cyrilzakka/clinical-trials huggingface dataset:
A Music-based VR Intervention for Upper Limb Motor Rehabilitation in Hemiparetic Patients

Hemiparesis affects the majority of stroke patients in the acute phase. In post-stroke motor rehabilitation patients can re-learn motor sequences through repetitive training. Research showed that virtual reality (VR) can be effectively used in upper limb motor rehabilitation by training motor coordination and gestures in an immersive virtual environment. Another promising line of intervention in post-stroke rehabilitation is the use of music, with evidence supporting the notion that a rhythmic accompaniment promotes the recovery of motor coordination in patients with hemiparetic stroke. Furthermore, studies showed a beneficial effect of the observation of movements performed by a third person in patients with post-stroke hemiparesis. Based this evidence, the present study aims at testing the feasibility and efficacy of a novel music-based VR intervention designed for upper limb motor rehabilitation in post-stroke hemiparetic patients. The treatment consists in upper limb repetitive training activities through the imitation of movements synchronized with a musical accompaniment and is delivered in 10 sessions over 2 weeks, supervised by a physical therapist. Participants wear a VR headset through which they observe egocentric 180° 3D videoclips. The experimental condition (group A) will be compared with a no-music condition (group B), to test the specific effect of music, and with traditional physiotherapy rehabilitation (group C), to test the efficacy of the approach. The investigators expect that the patients undergoing the experimental intervention (group A and group B) will show a greater upper limb motor function improvement, as compared to the active control group. As a secondary endpoint the investigators expect the music component to induce a greater motor improvement as compared to the experimental condition without music.


Eligibility Criteria:
Inclusion Criteria:

* Post-stroke patients in acute/subacute phase
* Upper limb hemiparesis (Ashworth scale: 0-2; MRC scale: 3-5)
* Age between 18 and 80 years
* Currently enrolled in inpatient rehabilitation

Exclusion Criteria:

* Psychiatric disorders,
* Neglect
* Epilepsy
* MMSE rating \< 24
* Difficulty with visual-spatial exploration
* Visual deficits.
Targeted Hypothermia During Cardiac Surgery

This study designed to evaluate the safety and feasibility of the NeuroSave device to rapidly reduce brain temperature while maintaining the brain at a lower temperature than the body core during cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Undergoing coronary revascularization or valvular cardiac surgery
* The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Human Research Ethics Committee (HREC) of the respective clinical site
* The study patient agrees to comply with all study -related procedures

Exclusion Criteria:

* Women known or suspected to be pregnant (as confirmed by a pregnancy test for all women of child-bearing age)
* Past history of cerebrovascular accident (stroke or TIA)
* History of clinically diagnosed active psychiatric conditions
* Emergency or salvage cardiac valve operations
* Body weight \< 50 kg
* Leukopaenia (WBC \< 3000 cell/mL), anaemia (Hgb \< 11g/dL), Thrombocytopaenia (Plt \< 50,000 cell/mL)
* Active upper GI bleeding within 3 months (90 days) prior to procedure
* Renal insufficiency (creatinine \> 265 micromol/L) and/or renal replacement therapy at the time of screening
* Estimated life expectancy \< 12 months (365 days)
* Structural abnormality or disease of nose, mouth, pharynx and oesophagus (excluding gastric reflux oesophagus disease),
* Currently participating in an investigational drug or another device study that would potentially impact the results of this study as determined by the PI. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials
Elucidating Age-related Comorbidity Patterns in Down Syndrome (DS)

This study is a non-drug, multicenter, prospective cohort study. It will be conducted in 300 volunteers from 12 to 45 years of age (inclusive) with a diagnosis of Down syndrome from 3 countries (France, Spain, United Kingdom (UK)). The basic hypotheses of the study are the following:

1. Diseases (and comorbidity) arise from one or more biological networks perturbed by the genetic disorder (trisomy 21) through interaction with environmental risks factors and epigenetic changes.
2. Health comorbidity patterns in DS individuals (particularly of obesity and related conditions) will likely vary by age and sex.
3. Obesity comorbidity patterns will relate to variation in factors including lifestyle, stress-response, severity of intellectual disability (ID) and variation in cognitive domains such as executive functioning.
4. Stress responses, as measured with cortisol concentrations, will differentiate individuals with DS who are obese and those who are not. Extremes in phenotype (Obese vs. Non-obese) will be related to differences in the metabolomic, transcriptomic, and microbiome concentrations.

