corneal and hair transplants).
* 10. Patients with a known allergy to steroid and their excipients or to Rituximab and its excipients or to acetaminophen and its excipients or to cetirizine and its excipients or to the protein of murine origin
* 11. Assessed to be unfit for participation by the investigators
Sex :
ALL
Ages :
- Minimum Age : 1 Year
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT04783675 | 220,984 |
{
"NCT_ID" : "NCT03807154",
"Brief_Title" : "Guided Online Self-help for Loneliness",
"Official_title" : "SOLUS - A Randomized Controlled Two-site Trial Comparing Internet-based Cognitive Behavioral Therapy and Internet-based Interpersonal Psychotherapy",
"Conditions" : ["Loneliness"],
"Interventions" : ["Behavioral: IPT", "Behavioral: ICBT"],
"Location_Countries" : ["Sweden"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-01-17",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-02-01",
"Study_Completion_Date(Actual)" : "2022-02-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-01-09",
"First_Posted(Estimated)" : 2019-01-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-01-12",
"Last_Update_Posted(Estimated)" : 2022-09-19",
"Last_Verified" : 2022-09"
}
}} | #Study Description
Brief Summary
The study seeks to investigate the efficacy of two internet-based self-help programmes administered with support from a therapist. The two active conditions consist of an internet cognitive behavioral therapy (ICBT) programme and a intervention of internet-based interpersonal psychotherapy (IIPT), both of which have been developed for the present study. The active conditions will be compared to a wait-list control group.
Participants will be recruited in Sweden with a nationwide recruitment.
#Intervention
- BEHAVIORAL : ICBT
- A nine week long ICBT-programme with therapist guidance. Based on cognitive and behavioral techniques that have been tailored to address loneliness.
- BEHAVIORAL : IPT
- A nine week long internet-based IPT-programme with therapist guidance. Contains three distinct phases: assessment phase (three weeks), focus phase (five weeks, during which the participants will choose from one of four primary problem areas during the three latter weeks), and end phase (one week). | #Eligibility Criteria:
Inclusion Criteria:
* Frequent and distressing experiences of loneliness
* Can speak, write, and read the primary language of the country in which they reside (Sweden or the United Kingdom).
* Have access to an internet connection and a computer/smart phone/tablet
* Are prepared to participate in the study, regardless of the type of treatment they are randomly assigned to.
Exclusion Criteria:
* Changes in dosage of psychopharmaceutic medication in the last three months prior to the start of the study or a planned change during the initial treatment period.
* Other ongoing psychotherapeutic treatment
* Suicidal plans
* A previously diagnosed personality syndrome
* Ongoing substance abuse
* Other acute treatment need related to a psychiatric disorder requiring attention from a mental health professional (e.g. eating disorders such as anorexia nervosa).
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03807154 | 248,710 |
{
"NCT_ID" : "NCT02665754",
"Brief_Title" : "Intralymphatic Immunotherapy for House Dust Mite, Dog, and Cat Allergy Using Tyrosine S® in Allergic Rhinitis",
"Official_title" : "The Efficacy and Adverse Effect of Intralymphatic Immunotherapy With Tyrosine S®, Allergen Extract for Immunotherapy, in Patients With Allergic Rhinitis Induced by House Dust Mite, Dog, and Cat Allergen",
"Conditions" : ["Allergic Rhinitis"],
"Interventions" : ["Biological: ILIT with extract of causal allergen", "Drug: Rescue medication for allergic rhinitis", "Biological: ILIT with normal saline"],
"Location_Countries" : ["Korea, Republic of"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-12",
"Study_Completion_Date(Actual)" : "2020-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-01-10",
"First_Posted(Estimated)" : 2016-01-28"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-01-24",
"Last_Update_Posted(Estimated)" : 2020-02-11",
"Last_Verified" : 2020-02"
}
}} | #Study Description
Brief Summary
The investigators will perform double-blinded placebo-controlled randomized clinical trial which evaluates the efficacy and safety of allergen-specific intralymphatic immunotherapy (ILIT) for allergens including Dermatophagoides farinae (Df), Dermatophagoides pteronyssinus (Dp), cat, and dog that are sensitized and provoke rhinitis-related symptoms in patients with allergic rhinitis (AR), using allergen extracts for allergen-specific immunotherapy (Tyrosine S, Allergy Therapeutic, West Sussex, UK).
