cyrilzakka/clinical-trials huggingface dataset:
Buprenorphine/Naloxone for Opiate-Dependence Treatment - 1

The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate-dependence treatment. The developmental objective for this combination product is an expansion of therapeutic options for the treatment of opiate dependence.

This multicenter pivotal clinical trial was comprised of two phases. The first phase, which was four weeks in length, was double-blind placebo controlled and was primarily used to evaluate the efficacy of buprenorphine/naloxone. The second phase, lasting 48 weeks, was primarily conducted to determine the safety of buprenorphine/naloxone.

Eligibility Criteria:
Inclusion Criteria:

1. DSM-IV (Diagnostic and Statistical Manual of the American Psychiatric Association) diagnosis of current opiate dependence.
2. Individuals seeking opiate-substitution pharmacotherapy for opiate dependence.
3. Males and non-pregnant, non-nursing females, 18 to 59 years of age (inclusive).
4. Individuals able to give informed consent and willing to comply with all study procedures (e.g., providing of urine samples under observation, completing questionnaires).

Exclusion Criteria:

1. Any acute or chronic medical condition that would make participation in the study medically hazardous (e.g., acute hepatitis, unstable cardiovascular, hepatic, or renal disease, unstable diabetes, symptomatic AIDS; not HIV-seropositivity alone).
2. Aspartate or alanine aminotransferase (AST, ALT) levels greater than three times the upper limit of normal.
3. Individuals currently taking systemic anti-retroviral or anti-fungal therapy.
4. Current dependence (by DSM-IV criteria) on any psychoactive substance other than opiates, caffeine, or nicotine.
5. Current, primary, Axis I psychiatric diagnosis other than opiate, caffeine, or nicotine dependence.
6. Females of childbearing potential who do not agree to use a medically acceptable method of birth control. Acceptable methods include

   1. oral contraceptive,
   2. barrier (diaphragm or condom) - a spermicide is not required due to the possibility of local irritation and allergic type reactions, but are recommended for use,
   3. levonorgestrel implant,
   4. intrauterine progesterone contraceptive system,
   5. medroxyprogesterone acetate contraceptive injection, or
   6. complete abstinence.
7. Enrollment in an opiate-substitution (i.e., methadone, levo-alpha-acetylmethadol) treatment program within 45 days of enrolling in the present study.
8. Individuals having taken (licitly or illicitly) LAAM, methadone, or naltrexone within days of enrolling in the present study.
9. Individuals having taken buprenorphine, other than as an analgesic, within 365 days of enrolling in the present study.
10. Participation in an investigational drug or device study within 45 days of enrolling in the present study.
11. Anyone, who in the opinion of site principal investigator, would not be expected to complete the first phase of the study protocol (e.g., due to pending incarceration or probable relocation from the clinic area).
An Internet-based Self-management Program for Adolescents With Arthritis

The purpose of this study is to demonstrate the effectiveness of the "Taking Charge: Managing JIA Online" Internet intervention, when compared with an attention (static education only websites) control group in improving pain and HRQL as well as other health outcomes (anxiety, depression, treatment adherence, pain coping, knowledge, and self-efficacy) in adolescents with JIA. The proposed study will enroll and randomize 294 adolescents with JIA attending 10 pediatric rheumatology hospital clinics in the Canada to either the experimental or control groups.

In summary, no rigorous Internet self-management intervention has been undertaken to improve HRQL, symptoms, treatment adherence, knowledge, and self-efficacy in youth with JIA. The proposed "Managing JIA Online" Trial will rigorously examine the effects of this Internet intervention on HRQL and other health outcomes thereby filling a significant gap in our knowledge related to promotion of self-management care for adolescents with JIA.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥12 and ≤ 18 years.
* Diagnosed with JIA (using International League of Associations for Rheumatology classification criteria)83 by their rheumatologist.
* Adolescents and parent/ primary caregiver are able to speak and read either English or French.
* Participants are willing and able to complete online measures. There will be no restrictions on medication use for this study.

