cyrilzakka/clinical-trials huggingface dataset:
Probiotic Intervention for Occasional Constipation

The goal of this clinical trial is to study the effect of probiotics on gut function in subjects with occasional constipation. The main question it aim to answer is if intake of probiotics will decrease the transit time. Participants will randomized to either consume probiotics or a placebo product.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18 - 65 years
* With occasional constipation
* Agrees to maintain current lifestyle habits
* Healthy
* Provided voluntary, written, informed consent to participate in the study

Exclusion Criteria:

* Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
* Allergy, sensitivity, or intolerance to study products or clinical assessment materials
* Chronic constipation
* Current or history of significant diseases or abnormalities of the gastrointestinal tract (examples (include but are not limited to atrophic gastritis, celiac disease, gluten intolerance/sensitivity, inflammatory bowel disease)
* Unstable metabolic disease or chronic diseases
* Unstable hypertension.
* Type I or Type II diabetes, cancer
* Significant cardiovascular event in the past 6 months. History of or current diagnosis with kidney and/or liver diseases
* Self-reported confirmation of current or pre-existing thyroid condition.
* Individuals with an autoimmune disease or are immune compromised
* Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis, blood/bleeding disorders
* Any other condition or lifestyle factor, that may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
A Dose Escalation Study of Tenofovir Alafenamide in Treatment-Naive Patients

This study evaluated two doses of tenofovir alafenamide versus tenofovir disoproxil fumarate (tenofovir DF).


Eligibility Criteria:
Inclusion Criteria

* HIV-1 RNA levels greater than or equal to 30,000 copies/mL
* CD4 count greater than or equal to 200 cells/mm3
* Serum creatinine \<1.5 mg/dl
* Hepatic transaminases less than or equal to 2.5 times the upper limit of normal
* Total bilirubin less than or equal to 1.5 mg/dL
* Adequate hematologic function
* Serum amylase less than or equal to 1.5 times the upper limit of normal
* Serum phosphate greater than or equal to 2.2 mg/dL
* Not pregnant

Exclusion Criteria

* Prior treatment with antiretroviral therapy
* Immunization within 30 days of study entry
* A new AIDS defining condition within 30 days of study entry
* Receiving nephrotoxic agents, probenecid, chemotherapeutic agents, corticosteroids, interleukin-2
Cooking for Health Optimization With Patients

Cooking for Health Optimization with Patients (CHOP) is the first known multi-site prospective cohort study with a nested Bayesian adaptive randomized trial in the preventive cardiology field of culinary medicine. It is also the first known longitudinal study to assess the impact of hands-on cooking and nutrition education on patient outcomes, with those classes taught by medical students and other future and current medical professionals who have first been trained in those classes on how to integrate diet and lifestyle counseling of patients with their respective scopes of clinical practice. CHOP is the primary research study of the world's first known medical school based teaching kitchen, The Goldring Center for Culinary Medicine at Tulane University School of Medicine. Medical trainees and professionals are followed in this study long-term to understand how the classes impact their competencies in patient counseling, attitudes about the counseling, and their own diets. Patients who consent to being randomized to these classes compared to standard of care are studied within the nested Bayesian adaptive randomized trial to understand how the classes impact their health outcomes, clinical and food costs, and the costs of health systems caring for these patient populations. CHOP is designed as a pragmatic population health trial to hopefully improve healthcare effectiveness, equity, and cost by establishing an evidence-based, scalable, sustainable model of healthcare intervention targeting the social determinants of health, while complementing the pharmacological and/or surgical management of patients.


Eligibility Criteria:
Inclusion Criteria:

* 7 to 115 years of age (patients), and currently a medical trainee or professional (including for physicians, nurses, physician assistants, and dieticians)

Exclusion Criteria:

* Inability to complete at least 2 intervention classes
Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use

This is a single center, prospective trial of pessary use prior to reconstructive pelvic floor surgery for pelvic organ prolapse. The goal of the study is to evaluate the change in pelvic floor symptoms with pessary use and subsequent reconstructive surgery. Additionally, we will assess the impact that preoperative pessary use has on patient self-reported preparedness for surgery.

It is anticipated that this trial will define the clinical utility of routine preoperative pessary placement, and by shaping patient expectations and increasing preparedness for surgery, we anticipate improving satisfaction and quality of life.

At the initial office visit baseline symptoms are evaluation with validated questionnaire.

The patients' will undergo pessary fitting at least 7 days (but no more than 28 days) prior to scheduled surgical prolapse repair.

Symptomatic change from baseline will be assessed with validated questionnaire preoperatively.

