cyrilzakka/clinical-trials huggingface dataset:
Optimizing Hand Rehabilitation Post-Stroke Using Interactive Virtual Environments

The complexity of sensorimotor control required for hand function as well as the wide range of recovery of manipulative abilities makes rehabilitation of the hand most challenging. The investigators past work has shown that training in a virtual environment (VE) using repetitive, adaptive algorithms has the potential to be an effective rehabilitation medium to facilitate motor recovery of hand function. These findings are in accordance with current neuroscience literature in animals and motor control literature in humans. The investigators are now in a position to refine and optimize elements of the training paradigms to enhance neuroplasticity. The investigators first aim tests if and how competition among body parts for neural representations stifles functional gains from different types of training regimens. The second aim tests the functional benefits of unilateral versus bilateral training regimens.The third aim tests whether functional improvements gained from training in a virtual environment transfer to other (untrained) skills in the real world.

The complexity of sensorimotor control required for hand function as well as the wide range of recovery of manipulative abilities makes rehabilitation of the hand most challenging. The investigators past work has shown that training in a virtual environment (VE) using repetitive, adaptive algorithms has the potential to be an effective rehabilitation medium to facilitate motor recovery of hand function. These findings are in accordance with current neuroscience literature in animals and motor control literature in humans. The investigators are now in a position to refine and optimize elements of the training paradigms to enhance neuroplasticity. The investigators first aim tests if and how competition among body parts for neural representations stifles functional gains from different types of training regimens. The second aim tests the functional benefits of unilateral versus bilateral training regimens.The third aim tests whether functional improvements gained from training in a virtual environment transfer to other (untrained) skills in the real world.

Eligibility Criteria:
Inclusion Criteria:

* Six months post cerebrovascular accident
* Residual upper extremity impairment that affects participation
* At least ten degrees of active finger extension
* Tolerate passive shoulder flexion to chest level

Exclusion Criteria:

* Severe neglect
* Severe aphasia
PostoperAtive Neurocognitive Dysfunction After Major AbdomiNal Surgery (PANDAMAN)

Predisposing and precipitating factors for perioperative delirium for the elderly remain elusive. This research will be conducted to determine risk factors of postoperative delirium.

This study intends to include 500 participants over 65 years old undergoing elective abdominal major surgery. The primary outcome is incidence of delirium at 7 days postoperatively, and the secondary outcomes include preoperative sleep disorders(Athens In-somnia Scale, AIS), postoperative cognitive impairment (Abbreviated Mental Test Score, AMTS), postoperative pain (NRS pain score), incidence of significant postoperative complications, length of hospital stay, and serum biomarkers levels.

Eligibility Criteria:
Inclusion Criteria:

1. 65 to 90 years old to receive elective major abdominal surgery (expected operation time over 2 hours); ,
2. American society of Aneshesiologists（ASA）physical status I-III;

Exclusion Criteria:

1. Mini-Mental State Examination (MMES) score \< 15;
2. Renal failure (requiring dialysis) or liver failure (Child-Pugh score \> 5);
3. Severe impairment due to structural or hypoxic brain injury, more than 2 days in ICU one month before surgery;
4. Underwent major heart, lung or abdominal surgery within 1 year;
5. Positive for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or symptomatic (e.g. fever, cough, loss of taste/smell);
6. The cognitive assessment cannot be completed because the subject is blind, deaf, or unable to communicate in the local language;
7. Long-term follow-up unavailable (homelessness, active psychosis or substance abuse).
Irinotecan Liposomes Combined with Epirubicin in Recurrent Non-muscle Invasive Bladder Urothelium Carcinoma After Anthracyclines Treatment

The goal of this clinical trial is to learn the dose-limiting toxicity of the new combined treatment with irinotecan liposomes (intravenous injection) and epirubicin (intravesical instillation) in anthracyclines treatment-failed non-muscle invasive bladder cancer adults.