Exclusion Criteria:

* Cognitive impairments (as assessed by reviewing medical chart and consultation with the patient's rheumatologist)
* Major co-morbid illnesses which may mitigate HRQL assessment

  * Excluded medical illnesses: inflammatory bowel disease, fibromyalgia, cancer, genetic disorders, diabetes
  * Excluded psychiatric conditions: post-traumatic stress disorder, panic disorder, bipolar disorder, psychosis, depression and major mood disorders. Adolescents currently on medications for major depression, bipolar disorder or psychosis would also be excluded.
* Adolescents that are currently participating in other CBT interventions.
Phase 2b Randomized Controlled Study of Tecemotide (L-BLP25) for Immunotherapy of NSCLC (Non-Small Cell Lung Cancer)

This is a prospective open label, controlled, randomized study to test the safety and efficacy of active specific immunotherapy with tecemotide (L-BLP25) for the treatment of subjects with Stage IIIB or Stage IV non-small cell lung cancer (NSCLC). To be eligible, subjects entering the trial will have to demonstrate either stable disease or a clinical response after first-line treatment (chemotherapy alone, or chemotherapy and radiotherapy) and have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. Following a 3 week washout period, subjects will be stratified by disease status (either Stage IIIB locoregional disease or Stage IIIB with malignant pleural effusion and Stage IV), and randomized to either best supportive care (BSC) plus tecemotide (L-BLP25) treatment or BSC alone.


Eligibility Criteria:
Inclusion Criteria:

* Stage IIIB or Stage IV NSCLC
* Stable disease or a clinical response following first-line treatment, consisting of either chemotherapy alone or chemotherapy and radiotherapy. Subjects must have completed the first-line treatment at least 3 weeks prior to study entry
* Eastern Cooperative Oncology Group (ECOG) performance status of greater than or equal to (\>=) 2
* Ability to understand and willingness to sign a written informed consent
* Other protocol-defined inclusion criteria could apply

Exclusion Criteria:

* Received immunotherapy within 4 weeks prior to study entry
* Received immunosuppressive drugs within 3 weeks prior to study entry
* Subjects with known brain metastases
* Past or current history of neoplasm other than lung carcinoma, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years
* Autoimmune disease or immunodeficiency
* Clinically significant hepatic, renal or cardiac dysfunction
* Subjects with clinically significant active infection
* Pregnant or breast feeding women, women of childbearing potential, unless using effective contraception as determined by the investigator
* Other protocol-defined exclusion criteria could apply
Comparison Between Limited Driving Pressure Ventilation and Conventional Mechanical Ventilation Strategies in Medical Intensive Care Patients With Acute Respiratory Failure

Background An appropriated mechanical ventilator setting for acute respiratory failure results of ventilator associated lung injury. Limited driving pressure and low tidal volume ventilation strategies show benefits decreasing mortality in acute respiratory distress syndrome, but there are no data in simple acute respiratory failure.

Background An appropriated mechanical ventilator setting for acute respiratory failure results of ventilator associated lung injury. Limited driving pressure and low tidal volume ventilation strategies show benefits decreasing mortality in acute respiratory distress syndrome, but there are no data in simple acute respiratory failure.

To compare lung injury score (LIS, Murray score) after invasive mechanical ventilation 7 days between groups of limited driving pressure ventilation versus low tidal volume ventilation strategies.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 year old MICU patient
* On Invasive mechanical ventilator less than 24 hr. before randomization

Exclusion Criteria:

* Suspected death within 48 hr. after randomization
* patients with tracheostomy tube
* Pregnancy
* Do not attempt resuscitation order
* Patient with ECMO before randomization
Virtual Reality Hypnosis for Chronic Pain Reduction

We would like to determine how well hypnosis works when induced through virtual reality medium for patients who have suffered a major burn injury in the past two years and suffer from chronic pain. These patients are coming back to the outpatient burn and plastic clinic at Harborview Medical Center for routine follow-up. We think that patients will find VR-Hypnosis interesting, and it will help them relax and feel less pain.


