cyrilzakka/clinical-trials huggingface dataset:
Effects of Transcranial Direct Current Stimulation (TDCS) in Drug-resistant Partial Epilepsy

Drug-resistant partial epilepsy has a heavy impact on quality of life and sometimes on life expectancy itself. Only a minority of patients may benefit from a curative epilepsy surgery. Neurostimulation, which can be an effective add-on treatment, is currently mainly represented by vagus nervus stimulation. Transcranial direct current stimulation, a non -invasive technique already used in other areas of neurology, may be efficient on some partial epilepsies, in particular through the individual configuration of stimulation, made possible by recent technological advances.

Main goal : To study the effect of transcranial electrical stimulation on the frequency of seizures in patients with drug-resistant partial epilepsy.

Hypothesis : Reduction of 50% or more in the frequency of occurrence of seizures within 24 hours following an individually configured TDCS session: responders in real TDCS vs placebo stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 15 years;
* Patients with drug-partial resistant epilepsy with the following characteristics:
* Disabling epilepsy despite an optimized pharmacological treatment.
* An average of one seizure a day or more during the week preceding the inclusion
* Focal epilepsy in which epileptogenic zone is documented by paraclinical examinations consistent with clinical data
* Existence of measurable EEG markers of epilepsy
* Anti-epileptic drug treatment unmodified during the 2 weeks preceding the inclusion no change to treatment planned during the study.
* Signed informed consent.

Exclusion Criteria:

* Patients under 15 years;
* Patients in which a standard quality EEG recording is not possible
* Patients with ictal bradycardia or ictal syncope ;
* Patients with heart disease which may result in heart arrhythmia ;
* Incapacitated patients (curatorship, guardianship), patients deprived of liberty.
* Pregnant or lactating women
* Vagus nervus stimulation is not an exclusion criteria
PET/MRI Scan for the Evaluation of Resectable Stage IA1-IB3 Cervical Cancer

This trial studies how well positron emission tomography/magnetic resonance imaging (PET/MRI) scan works in checking patients with stage IA1-IB3 cervical cancer that can be removed by surgery (resectable). PET/MRI scan may help doctors learn more about the spread of the disease.

PRIMARY OBJECTIVE:

I. To assess depth of cervical invasion with positron emission tomography/magnetic resonance imaging (PET/MRI) in patients with cervical cancer in clinical Federation of Gynecology and Obstetrics (FIGO) staging undergoing evaluation for surgical resection and correlate with pathology.

SECONDARY OBJECTIVES:

I. To correlate lymph node involvement on PET/MRI with pathology. II. To assess the inter-observer variability in the interpretation of PET/MRI. III. To correlate the quantitative imaging parameters of the tumor, such as the volumetric size, blood oxygen level dependent (BOLD), intravoxel incoherent motion (IVIM) analysis, apparent diffusion coefficient (ADC), diffusion tensor imaging (DTI), dynamic contrast-enhanced (DCE), metabolic tumor volume (MTV), total lesion glycolysis (TLG), standardized uptake value (SUV) and the glucose metabolic rate (GMR) with lymphovascular space invasion (LVSI) and tumor grade on surgical pathology.

OUTLINE:

Patients receive fludeoxyglucose F-18 and gadobutrol intravenously (IV) over 1 minute and undergo PET/MRI over 90-120 minutes.

Eligibility Criteria:
Inclusion Criteria:

* All patients with suspected clinical stage IA1-IB3 cervical cancer except patients with tumors \> 4 cm
* No contraindications to MRI
* Patients undergoing surgical procedure at MD Anderson
* Suspected cervical cancer

Exclusion Criteria:

* Patients who have contraindication to MRI
* Glomerular filtration rate (GFR) \< 30
* Pregnant patients
* Patients with history of previous radiation
* Patients with previous surgery for cervical cancer, unless residual tumor noted on physical exam
* Patients with endometrial cancer extending to the cervix
* Allergic reaction to gadolinium based contrast
* Body weight of greater than 450 (181.4 kg)
* Patients requiring general sedation
* Extremely claustrophobic patients
Spinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients

