cyrilzakka/clinical-trials huggingface dataset:
Self Stretching, Plantar Self Massage and Manual Stimulation on Balance and Reaction Time

The aim of this study is to investigate the instantaneous effects of self-stretching, plantar self-massage and manual stimulation on balance and reaction time in healthy individuals. 102 individuals meeting the inclusion criteria will be included in the study. Individuals will be randomly divided into 3 groups: static stretching group (n=34), self-massage group (n=34) and manual stimulation group (n=34). Static stretching will be applied to all individuals (n=102). In addition to static stretching, self-massage will be applied to individuals in the self-massage group (n=34). Individuals in the manual stimulation group (n=34) will receive manual stimulation in addition to static stretching. Individuals will be evaluated in terms of static balance, dynamic balance, reaction time and foot functionality before and immediately after the applications.


Eligibility Criteria:
Inclusion Criteria:

* being between 18 and 50 years old
* having Body Mass Index (BMI) limit to be 20-25
* having Normal range of motion of the ankle joint
* having the score of the foot is between 0 and +5 according to the foot posture index,
* having the score 3+ on ankle muscle strength

Exclusion Criteria:

* being pregnant
* having undergone surgery on the foot and ankle in the last 6 months
* history of lower extremity injury with residual symptoms in the past year
* having diseases that affect the balance such as rheumatic disease, osteoarthritis, multiple sclerosis
* being professional athlete
* presence of vestibular disease (Meniere, Vertigo etc.), diabetes, neuropathy Being in
* being in the menopausal period
* having hip flexor muscle shortening
* having basal ganglia disorders such as Parkinson's disease, Huntington's disease
* having sensory problems on the sole of the foot
Affera Global Registry

The Affera Global Registry is a prospective, global, multi-center, observational post-market registry (PMR). The purpose of this study is to describe clinical performance and safety data in a broad patient population treated with the Affera Platform.


Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 18 years of age or minimum age as required by local regulations
* Planned procedure using the commercially available Affera Platform
* Willing and able to comply with study requirements and give IC (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements

Exclusion Criteria:

* Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager
* Subject with exclusion criteria required by local law
Dobutamine Stress Echocardiography in Cardiac Resynchronization Therapy (CRT) Patients Selection

While cardiac resynchronization therapy (CRT) has a well demonstrated therapeutic effect in selected patients with advanced heart failure (HF) on optimized drug therapy, non-responder rate remains high. The low-dose dobutamine stress-echo (DSE) test to predict positive response to CRT (LODO-CRT) trial is designed to improve patient selection for CRT.

LODO-CRT is a multicenter prospective study enrolling HF patients with conventional indication to CRT (symptomatic stable NYHA class III-IV on optimized drug therapy, QRS≥120 msec, left ventricular (LV) dilatation, LVEF≤35%) is designed to assess the predictive value of LV contractile reserve (LVCR), determined through DSE, in predicting CRT response during follow-up. Assessment of CRT effects will follow two sequential phases: in phase 1 CRT response end-point is defined as left ventricular end-systolic volume (LVESV) reduction ≥ 10% at 6 months; in phase 2, both LVESV reduction and clinical status via a clinical composite score will be evaluated at 12 months follow-up. Predictive value of LVCR will be compared to other measures, such as LV dyssynchrony measures, through adjusted multivariable analysis. For the purpose of the study, target patient number is 270 patients (with 95% confidence, 80% power, α≤0.05).

LVCR assessment, using low-dose DES test, should effectively predict positive response to CRT both in terms of the reverse remodeling process as well as favorable long-term clinical outcome. Moreover, the predictive value of LVCR will be compared to that of conventional intra-LV dyssynchrony measures.

Eligibility Criteria:
Inclusion Criteria:

* severe HF despite optimized medical therapy
* NYHA functional class III-IV
* dilated cardiomyopathy of both ischemic and non-ischemic origin
* left ventricular ejection fraction (LVEF) \<=35%
* QRS complex duration ≥120 ms
* normal sinus rhythm.

Exclusion Criteria:

* younger than 18 years old
* unstable angina
* acute myocardial infarction
* coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past 3 months
* already implanted with a conventional implantable pulse generator or with an implantable cardioverter defibrillator (ICD)
* previously implanted with a CRT device
* chronic permanent atrial arrhythmias
Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening

The purpose of this study is to evaluate the effectiveness of a low literacy, physician and patient-directed intervention to promote colorectal cancer (CRC) screening among the medically underserved.

This study will test the separate and combined effect of two of these interventions: 1) a provider communication skills training using a continuous quality improvement (CQI) framework, and 2) a brief, multimedia Patient Education Program (PEP) that incorporates plain language, graphic design, and audio voice-over to overcome literacy limitations. Our provider intervention has demonstrated efficacy to significantly improve CRC screening recommendation rates. Our multimedia program has also been field tested among patients with limited literacy and was able to improve patient knowledge and intention to receive screening.

