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{
"NCT_ID" : "NCT03662308",
"Brief_Title" : "Heated Vest for Persons With Spinal Cord Injury",
"Official_title" : "Developing a Feedback-Controlled Heated Vest to Address Thermoregulatory Dysfunction in Persons With Spinal Cord Injury",
"Conditions" : ["Spinal Cord Injuries"],
"Interventions" : ["Device: Heated Vest", "Device: Non-Heated Vest"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-02-25",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-10-31",
"Study_Completion_Date(Actual)" : "2022-10-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-07-30",
"First_Submitted_that_Met_QC_Criteria" : 2024-01-30",
"First_Posted(Estimated)" : 2018-09-07"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-09-05",
"Last_Update_Posted(Estimated)" : 2024-05-06",
"Last_Verified" : 2024-05"
}
}} | #Study Description
Brief Summary
Persons with higher levels of spinal cord injury (above the 2nd thoracic vertebrae; tetraplegia) are unable to maintain normal core body temperature (Tcore) when exposed to cool environments. In persons with tetraplegia, even limited exposure to cool temperatures may cause Tcore to approach hypothermic values and impair cognitive performance. Conversely, an increase in Tcore from subnormal to normal range may improve cognitive performance. Prior work has shown that cool seasonal temperatures have an adverse effect on personal comfort and the ability to perform vital daily activities of self-care in persons with tetraplegia. Interventions that address the vulnerability to hypothermia are limited. A self-regulating heated vest designed specifically for persons with tetraplegia is a novel and promising strategy to address this problem. By more effectively maintaining Tcore, the vest can decrease the adverse impact of cool temperatures on comfort, quality of life, and performance of vital daily tasks for Veterans with tetraplegia during the cooler seasons.
Detailed Description
Persons with spinal cord injury (SCI), particularly cervical injuries (tetraplegia), are unable to effectively regulate core body temperature (Tcore) due to interruption of motor, sensory, and sympathetic pathways. Thus, control of distal extremity vasoconstriction (heat conservation) and shivering thermogenesis (heat production) are impaired, and the ability to maintain a constant Tcore is compromised. Persons with tetraplegia often report 'feeling cold,' frequently present with subnormal Tcore (35-36.5 degrees C), and are particularly vulnerable to hypothermia (Tcore\<35 degrees C) and associated impairment in cognitive performance, even when exposed to temperatures that are comfortable for able-bodied (AB) individuals. Cool seasonal temperatures have been shown to have a greater adverse effect on personal comfort, activities of daily living (ADLs), and vital daily activities in persons with tetraplegia than that of AB controls. Conversely, a minimal increase in Tcore from subnormal to normothermia, secondary to ambient heat may improve cognitive performance. Interventions addressing the tendency to poikilothermia and enhanced vulnerability to hypothermia in persons with tetraplegia are limited. Therefore, exploration of safe and efficacious bioengineering solutions to address the physiological, cognitive, and quality of life (QoL) issues associated with the routine exposure to cool temperatures that persons with tetraplegia often encounter is warranted.
The goals of this pilot study are to: 1) fully bench-test the heated vest for safety before performing any human subject testing; 2) study the safety and tolerability of a feedback-controlled heated vest in AB controls; and 3) study the efficacy of this heated vest to minimize the expected decline in Tcore and associated deterioration of cognitive performance during 2 hours of cool exposure in persons with tetraplegia.
In persons with tetraplegia, a two-condition (heated vest, non-heated vest) prospective study is being proposed to compare the physiological and cognitive responses to 2 hours of controlled cool exposure (18 degrees C) with a prototype heated vest vs. a similar, but non-heated vest (control condition). Eight subjects with tetraplegia (C3-T1, AIS A and B) and eight AB controls will be recruited for study participation. Before the prototype is tested on human subjects, it will have been fully bench tested and have satisfied all safety requirements and specifications. AB subjects will be observed to ensure the safety of the vest, which will be accomplished by determining the temperatures of the vest ( 39 degrees C) and subjective thermal sensation of no greater than 'warm' during a cool condition that will be identical to the condition which subjects with SCI will be exposed. Subjects with tetraplegia will test the efficacy of the heated vest, i.e. preventing the expected decline in Tcore and cognitive performance and increase in thermal comfort.
After the feedback-controlled heated vest has been fully bench-tested and has satisfied all safety requirements (interior vest temperature does not exceed 39 degrees C at maximal power) and design specifications (lightweight, slim, easy to don doff), the following specific aims will be addressed:
Primary Specific Aim: In a cool thermal chamber (18 degrees C), AB controls will wear the heated vest at maximal setting for 120 minutes in the seated position to determine (1) maximum temperatures of all areas of the interior (user's side) of the heated vest and (2) subjective comfort of the heated vest (safety testing).
Primary Hypotheses: The study of AB controls will demonstrate (1) All areas under the vest will have temperatures 39 degrees C. (2) All subjects will report a thermal sensation no greater than 'warm' this would include identification of 'hot spots' (Zhang 9-point Thermal Sensation Scale).
Secondary Specific Aim: During exposure to a cool environment (18 degrees C) for up to 120 minutes in the seated position, persons with tetraplegia will wear the heated vest to determine (1) change in Tcore, (2) change in cognitive performance, and (3) change in thermal comfort (efficacy testing).
Secondary Hypotheses: In persons with tetraplegia wearing the heated vest compared to the same persons wearing the non-heated vest, it's expected that (1) 30% of the subjects will have a decline of 0.5 degrees C in Tcore compared with 80% in the control condition, (2) 30% of the subjects will demonstrate a decline of at least 1 T-score in at least one of the following measures: Interference of Stroop Color and Word test, Digit Span of Wechsler Adult Intelligence Scale-Fourth Edition, compared with 80% in the control condition, and (3) a greater percentage of subjects reporting increased thermal comfort (Zhang 6-point Comfort Scale).
#Intervention
- DEVICE : Heated Vest
- Heated vest that regulates its heat output based on the user's skin, the user's core temperature, and the ambient temperature
- Other Names :
- Feedback-controlled heated vest
- DEVICE : Non-Heated Vest
- A similarly insulated (compared to the experimental vest), but non-heated vest
- Other Names :
- Active comparator vest, control condition | #Eligibility Criteria:
Inclusion Criteria:
Subjects with spinal cord injury (SCI) and able-bodied subjects will be recruited according to the following criteria:
* Duration of injury 1 year
* Neurological Level of SCI [C3-T1]; American Spinal Injury Association (ASIA) Impairment Scale (AIS) A & B
* Euhydration
* Subjects will be instructed to avoid caffeine and alcohol
* maintain normal salt and water intake
* avoid strenuous exercise for 24 hours prior to study
Exclusion Criteria:
* Known heart, kidney, peripheral vascular or cerebrovascular disease
* High blood pressure
* History of Traumatic Brain Injury (TBI) or diagnosed cognitive impairment
* Untreated thyroid disease
* Diabetes mellitus
* Acute illness or infection
* Dehydration
* Smoking
* Pregnant women
* BMI>30 kg/m2
* Broken, inflamed, or otherwise fragile skin
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
| NCT03662308 | 143,718 |
{
"NCT_ID" : "NCT00530998",
"Brief_Title" : "Minimally Invasive Surgery: Using Natural Orfices",
"Official_title" : "Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Trans-Vaginal Appendectomy and Cholecystectomy",
"Conditions" : ["Appendicitis", "Cholelithiasis", "Gallstones"],
"Interventions" : ["Procedure: Transvaginal Appendectomy", "Procedure: Transvaginal Cholecystectomy"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2007-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-09",
"Study_Completion_Date(Actual)" : "2019-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2007-09-17",
"First_Posted(Estimated)" : 2007-09-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2007-09-17",
"Last_Update_Posted(Estimated)" : 2020-03-10",
"Last_Verified" : 2020-03"
}
}} | #Study Description
Brief Summary
This is an observational study of pain and outcomes from females undergoing transvaginal NOTES removal of their appendix or gallbladder. Female subjects who elect to have a transvaginal NOTES removal of their appendix or gallbladder and agree to be in this study (through signature on the informed consent form) will be followed per standard of care, with additional follow-up for data collection including the following:
* Subjects will complete a 7 day pain/temperature log after surgery
* Subjects will complete a standardized sexual function questionnaire (Female Sexual Function Index) prior to surgery and 6 months after surgery
* Subjects will receive a phone call at 6 months and at 1 year after surgery to capture data related to safety, adverse events, hospitalizations and patient satisfaction
Additional data related to pain and outcomes will be collected at baseline/screening and at follow-up as necessary.
#Intervention
- PROCEDURE : Transvaginal Appendectomy
- The appendix will be removed via an incision in the vagina.
- PROCEDURE : Transvaginal Cholecystectomy
- The gallbladder will be removed via an incision in the vagina. | #Eligibility Criteria:
Inclusion criteria for transvaginal appendectomy:
* Females between the ages of 18 <= age <= 75
* Clinical diagnosis of appendicitis
* Emergency room evaluation within 36 hours of the onset of pain
* ASA Classification 1
* Mentally competent to give informed consent
* Scheduled to undergo a transvaginal NOTES appendectomy.
Exclusion criteria for transvaginal appendectomy:
* Pregnant women (need to have negative icon in ER)
* Morbidly obese patients (BMI >35)
* Patients who are taking immunosuppressive medications or are immunocompromised
* Patients with evidence of an abdominal abscess or mass
* Patients who present with a clinical diagnosis of sepsis or peritonitis
* Patients who have a history of prior transvaginal surgery. Patients with prior laparoscopic surgery will be included.
* Patients who endorse a history of ectopic pregnancy, pelvic inflammatory disease (PID), or severe endometriosis
* Patients with diffuse peritonitis on clinical exam
* Patients on blood thinners or aspirin or abnormal blood coagulation tests
Inclusion criteria for transvaginal cholecystectomy:
* Females between the ages of 18 and 75
* Diagnosis of gallstone disease which requires cholecystectomy
* ASA class 1
* Mentally competent to give informed consent
* Scheduled to undergo a transvaginal NOTES cholecystectomy
Exclusion criteria for transvaginal cholecystectomy:
* Pregnant women
* Morbidly obese patients (BMI > 35)
* Patients who are taking immunosuppressive medications and/or immunocompromised
* Patients with severe medical comorbidities will be excluded.
* Patients with a presumed gallbladder polyps, mass or tumor
* Patients with a history of prior transvaginal surgery. Patients with prior laparoscopic surgery will be included.
* Patients with a history of ectopic pregnancy, pelvic inflammatory disease, or severe endometriosis
* Patients with known common bile duct stones
* Patients on blood thinners or aspirin or abnormal blood coagulation tests
Sex :
FEMALE
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
| NCT00530998 | 258,277 |
{
"NCT_ID" : "NCT00796965",
"Brief_Title" : "Safety, Tolerability, and Pharmacokinetics of AZD7268 After Single Ascending Oral Doses in Healthy Subjects",
"Official_title" : "A Phase I, Single-center, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD7268 After Single Ascending Oral Doses in Healthy Subjects",
"Conditions" : ["Healthy Volunteer"],
"Interventions" : ["Drug: Placebo", "Drug: AZD7268"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2008-12",
"Study_Completion_Date(Actual)" : "2009-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-11-20",
"First_Posted(Estimated)" : 2008-11-24"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-11-21",
"Last_Update_Posted(Estimated)" : 2009-08-19",
"Last_Verified" : 2009-08"
}
}} | #Study Description
Brief Summary
Single Ascending Dose Study
#Intervention
- DRUG : AZD7268
- Solution/Capsule, Oral, once daily
- DRUG : Placebo | #Eligibility Criteria:
Inclusion Criteria:
* Provision of Informed Consent
* Healthy male subjects and female subjects (of non-child bearing potential) with suitable veins for cannulation or repeated venipuncture
Exclusion Criteria:
* Inability to understand or cooperate with given information
* Positive human immune deficiency virus (HIV), Hepatitis B, or Hepatitis C test
* Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology, and urinanalysis
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
| NCT00796965 | 21,439 |
{
"NCT_ID" : "NCT00486473",
"Brief_Title" : "Multihance Versus Magnevist in Breast MRI",
"Official_title" : "Phase III Multicenter Double-Blind, Randomized, Crossover Study to Compare MultiHance With Magnevist in Contrast-enhanced Magnetic Resonance Imaging (MRI) of the Breast",
"Conditions" : ["Breast Cancer"],
"Location_Countries" : ["Italy"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "DIAGNOSTIC",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2007-07",
"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" : 2007-06-13",
"First_Posted(Estimated)" : 2007-06-14"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2007-06-13",
"Last_Update_Posted(Estimated)" : 2010-07-15",
"Last_Verified" : 2010-07"
}
}} | #Study Description
Brief Summary
To show if one MRI contrast agent is better than another one in the diagnosis of malignant breast lesions compared to histopathology
#Intervention
- DRUG : Multihance
- 0.5 Molar at a single dose injection
- DRUG : Magnevist
- 0.5M at a single dose injection | #Eligibility Criteria:
Inclusion Criteria:
* Provides written informed consent
* Female
* Age >= 18 years
* Suspicious or known breast lesion based on results from mammography or ultrasound
* Planned to undergo histological diagnosis of breast lesion by having a non surgical biopsy or breast surgery within 30 days after the MRI exam
Exclusion Criteria:
* Body weight > 100 kg
* Pregnant or lactating
* Server or end-stage organ failure
* Moderate to severe renal impairment
* Undergoing radiotherapy or completed radiotherapy in the last 18 months
* Chemotherapy within 6 months of the 1st MRI exam
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
| NCT00486473 | 10,709 |
{
"NCT_ID" : "NCT05876013",
"Brief_Title" : "Reduced Knee Flexion Strength 18 Years After ACL Reconstruction in Hamstring Group Compared to Patellar Tendon Group",
"Official_title" : "Reduced Knee Flexion Strength 18 Years After ACL Reconstruction in Hamstring Group",
"Conditions" : ["ACL", "ACL Injury", "Cruciate Ligament Rupture", "ACL Tear", "Surgery"],
"Interventions" : ["Procedure: ACL reconstruction"],
"Location_Countries" : ["Norway"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-03-14",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-10-07",
"Study_Completion_Date(Actual)" : "2022-10-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-04-17",
"First_Posted(Estimated)" : 2023-05-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-05-16",
"Last_Update_Posted(Estimated)" : 2024-06-05",
"Last_Verified" : 2024-06"
}
}} | #Study Description
Brief Summary
Background: Bone-patellar tendon-bone (BPTB) and a double-looped semitendinosus gracilis (hamstring group) graft are commonly used for ACL reconstruction. Short-term and mid-term studies show little to no significant difference between the two groups, and there are a few long term studies to compare results between the two grafts.
Purpose: To compare the results after using either BPTB grafts or hamstring grafts 18 years after ACL reconstruction.
Study design: Randomized controlled trial; Level of evidence II. Methods: 114 patients with ACL rupture between 2001 and 2004 were randomized to reconstruction with either BPTB graft or a hamstring graft. Patients were operated at four major hospitals. The 18-year follow-up evaluation included isokinetic testing of muscle strength, patient-reported outcome measures, clinical knee examination and an assessment of radiological osteoarthritis using the Kellgren-Lawrence classification.
Hypothesis:Hypothesis is that there will be no difference in the long-term outcome between the two groups, as well hypothesis of no difference in patients with prosthesis after ACL reconstruction, arthrosis difference in operated knees and the rate of graft failure between the two groups. Previous follow-up studies showed a significant difference in total flexion work between the two groups, so detecting a persistent difference between the groups will be point of interest.
Detailed Description
Introduction Rupture of the anterior cruciate ligament (ACL) is a common soft-tissue knee injury, and has increased in number over the last twenty years. Reconstructing the ligament may be important for maintaining the stability and preventing further damaging of the knee. The two most commonly used grafts in reconstructions are the autologous patellar tendon grafts and hamstring tendon grafts There is yet to be a universally established agreement regarding which reconstruction method of an ACL is preferred. The method using the central third of the patellar tendon with proximal and distal bone blocks as the replacement has been used since the late 80s and is well documented with good results. When the technique using the hamstring tendon grafts was introduced, its popularity increased. Arguments favoring each of the methods depend on which variables one values the most. In some studies, the patellar tendon group reported problems regarding anterior knee pain and decreased sensitivity of the knee, whereas for the hamstring tendon group there was reported increased weakness of the hamstring muscles and knee laxity. However, the overall assessment and satisfaction in multiple short-term/semi-long studies have shown little to no difference .
The aim of this prospective randomized multicenter study is to compare the use of bone-patellar tendon-bone (BPTB) grafts and double-looped semitendinosus gracilis (DLSG) grafts for reconstruction of the anterior cruciate ligament, 17-20 years after the surgery. The null hypothesis is that there will be no significant differences at this long-term follow-up evaluation between the two methods.
Method and material of the first study- Drogset et al. recruited 115 patients with rupture of the anterior cruciate ligament in the period of 2001-2004, and randomized them to either reconstruction with bone-patellar tendon-bone (BPTB) grafts fixed with metal interference screw graft, or double-looped semitendinosus gracilis (DLSG) grafts fixed with Bone Mulch Screws and WasherLoc Screws. The surgeries were performed at four different hospitals.
After one and two years, the patients were examined by an independent observer, using a series of objective tests, as well as recording the patients' subjective opinion of their knee function. The subjective tests used were Tegner's activity score, Lysholm's functional score and Modified Cincinnati Score. The objective tests used were Lachmann's test, pivot shift and KT-1000, as well as Cybex and Biodex to measure muscle strength.
Method and material- The present study is a long-term follow-up of a prospective randomized multicenter study. The patient recorded outcome scores will be Tegner's activity score, Lysholms's functional score and the Knee injury Osteoarthritis Outcome Score (KOOS). The examinations include Lachmann's test, pivot shift and KT-1000. We also plan to include radiographs to evaluate the degree of arthrosis 17-20 years after the surgery, and Cybex or Biodex to examine the hamstring and quadriceps strength. The radiographic positioning will be knee AP weight-bearing standing bilateral and lateral view, as well as skyline projection. The Kellgren-Lawrence classification will be used to assess the degree of osteoarthritis.
Even though 115 patients were included in the original study, we will only attempt to contact 114 due to lost inclusion-papers between the 2-year and 7-year follow-up \[8\]. During the spring of 2022, the patients will receive an invite to participate in the follow-up study. Following this, patients will be contacted to uncover different circumstances that might exclude certain patients from the clinical assessment. This includes revision of the reconstruction in question, total knee replacement or total knee arthroplasty, and if the knee had been injured beforehand. The clinical examination will be carried out by both a medical student and an experienced orthopedic surgeon. Hopefully all the patients will be examined over the course of two days at each location, and if needed, the rest will be examined at a later date.
Hypothesis- Current hypothesis is that there will be no difference in the long-term outcome between the two groups. However, it will be interesting to see how many patients have received a prosthesis, and how many patients struggle with arthrosis. As the previous follow-up studies showed a significant difference in total flexion work between the two groups, we will be interested in detecting a persistent difference between the groups.
Another interesting aspect will be the rate of graft failure between the two groups.
Feasibility- The strength of the study is the randomization and the long follow-up period of 17-20 years. The possible limitations are the fact that there may be a problem recruiting enough patients to the follow-up, and that it might not be able to get x-rays of the patients at the different hospitals, as this is a matter of cost and availability. In addition, the different hospitals may not have a Biodex available.
Publicity plan- The goal for the paper is to be published in an international journal and probably be presented at conferences. For article, that hopefully will be published in journals, Marko Popovic will stand as first author, and Julie Holen and Julie Myhre as contributing authors. Jon Olav Drogset will be listed last, as the main supervisor.
Ethics- The REK-application was submitted on the 24th of December 2021. Application number: 391796. Additionally, the project will be reported to NSD when the REK-application is approved.
#Intervention
- PROCEDURE : ACL reconstruction
- Randomized between hamstring and patellar tendon graft
- Other Names :
- Graft choice, | #Eligibility Criteria:
Inclusion Criteria:
* Primary reconstructions of isolated ACL-ruptures. Surgery at least 6 weeks after injury. Age 18 <= age <= 45 years.
* The patient must understand and accept the written consent. The written consent must be signed by the patient before surgery.
* Normal two-plane X-ray of the knee.
Exclusion Criteria:
*>5mm + chronic MCL-injury in the same knee.
* Patient with major additional injury in the knee: combined instability, cartilage injuries Outerbridge grade 3 <= age <= 4 and at least 1cm in diameter on the femoral condyle and major meniscal lesions with meniscal repairs.
* Patients having problems following the protocol.
* The patient does not understand the written consent or will not sign it.
* Patients with a history of alcohol or drug abuse the last three years.
* The patient has received any investigational drugs within 30 days prior to admittance to this study.
* The patient has O.A., podagra, RA, Bechterew's disease or chondrocalcinosis.
* The patient has malalignment with more than 5 degrees valgus and no varus compared to a normal knee.
* The patient has patellofemoral instability.
* The patient is obese with BMI>30.
* The patient has a present or former serious illness that makes follow-up or rehabilitation of the patient difficult.
* Former major surgical procedures in the same knee, including prosthesis.
* Treated or untreated anterior cruciate ligament injury in the other knee.
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:
No
| NCT05876013 | 152,966 |
{
"NCT_ID" : "NCT02387619",
"Brief_Title" : "The Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine",
"Official_title" : "A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine in Healthy Male Volunteers",
"Conditions" : ["Hypertension", "Hyperlipidemia"],
"Interventions" : ["Drug: Rosuvastatin", "Drug: Rosuvastatin and Telmisartan/Amlodipine", "Drug: Telmisartan/Amlodipine"],
"Location_Countries" : ["Korea, Republic of"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-03",
"Study_Completion_Date(Actual)" : "2015-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-03-09",
"First_Posted(Estimated)" : 2015-03-13"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-03-09",
"Last_Update_Posted(Estimated)" : 2016-06-24",
"Last_Verified" : 2015-03"
}
}} | #Study Description
Brief Summary
A randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic drug interaction between rosuvastatin and telmisartan/amlodipine in healthy male volunteers
Detailed Description
A randomized, open-label, 2-treatment, 2-sequence, 2-period, multiple-dose, crossover design
#Intervention
- DRUG : Rosuvastatin
- Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin once daily for 9 days
- Other Names :
- Crestor
- DRUG : Telmisartan/Amlodipine
- Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine once daily for 9 days
- Other Names :
- Twynsta
- DRUG : Rosuvastatin and Telmisartan/Amlodipine
- Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days
- Other Names :
- Crestor and Twynsta | #Eligibility Criteria:
Inclusion Criteria:
* 19~55 years healthy male
* Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
* Subjects who agree to keep contraceptive methods during the clinical trial.
Exclusion Criteria:
* Subjects who are allergic to investigational drug.
* Subjects who have a medical history which can affect the clinical trial.
* Hypertension(Systolic BP >= 150mmHG or Diastolic BP >= 100mmHg), Hypotension(Systolic BP <= 100mmHg or Diastolic BP <= 65mmHg)
* Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
Sex :
MALE
Ages :
- Minimum Age : 19 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT02387619 | 132,245 |
{
"NCT_ID" : "NCT05032716",
"Brief_Title" : "EFFECT OF TREADMILL TRAINING ON BALANCE AFTER CHEMOTHERAPY IN CHILDREN WITH ACUTE LYMPHOBLASTIC LEUKEMIA",
"Official_title" : "Treadmill Training is an Effective Rehabilitation Program in Treatment of Children With Acute Lymphoblastic Leukemia",
"Conditions" : ["Acute Lymphoblastic Leukemia, Pediatric"],
"Interventions" : ["Other: Balance exrcises", "Other: Balance exrcises and Treadmill training"],
"Location_Countries" : ["Egypt"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-05-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-07-10",
"Study_Completion_Date(Actual)" : "2021-08-21},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-08-31",
"First_Posted(Estimated)" : 2021-09-02"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-08-31",
"Last_Update_Posted(Estimated)" : 2021-11-17",
"Last_Verified" : 2021-11"
}
}} | #Study Description
Brief Summary
Purpose: The present research was conducted to study the effect of treadmill training on balance after chemotherapy in children with acute lymphoblastic leukemia.
Subjects and Methods: Forty children with acute lymphoblastic leukemia included in the current research ranged of age from 8 to 12 years. The children participated in this study were assigned randomly into two equal number groups (A and B). Group (A) includes 20 children who received balance exercises, while group (B) includes 20 children who received the same balance exercises of group (A) and treadmill training. The treatment program was applied three sessions per week (60 min for every session) for 8 weeks. Balance Master System and Biodex Balance System were used to evaluate balance of all children in the three groups before and after the treatment program.
Detailed Description
The current research is a randomized control trial to differentiate between the treadmill training on balance after chemotherapy in children with acute lymphoblastic leukemia. Chemotherapy induced peripheral neuropathy is related to the intensity of treatment and dosage of chemotherapy which could affect the severity of its symptoms, it could result in serious problems like sensory changes and numbness , in case the sensory nerves were affected , muscle weakness and in-coordination in case the affected were the motor nerves. In addition to the psychological problems the patient experience as a result of CIPN, the patient also experience physical problems like injuries, fear of fall results from lack of sensory perception and muscle power. Treadmill training, motor training may favor proprioceptive feedback, leading to adjustments for adequate postural balance and functional performance. Treadmill exercises stimulate the kinetic, kinematic, and temporal features of walking. These exercises improve the strength of the muscles of the lower extremities, enhance motor learning, improve functional abilities, and activate the locomotor control system
#Intervention
- OTHER : Balance exrcises
- the group (20 children) received traditional exercise program with instructions given to the children for 60 min aiming to improve posture control and balance. Tools of traditional physical therapy exercises were; special tools were used for traditional physical therapy exercises include vestibular board, rolls of different sizes, blocks and wedges of different heights
- OTHER : Balance exrcises and Treadmill training
- the group (20 children) received the same traditional physical therapy program as the same applied in group of balance exercises, in addition to treadmill training (30 min). The child walked on the treadmill (motorized treadmill, ENTRED, Enraf-Nonius) at 75% of over-ground speed and individually prescribed low-endurance walking at 0% incline for 20 min, three times a week for 8 successive weeks. The walking area of the treadmill is made from heavy steel with a minimum 8-inch thickness and is available with cushioning in case of accidental impacts. Before the walking session, each child underwent 5 min of active stretching exercises that include prolonged and progressive stretching of the hamstrings, quadriceps muscles, and Achilles tendon. | #Eligibility Criteria:
Inclusion Criteria:
* able to recognize commands given to them,
* understand our verbal command and encouragement,
* and stand and walk independently without repeated falling
Exclusion Criteria:
* Children with impairment of sensation or
* other neurological or psychological problems,
* tightness and/or fixed deformity of lower limbs,
* any neurological, musculoskeletal, or mobility disorders,
* cardiac anomalies,
* vision or hearing loss
Sex :
ALL
Ages :
- Minimum Age : 8 Years
- Maximum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
| NCT05032716 | 124,532 |
{
"NCT_ID" : "NCT02251158",
"Brief_Title" : "Bioavailability of Tipranavir/Ritonavir Paediatric Solution Compared to Tipranavir/Ritonavir Capsules in Healthy Female and Male Subjects",
"Official_title" : "Relative Bioavailability of 500/200 mg of Tipranavir/Ritonavir Paediatric Solution Compared to 500/200 mg of Tipranavir/Ritonavir Capsules Following Oral Administration and Bioavailability of 500/200 mg Tipranavir/Ritonavir Paediatric Solution Under the Influence of Food in Healthy Female and Male Subjects. An Open-label, Randomised, Single-dose, Three-way Crossover Trial.",
"Conditions" : ["Healthy"],
"Interventions" : ["Drug: Tipranavir oral solution", "Drug: Ritonavir oral solution", "Drug: Tipranavir capsules", "Other: High fat breakfast", "Drug: Ritonavir soft gel capsules"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2003-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2003-12",
},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-09-25",
"First_Posted(Estimated)" : 2014-09-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-09-25",
"Last_Update_Posted(Estimated)" : 2014-09-29",
"Last_Verified" : 2014-09"
}
}} | #Study Description
Brief Summary
Study to determine the relative bioavailability of 500/200 mg of tipranavir/ritonavir (TPV/r) oral solution compared to 500/200 mg of TPV/r capsules following oral administration and to investigate the relative bioavailability of 500/200 mg of TPV/r oral solution with food versus without food.
#Intervention
- DRUG : Tipranavir oral solution
- DRUG : Tipranavir capsules
- DRUG : Ritonavir oral solution
- DRUG : Ritonavir soft gel capsules
- OTHER : High fat breakfast | #Eligibility Criteria:
Inclusion Criteria:
* Healthy males and females according to the following criteria:
Based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests
* No finding deviating from normal and of clinical relevance
* No evidence of a clinically relevant concomitant disease
* Age >= 18 and Age <= 55 years
* BMI >= 18.5 and BMI <= 29.9 kg/m2 (Body Mass Index)
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Exclusion Criteria:
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial (e.g. drugs which contain polyethylene glycol or vitamin E)
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Smoker (more than 10 cigarettes/day or 3 cigars/day or 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (more than 60 g/day)
* Drug abuse
* Veins unsuited for iv puncture on either arm (e.g. veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture)
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* History of any bleeding disorder or acute blood coagulation defect of vitamin K deficiency caused by anticoagulation therapy or malabsorption
* Vitamin E supplement intake
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of study centre
For female subjects:
* Pregnancy
* Positive pregnancy test
* No adequate contraception e.g. oral contraceptives, sterilization, intrauterine device
* Inability to maintain this adequate contraception during the whole study period
* Lactation period
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT02251158 | 64,974 |
{
"NCT_ID" : "NCT04488939",
"Brief_Title" : "Restylane® Skinboosters™ Vital in the décolletage Region",
"Official_title" : "A Prospective, Open-label Evaluation of Restylane® Skinboosters™ Vital in the décolletage Region",
"Conditions" : ["Decolletage Rejuvenation"],
"Interventions" : ["Device: Restylane® Skinboosters™ Vital (SBV)"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-03-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-12-30",
"Study_Completion_Date(Actual)" : "2020-12-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-07-22",
"First_Posted(Estimated)" : 2020-07-28"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-07-24",
"Last_Update_Posted(Estimated)" : 2021-02-10",
"Last_Verified" : 2020-07"
}
}} | #Study Description
Brief Summary
Restylane® Skinboosters™ Vital (SBV) is a smooth formulation without particles, which helps it distribute evenly and smoothly under the skin to aid in rejuvenation. This feature makes RSV particularly well suited for more superficial injections, such as at the level of the dermis.
SBV smooths fine lines and wrinkles and is intended to improve skin smoothness and appearance, as well as the elasticity and hydration of the skin in the face and dorsal hands. However, many clinicians have used SBV in other regions of the body. Given these attributes, SBV are particularly well suited for photo aged skin. A region that is susceptible to photo-ageing and may therefore benefit from the use of SBV is the décolletage. Photodamaged skin of the chest is characterized by atrophy, skin laxity, fine lines and wrinkles, dehydration and tactile roughness. Therefore, SBV may help to improve these signs of aging in the décolletage region.
Study Aim: To investigate the effectiveness and tolerability of SBV for rejuvenation of the décolletage region.
#Intervention
- DEVICE : Restylane® Skinboosters™ Vital (SBV)
- Hyaluronic acid | #Eligibility Criteria:
Inclusion Criteria:
* A score > 2 on the GDS, as assessed by the treating physician at Baseline.
* Females aged > 25 and < 70
* Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability and willingness to give consent to participate in the study.
* Signed and dated informed consent to participate in the study and unrestricted use of décolletage images for marketing purpose.
* If female of childbearing potential: a negative urine pregnancy test before all treatments is required.
Exclusion Criteria:
* Current Pregnancy or lactation [sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)];
* Patients meeting any official Restylane contra-indications;
* Inability to comply with follow-up and abstain from other treatments in the region of interest during the study period;
* Heavy smokers, classified as smoking more than 12 cigarettes per day;
* History of severe or multiple allergies manifested by anaphylaxis;
* Previous tissue revitalization therapy in the treatment area within 6 months before treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling, or dermabrasion;
* Subjects presenting with known allergy to hyaluronic acid (HA) filler or amide local anesthetics.
* Subjects presenting with porphyria.
* Subjects with active disease, such as inflammation, infection or tumors, in or near the intended treatment site.
* Subjects with bleeding disorders or in subjects who are taking thrombolytics or anticoagulants.
* Subjects using immunosuppressants.
* History of other décolletage treatment/procedure in the previous 6 months below the level of the neck that, in the treating investigator's opinion, would interfere with the study injections and/or study assessments or exposes the subject to undue risk by study participation.
* Tattoos, piercings or visible markings that in the treating investigator's opinion, may interfere with results or assessments [excessive sun damage, tan lines, dark spots, moles, scars (hypertrophic, keloid), tan lines].
* Cancer or precancer in the treatment area, e.g. actinic keratosis;
* History of bleeding disorders or treatment with thrombolytics, anticoagulants, or inhibitors of platelet aggregation (e.g. Aspirin or other non-steroid anti-inflammatory drugs [NSAIDs]), within 2 weeks before treatment;
* Patients using immunosuppressants;
* Patients with a tendency to form hypertrophic scars or any other healing disorders;
* Patients with known hypersensitivity to lidocaine or agents structurally related to amide type local anesthetics (e.g., certain anti-arrhythmics);
* Patients with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction.
Sex :
FEMALE
Ages :
- Minimum Age : 25 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT04488939 | 66,350 |
{
"NCT_ID" : "NCT01165164",
"Brief_Title" : "An Evaluation of the Nighttime Retention of Effect of an Investigational Lubricant Eye Drop (FID 115958D)",
"Conditions" : ["Dry Eye"],
"Interventions" : ["Other: FID 115958D (lubricant eye drop)"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-07",
"Study_Completion_Date(Actual)" : "2010-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-07-16",
"First_Posted(Estimated)" : 2010-07-19"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2010-07-16",
"Last_Update_Posted(Estimated)" : 2012-02-02",
"Last_Verified" : 2012-01"
}
}} | #Study Description
Brief Summary
The purpose of this study is to describe the night-time use of an investigational lubricant eye drop.
#Intervention
- OTHER : FID 115958D (lubricant eye drop)
- 1 drop in each eye at bedtime | #Eligibility Criteria:
Inclusion Criteria:
* Documented diagnosis of dry eye
* Current use of an eye ointment or tube gel
Exclusion Criteria:
* No nighttime contact lenses wear throughout the study period
* Must not have had punctal plugs inserted within 30 days preceding enrollment
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
| NCT01165164 | 188,080 |
{
"NCT_ID" : "NCT03618355",
"Brief_Title" : "Trial of eRapa in Prostate Cancer Patients",
"Official_title" : "Phase Ib Trial of Encapsulated Rapamycin (eRapa) in Prostate Cancer Patients Under Active Surveillance",
"Conditions" : ["Prostate Cancer"],
"Interventions" : ["Drug: eRapa (encapsulated rapamycin)"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-08-28",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-12-02",
"Study_Completion_Date(Actual)" : "2019-12-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-06-12",
"First_Posted(Estimated)" : 2018-08-07"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-08-01",
"Last_Update_Posted(Estimated)" : 2020-03-31",
"Last_Verified" : 2020-03"
}
}} | #Study Description
Brief Summary
This study is to determine the safety, pharmacokinetics/pharmacodynamics, and immunologic impact of encapsulated rapamycin in patients with low risk prostate cancer under active surveillance. There will be four groups of patients, each receiving a different dose of rapamycin.
Detailed Description
This is a phase Ib trial of encapsulated rapamycin to determine safety, pharmacokinetics/pharmacodynamics, and immunologic impact in patients with low risk prostate cancer under active surveillance. This new formulation, encapsulated rapamycin (sirolimus), provides a more predictable bioavailability of this drug than \[the other formulation\]. The encapsulated and targeted rapamycin (eRapa) can be delivered at a consistent and lower dosage, not only improving the toxicity profile but also capitalizing on the newly appreciated mechanism of partial and/or intermittent mTOR inhibition, making eRapa an ideal immuno-oncologic and chemopreventative agent. Low dose rapamycin has been shown to prevent cancer formation, progression, and/or recurrence in the majority of cancer histologies including the most prevalent: lung, breast, prostate, and colon cancers.
#Intervention
- DRUG : eRapa (encapsulated rapamycin)
- The eRapa (encapsulated rapamycin) drug product consists of sub-micron rapamycin particles incorporated into poly(methyl methacrylate) polymer (Eudragit® L 100 / S 100).
This improved formulation and better bioavailability enables eRapa to consistently provide approximately 30% more drug than sirolimus (unpublished data). Improved and predictable delivery allows for consistent and sustained lower dosing, which will result in an improved toxicity profile since the latter is proven to be related to blood concentration levels. This is a phase Ib trial in low risk (Gleason score ≤7 (3+4)) prostate cancer patients under active surveillance to establish dosage safety and treatment levels. | #Eligibility Criteria:
Inclusion Criteria:
*
The patient must:
* Have pathologically (histologically) proven diagnosis of prostate cancer with a Gleason score <=7 (3+4) and already undergoing active surveillance
* Be able to give informed consent
* Be age >= 18 years
Exclusion Criteria:
* Prostate cancer with a Gleason score >7
* Unable to give informed consent
* Age < 18
* Immunosuppressed state (e.g., HIV, use of chronic steroids)
* Active, uncontrolled infections
* On medications with strong inhibitors or inducers of CYP3A4 and or P-gp.
* On agents known to alter rapamycin metabolism significantly (Appendix H)
* Have another cancer requiring active treatment (except basal cell carcinoma or squamous cell carcinoma of the skin)
* Individuals with a reported history of liver disease (e.g., cirrhosis)
* Individuals who are not a good candidate for active surveillance in their treating physician's opinion
* Have a medical condition (e.g., anemia, anticoagulated) for which repeated phlebotomy may be problematic.
* Uncontrolled hypertension.
* Individuals that have abnormal screening vital organ function prior to enrollment
* Liver Function Test
* Bilirubin >2.0
* Alkaline phosphatase >5x upper limit of normal (ULN)
* ALT/AST >2x ULN
* Complete Blood Count:
* WBC elevated above the normal standard per the testing laboratory
* Hgb/Hct below the normal standards of the testing lab
* Platelets below the normal standards of the testing lab
* Total Cholesterol >240 mg/dL
* Triglycerides > 200 mg/dL
* Serum creatinine >2 and BUN >30
* Urinary protein: proteinuria >1+ on urinalysis or >1 gm/24hr
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03618355 | 107,093 |
{
"NCT_ID" : "NCT05370339",
"Brief_Title" : "Assessment of Sleep and Sleep Disruptors in Adolescents With Type 1 Diabetes",
"Official_title" : "Assessment of Sleep and Sleep Disruptors in Adolescents With Type 1 Diabetes",
"Conditions" : ["Type 1 Diabetes", "Insufficient Sleep"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-06-15",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-08-30",
"Study_Completion_Date(Actual)" : "2023-08-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-05-06",
"First_Posted(Estimated)" : 2022-05-11"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-05-06",
"Last_Update_Posted(Estimated)" : 2023-09-21",
"Last_Verified" : 2023-09"
}
}} | #Study Description
Brief Summary
The goal of this study is to identify causes of insufficient sleep and sleep disruptors in adolescents with type 1 diabetes. For this study, adolescents will wear an actigraphy watch and complete sleep diaries for seven days. On completion of the seven days, they will complete several questionnaires regarding sleep, fear of hypoglycemia, and anxiety and depression. A subset of participants will additionally complete a qualitative interview session to obtain a deeper understanding of sleep disruptors and barriers and facilitators to improving sleep health.
| #Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with T1D at least 3 months
* Receive clinical care at the Barbara Davis Center
Exclusion Criteria:
* Have an active underlying sleep disorder, such as narcolepsy, insomnia, or untreated sleep apnea
* Participation in an interventional research protocol
* Unable to complete study procedures
Sex :
ALL
Ages :
- Minimum Age : 11 Years
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
| NCT05370339 | 44,496 |
{
"NCT_ID" : "NCT03614871",
"Brief_Title" : "Snuff Use, Smoking, Periodontal Health and Premature Death: 30-year Study",
"Official_title" : "Snuff Use, Smoking, Periodontal Health and Premature Death: 30-year Study",
"Conditions" : ["Tobacco Use", "Periodontitis"],
"Interventions" : ["Other: Epidemiological study"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-01-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-07-01",
"Study_Completion_Date(Actual)" : "2018-07-13},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-07-23",
"First_Posted(Estimated)" : 2018-08-03"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-07-30",
"Last_Update_Posted(Estimated)" : 2018-08-03",
"Last_Verified" : 2018-07"
}
}} | #Study Description
Brief Summary
Snuff use and smoking associated with poor periodontal health, especially if used together.
Detailed Description
Aim: The investigators investigated how snuff use and smoking affect periodontal health parameters and mortality in a Swedish cohort, hypothesizing that snuff use increases the risks.
Material and methods: Study cohort of 1 532 subjects aged 30 to 40 (758 men and 774 women) from Stockholm area was clinically examined and followed up from 1985 to 2015. Associations were analysed between periodontal health parameters, snuff use, smoking and age of death. For analyses, all subjects were classified into four groups: 'dual-users' (current and ex-snuffers, current and ex-smokers); 'pure snuffers' (current and ex-snuffers); 'pure smokers' (non-snuffers, current and ex-smokers) and 'non-users' (non-snuffers and non-smokers). Cross-tabulation, chi-square and Fisher's exact tests were used.
#Intervention
- OTHER : Epidemiological study | #Eligibility Criteria:
Inclusion Criteria:
* In 1985 <= age <= 1986 a sample was selected from the registry file of all inhabitants of the Stockholm area, of people born on the 20th of any month from 1945 to 1954.The sample comprised 3200 people. They were informed about the purpose of the study and called for clinical investigation. 1681 (52.5%) individuals, 840 men and 841 women, participated in the study. From the remaining 1519 non-respondents to the initial call, 100 randomly selected subjects, 45 men and 55 women, were reinformed and persuaded and finally agreed to participate in this investigation. They were used as a drop-out control sample.
Exclusion Criteria:
* Other people
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT03614871 | 228,563 |
{
"NCT_ID" : "NCT03283202",
"Brief_Title" : "Study of Safety and Efficacy of Avadomide (CC-122) Combined With RCHOP for Newly-diagnosed DLBCL With Poor Risk Factors",
"Official_title" : "A Phase 1/2 Open-Label Multicenter Study of Avadomide (CC-122) in Combination With R-CHOP-21 for Previously Untreated Poor Risk (IPI>=3) Diffuse Large B-Cell Lymphoma",
"Conditions" : ["Diffuse B-Cell Lymphoma"],
"Interventions" : ["Drug: Prednisone", "Drug: Rituximab", "Drug: Avadomide (CC-122)", "Drug: Vincristine", "Drug: Cyclophosphamide 750mg/m2 by IV infusion"],
"Location_Countries" : ["Spain", "Canada", "Belgium", "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)" : "2017-10-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-07-30",
"Study_Completion_Date(Actual)" : "2020-12-16},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-09-06",
"First_Posted(Estimated)" : 2017-09-14"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-09-12",
"Last_Update_Posted(Estimated)" : 2021-04-29",
"Last_Verified" : 2021-04"
}
}} | #Study Description
Brief Summary
This is Phase 1/2 study of avadomide (CC-122) in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy, for first-line treatment of patients with Diffuse B-Cell Large B-Cell Lymphoma (DLBCL) that has poor risk factors. Approximately 40% of patients diagnosed with DLBCL are not cured with R-CHOP alone and would need additional treatment for DLBCL in the future. The addition of the experimental drug avadomide (CC-122) with R-CHOP could help in controlling DLBCL in this patient population.
Detailed Description
This research study is for patients who have been newly diagnosed with diffuse large B-cell lymphoma DLBCL and are receiving treatment for the first time.
This study will be conducted in two phases. Phase 1 will test the safety of increasing dose levels of avadomide (CC-122) when given in combination with R-CHOP-21 therapy to identify an appropriate dose and schedule for further evaluation in Phase 2. Phase 2 will evaluate the rate of complete response when adding avadomide (CC-122) to the R-CHOP-21 regimen in first-line treatment of patients with poor risk DLBCL.
This study is separated into three periods: the Screening period, the Treatment period and the Follow-up period. Before the patient can receive the drug the doctor will perform test to find out whether he/she can participate in the study. This is done during the Screening period. If the patient and the treating physician determine that the patient is eligible to participate in the study, the patient will be registered in the study and receive avadomide (CC-122) combined with R-CHOP.
