cyrilzakka/clinical-trials huggingface dataset:
Protect and Connect: Couple HIV Prevention for Drug Involved Male Offenders

This study is a randomized controlled trial (RCT) that will rigorously evaluate the implementation, effectiveness and cost-effectiveness of a couple-based integrated human immunodeficiency virus (HIV) and drug abuse prevention intervention (Connect II) with drug-involved male offenders charged with misdemeanors and their primary female sexual partners, implemented by frontline providers in Criminal Court, Community Court or probation (CCP) sites in NYC, compared to CCP standard treatment of care services (TAU). The primary outcomes are to reduce sexually transmitted infections (STIs) and increase condom use.

HIV/acquired immune deficiency syndrome (AIDS) and criminal justice involvement are critical intersecting public health issues for drug-involved men. Low income, Black and Hispanic men especially bear the burden of the HIV epidemic and are over-represented in the U.S. criminal justice system. Recent Centers for Disease Control and Prevention (CDC) surveillance data suggest that the health disparity in HIV rates is actually increasing for Black men: current estimates suggest 1 in 16 Black men in the U.S. will be infected with HIV in their life time. These HIV/STI transmission risks are fueled by high rates of poverty, incarceration, unemployment, and lack of access to health care and prevention services. The proposed study thus targets an underserved population at the epicenter of the epidemic in the U.S.

Eligibility Criteria:
Inclusion Criteria:

* Couples
* Both partners are aged 18 or older
* Identify each other as their primary sexual partner of opposite sex
* Relationship has existed at least 3 months
* At least one partner reports having unprotected vaginal or anal intercourse with the other partner in the past 90 days
* At least one partner reports exposure to an outside HIV risk in the past year
* Male partner reports and is verified by court records of being charged with a misdemeanor
* Male partner is currently under court supervision or probation

Exclusion Criteria:

* Either partner shows evidence of significant psychiatric or could impairment as confirmed by the MacArthur Competence Assessment Tool during the screening eligibility interview.
* Either partner reports severe physical or sexual violence perpetrated by the other partner in the past year as measured on the Revised Conflict Tactics Scale
* Either partner is unable to commit to participate in the study through to completion
* Either partner reports that the couple is planning a pregnancy within the next 12 months
* Either partner is not fluent in English as determined during Informed Consent
Facilitating Implementation of Cognitive Behavioral Therapy in Primary Care and Community Clinics

The investigators propose to test the effect of external facilitation on the extent that brief cognitive behavioral therapy (CBT) for depression is incorporated into routine practice in primary care and community based clinics in the VA. The investigators will provide training in brief CBT to mental health providers in participating clinics. To the investigators' knowledge, this will be the first study of the effect of external facilitation on outcomes of a training intervention.

We will test the effect of external facilitation on the extent that brief CBT for depression is incorporated into routine practice in primary care and community based clinics in the VA. We will provide training in brief CBT to mental health providers in participating clinics. To our knowledge, this will be the first study of the effect of external facilitation on outcomes of a training intervention.

Eligibility Criteria:
Inclusion Criteria:

* mental health clinicians in selected clinics who do or are willing to do psychotherapy.

Exclusion Criteria:

* clinicians who do not do psychotherapy in eligible clinics.
Efficacy and Safety of Oral Lactobacillus Plantarum GUANKE (CGMCC NO.21720) in Enhancement of Antibody Level After SARS-CoV-2 Vaccination (Trial 2)

Preliminarily explore the effect of oral probiotics in SARS-CoV-2 serum neutralizing antibody titer level and T cell response level (spot formation cell counting).

Provide a reference for determining the appropriate oral regimen. Provide necessary parameters for estimating the sample size of confirmatory clinical trial.

In selected communities or assigned clinical trial institutions, participants who intend to complete the third dose of SARS-CoV-2 vaccination will be invited in this study. Informed consent form will give to potential participants with well explained of trial contents during baseline. Participants who gave their signed informed consent form will be blocked randomized in a 1:1:1:1 ratio to intervention group A, intervention group B, intervention group C, or placebo group D.

