cyrilzakka/clinical-trials huggingface dataset:
Does Welchol (Colesevelam Hydrochloride) Improve Colonic Transit in Diarrhea-predominant Irritable Bowel Syndrome (D-IBS)?

Our hypothesis is that the medication approved for treatment of high blood cholesterol levels, Colesevelam HCl (WELCHOL), decreases colonic transit and permeability in patients with diarrhea due to irritable bowel syndrome.

This effect is thought to result from the effect of the medication on bile acids, which can cause diarrhea.

Background:

Irritable bowel syndrome (IBS) affects about 15% of the U.S. population, about 5% having predominant diarrhea; current treatment is suboptimal as it may not be tolerated, lead to side effects or insufficient benefit. Bile acid malabsorption (BAM) is recognized as a cause of chronic diarrhea and has been investigated as a mechanism for the phenotype of diarrhea predominant IBS (D-IBS). Increased exposure of the colon to bile acids which may result from accelerated small bowel transit or abnormal function of the apical sodium bile acid transporter (ASBT) has been postulated to cause functional diarrhea or symptoms of D-IBS by a number of mechanisms, such as increase colonic secretion, and mucosal permeability. Recent preliminary data suggest that doses of chenodeoxycholate (CDC) that are approved for the dissolution of gall stones are associated with accelerated colonic emptying and looser stool consistency.

Hypothesis:

The bile acid binding agent, Colesevelam HCl, decreases colonic transit and permeability in patients with D-IBS.

Specific Aim:

To investigate the effect of Colesevelam, which binds bile acids in the small intestine and reduces the concentration of bile acids in the colon, on colonic transit, permeability and the bowel function of patients with D-IBS.

Methods:

Twenty-four D-IBS participants will be randomized to placebo or treatment with Welchol (Colesevelam HCL) 1.875 gram b.i.d. for 12-14 days. A baseline colon transit, 24 hour urine for colon permeability, and blood for serum 7 alpha-hydroxy-4-cholesten-3-one (7 alpha-HCO) will be measured and venous blood DNA will be collected and stored. The measurement of serum 7 alpha-hydroxy-4-cholesten-3-one (7 alpha-HCO), which is a measurement of hepatic cholesterol synthesis, is closely related to the fecal loss of bile acids, and is a validated method for screening for BAM. Following treatment for 12 days, transit and permeability studies will be repeated. Bowel function symptoms will be recorded for the duration of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with D-IBS
* Aged 18-65 years
* No abdominal surgery (except appendectomy or cholecystectomy as long as patients IBS-diarrhea symptoms preceded the cholecystectomy

Exclusion Criteria:

* Participants with known chronic liver disease or Aspartate aminotransferase (AST) or Alanine transaminase (ALT) \> 2.0 X upper limit of normal
* Hypertriglyceridemia and pancreatitis by history
* Diabetes or hypoglycemia
* Significant coagulation disorder
* History of bowel obstruction
* Serum triglycerides \>500 mg/dL
* History of vitamin A, D, E, or K deficiencies
Prospective, Multicentre, Open-label Study Evaluating 1.5 mg/Day of Fondaparinux.

Fondaparinux is an antithrombotic agent having already received a regulatory approval by the European Authorities in venous thromboembolic event prevention after major orthopaedic surgery, as total hip replacement (THR), total knee replacement (TKR), hip fracture (HF). The bleeding risk associated with this prescription is highly related to renal function evaluated by creatinin clearance (CrCl). In order to reduce the bleeding risk, it has been proposed to prescribe fondaparinux 1.5 mg/day in patients with a CrCl between 20 and 50ml/mn instead of 2.5mg/day (European MMA). In the meantime, this approval is essentially based on simulated pharmakinetic data without any support of clinical data.

prospective, multicentre, open-label study evaluating the safety profile of fondaparinux 1.5 mg/day, subcutaneously administered, in patients with a renal impairment defined by a CrCl between 20 and 30 ml/min and undergoing a major orthopaedic surgery.

Fondaparinux 1.5mg/day subcutaneously administered during post-surgery 1 to 10 days with the 1st treatment administration performed 6 to 8 hours after the end of surgery.

