cyrilzakka/clinical-trials huggingface dataset:
Cerebello-Spinal tDCS as Rehabilitative Intervention in Neurodegenerative Ataxia

Neurodegenerative cerebellar ataxias represent a group of disabling disorders which currently lack effective therapies. Cerebellar transcranial direct current stimulation (tDCS) is a non-invasive technique, which has been demonstrated to modulate cerebellar excitability and improve symptoms in patients with cerebellar ataxias. In this randomized, double-blind, sham-controlled study followed by an open-label phase, the investigators will evaluate whether a repetition of two-weeks' treatment with cerebellar anodal tDCS and spinal cathodal tDCS, after a three months interval, may further outlast clinical improvement in patients with neurodegenerative cerebellar ataxia and can modulate cerebello-motor connectivity, at short and long term.

Neurodegenerative cerebellar ataxias represent a heterogeneous group of disabling disorders in which progressive ataxia of gait, limb dysmetria, oculomotor deficits, dysarthria and kinetic tremor are the prominent clinical manifestations. Both the hereditary and sporadic forms usually present in young adulthood, and are characterized by atrophy of cerebellar or brainstem structures. Currently, cerebellar ataxia lack effective disease-modifying therapies.

Cerebellar transcranial direct current stimulation (tDCS) is a non-invasive technique, which has been demonstrated to modulate cerebellar excitability and improve symptoms in patients with cerebellar ataxias. The present randomized, double-blind, sham-controlled study followed by an open-label phase will investigate a repetition of two-weeks' treatment with cerebellar anodal tDCS and spinal cathodal tDCS, after a three months interval, may further outlast clinical improvement in patients with neurodegenerative cerebellar ataxia and can modulate cerebello-motor connectivity, at short and long term. In addition the investigators will evaluate if tDCS intervention might improve cerebellar cognitive-affective syndrome in patients with ataxia.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a cerebellar syndrome and quantifiable cerebellar atrophy

Exclusion Criteria:

* Severe head trauma in the past
* History of seizures
* History of ischemic stroke or hemorrhage
* Pacemaker
* Metal implants in the head/neck region
* Severe comorbidity
* Intake of illegal drugs
* Pregnancy
Acoustic Radiation Force Impulse (ARFI)Technology in Prediction of Liver Fibrosis

Background: In patients with chronic liver diseases, liver fibrosis staging is crucial for hazard evaluation of future disease complication development and thus for the optimal decision making on treatment selections.In the era of antiviral and antifibrotic treatments, clinical and research demands are also increasing for non-invasive surveillance of liver fibrosis to evaluate the progression or regression. However, local baseline data on liver stiffness measurement (LSM) using ARFI technique is still lacking in Taiwan, where viral hepatitides are highly endemic. Aim: Using the ARFI elastosonography, we are dedicated to the aims to recruit patients based on strict but appropriate criteria, to complete the correlation and validity studies between ARFI quantification and the referenced METAVIR fibrosis scoring and to conduct subsequent innovative studies on liver diseases. Materials and Methods: We plan to perform the ARFI quantification for each HBV or HCV-infected patient immediately followed by priorly scheduled conventional liver biopsy for METAVIR scoring during the same session of examination. Statistics: The first year's study using ARFI will focus on the correlation testings and validity studies using receiver operating characteristics.

Contribution and Future Works: Using the ARFI quantification either as a causal factor or as a outcome, we can conduct future analyses ranging from validations, regressions to prospective time-to-event analysis among our cohorts.

Eligibility Criteria:
Inclusion Criteria:

* infected with HBV only or HCV only

Exclusion Criteria:

* concurrent HBV-HCV infection, etc.
Clinical Evaluation of Cervical Ripening in the Outpatient Setting

A randomized controlled trial of mifepristone 200mg vs balloon catheter for cervical ripening.

Artificial induction of labour is currently required in 25-30% of all pregnancies, in high-resource countries. While the pharmacological modifications to the collagen matrix of the cervix, that allow it to dilate (cervical ripening) occur spontaneously in many women, allowing labour to be induced with oxytocin, in others the process needs to be triggered artificially. Cervical ripening is traditionally accomplished with prostaglandins or mechanical agents, in processes that typically require 12-24 hours of hospital stay. More recently, a limited number of hospitals have shifted towards starting the process in house, but then allowing women to return home and be re-evaluated on the following day.

