cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of a Multimodal Physiotherapy Program With Virtual Reality Glasses in Duchenne and Becker.

Duchenne's Muscular Dystrophy and Becker Dystrophy, hereafter DMD and BMD, is a serious and progressive disease that affects 1 in 3,500-6,000 males born alive. Scale 6-minute walking test, is used for determine the inclusion of children with DMD in pharmacological studies. Furthemore, is used to verify a training effectiveness assessing muscular endurance and cardio-respiratory functions. This Research evaluates the feasibility and effectiveness of a multimodal physiotherapist program with virtual reality glasses.

In addition a physiotherapy program, virtual reality have a lot of importance advantages for train while motivated the kids.

A cross over study will be applied. In the control time, patient will received a initial evaluation and a final without making the physiotherapy program and without virtual reality glasses. The data will be collected by principal examiner.

In the intervention time the group will received 10 multimodal physiotherapy sessions, two or one per week, along six weeks. Also they are going to training walking with with virtual games.

Multimodal physiotherapist program describes the exercises to be performed, how long it will take, the number of repetitions and the way to do it with the physiotherapist in zoom session.

At the end of the multimodal physiotherapy program, variables will be evaluated by the principal examiner.

Eligibility Criteria:
Inclusion Criteria:

* Children between 4 and 15 years
* Duchenne and Becker Diagnosis ICD-10 issued by specialist in neurology.
* Children who can walk 10 m at last 120 seconds.
* First punctuation of North Start Ambulatory assessment bigger than 20 points.

Exclusion Criteria:

* An other Dystrophies.
* Older than 10 years.
* Not Physiotherapy. Not walk.
* Asociated heart disease Sprains, fractures. FC \>120, Sat O2 \<89%.
Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Ambulatory Patients With Mild COVID-19

This is an exploratory study to evaluate the efficacy of hydroxychloroquine (400 mg BID on D1 and 400 mg/day on D2 to D7) and azithromycin (500 mg/ 5 days) to treat mild ambulatory COVID-19 patients.

This is an exploratory study to evaluate the efficacy of hydroxychloroquine (400 mg BID on D1 and 400 mg/day on D2 to D7) and azithromycin (500 mg/ 5 days) to treat mild ambulatory COVID-19 patients.

We aim to demonstrate decrease in hospital related complications among ambulatory patients with mild COVID-19 by treating them with HCQ and AZT on top of standard care compared to patients who receive standard care only.

Ambulatory patients on day 3 of symptoms and with confirmed diagnosis of COVID-19 will receive the treatment.

Patients that do not fulfill the inclusion/exclusion criteria or that is not willing to participate in the study will be invited to consent the use of their data as part of a "control" group.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent from patient or legal representative.
2. Male or female, and:

   1. aged ≥ 70 years; or
   2. aged \< 70 with associated risk factors (chronic obstructive pulmonary disease; heart failure, immunosuppressed, obesity (BMI ≥ 35) uncontrolled diabetes and uncontrolled systemic arterial hypertension)
3. One or more mild symptoms characteristic of COVID-19 for 3 days, such as fever, cough and signs of respiratory distress, which do not require hospitalization.

Exclusion Criteria:

1. Participating in another RCT in the past 12 months;
2. Known allergy to HCQ or chloroquine
3. Any contraindication to HTC or AZT, including retinopathy and prolonged QT,
4. Severely reduced LV function
5. Severely reduced renal function;
6. Pregnancy or breast feeding
7. Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of the investigational products
Prevalence of Anatomical Variants of Dural Sinuses by Magnetic Resonance Venography Evaluation in Sohag

MR cerebral venography (MRV) is an MRI examination of the head with either contrast-enhanced or non-contrast sequences to assess patency of the dural venous sinuses and cerebral veins.


Eligibility Criteria:
Inclusion Criteria:

* Sohag by nationality and residence, male or female by sex, having normal cerebral MRV reported and consented to participate in the research work will be included in this research.