Eligibility Criteria:
Inclusion Criteria:

* Age 13 - 75 years
* Able to complete subjective evaluations of pain
* English-speaking
* Able to communicate orally

Exclusion Criteria:

* Age less than 13 years or greater than 75 years
* Incapable of indicating subjective evaluation of pain
* Non-English-speaking (Virtual Reality Hypnosis only available in English)
* Demonstrating delirium, psychosis, or Organic Brain Disorder
* Unable to communicate verbally
* Significant developmental disability
* Extreme susceptibility to motion sickness
* Significant head/or neck injury
* Pregnant women
Allogeneic Transplantation for Patients With Acute Leukemia or Chronic Myelogenous Leukemia (CML)

The purpose of the study is to evaluate the overall and disease free survival of recipients who have received G-CSF mobilized stem cells from HLA matched sibling donors.

Allogeneic Peripheral Blood Stem Cell Transplantation for Patients with Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia in First Remission or Chronic Myelogenous Leukemia in First Chronic Phase

Eligibility Criteria:
Inclusion Criteria:1. Any patient with one of the following hematologic malignancies in whom an allogeneic stem cell transplant is warranted: Specific disease categories include:

1. acute myelogenous leukemia, 1st or 2nd remission
2. acute lymphoblastic leukemia, 1st or 2nd remission
3. chronic myelogenous leukemia, 1st or 2nd CP, accelerated phase 2. Patient age \> 1 month and \< 55 yo 3. Patients must have a genotypically HLA identical sibling 4. Patient must have adequate function as follows:

a. total bilirubin \<2.5 and SGOT/SGPT \<2x normal b. adequate renal function as defined by creatinine \< 1.5 or a 24 hr creatinine clearance \>50 cc/min as determined by the Cockroft-Gault formula (to be done if serum creatinine \> 1.5) c. DLCO \> 60% predicted d. radionuclide cardiac scan with ejection fraction \>45% 5. Patient must be competent to give consent.

Inclusion criteria (Donor):

1. HLA identical family member
2. Donor or guardian must be competent to give consent
3. Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter

Exclusion Criteria:3.2 Exclusion Criteria (Patient):

1. Evidence of active infection or active hepatitis
2. Positive serologies for HIV-1,HIV-2 or hepatitis B surface ag+
3. Previous allogeneic stem cell/bone marrow transplant
4. Pregnant or lactating patients

4 Exclusion criteria (Donor):

1. Donors who for psychologic, physiologic or medical reasons are unable to tolerate PBSC harvest
2. Donors who are HIV+ or hepatitis B antigen +
3. History of allergic reaction to G-CSF
4. Female donors must be post-menopausal or have a negative pregnancy test
Survey of Women's Choice of Delivery Before Consulting With Her Obstetrician

We are surveying women who have had a previous cesarean section at the time of entry into prenatal care for their next pregnancy about their thoughts related to a trial of labor after cesarean (TOLAC) or repeat c-section.

This is a survey for women who have had a previous cesarean section, also known as a c-section, with their last pregnancy. The study is looking at what factors and people may influence the decisions women make about their birthing plan after they have had a previous c-section. If they qualify, women will be asked to complete a brief survey at their initial Ob/Gyn appointment before they see their Ob doctor. In order to qualify, women must:

* Be pregnant
* Have not seen an obstetrician for this pregnancy
* Be at least 18 years old
* Be able to read English
* Have had a prior pregnancy delivered by c-section
* Only had one prior c-section
* The c-section must have been the last pregnancy before this one

Questions that will be asked include:

* Demographic information (examples: age, race/ethnicity)
* Pregnancy information
* Delivery questions
* Factors that may influence her birthing plan

Participants will also be asked if the study staff can follow up after her delivery to see what kind of delivery she had (vaginal or c-section).