In the Treatment period the patient will receive treatment for up to 6 treatment cycles. Each treatment cycle is 21 days long. The full length of the treatment period will be approximately 4 months.
The follow-up period begins when the patient has completed treatment or is discontinued for any reason. During the follow-up period the patient will have fewer exams, test and visits. The first follow-up visit will be 28 days after treatment is completed or discontinued. After that, the follow-up visits will be every 3 months during the first year, then every 6 months until the study is closed.
Upon completion of the Phase 1 portion of the study, a decision not to proceed with the Phase 2 portion was taken by the Sponsor. The decision to terminate the study after Phase 1 was not based on any safety concerns that posed an unacceptable risk for this patient population and no safety issues have been identified
#Intervention
- DRUG : Avadomide (CC-122)
- Avadomide (CC-122) by mouth at the assigned dose in Ph 1 starting on Day 1 for 5 consecutive days per week, followed by 2 days without avadomide (CC-122) administration (5/7) for the first two weeks of a 21-day treatment cycle. If the highest proposed dose level to be explored in Phase 1 is applied, the dosing regimen will be 5/7 days for all 3 weeks of each 21-day treatment cycle.
- DRUG : Rituximab
- Rituxan 375 mg/m2 on Day 1 by intravenous (IV) infusion of a 21-day treatment cycle for up to a total of 6 cycles
- Other Names :
- Rituxan, MabThera
- DRUG : Cyclophosphamide 750mg/m2 by IV infusion
- Cyclophosphamide 750mg/m2 on Day 1 by IV infusion of a 21-day treatment cycle for up to a total of 6 cycles
- DRUG : Vincristine
- Vincristine 1.4 mg/m2 (maximum of 2.0 mg total) on Day 1 by IV bolus on Day 1 of a 21-day treatment cycle for up to a total of 6 cycles
- Other Names :
- Oncovin, Vincasar
- DRUG : Prednisone
- Prednisone 100 mg PO on Days 1 through 5 of each 21-day treatment or 100mg IV on Day 1 is also acceptable for up to a total of 6 cycles
- Other Names :
- Prednisolone | #Eligibility Criteria:
Inclusion Criteria:
* Subject is >= 18 years at the time of signing the informed consent form (ICF).
* Subject has documented, histologically locally confirmed, previously untreated CD20+ DLBCL (NOS) and the following histologies; refer to the World Health Organization (WHO) 2016 classification (Appendix G):
* DLBCL associated with chronic inflammation
* Epstein-Barr virus positive (EBV+) of the elderly
* T-cell/histiocyte-rich DLBCL 3. Subject is considered an appropriate candidate (per Investigator assessment) for induction therapy with 6 cycles of R-CHOP-21 immunochemotherapy.
4. Subject has a performance status (PS) of 0 <= age <= 2 according to the Eastern Cooperative Oncology Group (ECOG) scale. Subjects with ECOG PS of 3 may be included if decreased PS is secondary to DLBCL only, and not to comorbidities.
5. Subject has poor-risk disease defined as International Prognostic Index (IPI) score >= 3 (high-intermediate or high-risk classification) and has an age-adjusted IPI defined as <= 60 age-adjusted IPI score of 2 with elevated LDH are eligible.
6. Subject has measurable disease on cross-sectional imaging by computed tomography (CT) with at least one (post-biopsy) measurable lesion >= 2.0 cm in its longest dimension.
7. Subject must appropriately be able to complete Screening assessments before beginning treatment for DLBCL, in the judgement of the Investigator.
For subjects with bulky disease, B-symptoms, compressive disease, elevated bilirubin due to lymphoma, rapidly progressing adenopathies, or worsening performance status, pre-phase treatment with up to 100 mg/day prednisone, or equivalent, for a maximum of 10 days is permitted prior to beginning the treatment period, at the discretion of the Investigator. A washout period is not required, however, the Screening positron emission tomography (PET), CT, tumor biopsy (if needed), and bone marrow biopsy (if needed) should be completed before initiating corticosteroids.
8. Subject's central laboratory values must fulfill the following requirements during Screening: Blood product transfusions and hematopoietic growth factors may not be used to meet eligibility criteria. Screening samples should not be collected within 14 days after subject receives a blood product transfusion or growth factors.
If treatment needs to be urgently started and screening central laboratory results are not available then local laboratory results may be used to confirm eligibility. In these cases, the Celgene medical monitor must be consulted prior to beginning treatment. The investigator must still ensure that samples for the central laboratory are drawn before investigational product is administered and sent to the central laboratory.
1. Absolute neutrophil count (ANC) >= 1,500 cells/mm3 (1.5 x 109/L) unless secondary to extensive bone marrow involvement by lymphoma (ie, >= 50%) as demonstrated by unilateral bone marrow core biopsy performed during Screening or within 3 months prior to signing the ICF. In the case of documented extensive bone marrow involvement an ANC >= 1,000 cells/mm3 (1.0 x 109/L) is required.
2. Platelet count >= 100,000/mm3 (100 x 109/L) unless secondary to extensive bone marrow involvement by lymphoma (ie, >= 50%) as demonstrated by unilateral bone marrow core biopsy performed during Screening or within 3 months prior to signing the ICF. In the case of documented extensive bone marrow involvement, a platelet count of >= 75,000/ mm3 (75 x 109/L) is required.
3. Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) <= 3.0 x upper limit of normal (ULN). In the case of documented liver involvement by lymphoma, ALT/SGPT and AST/SGOT must be <= 5.0 x ULN.
4. Serum total bilirubin <= 2.0 mg/dL (34 μmol/L). In the case of Gilbert's syndrome, or documented liver or pancreatic involvement by lymphoma, serum total bilirubin must be <= 5.0 mg/dL (86 μmol/L).
5. Calculated creatinine clearance (CrCl) of >= 50 mL/min by the Cockcroft-Gault formula.
9. Subject must understand and voluntarily sign an Informed Consent Form (ICF) prior to any study-specific assessments/procedures being conducted.
10. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
11. Sufficient tissue from diagnostic tumor/ lymph node biopsy (from within 2 months prior to ICF signature) must be available for translational research purposes or subject is willing to undergo core needle or incisional/ excisional biopsy during Screening.
12. Females of childbearing potential (FCBP)1 must:
1. Agree to use two reliable forms of contraception simultaneously or to practice complete abstinence (True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence [eg calendar, ovulation, symptothermal or post-ovulation methods] and withdrawal are not acceptable methods of contraception.) from heterosexual contact during the following time periods related to this study: 1) for at least 28 days before starting avadomide (CC-122); 2) while taking avadomide (CC-122); 3) during dose interruptions; and 4) for at least 28 days after the last dose of avadomide (CC-122) as specified in the Pregnancy Prevention and Risk Management Plan (PPRMP)
2. Have a negative result confirmed for a medically supervised urine (or serum) pregnancy test (with a sensitivity of at least 25 mIU/mL) 10 <= age <= 14 days prior to the first dose of IP. A second pregnancy test performed within 24 hours prior to the first dose of IP must also be confirmed to be negative prior to IP administration.
* If urgent treatment is needed and requires a shorter window of screening, please immediately contact the medical monitor
13. Avoid conceiving for at least 12 months after the last dose of rituximab, or according to the local rituximab Prescribing Information or Summary of Product characteristics (SmPC); at least 28 days after the last dose of any other study drug.
1. Agree to ongoing pregnancy testing during the course of the study as outlined in the PPRMP.
14. Male subjects must:
1. Practice complete abstinence (True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence [eg calendar, ovulation, symptothermal or post-ovulation methods] and withdrawal are not acceptable methods of contraception.) or agree to use a condom during sexual contact with a pregnant female or a FCBP for at least 12 months after the last dose of rituximab.
2. Agree to not donate semen or sperm for at least 12 months following the last dose of rituximab.
15. All subjects must:
1. Understand that avadomide (CC-122) could have a potential teratogenic risk.
2. Agree to abstain from donating blood while taking IP and for at least 28 days following discontinuation of IP.
3. Agree not to share IP with another person
4. Be counseled about pregnancy precautions and risks of fetal exposure and agree to requirements of the Pregnancy Prevention and Risk Management Plan (PPRMP)
16. Subject is able to swallow pills.
Exclusion Criteria:
1. Subject is seropositive for or has active viral infection with hepatitis B virus (HBV):
1. HBV surface antigen (HBsAg) positive
2. HBV surface antigen (HBsAg) negative, HBV surface ant ibody (ant i-HBs) posit ive and/or HBV core antibody (ant i-HBc) positive, and detectable viral DNA Subjects who are seropositive because of prior HBV vaccination are eligible (anti- HBs positive, anti-HBc negative, and HBsAg negative).
2. Subject is known to be seropositive for, or have an active infection with, hepatitis C virus (HCV).
3. Subject is known to be seropositive for, or have an active infection with, human immunodeficiency virus (HIV).
4. Subject has any neuropathy > Grade 1. 5. Subject has impaired cardiac function or clinically significant cardiac diseases, including any of the following:
1. Left ventricular ejection fraction (LVEF) < 45% as determined by multi-gated acquisition scan (MUGA) or echocardiogram (ECHO).
2. Complete left bundle branch or bifascicular block.
3. Persistent or clinically meaningful ventricular arrhythmias.
4. Unstable angina pectoris or myocardial infarction <= 3 months prior to starting treatment in the study.
5. Troponin-T value > 0.4 ng/mL or B-type natriuretic protein (BNP) > 300 pg/mL by central laboratory assessment Subjects with baseline troponin-T > ULN or BNP > 100 pg/mL are eligible but must have a cardiologist evaluation prior to enrollment in the trial for baseline assessment and optimization of cardioprotective therapy.
If troponin-T is not usually tested by local laboratory then troponin-I may be used to confirm subject meets the Screening eligibility criteria. The central laboratory sample must still be collected prior to first dose and sent to central laboratory. Elevated cut-off value for troponin I will depend on the assay used at the site. If baseline troponin I >ULN, the subject must have a cardiologist consultation prior to enrollment and optimization of cardioprotective therapy.
In case of discrepancy between both troponin-I and troponin-T test, the troponin-T test will be repeated.
6. Subject has confirmed central nervous system (CNS) involvement by DLBCL. Subjects at risk for CNS involvement per Investigator assessment must receive prophylaxis. For subjects at risk, or with any neurological symptoms, testing for CNS involvement is required at Screening.
7. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
8. Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
9. Subject has any condition that confounds the ability to interpret data 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
| NCT03283202 | 178,717 |
{
"NCT_ID" : "NCT02426892",
"Brief_Title" : "Nivolumab and HPV-16 Vaccination in Patients With HPV-16 Positive Incurable Solid Tumors",
"Official_title" : "Phase II Trial of Nivolumab and HPV-16 Vaccination in Patients With HPV-16-Positive Incurable Solid Tumors",
"Conditions" : ["Solid Tumors"],
"Interventions" : ["Biological: ISA 101", "Drug: Nivolumab"],
"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)" : "2015-12-23",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-11-30",
"Study_Completion_Date(Actual)" : "2021-11-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-04-22",
"First_Submitted_that_Met_QC_Criteria" : 2023-03-27",
"First_Posted(Estimated)" : 2015-04-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-04-24",
"Last_Update_Posted(Estimated)" : 2023-04-18",
"Last_Verified" : 2022-12"
}
}} | #Study Description
Brief Summary
The goal of this clinical research study is to learn if nivolumab combined with ISA101 can help to control cancer that has spread. The safety of the study drugs will also be studied.
This is an investigational study. ISA101 is not FDA approved or commercially available. It is currently being used for research purposes only. Nivolumab is FDA approved to treat certain types of melanoma in patients who no longer respond to other drugs. Combining ISA101 with nivolumab is investigational. The study doctor can explain how the study drugs are designed to work.
Up to 28 participants will be enrolled in this study. All will take part at MD Anderson.
Detailed Description
Study Drug Administration:
There are 3 weeks in Cycle 1 and 2 weeks in Cycles 2 and beyond.
If you are found to be eligible to take part in this study, you will receive ISA101 by injection on Day 1 of Cycles 1, 2, and 4. You will be closely watched for the first 3 hours after each dose in order to check for any allergic reactions. Each time, you will receive 2 injections. One may be in your arm and one in your leg.
You will receive nivolumab by vein over 60 minutes on Day 8 of Cycle 1 and Day 1 of Cycles 2 and beyond.
Study Visits:
On Days 1 and 8 of Cycle 1 and Day 1 of every cycle after that:
* You will have a physical exam.
* Blood (about 4 teaspoons) will be drawn for routine tests.
On Day 1 of Cycle 1 and then 1 time a month after that, if you can become pregnant, blood (about 1 teaspoon) or urine will be collected for a pregnancy test.
At Week 11 and every 6 weeks after that, you will have a CT scan or MRI to check the status of the disease.
Additional Research Tests:
Blood (up to 20 teaspoons each time) will be drawn before you begin to receive the study treatment, before you receive ISA101 at Weeks 3 and 7, before you receive nivolumab at Weeks 9 and 11, then every 12 weeks after that. If the doctor thinks it is needed because of white blood cell recovery from stored cells, one of the every 12 week blood draws may be done earlier. These blood samples will be used for biomarker tests and tests of the immune system.
Length of Treatment:
You may take ISA101 for up to 3 doses. You may continue taking nivolumab for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if intolerable side effects occur, or if you are unable to follow study directions.
If the disease seems like it has gotten worse, you may decide to continue to receive nivolumab, if you are still eligible. It is possible the study drug may be working even though the tumor(s) got larger. However, there are risks of continuing to receive the study drug because the disease may actually be getting worse. This is described in the side effects section below.
Your participation on the study will be over after the follow-up.
Follow-up Visits:
At about 30 days and 70 days after the last study drug dose, and then as often as the doctor decides as needed, the following tests and procedures will be performed:
* You will have a physical exam.
* Blood (about 4 teaspoons) will be drawn for routine tests.
At about 30 days, 70 days, and every 6 weeks after that (if you stop the study drug\[s\] for reasons other than the disease getting worse), you will have a CT or MRI scan to check the status of the disease. If the disease gets worse, these scans will stop.
Every 3 months for up to 3 years after your last study drug dose, you will be asked how you are doing (either at a visit or by phone). The calls should last about 10 minutes.
#Intervention
- BIOLOGICAL : ISA 101
- 100 mcg administered subcutaneously for a total of 3 doses at 3 to 4 weeks intervals starting on Day 1.
- DRUG : Nivolumab
- 3 mg/kg administered by vein every 2 weeks beginning on Day 8 after the first vaccine dose.
- Other Names :
- BMS-936558, Opdivo | #Eligibility Criteria:
Inclusion Criteria:
* Signed Written Informed Consent: a. Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care. b) Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.
* Target Population: a. Men and women >= 18 years. b. Eastern Cooperative Oncology Group (ECOG) performance status of <= 1. c. Subjects with histologically- or cytologically-documented incurable Human Papillomavirus (HPV)-16 positive solid tumors including oropharyngeal squamous cell carcinoma (OPSCC), cervical, vulvar, vaginal, anal, penile cancer. Incurable HPV-16 solid tumors are defined as tumors which are not curable by salvage approaches including resection and/or re-irradiation. HPV-16 serotype will be assessed by Cervista assay.
* Target Population: Subjects can be treatment naïve for metastatic or incurable locally advanced HPV-16 positive solid tumors or can have one prior line of treatment.Patients are eligible upon progression after definitive local treatment (usually concurrent chemoradiation) if they are not candidates for salvage surgery or re-irradiation. Patients are also eligible after progression on first line chemotherapy for recurrent disease.
* Target Population: d. Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria; Radiographic Tumor Assessment performed within 28 days of study inclusion. e. Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site. f. Subject entering the study will need to consent for mandatory biopsy at study entrance and as an optional procedure at week 11 and at progression for biomarker evaluation. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is insufficient. g. Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to start.
* Target Population: h. All baseline laboratory requirements will be assessed and should be obtained within -14 days of study registration. Screening laboratory values must meet the following criteria: i) WBCs >= 2000/uL; ii) Neutrophils >= 1500/uL; iii) Platelets >= 100 x 10^3/uL; iv) Hemoglobin >= 9.0 g/dL; v) Serum creatinine of <= 1.5 X ULN or creatinine clearance > 40 mL/minute (using Cockcroft/Gault formula). Female CrCl= (140- age in years) x weight in kg x 0.85 72 x serum creatinine in mg/ dL. Male CrCl= (140- age in years) x weight in kg x 1.00 72 x serum creatinine in mg/ dL; vi) AST <= 1.5X ULN; vii) ALT <= 1.5X ULN; viii) Total bilirubin <= ULN (except subjects with Gilbert Syndrome who must have total bilirubin <3.0 mg/dl).
* Age and Reproductive Status: a) Women of childbearing potential (WOCBP) must use method(s) of contraception for 30 days + 5 half-lives (60 days) of the study drugs. For a teratogenic study drug and/or when there is insufficient information to assess teratogenicity (preclinical studies have not been done), a highly effective method(s) of contraception (failure rate of less than 1% per year) is required. Highly effective birth control in this study is defined as a double barrier method. Examples include a condom (with spermicide) in combination with a diaphragm, cervical cap, or intrauterine device (IUD). The individual methods of contraception should be determined in consultation with the investigator. b) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational product.
* Age and Reproductive Status: c) Women must not be breastfeeding. d) Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. The investigator shall review contraception methods and the time period that contraception must be followed. Men that are sexually active with WOCBP must follow instructions for birth control for a period of 90 days plus the time required for the investigational drug to undergo 5 half-lives (60 days).
Exclusion Criteria:
* Target Disease Exceptions: a. Subjects with active CNS metastases are excluded. Subjects are eligible if CNS metastases are adequately treated and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of <= 10 mg daily prednisone (or equivalent) for 2 weeks. b. Subjects with carcinomatous meningitis.
* Medical History and Concurrent Diseases: a. Subjects with active, known or suspected systemic autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. b. Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
* Medical History and Concurrent Diseases: c. Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways). d. Subjects with a history of interstitial lung disease. e. Other active malignancy requiring concurrent intervention. f. Subjects with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period.
* Medical History and Concurrent Diseases: g. Subjects with toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue that have not resolved to grade 1 (NCI CTCAE version 4) or baseline before administration of study drug. h. Subjects who have not recovered from the effects of major surgery or significant traumatic injury at least 14 days before the first dose of study treatment. i. Treatment with any investigational agent within 28 days of first administration of study treatment.
* Physical and Laboratory Test Findings: a) Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). b) Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection.
* Allergies and Adverse Drug Reaction: a) History of severe hypersensitivity reactions to other monoclonal antibodies. b) History of allergy or intolerance (unacceptable adverse event) to study drugs components.
* Sex and Reproductive Status: a) WOCBP who are pregnant or breastfeeding. b) Women with a positive pregnancy test at enrollment or prior to administration of study medication
* Prohibited Treatments and/or Restricted Therapies: a) Ongoing or planned administration of anti-cancer therapies other than those specified in this study. b) Use of corticosteroids or other immunosuppressive medications as per Exclusion Criteria 2b.
* Other Exclusion Criteria: a) Any other serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a subject's ability to comply with the study requirements, substantially increase risk to the subject, or impact the interpretability of study results. b) Prisoners or subjects who are involuntarily incarcerated. c) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
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
| NCT02426892 | 79,682 |
{
"NCT_ID" : "NCT04811274",
"Brief_Title" : "Macrophages, GM-CSF and MARS Proteinosis",
"Official_title" : "Study of Macrophage Function and of the GM-CSF Signaling Pathway in Alveolar Proteinosis by Mutations of the MARS Gene",
"Conditions" : ["Pulmonary Alveolar Proteinosis (PAP)", "MARS", "Genetic Mutation"],
"Interventions" : ["Biological: Blood collection", "Biological: Bronchoalveolar lavage fluid collection"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-06-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-11-06",
"Study_Completion_Date(Actual)" : "2021-11-06},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-03-19",
"First_Posted(Estimated)" : 2021-03-23"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-03-19",
"Last_Update_Posted(Estimated)" : 2024-10-30",
"Last_Verified" : 2024-09"
}
}} | #Study Description
Brief Summary
Mutations in the MARS gene encoding methionyl-tRNA synthetase are responsible for a genetic form of alveolar proteinosis (PAP), but the pathophysiological mechanisms of the respiratory phenotype are not known.
The main hypothesis is that the PAP phenotype in these patients is secondary to a defective clearance of the surfactant by the alveolar macrophages.
The main objective of the study is to study the clearance capacity of lipoproteinaceous material by macrophages of patients with MARS related PAP. This will be investigate in cultured macrophages derived from peripheral blood monocytes of patients (patients with MARS related PAP) and controls (patients without MARS related PAP).
Detailed Description
Pulmonary alveolar proteinosis (PAP) is a rare respiratory disease characterized by the accumulation of lipoproteinaceous material within the pulmonary alveoli, resulting in the majority of cases from a defective clearance of the surfactant by intra-alveolar macrophages.
Mutations in the MARS gene encoding methionyl-tRNA synthetase are responsible for a genetic form of alveolar proteinosis, but the pathophysiological mechanisms leading to mutations in the respiratory phenotype are not known.
The main hypothesis is that the alveolar proteinosis phenotype in these patients is secondary to a defective clearance of the surfactant by the alveolar macrophages.
The main objective of the study is to study the clearance capacity of lipoproteinaceous material by macrophages of patients with MARS related PAP. This will be investigate in cultured macrophages derived from peripheral blood monocytes of patients (patients with MARS related PAP) and controls (patients without MARS related PAP).
The subjects and the controls will be included during a hospitalization during which a blood sample and a bronchoscopy with broncoalveolar lavage must be performed as part of their care.
#Intervention
- BIOLOGICAL : Blood collection
- 2 to 5 ml
- BIOLOGICAL : Bronchoalveolar lavage fluid collection
- 5 to 25 ml | #Eligibility Criteria:
Inclusion Criteria:
* Minors from 0 <= age <= 17 hospitalized for their care at Necker Enfants Malades hospital and for whom a blood sample and a bronchoscopy with bronchoalveolar lavage must be performed as part of their care
* Information and consent of the holders of parental authority and the patient
Exclusion Criteria:
* Refusal of holders of parental authority or patient
Sex :
ALL
Ages :
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
| NCT04811274 | 28,301 |
{
"NCT_ID" : "NCT00976040",
"Brief_Title" : "Optimal Time to Start Antiretroviral Therapy in HIV-infected Adults With Cryptococcal Meningitis",
"Official_title" : "A Randomized Clinical Trial of Immediate Versus Standard Antiretroviral Therapy for HIV-infected Adults Presenting With Cryptococcal Meningitis",
"Conditions" : ["Cryptococcal Meningitis", "HIV Infections"],
"Interventions" : ["Other: Early antiretroviral therapy"],
"Location_Countries" : ["Botswana"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2009-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-11",
"Study_Completion_Date(Actual)" : "2011-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-09-11",
"First_Posted(Estimated)" : 2009-09-14"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-09-11",
"Last_Update_Posted(Estimated)" : 2012-02-07",
"Last_Verified" : 2012-02"
}
}} | #Study Description
Brief Summary
The goal of this randomized clinical trial is to compare early versus standard timing of initiation of antiretroviral therapy (ART) with respect to clearance of Cryptococcus neoformans from cerebrospinal fluid (CSF) among HIV-infected adults with Cryptococcal Meningitis.
The investigators hypothesize that early ART mediates more rapid clearance of C. neoformans from CSF, as manifested by a greater rate of decrease in C. neoformans colony forming units (CFUs) during the first 28 days after initiating antifungal treatment.
Secondary hypotheses are that recovery of pathogen specific cellular immunity directed at C. neoformans, as manifested by increases in the number and function of C. neoformans-specific peripheral blood mononuclear cells is associated with 1) ART and 2) pathogen clearance. In addition, patients randomized to the intervention arm will have more rapid clearance of antigen levels in CSF and serum and will have a lower incidence of grade 3 and 4 Adverse events.
#Intervention
- OTHER : Early antiretroviral therapy
- The intervention is early initiation of antiretroviral therapy after diagnosis of Cryptococcal meningitis.
In the intervention/experimental arm, triple-drug highly active antiretroviral therapy regimens will be initiated within 7 days of diagnosis of Cryptococcal meningitis. | #Eligibility Criteria:
Inclusion Criteria:
* HIV 1 infection confirmed by licensed ELISA kit and/or detectable Viral load.
* Confirmed Cryptococcal meningitis on the current admission by India ink or CSF cryptococcal antigen
* ART naive at the time of enrollment
* 21 years and above
* Ability and willingness to give written informed consent to participate in the study
* Able (as assessed by the patient's medical team)to initiate amphotericin B for cryptococcal meningitis
* Initiated amphotericin B 72 hours or less prior to assessment for enrollment or not on amphotericin B at the time of assessment for enrollment
* Agrees to obtain outpatient care after discharge within 50 kilometers from Princess Marina Hospital,Scottish Livingstone Hospital and Bamalete Lutheran Hospital
Exclusion Criteria:
* Recent (within the past 4 weeks) antifungal use
* Pregnant or breastfeeding
* Initiated anti-tubercular therapy 2 weeks or less prior to assessment for enrollment.
* Bacterial meningitis at the time of assessment for enrollment.
* Recent (within the past 1 month) use of the following:systemic cancer chemotherapy,oral or intravenous corticosteroids or other immunomodulators.
* Judged by study coordinator to be likely to initiate chemotherapy or any other immunomodulatory therapy prior to the 4 week LP.
* Imprisoned.
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT00976040 | 72,262 |
{
"NCT_ID" : "NCT00177710",
"Brief_Title" : "Pharmacokinetic Profile of Inhaled Liposomal Amphotericin B in Lung Transplant Recipients - Ambisome Study",
"Official_title" : "Pharmacokinetic Profile of Inhaled Liposomal Amphotericin B in Lung Transplant Recipients - Ambisome Study",
"Conditions" : ["Lung Transplantation", "Fungal Infections"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2006-01",
"Study_Completion_Date(Actual)" : "2007-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-09-13",
"First_Posted(Estimated)" : 2005-09-15"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-09-13",
"Last_Update_Posted(Estimated)" : 2008-12-17",
"Last_Verified" : 2008-12"
}
}} | #Study Description
Brief Summary
The purpose of this study is to determine the steady state concentrations of inhaled liposomal amphotericin B (Ambisome®) in lung transplant recipients via aerosolized nebulization.
Detailed Description
Each subject will receive 1 mg/kg/day of inhaled Ambisome® for four days prior to the BAL (bronchoalveolar lavage) procedure. The dosage of 1 mg/kg was calculated by extrapolating the dosage of 1.6 mg/kg for the surface area of the rat lung to the human lung surface area in a 60 kg individual.
All four doses will be given in the presence of a physician and/or study coordinator. The forty eight subjects will be randomized such that six subjects undergo the BAL at 1, 12, 24, 48, 72, 96, 120, and 168 hours after the last dose of inhaled Liposomal amphotericin B (AmBisome®).
A blood sample (5 ml) will be obtained prior to the fourth dose of study medication and on the day of bronchoscopy (pseudo steady state trough). Concentrations of amphotericin in the serum, and bronchoalveolar lavage will be measured at pre-specified intervals after administration of liposomal amphotericin B (AmBisome®) in lung transplant recipients undergoing routine bronchoscopy as mentioned earlier.
A 5 ml blood sample will be recovered at the time of bronchoscopy for the purpose of determination of serum amphotericin B concentration and for the determination of serum urea concentration.
The bronchoscopy and bronchoalveolar lavage of subjects is done as a part of routine transplant care. Subjects will be followed for the follow-up of results of bronchoscopy at the interval deemed necessary by their transplant pulmonologist. The samples (blood and bronchoalveolar samples) will be under the control of the principal investigator of this research project. To protect confidentiality, all personal identifiers (i.e., name, social security number, and birth date) will be removed (de-identified) and replaced with a specific code number. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location (ID lab at 8th floor Scaife Hall). The investigators on this study will keep the samples indefinitely. Samples may be given to investigators outside of UPMC or may be utilized in future studies about infectious diseases. If the samples are given to investigators not associated with this study, the samples will be provided without any identifiers. No genetic testing will be done on the samples obtained.
#Intervention
- DRUG : Amphotericin B | #Eligibility Criteria:
Inclusion Criteria:
* Male and female lung transplant recipients at University of Pittsburgh Medical Center >= 18 years will be eligible for the study.
* Single or double lung transplant recipients
* Willing to be available at the testing center for 4 consecutive days
* Able to comprehend and complete informed consent
Exclusion Criteria:
* Pregnant women or women capable of bearing children, who will not perform a urine pregnancy test
* Nursing mothers
* Subjects with hypersensitivity to amphotericin deoxycholate or liposomal amphotericin
* Subjects with a past history of bronchospasm associated with aerosol drug use
* Subjects with active bacterial or viral infection as defined by the current use of non-prophylactic antibiotic anti-viral medications
* Subjects with a forced expiratory volume in 1 second (FEV1) < 30% predicted or forced vital capacity (FVC) < 30% will not receive study medication.
* Subjects requiring supplemental oxygen
* Receipt of inhalational or intravenous (IV) amphotericin B within last 30 days
* Subjects with known fungal infection as per Mycoses Study Group (MSG) criteria on therapy with antifungal drugs or diagnosed on the day of bronchoscopy
* Serum creatinine > 1.9 mg/dl on the day of screening
* Liver enzymes ALT/AST/alkaline phosphatase greater than two times the normal limit
* Concurrent intravenous aminoglycoside use
* Subject with fever > 38.2°C
* Subjects on mechanical ventilation
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
| NCT00177710 | 104,287 |
{
"NCT_ID" : "NCT02867462",
"Brief_Title" : "Information Consultation by Radiotherapy Manipulator",
"Official_title" : "Information Consultation by a Manipulator Radiotherapy: Impact on Information to Patients Treated With Radiotherapy for Cancer",
"Conditions" : ["Cancer"],
"Interventions" : ["Other: manipulator consultation radiotherapy added to standard care", "Other: Standard care"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-05-10",
"Study_Completion_Date(Actual)" : "2017-05-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-08-11",
"First_Posted(Estimated)" : 2016-08-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-08-11",
"Last_Update_Posted(Estimated)" : 2017-12-02",
"Last_Verified" : 2016-08"
}
}} | #Study Description
Brief Summary
The medical teams are increasingly sought by patients to get the most possible information, probably expressed in a different form and thereby supplementing the information already received. Coulter et al. reached similar conclusions in their study of the writings of patient information documents. They point out, moreover, the best adaptation of the patients better informed compared to those with less or no information.
This need for information varies over time. It is present before treatment begins, continues during treatment and persists after treatment. Given the specific features of radiotherapy, the manipulators are important interlocutors to participate in the accompanying caregiver time.
In conclusion, the quality of information delivered to the patient has been poorly evaluated, let alone with validated tools in this area.
The impact of information on the tolerance of the treatment also needs to be confirmed, knowing that an informed patient seems less anxious and better prepared for future treatment.
#Intervention
- OTHER : Standard care
- standard care
- OTHER : manipulator consultation radiotherapy added to standard care | #Eligibility Criteria:
Inclusion Criteria:
* Patients with cancer of the head and neck, esophagus, stomach, breast, rectum, anal canal, prostate, lung, bile duct, pancreas or female genital histologically proven
* Patient being treated by radiotherapy alone or combined with chemotherapy / immunotherapy, exclusive treatment or adjuvant
* Age > 18 years
Exclusion Criteria:
* Patient has been treated with radiation to the tumor site
* Patient with metastatic stage disease
* Patient targeted for hypofractionated radiotherapy
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
| NCT02867462 | 55,645 |
{
"NCT_ID" : "NCT02948582",
"Brief_Title" : "Assessment of the Safety and Ability of a Once-a-day Dose of an Orally Inhaled Medicine [i.e., Glycopyrrolate Inhalation Solution = GIS] to Improve Airflow in the Lungs When Delivered Using an eFlow Nebulizer in Patients With Chronic Obstructive Pulmonary Disease (COPD)",
"Official_title" : "Randomized, Placebo-Controlled, Double-Blind, Dose Ranging, Single-Dose, 6-Way Crossover Study to Assess Safety, Efficacy and Pharmacokinetics of EP-101 Using eFlow Nebuliser in Patients With COPD",
"Conditions" : ["Chronic Obstructive Pulmonary Disease"],
"Interventions" : ["Drug: Glycopyrrolate Inhalation Solution12.5μg", "Drug: Glycopyrrolate Inhalation Solution 200μg", "Drug: Glycopyrrolate Inhalation Solution 100μg", "Drug: Glycopyrrolate Inhalation Solution 50μg", "Drug: Placebo 0.5mL", "Drug: Glycopyrrolate Inhalation Solution 400μg"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-11",
"Study_Completion_Date(Actual)" : "2010-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-10-26",
"First_Submitted_that_Met_QC_Criteria" : 2018-03-07",
"First_Posted(Estimated)" : 2016-10-28"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-10-27",
"Last_Update_Posted(Estimated)" : 2018-03-12",
"Last_Verified" : 2018-03"
}
}} | #Study Description
Brief Summary
The study assessed the safety and ability of an orally inhaled medicine \[i.e., Glycopyrrolate Inhalation Solution = GIS\] to improve airflow in the lungs when delivered using an eFlow nebulizer in 42 patients with Chronic Obstructive Pulmonary Disease (COPD). Each patient randomly received several, single doses of GIS, or placebo, separated by approximately 1 to 2 weeks. After the dose was given, lung airflow was measured over 24 hours and blood was collected to measure how much GIS was in the bloodstream. The study was conducted to find the once-a- day GIS dose that produced the highest improvement in lung airflow using the eFlow nebulizer.
#Intervention
- DRUG : Glycopyrrolate Inhalation Solution12.5μg
- Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily
- Other Names :
- GIS
- DRUG : Glycopyrrolate Inhalation Solution 50μg
- Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily
- Other Names :
- GIS
- DRUG : Glycopyrrolate Inhalation Solution 100μg
- Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily
- Other Names :
- GIS
- DRUG : Glycopyrrolate Inhalation Solution 200μg
- Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily
- Other Names :
- GIS
- DRUG : Glycopyrrolate Inhalation Solution 400μg
- Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily
- Other Names :
- GIS
- DRUG : Placebo 0.5mL
- Placebo 0.5mL via eFlow, once daily
- Other Names :
- Placebo | #Eligibility Criteria:
Inclusion Criteria:
* Male and female patients aged 40 through 75 years, inclusive
* A clinical diagnosis of COPD according to the GOLD guidelines
* Current smokers or ex-smokers with at least 10 pack-year smoking history (e.g., at least 1 pack/day for 10
* Post-bronchodilator FEV1 30 <= age <= 70% of predicted normal at the Screening Visit
* Post-bronchodilator FEV1/FVC ratio < 0.70 at the Screening Visit
* Improvement in FEV1 >12% and 150 mL following inhalation of ipratropium bromide at the Screening Visit
* Ability to perform reproducible spirometry according to the ATS/ERS guidelines
* Willing to stay at the study site for approximately 30 hours on each treatment visit
* Willing and able to provide written informed consent
Exclusion Criteria:
* Females who are pregnant or lactating at the Screening Visit, or if of childbearing potential not using one of the following acceptable means of birth control throughout the study:
* Abstinence
* Post-menopausal for at least two years
* Surgically sterile (i.e., tubal ligation, hysterectomy)
* Oral contraceptives (taken for at least one month prior to the Screening Visit)
* Approved implantable or injectable contraceptives (e.g., Norplant®, Depo-Provera® or equivalent)
* Barrier methods (e.g., condoms with spermicide)
* Intrauterine device (i.e., IUD)
* Vasectomy of male partner
* Non-heterosexual life style
* Current evidence or recent history of any clinically significant disease (other than COPD) or abnormality in the opinion of the Investigator that would put the subject at risk or which would compromise the quality of the study data; including but not limited to cardiovascular disease, myocardial infarction, cardiac failure, uncontrolled hypertension, life-threatening arrhythmias, uncontrolled diabetes, neurologic or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities
* Recent history of hospitalization due to an exacerbation of airway disease within 3 months or need for increased treatments for COPD within 6 weeks prior to the Screening Visit
* Primary diagnosis of asthma
* Prior lung volume reduction surgery or history of chest/lung irradiation
* Regular use of daily oxygen therapy
* Use of systemic (eg, intramuscular or intravenous) steroids within 3 months prior to the Screening Visit
* Respiratory tract infection within 6 weeks prior to the Screening Visit
* History of tuberculosis, bronchiectasis or other non- specific pulmonary disease
* History of urinary retention or bladder neck obstruction type symptoms
* History of narrow-angle glaucoma
* Clinically significant abnormal ECG
* Positive Hepatitis B surface antigen or positive Hepatitis C antibody
* Positive screening test for HIV antibodies
* Current or recent history (previous 12 months) of excessive use or abuse of alcohol
* Current evidence or history of abusing legal drugs or use of illegal drugs or substances
* Donation of 450 mL of blood within 8 weeks of the Screening Visit
* History of hypersensitivity or intolerance to aerosol medications
* Participation in another investigational drug study was received within 30 days prior to the Screening Visit
Ages :
- Minimum Age : 40 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02948582 | 14,984 |
{
"NCT_ID" : "NCT01082406",
"Brief_Title" : "Comparison of a Blood Clotting Drug (Recombinant Factor XIII) Produced by Two Different Manufacturers in Healthy Male Subjects",
"Official_title" : "A Single Centre, Randomised, Double-blind, Cross-over Trial in Healthy Male Subjects Investigating Bioequivalence and Pharmacokinetics of rFXIII (Avecia DS) to rFXIII (Novo Nordisk DS)",
"Conditions" : ["Congenital Bleeding Disorder", "Congenital FXIII Deficiency", "Healthy"],
"Interventions" : ["Drug: catridecacog", "Drug: recombinant factor XIII"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-07",
"Study_Completion_Date(Actual)" : "2010-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-03-05",
"First_Posted(Estimated)" : 2010-03-08"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2010-03-05",
"Last_Update_Posted(Estimated)" : 2016-09-21",
"Last_Verified" : 2016-09"
}
}} | #Study Description
Brief Summary
This trial is conducted in Europe. The aim of this clinical trial is to compare the metabolism of a blood-clotting drug (recombinant Factor XIII)) produced by two different manufacturers (Novo Nordisk and Avecia) in healthy male volunteers.
#Intervention
- DRUG : catridecacog
- Single dose of 35 IU/kg body weight recombinant factor XIII (catridecacog) (Novo Nordisk) administered iv (into the vein) followed by a single dose of 35 IU/kg body weight recombinant factor XIII (Avecia) administered iv.
- DRUG : recombinant factor XIII
- Single dose of 35 IU/kg body weight recombinant factor XIII (Avecia) to be administered iv (into the vein) followed by a single dose of 35 IU/kg body weight recombinant factor XIII (catridecacog) (Novo Nordisk) administered iv. | #Eligibility Criteria:
Inclusion Criteria:
* Body Mass Index (BMI) between 18.5 and 30 kg/m2
* Good general health based on assessment of medical history, physical examination, ECG (electrocardiogram), and clinical laboratory data at screening, as judged by the physician
* Non-smokers
Exclusion Criteria:
* Known history of thromboembolic event(s) or potential thromboembolic risk as judged by the physician
* Blood transfusion within 3 months of trial start
* Positive for hepatitis B or C infection
* Positive for Human Immunodeficiency Virus (HIV) infection
* Excessive consumption of a diet deviating from a normal diet as judged by the physician
* Blood or plasma donation within the last 3 months prior to trial start
* Subjects with any history of migraine
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:
Yes
| NCT01082406 | 158,206 |
{
"NCT_ID" : "NCT05642247",
"Brief_Title" : "Quantify the Value of Transmural Inflammation in the Treatment of Crohn's Disease With Ustekinumab:an Analysis Based on Imaging Science",
"Official_title" : "Quantify the Value of Transmural Inflammation in the Treatment of Crohn's Disease With Ustekinumab:an Analysis Based on Imaging Science",
"Conditions" : ["Inflammatory Bowel Diseases", "Crohn Disease", "Biologics"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-07-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-12-31",
"Study_Completion_Date(Actual)" : "2023-01-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-08-30",
"First_Posted(Estimated)" : 2022-12-08"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-12-07",
"Last_Update_Posted(Estimated)" : 2023-03-23",
"Last_Verified" : 2023-03"
}
}} | #Study Description
Brief Summary
Crohn's disease(CD),a type of inflammatory bowel disease(IBD), is a chronic intestinal recurrent inflammatory disease involving the entire digestive tract. And Ustekinumab, a monoclonal antibody against the p40 subunit of interleukin-12 and interleukin-23, is a newly targeted drug approved for the treatment of Crohn's disease in recent years.Based on the high-throughput imaging characteristic analysis technique, this study quantitatively analyzed the transmural inflammation of Crohn's disease, and discussed its prognostic value in the treatment of Ustekinumab, and further analyzed the increment of its relative clinical index.
| #Eligibility Criteria:
Inclusion Criteria:
* Inpatients with Crohn's disease diagnosed in the IBD center of Sixth Affiliated Hospital of Sun Yat-Sen University from January 2020 to June 2022
* Treated with Ustekinumab and followed up regularly for 20 weeks
* Complete pre-treatment cross-sectional imaging data (CTE/MRE and US)
Exclusion Criteria:
* The diagnosis is not clear
* Under the age of 18
* Lack of endoscopic and pathological data
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
| NCT05642247 | 265,428 |
{
"NCT_ID" : "NCT03513159",
"Brief_Title" : "Improvement of Transition From Hospital to Home for Older Patients in Germany",
"Official_title" : "Transsectoral Intervention Program for Improvement of Geriatric Care in Regensburg",
"Conditions" : ["Geriatric Patients in the Transition From Hospital to Home"],
"Interventions" : ["Behavioral: Pathfinder support"],
"Location_Countries" : ["Germany"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-04-25",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-06-30",
"Study_Completion_Date(Actual)" : "2021-02-28},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-04-17",
"First_Posted(Estimated)" : 2018-05-01"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-04-27",
"Last_Update_Posted(Estimated)" : 2021-03-03",
"Last_Verified" : 2021-03"
}
}} | #Study Description
Brief Summary
The aim of the transsectoral care project TIGER is the reduction of readmission rates of geriatric patients. This aim shall be achieved by improving the hitherto inadequate care process for geriatric patients in the transition from hospital to home. The program offers substantial support of patients and their informal caregivers in the transition process from hospital to home via so called pathfinders, specialized nurses in geriatrics.The pathfinders effectively intertwine stationary and ambulatory care teams caring for a patient, thereby augmenting and complementing effective hospital release management.
Detailed Description
Especially for older, chronically ill persons, a hospital stay can promote significant losses in functionality, independence and quality of life, and can increase nutrition deficits and the risk for infections, leading to the occurrence of severe gaps in care after hospital release and to an increased risk for readmission rates.
Even if the German government has recognized the necessity of a multiprofessional integrated care program for older, vulnerable patients and has installed a hospital release management program situated in hospitals in 2012, clarifying entitlements to benefits and setting up ambulatory services contacts, this does not yet meet the complex needs of geriatric patients and their informal caregivers.
Internationally, the Transitional Care Model (TCM) has been developed (M. Naylor et al. 1994) to address the deficits in care of older patients in transition between hospital to home. Via a series of defined activities, a disruption of the care supply chain for older patients in this transition process is being avoided.
The TIGER program will address the needs of geriatric patients and their informal caregivers and will support them via structured continuous activities, on the basis of the TCM, by so called pathfinders, nurses specialized in geriatrics. These pathfinders will develop an individual care plan with the patients, their informal caregivers and the hospital physicians already inside the hospital setting and will then develop and improve this further during up to twelve months after the hospital release of the patient. The pathfinders will coordinate the ambulatory care team services and closely involve the primary physicians. The patients and their informal caregivers will be empowered and educated to achieve a stabilization or improvement in functionality, independence, quality of life, coping with disease, nutritional status and wound healing process of the patients.
The aim of the program is that these activities will lead to a reduction of necessary readmission rates of geriatric patients.
Efficacy, practicability, and limitations of the program will be evaluated scientifically and economically and will be analyzed for a possible saving of costs for the health care system.