Eligibility Criteria:
Inclusion Criteria:

1. 18 ≤age ≤59 years;
2. Vaccinated with two doses of SARS-CoV-2 vaccine (manufactured by Sino Biopharmaceutical Limited or SINOVAC BIOTECH CO., LTD.) (≥6 months from the time of vaccination).
3. Plan to vaccinate third dose vaccination (manufactured by Sino Biopharmaceutical Limited or SINOVAC BIOTECH CO., LTD.);
4. Voluntarily participate in the study with signed informed consent form.

Exclusion criteria:

1. Pregnancy or lactation period;
2. Infected with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV);
3. History of autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus, dry syndrome, etc.);
4. Previously infected with SARS-CoV-2 or close contact of SARS-CoV-2 infected individual;
5. Other SARS-CoV-2 vaccination history (not manufactured by Sino Biopharmaceutical Limited or SINOVAC BIOTECH CO., LTD.);
6. End-stage cancer or other terminal diseases with life expectancy \<6 month;
7. History of severe cardiovascular and cerebrovascular diseases, such as heart failure, uncontrolled coronary heart disease, cardiomyopathy, uncontrolled arrhythmia, or history of myocardial or cerebral infarction within past six months;
8. Participating in other clinical trials.
Auriculotherapy Effectiveness on Stress and Anxiety in Nursing Student

Single-blind randomized controlled trial aimed to assess stress and anxiety levels in Nursing School students of Beneficence Portuguese Hospital and review the effectiveness of true and placebo auriculotherapy.

Although researches on stress have a strong focus on stress at work,it is very important the evaluation of the stress and its consequences in Nursing students. This allows to understand which stress factors experienced in a negative way could interfere on the adaptive success in school activities. Students can experience symptoms of the alarm phase of stress such as tachycardia, muscle tension, skin and cold extremities, and also the second phase of stress such as headache, sleepiness, irritability and difficulty concentrating. High levels of stress have a substantial effect on attention and can lead to errors, lack of concentration and fluctuations in the level of attention. The auriculotherapy may have an important role as a coping strategy for stress and anxiety. It is a fast, relatively simple, easily performed, safe and without major side effects.

Eligibility Criteria:
Inclusion Criteria:

* Average and high score by the List of Stress Symptoms
* Voluntary participation in the study
* Availability of time for submission to the sessions

Exclusion Criteria:

* Pregnancy
* Medical license or vacation during the period
* Low score of stress
Arrested Versus Beating Heart Techniques in Coronary Revascularisation

The individual contribution of the specific injuring mechanisms surgical trauma, extracorporeal circulation, and ischemia/reperfusion to clinical outcome in coronary revascularisation remains to be elucidated. The effect of these factors is analyzed in this randomized clinical trial by comparing the 3 surgical approaches: Conventional Coronary Artery Bypass Grafting (CCAB), with extracorporeal circulation and cardioplegic arrest; Off-Pump Coronary Artery Bypass Grafting (OPCAB), avoids extracorporeal circulation and global myocardial ischemia; and Pump-Assisted Coronary Artery Bypass Grafting (PACAB), with an unloaded and beating heart. The hypothesis addressed by the study is that the surgical invasiveness increases in the order: OPCAB, PACAB, CCAB.


Eligibility Criteria:
Inclusion Criteria:

* patients with double- or triple-vessel coronary artery disease
* patients with left ventricular ejection fraction =\< 40% or \>= 60%
* elective or urgent isolated coronary artery bypass grafting

Exclusion Criteria:

* previous cardiac surgery
* emergency indications
The Influence of Non-invasive Ventilation on Metabolism in Healthy Volunteers

Before inclusion in the trial. Careful medical history and medication use will be asked. Once included, 5 healthy subjects non-invasive ventilation(V60, Philips, Eindhoven, The Netherlands) will be administered at a level of positive end expiratory pressure (PEEP) of 4 cmH2O and without additional inspiratory support. Inspiratory support will then increase by 2 cmH2O every 2 minutes until 8 cmH2O is achieved for 2 minutes. The energy expenditure is measured using indirect calorimetry (Q-NRG®, Cosmed, Italy). To measure respiratory effort, the reversed RPE-scale was created for the purpose of the study. It uses the validated "rate of perceived exertion" scale (RPE-scale) which was altered by adding a reversed part. This could result in a score of -10 (no respiratory effort) until +10 ( maximal respiratory effort) where 0 represents the basal respiratory condition. Monitoring of heart rate, blood pressure and cardiac output will be done ( Nexfin®, BMEYE, Amsterdam, The Netherlands).

