cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety and Efficacy of RDX5791 for the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS-C)

This is a multi-center, Phase 2, randomized, double-blind, placebo controlled study of RDX5791 in subjects with IBS-C. Patients who are 18 to 75 years old, meeting the definition of IBS-C as defined by the Rome III Criteria for the Diagnosis of IBS will undergo a battery of screening procedures to determine eligibility for the trial.

The study will consist of a 2-week treatment-free screening period, a 4-week blinded treatment period, and a 2-week treatment-free follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Subject meets Rome III criteria for IBS-C
* If \> 50 years old, colonoscopy evaluation within 10 years
* All ages, negative colonoscopy if any "warning symptoms"
* Active disease during 2-week screening period
* Compliant with IVRS

Exclusion Criteria:

* Subjects has IBS-D, IBS-M or un-subtyped IBS according to Rome III criteria
* Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract
* Use of medications that are known to affect stool consistency
* Subject has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments or prevent completion of study
Establishing a Descriptive Cohort of Patients Cared for Operation on the Spine

This study aims to:

1. describe the monitoring of patients treated for spinal disorders.
2. create a comprehensive database of reliable and readily exploitable quickly to produce a library of cross publications between orthopedic surgery and neurosurgical services. This database will include clinical, functional , radiographic , educational, social and professional data.
3. obtain a cohort of patients in the comprehensive range of spinal pathologies.
4. standardize data collection in this cohort with similar national projects.


Eligibility Criteria:
Inclusion Criteria:

* The patient must be given free and informed consent and signed the consent
* The patient must be affiliated or beneficiary of a health insurance plan
* The patient is available for a 24-month follow-up
* The patient is at least 18 years old
* The patient has a symptomatic spinal pathology requiring surgical or orthopedic treatment

Exclusion Criteria:

* The patient is under judicial protection, guardianship or curatorship
* The patient refuses to sign the consent
* It is not possible to give informed information to the patient
* The patient does not fluently read French.
* the patient is not available for a 24-month follow-ip
Eczema Action Plan Improves Patient and Caregiver Understanding and Perception of Atopic Dermatitis Management

This is a randomized controlled study. The control group will consist of adult subjects and the caregivers of pediatric subjects with an established diagnosis of atopic dermatitis (AD), who are visiting a dermatologist for a standard AD office visit. In the control group, only verbal instruction (VI), the standard of care, will be provided. The intervention group will receive a similar VI with an additional component: an eczema education handout, as well as an individualized written Eczema Action Plan (EAP) that will illustrate how to recognize disease flare-ups and subsequent remissions. In addition, the EAP will provide detailed step-wise instructions regarding treatment modifications for the above-mentioned variations in treatment severity. To ensure that all patients ultimately receive the same level of care, the control group will also receive an EAP at the end of their consultation.

The goal of this study is to assess subjects' perception in the provider's use of an EAP and its effectiveness in helping patients understand their disease and management plan. In order to evaluate the primary end-points, subjects in both the control and treatment groups will be asked to complete post-consultation surveys. Four post-consultation outcomes will be measured: (1) caregivers' understanding of the disease and treatment, (2) caregivers' comfort level in following the EAP at home, (3) caregivers' anxiety level in managing the AD at home, and (4) caregivers' preference for VI + EAP as compared to VI alone, EAP alone, or neither the EAP nor the VI.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older fulfilling Hanifin and Rajka diagnostic criteria for AD, or adult caregivers for patients younger than 18 years of age, and the ability to comprehend study materials in English

Exclusion Criteria:

* Prior exposure to written action plans
A Case Control Study of the Prevalence of Pulmonary Hypertension in Patients With Myeloproliferative Diseases.

Pulmonary hypertension (PH) is defined as a group of diseases characterised by an elevated mean pulmonary artery pressure (Ppa) ≥25 mmHg at rest. Recently, chronic myeloproliferative diseases (CMPD) associated with pulmonary hypertension were included in the group 5 category, corresponding to PH for which the aetiology is unclear and/or multifactorial. CMPD include chronic myelogenous leukaemia, chronic neutrophilic leukaemia and chronic eosinophilic leukaemia (which primarily express a myeloid phenotype and polycythaemia vera), idiopathic myelofibrosis, and essential thrombocytosis in which erythroid or megakaryocytic hyperplasia predominates.

