cyrilzakka/clinical-trials huggingface dataset:
Contralaterally Controlled Functional Electrical Stimulation Plus Video Games for Hand Therapy After Stroke

Determine if adding a video game component to an electrical stimulation therapy improves hand function in stroke patients

A single-blinded randomized controlled trial will be carried out to assess the effects of 12 weeks of Contralaterally Controlled Functional Electrical Stimulation (CCFES) +Hand Therapy Video Games (HTVG) compared to CCFES. Dexterity and activity limitation will be assessed at 0 (baseline), 12 (end of treatment), and 36 (6 months follow-up) wks. The planned treatment dose will be the same for both groups: 10 sessions per week of self-administered treatment at home plus 20 sessions of group-specific occupational therapy in the lab over 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

-\> 6 months since a first clinical cortical or subcortical, hemorrhagic or nonhemorrhagic stroke

* age 21-80 years old
* unilateral upper limb hemiparesis with finger extensor strength of grade \<=4/5 on the Medical Research Council (MRC) scale AND a score of \>=1 and \<=11/14 on the hand section of the upper extremity Fugl-Meyer Assessment
* adequate active movement of the shoulder and elbow to position the hand in the workspace for table-top task practice (necessary for the lab task practice sessions)
* able to follow 3-stage commands
* able to recall 2 of 3 words after 30 minutes
* surface stimulation of the paretic finger and thumb extensors produces functional hand opening without pain (this will exclude those who have degree of flexor hypertonia that prevents stimulated hand opening)
* Functional passive range of motion (minimal resistance) at elbow, wrist, fingers, and thumb, i.e., there exists enough passive range of motion to reach and acquire table-top objects
* intact vision and hearing
* medically stable
* full voluntary opening/closing of the contralateral (less affected) hand
* demonstrate ability to follow instructions for operating the stimulator or have a caregiver who will assist them

Exclusion Criteria:

* co-existing neurologic diagnosis of peripheral nerve injury, Parkinson's disease, spinal cord injury, traumatic brain injury, or multiple sclerosis
* uncontrolled seizure disorder
* severely impaired cognition and communication
* uncompensated hemineglect
* arm or forearm skin breakdown or edema (to avoid edema-related shunting of current)
* insensate forearm (to avoid risk of electrical burns)
* history of potentially fatal cardiac arrhythmias with hemodynamic instability
* implanted electronic systems (e.g. pacemaker)
* botulinum toxin injections to any upper extremity muscle within 3 months of enrolling
* pregnant women due to unknown risks of surface stimulation during pregnancy
* participating in occupational therapy or other rehabilitation therapies to the upper extremity
* severe shoulder or hand pain
iPACES v3 MCI NIA Protocol Copied for iPACES v4 PD NINDS

The primary purpose of this study is to attempt to replicate and extend promising pilot findings regarding the cognitive benefits of in-home neuro-exergaming with iPACES (interactive Physical and Cognitive Exercise System v3) for persons with mild cognitive impairment (MCI), to evaluate effects for persons with Parkinson's Disease (PD). Participants will include persons with PD, and potentially, also their co-residing partner, who will exercise at home or accessible location, 3-5 times per week for at least 6 months, with follow-up one month after the main intervention. All participation is "remote" (completed at home, or location of choice), utilizing either one's own equipment ("bring-your-own-devices" BYODs: pedaler, phone/tablet, smart-watch) or some equipment which may be supplied by the grant-funded study and shipped directly to the home; all study measures are completed remotely (e.g., via phone app, website, biometric device, videoconference, email, snail mail, etc.).

A specific aim is to evaluate the effects of iPACES for persons with Parkinson's Disease, while also examining the potentially unique contribution of combining mental and physical exercise in an interactive way: "pedal-to-play" (iPACES), as compared with non-interactive, but simultaneous: "pedal-while-play" (PACE).