Detailed Description
After informed consent, subjects will be randomly assigned to ILIT group or placebo group in double-blind manner. In both group, causal allergen or placebo will be injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval. In ILIT group, initial dose of allergen will be 1,000-fold diluted solution from maximal concentration of allergen extract for subcutaneous immunotherapy (Tyrosine S, Allergy Therapeutic, West Sussex, UK) in volume of 0.1ml. If skin is highly reactive in skin prick test, the initial dose will be 10-fold dilution from maximal concentration where diameter of wheal is less than that of histamine. After the first dose, allergen concentration will be escalated 3-fold at second dose, and 10-fold at third dose if there are no (or mild) local or systemic hypersensitivity reaction. The allergen concentration will not change at second or third dose if there is moderate local or systemic reaction. The allergen concentration will decrease by 10 or 100-fold from previous concentration or further injection will be held if there is severe local or systemic reaction after sufficient explanation and discussion with subjects.
The investigators will evaluate allergic rhinitis symptom score before and 4, 12 months after the initial treatment. Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and Sino-Nasal Outcome Test (SNOT-20) will be used. Visual analogue scale (VAS) of symptoms including rhinorrhea, sneezing, nasal obstruction, postnasal drip, eye/nose/ear/palate itching, dyspnea, wheezing, chest discomfort as well as urticaria, angioedema, and itching on exposed skin during exposure to causal allergen in daily life will be also evaluated. Skin prick test (SPT), intradermal test (IDT), blood sampling for serum total immunoglobulin E (IgE), allergen-specific IgE, and allergen-specific immunoglobulin G4 (IgG4), nasal lavage for Th1, Th2, and Treg cytokines, and nasal provocation test (NPT) with Df and/or Dp allergen (in subjects whose AR symptoms are provoked by Df and/or Dp) will be also performed before and 4, 12 months after the initial treatment. In addition, the investigators evaluated the change of subjects' recognition of causal allergens, their avoidance, and AIT during this study. Using VAS, subjects were requested to score the rate of agreement with 'Allergen provokes allergic symptoms in daily life', 'Allergen avoidance can reduce allergic symptoms', 'Allergen-specific Immunotherapy (AIT) can reduce allergic symptoms', 'I can pay 50,000 Korean Won (KRW)/month for allergen avoidance', 'I can pay 100,000 KRW/month for allergen avoidance', 'I can pay 200,000 KRW/month for allergen avoidance', 'I can pay 150,000 KRW for each injection of ILIT', 'I can pay 300,000 KRW for each injection of ILIT', 'I can pay 600,000 KRW for each injection of ILIT' before and after SPT/IDT, after NPT, 4 months and 1 year after ILIT.
Adverse events will be recorded and graded according to Muller classification and Ring and Meissner classification.
#Intervention
- BIOLOGICAL : ILIT with extract of causal allergen
- 0.5 ml of allergen extract from D. farinae, D. pteronyssinus, cat, and/or dog for allergen specific immunotherapy (Tyrosine S, Allergy Therapeutic, UK) will be injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval.
- Other Names :
- Active ILIT
- BIOLOGICAL : ILIT with normal saline
- 0.5 ml of normal saline will be injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval.
- Other Names :
- Placebo ILIT
- DRUG : Rescue medication for allergic rhinitis
- Subjects are requested to administer oral antihistamine (cetirizine) or nasal glucocorticosteroid (ciclesonide) as rescue medication for allergic rhinitis in accordance with severity and frequency of allergic rhinitis symptoms according to Allergic Rhinitis and its Impact on Asthma (ARIA) guideline.
- Other Names :
- Rescue medication | #Eligibility Criteria:
Inclusion Criteria:
We enrolled subjects who suffered from AR, symptoms of which were provoked by Dp, Df, dog, and/or cat allergen. Concretely, two inclusion criteria should be met.
* Sensitization should be verified by skin prick test and the level of serum specific IgE measured by ImmunoCAP® (Thermo Fisher Scientific, Uppsala, Sweden).
* Subjects should complain of AR symptoms during exposure of house dust, dog and/or cat in daily life.
