cyrilzakka/clinical-trials huggingface dataset:
Analysis of Capillary Retinal and Papillary Vascularization in Patients With Amyotrophic Lateral Sclerosis - CAPISLA

Amyotrophic Lateral Sclerosis, or Charcot's disease, is a neurodegenerative disease affecting motor neurons. The disease affects between 5 and 10 people per 100,000 in the world, nearly 7,000 patients are affected in France. The only therapeutic treatment available to date in France is riluzole, which slows the progression of the disease. Amyotrophic Lateral Sclerosis is the first degenerative disease affecting motor neurons. However, recent evidence suggests that the impairment extends beyond motor neurons alone.

Optical Coherence Tomography analyzes made it possible to highlight ophthalmologic damage in patients with Amyotrophic Lateral Sclerosis, in particular at the macula and papilla, although some results are contradictory.

No angiographic Optical Coherence Tomography analysis has been performed to date in patients with Amyotrophic Lateral Sclerosis. However, in the hypothesis of microvascular involvement participating in the pathophysiology of neurodegeneration in Amyotrophic Lateral Sclerosis, these examinations could provide relevant clinical and pathophysiological data by studying the retinal microvascularization of patients with the disease.


Eligibility Criteria:
Inclusion Criteria:

Patient Amyotrophic Lateral Sclerosis :

* Patient diagnosed with bulbar or spinal ALS defined according to El Escorial criteria (probable or certain)
* Hospitalized in a day hospital at the Angers University Hospital as part of his usual follow-up

Control subject :

* Subject not affected by the disease studied and without a history of neurological disease.
* Subject matched in age and sex to a case (patient)

For all participants:

* Major upon inclusion
* Signature of informed consent to participate in the protocol

Exclusion Criteria:

Patient Amyotrophic Lateral Sclerosis and control subject :

* Simultaneous participation in another intervention protocol with an experimental treatment
* Subject unable to express consent
* Known ophthalmologic pathology (maculopathy, glaucoma, optic neuropathy, retinopathy whatever the etiology)
* Diabetic subject
* Cardiovascular history
* Inability to perform the ophthalmological examinations of the study
* Pregnant, lactating or parturient woman
* Subject under duress psychiatric care
* Subject to legal protection
* Subject not affiliated or not beneficiary of a social security scheme
Acupuncture in Myasthenia Gravis (AcuMG)

The purpose of the study is to determine the effect acupuncture treatment on individuals with a diagnosis of Myasthenia Gravis (MG). A total of 20 people with MG will be enrolled in this study to receive acupuncture treatment 2 times a week for 12 weeks. Participants will be randomized into two groups: 1) Immediate start and 2) Delayed start (12 weeks). The delayed start group will act as a control group for the first 12 weeks, but then receive acupuncture treatment for 12 weeks. It is hypothesized that patients with MG who receive acupuncture treatment will have improved quality of life and activities of daily living compared to no treatment.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide and provision of signed and dated informed consent form
* Age 18-80
* Diagnosis of MG

Exclusion Criteria:

* Non-English speaking
* Participation in acupuncture treatment outside of the study, while enrolled
* History of any other serious neurological, psychiatric, chronic pain disorders, or seizures
* History of bleeding diathesis, other bleeding disorders, or syncope with needle puncture
* History of cardiac arrhythmia or current pacemaker, neurostimulator, or other implanted stimulation device
* Recent or active substance use disorder
* Women who are currently pregnant, lactating, or planning to become pregnant during the study
* Any other medical conditions that could affect their ability to participate in acupuncture treatments for the study duration (as determined by study investigators)
* Active participation or past participation ≤3 months in any other interventional study.
* Unwilling to participate in all study related activities
Effects of Rifampin on the Pharmacokinetics of Nilotinib in Healthy Subjects

This study will evaluate the effect of 600 mg daily oral dose of rifampin (CYP3A4 inducer) on the pharmacokinetics of a single 400 mg oral dose of nilotinib in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult male (18 - 55 yrs) and sterile or post menopausal female subjects:
2. Body weight must be ≥50 kg and \<100 kg, with a body mass index (BMI) \>18 but \<33.