Eligibility Criteria:
Inclusion Criteria:

1. 50 years of age or older
2. meets criteria for MCI (per site staff/MD/neuropsychologist and confirmed by study-administered Montreal Cognitive Assessment; MoCA; score = between 16-26, non-inclusive; Milani, 2018)

4. available for participation for one year (tablet surveys, videoconference evaluations) 5. willing and able to exercise 3-5 times per week for at least 6 months 6. can pedal an under-table elliptical 7. can read off of a small tablet screen 8. proficient in English (speaking and reading for completion of interview, surveys, game); Spanish language option anticipated soon 9. can participate in testing and read and operate tablet touch screen (adequate hearing, vision, speech) 10. written approval from primary care physician and cardiologist (if applicable) to participate in exercise for this study 11. can provide informed consent

Exclusion Criteria:

1. already exercising at recommended levels (45 min of moderate intensity aerobic exercise 5-7x/wk)
2. significant history of cardiovascular problems
3. significant history of stroke
4. significant history of memory problems (e.g., dementia/Alzheimer's)
5. significant history of other neurological condition (e.g., seizures, etc.)
6. significant uncontrolled tremor such that would interfere with touch-screen use required throughout the study (surveys, game-play, etc.)
7. not prone to cybersickness (e.g., "car sickness" or problems with "screen time")
8. cannot provide informed consent (i.e., when phone screened with the Impaired Decision Making Capacity screen)
The Role of Dietary Carbohydrate and Fat Availability in the Regulation of Hepatic Lipid Content

The purpose of this study is to investigate dietary compositions effect on liverfat measured by magnetic resonance imaging.

Overweight but otherwise healthy men will be included in the study which is a randomized diet intervention study in a cross over design.

The study involves 2 intervention periods of 5 days each, during which the participant ingests two different types of experimental diet. Participants will in randomized order (determined by block randomization) ingest a diet with low carbohydrate and high fat content, and a diet with high carbohydrate and low fat content.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men being 18-50 years old.
* Overweight (BMI 25-35)
* Low to moderate physical activity level, defined as ≤ 1 weekly session of aerobic exercise.
* Non-smokers
* No use of medicine

Exclusion Criteria:

* Fasting blood glucose indicating overt diabetes (≥7 mmol/l)
* HbA1C \>48 mmol/mol
* Fasting plasma triacylglycerol indicating dyslipidemia (≥2.2 mmol/l)
* FIB-4 score \>1.45
* Contraindications for MR-scan: abdominal height exceed limitations of the MR-scanner, pacemaker or other electronic device implanted, implanted metal devices, severe claustrophobia.
the Efficacy of Oral Motor Therapy in Children With Autism

Children with Autism spectrum disorders have speech disorders, which in turn aggravate communication difficulties and lead to an increase in their core symptoms. This experiment attempts to investigate the efficacy of Chinese language oral motor therapy in improving various aspects of articulation, language ability, and behavior of children with autism in conjunction with the International General Autism Scale, and provides a basis for the rational formulation of clinical treatment plans.

Oral Motor Therapy (OMT) is a treatment process that uses tactile and proprioceptive stimulation techniques to promote the normalization of the sensory perception of the mouth (jaw, lips, tongue), suppress abnormal mouth movement patterns, and establish normal mouth movement patterns, following the principles of motor skill development.

This study investigates the efficacy of Chinese language oral motor therapy on improving various aspects of articulation, language ability, and behavior of children with autism. The study is divided into two parts, each eight weeks long. Eighty subjects who met the inclusion/exclusion criteria were randomly divided into 2 groups: the experimental group and the control group, in a 1:1 ratio. The experimental group was treated with 2 months of ABA+oral motor therapy followed by 2 months of ABA therapy; the control group was treated with 2 months of ABA therapy followed by 2 months of ABA+oral motor therapy.

Each subject underwent ABC, CARS, S-S, VB-MAPP, and ABLLS-R assessments before enrollment, 2 months after enrollment, and after discharge from the group.

Eligibility Criteria:
Inclusion Criteria:

1. Children who meet the DSM-V diagnosis of autism.
2. Age 2-5 years old, regardless of gender.
3. Native Chinese language.
4. No prior oral motor therapy.
5. Family members voluntarily participated in this study and signed an informed consent form.