Exclusion Criteria:

* Having the diagnosis of cerebral venous sinus thrombosis, and previous head injury are the exclusion criteria of this research, also patients with absolute or relative contraindications for imaging including; claustrophobia, metallic implants, pacemaker and prosthetic heart valves for MRI.
Gradual Vs. Rapid Buprenorphine Detoxification - 2

The purpose of this study is to determine an optimal detoxification dose reduction schedule with buprenorphine.


Eligibility Criteria:
Please contact site for information.
Spinal Versus General Anesthesia for Transabdominal Preperitoneal (TAPP) Repair of Inguinal Hernia

The purpose of the study is to assess whether spinal anesthesia is superior to the standard general anesthesia or not for patients undergoing transabdominal preperitoneal inguinal hernia repair (TAPP).

Anesthesia for laparoscopic procedures, including transabdominal preperitoneal inguinal hernia repair(TAPP) is synonymous with general anesthesia because of the adverse effects of the CO2 pneumoperitoneum on the awake patient, and regional anesthesia is preferred only in patients where general anesthesia is contraindicated. Α pilot study of our hospital has recently shown the feasibility to perform successfully and safely transabdominal preperitoneal inguinal hernia repair with low pressure CO2 pneumoperitoneum under spinal anesthesia.After this pilot study and based on previous experience in regional anesthesia for laparoscopic procedures, we designed a controlled randomized trial in order to compare spinal anesthesia with the standard general anesthesia for patients undergoing transabdominal preperitoneal inguinal hernia repair (TAPP).

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-III
* BMI ≤ 35
* Age ≥ 18
* Normal coagulation profile

Exclusion Criteria:

* Non-reducible/obstructed hernias
* Previous open surgery in the lower abdomen
* Contraindication for pneumoperitoneum
* Contraindication for spinal or/and general anesthesia
* History of chronic pain or daily intake of analgesics
* Psychiatric disorders
* Inability of patients to use PCA pump
Pharmacokinetic Study to Compare Two Formulations of Paracetamol

A pharmacokinetic study in healthy volunteers comparing two formulations of paracetamol fast release in fasted state.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers aged 18-55yrs willing to give written informed consent for the study
* BMI must be within the range 18.5 - 24.9 kg/m\^2
* Participant with a minimum weight of 50 kg

Exclusion Criteria:

* Participant with current or recurrent disease that could affect the action, absorption or disposition of the study medication or clinical or laboratory assessments (e.g. hepatic disorders, renal insufficiency, congestive heart failure)
* Participant with known or suspected intolerance or hypersensitivity to the study materials
* Participant who are vegetarian
* Participant smoking more than five cigarettes a day
Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis

The primary objective was to estimate the tolerability and safety of 2 doses of Teriflunomide administered once daily for 24 weeks, compared to placebo, in patients with multiple sclerosis \[MS\] with relapses who were on a stable dose of Glatiramer Acetate \[GA\].

The secondary objectives were:

* to estimate the effect of the 2 doses of Teriflunomide, compared to placebo, in combination with a stable dose of GA on Magnetic Resonance Imaging \[MRI\] parameters, relapse rate and patient-reported fatigue;
* to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with a stable dose of GA.

The duration of the study period for a participant was approximatively 44 weeks broken down as follows:

* Screening period up to 4 weeks,
* 24-week double-blind treatment period\*,
* 16-week post-treatment elimination follow-up period.

'\*' Participants successfully completing the week 24 visit were offered the opportunity to enter the optional long-term extension study LTS6047 - NCT00811395.

Eligibility Criteria:
Inclusion Criteria:

* Definite MS diagnosis according to McDonald's criteria;
* Relapsing clinical course, with or without progression;
* Expanded Disability Status Scale \[EDSS\] less or equal to 5.5 (ambulatory);
* Stable dose of Glatiramer Acetate \[GA\] for at least 26 weeks prior to the screening visit;
* No onset of MS relapse in the preceding 60 days prior to randomization;
* Clinically stable for 4 weeks prior to randomization.