Screening visit : \> 7 days before inclusion visit if THR and TKR Inclusion visit : day of surgery Visits with blood drawing: 3 visits scheduled during 1 to 10 days of treatment period Study end of treatment visit: D1 to D10 Study end visit: 1 month ± 15 days

Eligibility Criteria:
Inclusion Criteria:

* • age \> 18 years old,

  * undergoing a major orthopaedic surgery (THR, TKR, HF) whatever procedure techniques are used, 1st indication or 2nd indication,
  * requiring an antithrombotic prophylaxis,
  * presenting a renal impairment defined by a creatinin clearance (CrCl) between 20 and 50 ml/min calculated by Cockcroft and Gault's formula,
  * having signed the inform consent form.

Exclusion Criteria:

* contra-indications to fondaparinux,
* history of heparin inducted thrombopenia (HIT),
* platelets \< 100 g/l.
Increasing Affordable Fruits and Vegetables for Families With Food Insecurity

Investigator will test an intervention to increase use of a fruit and vegetable incentive program in South Carolina for families in the Supplemental Nutrition Assistance Program (SNAP) experiencing food insecurity. Caregivers are randomized to an intervention or an education-only, wait-list control group. The investigators hypothesize the intervention will improve diet-related outcomes, above and beyond the education-only wait-list control.

This study will test an intervention to increase use of a fruit and vegetable incentive program for families in the Supplemental Nutrition Assistance Program (SNAP) using a randomized controlled trial design. Caregivers are randomized to the intervention or an education-only wait-list control group. All caregivers are given brief education about a SNAP fruit and vegetable incentive program. Caregivers in the intervention are also given an initial "free trial" of this program and free home delivery. The primary aim is to examine intervention efficacy on diet-related outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Primary caregiver 18+ years of age
* Has a child 2-10 years of age
* Speaks English
* Screens positive for food insecurity
* Currently enrolled in the Supplemental Nutrition Assistance Program (SNAP)
* Lives with a feasible radius for home delivery
* Consistent access to a phone that receives text messages

Exclusion Criteria:

* Anticipate no longer being enrolled in SNAP during the study duration
* Recent use of the SNAP fruit and vegetable incentive program
* Caregiver or child has a medical condition that impacts their ability to eat fruits and vegetables
* Caregiver or child has a significant food allergy, preference, or intolerance that impacts their ability to eat fruits and vegetables
To Evaluate the Bioavailability of a Single Oral Dose of the Acetylsalicylic Acid Containing Dry Powder 500 mg in Comparison to the Bioavailability of a Single Oral Dose of Aspirin Tablets and Aspirin Effervescent Tablets in Healthy Adults.

To evaluate the bioavailability of a single oral dose of the Acetylsalicylic Acid containing dry powder 500 mg in comparison to the bioavailability of a single oral dose of aspirin tablets and aspirin effervescent tablets in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy ,male and female subjects 18 to 55 years of age, inclusive
* Body Mass Index (BMI) of approximately 18 to 30 kg/m2, and a total body weight \>50 kg (110 lbs)
* Results of screening and clinical laboratory tests are within normal limits or considered not clinically significant by the Principal Investigator or Sponsor
* Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, intramuscular injection or double-barrier and have a negative pregnancy test at Screening and on Day 0 of each treatment period. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy.

Exclusion Criteria:

* History of hypersensitivity to acetylsalicylic acid (ASA), naproxen sodium, acetaminophen, other non-steroidal anti-inflammatory drugs (NSAIDs), and similar pharmacological agents or components of the products
* History of gastrointestinal bleeding or perforation, including bleeding related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding).
* Have taken ASA, ASA-containing products, acetaminophen or any other NSAID (OTC or prescription) seven days prior to dosing or during the Treatment Periods, other than study product
* Loss of blood in excess of 500 mL within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis, or injury)
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic disease, or malignancies
* Positive alcohol or drug screen at Screening or on Day 0 of Treatment Periods 1,2 and 3
* Females who are pregnant or lactating
Evaluating Forced Oscillation Technique (FOT) in Abolishing Flow Limitation

To validate the capability of the Respironics Synchrony ventilator to properly detect Expiratory Flow Limitation (EFL) as compared to the gold standard method of detecting EFL via the Mead and Wittenberger technique.