We will implement both provider-only and combined provider-patient strategies within a federally qualified health center network to determine the most effective and efficient approach to promote CRC screening in these settings. Results from the study, supplemented by cost analyses and the process evaluation will directly inform translational strategies for cancer prevention within difficult community-based healthcare settings.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 50-75 years of age (in month 1 of the study)
* Patients have had two or more visits to the clinic during the past two years
* ACCESS Community Health Network patients
* University of Illinois Hospital \& Health Sciences System patients
* Patients ages 50 - 75 as of the start of the intervention study
* English or Spanish-Speaking

Exclusion Criteria:

* Patients \<50 or \> 75 years of age
* Patients who have had fewer than two or more visits to the clinic during the past two years
* Personal history of CRC or colorectal polyps, or of inflammatory bowel disease and a family history with a first-degree relative with CRC or colorectal polyps.
* Unable to speak English or Spanish
* Compliant with CRC screening (FOBT or FIT within the past year; flexible sigmoidoscopy within past 5 years; colonoscopy within past 10 years)
A Study of the Effects of Probiotics in Children Grades 1-3

The primary objective of this study is to determine the appropriate study design for a full-scale claims support study to evaluate the impact of 2 probiotics on healthy days in elementary school children relative to a placebo control.


Eligibility Criteria:
Inclusion Criteria:

* Be in good general health as reported by their parent(s)/legal guardian;
* Be willing to refrain from ingesting any product that contains fermented live bacteria (other than their test product) during the study as confirmed by their parent(s)/legal guardian(s);
* Be willing to continue their current dietary habits for the duration of the study as confirmed by their parent(s)/legal guardian(s)

Exclusion Criteria:

* Have a known hypersensitivity or allergy to any product ingredient to be ingested during the study, as reported by their parent(s)/legal guardian(s)
Organ Preservation: Weekly Carboplatin & Taxol w/Concurrent RT for Locally Advanced Laryngeal & Hypopharyngeal CA

Organ Preservation: Weekly Carboplatin \& Taxol w/concurrent RT for locally advanced laryngeal \& Hypopharyngeal CA


Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advanced laryngeal \& Hypopharyngeal CA
Evaluation of Vascular Regeneration After a Drug Eluting Stent Implantation

This is a prospective cohort, one center. twenty patients who will undergo percutaneous stent implantation with everolimus eluting stent will be include. The primary endpoint was the correlation between the change (baseline vs. 1 week) in the number of circulating endothelial progenitor cells and in cell functionality following an everolimus eluting stent implantation with the grade of neointimal hyperplasia measured by optical coherence tomography

For the purpose of the study, flow cytometry analyses will be performed before intervention, at 1 week, 1 month and 9 months. In addition, cell functionality analyses will be performed by quantification of colony forming units, aldehidrodehidrogenase activity, cell proliferation by WST-1 and senescence by !-galactosidase enzyme. At 9 months the degree of neointimal proliferation will be measured by optical coherence tomography . A clinical follow-up will be performed at 1 year. Secondary endpoints include: 1. to correlate the change in the number and cell functionality of circulation progenitor cells following everolimus eluting stent and the injury score analyses measured by optical coherence tomography, and the percentage of non covered struts by optical coherence tomography at 9 months.

2.-. To evaluate the role of other subtypes of cells CD 133+/Kinase Insert Domain Receptor (KDR+), CD 14+, mesenchymal stem cells, endothelial cell markers (VE cadherina, P1H12), integrin expression of Macrophage-1 antigen (MAC-1) and the development of neointimal hyperplasia.

Eligibility Criteria:
Inclusion Criteria:

* Patients who present stable angina, silent ischemia or unstable angina whenever there is no elevation of markers of myocardial damage above the limit of normality
* Presence of at least one severe coronary stenosis (\> 70% by visual analysis), susceptible of percutaneous treatment with stent implantation and an optical coherence Tomography study
* All patients should be taking statins at least 2 months prior to their inclusion in the study.

Exclusion Criteria:

* Age under 18 years and pregnant or fertile age,
* Patients with ST-elevation myocardial infarction or non-ST-elevation acute coronary syndrome with markers of recent myocardial damage (\<3 months),
* Patients in whom a drug-eluting stent and a bare stent have been implanted in the same procedure.
* Percutaneous treatment of restenotic lesions or total chronic occlusions.
* The use of stent pre-implantation ablation techniques (rotablator, directional atherectomy).
* Chronic renal insufficiency with serum creatinine greater than or equal to 2.5.
* Coronary revascularization in previous 3 months.
* Severe ventricular dysfunction (\<25%).
* Major trauma or surgery in the previous 3 months.
* Previous organ transplantation, active neoplastic process or inflammatory disease, treatment with immunosuppressors.
* Contraindication or allergy to thienopyridines.
* Life expectancy less than one year.
A Safety and Tolerability Single Ascending Dose Study in Healthy Volunteers

Targacept, Inc. is studying TC-2216 for a potential role in the treatment of central nervous system (CNS) neurobiological disorders in anticipation of seeking an indication in depression and/or anxiety.


