cyrilzakka/clinical-trials huggingface dataset:
REINVENT: A Brain and Muscle Computer Interface for Stroke

Stroke is a leading cause of adult disability in the United States. High doses of repeated task-specific practice have shown promising results in restoring upper limb function in chronic stroke (\>6 months after onset). However, it is currently challenging to provide such doses in standard clinical practice. At-home telerehabilitation services supervised by a clinician are a potential solution to provide higher-dose interventions. However, telerehabilitation systems developed for repeated task-specific practice typically require a minimum level of active movement. Therefore, severely impaired people necessitate alternative therapeutic approaches. Measurement and feedback of electrical muscle activity via electromyography (EMG) have been previously implemented in the presence of minimal or no volitional movement to improve motor performance in people with stroke. Specifically, muscle neurofeedback training to reduce unintended co-contractions of the impaired hand may be a targeted intervention to improve motor control in severely impaired populations. In this study, we examine the effects of a low-cost, portable, and modular EMG biofeedback system (Tele-REINVENT) for supervised and unsupervised upper limb telerehabilitation after stroke during a 6-week home-based training program that reinforces activity of the wrist extensor muscles while avoiding coactivation of flexor muscles via computer games.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe upper extremity hemiparesis and residual hand function (e.g., less than 20 degrees of active wrist or finger extension and enough muscle activity to measure with electromyography).

Exclusion Criteria:

* Taking anti-spasticity medication
* Significant vision loss (corrected vision is acceptable)
* Receptive aphasia
* Hand contractures
* Secondary neurological disease
Neurophysiological Characterization of Postherniotomy Pain

Sensory function is different in persistent postherniotomy pain patients than in operated controls, suggesting this to be a neuropathic pain syndrome. By performing quantitative sensory testing, the specific changes in pain patients will be revealed, thereby aiding in designing future treatment trials. MRI scans of the groin regions in pain patients and control patients will be evaluated by senior MRI specialists assessing potential pathology to the region (Mesh, inflammation, edema, funicle etc.) Assessors will be blinded to clinical status, and surgery.


Eligibility Criteria:
Inclusion Criteria:

* Male patients \>18 yrs
* Inguinal herniotomy \>1 yr previously
* No sign of hernia recurrence
* Unilateral chronic groin pain lasting more than 3 months
* Moderate/severe pain related impairment of everyday activities.

Exclusion Criteria:

* Other causes of persistent pain in groin region (hip, other surgical procedures)
Effect of Repeated Low-Level Red-Light Therapy on Retinal Function and Structure

The purpose of this clinical trial is to evaluate the effect of repeated low-level red-light (RLRL) therapy on the retinal function and structure among myopic teenagers.

Myopia constitutes a major threat to personal health globally for its increased prevalence. Moreover, its dose-related association with irreversible blindness complications such as myopic macular degeneration has been demonstrated. It is crucial to look for effective ways to control myopia in children to reduce risk of myopic pathologies in later life. Repeated low-level red-light (RLRL) therapy is an innovative and non-invasive therapeutic treatment for a variety of eye diseases. A previous randomized clinical trial suggested that RLRL could effectively controlled myopia progression without clinically observable side effects.

The purpose of this study is to evaluate the effect of RLRL on the retinal function and structure among myopic teenagers aged 15-16 years. The RLRL therapy will be carried out at school under supervision of the parents according to a standard protocol for the first month and then will be discontinued for 1 month. Detailed functional and structural examinations, including full field electroretinogram, multifocal electroretinogram, microperimetry, visual acuity, intraocular pressure, optical coherence tomography, optical coherence tomography angiography, cycloplegic spherical equivalent refraction, and biological parameters will be evaluated at 1 month, 2 months after enrollment.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 15-16 years at enrolment.
2. Myopia: cycloplegic spherical equivalent refractions (SERs) range from -1.00 to -5.00 diopters (D) and astigmatism less than -2.5 D in either eye.
3. Best corrected visual acuity equal to or better than 0.8 in either eye.
4. Normal fundus, or tessellated fundus.
5. Provision of consent and able to participate in all required activities of the study.