It will also learn if the combined treatment works to treat these patients. Additionally, the safety and biological mechanisms of the combined treatment will also be explored.

The main questions it aims to answer are:

* Does the combined treatment of irinotecan liposomes and epirubicin reverse anthracyclines resistance of participants?
* What medical problems do participants have after taking the combined treatment of irinotecan liposomes and epirubicin?
* What biological mechanisms underlie the effect of irinotecan liposomes on anthracyclines resistance? Participants will be classified into Arm A and Arm B.
* Arm A: Participants will receive an intravenous injection of irinotecan liposomes once every two weeks for one month, along with intravesical instillation of epirubicin once a week for one month. Patients will be evaluated by two professional urologists; those with a complete response or partial response will undergo transurethral resection of bladder tumor (TURBT) and intravesical therapy. Patients with stable or progressive disease will receive subsequent treatment at the investigator's discretion. Participants are required to visit the hospital for physical examination every two weeks.
* Arm B: In the first month after TURBT surgery, participants will receive intravenous injection of irinotecan liposomes once every two weeks for one month, and intravesical instillation of epirubicin once a week for one month, followed by once a month for six months. Participants are required to visit the clinic for physical examination once every two weeks in the first month, and once every three months after that.
* Keep a diary of their symptoms during the study period.


Eligibility Criteria:
Inclusion Criteria:

* cTa-cT1N0M0 patients with non-muscle invasive urothelial carcinoma
* Tumor recurrence occurred after anthracyclines treatment
* Systemic chemotherapy had not been used
* Tumor is measurable according to New response evaluation criteria in solid tumours: Revised RECIST guideline
* ECOG (ZPS, 5-point scale) 0-1

Exclusion Criteria:

* Age less than 18 years
* Patients with severe cardiac, cerebral, hepatic, or renal disease
* Severely malnourished patients
* Patients with mental illness and those without insight and unable to express exactly
* Combined with malignant tumors of other organs
* Systemic infectious diseases
Using Transcranial Direct Current Stimulation (tDCS) to Improve Post-Stroke Aphasia

This study tests whether weak electrical stimulation of the brain is effective in improving language or reading difficulties occurring after a brain injury or stroke.

This study tests whether aphasia or alexia, language and reading disorders occurring after traumatic brain injury or stroke, can be improved using transcranial direct current stimulation (tDCS). tDCS is a non-invasive technique that applies a small amount of direct electrical current to the brain in order to temporarily alter brain processing. Adults with aphasia/alexia resulting from stroke or traumatic brain injury will undergo baseline behavioral testing of various language and cognitive functions. Subjects who are willing to undergo MRI evaluation will also be scanned. They will then receive five days of either real or sham tDCS with standardized speech-language therapy, under a double-blind randomized placebo-controlled design. Behavioral assessments, and MRIs for those participating in the MRI portion of the study, will be performed again at multiple time points after completing tDCS to assess for changes in these measures.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Aphasia due to left hemisphere stroke diagnosed by a physician or speech-language pathologist

Exclusion Criteria:

* Skull defect at or near the site of tDCS delivery
* History of a significant stroke or traumatic brain injury other than the event that caused the aphasia
* History of other brain conditions that could impact interpretation of results (such as multiple sclerosis, brain tumor, encephalitis, premorbid dementia)
* Presence of implanted electrical or metallic devices in the head or body (except titanium; e.g. cochlear implants, implanted shunts with metal parts, deep brain stimulators, pacemakers, defibrillators)
* Presence of ferrous metal in the head (e.g. shrapnel)
* History of psychiatric disease requiring hospitalization, electroconvulsive therapy, or ongoing medication use (other than common selective serotonin reuptake inhibitor antidepressants)
* Pregnancy
* Severe comprehension deficits

Additional Exclusion Criteria for the optional MRI portion of the study:

* Presence of metal in the body (except titanium)
* Claustrophobia
Visual Reconstitution Therapy After Optic Neuritis

Incomplete remission after an optic neuritis attack is not uncommon. Visual reconstitution therapy is a software-based approach that has been shown to substantially improve residual visual field deficits in patients with pre- and postchiasmatic lesions.

