cyrilzakka/clinical-trials huggingface dataset:
Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma

Normally, p53 helps prevent tumors from forming in the body. Early studies have shown that Fenofibrate, a cholesterol-lowering drug, can restore normal function to p53 and can change the metabolism of HPV-positive tumors in a way that stops the growth of tumors. The purpose of this study is to understand how Fenofibrate can be used to treat HPV-positive cervical cancers and cervical dysplasia. Researchers will examine collected tissue samples and investigate various genes and proteins to see whether Fenofibrate has an effect on HPV-positive cervical cancers and cervical dysplasia.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have histologically or cytologic confirmed high grade dysplasia or cervical cancer. Histologic types include squamous cell, adenocarcinoma or adenosquamous cell carcinoma.
* Participants must be eligible for surgical management with LEEP, CKC or hysterectomy or chemoradiation
* Age ≥ 18 years
* Normal liver function (AST, ALT, bilirubin within institutional normal limits).
* Participants must be English speaking
* Participants must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Participants with active liver disease, including primary biliary cirrhosis and unexplained, liver function abnormality
* Participants with severe kidney impairment (CrCl ≤30 mL/min calculated using Cockcroft-Gault), or end-stage kidney disease on dialysis
* Participants with preexisting gallbladder disease including active gallstones
* Known hypersensitivity to fenofibrate or fenofibric acid
* Participants that are pregnant or breast feeding due to unknown risk to developing fetus/infant. Please note: Participants of child-bearing potential (have had menses within the past year or have not had total hysterectomy) are actively screened for pregnancy prior to diagnostic procedures and screened again prior to treatment.
Measurement of HIV Risk to Create Demand for Safe Male Circumcision

The study is aimed at testing whether use of a new index to measure risk for HIV in the context of HIV testing and counseling will increase demand for safe male circumcision (SMC) services among HIV-negative non-muslim men in Rakai. We will also study whether use of the index leads to positive sexual behavioral modifications among men. The study will also measure acceptability of the index among men.

Three randomized trials, one of which was conducted in Rakai, Uganda, have shown that safe male circumcision (SMC) reduces HIV acquisition in men by approximately 60%. Recommendations from the World Health Organization (WHO) and the Joint United Nations Programme (UNAIDS) emphasize that SMC should be considered an efficacious intervention for HIV prevention in countries and regions with heterosexual epidemics, high HIV and low male circumcision prevalence.

In Sub Saharan Africa, 14 countries including Uganda have been selected to scale up SMC, for these countries the target is to achieve 80% circumcision prevalence by 2015 and maintain it till 2025. The scale up would avert more than 20 percent of new infections among men and women. However SMC programs are faced with the challenge of low uptake of SMC by older sexually active men who might be at higher risk of HIV. The need to increase SMC coverage among men at high risk of HIV requires tools to measure individual HIV risk.

Rakai Health Sciences Program has received funding to carry out an individual randomized, unblinded, two-arm 1:1 trial comprising a total of 968 men (484 men per study arm) from Rakai Community Cohort Study (RCCS) to assess whether HIV Counseling and Testing (HCT), enhanced with measurement and communication of HIV risk (eHCT), increases uptake of SMC and leads to behavior modification among HIV-negative sexually active men aged 15-49 years in Rakai District, Uganda.

The study is using a risk nomogram developed from the Rakai Community Cohort Study data to measure individual HIV risk in the intervention group and standard HCT in the control arm. All men enrolled will be followed at six months to ascertain circumcision status and collect brief information on sexual behaviors such as number of sex partners, use of alcohol with sex, detailed data on their sexual partners etc.The study will also measure acceptability of the index among men.