Exclusion Criteria:

1. Female who is pregnant, test positive for a serum pregnancy test or currently breast feeding.
2. Contraindication to receiving nilotinib or rifampin.
3. Smokers or use of tobacco products or products containing nicotine in the last 30 days
4. A past medical history of clinically significant Electrocardiogram abnormalities, or a history/family history of long QT-interval syndrome.

Other protocol-defined inclusion/exclusion may apply.
McGRATH vs Macintosh Laryngoscopy Comparison in LMA Insertion

Various techniques have been developed to get a good LMA position, one of them is using a laryngoscope. The most popular laryngoscope used for LMA installation is the Macintosh type. Technological developments have brought laryngoscopes into the video era, one of which is McGRATH's laryngoscope, which from several studies about having an advantage in terms of the first attempt, time, complications, and hemodynamic stability of intubation. It needs to be proven through research on the comparison of clinical outcomes of LMA installation with McGrath laryngoscope and Macintosh laryngoscope.


Eligibility Criteria:
Inclusion Criteria:

* Patients underwent surgery with general anesthesia by LMA insertion in Sanglah General Hospital
* Agreed to be included in the study by signing informed consent
* American Society of Anesthesiologist physical status 1-2

Exclusion Criteria:

* Patients unfit for LMA insertion
* Patients with suspected airway management difficulty
* Pregnancy
* Morbid obese
Uric Acid and Surgical Prognosis

Preoperative serum uric acid significantly impacted mortality and morbidity in non-cardiac surgery.

Preoperative SUA levels demonstrate a nonlinear, sex-specific relationship with postoperative outcomes in non-cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older
* Patients who underwent non-cardiac surgery

Exclusion Criteria:

* Emergency surgery
* Pregnancy
* Cadavers
* Patients with missing preoperative SUA values or no follow-up after surgery
BAriatric Surgery Induced Chromosomal Change

The purpose of this study is to better understand the impact of weight-loss surgery on telomere length. Telomeres are a key marker of biological aging of cells. Telomere shortening is a natural process of aging. Several pathologies and lifestyles are associated with premature telomere shortening, such as obesity, diabetes mellitus or sedentary lifestyle. New evidence supports that telomere shortening can be partially reversed by lifestyle changes such as healthy diet, reduced stress, or increased physical activity.

This study aims to evaluate the impact of metabolic and bariatric surgery on telomere length as well as the role of type 2 diabetes resolution and oxidative stress improvement on telomere lengthening.

The investigators hypothesize that metabolic and bariatric surgery is associated with the lengthening of telomeres as a possible underlying mechanism of cancer risk reduction.

It is a prospective, single-center study including patients with obesity class II or more (Body Mass Index ≥ 35kg/m2) and patients having had metabolic and bariatric surgery more than 12 months ago.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 35 kg/m2 without previous bariatric surgery (control group) OR
* Having had Sleeve Gastrectomy or Roux-en-Y Gastric Bypass more than 12 months ago and without a weight regain of ≥ 15% of nadir weight (treatment group)

Exclusion Criteria:

* under 18 years of age
* no informed consent
Preload and Autonomic Responses With Cardiac Neuromodulation Therapy (CNT) (CS-06)

This investigation will evaluate the effect of RV pacing lead position on cardiac function and the modulation of the autonomic nervous system with Cardiac Neuromodulation Therapy (CNT) pacing signals. The study will be performed acutely prior to a pacemaker implant.

Subjects indicated for a dual chamber pacemaker implant or replacement who are not 100% dependent on right ventricular pacing may be eligible to participate in the study.

