cyrilzakka/clinical-trials huggingface dataset:
Turning Dysfunction After Stroke: Assessment and Intervention

The study aims to investigate the 1) differences between stroke patients and healthy controls in time, steps, angular velocity, stepping patterns, electromyographic responses during turning, and the association of turning to trunk control and motor function after stroke; 2) the effectiveness of trunk training on turning performance, trunk control and motor function in stroke patients.

This study has two parts. The first part is a cross-sectional observatory study.Eligible stroke and healthy subjects are asked their demographic data and assessed for turning performance (stepping patterns and electromyography data of trunk muscles), trunk control (muscle strength, active range of motion, muscle mass and motor control in trunk) and motor function (recovery of extremities and balance function). The second part is a randomized controlled trial. Stroke participants are randomly allocated into trunk exercise and control groups. Trunk exercise group receives trunk exercise including trunk muscles stretching, trunk muscles strengthening, and task-related trunk control training for 30 minutes per session, twice a week for 12 weeks while control group remains their regular activities. Turning performance, trunk control and motor function are evaluated before and after training session.

Eligibility Criteria:
Inclusion Criteria:

* age between 20 and 80 years old
* survivors of a single and unilateral stroke with hemiparesis experienced at least 6 months prior to their participation in the study
* able to walk independently over a distance of 10 m without walking aids or orthoses
* able to provide informed consent and follow instructions.

Exclusion Criteria:

* having additional musculoskeletal conditions or comorbid disabilities that could affect the assessment
* having cognitive problems with a Mini-Mental State Examination score less than 24 or aphasia that could prevent subjects from following instructions.
Impact of Number of Rank of B-lactam Antibiotics on Emergence on Multidrug Resistant Bacteria

This study evaluates the impact of rank of Beta lactam antibiotics on emergence of mutlidrug resistant bacteria colonization in intensive care

It's retrospective case controle study. Cases are colonized patient by multidrug resistant bacteria hospitalized in intensive care during the fist hospitalization in intensive care. Temoin are patients with the same characteristics than case but no colonized by multidrug resistant bacteria.

The emergence of multidrug resistant is a wordwide problem. B lactam resistant increase. The antibiotic prescription impact this problem.

B lactam antibiotic is prescribed everyday in intensive care unit. The switch of antibiotic is common. Antibiotic classes inclue a lot of rank with different spectum that impact the occurrence of resistant.

Eligibility Criteria:
Inclusion Criteria:

* all patient hospitalized more than 48 hours in intensive care unit in Besançon between january 2016 and december 2017

Exclusion Criteria:

* patient under guardianship
* patient allergic to Beta lactam
* colonization with mutidrug resistant the first week of hospitalization in intensive care unit
Optimizing Uptake of Methylaminolevulinat With Fractional Ablative Laser Technique

The objectives of this study is to investigate if pre-treating the skin with an ablative fractional laser that creates small micropores in the skin:

1. Increases the uptake of Methylaminolevulinat (MAL) in the skin.
2. Decreases the required incubation time of MAL when performing photo dynamic therapy.

12 healthy male individuals were included.

On the back, 25 areas measuring 2.8x2.8 cm were marked, plus one control area. We tested 2 variables.

1) Density of laser channels. 2) Methylaminolevulinat (MAL) concentration

1. Laser - Each area was randomized to receiving:

   * no treatment
   * 1% laser channel density
   * 2% laser channel density
   * 5% laser channel density
   * 10% laser channel density
   * 15% laser channel density
2. MAL - Each density was assigned to 4 areas. Within each density category, the four areas were randomized to receive:

   * vehicle
   * 4% MAL
   * 8%MAL
   * 16%MAL

The uptake of MAL was evaluated by fluorescence intensity measured with a florescence camera at t=

* 0min
* 30min
* 1h
* 1.5h 2h 2.5h 3h

Eligibility Criteria:
Inclusion Criteria:

* Male
* \>18 years old
* Fitzpatrick skin type I-III
* No UV exposure thee months prior to study
* Signed study consent

