cyrilzakka/clinical-trials huggingface dataset:
Obstructive Sleep Apnea (OSA) and Sex-Specific Responses to N-acetylcysteine (NAC)

This is a randomized controlled trial (RCT) of 4 weeks of study supplement N-acetylcysteine (NAC) versus placebo in persons with significant obstructive sleep apnea (OSA) who are receiving positive airway pressure therapy (PAP), the standard of care therapy. The purpose of the study is to determine if NAC is associated with sex-specific changes in overnight oxidative stress, inflammation, as well as endothelial dysfunction in persons with OSA.


Eligibility Criteria:
Inclusion Criteria:

* Apnea-hypopnea index ≥15 events/hr on portable sleep monitoring
* HbA1c \<6.5%

Exclusion Criteria:

* Body mass index (BMI) ≥40 kg/m2;
* Diagnosis of diabetes mellitus, defined as the use of any diabetes medication (including glucagon like peptide \[GLP\]-1 agonists) currently or in the previous three months or HbA1c ≥6.5%;
* Shift work (i.e., working hours that routinely cause sleep initiation after 1:00 a.m.);
* Another major sleep disorder (i.e., circadian rhythm disorder, any history of narcolepsy, concurrently diagnosed or medication-treated restless legs syndrome, concurrently diagnosed or medication-treated chronic insomnia with the exception of antidepressant therapy);
* Regular use (more than twice/week) of an opioid/narcotic, benzodiazepine, or prescription sleep medication other than antidepressants currently or within the last month;
* The use of N-acetylcysteine in any form (oral, intravenous, inhaled) in the last seven days
* The use of other over-the-counter antioxidant therapies including vitamin C or vitamin E in the preceding 10 days
* History of reduced ejection fraction heart failure, or chronic cardiac arrhythmia requiring medication or treatment;
* Unstable or uncontrolled medical or psychiatric comorbidity requiring hospitalization or change in medication during the previous three months;
* Use of biologics or immune modulators in the last year;
* Use of systemic steroids during the previous three months;
* Current tobacco smoking;
* Inability to sign informed consent;
* Currently use of positive airway pressure therapy or another OSA treatment (e.g., hypoglossal nerve stimulator, oral device);
* Recent history of alcoholism or drug abuse (within the last three months)
* Neurological condition that requires ongoing pharmacological therapy (e.g., Parkinson's disease, Alzheimer's dementia, multiple sclerosis, other degenerative neurological disease).
* Pregnancy
The Efficacy of the HIV/AIDS Symptom Management Manual

The goals of this research are: 1) To test the efficacy of a self-care symptom management manual by examining whether people who use the manual find it to be useful; 2) To examine symptom and demographic data related to self-care behaviors, symptom control, medication adherence and enhanced quality of life.

The University of California, San Francisco is the coordinating site for this multi-site international study.

People living with HIV/AIDS encounter many psychological, physiological, and cognitive symptoms, such as pain, diarrhea, fever, fatigue, depression, and confusion. These symptoms have been found to restrict a person's daily life significantly. Self-management of multiple HIV and medication side effects symptoms and maintaining optimal quality of life have, therefore, become major daily tasks for people living with HIV/AIDS.

This study is a randomized controlled trial with a two-group repeated measures design to test the efficacy of the symptom management manual. Two groups (experimental and control) will be assessed in a repeated measures design at 3 time points: baseline (time 0), one month (time 1), and two months (time 2). Data will be analyzed using longitudinal mixture modeling.

Comparison(s): HIV-positive patients receiving a symptom management manual and orientation to the manual, compared to HIV-positive patients receiving a nutrition manual and orientation to the manual.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed HIV/AIDS
* Adult (men and women, transgender)
* Presence of at least one symptom within the past week
* Consent
* May or may not be pregnant
* May or may not be on ART
* Able to use the manual with or without family support

Exclusion Criteria:

* Documented diagnosis of dementia
* Unable to understand consent procedure as judged by the person getting consent
* Self-reporting no symptoms within the past week
* Self-reports having had experience with a self-care Symptom Management Manual
A Comparison Study to Evaluate the Pharmacokinetics and Safety of NK-104-CR in Healthy Adult Volunteers

The purpose of this study is to compare the pharmacokinetics and safety of a controlled release (CR) version of pitavastatin (also referred to as NK-104) to immediate release (IR) pitavastatin in healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Subject provides written informed consent before any study-specific evaluation is performed.
* Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive.
* Subject has no clinically significant abnormalities on the basis of medical history, physical examination findings, or vital sign measurements, as judged by the Investigator.
* Subject is able and willing to comply with the protocol and study procedures.