After termination of the study clinical observation by principal investigator or co-investigator will be done for 15 minutes or until all side effects have worn off. If no side effects are observed, subjects will be released.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* pregnancy
* prisoners
* participation in interventional study in last 2 weeks before enrolment
* Current ongoing disease:
* Cardiac
* respiratory
* ear
* nose
* gastro-intestinal
* neurological
* psychiatric
Cardiac Arrest Extra Corporeal Oxygenation Membrane

French guidelines for Cardio Pulmonary Resuscitation (CPR) consider Extra-Corporeal Life Support (ECLS) as one option in Refractory out-of hospital Cardiac Arrest (ROHCA) patients with a no-flow less than five minutes and absence of spontaneous circulation 30 minutes after initiation of advanced CPR. Duration of both pre-CPR arrest (no-flow) and of CPR (low-flow) have been systematically highlighted as crucial prognostic factors in all observational studies focused on ROHCA.

In order to shorten the time to ECLS initiation, the most recent European Resuscitation Council guidelines recommend, in eligible ROHCA patients, a fast track access to ECLS implantation.

CHRU Nancy elaborated an operational strategy which was designed to improve the enrolment of eligible ROHCA patients and to reduce the delay time between recognition and ECLS initiation.

The objective of the present register was to assess prospectively the impact of this new operational strategy over a 5 years period.


Eligibility Criteria:
Inclusion Criteria:

* Witnessed out-of-hospital cardiac arrest
* in qualified geographical locations
* No Return of spontaneous circulation (ROSC) after 10 min of CPR
* No Flow \<1 min

Exclusion Criteria:

* Apparent obvious comorbidities
* Patient \< 18 yo
* Pregnancy
* Patient under protective supervision
Comparison of Conventional With Sonography Assisted Breast Surgery

Aim of the study is to test whether surgical removal of a tumor under sonographic control as compared to conventional method reduces the rate of resections and local relapse


Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years
* Female
* Presurgical validated breast cancer

Exclusion Criteria:

* Sonographically not defined report
* Lobular breast cancer
* Extensive ductal carcinoma in situ
Genetic Study of Age Related Hearing Loss

Age-related hearing loss, or presbyacusis, is one of the most common chronically handicapped conditions for the elderly. Many factors including genetics, diet, diseases, drugs, socioeconomic factors and environmental variables were considered to be related to the development of presbyacusis. Evidences have shown that genetic factors play an important role on presbyacusis. However, which genes or their genotypes are associated with presbycusis remain unknown.

The aim of this project was to evaluate the association between the genotype of candidate genes and presbyacusis by cross-section and case-control study. In the first stage, the investigators plan to select 700 healthy subjects older than 50 with symmetric, sensorineural hearing loss. The subjects will receive basic otologic examination, pure tone audiometry, questionnaire, and genotype analysis. Because gender and age would affect hearing loss significantly, The investigators will convert the hearing level of all subjects into a gender and age independent Z-score according to ISO 7029 standard. And, The investigators define subjects within higher 30 % of Z-score as the presbyacusis group, and subjects within lower 30% of Z-score as the control group. Finally, The investigators perform Chi square analysis to test the association between genotype of candidate genes or their combinations in both groups, and calculate the odds ratio for presbyacusis between different genotype of candidate genes. Further more, we will evaluate the effect of genotype of candidate genes, environment factors, and gene-environmental interaction on the severity of presbyacusis by multivariate logistic regression.

In the second stage, The investigators wish to know the pattern of genotype and hearing level in the high risk families, according to results from the first stage, by description and case-control study. The investigators will perform t-test to evaluate the difference of Z-score in both groups. Besides, The investigators try to evaluate the effects of genotypes, environment factors, and gene-environmental interaction on hearing level in high risk families by multivariate logistic regression.