Exclusion Criteria:

1. Children with co-occurring epilepsy.
2. Children with comorbid other psychiatric disorders.
3. Children with severe hearing impairment, history of visual impairment/blindness, organic disease of the mouth/throat, or significant medical illness or condition that prevents the child from participating in treatment procedures.
4. Children who received other oral motor training or speech articulation therapy during the intervention period.
5. Those who could not perform the intervention as planned after participating in the experiment.
6. Those deemed unsuitable by the investigator to participate in this experiment.
Study of BMS-663513 in Patients With Advanced Cancer

This is a Phase I/II, ascending, multi-dose study of BMS-663513, an agonistic anti-CD137 monoclonal antibody, administered every three weeks to patients with metastatic or locally advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) score of 0-1.
* Measurable disease.
* Absolute neutrophil count (ANC) \>= 1,500 cells/mm3
* Platelet count \>= 100K cells/mm3
* Hemoglobin \>= 9.0 g/dL
* Total bilirubin \<= 1.5 x IULN
* Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase \<= 2.5 x institutional upper limit of normal (IULN)
* Patients with advanced solid malignancies must have melanoma, renal or ovarian carcinoma

Exclusion Criteria:

* History of autoimmune diseases.
* Condition requiring the continued use of systemic or topical steroids or the use of immunosuppressive agents.
* Active/symptomatic brain metastasis.
* History of hepatitis B or C.
* Concurrent malignancy.
Effects of Avocado Intake on the Nutritional Status of Families

Avocados are an excellent source of fiber, potassium, magnesium, and poly- and mono-unsaturated fats. They can be a nutrient dense component of healthful dietary patterns and have the potential to improve the cardiovascular disease (CVD) risk profiles of families in the United States (US). The proposed research plan will focus on the contribution of avocado intake to the reduction in CVD risk of US families, by examining the effects of avocado intake on the overall nutritional status of families. Of particular interest is establishing these effects in ethnic populations such as Hispanics/Latinos. On average, Hispanic/Latinos are at increased risk for metabolic diseases that predispose to CVD. This 6-month cluster randomized trial in Hispanic/Latino Americans aims to accurately determine the impact of avocados on the overall dietary pattern of their families. Future research will extend the results of the current trial to a larger sample of ethnically diverse families in order to evaluate whether sustained changes occur in nutritional, cardiovascular and metabolic health status.

Specific Aim 1: To determine how avocados are incorporated into the family's dietary pattern and impact selected measures of nutritional status:

1. To determine if avocado intake substitutes for, or adds to, other sources of calories in the family diet.
2. To determine if avocado intake helps reduce between-meal snacking of family members.
3. To determine if avocados help families meet US Dietary Guidelines for recommended intake of: poly- and monounsaturated fats; vegetables; fiber; selected nutrients (vitamins C, D and E, Folate, Calcium, Magnesium, potassium, iron); lutein and other carotenoids.

Specific aim 2: To determine if increased avocado intake affects cardio-metabolic risk factors to include lipids, glucose, insulin, and HbA1c.

Eligibility Criteria:
Inclusion Criteria:

1. Be part of a family that consists of at least 3 individuals, but no more than 8, who reside in the same home
2. Self-identify as Latino or Hispanic
3. Be older than 5 years of age

Exclusion Criteria:

1. Families with members who have clinically severe chronic diseases requiring specific diets (e.g. stage IV congestive heart failure, chronic kidney disease requiring dialysis)
2. Those allergic to avocados
3. Those with LATEX allergy
4. Families who are already high consumers of avocados (i.e. more than 1 avocado per adult and more than ½ avocado per child per day);
5. Those who are unwilling to eat avocados.
6. Family members with nursing or pregnant females or females planning to become pregnant
7. Family members under the age of 5 years will not be counted toward the number of family members who will be expected to participate in the intervention (i.e., adhere to healthy diet tips or consume avocados)
8. Families intending to move, or which include family members intending to move, within the next 6 months
Urinary Artificial Sphincter in Children

Retrospective monocentric study of the outcomes of patients with neurogenic bladder who had a urinary artificial sphincter before the age of 18 years old. Hypothesis: what was the impact of the urinary artificial sphincter on the global management of the patient?