Exclusion Criteria:
* Uncontrolled or severe asthma according to Global Initiative of Asthma (GINA) guideline including a case in which forced expiratory volume in 1 s (FEV1) was less than 50% of predicted value
* Significant cardiovascular, hepatic, renal, hematologic, oncologic, or infectious diseases
* Administration of beta blocker, angiotensin converting enzyme inhibitor, tricyclic antidepressant, immunosuppressant including systemic glucocorticosteroid within last 2 weeks
* AR caused by other perennial or seasonal allergen
* Prior history of allergen-specific immunotherapy
* Rejection or low compliance,
* Pregnancy or lactation
* Vulnerable volunteer
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02665754 | 219,963 |
{
"NCT_ID" : "NCT00575250",
"Brief_Title" : "Education for Osteoporosis in Persons With Existing Fractures",
"Official_title" : "Osteoporosis Education Clinic Study",
"Conditions" : ["Osteoporosis"],
"Interventions" : ["Behavioral: Osteoporosis Prevention and Self-Management Course", "Behavioral: Introductory education session on osteoporosis"],
"Location_Countries" : ["Australia"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "HEALTH_SERVICES_RESEARCH",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2004-01",
"Study_Completion_Date(Actual)" : "2007-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2007-12-17",
"First_Posted(Estimated)" : 2007-12-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2007-12-17",
"Last_Update_Posted(Estimated)" : 2007-12-18",
"Last_Verified" : 2007-12"
}
}} | #Study Description
Brief Summary
We wish to investigate whether a weekly, 2½ hour group-based osteoporosis education intervention (the Osteoporosis Prevention and Self-Management Course), is different to one session course (1x 2½ hours) on osteoporosis knowledge, confidence to eat calcium-containing foods, confidence to exercise, and amount of exercise undertaken after three and nine months of follow-up in people aged over 50 years who have already had a bone fracture.
Detailed Description
Instruments used to determine change after 3 and 9 months:
Osteoporosis knowledge: Osteoporosis Knowledge Assessment Test (Winzenberg et al. BMC Musculoskelet Disord 2003) Calcium intake: Food frequency questionnaire (Angus et al. J Am Diet Assoc 1989) Calcium and exercise self-efficacy: Osteoporosis Self-Efficacy Scale (Horan et al Res Nurs Health 1998) Physical activity: CHAMPS II (Stewart et al. J Gerontol A Biol Sci Med Sci 2001)
#Intervention
- BEHAVIORAL : Osteoporosis Prevention and Self-Management Course
- Four weekly education sessions of 2 1/2 hours duration, in a group session facilitated by a community nurse and trained lay leader.
- BEHAVIORAL : Introductory education session on osteoporosis
- Introductory education session, 1 x 2 1/2 hours in a group session facilitated by a community nurse and trained lay person. | #Eligibility Criteria:
Inclusion Criteria:
* Presented to Modbury Hospital's Accident and Emergency Department with a new bone fracture
Exclusion Criteria:
* Residence in nursing home
* Fracture sustained in motor bike, push bike or motor vehicle accident
* Fracture sustained due to high trauma, such as fall from roof or ladder
* Dementia
* Inability to participate in group settings
* Inability to understand spoken English
* Inability to provide informed consent
* Pathological fracture
* Usual place of residence outside South Australia
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00575250 | 139,788 |
{
"NCT_ID" : "NCT02726230",
"Brief_Title" : "Bihar Family Health Initiative (Ananya)",
"Official_title" : "Bihar Family Health Initiative (Ananya)",
"Conditions" : ["Maternal and Child Health"],
"Interventions" : ["Behavioral: Ananya"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "HEALTH_SERVICES_RESEARCH",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-04",
"Study_Completion_Date(Actual)" : "2014-04},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-03-21",
"First_Posted(Estimated)" : 2016-04-01"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-03-27",
"Last_Update_Posted(Estimated)" : 2016-04-01",
"Last_Verified" : 2016-03"
}
}} | #Study Description
Brief Summary
Ananya was funded by BMGF to reduce maternal, newborn, and child mortality; fertility; and child undernutrition in Bihar, India. Ananya involved multi-level interventions designed to build front line health worker (FLW) capacities and reach to communities and households, as well as to strengthen public health facilities and quality of care to increase maternal and neonatal care and health behaviors, and thus survival. From 2012 to 2014, eight focal districts in western and central Bihar.received Ananya, while 30 districts did not. Data were collected from mothers of infants 0-11 months at baseline and mothers of infants 0-23 months at 2 year follow-up, from comparable public health blocks in Ananya and Control districts to assess Ananya effects on quality and quantity of FLW home visits, postnatal health behaviors, and among older infants/toddlers, complementary feeding and vaccination. Difference in difference analyses were used to assess Ananya outcome effects in this quasi experimental study.