The study will be conducted in n= 300 volunteers with DS from 3 countries (France, Spain, UK); equal numbers in 3 age groups (12 - 18 years; 19 - 34 years; 35 - 45 years). The total number of volunteers expected to be included in each country is n = 100.

From the initial cross-sectional cohort, individuals will be selected on the basis of obesity status and invited to participate in a nested case-control study (n = 30 for normal weight DS individuals and n = 30 DS individuals with extreme phenotype). In adults, normal weight is defined as BMI 18.5 to 24.9 and significant obesity as BMI \> 35 kg/m2. In children under age 18, the research team will use the International Obesity Task Force (IOTF) curves which are international norms) with IOTF \> 30 for obese and IOTF 18.5 - 25 for the normal weight group. The research team will monitor allocation using monthly eCRF recruitment reports for central allocation of recruits to ensure balance between age, sex and BMI between the "cases" and the "controls".

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 12 to 45 years
* With established genetic diagnosis of Down syndrome (full trisomy 21; based on karyotype results - not exclusion if not available but will need to confirm karyotype if not done previously)
* Availability of parent/caregiver to accompany the subject to clinical visits and to be willing to give written informed consent, when necessary

Exclusion Criteria:

* Confirmed mosaic trisomy 21, partial trisomy 21, or translocation
* Comorbid conditions - Participation is allowed as long as the condition(s) are considered stable and it do not interfere with the participation of the study
* Subjects with evidence of dementia or meeting clinical diagnoses for dementia
* Participation in a medication treatment trial in the last 3 months prior to the study
Assessment of Respiratory Function Cerebral Palsy Using Plyometric Exercise Sensorimotor Program

To examine if adding plyometric exercises to sensorimotor exercises would improve respiratory function in children and adolescents with cerebral palsy

Cerebral palsy (CP) is a varied group of developmental disorders secondary to a static immature brain injury that primarily results in persistent nonspecific impairment of movement and posture. Approximately 25% of all CP cases experience disturbance of motor function with unilateral spasticity pertaining to the upper and lower extremities contralateral to the affected cerebral hemisphere and categorized as spastic hemiplegia. Some asymmetries might be noted when hemiplegic children are attempting to perform motor activities. In supported standing, hemiplegic children may stand preferentially on their more functional side and exhibit postural malalignments that impair the ability to transfer body weight on the affected lower extremity.

Children and adolescents with CP have poor respiratory function, secondary to the disease process. Impaired airway clearance, recurrent aspirations, chest infections, poor cough mechanism, impaired lung function, deformity of the spine and chest, and poor nutrition status influence the respiratory condition of children and adults with CP resulting in reduced lung capacity in these individuals.

Plyometric exercises are a specific pattern of resistive strength training in which the muscle starts to contract eccentrically followed by rapid concentric contraction of the same muscle. It can jointly generate high velocity dynamic movements and high-impact force on the muscles and bones. Currently, a limited number of studies have analysed the efficacy of the plyometric training on respiratory function in children with CP or any other disabling health conditions. Preliminary studies have demonstrated the positive effect of plyometric exercises for the gross motor function in boys with unilateral CP.

Eligibility Criteria:
Inclusion Criteria:

* Age will be 8 - 14 years.
* children will be assigned to the study are suffering from spastic hemiplegic cerebral palsy (less than grade 1+ om Modified Ashwar Scale)
* Considering the physical problems, children will be chosen according to Growth Motor Function Classification System (GMFCS) with levels I-III
* The ability to understand simple verbal instructions.

