cyrilzakka/clinical-trials huggingface dataset:
Evaluating Telehealth Delivery of Brief Alcohol Screening and Intervention for College Students

This research study will test the efficacy of a telehealth version of the Brief Alcohol Screening and Intervention for College Students (BASICS), which is the gold standard prevention and intervention approach to target heavy alcohol use on college campuses across the United States.

In this study, the researchers will evaluate the efficacy of a tele-BASICS approach utilizing the ZOOM application compared to in-person BASICS and a lower threshold treatment as usual intervention. Three hundred mandated and 300 volunteer students who report hazardous drinking will be recruited from two large universities and randomly assigned to a condition (in-person BASICS, Tele-BASICS, or treatment as usual). Follow-up assessments will occur 1-, 3-, 6-, and 12-months post-baseline. The significance of this research lies in the potential to maximize access to the highest standard of care by establishing support for easier access without sacrificing any central features of the traditional BASICS intervention. In addition, many universities pragmatically adapted existing in-person interventions to remote-telehealth approaches in response to the COVID pandemic but now have no scientific basis for determining whether transitioning back to in-person approaches would be beneficial.

Eligibility Criteria:
Inclusion Criteria:

* between 18 and 26 years of age
* fluent in understanding English
* a registered student at one of the two intervention sites
* adequate internet capabilities to support video-conferencing
* access to a webcam, which is a standard features of most laptops, mobile devices, and desktops
* engage in binge drinking (i.e., 4 or more standard drinks in a sitting for women or 5 or more standard drinks in a sitting for men) at least once in the past month (for the volunteer sample only)
* experienced at least one negative alcohol-related consequence in the previous month (mandated students would meet this due to receiving an alcohol sanction)
* reports a score of 2 or higher on questions about a) interest in reducing their drinking, or b) interest in not increasing their drinking.

Exclusion Criteria:

* not meeting inclusion criteria or unwillingness to participate
Effects of a Legal Support Program on Women Experiencing Domestic Violence

Intimate partner violence (IPV) is a major public health concern. Worldwide, 1 in 3 women have experienced domestic abuse/ violence in their lifetime. In most cases, family lawyers, advocates are first contact before the police. If the children are involved, finding the legal options become the priority for women before leaving the abuser.

The purpose of this study was to compare the effectiveness of the HELP (Health, Education Legal Support Program) intervention among IPV survivors.


Eligibility Criteria:
Inclusion Criteria:

* Female survivors of Intimate Partner Violence
* 18 years old or older
* Gives informed consent

Exclusion Criteria:

* Diagnosed mental health condition
* Terminally ill
* Chronic condition
* On psychiatric medication
* Sexual assault
Inhaled Iloprost for Suspected COVID-19 Respiratory Failure

Acute respiratory distress syndrome (ARDS) is a type of respiratory failure characterized by the rapid onset of widespread inflammation in the lungs. ARDS is thought to be the main cause of respiratory failure in COVID-19 patients. Research is still ongoing to further elucidate the different ARDS subtypes that may exist in COVID-19. It is crucial to find new targets for treatment and support of COVID-19 patients with respiratory failure.

The investigators hypothesize that inhaled prostacyclins (Iloprost in this study) may improve inflammation and oxygenation in suspected or confirmed COVID-19 patients with respiratory failure.

Research participants: Suspected or confirmed COVID-19 patients presenting to the emergency department (ED) of intensive care units (ICU) with Hypoxemic respiratory failure.

Intervention: Inhaled Iloprost (Tradename Ventavis by Actelion Pharmaceuticals US, Inc.) three times daily for 5 days Methods: patients will be screened in ED and ICU for inclusion and exclusion criteria and then consent will be obtained. The intervention will be started within 48 hours of presentation. Baseline parameters on oxygenation, inflammatory markers, hemodynamics will be obtained and followed serially over the period of the intervention. Additional data about time to intubation, time on mechanical ventilation, lung mechanics, and need for prone positioning will also be collected.

Data will be analyzed for percentage improvement in oxygenation (Oxygen saturation and PaO2/FiO2 ratio), trends of inflammatory markers, and hemodynamic stability while Iloprost is administered.

