cyrilzakka/clinical-trials huggingface dataset:
HIV Prevention Counseling for Men Who Have Sex With Men

The purpose of this study is to see if a behavioral intervention, a special kind of counseling, can reduce the risk of HIV infection in men who have sex with men. The behavioral intervention will be compared to the standard risk reduction counseling that is given before and after getting an HIV test.

In standard pre- and post-test counseling, everyone is told the same things about how to prevent HIV. The behavioral intervention used in this study is designed to help each individual prevent HIV according to his specific problems and needs.

The intervention being evaluated in this trial is based on the extensive literature on behavioral approaches to risk reduction in MSM. These reviews recommend an intervention that, unlike the current standard HIV pre-test and post-test risk-reduction counseling, is tailored to an individual's unique problems and needs, lifestyle, and situations that contribute to high-risk behavior. Furthermore, there is a need for HIV-prevention intervention trials using biological endpoints (e.g., HIV seroconversion) in addition to behavioral change indices.

Participants are randomly assigned to receive either the behavioral intervention or the control risk-reduction counseling. The same counseling staff provides the two types of treatment. The behavioral intervention consists of 10 counseling sessions within a 4-month period followed by quarterly maintenance sessions for the remainder of the 3-year follow-up. The intervention is conducted on a one-to-one basis and targets condom use, change in sexual practices associated with HIV risk, and change in sexual practices in the context of alcohol and drug use. Participants in the control group receive pre- and post-test counseling at enrollment, then semiannually through Month 36. Beginning at Month 6, all participants complete routine semiannual visits. At each visit, Risk Assessment and phlebotomy for specimen collection for HIV antibody tests are administered. As is routine in most public counseling and testing venues, participants in the control condition do not see the same counselor consistently.

Eligibility Criteria:
Inclusion Criteria

Participants may be eligible for this study if they:

* Are an HIV-negative man who has had anal sex with another man in the 12 months prior to study entry.
* Are able to attend all scheduled study visits.
* Are able to provide information for locator purposes (address, phone number, etc.).
* Are at least 18 years old.

Exclusion Criteria

Participants will not be eligible for this study if they:

* Have been in a monogamous relationship for 2 years or more with an HIV-negative man. (Monogamous is defined as a relationship in which the members of the couple engage in sexual activities with only each other.)
* Have an obvious mental disorder or any another condition that would prevent them from completing the study.
* Are currently enrolled in any Phase III HIV vaccine trial, including the AIDSVAX Phase III trial sponsored by VaxGen, Inc.
* Are currently enrolled in HIVNET Protocol 014.
* Were enrolled in the HIVNET 015 Pilot Study.
Long Term Evaluation of Sevelamer HCl vs. Calcium-based Phosphate Binder in the Treatment of Hyperphosphatemia in Hemodialysis Patients

The study is designed to compare sevelamer vs. calcium-based phosphate binder in hemodialysis patients to achieve full-scale of medical care, including reduction of atherosclerotic risk factors, reduction of vascular access reconstruction rate, and pharmacoeconomic analysis.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged between 18-70 years old
* Subject with hyperphosphatemia (5.5 - 8.5 mg/dL) at both WK(-2) and WK0
* On stable TIW hemodialysis for 3 months or longer

Exclusion Criteria:

* Patients with hypercalcemia (corrected serum calcium \> 10.5 mg/dL)
* Any of the following abnormalities: ALT or AST \> 3X ULN; iPTH \> 1000 or \< 150 pg/mL
* History of dysphagia or swallowing disorders
* History of GI motility disorder or GI bleeding within 3 months prior to entry
Association Between Carotid Plaque Length and Cardiovascular Events

This multicenter study involved 5 hospitals (Changhai Hospital; Yueyang Hospital of Shanghai University of Traditional Chinese Medicine; Gongli Hospital; Putuo Hospital of Shanghai University of Traditional Chinese Medicine; No. 904 Hospital of the PLA Joint Logistics Support Force Wuxi). The study enrolled 3637 patients with coronary atherosclerosis who were confirmed by coronary angiography from January 2017 through December 2018.