The main aims this study is to compare efficacy and patient satisfaction of mifepristone vs balloon catheter for cervical ripening.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman scheduled for induction of labor.
* Age between 18 and 45 years.
* Understanding and capable to sign informed consent.
* Singleton pregnancy.
* Gestational age ≥ 37 0/7 weeks.
* Live fetus in cephalic presentation.
* Intact membranes
* Bishop score \< 6
* Estimated fetal weight \< 4500g
* Without contraindication to vaginal delivery
* No major fetal anomaly

Exclusion Criteria:

* Previous cesarean section or myomectomy
* Hypertension
* Diabetes
* Thyroid disease
* Maternal conditions with high risk of placental insufficiency
Safety & Efficacy of Encapsulated Allogeneic FVIII Cell Therapy in Haemophilia A

SIG-001-121 is a first-in-human (FIH), phase 1/2, multi-centre, open-label, dose escalation study to assess the safety, tolerability, and preliminary efficacy of SIG-001 in adults with severe or moderately severe haemophilia A without inhibitors. Up to three dose cohorts (3 patients each) are planned. Cohort expansions (up to 3 additional patients) may be triggered to collect additional information about safety and efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Males aged 18 years or older
* Diagnosis of Haemophilia A defined as ≤2% FVIII activity
* Greater than 150 exposure days to treatment with FVIII products
* Use of reliable barrier contraception if applicable
* Normal levels of von Willebrand factor (VWF) antigen
* Able and willing to provide informed consent
* Willing to withdraw from FVIII prophylaxis during specified periods in the study

Exclusion Criteria:

* Body mass index (BMI) ≥35
* Current FVIII inhibitors (\>0.6 Nijmegen Bethesda Units/mL) or prior Immune Tolerance Induction (ITI)
* History of allergic reaction or anaphylaxis to recombinant FVIII products or SIG-001 components
* Evidence of any bleeding disorder in addition to haemophilia A
* Abnormal laboratory values as defined in the protocol
* Active infection with Hepatitis B or Hepatitis C virus or currently managed with antiviral medications for Hepatitis B or C
* Uncontrolled HIV infection
* Active alcoholism or drug addiction during the 12 months before the screening visit
* Active malignancy or history of malignancy in the 5 years prior to study entry
* Participation in another investigational medicine or device study
* Prior administration of a gene therapy product
* Significant underlying disease or comorbidities that are a contraindication for general anaesthesia or laparoscopic procedure
Designing Virtual Reality-based Software for People With Multiple Sclerosis

The study aims to designing virtual reality-based testing and rehabilitation software for people with multiple sclerosis and assess the feasibility of software. Also, the effects of an 8-week virtual reality-based upper extremity training in persons with multiple sclerosis will be investigated.

Multiple sclerosis (MS) is a chronic, inflammatory, and demyelinating disorder that requires long-term rehabilitation. Numerous systematic reviews on MS have demonstrated the effectiveness of rehabilitation strategies such as exercise training, physical therapy, occupational therapy, and multidisciplinary therapy. However, despite the importance of upper extremity performance in daily functional activities, rehabilitation of people with MS (pwMS) generally focuses more on gait and balance, and upper extremity problems remain in the background.

In addition, rehabilitation treatments for pwMS are described as very long and systematic, leading to loss of motivation and adjustment. As a result, technology-based rehabilitation systems such as virtual reality (VR) have been promising in recent years and can provide person-centered task-oriented rehabilitation without needing a device or controller.

In pwMS, physiotherapy and rehabilitation programs based on today's VR studies are usually prepared with game software for computer users without physical disabilities. However, the number of these studies based solely on classical game software has a limited place in treating patients today and is considered insufficient. Moreover, this software is complicated for patients, has a fast-paced structure, and fails to provide disability-focused education or meet patient needs.