Eligibility Criteria:
Inclusion Criteria:

1. Male subjects aged 18-40 years old (both ages included).
2. Subjects must be in good health as determined by their medical history, physical examination, psychological examination, ECG, vital signs, standard EEG and laboratory tests. A volunteer with a clinical abnormality may be included only if the Investigator or his designee considers that the abnormality will not introduce additional risk factor for the subject's health, or interfere with the study objectives.
3. Subjects with a body mass index within the range 18-29 kg/m2 and a weight within the range of 60-90 kg.
4. Non-smoker subjects (a cotinine test will be performed at screening and Day -1
5. Subjects must be able to refrain from consuming xanthine containing beverages, and must refrain from intensive physical exercise during the study conduct (until the end of study visit).
6. Subjects must have signed an informed consent form indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study and comply with the study procedures and restrictions.
7. Subjects must be affiliated with, or a beneficiary of, a French social security system.

Exclusion Criteria:

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

1. Any clinically relevant acute or chronic diseases which could interfere with the subjects safety during the trial, or expose them to undue risk, or which could interfere with the study objectives.
2. History or presence of gastrointestinal, hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
3. Any history of drug or other significant allergy.
4. Likely to need any treatment (including dental care) during the study period.
5. Donation of one or more units of blood within 90 days prior to the screening.
6. Use of any prescription or over-the-counter medication within 14 days prior to admission on Day-1 (not including paracetamol in the range of 1gr/day). In addition any medications with central effects are prohibited for a period equal to 5 x half-life prior to admission (Day-1), should this period be longer than 14 days.
7. Alcohol consumption \> 40 g alcohol/day (1 glass (25 cl) of beer with 3° of alcohol = 7.5 g, or 1 glass (25 cl) of beer with 6° of alcohol = 15 g, or 1 glass (12.5 cl) of wine with 10° of alcohol = 12 g, or 1 glass (4cl) of aperitif with 42° of alcohol = 17 g).
8. Positive alcotest at screening and Day -1 .
9. Positive test result on hepatitis B surface antigen, hepatitis C antibody.
10. Positive test result on HIV 1 and 2 serology.
11. Excessive daily consumption of xanthines containing drinks (i.e \> 500 mg/day of caffeine).
Study to Evaluate DT-216 in Adult Patients With Friedreich Ataxia

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of intravenous DT-216 in adult patients with Friedreich Ataxia. This single ascending dose study is randomized, double-blind, placebo-controlled.


Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed diagnosis of Friedreich Ataxia with homozygous GAA repeat expansions
* Body mass index (BMI) between 17 and 32 kg/m2
* Stage 5.5 or less on the Functional Staging for Ataxia (FSA)

Exclusion Criteria:

* Has any concomitant medical condition that in the opinion of the investigator, puts the participant at risk or precludes participant from completing the study
* Has clinically significant abnormal laboratory results
* Has significant cardiac disease
* Received an investigational drug within 3 months of screening

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study To Understand How Radiolabelled PF-04449913 Is Taken Up By The Body, Broken Down And Then Removed From The Body

The study aims to understand, using radiolabelled PF-04449913, how this compound is modified by the body once it is absorbed. The study also aims to understand how much of the compound is broken down and how much leaves the body unchanged.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 55 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 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.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Subjects enrolled in a previous radionucleotide study or who have received radiotherapy within 12 months prior to screening or such that total radioactivity would exceed acceptable dosimetry.
* A positive urine drug screen or urine cotinine test
* 12 lead ECG demonstrating QTc \>450 or a QRS interval \>120 msec msec at Screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility. Subjects with family history of myocardial infarction, congenital long QT syndrome, torsades de pointes or clinically significant ventricular arrhythmias. Subjects should be within normal range of potassium, magnesium and calcium at screening.
Surface NeuroMuscular Electrical Stimulation in the Treatment of Chronic Venous Leg Ulcers

This study aims to determine if the use of surface neuromuscular electrical stimulation, applied to various motor points on the lower limb to elicit muscle contraction when combined with compression bandaging accelerates the rate of venous leg ulcer healing.

With an increasingly ageing population the incidence of venous ulceration is likely to rise. The negative impact of leg ulceration on patients' quality of life and on healthcare costs is well recognised. Increased prevalence combined with poor reported healing rates and high incidence of ulcer recurrence makes the development of a new treatment which could accelerate healing rates beyond that currently achieved using compression bandaging most desirable. Surface neuromuscular electrical stimulation in combination with compression bandaging may provide such a treatment.