Eligibility Criteria:
Inclusion Criteria:

* Uncircumcised, non-muslim, HIV-negative, sexually active in the previous 12 months

Exclusion Criteria:

* Refuses HIV testing, not willing to stay in Rakai for at least 6 months following enrollment or unwilling to be traced
Clinical Study of the Intravenous Blood Glucose System in Hospitalized Adult Elective or Non-Emergent Surgery and Medical/Surgical Intensive Care Unit Patients

The primary objective of this study is to evaluate the performance and safety of the intravenous blood glucose (IVBG) System relative to point of care (POC) meter performance when each method is compared to the Yellow Springs Instrument (YSI) under various conditions in the operating room (OR), ICU and general ward (GW) in subjects undergoing elective or non-emergent surgery as well as subjects admitted to the medical/surgical ICU. POC meter systems are currently used in the hospital environment to measure blood glucose values. The YSI is an accepted reference standard for assessing POC meter accuracy.

The secondary objective of this study is to evaluate the performance of the IVBG System as compared with the YSI under various conditions in the operating room (OR), intensive care unit (ICU) and general ward (GW) in subjects undergoing elective or non-emergent surgery as well as subjects admitted to the medical/surgical ICU.

Subjects will have their glucose values collected from the IVBG System and compared with paired plasma glucose measurements obtained using theYSI with comparative blood samples collected from a CVC, an arterial line or a peripheral vein.

* Blood samples collected per time point: approximately 2ml for waste and1mL for glucose measurement. In the event that a closed blood drawing system is utilized, the waste would be reduced or eliminated.
* The comparative blood samples will be drawn manually at a maximum frequency of once every four hours.
* Sample draws not to exceed 23 per subject for the duration of the study. This includes 18 comparative blood samples and 5 calibration samples to be draw as needed (e.g. recalibration). Including the partial thromboplastin time (PTT) draws described in section 3.1.2, there would be approximately 100 mL or 6.8 tablespoons drawn per subject. In the case where a closed blood drawing system is used consistently, this would be approximately 50 mL or 3.4 tablespoons per subject.

POC meter blood glucose measurements will be performed at the same time as the blood sample draws described above.

Eligibility Criteria:
Inclusion Criteria:

* ICU ≥ 24 hours
* sign ICF

Exclusion Criteria:

* transplant Pt
* brain injury/surgery
* DKA
* end stage disease
* restricted venous access
* hx of HITT
* contraindication for anti-coagulation Tx
* positive pregnancy test
* in other drug, device, or biologic study
The Efficacy and Safety of Repeat-dose Potenfill for Temporary Penile Enhancement

This clinical study is for small-penis syndrome males who have previously been treated with hyaluronic acid filler for the purpose of increasing their penis.

This study will determine the long-term efficacy and safety of Potenfill.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects aged above 19 and below 65. (20≤male≥65)
* Subjects will sign an informed consent form

Exclusion Criteria:

* Prior treatment for penile enhancement (e.g. fat, dermal graft).
* Allergic to hyalluronic acid.
America Walks: An Observational Study of Walking Behavior Based on Passive Step Tracking

America Walks is an observational research study to determine walking behavior of individuals in the United States. The entire study will be conducted virtually by requiring participants to download a mobile phone application (App), The App will leverage the mobile phone's step count sensor technology to automatically determine participants' daily walking activity. Participation is voluntary. Participants can choose not to participate or choose to participate and then stop participating. Participants decision will not result in any penalty or loss of benefits to which they are entitled.

This will be the first study to measure walking activity using mobile phones. It is well known that physical activity can promote well-being and help prevent several chronic diseases. It is recommended that an individual should do moderate to vigorous walking for 30 minutes or walk approximately 10,000 steps everyday. Several studies have reported measuring walking activity using self-reported surveys, or pedometers in samples ranging from a dozen to a couple of thousand participants. However these studies have largely required participants to enter their walking data manually, either from memory or from pedometer recordings.

With the rapid availability of activity sensors embedded in smart-phones (such as Apple's iPhone version 5S and up and several Google's Android phone models), it is now possible to track physical activity data passively from the end-user and do so for longer durations as individuals have increasingly begun to use their Phones as a continuous device of use.

Eligibility Criteria:
Inclusion Criteria:

* Be at-least 18 years old (self -reported)
* Must reside in the United States (50 states and the District of Columbia); this will be self reported by the participant by entering a zip code which will be checked for valid US zip codes.