#Intervention
- BEHAVIORAL : Pathfinder support
- A pathfinder will support the patient with structured activities. | #Eligibility Criteria:
Inclusion Criteria:
will go back home after Hospital stay, AOK Patient, MiniMentalStateExamination MMSE score of at least 22, is living within 50 km range of the hospital
Exclusion Criteria:
palliative status, planned readmission into hospital within next 4 weeks
Sex :
ALL
Ages :
- Minimum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
| NCT03513159 | 163,792 |
{
"NCT_ID" : "NCT01270243",
"Brief_Title" : "Bacterial Microbiota In The Tonsils Of Children",
"Official_title" : "Bacterial Microbiota In The Tonsils Of Children Undergoing Adenotonsillectomy And Normal Controls",
"Conditions" : ["Adenotonsillitis"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-12-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-02-18",
"Study_Completion_Date(Actual)" : "2017-02-18},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2011-01-03",
"First_Posted(Estimated)" : 2011-01-05"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-01-04",
"Last_Update_Posted(Estimated)" : 2023-04-26",
"Last_Verified" : 2023-04"
}
}} | #Study Description
Brief Summary
We, the investigators, propose to look at the bacteria on and in tonsils using gene microarrays. We expect to find previously reported bacteria but also the possibility of previously undetected organisms. We think that the bacterial pathogens present on the tonsillar surface are different from the tonsil core. And we also think that the bacteria of the tonsil surface will differ between patients undergoing adenotonsillectomy and normal controls with no adenotonsillar problems.
| #Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria for subjects undergoing surgery:
* Age 2 <= age <= 12 yrs
* Both males and females
* Undergoing adenotonsillectomy
Additional criteria for subjects in the recurrent infection group:
* Sleep questionnaire score <5
* Designated by surgeon as having recurrent adenotonsillitis as reason for surgery
Additional criteria for subjects in the airway obstruction group:
* Sleep questionnaire score >5
* Presence of positive polysomnogram desired but not necessary
* Designated by surgeon as having airway obstruction or sleep apnea as reason for surgery
Inclusion criteria for control subjects:
* Age 2 <= age <= 12 yrs
* Both males and females
* No history of adenotonsillar problems
* Sleep questionnaire score < 5
Exclusion Criteria:
Exclusion Criteria for both groups:
* Antibiotic intake in the past 10 days
* Other major medical problems (immune deficiency, cystic fibrosis, malignancy) In the surgery group: designated by surgeon as having both recurrent adenotonsillitis and airway obstruction as reason for surgery Menstruating females
Sex :
ALL
Ages :
- Minimum Age : 2 Years
- Maximum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
| NCT01270243 | 177,162 |
{
"NCT_ID" : "NCT02593344",
"Brief_Title" : "Peripheral Endothelial Function in Asthmatic Patients",
"Official_title" : "Peripheral Endothelial Function in Asthmatic Patients",
"Conditions" : ["Endothelial Function"],
"Interventions" : ["Device: Endopat"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-12-13",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-04-09",
"Study_Completion_Date(Actual)" : "2015-04-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-10-16",
"First_Posted(Estimated)" : 2015-11-01"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-10-30",
"Last_Update_Posted(Estimated)" : 2018-10-03",
"Last_Verified" : 2018-10"
}
}} | #Study Description
Brief Summary
The aim of the study is to assess the peripheral endothelial function in adult asthmatic patients and the relationship between the peripheral endothelial function and the pulmonary function.
Detailed Description
The primary criteria is the peripheral endothelial function that will be assessed by the measure of flow-mediated dilation (reactive hyperemia-peripheral artery tone index). The pulmonary function will be assessed by the measures of the FEV1, the forced vital capacity (FVC) and the expiratory flow between 25% and 75% (FEF25-75%). The relationship between these parameters of the pulmonary function and the peripheral endothelial function will be analyzed. In addition, a relationship between peripheral endothelial function and the level of asthma control (Asthma Control Test (ACT)), the cardiovascular risk factors (SCORE INdex) and the treatment for asthma (controllers) will be also assessed.
#Intervention
- DEVICE : Endopat
- measure of peripheral endothelial function by the reactive hyperemia-peripheral artery tone index with a specific device (Endopat) | #Eligibility Criteria:
Inclusion Criteria:
* All patients must have a clear-cut history of asthma at the time of enrolment into the trial (eventually confirmed in the past and documented by an increased hyperresponsiveness to methacholine; or a bronchodilator reversibility to a beta-2-adrenergic drug).
Exclusion Criteria:
* Patients with unstable asthma
* Patients with a significant acute disease other than asthma. A significant disease is defined as a disease which, in the opinion of the investigator, may influence the results of the trial.
* Pregnant or nursing women.
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
| NCT02593344 | 54,435 |
{
"NCT_ID" : "NCT03014739",
"Brief_Title" : "Evaluation of Shear Wave Elastography Reproducibility in Achilles Tendons and Plantar Fascia",
"Official_title" : "Evaluation of the Reproducibility of Young's Modulus and Shear Wave Velocity Measurements With SWE™ in Achilles Tendons and Plantar Fascia",
"Conditions" : ["Achilles Tendon", "Plantar Fascia"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-06",
"Study_Completion_Date(Actual)" : "2018-06},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-12-14",
"First_Posted(Estimated)" : 2017-01-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-01-05",
"Last_Update_Posted(Estimated)" : 2018-12-20",
"Last_Verified" : 2018-12"
}
}} | #Study Description
Brief Summary
Achilles tendon plays a significant role in walking and sporting activities, particularly through ankle joint and lower limbs stability. Ultrasound imaging can be the first-line examination of choice for patients suspected of having Achilles tendon injury, which is more and more frequent. Nowadays, ultrasound elastography can be used to evaluate the viscoelasticity properties of Achilles tendon, however little is known about the reproducibility of the technique. This study aims to evaluate the reproducibility of supersonic shear imaging SWE™ Young's modulus measurements of shear wave velocity (m/s) in Achilles tendon and plantar fascia.
#Intervention
- OTHER : Supersonic ShearWave Elastography
- ShearWave Elastography (SWE) is part of routine ultrasound examination | #Eligibility Criteria:
Inclusion Criteria:
* Volunteers with normal Achilles tendon:
* Normal adult aged > 18 years;
* Without lower limb malformation;
* With no symptoms of Achilles tendon lesion and no negative results of routine ultrasound examination for a possible tendinopathy.
Exclusion Criteria:
* Subjects who failed to meet all inclusion criteria were will be automatically excluded;
* Subjects who did will not wish or could will not sign the informed consent in person.
* Volunteers with abnormal Achilles tendon for any of these reasons:
* Lower limb malformation;
* Achilles tendon pain, Achilles tendon disease, surgical history of Achilles tendon surgery, morphologic abnormalities of Achilles tendon ( gray-scale/color Doppler/MRI/plain film);
* Suffer from systemic, metabolic and endocrine diseases, including but not limited to, diabetes, familial hyperlipidemia (FH), systemic lupus erythematosus (SLE), gout, ankylosing spondylitis, hyperthyroidism, chronic renal failure, etc.
* Pregnant women;
* Apply Ongoing hormone hormonal therapy;
* Athletes
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT03014739 | 44,045 |
{
"NCT_ID" : "NCT05442320",
"Brief_Title" : "Nails and Teeth as Biomarkers of Fluoride Exposure",
"Official_title" : "Influence of Different Toothpaste on Fluoride Concentration in Nails and Dental Fluorosis",
"Conditions" : ["Fluorosis, Dental"],
"Interventions" : ["Device: Biodent Toothpaste (Ilirija d.d., Ljubljana, Slovenia)"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-01-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-03-05",
"Study_Completion_Date(Actual)" : "2021-04-20},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-12-03",
"First_Posted(Estimated)" : 2022-07-05"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-06-29",
"Last_Update_Posted(Estimated)" : 2022-07-05",
"Last_Verified" : 2021-12"
}
}} | #Study Description
Brief Summary
To determine fluoride concentration in fingernails and estimate if there is a correlation between fluoride concentration in fingernails and fluoride concentration in toothpaste used. In addition, fluorosis of permanent incisors will be evaluated at 13 years of age and correlated with toothpaste fluoride concentration.
Detailed Description
Toothpaste with 1000 ppm fluoride and above are more effective in a caries prevention in comparison to toothpastes with lower fluoride concentration or to placebo. Higher fluoride concentrations in toothpastes increase risk for development of tooth fluorosis. Children in first three years of life are most susceptible due to formation of permanent incisors and first molars in this period, beside younger children ingest more toothpaste compared to older children. Fluoride exposure can be measured in nails, where the average plasma fluoride concentration is reflected. The aim of our study was to determine fluoride concentration in fingernails and estimate if there is a correlation between fluoride concentration in fingernails and fluoride concentration in toothpaste used. In our study were included parents and children who had participated in previous studies from parenting class until children's 3 years of age. At that time children were randomly assigned to one of two groups, of which one was being given a toothpaste with 500 ppm fluoride and the other with 1000 ppm fluoride. Children were examined regularly until the age of 3. Children were invited to participate in another clinical examination at 4 years of age. At the time of examination parents were asked to fulfil a questionnaire about oral hygiene habits and a sample of children's fingernails were taken. A questionnaire fulfilled 200 parents, 169 children were examined, finger nail fluoride was analysed by using a gas chromatography method in 161 children. We determined that in 76 % the toothpaste chosen was not appropriate according to EAPD guidelines, 66 % parents was using toothpaste with 500 ppm fluoride for their children. The mean fingernail concentration was 1,43 ng/mg (SD = 0,08). The difference between groups using toothpastes with different fluoride concentrations, and compared with other factors, was not statistically significant. The mean concentration of fluoride in nails of our test group was low compared to reported values in similar studies and there was no significant difference between groups regarding to toothpaste used.
In addition, fluorosis of permanent incisors will be evaluated at 13 years of age and correlated with toothpaste fluoride concentration.
#Intervention
- DEVICE : Biodent Toothpaste (Ilirija d.d., Ljubljana, Slovenia)
- Toothpaste with 500 or 1000 ppm of fluoride | #Eligibility Criteria:
Inclusion Criteria:
* participation in parenting class
* normal pregnancy
Exclusion Criteria:
* chronic systemic diseases
* genetic conditions
* complications at delivery
Sex :
ALL
Ages :
- Minimum Age : 0 Years
- Maximum Age : 14 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
| NCT05442320 | 15,962 |
{
"NCT_ID" : "NCT01181128",
"Brief_Title" : "Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Subjects With Severe Hemophilia A",
"Official_title" : "A-LONG: An Open-Label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding in Previously Treated Subjects With Severe Hemophilia A",
"Conditions" : ["Severe Hemophilia A"],
"Interventions" : ["Drug: Factor VIII (rFVIIIFc)", "Drug: Advate®"],
"Location_Countries" : ["United States", "Germany", "Austria", "Switzerland", "Hong Kong", "United Kingdom", "France", "Japan", "Israel", "Sweden", "South Africa", "Australia", "Italy", "New Zealand", "Brazil", "India", "Canada", "Spain", "Belgium"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-11",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-08",
"Study_Completion_Date(Actual)" : "2012-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-08-12",
"First_Submitted_that_Met_QC_Criteria" : 2014-08-18",
"First_Posted(Estimated)" : 2010-08-13"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2010-08-12",
"Last_Update_Posted(Estimated)" : 2021-01-08",
"Last_Verified" : 2017-07"
}
}} | #Study Description
Brief Summary
The primary objectives of this study are: to evaluate the safety and tolerability of rFVIIIFc administered as a prophylaxis (Arm 1), weekly (Arm 2), on-demand (Arm 3), and surgical treatment regimen; to evaluate the efficacy of the rFVIIIFc tailored prophylaxis regimen (Arm 1); to evaluate the efficacy of rFVIIIFc administered as an on-demand (Arm 3) and surgical treatment regimen. The secondary objectives of this study are: to characterize the PK profile of rFVIIIFc and compare the PK of rFVIIIFc with the currently marketed product, Advate®; to characterize the range of dose and schedules required to adequately prevent bleeding in a prophylaxis regimen, maintain hemostasis in a surgical setting, or to treat bleeding episodes in an on-demand, weekly treatment, or prophylaxis setting.
Detailed Description
Participants are assigned to one of three treatment regimens: 1) a tailored prophylaxis regimen, 2) a weekly dosing regimen, or 3) an on-demand regimen. Treatment continued for 28 (±2) to 52 (±2) weeks. PK assessments for all participants are conducted on varying schedules, according to participants' group assignments. Additionally, two subgroups are defined. One subgroup of participants undergo PK profiling with a single dose of the comparator Advate®. A second subgroup consists of participants from any of the treatment arms that required surgery during the study. Depending upon country location, participants might have the option of continuing treatment within study 8HA01EXT (NCT01454739).
#Intervention
- DRUG : Factor VIII (rFVIIIFc)
- Other Names :
- Recombinant Factor VIII Fc Fusion Protein
- DRUG : Advate®
- Other Names :
- octocog alfa, Antihemophilic Factor [Recombinant] Plasma/Albumin Free Method | #Eligibility Criteria:
Inclusion Criteria:
* Male, >=12 years with weight at least 40 kg
* Diagnosed with severe hemophilia A, defined as <1 IU/dL (<1%) endogenous Factor VIII)
* History of at least 150 documented prior exposure days to any Factor VIII product
* Platelet count >=100,000 cells/μL
Exclusion Criteria:
* History of Factor VIII inhibitors
* Kidney and liver dysfunction
* Diagnosed with other coagulation disorder(s) in addition to hemophilia A
* Prior history of hypersensitivity or anaphylaxis associated with any FVIII or IV immunoglobulin administration
Sex :
MALE
Ages :
- Minimum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT01181128 | 246,917 |
{
"NCT_ID" : "NCT04077788",
"Brief_Title" : "Change of Range of Motion of TMJ After Correction of Pelvic a Symmetry in Women With Cyclic Pelvic Pain",
"Official_title" : "Change of Range of Motion of TMJ After Correction of Pelvic a Symmetry in Women With Cyclic Pelvic Pain",
"Conditions" : ["Pelvic Pain"],
"Interventions" : ["Other: muscle energy technique"],
"Location_Countries" : ["Egypt"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-11-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-08-01",
"Study_Completion_Date(Actual)" : "2020-08-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-09-01",
"First_Posted(Estimated)" : 2019-09-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-09-01",
"Last_Update_Posted(Estimated)" : 2022-09-21",
"Last_Verified" : 2022-09"
}
}} | #Study Description
Brief Summary
Clinical experiences have shown that significant pain regression during a menstrual cycle has been often achieved by the use of spinal manipulative therapy (SMT) indicated in women with primary dysmenorrhea with coexisting functional disorders of lumbosacral (LS) spine. Namely, by activation of the nociceptive and vegetative system, LS spine disorders, before all segmental dysfunction and degenerative changes, can induce referred pain and reflex disturbances of pelvic organs (somatovisceral reflexes). Since significant improvement or disappearance of pain during a menstrual cycle is often achieved with adequate therapy of coexisting vertebral disorders in women with primary dysmenorrhea, it is important to recognise latent or manifest vertebral disorders in dysmenorrheic women using clinical examination (Grgić, 2009).
#Intervention
- OTHER : muscle energy technique
- Muscle energy technique:
1. Application of MET for bone of pelvis:
I) Pubis:
1. Cranial Os pubis.
2. Caudal os pubis.
II) ileum:
1. Anterior ileum.
2. Posterior ileum.
3. External Rotation (In flare) Lesion.
4. Internal Rotation (Out flare) Lesion.
III) sacrum:
1. Forward torsion of sacrum.
2. Backward torsion of sacrum.
2. Muscle energy technique for specific muscles of pelvis and spine:
1. Stretch of the Psoas Major.
2. Stretch of the paravertebral muscle.
3. Stretch of the piriforms. | #Eligibility Criteria:
Inclusion criteria:
* The age of the participants will be ranged from 25 <= age <= 35.
* Their body mass index will be ranged from 20 to 25 kg/m2.
* They will have regular menstrual cycle.
* They will not receive any hormonal therapy or taking any regular drugs.
Exclusion criteria:
The potential participants will be excluded if they meet one of the following criteria:
* Pelvic inflammatory diseases.
* Any pelvic pathological condition
Sex :
FEMALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT04077788 | 228,022 |
{
"NCT_ID" : "NCT02805972",
"Brief_Title" : "Biology and Experience of Eating in Women With Obesity",
"Official_title" : "Biology and Experience of Eating in Women With Obesity",
"Conditions" : ["Obesity"],
"Interventions" : ["Drug: Placebo", "Drug: Naloxone"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-05-20",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-07-25",
"Study_Completion_Date(Actual)" : "2018-07-25},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-06-01",
"First_Submitted_that_Met_QC_Criteria" : 2021-10-06",
"First_Posted(Estimated)" : 2016-06-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-06-15",
"Last_Update_Posted(Estimated)" : 2021-11-03",
"Last_Verified" : 2021-10"
}
}} | #Study Description
Brief Summary
The purpose of this study is to understand how the opioid system is involved in eating behavior.
Detailed Description
Obesity is associated with greater risk for cardiovascular disease (CVD), stroke, diabetes, and mortality, and is a heterogeneous condition with various causes and thus a diversity of intervention targets. Compulsive overeating afflicts 30% of people seeking obesity treatment and increases risk for CVD factors. This trial involves two participant visits to test whether opioid blockade (Day 1 or 2, depending on randomization), compared to placebo (Day 1 or 2, depending on randomization), will elicit common symptoms of opioid withdrawal, including nausea. Participants will receive each condition on separate days.
#Intervention
- DRUG : Naloxone
- 4 mg / 0.1 ml
- Other Names :
- Narcan
- DRUG : Placebo
- 0.1 ml
- Other Names :
- saline | #Eligibility Criteria:
Inclusion Criteria:
* Obese, as defined by BMI greater than or equal to 30
* Self-reported binge eating as defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), in the last 4 weeks
* If sexually active with men, must agree to use birth control until the final study visit is complete (e.g., barrier methods, oral contraceptive)
* Subject must be able to complete written informed consent procedures and be able to comply with the requirements of the study.
Exclusion Criteria:
* Pregnant or breastfeeding
* Severe hypotension (< 90/60 mmHg)
* Recent or current use of vasoconstrictor or vasodilator medication
* Current or history of diabetes
* Allergies to any ingredients in naloxone hydrochloride
* History of or current alcoholism or drug dependence
* Bulimia Nervosa as defined in DSM 5
* Current or past use of opiate-containing medications in the last 30 days
* Plan to use opiate-containing medications during study participation period
* Medical conditions that are contraindicated with intranasal procedures: Nasal septal abnormalities, nasal trauma, epistaxis, excessive nasal mucus, and intranasal damage caused by the use of substances (e.g., cocaine)
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data
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
| NCT02805972 | 49,485 |
{
"NCT_ID" : "NCT02691078",
"Brief_Title" : "Validation of 99mTc- EDDA - HYNIC -TOC Kits for Diagnosis of Neuroendocrine Tumors",
"Official_title" : "Validation of 99mTc- EDDA - HYNIC -TOC Kits for Diagnosis of Neuroendocrine Tumors",
"Conditions" : ["Neuroendocrine Tumors"],
"Interventions" : ["Other: 99m Tc - HYNIC -TOC EDDA and 111In - DTPA-octreotide"],
"Location_Countries" : ["Brazil"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "DIAGNOSTIC",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-01",
"Study_Completion_Date(Actual)" : "2018-01-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-02-11",
"First_Posted(Estimated)" : 2016-02-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-02-19",
"Last_Update_Posted(Estimated)" : 2023-09-01",
"Last_Verified" : 2023-08"
}
}} | #Study Description
Brief Summary
Evaluation of the properties of the image capture test using 99m Tc - HYNIC -TOC EDDA (octreotide labeled with 99mTc) for the diagnosis of neuroendocrine tumors compared to the 111In - DTPA-octreotide.
#Intervention
- OTHER : 99m Tc - HYNIC -TOC EDDA and 111In - DTPA-octreotide
- The patient will undercome an PET/CT exam with 99m Tc - HYNIC -TOC EDDA, after 20 days of wash out, the same patient will undercome the same exam with 111In - DTPA-octreotide in order to compare both radiopharmaceuticals | #Eligibility Criteria:
Inclusion Criteria:
* Patients with histological diagnosis of neuroendocrine tumors
* Patients with indication for the staging exam with 11In
* Patients diagnosed in any tumor stage
* Patients with > 18 years
* Male and female patients
* Patients not receiving somatostatin analogues for at least 1 month before image capturing
Exclusion Criteria:
* Pregnant women
* Patients with previous tumor resection of the primary tumor without metastatic disease
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
| NCT02691078 | 211,446 |
{
"NCT_ID" : "NCT01808573",
"Brief_Title" : "A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting",
"Official_title" : "A STUDY OF NERATINIB PLUS CAPECITABINE VERSUS LAPATINIB PLUS CAPECITABINE IN PATIENTS WITH HER2+ METASTATIC BREAST CANCER WHO HAVE RECEIVED TWO OR MORE PRIOR HER2-DIRECTED REGIMENS IN THE METASTATIC SETTING (NALA)",
"Conditions" : ["HER2+ Metastatic Breast Cancer (MBC)"],
"Interventions" : ["Drug: capecitabine", "Drug: neratinib", "Drug: lapatinib"],
"Location_Countries" : ["Netherlands", "United States", "Germany", "Singapore", "Austria", "Switzerland", "Hong Kong", "Finland", "Czechia", "United Kingdom", "France", "Japan", "Israel", "Sweden", "Taiwan", "Russian Federation", "Australia", "Argentina", "Italy", "Turkey", "Denmark", "Ireland", "Brazil", "Korea, Republic of", "Portugal", "Canada", "Spain", "Belgium"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-03-29",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-09-28",
"Study_Completion_Date(Actual)" : "2019-12-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-03-04",
"First_Submitted_that_Met_QC_Criteria" : 2019-12-09",
"First_Posted(Estimated)" : 2013-03-11"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-03-07",
"Last_Update_Posted(Estimated)" : 2021-06-11",
"Last_Verified" : 2021-05"
}
}} | #Study Description
Brief Summary
This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting.
Detailed Description
This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting. Patients will be randomized in a 1:1 ratio to one of the following treatment arms:
* Arm A: neratinib (240 mg once daily) + capecitabine (1500 mg/m\^2 daily, 750 mg/m\^2 twice daily \[BID\])
* Arm B: lapatinib (1250 mg once daily) + capecitabine (2000 mg/m\^2 daily, 1000 mg/m\^2 BID)
Patients will receive either neratinib plus capecitabine combination or lapatinib plus capecitabine combination until the occurrence of death, disease progression, unacceptable toxicity, or other specified withdrawal criterion.
#Intervention
- DRUG : neratinib
- Other Names :
- Nerlynx
- DRUG : capecitabine
- Other Names :
- Xeloda
- DRUG : lapatinib
- Other Names :
- Tykerb, Tyverb | #Eligibility Criteria:
Inclusion Criteria:
* Aged >=18 years at signing of informed consent.
* Histologically confirmed MBC, current stage IV.
* Documented HER2 overexpression or gene-amplified tumor immunohistochemistry 3+ or 2+, with confirmatory fluorescence in situ hybridization (FISH) +.
* Prior treatment with at least two (2) HER2-directed regimens for metastatic breast cancer.
Exclusion Criteria:
* Received previous therapy with capecitabine, neratinib, lapatinib, or any other HER2 directed tyrosine kinase inhibitor.
Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
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
| NCT01808573 | 1,445 |
{
"NCT_ID" : "NCT02279537",
"Brief_Title" : "Real Life of Aflibercept In FraNce: oBservatiOnnal Study in Wet AMD",
"Official_title" : "A Retrospective and Prospective Non-interventional Open Label Study to Assess the Real Life of Treatment-naive Patients With Wet Age-related Macular Degeneration in Routine Clinical Practice in France and Starting an Anti VEGF Therapy With Aflibercept",
"Conditions" : ["Wet Macular Degeneration"],
"Interventions" : ["Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-01-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-04-17",
"Study_Completion_Date(Actual)" : "2019-04-17},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-10-29",
"First_Posted(Estimated)" : 2014-10-31"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-10-29",
"Last_Update_Posted(Estimated)" : 2023-11-07",
"Last_Verified" : 2023-11"
}
}} | #Study Description
Brief Summary
The purpose of this study is to collect real-life data on patients with wet age related macular degeneration (AMD) for whom treatment with Eylea was initiated
Detailed Description
The study is both retrospective and prospective to collect local real life data on patients under routine treatment. The observation period starts on January 2014. Patients who have received the 1st injection with Eylea from January 2014 will be enrolled.
Patients will be followed up for a period of 48 months or until it is no longer possible
#Intervention
- DRUG : Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- Administration by intravitreal injection | #Eligibility Criteria:
Inclusion Criteria:
* Patient with a diagnosis of wet AMD will be enrolled after the decision for treatment with Aflibercept (Eylea) has been made
* Patient with 1st injection of Eylea from 01 January 2014 until 30 April 2015 will be enrolled
* Prior/current treatment with any anti-VEGF intravitreal injections or macular laser (laser and/or visudyne/PDT) in the fellow eye is allowed
* Man or woman aged 18 years or more
* Patient who has been given appropriate information about the study objectives and procedures and who has given his/her written, informed consent;
Exclusion Criteria:
* Patient with another retinal disease: diabetic retinopathy, diabetic macular oedema (DME), myopic choroidal neovascularization, retinal vein occlusion (RVO), central serous chorioretinopathy (CSC), angioid streaks
* Patient who does not meet the local indication criteria for Eylea treatment.Contraindications listed in the Summary of Product Characteristics (SmPC) must be taken into account
* Patient who has previously been treated with any macular laser (laser and/or visudyne/PDT) or any anti-VEGF intravitreal injections for the study eye
* Patient taking part in an interventional study at the time of enrolment.
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
| NCT02279537 | 200,255 |
{
"NCT_ID" : "NCT01095562",
"Brief_Title" : "Safety and Efficacy Study for Cognitive Deficits in Adult Subjects With Schizophrenia",
"Official_title" : "A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety and Efficacy of ABT-126 in the Treatment of Cognitive Deficits in Schizophrenia (CDS)",
"Conditions" : ["Cognitive Deficits in Schizophrenia"],
"Interventions" : ["Drug: ABT-126", "Drug: Placebo"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-08",
"Study_Completion_Date(Actual)" : "2011-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-03-26",
"First_Posted(Estimated)" : 2010-03-30"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2010-03-26",
"Last_Update_Posted(Estimated)" : 2018-06-06",
"Last_Verified" : 2013-01"
}
}} | #Study Description
Brief Summary
This is an efficacy and safety study evaluating an experimental treatment for cognitive deficits in adults with schizophrenia.
Detailed Description
This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-126 in approximately 210 adults with schizophrenia. Subjects will be randomized to one of three treatment groups (ABT-126 Dose 1, ABT-126 Dose 2 or placebo) for a 12-week Treatment Period. The purpose of this research study is to find out whether ABT-126 compared to placebo can improve cognition and what side effects ABT-126 may cause. Cognition is the way a person thinks, and it includes abilities like paying attention, focusing, remembering things, and solving problems. Acronyms listed in the Outcomes and/or Eligibility sections for this study are defined below: • MCCB: Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery • UPSA-2: University of California at San Diego (UCSD) Performance-Based Skills Assessment-2 • CANTAB: Cambridge Neuropsychological Test Automated Battery • PANSS: Positive and Negative Syndrome Scale • NSA-16: Negative Symptom Assessment-16 • CGI-S: Clinical Global Impression - Severity
#Intervention
- DRUG : ABT-126
- ABT-126 Dose 1, ABT-126 Dose 2
- DRUG : Placebo
- Placebo | #Eligibility Criteria:
Inclusion Criteria
* Has current DSM-IV-TR diagnosis of schizophrenia confirmed by the Mini-International Neuropsychiatric Interview.
* Is clinically stable while receiving antipsychotic therapy with one or two atypical antipsychotic medications: lack of hospitalizations from 4 months of Initial Screening Visit; taking same antipsychotic medication(s) for at least 8 weeks prior to the Day -1 visit; core positive symptoms of PANSS no worse than moderate in severity throughout Screening Period of at least 4 weeks.
* Has been diagnosed with or treated for schizophrenia for at least 2 years prior to Initial Screening Visit.
* Has had continuity in psychiatric care (e.g., mental health system, clinic or physician) for at least 6 months prior to Initial Screening Visit.
* Has an identified responsible contact person (e.g., family member, social worker, case worker, or nurse) that can provide support to the subject and ensure compliance with protocol requirements.
Exclusion Criteria
* Has valid current or past diagnosis of schizoaffective disorder, bipolar disorder, manic episode, dementia, posttraumatic stress disorder, obsessive compulsive disorder, or a current major depressive episode.
* Has history of substance abuse (excluding nicotine or tobacco products) or alcohol abuse within 6 months prior to Screening Visit; has a substance dependence disorder (excluding nicotine or tobacco products) that has not been remitted for at least 1 year prior to Initial Screening Visit.
* Is taking any medication for extrapyramidal symptoms at any time from the Initial Screening Visit until the Day -1 Visit.
* Is taking any antidepressant that is excluded, including tricyclic antidepressants and monoamine oxidase inhibitors, at any time from 8 weeks prior to the Day -1 Visit.
* Has significant suicidal ideation at Initial Screening Visit.
* Has had a suicide attempt within 1 year prior to the Day -1 Visit.
* Has participated in another trial utilizing the MATRICS Consensus Cognitive Battery (MCCB) or UCSD Performance-Based Skills Assessment (UPSA) (any version) within 6 months prior to Initial Screening Visit.
* Is currently enrolled in any form of cognitive remediation training.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
| NCT01095562 | 59,932 |
{
"NCT_ID" : "NCT00963001",
"Brief_Title" : "Effect of Food on the Pharmacokinetics of Oral Treprostinil",
"Official_title" : "Effect of Different Meal Types on the Pharmacokinetics of a Single 1 mg Oral Dose of UT-15C (Treprostinil Diethanolamine) Sustained Release Tablets in Healthy Volunteers",
"Conditions" : ["Hypertension, Pulmonary", "Pulmonary Arterial Hypertension"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2009-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-11",
"Study_Completion_Date(Actual)" : "2009-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-08-19",
"First_Posted(Estimated)" : 2009-08-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-08-19",
"Last_Update_Posted(Estimated)" : 2010-03-08",
"Last_Verified" : 2010-03"
}
}} | #Study Description
Brief Summary
The purpose of this study is to assess the pharmacokinetic and safety profile of a single dose of oral treprostinil following four different meals of varying caloric and fat content.
#Intervention
- DRUG : Treprostinil diethanolamine
- Subjects will each receive a single 1 mg sustained release tablet of treprostinil diethanolamine by mouth within 10 minutes of consuming each of four standardized meals on Study Days 1, 8, 15, and 22.
- Other Names :
- UT-15C, UT-15C SR, Oral treprostinil
- OTHER : Standardized meals
- Each subject will receive one of four different standardized meals of varying caloric and fat content in a randomized sequence such that all subjects will receive all four meals over the course of the study. Each subject will receive one standardized meal for breakfast on Study Days 1, 8, 15, and 22. | #Eligibility Criteria:
Inclusion Criteria:
* Subject is healthy and between the ages of 18 and 55 years, inclusive, at Screening.
* Female subjects must weigh between 45 and 100 kg, inclusive, with a BMI between 19.0 <= age <= 29.9 kg/m2, inclusive at Screening. Male subjects must weigh between 50 and 120 kg, inclusive, with a BMI between 19.0 <= age <= 32.0 kg/m2, inclusive at Screening.
* Subject has a medical history, physical examination, vital signs, ECG and clinical laboratory results within normal limits or considered not clinically significant by the Investigator at Screening.
Exclusion Criteria:
* Subject has any clinically relevant abnormality identified during the screening physical examination, 12-lead ECG, or laboratory examinations.
* Subject has a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug.
* Subject has a clinically significant history of neurological, cardiovascular, respiratory, endocrine, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary, and/or musculoskeletal disease; glaucoma; a psychiatric disorder, or any other chronic disease, whether controlled by medication or not.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT00963001 | 46,691 |
{
"NCT_ID" : "NCT04633486",
"Brief_Title" : "Endoscopically One-year Follow-up in Patients After Small-bowel Transplantation",
"Official_title" : "Endoscopically One-year Follow-up in Patients After Small-bowel Transplantation, Role of SASAKI Score",
"Conditions" : ["Intestinal Graft Dysfunction"],
"Location_Countries" : ["Germany"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-04-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-11-15",
"Study_Completion_Date(Actual)" : "2019-11-15},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-11-06",
"First_Posted(Estimated)" : 2020-11-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-11-12",
"Last_Update_Posted(Estimated)" : 2020-11-18",
"Last_Verified" : 2020-11"
}
}} | #Study Description
Brief Summary
Intestinal transplantation is associated with high numbers of ejection events. A close endoscopic controll of the intestinal graft is possible. Sasaki et al. presented 2002 an endoscopic score using zoom-endoscopes for early detection of rejection events.
Detailed Description
Small bowel transplantation is a potentially life-saving procedure for patients with irreversible gut failure, especially for those with total parenteral nutrition complications, inability to adapt to quality-of-life limitations posed by intestinal failure, and high risk of death if the native gut is not removed. Endoscopy provides the quickest method for assessing the overall health of graft mucosa and is essential in obtaining specimens from large areas for histologic evaluation, which continues to remain the gold standard for a diagnosis of rejection. Recently, the use of zoom videoendoscopy has been reported as a better evaluation of intestinal mucosa than the use of a standard endoscope. Acute cellular rejection in short-term follow-up, appears with acute and dramatic clinical symptoms (fever, vomiting, nausea, increased stomal output/diarrhea, abdominal pain, and distension), so that it is rarely predictable with surveillance.
Comparison of endoscopic and histo-pathologic findings should be performed.
#Intervention
- DIAGNOSTIC_TEST : zoom-endoscopy
- Endoscopic monitoring of intestinal transplant recipients is done with zoom-endoscopes for exact diagnostic of intestinal mucosa.
- Other Names :
- ZVE | #Eligibility Criteria:
Inclusion Criteria:
* intestinal transplant recipients
Exclusion Criteria:
* younger age (< 16)
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:
No
| NCT04633486 | 90,603 |
{
"NCT_ID" : "NCT04875910",
"Brief_Title" : "Effectiveness of Telerehabilitation in Improving Walking and Balance Among Stroke Survivors?",
"Official_title" : "Could Telerehabilitation be a Promising Tool in Improving Walking and Balance Among Stroke Survivors? 'Case Study'",
"Conditions" : ["Stroke"],
"Interventions" : ["Other: Home-based exercise program"],
"Location_Countries" : ["Saudi Arabia"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-03-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-04-28",
"Study_Completion_Date(Actual)" : "2021-04-28},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-05-01",
"First_Posted(Estimated)" : 2021-05-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-05-03",
"Last_Update_Posted(Estimated)" : 2021-05-06",
"Last_Verified" : 2021-03"
}
}} | #Study Description
Brief Summary
A good rehabilitation program may not be accessible for all individuals living with stroke due to cost, transportation and compliance. Telerehabilitation is an alternative health care program that may help in overcoming this issue. In this study we aim to find if the use of telerehabilitation in Saudi Arabia would improve balance and walking in stroke survivors during this pandemic.
Detailed Description
Background: Rehabilitation program is commonly provided after stroke to improve functional outcomes. A good rehabilitation program may not be accessible for all individuals living with stroke due to cost, transportation and compliance. Telerehabilitation is an alternative health care program that has been used to provide therapy for stroke survivors living in rural areas. With COVID-19 pandemic, many stroke survivors have lost their access to rehabilitation. Therefore, telerehabilitation may help in overcoming this issue. In this study we aim to find if the use of telerehabilitation in Saudi Arabia would improve balance and walking in stroke survivors during this pandemic.
Methods: 2 stroke survivors ( male and female/ \>6 months post stroke) are included in this case study. Participants will receive a task-specific activity training (3days/week moderate exercises for 4 weeks) Both participants will provide feedback through questionnaires pre and post the 4 weeks intervention. We will use the Activities- specific balance confidence (ABC) scale, Lower limb functional scale (LEFS) and Stroke severity quality of life scale ( SS-Qol).
• Intervention: The participants will follow a home-based exercise through videos with follow up from the therapists for 4 weeks.
#Intervention
- OTHER : Home-based exercise program
- The exercise program will include task specific training to improve balance and the training will progress every two weeks. A Physical therapist will be following up and monitoring the participants adherence to the training by audio or video call.
The exercise program for Week 1: Sit to Stand 5 times, Steps forward, backward and to the sides 5 times, 10 meters walk. 45 minutes session /3 times per week. Week 2: Sit to stand 10 times, Steps forward, backward and to the sides 5 times , Sit and reach 5 min for each hand and walk for 15 meters. 45 minutes session, 3 times per week. Week3 Sit to stand 10 times, Step on bench 5 times, Stand and reach 5 and walk for 15 meters. 45 minutes session, 3 times per week. Week 4 Stand and reach 5 times, Step on bench 10 times, climbing stairs (5 steps flight stairs up and down) and walk for 20 meters. 50 minutes session, 3 times per week. | #Eligibility Criteria:
Inclusion Criteria:
* Subjects who have been diagnosed with stroke 6 months or more.
* Either right or left hemiparesis.
* Subjects able to walk with or without assistive device.
* age between 40 <= age <= 70. 5) Subjects can understand and follow commands.
Exclusion Criteria:
* subjects with uncontrolled Blood pressure, heart rate or breathing problems.
* Having an orthopedic problem or pain that limits walking and standing.
* Subject with vestibular disorders.
* Subjects with cognitive disorders. 5) Subjects with hemi spatial neglect
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT04875910 | 108,890 |
{
"NCT_ID" : "NCT01938300",
"Brief_Title" : "Magnesium and Rotational Thromboelastometry (ROTEM) in Colorectal Cancer Surgery",
"Conditions" : ["Colorectal Cancer"],
"Interventions" : ["Drug: Magnesium Sulfate", "Drug: Normal saline"],
"Location_Countries" : ["Korea, Republic of"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-10",
"Study_Completion_Date(Actual)" : "2013-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-08-30",
"First_Posted(Estimated)" : 2013-09-10"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-09-04",
"Last_Update_Posted(Estimated)" : 2015-11-20",
"Last_Verified" : 2013-11"
}
}} | #Study Description
Brief Summary
Magnesium sulphate is given to the patients during the colorectal cancer surgery under the hypothesis that it would attenuate the postoperative hypercoagulability. The investigators intend to characterize the changes of coagulation in colorectal cancer patients by using the point-of-care device after the infusion of magnesium sulphate.
#Intervention
- DRUG : Magnesium Sulfate
- DRUG : Normal saline | #Eligibility Criteria:
Inclusion Criteria:
* The patients undergoing a laparoscopic colorectal cancer surgery
Exclusion Criteria:
* Renal disease
* Hepatic disease
* Neuromuscular disease
* Coagulation disorder
* Cardiopulmonary disease
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01938300 | 163,855 |
{
"NCT_ID" : "NCT01304108",
"Brief_Title" : "Improving Venous Thromboembolism Prophylaxis",
"Official_title" : "Spreading and Improving DVT Prophylaxis at Mayo Clinic (DVT-P-Spread)",
"Conditions" : ["Venous Thromboembolism", "Delivery of Health Care", "Quality Improvement"],
"Interventions" : ["Other: Usual Care", "Other: BLAZE Pop up", "Other: VTE-P Tollgate"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "HEALTH_SERVICES_RESEARCH",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2009-01",
"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" : 2010-07-09",
"First_Posted(Estimated)" : 2011-02-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-02-24",
"Last_Update_Posted(Estimated)" : 2011-02-25",
"Last_Verified" : 2011-02"
}
}} | #Study Description
Brief Summary
Preventing the formation of blood clots in the veins so they do not injure leg veins or travel to the lungs, also called venous thromboembolism prophylaxis (VTE-P) is an essential component of safe in-patient care, yet it is deployed sub-optimally in many hospitals, including The investigators own. Two prior VTE-P improvement projects were completed at Mayo Clinic hospitals, one in the Department of Medicine, and the other in selected divisions of the Department of Surgery. Both projects resulted in marked improvement in the percentage of patients receiving appropriate VTE-P. This project seeks to utilize the lessons learned from these two pilots along with known best practices for \"spreading\" to deploy methods that enhance VTE-P to the entire hospitalized population. The investigators seek appropriate VTE-P rates exceeding 95%.
Detailed Description
Venous thromboembolism prophylaxis (VTE-P) is an essential component of safe in-patient care, yet it is deployed sub-optimally in many hospitals, including our own. Two prior VTE-P improvement projects were completed at Mayo Clinic hospitals, one in the Department of Medicine, and the other in selected divisions of the Department of Surgery. Both projects resulted in marked improvement in the percentage of patients receiving appropriate VTE-P. This project seeks to utilize the lessons learned from these two pilots along with known best practices for \"spreading\" to deploy methods that enhance VTE-P to the entire hospitalized population. The investigators seek appropriate VTE-P rates exceeding 95%. This began as a quality improvement project. The investigators have taken baseline measures of VTE-P rates in our hospitals, intervened with various electronic prompts to use appropriate VTE-P, and have and will re-measure VTE-P rates. The investigators intend to present and publish our methods and results so that lessons learned may be shared and applied elsewhere.
#Intervention
- OTHER : VTE-P Tollgate
- Add VTE-P tollgate order set that requires a decision regarding VTE-P for every patient admitted or transferred in our hospital system
- OTHER : BLAZE Pop up
- Develop and deploy a rules-based popup that reminds prescribers interfacing with the orders system when a patient does not have an active VTE-P plan.
- OTHER : Usual Care
- No addition to the baseline system for care | #Eligibility Criteria:
Inclusion Criteria:
* Inpatients with > 17 yearsyears old
Exclusion Criteria:
* Outpatients
* Inpatients with age less than or equal to 17 years
Sex :
ALL
Ages :
- Minimum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
| NCT01304108 | 136,228 |
{
"NCT_ID" : "NCT01308775",
"Brief_Title" : "Comparing (SIS.NET) to Standard Care in Patients Who Have Completed the Acute Phase of Treatment for Early Breast Cancer",
"Official_title" : "A Pilot Study Comparing a Patient-Centered Symptom Reporting Follow Up Program (SIS.NET) to Standard Care in Patients Who Have Completed the Acute Phase of Treatment for Early Breast Cancer",
"Conditions" : ["Breast Cancer"],
"Interventions" : ["Behavioral: SIS.NET, Routine Follow-up"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-03",
"Study_Completion_Date(Actual)" : "2015-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2011-02-24",
"First_Posted(Estimated)" : 2011-03-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-03-02",
"Last_Update_Posted(Estimated)" : 2015-03-09",
"Last_Verified" : 2015-03"
}
}} | #Study Description
Brief Summary
This is a pilot study that will compare two systems of breast cancer follow up care and will evaluate a number of parameters indicating quality and efficiency of care delivery as well as patient satisfaction with care. Approximately 100 breast cancer patients who have completed the acute phase of treatment will be randomized to one of two follow up care plans.
Detailed Description
Over 200,000 women were diagnosed with breast cancer in the year 2006. Many of these women will be rendered free of cancer, but will need ongoing disease specific care and surveillance. The estimated number of breast cancer survivors in the year 2003 was 2.3 million (1). With outcomes improving after the diagnosis of early breast cancer, the number of breast cancer survivors in follow up care will continue to increase and eventually result in an unmanageable load on the subspecialties of medical and surgical oncology. Most of these patients continue to be seen by an oncology specialist for at least five years after their cancer diagnosis, but this type of follow up may not be necessary or optimally utilized.
Alternate Strategies for Health Care Delivery Studies suggest that oncology follow up care is costly to the health care system no matter who the provider is, and in some cases, diagnostic tests are overused (2). In a randomized trial of 296 women with a history of breast cancer in Great Britain, transfer of routine follow-up care to a family physician did not result in an increase in the time to diagnosis of recurrence (3). Patient satisfaction was greater and health service costs were less, and anxiety and health related quality of life were unaffected (4, 5). A similar multicenter trial of 968 early-stage breast cancer patients in Canada who had completed adjuvant treatment randomized patients to follow up in a cancer center or with their own family physician (6). This study found no statistically significant differences in number of recurrences, deaths, recurrence related serious clinical events, or patient reported health-related quality of life questionnaires between the groups. While transferring oncology follow-up care back to primary care physicians seems a reasonable alternative, the shortage of primary care physicians in certain regions of the US and around the world, limits this approach (7, 8). A study in Sweden compared nurse-led follow-up vs. physician follow-up in 264 consecutively selected women with newly diagnosed Stage I or II breast cancer (9). Outcomes included measures of patient well-being, satisfaction, access to medical care, and medical safety. Questionnaires containing the Hospital Anxiety and Depression Scale (HADS), and the Satisfaction and Accessibility (SaaC) scale were obtained at baseline and twice a year over a period of 5 years. Number of contacts with health care services, number of diagnostic procedures, and time to recurrence or death were monitored. Ratings of HADS and SaaC scales did not show any statistically significant differences between the follow-up groups. The levels of anxiety and depression were generally low, and levels of patient satisfaction high. There were no differences between the groups concerning time to recurrence or death suggesting that follow-up care with an experienced nurse professional is safe and effective.