Based on previous studies of Iloprost on ARDS patients, the investigators anticipate an improvement in oxygenation and inflammatory parameters and possible prevention of intubation with shorter mechanical ventilation times. Iloprost showed a safe profile with stable hemodynamics during administration.

Eligibility Criteria:
Inclusion Criteria:

1. Suspected or confirmed COVID-19 patient by PCR
2. O2 saturation =\<92% on 5 or more l/min of O2 by NC or Face mask
3. On CPAP, HFNC or Invasive ventilation
4. Enrollment within 48h of onset of hypoxemia

Exclusion Criteria:

1. Age \<18
2. Pregnancy or Positive pregnancy test at the time of screening
3. Clinical evidence of left atrial hypertension or known chronic CHF
4. Persistent Hypotension SBP\<85 on presentation
5. Mechanical ventilation \>7 days
6. Patients who received iloprost treatment for any indication within 48 hours prior to enrollment in the clinical trial or patients who were on thrombin inhibitors, or nitric oxide within the previous 24 h before study randomization are also excluded.
7. Patients with contraindication for ilioprost
Effect of Probiotics Among Overweight and Obese Saudi Adults

Obesity is classified as a low-grade chronic and systemic inflammatory disease and results from complicated interactions between genes and environmental factors, which leads to many diseases and affects the quality of life. There are growing interests in the effectiveness of probiotics as a supplementation to treat obesity through regulating microbiota host metabolism. Probiotics may influence the interplays among gut, brain, adipose, and liver in a way leading to weight. Since limited studies have been conducted on human subjects, more investigation is needed in this field. Therefore, this study sheds light on the investigation of the anti-obesity effect of probiotic supplementation.

This study expects that the multi-strain probiotic product will induce beneficial changes in gut microbiota including reduction in weight, especially the visceral fat, which leads to reduction in systemic inflammatory state associated with fat accumulation. In order to evaluate the changes, ninety adult Saudi overweight or obese adult will be enrolled in this clinical trial and randomized to receive daily placebo or probiotics "MCP® BCMC® strains" for 12 weeks in a double-blind study. Biochemical markers will be measured through blood samples analyzed. Measurements and samples will be obtained at baseline and by the end of the study, at 12 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Adult's male and female ages between 19 to 40 years.
2. BMI (in kg/m2) from 25 to 35, (WHO, n. d.) Waist Circumference (WC) \> 88 cm (women) or \> 102 cm (men) (lean et al, 1995).
3. Stable body weight in the previous month of the trial.

Exclusion Criteria:

* Participants who suffer from diseases and on treatment, such as immune system diseases or thyroid disorders.
* Pregnant women or who plans to be pregnant.
* Participants who had gastrointestinal surgery.
* Hormone replacement therapy.
* Participants who taking antibiotic.
* Participants who consume probiotic or prebiotic supplementation regularly.
Motivational Incentives for Alcohol Abstinence in American Indian and Native Alaskan Adults

This study examines the impact of a culturally tailored version of contingency management treatment on alcohol in 400 alcohol dependent American Indians and Alaskan Natives. Participants will be recruited from addiction treatment agencies and throughout the community. Those who complete a 4 week induction period will be randomized to receive 12 weeks of contingency management or a non-contingent control condition. Individuals will then be followed for an additional 3-months to assess the long term efficacy of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Self reported American Indian/Alaskan Native
* Current alcohol dependence
* 5 or more standard drink on 1 or more occasions in the last 30 days
* Ability to read and speak English
* Ability to provide written informed consent

Exclusion Criteria:

* Illicit drug use greater than alcohol use in the last 90 days
* A risk of dangerous alcohol withdrawal
* Any medical or psychiatric condition, such as organic brain disorder, dementia, or psychotic disorder
Eating Disorders Among Adolescents

The aim of the present study is to evaluate the prevalence of eating disorder among adolescents. Also, to evaluate psychiatric comorbidity, sleep problems, alexithymia and emotion dysregulation associated with patients had eating disorders. In addition, to identify possible risk factors associated with eating disorder among adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Age between 10 to 18 years old.
* Males and females are included.