Exclusion Criteria:

* Does not have a device that supports Apple HealthKit (iPhone 5s or above) or doesn't not have an Android phone with step count sensors
High Gastrointestinal Bleed Risk Outcomes in Patients With Non-valvular Atrial Fibrillation (NVAF) in France

This study is a retrospective analysis of observational cohorts using data from prospectively collected administrative/claims data to investigate treatment patterns, and safety and effectiveness outcomes in patients with NVAF with high risk of gastrointestinal bleed who initiate anticoagulant treatment with a Vitamin-K Antagonists (VKAs) or direct-acting oral anticoagulants (DOACs).


Eligibility Criteria:
Inclusion Criteria:

Patients covered by the French national health insurance general scheme With at least one reimbursement of AC treatment (apixaban, rivaroxaban, dabigatran, or VKAs) Aged ≥18 years as of the index date With a diagnosis of atrial fibrillation (AF) prior to or on the index date With at least one risk factor for gastrointestinal bleeding

Exclusion Criteria:

Patients with different types of AC treatment at the index date Patients with a diagnosis or procedure code indicative of rheumatic mitral valvular heart disease or valve replacement procedure Individuals with a diagnosis of VTE during the 12 months prior to or on the index date
Placebo Controlled Trial of Bosentan in Scleroderma Patients

The purpose of this study is to determine whether the drug Bosentan improves exercise tolerance in scleroderma patients.

Pulmonary hypertension (PAH) is a common and usually fatal form of lung disease in systemic sclerosis (SSc). Multiple drugs have been approved for the treatment of New York Heart Association (NYHA)Class III/IV PAH in scleroderma. Bosentan is an endothelin-1 antagonist which showed significant improvement in distance walked during 12 week clinical trials in PAH patients (7). Therapy for asymptomatic systemic sclerosis patients diagnosed incidentally with PAH (World Health Organization (WHO) Functional Class I) remains controversial. We hypothesize that asymptomatic or minimally symptomatic patients with systemic sclerosis and normal resting pulmonary artery pressures who demonstrate an abnormal rise in pulmonary artery systolic pressure with stress Doppler echocardiography testing represent a subset of patients who already have pulmonary vascular disease and who are at risk for the development of severe PAH. We further hypothesize that early identification and treatment of such patients may retard the progression of that disease.

Hypotheses:

1. Stress echocardiography identifies early pulmonary vascular disease by detecting exercise-induced pulmonary hypertension in patients with systemic sclerosis.
2. Treatment of exercise-induced PAH with Bosentan will lead to improved exercise endurance in patients with systemic sclerosis.

Subjects will be recruited from those patients who have had an abnormal exercise test as part of an earlier study, Exercise Echocardiograms in Scleroderma (IRB# 03-363).

Eligibility Criteria:
Inclusion Criteria:

* SSc patients \> 18 with NYHA functional Class I/II symptoms, informed consent, and who are willing to participate in the Pulmonary Hypertension Assessment and Recognition of Outcomes in Scleroderma (PHAROS) long term study (Georgetown IRB 04-227)
* Right heart catheterization with

  1. Normal Mean Pulmonary Arterial Pressure (PAP) at rest
  2. Mean PAP \> 30 with exercise
  3. Wedge Pressure \< 18
* Entry criteria for participating in the exercise echocardiogram study (Georegtown IRB 03-363)

  1. Diffusing Capacity (DLCO) \<60 with a Forced Vital Capacity (FVC) \>60%, or
  2. FVC/DLCO \> 1.6, or
  3. a resting Pulmonary Arterial Systolic Pressure (PASP)\> 40mmHg

Exclusion Criteria:

* Established resting pulmonary hypertension
* Congestive heart failure
* Diastolic dysfunction
* Pregnancy
* Inability to adequately walk/exercise
* Severe liver disease
TAK-114 Single- and Multiple-Dose Phase 1 Study

The purpose of this study is to evaluate the safety and tolerability of TAK-114 following single and multiple ascending oral doses in healthy Japanese male participants.

This is a phase 1, randomized, double-blind, placebo-controlled, single and multiple oral dose study in healthy Caucasian and Japanese male participants.