Exclusion Criteria:

* Other chronic disease of the immune system, liver function impairment or chronic pancreatic disease;
* Pregnant or nursing woman;
* Alcohol or drug abuse;
* Use of cladribine, Mitoxantrone, or other immunosuppressant agents such as Azathioprine, Cyclophosphamide, Cyclosporin, Methotrexate or Mycophenolate before enrollment;
* Human immunodeficiency virus \[HIV\] positive status;
* Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Assessment of Safety and Tolerability of Chitosan-N-acetylcysteine Eye Drops in Subjects While Wearing Contact Lenses and Before Insertion of Contact Lenses

The "dry eye syndrome" DES is a highly prevalent ocular disease, in particular in the elderly population. One mainstay of therapy for patients suffering from DES is the use of topically administered lubricants. However, despite many efforts, no "ideal" formulation has yet been found.

Recently, Croma Pharma has introduced chitosan-N-acetylcysteine eye drops, designed for treatment of symptoms related to DES. Chemically, chitosan is a polycationic biopolymer with favourable biological properties such as high biocompatibility and low toxicity. Additionally, the new formulation comprises N-acetylcysteine, which has been used in ophthalmology because of its mucolytic properties for several years. Based on theoretical considerations, one can hypothesize that the new chitosan derivative may show an increased adhesion to mucins of the ocular surface and may therefore be particularly beneficial in reducing the symptoms associated with DES. We have recently shown in a phase I trial that single instillation of chitosan-N-acetylcysteine eye drops is well tolerated in young healthy subjects.

However, no data is yet available about safety and tolerability of chitosan-N-acetylcysteine in subjects wearing contact lenses. This is of special interest because the tear film is critical to successful contact lens wear. Disturbances of the quantity or quality of the tear film results in intolerance of contact lens wear and possible damage to the ocular surface. This trial seeks to investigate the local tolerability and possible ocular discomfort of chitosan-N-acetylcysteine eye drops after repeated instillation .


Eligibility Criteria:
Inclusion Criteria:

* Regular contact lens wear since 3 years minimum
* Daily wearing time of the contact lens of 8 hours or more
* Good tolerability of the contact lenses without ocular discomfort or local signs of chemosis, conjunctival redness or other signs of intolerability as judged by the investigator.
* Subject willing to continue contact lens use for the study period
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings except ametropia

Exclusion Criteria:

* Participation in a clinical trial in the 3 weeks preceding the study
* Use of colored contact lenses
* Abuse of alcoholic beverages or other drugs
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Pregnancy
Eylea Post Marketing Surveillance(PMS)

The objective of this PMS is to gain information about safety and efficacy in real practice as a regulatory commitment required by MFDS


Eligibility Criteria:
Inclusion Criteria:

* Patients determined to start EYLEA treatment
* Patients who agree and sign informed consent
* Patients who receive EYLEA treatment for the first time
* Patients who meet one of the following

  * Patients diagnosed by physician as having neovascular (wet) age-related macular degeneration wAMD
  * Patients diagnosed by physician as having visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO)
  * Patients diagnosed as having visual impairment due to diabetic macular edema (DME)
  * Patients diagnosed as having visual impairment due to myopic choroidal neovascularization (mCNV)

Exclusion Criteria:

* Patients who have received anti-VEGF therapy within 90 days
* Patients who are contraindicated based on the approved product label

  * Ocular or periocular infection
  * Active severe intraocular inflammation
  * Known hypersensitivity to any ingredient of this drug
Standard Versus Intensive Monitoring After Myocardial Infarction Looking for Atrial Fibrillation

After a myocardial infarction (MI), patients discharged home in sinus rhythm may develop AF that is asymptomatic, undetected, and undertreated. Previous studies (CARISMA and ARREST) have demonstrate high rates of new-onset AF recorded on implantable loop recorder (ILR), although the routine implantation of ILRs post-MI remains costly and invasive. The external loop recorder may effectively identify patients with new-onset AF through a validated diagnostic algorithm and targeted monitoring during a high-risk period (immediately after hospital discharge). We will prospectively randomize patients to receive an external loop recorder or standard care, evaluating rates of new-onset AF developing within 30 days after MI.

The SIMPL-AF trial will evaluate the role of intensive monitoring after myocardial infarction, assessing for new-onset AF after hospital discharge. Patients will be randomized to receive intensive monitoring or standard care in a 2:1 distribution. Patients randomized to intensive monitoring will receive a SpiderFlash® monitor, worn for 30-days after discharge and returned for analysis.