Patients with coronary atherosclerosis who were confirmed by coronary angiography were eligible for the study. Carotid ultrasonography was simultaneously performed, and carotid intima-media thickness (IMT), maximum thickness and length of all plaques were measured.

Eligibility Criteria:
Inclusion Criteria:

* Patients≥18 years old, those who underwent carotid ultrasonography and first coronary angiography simultaneously.

Exclusion Criteria:

* Patients with known coronary artery disease, previous coronary or carotid revascularization, missing carotid ultrasound or coronary angiography results.
Non-invasive Pulmonary Artery Prediction

Cardiac remote monitoring devices have expanded our ability to track physiological changes used in the diagnosis and management of patients with cardiac disease. Implantable remote monitoring technologies have been shown to predict heart failure events, and guide therapy to reduce heart failure hospitalizations. The CardioMEMs System, the most studied and established remote monitoring system, relies on a pulmonary artery implant for continuous PAP measurement. However, there are no commercially available wearable systems that can reproduce continuous PAP tracings.

This study aims to determine if a machine-learning algorithm with data from a wearable cardiac remote-monitoring system incorporating EKG, heart sounds, and thoracic impedance can reproduce a continuous PAP tracing obtained during right heart catheterization.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects age 18+ years
2. Undergoing a right heart cardiac catheterization or in the cardiac care unit with active monitoring using an arterial line or Swan-Ganz catheter.

Exclusion Criteria:

1. Vulnerable population
2. Unable to consent for any reason
3. Unstable patient
4. Known skin reaction to latex or adhesives
Developing Text-based Support for Parents of Adolescents After an Emergency Department Visit

The researchers seek to develop a text message intervention for caregivers of adolescents at elevated suicide risk following discharge from emergency department (ED) care.

Participants in the trial included 120 youth-parent dyads (120 youths and 120 parents). As the ultimate focus of the intervention is on improving youth outcomes, participant-related descriptives are provided for youth participants, except where noted specifically to be parent-related data.

Eligibility Criteria:
Parent eligibility:

Inclusion Criteria:

* Parent of eligible teen

Exclusion Criteria:

* Not owning a cell phone with text messaging capability.

Teen eligibility:

Inclusion Criteria:

* Recent suicidal ideation (within last 2 weeks) and/or suicide attempt within the last month.

Exclusion Criteria:

* Youth with severe cognitive impairment or altered mental status (e.g., psychosis, manic state)
* Youth with severe aggression/agitation
* No availability of a legal guardian
The Fasting II Study

This study will determine whether an intensive fasting protocol alters hemoglobin A1c measurements or other markers of metabolic and cardiovascular risk by performing a 5-week clinical trial of fasting among 12 pre-diabetic individuals or diabetics whose disease is controlled by diet. Participants will undergo a 5-week intervention of once-per-week 24-hour water-only fasting, including at baseline and at the end of the week for each week of the study (a total of 6 24-hour fasts).


Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant female, ≥30 and \<70 years of age.
2. Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
3. Prior evidence of pre-diabetic state, with one of the following:

   1. Pre-diabetic with a measured hemoglobin A1c (HbA1c) ≥6.0% or fasting glucose \>100 mg/dL without a clinical diabetes diagnosis
   2. Clinically-diagnosed type II diabetic with HbA1c ≥6.0% or fasting glucose ≥110 mg/dL and whose disease is controlled by diet alone.
4. Evidence of metabolic syndrome by having at least 3 of the following 5 criteria:

   1. Fasting glucose level \>100 mg/dL.
   2. Blood pressure ≥135 mmHg systolic or ≥85 mmHg diastolic, or use of an antihypertensive medication.
   3. High-density lipoprotein cholesterol \<40 mg/dL in males or \<50 mg/dL in females.
   4. Triglycerides ≥150 mg/dL or use of a cholesterol-lowering medication.
   5. Waist circumference \>40 inches (102 cm) for males or \>35 inches (88 cm) for females (or body mass index \>25 kg/m2).

