cyrilzakka/clinical-trials huggingface dataset:
Personalized Integrated Alcohol and Sexual Assault Prevention Among College Students

Heavy episodic drinking and sexual assault are problematic on college campuses. This study includes a randomized controlled trial of Positive Change (+Change), an integrated alcohol and sexual assault prevention program, compared to an attention-matched control condition across two universities in reducing alcohol use, sexual assault victimization, sexual assault perpetration, and increasing sexual assault bystander intervention. This study will also test the efficacy of +Change plus Booster session, an identical version of +Change delivered 6 months after the baseline, compared to +Change alone in long-term reductions in alcohol use, sexual assault victimization, sexual assault perpetration, and increases in sexual assault bystander intervention. This research is the next step of a NIAAA-funded planning grant (R34AA025691).

Aim 1: Test the efficacy of Positive Change (+Change) among college students in each risk group (cisgender heterosexual men; cisgender heterosexual women; LGBTQ). Students aged 18-25 who engage in heavy episodic drinking will be recruited from 2 large public universities (n = 3,300) and will be randomly assigned to +Change, +Change plus +Booster, or an attention control. Alcohol use, sexual assault (victimization and perpetration), and bystander intervention will be assessed at baseline, 3-, 6-, 9-, and 12-month follow-ups.

H1a: +Change conditions (+Change and +Change plus Booster) will result in less alcohol use, less sexual assault (victimization and perpetration), and more bystander intervention compared to the control condition at 3-month follow-up and maintained at 6 months.

H1b: +Change plus booster at 6-months will maintain less alcohol use, less sexual assault (victimization and perpetration), and more bystander intervention compared to +Change over 9- and 12-month follow-ups (i.e., less decay of change).

Aim 2: Investigate theoretical mechanisms through which +Change conditions impact alcohol use (e.g., descriptive drinking norms, drinking to cope with minority stress for LGBTQ students), sexual assault victimization and perpetration (e.g., sexual assault-related norms, sexual assault resistance self-efficacy, hypergender ideology), and bystander intervention (e.g., bystander intervention self-efficacy).

Exploratory Aim: Examine +Change efficacy among LGBTQ subgroups (lesbian, gay, bisexual, trans, non-binary gender, gender queer, queer/questioning, intersex, asexual).

Eligibility Criteria:
Inclusion Criteria:

* 18-25 years old
* Current student at university of study
* Valid email address at university of study
* Endorse engaging in heavy episodic drinking at least once in the past month on the screening survey

Exclusion Criteria:

• There are no exclusion criteria other than not meeting inclusion criteria
Community Based Exercise Program for Well Cancer Survivors

This project will create a community based exercise program for well cancer survivors. The goal is that the YMCA will gain the competence to work with this unique population in a safe and productive manner.

All well, adult, cancer survivors are eligible to participate.

Eligibility Criteria:
Inclusion Criteria:

* All well cancer survivors who are medically stable.

Exclusion Criteria:

* Children are not eligible for this project.
EFFECT OF ANESTHESİA TECHNIQUES ON POSTOPERATİVE COGNİTİVE DYSFUNCTION FOR MMSE AND NSE LEVEL

The aim of this study is to compare the effects of total intravenous anesthesia and inhalation anesthesia methods on postoperative cognitive dysfunction according to Mini Mental State Examination scores and Neuron Specific Enolase levels in lumbar disc herniectomy operations.


Eligibility Criteria:
Inclusion Criteria:

-Lumbal disc herniectomy operation 18-65 age

Exclusion Criteria:

* Patients before and after the coronary artery bypass graft surgery
* patients in the last trimester of pregnancy
* patients with severe heart failure
* liver failure
* kidney failure
* malignant hyperthermia
* lactating patients
* patients with vision or hearing problems
* patients having difficulty in understanding and speaking Turkish
* Parkinson's and Alzheimer's disease
* alcohol and drug addicts
* morbidly obese patients
* intraoperative hypotension, hypertension and hypoxemia
Characteristic of Intestinal Flora in Male Elderly With Small Intestinal Bacterial Overgrowth

We will focus on the intestinal flora structure, risk factors and clinical features of male elderly with SIBO in our study.