The management of patients with neurogenic bladder is complex. Several patients have been operated multiple times. Surgical procedures such as Mitrofanoff's, bladder neck surgery, bladder augmentation, and urinary artificial sphincter are common. The investigators wanted to analyze the participants' data, which led to the indication of a urinary artificial sphincter and its outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were younger than 18 years old when they had an urinary artificial sphincter

Exclusion Criteria:

* Patients who were 18 years old or older when they had an urinary artificial sphincter
Respiratory Muscle Function Changes and Effects of Chest Physiotherapy Education Interventionin Advanced Lung Cancer

The purpose for the 1st phase of this study are to exam longitudinal changes and the impact of various treatments on the respiratory muscle function, and the relations with dyspnea, functional capacity, quality of life, 6- and 12-month respiratory morbidity, and survival status (control group). The 2nd phase of this study will investigate the potential beneficial effects of chest physiotherapy in the same patient population (intervention group).

Respiratory muscle function is critical for maintaining effective alveolar ventilation, and airway secretions clearance. The reduction in respiratory muscle function might lead to chronic respiratory insufficiency, and potentially to life-threatening problems. Respiratory muscle function and the impacts of various treatments regimens have not been investigated longitudinally in patients with advanced lung cancer patients.

The purposes for the 1st phase of this study are to exam longitudinal changes and the impact of various treatments on the respiratory muscle function, and the relations with dyspnea, functional capacity, quality of life, 6- and 12-month respiratory morbidity, and survival status (control group). The 2nd phase of this study will investigate the potential beneficial effects of chest physiotherapy in the same patient population (intervention group).

Methods: 102 patients with advanced lung cancer per group will be recruited from the National Taiwan University Hospital. Demographic and clinical signs/syndromes will be obtained from the chart. Pain and dyspnea will be measured using visual analog scale. Respiratory muscle strength will be tested by measuring maximal inspiratory and expiratory pressure (PImax and PEmax, respectively). Spirometric variables, forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) will be measured. Functional capacity will be measured using Karnofsky performance status and Simmonds functional assessment. Anxiety/depression symptom will be measured using Hospital Anxiety and Depression Scale. Quality of life will be measured using European Organization for Research and Treatment of Cancer, EORTC QLQ-C30 and LC13 questionnaire. Six- and 12-month respiratory complication morbidity and survival status will be recorded in the prospective nature.

Clinical relevance: The prevalence of lung cancer is increasing in the recent years. To understand the indications for chest physiotherapy (e.g., respiratory muscle weakness and its related sequels) and the effects of chest physiotherapy program will shed light on if routine chest physiotherapy should be implanted for patients with advanced lung cancer during treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of stage III/V lung cancer
* Normal cognition (a Mini Mental State Examination score of more than/equal to 24 points)
* Able to finish all tests

Exclusion Criteria:

* A clinical diagnosis affecting respiratory muscle function and functional activity performance (e.g. musculoskeletal disorders)
* Unable to perform acceptable-quality spirometry
Efficacy of the REThink Therapeutic Online Game

This study aims to test the efficacy of the REThink therapeutic online video game. Children and adolescents (N = 150), aged between 10-16 years, will be randomly assigned to one of three groups: 1) REThink group, 2) Rational-Emotive-Behavioral Education (REBE) group and 3) wait-list condition.

Background:The prevalence of emotional disorders in children and adolescents is constantly growing and leads to long-term negative consequences for later functioning. An efficient way to approach emotional disorders in youths is to provide adequate services to them prior to the onset of symptoms. A new strategy for implementing prevention programs in youths is the use of therapeutic games. The aim of this study is to test the effectiveness of the REThink therapeutic online game,in helping children and adolescents, aged between 10-16 years, to develop psychological resilience.