This investigation will evaluate the effect of RV pacing lead position on cardiac function and the modulation of the autonomic nervous system using Cardiac Neuromodulation Therapy (CNT) pacing signals at different positions of the RV pacing lead.

A standard conductance catheter will be introduced through the femoral artery and advanced into the left ventricle to measure cardiac volumes and pressure.

Arterial blood pressure will be measured from the other femoral artery with an additional sheath.

The Moderato® IPG will be used to generate Cardiac Neuromodulation Therapy (CNT) signals and deliver them to the patient through the cable and leads. A range of CNT signal parameters will be used to assess the effect on sympathetic activity at different positions of the RV pacing lead. Ventricular pressure and volume readings from the conductance catheter and arterial pressure readings will be recorded and analyzed to assess the effect of CNT signals on cardiac function, sympathetic activity and blood pressure.

The effects of CNT signal over a range of parameter settings will be studied for the different RV lead positions.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥ 18 years of age
2. Subject requires implantation or replacement of a dual chamber pacemaker or requires an upgrade from a single chamber to a dual chamber pacemaker
3. Subject has known Hypertension
4. Subject is willing and able to comply with the study and procedures.

Exclusion Criteria:

1. Subject has symptoms of heart failure, NYHA Class II or greater
2. Subject has significant (\>2+) mitral regurgitation, aortic regurgitation or aortic stenosis.
3. Subject has permanent atrial fibrillation
4. Subject has atrial fibrillation on the day of the study.
5. Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm
6. Subject is on dialysis
7. Subject has a history of prior neurological events (stroke or TIA) within the past year or a neurological event (stroke or TIA) at any prior time that has resulted in residual neurologic deficit.
8. Subject has a history of autonomic dysfunction
9. Women who are pregnant or breast-feeding
10. Subject cannot or is unwilling to provide informed consent.
Estradiol, Progesterone and Endometrial Thickness in Frozen Euploid Embryo Transfer

The development and improvement in Preimplantation genetic diagnosis/screening (PGS) in association with the efficacy and security of vitrification and trophectoderm biopsy, more efficient stimulation schemes and laboratory improvements in culture and embryo selection have contributed to high success of the assisted reproductive technologies(ART). Transferring an euploid embryo avoids one of the main reasons of miscarriage and implantation failure ( Rubio et al, 22016) and overcomes one of the most important confounding factors. Usually, the transfer of euploid embryos is performed under standard hormone replacement therapy (HRT) and are referred to as FET-PGS cycles( Frozen embryo transfer). The study of FET-PGS cycles with the transfer of a single euploid blastocyst is the best model for evaluation of the impact of the endometrial preparation . Among factors influencing FET outcomes, patient's age, endometrial preparation, endometrium thickness, endometrial pattern, number and quality of embryos transferred , difficulty at ET, recently P4 have received more attention .

The importance of Progesterone (P4) in embryo implantation has been widely studied. P4 plays an important role in endometrial gland formation, embryonic implantation and pregnancy maintenance, both in natural and artificial cycles.


Eligibility Criteria:
Inclusion Criteria:

* Frozen embryo transfer (FET) of at least one single euploid embryo.
* Estradiol \> 75pg/ml.
* Progesterone \> 4 ng/ml.
* Endometrial thickness between 6 mm and 18 mm.

Exclusion Criteria:

* Patients with FET of no diagnostic or mosaic embryos, or known uterine abnormality were excluded.
* Natura cycle protocol.
Study to Evaluate HT-4253 in Healthy Subjects

The primary objectives of this study are to evaluate the safety and tolerability of HT-4253 when administered as single oral doses and multiple oral doses at escalating dose levels in healthy volunteer subjects.

The secondary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of HT-4253.


Eligibility Criteria:
Inclusion Criteria:

* Age is ≥ 18 years to 65 years
* Body mass index between 18 and 32 kg/m2
* Female subjects must be surgically sterile or post menopausal for at least 12 months. Females may be of child-bearing potential but must use double contraception.