The primary hypothesis of this randomized, controlled clinical trial is, that visual reconstitution therapy is superior to active comparator treatment in improving the visual field after optic neuritis.

Patients with an acute optic neuritis (between 60 and 180 days before screening) or with residual visual deficits after a past optic neuritis are randomized in two treatment groups. Group A is instructed to perform software-based visual reconstitution therapy on a home PC daily and regularly for 30 minutes over a period of six month. Group B will perform a similarly, also software-based training program, developed to improve saccadic eye movements rather than visual fields. Patients are blinded to the respective treatment.

Eligibility Criteria:
Inclusion Criteria:

* Definite Optic Neuritis within 60-180 Days or \< 12 months before Screening
* Visus \> 0.05
* Visus \< 0.7 or confirmed visual field deficit
* Ability to give Informed Consent

Exclusion Criteria:

* Systemic Treatment with Glucocorticosteroids within 30 days prior to Screening
* Additional significant ophthalmological disease
* Pregnancy
* History of Epilepsy
* Significant arterial Hypertension
Balloon Assisted Transarterial Therapy for Hepatocellular Carcinoma

To prove the treatment concept of the use of balloon assistance in transarterial therapy for HCC.

Transcatheter arterial chemoembolization (TACE) has been playing an important role in the treatment algorithm for patients with multifocal or large intrahepatic lesions of hepatocellular carcinoma (HCC) not eligible for surgical resection, transplantation, or local ablative therapy. The use of balloon assisted TACE has been proposed recently and it could be one of the possible ways to improve the effectiveness of drug delivery to the target tumor and therefore leading to improved treatment outcome.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of age above 18 years
2. Patients who are indicated for transarterial treatment for HCC
3. Child-Pugh A or B cirrhosis
4. Eastern Cooperative Oncology Group performance score 0 or 1
5. BCLC A or B
6. No previous treatment with liver resection, ablation, chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy),
7. HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology.
8. No extra-hepatic involvement on non-enhanced CT thorax and triphasic contrast enhanced CT abdomen.
9. No invasion of portal vein or hepatic vein
10. Massive expansive tumor morphology with measurable lesion on CT (characterized by well-defined spherical or globular configuration, with or without tumor capsule or satellite lesions)
11. Total tumor mass \< 50% liver volume
12. Size of any individual tumor \<= 7cm in largest dimension
13. Serum creatinine \< 130 umol/L or Creatinine clearance \> 55 ml/min.

Exclusion Criteria:

1. Concurrent ischemic heart disease or heart failure
2. History of asthma, chronic obstructive airway disease or respiratory decompensation.
3. History of acute tumor rupture presenting with hemo-peritoneum
4. Biliary obstruction not amenable to percutaneous or endoscopic drainage
5. Child-Pugh C cirrhosis
6. History of hepatic encephalopathy
7. Intractable ascites not controllable by medical therapy
8. History of variceal bleeding within last 3 months
9. Serum total bilirubin level \> 50 umol/L
10. Serum albumin level \< 26 g/L
11. INR \> 1.3
12. Infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules)
13. Arterio-portal venous shunt affecting \>1 hepatic segment on CT
14. Arterial-hepatic venous shunt with hepatic vein opacified in arterial phase on CT
Nurigra Chewable Tablet in Healthy Adult Male Volunteers

The purpose of this study is to evaluate pharmacokinetics of sildenafil citrate in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy and male subjects aged 20 to 45 years
* A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)
* A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints.