For this reason, it is necessary to develop specific game software for pwMS. The study aims to develop virtual reality exergame software for upper extremity rehabilitation in pwMS and evaluate the usability.

Persons who are followed by the outpatient Multiple Sclerosis Clinic of Dokuz Eylül University Hospital will participate in the study. Fifteen participants will be included to determine the feasibility of the software, and they will experience the system for one session. Then 15 participants will be included to investigate the effects of software on upper extremity functions during 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Having a definitive diagnosis of MS according to the 2017 McDonald criteria
* Being over 18 years old
* To be willing to participate in the study.

Exclusion Criteria:

* Having a neurological disease other than MS
* Cognitive disability at a level that hinders assessment and treatment.
* Having a relapse 30 days before or during the study
Noninvasive 3D Mapping in Persistent Atrial Fibrillation, to Describe Modifications of the Arrhythmogenic Substrate After Pulmonary Vein Isolation and Identify Potential Predicting Factors of Ablation Success

Atrial fibrillation (AF) is the most common cardiac arrhythmia in adults. It is a major cause of ischemic stroke and heart failure. Intravascular cardiac ablation of the left atrium by catheter delivery is an efficient treatment to restore sinus rhythm. AF ablation is a class IIa treatment for patients with symptomatic persistent AF refractory or intolerant to antiarrhythmic medication. There are still many debates considering the ablation strategy. The pulmonary veins remain the cornerstone of AF ablation therapy, even in persistent AF. There is a large electrical remodeling occurring in the left atrium between paroxysmal AF, early persistent AF and long-standing persistent AF. However, no multicentric and randomized study has demonstrated so far the interest of targeting other left atrial substrate, such as rotors or focal sources.

Our study aims to describe with a noninvasive mapping system the arrhythmogenic substrate of persistent AF \> 6 months pre- and post-cardioversion, and after pulmonary vein isolation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with documented persistent Atrial Fibrillation lasting longer than 6 months documented by 24h holter monitoring
2. Age between 18 and 75 years
3. Efficient oral anticoagulation during at least 1 month before the procedure
4. Social security affiliation
5. Feasible patient follow-up
6. Patient willing to comply with study requirements and give informed consent to participate in this clinical study
7. Indication for Pulmonary Vein isolation

Exclusion Criteria:

1. Previous atrial fibrillation ablation
2. Previous left atrial ablation or surgery
3. Atrial fibrillation without spontaneous RR interval \> 1000ms and with LVEF \< 35% (measured by TTE)
4. Presence of a mechanical mitral valve
5. Current intracardiac thrombus
6. Any condition contraindicating chronic anticoagulation
7. Uncontrolled hyperthyroidism
8. Anteroposterior LA diameter \> 55 mm measured by TTE
9. Body mass index ≥ 40 kg/m2
A Long-term Follow-up of the HIV-NAT Cohort

With HIV/AIDS increasingly considered a chronic disease, 24-, or 48-week data from antiretroviral studies are no longer sufficient. Only with long-term follow-up and outcome data will shed some much-needed light on the answers of questions that have stumped us for several years. Data from a large observational cohort of patients treated with combination antiretroviral therapy will provide further insights into the long-term safety and durability of various antiretroviral therapeutic approached, the efficacy of HIV viral load and CD4 cell counts as predictors of disease progression and mortality, and the importance of adherence.

Primary Objective:

To collect and evaluate long-term clinical outcomes of HIV infected participants previously enrolled in HIV-NAT trials.

Secondary Objective:

To Assess:

1. Long-term consequences of initiation of antiretroviral as predicted by baseline CD4 cell count and/or baseline plasma HIV RNA level
2. Incidence of lipodystrophy and other metabolic complications in three different groups of patients initially treated with NRTI-based regimens, NNRTI-based regimens, or PI-based regimens
3. Class-specific incidence of lipodystrophy and metabolic complications such as d4T versus AZT, nevirapine versus efavirenz and individual PIs (IDV, SQV, Kaletra, and atazanavir)
4. Resistance profiles in patients on different antiretroviral regimens
5. Long-term consequences of antiretroviral agents on cardiovascular, renal, hepatic, and endocrine function, skin, gastrointestinal system and urogentital tract
6. Incidence of opportunistic infections or malignancy including hepatocarcinoma in patients with HIV/HCV or HIV/HBV co-infection
7. Immune recovery syndrome
8. Adherence to different antiretroviral regimens
9. Quality of life

