cyrilzakka/clinical-trials huggingface dataset:
Observational Study of Sifrol® in Patients With Primary Restless Legs Syndrome (RLS)

Study to evaluate treatment effect of pramipexole on RLS severity as measured by IRLS, CGI-I and RLS-6 and to evaluate the time needed to reach maintenance dose of Pramipexole (PPX)


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from primary RLS who are planned to be initiated on treatment with pramipexole as part of the routine care could be included into the study
* Patients not pre-treated with any dopaminergic agent (de novo patients) or patients pretreated with dopaminergic medication
* Male or female patients of any age

Exclusion Criteria:

* Treating physicians are asked to consider the regulations described in the Summary of Product Characteristics (SPC) for the treatment with pramipexole
Mobile-based Peer Mentoring for Smoking Cessation

Despite the availability of a variety of effective treatments for smoking cessation, uptake of treatments is low. The increasing use of smartphone technology presents an exceptional opportunity to expand access to low-cost smoking cessation services. In this pilot study, the investigators will use a text-messaging platform to test peer mentoring for smoking cessation, delivered by former smokers. While peer mentoring is a common approach to health behavior change, it has rarely been used to maximum effect by smoking cessation programs. The text-messaging platform serves as the basis for a randomized controlled trial to test the effectiveness of peer mentoring for smoking cessation.

This pilot will include approximately 200 U.S. adult smokers who will be randomly assigned to a peer mentor or not. Participants in the control group will receive automated text messages used in SmokefreeTXT, a nationwide text-messaging service sponsored by the National Cancer Institute (NCI) in which users receive one to five automated messages per day for up to eight weeks. Smokers in the intervention group will receive a modified version of the same automated messages from SmokefreeTXT, but with additional personalized messages from an assigned peer mentor. Mentors will provide responses to specific questions or comments a smoker may have after receiving the automated messages.

The intervention will last 8 weeks. The study includes primary outcomes to measure the acceptability, engagement, user experience, and early efficacy of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Current resident of the U.S.
* Smoked 100 or more cigarettes in lifetime
* Current cigarette smoker
* Access to a device that can take pictures to be uploaded to a website
* Willing to complete a salivary cotinine test

Exclusion Criteria:

* Not a current user of nicotine replacement therapy
* Not a current user of electronic cigarettes
TMC435 HPC1004 - Phase I Study Investigating the Pharmacokinetics of TMC435 in Healthy Chinese Volunteers

The purpose of this study is to assess the pharmacokinetics, safety and tolerability of single and multiple oral doses of TMC435 in Chinese healthy volunteers. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.

TMC435 is being investigated for the treatment of chronic hepatitic C infection. The results of this study will provide dosing recommendations for the administration of TMC435 in Chinese HCV-infected patients. This is a Phase I, open label (both participant and investigator know the name of the medication given at certain moment), randomized (study medication is assigned by chance) study to investigate the pharmacokinetics, safety and tolerability of TMC435 after single and repeated intakes. Each participant will receive 2 treatments. First, participants will receive TMC435 as a single dose of 100 or 200 mg. Thereafter, in the multiple dose part, 100 or 200 mg TMC435 will be administered during 5 consecutuve days every morning. Both treatments will be administered with food. There will be a washout period of at least 72 hours between the 2 treatments. The main focus of the trial is the pharmacokinetic characteristics (level-profile of TMC435 over time in the blood stream). This evaluation requires multiple blood samples from Day 1 till Day 3 in the first session and from Day 1 till Day 11 in the second session. Safety assessments (blood and urine tests, blood pressure, pulse, electrocardiogram, and physical examination) will follow a different schedule and will be performed during each treatment period, up to 4 weeks after the last. Each volunteer participate in 2 treatments, i.e., single dose period and multiple dose period. In the single dose part, planned doses will be 100 or 200 mg TMC435. In the multiple dose part, TMC435 will be administered during 5 consecutive days every morning.

Eligibility Criteria:
Inclusion Criteria:

* Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram. Body Mass Index of 18.0 to 30.0 kg/m² and non-smoker or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months.

Exclusion Criteria:

* Infection with Hepatitis A, B or C virus
* infection with the Human Immunodeficiency Virus (HIV)
* Women who are pregnant or breastfeeding
* History of, or any current medical condition which could impact the safety of the participant in the study.
Motor Development of Normal Children

The goal of this type of study: observational study is to compare motor development between urban and rural regions in pre-school age children. The main questions it aims to answer are:

* Is there difference in gross motor development of normal children aged from four to six years between urban and rural areas?
* Is there difference in fine motor development of normal children aged from four to six years between urban and rural areas?

Participants will be asked to perform tasks of bruininks-oseretsky test of motor proficiency, second edition.

Researchers will compare urban group and rural group to see if there is any difference in motor development.