Exclusion Criteria:

* Visual and hearing impairment; surgery within the last three months preventing them from taking part in sensorimotor physical therapy
* Severe oromotor issues
* Severe chest infections
Acupuncture and Insulin Doses in Insulin-treated Type 2 Diabetes

This study is a randomized, single blinded, cross-over interventional study for evaluating the effect of acupuncture versus sham acupuncture in diabetic type 2 patient in insulin treatment. Primary end-point of the study is the difference of daily units of insulin between treatment and control group; secondary end point are the variation of glycated hemoglobin levels, lipids panel (total cholesterol, low density lipoprotein, high density lipoprotein, triglycerides), C reactive protein and adiponectin. Variation of epicardial fat thickness will be also evaluated by echography. Acupuncture and sham treatment will be administered twice a week for 3 months and, after a pause of one month and cross-over between groups for other three months. Acupuncture treatment will include use of somatic points (SP6; ST36; KI3; CV4; CV12; TE5; LI4; LI11; YinTang; ST28; BL23; BL22; BL20; BL13) and auricular points (most tender point on palpation with pressure feelers of 400 g on Stomach, Endocrine, Spleen, Kidney, Hungry, Shen man and Pancreas auricular points). Sham acupuncture will be applied distal from acupuncture points and areas used for treatment, with shallow insertion and without manipulation of the needle (15 needles in total on thorax, abdomen, back, arms and legs).


Eligibility Criteria:
Inclusion Criteria:

* type 2 Diabetes Mellitus
* insulin therapy \> 20 UI daily for at least 6 months
* HbA1c \< 69 mmol/mol

Exclusion Criteria:

* Class I Psychiatric illness not adequately treated
* Actual pregnancy or breastfeeding, or pregnancy planning.
* Corticosteroid treatment
* Severe heart failure (NYHA III-IV)
* Severe renal failure (pre-dialysis o dialysis),
* Severe liver insufficiency (overt cirrhosis)
* Severe respiratory failure (oxygen therapy)
Flotation-REST for Chronic Pain, Stress, and Sleep

This randomized crossover trial aims to examine the effects of Flotation-REST (Reduced, Environmental, Stimulation, Technique/Therapy) compared to laying in a dark room (with reduced environmental stimulation) for those with chronic musculoskeletal pain. This design will allow for comparisons between the two interventions on daily diary assessments of pain, stress, and sleep, both between groups and within individuals.

Chronic pain is a prevalent and significant health problem. Previous research shows that Flotation-REST may be an effective treatment for reducing pain but little is known about the short-term effects of a single session of Flotation-REST on the day-to-day variability of pain, stress, and sleep. Sleep, stress, and pain are all bidirectionally related to each other, and previous research shows that Flotation-REST may positively influence all three of these outcomes. Therefore, the primary aim of this study is to examine changes in pain, stress, and sleep following Flotation-REST. The secondary aim is to investigate whether various subjective experiences during the intervention are associated with changes in pain, stress, and sleep following the interventions.

Eligibility Criteria:
Inclusion Criteria:

* Chronic musculoskeletal pain (e.g., back pain or upper or lower extremity pain, arthritis, fibromyalgia) on more days than not for the past 3 months
* Psychologically healthy
* Adults between the ages of 18-75 years.

Exclusion Criteria:

* Previous experience in a flotation-REST device.
* Diagnosed with neuropathic pain condition or endorsing more than 4 peripheral neuropathy symptoms.
* Diagnosed with any psychiatric condition (e.g., schizophrenia or bipolar disorder).
* Active suicidality with intent or plan.
* Currently taking SSRI medication.
* History of neurological conditions (e.g., epilepsy, stroke, severe traumatic brain injury, Parkinson's disease, Alzheimer's disease or other forms of dementia)
* Any skin conditions or open wounds that could cause pain when exposed to saltwater
* Inability to lay comfortably for 60 minutes
* Pregnant
* Started a new sleep or pain medication within the last 6 weeks
Effects of Transvertebral Direct Current Stimulation in Humans

This study will evaluate the effects of non-invasive stimulation of the spinal cord in people with spinal cord injury.