Our previous study had found that the prevalence rate of small intestinal bacterial overgrowth(SIBO) in male elderly was high up to 63.1%. In the recent years, SIBO has been found be associated not only with abdominal symptoms such as abdominal distention, pain and so on, but also with various diseases such as diabetes, Alzheimer's disease, joint pain, chronic prostatitis, fatty liver, liver cirrhosis etc. SIBO has significant impact on the health of elderly. Methane and hydrogen lactulose breath test(LBT) is effective and noninvasive for the diagnosis of SIBO. High throughput sequencing is a leading technique for the study of intestinal microflora.

Although more and more studies have focused their concern on the intestinal flora now, few SIBO-related studies are available in elderly patients. But we have found SIBO was very popular in the elderly. The conflict between high prevalence rate of SIBO in elderly and very few relevant studies is barrier to study of pathophysiology, early diagnosis and treatment of SIBO in elderly adults.

So in our study, we will apply LBT and high throughput sequencing technique to study the intestinal flora structure, risk factors and clinical features of male elderly patients with SIBO. And further, we will try to develop standard treatment for elderly patients with SIBO.

Eligibility Criteria:
Inclusion Criteria:

* no use of antibiotics in the past 1 month, no use of prokinetic drugs and probiotics in the past 1 week

Exclusion Criteria:

* active inflammation, cardiac insufficiency, respiratory insufficiency, hepatic insufficiency, renal insufficiency, cirrhosis, thyroid diseases, Crohn disease, ulcerative colitis, hepatobiliary and pancreatic disease
Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration

This study will assess the safety, tolerability, and serum pharmacokinetics of intravitreal LFG316 in patients with advanced age-related macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

* Male or female AMD patients 55 to 90 years old, inclusive. In either eye, diagnosis of geographic atrophy or choroidal neovascularization due to AMD
* ETDRS best corrected visual acuity of 60 letters or worse in the study eye.

Exclusion Criteria:

* Retinal disease other than AMD in study eye which, in the investigator's opinion, may pose a safety risk or interfere with the study.
* Choroidal neovascularization due to a cause other than AMD.
* In the study eye, media opacity that interferes with fundus imaging or is likely to require surgery during the study period.
* Any of the following treatments to the study eye within 14 days prior to dosing: ranibizumab (Lucentis), bevacizumab (Avastin), pegaptanib (Macugen), or other VEGF inhibitor; OR likely requirement for one of the above treatments within 14 days of LFG316 administration.
* Any of the following within 30 days prior to dosing: photodynamic therapy treatment in the study eye; extrafoveal or juxtafoveal thermal laser photocoagulation in the study eye; systemic or topical (ophthalmic) steroid use in the study eye; bacterial keratitis in the study eye; OR intraocular surgery (including cataract surgery) in the fellow eye.
* Any of the following within 90 days prior to dosing: intraocular surgery (including cataract surgery) in the study eye; OR intravitreal or periocular corticosteroid injection in the study eye.
* Participation in another interventional clinical study, or use of any experimental treatment for AMD or any other investigational new drug within 12 weeks prior to the start of study treatment. Clinical trials solely involving over-the-counter vitamins, supplements, or diets will not exclude the patients from study participation.
* Any medical condition likely to interfere with the patient's participation in the study, or likely to cause serious adverse events during the study.

Other protocol-defined inclusion/exclusion criteria may apply
Metformin IN Asthma for Overweight and Obese Individuals (MINA)

This is a randomized clinical trial of metformin among overweight or obese adults with not well-controlled asthma despite maintenance inhaler therapy.

This is a randomized, placebo-controlled, parallel-arm pilot clinical trial. Adult participants who are overweight or obese and have not well-controlled asthma despite use of an inhaled corticosteroid will be randomized to metformin, an FDA-approved medication for the treatment of type 2 diabetes mellitus, or to placebo, to be taken daily for a total duration of six months. Recruitment will occur at two sites in the United States.