Positive end expiratory pressure (PEEP) is used in COPD patients to counteract the intrinsic PEEP (PEEPi), which represents the end expiratory recoil pressure of the total respiratory system due to the presence of dynamic hyperinflation (DH).

DH commonly occurs in COPD, where the presence of expiratory flow-limitation (EFL) requires the patient to breath at higher lung volumes to produce the necessary after appropriate leak correction, showed a sensitivity and specificity in detecting EFL expiratory flow. To be effective, the PEEP level applied to the patient should be equal to PEEPi.

The continuous monitoring of EFL could be a useful tool to select the minimum PEEP level required to abolish it.

EFL can be detected using the forced oscillation technique (FOT) by an index which quantifies, for each breath, the within-breath variations of respiratory reactance (delta Xrs) at 5Hz.

Eligibility Criteria:
Inclusion Criteria

1. Age \< 80 years
2. Moderate - Severe COPD diagnosed by spirometry (according to the GOLD criteria - Global Initiative for Chronic Obstructive Lung Disease criteria)
3. Free from any exacerbation in the 6 weeks preceding the study

Exclusion Criteria

1. Any co-existing cardio-pulmonary conditions which may result in a picture of ventilatory failure such as congestive cardiac failure, chest wall or neuromuscular disease, bronchopneumonia, pulmonary fibrosis, bronchiectasis, cystic fibrosis or obesity-hypoventilation syndrome
2. Clinically unstable; exacerbation within the preceding 6 weeks
3. The presence of pulmonary or extra-pulmonary neoplasia that is still active
4. The presence of a bleeding diathesis
5. Unstable coronary artery disease
6. Presence of tuberculosis, current infection or potentially infectious pathogen
7. Inability to provide informed consent to the study
Cardiac 3D MRI in Pediatric Cancer Patients

This is a non-randomized prospective pilot study in a single academic center with historic controls. This study will compare Cardiac Magnetic Resonance Images (MRI) of patients who have undergone childhood cancer treatment that has cardio-toxic effects to historic controls. The ultimate goal of this study is to develop a safe and effective method for early diagnosis of heart problems in children who are receiving chemotherapy treatments that may be toxic to the heart.

The following tests and procedures will be performed after consent has been obtained. All tests and procedures noted below are being done for the sole purpose of the study:

Visit 1. Subjects will be asked to complete some questionnaires and answer questions regarding smoking status and use of alcohol or smokeless tobacco. We will also gather basic information such as age, height, weight, gender, ethnicity, race, pertinent medical history as well as collect vital sign information (height, weight, blood pressure, heart and respiratory rate.) Next, subjects will undergo a routine transthoracic echocardiogram.

Visit 2. Following the completion of the echocardiogram, and if selected to take part in the study, subjects will be schedule for a cardiac MRI test within a 3 months period.

When subjects come in for Visit 2, they will receive a 12 lead electrocardiograph (ECG) before the cardiac 3D MRI.

All females who are capable of becoming pregnant, except those who are age 11 and under, will then undergo urine pregnancy testing. If it is found that you are pregnant you will not be allowed to be in the study. If the female is under 18 and a positive pregnancy test result is obtained, we will inform both the participant and her parent/guardian.

Subjects may then be placed in a "simulated" MRI to teach them what it will be like to enter the scanner and also train them on how to breathe calmly and regularly during the scan.

Training will involve the use of a PrimeSense 3D sensor, similar to the cameras used in active videogame systems such as the Xbox Kinect, which will generate a 3D picture of their chest as they breathe. Following this training session, subjects will then undergo cardiac 3D MRI. Study participations will end after this visit.