Various strategies have been studied to evaluate alternatives to routine clinic visits and referrals to subspecialists in order to improve access to care and to lower health care costs. One such study tested the hypotheses that virtual outreach would reduce number of contacts with the health care system, reduce the number of medical tests and interventions, and have a positive impact on patient satisfaction. A randomized controlled trial was conducted which compared standard outpatient referral to joint teleconsultations between general practitioners (GP), specialists, and patients (10). Patients randomized to virtual outreach underwent a joint teleconsultation, in which they and their GP consulted with a hospital specialist via a videolink. In this study, patients in the virtual outreach group were more likely to be scheduled for a follow-up appointment, but fewer tests and investigations were ordered. In the 6-month period following the initial consultation, there were no significant differences in number of contacts or outpatient visits with GP, inpatient stays, procedures, or prescriptions between the randomized groups. Patient satisfaction was greater after a virtual outreach consultation, and patient enablement and the physical and psychological scores of the Short Form-12, did not differ between the randomized groups. Interestingly, health care costs over 6 months were greater for the virtual outreach consultations than for conventional outpatients, but overall cost, time, and productivity savings to patients were identified. This study represents an example of how technology can be utilized to streamline care and provide more patient centered services, but that these services may not save money overall in the health care system. The need to assess the cost-effectiveness and patient outcomes of alternate surveillance and follow up strategies was recently highlighted in a review article by Tolaney (11).
UCSF and Dynamic Clinical Systems (DCS) Collaboration The UCSF Breast Care Center has embarked upon collaboration with Dynamic Clinic Systems to implement a computer based, patient centered system of symptom reporting and data collection to improve clinical care to our patients and generate databases of patient reported symptoms and outcomes information for research purposes. Dynamic Clinical Systems (DCS) is a provider of real-time Web-based applications focusing on the patient-clinician interaction. The DCS approach enables patients to provide health data electronically. Clinicians may use this data for research, medical documentation, and registries depending on the type of data collected and the consent of the patient.
Through this system, patients will report their own health information via the DCS web-based Integrated Survey System (ISS). The process is as follows: A real-time interface downloads appointments from the hospital scheduling system into ISS. Survey groups are automatically scheduled based on pre-defined timing parameters. Prior to sending the patient their first survey, each patient will be called and welcomed to the program and asked if they use the internet. If they do, they will be given instructions for completion of surveys at home. If they need assistance, they will be given an appointment to come to our resource center and work with our staff member to complete the survey. The patient will be notified (via automatically-generated email from ISS or hospital letter/phone) to either sign on and take the survey from home or come to clinic early to take the survey. Once logged in, the patient has the opportunity to indicate online consent (to be approved by CHR) to share data for research purposes. An analyst will monitor the progress of survey completion and will call any patient whose surveys are not complete prior to their clinic appointment to facilitate survey completion. At the end of the process, a patient summary report is generated in ISS displaying a summary of patient survey answers, longitudinal comparisons of previous surveys, red flags and warnings, and quality measures. The clinician uses this report during the clinic visit to focus the discussion on highlighted items.
DCS is a service vendor who has built and who services the online-questionnaire platform. All content in the questionnaires has been created and reviewed by the investigators at UCSF (with the exception of standardized surveys such as the SF-36 and other validated questionnaires). Other than this, the DCS has no role in this study, and it does not receive or have access to information regarding study outcomes (such as in terms of patient visits or interventions) from either arm of the study.
We plan to implement and evaluate a comprehensive survivorship program, supported by this interactive web-based system for reporting physical and psychological symptoms. The system will capture structured data that then can be used to drive translation of research findings to improve care for survivors. The System for Individualized survivorship care, based on patient Self-reported data, with review by Nurse practitioners, targeted Education, and Triage to appropriate services to improve symptom management and outcomes will be called SIS.NET
#Intervention
- BEHAVIORAL : SIS.NET, Routine Follow-up
- * SIS.NET - One or two oncology related clinic visits per year (as recommended by the American Society of Clinical Oncology breast cancer follow up guidelines (18)), with additional access to oncology care driven by ongoing review of patient's self reported symptoms through web-based questionnaires.
* Routine follow up care with appointment frequency determined by the treating medical oncologist or oncology/breast surgeon. Patients complete the same web-based symptom questionnaires within 30 days of a scheduled clinic visit but the results are not reviewed until their clinic visit. | #Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with Stage I to Stage III breast cancer that have completed their acute phase of treatment. (This includes surgery, radiation, chemotherapy, or any experimental therapies offered in a clinical trial as adjuvant treatment.)
* Patients who received chemotherapy must be 6 months out from completion of chemotherapy.
* For patients who receive adjuvant hormonal therapy (with or without prior chemotherapy), patients must be 3 months out from initiation of hormonal therapy.
* For patients who do not receive adjuvant chemotherapy or hormonal therapy, patients must be 3 months out from surgery and radiation therapy.
* Patients must have recovered from all serious side effects of acute phase of treatment for breast cancer.
* Patients must be willing to complete symptom reporting questionnaires at the intervals assigned by their care group.
* Patients must have hematologic, cardiac, hepatic, and renal function that are back to their pre-treatment values.
* Patient must be able to read and speak English sufficiently to complete symptom reporting questionnaires and discuss details of symptoms and health status over the telephone.
* Patient must have access to a computer on which to complete the on-line surveys or must be willing to come to the UCSF Cancer Resource Center to complete questionnaires at the intervals assigned by their care group.
Exclusion Criteria:
* History of severe depression or an anxiety disorder that is felt to interfere with a patient's ability to accurately self-report symptoms.
* Complications from breast surgery or reconstruction, or from chemotherapy or radiation that may require regular ongoing clinic visits for physical and/or laboratory evaluation.
-
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
| NCT01308775 | 221,124 |
{
"NCT_ID" : "NCT06269822",
"Brief_Title" : "Autonomic Dysfunction in Temporal Lobe Epilepsy and SUDEP",
"Official_title" : "Electrophysiological Evaluation of Autonomic Dysfunction in Persons With Temporal Lobe Epilepsy and Its Relation Ship With Sudden Unexpected Death of Epileptic Patient (SUDEP) Risk Development(",
"Conditions" : ["Temporal Lobe Epilepsy"],
"Interventions" : ["Diagnostic Test: Sympathetic skin response, heart rate variability test, quantitative EEG"],
"Location_Countries" : ["Egypt"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-09-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-11-25",
"Study_Completion_Date(Actual)" : "2024-01-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2024-02-10",
"First_Posted(Estimated)" : 2024-02-21"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2024-02-17",
"Last_Update_Posted(Estimated)" : 2024-02-21",
"Last_Verified" : 2024-02"
}
}} | #Study Description
Brief Summary
The study aimed at detection of autonomic dysfunction among cases with temporal lobe epilepsy; using different electrophysiological techniques.
Moreover, it aimed at finding any correlation between electrophysiological tests and SUDEP risk.
Detailed Description
Temporal lobe epilepsy (TLE) is the commonest focal form of epilepsy; representing 60% of all epilepsies . It has two major subtypes; neocortical (nTLE) and mesial (mTLE), each with different presentations.
Its diagnosis depends on detailed clinical history, neurological examination as well as neurophysiological (including EEG), and neuroimaging diagnostic tests which are mandatory in localizing the pathology.
Intimate connection between epileptic networks and the autonomic nervous system had been revealed. Seizures could affect autonomic functions whether directly through activation of cortical autonomic centers or indirectly through the released catecholamines.
The SUDEP is considered as one of the most serious complications of epilepsy and second most common cause of death from neurological diseases after stroke. Autonomic dysfunction could have a potential role in the pathophysiology of sudden unexpected death of epileptic patients (SUDEP).
Attention has been focused on biomarkers that could assist in the detection and early stratification of SUDEP risk. Such biomarkers include neurophysiological tests, imaging findings, laboratory findings.
Among the introduced neurophysiological biomarkers are electroencephalogram (EEG), sympathetic skin response (SSR) and heart rate variability (HRV).
The HRV is considered as simple, sensitive index of cardiovagal function. Reduced heart rate variability (HRV) is a strong predictor of sudden death in patients with heart disease.
The electrodermal activity (EDA )or SSR is referred as the most popular used test for assessment the sudomotor function . The EDA had been proven to be a reliable biomarker for detecting generalized tonic-clonic seizures (GTCs) through a wearable device.
Frontal midline theta activity was studied using quantitative EEG (QEEG); that confirmed the presence of interactive relationships between activities of the peripheral autonomic system and the cortical network. The QEEG technique had been introduced in the thirties of the last century. Yet, it had not been applied before on epileptic patients to assess either the central autonomic function or the SUDEP risk and thus, this is considered as the first study to address such issue.
#Intervention
- DIAGNOSTIC_TEST : Sympathetic skin response, heart rate variability test, quantitative EEG
- Sympathetic skin test (electrodermal activity) to test for sympathetic function Heart rate variability test to assess cardiovagal function Quantitative EEG to quantitatively assessing the brain function using fast fourier transform technique | #Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed as temporal lobe epilepsy(TLE) depending on clinical semiology and EEG temporal inter-ictal epileptiform discharges
Exclusion Criteria:
* Any identifiable disease that could affect autonomic nervous system function including diabetic patients.
* Any drug that could affect autonomic nervous system function including oral contraceptives
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
| NCT06269822 | 30,409 |
{
"NCT_ID" : "NCT04692649",
"Brief_Title" : "Comparison of Pragmatic Posterior Capsular Stretch and Crossbody Stretch on the Shoulder Mobility",
"Official_title" : "Comparision of Shoulder Stretches",
"Conditions" : ["Shoulder Impingement", "Shoulder Pain", "Adhesive Capsulitis", "Rotator Cuff Tears", "Posterior Capsule Tear", "Glenohumeral Subluxation", "Glenohumeral Dysplasia", "Acromioclavicular; Sprain (Strain)", "Internal Rotation Contracture-shoulder", "External Rotation Contracture-Shoulder", "Flexion Contracture", "Extension Contracture-Shoulder"],
"Interventions" : ["Other: cross body stretch", "Other: pragmatic posterior capsular stretch"],
"Location_Countries" : ["Pakistan"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-01-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-03-10",
"Study_Completion_Date(Actual)" : "2021-04-15},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-12-30",
"First_Posted(Estimated)" : 2021-01-05"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-12-30",
"Last_Update_Posted(Estimated)" : 2022-05-03",
"Last_Verified" : 2022-04"
}
}} | #Study Description
Brief Summary
Various stretches are used to lengthen the posterior shoulder capsule. No study has reported the comparison of the pragmatic posterior capsular stretch and cross body stertch
Detailed Description
Background: Posterior capsular tightness (PCT) is frequently seen in shoulders in athletic population and shoulder disoders. PCT leads to variation in scapular and humeral kinematics. Two techniques considered in our study for regaining normal range of motion at shoulder joint and improving PCT, one is the pragmatic posterior capsular stretch (PPCS) \& the other one is cross body stretch (CBS) Objective: The aim of our study id to compare the short term/intermediate term effect of PPCS and CBS on range of motion on shoulder joint in healthy individuals. And to evaluate the feedback of subjects regarding both the interventions.
Methodology: Sixty a symtomatic shoulder of 30 subjects (15 males, 15 females) were recruited for this restricted randomised control trials. A simple random sampling technique was used. Subjects were screen through a functional movement screening tool of shoulder mobility. The change in hand behind neck and hand behind back will be measured through measuring tape. Shoulder ROM and functional movements for both the stretches will be campared. Particpants will be follwed for 4 weeks for the change in their shoulder range of motion.
#Intervention
- OTHER : pragmatic posterior capsular stretch
- pragmatic posterior stretch is used to increase the length of the posterior capsule
- OTHER : cross body stretch
- crossbody stretch performed by an individual | #Eligibility Criteria:
Inclusion Criteria:
* Age groups of males and females including 20 <= age <= 35 years
* Subjects who fall in grade 1 and 2 of functional movement screening of shoulder during the screening process.
Exclusion Criteria:
* Individual with shoulder pain, fracture or dislocation less than 1 year
* Individuals with any known shoulder pathology
* Subjects receiving current physiotherapy treatment
* Subjects having enough range of motion( can reach T2 hand behind neck)
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT04692649 | 131,885 |
{
"NCT_ID" : "NCT05256095",
"Brief_Title" : "Thinking in Speech for Children With Autism",
"Official_title" : "Thinking in Speech for Children With Autism - Pilot Study",
"Conditions" : ["Autism Spectrum Disorder", "Speech"],
"Interventions" : ["Behavioral: Thinking in Speech"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "SEQUENTIAL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-05-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-08-10",
"Study_Completion_Date(Actual)" : "2022-08-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-02-15",
"First_Posted(Estimated)" : 2022-02-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-02-15",
"Last_Update_Posted(Estimated)" : 2024-10-03",
"Last_Verified" : 2024-10"
}
}} | #Study Description
Brief Summary
This study examines a cognitive therapy for autistic children, Thinking in Speech. Thinking in Speech helps children with autism independently cope with everyday events that cause stress, by developing their ability to use 'inner speech'.
Detailed Description
The purpose of this study is to examine the effectiveness of Thinking in Speech (TiS) in teaching children to identify when they are experiencing a problem and learn to ask for help appropriately.
Participants. Participants will be 20 verbal children, aged 7-11, who have been diagnosed with autism or related neurocognitive disorders. Therapists will be experienced and certified speech-language pathologists (SLPs) who will be trained to use TiS For this grant, investigators will develop a standardized training program that can be administered to community SLPs. Training will consist of background reading and discussions, analysis of past therapy sessions, and practice sessions with individualized feedback provided by a trainer. Training will focus on developing the child's ability to ask for help. Asking for help requires a complex combinations of executive functions and being able to adopt the perspective of another person. Training sessions will be recorded for use in further training development and enhancements. A five-week training program is anticipated.
Procedure: Both training and therapy will be delivered remotely. The therapists will plan to conduct sixteen 30-minute remote therapy sessions over 8 weeks - the actual time frame will depend on the health and scheduling demands of the therapists and children. All TiS sessions will be video-recorded. Children will be randomly assigned to either receive therapy immediately or to be placed on a 10-week wait-list after which they will receive therapy.
#Intervention
- BEHAVIORAL : Thinking in Speech
- Thinking in Speech is a therapy to help children with autism learn to cope with daily stressors and improve their communication. | #Eligibility Criteria:
Inclusion Criteria:
* Verbal language ability as reported by the caregiver
* Ages 7 <= age <= 11
* Prior autism or related neurocognitive diagnosis
* Child proficient in English
* Caregiver proficient in English
* Residing in Pennsylvania
* Access to internet at home
Exclusion Criteria:
* History of major child mental illness (e.g., bipolar, schizophrenia, psychosis)
* Child visual and/or hearing impairment that interferes with his/her ability to participate in therapy
Sex :
ALL
Ages :
- Minimum Age : 7 Years
- Maximum Age : 11 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
| NCT05256095 | 120,716 |
{
"NCT_ID" : "NCT00257010",
"Brief_Title" : "A 1-year Study in Adolescents to Assess the Long-term Safety of Almotriptan Malate When Treating Their Migraine Headaches",
"Official_title" : "Long-Term, Open-Label Safety Study of Oral Almotriptan Malate 12.5 mg in the Treatment of Migraine in Adolescents",
"Conditions" : ["Migraine"],
"Interventions" : ["Drug: Almotriptan Malate"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2005-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2007-12",
"Study_Completion_Date(Actual)" : "2007-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-11-18",
"First_Submitted_that_Met_QC_Criteria" : 2013-10-11",
"First_Posted(Estimated)" : 2005-11-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-11-18",
"Last_Update_Posted(Estimated)" : 2014-02-21",
"Last_Verified" : 2014-01"
}
}} | #Study Description
Brief Summary
The purpose of this study is to evaluate the long-term safety of almotriptan malate (a migraine headache medication) in the treatment of migraine headaches in adolescents for up to one year.
Detailed Description
Almotriptan malate, and several other treatments for migraine headaches, known as triptans, are approved for the treatment of migraine headaches in adults. To date, none of these have been approved by the Food and Drug Administration (FDA) for use in adolescents. This is an open-label, multi-center study that will enroll approximately 450 patients aged 12 - 17 years old with a history of one to 14 migraines per month for the 6 months prior to entering the study. The total study duration will be up to one year. There is a screening phase to determine if the patient is eligible for study entry, followed by an open-label treatment phase that can last up to one year. Almotriptan malate 12.5 mg tablets will be used to treat all migraine headaches during the study, as needed. The primary outcome of the study is an assessment of the long-term safety of almotriptan malate in adolescent migraine sufferers. The study hypothesis is that the almotriptan malate will be safe and well tolerated in the treatment of adolescent migraine headaches. Safety measurements will be performed at set time points during the study and will include laboratory tests, physical and neurological exams, electrocardiograms (ECGs) and the incidence of adverse events. A diary will be completed by the patient for each migraine headache for which they take almotriptan malate. Migraine pain information and almotriptan malate use will be recorded in the headache diary. An equal number of patients in the 12 - 14 year old range as the 15 - 17 year old range will be enrolled. Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain. The dose may be repeated once if the pain continues 2 hours after the first dose, but no more than 2 doses can be taken within a 24-hour period. Study medication will be taken for up to one year.
#Intervention
- DRUG : Almotriptan Malate
- Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain | #Eligibility Criteria:
Inclusion Criteria:
* Have a history of migraine for at least one year
* Have an average of 1 - 14 migraines per month for the 6 months prior to study entry
* Able to swallow oral medication
* Able to complete a headache diary
* Only taking one migraine preventive medication and on the same dose of that medication for at least 30 days before entering the study)
Exclusion Criteria:
* Have an allergy to almotriptan malate or have stopped taking almotriptan malate due to side effects
* Have 15 or more days within a month in which you have a headache
* Usually experience migraine aura (most common symptoms being visual disturbances or tingling sensations before migraine pain begins) without a headache
* Experience more than 6 non-migraine headaches per month
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
| NCT00257010 | 139,415 |
{
"NCT_ID" : "NCT02776917",
"Brief_Title" : "Study of Cirmtuzumab and Paclitaxel for Metastatic or Locally Advanced, Unresectable Breast Cancer",
"Official_title" : "A Phase 1b Pilot Clinical Trial of Cirmtuzumab, an Anti-ROR1 Monoclonal Antibody, in Combination With Paclitaxel for the Treatment of Patients With Metastatic, or Locally Advanced, Unresectable Breast Cancer",
"Conditions" : ["Breast Neoplasms"],
"Interventions" : ["Drug: Cirmtuzumab + Paclitaxel"],
"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)" : "2018-08-15",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-07-13",
"Study_Completion_Date(Actual)" : "2024-02-26},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-05-16",
"First_Posted(Estimated)" : 2016-05-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-05-17",
"Last_Update_Posted(Estimated)" : 2024-04-10",
"Last_Verified" : 2024-04"
}
}} | #Study Description
Brief Summary
This is a pilot phase 1b study to investigate the safety and side effects of combining the ROR1-targeting monoclonal antibody, cirmtuzumab, with paclitaxel for patients with HER2 negative, metastatic breast cancer. Cirmtuzumab is a type of drug called a monoclonal antibody. This drug is designed to attach to a protein called receptor-tyrosine-kinase like orphan receptor 1 (ROR1) on the surface of breast cancer cells. Cirmtuzumab blocks the growth and survival of the breast cancer cells in laboratory tests. ROR1 is rarely expressed on healthy cells. Cirmtuzumab is considered experimental and is not approved by United States (U.S.) Food and Drug Administration (FDA).
Detailed Description
* This is a phase 1b, open-label, non-randomized, fixed dose study in patients with HER2 negative metastatic, or locally advanced, unresectable breast cancer.
* Cirmtuzumab and paclitaxel will be administered until disease progression or unacceptable toxicity. Cirmtuzumab or paclitaxel may be continued alone if the other drug is discontinued due to toxicity, as long as the subject is tolerating the drug and does not exhibit disease progression.
* Blood and tissue samples will be collected at pre-specified times to enable pharmacokinetic and correlative studies.
* Adverse events (AE) will be monitored throughout the trial. Reporting of AEs will be in accordance with CTCAE version 4.03.
* Assessment of tumor response will be performed by physical examination and/or by radiographic imaging and according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
* Patients will be assessed at 28 days following the last dose of cirmtuzumab to assess tumor response and at 56 days following the last dose of cirmtuzumab to assess any adverse events and to document any concomitant cancer therapy.
#Intervention
- DRUG : Cirmtuzumab + Paclitaxel
- Cirmtuzumab and paclitaxel may be administered until disease progression or unacceptable toxicity. Cirmtuzumab or paclitaxel may be continued alone if the other drug is discontinued due to toxicity.
- Other Names :
- UC-961, Taxol | #Eligibility Criteria:
INCLUSION CRITERIA:
* Biopsy-confirmed, metastatic or locally advanced surgically unresectable, HER2 negative breast cancer. HER2 status should reflect the most recent biopsy results. Note: HER2 negative breast cancer is defined according to the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines 2013 for HER2 testing performed in a CLIA-certified laboratory.
* ER/PR negative (<10% of cells staining for ER or PR) breast cancer or have ER/PR positive (>=10% of cells staining for ER or PR) breast cancer that has exhausted standard endocrine therapy and/or in the opinion of the treating oncologist, warrants cytotoxic chemotherapy.
* Measurable disease as defined by RECIST v1.1. Measurable lesions will be confirmed by radiographic imaging (CT or MRI). Patients with bone only disease will be eligible if disease is considered measurable and a soft tissue component is present and can be biopsied..
* There is no limit to prior lines of therapy, but patients must not have received prior taxane chemotherapy in the metastatic setting.
* ECOG Performance Status <= 2.
* Adequate organ function as defined below:
* Absolute Neutrophil Count >= 1.0 x 10^9/L
* Platelet count >= 100,000 /μL
* Hemoglobin >= 8.0 g/dL
* Total bilirubin <= 1.5 x upper limit of normal
* AST and ALT <= 3 x upper limit of normal
* Serum creatinine <= 2 x upper limit of normal OR Creatinine clearance > 40 ml/min/1.73 m^2
* Women of child-bearing potential and male subjects who are sexually active with a woman of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 6 months following last infusion of cirmtuzumab. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Existing neuropathy must be no greater than Grade 1.
* No concurrent antibody therapy can be planned with the exception of denosumab for use in bone metastasis.
* CNS metastases are allowed as long as the metastases are asymptomatic, have been treated with radiation, and have been stable for > 6 weeks off steroids.
EXCLUSION CRITERIA:
* Patient is currently receiving chemotherapy or has received another chemotherapy within 5 half-lives, radiotherapy or immunotherapy within 2 weeks prior to study treatment initiation.
* Patient has known, untreated and/or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Patient had disease that was refractory to paclitaxel in the neoadjuvant setting and/or developed metastatic breast cancer within 6 months of neoadjuvant or adjuvant taxane chemotherapy.
* Patient has had major surgery within 3 weeks prior to enrollment.
* Patient has severe and/or uncontrolled medical disease(s) (i.e., myocardial infarction within 6 months of study, CKD stage IV or above, severe chronic pulmonary disease or active infection).
* The patient has known acute or chronic hepatitis B or C.
* The patient has a history of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel.
* The patient has a history of another malignancy within 2 years prior to study entry, except curatively treated non-melanotic skin cancer, cervical carcinoma in situ or stage I colon cancer.
* Patient has a history of non-compliance or other medical illness that would preclude compliance with study procedures.
* Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
* Patient has severe cardiac insufficiency (NYHA III or IV) with uncontrolled and/or unstable cardiac or coronary artery disease
* Patient is pregnant or nursing. There is a potential for congenital abnormalities and for this regimen to harm nursing infants.
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
| NCT02776917 | 94,433 |
{
"NCT_ID" : "NCT01901042",
"Brief_Title" : "Efficacy of Symbiotic in the Reduction of Acute Radiation Proctitis Symptoms",
"Official_title" : "Efficacy of Symbiotic in the Reduction of Acute Radiation Proctitis Symptoms. A Randomized, Double-blind, Placebo-controlled Trial",
"Conditions" : ["Radiation Proctitis", "Prostate Cancer"],
"Interventions" : ["Dietary Supplement: Symbiotic", "Dietary Supplement: Maltodextrin"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2", "PHASE3"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-01",
"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" : 2013-05-26",
"First_Posted(Estimated)" : 2013-07-17"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-07-13",
"Last_Update_Posted(Estimated)" : 2013-07-17",
"Last_Verified" : 2013-07"
}
}} | #Study Description
Brief Summary
Radiation proctitis is quite common in treatment of pelvic tumors. We investigated whether the use of symbiotic would prevent early symptoms of radiation proctitis and improve the quality of life in patients undergoing radiotherapy for prostate cancer treatment. We randomized patients to intake one sachet of either a symbiotic product containing 4.3 g of dietary fiber and Lactobacillus reuteri in a concentration greater than 10(8)colony forming units (CFU)(Fibermais Flora Nestlé Brazil) or sachets containing 5 g of maltodextrin. They were instructed to dilute one sachet in 200mL of water and drink once a day during the week before the beginning of radiotherapy sessions, and increase the dose to two sachets daily after the beginning of the sessions for four weeks. Every week a questionnaire named EORTC QLQ-PRT23 was applied to evaluate GI symptoms and quality of life.
Detailed Description
This is a prospective randomized, double-blind, placebo-controlled trial. The study included consecutively 20 patients referred for treatment of prostate cancer using three-dimensional conformal radiotherapy (3D-RCT). All patients who agreed to participate signed an informed consent form. The exclusion criteria used in this study were: a patient's refusal to participate in the research and history of surgery involving the rectum or inflammatory bowel disease Patients were randomly assigned to receive sachets containing either a symbiotic product in powder form containing 4.3 g of dietary fiber and Lactobacillus reuteri in a concentration greater than 1.0 x 108 colony forming units (CFU), with five grams per sachet (Fibermais Flora Nestlé Brazil) (symbiotic group) or maltodextrin (5g) with identical casing and identical aspect of the symbiotic group. All subjects were instructed to dilute one sachet in a glass of water and drink once a day during the week before the beginning of radiotherapy sessions, increasing the dose to two sachets daily after the beginning of the sessions.
EORTC QLQ-PRT23 questionnaire Each participant answered the questions of the EORTC QLQ-PRT23 questionnaire before the beginning of radiotherapy and immediately after the first, second, third and fourth weeks of treatment. The questions were always asked by an examiner blinded to the study design and type of treatment used. The EORTC QLQ-PRT23 questionnaire, originally developed in English, was translated into Portuguese following the protocol described at the EORTC Translation Procedure : The sum of points obtained by each patient through the first 21 questions of the EORTC QLQ-PRT23 was recorded. All these 21 questions received a number of points according to the intensity of each symptom or problem during the previous week, as follows: - 'Not at all' = 1 point; 'A little' = 2 points; 'Quite a bit' = 3 points; and 'Very much' = 4 points.
Radiotherapy protocol A total dose of 66-76 Gy during 6-8 weeks was programmed for each individual. Patients were followed-up until the fourth week of radiotherapy and the cumulative dose of radiation was compared weekly between the two groups. Each patient was scheduled to receive a dose of two grays (Gy) per day, from Monday to Friday with weekend interval, totaling 10 Gy per week and 40 Gy after the 4th week of treatment. The irradiated rectal volume after an accumulated dose of 40 Gy was compared between the two groups using dose-volume histograms and presented in percentages of the rectal volume which received 10 Gy (V10), 20 Gy (V20), 30 Gy (V30), and 40 Gy (V40).
Outcome variables The endpoints of the study were the intensity of the gastrointestinal symptoms and quality of life. All patients were scored with the sum of questions from 1 to 21 to represent both gastrointestinal symptoms and quality of life; and the sum of the scores obtained with questions numbered from 1 to 15, which refer only to gastrointestinal symptoms. Presence of blood in stools and tenesmus intensity were also assessed according to the score described above and used in the questionnaire. It was also recorded the maximum number of evacuations that each patient had over a period of 24 hours each week.
Statistical analysis For the calculation of the sample, it was estimated that the symbiotic group would present a median of four points lower than the score of the placebo group over four weeks. A total of twenty patients (10 in each group) was calculated considering an error alpha of 1% and a beta error of 90%. The Statistical Package for Social Sciences (SPSS) for Windows 9.0 was used for statistical analysis. A level of 5% (p \<0,05) was established for significance. Fischer's test or chi-square test was used for categorical variables. For continuous data, we used the Mann-Whitney or Student's t according to the homogeneity (Levene test) and normality (Kolgomorov-Smirnov test) data. Repeated measures ANOVA was used to analyze the responses obtained by the EORTC QLQ-PRT23 questionnaire.
#Intervention
- DIETARY_SUPPLEMENT : Symbiotic
- Sachets with a symbiotic product in powder form containing 4.3 g of dietary fiber and Lactobacillus reuteri in a concentration greater than 1.0 x 108 colony forming units (CFU), with five grams per sachet (Fibermais Flora Nestlé Brazil).
- Other Names :
- FiberMais Flora (Nestlé, Brazil)
- DIETARY_SUPPLEMENT : Maltodextrin
- Control patients will receive sachets containing maltodextrin
- Other Names :
- Placebo supplement | #Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing radiotherapy due to prostate cancer
Exclusion Criteria:
* refuse to participate, previous rectal condition or surgery, inflammatory bowel disease
Sex :
MALE
Ages :
- Minimum Age : 50 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01901042 | 223,085 |
{
"NCT_ID" : "NCT00647946",
"Brief_Title" : "Study to Evaluate Changes in Limb Fat When Switching From a Thymidine Analogue",
"Official_title" : "A Phase II, Open-Label, Multicentre, Randomised, Comparator Study of Substitution With Tenofovir or Abacavir in HIV-1 Infected Individuals, With a Viral Load < 50 Copies/mL, Receiving a Thymidine Analogue (Zidovudine or Stavudine) as Part of Their Highly Active Antiretroviral Therapy (HAART)",
"Conditions" : ["Lipodystrophy"],
"Interventions" : ["Drug: abacavir 300mg twice daily", "Drug: tenofovir DF"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2003-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2004-10",
"Study_Completion_Date(Actual)" : "2006-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-03-27",
"First_Posted(Estimated)" : 2008-04-01"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-03-27",
"Last_Update_Posted(Estimated)" : 2008-06-30",
"Last_Verified" : 2008-06"
}
}} | #Study Description
Brief Summary
A previous study substituting zidovudine or stavudine to abacavir in patients with severe or moderate lipoatrophy has shown an increase in limb fat by DEXA. This study was conducted over a 24-week period and although improved outcomes were documented by objective measures, DEXA scans, subjective observation did not correspond. Longer-term follow up of these patients is required.
This 48 week study is designed to compare the substitution of the thymidine analogues zidovudine (ZDV) or stavudine (D4T) with either tenofovir DF or abacavir, in patients treated with highly active antiretroviral therapy (HAART), and show improved outcomes on total limb fat mass, improved body shape by dual energy x-ray absorptiometry (DEXA) and computed tomography (CT) scans and improved cholesterol and triglycerides.
Detailed Description
This is a phase II, open-label, multicentre, randomised, two-arm study of 48 weeks duration. One hundred HIV infected individuals who have documented lipodystrophy at \> 1 body/facial site and currently receiving zidovudine (ZDV) or stavudine (d4T) will be recruited.
#Intervention
- DRUG : tenofovir DF
- tenofovir DF 300mg once daily along with the other antiviral drugs
- DRUG : abacavir 300mg twice daily
- abacavir 300mg twice daily along with the other antiviral drugs | #Eligibility Criteria:
Inclusion Criteria:
* Subjects who are male or female > 18 years
* Subjects who are HIV-1 infected as documented by a licensed HIV-1 antibody ELISA
* Female subjects of childbearing potential must have a negative serum pregnancy test (beta-HCG) within 28 days of trial day 1. Women of childbearing potential must agree to use a barrier method of contraception
* Female subjects must not be pregnant or lactating
* Subjects who in the opinion of the investigator have the ability to understand and provided written informed consent to participate in the trial
* Subjects who in the opinion of the investigator have clinical lipoatrophy at > 1 body/facial site
* Subjects currently receiving nucleoside analogue regimen including stavudine (d4T) or zidovudine (ZDV)
* Subjects who are stable on current therapy for >16 weeks
* Subjects with no prior exposure to tenofovir, abacavir, or adefovir
* Subjects with no known K65R, 69S mutations or 3 or more thymidine analogue mutations
* Subjects with documented viral load <50 copies/ml on 2 consecutive occasions including most recent clinic attendance
Exclusion Criteria:
* Subjects who in the investigator's opinion are unlikely to complete the 48 week trial period
* Currently active opportunistic disease or documented wasting syndrome
* Currently receiving chemotherapy for malignancy
* Subjects who in the opinion of the investigator are unlikely to retain viral response after switching based on treatment or transmission history
* Currently receiving an insulin sensitising agent (glitazone or metformin)
* Anabolic steroids in the last 16 weeks other than testosterone at replacement doses (<250mg/2 weekly)
* Growth hormone use in the last 16 weeks
* Statin therapy (HMG CoA reductase inhibitor) commenced in the last 16 weeks (patients stable on statins my be included)
* Current alcohol or illicit drug use which, in the opinion of the investigator, may interfere with the subjects' ability to comply with the dosing schedule and protocol evaluations
* Receiving concurrent medications that - in the opinion of the investigator and according to drug product labelling - will result in clinically significant interactions with tenofovir or abacavir
* Pregnant or breast feeding
* Previously received more than 3 months zidovudine monotherapy
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
| NCT00647946 | 119,347 |
{
"NCT_ID" : "NCT05372380",
"Brief_Title" : "A Study to Evaluate Drug-drug Interactions Between BR1017-1 and BR1017-2 in Healthy Volunteers",
"Official_title" : "An Open Label, One-sequence, 3-period Study to Evaluate Drug-drug Interactions and Safety Between 'BR1017-1' and 'BR1017-2' in Healthy Volunteers",
"Conditions" : ["Hypertension", "Hypercholesterinemia"],
"Interventions" : ["Drug: BR1017-2", "Drug: BR1017-1"],
"Location_Countries" : ["Korea, Republic of"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SEQUENTIAL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-05-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-06-04",
"Study_Completion_Date(Actual)" : "2022-06-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-05-09",
"First_Posted(Estimated)" : 2022-05-12"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-05-09",
"Last_Update_Posted(Estimated)" : 2023-02-08",
"Last_Verified" : 2023-02"
}
}} | #Study Description
Brief Summary
To evaluate the influence of BR1017-1 and BR1017-2 on pharmacokinetics and safety when administered separately or co-administered to healthy volunteers.
Detailed Description
A total of 32 subjects will be enrolled in one sequence group. The investigational products will be administered according to the treatment groups (F, AE, F+AE) assigned to one sequence group in Period 1, Period 2, and Period 3.
#Intervention
- DRUG : BR1017-1
- Administration to the F/F+AE group: BR1017-1 will be administered 1 tablet QD, five-day repeat dose
- Other Names :
- Fimasartan 60mg
- DRUG : BR1017-2
- Administration to the AE group: BR1017-2 will be administered 1 tablet QD, 9-day repeat dose Administration to the F+AE group: BR1017-2 will be administered 1 tablet once QD, 5-day repeat dose.
- Other Names :
- Atorvastatin 40mg / Ezetimibe 10mg | #Eligibility Criteria:
Inclusion Criteria:
* Health adults aged 19 to 55 at screening.
* Male adults whose weight is >=50kg and female adults whose weight is >=45kg, and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2 BMI (kg/m2) = weight (kg) / [height (m)]2
* Those who are given detailed explanations about the trial and express their voluntary consent to participate in the trial by signing a written consent before screening procedure begins.
Exclusion Criteria:
* Those who have history of clinically significant diseases including hypersensitivity reaction, intolerability and anaphylaxis to major ingredients and other ingredients of the investigational products.
* Those who have history of clinically significant diseases related to liver (including severe hepatopathy), kidney (including severe renal impairment), digestive system (including pancreatitis), respiratory system, musculoskeletal system, endocrine system (patients with diabetic ketoacidosis, diabetic coma and precoma, type 1 diabetes, etc.), neuropsychiatric system, hemato-oncology system, cardiovascular system (including heart failure and orthostatic hypotension), etc.
* Those who have medical history of gastrointestinal system diseases (for example: Crohn's disease, peptic ulcer disease, etc.) or operations that may influence the absorption of investigational products. (However, appendectomy, hernia operation, endoscopic polypectomy and hemorrhoids/anal fissure/anal fistula surgeries are excluded.)
* Those who are judged unfit for the trial at screening as follows:
* Serum ALT, AST and total bilirubin > twice the upper limit of normal levels
* e-GFR < 60 mL/min/1.73m2 (using the CKD-EPI equation)
* Positive to HBsAg, HCV Ab, HIV and Syphilis regain test (RPR)
* Systolic blood pressure of > 160 mmHg or < 110 mmHg, or diastolic blood pressure of > 100 mmHg or < 70 mmHg from vital signs measured from sitting position after 3 minutes of resting.
* Those whose test results at screening other than those mentioned in paragraph 4) above are abnormal and judged clinically significant
* Those who have participated in other clinical trials and have been administered with other investigational products in 180 days prior to the first administration of the investigational product. (The day after the last administration of any previous clinical trial's investigational product shall be counted as day 1 of the end of trial.)
* Those who took prescription drugs (including herbal medicine prescriptions) or OTC in 14 days prior to the first administration of the investigational products, or those who have not expressed their consent for drug prohibition from 14 days before the first administration of the investigational products until the end of study. (However, medicinal products may be administered if the subjects' safety and study results are considered to be unaffected according to the investigator's judgement.)
* Those who have given whole blood donation in 8 weeks before the first administration of the investigational products, who have given plasma/platelet donation or received blood transfusion in 4 weeks before the first administration of the investigational products and who have not expressed their consent for blood-donation prohibition from the first administration of the investigational products until 30 days after the final administration.
* Those who have history of continuous, excessive smoking or alcohol intake in 6 months before screening (Alcohol: > 21 units/week (1unit=10g=12.5mL); Smoking: > 10 cigarettes/day), those who cannot stop smoking or caffeine intake during hospitalization or those who cannot stop drinking from 48 hours before the first administration throughout the entire study period.
☞ Amount of alcohol (g) = Amount of intake (ml) x alcoholicity (%) x 0.8* (*10g=12.5mL)
* Those who have history of diet (e.g., grapefruit juice) and health/functional food intake that can influence absorption, distribution, metabolism and excretion of the investigational products in 3 days from the first administration of the investigational product or who cannot stop the intake of such diet and food from 3 days before the first administration until the end of study.
* Those who have drug abuse (especially centrally acting drugs including sleeping pills, centrally acting pain liver, opiates or psychoactive drugs), have history of drug abuse or whose urine drug test is positive.
* Those who cannot use contraceptive measures (including sterilization operation of the subject and his/her partner, intrauterine contraceptive device and use of diaphragm or condom) that are allowed for clinical trials from the first administration of the investigational products until the last visit.
* Those who have genetic problems including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
* Those who have history of hypersensitivity or allergy on Yellow No. 5 (Sunset Yellow FCF) ingredients.
* Female participants who are pregnant or breastfeeding, or those whose pregnancy test is positive.
* Others who are judged to be ineligible to participate in the trial by the investigator.
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT05372380 | 47,145 |
{
"NCT_ID" : "NCT03894982",
"Brief_Title" : "Family Learning on Asthma Topics",
"Official_title" : "Family Learning on Asthma Topics",
"Conditions" : ["Asthma"],
"Interventions" : ["Other: Group Classes"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-05-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-05-31",
"Study_Completion_Date(Actual)" : "2020-05-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-03-27",
"First_Posted(Estimated)" : 2019-03-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-03-27",
"Last_Update_Posted(Estimated)" : 2020-08-04",
"Last_Verified" : 2020-07"
}
}} | #Study Description
Brief Summary
1. Hypothesis: The Family Learning on Asthma Topics (F.L.O.A.T) in the form of a a group teaching environment for family education stemming from standardized education materials on asthma, created and taught by nationally certified asthma educators will promote optimal asthma knowledge, management and quality of life among the individuals with asthma and their caregivers.
2. Aim 1: To determine if the availability of educational services outside of regular clinic hours or admission status could improve asthma outcomes and decrease unnecessary medical utilization.
3. Aim 2: By providing small-group learning environments for families, the investigators aim to encourage families to learn from each other's experiences and to decrease stigma around the disease.
Detailed Description
I. Hypotheses and Specific Aims:
1. Hypothesis: The Family Learning on Asthma Topics (F.L.O.A.T) in the form of a a group teaching environment for family education stemming from standardized education materials on asthma, created and taught by nationally certified asthma educators will promote optimal asthma knowledge, management and quality of life among the individuals with asthma and their caregivers.
2. Aim 1: To determine if the availability of educational services outside of regular clinic hours or admission status could improve asthma outcomes and decrease unnecessary medical utilization.
3. Aim 2: By providing small-group learning environments for families, the investigators aim to encourage families to learn from each other's experiences and to decrease stigma around the disease.
II. Background and Significance:
Despite recent improvements in treatment and the ongoing research in better understanding of the disease, emergency room visits and hospitalization rates for asthma remain high. The Centers for Disease Control and Prevention surveillance data reports that at a national level, health care use for emergency department services for asthma was 1.6 million in 2013, and that of 439,435 hospital admissions for asthma 136,669 or 31% are for children below the age of 18 years of age. The annual cost of asthma on the U.S. economy equates to more than $80 billion in medical expenses, including days missed from school, work and even death. Nurmagambetov, et.al. in their study state that the 'combined costs of medical care, mortality, and absenteeism render the total cost of asthma a substantial and serious economic burden on society. These findings highlight the critical need to support and further strengthen asthma control strategies through increased provision of guideline-based care, improvements in self-management, and reduction of environmental asthma triggers to reduce ER visits, hospitalizations, absenteeism, and mortality'.
Bäuerle et al. used a prospective single-center controlled trial to show that by providing motivating and patient-oriented didactics on asthma, there is a statistically significant increase in asthma health outcomes and that asthma control can be improved by education measures. Although it is a key component of all international asthma guidelines, education in self-management is still insufficiently available in primary care settings. In the ambulatory setting, there are some families that require more extensive education and time is limited in a usual care appointment to address all their specific asthma needs.
Providing patient education by an experienced asthma educator is an important step in supporting patients and families as they are diagnosed with asthma and as they adapt to life with a chronic condition. Educating families about the nature of the disease, triggers, identification of early signs and symptoms, principles of treatment, and asthma management can reduce children's use of acute care services. According to Srof et al., asthma management education programs should be connected to the chronic illness management within the fabric of the family system. The paradigm of group education supports engagement, promoting communication among all participants including facilitator to enhance a social construct for validating personal experiences, empowering caregivers, and solving asthma management problems.
III. Preliminary Studies/Progress Report: none
IV. Research Methods
A. Outcome Measure(s):
Decrease emergency room visits, hospitalizations, and systemic steroid use for each child 12 months after completing the three, group classroom educational sessions.
1. Description of Population to be Enrolled:
The investigators will enroll legal guardians and or primary caregiver (18 years and older) of children 4-17 years of age along with those children/adolescents who have a diagnosis of asthma, and have documented poor control as evidenced by requiring two or more systemic steroids, one or more hospitalizations and/or two or more ED visits due to asthma in the 12 months prior to the asthma clinic or hospital visit. Patients and caregivers will be English or Spanish speaking.
2. Study Design and Research Methods:
Patients and caregivers will be recruited from the Pulmonary outpatient clinic and inpatient services at Children's Hospital Colorado. Patients will also be referred to the Family Learning on Asthma Topic (F.L.O.A.T) program by health care providers participating in these clinics/inpatient service. Children will be: 1) 4-17 years age, 2) have poor evidence of asthma control based on \> 2 systemic steroid courses; \> 2 Emergency Room visits; and \>1 hospitalization for asthma exacerbation in the preceding 12 months. The investigators anticipate to enroll 75 patients and enrollment to begin in the Spring 2019 through the Spring 2020.