The study is composed of three parts, Single-dose Ascending Part, Food Effect Part and Multiple-dose Ascending Part. Single-dose Ascending Part and Multiple-dose Ascending Part are designed as a randomized, double-blind or open-label, placebo-controlled, sequential-cohort, ascending single or multiple oral dose study of TAK-114 or matched placebo. The Food Effect Part is designed as a randomized, open-label, 2-period crossover study of a single dose of TAK-114.

Eligibility Criteria:
Inclusion Criteria:

Healthy Japanese participants:

* Must be willing to provide written informed consent and in the investigator's opinion able to comply with the study protocol.
* Is aged 20 to 45 years, inclusive.
* Weighs at least 50 kilogram (kg) and have a body mass index (BMI) between 18.5 and 25.0 kilogram per square meter (kg/m\^2).

Healthy Caucasian participants:

* Must be willing to provide written informed consent and in the investigator's opinion able to comply with the study protocol.
* Is aged 20 to 45 years, inclusive; are of Caucasian descent (born to Caucasian parents and grandparents and has lived outside original country for less than 5 years) and maintains their original diet and lifestyle.
* Weighs at least 50 kg and have a body mass index between 18.5 and 30.0 kg/m2.

Exclusion Criteria:

• Participants have a known hypersensitivity to any component of the formulation of TAK-114 or any herb medicine or supplement related to Indigo naturalis.
Swift Outpatient Alternatives for Rapid Stabilization

The goal of this clinical trial is to improve the effective outpatient management of acute youth suicide risk by optimizing intervention components to build an efficient, evidence-based intervention that is responsive to the needs of, and coordinated with, providers in primary care settings. The main questions are:

1. What is the strongest combination of SOARS components associated with reduction in youth suicidal thoughts and behavior (STB)?
2. Do age and STB history moderate the impact of the effects of the SOARS intervention components?
3. Do therapeutic alliance, youth and caregiver self-efficacy account for changes in youth STBs?
4. What helps medical outpatient providers refer to SOARS and continue care after SOARS?

The investigators are comparing different treatment sequences for suicidal thoughts and behaviors. The treatment package families are assigned will be determined by randomization.

All participants will receive 1 session of Collaborative Assessment and Management of Suicidality (CAMS) and care management. CAMS treatment primarily focuses on working with a therapist to understand the reasons why the participants are thinking about suicide Additional components which the participant may be randomly assigned to receive include coping skills training for youth, skills training for parents, and additional safety strategies. Each treatment type is designed to help adolescents and young adults with suicide risk.

Participants will be randomly assigned to an intervention sequence for a minimum of 1 session (120 minutes) and maximum of 8 sessions (440 minutes, divided across separate youth and caregiver components).

Caregivers will receive at least 1 session and a maximum of 4 sessions. Depending on the randomization, caregivers may be assigned to receive skills related to caregiving and safe storage of items that could be used for harm.

To see how the treatment is going participants will receive study assessments at the beginning of the study, 1-month, and 2-months. Study assessments will ask about demographics, suicide attempts, suicidal ideation, non-suicidal self-injury, experiences with treatment, substance use, and social experiences. The research team will also collect information from medical records.

Eligibility Criteria:
Inclusion Criteria:

* Acute suicidal thoughts or past month suicide attempt as reported on positive responses to the Ask Suicide Screening Questionnaire (ASQ),

Exclusion Criteria:

* urgent medical care secondary to self-injurious behavior, psychosis, eating disorder that requires full or partial inpatient care, or
* intellectual disability warranting a different treatment pathway;
* limited English, Spanish, Vietnamese, or Chinese proficiency that would interfere with ability to complete study assessments;
* unwillingness to participate in psychotherapy,
* caregiver unwilling or ineligible to participate;
* and previous enrollment in SOARS program or other P50 project as to not confuse longitudinal follow-up.
Study of Genetic Anomalies of Complement Related Proteins in Patients With IgA Glomerulonephritis

OBJECTIVES: I. Determine whether allelic differences associated with the fourth component of complement, type-1 complement receptor expressed on erythrocytes, and Fc receptor FcgRIII contribute to the pathogenesis of IgA glomerulonephritis (IgA-N).