The purpose of this research:

1. Assess Prevalence of PH in patients with CMPD in Northern Israel
2. Describe the demographics and clinical course in patients with CMPD who are diagnosed with PH.

study will include the following:

* sex
* age
* BMI
* ethnicity
* age diagnosed with Myeloproliferative disease
* clinical manifestations of the myeloproliferative disease
* JAK2 mutation
* known hematological complications

Eligibility Criteria:
Inclusion Criteria:

1) consenting patients diagnosed with a myeloproliferative disease

Exclusion Criteria:

1) Refusal to have an echocardiogram or answer the St. George respiratory questionnaire
A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction

The purpose of this trial is to investigate the potential benefits/risks regarding pretreatment with prasugrel in non-ST-elevation myocardial infarction (NSTEMI) participants with elevated troponin scheduled for coronary angiography/percutaneous coronary intervention (PCI).

This trial consists of two arms. One arm is a non pre-treatment arm. Participants in this arm will receive placebo immediately after NSTEMI diagnosis and prior to the diagnostic coronary angiography. A 60 mg prasugrel loading dose will be given immediately after coronary angiography when proceeding to PCI. Subsequently, participants will receive daily maintenance doses of prasugrel until day 30. Participants who are greater than or equal to 75 years of age or who have a body weight less than 60 kilograms (kg) will receive 5 mg oral dose daily. All others will receive a 10 mg oral daily maintenance dose for 30 days.

The other arm is a pre-treatment arm where participants will receive a split loading dose regimen with 30 mg of prasugrel administered immediately after NSTEMI diagnosis and prior to diagnostic coronary angiography. The remainder of the loading dose (30 mg) will be administered when the participants are proceeding to PCI. Subsequently, participants will receive daily maintenance doses of prasugrel until day 30. Participants who are greater than or equal to 75 years of age or who have a body weight less than 60 kg will receive 5 mg oral dose daily. All others will receive a 10 mg oral daily maintenance dose for 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Have acute coronary syndrome consisting of non-ST-segment elevation with elevated troponin
* Scheduled for coronary angiography/PCI greater than or equal to 2 and less than 24 hours from time of planned randomization, but no more than 48 hours from randomization
* Must be eligible for treatment with prasugrel, aspirin (ASA), and a glycoprotein IIb/IIIa receptor (GPIIb/IIIa) inhibitor as per respective labels
* May be on a maintenance dose of clopidogrel 75 mg and must be able to switch to prasugrel
* Must be enrolled at a cardiac catheterization laboratory hospital or at a hospital/ambulance service affiliated with a cardiac catheterization laboratory hospital

Exclusion Criteria:

* Present with ST-segment elevation myocardial infarction (STEMI) at the time of entry or randomization
* Have cardiogenic shock
* Have refractory ventricular arrhythmias
* Have New York Heart Association (NYHA) Class IV congestive heart failure (CHF)
* Have had cardiac arrest within 1 week of entry or randomization into the study
A Multicenter Study to Evaluate the ROX Arteriovenous Coupler in Patients With Treatment-Resistant Hypertension

The purpose of this study is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of treatment-resistant hypertension must be made on the basis of current findings, medical history, and physical examination

Exclusion Criteria:

* Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study.
Preoperative Topic Diclofenac as a Prevention of Postoperative Macular Edema in Patients With Diabetic Retinopathy

Diabetes has many negative effects on patients' general health. Among many other consequences it speeds up the cataract formation and that is why diabetic patients need cataract surgery very often. The known side effect of cataract surgery even in otherwise healthy patients is postoperative edema of the back of the eye (what causes decrease of vision), which has greater incidence especially in patients who have diabetic eye problems. The cause of that might be the intraocular inflammation which was previously demonstrated to be significantly more prominent in patients with untreated diabetic eye problems. Therefore we will examine if the 7 day use of anti-inflammatory eye drops prior to the cataract surgery prevent the formation of the edema of the back of the eye.


Eligibility Criteria:
Inclusion Criteria:

* presence of nonproliferative diabetic retinopathy
* presence of the cataract (LOCS 2-3)

Exclusion Criteria:

* other chronic or acute eye diseases
* hypersensitivity to any component of the diclofenac eye-drops patients on oral anticoagulant therapy
* allergy to salycilates
Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients

The purpose of this study is to determine the safety, tolerability and efficacy of Amlodipine and Olmesartan medoxomil among Hypertensive Filipino patients.