#Intervention
- BEHAVIORAL : Ananya
- The Ananya program was developed and implemented via a partnership of the Bill and Melinda Gates Foundation and the Government of Bihar as a means of improving reproductive, maternal, newborn and child health (RMNCH) outcomes in the state, in particular focusing on improving health behaviors and service utilization in the final trimester of pregnancy and early postpartum period. Ananya was designed as a series of supply- and demand-side efforts to improve health. Efforts were focused on strengthening outreach services in quantity and quality, improving quality of facility services, and mobilizing communities to improve health behaviors. The Ananya program included training, mobilizing, and monitoring of government frontline health workers (FLWs, including anganwadi workers- AWWS, auxiliary nurse midwives- ANMs, and community health workers-ASHAs) to increase quantity and quality of home visits for RMNH screenings and services, and media messages to increase demand for services. | #Eligibility Criteria:
Inclusion Criteria:
* Mothers of infants 0 <= age <= 23 months residing in the catchment area of the subcenters (public health facilities) included in this study.
Sex :
FEMALE
Ages :
- Minimum Age : 15 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
| NCT02726230 | 29,592 |
{
"NCT_ID" : "NCT02330978",
"Brief_Title" : "Intravitreal Mesenchymal Stem Cell Transplantation in Advanced Glaucoma.",
"Official_title" : "Intravitreal Autologous Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Patients With Advanced Glaucoma. Phase I: Safety Study.",
"Conditions" : ["Retinal Degeneration", "Primary Open-angle Glaucoma"],
"Interventions" : ["Biological: Culture and isolation of autologous bone-marrow mesenchymal stem cells", "Procedure: Intravitreal transplantation of mesenchymal stem cell"],
"Location_Countries" : ["Brazil"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-09",
"Study_Completion_Date(Actual)" : "2016-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-12-31",
"First_Submitted_that_Met_QC_Criteria" : 2019-04-16",
"First_Posted(Estimated)" : 2015-01-05"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-12-31",
"Last_Update_Posted(Estimated)" : 2019-07-08",
"Last_Verified" : 2019-04"
}
}} | #Study Description
Brief Summary
Bone marrow-derived mesenchymal stem cells (MSC) therapy is a promising treatment for several degenerative diseases, including retinopathies and glaucoma, however no previous safety study involving humans has been conducted. The objective of this study is to evaluate effects of autologous bone marrow-derived MSC transplantation in the worst eye of 10 patients with legal bilateral blindness due to glaucoma. Primary outcome are types and severity of adverse effects. Secondary outcomes are changes in visual field, visual acuity, optical coherence tomography, and retinal ganglion cells function.
#Intervention
- PROCEDURE : Intravitreal transplantation of mesenchymal stem cell
- BIOLOGICAL : Culture and isolation of autologous bone-marrow mesenchymal stem cells | #Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Advanced Bilateral Open-Angle Glaucoma;
* Best corrected visual acuity less than 0,1 in the better eye;
* Social and cognitive ability to participate.
Exclusion Criteria:
* Severe systemic morbidities;
* Other ocular blind conditions associated;
* Impossibility in performing any of the proposed examinations.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02330978 | 235,362 |
{
"NCT_ID" : "NCT01007149",
"Brief_Title" : "Effect of Omalizumab in Patients With Severe Persistent Non-atopic Uncontrolled Asthma",
"Official_title" : "A 16-week Treatment, Multicenter, Randomized, Double Blind, Placebo-controlled, Parallel-group Study to Assess the Effect of Omalizumab on the Expression of FcεRI Receptors of Blood Basophils and Dendritic Cells in Patients With Severe Persistent Non-atopic Asthma, Uncontrolled Despite Optimal Therapy",
"Conditions" : ["Asthma"],
"Interventions" : ["Drug: Placebo", "Drug: omalizumab"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2009-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-02",
"Study_Completion_Date(Actual)" : "2011-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-10-30",
"First_Submitted_that_Met_QC_Criteria" : 2012-05-07",
"First_Posted(Estimated)" : 2009-11-03"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-11-02",
"Last_Update_Posted(Estimated)" : 2012-07-20",
"Last_Verified" : 2012-07"
}
}} | #Study Description
Brief Summary
This study will assess the change in the expression of FcεRI receptors of blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in adult patients with non-atopic severe persistent asthma, uncontrolled despite optimal therapy.