The pessary will be removed at the time of surgery, and the patient will undergo surgical correction of their pelvic organ prolapse (including all restorative surgical procedures, abdominal and transvaginal). A concomitant anti-incontinence procedure will be performed at the discretion of the treating physician in consultation with the patient.

The patients' symptomatic outcome from surgery will then be reassessed by validated questionnaire at 6 weeks and 3 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years of age
* With symptomatic pelvic organ prolapse
* Electing for surgical repair of pelvic organ prolapse (transvaginal or transabdominal) at least 7 days after office consultation
* Understand and have signed written informed consent for preoperative pessary placement.

Exclusion Criteria:

* Previous use of a pessary for pelvic organ prolapse
* Patients undergoing obliterative prolapse surgery (i.e. Colpocleisis),
* Are scheduled for surgery for pelvic organ prolapse less than 7 days after office consultation or greater than 4 weeks after office consultation
* Have an isolated rectocele
* Have allergies to both latex and silicone
* Have an active pelvic infection
Ultra-rapid Opiate Detoxification Using Deep Sedation and Prior Oral Buprenorphine Preparation.

The methods of detoxification under general anesthesia have been criticized because of limited data on safety and long-term follow-up. Premedication with buprenorphine has been advocated to improve safety. In current study we want to evaluate the importance of buprenorphine preparation in rapid opioid detoxification process, under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Opioid addiction

Exclusion Criteria:

* Age \< 18 Pregnancy
Etanercept Treating Patient With Acute ST Segment Elevated Myocardial Infarction

Our aim is to observe whether anti-TNF-alpha regimen will effect serum adiponectin concentration after myocardial infarction/reperfusion and also beneficial for the patients undergoing percutaneous coronary intervention (PCI).

Ischemic/reperfusion injury in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) is associated with increased inflammatory cytokines that including TNF-alpha that can exert deleterious effects and therefore contribute to cardiac dysfunction and cardiomyocytes apoptosis. Several studies on rodents have reported administration of sTNFR-Fc, a scavenger of the pro-inflammatory cytokine TNF-alpha at the time of reperfusion would protect against ischemic/reperfusion injury. Also reports had shown that serum TNF-alpha concentration is negatively correlated with a cardioprotective cytokine adiponectin. Adiponectin (Ad) is an abundant protein hormone regulatory of numerous metabolic processes. The major intracellular pathway activated by Ad includes phosphorylation of AMP-activated protein kinase, which is responsible for many of Ad's metabolic regulatory, anti-inflammatory, vascular protective, and anti-ischemic properties. The aim of the present study was to verify whether the administration of Etanercept, an FDA approved rheumatoid arthritis treating sTNFR-Fc, at the reperfusion time would protect against ischemic/reperfusion injury on patient, and effect serum adiponectin level.

Eligibility Criteria:
Inclusion Criteria:

* patients with acute ST segment elevated myocardial infarction in 12h

Exclusion Criteria:

* Cardiogenic shock
* old myocardial infarction
* other causes of cardiac insufficiency
* tumor
* Coronary anatomy unsuitable for PCI or Need of emergency coronary artery by-pass grafting
* Pregnancy
Intraoperative Hyperspectral Imaging in Gastrointestinal Anastomoses

In this study, gastrointestinal anastomoses are examined with a hyperspectral camera.

The anastomoses were examined under standardized conditions directly after creation. The measurements were performed like described before, using the TIVITA Tissue system (Diaspective Vision GmbH, Am Salzhaff, Germany). This HSI-camera provides hyperspectral images with a high spectral resolution (5 nm) in the visible and near infrared range (500-1000 nm). The distance between camera and object was 30 cm for all measurements. The Number of Effective Pixels at this distance is 640 × 480 (x-, y-axis. The resulting field of view (FOV) has the dimensions 6.4 × 4.8 cm2 and a spatial resolution of 0.1 mm/pixel. The FOV is illuminated by 8 halogen spots (20 W each). The ceiling lights and other light sources were switched off, to avoid artifacts during the measurement (approximately 10 seconds). A RGB image and 4 false color images that represent physiologic parameters are intraoperatively provided by an analysis software. This work is focused on tissue oxygenation (StO2), which represents the relative blood oxygenation in the microcirculation of superficial tissue layers (approximately 1 mm) and the near-infrared (NIR) Perfusion Index, representing tissue layers in 4-6 mm penetration depth.