Family Learning on Asthma Topics classes will aim to emphasize, encourage, and support teaching methods that include standardized instructions. There will be three topics lasting approximately 45 minutes: General Asthma Knowledge; Asthma Triggers, Medications, and Self-Management. These topics were chosen based on the EPR-3 guideline recommendations to ensure the continuity of messaging. Each class size will be approximately 8 persons and will be taught by a Certified Asthma Educator (AE-C) and will be held in the Family Learning Center at the Children's Hospital Colorado. Classes will be taught in both English and Spanish. An in person Spanish asthma educator will be available to help teach the classes.
The materials used for each class were created by the CHCO Health Literacy Team in collaboration with Asthma Educator Certified members of the Breathing Institute to ensure that evidence-based information will be communicated effectively to patients and families. Instead of a lecture style course, each class will facilitate interactive learning for patients and families to help them prepare for real life problem-solving and to promote self-awareness regarding medication use.
Patient and families enrolled will be notified of the class schedule and receive reminders 1 week and the day before each of their classes either through email, phone call and or text messaging.
There will be a general asthma knowledge questionnaire consisting of 12 questions and the standardized Asthma Control Test (ACT) that consists of 7 standardized questions, one for children 4 - 11 years of age and one for children 12 years and older, that participants will fill out at the start of their first class. After each class, there will be 4 questions to be answered regarding their understanding of that class. Handouts and visuals will be available in English and Spanish pertaining to information about that class. Other class materials will include a folder to keep their handouts in and paper and pencils for note taking. Peak flow meters and their Asthma Action Plans will also be provided. At the completion of the class series there will be a satisfaction survey, participants will fill out anonymously.
Twelve months following the completion of the class series, the investigators will be conducting a chart review gathering data on frequency of emergency room visits, hospitalizations and systemic steroid use for asthma exacerbations along with any routine follow up visits for asthma.
3. Description, Risks and Justification of Procedures and Data Collection Tools:
Data collected will be through pre and post class questionnaires, Asthma Control Test (ACT), validated Inhaler Technique Assessment Tool (iDAT), and demographic information filled out by the families and noted in their EMR (EPIC). Information about participant's asthma care utilization and systemic steroid use will be obtained through EMR/EPIC chart review, 12 months prior to enrollment and 12 months post last completed class. All information will be entered in to a secure REDCap data base and paper copies will be kept in the locked research cabinet of study personnel.
E. Potential Scientific Problems: The investigators do not anticipate any scientific problems
F. Data Analysis Plan:
Inclusion requirements will be defined through the electronic medical record based on inclusion requirements by either the outpatient pulmonary team or inpatient asthma education team.
After enrollment the following information will be placed into RedCap (HIPPA compliant database) from the EMR: Childs name, DOB, Race, Ethnicity, Cell phone number, Email, Zip Code, Sex, Preferred language (caregiver), Pulmonary or Allergy specialist seen within the previous year, Payer, Hospital visits (ED and hospital visits) 12 months prior to consent.
Right after enrollment a pre-knowledge base survey of 12 questions and asthma control survey of 7 questions will be sent via RedCap to caregivers defined phone and email. The data will be collected electronically and stored in RedCap.
Throughout the 4-month study period, every week an administrative support person will pull the child's name, caregivers name, designated contact phone number, and email from RedCap databased to send a text, email, and phone call reminders of upcoming classes and asking the caregiver to reply electronically if they are planning on attending. The administrative assistant will review the reply's and notify the educators of the number of class attendees and their names.
Upon completing each of the three classes the instructor will ask for the administrative assistant to send a post knowledge bases survey of 4 questions out of RedCap to the primary caregiver. The electronic responses will be electronically entered into RedCap.
Upon completion of the 3 classes and/or 4months the administrative assistant will send a post-knowledge survey consisting of 12 questions, an asthma control test survey of 7 questions, and a satisfaction survey to the primary caregiver. The electronic responses will be entered into RedCap.
Each quarter the overview of pre-knowledge base survey results, post-knowledge survey results and satisfaction survey will be reviewed by the team members to evaluate if any changes need to be made to the education curriculum.
Child specific data will be reviewed 12 months after completion of the classes and/or study.
G. Summarize Knowledge to be Gained:
By conducting this group focused asthma education series for high risk asthmatics and their care givers, the investigators anticipate improved knowledge along with retention of knowledge gained through these classes thereby reducing exacerbations, and need for acute care interventions. Group centered learning will enhance opportunities to learn from others who may have similar experiences and will generate discussion and new skills and ideas.
#Intervention
- OTHER : Group Classes
- Family Learning on Asthma Topics classes will aim to emphasize, encourage, and support teaching methods that include standardized instructions. There will be three topics lasting approximately 45 minutes: General Asthma Knowledge; Asthma Triggers, Medications, and Self-Management. These topics were chosen based on the EPR-3 guideline recommendations to ensure the continuity of messaging. Each class size will be approximately 8 persons and will be taught by a Certified Asthma Educator (AE-C) and will be held in the Family Learning Center at the Children's Hospital Colorado. Classes will be taught in both English and Spanish. | #Eligibility Criteria:
Inclusion Criteria:
* Legal guardians and or primary caregiver (18 years and older) of children 4 <= age <= 17 years
* Children/adolescents who have a diagnosis of asthma, and have documented poor control as evidenced by requiring two or more systemic steroids, one or more hospitalizations and/or two or more ED visits due to asthma in the 12 months prior to the asthma clinic or hospital visit.
* Patients and caregivers will be English or Spanish speaking.
Exclusion Criteria:
* children < 4 yrs of age
* children with multiple chronic lung diseases
* Children and families whose primary language is other than English or Spanish
Sex :
ALL
Ages :
- Minimum Age : 4 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
| NCT03894982 | 15,888 |
{
"NCT_ID" : "NCT05203185",
"Brief_Title" : "Nudging Provider Adoption of Clinical Decision Support",
"Official_title" : "Nudging Provider Adoption of Clinical Decision Support",
"Conditions" : ["Pulmonary Embolism"],
"Interventions" : ["Other: Pulmonary Embolism Risk Kalculator (PERK)"],
"Location_Countries" : ["United States"],
"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)" : "2021-07-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-04-30",
"Study_Completion_Date(Actual)" : "2022-04-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-01-10",
"First_Submitted_that_Met_QC_Criteria" : 2023-06-01",
"First_Posted(Estimated)" : 2022-01-24"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-01-10",
"Last_Update_Posted(Estimated)" : 2023-06-26",
"Last_Verified" : 2023-06"
}
}} | #Study Description
Brief Summary
The central hypothesis of this proposal is that the addition of a theory-informed 'nudge' to a clinical decision support (CDS) tool will address identified behavioral barriers to use and significantly improve adoption by providers. Nudges are applications of behavioral science, defined as positive reinforcement and indirect suggestions that have a non-forced effect on decision making. This study will use a behavioral theory-informed process to develop a new CDS tool that includes a nudge that addresses barriers to adoption.
Detailed Description
The research team developed and pilot tested two CDS tools for pulmonary embolism (PE) risk stratification in the Emergency Department (ED). One of the tools incorporated two behavioral theory-informed nudges in the user interface. The research team's objective was to pilot test the tools to demonstrate feasibility as well as examine preliminary efficacy of the nudges on provider adoption of the tool. This cluster non-randomized controlled trial took place between September 20th, 2021 and March 3rd, 2022 in two EDs that are a part of a large academic health system in the New York City metropolitan area. All ED providers (physicians, physician assistants and nurse practitioners) seeing patients for the evaluation of PE during this time were included in the trial. The EDs were chosen based on their comparable size and acuity levels.
#Intervention
- OTHER : Pulmonary Embolism Risk Kalculator (PERK)
- Nudges are applications of behavioral science, defined as positive reinforcement and indirect suggestions that have a non-forced effect on decision making. Nudges will be to the PE CALC CDS tool to develop the new CDS tool, PERK. | #Eligibility Criteria:
Inclusion Criteria:
* Medical doctors, nurse practitioners and physician assistants working full time at Huntington Hospital and Long Island Jewish Valley Stream
Exclusion Criteria:
* Does not meet the inclusion criteria
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT05203185 | 267,167 |
{
"NCT_ID" : "NCT02730104",
"Brief_Title" : "Community-based Neuroendocrine Tumor (NET) Research Study",
"Official_title" : "Prospective Observational Study in Patients With Locally Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumors Treated With Lanreotide Depot in a US Community Oncology Setting",
"Conditions" : ["Gastroenteropancreatic Neuroendocrine Tumors"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-11-23",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-05-13",
"Study_Completion_Date(Actual)" : "2020-05-13},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-04-01",
"First_Posted(Estimated)" : 2016-04-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-04-01",
"Last_Update_Posted(Estimated)" : 2020-06-26",
"Last_Verified" : 2020-06"
}
}} | #Study Description
Brief Summary
The purpose of this trial is to assess time to disease progression of patients with locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors treated with Lanreotide Depot. This is an observational study therefore all data collected will be in accordance with the routine practice of physicians.
| #Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed locally advanced or metastatic, well-differentiated neuroendocrine tumor (NET) of the small bowel, stomach, colon/rectum, or pancreas (low or intermediate grade; i.e. G1 or G2)
* Treatment with lanreotide depot (Somatostatin Analogue-naïve patients and patients with prior treatment with octreotide long-acting repeatable (LAR) are permitted)
* Radiographically measurable disease
* Has signed the most recent written Patient Informed Consent Form
Exclusion Criteria:
* Known hypersensitivity to lanreotide
* Poorly differentiated or high grade carcinoma, or patients with neuroendocrine tumors not of lung or thymic origin
* Patients who have previously initiated treatment with lanreotide depot prior to the start of the study cannot have progressed between lanreotide initiation and study entry
* Significant history of uncontrolled cardiac disease (ie, myocardial infarction within 6 months prior to enrollment or has congestive heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities)
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
| NCT02730104 | 74,219 |
{
"NCT_ID" : "NCT01870258",
"Brief_Title" : "Myocardial Infarction Prediction",
"Official_title" : "Prediction of Acute Myocardial Infarction With Artificial Neural Networks in Patients With Nondiagnostic Electrocardiogram",
"Conditions" : ["Myocardial Infarction", "Artificial Neural Network"],
"Interventions" : ["Other: ANN prediction of myocardial infarction"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "DIAGNOSTIC",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-04",
"Study_Completion_Date(Actual)" : "2012-06},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-05-24",
"First_Posted(Estimated)" : 2013-06-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-06-04",
"Last_Update_Posted(Estimated)" : 2013-06-06",
"Last_Verified" : 2013-06"
}
}} | #Study Description
Brief Summary
prediction of MI in patients with chest pain and nondiagnostic ECG was done in 2 weeks
Detailed Description
Myocardial infarction remains one the leading causes of mortality and morbidity and involves a high cost of care. Early prediction can be helpful in preventing the development of myocardial infarction with appropriate diagnosis and treatment. Artificial neural networks have opened new horizons in learning about the natural history of diseases and predicting cardiac disease.
Methods: A total of 935 cardiac patients with chest pain and nondiagnostic electrocardiogram (ECG) were enrolled and followed for 2 weeks in two groups based on the appearance of myocardial infarction. Two types of data were used for all patients: nominal (clinical data) and quantitative (ECG findings). Two different artificial neural networks - radial basis function (RBF) and multi-layer perceptron (MLP) - were used.
#Intervention
- OTHER : ANN prediction of myocardial infarction
- Other Names :
- sofware detected risk of new myocardial infraction | #Eligibility Criteria:
Inclusion Criteria:
* patient with chest pain refered to ER with nondiagnostic ECG
Exclusion Criteria:
* 1) Absence of a history of myocardial infarction
* 2) Absence of bundle branch block, Wolf-Parkinson-White abnormality, ventricular hypertrophy or previous ECG signs of myocardial infarction,
* 3) Absence of a history of percutaneous coronary surgery or coronary artery bypass grafting,
* 4) Absence of ECG abnormalities attributable to drugs such as digoxin or tricyclic antidepressants.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 72 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01870258 | 94,038 |
{
"NCT_ID" : "NCT03942822",
"Brief_Title" : "Chia Supplementation and Non Alcoholic Fatty Liver Disease",
"Official_title" : "Effect of a Chia Supplemented Diet (Salvia Hispanica) on the Cardiometabolic Risk Profile in Patients With NAFLD (Non Alcoholic Fatty Liver Disease)",
"Conditions" : ["Non-Alcoholic Fatty Liver Disease", "Dietary Modification"],
"Interventions" : ["Dietary Supplement: Milled chia seeds"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-09-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-09-01",
"Study_Completion_Date(Actual)" : "2017-09-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-04-25",
"First_Posted(Estimated)" : 2019-05-08"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-05-07",
"Last_Update_Posted(Estimated)" : 2019-05-08",
"Last_Verified" : 2019-05"
}
}} | #Study Description
Brief Summary
Parallel to epidemic obesity, non-alcoholic fatty liver disease (NAFLD) prevalence has markedly increased during the last years, and recent data point out that one of three adults courses with this disease. NAFLD etiopathogeny is multifactorial, an inadequate diet characterized by high fructose content and deficient consumption of omega-3 fatty acids, scarce physical activity, excess abdominal visceral fat (AVF), insulin resistance, and genetic susceptibility have shown to be relevant determinants. Although NAFLD can progress to cirrhosis and hepatic carcinoma, its most frequent complications are type 2 diabetes mellitus (DM2) and coronary artery disease (CAD); therefore, NAFLD is considered a multisystemic disease and a public health problem.
Currently, no specific pharmacological treatment is available for NAFLD, hence, modifications in life style, including weight loss by caloric restriction and increased physical activity, are still the treatment of choice for this type of patients. Recent studies indicate that the supplementation of the diet with omega-3 fatty acids of marine origin (eicosapentanoic acid \[EPA\]/docosahexaenoic acid \[DHA\]) and the Mediterranean-style diet (rich in omega-3, antioxidants, and fiber) are efficient for NAFLD treatment, because they diminish the intrahepatic fat content and improve the metabolic profile, even in non-caloric restriction diets. However, the socioeconomic and cultural characteristics make the consumption of these food difficult in some populations, which has led to the search of alternative vegetal sources rich in these nutrients.
Although, there is evidence in animal models suggesting that chia (Salvia hispanica L.) could be an alternative able to reduce the intrahepatic fat content, its effect on NAFLD has not been studied in humans. Hence, the objective of this study was to analyze whether the consumption of an isocaloric diet supplemented with 25 g/day of chia can diminish NAFLD and the metabolic anomalies that accompany the disease.
Detailed Description
Participants were chosen from the control group of the Genetics of the Atherosclerotic Disease (GEA, for its initials in Spanish) study, performed at the Institute National of Cardiology 'Ignacio Chávez' in Mexico City, Mexico. The protocol was approved by the Research and Ethics Committee of the Instituto Nacional de Cardiología 'Ignacio Chavez' under the number 16-980. Candidates that accepted to participate in the study signed voluntarily the informed consent.
In order to know eating habits and standardize macronutrient dietary composition, 24-hour dietary recalls will be applied in the first visit, considering two weekdays and one day of the weekend. Patients will be instructed to maintain constant their physical activity throughout the study. To standardize macronutrient dietary composition, an isocaloric diet (55% carbohydrate, 30% fat, and 15% protein diet) will be indicated two weeks before starting chia supplementation. After this, participants will be instructed to keep up this macronutrient composition during all the intervention period. 30 packages of 25 g of chia seeds will be provided to each patient monthly, with the instruction to mill one package per day, pointing out on the relevance of consume the milled chia accompanied by with water, salads, cereal, or other dishes, from breakfast through lunch but always before 6:00 PM. To favor treatment adherence and record adverse events (loss appetite loss, constipation, diarrhea, flatulence and nausea, allergy or chía chia intolerance), patients will be contacted once a week during the intervention. Adherence will be determined by counting empty chia packages, and evaluation of alpha linolenic acid (ALA) concentration in plasma, which is the chia's seeds main fatty acid compound.
Anthropometric evaluation, laboratory test, and computed tomography studies will be made at baseline and after the 8-wk intervention.
Nutritional intervention and food intake evaluation In order to know eating habits and standardize macronutrient dietary composition, 24-hour dietary recalls will be applied in the first visit, considering two weekdays and one day of the weekend. Patients will be instructed to maintain constant their physical activity throughout the study. To standardize macronutrient dietary composition, an isocaloric diet (55% carbohydrate, 30% fat, and 15% protein diet) will be indicated two weeks before starting chia supplementation. After this, participants will be instructed to keep up this macronutrient composition during all the intervention period. 30 packages of 25 g of chia seeds will be provided to each patient monthly, with the instruction to mill one package per day, pointing out on the relevance of consume the milled chia accompained by with water, salads, cereal, or other dishes, from breakfast through lunch but always before 6:00 PM. To favor treatment adherence and record adverse events (loss appetite loss, constipation, diarrhea, flatulence and nausea, allergy or chía chia intolerance), patients will be contacted once a week during the intervention.
Adherence will be determined by counting empty chia packages, and evaluation of alpha linolenic acid (ALA) concentration in plasma, which is the chia's seeds main fatty acid compound. Participants wre excluded when the adherence was lower tan 80% according to the package counting, or when plasma ALA concentration increased less than 30%.
Anthropometric evaluation, laboratory test, and computed tomography studies will be made at baseline and after the 8-wk of diet intervention.
Anthropometric evaluation: Weight and height will be recorded using a calibrated scale and wall stadiometer, with an accuracy of 0.1 Kg kg and 0.1 cm, after removing excess clothing and shoes. The body mass index (BMI) was calculated as weight (kg)/height (m2). Waist circumference will be measured with a non-stretch tape, at the midway between the lowest rib and the iliac crest without clothes around the waist.
Laboratory tests: After 10-h fasting and 20 min in sitting position, venous blood will be collected in assay tubes without anticoagulant and in tubes with K2-EDTA (1.8 mg/mL). Glucose, total cholesterol, triglyceride, and high density lipoprotein cholesterol (HDL-C) concentrations will be determined using direct standard enzymatic colorimetric methods on a COBAS c311 (Roche Diagnostics, Mannheim, Germany). Low density lipoprotein cholesterol (LDL-C) concentration was estimated using the De Long formula. The reproducibility and precision of these determinations in our laboratory is assessed by the Center for Disease Control and Prevention Lipids Standardization Program (LSP-CDC, Atlanta, GA, USA). Plasma free fatty acids (FFA) will be measured by an enzymatic-colorimetric assay (Wako Diagnostics, Chuo-Ku Osaka, Japan). Total fatty acids, including ALA will be extracted according to Folch method, and analyzed in a Shimadzu GC-8A gas chromatograph equipped with an SP2330 capilar column (25m x 0.25 mm x 0.25). Fatty-acid concentrations will be calculated in relation to heptadecanoic acid methyl ester as internal standard, fatty acids peaks will be identified by using the Supelco 37 component FAME Mix (CRM47885). A plasma control sample will be run in each extraction assay, to obtain an ALA inter-assay coefficient variation.
Computed tomography study: Computed tomography (CT) is a validated method for measuring visceral adipose tissue (VAT) and evaluate non alcoholic fatty liver disease. In the present study, these measurements will be obtained using a 64-slice scanner (Somatom Cardiac Sensation 64, Forcheim, Bavaria, Germany). To determine the liver and spleen attenuation index, a single slice CT scan is obtained at the level of T11-T12 or T12-L1. Fatty liver is defined as a liver/spleen attenuation ratio lower than 1.0. To calculate the amount of total abdominal tissue (TAT) and VAT, a single slice scan is obtained at the level of L4-L5, the area is expressed in square centimeters (cm2). Subcutaneous abdominal tissue (SAT) was calculated by subtracting the VAT from the TAT area.
#Intervention
- DIETARY_SUPPLEMENT : Milled chia seeds
- 8 weeks of an isocaloric diet supplemented with 25 g/day of milled chia | #Eligibility Criteria:
Inclusion Criteria:
* Tomographic diagnosis of NAFLD
* Insulin resistance (HOMA-IR > 3.7 in women and 3.4 in men)
Exclusion Criteria:
* Previous diabetes diagnosis
* Use of hypoglycemic or hypolipidemic medications
* Significant weight changes during the previous 3 months (± 5% of their habitual weight)
* Consumption of vitamins, herbal or food supplements
* Gastrointestinal, renal, or hepatic diseases
* Eating, psychiatric or cognitive disorders that would hinder them of understanding and complying with the instructions of the study.
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03942822 | 67,317 |
{
"NCT_ID" : "NCT02827461",
"Brief_Title" : "Heritability of Sleep Homeostasis in Twins",
"Official_title" : "Heritability of Sleep Homeostasis in Twins",
"Conditions" : ["Hereditability of Sleep Homeostasis in Twins"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2003-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-08",
"Study_Completion_Date(Actual)" : "2008-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-06-27",
"First_Posted(Estimated)" : 2016-07-11"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-07-07",
"Last_Update_Posted(Estimated)" : 2016-07-11",
"Last_Verified" : 2016-07"
}
}} | #Study Description
Brief Summary
The purpose of this study is to understand the hereditability of sleep homeostasis, i.e., drive for sleep by looking at monozygotic and dizygotic twins.
Detailed Description
Excessive daytime sleepiness is a prevalent problem in our society associated with an increased risk of vehicular crashes and industrial accidents. Sleepiness is, in part, determined by fundamental biology relating to sleep homeostasis, i.e., the rate of accumulation of the pressure for sleep during wakefulness. A differential susceptibility to sleep deprivation is reported in normal subjects with large intraindividual differences in the degree of functional impairment produced by the same duration of sleep. Genetics are likely to play an important role in sleep homeostasis as shown by recent studies in inbred mouse strains, but whether genetics plays any role in humans and, if so, the magnitude of this role, is unknown. This proposal is based on the hypothesis that sleep homeostasis is a heritable trait in humans. Given the complexity of phenotyping to study sleep homeostasis, the investigators propose that studying differences in the variances of the phenotype between monozygotic and dizygotic twins is the optimal approach to estimate heritability of sleep homeostasis. The investigators will assess sleep homeostasis in 80 pairs of monozygotic and 80 pairs of dizygotic twins by quantifying the increase in delta power during recovery sleep following sleep deprivation and the increase in theta power during the period of prolonged wakefulness. Subjects will be recruited using the PennTwins Cohort, a population-based cohort of about 1,800 twin pairs. If heritability of sleep homeostasis is shown, this EEG-based phenotyping strategy could not be easily applied to the larger scale population studies that will be required to assess underlying genetic variants. Thus, part of the overall strategy is to evaluate, and potentially validate, other approaches to phenotyping that are less physiologically rigorous but are more easily applied to a larger number of subjects. Therefore, as a subsidiary goal, the investigators will also estimate heritability of performance lapses during prolonged wakefulness as a surrogate method to assess sleep homeostasis. The investigators will particularly determine whether the differences in the measures based on our physiological intensive phenotypes between pairs of dizygotic twins are reflected in differences in this phenotyping approach that is simpler to perform. Such a result would indicate that this simpler method could be used in larger scale population studies, and will be part of future strategies to elucidate genetic variants determining sleepiness.
| #Eligibility Criteria:
Inclusion Criteria:
* Being a twin with a twin of same gender
* Age between18 and 55 years
Exclusion Criteria:
All exclusion criteria apply to both members if one twin has any exclusion. The exclusion criteria include the following:
* Previous diagnosis of sleep disorder, e.g., narcolepsy, obstructive sleep apnea; presence of conditions that could interrupt sleep, e.g., chronic pain, asthma, arthritis; presence of fibromyalgia; previous clinical diagnosis of major depression; history of alcoholism or drug abuse; any medical disorder that limits their ability to participate in protocol;
* Use of sedative/hypnotics to promote sleep; use of stimulants, e.g., methylphenidate; use of modafinil; excessive use of caffeine (>500 mg/day); use of psychoactive medications, e.g., antidepressants;
* Shift-work; regular travel across time zones, in particular in the 6 weeks prior to study enrollment; irregular sleep/wake patterns. (This will be assessed prior to in-depth phenotyping by measurement of rest/activity at home (see further below);
* Inability to comprehend English (questionnaires and consent form are in English),
* The study will exclude women who are pregnant or perimenopausal but include women who are postmenopausal without hot flashes, or premenopausal.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT02827461 | 243,743 |
{
"NCT_ID" : "NCT00067106",
"Brief_Title" : "Antiviral Therapy and HIV in the Female Genital Tract",
"Official_title" : "Antiviral Therapy and HIV in the Genital Tract of Women",
"Conditions" : ["HIV Infections"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2003-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2007-03",
"Study_Completion_Date(Actual)" : "2009-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2003-08-11",
"First_Posted(Estimated)" : 2003-08-13"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2003-08-12",
"Last_Update_Posted(Estimated)" : 2015-05-19",
"Last_Verified" : 2014-09"
}
}} | #Study Description
Brief Summary
HIV is found in both the blood and the genital tract. This study will compare the levels and types of HIV found in the blood with the levels and types of HIV found in the female genital tract.
Study hypotheses: 1) In the presence of antiretroviral therapy, viral replication within the female genital tract may lead to the development of drug resistance that is different from that of virus in the blood plasma. 2) Antiretroviral drug levels in the female genital tract may often be lower than in the blood plasma and differences in drug exposure may be associated with differences in virus replication and selection of resistant HIV variants during drug failure. 3) HIV can be recovered in vitro from cells in the female genital tract during successful therapy, and it may be genetically different from the HIV variants recovered from the blood cell latent reservoir on the same visit.
Detailed Description
Approximately 42 million adults are living with HIV/AIDS. The predominant mode of HIV transmission worldwide is through heterosexual contact. While many behavioral and biologic factors are associated with sexual transmission of HIV, viral load has been identified as the chief predictor of the risk of sexual transmission. Research has shown a strong correlation between blood plasma viral load and genital tract viral load. Antiretroviral medications can reduce blood plasma and genital tract HIV RNA levels, but antiretrovirals also lead to drug resistant HIV. In the United States and Europe, 2% to 27% of newly infected patients are infected with drug resistant HIV. There are reports of resistant genotypic variants in the genital tract that differ from variants found in the blood.
Understanding the dynamics of HIV in the genital tract is of great importance in strategies to control transmission of HIV. This study will evaluate the levels and variants of HIV in the blood and genital tracts of women taking antiretroviral medication.
Both women who are failing their current antiretroviral regimen (Group 1) and those who are fully suppressed on antiretroviral therapy (Group 2) will be enrolled in this study. Women in Group 1 will have study visits at study entry, 2 weeks after changing medications, then every 4 weeks until the amount of HIV in the blood and genital tract are undetectable. Drug levels in the blood and genital tract will also be measured at the first visit and after changing medications. Once the level of HIV is undetectable, women will be seen every 3 months for 36 months. Women in Group 1 will be followed no more than 42 months. Women in Group 2 will have study visits for blood and genital tract collections at study entry and then every 4 weeks for 12 months.
| #Eligibility Criteria:
Inclusion Criteria:
* HIV-infected
* Viral load below detectable limits for at least 6 months prior to study entry
* Have not failed an antiretroviral regimen or have failed only one previous antiretroviral regimen
Inclusion Criteria:
* HIV-infected
* Viral load more than 1,000 copies/ml on at least two occasions, with one viral load more than 10,000 copies/ml
* Expect to change to a new antiretroviral regimen
Exclusion Criteria:
Women not on antiretroviral therapy
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
| NCT00067106 | 159,119 |
{
"NCT_ID" : "NCT03587246",
"Brief_Title" : "Comparison of Uterine Peristaltic Wave Frequencies Between Pregnant and Non-pregnant Women in Embryo Transfer Cycles",
"Official_title" : "Comparison of Uterine Peristaltic Wave Frequencies Between Pregnant and Non-pregnant Women in Embryo Transfer Cycles",
"Conditions" : ["Uterine Peristaltic Frequencies Between Pregnant and Non-pregnant Women in Embryo Transfer Cycles"],
"Interventions" : ["Diagnostic Test: 3DTVUS : Uterine peristaltic frequencies"],
"Location_Countries" : ["Thailand"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-07-26",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-12-30",
"Study_Completion_Date(Actual)" : "2018-12-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-07-02",
"First_Posted(Estimated)" : 2018-07-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-07-02",
"Last_Update_Posted(Estimated)" : 2019-03-21",
"Last_Verified" : 2019-03"
}
}} | #Study Description
Brief Summary
Eligibility criteria
* Infertile woemn undergo IVF \& embryo transfer cycles at infertility clinic at King Chulalongkorn Memorial Hospital Measurement
* Uterine peristaltic wave frequencies \& Junctional zone thickness by 3D-TVUS on the day of oocyte retrieval in fresh embryo transfer participants \& day before progesterone supplementation in frozen-thawed embryo transfer participants
* Serum progesterone \& estradiol level in the same day
Detailed Description
The patients who were planning to undergo fresh embryo transfer cycles used GnRH antogonist protocol. Ovarian stimulation was initiated on the menstrual cycle day 3 with use of daily subcutaneous injection of gonodotrophin; human menopausal gonadotrophin (Menopur®), recombinant FSH-alpha (Gonal-F®), recombinant FSH-beta (Puregon®). After 5 days of stimulation, the dosage of gonadotrophin was adjusted based on ovarian response, as assessed by follicular size monitoring and serum estradiol levels. To prevent premature LH surges, ganirelix (Orgalutran®) was administered by subcutaneous injection when at least one follicle reached a diameter of 13 mm. When the leading follicle reached 18 mm in diameter, final oocyte maturation was triggered by subcutaneous injection of recombinant hCG (Ovidrel®) 0.25 mg or double triggered by addition subcutaneous injection of triptorelin (Diphereline®) 0.1 mg. Oocyte retrieval was performed 36 hours after drug administration. Insemination of retrieved oocytes was performed by intracytoplasmic sperm injection (ICSI). Progesterone supplement was started on the day of ovum pickup with 400 mg-micronized vaginal progesterone pessary (Cyclogest®) two times a day. Embryo transfer was performed on day 4 to day 6 of progesterone supplement.
The patients who were planning to undergo frozen embryo transfer cycles used artificial endometrial preparation or natural cycles. Endometrial priming was achieved with daily oral estradiol valerate (Progynova®) 6-8 mg per day beginning on the
cycle day 3 for 12 days. Endometrial thickness was assessed by transvaginal ultrasonography. Once the endometrium thickness reaches 8 mm with trilaminar appearance, 400-mg micronized vaginal progesterone pessary was started daily. Embryo transfer was performed on day 4 to day 6 of progesterone supplement. In the participants were not achieved the goal, dosage of oral estradiol valerate was increased and/or 50 microgram-transdermal estradiol hemihydrates (Climara®) was added. Two to three days after adjusted dose, the endometrial thickness was reassessed and progesterone was administered as mentioned above if the goal was reached. Cycle cancellation was chosen if the thickness was not optimal.
Embryo transfer was performed following ASRM guidance using either soft or metallic catheter. The procedure was done gently avoiding fundal contact with transabdominal ultrasonography monitoring.
All participants were examined uterine peristaltic wave frequencies and thickness of junctional zone two times by three- dimensional transvaginal ultrasonography (3D-TVUS). The first measurement was performed on day 2 of menstrual cycle. The second measurement was performed on the day planning to start progesterone administration in frozen-thawed embryo transfer protocol and the day of oocyte retrieval in fresh embryo transfer protocol.
Three-dimensional ultrasonography machine, Voluson S6 (GE, USA), was used with RIC5-9W real-time 4D micro-convex endovaginal curved linear probe by single operator. All participants were instructed to avoid sexual activity before evaluation for two days. The patient was lying relaxed in a lithotomy position after emptying the bladder. To avoid stimulating the cervix, the probe was gently introduced into the vagina and uterine peristaltic wave was measured first. Two-minute video of fixed mid-sagittal plane of uterus was recorded. Three dimensional sonographic features were obtained by applying volume box covered the mid-sagittal plane of uterus. Coronal plane of uterus was appeared after automatic sweep of mechanical transducer by multiplanar and OMNI view. Speckle reduction imaging (SRI) and volume contrast imaging (VCI) modality was set up at SRI 0-2 and VCI 2-4 mm. Thickness of junctional zone was measured as the distance from the basal endometrium to the internal layer of the outer myometrium, which appeared as relative hypoechoic linear lining around the endometrium. All sides of uterine wall were evaluated; fundal, lateral, anterior, and posterior wall. Each side was measured at two regions, the thickest and the thinnest distance and the average thickness of each wall was obtained by dividing of the sum of thickest and thinnest area. Finally, the average thickness of four uterine walls was obtained. Uterine peristaltic wave frequencies were analyzed with 4X of regular speed using a VLC media player by two independent observers. The mean of
peristaltic wave frequencies between two persons were obtained if the frequencies were not concordance.
Hormonal levels were checked for analysis two times in each patient. First measurement, serum luteinizing hormone (LH) and estradiol hormone levels were measured at day 2 of menstrual cycle in all participants. The patients in fresh embryo transfer cycles, serum follicle stimulating hormone (FSH) measurement was added. Second measurement, serum estradiol and progesterone hormone levels were checked in the same day of 3D-TVUS assessment.
Two weeks after embryo transfer, serum beta-hCG was first measured. In the patients with rising hCG level, serum level was reassessed at week 3 and week 4 after embryo transfer and transvaginal ultrasonography was performed at week 4 after the transfer. Vaginal progesterone was continued in the same dose and intramuscular 17-hydroxyprogesterone caproate (Depot- proluton®) was added weekly. Luteal support was continued until 12 weeks of gestation. In non-pregnant women, vaginal progesterone was stopped after first measurement of serum beta-hCG. Clinical pregnancy was defined as the presence of intrauterine gestational sac four weeks after embryo transfer.
#Intervention
- DIAGNOSTIC_TEST : 3DTVUS : Uterine peristaltic frequencies
- Perform three-dimensional transvaginal ultrasonography To observe uterine peristaltic frequencies in embryo transfer cycles | #Eligibility Criteria:
Inclusion Criteria:
* women age < 45years
* BMI < 35 kg/m2
* at least one of good quality embryo in embryo transfer cycle by Istanbul consensus workshop morphologic grading Day3 : Grade 1 <= age <= 2, Day4 : Grade 1 <= age <= 2 , Day5 : stage of development grade 2 <= age <= 4
Exclusion Criteria:
* structural intrauterine cavity distortion
* leiomyoma FIGO subclassification 3
* adenomyosis
* recurrent pregnancy loss
* recurrent implantation failure
* urerine relaxant drugs
* difficult embryo transfer
Sex :
FEMALE
Ages :
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
| NCT03587246 | 120,381 |
{
"NCT_ID" : "NCT05133505",
"Brief_Title" : "Characterisation of TIM-3/Gal-9 Immune Checkpoints in Primary Central Nervous System Diffuse Large B Cell Lymphomas",
"Official_title" : "Characterisation of TIM-3/Gal-9 Immune Checkpoints in Primary Central Nervous System Diffuse Large B Cell Lymphomas",
"Conditions" : ["Lymphoma, B-Cell"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2002-01-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-10-01",
"Study_Completion_Date(Actual)" : "2021-11-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-11-12",
"First_Posted(Estimated)" : 2021-11-24"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-11-12",
"Last_Update_Posted(Estimated)" : 2021-11-24",
"Last_Verified" : 2021-11"
}
}} | #Study Description
Brief Summary
Primary central nervous system diffuse large B cell lymphoma is a rare and aggressive entity of diffuse large B cell lymphoma. A previous transcriptomic study showed an overexpression of TIM-3 and Gal-9 in the tumor microenvironment. The investigators aimed to characterise TIM-3/Gal-9 immune checkpoints by using immunohistochemistry in the tumor microenvironment of primary central nervous system diffuse large B cell lymphoma.
| #Eligibility Criteria:
Inclusion criteria:
* patient with a Diagnosis of LBDGC-SNC
Exclusion criteria:
* immunocompromised patients
* patients with a history of previous or associated low-grade lymphoma
* patients with a history of systemic LBDGC with secondary localization to the SNC
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
| NCT05133505 | 244,786 |
{
"NCT_ID" : "NCT02946931",
"Brief_Title" : "All-Case Surveillance of Prizbind®",
"Official_title" : "The Drug Use-results Survey (All-Case Surveillance) on Prizbind® for Intravenous Solution 2.5 g in Japan",
"Conditions" : ["Hemorrhage"],
"Interventions" : ["Drug: Prizbind®"],
"Location_Countries" : ["Japan"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-11-18",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-11-03",
"Study_Completion_Date(Actual)" : "2020-11-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-10-25",
"First_Submitted_that_Met_QC_Criteria" : 2021-11-02",
"First_Posted(Estimated)" : 2016-10-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-10-25",
"Last_Update_Posted(Estimated)" : 2022-09-09",
"Last_Verified" : 2022-08"
}
}} | #Study Description
Brief Summary
To evaluate safety and effectiveness of Prizbind® for Intravenous Solution 2.5 g under Japanese clinical condition.
#Intervention
- DRUG : Prizbind®
- Prizbind®
- Other Names :
- Idarucizumab | #Eligibility Criteria:
Inclusion criteria:
Patients who are prescribed with Prizbind® for Intravenous Solution 2.5 g by the discretion of investigators
Exclusion criteria:
None
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
| NCT02946931 | 2,233 |
{
"NCT_ID" : "NCT04529005",
"Brief_Title" : "Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant Recipients",
"Official_title" : "Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant",
"Conditions" : ["Shock, Surgical", "Shock", "Hypotension and Shock", "Kidney Transplant; Complications", "Intraoperative Hypotension", "Postoperative Hypotension"],
"Interventions" : ["Drug: Angiotensin II"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-08-13",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-08-01",
"Study_Completion_Date(Actual)" : "2021-08-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-08-14",
"First_Submitted_that_Met_QC_Criteria" : 2022-11-26",
"First_Posted(Estimated)" : 2020-08-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-08-24",
"Last_Update_Posted(Estimated)" : 2022-12-21",
"Last_Verified" : 2022-11"
}
}} | #Study Description
Brief Summary
The current standard of catecholamine vasopressor management of perioperative hypotension in kidney transplant patients carries significant risks and falls short in many ways. Currently, there is an absence in the scientific literature and research describing the hemodynamic effectiveness and safety of novel pharmacologic agents such as angiotensin II (Giapreza - Ang II) in perioperative kidney transplant patients. Phase 3 registration trials have demonstrated the superior safety and efficacy of Ang II (Giapreza) in distributive shock patients compared to traditional vasopressor agents and the novel mechanism of action may provide additional protection in renal transplant patients. The pilot study entails giving informed and consenting kidney transplant recipients Ang II (Giapreza) as their first vasopressor if the need for vasopressors emerge either intraoperatively or postoperatively in kidney transplant recipients. The primary objective is to evaluate the safety and hemodynamic effects of Ang II (Giapreza) in the renal transplant population.
#Intervention
- DRUG : Angiotensin II
- If intraoperative or postoperative hypotension occurs (e.g. SBP \< 120 mmHg) and the attending surgeon and/or attending anesthesiologist deems vasopressor therapy to be necessary, angiotensin II (Giapreza) will be the first vasopressor used for management. | #Eligibility Criteria:
Inclusion Criteria:
* Adult patients > 18 years
* Receiving deceased donor kidney transplant
* Pre-transplant Ejection Fraction (within past 18 months) > 50%
* Intraoperative or postoperative distributive shock (according to hospital and study protocol) requiring vasopressor support
Exclusion Criteria:
* Pregnant patients (they would be excluded from receiving a transplant)
* Prisoners
* History of mesenteric ischemia
* History of aortic dissection
* History of abdominal aortic aneurysm
* Allergy to mannitol
* Absolute neutrophil count < 1000 cell/mm3 (within past 18 months)
* Diagnosis of Raynaud's phenomenon, systemic sclerosis or vasospastic disease
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
| NCT04529005 | 241,265 |
{
"NCT_ID" : "NCT05078762",
"Brief_Title" : "Immersive Virtual Reality in Simulation-based Bronchoscopy Training",
"Official_title" : "Immersive Virtual Reality in Simulation-based Bronchoscopy Training - a Randomized Trial",
"Conditions" : ["Virtual Reality", "Medical Education"],
"Interventions" : ["Other: Immersive Virtual Reality"],
"Location_Countries" : ["Denmark"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-10-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-01-30",
"Study_Completion_Date(Actual)" : "2022-02-28},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-09-22",
"First_Posted(Estimated)" : 2021-10-14"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-10-05",
"Last_Update_Posted(Estimated)" : 2022-03-09",
"Last_Verified" : 2022-03"
}
}} | #Study Description
Brief Summary
The purpose of this single-center randomized study is to investigate whether bronchoscopy training in an immersive Virtual Reality (iVR) environment will make the surgeon better at handling distractions and increase the quality of the bronchoscopy.
The participants will be stratified according to gender and randomized into two groups. Both groups will initially train on the bronchoscopy simulator without VR. Afterwards the intervention group will train in an iVR environment with Virtual Reality Goggles while using the bronchoscopy simulator, while the control group will train without VR goggles.
Afterwards both groups will be tested in the iVR environment in a test scenario
#Intervention
- OTHER : Immersive Virtual Reality
- Training in an iVR environment with Virtual Reality Goggles while using the bronchoscopy simulator, while the control group will train without VR goggles.
- Other Names :
- iVR | #Eligibility Criteria:
Inclusion Criteria:
* Residents working in Denmark in thoracic surgery and pulmonary medicine
* Participants are required to have a medical license.
Exclusion Criteria:
* Previous participation in trials involving bronchoscopy training.
* Experience with independent bronchoscopy.
* No informed consent.
* Unable to speak Danish on a conversational level.
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
| NCT05078762 | 54,835 |
{
"NCT_ID" : "NCT04113694",
"Brief_Title" : "Evaluation of Extended Wear Infusion Set (EWIS) in Patients With Type 1 Diabetes",
"Official_title" : "Evaluation of Extended Wear Infusion Set (EWIS) in Patients With Type 1 Diabetes",
"Conditions" : ["Diabetes"],
"Interventions" : ["Device: Extended Infusion Set"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-10-14",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-11-05",
"Study_Completion_Date(Actual)" : "2020-11-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-10-01",
"First_Submitted_that_Met_QC_Criteria" : 2021-09-29",
"First_Posted(Estimated)" : 2019-10-03"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-10-01",
"Last_Update_Posted(Estimated)" : 2021-10-01",
"Last_Verified" : 2021-09"
}
}} | #Study Description
Brief Summary
The purpose of this study is to collect confirmatory clinical data to support 6 or 7 days wear of EWIS (Extended Wear Infusion Set).
Detailed Description
This study is a multi-center, non-randomized, prospective single arm study with Type 1 patients with diabetes on insulin pump therapy with Continuous Glucose Monitoring (CGM). A total of up to 300 subjects age 18-80 will be enrolled at up to 20 investigational centers in the US. Each subject will wear their own MiniMed™ 670G insulin system. Each subject will be given 12 infusion sets to wear (each infusion set for at least 174 hours, or until infusion set failure if this occurs before 174 hours). Subjects will change insulin reservoirs at least every 174 hours. The time of infusion set insertion will be taken from Daily Log. Subjects can expect to participate for approximately 12-16 weeks.
#Intervention
- DEVICE : Extended Infusion Set
- Each subject is asked to wear each Extended Wear Infusion Set for at least 174 hours.
- Other Names :
- Extended Wear Infusion Set | #Eligibility Criteria:
Inclusion Criteria:
* Subject is age 18 - 80 years at the time of screening
* Subject has type 1 diabetes for more than one year Study specific inclusion criteria
* Subject is on the MiniMed™ 670G insulin pump therapy within 1 year prior to screening and willing to utilize Auto Mode and CGM with Guardian™ Sensor (3) during the study.
* Subject is willing and able to perform study procedures as per investigator discretion
* Subject is willing to take one of the following insulins and can financially support the use of either of the 2 insulin preparations throughout the course of the study (i.e. co-payments for insulin with insurance or able to pay full amount):
1. Humalog™* (insulin lispro injection)
2. NovoLog™* (insulin aspart)
Exclusion Criteria:
* Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks.
* Subject is female and has a positive pregnancy screening test
* Subject is female of child bearing age and who is sexually active should be excluded if she is not using a form of contraception deemed reliable by investigator
* Subject is female and plans to become pregnant during the course of the study
* Subject has Glycosylated hemoglobin (HbA1c) > 8.5 % at time of screening. Note: All HbA1c blood specimens will be sent to and tested by a NGSP certified Central Laboratory. HbA1c testing must follow National Glycohemoglobin Standardization Program (NGSP) standards.