Exclusion Criteria:

* Subject is a woman who is pregnant or breastfeeding.
* Subject has clinically relevant abnormalities in the screening or check-in assessments.
* Subject has received an investigational drug within 30 days before the first dose of study drug.
Study Of The Effects Of SB 480848 (Darapladib) On The Electrical Conduction Of The Heart

This is a study to assess the effects of darapladib on the cardiac conduction of the heart as compared to placebo and moxifloxacin. This a four period crossover design with each period lasting about 10 days. There will be a 7 to 10 day wash out in between each period.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Body weight greater than 50 kg (110 lbs) and a body mass index between 19 and 30
* Signed and dated written informed consent prior to admission to the study
* Subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions

Exclusion Criteria:

* cardiac abnormalities
* history of asthma or severe allergic reactions
* history of alcohol or drug abuse
* use of prescription or non-prescription drugs or vitamins or herbal supplements
* history of cholecystectomy or biliary tract disease
* pregnant or nursing women
* history of allergy to the study drugs
TRACS STUDY: Transfusion Requirements After Cardiac Surgery

Blood transfusion is related to worse outcomes and the triggers for red blood cells transfusion are not well defined in cardiac surgery. Retrospective studies in cardiac surgery do not show benefits of red blood cell transfusion in reduction of morbidity and mortality in cardiac surgery. There are no prospective studies comparing outcomes between restrictive or liberal strategy in cardiac surgery.This study is a double-blind randomized study comparing clinical outcomes between two strategies of transfusion in cardiac surgery - liberal or restrictive.

Blood transfusion is commonly performed in patients submitted to cardiac surgery. However, there are many studies reporting adverse effects of this intervention and final data on benefits are not available. There are no prospective studies in cardiac surgery regarding red blood cell transfusions requirements. There are retrospective studies in cardiac surgery suggesting worse outcomes including higher rates of mortality in patients submitted to red blood transfusion. Hematocrit levels around 30% are usually recommended not evidence based. Our purpose is to prospectively evaluate two strategies of transfusion in 500 patients submitted to elective cardiac surgery: a liberal strategy - patients receive blood transfusion when hematocrit is lower than 30% since the intraoperative period until the ICU discharge; a restrictive strategy - patients receive blood transfusion only when hematocrit is lower than 24%.

Clinical outcomes, costs and quality of life will be compared.

Eligibility Criteria:
Inclusion Criteria:

* All elective primary and redo adult cardiac surgical patients for coronary artery bypass grafting, valve procedure or combined procedures
* Adults patients
* Written informed consent

Exclusion Criteria:

* Age less than 18 years
* Transplant procedures
* Emergency procedures
* Aortic repairs
* Congenital procedures
* Previous anemia (hemoglobin lower than 10 g/dL)
* Previous thrombocytopenia (platelet number lower than 100.000/mm3)
* Previous known coagulopathy
* Pregnancy
* Those unable to receive blood transfusion
* Patients who refused participation in the study
The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA).

This is a research study using caffeine in children who have an obstructive sleep apnea (OSA). OSA means children who stop breathing during their sleep due to obstruction in their airway. The purpose of this study is to determine whether caffeine when given in the vein, will wake children up faster and decrease post-anesthesia airway obstruction, as well as the safety and if the drug agrees with the child compared to a placebo (an inactive or dummy agent).

Patients with OSA are reported to have a higher rate of severe respiratory complications associated with upper airway obstruction during anesthesia and sedation or immediately after anesthesia. Children with OSA (especially those under three years of age, those with severe OSA, cerebral palsy or craniofacial anomalies) are at increased risks for post-operative complications, and require careful monitoring post-operatively.