Methods: To test the effectiveness of the REThink therapeutic online game, 150 children and adolescents aged between 10-16 years will be included in the study. Participants will be randomly assigned to one of three groups: 1) the online therapeutic game intervention (REThink group), 2) the control condition Rational-Emotive-Behavioral Education (REBE) group and 3) the wait-list condition. Participants in the REThink group will play the seven levels of the game, structured into seven modules. In the REBE group, participants will follow seven REBE lessons, structured based on the strategies practiced in each of the REThink level. Assessment of participants will be made before, at the middle, at the end of the intervention, and at 6 months after the intervention.

Results: It is expected that participants in the REThink group will provide significantly better results regarding primary outcomes, namely psychological adjustment and the intensity of emotions. Significant improvements are expected at post-test and follow up for the REThink group regarding secondary outcomes, emotion regulation skills, temperamental variables, anxiety in a stressful situation, problem solving skills, relaxation skills,and alpha asymmetry index, compared to wait-list condition, and similarly to the REBE group. Also, it is expected that REThink efficacy will be related to changes in irrational beliefs, and negative and positive automatic thoughts. In addition, it is expected that the REThink game will register high satisfaction with the intervention.

Conclusions: This is randomized controlled trial which aims to analyze the effectiveness of a new therapeutic game developed for children and adolescents will provide important information regarding this promising tool.

Eligibility Criteria:
Inclusion Criteria:

* aged between 10-16 years
* provided written parental consent

Exclusion Criteria:

* Intellectual disability or physical limitations precluded the use of the computer program
* Had a major mental health disorder
* Had had (in past three months) or was having psychotherapy or psychiatric treatment
MiRNAs Evaluating Lymphocyte Proliferation and Apoptosis as Well as Prognosis of Sepsis

Sepsis is a systemic inflammatory reaction caused by infection, trauma, etc. In the process of sepsis, the apoptosis of lymphocyte serves as a vital factor of immune dysfunction. Micro-RNAs (miRNAs) are endogenous small non-coding RNA molecules. Our previous studies have showed the diagnostic and prognostic value of a series circulant miRNAs in human serum in sepsis. The present research further study the regulatory mechanism of those miRNAs in lymphocyte in sepsis. Our research is based on the clinical value of miR-223, miR-15a, miR-16. The investigators discuss the potential role of miR-223, miR-15a, miR-16 in regulating the proliferation and apoptosis of lymphocyte in sepsis and aim to find new targets for sepsis treatment.

Blood samples were collected from the Chinese People's Liberation Army General Hospital. The investigators collected samples in emergency intensive care unit (EICU), surgical intensive care unit (SICU) and respiratory intensive care unit (RICU) between July 2014 to March 2015. Septic patients were divided into sepsis, severe sepsis and septic shock according to the diagnostic criteria. Peripheral white blood cells were sorted into monocytes, lymphocytes and neutrophils by using flow cytometry (Flow Cytometry, FCM). Jurkat T cell lines were purchased from Chinese Academy of Medical Sciences Institute of basic medical sciences. miRNAs agomirs and antagonists were used to establish miR-223, miR-15a, miR-16 overexpression and knock-out transient transfection cell lines. Western blot was used to detect difference expression of protein expression.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Sepsis
* Agree with this study

Exclusion Criteria:

* Age \<18 years
* Died within 24 hours
* Combined with HIV infection
* Agranulocytosis
Safety and Efficacy Study of A0001 in Subjects With Friedreich's Ataxia

This is a Phase 2a double-blind, placebo-controlled study with two dose levels of A0001 given twice daily for 28 days. Potential subjects will be screened first to determine eligibility, after which they will be randomized to receive either a high dose of A0001, a low dose of A0001 or placebo for 28 days.

Eligible subjects will return within 21 days of screening for the baseline visit and randomization to one of three potential treatments. The subjects will be required to take 3 capsules of study medication in the morning with a morning meal and 3 capsules of study medication at night with an evening meal for 28 days. Additional visits to the clinic are planned for Day 14 and Day 28, at which time a number of clinical and biochemical assessments will be done.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with genetically confirmed Friedreich's Ataxia (GAA or point mutation)
* Impaired Glucose Tolerance, measured by Oral GTT

Exclusion Criteria:

* Overt Diabetes Mellitus
* Presence of clinically significant cardiovascular disease