Eligibility Criteria:
Inclusion Criteria:

1. Pre-school normal children of both sexes.
2. Age will range from four to six years.

Exclusion Criteria:

1. Past history of any diseases or injuries during pregnancy and labor period.
2. History of cardiac or respiratory diseases.
3. Neurological disorders.
4. Visual or auditory defects.
5. Congenital or acquired deformities
Influence of the Number of Layers of a One Bottle Adhesive on the Longevity of Composite Restorations in Primary Molars

The aim of this study is to determinate the influence of an alternative adhesive application protocol (i.e. consecutive application of an extra adhesive layer)on restoration longevity in primary molars.

Adhesive systems based on total etch technique remains the most popular products among dental practitioners. These systems are based on the use of an acid conditioner to remove the smear layer and demineralize the enamel and dentin. After the removal of the conditioner by rinsing, a mixture containing the primer and adhesive - i.e. one bottle adhesives - is applicated over the demineralized tissues. The polymerization of the adhesive monomers into microporosities created by acid conditioning forms the structure knowing as hybrid layer or resin-dentin interdifusion zone. A common problem related to total etch technique is the incomplete infiltration of adhesive monomers through demineralized dentin, resulting in the presence of a zone of unprotected collagen fibrils beneath the hybrid layer that is prone to enzymatic degradation. According to some laboratory studies, consecutive application of multiple adhesive coats results in quantitative and qualitative improvements in dental adhesion. In addition to increasing the values of bond strength to dentin, consecutive application of multiple adhesive layers enhances the infiltration of adehesive monomers through demineralized dentin, resulting in a more homogenous hybrid layer.

Eligibility Criteria:
Inclusion Criteria:

* Presence of two or more pairs of caries lesions in occlusal or occluso-approximal surfaces of primary molars

Exclusion Criteria:

* Systemic diseases in which dental treatment is a risk to patient's life
* Bruxism
* Orthodontic appliance
* Absence of occlusal contact in eligible teeth
* Signs and symptoms of pulp infflamation or necrosis
Bioavailability of EPA + DHA Enriched Canned Tuna and Its Acute Effects

Evidence has suggested that omega-3 fatty acids, namely eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), have an important role in promoting cardiovascular health. However, the currently available scientific literature describing the postprandial effects and bioavailability of these fatty acids, particularly when they are incorporated into high protein food item, like canned tuna, is far from conclusive.

The aim of this study is to evaluate the acute bioavailability of EPA + DHA enriched canned tuna and its acute effects on cardiovascular risk markers, in healthy human volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Adult men or women
* Age 18 - 59 years
* Willing to maintain usual diet and physical activity patterns
* Willing to comply with study protocol and procedures
* Willing to provide written informed consent

Exclusion Criteria:

* Pregnant, breastfeeding or planning to become pregnant within the study period
* Subjects with current or previous cardiovascular disease (ischemic cardiovascular disease, angina stable or unstable; myocardial infarction, stroke or symptomatic peripheral arteriosclerosis)
* Subjects with liver or kidney diseases or cancer
* Diabetes mellitus (fasting glycemia\> 126 mg / dL)
* Uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg)
* Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to cooperate during the study
* Subjetcs with gastrointestinal disorder or under prescription for medication affecting gastrointestinal function or absorption of nutrients
* Known allergy (or sensitivity) to omega-3 fatty acids, fish (tuna), crustaceans, lactose or any meal ingredient
* With antihypertensive therapy
* Health condition that prevents compliance with study requirements
* Subjects under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries
* Subjects under prescription of anticoagulant drugs
* Dietary patterns or supplement use that could interfere with study evaluations
* Subjects not willing to avoid the consumption of fish oil or food supplements, including fatty acids, during the study (except as indicated in the study protocol)
* Use of antibiotics in the last 4 weeks and laxatives in the last 2 weeks
A Bioequivalence Study Of AG-013736 Tablets In Healthy Volunteers

The hypothesis of this study is that one 5 mg tablet of axitinib has similar drug concentrations in plasma compared to five 1 mg tablets of axitinib after oral dosing.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 47 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead electrocardiogram (ECG) and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* An informed consent document signed and dated by the subject or a legally acceptable representative.

Exclusion Criteria:

* Evidence of significant disease of the blood, kidney, endocrine system, lungs, gastrointestinal, heart, liver, psychiatric, neurologic, or allergic (including drug allergies, but excluding season allergies).
* Active smokers or users of tobacco containing products and other drugs
* Pregnant or nursing females; females of childbearing potential including those with tubal ligation.
Preliminary Study for Selective Detection of the CD8+ Myelin Specific T Cell in the Blood of Multiple Sclerosis Patients

Most experts in the field consider Multiple Sclerosis as the main auto immune disease of the central nervous system. In spite of many works, the data in the literature concerning the antigens targeted by the CD8+ T-Cell response are still contradictory and insufficient.