Eligibility Criteria:
Inclusion Criteria:

* Filipino hypertensive subjects ages 18-65 years old whether naive or currently taking any other anti-hypertensive or those on monotherapy using CCBs or ARBs whom they want to shift on a fixed dose combination drug

Exclusion Criteria:

* Patients with contraindications to any of the component of the fixed drug (amlodipine or olmesartan medoxomil) or with malignant or secondary hypertension
Review of Molecular Profiling-Real Time Polymerase Chain Reaction (Rt-Pcr) in Unknown Primary Cancer

This will be a retrospective review of 30 patients with unknown primary cancer who have had commercially available RT-PCR assays performed on biopsied tumors, in order to determine if the assay results are consistent with clinical features and useful for planning initial therapy or changing therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with RT-PCR testing completed since commercialization of the RT-PCR assay in 2007.
Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS

A placebo-controlled, randomized, double-blind, parallel group, phase III multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. Subject enrollment may begin in the hospital and will continue following release from the hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (4-12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.

This is an event driven study to reach statistical power given all other assumptions. Subjects will visit the clinic 1 month after randomization and at regular intervals thereafter. Additionally, for any subject prematurely discontinuing study medication, assessments will be conducted every 6 months for the collection of study endpoints.

Those who are likely to qualify will undergo Genotype Assay Testing to evaluate genetic determination or the presence of the AA genotype. The test is investigational and test procedures are Roche Molecular Diagnostics protocol ADCY9-COB-389.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with the appropriate genetic background and recently hospitalized for ACS (between 4 and 12 weeks following the index event), will be enrolled in this trial.
* AA genotype at variant gene as determined by Genotype Assay testing, conducted at a designated investigational testing site (ITS)
* Clinically stable, ie, free of ischemic symptoms at rest or with minimal exertion for at least 1 week prior to randomization
* Prior to randomization, subject must have evidence of guidelines-based management of LDL-C, at a minimum to include medical and dietary treatment to a target level of LDL-C \<100 mg/dl (\<2.6 mmol/L).

Exclusion Criteria:

* Females who are pregnant (negative pregnancy test required for all women of child-bearing potential at Visit 2, Day 0) or breast-feeding
* Women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for \>12 months) who are not using at least one method of contraception\*
* New York Heart Association (NYHA) Class III or IV heart failure
* Last known hemoglobin \<10 g/dL
* Index ACS event presumed due to uncontrolled hypertension

(\*) Varies by region
The Prevalence of Vitamin D Deficiency in Patients With Alzheimer's Disease

Recent studies indicate that there is a relationship between cognitive decline and vitamin D deficiency. Up to now, no study has investigated the prevalence of vitamin d deficiency in patient with Alzheimer's disease. Our aim is to investigate the prevalence of vitamin D deficiency and analysis the associated characteristics in patients with Alzheimer's disease.

Vitamin D has many physiological functions via skeletal and extra-skeletal effects. Nowadays, it is well known that vitamin d deficiency causes to an increase in disease burden. As the role of vitamin D, the maintenance of balance, the improvement of muscle power, and the augmentation of innate immunity were proven. Some recent studies showed that vitamin D deficiency associates with cardiovascular diseases, autoimmune diseases, and the risk of cancer.

Vitamin D carries out your functions by vitamin d receptors (VDR) located in many cells. Brain neurons and glial cells are including VDR's. It is presumed that the functions of vitamin d in neurons are the regulation of neurotransmission, neuron protection, and immunomodulation. Also,vitamin D has a role in brain development and maturation. Except the functions in central nerve system, vitamin D has effects on peripheral nerve system. It was reported that nerve transduction velocity decreased in vitamin d deficiency.

Vitamin D deficiency and Alzheimer's disease are major public health problems that their incidences increase in advanced ages.Recent studies indicate that there is a relationship between cognitive decline and vitamin D deficiency. VDR receptors in brain specially in hippocampus, hypothalamus, limbic system, subcortical and spinal motor areas were determined.

Up to now, no study has investigated the prevalence of vitamin d deficiency in patient with Alzheimer's disease. Our aim is to investigate the prevalence of vitamin D deficiency and analysis the associated characteristics in patients with Alzheimer's disease.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have Alzheimer's dementia and their diagnosis must be made according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer Disease and Related Disorders Association (NINCDS/ADRDA) and DSM-IV criteria
* The informed consent form must be given by patients and/or their representatives

Exclusion Criteria:

* if the causes of dementia (lewy body dementia, vascular dementia, pick disease, frontotemporal dementia...) is out of Alzheimer's dementia,
* having chronic liver disease and/or end-stage renal disease
* if the informed consent form is being withdrawn
Expression of MCM5 in Urine in Patients With Urothelial Cancers

In patients with non-muscle-invasive bladder cancer, the development and introduction to the clinical practice of an adequately accurate biomarker may allow to limit the indications for performing control cystoscopy. Thus, it will reduce the discomfort and stress of patients, the risk of complications of the invasive procedure and probably significantly reduce the costs incurred by healthcare systems.

