cyrilzakka/clinical-trials huggingface dataset:
Trunk and Upper Extremities Program Effect in Decreasing Compensation Patterns in Unilateral Cerebral Palsy Children

The goal of this clinical trial is to test the effectiveness of a trunk and upper extremities exercise program. The main questions it aims to answer are:

Whether the program decreases compensation patterns in unilateral cerebral palsy children Whether the program decreases pain in unilateral cerebral palsy children Whether the program improves bimanual ability in unilateral cerebral palsy children Participants will undertake and 8-week program exercise at home If there is a comparison group: Researchers will compare with the control group to see if this program decreases compensation patterns.

Children in control group will continue with their daily activities. Children in experimental group, apart from their daily activities, will undertake an 8-week program exercise at home for strengthening the trunk and the proximal part of both upper extremities. It contains 3 progressions that can be applied if needed.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral cerebral palsy diagnostic
* Level I or II of the Manual Ability Scale Classification

Exclusion Criteria:

* Have received any intervention with botulinum toxin or shock waves in the previous six months or have them scheduled during the intervention
* Are undergoing treatment with intensive therapies.
* To have known alteration in the hips
* Have very serious attention or comprehension difficulties that prevent them from following instructions.
* Suffer uncontrolled epilepsies
* Suffer from severe visual problems.
A Study of Lasmiditan in Healthy Chinese Participants

This is a study of lasmiditan in healthy Chinese participants. The purposes are:

* To evaluate the safety of lasmiditan
* To learn more about how the body processes lasmiditan

The study will last up to 50 days for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy Chinese (all 4 biological grandparents and both biological parents to be of Chinese origin) males or females, as determined by medical history and physical examination
* Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter, inclusive
* Are able and willing to give signed informed consent

Exclusion Criteria:

* Have known allergies to lasmiditan, related compounds or any components of the formulation
* Have an abnormal blood pressure and/or pulse rate as determined clinically significant by the investigator
* Have a history of, show evidence of, or are undergoing treatment for significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, depression)
* Have a history of central nervous system (CNS) conditions such as strokes, transient ischemic attack, significant head trauma, CNS infections, migraines, brain surgery, or any other neurological conditions that, in the opinion of the investigator, increases the risk of participating in the study
* Regularly use known drugs of abuse and/or show positive findings on drug screening
The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients

This is a randomized, controlled, single center study to evaluate the efficacy of Thymoglobulin induction therapy in combination with Mycophenolate Mofetil, tacrolimus, and steroids in the prevention of CAV. Approximately half of the patients will be randomized to receive a total of 5 doses of Thymoglobulin during the study. The first dose of Thymoglobulin will be administered at 1.5 mg/kg via intravenous infusion over 6 hours immediately upon arrival to the ICU post-operation (day 1). Subsequent doses of 1.5 mg/kg will be administered on days 2, 3, 4, and 5 via IV infusion over 4 hours.

Mechanistic assays (T-reg cells, Lym subsets, B cell subsets, IL-1b, cytokines, TGFb, IL-21 to be drawn at Pre-transplant, 3, 6, 12 months post-transplant) will also be performed.

All patients will be followed and monitored according to standard of care protocols for heart transplant recipients at our center.


Eligibility Criteria:
Inclusion Criteria for Study Entry:

1. Subjects must be undergoing their first allograft transplant
2. Men and non-pregnant women must be 18 to 70 years old
3. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to transplantation. The sensitivity must be equal to at least 50 mIU/mL. (Urine test is allowed in addition to serum test in patients where serum results are delayed)
4. Men with a female partner of child bearing age and women of childbearing potential must use two reliable forms of contraception simultaneously. Effective contraception must be used before beginning study drug therapy, and for 4 months following discontinuation of study drug therapy.
5. Subjects must be willing and capable of understanding the purpose and risks of the study, and must sign a statement of informed consent
6. Subjects with a Creatinine \< 2.0 mg/dl at time of transplant

Exclusion Criteria for Study Entry:

1. Allergy to Thymoglobulin-Thymoglobulin is contraindicated in patients with history of allergy or anaphylaxis to rabbit proteins or to any product excipients, or who have active acute or chronic infections which contraindicate any additional immunosuppression
2. Previous organ transplants
3. Patients receiving multiple organs
4. Patients with a BMI higher than 35
5. Patients with PRA ≥ 25%
6. Patients requiring VAD upon completion of transplantation surgery.
7. HIV-1, HTLV-1, chronic Hepatitis B, or chronic Hepatitis C infection
8. Documented or strong suspicion for pre-operative active infection that has not yet been adequately treated with the recommended course of antimicrobial therapy
9. Presence of any chronic myelosuppressive disease or agent that has resulted in either chronic leucopenia or chronic thrombocytopenia
10. Active peptic ulcer disease and active GI bleeding
11. Patients who have received within the past 30 days or require concomitant treatment with other investigational drugs (except for those listed in section 8.6 "Concomitant treatment")
12. Patients with a history of AL amyloidosis (TTR amyloids) are permitted
The Use Of Domperidone For The Relief Of Refractory Upper Gastrointestinal GI Symptoms

To prescribe oral domperidone for patients with upper GI symptoms who have failed or suffered adverse effects from standard medical therapy.

The primary objective of this study is to prescribe oral domperidone for patients with upper GI symptoms who have failed or suffered adverse effects from standard medical therapy

Eligibility Criteria:
Inclusion Criteria:

1. Males or females who are 18 years of age or older
2. Symptoms or manifestations secondary to Gastro esophageal reflux disease (GERD) (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to standard therapy.

Exclusion Criteria:

1. i. History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.

   ii. Clinically significant bradycardia, sinus node dysfunction, or heart block.

   iii. Prolonged QTc (QTc\>450 milliseconds for males, QTc\>470 milliseconds for females)

   iv. Clinically significant electrolyte disorders.
2. Gastrointestinal hemorrhage or obstruction.
3. Presence of a prolactinoma (prolactin-releasing pituitary tumor).
4. Pregnant or breast feedings female.
5. Known allergy to domperidone
Bone Health of People With Cystic Fibrosis

People with cystic fibrosis (CF) now frequently live into adulthood and with this extended life expectancy has come new clinical problems. Poor bone health, including osteoporosis and bone fractures, is one of these increasingly important conditions. Preventing the negative outcomes of poor bone health in later life is primarily related to ensuring optimal growth (weight and height) and obtaining maximal amount of bone mass during growth and development. This study will identify factors that influence bone health in a sample of children, adolescents and young adults as measured by dual energy x-ray absorptiometry and new bone densitometry methods (peripheral quantitative computerized tomography \[p-QCT\] and bone sonometer). We will also identify factors which influence changes in bone status over a 12-month follow-up period in a subsample of people with CF.

A total of 100 subjects with CF and pancreatic insufficiency (8-25 y, half female) will be recruited from the Children's Hospital of Philadelphia (CHOP) and the Delaware Valley region. All subjects will have baseline measurements obtained at the Nutrition and Growth Lab at CHOP. A subset of subjects will return for 12-month follow-up measurements.

We will evaluate the influences on bone health, including: gender, stage of pubertal development, body weight and height, food intake (especially calcium and vitamin D), use of steroid medications by mouth, IV administration or inhalation, physical activity and lung health. We will also follow the changes in bone health and growth over 12 months, and see what factors are associated with good and poor bone development.

In addition, the information from this study will be very important to planning the future trials of medication and other interventions to treat and, hopefully, to prevent poor bone health in people with CF.

Eligibility Criteria:
Inclusion:

* Diagnosis of cystic fibrosis with pancreatic insufficiency
* FEV-1 ? 40% predicted
Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation

Project Aim: To determine if intramuscular epinephrine is an effective adjunct to inhaled bronchodilators (β2 agonists) for children with severe asthma exacerbation.

Hypothesis: IM epinephrine is an efficacious adjunct to inhaled bronchodilators (β2 agonists) for children with severe asthma exacerbation.

Intervention: Subjects will be randomly assigned (50% chance) to receive a weight based dose of IM epinephrine 1:1000 or no adjunctive medication. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.

In addition to the study intervention, the standardized treatment pathway based on the current asthma guidelines in use at the investigator's center will be utilized. This pathway includes nebulized albuterol, ipratropium bromide, and systemic corticosteroids. The duration and dosages of these other interventions will be administered at the discretion of the treating provider.


Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 6 years and less than 18 years
2. Pre-existing diagnosis of asthma
3. Presenting to the ED with an asthma exacerbation

Exclusion Criteria:

1. History of chronic lung or upper airway disease other than asthma
2. History significant, uncorrected congenital heart disease or cardiac arrhythmia
3. History of thyroid disease
4. Impending respiratory failure
5. Allergy to epinephrine
6. Pregnancy
7. PEFR\>60% of predicted and clinical asthma score less than 8
Comparison of PRS According to Inhalation Agent During LDLT

The investigators tried to evaluate the effect of desflurane on the incidence of postreperfusion syndrome during living donor liver transplantation surgery. The investigators used sevoflurane as a comparison.


Eligibility Criteria:
Inclusion Criteria:

* elective LDLT

Exclusion Criteria:

* age \< 18, age \> 65
* patient refusal
* re-transplantation
A Phase 1/2 Study of AEB1102 in Patients With Arginase I Deficiency

A Phase 1/2 Open-label Study in Patients with Arginase I Deficiency to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous AEB1102. This study is designed to evaluate the safety and tolerability of IV administration of AEB1102 for the treatment of pediatric and adult patients with Arginase I deficiency and hyperargininemia. This study will be conducted in 2 parts: Part 1 (Single Ascending Dose Escalation) and Part 2 (Repeated Dosing). Each part will be preceded by a baseline assessment of arginine levels. All patients who participate in Part 1 may continue AEB1102 dosing in Part 2 if they qualify for continued dosing. A data safety monitoring board (DSMB) will provide independent review of study safety data and recommend whether the sponsor should continue the study as planned, modify the study protocol, or discontinue the study.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of Arginase I deficiency
* Adequate organ function: Hgb ≥ 10 g/dL, ANC ≥ 1.5 x 109/L, plt count ≥ 100,000/µL; liver transaminase levels ≤ 2.5x ULN, total bilirubin ≤ 2.0 mg/dL; serum creatinine \<1.5 x ULN
* If female and of child-bearing potential, has a negative serum pregnancy test within 7 days before enrollment
* If a sexually active (male or female), must be surgically sterile, post-menopausal (female), or must agree to use a physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration
* Patient or legal guardian is able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures and continuation of prescribed diet without modification) prior to any screening procedures

Exclusion Criteria:

* Transfusion of ≥ 2 u RBC within 60 days
* Active infection requiring systemic treatment
* Known infection with HIV, Hep B or Hep C
* Severe hyperammonemia requiring hospitalization within 14 days. Had more than one episode of hyperammonemia requiring hospitalization within the 30 days prior to enrollment.
* Current uncontrolled hyperammonemia
* Has a history of hypersensitivity to PEG or any other component of the AEB1102 (Co-ArgI-PEG) formulation
* If female, is lactating or breast feeding

PART 2 INCLUSION CRITERION:

1. Did not experience any safety or tolerability event in Part 1 which would preclude continued participation and dosing of AEB1102
The Study of Wound Dressings for Portable NPWT

Introduction Negative pressure wound therapy (NPWT), also known as topical negative pressure, has become a popular therapy for the treatment of many acute and chronic wounds. In many randomized controlled trials(RCTs), NPWT also has benefit in diabetic foot ulcer and pressure ulcer. However, most studies used commercial VAC device in combined with polyurethane (PU) foam. It is not yet clear where NPWT combined with gauze as wound filler is as effective as the PU foam. This RCT evaluated the efficacy of the gauze and PU foam, two kinds of fillers routinely used in negative pressure wound therapy, on the healing of the diabetic lower-extremity ulcers and the pressure ulcer.