The primary objective of this study is to evaluate at the incidence of new-onset AF at 30-days post-MI using an intensive monitoring strategy, compared to standard of care. Secondary objectives include the impact of intensive monitoring on oral anticoagulation rates at 90-days and 1-year after monitoring, and the risk factors for developing new-onset AF, and the variables associated with initiating or withholding anticoagulation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ST-elevation myocardial infarction (STEMI) or Non-ST-elevation myocardial infarction (NSTEMI; Third Universal Definition of MI) with or without PCI. All patients must have troponin elevation.
* No history of AF during hospitalization, at discharge, or pre-existing AF documented on history (i.e. hospital records, previous hospitalization, ECG records).
* No anticoagulation for AF or other indications (i.e. LV thrombus, heart valves, venous thromboembolism/deep venous thrombosis).
* No concomitant disease expected to reduce expected lifespan to \<2 yrs.

Exclusion Criteria:

* Patients receiving CABG surgery during this hospitalization or planned cardiac surgery within the next 3 months.
* Patients with spontaneous coronary artery dissection (SCAD), non-atherosclerotic coronary disease (NACAD), and Takotsubo cardiomyopathy are excluded from this study.
* Patients with contraindications to anticoagulation.
* Patients with a chronic skin disorder on the upper torso, or an allergy to medical tape or glue.
Feasibility of a Walking Program for Cancer Survivors Receiving Radiation Therapy

This pilot study will assess whether a supported pedometer-based walking program is helpful in maintaining physical activity for breast and head-and-neck cancer patients who are undergoing radiation therapy. Follow-up monitoring sessions will be scheduled to help provide support for physical activity during radiation therapy. We will also examine the relationship of physical activity and quality of life outcomes to help inform future research.

Will the integration of a patient-centered exercise prescription and supportive counseling attenuate declines in physical activity during radiation therapy? To address this question, this study will assess the feasibility of a patient-centered walking program for breast and head-and-neck cancer patients undergoing radiation therapy. Follow-up monitoring sessions will be scheduled to help provide support and ongoing counseling to facilitate increased activity (through walking) during radiation therapy. We will also examine the effect of the walking program on other outcomes such as happiness, depression and sleep to determine point estimates and measures of variability to inform future research.

Eligibility Criteria:
Inclusion Criteria:

* Survivors with a diagnosis of breast cancer or head and neck cancer
* Adults aged 18 years or older
* Commencing adjuvant radiation therapy treatments
* Karnofsky Performance Status greater than or equal to 60%

Exclusion Criteria:

* Clinical or radiological evidence of active disease, either local or metastatic
* Serious non-malignant disease, such as cardiac failure or advanced arthritis of weight bearing joints, which would preclude daily treatment and follow-up
* Patients for whom physical activity or exercise is contraindicated
* Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol
* Unable to comply with the protocol, measurement and follow-up schedule (e.g., scheduling conflicts, time commitment)
Comparison of Activator Manipulation Versus Manual Side Posture Manipulation in Patients With Low Back Pain

This study compared the treatment effect of Activator Methods Chiropractic Technique (AMCT) and manual Diversified type spinal manipulative therapy in a sample of patients with acute and sub-acute low back pain.

The purpose of this study is to compare the effects of (MFMA) Activator instrument adjusting to manual side posture (HVL) adjustments in patients with acute low back pain.

Primary outcomes measured include pain measurement with a VAS scale, the use of the Oswestry pain scale questionnaire, and the Bournemouth back pain scale questionnaire.

An additional aim of this study is to evaluate feasibility of recruitment, data collection, and other procedures which can lead to additional studies with larger number of subjects including a control group.

Eligibility Criteria:
Inclusion Criteria:

1. Being 18 years or older;
2. Having current acute or sub-acute low back pain defined as pain that has not lasted more than 16 weeks;
3. Minimum score of 30mm on a 100mm visual analog pain scale.