Exclusion Criteria:

* Known allergy to substances in MAL or Unguentum M cream.
* Previous keloid
* Use of topical or systemic photosensitizing drug
* Evaluated to not be able to follow treatment protocol
Cortical Enhancement of Posture, Movement Planning, and Execution of Upright Reaching Following Stroke

Stroke is the leading cause of disability and diminished quality of living that frequently includes impairments of postural control and upper extremity (UE) function. The interaction of posture and UE coupling in terms of movement planning, initiation, and execution is not well understood. StartReact responses triggered by a loud acoustic stimulus (LAS) during the planning and preparation of goal intended actions has been used to probe the state of brainstem neuronal excitability related to posture and movement sequencing. The purpose of this study is to examine posture and goal-directed movement planning and execution using startReact responses and to evaluate posture and UE movement sequence during reaching while standing in individuals with chronic hemiparesis and healthy controls. Secondly, the investigators will determine the modulatory role of the cortical premotor areas (PMAs) in startReact responses in healthy controls and in persons with stroke by using transcranial direct current stimulation (tDCS) to up- or down-regulate PMAs excitability.


Eligibility Criteria:
Inclusion Criteria for stroke:

* Unilateral cortical or white matter subcortical stroke
* Age 40 yrs and older
* ≥ 6 months post ischemic stroke or ≥ 12 months post hemorrhagic stroke
* Residual arm hemiparesis as indicated by Fugl-Meyer Upper Extremity score between 20-65
* Having the ability to perform reaching movements with the paretic arm in standing without an assistive device.

Exclusion Criteria for stroke:

* Stroke involving bilateral hemisphere, brainstem or cerebellum
* Any medical condition precluding participation in testing
* Other health conditions affecting balance and upper extremity movement function beyond the effects of stroke.

Inclusion Criteria for healthy controls:

* Age-matched to the stroke subjects
* Without a history of stroke or any known neurological conditions
* Having the cognitive ability to follow two-step commands and give informed consent

Exclusion Criteria for healthy controls:

* Any medical condition precluding participation in testing
* Other health conditions affecting balance and upper extremity movement function beyond the effects of stroke.

Participants were also excluded if they did not meet the TMS safety criterion including having implantable medical devices, history of seizures, taking medications to reduce anxiety, sedatives, and seizure, and pregnancy.
Music Listenıng And Training Before Coronary Angıography

The aim of this study was to investigate the effects of education and music listening on the anxiety and physiological parameters experienced by individuals undergoing elective coronary angiography.

The aim of this study was to investigate the effects of education and music listening on the anxiety and physiological parameters experienced by individuals undergoing elective coronary angiography.

The population of the study consisted of individuals undergoing elective coronary angiography in the Cardiology Department of Abant İzzet Baysal University İzzet Baysal Training and Research Hospital. The study was conducted in a randomized controlled manner with three groups: 34 individuals in music listening group (M1), 34 individuals in information training group (M2) and 34 subjects in control group. In order to collect data, CAG (Coronary angiography) Procedure Training Form, Patient Identification Form, Physiological Parameters Form and Visual Analogue Scale and Spielberg State and Trait Anxiety Scale were used. Data were collected by face to face interview technique. Descriptive statistics, Independet Simple test, Paired sample t test, Kruskall Wallis, Mann Whitney U test and Wilcoxon signed rank test were used in the analysis of the data and the significance level was accepted as p \<0.05.

Eligibility Criteria:
Inclusion Criteria:

Applying femoral CAG electively,

* The first time CAG will be held,
* Performing the CAG procedure for diagnostic purposes,
* Not trained on the CAG process,
* Volunteering to participate in the study,
* No problem in verbal communication,
* No hearing loss,
* Being able to read and write,
* Has not been diagnosed with psychiatric illness,
* Being conscious,
* Being 18 or older.