Exclusion Criteria:

* A subject with sign or symptoms or previously diagnosed disease of liver
Compatibility of Participation Levels of Adolescents With Attention Deficit and Hyperactivity Disorder

The goal of this study is to assess the agreement between the outcomes of adolescents with attention deficit hyperactivity disorder (ADHD) who participated in Participation and Environment Measurement Child \& Youth (PEM-CY) by the adolescent and primary caregiver. There are a few studies in the literature that look at the participation of teenagers with ADHD, but none that look at the participation of adolescents with ADHD from both the perspective of the adolescents and the primary caregivers. The primary caregiver's measurement results and the adolescents' measurements do not concur, according to this study's hypothesis.

Attention deficit hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders in childhood. In addition to fundamental symptoms like inattention and hyperactivity/impulsivity, ADHD can be accompanied by a variety of diseases. Adolescents with ADHD are less likely to participate in activities at home, school, or in the community as a result of this. In comparison to children without ADHD, Shimoni et al. found that children with ADHD participate less frequently in most leisure activities, like formal leisure activities less, and have a lower desire for participation in specific leisure activities, such as physical and social leisure activities.

Adolescents and their primary caregivers have disagreements on a variety of topics. This disagreement is also likely to arise when it comes to choose who will participate. Furthermore, while measuring the level of engagement, the need of gathering information from various sources is clear. The Participation and Environment Measurement-Children and Youth (PEM-CY) is a scale that evaluates parents' or caregivers' involvement with children and young people in the home, school, and community. Adolescents with ADHD had lower levels of participation in the home, school, and community than control groups, according to research. However, no study analyzing this level of bidirectional participation could be found in the existing literature (adolescent-primary caregivers).

As a result, the primary goal of this study is to examine the participation of adolescents with ADHD from the perspectives of adolescents and primary caregivers using The Participation and Environment Measure for Children and Youth (PEM-CY), as well as to demonstrate the agreement between these two evaluations. Furthermore, it will be compared to healthy controls in terms of participation and agreement rates.

Eligibility Criteria:
Inclusion Criteria:

* Age between 7 years and 12 years;
* Diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) by a child and adolescent health psychiatrist, regardless of subtype, according to DSM-V criteria
* Have cognitive ability to follow instructions for assessment measures

Exclusion Criteria:

* Children have any other psychiatric diagnosis like autism spectrum disorder, psychotic symptoms, depression, etc.
* Children have any neurological or orthopedic disorders like head injury, cerebral palsy, epileptic seizure, visual and speech disorder.
Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU

The study will examine dexmedetomidine levels in the blood of critically ill intensive care patients to understand how it is broken down by the body.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained from the patient's legal representative according to local regulations before starting any study procedures other than pre-screening
* Patients sedated and ventilated in ICU for whom sedation is expected to be clinically required for at least 24 hours, as determined by the responsible physician
* Prescribed light to moderate sedation (target RASS = 0 to -3)

Exclusion Criteria:

* Acute severe intracranial or spinal neurological disorder due to vascular causes, infection, intracranial expansion or injury
* Uncompensated acute circulatory failure at screening (severe hypotension with mean arterial pressure(MAP) \< 55 mmHg despite vasopressor and inotrope therapy)
* Heart rate (HR) \< 50 beats/min for longer than 5 min between screening and starting study treatment
* Atrioventricular (AV)-conduction block II-III (unless pacemaker installed)
* Severe hepatic impairment (e.g. bilirubin \> 101 μmol/L)
* Need for continuous muscle relaxation
* Any condition which would significantly interfere with the collection of study data
* Burn injuries or other conditions requiring regular anesthesia or surgery
* Use of centrally acting alpha-2 agonists or antagonists within 24 hours prior to starting the study (e.g. dexmedetomidine, clonidine, tizanidine, apraclonidine and brimonidine)
* Known allergy to dexmedetomidine or any excipients of the study treatment
* Patients who have or are expected to have treatment withdrawn or withheld due to poor prognosis
* Patients receiving sedation for therapeutic indications rather than to tolerate the ventilator (e.g. epilepsy)
* Patients unlikely to require continuous sedation during mechanical ventilation (e.g. Guillain-Barré syndrome)
* Patients who are unlikely to be weaned from mechanical ventilation; e.g. diseases/injuries primarily affecting the neuromuscular function of the respiratory apparatus such as clearly irreversible disease requiring prolonged ventilatory support (e.g. high spinal cord injury or advanced amyotrophic lateral sclerosis)
The BreaD Study - Bio-availability of D2 Vitamin Present in Bread