Exclusion Criteria:

* Any clinically significant central nervous system, cardiac, pulmonary, renal, gastrointestinal, endocrinological, respiratory, or metabolic conditions (or history), or other pathological or physiological conditions,
* History of suicidal behavior and/or ongoing suicidal ideation per C-SSRS evaluation when screening
* Use of any medications, including prescription, over-the-counter (OTC) medications, vitamins, herbal preparations, and supplements
* Positive drug screen or alcohol breath tests
* History of heavy smoking more than 10 cigarettes a day or the tobacco/nicotine equivalent within 3 months of Screening or refuses to abstain from tobacco or nicotine-containing products throughout the duration of the study
* Clinical significant abnormalities in laboratory test results
* Chronic or current active infectious disease
Physical Condition and Bariatric Surgery

The aim of this project is to investigate in obese patients the changes induced by bariatric surgery on the various components of the physical condition and their postoperative evolution following an intervention combining a physical activity program (aquabike vs bicycle) with or without protein supplementation.

Physical condition will be evaluated in obese patients before surgery and 1, 4, 6, 12, 18 and 24 months after surgery.

Between 1 and 4 months after surgery, participants will be assigned to one of the postoperative care groups:

* Control
* Control + protein supplementation
* Training in aquabike
* Training in aquabike + protein supplementation
* Bicycle training
* Bicycle training + protein supplementation

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Age between 18 and 60 years
* Body mass index: BMI\> 40 kg / m2
* Candidates for bariatric surgery

Exclusion Criteria:

* Subject under 18 or over 60 years of age
* Biological assessment considered abnormal by the investigator
* HIV serology or known positive HCV
* Pregnant or nursing women
* For women of childbearing age: beta-hCG positive dosage or absence of contraception deemed reliable (oral contraceptive, IUD, implant or hormonal patch)
* Medical or surgical history (judged by the investigator to be inconsistent with the study)
* Subject with cardiorespiratory and / or osteo-articular disorders limiting their ability to perform physical tests or training
* Subject with cardiovascular or neoplastic disease
* Subjects with an infection in the 3 months prior to inclusion
* Hypercorticism and uncontrolled dysthyroidism
* Patient with known neuro-muscular pathology: myopathy, myasthenia gravis, rhabdomyolysis, paraplegia, hemiplegia
* Patient with chronic or acute inflammatory disease the 3 months before inclusion
* CRP\> 20 mg / l
* Person treated with or having stopped treatment for less than 3 months prior to inclusion by corticosteroids, immunosuppressant, anabolic agent, growth hormone
* Person with an unstable psychiatric condition
* Blood donation in the two months preceding the study
* High alcohol consumption (\> 2 to 3 drinks per day depending on sex) or presence of drug addiction
* Significant smoking (\> 5 cigarettes / day or equivalent in cigars or pipe tobacco)
* Intense sports activity (\> 5 hours / week)
* Subjects excluded from another study or having received more than 4500 € in the year following their participation in clinical studies
The Effects Of Instrument Cervical Manual Therapy Methods And Proprioceptive Neuromuscular Facilitation Techniques

The location of neck pain is usually shown as "pain occurring between the occiput and the third thoracic vertebra". The annual incidence of mechanical neck pain is 12/1000 patients and is one of the most common reasons for visiting physicians. Neck pain usually lasts longer than 3 months and results in a high cost to society

Movement in one plane in the cervical spine is due to the contribution of vertebrae from other planes. This complicates the kinematics and injury mechanism of the cervical region. Considering the mechanism of injury, demographic information to be obtained from the person is very important.