Eligibility Criteria:
Inclusion Criteria:

* Pregnant Women
* 18 years old or older
* Prior pregnancy with cesarean delivery
* No prior obstetric physician care during current pregnancy

Exclusion Criteria:

* More than one prior cesarean
* Women who cannot read English
Incidence Of Hepatitis In Intensive Care Unit

The aim is to investigate incidence of HBsAg, anti-HCV in serum samples and evaluation of biomarkers taken from patients who were followed the intensive care unit of Sakarya University Training and Research Hospital and The intensive care unit attracts attention by making health workers more susceptible to the risk of hepatitis.

This retrospective study included 536 cases who were followed with various diagnoses in intensive care units between 1 Ocak 2015 ile 1 Ocak 2016, covering the six months period, retrospectively. Sakarya University's Faculty of Medicine Review Board (71522473/050.01.04/113) approved the study after approval of the research ethics committee (. Medical record forms and electronic medical record system of the hospital were used in the analysis of medical data with regard to age, sex, HBsAg, anti-HCV, AST, ALT, bilirubin, creatinine levels.

Eligibility Criteria:
Inclusion Criteria:

All patients who were followed in the intensive care unit

Exclusion Criteria:

None
Physical Exercise and Nutrition in Functional Gastrointestinal Disorders in Obese Children

A prospective observational case-control study evaluating the effect of a weight loss intervention program on functional gastrointestinal disorders among overweight and obese children.

The investigators intend to conduct a prospective observational case-control study of overweight and obese children, aged 6-18 years, followed in the child health and sport center at Meir medical center, Kfar-Saba, Israel.

Overweight and obese subjects, defined as body mass index (BMI) percentile ≥85%, will be offered to participate. Healthy subjects with normal BMI percentile from other pediatric outpatient clinics as well as relatives and friends of physicians from the pediatric division will be enrolled and serve as the control group.

Study visits will be at enrollment and after 3 and 6 months of participation in the intervention program. During the visits the investigators will collect anthropometric measurements (height, weight, BMI, total body fat). Participants (age 10y and above) or their parents (age 6-10y) will fill a validated questionnaire for diagnosis of FGID based on ROME IV criteria. The investigators will also collect data from exercise capability testing and quality of life questionnaires performed regularly (and irrespective of this study) during the intervention program.

The investigators will then compare between subjects who succeeded to those who failed in losing at least 5% of their initial body weight as well as to healthy controls with normal BMI percentile.

Eligibility Criteria:
Inclusion Criteria:

* obese / overweight children participating in the life style modification program at the child sport and health center

Exclusion Criteria:

* other known chronic non-functional gastrointestinal conditions (e.g. Celiac disease, inflammatory bowel disease)
Access to Chiropractic Care During the COVID-19 Pandemic

This is a prospective comparative cohort trial taking place during the first year of the Coronavirus-19 (COVID-19) pandemic in Spain. Chiropractic patients throughout Spain were invited to participate independently of the care received, including patients who had stopped visiting their chiropractors since the pandemic hit. The main exposure variable is the access to chiropractic care services, and the degree of this exposure during the months following initial lockdown phase in Spain. Participants will fill an online questionnaire with self-reported outcome-measures.


Eligibility Criteria:
Inclusion Criteria:

* chiropractic patients with pain, active when lockdown was declared, over the age of 16

Exclusion Criteria:

* new patients in the clinic after the pandemic hit
Predictive Proteomic Factors of the Response to Concomitant Radiochemotherapy in Esophageal Cancer

The scope of the trial is to predict the early complete clinical response to exclusive concomitant radiochemotherapy in esophageal cancer by the study of the pre- and per- therapeutic proteomic profile.

Further informations will be provided by Centre Oscar Lambret.

Eligibility Criteria:
Inclusion Criteria:

* Invasive esophageal carcinoma at any stage (all T, N0 or N1, M0 or M1a), histologically proven
* Treated by exclusive concomitant radiochemotherapy
* Written informed consent

Exclusion Criteria:

* Presence of a second uncontrolled cancer
* Metastatic carcinoma
* Metastatic disease, except cervical lymphnodes... (M1a)
* In situ carcinoma
* Eso-gastric junction cancer (Siewert II ou III)
* Inclusion in a clinical trial with an experimental drug during the study and until 15 weeks after the end of radiotherapy)
sTep dOWn Inhalers in the reAl woRlD

To establish the feasibility of stopping inhaled steroids and switching or maintaining dual bronchodilation in one visit - in the real world, for people with COPD.