Exclusion Criteria:

* - participants were previously diagnosed with any psychiatric disorder.
A Study Comparing Green Fluorescent Dye and Radioactive Dye for Sentinel Lymph Node Biopsy in Pediatric Cancers

This study is being done in patients that have tumors to find out how well sentinel lymph nodes (SLNs) can be found with a special dye called indocyanine green (ICG).


Eligibility Criteria:
Inclusion Criteria:

* Patients \<30 years old with an extracoelomic solid tumor, diagnosis confirmed at the enrolling institution, requiring SLN biopsy
* Women of childbearing potential must have a negative pregnancy test (urine or blood) pre-operatively as per the standard hospital policy. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant.
* Patients who are cleared for surgery

Exclusion Criteria:

* History of reaction to ICG, iodides, or technetium radiocolloid
* Intracoelomic primary tumors or tumors expected to drain to an intracoelomic SLN
* Patients with extensive prior surgery at the primary site or nodal basin expected to affect the lymphatic drainage
* Patients unwilling or unable to sign informed consent
* Women who are pregnant or breast-feeding
China S3: Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 THV in the Chinese Population

To evaluate the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are considered at high risk for surgical valve replacement.

Edwards SAPIEN 3 Transcatheter Heart Valve and Commander delivery system will be used for this study.

A maximum of 60 patients with symptomatic severe calcific aortic stenosis requiring transcatheter aortic valve implantation (TAVI), who are considered high risk for surgical valve replacement who received a SAPIEN 3 THV.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are considered to be operable and high risk for surgical valve replacement: STS Score ≥ 8 and ≤ 15 or Logistic EuroSCORE ≥ 15 and ≤ 40. If STS score is below 8 and Logistic EuroSCORE is below 15, patients should have other clinical or anatomical risk factors that would be considered high risk for surgery and documented by the heart team.
2. Severe symptomatic aortic stenosis requiring aortic valve replacement characterized by one or more of the following within 60 days prior to the index procedure: AVA \< 0.8 cm2, Indexed AVA \<0.5 cm2/m2, mean gradient \> 40mmHg, or peak aortic jet velocity \> 4.0m/sec.
3. NYHA Functional Class II or greater.
4. The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the EC of the respective clinical site.
5. The study patient agrees to comply with all required postprocedure follow-up visits.

Exclusion Criteria:

1. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment.
2. Aortic valve is a congenital unicuspid or is non-calcified.
3. Aortic valve is bicuspid and the patient is less than 60 years old, or the aortic valve is bicuspid with no raphe (Sievers classification type 0).
4. Anomalous coronary artery that would interfere with proper placement of the valve.
5. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \>3+).
Survey Examining the Frequency and Severity of Acid Related Symptoms While Taking Nexium

This study will assess the effectiveness of Nexium at alleviating upper GI symptoms in subjects and evaluate with which treatment regimen and on which indications acid suppression with isomeric proton pump inhibitor is used in routine clinical practice in Albania.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have had upper GI symptoms requiring acid suppression treatment
* Treatment with Nexium is in accordance with indications and dosing approved in Albania.
* Start of treatment at least 2 weeks prior to enrollment to this study 5. Written informed consent is signed.

Exclusion Criteria:

* Known hypersensitivity to Nexium or any other constituents of the formulation
* Concomitant administration of atazanavir and nelfinavir.
* Alarming upper GI symptoms (i.e. significant unintended weight loss, vomiting, dysphasia, hematemesis, melena, fever, jaundice or any other sign indicating serious or malignant disease
Study of TU7710 in Warfarin Anti-coagulated Healthy Male Subjects

This is a Phase 1a, double-blind, randomized, placebo- controlled, SAD study to assess safety, tolerability, PK, and PD of TU7710 in warfarin treated healthy male participants.

The 40 subjects will be divided into 5 cohorts, and the subjects assigned to each cohort will be randomly assigned with 6 persons receiving TU7710 and 2 persons receiving a placebo for TU7710. Each cohort will proceed in sequence and the next cohort study will be decided by the Safety Monitoring Committee (SMC) .