#Intervention
- DRUG : omalizumab
- Omalizumab was supplied in 5mL vials with solution for subcutaneous injection.
- DRUG : Placebo
- Placebo was supplied in vials with solution for subcutaneous injection. | #Eligibility Criteria:
Inclusion Criteria:
Severe persistent asthma with the following characteristics:
* Uncontrolled according to Global Initiative for Asthma (GINA) 2007 guidelines and at least 2 exacerbations having required systemic corticosteroid and/or at least 1 hospitalization or emergency room visit in the past year.
* Treated with high-dose inhaled corticosteroid (i.e. > 1,000 µg beclometasone dipropionate equivalent per day) plus inhaled long-acting β2 agonist (with or without maintenance oral corticosteroid).
* Non-atopic, i.e. negative blood multiallergic testing and negative Aspergillus-specific IgE-radio allergosorbent blood test and negative skin prick tests to a battery of common aeroallergens
Exclusion Criteria:
* Current smokers or smoking history stopped for less than 3 years or > 10 pack years.
* Asthma exacerbation during the 4 weeks prior to randomization.
* Active lung disease other than non-atopic asthma.
* Patients with an active cancer, a suspicion of cancer or any history of cancer with less than 5 disease free years.
* Pregnant or nursing (lactating) women.
* Treatment with omalizumab.
Other protocol-defined inclusion/exclusion criteria may apply
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01007149 | 150,262 |
{
"NCT_ID" : "NCT00904527",
"Brief_Title" : "Interest of Relaxation From Patients With Pain Due to Migraine",
"Official_title" : "Interest of Relaxation From Patients With Pain Due to Migraine",
"Conditions" : ["Migraine"],
"Interventions" : ["Behavioral: relaxation (Schultz)"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2006-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-04",
"Study_Completion_Date(Actual)" : "2009-04},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-05-18",
"First_Posted(Estimated)" : 2009-05-19"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-05-18",
"Last_Update_Posted(Estimated)" : 2015-07-28",
"Last_Verified" : 2015-07"
}
}} | #Study Description
Brief Summary
The purpose of this study is to determine whether relaxation (autogenic training of Schultz) is effective in treatment for migraine.
Detailed Description
This randomized, multicenter study compares 2 parallel groups of patients with migraine :
* I: patients are treated with relaxation + medical treatment (beta-bloquant or Oxetorone)+ patients' education
* II: patients are treated only with medical treatment + patients' education.
Visit 1 : 1 month before randomization for patient's selection and baseline data
Visit 2 (J0): inclusion (randomization) During the first 2 months patients from group I benefit from relaxation consultations.
Visit 3 (2 months after randomization)and visit 4 (4 months after randomization) : evaluation of the efficacy of the two treatment strategies.
Primary endpoint :
- number of days with migraine per month from J0 to visit 4.
Secondary endpoints :
* monthly drug consumption
* percentage of patients who respond (50 % frequency reduction)
* quality of life (SF 36)
Each day, patients note in a notebook if a migraine appears and its intensity.
#Intervention
- BEHAVIORAL : relaxation (Schultz)
- Patients have relaxation consultations during 2 months | #Eligibility Criteria:
Inclusion Criteria:
* > 18 yearsyears
* 5 to 14 days of migraines per month
Exclusion Criteria:
* Headache by medication abuse
* Patients who already know relaxation technics
* Depression
* Contra indication of using beta-bloquant or Oxetorone
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00904527 | 5,801 |
{
"NCT_ID" : "NCT00114491",
"Brief_Title" : "Rosuvastatin Affecting Aortic Valve Endothelium",
"Official_title" : "Rosuvastatin Affecting Aortic Valve Endothelium - RAAVE",
"Conditions" : ["Atherosclerosis", "Hypercholesterolemia"],
"Location_Countries" : ["Portugal"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2003-09",
"Study_Completion_Date(Actual)" : "2005-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-06-15",
"First_Posted(Estimated)" : 2005-06-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-06-15",
"Last_Update_Posted(Estimated)" : 2006-10-31",
"Last_Verified" : 2006-10"
}
}} | #Study Description
Brief Summary
Recent studies support the hypothesis that aortic stenosis (AS) develops due to atherosclerosis affecting the aortic valve endothelium. The study's aim was to assess Rosuvastatin on the hemodynamic progression and inflammatory markers of AS by treating low-density lipoprotein (LDL) in patients with AS according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATPIII) guidelines for one year.
