cyrilzakka/clinical-trials huggingface dataset:
Rifaximin, Loperamide and the Combination to Treat Travelers' Diarrhea

Most cases of travelers' diarrhea are caused by bacterial pathogens which respond slowly to antibiotic treatment.The study was designed to determine the value of rapidly acting loperamide (imodium) combined with curative dose of the poorly absorbed rifaximin in travelers' diarreha treatment.

During short-term study, adult U.S. students in Mexico (n = 310) with acute diarrhea (≥ 3 unformed stools with enteric symptoms) were enrolled in a double-blind, randomized trial wherein they were given rifaximin 200 mg three times a day for 3 days (R) (n = 102), loperamide 4 mg initially followed by 2 mg after each unformed stool not to exceed 8 mg/day for 2 days (L) (n = 104) or both drugs in the same dosage schedule (L/R) (n = 104). The major outcome parameter was time from initiation of therapy until passage of the last unformed stool before becoming well (TLUS).

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria include: IRB approval; signing of a consent form;18 years of age or older, providing of an unformed pre-treatment stool; females must be non-pregnant and not nursing.

Exclusion Criteria:

* Exclusion criteria include: diarrhea longer than 72 hours; moderate or severe dehydration, pregnancy or breast feeding, receipt of trimethoprim-sulfamethoxazole, azalide, doxycycline, or a fluoroquinolone in the past week; unstable medical condition; hypersensitivity to rifaximin or rifampin; fever (\>100.6o F) or bloody diarrhea.
Fragmin In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism In Cancer Patients

To collect postmarketing data about Fragmin safety and efficacy in the treatment of deep vein thrombosis with or without pulmonary embolism in cancer patients.

Method: consecutive patient sampling. Patients were (are) included in the study in consecutive manner if they fulfilled the inclusion criteria and any of the exclusion criteria were not present.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patient of 18 - 70 years of age.
* Cancer patient with proven deep-vein thrombosis with or without pulmonary embolism confirmed by combination of clinical signs and symptoms, pulmonary hypertension on echocardiogram, X-ray examination of the lung and eventually perfusion/ventilation scan of the lung.

Exclusion Criteria:

* Bleeding
* Hypersensitivity to FRAGMIN® or other low-molecular weight heparins.
* Serum creatinine level \> 150 umol/l.
* Platelet count of less than 100 000 per cubic millimeter at the beginning of the therapy.
* Patient on oral anticoagulation therapy in the last 7 days.
Sildenafil and Stroke Recovery

This is a small, pilot randomized clinical trial of administering sildenafil citrate to individuals within 10 days of ischemic stroke who have motor impairment and who are undergoing inpatient rehabilitation compared to placebo. The primary outcome is motor recovery at one and three months.

Individuals who are within 4-10 days post ischemic stroke with arm hemiparesis or hemiplegia who are admitted to inpatient rehabilitation are randomized to receive either sildenafil citrate (25 mg once per day) or placebo for 14 days. These individuals receive usual rehabilitation and medical care. Primary outcomes are motor skills and walking speed at one and three months.

If willing and able, participants undergo an MRI to measure the integrity of the white matter pathways in the motor system using diffusion tensor imaging. Repeat MRIs are obtained at one and three months. The investigators will examine if such white matter integrity predicts response to the drug and if the drug facilitates changes in white matter.

Eligibility Criteria:
Inclusion Criteria:

1. between 4 and 9 days post-ischemic stroke;
2. admitted to inpatient rehabilitation;
3. cognitively able to provide consent or assent;
4. were living independently in the community prior to their stroke.

Exclusion Criteria:

1. hemorrhagic stroke or subarachnoid hemorrhage;
2. other neurological or psychiatric conditions deemed by the investigator to impair participation;
3. no previous stroke on same side of brain unless that stroke was cerebellar
4. moribound or not expected to live 6 months;
5. contraindications to taking sildenafil in pill or syrup form;
6. other medical conditions that would limit ability to participate in the study, specifically a) currently taking the P450 enzyme inhibitors (erythromycin, ketoconazole, itraconazole, saquinavir), b) currently taking the protease inhibitor ritonavir, c) currently taking nitrates or have a history of requiring nitrates treatment, d) have left ventricular outflow obstruction (i.e., aortic stenosis, idiopathic hypertrophic subaortic stenosis as confirmed by review of standard of care echo received before admission to rehabilitation), e) have severely impaired autonomic control of blood pressure, f) have previous history of symptomatic hypotension, g) have severely impaired hepatic function, h) is pregnant or become pregnant during the course of the study, i) Any medical condition which, in the opinion of the investigator, may compromise compliance with the objectives and/or procedures of the protocol.
7. scores \> 50 on the upper extremity section of the Fugl-Meyer or no walking/gait impairment

   For the MRI portion of the study only:
8. contraindication to MRI: ferrous metal in body, lead included body art, claustrophobia, pacemaker
9. allergic to or had previous reaction to gadolinium
Oxytocin and Social Behavior Over the Lifespan

This study will investigate if intranasal oxytocin (a hormone naturally produced in the body) promotes motivation for, and engagement in, social activities in older adults.