Although the etiology of obstructive sleep apnea is mainly obstruction due to anatomical and neuromuscular abnormalities, we believe that a central element may contribute to OSA.

The aim of this study is to evaluate whether administration of caffeine to children with OSA, scheduled for elective T \& A under general anesthesia contributes to a faster recovery, less post-operative complications, and a shorter stay in the PACU, DSU and the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Children between 2.5-18 years old
* Diagnosed with obstructive sleep apnea
* Undergoing elective tonsillectomy and adenoidectomy

Exclusion Criteria:

* Age below 2.5 or above 18 years
VA111913 TS: First in Human Study

This is a first-in-human study of VA111913 TS, a new chemical entity being developed for the treatment of dysmenorrhea. This study is designed to investigate determine the safety, tolerability and pharmacokinetics of VA111913 TS after single and multiple doses in healthy non-pregnant female volunteers of child bearing age.

VA111913 TS is a selective V1a-receptor antagonist. The hypothesised mechanism of action of a V1a receptor antagonist in dysmenorrhea has been described in literature. Contractions of the uterine muscle are required for normal menstruation. Women with dysmenorrhea have increased uterine myometrial tone and contractions and decreased blood flow to the uterus. These abnormalities have been shown to lead to the pain experienced in dysmenorrhea. Thus, if a drug is able to reduce the hyperreactivity of the uterus to physiological levels then the pain experienced in dysmenorrhea may be controlled. In humans, vasopressin, via the V1a receptor, is able to potently induce contractions in both uterine smooth muscle and uterine blood vessels. Thus, a V1a receptor antagonist will potentially inhibit these contractions and in turn reduce the pain experienced in dysmenorrhea.

Eligibility Criteria:
Inclusion Criteria:

* Healthy females 18 to 45 years of age.
* Subjects must have a negative pregnancy test at screening and admission. Using acceptable form of contraceptive during and after study.

Exclusion Criteria:

* Administration of any IMP within 12 weeks before entry to the study or any prescribed medicine within 14days of the study.
* Any clinically important medical disease, condition or abnormal laboratory test results.

Other protocol-defined inclusion/exclusion criteria may apply
Single Injection of REGN475/SAR164877 in the Treatment of Chronic Pancreatitis Pain

Primary objective was to demonstrate the activity of REGN475/SAR164877 in reducing the pain associated with chronic pancreatitis.

Secondary objectives were:

* to assess the safety and tolerability of REGN475/SAR164877 in patients with chronic pancreatitis pain;
* to characterize the pharmacokinetic, pharmacodynamic, and immunogenicity profiles of REGN475/SAR164877 in this population;
* to measure the change in the total daily dose of rescue medications required.

The duration of the study period for each participant was up to 14 weeks, including a screening period up to 2 weeks, and 12-week follow-up after the injection.

Eligibility Criteria:
Inclusion criteria:

* Moderate to severe abdominal pain due to chronic pancreatitis of at least 6 months duration.

Exclusion criteria:

* Mild pain on the Pain Intensity-Numeric Rating Scale \[PI-NRS\] at screening and randomization visits;
* Narcotic addiction;
* Recent pancreatic surgical or endoscopic intervention for chronic pancreatitis pain;
* Unwillingness to use study-defined rescue analgesia exclusively.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Cognitive Behavioral Therapy for Arthritis Pain and Insomnia in Older Adults

This study compares the efficacy of three group interventions for people with co-morbid osteoarthritis (OA) and insomnia to help them manage their OA symptoms. The investigators hypothesize that a combination cognitive-behavioral treatment will produce significantly greater initial and long-term improvements in OA symptoms than will the other two treatments.

This study is only for members of the Group Health Cooperative (GHC) of Puget Sound who have both osteoarthritis pain and insomnia. The first part of the study involves filling out a mailed survey. Based on the results of the survey some respondents will be eligible for the second part of the study. Our goal in the second part is to test three different treatments for managing OA symptoms. The programs teach about things people with arthritis can do to improve the quality of their lives. All three programs deal with pain, sleep, mood and activity-but each has a slightly different focus. Participants will be randomly assigned to one of the three programs. Each program is made up of six weekly group sessions that last about 90-120 minutes. The programs will be co-led by licensed therapists and each will include 8-12 members. Study participants will also take part in a series of visits at their homes over the next 18 months. At each visit the investigators will ask them to do a few other study activities, such as keep a 7-day diary of their sleep and fill out a survey about their arthritis pain. With their permission the investigators will also ask them to let us collect some information from their GHC medical records.