Eligibility Criteria:
Inclusion Criteria:

* Childhood cancer treatment which has been completed
* Received anthracyclines as part of childhood cancer treatment, at least 150 mg/m2 as cumulative dose
* normal left ventricular systolic and diastolic functions on echocardiogram

Exclusion Criteria:

* Ongoing cancer treatment
* Pregnancy
* Inability to undergo a cardiac MRI
* Abnormal ventricular systolic or diastolic function on echocardiogram
The ctDNA-RECIST Trial Part One

A study investigating if analysis of circulating tumor DNA (ctDNA) can guide palliative treatment in patients with gastrointestinal cancer.

Background:

Circulating tumor DNA, (ctDNA) has the potential to better monitor treatment efficacy compared to imaging, possibly sparing the patient for ineffective treatment and their associated toxicity an allowing for an early change of the treatment approach.

Based on multiple dataset we have defined ctDNA-RECIST - the ctDNA response evaluation criteria.

Aim: This phase II randomized trial evaluates the use of ctDNA Response Evaluation Criteria in Solid Tumors (ctDNA-RECIST) versus standard imaging-based RECIST to guide treatment decisions in patients with metastatic gastrointestinal cancers.

Design: Patients are randomized 1:1. Patients in Arm A are offered standard treatment with response evaluation according to the RECIST criteria based on imaging, and treatment pauses according to institutional guidelines.

In Arm B, treatment response is evaluated based on change in ctDNA between the baseline sample and the evaluation and confirmation sample, according to ctDNA-RECIST:

* Progressive disease: An increase of ctDNA above the previous value with no overlap of the two CI's
* Stable disease: A value within CI of the previous value. The category also includes samples with both previous and present value being 0 (undetectable).
* Partial Response: A decrease below the previous value with no overlap of the two CI'S but the lower CI does not overlap 0.
* Complete response: Decreasing value to an undetectable level
* Near complete response: A decrease below the previous value with no overlap of the two CI'S and with the lower CI overlapping 0

Complete and near complete response can be combined and classified as maximal response.

The study is initiated as a feasibility study (part one)and will continue into the expansion trial after interim analysis.(part two)

Eligibility Criteria:
Inclusion Criteria:

* Incurable metastatic gastrointestinal cancer
* Indication for first or second-line systemic treatment
* Measurable disease according to RECIST v.1.1
* CT of chest and abdomen less than 30 days old at time of treatment initiation
* Age at least 18 years
* ECOG performance status 0-2
* Clinically eligible systemic palliative treatment at investigators decision.
* Adequate bone marrow, liver and renal function allowing systemic chemotherapy
* Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable
* Written and verbally informed consent

Exclusion Criteria:

* Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with combination chemotherapy
* Other concurrent malignant tumor except non-melanoma skin cancer or carcinoma in situ cervicis uteri
* Pregnant (positive pregnancy test) or breast-feeding women
Implementation of Group Problem Management Plus (PM+) in Adult Syrian Refugees in Turkey: RCT (STRENGTHS)

To implement Group Problem Management Plus (PM+) in Syrian refugees with this RCT to evaluate feasibility, acceptability, effectiveness and cost-effectiveness of the culturally adapted Group PM+ intervention for adult Syrian refugees in Turkey.

The STRENGTHS (Syrian REfuGees MeNTal HealTH Care Systems) study is a 5-year study that started in January 2017 with funding from the European Commission Horizon 2020 scheme. Turkey is one of the eight sites in STRENGTHS project that this study will be conducted. The main aim of STRENGTHS in Turkey is to evaluate the feasibility, acceptability, effectiveness and cost-effectiveness of the culturally adapted psychological intervention Group Problem Management Plus (PM+) intervention for adult Syrian refugees in Turkey.

Study participants (n=380) will consist of adult Syrian refugees (18 years and older) in Turkey with self-reported functional impairment (WHODAS 2.0 \>16) and elevated psychological distress (K10 \>15.9). Participants will be randomly allocated either to the treatment group who will receive five sessions of PM+ or to the enhanced care-as-usual (E-CAU) group. Participants in the comparison group will receive E-CAU only. The primary outcome will be the decrease in psychological distress from baseline to three-month post-intervention assessment, measured through the Hopkins Symptoms Checklist (HSCL-25).