Exclusion Criteria:

1. Secondary myopia, such as a history of retinopathy of prematurity or neonatal problems, or syndromic myopia with a known genetic disease or connective tissue disorders, such as Stickler or Marfan syndrome.
2. Strabismus and binocular vision abnormalities in either eye.
3. Refractive media opacity: corneal opacities, cataract, or implanted intraocular lens, etc.
4. Ocular abnormalities that affect retinal function: macular degeneration, diabetic retinopathy, retinal detachment, glaucoma, or ocular hypertension, endophthalmitis, uveitis, optic neuropathy, etc.
5. Previous history of refractive surgery, intraocular surgery, laser therapy, and intravitreal injection, etc.
6. Systemic abnormalities: diabetes, hypertension, etc.
7. Drugs therapies with toxicity effect on the retina: hydroxychloroquine, etc.
8. Prior treatment of myopia control in the past three months, drugs, orthokeratology, progressive addition lenses, bifocal lens, etc.
9. Other contraindications, including but not limited to ocular or other systemic abnormalities, that the physician may consider inappropriate for enrolment.
Valerian for Conscious Sedation in Patients Submitted to Impacted Lower Third Molars Surgery

The aim of the present study was to evaluate the efficacy of Valeriana officinalis L. 100 mg in single oral doses one hour preoperative as conscious sedation during the impacted lower third molar surgery.

Evaluate the efficacy of Valeriana officinalis L. (Valerian) for control of anxiety during third molar surgery. Study design: A single oral dose of either valerian (100 mg) or placebo was randomly administered one hour before each surgical procedure to 20 volunteers between 17 and 31 years of age. Anxiety level was assessed through questionnaires, physiological parameters (blood pressure and heart rate) and the observation of signs.

Eligibility Criteria:
Inclusion Criteria:

* Indication for bilateral extraction of asymptomatic impacted mandibular third molars in similar positions based on the Pell \& Gregory classification

Exclusion Criteria:

* Use of any type of medication in the 15 days prior to the onset of the study; history of hypersensitivity to the drugs, substances or materials employed in the experiment; pregnancy or lactation
Aripiprazole in Patients With Psychosis Associated With Parkinson's Disease

The purpose of this clinical research study is to assess the safety and tolerability of aripiprazole in patients with psychosis associated with Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of idiopathic Parkinson's disease.
* Psychosis related to Parkinson's disease.

Exclusion Criteria:

* Psychosis present prior to diagnosis of Parkinson's disease.
Effect of Apelin on Insulin Sensitivity: Proof of Concept in Healthy Volunteers

The (PYR1)-apelin-13 is an endogenous peptide discovered relatively recently (1998). The apelin and its receptor, which is named apj, are expressed in many tissues including sensitive to the action of insulin, such as skeletal muscle, adipose tissue and heart tissue.

Recent work by the team of Prof. P.Valet (INSERM U1048, Toulouse) opened a new field of investigation, demonstrating for the first time in mouse models that apelin exerts a glucose-regulating in vivo action. The investigators propose a translational clinical research project whose goal is to provide the proof of concept of the favorable influence of apelin on insulin sensitivity in humans.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 18 to 40 years.
* BMI between 25 and 30 kg / cm ² (excluding terminals).
* Free of known chronic disease and any medication (any medication within 30 days prior to the inclusion visit).
* Non-pathological ECG.
* Heart rate between 50 and 80 beats per minute rest.
* Complete Blood Count (CBC) with no significant anomaly in terms of the investigator.
* Liver function tests without clinically significant abnormalities in terms of the investigator.
* Renal function tests without clinically significant abnormalities in terms of the investigator.
* Serum electrolytes without clinically significant abnormalities in terms of the investigator.
* Fasting plasma glucose less than 1.1 g / l.
* HbA1c within the normal range (4-6%).
* Good peripheral vein (forearm and back of the hand).
* Agreement to participate in the establishment of a serum bank.
* Sedentary or practicing occasional physical activity.
* Ability to sign informed consent.
* Affiliation to a social security scheme.