Eligibility Criteria:
Inclusion Criteria:

* all gastrointestinal anastomoses

Exclusion Criteria:

* inability to consent
Nicotinamide Riboside Supplementation and Exercise Training to Promote Healthy Longevity

The prevalence of age-related chronic diseases (like obesity, type 2 diabetes and cardiovascular diseases) is mounting worldwide, reaching pandemic proportions. These age-related chronic diseases are associated with diminished skeletal muscle mitochondrial function in humans. Nicotinamide adenosine dinucleotide (NAD) is a coenzyme that regulates mitochondrial function, therefore, plays an important role in energy metabolism. Importantly, it has been shown that high cellular NAD+ levels as well as a high NAD+/NADH ratio promote metabolic and mitochondrial health. In contrast, NAD+ bioavailability declines upon aging in humans as well as in animal models of metabolic disorders and type 2 diabetes. These findings fuel the notion of boosting the NAD+ bioavailability in order to improve metabolic disturbances and mitochondrial dysfunction in aged individuals. Supplementation with nicotinamide riboside (NR), a naturally occurring form of vitamin B3, boosts cellular NAD+ levels. However, in contrast to animal studies, NR supplementation in humans has so far been unsuccessful in improving skeletal muscle mitochondrial function, exercise capacity or insulin sensitivity. Interestingly, Recently, it has been suggested that metabolic conditions where NAD+ levels become limited, is needed for NR supplementation to exert beneficial health effects. This metabolic condition could be achieved by exercise. However, studies combining NR and exercise are lacking, and that is why we will perform the present study.


Eligibility Criteria:
Inclusion Criteria:

* Participants are able to provide signed and dated written informed consent prior to any study specific procedures
* Aged ≥ 60 and ≤ 80 years
* Body mass index (BMI) 25 - 35 kg/m2
* Stable dietary habits (no weight loss or gain \> 5 kg in the past 3 months)
* No signs of active cardiovascular disease, liver or kidney malfunction

Exclusion Criteria:

* Patients with congestive heart failure and and/or severe renal and or liver insufficiency
* Uncontrolled hypertension
* Any contra-indication for MRI scanning
* Alcohol consumption of \> 3 servings per day for man and \>2 servings per day for woman
* Smoking
* Unstable body weight (weight gain or loss \> 5kg in the last 3 months)
* Engagement in structured exercise activities \> 2 hours a week
* Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator which would possibly hamper our study results
* Use of food supplements containing NR or Resveratrol (similar working mechanisms)
Hangzhou Hospital Staff Cohort

The Hangzhou Hospital Staff Cohort (HHSC) is a prospective cohort study among staffs from three hospitals located in Hangzhou, China, including the Hangzhou First People's Hospital, Hangzhou Women's Hospital, and Hangzhou Red Cross Hospital. Participants recruitment and baseline survey including anthropometric, lifestyle and clinical measurement, as well as biological samples collection are initiated in January 2021. Recruited hospital staff are followed up every year during the medical examination organized by their employer. The primary aim of the HHSC study is to investigate the prospective associations of diet, physical activities, sleep, and other lifestyle factors with the long-term metabolic health of the hospital staffs. The secondary aim of the HHSC study is to integrate multi-omics data including genomics, metabolomics, proteomics and microbiome by a machine learning algorithm, to probe into the complex mediating roles of gene, metabolism and gut microbiota linking lifestyle factors with metabolic health.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18 years or older
* Serving staffs of designated hospitals

Exclusion Criteria:

* Participants with cancer
* Participants with other serious medical disorders
A Smoking Cessation Trial in HIV-infected Patients in South Africa

The purpose of this study is to conduct a randomized controlled trial (RCT) of intensive anti-smoking counseling plus nicotine replacement therapy versus intensive anti-smoking counseling alone among HIV-infected patients in South Africa, and to concurrently measure the prevalence of smoking among HIV-infected patients in South Africa.

Tobacco use is estimated to be responsible for over 5 million deaths globally every year and HIV/AIDS kills 2 million worldwide, with persons living in the developing world especially at risk. However, the association between tobacco use and HIV is not clearly understood. The introduction of highly active antiretroviral therapy (HAART) has led to longer duration of survival following HIV-infection in the developed world, and now that HAART is being rolled out in the developing world, survival will increase in these highly endemic regions as well. Given this increase in survival, more people will die of non-HIV related illnesses for which smoking plays an important causal role. Smoking cessation for HIV-infected persons has been studied in the US though these studies have had small numbers and limited follow-up. US based studies suggest that approaches that combine nicotine replacement therapy (NRT) and counseling interventions are most successful. Optimal approaches in resource-limited settings have not been determined.

This study will compare intensive counseling plus NRT versus intensive counseling only, comparing smoking cessation at 2, 6 and 12 months. At 6 months, patients who are still current smokers will be given a second opportunity to receive their group assigned intervention, either intensive counseling plus NRT or intensive counseling alone. We will relate smoking exposure and cessation to HIV progression as measured by immunologic and viral markers, risk of respiratory infections, including tuberculosis, and AIDS-related malignancies. The RCT will be performed at the Tshepong HIV Wellness Clinic in Klerksdorp, South Africa, associated with the Reproductive Health \& HIV Research Unit of the University of the Witwatersrand, South Africa.