Using a double-blind and placebo controlled design, this study seeks to determine if a short course of exogenous oxytocin (OT) will induce changes in social activities in residentially housed older adults (OAs) during a 10-day treatment period, and after it ends. Because OT is associated with peri-reproductive behaviors, OT release in OAs is expected to be attenuated relative to younger adults. If OT release is low in OAs as we hypothesize, augmenting OT may increase their desire for social interactions, increase the frequency of participation in social activities and augment the number of and quality of social ties, thereby providing protection against disease, early death, cognitive decline, and depression. Research in rodents suggests that social interactions themselves may change chronic OT levels (Carter \& Keverne, 2002; Carter \& Altemus, 1997), in a positive feedback loop. In order to demonstrate OT as the causal mechanism, we propose to infuse oxytocin and then track the desire for, quantity of, and quality of social activities.

Eligibility Criteria:
Inclusion Criteria:

* residentially housed
* English fluency

Exclusion Criteria:

* non ambulatory
* severe psychiatric problems presently or in the recent past
* severe medical problems (e.g., cancer, diabetes, advanced heart disease)
* irregular heart beat
* treatment using psychoactive medications (other than antiepileptics, mood stabilizers, or Ambien)
* inability to adequately communicate with the research team
* treatment with an experimental drug
* excessive fatigue suggesting hypothyroidism
Validation of the ICH Score for the Prediction of 12-month Functional Outcome in Patients With Primary Intracerebral Hemorrhage

The goal of this observational study is to analyze the validity of the intracerebral hemorrhage (ICH) Score and a new modified ICH score for the prediction of 12-month functional outcome in patients with primary ICH.

Participants who were admitted to NTUH rehabilitation ward will be followed up to 12 months after the onset of ICH. The follow-up will be conducted by phone interviews.

The ICH Score had been utilized to predict the 30-day mortality after acute intracerebral hemorrhage (ICH), but there's still no reliable tool in predicting the long-term functional outcome in ICH patients. Recently, there have been some studies that use ICH score to predict the prognosis of functional outcome in ICH patients. However, most studies included patients in western societies. Relevant studies in Taiwan were scarce. The present study will follow up the patients with ICH, who were admitted to NTUH rehabilitation ward, up to 12 months post stroke. The follow-up will be conducted by phone interviews at certain time after the onset of ICH. Investigators aim to analyze the validity of the ICH Score for the prediction of 12-month functional outcome in patients with primary ICH. Investigators will also add other variables to see if the revised score could better predict the prognosis among ICH patients.

Eligibility Criteria:
Inclusion Criteria:

* Aged 20 years or older
* Had been admitted to a neurology, neurosurgery, or rehabilitation ward with a diagnosis of primary intracerebral hemorrhage (ICH)
* Had a diagnosis of ICH confirmed by a brain computed tomography (CT)
* Have written informed consent given by themselves or by their legal representative

Exclusion Criteria:

* ICH related to aneurysm, arteriovenous malformation, or trauma
* Died before discharge
Efficacy of Hydrotherapy in Peripheral Neuropathy

The purpose of the study is to evaluate the efficacy of hydrotherapy on pain and balance in patients affected by neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* patients affected by peripherical neuropathy able to walk

Exclusion Criteria:

* pain of water
* medical contraindications at treatment in heated swimming pool
RCT of Ballon Technique VS Selective Ophthalmic Artery Infusion For the Retinoblastoma Patients

Retinoblastoma is the most common intraocular tumor in children..IAC--Targeted Treatment for Intraocular Retinoblastoma,Is minimally invasive procedure that infuse chemotherapy select into the ophthalmic artery, its can increasing the drug concentration reaching the tumor and reducing systemic toxicity compared with traditional intravenous treatment.: one is Ballon technique , another is selective ophthalmic artery infusion.This study evaluates the difference of Ballon technique and selective ophthalmic artery infusion effect in the treatment of retinoblastoma. Half of participants will receive, Ballon technique while the other half will receive selective ophthalmic artery infusion

Delivering the chemotherapeutic agent in the arterial system through the ophthalmic artery transforms the treatment of retinoblastoma from systemic chemotherapy to local chemotherapy. Two alternative means can be used,The purpose of this study is to show that Ballon technique and SOAI delivered directly through the artery supplying the eye (ophthalmic artery) to patients with retinoblastoma is a safe and effective treatment.