This study will use a non-invasive form of spinal stimulation, called transvertebral direct current stimulation, or tvDCS. It currently is not clear what effects this type of stimulation has on the excitability of the brain and spinal cord in people with spinal cord injury. In this study, subjects will participate in 3 sessions, with at least 1 week in between sessions, during which they will get a different condition of tvDCS. We will test the excitability of the brain and spinal cord before and after tvDCS in each session.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years of age
* Motor incomplete spinal cord injury classified as B, C, or D by the American Spinal Injury Association Impairment Scale (AIS)
* More than 12 months post-injury
* Lesion at of above thoracic level T8
* Body mass index \<30 (in order to facilitate reliable location of body landmarks guiding stimulation)
* Severe gait deficit

Exclusion Criteria:

* Unstable cardiopulmonary conditions
* History of seizure, head injury with loss of consciousness, severe alcohol or drug abuse, and/or psychiatric illness
* Cognitive deficits severe enough to preclude informed consent
* Positive pregnancy test of being of childbearing age and not using appropriate contraception
* Ferromagnetic material in the brain or in the spine (except for titanium for segmental fixation of the spine)
* Cardiac or neural pacemakers
* Fixed contractures in the lower extremities
* Uncontrolled diabetes
* Severe osteoporosis
* Severe spasticity
* Decubitus ulcers which interfere with harness support or walking
* Severe orthostatic hypotension
Clinical and Biomolecular Assessment for the Monitoring of Patients Undergoing Regenerative Medicine Treatments with Orthobiologics

the aim is to improve the evaluation of the outcomes of regenerative medicine treatments performed in the regenerative medicine centers involved in the study.

patients who undergo regenerative medicine treatments present acute and chronic pathologies of the musculoskeletal system, of the stomatological system and of the integuments.

Objective pre, peri and post treatment evaluations are collected. A dedicated software collects the PROMs compiled by the patients, the objective clinical data and the biomolecular evaluations.


Eligibility Criteria:
Inclusion Criteria:

* patients who received indication for regerative medicine treatment for one of the following pathologies: Knee or hip or ankle osteoarthritis, patellar or Achilles tendon pain, shouder or elbow pain;
* males and females;
* age \>= 6 years.

Exclusion Criteria:

* age \< 6 years
* patients not compliant with post-treatment monitoring procedures
* pregnancy
Confirmatory Study of OPC-12759 Ophthalmic Suspension

The purpose of this study is to verify whether OPC-12759 ophthalmic suspension is effective compared with active control in dry eye patients.


Eligibility Criteria:
Inclusion Criteria:

1. Out patient
2. Subjective complaint of dry eye that has been present for minimum 20 months
3. Ocular discomfort severity is moderate to severe
4. Corneal - conjunctival damage is moderate to severe
5. Unanesthetized Schirmer's test score of 5mm/5minutes or less
6. Best corrected visual acuity of 0.2 or better in both eyes

Exclusion Criteria:

1. Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca
2. Ocular hypertension patient or glaucoma patient with ophthalmic solution
3. Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study
4. Anticipated use of contact lens during the study
5. Patient with punctal plug
6. Any history of ocular surgery within 12 months
7. Female patients who are pregnant,possibly pregnant or breast feeding
8. Known hypersensitivity to any component of the study drug or procedural medications
9. Receipt of any investigational product within 4 months.
Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Relapser Genotype 2 Hepatitis C Infected Patients

This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and Ribavirin (RBV) in patients with genotype 2 hepatitis C, who relapsed after previous treatment.