Exclusion Criteria:

Radial application of CAG,

* Previously performing coronary angiography,
* Performing the CAG procedure for therapeutic purposes (stent, balloon, etc.),
* Having received training on the KAG process,
* Does not want to participate in the study
* Problems in verbal communication,
* Hearing loss,
* Psychiatric illness is found.
* Consciousness is closed.
Predictive MRI Metrics for Tumor Aggressiveness in Papillary Thyroid Cancer

Magnetic resonance imaging (MRI) is a diagnostic technique that takes pictures of organs of the body. It uses magnetic fields and radio waves that cannot be felt. Perfusion MRI uses faster imaging. It also includes a contrast material that is given by vein. This makes specific organs, blood vessels, or tumors easier to see. Diffusion MRI lets us measure the motion of water in the tumor.

Perfusion and diffusion MRI give extra information which is not available with the regular MRI. A regular MRI only shows pictures of the tumor. Thyroid MRI scans are not part of the current standard of care. The purpose of this study is to see if new MRI methods can give us more information about the tumor.

The aim of this pilot study clinical trial is to provide MRI biomarkers as quantitative (surrogate) biomarkers of aggressiveness in papillary thyroid cancer (PTC) including PMCs and to lay out the scientific basis for their translation into patient management. In this study we will perform specially designed diffusion weighted MRI (DW-MRI) and dynamic contrast agent MRI (DCE-MRI) protocols in the PTC patients.

DW-MRI allows for quantifying water diffusion which has been shown to be related to tumor cellularity (29). Particularly, appropriate modeling with DW-MRI data acquired at multiple b values will enable quantifying tumor cellularity and vascularity simultaneously (30-32). DCE-MRI with proper compartmental modeling will yield metrics related to tumor-vessel permeability, tumor perfusion, and extracellular-extravascular volume fraction (33, 34). These facts provide the potential of DW-MRI and DCE-MRI metrics as quantitative imaging biomarkers of tumor aggressiveness in PTCs. The DW-MRI and DCE-MRI may ultimately help in personalized management approach, in which imaging biomarkers may be used to recommend either immediate surgery or active surveillance for PTC patients.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven Papillary Thyroid Cancer (regardless of genotype and including all subtypes such as follicular or mixed papillary follicular) or suspicious for Thyroid Cancer
* Thyroidectomy or lobectomy planned as definitive treatment for Thyroid Cancer or patients on active surveillance management approach
* Age ≥18 years

Exclusion Criteria:

* Patient would require anesthesia for the study
* Patients who are claustrophobic Patients with tumor size greater than 5 cm in diameter as measured at imaging (ultrasonography or MRI) before treatment
* Patients who have presence of a known contraindication to MRI

  * Pacemaker
  * Aneurysmal clips
  * Metal implants in field of view
  * Pregnant
  * Age and mental status wherein he/she is unable to cooperate for MRI study Patients who have presence of a known contraindication to DCE-MRI may not participate in that portion of the study
  * Known reaction to Gd-DTPA, contrast agent
  * Chronic kidney disease
  * nursing women
Prevention of Weight Gain and Dyslipidemia by Green Tea in Patients Initiating Therapy With Olanzapine

The purpose of this study is to determine if taking green tea capsules can help prevent weight gain in patients that start therapy with Zyprexa® (olanzapine).

Atypical antipsychotic (AA) medications are associated with obesity, diabetes mellitus, dyslipidemia, and cardiovascular disease.1 The prevalence of obesity in the AA medicated population ranges from 40-60%, compared to 30% of the general population. Treatments that are aimed at either reducing the burden of obesity in psychotic illness or preventing the weight gain and other metabolic changes associated with AA are needed. One potential therapy that has received inadequate clinical evaluation is Green tea (Camillia sinensis; GT). GT contains flavonoids including epigallocatechin gallate (EGCG), as well as caffeine, that have been documented to promote weight and fat loss in normal to overweight healthy subjects. Recently green tea was shown to significantly decrease plasma LDL and triglyceride concentrations and increase HDL concentrations in obese women. GT has never been evaluated for its potential to prevent weight gain or changes in plasma lipid concentrations in patients initiating therapy with AA. However, case reports of individuals indicate that treatment with a green tea extract may have efficacy in preventing weight gain in 4 patients that initiated treatment with quetiapine.