Surface neuromuscular electrical stimulation (SNMES) is the application of an electrical stimulus to motor points in the body using electrodes placed on the surface of the skin to elicit a muscular contraction. It has been shown that SNMES of the calf muscles, when used in conjunction with compression therapy, provides improved venous flow velocities over compression therapy alone. Furthermore, the week-long effect of SNMES and compression therapy on healthy participants was found to be well tolerated by all participants and resulted in increases in stimulated venous flow and muscle strength. A combined SNMES and compression treatment protocol which stimulates peripheral venous blood flow may help to alleviate harmful venous pressures in venous leg ulcer patients and provide some degree of strengthening of the calf muscles, thus helping to accelerate the healing rates of venous ulcers.

Eligibility Criteria:
Inclusion Criteria:

* Primary or recurrent venous leg ulcer.
* Ankle-brachial pressure index \> 0.8
* Ulcer size between 1 and 200 cm2
* Patient suitable for full compression bandaging

Exclusion Criteria:

* History of symptomatic heart disease.
* Pregnancy
* Presence of implants in the lower leg or a pacemaker
* History of a neurological disorder
* Presence of any contraindications for the use of compression stockings such as severe arterial disease i.e. Ankle brachial pressure index (ABPI) \<0.8
* Presence of cognitive difficulties which may prevent the patient or his/her carer from using the stimulator appropriately.
* Patients unable to provide informed consent
* Patients receiving dialysis
* Patients receiving steroids
* Patients receiving methotrexate
* Ulcer located in the area of electrode placement
* Patients in reduced compression bandaging system
Sust-AIns: Sustainment of Suicide Prevention Programs in American Indian Settings

The proposed study is part of the research project for a National Institute of Mental Health K01 grant to Dr. Haroz. The overall research project is focused on understanding how to sustain evidenced-based mental and behavioral health programs in tribal contexts. The aim of this study is to pilot test sustainment strategy interventions across tribal settings using mixed-methods.

Among the most pressing issues in mental health Dissemination and Implementation research (D\&I) is the lack of knowledge about how to sustain mental health prevention and treatment services for which there is substantial evidence of impact. Most D\&I studies focus on adoption and initial implementation, with few studies (\<20) rigorously exploring sustainment. The sustainment of services has been described as "one of the greatest, yet least understood, challenges in the field of implementation science." The gap in knowledge is even greater for low-resource contexts, as few studies have focused on these settings. This project aims to address this gap by developing and testing sustainment strategies for an evidenced-based youth suicide prevention program in a low-resource, American Indian (AI) contexts.

Eligibility Criteria:
Inclusion Criteria:

* Knowledgeable about the implementation of the suicide prevention program
* Over the age of 18
* Available to participate in required study meetings and assessments
* Fluent in English

Exclusion Criteria:

* Factors identified at baseline that preclude full participation including: being under the influence of a substance; active psychosis or mania; any other condition that makes an individual lack capacity to give consent.
A Pilot Study to Identify Biomarkers Associated With Chronic Traumatic Brain Injury

The aim of this research is to determine if the biological fluids (blood/saliva) from chronic brain-injured patients (both blast and non-penetrating TBI) contain reproducible protein markers. To accomplish this two populations of chronic TBI patients who are receiving treatment at The Institute for Research and Rehabilitation (TIRR): blast injury victims and non-penetrating TBI will be studied. Using multiple proteomic approaches including mass spectrometry, multiplex ELISAs, and antibody microarrays, as well as RNA profiling, the investigators aim to identify biomarkers in the blood/saliva of patients suffering from chronic TBI and to determine the similarities/differences between the blast and non-penetrating injury groups. Identification of these biochemical changes will give insight into the long-lasting changes associated with head injury, and may identify new targets for treating the associated pathologies.


Eligibility Criteria:
Chronic TBI patients:

Inclusion Criteria

Have a history of head trauma manifesting in one or more of the following:

* Loss of consciousness
* Post-traumatic amnesia
* Focal neurologic deficits, seizure
* Persistent symptoms of increased arousal (e.g. difficulty falling or staying asleep, anger and hypervigilance)
* Impairment in social, occupational, or other important areas of functioning (e.g. problems with work and relationships.)

Exclusion Criteria

Inability to obtain informed consent and if they are non-communicative (i.e. in a vegetative state).

Healthy volunteers:

Inclusion Criteria

* No significant medical history
* Take no medications (other than birth control pills)
* Fever free
* No history of head trauma or recent injury/infection
* No history of neurological or psychiatric disorders or alcohol or drug dependency.

Exclusion Criteria

* Inability to provide informed consent
* age/gender match not available in TBI cohort