Eligibility Criteria:
Inclusion Criteria:

* Age 60+
* Continuously enrolled in Group Health one year prior to sample pull
* Primary care clinic at selected clinics
* Not in "No Contact File"
* Diagnosis 715xx (Osteoarthritis) in prior three years

Exclusion Criteria:

* Not continuously enrolled in Group Health for at least one year
* Medical record information indicates a diagnosis of:

  1. rheumatoid arthritis
  2. obstructive sleep apnea
  3. periodic leg movement disorder
  4. restless leg syndrome
  5. sleep-wake cycle disturbance
  6. rapid eye movement (REM) behavior disorder
  7. dementia or receiving cholinesterase inhibitors
  8. Parkinson's disease or other neurodegenerative disease known to directly impact sleep
  9. cancer in the past year and receiving chemotherapy or radiation therapy in the past year
  10. inpatient treatment for congestive heart failure within the previous 6 months
Prostate Embolization in Chronically Surveyed Patients: Effectiveness of Unilateral vs. Bilateral Embolization

Prostate embolization is an alternative treatment to trans urethral prostate resection in the context of benign prostatic hypertrophy. This embolization treatment is also of interest in patients with chronic anuria surveyed in relation to their prostatic hypertrophy for disundation. This survey causes discomfort and urinary tract infection. It is a population with tortuous arteries, a severe atherosclerotic overload making embolizations complex and long. Often, only unilateral embolization is possible. The purpose of this study is to compare the effectiveness in terms of disundation of unilateral vs. bilateral embolization of the prostatic arteries

Prostate embolization is an alternative treatment to trans urethral prostate resection in the context of benign prostatic hypertrophy. This embolization treatment is also of interest in patients with chronic anuria surveyed in relation to their prostatic hypertrophy for disundation. This survey causes discomfort and urinary tract infection. It is a population with tortuous arteries, a severe atherosclerotic overload making embolizations complex and long. Often, only unilateral embolization is possible. The purpose of this study is to compare the effectiveness in terms of disundation of unilateral vs. bilateral embolization of the prostatic arteries.

Method of observation or investigation chosen:

Retrospective, observational collection with division of patients into two groups according to unilateral or bilateral embolization of the porstatic arteries.

Origin and nature of the data Patient's medical record: imaging stored in the PACS to confirm unilateral or bilateral embolization, perform measurements of prostate volume, urological medical record to see the effectiveness of embolization in terms of disundation, comfort of life, tolerance of embolization, effectiveness in terms of urination (IPSS score)

Data flow mode:

Data stored in redcap.

Eligibility Criteria:
Inclusion Criteria:

* Elderly patients (\>70 years old)
* with contraindications to surgery,
* with a chronic urinary catheterization

Exclusion Criteria:

* \<70 years old
* without contraindications to surgery
* without chronic urinary catheterization
Study Evaluating the Efficacy and Safety of Remifentanil in a Rapid Sequence Induction for Fragile Subjects

The primary objective is to determine whether, during a rapid sequence intubation by etomidate, and succinylcholine Sellick maneuver, the administration of remifentanil at 2 different dosages (0.5 and 1.0 microgram per kg body weight), reduces potentially dangerous reactional tachycardia.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring rapid sequence intubation for whatever reason. This includes the following: a full stomach, obesity, diabetic gastroparesis, gastroesophageal reflux
* Patient able to give informed consent, and sign the consent.

Exclusion Criteria:

* Contraindication for the use of any drugs used (regardless of the patient group): a history of serious side effects, allergic reaction
* Morbid obesity (Body Mass Index \> 40)
* Emergency situation with unstable hemodynamics, and stabilization is impossible before induction
* Inclusion in another research project within the past 3 months
* The patient is not insured or beneficiary of a health insurance plan (for the French centers)
* Patient under guardianship of any kind
* Patient unable to give informed consent
* Refusal to sign the consent form
Carotid Atherosclerosis in Patients With Aortic Coarctation

Despite aortic coarctation (CoA) repair these patients have cardiovascular complications and coronary artery disease is the most common cause of death.