We hypothesize that intake of GT in the form of a dietary supplement will result in significantly less weight gain than supplementation with placebo in patients initiating therapy with Zyprexa®. We propose to conduct an 12-week double-blind, placebo-controlled pilot study of 48 out-patient volunteers to determine if twice daily supplementation with GT 1) attenuates weight and fat gain in patients initiating therapy with Zyprexa® and 2) attenuates changes in cardiovascular risk factors including plasma lipoprotein and triglyceride concentrations. The experiments will be performed on patients who initiate therapy with Zyprexa® with a BMI \< 40kg/m2 that do not have dyslipidemia requiring pharmacologic intervention.

Eligibility Criteria:
Inclusion Criteria:

* Concurrently taking Zyprexa® for a psychiatric indication such as bipolar disorder or schizophrenia
* Stable body weight (+ 5%) for at least 2 weeks prior to baseline visit
* No weight loss program participation within past 3 months

Exclusion Criteria:

* Treatment with an atypical Anti-psychotic treatment other than olanzapine with the past 6 months
* BMI \> 40 kg/m2
* Use of any dietary supplements related to weight gain or weight loss within past 1 month
* Use of any medication related to weight or plasma lipid concentration (other than hormonal contraceptives). This includes, but not limited to: antihypertensives, benzodiazepines statins, and psychostimulants.
* Uncontrolled hypertension (SBP \>140 or DBP \> 90 mmHg)
* Use of a hypertensive medication
* Known active alcohol or substance abuse or consumption of \> three alcoholic beverages/day.
* Active cardiovascular disease
First Heroes: Engaging Fathers in the First 1000 Days

The First Heroes study plans to influence weight and health trajectories, modify disease risk, and improve health care services for mother-father-infant triads from racial/ethnic minority and health disparity populations.

This study is a two-arm, randomized controlled trial recruiting from Massachusetts General Hospital (MGH) obstetrics practices. This study will enroll 250 father-mother dyads in the second trimester of pregnancy and intervene through their offspring's 1-year birthday. Each mother-father dyad participating will be randomly assigned to one of two arms: 1. Obstetric and Pediatric Standard of Care + New Parent Engagement Intervention Arm or; 2. Obstetric and Pediatric Standard of Care + Safety Control Arm.


Eligibility Criteria:
Inclusion Criteria:

* Parental dyads must meet the following criteria:
* Pregnant females and father of the baby, both aged ≥ 18 years
* Singleton pregnancy
* Planned involvement during the first year of the child's life
* Planning to receive post-partum and pediatric care for child at any pediatric practice within the MassGeneral Brigham (Partners) Healthcare system
* Ability to speak in English or Spanish
* Capable of giving consent

Exclusion Criteria:

* Dyads whose unborn child is found to have a severe defect or comorbidity upon 18-20 week ultrasound.
* Mothers who intend on raising a child alone without any participation from the father of the child.
A Study of Anti-VEGF Monoclonal Antibody hPV19 in Patients With Solid Tumors

hPV19 is a monoclonal antibody (mAb) directed against vascular endothelial growth factor (VEGF). hPV19 binds to human VEGF with unique binding site on VEGF different from that of Bevacizumab(Avastin) and inhibits the binding of VEGF to it's receptors, VEGF-R1 and VEGF-R2. By preventing VEGF binding to its receptors, growth of tumor blood vessels are inhibited and tumor growth prevented or slowed. In this study we are investigating the tolerability, safety, pharmacokinetics and anti-tumor activity of hPV19 in combination with chemotherapy in patients with solid tumors. hPV19 will give to patients by intravenous(i.v.) infusion with a single and multiple doses.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed malignity
* Measurable disease
* Performance status 2 or less(ECOG)
* Life expectancy ≥3 months

Exclusion Criteria:

* hepatitis C virus (HCV), or HIV antibody positive
* Previously received anti-VEGF mAb or fusion-protein drugs within 28 days nearly
* Evidence of serious infection
Defining a Standard Set of Value-Based Patient-Centered Outcomes for Endometriosis