This is an early phase, proof-of-concept clinical trial assessing the safety and feasibility of non-invasive spinal cord stimulation to prevent respiratory muscle atrophy in mechanically ventilated ARDS patients. The investigators will recruit 10 elective surgery patients (surgery cohort) and 10 ARDS patients (ARDS cohort) for this study. A non-invasive, alpha-prototype Restore Technology stimulator using hydrogel surface electrodes will be used to stimulate the spinal cord at the cervical or thoracic level.

Stimulation will be conducted in closed-loop fashion at the start of inspiratory cycle. Signal from a chest belt will be used to synchronize stimulation with ventilator and prevent interference with ventilator (see Protection of Human Subjects). Prior to treatment stimulation, mapping will be conducted at 1 Hz with electrodes placed in locations identified to be optimal in the surgery cohort. Assessment of evoked EMG responses from respiratory muscles will be conducted. Once this electrode configuration is confirmed as effective (capable of evoking EMG activity), stimulation with this configuration will be applied for treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female 18-85 years;
2. Intubated with confirmed diagnosis of ARDS (by Berlin Criteria: acute onset within one week of known insult, bilateral airspace opacities not fully explained by pleural effusions, atelectasis, and/or nodules, respiratory failure not explained by heart failure or fluid overload, PaO2/FiO2 ratio \< 300); or identified as a patient admitted to the intensive care unit (ICU) after non-cardiac surgery;
3. Able to provide informed consent or available next of kin able to provide informed consent;
4. Have intact chest/lung, upper and lower extremity anatomy;
5. The neuromuscular connections between the spinal cord, diaphragm, and intercostal muscles are intact;
6. Enrollment of subject within 48 hours of intubation;
7. Able to induce evoked response of diaphragm muscle by spinal cord TES.

Exclusion Criteria:

1. Phrenic nerve or diaphragm pacer;
2. History of seizure disorder or on anti-epileptic medication for the treatment of seizures;
3. Compromised skin in back (neck, upper and lower back);
4. Pregnancy;
5. Implanted devices: cardiac pacemakers, implanted defibrillators, implanted neurostimulators, phrenic nerve pacers;
6. BMI greater than or equal to 35;
7. Pharmacological paralysis/neuromuscular blockade\*.
Determination of the Acute Effects of Aortic Stenosis on Coronary Artery Haemodynamics

Narrowing of the main valve which controls blood leaving the heart leads to a marked increase in death. To overcome this narrowing the heart muscle thickens abnormally and contracts more vigorously. However, in doing so, blood flow patterns to the heart muscle change through mechanisms which are incompletely understood. New technology allows such heart valve blockages to be fixed using balloons and metal stents inserted through tubes placed in arteries in the leg. Using sensors placed in these tubes it is possible to make detailed measurements of coronary flow and pressure, and apply new mathematical techniques to allow a better understanding of the detrimental effects that aortic stenosis has on coronary flow, before and after valve surgery.


Eligibility Criteria:
Inclusion Criteria:

* Severe Aortic Stenosis undergoing TAVI
* Normal coronary arteries
* Normal left ventricular function
* No other valvular pathology

Exclusion Criteria:

* Unable to consent
* Left ventricular impairment
* Left ventricular regional wall motion abnormality
* Other valve abnormality
SiFi vs FNB Local Anesthesia for Hip Fracture Surgeries

The goal of this clinical trial is to compare two commonly used local/regional anesthesia techniques in adults patients undergoing hip fracture surgery. The main question\[s\] it aims to answer are: • the impact of both interventions on patient level of pain. • impact on postoperative analgesics administered Participants will be randomly assigned to one of two local/regional anesthesia techniques, either femoral nerve block (FNB) or suprainguinal fascia iliaca block (SiFi). Both techniques are the usual practice at the hospital, and we are NOT aiming to experiment on new anesthesia technique in this study.