Eligibility Criteria:
Inclusion Criteria:

* subjects aged 45 or above, both male and female came to the hospital for health check up

Exclusion Criteria:

* known ontological disease age under 45 noise exposure history history of ototoxicity psychiatric diseases
An eHealth Intervention for Obsessive Compulsive Disorder in Youth With Autism Spectrum Disorder

This study is a feasibility study of Internet-delivered CBT for OCD in children and adolescents (7-17 years) with comorbid Autism Spectrum Disorder.

The main objectives of this study is to evaluate the feasibility, acceptability and preliminary efficacy of internet-delivered Cognitive Behavioral Therapy (ICBT) for Obsessive Compulsive Disorder (OCD) in children and adolescents (7-17 years) with Autism Spectrum Disorders (ASD). The study will an open trial with-in group mean comparison design (n=18). The treatment is delivered over 16 weeks. Study participants will be followed up at 3 (primary endpoint), 6 and 12 months after completed treatment. ICBT is expected to decrease OCD-symptoms.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of OCD according to DSM-5
* a diagnosis of autism according to DSM-IV or DSM-5, confirmed with the Autism Diagnostic Interview- Revised or Autism Diagnostic Observation Schedule version 1 or 2 and by medical records
* a total score of ≥ 16 on the Children's Yale-Brown Obsessive-Compulsive Scale
* age between 7 and 17 years
* ability to read and write Swedish
* access to the internet
* a parent that is able to co-participate in the treatment
* participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment

Exclusion Criteria:

* a diagnosis of psychosis, bipolar disorder, severe eating disorder or intellectual disabilities
* comorbid hoarding disorder or OCD with hoarding as a principal symptom.
* suicidal ideation
* subject not able to read or understand the basics of the ICBT material
* completed CBT for OCD within last 12 months (defined as at least 5 sessions of CBT including exposure and response prevention)
* ongoing psychological treatment for OCD or any anxiety disorder
* OCD treatment is not an immediate priority
Pamiparib for Consolidation Treatment of Unprogressed LS-SCLC After Concurrent Chemoradiotherapy

This study is a prospective, single-arm, phase II clinical trial, with 1-year PFS as the endpoint, to evaluate the efficacy and associated toxicity of Pamiparib as single-agent consolidation treatment in patients with limited-stage small cell lung cancer(LS-SCLC) patients who have not progressed following platinum-based concurrent chemoradiotherapy(cCRT) .


Eligibility Criteria:
Inclusion Criteria:

* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry, had good compliance and cooperated with the follow-up.
* Age at least 18 years
* Pathologically (histologically or cytologically) proven diagnosis of limited stage small cell lung cancer (Stage Tx, T1-T4, N0-3, M0, American Joint Committee on Cancer \[AJCC\] staging, 8th edition \[Ed.\]), within 60 days prior to registration
* Patients must have had measurable disease (per Response Evaluation Criteria in Solid Tumors \[RECIST\], version 1.1) prior to the required cycle of cCRT
* Patients must be free of disease progression and not be able to receive other antitumor therapy within 6 weeks of completion of cCRT
* Patients must submit archived or freshly biopsied tumor tissue (formalin-fixed, paraffin-embedded tissue block or approximately 15 unstained sections \[must have \>8 sections\]) along with the relevant pathology report.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 30 days prior to registration
* Patient life expectancy must be \>12 weeks

Exclusion Criteria:

* Mixed SCLC or NSCLC confirmed by histology
* Previous tumor resection for LS-SCLC
* Any patient treatable by surgery or stereotactic body radiation therapy/stereotactic ablative radiation therapy should be excluded
* Expected to receive any other form of anti-tumor therapy during the study period
* Previous treatment with PARP inhibitor drugs
* Any active malignancy within 2 years prior to enrollment, excluding the specific cancers being studied in this study and locally recurrent cancers that have been cured (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, cervical cancer carcinoma in situ or carcinoma in situ of the breast)
* Women who are pregnant, breastfeeding, or planning to become pregnant during the study
* Concurrent participation in another therapeutic clinical trial
Evaluation of Needle Core Biopsy of Axillary Sentinel Lymph Node in Breast Cancer

The purpose of the study is to determine if it is possible to identify and perform a needle biopsy of the sentinel lymph node. The investigators hope to identify breast cancer cells in the lymph nodes under the arm without making an operation necessary.