30 patients distributed in 3 groups of 10 patients with specific inclusion criteria will participate in this trial:

* 10 MS patients in early disease onset,
* 10 MS patients under Natalizumab treatment
* and control group of 10 patients with other neurological diseases.

The aim of this clinical trial is to detect the CD8+ myelin specific T-Cells in the blood of Multiple Sclerosis patients.

Eligibility Criteria:
Inclusion Criteria:

Group 1: HLA-A2 patients whose Multiple Sclerosis has just been diagnosed

* 18 year old and older patients,
* HLA-A2 Patients with Multiple Sclerosis or clinically isolated syndrome at high risk of being affected by Multiple Sclerosis (criteria of spatial scattering according to the 2010 or 2005 McDonald's criteria)
* Patients without treatment or treated with immunomodulating therapy
* Patients affiliated to health insurance coverage
* Information and comprehensive agreement signed by the patient and the investigator

Group 2: HLA-A2 patients hospitalized in the neurology department who are not affected with a neuroimmunological disorder

* 18 year old and older patients,
* HLA-A2 patients hospitalized in the neurology department
* Patient not affected by Multiple Sclerosis or a related inflammatory disorder
* Affiliated or profitable subject of a national insurance scheme
* Patients affiliated to health insurance coverage
* Information and comprehensive agreement signed by the patient and the investigator

Group 3: HLA-A2 Multiple Sclerosis patients treated by Natalizumab therapy

* 18 year old and older patients,
* HLA-A2 patients with relapsing remitting (RR) MS fulfilling McDonald 2005 or 2010 Multiple Sclerosis diagnostic criteria
* Patients treated by Natalizumab therapy for at least 3 months
* Patients affiliated to health insurance coverage
* Information and comprehensive agreement signed by the patient and the investigator

Exclusion Criteria:

Group 1 and 3:

* Patients undergoing immunosuppressive therapy at present or in the past except Natalizumab
* Pregnant women

Group 2:

* Patients undergoing immunosuppressive therapy at present or in the past
* Patients affected by Multiple Sclerosis or a related disorder
* Pregnant women
Intraoperative Brain Microdialysis to Assess Neuroinflammation in Epileptic Tissue Immediately Prior to Surgical Resection.

This research study will investigate the fluid from the area of the brain that is being removed during clinical epilepsy surgery. The goal is to analyze this fluid for inflammatory markers that can potentially help identify new strategies in the future to control seizures in individuals with epilepsy who fail to respond to currently available drugs.


Eligibility Criteria:
Inclusion Criteria

* Failure to respond to at least two trials of anti-seizure drugs with different mechanisms of action
* Normal MRI

Exclusion Criteria

* Active immunomodulatory therapy
* Autoimmune disorder
* Signs or symptoms consistent with comorbid infection
* Oncological comorbidity
Dialysis Weaning in Intensive Care Units (Dialysis STOP)

Evaluation of daily urinary urea excretion, to guide Renal Replacement Therapy weaning, in Intensive Care Units.

The objective is to show that remove the dialysis catheter, once daily urinary urea excretion is greater than 1.35 mmol/kg/d, would increase more than 3 days the number without dialysis catheters, and thus without dialysis, the first 28 days after insertion.

Daily urinary urea excretion = urea (mmol/L) x diuresis (L/d) / weight (kg).

Daily urinary excretion of urea may provide a safe and reproducible renal replacement therapy withdrawal criterion, according to a recent French study (citations). A rate greater than 1.35 mmol/kg/d would predict a weaning success of 97.1% at 1 week. This criterion is influenced by the use of diuretics, and is easily accessible and achievable. Daily urinary urea excretion is representative of the recovery of renal function. The French study establishing this new withdrawal criterion was monocentric and retrospective. However, we changed our practices as soon as we became aware of them.

French multicentric (Bordeaux University Hospital, Libourne, Pau and Bayonne Hospitals) study, before and after:

* Period before: patients who were dialysed in the intensive care units of Bordeaux, Libourne, Pau and Bayonne, from November 2013 to November 2015.
* Period after: patients selected prospectively in the 4 hospitals.

When diuresis \> 100 ml/d, an urinary ionogram is realized daily. Measurement of urinary urea excretion every day. Ablation of the catheter as soon as daily urinary urinary excretion \> 1.35 mmol/kg/d.

Measurement of daily urinary excretion the following 3 days.

Eligibility Criteria:
Inclusion Criteria:

* All patients \> 18 of age, who have a Renal Replacement Therapy, in intensive care unit,
* with a diuresis \> 100 ml/d.