Detailed Description
Background: Recent retrospective studies support the hypothesis that statins slow the progression of aortic stenosis. The aim of this study was to assess the effect of Rosuvastatin on hemodynamic progression of aortic stenosis by treating patients with aortic stenosis and elevated LDL-cholesterol for 18 months.
Methods: We performed an open-label, prospective study evaluating 121 consecutive patients with asymptomatic moderate to severe aortic stenosis (AVA≥ 1.0 cm2), (mean age 73.7±8.9 years; 57 men and 64 women), treated with and without Rosuvastatin according to the NCEP-ATPIII guidelines. Echocardiographic, serum lipid, and inflammatory markers were measured at baseline and every 6 months for 18 months.
#Intervention
- DRUG : Rosuvastatin | #Eligibility Criteria:
Inclusion Criteria:
* Asymptomatic AS
* Normal ejection fraction
* Elevated LDL >130 mg/dl
Exclusion Criteria:
* Echocardiographic evidence of rheumatic mitral valve disease,
* Previous statin therapy,
* Congenital heart disease (bicuspid aortic valve),
* Subaortic obstruction,
* Creatinine >= 2,0 mg/dl (to avoid the potential confounder of an elevated serum [CaP04]),
* Evidence of liver disease,
* Greater than mild aortic regurgitation and previous aortic valve surgery
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT00114491 | 54,748 |
{
"NCT_ID" : "NCT02169609",
"Brief_Title" : "Safety Study of Dinutuximab Combined With Immunotherapy to Treat Neuroblastoma",
"Official_title" : "Phase II Single Arm Study to Assess Dinutuximab (Ch 14.18) Combined With the Cytokines Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) and IL-2 in Patients With High-risk Neuroblastoma Not Eligible to Other Immunotherapy Trials",
"Conditions" : ["Neuroblastoma", "Neoplasm, Residual", "Effects of Immunotherapy"],
"Interventions" : ["Drug: Dinutuximab. Immunotherapy"],
"Location_Countries" : ["Spain"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-11-26",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-12-26",
"Study_Completion_Date(Actual)" : "2018-12-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-06-12",
"First_Posted(Estimated)" : 2014-06-23"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-06-18",
"Last_Update_Posted(Estimated)" : 2024-04-22",
"Last_Verified" : 2024-04"
}
}} | #Study Description
Brief Summary
The purpose of this study is to evaluate safety of the triple COG schema with the monoclonal antibody Dinutuximab + cytokines (GM-CSF and IL2) and isotretinoin (13-cis-retinoic acid, or RA) in patients with high-risk neuroblastoma.
Detailed Description
Assess toxicity and safety of subcutaneous GM-CSF and iv IL-2 in enhancing Dinutuximab-mediated ablation of Bone Marrow (BM) disease in patients with high-risk neuroblastoma who have achieved a Complete Response or Very Good Partial Response of the macroscopic disease in the investigators institution.
Assess response of minimal residual disease (MRD) of the anti-GD2 monoclonal antibody Dinutuximab combined with granulocyte-macrophage colony stimulating factor (GM-CSF) and IL-2 in patients with high-risk neuroblastoma (NB). More precisely, to apply real-time quantitative RT-PCR to test the hypothesis that minimal residual disease content of BM after the first treatments with dinutuximab/GM-CSF has significant prognostic impact on relapse-free survival.
#Intervention
- DRUG : Dinutuximab. Immunotherapy
- Patients will receive 5 courses of Dinutuximab + GM-CSF + IL2 at intervals of 28 days for all courses. In addition, all patients will receive isotretinoin (13-cis-retinoic acid, or RA) at 160 mg/m2/dose twice a day for 14 days every 28 days, for 6 courses.
Patients come off study if progressive disease develops at any time after cycle 1 or life-threatening grade 4 toxicity occurs clearly attributable to Immunotherapy.