Eligibility Criteria:
Inclusion Criteria:

* Genotype 2, chronic hepatitis C
* Relapsers (patient who relapsed after previous treatment)
* Able and willing to follow contraception requirements

Exclusion Criteria:

* Cirrhosis of the liver or hepatic failure
* Hepatitis B surface antigen-positive or HIV antibodies-positive
* History of, or concurrent hepatocellular carcinoma
* History of, or concurrent depression, schizophrenia,; or suicide attempt in the past
* Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant
Antegrade Screw Placement Technique in Anterior Column of Acetabulum

This retrospective observational study aims to define the optimal antegrade entry point for screw placement in the anterior column fixation corridor (ACFC) of the acetabulum. Using fluoroscopic visualization techniques, the study examines computed tomography (CT) scans from 500 healthy adult patients to simulate screw placement and measure anatomical parameters. The goal is to determine patient-specific entry points and to assess the feasibility of screw placement using axial fluoroscopic views. The study also investigates gender-specific anatomical variations to provide insights for safer and more precise screw placement during anterior column fixation in pelvic surgery.

This study focuses on developing and validating a fluoroscopic visualization technique for identifying the optimal antegrade entry point (OAEP) in the anterior column fixation corridor (ACFC) of the acetabulum during pelvic surgery. Using three-dimensional reconstructions from pelvic computed tomography (CT) data of 500 healthy adults, the study simulates screw placement within the ACFC. A cylinder representing the screw is inserted virtually through the OAEP, ensuring that it remains within the confines of the fixation corridor without breaching its boundaries. The study records anatomical measurements, including the corridor's diameter, length, and the angles required for sagittal and coronal plane inclinations to visualize the OAEP.

The study also examines gender-specific anatomical variations, including differences in ACFC diameter, length, and required fluoroscopic angles. By defining patient-specific entry points and establishing a reliable fluoroscopic technique, this study aims to provide a practical and accessible method for anterior column fixation, minimizing complications and improving the safety and precision of screw placement in pelvic surgeries.

This novel approach has the potential to offer a cost-effective alternative to more expensive navigation systems, making it widely applicable in clinical settings.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pelvic computed tomography (CT) scans that provide complete anatomical details of the pelvis.
* Patients aged 18 to 65 years.
* Patients with fully matured bone structures, without evidence of fractures, deformities, or prior orthopedic surgery.
* Patients with no history of rheumatologic disease, advanced osteoporosis, bone metastasis, or metabolic bone disorders.

Exclusion Criteria:

* Patients with pelvic CT scans that do not fully display the anatomical structures.
* Patients younger than 18 years or older than 65 years.
* Patients with pelvic fractures, deformities, or prior orthopedic surgeries.
* Patients with incomplete clinical or radiological data.
* Patients with rheumatologic sequelae, bone metastasis, or metabolic bone diseases.
An Extension Trial to Investigate Long-Term Treatment With Transdermal Rotigotine in Idiopathic Restless Legs Syndrome

This is a multicenter, open-label trial to assess safety and tolerability of rotigotine (SPM 936) in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal dose for up to 1 year. Subjects who successfully completed the Maintenance Period and the Taper Period of SP792 are allowed to enroll in this trial.

All subjects will begin the Titration Period at a daily dosage of 1.125mg rotigotine (2.5cm2 patch). Subjects will be up-titrated at 7-day intervals in 1.125mg (2.5cm2 increments, initial titration step only) and 2.25mg intervals (5cm2) increments to a maximum dose of 6.75mg/day (15cm2) rotigotine. The maximum length of titration is 28 days (±3 days), although not all subjects will require 28 days to reach their optimal dose.

A subject's dose may be increased or decreased, as needed by the investigator to maintain a subject's effective dose during the Maintenance Period. A Taper Period is provided to allow for safe, gradual withdrawal from trial medication


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic restless legs syndrome

Exclusion Criteria:

* Subject has an ongoing serious adverse event from SP792 that is assessed to be related to the trial medication by the investigator and/or the sponsor.
* Subject is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, 2 years postmenopausal, or does not consistently use 2 combined effective methods of contraception, including at least 1 barrier method, unless sexually abstinent.
* Subject has any medical or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject's ability to participate in this trial.