Hip fracture in the elderly is an increasingly common problem worldwide. Nearly all patients with a hip fracture undergo surgery. Patients with hip fractures often have significant pain, particularly with movement, and surgical fixation is associated with significant pain.

The treatment of pain with the use of a multimodal analgesic regimen is a major priority for elderly patients with hip fractures. These patients are often frail and have multiple medical comorbidities. Hence the use of non-steroidal anti-inflammatories drugs and systemic opioids may be contraindicated or complicated by adverse effects. Regional anesthesia techniques including femoral nerve blocks (FNB) and fascia iliaca compartment blocks (FICB) are frequently utilized as part of multimodal analgesia due to their relative lack of side-effects. Femoral nerve blockade and suprainguinal fascia iliaca (SiFi) blockade have been described for this indication. Several studies have investigated the analgesic efficacy of the SiFi block after total hip arthroplasty. However, randomized controlled trials on the analgesic efficacy of the SiFi block for pain after hip fracture surgery are not plentiful and subject to methodological concerns.

Objectives:

The primary objective is to test the hypothesis that in patients undergoing hip fracture surgery, suprainguinal fascia iliaca block is associated with improved pain scores and a reduction in opioid utilization when compared with femoral nerve block. Secondary objectives will be to compare time to mobilization, time to readiness for discharge and complications associated with both nerve block techniques.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or greater
* Having hip fracture surgery at the University of Alberta Hospital
* Suitable for multimodal analgesia including a peripheral nerve block

Exclusion Criteria:

* Contraindication to a nerve block technique
* Refuses consent for a nerve block technique
Study of Diagnosis of Color Power Doppler Combined Minimally Invasive Sampling for Endometrial Diseases

The postmenopausal women with vaginal bleeding were selected in this cross-sectional study. The basic characteristics information and endometrial blood flow energy index of endometrium were detected by color power Doppler ultrasound, and the energy histogram of endometrium was obtained. The specimen of uterine cytology and endometrial tissue were obtained through minimally invasive endometrium sampler, which were diagnosed by pathology. The statistical data were used to detect endometrial and precancerous lesions to observe the endpoint, and to provide the energy histogram model of the early warning endothelial diseases.

The postmenopausal women with vaginal bleeding are selected in this cross-sectional study. The uterine bleeding in patients with blood system diseases, reproductive organ outside the uterus, other organs cancer metastasis to the uterus are excluded. The objects are divided into two groups(patients with endometrial benign diseases and patients with endometrial cancer and precancerous diseases) according to endometrial cytological and histological pathology. The endometrial thickness, basic characteristics information and endometrial blood flow energy index, endometrial vascularization index, blood flow index are detected by color power Doppler and the energy histogram of endometrium is obtained using a Voluson E8 (GE Medical Systems, USA) ultrasound system. Moreover,The specimen of uterine cytology and endometrial tissue are obtained through minimally invasive endometrium sampler, which were diagnosed by pathology.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with vaginal bleeding

Exclusion Criteria:

* Vaginal bleeding caused by hematological system diseases or genitals outside the uterus
* Uterine bleeding caused by other organ cancers metastasize to the uterus
Evaluation of a Serious Game for Patients With Bipolar Disorder Involved in a Psychoeducation Group

Bipolar disorder is a condition characterized by succession of episodes- manic, hypomanic, and depressive episodes. Major risks factors of relapses are poor compliance, sleep disorder, and toxics consumption. The aims of psychoeducation programs are to increase compliance and knowledge about bipolar disorder. Serious game are supposed, in bipolar disorder, to strengthen the efficacy of psychoeducation programs. Bipolife® is a serious game which purpose is to help bipolar patients to deal with their conditions, through 3 mains messages : to pursue the treatment, to have daily routine and to request the psychiatrist in case of relapse.