Eligibility Criteria:
Inclusion Criteria:

* HIV infected patients( children and adults) previously participated HIV-NAT studies
* HIV infected patients( children and adults) currently participate in HIV-NAT trials
* Able to provide written consent

Exclusion Criteria:

* Unable to provide written consent
Comparison of Treatments of Osteoporotic Compression Fracture Using Rigid Brace, Soft Brace, and no Brace

The treatment outcomes in the treatment without brace would be non-inferior to those in use of rigid or soft brace.

Bracing has been considered as a landmark step in conservative management for osteoporotic compression fractures. However, no prospective, randomized, and controlled clinical trials are available to document for the efficacy of wearing of the rigid or soft brace for the management of osteoporotic compression fracture. Therefore, the current trial was therefore designed to compare the outcome for improvement of disability and pain in patients with osteoporotic compression fracture using rigid, soft, or no brace.

Eligibility Criteria:
Inclusion Criteria:

* the presence of acute back pain caused by a single level vertebral fracture within 3 days of minor trauma such as fall from height,
* compression fracture between T 7 and L3 including injuries of only anterior compartment of vertebral body without neurologic deficit.

Exclusion Criteria:

* the presence of more than two recent vertebral fractures,
* pathologic malignant compression fractures,
* neurologic complications,
* a history of previous injury or surgery to the fractured level,
* inability to complete the questionnaires about pain and disability.
T-piece Versus Pressure-support for the Spontaneous Breathing Trial

The main objective will be to compare the number of ventilator-free days within the 28 days following the first spontaneous breathing trial between strategies of extubation performing spontaneous breathing trials with T-piece trials or with Pressure-Support trials.

To do that, the study director proposed to conduct a prospective multicenter randomized controlled open-label trial comparing these 2 strategies of weaning in patients at high-risk of extubation failure in the Intensive Care Unit.

Patients included will be randomized before performing the first spontaneous breathing trial and will be assigned to one of the following two groups according to the weaning strategy: T-piece trial group or Pressure-Support trial group.


Eligibility Criteria:
Inclusion Criteria:

1. Duration of mechanical ventilation prior to the first spontaneous brathing trial \> 24h
2. Patients at high-risk of reintubation according to the following criteria: Patients older than 65 years, or those having any underlying chronic cardiac or lung disease.
3. Patient meeting all weaning criteria according to the international conference consensus on weaning.

   * Respiratory rate ≤ 35 breaths per minute,
   * Adequate oxygenation defined as SpO2 \> 90% with FiO2 ≤ 0.4 or PaO2/FiO2 \> 150 mm Hg with positive end-expiratory pressure (PEEP) ≤ 8 cmH2O,
   * Adequate cough,
   * Patient awake with a Richmond Agitation-Sedation Scale between +1 and -2
   * No continuous sedation,
   * Hemodynamic stability with no need for vasopressors (or minimal dosis).
4. Informed consent given by the relatives or the patient himself.

Exclusion Criteria:

1. Patients admitted for traumatic brain injury
2. Pre-existing peripheral neuromuscular disease (underlying myopathy or myasthenia gravis)
3. Do-not-reintubate order at time of the first spontaneous breathing trial
4. Patient previously included in the study
5. No Health insurance coverage
6. People under protection: Pregnant or breastfeeding women, minor patients, subjects with guardianship or under law protection.
7. Refusal to participate
The Effect of Nutritional Interventions on Exercise-induced Muscle Damage

The study is a randomized, double-blinded, placebo-controlled trial that will include the participation of 69 women, aged 18-40 years. The aim of the study is to test nutritional strategies that help to minimize the effects of muscle damage induced by exercise.

The procedures will be performed at the Federal University of Health of Porto Alegre (UFCSPA).