* Subject has had a history of 1 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening
1. Medical assistance (i.e. Paramedics, Emergency Room [ER] or Hospitalization)
2. Coma
3. Seizures
* Subject has taken any oral, injectable, or IV glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study.
* Subject is unable to tolerate tape adhesive in the area of infusion set
* Subject has any unresolved adverse skin condition in the area of infusion set placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)
* Subject has infection in the area of infusion set placement at time of screening
* Subject has had Diabetic Ketoacidosis (DKA) in the 12 months prior to screening visit.
* Subject is currently abusing illicit drugs
* Subject is currently abusing alcohol
* Subject is on dialysis (for renal failure)
* Subject has history of adrenal disorder
* Subject has a history of inpatient psychiatric treatment in the past 6 months prior to screening
* Subject has any condition that the Investigator believes would interfere with study participation
* Subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator
* Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
* Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
* Subject is using pramlintide (Symlin), SGLT2 inhibitors, GLP agonists, biguanides, DPP-4 inhibitors or sulfonylureas more than 2 weeks from time of screening
* Subject has been diagnosed with chronic kidney disease requiring dialysis or resulting in chronic anemia
* Subject has history of cardiovascular disease defined as any ischemic related event or clinically significant arrythmia.
* Subject has hypothyroidism and has out of reference range thyroid-stimulating hormone (TSH) on screening visit (prior labs in the last 3 months are sufficient). Subject may repeat TSH draw to verify eligibility if not in range
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
| NCT04113694 | 59,703 |
{
"NCT_ID" : "NCT02960204",
"Brief_Title" : "Emricasan, an Oral Caspase Inhibitor, in Subjects With NASH Cirrhosis and Severe Portal Hypertension",
"Official_title" : "A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects With Non-Alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension",
"Conditions" : ["Cirrhosis", "Portal Hypertension", "Non-alcoholic Steatohepatitis"],
"Interventions" : ["Drug: Emricasan", "Drug: Placebo"],
"Location_Countries" : ["Germany", "Spain", "United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-10-17",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-10-02",
"Study_Completion_Date(Actual)" : "2019-04-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-07-29",
"First_Submitted_that_Met_QC_Criteria" : 2021-12-16",
"First_Posted(Estimated)" : 2016-11-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-11-07",
"Last_Update_Posted(Estimated)" : 2022-02-11",
"Last_Verified" : 2021-12"
}
}} | #Study Description
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled trial involving subjects with NASH cirrhosis and severe portal hypertension (defined as HVPG ≥12 mmHg as determined by the central reader assigned to this study). Upon successful screening, subjects will be randomized to receive either emricasan 50 mg BID, 25 mg BID, or 5 mg BID or matching placebo BID.
#Intervention
- DRUG : Emricasan
- DRUG : Placebo | #Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects >= 18 years, able to provide written informed consent and able to understand and willing to comply with the requirements of the study.
* Cirrhosis due to NASH with exclusion of other causes of cirrhosis (e.g. chronic viral hepatitis, alcoholic liver disease, etc.)
* Compensated cirrhosis OR Decompensated cirrhosis with no more than 1 prior significant decompensating event
* Severe portal hypertension defined as HVPG >=12 mmHg
* Subjects who are on NSBB, nitrates, diuretics, lactulose, rifaximin, or statins must be on a stable dose for at least 3 months prior to Day 1
* Willingness to utilize effective contraception (for both males and females of childbearing potential) from Screening to 4 weeks after the last dose of study drug
Exclusion Criteria:
* Evidence of severe decompensation
* Severe hepatic impairment defined as a Child-Pugh score >=10
* ALT (alanine transaminase) > 3 times upper limit of normal (ULN) or AST (aspartate transaminase) >5 times ULN during screening
* Estimated creatinine clearance <30 mL/min
* Prior transjugular intrahepatic portosystemic shunt or other porto-systemic bypass procedure
* Known portal vein thrombosis
* Symptoms of biliary colic, e.g. due to symptomatic gallstones, within the last 6 months, unless resolved following cholecystectomy
* Current use of medications that are considered inhibitors of OATP1B1 and OATP1B3 transporters
* Alpha-fetoprotein >50 ng/mL
* History or presence of clinically concerning cardiac arrhythmias, or prolongation of screening (pre-treatment) QTcF interval of >500 msec
* History of or active malignancies, other than those successfully treated with curative intent and believed to be cured
* Prior liver transplant
* Change in diabetes medications or vitamin E within 3 months of screening
* Uncontrolled diabetes mellitus (HbA1c >9%) within 3 months of screening
* Significant systemic or major illness other than liver disease
* HIV infection
* Use of controlled substances (including inhaled or injected drugs) or non-prescribed use of prescription drugs within 1 year of screening
* If female: planned or known pregnancy, positive urine or serum pregnancy test, or lactating/breastfeeding
* Previous treatment with emricasan or active investigational medication (except methacetin) in a clinical trial within 3 months prior to Day 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
| NCT02960204 | 113,410 |
{
"NCT_ID" : "NCT01364961",
"Brief_Title" : "Resveratrol and Serum Apo A-I",
"Official_title" : "The Effects of Resveratrol on Serum Apolipoprotein A-I Concentrations in Men and Women With Low HDL-cholesterol Concentrations",
"Conditions" : ["Dyslipidemia"],
"Interventions" : ["Dietary Supplement: Resveratrol capsules"],
"Location_Countries" : ["Netherlands"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-12",
"Study_Completion_Date(Actual)" : "2013-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2011-01-17",
"First_Posted(Estimated)" : 2011-06-03"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-06-01",
"Last_Update_Posted(Estimated)" : 2013-11-13",
"Last_Verified" : 2013-11"
}
}} | #Study Description
Brief Summary
Although much effort has been done to lower LDL-cholesterol concentrations, there is still a substantial risk for cardiovascular disease (CVD). Another strategy to lower the risk for CVD is elevating the HDL-cholesterol (HDL-C). Both in vitro and in vivo studies showed that elevating HDL-C or apolipoprotein A-I (Apo A-I) levels protect against CVD. However, despite many initiatives, no new widely applicable intervention strategies with proven efficacy have been developed.
Epidemiologic studies have shown that a higher polyphenol intake is associated with a lower risk for CVD. Resveratrol, a polyphenol, could, through several beneficial mechanisms, exert a positive effect on formation of atherosclerotic plaques and thus on developing CVD. It has been shown in animals that resveratrol elevates PPAR-alpha activity. This may lead to elevated apo A-I and HDL-C levels in the blood. However, these effects are not shown in human intervention studies.
#Intervention
- DIETARY_SUPPLEMENT : Resveratrol capsules
- 2 x 75 mg resveratrol each day, for 4 weeks
- Other Names :
- Resveratrol will be provided as resVida® | #Eligibility Criteria:
Inclusion Criteria:
* aged between 45 and 70 years
* HDL-C <1.0 mmol/L (men)
* HDL-C <1.3 mmol/L (women)
* serum total cholesterol <8.0 mmol/L
* plasma glucose <7.0 mmol/L
* BMI between 25 - 35 kg/m2
* non-smoking
* willingness to abstain from resveratrol rich products from two weeks prior to the study and the duration of the study:
* grapes and grape juice
* wine (red and white)
* all berries
* peanuts
* peanut butter
* soy (products)
* pomegranate
Exclusion Criteria:
* unstable body weight (weight gain or loss >3 kg in the past 3 months)
* indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
* use of medication or a medically-prescribed diet known to affect serum lipid or glucose metabolism
* Active cardiovascular disease (for instance congestive heart failure) or recent (<6 months) event, such as acute myocardial infarction or cerebro-vascular accident
* not willing to stop the consumption of vitamin supplements, fish oil capsules or products rich in plant stanol or sterol esters 3 weeks before the start of the study
* men: consumption of >21 glasses of alcohol-containing drinks per week women: consumption of >14 glasses of alcohol-containing drinks per week
* abuse of drugs
* pregnant or breastfeeding women
* participation in another biomedical study within 1 month prior to the screening visit
* having donated blood (as blood donor) within 1 month prior to the screening visit or planning to do so during the study
* impossible or difficult to puncture as evidenced during the screening visits
Sex :
ALL
Ages :
- Minimum Age : 45 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT01364961 | 262,988 |
{
"NCT_ID" : "NCT01013090",
"Brief_Title" : "Fluid Volume-hypotension Association in Cesarean Under Neuraxial Anesthesia",
"Official_title" : "Fluid Volume-hypotension Association in Elective Cesarean Section Under Neuraxial Anesthesia",
"Conditions" : ["Cesarean Section"],
"Interventions" : ["Drug: Six percent hydroxyethyl starch", "Drug: Ringer's Lactate"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2009-07",
"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" : 2009-11-12",
"First_Posted(Estimated)" : 2009-11-13"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-11-12",
"Last_Update_Posted(Estimated)" : 2009-12-23",
"Last_Verified" : 2009-12"
}
}} | #Study Description
Brief Summary
Hypotension resulted from neuraxial block is a common problem, of which is a special issue in patients undergoing Cesarean section. A large number of studies and clinical guidelines suggest that fluid loading, pre- or co-anesthesia, is a promising manner in preventing hypotension. However, it is still a controversy because the fact of a relatively increased blood volume in parturients. In addition, although it is effective of fluid management, it's precise relationship between fluid (crystalloid or colloid) volume and the proportion of hypotension in Cesarean patients under neuraxial anesthesia is still unknown. The investigators designed this trial to clarify the accurate relationship between fluid volume in an escalated manner and the occurrence of hypotension analyzed with a non-linear regression, and wanted to present the 50% effective volume (EV50) of fluid including crystalloid and colloid in preventing hypotension in patients undergoing Cesarean section.
#Intervention
- DRUG : Ringer's Lactate
- Ringer's Lactate 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 15 ml/kg is given to patients pre-, co- and post-neuraxial blocks
- Other Names :
- Lactated Ringer's solution
- DRUG : Six percent hydroxyethyl starch
- Six percent hydroxyethyl starch 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 15 ml/kg is given to patients pre-, co- and post-neuraxial blocks
- Other Names :
- HES/HAES | #Eligibility Criteria:
Inclusion Criteria:
* 21 <= age <= 40 yr
* First time of delivery
* ASA status I-II
* No premature
* No genetic and infectious diseases
* Chinese
Exclusion Criteria:
* < 21 yr
* > 40 yr
* Subjects with cardiac and pulmonary disorders
* Dislocation of placenta
* Pregnant hypertension
* Allergy to local anesthetics
* Unwilling to cooperation
* Need intraoperative administration of vascular active agents
* With significant delivery side effects
* With contradictions of neuraxial anesthesia
Sex :
FEMALE
Ages :
- Minimum Age : 21 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
| NCT01013090 | 177,925 |
{
"NCT_ID" : "NCT02344524",
"Brief_Title" : "Drainage of Traumatic Hemothorax and Pneumothorax: Small Bore Versus Large Bore Chest Drain",
"Official_title" : "Drainage of Traumatic Hemothorax and Pneumothorax: Small Bore Versus Large Bore Chest Drain- a Randomized Controlled Trial",
"Conditions" : ["Traumatic Hemothorax and Pneumothorax"],
"Interventions" : ["Device: Intercostal drainage"],
"Location_Countries" : ["India"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-11",
"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" : 2015-01-12",
"First_Posted(Estimated)" : 2015-01-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-01-17",
"Last_Update_Posted(Estimated)" : 2015-01-26",
"Last_Verified" : 2015-01"
}
}} | #Study Description
Brief Summary
The purpose of this trial is to study the role of small bore chest drains in draining traumatic hemothorax and pneumothorax.
Detailed Description
The precise role of small bore chest drains in treating post traumatic pleural collections, especially hemothorax is not well established. This trial is conducted to study the efficacy and safety profile of small bore chest drains in trauma patients with hemothorax and pneumothorax.
#Intervention
- DEVICE : Intercostal drainage
- Small bore chest drains are inserted by modified Seldinger's technique. Large bore chest drains are inserted by blunt dissection technique. | #Eligibility Criteria:
Inclusion Criteria:
* Patients with traumatic hemothorax, pneumothorax and hemopneumothorax
Exclusion Criteria:
* Patients with tension pneumothorax
* Patients requiring emergency thoracotomy
* Patients who had undergone chest drain insertion elsewhere
* Patients lost to follow up
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT02344524 | 68,230 |
{
"NCT_ID" : "NCT00000293",
"Brief_Title" : "Effect of Nefazodone on Relapse in Females With Cocaine Abuse - 10",
"Official_title" : "Effect of Nefazodone on Relapse in Females With Cocaine Abuse",
"Conditions" : ["Cocaine-Related Disorders"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "1999-01",
"Study_Completion_Date(Actual)" : "2001-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 1999-09-20",
"First_Posted(Estimated)" : 1999-09-21"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 1999-09-20",
"Last_Update_Posted(Estimated)" : 2017-01-12",
"Last_Verified" : 2016-11"
}
}} | #Study Description
Brief Summary
The purpose of this study is to determine the effect of nefazodone on relapse to cocaine use in depressed and non-depressed females with cocaine abuse/dependence.
Detailed Description
The purpose of this study is to determine the effect of nefazodone on relapse to cocaine in women and if a greater effect will be seen in the dependent condition. A relapse and coping skills questionnaire will be utilized to determine the various factors important to the relapse process.
#Intervention
- DRUG : Nefazodone | #Eligibility Criteria:
Inclusion Criteria:
Female, ages 18 <= age <= 55, cocaine abuse/dependence, use of cocaine 7 days of the last 30 days or of the 30 days prior to current abstinence, less than 90 days current abstinence, at least an 8th grade education.
Exclusion Criteria:
Unstable medical conditions; current use of Hismanal, Seldane, or Propulsid; dx of MR, OBS, bipolar, schizophrenia.
Sex :
FEMALE
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
| NCT00000293 | 234,771 |
{
"NCT_ID" : "NCT01474044",
"Brief_Title" : "To Evaluate the Efficacy and Safety of Vitamin B12 Contains Extract of Lamb's Stomach in Treatment of Chronic Atrophic Gastritis (CAG)",
"Official_title" : "A Phase IV Study to Evaluate the Efficacy and Safety of Vitamin B12 Contains Extract of Lamb's Stomach in Treatment of Chronic Atrophic Gastritis",
"Conditions" : ["Chronic Atrophic Gastritis (CAG)"],
"Interventions" : ["Drug: Gastropylor Complex Capsules", "Other: Placebo Comparator"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-02",
"Study_Completion_Date(Actual)" : "2013-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2011-10-27",
"First_Posted(Estimated)" : 2011-11-17"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-11-14",
"Last_Update_Posted(Estimated)" : 2013-07-09",
"Last_Verified" : 2013-07"
}
}} | #Study Description
Brief Summary
The purpose of this study is to determine whether Gastropyloric Complex Capsules are safe and effective in the treatment of chronic atrophic gastritis (CAG).
Detailed Description
Till now, there is no ideal treatment to chronic atrophic gastritis(CAG). This study is try to find a possible treatment to CAG with Gastropyloric Complex Capsules.
#Intervention
- DRUG : Gastropylor Complex Capsules
- 3 pills, three times a day, after meal
- Other Names :
- Gastropyloric Extracts and Vit B12 Complex Capsules
- OTHER : Placebo Comparator
- Placebo that is same as gastropyloric complex capsules
- Other Names :
- Placebo | #Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 70 years, male or female
* Histologically diagnosed CAG
* HP negative confirmed by gastric mucosal staining
* Signed an written informed consent
Exclusion Criteria:
* CAG with high-grade intraepithelial neoplasia
* Severe gastric mucosal erosion or bleeding needing treatment
* Active peptic ulcer, GERD, or esophageal stricture
* History of upper GI tract surgery
* History of malignant diseases
* With depression, anxiety neuroses, or hysteria
* Heart failure (NYHA class lll or lV), liver disease (ALT >= 80 IU/L, AST >= 80 IU/L) or renal disease(Cr >= 150 ummol/L)
* Uncontrolled hypertension
* Uncontrolled diabetes
* Alcohol abuse
* Drug allergy
* Participated in another investigational study within 4 weeks prior to Visit 0
* Pregnancy, be a nursing mother or without conception control
* There is any concern by the investigator regarding the safe participation of the participant in the study or for any other reason; the investigator considers the participant inappropriate for participation in 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
| NCT01474044 | 72,183 |
{
"NCT_ID" : "NCT02842515",
"Brief_Title" : "Feasibility of the Preparation of an Advanced Therapy Medicinal Product for Dental Pulp Regeneration",
"Official_title" : "Study the Feasibility of Preparing an Autologous Advanced Therapy Medicinal Product for the Dental Pulp Regeneration in the Patient With Irreversible Pulp Inflammation or Dental Trauma",
"Conditions" : ["Dental Stem Cells", "Dental Pulp Regeneration"],
"Interventions" : ["Other: teeth avulsion"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-07",
"Study_Completion_Date(Actual)" : "2015-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-07-18",
"First_Posted(Estimated)" : 2016-07-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-07-20",
"Last_Update_Posted(Estimated)" : 2016-07-25",
"Last_Verified" : 2016-07"
}
}} | #Study Description
Brief Summary
Current endodontic treatment are based essentially on the ouster of parenchyma in case of trauma or irreversible pulp inflammation. These situations typically affect immature teeth in subjects aged from 8 to 15 years. Consequently, loss of a functional pulp is leads to discontinuation of root development and apical closure. The challenge for the clinician in the management of such situations is then preserving a pulp vitality. But current practices consist in a filling of the endo-canal system with an inert or semi-inert material. In this case, no pulp vitality is present. New treatment methods are needed. The objective Pulp'R is the study the feasibility of preparing an autologous combined advanced therapy medicinal product (ATMP) for dental pulp regeneration in the patient with irreversible pulp inflammation or dental trauma.
#Intervention
- OTHER : teeth avulsion | #Eligibility Criteria:
Inclusion Criteria:
* Patients aged from 8 <= age <= 15, with at least one tooth affected by a carious process,
* Patients aged from 8 <= age <= 15 with major trauma preventing the maintenance of the tooth in the arch
* Patients aged from 16 <= age <= 20 requiring avulsion germs wisdom teeth,
* Ability to carry out the extraction of pulp chamber content
* Signature of informed consent (from the patient and his guardian)
* Indication that the subject has understood the purpose and procedures required by the study and agrees to participate in the study and comply with the requirements and limitations inherent in this study,
* Patient with French social insurance.
Exclusion Criteria:
* Lack of ability to collect the dental pulp,
* Presence of necrosis in pulp complex or the possibility of preserving the pulp through appropriate techniques,
* Legal incapacity or limited legal capacity
* Patient unlikely to cooperate in the study and / or low cooperation anticipated by the investigator,
* Patient without health insurance,
* The patient is in the period of exclusion of another study,
* Patients with congenital pathology of dental pulp (amelogenesis and dentinogenesis imperfect)
* Patient with intrapulpal calcification or violations of pulp obliteration
* Teeth having external or internal inflammatory resorption
* Teeth diagnosed with pulp necrosis process
* Teeth undergoing fragmentation for their avulsion
* Time of pulp air exposition > 2 hours (risk of bacterial contamination)
Sex :
ALL
Ages :
- Minimum Age : 8 Years
- Maximum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT02842515 | 197,207 |
{
"NCT_ID" : "NCT03876496",
"Brief_Title" : "Sensable®Care System: Establishing a Communications System for Patient Fall Reduction",
"Official_title" : "A Phase One Feasibility Study of the Sensable®Care System: Establishing a Communications System for Patient Fall Reduction",
"Conditions" : ["Fall From Bed"],
"Interventions" : ["Device: SensableCare System"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["EARLY_PHASE1"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-09-24",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-10-21",
"Study_Completion_Date(Actual)" : "2017-12-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-08-22",
"First_Posted(Estimated)" : 2019-03-15"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-03-13",
"Last_Update_Posted(Estimated)" : 2019-03-15",
"Last_Verified" : 2019-03"
}
}} | #Study Description
Brief Summary
The purpose of this study is to test the effectiveness, safety and side effects of Sensable®Care System for inpatients. The Sensable®Care System uses pressure sensors and computer software to sense how patients are positioned on the bed in order to reduce bed falls. The Sensable®Care System Mattress has sensors embedded in them, which will be monitored by the nurses in your unit.
This study has three specific aims:
1. To assess the comfort of the system when used with hospitalized patients;
2. To observe how the system can be integrated into nurses' and hospital staff's regular workflow to help to modify and improve the system.
3. To analyze data from nursing response to alerts generated from hospitalized patients to improve alert system performance.
#Intervention
- DEVICE : SensableCare System
- The Sensable®Care Mattress has sensors embedded in it. Sensable®Care System is able to identify if the subject is stirring in bed, sitting up from the bed, attempting to leave the bed, or being out of the bed. If the subject is found to be in any of these four scenarios, four different types of alerts/notifications will warn clinicians: Stirring Notification, Sitting Up Notification, Bed Leaving Alert, Out of Bed Alert, will be generated by Sensable®Care System respectively.
Once these four alerts/notifications are generated, designated attending nurses or caregivers equipped with a mobile app will receive audible, vibratory, and/or visual alerts from the Dashboard with subject's room number and type of alert displayed mobile app. Thus, interventions/assistance can be carried out presumably early. Harm to patient safety may be prevented.
- Other Names :
- MedicusTek | #Eligibility Criteria:
Inclusion Criteria:
* Gender: male or female
* Age: 18 years and older
* Racial and ethnic origin: all ethnic groups
* Hospital status: admitted in-patient or a patient under observation
* Expected hospital length of stay: minimum of 23 hours
* Willingness to participate in the study
* Moderate to High fall risk scoring a 2 or greater on the Mobility or Mental/LOC/Awareness status sections of the Hester Davis Fall Risk Assessment.
Exclusion Criteria:
* Declined to participate
* Patients less than 18 years
* Patients who have been identified as a low fall risk or moderate fall risk with score less than 2 on the Mobility or Mental/ LOC/Awareness status sections of the Hester Davis Fall Risk Assessment
* Women who are documented as pregnant during the study period
* Patients who are medically unstable; as per the discretion of the primary nurse
* Patients who are actively in the dying process, at the discretion of the primary nurse
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
| NCT03876496 | 95,550 |
{
"NCT_ID" : "NCT03472625",
"Brief_Title" : "The Incidence of Aphasia, Dysarthria and Dysphagia Following Stroke",
"Official_title" : "The Incidence, Severity and Recovery of Aphasia, Dysarthria and Dysphagia Following Stroke in a Tertiary Hospital",
"Conditions" : ["Acute Stroke"],
"Interventions" : ["Diagnostic Test: Screening and diagnosis of aphasia, dysarthria, dysphagia"],
"Location_Countries" : ["Belgium"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-03-14",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-10-04",
"Study_Completion_Date(Actual)" : "2019-10-04},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-03-05",
"First_Posted(Estimated)" : 2018-03-21"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-03-14",
"Last_Update_Posted(Estimated)" : 2024-09-19",
"Last_Verified" : 2024-09"
}
}} | #Study Description
Brief Summary
The objective of the study is to estimate the incidence and recovery of aphasia, dysarthria and dysphagia in an acute setting (first week) with the NIHSS sub-item scores for language and speech and a dysphagia screening.
Furthermore, we will evaluate the severity of aphasia, dysarthria and dysphagia in an acute setting (first few days) with standardized measurements (ScreeLing, BNT, NSVO-Z, perceptual assessment, MASA/FOIS).
To evaluate the effect of early IVT/EVT in patients with ischemic stroke on functional outcomes for language and speech via the NIHSS scale.
Detailed Description
Study population:
Patients who are admitted to the acute Stroke Unit of the University Hospital Ghent will be recruited.
Study course:
The study has a prospective, observational design, with each participant receiving regular standard of care as follows: patients will undergo a clinical examination by a staff neurologists or the present attending in the emergency room. Tailored medical treatment will be given to each patient considering the type of stroke etc. as is standard of care (e.g. thrombolysis and/or thrombectomy for patients with ischemic stroke). Patients that are stable enough are transferred to the Stroke Unit where the neurologist or attending of the unit will reassess all stroke patients. NIHSS scores will be reported at least at day 2 +/- 1. A dysphagia screening is performed by the Stroke Unit nurses when the patient arrives at the Stroke Unit. The scores of the sub-items language and speech of the NIHSS and the dysphagia screening combined with a general screening by a speech language pathologist will be used to confirm or discard aphasia, dysphagia and dysarthria (incidence). When aphasia, dysarthria and/or dysphagia is confirmed, standardized tests will be performed. For this study, data of the following tests will be included for analysis: ScreeLing and/or BNT (aphasia), NSVO-Z and a perceptual assessment (dysarthria), MASA and/or the FOIS (dysphagia). At day 7 +/- 1, NIHSS scores will be reassessed (recovery in time). The diagnostic assessments and the NIHSS sub-items speech/language will be used to investigate the severity and recovery of the symptoms in time. Reports of the neurological clinical examination at follow-up will be retrospectively investigated if possible for additional information about recovery in time.
The total duration of data collection will be approximately 1 week and if possible three months follow-up.
#Intervention
- DIAGNOSTIC_TEST : Screening and diagnosis of aphasia, dysarthria, dysphagia
- Screening (day 2 +/- 1; day 7 +/-1): NIHSS (National Health Institute Scale) 9 and 10 scores, dysphagia screening (nurse), speech-, and language screening (speech therapist)
Diagnostic assessment (day 2 +/-1-):
Dysphagia: MASA (Mann Assessment of Swallowing Abilities), FOIS (Functional Oral Intake Scale) Dysarthria: perceptual assessment, NSVO-Z (Nederlands spraakverstaanbaarheidsonderzoek - zinnen) Aphasia: ScreeLing, BNT (Boston Naming Test) | #Eligibility Criteria:
Inclusion Criteria:
* Acute stroke patients admitted at the Acute Stroke Unit at the university hospital (Ghent)
Exclusion Criteria:
* Previous aphasia, dysarthria, dysphagia
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT03472625 | 67,572 |
{
"NCT_ID" : "NCT01288638",
"Brief_Title" : "Lifestyle Intervention for Polycystic Ovary Syndrome: Pulse-Based Diet and Exercise",
"Official_title" : "A Lifestyle Intervention for Women With Polycystic Ovary Syndrome: The Role of a Pulse-Based Diet and Aerobic Exercise on Infertility Measures and Metabolic Syndrome Risk",
"Conditions" : ["Polycystic Ovary Syndrome", "Metabolic Syndrome"],
"Interventions" : ["Other: TLC diet", "Other: Pulse-based diet"],
"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)" : "2011-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-07",
"Study_Completion_Date(Actual)" : "2017-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2011-01-13",
"First_Posted(Estimated)" : 2011-02-02"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-02-01",
"Last_Update_Posted(Estimated)" : 2017-10-17",
"Last_Verified" : 2017-10"
}
}} | #Study Description
Brief Summary
The purpose of our study is to evaluate the effectiveness of a lifestyle program for women with Polycystic Ovary Syndrome (PCOS). The investigators want to assess the effect of a pulse-based diet (i.e. a diet that contains lentils, chick-peas, peas, and beans) and aerobic exercise for improving PCOS disease features and risk factors for metabolic syndrome. We would like to determine the therapeutic effects of a lifestyle program that combines a pulse-based diet and exercise on the multiple disease measures of PCOS and metabolic syndrome.
Detailed Description
To date, we have developed the pulse-based and meat-based healthy meals following Therapeutic Lifestyle Changes (TLC)guidelines recommended by NCEP for the intervention. We have been recruiting and enrolling participants into the study with our few set of participants having completed the 4 month intervention. Baseline data have been also collected on all participants assessed for PCOS. Preliminary measurements on POCS characteristics, baseline dietary and exercise habits of women with PCOS will be soon available.
This study involves an intervention comparing a diet containing pulses (i.e. beans, peas, chick peas, lentils) to a diet recommended by the National Cholesterol Education Program (NCEP) for improving markers of metabolic syndrome and fertility in women with poly cystic ovarian syndrome who are also enrolled in an aerobic exercise program. To date, seven women in the pulse-diet group have completed the intervention, nine women in the group receiving the NCEP diet have completed the intervention, four women are currently enrolled on the pulse diet and two women are currently enrolled on the NCEP diet.
#Intervention
- OTHER : Pulse-based diet
- The pulse based-diet will include meals prepared with dry peas, lentils, chickpeas, and beans. Two meals will be supplied daily for 16 weeks to those participants on the pulse-based diet program. Meals will contain approximately 90g dried peas, 225 g chickpeas or beans, or 150g lentils.
- OTHER : TLC diet
- Grocery gift cards will be provided weekly for 16 weeks to those participants in the placebo group. Recipe booklet will be given to follow Therapeutic Lifestyle Changes (TLC) guidelines, recommended by National Cholesterol Education Program (NCEP) and will be based on lean-meats for the protein source. The recipes will exclude pulses. | #Eligibility Criteria:
Inclusion Criteria:
* Female
* Diagnosis of PCOS
* Aged 18 <= age <= 35 years
Exclusion Criteria:
* Taking birth control or fertility medications
* Medical conditions that limit exercise or which limit consumption of a pulse-based diet (allergies or intolerances)
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
| NCT01288638 | 134,235 |
{
"NCT_ID" : "NCT02856295",
"Brief_Title" : "anti10a Levels in Women Treated With LMWH in the Postpartum Period",
"Official_title" : "anti10a Levels in Women Treated With LMWH in the Postpartum Period for Preventing Vein Thrombosis Events: A Comparison of Two Doses",
"Conditions" : ["Venous Thromboembolism"],
"Interventions" : ["Drug: clexane (LMWH)"],
"Location_Countries" : ["Israel"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-11-20",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-08-01",
"Study_Completion_Date(Actual)" : "2022-08-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-07-13",
"First_Posted(Estimated)" : 2016-08-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-08-03",
"Last_Update_Posted(Estimated)" : 2022-11-15",
"Last_Verified" : 2022-11"
}
}} | #Study Description
Brief Summary
The aim of this study is to compare between anti-10a levels in postpartum women receiving different prophylactic doses of LMWH: one group with LMWH doses adjusted by the women's weight and the second group receiving 1mg/kg to a maximum dose of 120 mg
Detailed Description
pregnancy and postpartum period are associated with increased risk of thromboembolism. this risk is further increased in women with thrombophilia.
This risk is higher in the postpartum period compared with pregnancy period, especially the risk for pulmonary embolism (PE). The American College Of Obstetrics and Gynecologists, The American college of chest physicians and The Royal College of obstetricians and gynecologists recommend using low molecular weight heparin during the postpartum period in women with thrombophilia and women with risk factor for developing thromboembolism. there is no specific guidelines regarding the best protocol based on the level of anti-10 a.
This study will compare between two protocols based on anti-10a levels.
#Intervention
- DRUG : clexane (LMWH)
- to compare tow doses of clexane for preventing VTE in postpartum women | #Eligibility Criteria:
Inclusion Criteria:
* postpartum women supposed to receive LMWH according to obstetric indications
Exclusion Criteria:
* known allergy to clexane
* active bleeding postpartum
* thrombocytopenia < 75000
* recent cerebrovascular accident / transient ischemic attack (<4 weeks)
* glomerular filtration rate) < 30 ml/min)
* active liver disease
* malignant hypertension (systolic > 200 mmHg, diastolic> 120 mmHg)
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT02856295 | 105,931 |
{
"NCT_ID" : "NCT01706328",
"Brief_Title" : "A Study to Assess the Efficacy of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)",
"Official_title" : "A 12-Week Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)",
"Conditions" : ["Pulmonary Disease, Chronic Obstructive"],
"Interventions" : ["Drug: Placebo Inhalation Powder ACCUHALER/DISKUS", "Drug: FF/VI 100/25 Inhalation Powder NDPI", "Drug: Placebo Inhalation Powder NDPI", "Drug: Fluticasone Propionate/Salmeterol 250/50 Inhalation Powder ACCUHALER/DISKUS", "Drug: Salbutamol as needed"],
"Location_Countries" : ["Ukraine", "United States", "Germany", "Romania", "Russian Federation"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-10-15",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-06-17",
"Study_Completion_Date(Actual)" : "2013-06-17},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-10-11",
"First_Submitted_that_Met_QC_Criteria" : 2014-01-23",
"First_Posted(Estimated)" : 2012-10-15"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-10-11",
"Last_Update_Posted(Estimated)" : 2018-05-02",
"Last_Verified" : 2018-04"
}
}} | #Study Description
Brief Summary
This will be a Phase IIIb multicentre, randomized, double-blind, double-dummy, 12-week parallel group study evaluating the effects of once daily in the morning treatment of FF/VI Inhalation Powder versus Fluticasone Propionate/Salmeterol Inhalation Powder twice daily on lung function in COPD subjects.
Subjects will be screened and will enter a 2-week, single-blind (placebo), Run-In Period to evaluate the subject's adherence with study treatment, study procedures and assessment of disease stability.
At the end of the Run-In Period, subjects will return to the Clinic and who meet all of the Randomization Criteria will be randomized to double-blind study medication (12-week treatment period). Subjects will be randomized to receive either FF/VI 100/25 via NDPI or Fluticasone Propionate/Salmeterol 250/50mcg via ACCUHALER/DISKUS. Matching placebos will be available in NDPI and ACCUHALER/DISKUS. Each morning (approximately 6-10 AM) subjects will take 1 inhalation from the NDPI followed by 1 inhalation from the ACCUHALER/DISKUS. Each evening (approximately 6-10 PM), approximately 12 hours after the morning dose with blinded study medication, subjects will take 1 inhalation from the ACCUHALER/DISKUS. Subjects will return to the clinic at the end of the treatment period.
A follow-up phone contact will be performed approximately 7 days after the last clinic visit. The overall study duration (Screening to Follow-up) for each subject is approximately 15 weeks.
#Intervention
- DRUG : FF/VI 100/25 Inhalation Powder NDPI
- Subjects randomized to the FF/VI Inhalation Powder Novel Dry Powder Inhaler (NDPI) arm will receive a single inhalation of 100 mcg FF and 25 mcg VI via NDPI every morning for 12 weeks.
- DRUG : Fluticasone Propionate/Salmeterol 250/50 Inhalation Powder ACCUHALER/DISKUS
- Subjects randomized to the Fluticasone Propionate/Salmeterol Inhalation Powder ACCUHALER/DISKUS arm will receive a single inhalation of 250 mcg Fluticasone Propionate and 50 mcg Salmeterol via ACCUHALER/DISKUS once in the morning and once in the evening for 12 weeks.
- Other Names :
- ACCUHALER and DISKUS are registered trade marks of the GlaxoSmithKline Group of companies
- DRUG : Placebo Inhalation Powder NDPI
- Subjects randomized to the Fluticasone Propionate/Salmeterol Inhalation Powder ACCUHALER/DISKUS arm will receive a single inhalation of placebo inhalation powder via NDPI every morning for 12 weeks.
- Other Names :
- ACCUHALER and DISKUS are registered trade marks of the GlaxoSmithKline Group of companies
- DRUG : Placebo Inhalation Powder ACCUHALER/DISKUS
- Subjects randomized to the FF/VI Inhalation Powder NDPI arm will receive a single inhalation of placebo inhalation powder via ACCUHALER/DISKUS once in the morning and once in the evening for 12 weeks.
- DRUG : Salbutamol as needed
- Salbutamol inhalation powder | #Eligibility Criteria:
Inclusion Criteria:
* A male or female >=40 years at Screening (Visit 1).
* Capable of giving written informed consent.
* Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy.
* Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society.
* Subject with a measured post-albuterol (salbutamol) FEV1/forced vital capacity(FVC) ratio of <=0.70 at Screening.
* Subjects with a measured post-albuterol (salbutamol) FEV1 <=70% of predicted normal values.
* Subjects with a current or prior history of >=10 pack-years of cigarette smoking at Screening.
Exclusion Criteria:
* Current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD).
* Other respiratory disorders (alpha1-antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases, or other active pulmonary diseases).
* Lung volume reduction surgery within the 12 months prior to Screening.
* Hospitalized due to poorly controlled COPD within 12 weeks of Screening.
* Poorly controlled COPD (occurrence of the following in the 6 weeks prior to Screening -Acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician).
* Lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Screening.
* Moderate/severe COPD exacerbation/lower respiratory tract infection during Run-In Period.
* Abnormal and clinically significant 12-lead ECG at Screening
* Historical or current evidence of uncontrolled or clinically significant disease like cardiovascular, hypertension, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease), peptic ulcer disease, or haematological abnormalities. 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.
* History of hypersensitivity to any of the study medications or components of the inhalation powder; or history of severe milk protein allergy.
* Known or suspected history of alcohol or drug abuse within the last 2 years.
* Subjects who are medically unable to withhold their albuterol (salbutamol) and/or their ipratropium for the 4-hour period required prior to spirometry testing at each study visit.
* The subject has taken any other investigational drug within 30 days or 5 half-lives of the investigational product (IP) prior to the first dosing day in the current study.
* Use of additional medications prior to Screening (list of medications and time intervals are different for different class of medications and are indicated in the protocol)
* Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e., <=12 hours per day) is not exclusionary.
* Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Screening
* Subjects at risk of non-compliance, or unable to comply with study procedures.
* Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study.
* Women who are pregnant or lactating or are planning on becoming pregnant during the study.
* Previously randomized to either the HZC113109 or HZC112352 clinical studies.
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
| NCT01706328 | 235,969 |
{
"NCT_ID" : "NCT00623792",
"Brief_Title" : "Study on Impact of Lifestyle Change and Weight Loss Before Bariatric Surgery",
"Official_title" : "Preoperative Lifestyle Intervention in Bariatric Surgery",
"Conditions" : ["Severe Obesity", "Bariatric Surgery"],
"Interventions" : ["Behavioral: Preoperative lifestyle Intervention"],
"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)" : "2008-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-12",
"Study_Completion_Date(Actual)" : "2013-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-02-14",
"First_Posted(Estimated)" : 2008-02-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-02-25",
"Last_Update_Posted(Estimated)" : 2016-03-17",
"Last_Verified" : 2016-03"
}
}} | #Study Description
Brief Summary
The purpose of the trial is to determine whether a preoperative lifestyle intervention (targeting diet, exercise, and preparation for surgery) will favorably impact obesity-related parameters prior to bariatric surgery and improve short-term postoperative outcomes.
Detailed Description
This is a randomized, controlled trial to evaluate the impact of a preoperative lifestyle intervention that targets diet, exercise, and preparation for surgery as an adjunct to the surgical treatment of obesity. Patients will be randomized to a 6-month lifestyle intervention (n = 100) or to usual care (n = 100) prior to undergoing bariatric surgery. We aim to evaluate the effect of the intervention on select pre- and postoperative outcomes. We hypothesize that patients who participate in the preoperative intervention will exhibit greater improvements in weight and related outcomes and better preparation for surgery than those who receive usual care. After operation, we hypothesize that patients who participate in the intervention will exhibit better compliance and fewer behavior-related eating problems, as well as a lower rate of complications and fewer outpatient visits with surgery-related conditions than those who received usual preoperative care. Our secondary aim is to determine whether the intervention affects weight/BMI trajectory through 24 months after operation.
#Intervention
- BEHAVIORAL : Preoperative lifestyle Intervention
- 6 month individual intervention consisting of weekly face-to-face and telephone sessions addressing diet, activity and preparation for surgery, followed by 3 'booster' telephone calls after surgery | #Eligibility Criteria:
Inclusion Criteria:
* Any candidate for weight loss surgery who is at least 18 years [At the University of Pittsburgh Medical Center, bariatric surgery is recommended as a treatment for individuals with Class III obesity (BMI > 40), or Class II obesity (BMI 35- 40) and serious obesity-related health problems]
Exclusion Criteria:
* Mental retardation or psychosis
* Previously diagnosed genetic obesity syndrome
* Participation in a structured weight management program in the 6 months prior to study enrollment
* Uncontrolled psychiatric symptomatology sufficiently severe to require immediate treatment
* Pregnant or lactating in the previous 6 months
* Taking a medication known to affect body weight such as oral steroids in the previous 6 months
* Any previous surgery for weight loss
* Deemed high risk surgical candidate.
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
| NCT00623792 | 80,640 |
{
"NCT_ID" : "NCT05866341",
"Brief_Title" : "Nitrate Consumption and Gingival Inflammation",
"Official_title" : "Influence of the Regular Consumption of a Nitrate Containing Juice Beverage on Gingival Inflammation and the Salivary Nitrate/Nitrite Relationship in Periodontitis Patients",
"Conditions" : ["Gingivitis"],
"Interventions" : ["Dietary Supplement: nitrate-rich lettuce juice", "Dietary Supplement: nitrate-depleted lettuce juice"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-08-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-11-30",
"Study_Completion_Date(Actual)" : "2014-11-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-04-26",
"First_Posted(Estimated)" : 2023-05-19"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-05-09",
"Last_Update_Posted(Estimated)" : 2023-09-21",
"Last_Verified" : 2023-09"
}
}} | #Study Description
Brief Summary
The aim of this investigation is to evaluate the impact of the 14- day consumption of a nitrate-rich diet on the the extent of gingival inflammation in a cohort of periodontal aftercare patients. Recorded parameters were gingival index, plaque control record, salivary nitrate/nitrite level and vascular parameters
Detailed Description
This investigation evaluated the impact of a nitrate-rich diet on the extent of gingival inflammation in a cohort of periodontal aftercare patients. Forty-four (23 test/21 placebo) periodontal aftercare patients with chronic gingivitis were enrolled. At baseline, gingival index (GI), plaque con- trol record (PCR) and salivary nitrate level (SNL) were recorded, followed by sub- and supragingival debridement. Subsequently, participants were randomly provided with 100 ml bottles of a lettuce juice beverage to be consumed 39 daily over 14 days, containing either a standardized amount of nitrate resulting in an intake of approximately 200 mg nitrate per day (test) or being devoid of nitrate (placebo).
#Intervention
- DIETARY_SUPPLEMENT : nitrate-rich lettuce juice
- Consumption of a daily dosage of 200 mg nitrate via the consumption of a 300mö of a nitrate-rich lettuce juice
- DIETARY_SUPPLEMENT : nitrate-depleted lettuce juice
- Daily consumption of 300 ml of a nitrate-depleted lettuce juice | #Eligibility Criteria:
Inclusion Criteria:
* number of teeth >= 10
* body mass index (BMI) >= 24 <= 30
* presence of mild to moderate gingivitis (Gingiva Index > category GI 0 <= category GI 2) at a minimum of 3 teeth
* history of periodontal disease and inclusion in a regular scheme of supportive periodontal therapy (regularly repeated subgingival biofilm removal 2 <= age <= 4 x/year)
Exclusion Criteria:
* manifestation of severe gingivitis (Gingiva Index = 3) at any tooth
* manifestation of inflammatory oral mucosal diseases other than gingivitis
* xerostomia (salivary flow <= 0.1 ml/minute)
* inability for regular oral home care
* known allergies and intolerances to any of the ingredients of the experimental juice beverages
* inability to follow the study protocol due to intellectual or physical handicaps
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
| NCT05866341 | 129,750 |
{
"NCT_ID" : "NCT06041646",
"Brief_Title" : "Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder",
"Official_title" : "Characterization of Tachyphylaxis, Tolerance, and Withdrawal After Discontinuation of Igalmi in Frequently Agitated Schizophrenic or Bipolar Patients After 7 Days of PRN Treatment",
"Conditions" : ["Bipolar Disorder", "Schizophrenia", "Agitation,Psychomotor", "Schizo Affective Disorder", "Schizophreniform Disorders"],
"Interventions" : ["Drug: Sublingual film containing Igalmi"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2023-10-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-04-29",
"Study_Completion_Date(Actual)" : "2024-04-29},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-09-11",
"First_Posted(Estimated)" : 2023-09-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-09-11",
"Last_Update_Posted(Estimated)" : 2024-05-13",
"Last_Verified" : 2023-12"
}
}} | #Study Description
Brief Summary
This is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and withdrawal following repeated doses of Igalmi in adult males and females with agitation associated with schizophrenia or bipolar disorder.