Exclusion Criteria:

* Patients still presenting "hard" criteria for RRT: metabolic acidosis with pH \< 7.15 and PCO2 \<50mmHg; acute pulmonary edema (\> 5l 02 or 50% FiO2 for Sp02 \> 95%) objectified by echocardiography; K\> 5.5 mmol/l after treatment
* Renal transplantation
* Long-term chronic kidney injury or short-term dialysis project (arteriovenous fistula created).
* Acute Kidney Injury secondary to thrombotic microangiopathy
* Acute Kidney Injury secondary to an obstacle even if dialysed
* RRT started for toxic cause without IRA (lithium,...)
Biomarker Cost-Benefit Analysis of EFNEP

The goal of this integrated project is to assess whether EFNEP is a cost-effective nutrition education intervention that generates sustained improvement in chronic disease biomarkers. This project will be unique in its use of objective biomarkers, instead of self-reported behaviors, to quantify the economic benefits generated by EFNEP through chronic disease prevention. A paired location untreated control group quasi-experimental design will be employed, with biomarkers (BMI, blood pressure, HbA1c) measured for 500 adults across four representative state EFNEP programs (CO, FL, MD, WA). Biomarkers will be measured pre-EFNEP, 6-months-post-EFNEP and 1-year-post-EFNEP. Analytical techniques will include cost-benefit, bivariate, and multivariate analyses.

According to the CDC, 60% of US adults have a diagnosed chronic disease. This indicates the need for focused efforts to change modifiable risk factors including diet and exercise. The Expanded Food and Nutrition Education Program (EFNEP) aims to prevent chronic diseases by educating and encouraging vulnerable populations to adopt a healthy diet and physical activity. Addressing the program priority area Diet, Nutrition and the Prevention of Chronic Diseases, the long-term goal of this integrated project is to assess whether EFNEP is a cost-effective nutrition education intervention that generates sustained improvement in chronic disease biomarkers. This project will be unique in its use of objective biomarkers, instead of self-reported behaviors, to quantify the economic benefits generated by EFNEP through chronic disease prevention.

Project research objectives include analyzing EFNEP's sustained impact on chronic disease biomarkers and developing and applying a biomarker-based cost-benefit analysis methodology. Extension objectives are to develop an online cost-benefit analysis tool and webinar for nutrition education program evaluation. Education objectives are to provide graduate students with experiential learning opportunities in data collection and analysis.

A paired location untreated control group quasi-experimental design will be employed, with biomarkers (BMI, blood pressure, HbA1c) measured for 500 adults across four representative state EFNEP programs (CO, FL, MD, WA). Biomarkers will be measured pre-EFNEP, 6-months-post-EFNEP and 1-year-post-EFNEP. Analytical techniques will include cost-benefit, bivariate, and multivariate analyses. Project results will expand the EFNEP knowledge-base, allowing for program content and delivery modifications that maximize the impact of taxpayer dollars allocated to chronic disease prevention.

Eligibility Criteria:
Inclusion Criteria:

* Free-Living
* Speaks and understands English and/or Spanish
* Income at or below 185% of the Federal Poverty Line

Exclusion Criteria:

* Being pregnant, nursing, and/or less than 9-months postpartum
Recovery After Robotic Urogynecological Surgery: The Patient's Perspective

The purpose of the study is to describe the patient experience, including pain scores, use of pain medications, resumption of usual activities, and bowel function in the post-operative period following robotic urogynecologic surgery. Additionally, to describe peri-operative parameters of robot-assisted urogynecologic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Women who underwent DaVinci-assisted laparoscopic surgery
* Completion of a post-operative quality assurance questionnaire from 09/2007 - 09/2008

Exclusion Criteria:

* Any women not meeting above inclusion criteria
Intrastromal Corneal Ring Segments and Toric Phakic Posterior Intra-ocular Lenses Implantation in Keratoconus

To compare visual and refractive measurements of intrastromal corneal ring segments versus toric phakic posterior intra-ocular lenses implantation in keratoconus

* The study is a prospective comparative interventional case series. It will be conducted in Minia university hospital and Roaa Laser Vision Correction Center.
* Fourty eyes will be evenly allocated into two groups:

Group (A): 20 eyes will undergo corneal collagen cross linking (epithelium off) 1 month after Femtosecond laser assisted intrastromal corneal keraring segments.

Group (B): 20 eyes will undergo toric phakic posterior IOL implantation 1 year after corneal collagen cross linking (epithelium off).

• An informed written consent to be involved in the study will be obtained from each patient.

Eligibility Criteria:
Inclusion Criteria:

* Keratoconus grade I to III according to the Amsler-Krumeich classification

Exclusion Criteria:

* Acute hydrops or grade IV keratoconus
* Any ocular diseases or surgeries
* Corneal thickness less than 400 µm at the thinnest corneal point, and at least 450 µm at the incision site for ICRS group
* Corneal pacities