Randomized participants will have regular telemedicine visits to assess side effects and adherence. Additionally, participants will have a measurement of asthma outcomes at randomization and at 3 and 6 months after randomization.

The purpose of this study is to determine feasibility to inform a future multi-center clinical trial of metformin in this population.

Eligibility Criteria:
Inclusion Criteria:

* Physician-diagnosed asthma on maintenance therapy
* Not well-controlled asthma (ACT score \<20, or at least one asthma exacerbation requiring corticosteroids in the prior 12 months)
* Overweight or obesity: Body mass index ≥25kg/m2
* Adult: Age ≥18

Exclusion Criteria:

* Currently pregnant, expect to become pregnant in the next 6 months or are currently breastfeeding
* Major cardiovascular disease: heart failure, heart attack or stroke within the last 6 months
* Other chronic lung disease, inclusive of chronic obstructive pulmonary disease, bronchiectasis, interstitial lung disease, pulmonary fibrosis
* Active smoking or former smoker with ≥20 pack-year smoking history
* Chronic kidney disease: estimated glomerular filtration rate ≤60 mL/min/1.73 m2
* Heavy alcohol use: in a typical week, 8 or more drinks for a woman or 15 or more drinks for a man
* Liver disease: elevation in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2x the upper limit of normal or prior diagnosis of liver disease
* Anemia: hemoglobin \< 13 g/dl in males and hemoglobin \< 11 g/dl in females
* Taking Glucagon Like Peptide 1(GLP-1) medications for weight loss
* Diabetes (Hemoglobin A1C ≥ 6.5% or taking metformin or other medications used to treat diabetes)
* Participation in any other clinical trial (observational studies are permitted)
Home-based Cardiac Rehabilitation With Spot-jogging

The first purpose of this study is to investigate the physiological changes of heart failure patients during cardiopulmonary exercise test with spot jogging and compare them with the standard stationary bike cardiopulmonary exercise test. The second one is to compare the effect between home-based cardiac rehabilitation using different step frequency and toe lift or not to adjust spot jogging intensity and outpatient center-based cardiac rehabilitation for heart failure patients.

This is a pilot, prospective, randomized controlled trial design. We will recruit 40 heart failure patients aged over 18 year-old who have completed stationary bike cardiopulmonary exercise test and was referred to phase II cardiac rehabilitation. After providing informed consent, participants will be randomly assigned to either the home-based cardiac rehabilitation group or the outpatient center-based cardiac rehabilitation group. All participants will undergo spot jogging cardiopulmonary exercise test and six-minute walking test. The home-based spot jogging cardiac rehabilitation group will receive exercise intensity guidance in the outpatient cardiac rehabilitation room for 30 minutes of spot jogging and treadmill exercise during the first, fourth, and seventh weeks, and will perform spot jogging for 30 minutes twice a week at home. The outpatient center-based cardiac rehabilitation group will perform stationary bike or treadmill exercise for 30 minutes twice a week in the outpatient cardiac rehabilitation room. Both groups will achieve their target heart rate or 13 in rating perceived exertion. After 18 exercise sessions, participants will undergo stationary bike exercise test and six-minute walking test again.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure patients aged over 18 year-old who have completed stationary bike cardiopulmonary exercise test and was referred to phase II cardiac rehabilitation.

Exclusion Criteria:

* Atrial fibrillation
* Other neurological or musculoskeletal issues that affect physical activity.
* Undergoing dialysis.
* Having a pacemaker.
* Unable to cooperate in completing cardiopulmonary exercise testing.
* Do not agree to participate in the trial.
The Jetstream (JET) Post-market Registry

The scope of the JET registry to observe long term treatment effects of Jetstream Navitus on various lesions types/morphologies.