This is a multicentric randomized controlled study with two harms parallels. After a classic psychoeducation group program, patients are randomized in two groups : interventional group and control group with treatment as usual.

The main objective is to evaluate the observance in the two groups. The other objectives are to evaluate daily routine, global functioning, and access to health care. Evaluations are realized at one and four months after inclusion visit. Acceptability and satisfaction about the serious game Bipolife® will be assessed in the interventional group.

Bipolife® is a serious game for bipolar patients, developed by Astra Zeneca laboratory in collaboration with a french company named Ubisoft. The aim of this interactive tool is to help patient to have a better understanding of their condition and to identify their daily routine which can impact on it.

Three visits :

At the inclusion visit (V0), on the 15days following the end of the psychoeducation group, the investigator evaluate mood, habits, daily routine, and verify inclusion criteria of the participants, in particular euthymic status. The participants are randomized by bloc in each center, in two groups : interventional group (Bipolife®) and control group.

Instructions on interventional group are to periodically connect to BIPOLIFE until next visit.

On the first visit, one month later (V1) and on the second visit, four months later (V2), the investigator evaluate compliance, routine habits and mood.

Eligibility Criteria:
Inclusion criteria:

* diagnosis of bipolar disorder according to the Diagnostic and Statistical Manual (DSM) IV
* euthymic status at least since 3 months
* participation to a psychoeducation group ending on the 15 last days
* realized at less 50% of the sessions of psychoeducation group
* free access to a computer with internet connection
* signed informed consent

Exclusion criteria:

* decline of participation
* patient on protective measures (guardianship or trusteeship)
Validity and Reliability of Jump Height

The primary objective is to test intratester and intertester reliability of maximum jump height using the sensor Orthelligent Pro.

The secondary objective is to test the concurrent validity of maximum jump height measured with the Orthelligent Pro compared to the gold standard which is the force plate.

In everyday physiotherapy practice, there is often no budget for expensive measuring instruments. Thus, devices such as a force plate are rarely available. Physiotherapists are always looking for inexpensive, practical and portable measuring instruments to evaluate therapy outcomes and to make reliable statements about the time for Return to Sport. Maximum jump height is a performance-determining factor in various jump-intensive game sports. In addition, the jump height serves as an important criterion to decide when an athlete can return to his usual sport after an injury. There is a new sensor on the market that measures jump height. This sensor is called Orthelligent Pro. It is shown to be a cost-effective and feasible measurement method for return to sport in physical therapy practice. So far, validity and reliability has never been tested. Therefore, this study aims to test the validity and reliability of the Orthelligent Pro for the measurement of maximum jump height. Two visits will take place 1-2 weeks apart. At the first visit, participants will complete 2x3 single-leg countermovement jumps measured by two testers each. At the second visit, three jumps are completed measured by the first tester.

The primary objective is to evaluate the intra-and intertester reliability of maximum jump height using Orthelligent Pro. The secondary objective is to test the concurrent validity of maximum jump height measured with the Orthelligent Pro compared with the gold standard which is the force plate. The primary and secondary endpoints are maximum jump height measured in centimeters.

Eligibility Criteria:
Inclusion Criteria:

* male and female persons aged 18-65 years
* performing at least 1x / week a training including jumping elements
* familiar with counter movement jumps
* good knowledge of German
* understand verbal and written instructions
* signed informed consent

Exclusion Criteria:

* known pregnancy
* known or suspected non-compliance with the protocol
* drug or alcohol abuse
* inability of the individual to follow the testing procedures, e.g., due to language problems, mental illness, dementia, etc.
* injuries of the lower extremity in the past year
* concomitant diseases of the foot, knee or hip
* tiring activity of the lower extremity the day before the test
* vigorous activity of the lower extremity one hour before the test
Safety, Tolerability, Pharmacokinetics (PK), and Activity of ATYR1940 in Participants With Muscular Dystrophy - Study Extension

The purpose of this study is to assess the safety and tolerability profile of ATYR1940 in the treatment of adult participants with molecularly defined genetic muscular dystrophies.