- Other Names :
- Ch14.18, Sargramostim, GM-CSF, Isotretinoin, 13-cis-retinoic acid, or RA, Interleukin-2 (IL-2) | #Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of neuroblastoma as defined by international criteria by histopathology or bone marrow metastases. Patients age must be less than 18 years at the time of initial diagnosis.
* Neuroblastoma, as defined by risk-related treatment guidelines and the International Neuroblastoma Staging System, stage 4 with (any age) or without (>18 months) MYCN-amplification, or MYCN-amplified neuroblastoma other than stage 1, or high-risk neuroblastoma defined based on the 3-gene molecular profile developed at our institution (Garcia I, et al. CCR 2012).
* Group 1 patients have neuroblastoma (as defined above) resistant to standard therapy, as evidenced by incomplete response in bone marrow, but no MIBG-avid soft tissue or bone tumor and no progressive disease.
* Group 2 patients have no evidence of measurable disease
3 - Patients must have a Lansky or Karnofsky Performance Scale score of > 50% and patients must have a life expectancy of > 2 months.
4- Pre-enrollment tumor survey: Prior to enrollment a determination of residual disease must be Performed (Tumor imaging studies including CT or MRI, MIBG scan, bone marrow aspiration & biopsy, and blood and bone marrow samples). This disease assessment is required for eligibility.
5 - Patients must have adequate organ functions at the time of registration:
* Hematological: Total absolute phagocyte count (APC = neutrophils + monocytes) is at least 1000/microL
* Renal: Adequate Renal Function Defined As: Creatinine clearance or radioisotope GFR > 70 mL/min/1.73 m2 or serum creatinine based on age/gender.
* Hepatic- total bilirubin < 1.5 x normal, and SGPT (ALT) < 5 x normal. Veno-occlusive disease, if present, should be stable or improving.
* Cardiac- shortening fraction of > 30% by echocardiogram, or if shortening fraction abnormal, ejection fraction of > 55% by gated radionuclide study.
* Pulmonary- FEV1 and FVC > 60% of predicted by pulmonary function test. For children who are unable to do PFTs, no evidence of dyspnea at rest, no exercise intolerance.
* Central nervous system- Patients with seizure disorder may be enrolled if on anticonvulsants and wellcontrolled. CNS toxicity < Grade 2.
6 - Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method. Female patients who are lactating must agree to stop breast-feeding.
7 - Signed informed consent indicating awareness of the investigational nature of this program.
Exclusion Criteria:
* - Existing severe major organ dysfunction, i.e., renal., cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity >= grade 3.
* - Progressive disease or MIBG-avid soft tissue/bone tumor.
* - Active life-threatening infection.
* - Inability to comply with protocol requirements.
* - Patient is eligible for SIOP HR-NB-01 protocol (= newly diagnosed high-risk neuroblastoma patient in a center where the SIOP protocol is open for enrollment).
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT02169609 | 209,141 |
{
"NCT_ID" : "NCT00796614",
"Brief_Title" : "Study to Evaluate the Efficacy and Safety of Tamsulosin in Children With Neurogenic Bladder",
"Official_title" : "A Phase IIb/III, Multi-centre, Double-blind, Randomised, Placebo-controlled, Dose Ranging Study of Tamsulosin Hydrochloride (Low, Medium and High Dose) as Treatment in Children With Neuropathic Bladder for Three Months",
"Conditions" : ["Bladder, Neurogenic"],
"Interventions" : ["Drug: Placebo", "Drug: tamsulosin hydrochloride"],
"Location_Countries" : ["India", "Ukraine", "Mexico", "United States", "Germany", "South Africa", "Russian Federation", "Spain", "Brazil", "Philippines", "Italy", "Belgium", "Korea, Republic of"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2", "PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2008-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-02",
"Study_Completion_Date(Actual)" : "2009-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-11-20",
"First_Submitted_that_Met_QC_Criteria" : 2012-08-06",
"First_Posted(Estimated)" : 2008-11-24"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-11-20",
"Last_Update_Posted(Estimated)" : 2015-10-29",
"Last_Verified" : 2015-09"
}
}} | #Study Description
Brief Summary
Aim of this study is to evaluate the efficacy and safety of a range of doses of tamsulosin hydrochloride as treatment in children with an elevated detrusor leak point pressure associated with a known neurological deficit