Eligibility Criteria:
Inclusion Criteria:

* Adults of 18 years or above
* Syrian under temporary protection status
* Arabic-speaking
* Elevated levels of psychological distress (K10 \>15) and reduced psychosocial functioning (WHODAS 2.0 \>16)

Exclusion Criteria:

* Acute medical conditions
* Imminent suicide risk or expressed acute needs/protection risks (e.g., a young woman who expresses that she is at acute risk of being assaulted or killed)
* Severe mental disorder (psychotic disorders, substance-dependence)
* Severe cognitive impairment (e.g., severe intellectual disability or dementia)
Diet/Activity of Mexican American and Anglo Children

To perform a follow-up study of physical activity and dietary behaviors and their determinants in 10- to 11-year-old Anglo and Mexican-American children from low- and middle-socioeconomic status (SES) families who were studied initially when they were 4 to 7 years old.

BACKGROUND:

It is well documented that the roots of cardiovascular diseases (CVD) are evident in childhood, and elevated levels of serum lipids, blood pressure and body fat are common in childhood. These risk factors are, in turn, related to childhood dietary and physical activity habits. To understand the early development of CVD, it is therefore important to study factors that influence diet and physical activity behaviors in children. Most studies concerned with the determinants of diet and physical activity in children are cross-sectional, limiting their utility for improving understanding of the development of these key health behaviors.

The study allowed prospective analyses of the behaviors over a significant portion of the prepubertal age range. Knowledge of the determinants, stability, and relationships of childhood dietary and physical activity behaviors to physiologic risk variables could be useful for setting priorities and designing public health interventions for the next generations of youth.

The major contribution of this San Diego SCAN study was in the longitudinal analysis of dietary and physical activity behaviors in children. The follow-up assessment of the 10-to 11-year-old cohort and their mothers produced data that substantially improved understanding of the determinants and tracking of children's dietary and physical activity behaviors, as well as their relations to CVD risk factors.

DESIGN NARRATIVE:

Selection of subjects studied was based on social learning/cognitive theory, which states that behaviors are a function of personal and environmental factors. The specific aims of the study were as follows: 1) To study the determinants of physical activity and dietary intake of fat, sodium, and calories, and changes in these behaviors in children from ages 4 to 10-11. 2) To determine the relationships between diet and physical activity practices and physiologic indicators of risk, such as blood pressure, adiposity, body mass, and serum lipoproteins at ages 4 to 10-11. 3) To describe the time trends and the degree of tracking of physical activity habits and nutritional intake of fat, sodium, and calories in children from ages 4 to 10-11. The study was renewed in 1999.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
The Role of Walnut Consumption on Sleep Quality

Walnuts have a unique nutritional profile, including the sleep-regulating hormone melatonin, tryptophan, and omega-3 fatty acids, the two latest nutrients involved in melatonin and serotonin synthesis. Although it has been claimed that walnuts may improve sleep, to the investigators' knowledge, no studies have been conducted to objectively determine the impact of walnut consumption on sleep and overall well-being. Therefore, this study aims to investigate the effect of daily walnut consumption on sleep parameters (such as quality and duration). Secondarily, it aims to investigate the impact of daily walnut consumption on body composition, eating behavior, and well-being.

The study to investigate the effect of daily walnut consumption on sleep quality will be conducted in an 18-week randomized crossover trial, in which participants will be initially assigned to intervention or control conditions for 8-weeks. After 2 weeks of washout, subjects will be crossed over to the alternate intervention and will continue for another 8 weeks. Note that throughout the whole study, each participant will attend 5 visits: 1 initial visit (baseline) and 2 visits in each one of the study conditions (intervention and control).

Eligibility Criteria:
Inclusion Criteria:

* BMI 19-26 kg/m\^2
* Habitual moderate exercise level
* No recent history of weight change exceeding 2.3kg (5lb) within the prior 3 months.

Exclusion Criteria:

* Nuts allergy
* Any acute or chronic diseases
* Smokers
* Any drugs or supplementations
* Any alimentary restrictions or specific diets
* Being a shift or night workers
* Being unable to give written informed consent.