The exercise-induced muscle damage is associated with eccentric activities affecting muscle structural unit through micro-injury that can promote a local inflammatory response, muscle damage and delayed onset muscle soreness. These events can cause an impact on athletic performance and lower adherence to the training programs. To optimize muscle recovery after the damage caused by exercise is essential to ensure adequate caloric intake , with required amounts of macronutrients and micronutrients. Recent studies have been showed that the protein intake before sleeping is a effective strategy to inhibit muscle protein degradation, stimulate muscle protein synthesis and facilitate adaptive response of skeletal muscle to physical exercise. Furthermore, evidences on the use of anti-inflammatory nutrients have suggested that diets rich in omega 3 can reduce inflammation through inhibition of pro-inflammatory mediators. Therefore, the intake of this nutrient combined with a protein meal before sleeps and the control of food intake can improve adherence to sports training. The study will consist of three groups where everyone will receive an individualized diet. A randomization procedure will determine the type of intervention. The distribution of the groups will be as follows: group 1 (control) - volunteers follow individualized diet and olive oil capsules and maltodextrin; group 2 - intervention with omega 3 more individualized diet ; group 3 - omega 3 and whey protein isolate intervention more individualized diet.

The order of procedures to be performed will be: (1) Nutritional and Anthropometric assessment; (2) Individual orientation of diet and distribution of supplements; (3) Baseline assessment (peak torque, muscle pain levels and vastus lateralis and rectus femoris echo intensity; (4) Muscle damage induction by eccentric exercise protocol; (5) Reviews after 24h, 48h, 72h, which will follow the routine and the methods applied at baseline.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 40 years aged
* BMI 18,5-25kg/m2
* physical exercise: \< 150 minutes per week

Exclusion Criteria:

* pregnancy/ lactation
* vegetarian/vegan
* chronic disease
* pulmonary and neurologic disease
* muscle injury/knee muscle injury
* medication use: anti-inflammatory and anticoagulant
* fish oil and derivate allergy
* dietary supplements use in the last month: whey protein, casein, albumin, glutamin, meat and soy protein, creatine, branched chain amino acid, high calorie supplement, n-3 supplement and antioxidants
A Study of Oral MBQ-167 in Participants With Advanced Breast Cancer

A Phase 1, open-label, dose-escalation clinical trial of MBQ-167 in participants with advanced Breast Cancer for whom Standard of Care (SOC) has failed or has proven intolerable.

The main questions this clinical trial aims to answer are:

* What, if any, are the side effects of different dose levels in humans?
* What is the maximum tolerated dose?
* How does the human body process the drug?
* Does the drug slow, stop or eliminate cancer in human participants?

Participants will be asked to:

* provide informed consent
* be evaluated by physicians and provide laboratory specimens to determine if eligible
* take MBQ-167 orally twice a day for at least 21 days
* may continue dosing, if safe to do so, until not effective or other decision to stop is made
* participate in multiple visits that include additional evaluations, laboratory tests and diary review until after stopping the investigational drug

Eligibility Criteria:
Key Inclusion Criteria:

* The investigator will evaluate these and other criteria to determine whether a participant can be included in this study.
* Histologically and/or cytologically confirmed advanced breast cancer which has progressed after treatment with approved therapies or for which there are no standard therapies available.
* Participants with known brain metastases may be eligible if specific conditions are met.
* Life expectancy ≥6 months, in the opinion of the investigator, after starting MBQ-167.
* Are able to swallow capsules twice daily with a meal.

Key Exclusion Criteria:

* The investigator will evaluate these and other criteria to determine whether a participant should be excluded from this study.
* Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of MBQ-167.
* Females who are pregnant or breastfeeding.
* Participants who have received any anticancer treatment within 4 weeks or any investigational agent within 28 days prior to the first dose of trial drug or who have not recovered from any acute toxicity greater than Grade 0 or 1 related to previous anticancer treatment.
* Participants who have received any anticancer treatment within 4 weeks or any investigational agent within 28 days prior to the first dose of trial drug or who have not recovered from any acute toxicity greater than Grade 0 or 1 related to previous anticancer treatment.
* Active malignancies other than advanced breast cancer will be excluded from the study.