#Intervention
- DRUG : tamsulosin hydrochloride
- Oral
- Other Names :
- Flomax, Omnic
- DRUG : Placebo
- Oral | #Eligibility Criteria:
Inclusion Criteria:
* Neuropathic bladder secondary to a known neurologic deficit (e.g. spina bifida)
* Elevated detrusor leak point pressures (LPP) >=40 cm H2O confirmed by two measurements
Exclusion Criteria:
* Clinically significant abnormalities as determined by the investigator
* A history of relevant orthostatic hypotension, fainting spells or blackouts
Sex :
ALL
Ages :
- Minimum Age : 2 Years
- Maximum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
| NCT00796614 | 105,864 |
{
"NCT_ID" : "NCT01759706",
"Brief_Title" : "Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy",
"Official_title" : "Safety and Feasibility Study of an Enhanced Recovery After Surgery Protocol in Patients Undergoing Elective Pancreaticoduodenectomy.",
"Conditions" : ["Pancreatic Neoplasms"],
"Interventions" : ["Drug: PONV prophylaxis with Ondansetron + Dexamethasone", "Procedure: Standard perioperative care", "Drug: Pre-anesthetic medication with diazepam", "Behavioral: Preadmission counselling", "Drug: Preoperative bowel preparation with sodium phosphate", "Other: Postoperative mobilization program", "Behavioral: Enhanced recovery after surgery protocol", "Drug: Epidural analgesia with naropin + sufentanil"],
"Location_Countries" : ["Italy"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-12",
"Study_Completion_Date(Actual)" : "2013-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-12-21",
"First_Posted(Estimated)" : 2013-01-03"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-01-02",
"Last_Update_Posted(Estimated)" : 2014-12-05",
"Last_Verified" : 2014-12"
}
}} | #Study Description
Brief Summary
The purpose of this study is to assess the adherence to an enhanced recovery after surgery (ERAS) pathway and the impact of the ERAS protocol on postoperative short-term outcome in patients undergoing pancreaticoduodenectomy (PD).
Detailed Description
A specific enhanced recovery after surgery (ERAS) protocol has been applied since October 2010 in consecutive patients undergoing pancreaticoduodenectomy (PD) in a high volume Institution. Patient compliance for each item has been assessed. Each ERAS patient was matched with a patient who received standard perioperative care. Match criteria were age, gender, malignant / benign disease, and PD prognostic score.
#Intervention
- BEHAVIORAL : Enhanced recovery after surgery protocol
- ERAS items implemented were: preadmission counselling, preoperative immunonutrition, no preoperative bowel preparation, epidural analgesia, no pre-anesthetic medication, intraoperative iv fluid restriction, PONV and hypothermia prophylaxis, removal of nasogastric tube (NGT) at the end of surgery, mobilization protocol, solid food diet from POD 2, early stop of iv infusions and removal of urinary catheter.
- PROCEDURE : Standard perioperative care
- Epidural analgesia, pre-anesthetic medication with diazepam, bowel preparation with oral assumption of sodium phosphate, removal of nasogastric tube on POD 1, solid food diet from POD 4
- DRUG : PONV prophylaxis with Ondansetron + Dexamethasone
- Postoperative nausea and vomiting prophylaxis with Ondansetron + Dexamethasone.
- Other Names :
- Zofran + Decadron
- OTHER : Postoperative mobilization program
- Patient mobilization for 2 hours on first postoperative day Patient mobilization for 4 hours on first postoperative day + assisted deambulation in the room Patient mobilization for 6 hours on first postoperative day + assisted deambulation in the ward
- DRUG : Epidural analgesia with naropin + sufentanil
- Midthoracic epidural analgesia with naropin 0.2 % plus sufentanil 0,5 mcg/mL
- Other Names :
- Disufen
- DRUG : Pre-anesthetic medication with diazepam
- Premedication before general anesthesia
- Other Names :
- Valium
- BEHAVIORAL : Preadmission counselling
- Patient multidisciplinary preoperative counselling, including anesthesiologist, surgeon and nurse.
- DRUG : Preoperative bowel preparation with sodium phosphate
- Preoperative bowel preparation with oral assumption of sodium phosphate
- Other Names :
- Phospho-Lax | #Eligibility Criteria:
Inclusion Criteria:
* All patients undergoing elective pancreaticoduodenectomy
Exclusion Criteria:
* Intraoperative detection of metastatic disease (non-operability)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01759706 | 158,823 |
Subsets and Splits