COPD patients prescribed a combination of any inhaled corticosteroid (ICS), long acting beta agonist (LABA) and long acting muscarinic antagonist (LAMA) will be switched to a single LABA/LAMA combination inhaler, stopping their ICS. They will be followed up for 12 months.

Participants are shown the four currently available LABA/LAMA combination inhalers and instructed on their use. The clinical specialist will use standard prompts in an effort to demonstrate the inhalers in an unbiased way. The participants will choose: Ultibro® (Breezhaler device) or Duaklir® (Genuair device) or Anoro® (Ellipta device) or Spiolto® (Respimat device) and they will be prescribed the inhaler of their choice provided they can demonstrate effective use.

Patients will be reviewed 4, 12, 26 and at 52 weeks after switching with clinical outcomes measured at these points. As this is a real-world open study the patients and GPs are instructed that treatments can be changed at any point as clinically indicated, including restarting an ICS.

Eligibility Criteria:
Inclusion Criteria:

* GP diagnosis of COPD
* Post bronchodilator FEV1/FVC ratio \<70% with FEV1\<80% predicted
* Current or ex smoker equal or greater than 10 pack years
* Taking an ICS, LABA \& LAMA

Exclusion Criteria:

* Unable or unwilling to sign informed consent
* Any previous or current diagnosis of asthma
* Any features of asthma or large variability in symptoms
* History of atopy
* Any previous blood eosinophil count \>600mm3
* A moderate or severe exacerbation of COPD (needing systemic glucocorticosteroids or hospital admission for \>24 hours) within the last 6 weeks
* Life expectancy \< 1 year
Effects of Antibodies to White Blood Cells on Platelet Transfusion Patients

This study will determine if transfusion of platelets containing HLA antibodies (certain antibodies to white blood cells) are more likely to cause transfusion reactions than transfusion of platelets that do not contain HLA antibodies.

People 18 years of age or older who donate platelets at the NIH Clinical Center may be eligible for this study.

An extra tube of blood (about one teaspoon) is obtained from participating donors at the time of their donation at the NIH Platelet Center. The blood plasma in the extra tube is tested for HLA antibodies and antibodies to certain white blood cells called granulocytes. The research sample is assigned a code number for identification and sent to the HLA Laboratory in the Department of Transfusion Medicine.

Leukocyte antibodies can cause febrile transfusion reactions, pulmonary reactions to granulocyte transfusions, and transfusion related acute lung injury (TRALI). Despite the fact that the role of leukocyte antibodies in these reactions was first described almost 50 years ago, and that TRALI is now the leading cause of transfusion related fatalities, much remains uncertain concerning the role of HLA antibodies in these reactions. The primary purpose of this study is to retrospectively and prospectively determine if the incidence and nature of transfusion reactions differs in Clinical Center (CC) patients that were transfused with platelet components from donors with HLA antibodies and those without HLA antibodies. In addition, this study will prospectively determine the incidence of HLA antibodies in the NIH Department of Transfusion Medicine (DTM) platelet donor population. In this natural history study a 10-mL blood sample will be drawn from 600 platelet donors at the time that they are in the DTM donating platelets and it will be tested for HLA antibodies in the DTM. The blood sample for HLA antibody testing will be collected with other samples collected as part of the regular platelet donation process. Reactions in platelet transfusion recipients will be assessed by reviewing CC and DTM patient records.

Eligibility Criteria:
* INCLUSION CRITERIA:

  1. Both male and female donors
  2. Any ethnic group
  3. 18 years of age or older
  4. Must meet the criteria for donating platelets in the DTM

EXCLUSION CRITERIA:

1. Donors are not eligible to donate platelets in the DTM