Eligibility Criteria:
Inclusion Criteria:

* Current, daily smoker (biochemically verified via a positive result on the SmokeScreen® test from GFC Diagnostics Ltd., as described in the outcomes)
* Be willing to set a quit date within 2 weeks after baseline assessment
* Agree to participate in study and anticipated to be attending Tshepong Wellness Clinic, Jouberton Community Health Center, or Grace Mokhomo Community Health Center (due to HIV infection) for at least 6 months

Exclusion Criteria:

* Pregnant or nursing
* Currently using smokeless tobacco (including electronic cigarettes, NRT or other cessation treatment)
* Tuberculosis confirmed case
* Weight \<45 kg or BMI \<20
* Suffering from any unstable medical condition which could preclude use of the nicotine patch:

  * unstable angina
  * uncontrolled hypertension
  * active skin disease (e.g. psoriasis)
  * history of skin allergy
NAVISCORE PMCF Study ( rEPIC04F )

Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Naviscore scoring balloon to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Naviscore.

The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Naviscore scoring balloon in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patient treated with Naviscore according to routine hospital practice and following instructions for use
* Informed consent signed

Exclusion Criteria:

• Not meet inclusion criteria
Amlodipine Plus/Minus Atorvastatin for Protection of Arteries

The primary objective of this study is to test the hypothesis that amlodipine plus atorvastatin given in a single tablet (Caduet), compared with amlodipine alone (Norvasc), has a stronger effect in protection of arterial structure and function.


Eligibility Criteria:
Inclusion Criteria:

1. Women or men, aged from 40 to 75 years;
2. Women with child-bearing potential should apply an adequate non-pharmacological contraceptive technique;
3. Untreated patients or those on a single antihypertensive drug (except calcium channel blocker ) but with an uncontrolled blood pressure on conventional measurement, ranging from 140 to 179 mm Hg systolic or from 90 to 109 mm Hg diastolic. The conventional blood pressure is the average of 3 consecutive measurements in the sitting position or a single visit.
4. The 24 h ambulatory blood pressure should be at least 130 mm Hg systolic or 80 mm Hg diastolic, or higher;
5. Fasting total cholesterol concentration ranging from 4.14 to 6.22 mmol/L (160 to 240 mg/dL);
6. Endothelium-dependent flow-mediated dilatation (FMD) below 10%;
7. Serum activity of aspartate aminotransferase (AST), alanine aminotransferase (ALT), and creatine kinase (CK) should be within the normal range;
8. Patients should not be on treatment with statins or other lipid-lowering drugs within 3 months of randomization;
9. The patients should sign the informed consent form prior to the participation in the trial at the first visit;
10. Patients should be independent and likely to adhere to the study protocol.

Exclusion Criteria:

1. Secondary hypertension;
2. Low-density lipoprotein cholesterol (LDL-C) below 2.59 mmol/L (100mg/dL);
3. Renal dysfunction defined as eGFR\<60ml/min/1.73m2;
4. Current treatment with specific drugs or diets, such as fibrates (especially gemfibrozil), verapamil, amiodarone, grapefruit juice;
5. Excessive alcohol consumption defined as drinking more than 1L/day;
6. Stroke within 2 years of randomization or myocardial infarction occurred previous;
7. Known contra-indications to a dihydropyridine calcium channel blocker or statins;
8. Any life threatening condition;
9. Current participation in another trial or trials.
The Effects of BCRP Q141K on Allopurinol Pharmacokinetics and Dynamics

Subjects will undergo a placebo and allopurinol phase to better understand the effects of the reduced function BCRP Q141K variant on allopurinol pharmacokinetics and pharmacodynamics.


Eligibility Criteria:
Inclusion Criteria:

* self-identified as Asian/European ancestry
* generally healthy with approved lab values for CBC,HFP,RFP, and uric acid
* Subjects with the ABCG2 genotype, homozygous, heterozygous or homozygous for the major allele of rs2231142 will be recruited

Exclusion Criteria:

* vascular disease
* renal impairment
* medications/supplements that affect uric acid levels
* pregnant or lactating women
* prior history of allergic reaction to allopurinol or testing positive for HLA-B\*5801 allele
* risk of urinary or gastric retention or narrow-angle glaucoma
* impaired hepatic function
* evidence of anemia
* evidence or diagnosis of congestive heart failure
* smokers
* subjects with a mutation other than rs2231142 in the ABCG2 genotype
* subjects taking hormonal contraceptives or other hormonal medications
* evidence of recreational drug use as determined by questionnaire