Exclusion Criteria:

1. Pregnant and/or lactating women and women of child bearing potential who are not using acceptable means of contraception. Women of childbearing potential must be using adequate measures of contraception (as determined by the Principal Investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period. Women of childbearing potential must have a negative pregnancy test at screen.
2. Diabetics taking any of the following anti-diabetic medications: insulin, metformin, thiazolidinediones, sulfonylureas, alpha-glucosidase inhibitors, meglitinides, or incretins.
3. Prior experience with fasting more than once per month (for 20 hours or more), on average during the last year.
4. Very low body mass index (BMI) (\<18.5 kg/m2) or high BMI (\>40 kg/m2).
5. Individuals who are nutritionally compromised, as assessed by the Principal Investigator.
6. Any immunodeficiency or prior solid organ transplantation or renal disease.
7. Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
8. Other conditions that in the opinion of the Principal Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.
Effects of Schroth Method and Proprioceptive Neuromuscular Facilitation Technique in Patients With Idiopathic Scoliosis

The aim of this study is to compare the effects of schroth method and proprioceptive neuromuscular facilitation techniques on pain, mobility, and quality of life in patients with idiopathic scoliosis.

Scoliosis is a three-dimensional deformity that causes the spine to curve sideways. The most common type of scoliosis is "idiopathic," which means the exact cause is unknown. It accounts for approximately 85% of cases. The prevalence rate of 2-5% with a Cobb angle greater than 10 degrees. All previous studies in which schroth method with other different techniques has been performed have shown greater improvement in the management of scoliosis. However, there is no clinical significance work on the Comparative effect of the schroth method and PNF. Previous literature showed no significant improvement in mobility and quality of life. This study aims to find evidence of clinical significance work on effects of Schroth method and proprioceptive neuromuscular facilitation technique on pain, mobility, and quality of life in patients with idiopathic scoliosis in both gender

Eligibility Criteria:
Inclusion Criteria:

* Participants with Lenke curve type 1 scoliosis and other types of scoliotic curve magnitude will be included.
* Cobb angle 10-30

Exclusion Criteria:

* Participants with any surgical and traumatic history of spine
* Participants prescribed with brace treatment
* Subjects with Non-idiopathic scoliosis
* Subjects with any systematic disease e.g. (cardiovascular, vestibular, rheumatological, neuromuscular and pulmonary disease)
Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UC

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 2 doses of GED-0507-34-Levo in subjects with active, mild-to-moderate UC.

This is a Phase 2, Proof of Concept, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 2 doses of GED-0507-34-Levo in subjects with active, mild-to-moderate Ulcerative Colitis.

The study will consist of 3 phases:

* Screening Phase - up to 4 weeks
* Double-blind Placebo-controlled Phase - Weeks 0 to 8
* Follow-up Phase - Week 9

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 and over at the time of signing the informed consent.
* Diagnosis of UC with a duration of at least 3 months prior to the Screening Visit.
* MMS ≥ 4 to ≤ 8 (range: 0 - 9) prior to randomization in the study
* Subjects are required to have a colonoscopy if one has not been performed within 12 months prior to the Screening Visit.
* Subjects who have relapsed on maintenance therapy with doses of 5-ASA ≤ 2.4 g/day

Exclusion Criteria:

* Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis, or diverticular disease-associated colitis.
* UC restricted to the distal 15 cm or less (eg, ulcerative proctitis).
* Subjects who have had surgery as a treatment for UC or who, in the opinion of the Investigator, are likely to require surgery for UC during the study.
* Clinical signs suggestive of fulminant colitis or toxic megacolon.
* Evidence of pathogenic enteric infection.
* History of colorectal cancer or colorectal dysplasia.
* Prior use of any TNF inhibitor (or any biologic agent).
* Prior use of mycophenolic acid, tacrolimus, sirolimus, cyclosporine, or thalidomide.
* Use of budesonide-MMx within the last 8 weeks.
* Use of oral and/or IV corticosteroids within 2 weeks of the Screening Visit.
* Use of immunosuppressants (azathioprine \[AZA\], 6-mercaptopurine \[6-MP\] or methotrexate \[MTX\]) within 8 weeks of the Screening Visit.
"Volatile Anesthetic Protection Of Renal Transplants: VAPOR-1-trail

To compare the renal protective properties of two currently used anaesthetic techniques - a sevoflurane-remifentanil/sufentanil combination with a propofol-remifentanil/sufentanil combination for anaesthesia in patients undergoing living donor kidney donation/transplantation.