Vitamin D3 is synthesized in skin exposed to ultraviolet-B-irradiation of sunlight. However, in Northern Europe, including Finland, exposure to sunlight is limited or non-existent in winter. Between November and March, dietary or supplementary vitamin D intake is essential to maintain adequate serum 25-hydroxyvitamin D (S-25(OH)D) concentrations. There are only a few natural dietary sources of vitamin D. Fish and egg yolks contain significant amounts of vitamin D3 (cholecalciferol), and some wild mushrooms are a source of vitamin D2 (ergocalciferol). Thus, vitamin D fortification of certain foods has been accepted as one strategy to improve vitamin D status of these populations. Vitamin D3 is currently mostly used in fortified products in Europe, although the production of plant-derived vitamin D2 would be more cost-effective. Data on the impact of food-derived vitamin D2 on S-25(OH)D3 are limited. An important consideration is whether food-based sources of vitamin D2 are effective in raising S-25(OH)D or whether they have a negative impact on S-25(OH)D3. The investigators investigated the bioavailability of vitamin D2 from UVB-radiated baking yeast in bread in terms of efficacy of raising total S-25(OH)D) as well its possible effects on S-25(OH)D2, S-25(OH)D3, serum parathyroid hormone (S-PTH) and serum calcium concentrations compared with D2 and D3 supplementation in a randomized placebo-controlled trial in young healthy females during winter in Finland.


Eligibility Criteria:
Inclusion Criteria:

* good general health (no continuous medication),
* Caucasian origin,
* body mass index (BMI) \<30 kg/m2
* age 20-40 years

Exclusion Criteria:

* diagnosed celiac disease or cereal allergy
* a vacation in a sunny place during the study or within the preceding 2 months
* regular use of vitamin D supplements \>15 µg/d
* pregnancy or breastfeeding during the study
Observational Study of TissuePatch SF in Prevention of Air Leaks Following Lung Resection

Post-market, observational study to assess effectiveness of TissuePatch SF in managing/preventing air leaks after lung resection.

Post-market study conducted to assess the continuing effectiveness and safety of TissuePatch SF when used as an adjunct to standard suture/staple closure of clinically significant (Macchiarini Grade ≥1) intra-operative visceral pleural air leaks incurred during lobectomy and segmentectomy (open or minimally invasive), including those performed as video-assisted thoracic surgery (VATS), in adults.

Eligibility Criteria:
Inclusion Criteria:

1. Is ≥18 and \<80 years of age
2. Undergoing planned (not emergent) video-assisted thoracic surgery pulmonary resection
3. Understands and is willing to comply with all study related procedures
4. Has provided signed informed consent

Exclusion Criteria:

1. Women who are pregnant or lactating or, if of childbearing potential, are unwilling to use birth control for 6-months following surgery
2. Has severe congestive heart failure, pulmonary or renal failure, serious haematological disorder or significant liver disease
3. Has previously undergone a pneumonectomy
4. Has a bronchial fistula
5. Has or is suspected of having an active infection at or near the planned surgical site
6. Has a known allergy or sensitization to TissuePatch SF or its constituent components
7. In the investigator's opinion, has a life expectancy of less than 12 months
8. Has, in the investigator's opinion, any disease or condition, physical or psychological, that could interfere with the evaluation of TissuePatch SF or compliance with study procedures

Intra-Operative Exclusion Criteria:

1. \>3 identified air leaks
2. No air leaks Macchiarini Grade ≥1