Endometriosis is a chronic disease that affects one out of 10 women. Endometriosis care is full of variation. Recommendations for optimal management vary between clinician and centers. One way of dealing with this unwanted variation is the shift towards a value -based endometriosis care. Value-based healthcare (VBHC) is a strategy focused on the optimization of the balance between outcomes that are important to patients and cost to achieve these outcomes. To do so, for a given condition it is important to define a standardized set of outcomes metrics allowing quality of care monitoring and comparison in order to optimize clinical practices and patient pathways. A common set of outcomes combining clinical outcomes (Clinical Reported Outcome Measures, CROMs) as well as quality of life and functional recovery indicators through Patient Reported Outcome Measures (PROMs). Different standardized data sets have already been developed to measure outcomes in other pathologies, however a standardized set of outcome measurements have not yet been determined for endometriosis. The objective of this study is to determine a standard set of outcome measurements for endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* Profession: gynecologists, radiologist, psychologists, nurses and researchers having an expertise in the field of endometriosis
* Patient experts having an active role in an endometriosis patient association

Exclusion Criteria:

* Retirement
The Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine

A randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic drug interaction between rosuvastatin and telmisartan/amlodipine in healthy male volunteers

A randomized, open-label, 2-treatment, 2-sequence, 2-period, multiple-dose, crossover design

Eligibility Criteria:
Inclusion Criteria:

* 19\~55 years healthy male
* Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
* Subjects who agree to keep contraceptive methods during the clinical trial.

Exclusion Criteria:

* Subjects who are allergic to investigational drug.
* Subjects who have a medical history which can affect the clinical trial.
* Hypertension(Systolic BP ≥ 150mmHG or Diastolic BP ≥ 100mmHg), Hypotension(Systolic BP ≤ 100mmHg or Diastolic BP ≤ 65mmHg)
* Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
Study of the Safety and Tolerability of REGN2222(SAR438584) in Healthy Adult Volunteers

This is a phase 1, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetic (PK) profile, and immunogenicity of REGN2222 ascending in cohorts of healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. A healthy man or woman aged 18 to 60 years
2. Body mass index between 18.0 kg/m2 and 32.0 kg/m2, inclusive
3. Willing and able to comply with clinic visits and study-related procedures
4. Provide signed informed consent

Exclusion Criteria:

1. Serum hemoglobin, creatinine, alkaline phosphatase, CPK, and/or hepatic enzymes (aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\], total bilirubin \[unless the investigator has evidence that increased bilirubin corresponds to a Gilbert's type syndrome with elevated indirect bilirubin\]) that is \>1.5 the upper limit of normal (ULN), or any laboratory findings showing evidence of organ dysfunction or any clinically significant abnormalities from the normal range, as determined by the investigator at the screening visit
2. Use of any concomitant medications within 30 days or at least 5 half-lives, whichever is longer, of the screening visit, including prescription medications (except contraceptives), nutritional supplements, and over-the-counter medications (except acetaminophen)
3. Hospitalization for any reason within 60 days of the screening visit
4. History of or positive human immunodeficiency virus (HIV) screen result at the screening visit
5. History of or positive blood test result for hepatitis B surface antigen and/or hepatitis C virus antibody at the screening visit
6. History of autoimmune disease
7. History of respiratory disease (e.g, asthma, chronic obstructive pulmonary disease)
8. History of drug or alcohol abuse within 1 year prior to the screening visit
9. Participation in any clinical research study evaluating another investigational drug or therapy within 30 days, or within at least 5 half-lives, of the investigational drug (whichever is longer) prior to the screening visit
10. Pregnant or breastfeeding woman
11. Sexually active men\* or women of childbearing potential\*\* who are unwilling to practice adequate contraception during the study, and up to 3 months after the last dose of the study drug (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)

    * Contraception is not required for men with documented vasectomy. \*\*Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of childbearing potential. Contraception is not required for women with documented hysterectomy or tubal ligation.