The aim with this study was to measure intima-media thickness (IMT) and plaques in arteries compared to cardiovascular markers in controls and patients with CoA.

Eligibility Criteria:
Inclusion Criteria:

* sex and age-matched controls

Exclusion Criteria:

* acute and chronic inflammation disease, underlying malignancies and diabetes mellitus.
Benzo[a]Pyrene Ultralow Dose-Response Study

Evaluation of the pharmacokinetics for \[14C\]-benzo\[a\]pyrene (\[14C\]-BaP) and metabolites in plasma and urine over 48 hours following 4 oral doses of 25, 50, 10 and 250 ng (2.7-27 nCi).

The pharmacokinetics for \[14C\]-BaP and metabolites will be assessed by UHLPC-Accelerator Mass Spectrometry (AMS, Lawrence Livermore National Laboratory) in plasma and urine collected over 48 hours following oral doses of 25, 50, 100 or 250 ng (2.7-27 nCi). Metabolite profiles and kinetics of elimination over this dose range are predicted to be consistent with a BaP physiologically based pharmacokinetic (PBPK) model developed by Pacific Northwest National Laboratory (PNNL). A non-smoker, not exposed occupationally, receives 270-700 ng of BaP daily; about 95% dietary. The WHO has set an estimated safe daily lifetime (70 year/70 Kg individual, cancer endpoint) exposure to BaP of 42-350 ng. This protocol represents de minimus risk.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for women:

  * Age 21-65 (inclusive)
  * Must be post-menopausal or have had surgical sterilization to eliminate any possibility for fetal exposure
  * Willing to defer blood donation for one month before, throughout, and one month after completion of study activities
  * Willing to avoid consuming cruciferous vegetables, I3C or DIM supplements, smoked or cured meat or cheeses, or charcoal-grilled meats for 2 weeks prior to and during each study cycle (gas grilled foods acceptable)

Inclusion criteria for men:

* Age 21-65 (inclusive)
* Willing to defer blood donation for one month before, throughout, and one month after completion of study activities
* Willing to avoid consuming cruciferous vegetables, I3C or DIM supplements, smoked or cured meat or cheeses, or charcoal-grilled meats for 2 weeks prior to and during each study cycle (gas grilled foods acceptable)

Exclusion Criteria:

Exclusion criteria for both men and women:

* Smoker (tobacco or other substances) or use of smokeless tobacco in past 3 months or living with smoker
* Regular use of medications that affect gut motility or nutrient absorption (e.g. cholestyramine, sucralfate, orlistat, pro- or anti-motility agents)
* History of gastrointestinal surgery (e.g. bariatric surgery, cholecystectomy) or gastrointestinal disorder (Crohn's disease, celiac disease, IBS, or colitis)
* Current or history of kidney or liver disease
* Prior high-dose 14C exposure from medical tests. (micro-dose 14C exposure not exclusionary)
* Occupational PAH exposure (e.g. roofers, asphalt pavers, fire-fighters, etc.)
High Volumes of Hypertonic Saline and Chest Physiotherapy in CF Patients

Background Nebulised hypertonic saline (HS) is an established basic airway clearance treatment in Cystic Fibrosis (CF). However, there is scarce evidence regarding the practical implementation and administration of different HS volumes, including physiotherapy and aspects of breathing pattern.

The aim of the study was to implement standardised and age-adjusted nebulised volumes of hypertonic saline in cystic fibrosis patients, included in physiotherapy and lung drainage techniques.

Aims: To establish a safe, efficient routine for implementation of HS in daily treatment and to investigate the efficiency and tolerance of high volumes of HS integrated with chest physiotherapy.

HS was given twice daily with volumes of 4,5 ml in children aged 0-5 years, 6 ml at age 6-16 years and 9 ml at age \> 16 years. The protocol included guidance of standardized breathing pattern, upright and sideways positioning and voluntary cough.

Eligibility Criteria:
Inclusion Criteria:

* Cystic fibrosis

Exclusion Criteria:

* Non-adherence