Exclusion Criteria:

* Risk factor, treatment or ECG as recommended by International Conference on Harmonization E14 (ICH E14) "Clinical Evaluation of QT / corrected QT interval (QTc Interval= Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs"
* Repeated a QTc interval\> 450 ms measurement
* Risk factor: myocardial infarction, hypokalemia, family history of long QT syndrome
* Personal history of cancer.
* Positive HIV serology.
* Hepatitis B serology positive.
* Positive hepatitis C serology.
* Cognitive impairment or mental illness (at the discretion of the investigator).
* Chronic excessive alcohol consumption (consumption\> 30g/jour or 210g/week).
* Person under judicial protection, guardianship.
* Subject with a resting systolic blood pressure greater than 140 mm Hg and diastolic blood pressure greater than 90 mmHg
* Smoking\> 10 cig / day and can not be interrupted for 24 hours.
* Subject exclusion period of another protocol.
A Conversational Agent (Cecebot) to Improve Insomnia in Stage I-III Breast Cancer Survivors

This clinical trial evaluates the effect of conversational agent, Cecebot, on improving insomnia in stage I-III breast cancer survivors. Sleep disturbance ranks among the top concerns reported by breast cancer survivors and is associated with poor quality of life. Many breast cancer survivors also have decreased physical activity, which may also have a negative impact on sleep and quality of life. Cognitive behavioral therapy for insomnia (CBTi) and physical activity interventions have individually been reported to improve sleep and to have a positive impact on quality of life. Cecebot is a personalized short messaging service (SMS)-based behavioral intervention that combines CBTi and physical activity strategies that may improve sleep for breast cancer survivors.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (INTERVENTION): Patients receive sleep education SMS conversations and access to website content modules over 10 minutes 2-4 times per week, sleep compression SMS conversations once weekly (QW), and wear activity tracker daily on weeks 1-6.

GROUP II (WAITLIST CONTROL): Patients receive sleep education SMS conversations and access to website content modules over 10 minutes 2-4 times per week, sleep compression SMS conversations QW, and wear activity tracker daily on weeks 7-12.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Prior diagnosis of stage I-III invasive breast cancer
* Female gender
* Clinically significant insomnia symptoms, defined as a Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance 8 T-score of 60 or greater
* Insomnia complaints lasting ≥ 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, indicating ability to perform activities of daily living
* Own a smartphone with Internet connectivity
* Willing and able to complete the intervention with personal smartphone
* Proficient in speaking and reading English

Exclusion Criteria:

* Prior diagnosis of restless leg syndrome, periodic leg movement disorder, narcolepsy, or rapid eye movement (REM) behavior disorder
* Current sleep apnea (treated or untreated)
* Current shiftwork
* Actively receiving chemotherapy or radiation (endocrine therapy permitted)
* Previously received CBTi therapy with a professional therapist
* Contraindications to CBTi including:

  * Active psychosis
  * Uncontrolled bipolar disorder
  * Severe depression
  * Active substance use disorder (moderate or greater severity)
* Use of prescribed sleep medication \> 3 times per week
* Previously participated in user testing of the study intervention (Cecebot)
* Unwilling or unable to complete study procedures
A Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Diffuse Systemic Sclerosis (Scleroderma)

Systemic sclerosis (scleroderma) is an autoimmune connective tissue disease that involves the skin and other internal organs for which there are few effective treatment options. We hypothesize that treatment with abatacept, a new therapy recently approved for the treatment of rheumatoid arthritis, may reduce the progression of skin thickening and fibrosis in people with scleroderma.

Systemic sclerosis is an autoimmune connective tissue disease of unknown etiology characterized by progressive fibrosis of the skin and internal organs, vascular damage, and autoantibody production. Although the disease is relatively rare, it is associated with considerable morbidity and mortality. There have been improvements in survival over the past few decades; however, this has been related to better management of vascular manifestations of disease including renal crisis, pulmonary hypertension, gastroesophageal reflux disease, and Raynaud's phenomenon. Clinical studies of disease modifying therapies for cutaneous disease to date have been relatively unsuccessful.