Detailed Description
This is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and withdrawal following repeated doses of Igalmi in adult males and females (18 to 65 years old, inclusive) with agitation associated with schizophrenia or bipolar disorder. Subjects will be screened for eligibility within 15 days of first dose and no study procedures will occur unless subjects provide written informed consent. Subjects will receive single doses of 180 μg of Igalmi as needed for the treatment of agitation over a period of 7 days followed by a 3- day follow-up period during which time no Igalmi will be administered in an effort to characterize any potential withdrawal. Subjects will sublingually self-administer Igalmi for an agitation episode that reaches a pre-dose PEC total score of 14 or greater, as determined by a trained rater. Safety assessments will be conducted before and after each dose. If the subject's agitation is recurrent or persistent, repeat doses of 90 µg may be administered (no more than 2 repeat doses within a 24-hour period) in the absence of any safety concerns or adverse events.
#Intervention
- DRUG : Sublingual film containing Igalmi
- Sublingual film containing 180 µg of Igalmi (dexmedetomidine)
- Other Names :
- Dexmedetomidine, BXCL501 | #Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects between the ages of 18 <= age <= 65, inclusive.
* Subjects who have met DSM-5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder or bipolar I or II disorder.
* Subjects who are currently moderate to severely agitated at least 3 days a week.
* Subjects who read, understand, and provide written informed consent.
* Subjects who are in good general health prior to study participation as determined by a detailed medical history and in the opinion of the Principal Investigator.
* Subjects who agree to use a medically acceptable and effective birth control method
* Subjects must be willing to remain in-clinic for the duration of the study.
Exclusion Criteria:
* Subjects with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or drugs of abuse during screening.
* Use of benzodiazepines or other hypnotics or antipsychotic drugs in the 6 hours before study treatment.
* Subjects with congenital prolonged QT syndrome.
* Prior treatment with Igalmi
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
| NCT06041646 | 119,857 |
{
"NCT_ID" : "NCT01919697",
"Brief_Title" : "Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)",
"Official_title" : "An Open-Label Extension (OLE), Long-term Safety and Tolerability Study of Plecanatide in Patients With Chronic Idiopathic Constipation (CIC)",
"Conditions" : ["Chronic Idiopathic Constipation"],
"Interventions" : ["Drug: Plecanatide"],
"Location_Countries" : ["Canada", "United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-01",
"Study_Completion_Date(Actual)" : "2016-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-08-07",
"First_Submitted_that_Met_QC_Criteria" : 2019-06-11",
"First_Posted(Estimated)" : 2013-08-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-08-07",
"Last_Update_Posted(Estimated)" : 2019-07-02",
"Last_Verified" : 2019-06"
}
}} | #Study Description
Brief Summary
This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in patients with Chronic Idiopathic Constipation (CIC).
Detailed Description
This is an open-label extension study of plecanatide in the treatment of patients with CIC who previously completed Synergy Protocols SP304-20210 and SP304203-00 (The CIC3 Study).
The planned duration of each patient's study participation is up to 411 days, including up to 33 days of screening, 8 study visits over 52 weeks of treatment and a follow-up visit 2 weeks after the last dose of study drug.
#Intervention
- DRUG : Plecanatide | #Eligibility Criteria:
Inclusion Criteria:
* Patient completed a previous double-blind plecanatide study and was compliant with the study requirements.
* Patient is in good health without unstable acute illness or exacerbation of an unstable chronic illness or chronic disease that may affect study assessments, particularly if there has been a significant change to health status since the previous plecanatide study.
Exclusion Criteria:
* Patient has had major surgery including laparoscopic procedures requiring general anesthesia within 60 days of Day 1.
* Patient has a medical history of hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
* Patient has taken a protocol-prohibited drug without the appropriate washout period.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 81 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT01919697 | 244,486 |
{
"NCT_ID" : "NCT03297567",
"Brief_Title" : "Physical Therapy Guidelines For Hospitalized Elderly",
"Official_title" : "Control Group, Randomized, Blind Assessment of Physical Therapy Guidelines For Hospitalized Elderly",
"Conditions" : ["Physical Activity", "Hospitalization", "Aged", "Exercise"],
"Interventions" : ["Behavioral: verbal guidance and a booklet"],
"Location_Countries" : ["Brazil"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-09-30",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-09-30",
"Study_Completion_Date(Actual)" : "2019-02-28},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-09-21",
"First_Posted(Estimated)" : 2017-09-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-09-25",
"Last_Update_Posted(Estimated)" : 2019-10-04",
"Last_Verified" : 2019-10"
}
}} | #Study Description
Brief Summary
Introduction: The level of physical activity decreases progressively with age. Elderly subjects who are physically active have lower rates of morbidity and mortality when compared to those inactive. Hospitalization leads to long periods of bed rest and physical inactivity, with consequent muscle atrophy, generalized weakness, and decreased independence and functionality. Therefore, preventing inactivity, loss of muscle strength and the worsening of functional performance during hospitalization may be a way to avoid loss of independence. And while movement has been increasingly promoted as an important part of the recovery of hospitalized patients, many of them still spend much of the time bedridden while in hospital. Objectives: To evaluate the impact of a guiding program on the importance of remaining active during hospitalization in relation to the level of physical activity, functionality and muscular strength of elderly patients and to identify the main barriers that impede them to perform physical activities in the hospital environment. Methods: Randomized and controlled trial which will include elderly patients admitted to the Respiratory Diseases and Medical Clinic wards of the Institute of Medical Assistance to State Public Servants, in São Paulo. The intervention group will receive verbal guidelines and one booklet on the deleterious effects of hospitalization and the importance of staying active during hospitalization. All patients will be evaluated through accelerometry to identify the level of physical activity during hospitalization. Functionality will be evaluated through the DEMMI scale, muscular strength through handgrip and the main barriers to stay active during hospitalization by applying a questionnaire. The days of hospitalization and the clinical complications presented by the patients during the stay in the hospital will be noted. The difference of the outcomes of the level of physical activity and functionality before and after the intervention will be compared between the control and the intervention group through a t-test. The length of hospital stay will be analyzed by the Kaplan-Meier test and the incidence of complications by the chi-square test.
Detailed Description
Experimental Design: Patients located during the study period and who meet the eligibility criteria will be invited to participate and, after signing the informed consent form, will be evaluated for anthropometric and clinical characteristics. At this moment, patients will be randomized into two groups: intervention and control. The intervention group will receive verbal guidance and a booklet developed by the authors on the deleterious effects of hospitalization and the importance of staying active during hospital admission on the day they are included in the study. The control group will not receive any type of intervention, nor even verbal guidance. Patients from both groups will have an accelerometer placed on the wrist in the dominant limb, which should only be removed at hospital discharge. Besides the level of physical activity, patients will be evaluated for functionality, peripheral muscle strength, length of hospital stay, and incidence of complications during the hospitalization period. The researchers will contact the patients via telephone within 72 hours after hospital discharge in order to apply a questionnaire for identification of the main barriers to stay active during hospitalization.
#Intervention
- BEHAVIORAL : verbal guidance and a booklet
- Patients allocated to the intervention group will receive verbal instruction from the researchers on the importance and benefits of movement during hospital stay, as well as what they should do to increase the level of physical activity. These patients will receive the same guidelines through a playable, easy-to-understand and inexpensive booklet developed by the researchers themselves in PowerPoint 2016 (Microsoft) in order to remedy any doubt or forgetfulness during the hospitalization period | #Eligibility Criteria:
Inclusion Criteria:
* Admitted in the last 48 hours to the Respiratory Diseases and Medical Clinic wards
* Patients should not present restrictions to leave the bed
* Patients should not present need for professional help or accompanying person for locomotion
* Patients should not present local restriction for the placement of accelerometers (skin infections, amputation or fracture in the dominant limb)
* Patients should not present contact or respiratory isolation
* Patients should not present difficulty in understanding the guidelines or evaluations
Exclusion Criteria:
* Patients requiring hospital transfer
* Patients in need of surgical intervention
* Patients who not use the accelerometer during the proposed evaluation period
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03297567 | 24,570 |
{
"NCT_ID" : "NCT02752269",
"Brief_Title" : "Early Detection of Pulmonary- and Pulmonary Vascular Disease in Sjögren Syndrome",
"Official_title" : "Early Detection of Pulmonary- and Pulmonary Vascular Disease in Patients Suffering From Sjögren Syndrome",
"Conditions" : ["Sjögren Syndrome", "Pulmonary Hypertension"],
"Location_Countries" : ["Austria"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-06-30",
"Study_Completion_Date(Actual)" : "2019-06-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-11-24",
"First_Posted(Estimated)" : 2016-04-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-04-22",
"Last_Update_Posted(Estimated)" : 2020-03-18",
"Last_Verified" : 2020-03"
}
}} | #Study Description
Brief Summary
According to the literature available pulmonary hypertension is present in 12 to 23% of patients suffering from Sjögren Syndrome. However epidemiological data are based on non-invasive measurements using echocardiography. Furthermore, no data are available regarding exercise hemodynamics in those patients.
This study investigates pulmonary hemodynamics at rest and during exercise in patients suffering from primary and secondary Sjögren Syndrome. Patients under suspicion for pulmonary hypertension (PH) will be offered further investigations including right heart catheterization.
Detailed Description
Patients with primary and secondary Sjögren Syndrome will be investigated using echocardiography, exercise echocardiography, pulmonary function testing, laboratory testing, electrocardiogram and 6 minute walking test. Those patients under clinical suspicion for pulmonary hypertension will be offered further investigations including right heart catheterization to rule out or verify the diagnosis of manifest pulmonary hypertension.
| #Eligibility Criteria:
Inclusion Criteria:
* informed Consent
* diagnosis of Sjögren Syndrome
* age: 18 - 90 yrs
Exclusion Criteria:
* uncontrolled systemic hypertension (at rest >150 mmHg systolic or 95 mmHg diastolic)
* relevant systolic (EF<50%) or diastolic (>Grade 1) left ventricular dysfunction
* uncontrolled ventricular arrhythmias
* uncontrolled supraventricular bradycardia or tachycardia
* myocardial infarction within the last 12 months
* pulmonary embolism within the last 6 months
* larger surgical interventions within the last 12 months
* musculoskeletal or vascular disease, that may affect ergometric investigations
* pregnancy (anamnesis)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT02752269 | 114,745 |
{
"NCT_ID" : "NCT03141164",
"Brief_Title" : "Peripheral Vision Training Study",
"Official_title" : "Peripheral Vision Training Study",
"Conditions" : ["Visual Impairment", "Cognitive Change"],
"Interventions" : ["Other: computerized training"],
"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)" : "2017-05-30",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-09-30",
"Study_Completion_Date(Actual)" : "2020-09-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-04-28",
"First_Posted(Estimated)" : 2017-05-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-05-03",
"Last_Update_Posted(Estimated)" : 2021-06-08",
"Last_Verified" : 2021-06"
}
}} | #Study Description
Brief Summary
This study will train participants (young people and older adults) to do a visual task, and will assess whether this results in changes in behavioral assessments. In some participants, we will be also testing whether MRI measures (cortical thickness, functional connectivity) change with training.
#Intervention
- OTHER : computerized training
- Computerized training | #Eligibility Criteria:
Inclusion criteria:
* Right handed individuals
* Aged 19 <= age <= 89
* In good health as self-reported or visual impairments due to partial vision loss
* Normal or corrected-to-normal vision with contact lenses or visual impairments due to partial vision loss
Exclusion criteria:
* Younger than >= 18 years than 89
* Being hearing-impaired
* Not in good health except due to partial vision loss
* Having a previous serious head injury or neurological disorder, or loss of consciousness for more than 2 minutes
* Having hallucinations or delusions
* Having a current or past history of a substance abuse disorder
* Currently taking psychoactive medications
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 89 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
| NCT03141164 | 188,142 |
{
"NCT_ID" : "NCT03572387",
"Brief_Title" : "A Pilot Study of 5-AZA and ATRA for Prostate Cancer With PSA-only Recurrence After Local Treatment",
"Official_title" : "A Pilot Study of the Combination of 5-azacitidine (5-AZA) and All-trans Retinoic Acid (ATRA) for Prostate Cancer (PCa) With PSA-only Recurrence After Definitive Local Treatment",
"Conditions" : ["Prostatic Neoplasms", "Prostate Neoplasms", "Prostate Cancer"],
"Interventions" : ["Drug: 5-Azacitidine", "Drug: Lupron", "Drug: all trans retinoic acid"],
"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)" : "2018-08-20",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-06-19",
"Study_Completion_Date(Actual)" : "2022-07-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-06-18",
"First_Submitted_that_Met_QC_Criteria" : 2024-04-04",
"First_Posted(Estimated)" : 2018-06-28"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-06-26",
"Last_Update_Posted(Estimated)" : 2024-04-30",
"Last_Verified" : 2024-04"
}
}} | #Study Description
Brief Summary
This is a prospective, open-label, randomized, cross-over, pilot study of reprogramming therapy in patients with recurrent PCa based on rising PSA only. The primary objectives are to compare the disease progression-free rate at the end of 12 weeks of treatment between 5-AZA+ATRA and no therapy and to assess safety of the 5-AZA and ATRA combination. All study enrollees will receive Lupron. After one month, they will be assigned in a 1:1 randomization to either the '5-AZA+ATRA' group or the 'no therapy' group. Patients in the '5-AZA + ATRA' group will receive treatment on a 28-day cycle, in the absence of prohibitive toxicities, for 3 cycles. In the 'no therapy' group, patients will initially be observed for 3 cycles and then receive treatment for 3 cycles, in the absence of prohibitive toxicities. After the treatment period, all patients will be followed for up to 24 months from the start of the study or until the events leading to discontinuation are observed.
#Intervention
- DRUG : 5-Azacitidine
- subcutaneously on days 1-5 at a dose of 40 mg/m\^2
- Other Names :
- 5-AZA
- DRUG : all trans retinoic acid
- 45 mg/m\^2, will be taken orally on days 3-7 of each cycle, divided into two doses
- Other Names :
- ATRA
- DRUG : Lupron
- 7.5 mg x 1
- Other Names :
- Leuprolide | #Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed adenocarcinoma of the prostate
* Rising PSA
* PSADT <= 10 months prior to initiation of ADT
* No evidence of regional or active distant metastases, except for regional metastasis where salvage radiation therapy is not an option
* Indication for ADT after receiving definitive local therapy
* Males >= 18 years.
* ECOG performance status of <= 2
* Men must agree to use a condom and not father a child or donate sperm for the duration of the study and for 90 days after completion of therapy
* Ability to understand and the willingness to sign a written informed consent
* Ability to adhere to the study visit schedule and requirements of the protocol
Exclusion Criteria:
* Patients who have received ADT and/or other chemotherapy within 3 months prior to entering the study.
* Patients who have had radiotherapy or surgery within 4 weeks prior to entering the study. Minimally-invasive procedures for the purpose of diagnosis or staging of the disease are permitted.
* Patients may not be receiving any other investigational agents.
* Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 5-AZA and ATRA.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Significant active cardiac disease within the previous 6 months
* Inadequate organ and marrow function as defined below:
* leukocytes <= 3,000/mcL
* absolute neutrophil count <= 1,500/mcL
* platelets <= 100,000/mcl
* total bilirubin above normal institutional limits
* AST(SGOT)/ALT(SPGT) >= 2.5 X institutional upper limit of normal
* creatinine above normal institutional limits
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03572387 | 204,031 |
{
"NCT_ID" : "NCT05708976",
"Brief_Title" : "HypErthermia as an Additional Treatment for the Biology and Experience of Depression: Study 2",
"Official_title" : "HypErthermia as an Additional Treatment for the Biology and Experience of Depression: Study 2",
"Conditions" : ["Major Depressive Disorder", "Depression"],
"Interventions" : ["Device: Sham Whole-Body Hyperthermia (Sham WBH)", "Device: Active Whole-Body Hyperthermia (Active WBH)", "Behavioral: Cognitive Behavioral Therapy (CBT)"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2023-02-15",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-09-30",
"Study_Completion_Date(Actual)" : "2024-09-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-01-23",
"First_Posted(Estimated)" : 2023-02-01"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-01-23",
"Last_Update_Posted(Estimated)" : 2024-12-06",
"Last_Verified" : 2024-12"
}
}} | #Study Description
Brief Summary
This randomized two-arm intervention trial administers 8 weekly cognitive behavioral therapy (CBT) sessions and 4 bi-weekly active whole-body hyperthermia (active WBH) sessions or 4 bi-weekly sham WBH sessions to adults aged 18 years or older with major depressive disorder (MDD).
Detailed Description
Major Depressive Disorder afflicts more than 300 million people worldwide and is the leading cause of life years lost to disability. Current treatments have important limitations in efficacy and, in the case of medication, substantial side-effects. There is thus a compelling need for additional effective, well-tolerated treatments. One such potential treatment is whole-body hyperthermia (WBH). The investigators hypothesize that active WBH may be particularly effective in combination with cognitive behavioral therapy (CBT), an established treatment for depression. This randomized two-arm trial will pilot and optimize procedures for randomizing participants to receive CBT (8 weekly sessions) and 4 bi-weekly whole-body hyperthermia (active WBH) or 4 bi-weekly sham WBH sessions. This work holds important promise to improve treatment of depression and advance understanding of the role of integrated mind-body therapies for mood disorders.
#Intervention
- BEHAVIORAL : Cognitive Behavioral Therapy (CBT)
- Cognitive Behavioral Therapy (CBT) is a behavioral (psychotherapeutic) intervention for major depressive disorder (MDD). A highly trained masters' or PhD-level clinician will administer 8 weekly CBT sessions (\~50 minutes each), following the standard cognitive behavioral therapy for depression protocol.
- DEVICE : Active Whole-Body Hyperthermia (Active WBH)
- Active whole-body hyperthermia (active WBH) will be administered by trained research assistants. Preparation for the active WBH session, the active WBH session, and cool down will last 3.5 hours, with heating lasting approximately 90-100 minutes (and no longer than 140 minutes). The treatment will take place in an infrared sauna dome, and the active heating phase will last until the participants has achieved a core (rectal) temperature of 38.5 C.
- Other Names :
- Active Sauna Sessions
- DEVICE : Sham Whole-Body Hyperthermia (Sham WBH)
- Sham whole-body hyperthermia (sham WBH) will be administered by trained research assistants. Preparation for the sham WBH session, the sham WBH session, and cool down will last 3.5 hours, with heating lasting approximately 90-100 minutes (and no longer than 140 minutes). The treatment will take place in an infrared sauna dome, and the sham WBH session will minimally impact core body temperature.
- Other Names :
- Sham Sauna Sessions | #Eligibility Criteria:
Inclusion Criteria:
* Age of at least 18 years
* Current major depressive episode of at least 2 weeks duration as assessed by the Structured Clinical Interview for DSM-5 (SCID) and a Beck Depression Inventory-II (BDIII) score > 21 at screening
* Able to understand the nature of the study and able to provide written informed consent prior to conduct of any study procedures
* Must have smartphone onto which the participant can download an app from Apple App or Google Play stores
* Ability to lie supine (on back) for 2 hours (required for sauna sessions)
Exclusion Criteria:
* >30% reduction in BDI-II score between Screen #1 and Screen #2 (conducted ~1 week after Screen #1)
* Suicide attempt in the past 12 months defined using the SAMHSA suicidality question during the clinician-administered interview or active suicidal ideation as indexed by a score of 3 on the BDI-II suicidality item during the clinician-administered interview
* Any of the following medical conditions: cardiovascular disease (other than controlled hypertension), seizure disorder, history of cerebrovascular accident (CVA) or other serious neurological condition (e.g. Parkinson's disease, multiple sclerosis, or dementia), current neoplasia, any active enclosed infection (e.g. dental abscess, joint infection), hemophilia or other cause for excessive bleeding (e.g. platelet disorder), or other medical condition that in the opinion of investigators may increase the risk of WBH
* Comorbid psychiatric conditions or history of comorbid psychiatric conditions that might better explain depressive symptoms, including schizophrenia, schizoaffective disorder, Bipolar Disorder I, Obsessive Compulsive Disorder, Anorexia Nervosa, Bulimia Nervosa, Alcohol Dependence, or Drug Dependence
* Known hypersensitivity to hyperthermia and/or infrared exposure
* Inability to fit into the sauna device
* Breast implants
* Pregnancy, active lactation or intention to become pregnant during the study period
* Use of any medication that might impact thermoregulatory capacity, including: Diuretics, barbiturates, beta-blockers, antipsychotic agents, anti-cholinergic agents or chronic use of antihistamines, aspirin (other than low-dose ASA for prophylactic purposes), medication prescribed for the treatment of depression (antidepressant medication [ADM]) including but not limited to: selective serotonin reuptake inhibitors [SSRIs], Serotonin and norepinephrine reuptake inhibitors [SNRIs], Monoamine oxidase inhibitors [MAOIs], Tricyclics [TCAs], and atypical antipsychotic and antidepressant medications (participants must have been free of these medications for at least 4 weeks), antibiotics (past 14 days), pain medication (opioids) due to procedure, e.g., dental procedure (past 14 days), Emergency contraception pill (past 14 days) any other medication that in the judgment of the PI would increase risk of study participation or introduce excessive variance into physiological or behavioral responses to WBH recent use (multiple consecutive doses) of: non-steroidal anti-inflammatory drugs (NSAIDs), systemic corticosteroids, cytokine antagonists
* Regular use of any nicotine products, including cigarettes, vapes, chewing tobacco, or other forms of nicotine (if use is not regular, must be willing to refrain for 24 hours before and 24 hours after WBH session)
* Unwilling to refrain from using marijuana products and alcohol for the 24 hours before and 24 hours after WBH session
* Unwilling to refrain from heavy exercise on the day of WBH sessions
* Unwilling to refrain from engaging with sauna, hot yoga, cold plunges, cryotherapy, and hot tub/jacuzzi outside of study (prospective participant must not have engaged with any of these activities for 30 days prior to their baseline study visit).
* Has begun new psychotherapy treatment in the prior 6 weeks
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
| NCT05708976 | 82,642 |
{
"NCT_ID" : "NCT01923610",
"Brief_Title" : "Safety and Immunological Response of a Boosting Dose of MVA-B in Healthy Volunteers After 4 Years of Receiving MVA-B",
"Official_title" : "Safety and Immunological Response of a Boosting Dose of MVA-B in Healthy Volunteers After 4 Years of Receiving MVA-B",
"Conditions" : ["HIV Infections"],
"Interventions" : ["Biological: Experimental"],
"Location_Countries" : ["Spain"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-09",
"Study_Completion_Date(Actual)" : "2014-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-08-13",
"First_Posted(Estimated)" : 2013-08-15"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-08-14",
"Last_Update_Posted(Estimated)" : 2017-03-21",
"Last_Verified" : 2017-03"
}
}} | #Study Description
Brief Summary
24 healthy male and female volunteers who are at low risk of HIV infection and entered into the RISVAC02 study and were randomly allocated to receive 3 intramuscular injections of MVA-B at weeks 0, 4 and 16 will receive a boosting dose 4 years thereafter.
Participants will attend one of two clinical centres on at least 5 occasions over 16 weeks. These visits will comprise:
* Screening
* Trial entry and boosting immunisation
* Early follow-up after immunisation
* Follow-up x 2 including the final visit Participants will have blood and urine collected, and receive 1 immunisation. They will be counselled prior to and following a HIV test, and given health education on prevention of sexually transmitted infections including HIV. T
The two centres which participate are:
* Hospital Clinic, Barcelona and
* Hospital Gregorio Marañón, Madrid The primary objective is to explore the safety and immunogenicity of MVA-B.
#Intervention
- BIOLOGICAL : Experimental
- Biological/Vaccine: MVA-B Modified Pox virus, strain MVA clade -B (expressing HIV-1 Bx08gp120 and IIIB gagpolnef)
-\~ 1 x 10e8 pfu/ml 3 immunisations at week 0, 4 and 16 | #Eligibility Criteria:
Inclusion Criteria:
* male or female
* age between 18 and 55 years on the day of screening
* available for follow-up for the duration of the study (52 weeks from screening)
* able to give written informed consent
* at low risk of HIV and willing to remain so for the duration of the study low risk of HIV infection defined as: no history of injecting drug use in the previous ten years no gonorrhoea or syphilis in the last six months no high risk partner (e.g. injecting drug use, HIV positive partner) either currently or within the past six months no unprotected anal intercourse in the last six months no unprotected vaginal intercourse outside a relationship with a regular known/presumed HIV negative partner in the last six months
* willing to undergo a HIV test
* willing to undergo a genital infection screen
* if heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable contraceptive; IUCD; consistent record with condoms if using these; physiological or anatomical sterility in self or partner) from 14 days prior to the first vaccination until 4 months after the last, and willing to undergo urine pregnancy tests prior to each vaccination
* if heterosexually active male, using an effective method of contraception with their partner from the first day of vaccination until 4 months after the last vaccination
Exclusion Criteria:
* positive for hepatitis B surface antigen, hepatitis C antibody, antibody responses to vaccinia or serology indicating active syphilis requiring treatment
* pregnant or lactating
* clinically relevant abnormality on history or examination including history of grand-mal epilepsy, severe eczema, immunodeficiency or use of immunosuppressives in preceding 3 months
* receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of enrolment
* receipt of blood products or immunoglobin within 4 months of screening
* participation in another trial of a medicinal product, completed less than 30 days prior to enrolment
* history of severe local or general reaction to vaccination defined as local: extensive, indurated redness and swelling involving most of the front-lateral thigh or the major circumference of the arm, not resolving within 72 hours general: fever >= 39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal
* HIV 1/2 positive or indeterminate on screening
* positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment
* grade 1 routine laboratory parameters
* unlikely to comply with protocol
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT01923610 | 104,678 |
{
"NCT_ID" : "NCT02565706",
"Brief_Title" : "Online WIC Nutrition Education to Promote Farmers' Market Fruit and Vegetable Purchases and Consumption",
"Official_title" : "Online WIC Nutrition Education to Promote Farmers' Market Fruit and Vegetable Purchases and Consumption",
"Conditions" : ["Cardiovascular Diseases", "Cancer", "Type 2 Diabetes", "Obesity"],
"Interventions" : ["Behavioral: WIC Fresh Start Program", "Behavioral: Existing Online Health Education"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-06",
"Study_Completion_Date(Actual)" : "2016-06},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-09-29",
"First_Submitted_that_Met_QC_Criteria" : 2019-10-25",
"First_Posted(Estimated)" : 2015-10-01"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-09-30",
"Last_Update_Posted(Estimated)" : 2019-10-30",
"Last_Verified" : 2019-10"
}
}} | #Study Description
Brief Summary
This study is evaluating the WIC Fresh Start program, a theory-driven, web-based nutrition education lesson to promote farmers' market fruit and vegetable purchases and consumption among women enrolled in the Special Supplemental Nutrition Program for Women, Infants and Children (WIC).
Detailed Description
This study is evaluating the WIC Fresh Start program, a theory-driven, web-based nutrition education lesson to promote fruit and vegetable (FV) consumption among women enrolled in the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). Designed to leverage vouchers provided to WIC participants for FV purchases through the Farmers' Market Nutrition Program (FMNP) and monthly cash value vouchers (CVVs) redeemable at farmers' markets, the lesson is conceptually grounded in formative research on knowledge, attitudes and skills influencing farmers' market FV purchases and consumption and theoretical understanding of approaches for modifying them. Lesson content delivery is primarily through short video segments and audio output to increase accessibility for low-literate learners. Informed by a community-based participatory research approach, WIC participants are engaged as full partners in the development of the lesson and the delivery of content (videos feature WIC participants). The setting is a large WIC agency serving three New Jersey counties. Separate samples of women were recruited to participate in 1) focus groups for guiding lesson content development (N = 56 participants) and pretesting the resulting content (N = 52 participants), 2) cognitive testing to assess the clarity and interpretability of items and response formats in measures of knowledge, attitudes and skills developed for the study (N = 15), 3) one-on-one sessions to assess reactions to initial versions of video segments developed for the lesson (N = 20), and 4) the outcome evaluation (N = 744). Stratified based on FMNP voucher receipt, participants are randomized to receive the lesson or existing online health education. Outcome measures (administered orally to reduce literacy demands of the response task) are completed at pretest (immediately before the lesson), posttest (two weeks after the lesson), and 3 and 6 months after posttesting. Short- and long-term lesson effects on FV intake, FMNP voucher redemption and the redemption of CVVs at farmers' markets will be evaluated. Evidence for mediation by knowledge, attitudes, and skills of lesson effects on FV intake and voucher redemption, dose-response relationships, and user satisfaction with the lesson also will be examined.
#Intervention
- BEHAVIORAL : WIC Fresh Start Program
- The intervention is an online lesson to promote farmers' market FV purchases and consumption. The lesson comprises three modules, each consisting of 1) behavior change content presented through a video segment featuring WIC participants, and 2) an interactive activity to build targeted knowledge, attitudes, and skills.
- BEHAVIORAL : Existing Online Health Education
- Any of seven existing online WIC health education lessons (lessons are available on breastfeeding, being active, fruits and vegetables, calcium, cholesterol, oral health and iron). The lessons consist of an introductory segment presented with online text and graphics. After reading this material, viewers have the option to complete one of four lesson activities. The activities provide opportunities for viewers to read further on the topic and are designed to reinforce key points of the lesson. | #Eligibility Criteria:
Inclusion Criteria:
* Pregnant or postpartum WIC participant
* Female caregiver of infant/child WIC participant
Exclusion Criteria:
* Restrictions on food intake
* Classified by WIC as high risk/requiring an individualized nutrition care plan
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
| NCT02565706 | 150,045 |
{
"NCT_ID" : "NCT05852483",
"Brief_Title" : "Predictors of Readmission in Patients Undergoing PNL",
"Official_title" : "Perioperative Predictors of Postoperative Readmission Among Patients Undergoing Percutaneous Nephrolithotomy",
"Conditions" : ["Kidney Stone"],
"Location_Countries" : ["Egypt"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-04-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-10-01",
"Study_Completion_Date(Actual)" : "2022-12-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-05-02",
"First_Posted(Estimated)" : 2023-05-10"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-05-09",
"Last_Update_Posted(Estimated)" : 2023-05-17",
"Last_Verified" : 2023-05"
}
}} | #Study Description
Brief Summary
To identify predictors of patients postoperative readmission after PNL
Detailed Description
Percutaneous nephrolithotomy (PCNL) is a minimally-invasive procedure to remove stones from the kidney by a small puncture wound (up to about 1 cm) through the skin. It is usually done under general anesthesia or spinal anesthesia. Despite the advancements in endoscopic technologies technique and training, the procedure is still associated with complications, which can occur during the intervention or in the early or late postoperative period. Known complications to PCNL are fever (2.8-32.1%), bleeding requiring transfusion (0- 45%), organ injury (0-1.7%) and sepsis (0.3-1.5%) these complications consider life threatening and increase risk of patient readmission Readmission is defined as a state when the patient is admitted to the same or a different hospital after being discharged from the applicable hospital to a non-acute setting, such as his home within a specified time period . Hospital readmissions are frequent and costly, and are estimated to cost the US health care system \> $12-17 billion annually . Readmissions occurring within the first week after discharge are often related to the stress of acute illness as well as heightened self-care needs, new medications, and impaired function while those occurring later reflect chronic illness Nurses could play a pivotal role in preventing readmissions through appropriate discharge teaching and following up with the patients after discharge through telephone conversations. Early identification of patients' problems and taking appropriate measures to handle these problems at an early stage helps to prevent further post-discharge complications and improves patient outcomes.
Nurse should emphasize to the patient the importance of reporting symptoms to physician immediately. Postoperative care should include: close monitoring of vital signs, close observation of urine output and color changes, wound care and careful observation for dressing and tube drainage.
Many studies have been found in the literature on readmissions after urological surgeries and their causes in recent years . These studies include general urological surgical procedures, and there are limited studies examining potential predictive factors for endourology and stone surgery
| #Eligibility Criteria:
Inclusion Criteria:
* Adult male and female patients
* patients shechedled for PNL
* age range from)18 <= age <= 65(years
Exclusion Criteria:
* Failed PNL
* psychiatric patients
* coagulopathy
* patients refused to participate in the study
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
| NCT05852483 | 218,093 |
{
"NCT_ID" : "NCT00429793",
"Brief_Title" : "Temsirolimus in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer",
"Official_title" : "A Phase II Evaluation of CCI-779 (Temsirolimus, NCI-Supplied Agent, NSC #683864, IND #61010) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma",
"Conditions" : ["Fallopian Tube Cancer", "Primary Peritoneal Cavity Cancer", "Recurrent Ovarian Epithelial Cancer"],
"Interventions" : ["Drug: temsirolimus"],
"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)" : "2007-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-01",
"Study_Completion_Date(Actual)" : "2012-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2007-01-30",
"First_Submitted_that_Met_QC_Criteria" : 2013-09-17",
"First_Posted(Estimated)" : 2007-02-01"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2007-01-30",
"Last_Update_Posted(Estimated)" : 2019-07-24",
"Last_Verified" : 2019-07"
}
}} | #Study Description
Brief Summary
This phase II trial is studying the side effects and how well temsirolimus works in treating patients with refractory or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description
OBJECTIVES: Primary I. Determine the 6-month progression-free survival (PFS) or objective tumor response in patients with refractory or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer treated with temsirolimus.
II. Determine the toxicity of this drug in these patients.
Secondary I. Determine the duration of PFS and overall survival of these patients.
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.
#Intervention
- DRUG : temsirolimus
- Given IV
- Other Names :
- CCI-779, cell cycle inhibitor 779, Torisel | #Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed ovarian epithelial, fallopian tube or primary peritoneal cavity cancer
* Recurrent or refractory
* Prior treatment with >= 1 platinum-based chemotherapeutic regimen for management of primary disease (containing carboplatin, cisplatin, or another organoplatinum compound) required
* Initial treatment may have included any of the following:
* High-dose therapy
* Intraperitoneal therapy
* Consolidation therapy
* Noncytotoxic agents
* Extended therapy administered after surgical or nonsurgical assessment
* Patients must meet >= 1 of the following criteria:
* Treatment-free interval after platinum therapy of < 12 months for patients who received only 1 platinum-based regimen
* Progressed during platinum-based therapy
* Refractory disease after a platinum-based regimen
* Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
* Must have >= 1 target lesion
* Tumors within a previously irradiated field will be designated as 'non-target' lesions unless progression is documented or a biopsy is obtained >= 90 days after completion of radiotherapy
* Not eligible for a higher priority GOG protocol, if one exists
* GOG performance status (PS) 0 <= age <= 2 for patients who have receive one prior regimen OR GOG PS 0 <= age <= 1 for patients who have received 2 <= age <= 3 prior regimens
* Absolute neutrophil count >= 1,500/mm³
* Platelet count >= 100,000/mm³
* Creatinine <= 1.5 times upper limit normal (ULN)
* Bilirubin <= 1.5 times ULN
* AST <= 2.5 times ULN
* Alkaline phosphatase <= 2.5 times ULN
* No neuropathy (sensory and motor) > grade 2
* Fasting cholesterol < 350 mg/dL
* Fasting triglycerides < 400 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active infection requiring antibiotics (with the exception of uncomplicated UTI)
* No other invasive malignancies within the past 5 years, except for non-melanoma skin cancer, breast cancer, or head and neck cancer
* See Disease Characteristics
* Recovered from prior surgery, radiotherapy, or chemotherapy
* At least 1 week since prior hormonal therapy directed at the malignant tumor
* At least 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin
* Patient must remain free of recurrent or metastatic disease
* At least 3 years since prior adjuvant chemotherapy for localized breast cancer
* Patient must remain free of recurrent or metastatic disease
* At least 3 weeks since other prior therapy directed at the malignant tumor, including immunologic agents
* No prior temsirolimus
* No prior cancer treatment that would preclude study therapy
* No prior radiotherapy to > 25% of marrow-bearing areas
* No prior radiotherapy to any portion of the abdominal cavity or pelvis, except for the treatment of ovarian cancer
* No prior non-cytotoxic therapy for management of recurrent or persistent ovarian disease, except for therapy that was part of the primary treatment regimen
* Two additional cytotoxic regimens (defined as any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa) for management of recurrent or persistent ovarian disease allowed
* Concurrent low molecular weight heparin allowed provided PT/INR <= 1.5
* Concurrent hormone replacement therapy allowed
* No concurrent amifostine or other protective reagents
* No concurrent prophylactic filgrastim (G-CSF)
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
| NCT00429793 | 210,592 |
{
"NCT_ID" : "NCT00929656",
"Brief_Title" : "Combined Neural and Behavioral Therapies to Enhance Stroke Recovery",
"Official_title" : "Combining Neural and Behavioral Therapies to Enhance Stroke Recovery",
"Conditions" : ["Stroke"],
"Interventions" : ["Procedure: Sham rTMS", "Procedure: Real rTMS", "Procedure: Unimanual paretic UE Training"],
"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)" : "2013-02-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-09-30",
"Study_Completion_Date(Actual)" : "2015-09-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-06-25",
"First_Submitted_that_Met_QC_Criteria" : 2017-04-11",
"First_Posted(Estimated)" : 2009-06-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-06-26",
"Last_Update_Posted(Estimated)" : 2017-08-21",
"Last_Verified" : 2017-07"
}
}} | #Study Description
Brief Summary
Stroke is the leading cause of long-term disability in this country with more than 1 million Americans reporting difficulty with daily activities. Loss of independence in self-care tasks is primarily due to limited recovery of the arm. This study will determine if the addition of Transcranial Magnetic Stimulation (TMS) to excite the lesioned hemisphere (side of the brain affected by the stroke), to progressive functional task exercise either of the weakened arm alone or of both arms together will improve arm recovery to a greater degree than one of these two types of arm exercise alone. Individuals post-stroke will participate in 16 sessions of 1) arm rehabilitation alone (with the weaker arm only or with both arms together) or 2) arm rehabilitation plus TMS. The investigators will assess arm movement ability and function immediately following the 4-week intervention and at a 30-day follow-up to determine retention of immediate gains. The investigators hypothesize that those who receive TMS as an adjuvant will have improved arm movement ability than those who only exercise.
Detailed Description
Limited recovery of upper extremity (UE) function post-stroke continues to be one of the greatest challenges faced in neurorehabilitation. There is an urgent unmet need to identify effective approaches to drive UE recovery in this population. In response to this challenge, the overall purpose of this proposed research plan is to develop rehabilitation interventions that restore UE motor recovery. Contemporary approaches to motor rehabilitation are based on evidence that behavioral experience drives cortical reorganization following neural injury. Although the rationale of driving the damaged motor cortex by focused training of the paretic UE appears straightforward, and has historically been the focus of rehabilitation, functional recovery remains limited. There remains a gap between this central neurobiological change and a meaningful behavioral change. There is a need, therefore, to augment or potentiate behavioral experience. This proposal will address this gap by examining two potential drivers of the lesioned hemisphere: 1) the non-lesioned hemisphere via engagement of the unaffected UE in behavioral training and 2) stimulation of the lesioned hemisphere via repetitive Transcranial Magnetic Stimulation (rTMS). This proposal builds on the foundation of the applicant's previous work which suggested that the contralesional, intact, hemisphere could be used to drive the lesioned hemisphere through bimanual movement. Additionally, it is possible to drive the lesioned hemisphere externally using rTMS to enhance cortical stimulation. Thus, pairing externally-driven enhancement of cortical excitability with internally-driven activation of the intact hemisphere during bilateral movements could combine to further increase excitability in the lesioned hemisphere and manifest improved movement capability of the paretic UE. The fundamental hypothesis guiding this proposal is that increased excitability of the lesioned cortex will improve behavioral function of the paretic UE post-stroke. To investigate the overall hypothesis the investigators will examine these drivers of cortical excitability and their role in UE recovery by addressing the following aims:
Specific Aim 1. Determine the magnitude of difference in central and behavioral changes in individuals with post-stroke hemiparesis randomized to a bilateral versus unilateral UE motor training program.
Specific Aim 2a. Determine the magnitude of difference in central and behavioral changes in individuals with post-stroke hemiparesis randomized to behavioral UE training compared to behavioral UE training + rTMS.
Specific Aim 2b. Determine the differential effects of rTMS on bilateral behavioral training compared to unilateral behavioral training as measured both centrally and behaviorally in individuals with post-stroke hemiparesis Post-stroke upper limb paresis and resultant loss of functional ability continues to present a barrier to those post-stroke in returning to full societal participation. Interventions that directly target the mechanism of hemiparesis, including decreased excitability of the lesioned hemisphere, are most likely to promote true recovery as opposed to the oft observed functional compensation in these individuals.
#Intervention
- PROCEDURE : Real rTMS
- rTMS application to lesioned hemisphere; 10 Hz, 1000 pulses
- PROCEDURE : Sham rTMS
- sham rTMS application to lesioned hemisphere; 10 Hz, 1000 pulses
- PROCEDURE : Unimanual paretic UE Training
- UE exercise for 4 hours (two hours 1:1 with therapist and two hours independent at home) for 16 sessions (4 sessions/week for 4 weeks) | #Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of 1st stroke > 6 months
* Sub-cortical stroke confirmed with CT or MRI
* Passive range of motion in bilateral shoulder and elbow within functional limits
* UE Fugl-Meyer shoulder/elbow subcomponent score between 15 - 25
* 18 <= age <= 80 years
Exclusion Criteria:
* Use of medications that may lower seizure threshold
* History of epilepsy, brain tumor, learning disorder, mental retardation, drug or alcohol abuse, dementia, major head trauma, or major psychiatric illness
* evidence of epileptiform activity on EEG obtained before beginning treatment
* history or radiographic evidence of arteriovenous malformation, intracortical hemorrhage, subarachnoid hemorrhage, or bilateral cerebrovascular disease,
* history of cortical stroke
* history of implanted pacemaker or medication pump, metal plate in skull, or metal objects in the eye or skull
* pregnancy
* pain in either upper extremity that would interfere with movement
* unable to understand 3-step directions
* orthopedic condition in back or UE or impaired corrected vision that would alter kinematics of reaching
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
| NCT00929656 | 201,486 |
{
"NCT_ID" : "NCT02452814",
"Brief_Title" : "Long Term Extension Study is Designed to Monitor Long-Term Efficacy and Safety of Miravirsen Sodium in Combination With Telaprevir and Ribavirin in Subjects With Chronic Hepatitis C Virus Genotype 1 Infection",
"Official_title" : "Long-term Extension to a Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Combination With Telaprevir and Ribavirin in Null Responders to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Genotype 1 Infection",
"Conditions" : ["HCV"],
"Location_Countries" : ["Puerto Rico", "United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-05-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-05-03",
"Study_Completion_Date(Actual)" : "2017-05-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-05-11",
"First_Posted(Estimated)" : 2015-05-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-05-20",
"Last_Update_Posted(Estimated)" : 2018-02-06",
"Last_Verified" : 2018-02"
}
}} | #Study Description
Brief Summary
Long Term Observational Extension Study Designed to Monitor Long-Term Efficacy and Safety of Miravirsen Sodium in Combination with Telaprevir and Ribavirin in Subjects with Chronic Hepatitis C Virus Genotype 1 Infection
| #Eligibility Criteria:
Inclusion Criteria:
* Participated in Study SPC3649 <= age <= 205 (this would include those who completed study SPC3649 <= age <= 205, those who discontinued or terminated the study early for whatever reason (including treatment failure) and those who opted to receive approved therapy for the treatment of HCV infection).
Exclusion Criteria:
* Those unwilling to provide informed consent for participation in this study.
* Subjects who have received investigational drug therapy after discontinuation, termination, or successful completion of Study SPC3649 <= age <= 205.
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
| NCT02452814 | 105,868 |
{
"NCT_ID" : "NCT02966860",
"Brief_Title" : "Single-Dose PK Study of an Oxycodone/Acetaminophen Solution in Healthy Subjects",
"Official_title" : "A Single-Dose Study Evaluating the Oral Pharmacokinetics of an Oxycodone/Acetaminophen Solution in Healthy Subjects Under Fasted Conditions",
"Conditions" : ["Healthy Volunteers"],
"Interventions" : ["Drug: Oral solution OC/APAP"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-09",
"Study_Completion_Date(Actual)" : "2016-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-11-06",
"First_Posted(Estimated)" : 2016-11-17"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-11-15",
"Last_Update_Posted(Estimated)" : 2017-04-05",
"Last_Verified" : 2017-04"
}
}} | #Study Description
Brief Summary
A single-dose study evaluating the oral PK of an oxycodone/apap solution in healthy subjects under fasted conditions
Detailed Description
An open-label, single-dose, single-center study evaluating the oral PK of an oxycodone/apap solutions in healthy subjects under fasted conditions
#Intervention
- DRUG : Oral solution OC/APAP | #Eligibility Criteria:
Inclusion Criteria:
* Subjects must be adequately informed and understands the nature and risks of the study and must be able to provide a signature and date on the informed consent form (ICF).