Eligibility Criteria:
Inclusion Criteria:

1. No age limit, no gender limit, monocular or binocular affected;
2. New diagnosed cases, without any previous treatment;
3. Clinical diagnosed as retinoblastoma, and in group C, D or E according to IIRC standard; Binocular affected with one eye enucleated;
4. Normal bone marrow function
5. Normal liver function
6. Normal kidney function
7. Normal coagulation function
8. To be willing to take part in the clinical trial and sign the informed consent form; 9. To be willing to have these tumor sites surgically removed and do the follow up accordingly.

Exclusion Criteria:

1. Diagnosis is not clear;
2. With other sever ocular diseases (for example: neovascular glaucoma, iris neovascularization);
3. With sever systemic diseases, include abnormal liver or kidney function, abnormal routine blood test or coagulation function, congenital heart diseases and dysaudia;
4. Took part in other clinical study within 3 months;
5. Refuse to take part in this clinical study;
6. Is not willing to do the follow up accordingly or follow up less than 2 times.
A Study of Angiotensin-II Receptor Blocker on Cardiovascular Remodeling (VALUE Trial)

The purpose of this study is to evaluate the effectiveness and mechanism of action of Losartan in the treatment of coarctation of aorta.


Eligibility Criteria:
Inclusion Criteria:

* B/S1 hypertension
* SBP 100-139 average based on 3 office measurements.
* Age 18 or Older
* Previous COA Repair

Exclusion Criteria:

* Currently on beta blocker (BB) therapy
* Pregnancy/lactating
* eGFR\<30
* Hyperkalemia (serum potassium \>5.5mmol/L)
* Severe Aortic or Mitral valve stenosis or regurgitation
* Epicardial CAD diagnosis
* Received antihypertensive medications within the past year
Contraception Decision Aid Use and Patient Outcomes

The purpose of this study is to assess the impact of a contraception decision aid mobile application on: (a) decisional conflict, (b) reproductive health self-efficacy, (c) contraceptive and reproductive health literacy, and (d) contraceptive use intentions.

After being informed about the study and the potential risks, all participants giving written informed consent will be randomly assigned in a double-blind manner (participant and investigator) in a 1:1 ratio to complete an interactive contraception decision aid health questionnaire (Tuune) or a standard medical questionnaire (Control). After, all participants will be asked questions assessing: (a) decisional conflict, (b) reproductive health self-efficacy, (c) contraceptive and reproductive health literacy, and (d) contraceptive use intentions.

Eligibility Criteria:
Inclusion Criteria:

* Females 18 to 34 years of age who enroll to participate in the study, which will take place on the campus of Texas Christian University.

Exclusion Criteria:

* Women who are currently pregnant or breastfeeding.
* Women who wish to become pregnant within the next 12 months.
Adsorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled SPD557 in Volunteers

Phase I study to evaluate the excretion of radioactivity, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of \[14C\] SPD557 in healthy male volunteers aged 18 to 50 years (inclusive).The purpose of this study is to investigate how and how quickly SPD557 or its break down products are excreted by analysing blood, faeces and urine samples collected during the study.


Eligibility Criteria:
Key Inclusion Criteria:

* Males ages 18 to 50 years
* Have a body mass index (BMI) of ≥18.5 and ≤30 kg/m2
* Subject is willing to comply with any applicable contraceptive and sperm donation requirements

Key Exclusion criteria:

* Have participated in a \[14C\]-study within the last 6 months.
* Exposure to clinically significant radiation within 12 months prior to dose (for example, serial X-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring).
* Male subjects who consume more than 21 units of alcohol per week or 3 units per day.
* Subjects who report typically having more than 2 bowel movements per day, less than 3 bowel movements per week or those whose bowel habits have changed significantly within 30 days
OCT Guided Punctal Stenosis Management

This is a clinical trial study that was conducted on patients with punctal stenosis.We studied the diameter of stenosed puncta before and after treatment with preserved free steroid eye drops using AS-OCT.

The study was conducted on 40 eyes of 24 patients have acquired inflammatory punctal stenosis and 20 eyes of 10 patients of normal asymptomatic subjects as control group. We studied the external punctal diameter, visibility of the internal punctum and punctal depth before treatment using AS-OCT, and then patients were re-evaluated after one month of treatment with preservative free methylprednisolone 5% eye drops.

Eligibility Criteria:
Inclusion Criteria:

* Patients have acquired inflammatory punctum stenosis complaining of epiphora of different etiologies.

Exclusion Criteria:

* Previous lacrimal surgery.
* Lid margin malposition such as ectropion, entropion or lid retraction.
* Medial lid masses obscuring punctum.
* History of ocular trauma involving lid margin or punctum.
Phenotype-Tailored Lifestyle Intervention for Obesity: a Randomized Trial

The purpose of this study is to develop an evidence-based precision medicine approach for obesity that enhances weight loss and promotes weight loss maintenance.