Exclusion Criteria:

Exclusion criteria consisted of the following:

1. Have any of six possible un underlying causes of low back symptoms in their history (spinal osteomyletisosteomyelitis, spinal fracture, herniated disc, ankylosing spondylitis, cauda equina syndrome, or cancer, excluding nonmalignant skin cancer);
2. Have undergone surgery involving the low back; (
3. Have received workers'compensation benefits within the preceding year or were potentially involved in litigation relating to back problems;
4. Pregnancy, because of possible need for exposure to diagnostic x-rays;
5. Have participated as a subject in research previously at the trial clinic site;
6. Have received spinal manipulation within the preceding 3 months or on more than three occasions during the preceding year.
7. Subjects with sciatica were excluded if they had any one of the following:

   * Ankle dorsiflexion / plantar flexion weakness;
   * Great toe extensor weakness;
   * Absence of knee or ankle reflexes;
   * Loss of light touch sensation in the medial, dorsal, and lateral aspects of the foot;
   * Ipsilateral straight-leg-raising test (positive result: leg pain at \<60°);
   * Crossed straight-leg-raising test (positive result: reproduction of contralateral pain).

   These six neurologic tests allow detection of most clinically significant nerve root compromises resulting from L4-L5 or L5-S1 disc herniations, which together make up more than 90% of all clinically significant radiculopathies attributable to lumbar disc herniations (21-25). Because approximately 12% of ambulatory patients with back pain h
8. Have symptoms of sciatica or leg pain without neurologic compromise related to lumbar disc herniation,\[5\] investigators attempted to include such subjects in the trial.

The criteria described above were intended to minimize the likelihood of including subjects with a lumbar disc herniation.
The Silent Cortical Infarcts in the Cerebral Amyloid Angiopathy: Is There a Link With Subarachnoid Hemorrhage?

The Cerebral Amyloid angiopathy (CAA) is the leading cause of cortical hemorrhage after 65 years. The presence of cerebral infarction is also reported anatomically in the AAC. MRI studies of these infarcts are rare. They are described as punctate, cortical silent. Frequency and pathophysiology is poorly understood. The investigators put the question of a link with hemorrhagic lesions of the AAC.

Main objective / secondary

The objectives are:

* To assess frequency of cortical infarcts in the cohort of patients recruited consecutively likely AAFC GHPSJ since 2007
* To assess the link between the presence of myocardial infarction and the clinical characteristics of patients and
* To study the relationship between topography and the brain hemorrhage one hand, meningeal hemorrhage other.

Inclusion / exclusion Any patient who was diagnosed as carrying a probable AAC according to the Boston criteria and has had a brain MRI with the following sequences: classic or enhanced diffusion (or DTI B2000), T1, T2 FLAIR, T2EG (T2 \* or SWAN)

Methodology This is a non-interventional study single center, including AAC patients hospitalized in the Hospital Group Paris Saint-Joseph from May 2007 to May 2014.

Clinical patient characteristics were collected from their medical records. Patients are aware of the potential use of their data for medical research by information contained in the handbook of the institution.

Brain MRI will be proofread by a neurologist and a neuroradiologist to clarify:

* the number and location of myocardial puncture
* the number and location of macro-bleeding
* the number of microbleeds (micro-bleeding)
* the presence and location of subarachnoid hemorrhage and / or hemosiderosis
* the location of the puncture infarction compared to macro-hemorrhage and subarachnoid hemorrhage / hemosiderosis: ipsilateral \<5cm, ipsilateral\> 5cm, another location The clinical data and MRI will be entered on a file, with data anonymisation. Statistical analysis will be done by a neurologist service.

Number of topics:

* It is estimated that enrollment of patients with AAC by the UNV GHPSJ is approximately 10 patients per year. The number of screened patients during the study period should be about 70.
* Taking into account those whose MRI will be judged of insufficient quality (excluded), the number of patients included in the analysis should be around 50.

Eligibility Criteria:
Inclusion Criteria:

* Any patient who was diagnosed as carrying a probable AAC according to the Boston criteria and has had a brain MRI with the following sequences: classic or enhanced diffusion

Exclusion Criteria:

* No conditions