* Subjects must have a health status of 'healthy' assessed by the investigator, defined as no clinically significant deviation from normal in medical history, physical examination, and clinical laboratory determinations.
* Subjects must be males or nonpregnant, nonlactating females, between 18 and 55 years (inclusive) at time of the Screening Visit.
* Subjects must have a body mass index (BMI) >= 19.0 and <= 30.0 kg/m² with a minimum weight of 110 pounds for females and 130 pounds for males at the Screening Visit. The BMI will be calculated using the standard formula of weight (kg)/(height [m])2.
* Female subjects must have a negative serum pregnancy test at the Screening Visit and check-in to the study site. All female subjects who are biologically capable of having children must agree and commit to the use of 2 acceptable methods of birth control, defined as nonhormonal forms of contraception, condoms or diaphragms with spermicidal foam 14 days prior to check-in to the study site and for the duration of study participation. Unacceptable methods of birth control include abstinence, hormone-containing intrauterine devices, uterine ablation, hormonal forms of contraception, rhythm, and withdrawal methods. Female subjects who are not biologically capable of having children are defined as postmenopausal female subjects who have been amenorrheic for at least 12 consecutive months prior to the Screening Visit or are surgically sterile.
* Male subjects with reproductive potential must agree to use an acceptable method of contraception for the duration of the study (surgical sterilization [vasectomy] or condom with spermicide).
* Subjects must be able to communicate effectively with study personnel.
* Subjects must be able and willing to follow all protocol requirements and study restrictions.
Exclusion Criteria:
* A subjects is ineligible for the study if he or she meets any of the following criteria at the Screening Visit or at check-in to the study site:
* Subject is from a vulnerable population, as defined by the Code of Federal Regulations Title 45, Part 46, Section 46.111(b), including but not limited to employees (temporary, part-time, full time, etc.) or a family member of the research staff conducting the study, or of the sponsor, or of the clinical research organization, or of the institutional review board (IRB).
* Subject has a history of any drug allergy, hypersensitivity, or intolerance to any opioids, APAP, or naltrexone which, in the opinion of the investigator, would place the subject at particular risk and compromise the safety of the subject in the study.
* Subject has a positive test result for human immunodeficiency virus (HIV), hepatitis B (surface antigen), or hepatitis C virus antibody.
* Subject has a thyroid-stimulating hormone (TSH) value that is outside the reference range at the Screening Visit.
* Subject has donated or had significant loss of whole blood (480 mL or more) within 30 days, or plasma within 14 days, prior to the Screening Visit or plans to donate blood or plasma while enrolled in this study.
* Subject has smoked or used nicotine-containing products 6 months prior to the Screening Visit.
* Subject has current or recent (within 2 years of the Screening Visit) drug or alcohol abuse, as defined in Diagnostic and Statistical Manual of Mental Disorders Fifth Edition, Diagnostic Criteria for Drug and Alcohol Abuse.
* Subject has current or recent (within 3 months of the Screening Visit) gastrointestinal (GI) disease (including, but not limited to, peptic ulcer, diverticulitis, bowel obstructions, adhesions, malabsorption, paralytic ileus, gastritis, or diarrhea) or any GI surgery that could impact the absorption of study drug (including, but not limited to, cholecystectomy and gastric bypass or gastric band surgery).
* Subject had any major surgery within 3 months prior to the Screening Visit.
* Subject has a history, or laboratory evidence of, a bleeding or clotting disorder or condition.
* Subject is unable to tolerate venipuncture and/or venous access.
* Subject has any medical, psychiatric and/or social reason for exclusion, as determined by the investigator.
* Subject has a positive test result for drugs of abuse (minimum: opioids, barbiturates, cannabinoids, benzodiazepines, cocaine, amphetamine), cotinine, or alcohol at the Screening Visit or at check-in to the study site.
* Subject used any other investigational medicinal product (study drug) within 30 days prior to the Screening Visit and throughout the duration of the study or plans to participate in another clinical study while concurrently enrolled in this study.
* Subject has taken prescription drugs or over-the-counter (OTC) medications, vitamins, minerals, or dietary/herbal supplements (including grapefruit juice and grapefruit-containing products, St. John's wort and St. John's wort-containing products) within 14 days prior to check-in to the study site and throughout the duration of the study.
* Subject has a history of conditions which might be specifically contraindicated or require caution to be used during the administration of any drug in the study.
* Subject presents with a history of acute illness within 14 days prior to check-in to the study site and throughout the duration of the study.
* Subject has an electrocardiogram (ECG) parameter (confirmed by repeat evaluation) outside the following limits: PR >= 210 ms, QRS >= 120 ms, QT >= 500 ms; QT interval corrected for heart rate incorporating Bazett's formula (QTcB) >= 450 ms.
* Subject has other clinically significant ECG abnormalities, as assessed by the investigator.
* Subject has an oxygen saturation of < 95%.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
| NCT02966860 | 18,446 |
{
"NCT_ID" : "NCT01267422",
"Brief_Title" : "Safety and Efficacy Study of rAAV2-ND4 Treatment of Leber Hereditary Optic Neuropathy (LHON)",
"Official_title" : "Safety and Efficacy Study of a Single Intravitreal Injection of rAAV2-ND4 Treatment of Leber Hereditary Optic Neuropathy",
"Conditions" : ["Leber Hereditary Optic Neuropathy"],
"Interventions" : ["Drug: rAAV2-ND4"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-11",
"Study_Completion_Date(Actual)" : "2015-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-12-27",
"First_Submitted_that_Met_QC_Criteria" : 2016-03-29",
"First_Posted(Estimated)" : 2010-12-28"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2010-12-27",
"Last_Update_Posted(Estimated)" : 2018-01-31",
"Last_Verified" : 2018-01"
}
}} | #Study Description
Brief Summary
This study is meant to assess the safety and efficacy of rAAV2-ND4 treatment of Leber hereditary optic neuropathy with 11778 LHON mutation.
Detailed Description
Leber's Hereditary Optic Neuropathy (LHON) is a maternally inherited ocular disorder associated with a mutation in mtDNA . The common manifestation is visual loss which caused by the respiratory chain enzymes complex dysfunction resulting in increased oxidative stress enzymes production.
Material and Method Seven patients with 11778 LHON mutation were randomly treated with a Single IVT Injection of recombinant Adeno-Associated Virus-NADH dehydrogenase, subunit 4 (complex I)（rAAV2-ND4)（0.05ml).The dose was 5 × 10\^9 vg/0.05 mL for patients younger than 12 years old, and 1 × 10\^10 vg/0.05 mL for patients older than 12 years old. The visual acuity, visual evoked potential （VEP）,optical coherence tomography（ OCT）, computerized visual field, electroretinograms(ERG), retinal nerve fiber layer(RNFL)and Liver and kidney function in plasma were compared before and after treatment at 1,3,and 6, months interval.
#Intervention
- DRUG : rAAV2-ND4
- injection
- Other Names :
- rAAV2-ND4 gene therapy | #Eligibility Criteria:
Inclusion Criteria:
* comply with Leber hereditary optic neuropathy diagnostic criteria.
* in patients with informed consent, voluntary participation.
* signed informed consent.
* 8 <= Age <= 60 years, good health, the patient can tolerate local anesthesia surgery.
* to comply with doctor's instructions, can in the time of referral.
Exclusion Criteria:
* Cardiopulmonary and renal function in severe weakness, cancer, a variety of bleeding disorders, acute sensing disease, high fever, high fever disease, women during pregnancy, heart disease, such as post-operative recovery period.
* Are participating in other clinical studies of patients.
* Patients with mental disorders.
Sex :
ALL
Ages :
- Minimum Age : 8 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
| NCT01267422 | 30,851 |
{
"NCT_ID" : "NCT06703970",
"Brief_Title" : "Platelet Rich Plasma Versus Corticosteroids in Knee Osteoarthritis Pain",
"Official_title" : "The Efficacy of Platelet Rich Plasma Compared with Corticosteroid Injections for the Treatment of Pain Associated with Knee Osteoarthritis",
"Conditions" : ["Knee Osteoarthritis (OA)"],
"Interventions" : ["Device: Platelet Rich Plasma Joint Injection", "Drug: Corticosteroid Injection"],
"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)" : "2022-02-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-07-16",
"Study_Completion_Date(Actual)" : "2024-07-16},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2024-11-20",
"First_Posted(Estimated)" : 2024-11-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2024-11-21",
"Last_Update_Posted(Estimated)" : 2024-11-25",
"Last_Verified" : 2024-11"
}
}} | #Study Description
Brief Summary
Prospective, multi-center, randomized trial comparing platelet rich plasma (PRP) versus corticosteroid injection for the treatment of symptoms of knee osteoarthritis. The purpose of the study is to determine which therapy provides a greater reduction in patient reported outcome measures of pain and function.
Detailed Description
Platelet rich plasma has become increasingly utilized as a treatment option for knee osteoarthritis. Corticosteroids is currently an approved medication to treat the symptoms of the knee osteoarthritis. There is limited evidence in a prospective randomized manner powered adequately to determine a difference between these treatments for pain associated with knee osteoarthritis.
Prospective, multi-center, single blind (participant), randomized trial comparing platelet rich plasma (PRP) versus corticosteroid injection for the treatment of symptoms of knee osteoarthritis. The purpose of the study is to determine which therapy provides a greater reduction in patient reported outcome measures of pain and function.
#Intervention
- DRUG : Corticosteroid Injection
- 5 milliliters (mL) injection of corticosteroid (1cc Kenalog, 4cc Xylocaine) Kenalog - 40 (triamcinolone acetonide injectable suspension, USP) Xylocaine - MPF (lidocaine HCl Injection, USP)
- DEVICE : Platelet Rich Plasma Joint Injection
- \~3 milliliters (mL) injection of autologous PRP Magellan Autologous Concentration System, ISTO Biologics | #Eligibility Criteria:
Inclusion Criteria:
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged 21 <= age <= 80 years
* Radiographic diagnosis of Kellgren-Lawrence (KL) grade of II or III knee osteoarthritis
* Indicated for a knee injection to treat knee OA symptoms
Exclusion Criteria:
* Any injections into the target knee within three months
* Current overlying skin infection
* Current or previous diagnosis of 'chronic pain'
* Opioid tolerant at time of screening (for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid.)
* Allergy to any potential ingredients or medications utilized in any of the two groups
* Treatment with another investigational drug or other intervention for pain
* Diagnosis of Diabetes Mellitus
* If female, pregnant or planning to be pregnant within the following 3 months or study duration
* Any condition(s) or diagnosis, both physical or psychological, or physical exam finding in the opinion of the investigator that would precludes participation
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT06703970 | 160,041 |
{
"NCT_ID" : "NCT01390064",
"Brief_Title" : "Vaccination of High Risk Breast Cancer Patients",
"Official_title" : "Phase 1 Safety Study of a Carbohydrate Mimotope Based Vaccine With MONTANIDE ISA 51 VG Adjuvant",
"Conditions" : ["Stage IV Breast Cancer"],
"Interventions" : ["Biological: Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-07",
"Study_Completion_Date(Actual)" : "2019-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2011-06-29",
"First_Submitted_that_Met_QC_Criteria" : 2019-02-19",
"First_Posted(Estimated)" : 2011-07-08"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-07-07",
"Last_Update_Posted(Estimated)" : 2019-08-20",
"Last_Verified" : 2019-08"
}
}} | #Study Description
Brief Summary
Objective - Determine the safety and tolerability of a peptide mimotope-based vaccine upon immunization of breast cancer subjects.
Detailed Description
After signing Institutional Review Board (IRB) approved consent, cohorts of 3-6 stage IV breast cancer subjects will be enrolled into the study. The vaccine doses will be prepared and dispensed by the University of Arkansas for Medical Sciences (UAMS) Pharmacy following the manufacturer's instructions. Subjects will receive 1.0 mL subcutaneous (SC) injections of the vaccine on 5 separate occasions during Weeks 1, 2, 3, 7, and 19. The first cohort will begin with the 300 mg dose, and then the subsequent cohorts will escalate to 500 mg or de-escalate to 100 mg as determined by the toxicity criteria. The immunization at week 19 is considered a booster immunization. The vaccine will be administered at rotating sites on the limbs or abdomen. The study will last for approximately 12 - 24 months.
#Intervention
- BIOLOGICAL : Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG
- All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule | #Eligibility Criteria:
Inclusion Criteria:
* Female subjects of all races with histologically or cytologically confirmed stage IV breast cancer are eligible. The cancer may be newly diagnosed metastatic or relapsed after primary or adjunctive therapy and must not have required a treatment change for 2 months. Treatments with anti-estrogen therapy or chemotherapy are allowed. The chemotherapy regimen cannot contain steroids in the pre or post supportive care medications. If a subject is on an investigational drug, the drug must be cleared from the body over a period of 4 weeks.
* Disease staging will be done according to the American Joint Commission on Cancer (AJCC), sixth edition.
* Age 18 years and older of all races and ethnicity.
* ECOG Performance Status 0 or 1.
* Subjects must not have an active infection requiring treatment with antibiotics.
* Subjects must not have other significant medical, surgical or psychiatric conditions, or require any medication or treatment, which may interfere with compliance of the treatment regimen.
* Subjects must not have a diagnosis or evidence of organic brain syndrome, significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the full protocol.
* Subjects must have no other current malignancies. Subjects with prior history at any time of any in situ cancer, including lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ or basal or squamous skin cancer are eligible, provided they are disease-free at the time of registration. Subjects with other malignancies are eligible if they have been continuously disease free for >= 5 years prior to the time of registration.
* Subjects must not have autoimmune disorders or conditions of immunosuppression. This includes, but is not limited to being treated with corticosteroids, including oral steroids (i.e. prednisone, dexamethasone), continuous use of topical steroid creams or ointments or any steroid-containing inhalers. Subjects who have been on systemic steroids will require a 6-week washout period. Subjects who discontinue the use of these classes of medication for at least 6 weeks prior to registration are eligible if, in the judgment of the treating physician, the subject is not likely to require these classes of drugs during the treatment period. Replacement doses of steroids for subjects with adrenal insufficiency are allowed.
* Women of childbearing potential must not be pregnant (negative serum pregnancy test must be done 48 hours prior to receiving the first dose of study drug) or breastfeeding,due to the unknown effects of peptide/mimotope vaccines on a fetus or infant.
* Women of childbearing potential must be counseled to use an accepted and effective method of contraception (including abstinence) while on treatment and for a period of 18 months after completing or discontinuing treatment. Accepted methods include oral contraceptives, barrier method, Intrauterine Devices (IUDs), and abstinence.
* Subjects must have obtained a white blood cell (WBC) count >= 3,000/mm3 and platelet count >= 100,000/mm3 within 2 weeks prior to registration.
* Subjects must have a serum glutamic-oxaloacetic transaminase (SGOT)/aspartate aminotransferase test (AST) and bilirubin <= 2 x institutional upper limit (IUL) of normal and serum creatinine <= 1.8 mg/dl, all obtained within 2 weeks prior to registration.
* Subjects must be immunocompetent as measured by responsiveness to two recall antigens by skin testing.
* All subjects who wish to participate in the study must sign an informed consent approved by the UAMS Institutional Review Board (IRB).
* Laboratory tests must be completed within 2 weeks before the first dose.
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
| NCT01390064 | 102,050 |
{
"NCT_ID" : "NCT00299338",
"Brief_Title" : "A Dose Response and Safety Study of Procaine HCl in HIV-Infected Patients",
"Official_title" : "A Pharmacokinetic and Safety Study of Procaine HCl in HIV-1 Infected Patients",
"Conditions" : ["HIV Infections"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "1997-09",
"Study_Completion_Date(Actual)" : "2001-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2006-03-02",
"First_Posted(Estimated)" : 2006-03-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2006-03-02",
"Last_Update_Posted(Estimated)" : 2006-04-03",
"Last_Verified" : 2006-03"
}
}} | #Study Description
Brief Summary
This a Phase I/II non-randomized, open-label clinical study of 8 weeks duration using SP01A in HIV positive patients on a stable antiretroviral regimen. Dose response and safety associated with oral administration of four doses (200 mg, 400 mg, 600 mg, and 800 mg daily) of SP01A will be studied in a total of 24 study subjects. In addition, six HIV-negative subjects will be recruited as a control for cortisol secretion only and will not receive study medication.
Detailed Description
STUDY PLAN: DESCRIPTION This investigation will be a non-randomized, open-label study of four doses of SP01A in 24 individuals infected with HIV who are being treated with triple combination antiretroviral therapy. Additionally, a group of six HIV-negative subjects (group E) is being recruited as a control for cortisol secretion. This group will not receive study medication nor will they be evaluated for dose response or safety parameters.
DISCUSSION OF STUDY DESIGN, INCLUDING CONTROL GROUP Patients will receive the following doses of SP01A and will be divided into a low dose and high dose group for further analyses. There will be two segments within the low dose group. Group A will receive 200 mg of SP01A once per day. Group B will be administered 200 mg of SP01A twice daily. Similarly, there will be two segments in the high dose group. Group C will be treated with 200 mg of SP01A three times per day, while Group D will be administered 400 mg of SP01A twice daily.
A fifth group will also be introduced. This group, Group E, will serve as a control group and not receive any treatment.
The study will be conducted at a single investigative center (AIDS ReSearch Alliance, West Hollywood, CA). Six subjects with a diagnosis of HIV who are also receiving triple combination antiretroviral therapy and have been so doing for a minimum of 2 months are planned per group. Patients will be admitted to an in-patient facility for 72 hours. After an initial night to acclimate the patients to the facility, a 24-hour measurement of cortisol secretion in blood and urine will be conducted. After this is complete, patients will receive an initial single dose of SP01A orally. (200 mg SP-01A for group A, 400 mg for group B, 600 mg for group C, and 800 mg for group D). Blood and urine samples will also be collected for 24 hours to further evaluate the safety of the study medication. Patients will then be discharged from the facility.
After a 4-day washout, patients will return to the facility to start an 8-week dose-response study, sequentially using the four doses that will now be divided (200 mg daily for group A, 200 mg twice a day for group B, 200 mg three times per day for group C, and 400 mg twice daily for group D).
Subjects will return to the study center the day they are screened and as close to the same day of the week as practical during Weeks 1 (baseline), 2, 3, 4, 5, 6, 7, 8 (end of treatment) and 10 (post-treatment for examinations and specimen collection, as well as evaluation of reactions to study treatment). At the end of the 8-week drug administration period, patients will again be admitted to an in-patient facility for 72 hours. As before, patients will have an initial night to acclimate to the facility, followed by a 24-hour measurement of cortisol secretion in blood and urine. In the morning, following and ending the 24 hour basal cortisol secretion, patients in the four successive groups (A, B, C, and D), will receive their last dose of medication. They will also give their last blood and urine samples over the next 24 hours for additional safety sample collection. The total duration of study subject participation will be 11 weeks.
The six HIV negative subjects will be enrolled in group E. After an initial night to acclimate to the facility, blood and urine samples will be collected to determine baseline 24 hour blood and urine cortisol secretion. Patients will then be discharged. No study medication will be given to patients in group E.
#Intervention
- DRUG : SP01A | #Eligibility Criteria:
Inclusion Criteria:
* Eighteen years of age or older (male or female).
* If female, agreed to use suitable contraception to prevent pregnancy.
* HIV positive as confirmed by viral load using nucleic acid sequence based amplification (NASBA), or enzyme-linked immunosorbent assay (ELISA) and Western Blot, for cohort A, B, C, and D. HIV negative by ELISA and Western blot for cohort E.
* Karnofsky Performance Status score of at least 60.
* No active opportunistic infection. Prophylaxis for MAl, CMV, Pneumocystis Pneumonia except Bactrim), or herpes was permitted.
* Current CD4 count >200.
* Stable triple therapy antiretroviral regimen (cohorts A, B, C, and D) for the preceding 8 weeks and willing to make no changes in regimen during the study.
* Not taking any unapproved or experimental treatment for HIV, including antiretrovirals and immune modulators (such as interferons or interleukins).
* Capable and willing to provide informed consent.
* Agreed not to take Epoetin during the trial.
* Baseline laboratory values:
Neutrophils > 1000 cells/mm3; Platelets > 75,000 cells/mL; SGOT <3 times upper limit of normal; SGPT <3 times upper limit of normal; Creatinine <2.0 mg/dL.
Exclusion Criteria:
* Known or suspected allergy to procaine hydrochloride.
* Patients taking DHEA supplementation or oral ketoconazole (which have anticortisol properties).
* Patients using sulfonamides (including Septra/Bactrim).
* Required use of sulfonamides, eg, Septra/Bactrim. (Procaine hydrochloride may inactivate sulfonamides).
* Patients with glaucoma using anti-cholinesterase inhibitors (Humorsol [demecarium bromide] echothiophate iodide, Floropryl [isoflurophate], Isopto-Eserine [physostigmine salicylate]). Anti-cholinesterase Inhibitors should not be used while on procaine hydrochloride, since procaine itself has some anti-cholinesterase activity.
* Patients with less than 6 months life expectancy.
* Patients with adrenal insufficiency (determined by screening ACTH stimulation test).
* Patients with lymphoma.
* Patients with active hepatitis (viral or drug induced).
* Patients with cancer, except peripheral Kaposi's sarcoma.
* Patients on dialysis.
* Patients who are pregnant.
* Female patients of childbearing age who can not use two forms of birth control or abstain from sexual intercourse during the trial.
* Any medical, psychological, psychiatric, or substance use problem that, in the opinion of the Principal Investigator, interferes with the patient's ability to complete 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
| NCT00299338 | 116,763 |
{
"NCT_ID" : "NCT03808285",
"Brief_Title" : "Denosumab Related Osteonecrossi of the Jaw : : an Emergent and Potentially Complex Bone and Joint Infection",
"Official_title" : "Denosumab Related Osteonecrossi of the Jaw : : an Emergent and Potentially Complex Bone and Joint Infection",
"Conditions" : ["Bone and Joint Infection", "Osteomyelitis", "Adverse Drug Event"],
"Interventions" : ["Other: mandibular osteomylitis"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-01-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-12-31",
"Study_Completion_Date(Actual)" : "2018-12-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-01-04",
"First_Posted(Estimated)" : 2019-01-17"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-01-15",
"Last_Update_Posted(Estimated)" : 2019-02-01",
"Last_Verified" : 2019-01"
}
}} | #Study Description
Brief Summary
The aim of this study is to adescription of mandibular osteomylitis in patients having had a treatment by DENOSUMAB. Indeed, one of the adverse effect ot this molecule is to induce mandibular infection.
#Intervention
- OTHER : mandibular osteomylitis | #Eligibility Criteria:
Inclusion Criteria:
* patients having a mandibular osteomylelitis due to DENOSUMAB
Exclusion Criteria:
* none
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
| NCT03808285 | 204,838 |
{
"NCT_ID" : "NCT00508833",
"Brief_Title" : "Safety and Efficacy of SmithKline Beecham (GlaxoSmithKline [GSK]) Biologicals' Candidate Adjuvanted Vaccines (287615)",
"Official_title" : "Safety and the Efficacy of GSK Biologicals' Candidate Adjuvanted Vaccines (287615) Containing HBsAg With Various Adjuvants to Induce Cytotoxic T Lymphocytes (CTL) in Healthy Adult Volunteers",
"Conditions" : ["Hepatitis B Disease"],
"Location_Countries" : ["Belgium"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2000-03",
},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2007-07-27",
"First_Posted(Estimated)" : 2007-07-30"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2007-07-27",
"Last_Update_Posted(Estimated)" : 2007-07-30",
"Last_Verified" : 2007-07"
}
}} | #Study Description
Brief Summary
This study was done to evaluate the effect of various adjuvants in combination with HBsAg as a model antigen on the induction of immune responses, mainly cytotoxic T lymphocytes (CTL) in healthy volunteers. The study was also done to evaluate the safety and reactogenicity of the various adjuvanted vaccines.
#Intervention
- BIOLOGICAL : 287615 containing HBsAg with adjuvants | #Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers between 18 and 40 years
* Written informed consent obtained from subject
* Female of non-childbearing potential
Exclusion Criteria:
* Any hepatitis B vaccination.
* Positive HBV serological markers: anti-HBs, anti-HBc, and/ or HBsAg
* Pregnancy or lactating female
* Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days or 7 half-lives (whichever is the longer) preceding the first vaccine administration
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
| NCT00508833 | 216,736 |
{
"NCT_ID" : "NCT00000800",
"Brief_Title" : "Methadone Effects on Zidovudine (ZDV, AZT) Disposition",
"Official_title" : "Methadone Effects on Zidovudine (ZDV, AZT) Disposition",
"Conditions" : ["HIV Infections"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Completion_Date(Actual)" : "1998-10},
"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 whether methadone maintenance alters the pharmacokinetics of zidovudine (AZT). To determine whether any such effect of methadone on disposition of AZT is time dependent and whether a metabolic interaction between AZT and methadone exists.
Injection drug users represent an increasing proportion of HIV-infected persons. Since daily methadone maintenance is the major chemical treatment for injection drug abuse, it is important to determine the impact of methadone on AZT absorption, distribution, and elimination.
Detailed Description
Injection drug users represent an increasing proportion of HIV-infected persons. Since daily methadone maintenance is the major chemical treatment for injection drug abuse, it is important to determine the impact of methadone on AZT absorption, distribution, and elimination.
After 6 days of inpatient detoxification with clonidine, patients addicted to opiates are randomized to receive either oral or intravenous AZT for the first dose, followed by determination of plasma and urine pharmacokinetics. On the second day of AZT dosing, the alternate form of administration will be used for the first dose. On both days, all other doses are given orally. Patients then begin methadone maintenance in combination with AZT for 7 days of inpatient treatment, with further pharmacokinetic sampling. After hospitalization for 16 days total, patients continue AZT/methadone treatment on an outpatient basis, and then 2 months later are readmitted as inpatients for 5 days for further pharmacokinetic sampling. Control patients who are not addicted to opiates are hospitalized for 3 days at study entry and are randomized for AZT treatment and pharmacokinetic sampling in the same manner as the first group, although they will not receive methadone treatment. Control patients are readmitted for 2 days after 1 week of AZT treatment and then again after 59 days of AZT treatment.
#Intervention
- DRUG : Methadone hydrochloride
- DRUG : Zidovudine | #Eligibility Criteria:
Inclusion Criteria
Patients must have:
* Documented HIV infection.
* CD4 count 100 - 500 cells/mm3.
* No active opportunistic infection or wasting syndrome.
* Opiate addiction or prior enrollment in a methadone treatment program (methadone recipients only).
* Admission to General Clinical Research Center at Yale-New Haven Hospital for clonidine detoxification (methadone recipients only).
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Inadequate IV access.
* Benzodiazepine abuse.
Concurrent Medication:
Excluded:
* Amiodarone.
* Anesthetics, general.
* Azithromycin.
* Barbiturates.
* Carbamazepine.
* Cimetidine.
* Ciprofloxacin.
* Clarithromycin.
* Dexamethasone.
* Disulfiram.
* Erythromycin.
* Fluoroquinolones.
* Fluoxetine.
* Gestodene.
* Hydrochlorothiazide.
* Hypoglycemics, oral.
* Isoniazid.
* Itraconazole.
* Ketoconazole.
* Levomepromazine.
* MAO inhibitors.
* Methoxsalen.
* Nafcillin.
* Narcotic analgesics.
* Naringenin.
* Norethindrone.
* Omeprazole.
* Pentazocine.
* Phenothiazines.
* Phenytoin.
* Quinidine.
* Ranitidine.
* Rifabutin.
* Rifampin.
* Sedative Hypnotics.
* Sulfaphenazole.
* Tranquilizers (except at discretion of investigator and protocol chair).
* Tricyclic antidepressants.
* Troleandomycin.
* Warfarin.
Prior Medication:
Excluded within 4 weeks prior to study entry:
* Rifampin or its derivatives.
* Phenytoin.
* Barbiturates.
* Cimetidine.
* Other drugs known to induce or inhibit hepatic microsomal enzymes.
Excluded within 14 days prior to study entry:
* Any other experimental drug.
* Drugs with known nephrotoxic potential.
Excluded within 72 hours prior to study entry:
* Amiodarone.
* Anesthetics, general.
* Azithromycin.
* Carbamazepine.
* Ciprofloxacin.
* Clarithromycin.
* Dexamethasone.
* Disulfiram.
* Erythromycin.
* Fluoroquinolones.
* Fluoxetine.
* Gestodene.
* Hydrochlorothiazide.
* Hypoglycemics, oral.
* Isoniazid.
* Itraconazole.
* Ketoconazole.
* Levomepromazine.
* MAO inhibitors.
* Methoxsalen.
* Nafcillin.
* Narcotic analgesics.
* Naringenin.
* Norethindrone.
* Omeprazole.
* Pentazocine.
* Phenothiazines.
* Quinidine.
* Ranitidine.
* Rifabutin.
* Sedative Hypnotics.
* Sulfaphenazole.
* Tranquilizers (except at discretion of investigator and protocol chair).
* Tricyclic antidepressants.
* Troleandomycin.
* Warfarin.
Continued active drug or alcohol abuse or dependence that would decrease the probability of study completion.
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
| NCT00000800 | 166,075 |
{
"NCT_ID" : "NCT01797133",
"Brief_Title" : "A Comparative Study of ID Fellow-based VS. Pharmacist-based Antibiotic Pre-authorization",
"Official_title" : "A Comparative Study of ID Fellow-based Pre-authorization VS. Pharmacist-based Pre-authorization in Reducing Antibiotic Consumptions and Hospital Expenditures",
"Conditions" : ["All Hospitalzied Patients", "No Specific Conditions Requires"],
"Interventions" : ["Procedure: Pharmacist-based antibiotic pre-authorization", "Procedure: ID fellow-based antibiotic pre-authorization"],
"Location_Countries" : ["Thailand"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-12",
"Study_Completion_Date(Actual)" : "2013-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-02-17",
"First_Posted(Estimated)" : 2013-02-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-02-20",
"Last_Update_Posted(Estimated)" : 2016-02-22",
"Last_Verified" : 2016-02"
}
}} | #Study Description
Brief Summary
We will conduct a cluster randomized controlled trial to compare two antibiotic pre-authorization strategies (Fellow-based vs. Pharmacist-based). We believe that amount and duration of antibiotic consumption would be lower in the pharmacist group while the clinical outcome would be equivalent between two groups.
Detailed Description
Study design: A cluster randomized controlled trial Settings: 6 general medical wards at Siriraj Hospital, Bangkok, Thailand
#Intervention
- PROCEDURE : ID fellow-based antibiotic pre-authorization
- All prescriptions of controlled antibiotics (Piperacillin/Tazobactam, Imipenem/Cilastatin, Meropenem and Doripenem) can be freely prescribed for the first 72 hours. After that, the prescription requires approval. Antibiotic preauthorization program will be operated by ID-fellows, under the supervision of ID staffs.
- PROCEDURE : Pharmacist-based antibiotic pre-authorization
- All prescriptions of controlled antibiotics (Piperacillin/Tazobactam, Imipenem/Cilastatin, Meropenem and Doripenem) can be freely prescribed for the first 72 hours. After that, the prescription requires approval. Antibiotic preauthorization program will be operated by general pharmacists, under the supervision of ID staffs. | #Eligibility Criteria:
Inclusion Criteria:
* Hospitalized patients
* Received at least one dose of controlled antibiotics (Piperacillin/Tazobactam, Imipenem/Cilastatin, Meropenem or Doripenem)
* Each patient may be enrolled more than once, if he/she receives the controlled antibiotic for a new episode of infection (at least 48 hour apart)
Exclusion Criteria:
* Died prior to receive the controlled antibiotic
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:
No
| NCT01797133 | 249,747 |
{
"NCT_ID" : "NCT02356887",
"Brief_Title" : "Internal Jugular Vein Flow in the Sitting Position",
"Official_title" : "Measurement of Flow in Internal Jugular Vein in the Sitting Position: an Ultrasound Study on Healthy Volunteers",
"Conditions" : ["Jugular Venous Flow"],
"Interventions" : ["Diagnostic Test: Jugular venous ultrasound"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "DIAGNOSTIC",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-02",
"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" : 2015-02-02",
"First_Submitted_that_Met_QC_Criteria" : 2020-07-11",
"First_Posted(Estimated)" : 2015-02-05"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-02-04",
"Last_Update_Posted(Estimated)" : 2023-01-10",
"Last_Verified" : 2022-12"
}
}} | #Study Description
Brief Summary
During neurosurgical procedures, patients need to be placed in sitting position for surgical access especially in surgeries in the vertex or posterior fossa. Due gravitational effect of sitting position the flow in IJV may be reduced. Venous air embolism (VAE) is a common complication of sitting position craniotomy and carries high mortality and morbidity. Venous pressure decreases as the head of the patient is raised above the heart. Hence, negative venous pressure in the cerebral venous system promotes entrapment of air in accidental opening of the sinuses.
Common methods to prevent VAE in sitting position include increasing the venous pressure by either jugular venous compression and/or increasing the venous pressure by adding positive end expiratory pressure (PEEP). Both these methods can decrease venous return and can lead to brain swelling.. In addition, improper neck position can cause the kinking of the IJV which may lead to decreased venous drainage and increased ICP. This has been shown to be the contributing factor for intraoperative brain swelling and postoperative neck and tongue swelling leading to airway obstruction. Optimal brain perfusion is best in the neutral position of the head, but surgery cannot always be performed with this.
Detailed Description
Currently, there are no studies that looked into the IJV flow in sitting position and effect of venous outflow obstruction on the IJV flow. Valsalva maneuver (forced inspiration with closed glottis) and /or compression of internal jugular veins (IJV) are the two commonly used physiological methods that can cause venous outflow obstruction. A custom made neck collar can be used for compression of internal jugular vein and previous investigations have used a similar device in a rat model to demonstrate the protective effects on slosh-mediated brain injury by increasing intracranial blood volume . While the collars have not yet been studied on people for their effectiveness at preventing concussions, many studies have looked at the effect of neck collars on both jugular compression and ICP..
The purpose of this study is to measure the venous blood flow of healthy volunteers by the use of an ultrasound and Doppler velocimetry in sitting position. the investigators will measure the IJV flow on both sides in sitting position at rest and at two conditions of venous outflow obstruction- 1. Neck compression using a custom made collar and 2. During 30 seconds Valsalva maneuver. This study will provide information on the cerebral venous drainage. This information will be very useful in planning and positioning of patients undergoing neurosurgical procedures and to prevent complications from the improper patient position.
#Intervention
- DIAGNOSTIC_TEST : Jugular venous ultrasound
- All volunteers will be fully awake throughout the study and be kept comfortable. A cross will be marked where the left and right IJV cross the level of C6. This is where all the measurements will be taken in 3 different conditions at rest, jugular occlusion and valsalva maneuver. At each conditions, the left and right IJV will be scanned with an ultrasound measuring the cross sectional area and Doppler velocity of the IJV. The least amount of pressure will be used to press on the ultrasound probe and the measurements will be obtained at end inspiration. The IJV flow is then calculated. | #Eligibility Criteria:
Inclusion Criteria:
* Adult healthy volunteers who are above the age of 18 ASA 1
* Body mass index (BMI) less than and equal to 35
Exclusion Criteria:
* Lack of informed consent
* Language barrier
* Medical students and anesthesia residents going through the department as part of their rotation
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
| NCT02356887 | 217,018 |
{
"NCT_ID" : "NCT02400463",
"Brief_Title" : "A Pilot Study of Ruxolitinib in Secondary Hemophagocytic Syndrome",
"Official_title" : "Pilot Study of Ruxolitinib in Secondary Hemophagocytic Syndrome",
"Conditions" : ["Hemophagocytic Syndrome (HPS)"],
"Interventions" : ["Drug: Ruxolitinib"],
"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)" : "2016-02-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-10-10",
"Study_Completion_Date(Actual)" : "2020-01-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-01-22",
"First_Submitted_that_Met_QC_Criteria" : 2020-11-11",
"First_Posted(Estimated)" : 2015-03-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-03-23",
"Last_Update_Posted(Estimated)" : 2021-01-25",
"Last_Verified" : 2021-01"
}
}} | #Study Description
Brief Summary
This is a pilot study to determine the efficacy of Ruxolitinib in secondary hemophagocytic syndrome. The primary objective is to assess the efficacy of ruxolitinib 15 mg PO twice daily in patients with HPS. The primary endpoint is overall survival at two months.
Detailed Description
Hemophagocytic Syndrome (HPS) is a disorder characterized by pathological activation of the immune system resulting in a systemic disorder characterized by excessive cytokine production and macrophage activation, culminating in cytopenias and evidence of hemophagocytosis on tissue specimens. The disorder can be sporadic or familial due to one of several mutations and is primarily seen in the pediatric population, with a reported incidence of 1 case per 3000 admissions. The actual incidence in adults is unknown and can be rarely sporadic, or secondary to viral infections, malignancy, or autoimmune disease.
HPS is a universally fatal disease if untreated. In adults, the median survival has been reported to be less than 2 months if diagnosis and treatment is delayed. Adult patients are treated with pediatric protocols with early institution of etoposide and steroids and consolidation with allogeneic stem cell transplant in appropriately selected patients if a familial form is identified. Other treatment strategies have been attempted, including rituximab, infliximab, entaracept, tocilizumab, and alemtuzumab. These anecdotal reports highlight the therapeutic potential of cytokine-targeted therapies in this disorder.
This is a pilot study to determine the efficacy of Ruxolitinib in secondary hemophagocytic syndrome. The primary objective is to assess the efficacy of ruxolitinib 15 mg PO twice daily in patients with HPS. The primary endpoint is overall survival at two months.
Patients will receive Ruxolitinib at 15 mg twice daily orally either on an empty stomach or with food for 4 weeks (28 days) in a 4 week (28 day) cycle. Ruxolitinib will be administered in continuous 28-day cycles.
In the absence of treatment delays or cessation due to adverse events, treatment may continue indefinitely or until one of the following criteria applies:
* Disease progression.
* Intercurrent illness that prevents further administration of treatment.
* The investigator considers it, for safety reasons, to be in the best interest of the patient.
* Unacceptable adverse events such as any toxicity or other issue that causes a delay of study drug administration by more than 4 weeks.
* General or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator.
* Patient decision to withdraw from treatment (partial consent) or from the study (full consent.
* Death.
Patients will be followed for toxicity for 30 days after treatment has been discontinued or until death, whichever occurs first.
#Intervention
- DRUG : Ruxolitinib | #Eligibility Criteria:
Inclusion Criteria:
* Patients, or their legally authorized representative, must voluntarily provide written IRB-approved informed consent.
* Males and females, 18 years or older at the time of enrollment.
* Patients must meet the diagnostic criteria for HPS (at least 5 of the following): fever, splenomegaly, cytopenia involving >=2 cell lines (Hemoglobin <9 g/dL; platelets <100,000/μL; absolute neutrophil count <1000/μL), hypertriglyceridemia or hypofibrinogenemia, tissue demonstration of hemophagocytosis, low or absent NK (Natural Killer) cell activity, serum ferritin >=3000 ug/L, soluble IL-2 receptor (CD25) >2400 U/mL.
* In the investigator's opinion, the patient has the ability to participate fully in the study, and comply with all its requirements.
Exclusion Criteria:
* CNS (Central Nervous System) involvement
* Malabsorption
* Known secondary HPS (Hemophagocytic Syndrome) that is otherwise treatable (e.g. non-Hodgkin's lymphoma).
* Pregnant or lactating female: all females of child-bearing potential must have a negative serum pregnancy test within 7 days of treatment; lactating females must discontinue breast feeding.
* Estimated creatinine clearance <15mL/min
* Has received any prior systemic therapy, excluding corticosteroids, within 7 days (or 5 half-lives) of treatment.
* No active malignancy at the time of enrollment, except nonmelanoma skin cancers or carcinoma in situ. Patients with a prior history of malignancy are eligible if their malignancy has been definitely treated or is in remission and does not require ongoing adjuvant or cancer-directed therapies.
* Active hepatitis B or hepatitis C or known HIV infection
* Known (and biopsy-confirmed) liver cirrhosis; or, a reported history of liver cirrhosis with a Model for End-stage Liver Disease (MELD) score >20.
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
| NCT02400463 | 41,590 |
{
"NCT_ID" : "NCT04291300",
"Brief_Title" : "Lutetium-177-PSMA Radioligand Therapy in Advanced Salivary Gland Cancer Patients",
"Official_title" : "Lutetium-177-PSMA Radioligand Therapy for Advanced Salivary Gland Cancer, a Phase II Pilot Study.",
"Conditions" : ["Salivary Gland Cancer", "Salivary Duct Carcinoma", "Adenoid Cystic Carcinoma"],
"Interventions" : ["Drug: Lutetium-177-PSMA-I&T"],
"Location_Countries" : ["Netherlands"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-05-26",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-02-13",
"Study_Completion_Date(Actual)" : "2023-02-13},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-02-28",
"First_Posted(Estimated)" : 2020-03-02"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-02-28",
"Last_Update_Posted(Estimated)" : 2023-05-10",
"Last_Verified" : 2023-05"
}
}} | #Study Description
Brief Summary
Phase 2 pilot study, which evaluates the safety and efficacy of Lutetium-177-PSMA radioligand therapy in advanced salivary gland cancer patients.
Detailed Description
Rationale: Prostate specific membrane antigen (PSMA) is a transmembrane protein, which is expressed on prostate cancers cells and other malignancies. Recently, several ligands have been developed that target PSMA. Linked to Gallium-68, this enables diagnostic 68Ga-PSMA-PET/CT scans. Linked to Lutetium-177 enables therapeutic 177Lu-PSMA Radioligand therapy. Most research on the diagnostic and therapeutic possibilities of PSMA has been conducted in patients with advanced prostate cancer.
This research group investigates whether these findings also apply to salivary gland cancer (SGC), a rare cancer. Previously the investigators conducted a phase II 68Ga-PSMA imaging study (NCT03319641), to evaluate PSMA ligand uptake in locally advanced, recurrent and metastatic (R/M) ACC and SDC (two subtypes of SGC). A relevant PSMA-ligand uptake was observed in 93% of ACC patients and 40% of SDC patients. Therefore we consider 177Lu-PSMA radioligand therapy a potential new treatment option for these subtypes of SGC.
Objective: To evaluate the safety and efficacy of 177Lu-PSMA RLT in patients with R/M ACC and SDC with PSMA ligand uptake.
Study design: Phase II pilot study, single centre, two cohorts.
#Intervention
- DRUG : Lutetium-177-PSMA-I&T
- 4 cycles of 7.4 GBq 177Lu-PSMA every 6 weeks.
- Other Names :
- Lutetium-177 Prostate Specific Membrane Antigen | #Eligibility Criteria:
Inclusion Criteria:
* Patients must have the ability to provide written informed consent.
* Patients must be >= 18 years.
* Patients must have an ECOG performance status of 0 to 2.
* Patients must have histological, pathological, and/or cytological confirmation of either adenoid cystic carcinoma or salivary duct carcinoma.
* Patients must have incurable, local or regional recurrent or metastatic ACC or SDC.
* Patients with ACC can only participate in case of objective growth in the last three months or complaints due to the disease.
* Patients must have adequate organ function:
* Sufficient bone marrow capacity as defined by: WBC count (white blood cell) >=2.5x10^9/L, PLT (platelet) count >=100x10^9/L, Hb >=6 mmol/L, absolute neutrophil count (ANC) >=1.5x10^9/L
* Adequate liver function as defined by:Total bilirubin <=1.5 x ULN. For patients known with Gilbert's Syndrome <= 3 x ULN is permitted. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=3.0 × ULN OR <=5.0 × ULN for patients with liver metastases.
* Adequate kidney function as defined by:serum creatinine <=1.5 x ULN or creatinine clearance >= 50 mL/min
* Patients must have measurable disease at baseline. Defined as >= 1 lesion >= 2 cm (long axis) that is present on baseline CT.
* Patients must have a positive 68Ga-PSMA PET/CT scan, defined by at least one lesion >= 1.5 cm (long axis) with a ligand uptake above liver level.
Exclusion Criteria:
* Patients whom are pregnant or breast feeding.
* Patients with reproductive potential not implementing adequate contraceptives measures.
* Patients with known brain metastases or cranial epidural disease or intracardial metastases.
* Patients with concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation.
* Patients with urinary tract obstruction or marked hydronephrosis
* Less than 4 weeks since last myelosuppressive therapy or other radionuclide therapy.
* Concomitant cancer treatments
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
| NCT04291300 | 168,144 |
Subsets and Splits