Subjects will be participated in the study after warfarin anti-coagulation to maintain the INR between 2.00 and 3.00 as a preventive measure for potential thrombosis prior to the IP administration.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥19 and ≤45
* BMI of ≥18.0 kg/m2 and ≤30.0 kg/m2
* Body weight of ≥55.0 kg and ≤90.0 kg
* Provide informed consent and willing to comply with study requirements.

Exclusion Criteria:

* History or at risk of developing diseases related to venous thromboembolic events or has family history of such disease
* History of major bleeding/traumatic event or major surgery within 6 month
* History of any other clinically relevant coagulation disorder (such as gastrointestinal bleeding, hemorrhoid hemorrhage)
* Abnormal coagulation related laboratory abnormal test results, including protein C, protein S, PT, aPTT
* history or current symptoms of gastrointestinal, liver, or renal disease that may affect the pharmacokinetics of the IP
* History of or are currently with hepatitis B or C (active or carrier state) or human immunodeficiency virus (HIV) or syphilis infection.
* Currently smoking or have smoked within 1 month before IP or positive cotinine results
* History of alcohol abuse or positive alcohol breath test
* Excessive caffeine intake within 7 days before IP
* INR results not between 2.0\~3.0 range after warfarin treatment
* History of hypersensitivity to medicinal product similar to TU7710 active ingredient or excipient
* Laboratory abnormal test results, such as QTcF \<340msec or \>450msec (or family history of long QT syndrome), LDL \>190mg/dl , Total cholesterol \>300mg/dl, triglycerides \> 350mg/dl, ALT \>1.5\*ULN, AST \>1.5\*ULN, bilirubin \>1.5\*ULN
* Abnormal vital sign SBP \>140mmHG, DBP \<90mmHg, heart rate \<40bpm or \>85bpm
* Any medical history that may increase the risk or affect the evaluation of study objectives by participating in this study at the discretion of the investigator. (e.g., neurology or psychiatric history)
A Clinical Trial of Precise Positioning and Intelligent Operation of Surgical Robots to Reconstruct Cruciate Ligaments

30 patients with the first rupture of the cruciate ligament were divided into two groups as 1:1. Experimental group will be treated with arthroscopic robot-assisted navigation and positioning for cruciate ligament reconstruction. Control group will be treated with conventional reconstruction. This project is used to verify the advantages of surgical robots assisting surgeons in cruciate ligament reconstruction surgery.

In this study, 30 patients with the first rupture of the cruciate ligament were recruited as the research objects, and the ratio of the experimental group and the control group was 1:1. Patients in the experimental group will be treated with arthroscopic robot-assisted navigation and positioning for cruciate ligament reconstruction, and patients in the control group will be treated with conventional reconstruction. All subjects will undergo CT evaluation and clinical function evaluation. This project is used to verify the advantages of surgical robots assisting surgeons in cruciate ligament reconstruction surgery.

Eligibility Criteria:
Inclusion Criteria:

1. 18-45 years old, with closed epiphyses;
2. For the first time, the knee joint is simply ruptured with a cruciate ligament and requires surgical reconstruction; it can be combined with meniscus injury, and the Outerbridge injury score is ≤ II;
3. There is no history of trauma or fracture of the ipsilateral knee joint;
4. The medial collateral ligament or the lateral collateral ligament is not damaged or only slightly damaged (no more than degree I).

Exclusion Criteria:

1. BMI is less than 18.5 or greater than 35 kg/m2;
2. Patients with moderate or severe knee degeneration;
3. Those with limited flexion angle (\<120 degrees);
4. Cartilage defect area is greater than 2 cm2 or Outerbridge damage score\> Grade II.
PET Imaging of Fibroblast Activation in Atherosclerosis

Fibroblast activation protein (FAP) is a fibroblast-specific marker expressed in atherosclerosis, associated with endothelial-to-mesenchymal transition and a rupture-prone plaque phenotype. This study aims to evaluate in-vivo fibroblast activation in carotid and coronary atherosclerotic diseases with FAPI PET and its correlation with histological vulnerability and clinical outcome.