Eligibility Criteria:
Inclusion:

• men or women between 18 to 65 years with obesity (BMI\>30kg/m2).

Exclusion:

* weight change greater than 3% in the previous 3 months
* history of bariatric surgery and bariatric endoscopy
* untreated psychiatric disorders including binge eating disorders and bulimia
* current use of AOMs
* history of use of medications affecting weight or energy intake or energy expenditure in the last 6 months
* history of type 1 diabetes mellitus or uncontrolled medical conditions (e.g., uncontrolled hypertension)
* women who are pregnant or plan to become pregnant,
* any condition that limits their participation in the study
* Principal Investigator discretion
Antiemetic Efficacy and Safety of Dexamethasone in Obstetric Surgical Patients

This is a randomised controlled double blinded clinical trial to determine the antiemetic efficacy and safety of either 8 mg of dexamethasone or normal saline (placebo) given 1 hour before induction of either spinal or general anaesthesia in 2 arms (of 150 each).


Eligibility Criteria:
Inclusion Criteria:

* all woman above 18 years old presenting for obstetric surgery and have consented to study.

Exclusion Criteria:

* refusal/unable to consent,
* younger than 18 years old,
* hypertensive,
* diabetic,
* preeclamptic,
* sepsis,
* ASAIIIE plus.
IADAPT-Third Phase

The goal of this research study is to compare a booklet and a DVD for patients with knee osteoarthritis, osteoporosis, or rheumatoid arthritis.

If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups:

* Group 1 will watch a DVD and receive a booklet of information about their disease type (knee osteoarthritis, osteoporosis, or rheumatoid arthritis).
* Group 2 will read a booklet about their disease type.

All the materials including the DVD, booklet, and questionnaires will be in English and Spanish. You may choose which language you prefer to use while watching and/or reading the materials.

You will be asked to complete questionnaires before and after watching the DVD or reading the booklet. We will ask you about how the material made you think and feel and how easy or hard the material was to understand.

You will also fill out short questionnaires that include questions about your demographic information, your health, your thoughts about bone/joint disease, how you might choose treatments for bone/joint disease, and how you make treatment decisions. These questionnaires will take up to 45 minutes to complete in the clinic.

This first visit will take about 60-90 minutes total to complete. If you are unable to complete this first visit today you will need to complete it within the next two weeks.

You will be asked to fill out these questionnaires again 3 months and 6 months later, by mail. The study staff will mail you the questionnaires, along with a postage-paid return envelope that you can use to send the questionnaires back. If you prefer you can also complete the questionnaires over the phone or the research staff can meet you at the clinic or your home to complete the questionnaires at 3 and 6 months.

Your participation on this study will be over after you have mailed back the 6-month questionnaires.

This is an investigational study.

Up to 828 participants will take part in this multicenter study.

Eligibility Criteria:
Inclusion Criteria:

1. Knee Osteoarthritis (OA): (a) age 45 and over (b) prior diagnosis of knee OA (unilateral or bilateral) by a physician.
2. Rheumatoid Arthritis (RA): (a) age 18 and over, (b) compliance with American College of Rheumatology criteria for the diagnosis of RA, (c) and disease duration \< or = 10 years
3. Osteoporosis (OP): (a) female gender, (b) age 45 and over, (c) and at least 3 years post-menopausal
4. Adequate cognitive status as determined by the research assistant (see description in "Recruitment Eligibility")
5. Ability to communicate in English or Spanish language without a translator
6. Have access to a telephone

Exclusion Criteria:

1. Hospitalized
2. Patients with RA or knee OA who also have any other connective tissue disease or spondyloarthropathy.
3. Patients with diagnosis of RA and disease duration (\>10 years)
4. Patients who do not sign the informed consent
MP1032 Treatment in Patients With Moderate to Severe COVID-19

The purpose of this study is to evaluate the efficacy and safety of MP1032 with standard of care (SoC) verses placebo with SoC in hospitalized adults participants with moderate to severe coronavirus disease 2019 (COVID-19).


Eligibility Criteria:
Key Inclusion Criteria:

* Participant is admitted to hospital and has a positive severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) test by standard reverse transcription-polymerase chain reaction (RT-PCR) assay or equivalent test
* Participant has the presence of any symptom(s) suggestive of moderate or severe systemic illness with COVID-19

Key Exclusion Criteria:

* Participant, in opinion of the investigator, is not likely to survive \>=48 hours beyond Day 1
* Participant has a diagnosis of asymptomatic COVID-19, mild COVID-19, or critical COVID-19 on Day 1
* Participant has a documented medical history of infection with hepatitis A, B, C, or with human immunodeficiency virus (with a detectable viral load and CD4 count \<500 cells per micro liter), or a documented active infection with tuberculosis.
* The Participant has clinically significant electrocardiogram (ECG) abnormalities at screening

Other protocol defined inclusion/exclusion criteria may apply