The rationale for this study is that for patients without enlarged lymph nodes under the arm, sentinel lymph node biopsy is the standard way of determining if breast cancer has spread to the lymph nodes under the arm. While the complications from a sentinel lymph node dissection are less than that of a complete axillary lymph node dissection, sentinel lymph node dissection still carries small risks of arm swelling, decreased movement, fluid collections, nerve injury, and pain. Furthermore, the majority of sentinel lymph nodes do not contain cancer. The investigators hope to develop a method to find cancer in the axillary lymph nodes and avoid the complications of an operation.

In patients already scheduled to undergo sentinel lymph node dissection in the operating room, the investigators will first perform an axillary ultrasound guided core needle biopsy percutaneously. Patients will have already undergone prior injection of radioisotope and blue dye and as a standard procedure or the sentinel lymph node dissection. After induction of anesthesia, the investigators will identify the location of the sentinel node with a gamma probe to identify the "pre-incision hot spot." Axillary ultrasound will then be used to identify the location of the lymph node and a percutaneous core needle biopsy of the targeted lymph node will be performed. The core biopsy specimen will be evaluated for the presence of blue staining and radioisotope uptake intraoperatively. The core biopsy specimen will then will be sent for pathologic analysis. The percutaneous biopsy should take about 10 minutes of additional operating room time. The operation will then proceed as planned with dissection and removal of the remaining sentinel node(s). Core samples and sentinel lymph nodes will be evaluated in a similar fashion per existing sentinel node protocol.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients eligible for sentinel node dissection
* Invasive ductal or invasive lobular carcinoma
* Ductal carcinoma in situ undergoing total mastectomy
* Clinically node-negative
* 18-100 years

Exclusion Criteria:

* Inflammatory breast cancer
* Pregnant or lactating
* Preoperative chemotherapy
* Prior axillary ultrasound guided core needle biopsy
Single Ascending Dose Study of PBI-4547 in Healthy Subjects

This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of PBI-4547 in healthy adult participants.

This is a first-in-human, single-ascending dose study of PBI-4547 in healthy adult participants. PBI-4547 is a synthetic ligand of G protein-coupled receptor (GPR)40 and GPR84, which have been reported to play a role in fibrosis in various animal models as well as in tissue culture.

A total of 40 healthy adult participants will sequentially receive 1 of 5 doses of PBI-4547 (Dose1, 2, 3, 4 or 5) or matching placebo, with each cohort of 8 participants randomized in a 3:1 ratio to receive PBI-4547 or matching placebo.

A food-effect cohort will be added after review of the PK results of at least the first dose, and the following 2 doses, if needed. In this cohort participants will initially receive the study drug under fasting conditions (Period 1) followed by the same dose after the ingestion of a high-fat meal (Period 2) after a 14-day washout period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male participants or non-childbearing potential female participants, ≥18 and ≤55 years.
* Body mass index \> 18.5 and \< 30.0 kg/m\^2, and body weight ≥ 50.0 kg for male participants and ≥ 45.0 kg for female participants.
* Continuous non-smoker who has not used tobacco or nicotine-containing products for at least 3 months prior to screening.
* Male participants with a pregnant partner must agree to use a condom from the first dosing until at least 90 days after study drug administration.
* Male participants must be willing not to donate sperm until 90 days after study drug administration.

Exclusion Criteria:

* Any clinically significant abnormality or abnormal laboratory test results.
* An estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m\^2.
* Positive urine drug screen and history of significant drug abuse.
* History of significant allergic reactions to any drug.
* Use of any drugs known to induce or inhibit hepatic drug metabolism.
* Positive pregnancy test or breast-feeding participant.
* Clinically significant abnormalities in ECG, blood pressure, and heart rate at screening.
* History of significant alcohol abuse or regular use of alcohol.
* Use of medication other than topical products without significant systemic absorption.
* Donation of plasma.