Eligibility Criteria:
Inclusion Criteria:

* Those with neck pain
* Being between 20-60 years old

Exclusion Criteria:

* High blood pressure
* Cardiopulmonary disease
* Malignant
* Operation, injection, etc. for the neck in the last 3 months. those with a history of treatment
* Spine surgery
* Psychological disturbance
* Neurological and orthopedic deficits
Effects of Chemoradiation and Surgery on Cardiopulmonary Fitness and Tumor Neoplastic Phenotype in Gastrointestinal Malignancies

There is growing evidence of the integral role of exercise following cancer treatment. Randomized trials show that exercise improves post treatment symptoms and quality of life in breast and prostate cancer patients.Regular exercise reduces cancer specific and all cause mortality for patients with breast, prostate, brain or colorectal cancer. Nearly a 40-50% relative risk reduction in cancer specific death and 20-50% relative risk reduction in all cause mortality have been reported with exercise. At present it is unknown if preclinical pleiotropic effects on tumors through aerobic exercise are clinically relevant. Before launching into further studies of exercise training on changes in tumor hypoxia and response to CRT in rectal cancer patients, it is first important to understand: 1. Whether measures of exercise exposure (i.e., exercise capacity and self-reported exercise behavior) are associated with markers of tumor hypoxia at diagnosis (prior to initiation of CRT) and 2. Whether changes in measures of exercise exposure over the course of CRT are related to changes in tumor hypoxia and response to CRT.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed gastrointestinal malignancy
2. Plan for chemoradiation
3. At least 18 years old
4. Karnofsky performance status of at least 70% at study entry
5. Ability to read and understand English
6. Signed informed consent prior to initiation of study-related procedures
7. All women of childbearing potential must have a negative serum pregnancy test prior to study entry

Exclusion Criteria:

1. Significant cardiac disease (i.e., left ventricular ejection fraction of \<50%, unstable angina, placement of cardiac stents and myocardial infarction within previous 6 months)
2. Contraindications to a cardiopulmonary exercise test as recommended by the American Thoracic Society: (a) acute myocardial infarction (3-5 days), (b) unstable angina, (c) uncontrolled arrhythmias causing symptoms or hemodynamic compromise, (d) syncope, (e) acute endocarditis, (f) acute myocarditis or pericarditis, (g) uncontrolled heart failure, (h) acute pulmonary embolus or pulmonary infarction, (i) thrombosis of lower extremities, (j) suspected dissecting aneurysm, (k) uncontrolled asthma, (l) pulmonary edema, (m) room air desaturation at rest ≤85%, (n) respiratory failure, (o) acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise, (p) mental impairment leading to inability to cooperate, and (q) extensive bone metastases
3. KPS\<70%
4. Females who are pregnant
Evaluating the Safety and Effect of abobotulinumtoxinA in the Gastrocnemius Muscle to Improve Equinus and Plantar Fasciitis Pain

The purpose of this research is to collect safety and efficacy data on injection of botulinumtoxinA (AbobotulinumtoxinA /Dysort) into the gastrocnemius (calf) muscle to improve equinus (lack of flexibility to bring the top of the foot towards the front of the leg) in subjects with plantar fasciitis and relieve pain associated with this condition. The use of AbobotulinumtoxinA is considered experimental in this study because it has not been approved by the United States Food and Drug Administration (FDA) for the treatment of plantar fasciitis.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old and not older than 75 years.
2. History of Plantar fasciitis for a minimum of 6 weeks
3. History and physical examination consistent with plantar fasciitis and a diagnostic ultrasound study showing thickening of the plantar fascia \>5 mm (normal is 3 mm)
4. Minimum Visual Analog Scale (VAS) score of 4.
5. Failed conservative care with at least two of the following treatments: Stretching, rest, shoe modifications, insoles or orthotics, physical therapy, or cortisone injection.
6. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests.
7. Subject understands and is willing to participate in the clinical study and can comply with visit and post -injection questionnaire schedules.

Exclusion Criteria:

1. Patients with history of diabetes, back issues, nerve issues or previous surgery of the foot or calf.
2. Patients with no pain in the heel region.
3. Subject is pregnant or breast- feeding.