The purpose of this study is to assess the safety and tolerability profile of ATYR1940 in the treatment of adult participants with molecularly defined genetic muscular dystrophies, and to additionally explore the pharmacokinetics and biologic activity of ATYR1940 in adult participants with molecularly defined genetic muscular dystrophies. Participants who successfully complete the parent study (NCT02239224) are eligible for enrollment into this long-term extension study.

Eligibility Criteria:
Inclusion Criteria:

* Participant has an established, genetically-confirmed, diagnosis of facioscapulohumeral dystrophy with clinical findings meeting existing criteria.
* Participant is a male or female aged 18 to 65 years, inclusive.
* Participants who previously participated in study ATYR1940-C-002 and who meet the entry criteria above for the current study will be eligible for enrollment.

Exclusion Criteria:

* Participant is currently receiving treatment with an immunomodulatory agent or has a history of such treatment, including targeted biological therapies (for example, etanercept, omalizumab) within the 3 months before Baseline; corticosteroids within 4 weeks before Baseline; or non-steroidal anti-inflammatory agents (NSAIDs) within 2 weeks before Baseline.
* Participant has a severe retinopathy.
* Participant has a history of obstructive or restrictive lung disease (including interstitial lung disease, pulmonary fibrosis, or asthma), or evidence for interstitial lung disease on Screening chest radiograph.
* Participant has evidence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, metabolic, dermatological, or gastrointestinal disease, or has a condition that requires immediate surgical intervention, other treatment or may not allow safe participation.
* Participant has used any investigational product or device (other than a mobility assistance device) within 30 days before Baseline.
* If female and of childbearing potential (premenopausal and not surgically sterile), participant has a positive pregnancy test at Screening or is unwilling to use contraception from the time of Screening through the 1-month Follow-up visit. Acceptable methods of birth control include abstinence, barrier methods, hormones, or intra-uterine device.
* If male, participant is unwilling to use a condom plus spermicide during sexual intercourse from the time of Screening through the 1-month Follow-up visit.
16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Psoriatic Arthritis

The purpose of this study was to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active PsA despite current or previous NSAID or DMARD therapy


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria.
* Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative.
* Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis.
* Inadequate control of symptoms with NSAID.
* Other protocol-defined inclusion criteria do apply.

Exclusion Criteria:

* Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process.
* Subjects taking high potency opioid analgesics.
* Previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor.
* Ongoing use of prohibited psoriasis treatments / medications.
* Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα.
* Previous treatment with any cell-depleting therapies.
Risk Factors of Meconium Obstruction and Respiratory Distress Syndrome in Preterm Infants

Although the pathophysiology of meconium obstruction of prematurity (MOP) is not clear, it is known that the decrease of the intestinal peristalsis due to decreased intestinal perfusion during antenatal or perinatal period. Recently, the level of citrulline has been used as an index of function and injury of the small intestine State. This study aimed to evaluate citrulline level of cord blood as a marker for early detection and observe changes in intestinal blood flow in MOP patient.

And We aimed to confirm the efficacy of the AT/ET ratio (ratio of the pulmonary artery time-to-peak velocity interval to the right ventricular ejection time) of the prenatal pulmonary artery as a noninvasive predictor of neonatal respiratory distress syndrome.


Eligibility Criteria:
Inclusion Criteria:

* premature infants born less than 34 weeks from mother with pregnancy induced hypertension, pre-eclampsia or eclampsia

Exclusion Criteria:

* major congenital anomalies
* infants with hypotension while using inotropics
Effect of Kinesiotaping on Elbow Joint Proprioception

assessing the effects of kinesiotape application on elbow joint proprioception

assessing the effects of kinesiotape application on elbow joint proprioception by evaluating joint position sense

Eligibility Criteria:
Inclusion Criteria:

* 18-85 years

Exclusion Criteria:

* any elbow disorders
* any neurological disorders