II. Compare genetic anomalies of these key components in immune complex processing and clearance between juvenile vs adult onset IgA-N vs normal controls.

PROTOCOL OUTLINE:

Participants undergo qualitative genetic analysis of complement-related proteins. Studies include: genomic re-arrangement of 4-gene unit, C4 DNA sequence and RNA expression, type-1 complement receptor DNA sequence, Fc-gamma receptor IIIA isoform analysis, classical and alternative complement activation pathway assays, plasma C4 and C4d protein levels, and immunoglobulin patterns in glomerular deposits.

Eligibility Criteria:
* IgA glomerulonephritis
UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis

To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive cirrhotic subjects.

Masking is Double blind for RBV: two or more parties are unaware of the intervention assignment.

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Subjects chronically infected with HCV genotype 1
* Subjects with compensated cirrhosis
* HCV RNA ≥ 10,000 IU/mL at screening
* Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), Ribavirin (RBV), or HCV Direct Acting Antivirals (DAA) (protease, polymerase inhibitor, etc.)
* Treatment-experienced subjects are eligible including exposure to anti-HCV agents of a mechanistic class other than those contained in the Daclatasvir (DCV) / Asunaprevir (ASV) /BMS-791325 triple regimen is permitted. Examples of permitted agents include, but are not limited to nucleoside/nucleotide inhibitors of nonstructural protein 5B (NS5B) polymerase, inhibitors of cyclophilin, or inhibitors of microRNA.

Exclusion Criteria:

* Subjects without cirrhosis
* Liver or any other organ transplant
* Current or known history of cancer within 5 years prior to screening
* Documented or suspected hepatocellular carcinoma(HCC)
* Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
Feasibility Study of a Neuromuscular Fatigue Test and Associated Hemodynamic Responses: Application in Healthy Volunteers for Use in Patients with Chemotherapy-treated Breast Cancer

This cross-sectional and single-center study aims to progressively induce an increase in peripheral fatigue during successive efforts in healthy subjects. Participants will undergo three evaluations, each lasting one and half hours, to validate the test and assess its reproducibility. These three visits will be conducted at a minimum interval of 48 hours.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman
* Informed consent
* Age ≥ 18 years old
* Affiliation to a social security system
* Able to speak, read and understand French
* Practice physical activity 1 to 5 times per week, without reaching a level of intense training or high-level performance.

Exclusion Criteria:

* History of cancer
* Any known chronic pathology
* Protected minor or adult
* Psychiatric, musculoskeletal or neurological problems
* Implantation of a pacemaker
* Pregnant woman
* Presenting at least one contraindication to the use of transient blood flow occlusion
Behaviours and Emotions in Preschoolers

In this TARGet Kids! Study, we want to find out whether a short questionnaire can be used to help find out about mental health problems in preschool age children.

Research indicates that more than 1 in 10 preschoolers have significant social, emotional and behavioural problems also known as mental health problems. Unfortunately, parents and doctors rarely identify mental health problems in young children in order to begin treatment. We are testing a short five-minute questionnaire completed by parents to see if this may help a doctor notice if a child has social, emotional and behavioural problems.

In addition, we also hope to find out if the presence of feelings of stress and depression in on or both parents may be associated with mental health problems in their preschool child.

This study is being conducted by researchers at SickKids and St. Michael's Hospital.

Eligibility Criteria:
Inclusion Criteria:

1. Child is between age 2 to 4 years.
2. Parent is the primary caretaker for the child and is able to speak, read and understand English well enough to complete the forms and the PAPA interview.
3. Either one or both parents (primary caretakers) are available to participate in the study.

Exclusion Criteria:

1. Children with associated health conditions affecting growth (e.g. failure to thrive, cystic fibrosis);
2. Children with any acute or chronic conditions except for asthma and high functioning autism;
3. Children with severe developmental delay;
4. Children with a gestational age of less than 32 weeks;
5. Families who are not fluent in English.