Eligibility Criteria:
Inclusion Criteria:

* All patients: Age \> 18 years

Exclusion Criteria:

* patient refusal
* BMI\< 17, \>35
* neurological disorder
* recent use of psycho-active medication, including alcohol.
* Donor-recipient couples from the ABO-incompatible program
* Altruistic donor
Prevention of Disease Progress in Chronic Hepatitis C Patients With Liver Fibrosis (Study P02570AM2)(COMPLETED)

The objective of the study is to evaluate the safety and efficacy of PEG-Intron versus no treatment for the prevention of fibrosis progression in adult participants with moderate to severe liver fibrosis secondary to chronic hepatitis C, who failed PEG-Intron plus Rebetol treatment in protocol P02370 (NCT00039871).


Eligibility Criteria:
Inclusion Criteria:

* Age at entry in study P02370 (NCT00039871) 18-65 years;
* Nonresponder to PEG-Intron plus Rebetol in study P02370

Exclusion Criteria:

* Participants who did not participate in the P02370 study.
* Any medical condition, including but not limited to decompensated liver disease, malignancy or substance abuse, that developed during the P02370 study which could interfere with the participant's participation in and completion of this study.
Pallidal Stimulation in Patients With Idiopathic Generalised Dystonia

Pallidal stimulation is effective in patients with generalised idiopathic dystonia. The aim of this study is to:

1. evaluate the efficacy and safety of this treatment in patients with idiopathic generalised dystonia, 3 years after surgery and
2. assess the recurrence of the motor symptoms after the switch off.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic generalised dystonia
* Pallidal stimulation

Exclusion Criteria:

* Mini-mental status (MMS) \< 24
* Severe psychiatric disorder
The Modular Protocol for Mental Health (MPMH)

Currently, our best psychological treatments for anxiety and mood disorders only focus on individual diagnoses. So, there are separate treatments for Panic Disorder, or Depressive Disorder, or Social Anxiety, etc. These 'diagnosis-specific' treatments work well for people whose problems fit neatly into a single diagnosis. However, they work far less well for people with complex problems involving multiple diagnoses, and 50% of patients fail to respond well to these existing treatments.

The purpose of this study is to test a new psychological treatment for anxiety and mood problems (the Modular Protocol for Mental Health \[MPMH\]). Instead of focusing on any single diagnosis, MPMH combines the best treatment techniques into 10 modules to target problems common across all of the different mood and anxiety diagnoses (e.g., intense emotions, negative thinking, upsetting memories, distressing habits). MPMH should therefore be a better treatment for the large numbers of individuals whose problems do not fit neatly into a single diagnosis and for whom any treatments targeting a single diagnosis would leave significant difficulties unaddressed.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a primary diagnosis of a unipolar mood, anxiety, stress or obsessive-compulsive disorder with at least one additional comorbid diagnosis according to the DSM-5. The criteria for diagnosis will be based on the Structured Clinical Interview for the DSM (SCID) which assesses disorders according to DSM-5 diagnostic criteria.
* To be eligible participants will also need to score \>10 on either the Patient Health Questionnaire (PHQ-9) or Generalised Anxiety Disorder -7 item scale, GAD-7 (see Study Measures above).

Exclusion Criteria:

* Current/past psychosis or bipolar disorder
* Current full diagnosis of substance use disorder
* Organic brain damage
* Complex trauma history or recurrent self-injury requiring specialist services (as deemed by the NHS Clinical Care team)
* Current suicidality that warrants immediate clinical attention and constitutes a current risk of harm to the individual.
Effects of Dexmedetomidine on Oxygenation and Lung Mechanics in Morbidly Obese Patients Undergoing Bariatric Operations

The study aims to investigate the effect of dexmedetomidine on oxygenation and lung mechanics in morbidly obese patients

The patients of interest are morbid obese patients scheduled for bariatric surgery. Dexmeditomidine will be infused intraoperatively after induction of anesthesia. lung mechanics (dead space and compliance) as well as oxygenation (PF ratio) will be monitored intraoperatively and postoperatively

Eligibility Criteria:
Inclusion Criteria:

- Morbid obese (body mass index \> 40) with documented restrictive lung disease scheduled to bariatric operation.