* To observe the treatment effects of the Jetstream NAVITUS System in long, occluded, diffuse, thrombotic or calcified lesions in peripheral arterial disease of the common femoral, superficial femoral, or popliteal arteries.
* To assess and quantify vessel patency 1 year post atherectomy treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 18 years of age.
* The target de novo or restenotic Percutaneous Transluminal Angioplasty (PTA) lesion(s) is/are located in the common femoral, superficial femoral or popliteal arteries.
* The reference vessel lumen (proximal to target lesion) is ≥ 4.0mm.
* Evidence of ≥ 70% stenosis or occlusion confirmed by angiography.
* Guidewire must cross lesion(s) within the true lumen, without a sub-intimal course before the patient is considered as entered into the study.
* Patient is an acceptable candidate for percutaneous intervention using the Jetstream NAVITUS System in accordance with its labeled indications and instructions for use.
* Lesion length ≥ 4cm.
* Patient has a Rutherford category score of 1-3.
* Patient has signed approved informed consent.
* Patient is willing to comply with the follow-up evaluations at specified times.

Exclusion Criteria:

* Patient has an uncontrollable allergy to nitinol, stainless steel or other stent materials or to contrast agent.
* Patient is unable to take appropriate anti-platelet therapy.
* Patient has no patent distal runoff vessels.
* Patient has critical limb ischemia (i.e., Rutherford class 4-6)
* Limited vascular access that precludes safe advancement of the Jetstream NAVITUS System to the target lesion(s).
* Interventional treatment is intended for in-stent restenosis.
* Patient has target vessel with moderate or severe angulation (e.g., \>30 degrees) or tortuosity at the treatment segment.
* Patient has a history of coagulopathy or hypercoagulable bleeding disorder.
* Patient is receiving hemodialysis or has significantly impaired renal function (creatinine is \> 2.5 mg/dl) at the time of treatment.
* Patient has evidence of intracranial or gastrointestinal bleeding within the past 3 months.
* Patient has had severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days.
* Patient has had surgical or endovascular procedure in the same vascular territory within 30 days prior to the index procedure.
* Patient has any planned surgical intervention or endovascular procedure within 30 days after the index procedure.
* Use of another debulking device during the index procedure prior to the Jetstream NAVITUS System will exclude the patient.
Anti Inflammatory Lipid Mediators in Asthma Lipid Anti-Inflammtory Mediators in Asthma

The main purpose of this Phase 2 double blind, placebo controlled crossover clinical study is to demonstrate the efficacy and safety of CXA-10 in obese adult asthmatics. Obesity induces a chronic systemic inflammatory state characterized by impaired adipokine signaling, pro-inflammatory cytokine responses, inflammatory cell activation and enhanced generation of oxidative inflammatory mediators. This impacts the lung, increasing the severity of asthma and its exacerbations. This research will evaluate how a synthetic nitro-fatty acid (CXA-10, 10-nitro-octadec-9-enoic acid) suppresses the systemic and airway inflammation that contributes to the obese asthmatic phenotype. Current data support the pleiotropic signaling actions of CXA-10 to induce adaptive signaling actions that beneficially modulate adipokine and cytokine expression and inhibit systemic and pulmonary inflammation. The investigators hypothesize that CXA-10 induced signaling responses will alleviate obesity-related airway hyperreactivity in obese adult asthmatics.


Eligibility Criteria:
Inclusion Criteria:

1. Adequate completion of informed consent process with written documentation. Male and female patients, 18 to 65 years old. Female subjects should be either post-menopausal or surgically sterile, or, if child-bearing potential (WOCP) should agree to use an acceptable method of contraception, for the duration of the study, with a negative pregnancy test prior to entering the study.
2. BMI \>/= 30
3. Diagnosis of asthma: based on previous physician diagnosis for \> 6 months, and baseline pre-bronchodilator (BD) FEV1 between 50 and 95% predicted with either a 12% or greater bronchodilator response to 4 puffs of albuterol or PC20 methacholine (16 mg) if \<12% change post BD
4. Regular treatment with inhaled corticosteroids (ICS) (up to 1000 mcg/day fluticasone/equivalent), long acting beta agonists (LABA), and/or long-acting muscarinic antagonists (LAMA), which can be combination medication for at least 3 months; on a stable dose for the 4 weeks prior to Visit 0

Exclusion Criteria:

1. Respiratory tract infection within the last 4 weeks
2. Oral or systemic corticosteroid burst within the last 4 weeks
3. Asthma-related hospitalization within the last 6 weeks
4. Three or more asthma exacerbations requiring treatment with systemic corticosteroids in the past year consistent with severe asthma
5. Asthma-related ER visit within the previous 4 weeks
6. Current smoking or have former smokers that quit within the previous 1 year, or 10 pack years
Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients

The purpose of this study is to determine the effect of conversion from calcineurin inhibitor to sirolimus based therapy on renal function.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 13 years.
* Receiving CsA or tacrolimus from the time of transplantation or within 2 weeks thereafter
* Patients with a functioning allograft and a Nankivell GFR greater than or equal to 20 mL/min, within 2 weeks before randomization

Exclusion Criteria:

* Biopsy-confirmed acute rejection within 12 weeks before randomization, that was determined to require antirejection treatment
* Patients in whom kidney-pancreas or other multiple organ transplants have been performed
Efficacy and Safety of Itopride vs Placebo in Heartburn

The purpose of this study is to evaluate the effects of itopride in patients with heartburn.


Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy males and females aged 18-70, with at least 3 episodes of heartburn or acid regurgitation per week.
Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19 in Prostate Cancer Using High Field MRI (3 Tesla), PET, and Biomarkers

This study will use high field MRI (3 Tesla), PET and biomarker to follow prostate cancers and determine if these tests can detect cancers that become aggressive.

This study may lead to the identification of additional investigations that can monitor for signs of disease progression in active surveillance protocols. This can directly benefit patients by providing them with greater confidence that their disease is being accurately monitored. In addition, this study may be beneficial to the general management of prostate cancers by adding to our knowledge of these investigations characterizing prostate cancers.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven adenocarcinoma of the prostate
* Registration must occur within 16 weeks of last biopsy
* History and physical exam (including DRE) within 8 weeks prior to registration
* Patients must have indolent prostate cancer including all of the following: Low risk prostate cancer, less or equal to 50 % of core biopsies involved with disease, and less or equal to three biopsies involved with disease
* Patients must have a minimum of six biopsies (sextant) at registration
* PSA test within 8 weeks registration
* Creatinine level below 100 umol/L within 8 weeks of registration
* Patients must have no contraindications to MRI scans
* No history of previous malignancies except non-melanoma skin tumors or other malignancies with a greater than 5 year life expectancy
* Patients must be reliable for follow up

Exclusion Criteria:

* Patient does not have histologically-proven adenocarcinoma of the prostate
* Last biopsy greater than 16 weeks prior to registration
* History and physical exam (including DRE) greater that 8 weeks prior to registration
* Patient does not have indolent disease
* Patient has less than six sextant biopsies at registration
* PSA test done greater than 8 weeks from registration
* Creatinine level greater than 100 umol/L within 8 weeks of registration
* Contraindications to MRI scans
* History of previous malignancies other than non-melanoma skin tumors or other malignancies with a greater than 5 year life expectancy
* Patients that are not reliable for follow up
Impact of an Oligomeric Diet in Intestinal Absorption and Inflammatory Markers in Patients With Crohn Disease

This is a randomized, multicenter, translational, triple-blind, clinical trial in patients with Crohn's disease, who will be prescribed an oral nutritional supplement to control symptoms in the acute phase and to recover in the remission phase.

Multicentric, parallel, randomized, double blind and controlled clinical-nutritional study of 6 months of intervention and 3 study groups of treatment: Experimental group (peptidic diet with a mix of probiotics); Experimental group with placebo (peptidic diet with a placebo); and Control group (control with a polymeric nutritional oral supplement with a placebo) to evaluate the effect on the nutritional status, inflammatory markers and the intestinal absorption

Eligibility Criteria:
Inclusion Criteria:

* Unintentional weight loss of 5% in 6 months or a BMI less than 20kg/m2 or does not get the energy requirements with normal food.
* Willing to comply with the prescribed diet follow-up for CD.

Exclusion Criteria:

* Having received antibiotics in the previous 3 months
* Having undergone intestinal resection surgery≥70-75%
* Refuse to participate in the study
* Comorbidity that allows to suspect survival \<1 year