Fibroblast activation protein (FAP) is a fibroblast-specific marker expressed in atherosclerosis. Abundant FAP-expressing cells in atherosclerotic plaques co-express endothelial biomarkers involved in endothelial-to-mesenchymal transition. FAP upregulation is also associated with a rupture-prone plaque phenotype with a thin fibrous cap. Positron emission tomography (PET) with 68Ga-FAPI-04 has been demonstrated as a feasible method to image fibroblastic activation in the arterial wall. The current study aims to evaluate in-vivo fibroblast activation in carotid and coronary atherosclerotic diseases with FAPI PET and its correlation with histological vulnerability and clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* For the carotid stenosis group: patients with symptomatic carotid stenosis with \>50% stenosis on carotid CTA; OR patients with unsymptomatic carotid stenosis with \>70% stenosis on carotid CTA
* For CAD group: patients with stable ischemic heart disease OR acute coronary syndrome, including ST-elevation MId, non-ST elevation MI, and unstable angina
* signed informed consent

Exclusion Criteria:

* Pregnancy, lactation, or intention to become pregnant during the study
* Contradiction to MRI or CTA
Safety and Efficacy of Albiglutide in Type 2 Diabetes

The purpose of this study is to determine the safety, tolerability and efficacy of albiglutide in the treatment of type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* BMI 20-45kg/m2

Exclusion Criteria:

* NYHA Class II to IV heart failure
* females who are pregnant, lactating, or less than 6 weeks post-partum
Stress Hormones and IUDs

Determine what kind of side effects women experience in the first year after they start using an intrauterine device.

The purpose of this study is to find out if there is a difference in levels of stress hormones in women who use copper or hormonal intrauterine devices (IUDs). This study will provide more information on the potential effect of levonorgestrel intrauterine system (LNG-IUS) use on an individual's stress response. Ultimately, this study hopes to provide data to better counsel women on potential mood effects of the LNG-IUS. From a research and clinical management perspective, hair cortisol may provide a tool to evaluate women at risk for discontinuation of hormonal contraception due to concern of mood symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy
* Age 18-39 years
* Regular menstrual cycles
* Getting an IUD for the purpose of contraception

Exclusion Criteria:

* History of mood disorders
* BMI less than 18.5 or greater than 35
* Chronic medical conditions
* Recently pregnant or lactating
A Trial to Compare Antibacterial vs. Placebo Mouthwash to Reduce the Incidence of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men (MSM) Taking HIV Pre-Exposure Prophylaxis (PrEP)

The study involves a randomized placebo controlled trial that aims to assess if a mouthwash (Listerine cool mint, LCM) is able to reduce the cumulative incidence of gonorrhoea (Ng), chlamydia (Ct) and syphilis in men who have sex with men and receiving preexposure prophylaxis (PrEP) at the Institute of Tropical Medicine (ITM).

The study aims to assess if there is a difference in the incidence rate of gonorrhea, chlamydia and syphilis detected at any site whilst individuals are on daily and pre/post sex Listerine cool mint (LCM) vs. placebo mouthwash.

The study has a double-blind, cross-over design, in which subjects will be screened at the ITM and, if eligible, will be enrolled and randomized to group 1 (LCM) or group 2 (placebo). After 3 months, a crossover will occur and subjects will switch to the other intervention. Each participant will therefore be enrolled for 6 months (2 x 3 months, no wash out period).

Subjects will be recruited from the existing PrEP cohort at the Institute of Tropical Medicine Antwerp. A total of 320 subjects will be recruited (160 in each arm).

Eligibility Criteria:
Inclusion Criteria:

* Men aged 18 or more
* Enrolled in Belgian PrEP program at ITM
* Has had sex with another man in the previous year
* Has had a symptomatic or asymptomatic STI (Ct/Ng/syphilis) in the previous 2 years
* Willing to be enrolled in the cohort for 6 months and attend 3 monthly follow up visits
* Willing to comply with the mouthwash study schema and willing to ask their casual partners to mouthwash pre- and post-sex
* Prepared to fill out the online diary once a week
* Able and willing to provide written informed consent

Exclusion Criteria:

* Currently using a mouthwash and unwilling to cease use of this mouthwash
* Enrolment in another interventional trial
* Tests HIV positive at screening