Exclusion Criteria:

* Heart failure
* ِِِِArrhythmia
* Heart block
* Severe liver or kidney impairment.
Ventilatory Management of the Preterm Neonate in the Delivery Room

The purpose of this study is to evaluate sustained lung inflation followed by early nCPAP as delivery room ventilatory management for preterm neonates at risk of respiratory distress syndrome in reducing their need for mechanical ventilation and ameliorating lung injury without inducing adverse effects compared with intermittent bag and mask ventilation.

Neonatal resuscitation provides lifesaving intervention that, if properly conducted, not only can reduce mortality but probably can significantly decrease subsequent morbidity.

Premature infants need appropriate respiratory support and a lung-protective strategy, starting from the delivery room where, on the contrary, an inadequate respiratory approach may influence pulmonary outcome.

Mechanical ventilation in the form of positive pressure ventilation has remained the mainstay of treatment of respiratory distress syndrome (RDS) in preterm babies. In recent years, a number of new ventilation strategies have been introduced but the problem of bronchopulmonary dysplasia (BPD) has not been solved.

Sustained lung inflation (SLI) lead to a large increase in the tidal volume and the functional residual capacity(FCR) as this intervention may influence the clearance of lung fluids and allow a more even distribution of air throughout the lungs, thus facilitating the formation of FRC.

Nasal CPAP and early PEEP act through stabilization and subsequent recruitment of collapsed alveoli, increased FRC resulting in increased alveolar surface area for gas exchange and a decrease in intrapulmonary shunt .also it conserves endogenous surfactant.

Previous studies with promising results showed that a combination of sustained lung inflation and early nasal CPAP may be the most effective and least injurious way to recruit the lung in preterm neonates at birth.

This study will evaluate sustained lung inflation followed by early nCPAP as delivery room ventilatory management for preterm neonates at risk of respiratory distress syndrome in reducing their need for mechanical ventilation and ameliorating lung injury without inducing adverse effects compared with intermittent bag and mask ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants (gestational age \< 34 weeks)

Exclusion Criteria:

* 1. Neonates with major congenital anomalies (congenital heart disease, neural tube defect, trisomy, etc.).

  2.Meconium aspiration syndrome, congenital diaphragmatic hernia and anterior abdominal wall defect.

  3.Maternal chorioamnionitis. 4.Neonates with gestational age \< 26 weeks and /or birth weight less than 750 grams.
Double Blind Study of Hypertonic Saline vs Mannitol in the Management of Increased Intracranial Pressure (ICP).

The study goal is to compare the management of increased intra-cranial pressure (ICP) using 3% hypertonic saline vs. mannitol (given in same osmolar loads).

Primary hypothesis:

1. Hypertonic saline will be non-inferior to mannitol in decreasing elevated ICP.

Secondary hypotheses:

1. Hypertonic saline therapy will result with fewer complications than mannitol
2. ICP reduction duration will be longer using hypertonic saline when compared with mannitol

There is growing evidence in the literature indicating that ICP and Cerebral Perfusion Pressure measurements may not be sufficient in the management of elevated ICP. Based on this evidence, monitoring of partial brain tissue oxygenation has gain acceptance among neurosurgeons and neurointensivists, and has become a standard of care monitor in some centers across the country. There is, however, insufficient information in the literature describing the effects of hyperosmolar medications on regional brain tissue oxygenation.

We intend to undertake this non-inferiority, prospective, randomized double-blind study to answer very important clinical questions not yet answered in the literature: Will hypertonic saline therapy, given at equiosmolar load, be non-inferior to mannitol in reducing elevated ICP?

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* elevated ICP requiring ICP monitoring
* ICP ≥ 25 mmHg 5 min after ICP bolt or EVD placement

Exclusion Criteria:

* Requiring decompressive craniotomy or post decompressive craniotomy
* Hyponatremia (sodium level \< 125 mEq/L)
* Hypernatremia (sodium \> 155 mmol/L)
* Serum osmolality ≤ 250 mOsm/kg
* Serum osmolality ≥ 320 mOsm/kg
* Physical exam compatible with brain death
* Patients on hemodialysis with end-stage renal disease