The aim of the present study is to determine the usefulness of the determination of MCM5 protein expression in the urine of patients with urinary bladder or upper urinary tract cancer.


Eligibility Criteria:
Inclusion Criteria:

* age \>18 years,
* written consent to participate in the study,
* ability to void and collect \>50ml of urine,
* recurrent bladder cancer confirmed by cystoscopy (group 1) or upper urinary tract tumor confirmed by imaging studies (group 2) or no history of urological/gynecological cancers (controls)

Exclusion Criteria:

* urinary tracy infection,
* nephrolithiasis
Effectiveness and Mechanism of Online Peer Companion Intervention on Children With Autism Spectrum Disorders

The goal of this interventional study was to examine the effectiveness and mechanism of online peer companion intervention (OPCI) on the social abilities and mental health of ASD children. The main questions it aims to answer are:

1. Whether OPCI is effective on the social abilities and mental health of ASD children;
2. What impact does OPCI have on the social abilities and mental health of ordinary children;
3. What impact does OPCI have on the mental health of both children's parents;
4. What are the mechanisms of OPCI on ASD children.


Eligibility Criteria:
Inclusion Criteria of ASD Children:

* 7-15 years old and diagnosed as mild ASD;
* Basic ability to speak independently and fluently communicate with peers;
* Could use mobile phones, tablets, computers, or other electronic devices for this online intervention.

Exclusion Criteria of ASD Children:

* Diagnosed as moderate or severe ASD;
* Unable or unwilling to communicate with peers independently
* No phones or other alternative electronic devices for the intervention Inclusion

Criteria of Ordinary Children:

* 9-18 years old with normal development, no diagnosis of ASD, learning disabilities, ADHD, and other mental disorders;
* Lively and outgoing, able to assume the role of topic organizer in communication with peers;
* Could use mobile phones, tablets, computers, or other electronic devices for this online intervention.

Exclusion Criteria of Ordinary Children

* Diagnosis of ASD or other neurodevelopmental and mental disorders;
* Introverted or unwilling to play with peer ASD children
* No phones or other alternative electronic devices for the intervention
Outpatient Percutaneous Coronary Intervention

To determine the safety and feasibility of same day discharge after elective coronary percutaneous intervention in a selected stable patient population. The hypothesis to be tested is that in an appropriately selected stable coronary artery disease population post percutaneous coronary intervention, early discharge is safe and feasible.

A select stable population of patients undergoing percutaneous coronary intervention are randomized to standard of care in-hospital stay for one night or early discharge to a nearby hotel. During PCI, patients receive bivalirudin as their anti-coagulant and also must be eligible for an angioseal closure device. Patients that stay overnight in the hotel must be accompanied by a family member. They return to the cath lab the next day for groin check and blood work. Satisfaction questionnaires are filled out by all patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stable coronary artery disease scheduled for elective percutaneous coronary intervention

Exclusion Criteria:

* Patients with acute coronary syndrome, patients with an MI within 30 days, an ejection fraction \<30%, those with history of IV Dye allergy, creatinine level\>2.2, those with increased risk of infection, those with history of bleeding diathesis or anemia (hemoglobin\<11.0 g/dl, platelets \<100,000 tho/ul)
Controlled MAP in the Brain Injury Patient (COMAT Study)

The goal of this randomized controlled trial will be to show that the use of a novel automated system to guide vasopressor administration in brain injury patients will results in more time spent with a mean arterial pressure (MAP) within the predefined MAP (+/- 5 mmHg of the target MAP) compared to patients managed without any automated system (manually management)

In brain injury patients, the maintenance of MAP within a very narrow range is desired to avoid complications related to hypoperfusion (undertreatment) or hypertension (over treatment). However, the MAP needed to reach can vary over time based on intracranial pressure. Additionally, it is well know that the nurses in the Intensive care unit managed multiple patients simultaneously and cannot dedicate 100% of his-her time to adjust drugs infusions. Using a novel automated system can overcome this issue and may lead to more time in MAP target (+/- 5mmHg) than the traditional management.

After initial rescuscitation of the patients, patients in both groups will have the same baseline maintenance fluid administration of 1-2 ml/kg/h of crystalloid solution and additionnal fluid boluses administered following the EV1000 monitoring device. The only difference will be the management of vasopressor titration (manual by nurses vs automated via a closed-loop system)

Eligibility Criteria:
Inclusion Criteria:

* severe brain injury patients (Glasgow score \<9), intubated, ventilated and sedated.

Exclusion Criteria:

* Glasgow score \> 8
* Bilateral mydriasis at the initial management (Ambulance and first hour of arrival)