Although the etiology of the disease remains unknown, several observations support the role of activated T cells in both the blood and skin of affected patients. Abatacept, a recombinant fusion protein that blocks T cell activation, has recently been approved by the FDA for rheumatoid arthritis. We hypothesize that inhibition of T cell activation with abatacept may be efficacious in the treatment of patients with diffuse systemic sclerosis. This is a randomized, double-blinded, placebo-controlled clinical trial of abatacept versus placebo in patients with diffuse systemic sclerosis. Changes in validated measures of skin thickness and disease activity over 6-months of treatment will be compared between patients receiving abatacept and those receiving placebo. Patients will be randomized 2:1 to receive abatacept.

The protocol was amended during the study and the outcome measures "Change in Serum Autoantibody Profile" and "Change in Serum Cytokine Profile" were changed to exploratory outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diffuse systemic sclerosis
* age 18 years or older
* Adequate renal, pulmonary, and cardiovascular function
* Willingness to use effective contraception for the duration of the study if subject is of childbearing potential\&#xA;

Exclusion Criteria:

* Other connective tissues diseases or overlap syndromes including MCTD, SLE, RA, eosinophilic fasciitis, and limited systemic sclerosis or morphea
* Use of disease modifying agents including methotrexate, cyclosporine,azathioprine, mycophenolate mofetil, minocycline, doxycycline, minocycline, thalidomide, penicillamine, tamoxifen, colchicine, or investigational agent within 90 days of screening visit
* HIV, Hepatitis B or Hepatitis C infection
* use of prednisone greater than 10mg daily for 28 days prior to screening visit
* women who are breastfeeding or pregnant
Effects of a Probiotic on Body Weight

Probiotics administration is associated with health benefits on gut barrier integrity and immunological functions of the gastrointestinal tract. Recently, probiotics consumption was proposed to reduce fat mass and body weight in rodents (Lee HY. et al. 2006; Hamad EM. et al. 2009) as well as abdominal fat in human (Kadooka Y, 2010). The mechanisms explaining the effects of probiotics in weight control are not well understood.

The primary objective of the clinical trial is to investigate whether a consumption of a probiotic formula when compared to an intake of a placebo, is associated with a greater reduction of body weight.


Eligibility Criteria:
Inclusion Criteria:

* Age: between 18 and 55 years old
* Weight: 30.0 kg/m2 ≤ BMI ≤ 39.9 kg/m2
* Non smokers
* Good general health
* A 2 weeks probiotics washout period prior to treatment initiation

Exclusion Criteria:

* Under antibiotics or treatments (medication or nutritional program) affecting body weight or glucose control for the last 3 months
* Currently participating or having participated in another clinical trial during the last 6 months prior to the beginning of this study
* Pregnant women, women who have given birth in the past year, women planning pregnancy in the next 6 months or menopausal women
* Excessive consumption of products enriched in probiotics (\> 4 servings per week).
* History of drug or alcohol (\> 2 drinks daily) abuse
* Abnormal thyroid hormone levels
* Intake of medication that could affect body weight and/or energy expenditure
* Family history of type 2 diabetes in first degree relatives
* Allergy to the ingredients in the study product and placebo
* Participant with anaemia
* Participant with a recent history of large weight fluctuations (e.g., \> 10 kg in the past year
* Immune-compromised conditions
* Participant experiencing nausea, fever, vomiting, bloody diarrhoea or severe abdominal pain
* Participant with co-morbidity associated with obesity:

  * Hypertension (≥ 140/90 mm Hg)
  * Current use of antihypertensive medications, depression
  * Prediabetes (fasting glucose \>100mg/dL)
  * Family history of premature coronary artery disease
  * LDL \> 2.0 mmol/L
  * HDL \< 1.3 mmol/L
  * Smoking
  * Obstructive sleep apnea
  * Type 2 diabetes
  * Cardiovascular disease.
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects

The purpose of this study is to determine the effect of the administration of multiple doses of GLPG4716 on the amount of midazolam (MDZ) that gets into the blood when the two drugs are administered together compared to when midazolam is administered alone. Other objectives of this study are to evaluate the safety and tolerability of GLPG4716 when administered with midazolam and assess the amount of GLPG4716 that gets into the blood when administered with midazolam. This study will also assess the effect of food on the amount of GLPG4716 that gets into the blood.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 55 years of age (extremes included), on the date of signing the informed consent form. Female subjects should be of non-childbearing potential.
* A body mass index between 18.0 and 30.0 kg/m2, inclusive.
* Judged to be in good health by the investigator based upon:

  * The results of a medical history
  * Physical examination
  * Vital signs
  * Oxygen saturation
  * 12-lead electrocardiogram
  * Fasting clinical laboratory safety tests. Aspartate aminotransferase and alanine aminotransferase must be no greater than 1.5x upper limit of normal range and total bilirubin no greater than 1x upper limit of normal. Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator.

This list only contains the key inclusion criteria.

Exclusion Criteria:

* Known hypersensitivity to ingredients of GLPG4716 and/or MDZ
* History of a significant allergic reaction to ingredients of GLPG4716 and/or MDZ as determined by the investigator.
* Treatment with any medication including:

  * Over-the-counter and/or prescription medication
  * Dietary supplements
  * Nutraceuticals, vitamins and/or herbal supplements, and hormonal replacement therapy
  * Except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) in the last 2 weeks or 5 half-lives of the drug, whichever is longer, prior to the first dosing.

This list only contains the key exclusion criteria.
Angiotensin Converting Enzyme Inhibitors in Marfan Syndrome

The purpose of this research is to assess the effects of a drug called perindopril on the aorta in people known to have Marfan Syndrome. The aorta is the major artery of the body that comes out of the heart and supplies blood to the body. We know that in people with Marfan Syndrome, the aorta is stiff and this stiffness results in its enlargement over many years. This enlargement of the aorta can be very serious. We know from treatment of other heart conditions that drugs of the same type as perindopril reduce stiffness of the arteries. This type of drug has never been tried in people with Marfan Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-40
* Diagnosis of Marfan Syndrome, on the basis of the Ghent Criteria

Exclusion Criteria:

* Age \<18, \>40
* Women of child-bearing potential not on adequate contraception
* Serum creatinine of \>0.11
* A history of intolerance to ACEI
* Patients on angiotensin receptor blockers
* Blood pressure \>140/90mmHg
* History of previous aortic surgery
Effects of Insufflated Gas on Core Temperature and Post-operative Pain During Laparoscopic Surgery

During laparoscopy, administration of cold and dry carbon dioxide (CO2) leads to hypothermia. Different types of gas conditioning have been studied in order to prevent this specific hypothermia. Intra-abdominal administration of local anesthetics has also been studied in order to prevent post-operative pain. In both cases, some results have been described.

The investigators propose to evaluate in a prospective, randomized, double blind trial, the impact of 4 different types of conditioning of insufflated gas during laparoscopy for womb surgery on hypothermia prevention and post-operative pain. These 4 types of gas conditioning are:

* CO2 wet and cold with nebulized Nacl and direct intra-abdominal administration of Nacl
* CO2 wet and cold with nebulized ropivacaïne 0.75% and direct intra-abdominal administration of Nacl
* CO2 dry and cold with direct intra-abdominal administration of ropivacaïne 0.2%
* CO2 dry and cold with direct intra-abdominal administration of Nacl

The investigators use a new device (Aeroneb® Pro \[Aerogen® Company\]) which can wet (by nebulization) the insufflated gas and therefore permits intraperitoneal medicament administration (local anesthetics).


Eligibility Criteria:
Inclusion Criteria:

* Womb surgery by laparoscopy
* Female
* Aged over 18 years
* No emergency

Exclusion Criteria:

* Laparotomy
* Protocol rejected by the patient
* Request of the surgeon or the anesthesiologist to know the administration solution or the insufflated gas