Methods From 2010/1 to 2015/01, the in-patient persons with difficult to heal diabetic ulcer or Grade 4 pressure ulcer were enrolled. These patients were divided into two groups randomly. The letter of consent was signed by the patient or patient's family. After debridement of the infective wound, the wound of experimental group was packed with a moistened Polyhexamethylene biguamide (PHMB) impregnated gauze (Kerlix AMD, Covidien). A noncollapsible drainage tube (Blake drain, Ethicon) was applied to the wound, and then sealed with 3M Tegaderm Film. The system was connected to a 1-bottle water-seal chest drainage system and to standard wall suction at 125 mmHg negative pressure. The dressing was changed at 72- to 96-hour intervals (twice a week) for a period of 3 weeks. To the control group, the PU foam dressing from KCI was packed and sealed to the wound with the same continuous wall suction at -125mmHg. Investigators observed and recorded the ulcer area twice a week on each time of changing dressing in the following 3 weeks. The percentage of wound area reduction(PWAR) was used as a predictor of wound healing. The repeated measuring data were analyzed using linear mixed mode with SPSS statistical software. This clinical study was approved and monitored by Institutional Review Board of Show Chwan Memorial Hospital.


Eligibility Criteria:
Inclusion Criteria:

* in-patient persons with the pressure ulcer or diabetic ulcer

Exclusion Criteria:

* Patient who has uncontrolled medical condition, such as sepsis, cellulitis
* Patient with diabetic ulcer who has severe PAOD untreated
Direct and Indirect Benefits of Influenza Vaccine Versus Placebo in Healthy Children

While immunisation of school-age children against influenza is not recommended in Hong Kong, past experience in Japan and elsewhere suggests that immunisation of children may protect the wider community through its indirect transmission-limiting impact as well as the direct immunologic protection afforded vaccinated children themselves. We aim to assess whether vaccinating children against influenza protects vaccinees as well as their household contacts from infection.

Design and subjects: A double-blind randomised controlled trial of 800 subjects aged 6-17 drawn from the general population and their 2000 household contacts. The subjects will be randomised in a 3:2 ratio to the intervention and placebo groups, respectively. Serum samples will be collected from subjects pre- and 1 month post-vaccination, and after the influenza season. Serum samples will be collected from household contacts at baseline and at the end of the influenza season. During the follow-up period, subjects and household members will keep symptom diaries and those reporting influenza-like-illness will be offered free doctor consultations or home visits where we will arrange for collection of nose and throat swabs.

Study instruments: An antibody titre of ≥40 in the post-vaccine serum will be used to define seroprotection to those particular strains, while a four-fold or higher increase in antibody titres between baseline and end-of-season follow-up of the household contacts will define influenza infection during the season. Subjects and household contacts will be asked to keep symptom diaries, and during episodes of ILI we will collect nose and throat swabs for laboratory confirmation of influenza infection; the primary serology results will then be compared with clinical and laboratory-confirmed influenza episodes.

Interventions: 1 (intervention) inactivated influenza vaccine (Vaxigrip, Sanofi Pasteur); 2 (placebo) saline injection.

Main outcome measures: The proportions of subjects and household contacts with serology-confirmed influenza infection during follow-up among the 2 intervention arms.

Analysis: Intention to treat, adjusting for within-household correlation in influenza attack rates.

Eligibility Criteria:
Inclusion Criteria:

* All vaccinees must be Hong Kong residents aged between 6 and 17.

Exclusion Criteria:

* Vaccinees should not be allergic or hypersensitive to the active substances or components (eggs, chicken proteins, formaldehyde, neomycin, etc.) used in the vaccines or where vaccination is otherwise contraindicated. Subjects should not have an underlying immunocompromised condition or be receiving immunosuppressive agents.
Epigenetic Changes in Psychotherapy of Adolescents With Borderline Personality Pathology

The link between epigenetic changes as an effect of psychotherapy has been investigated recently. Genes investigated in these studies were brain-derived neurotrophic factor (BDNF), NR3C1, FKBP51, MAOA and GLUT1. Change in methylation of these genes could be a biomolecular mechanism of psychotherapy induced changes. This study project aims at providing evidence for a biological mechanism of personality disorder interventions in adolescence by investigating the link between epigenetic changes as an effect of psychotherapy. It investigates the correlation between changes in the methylation of the FKBP5 gene and psychotherapy induced changes in symptoms and functioning.


Eligibility Criteria:
Inclusion Criteria:

* adolescents presenting 3 or more criteria for BPD in the Structured clinical interview for the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) axis II personality disorders (SCID-II)

Exclusion Criteria:

* difficulties to understand or comply with instructions
* psychotic disorders
* pervasive developmental disorders
* severe somatic or neurological disorders
* severe and persistent substance addiction
* elevated risk for complications related to blood sampling
Denosumab vs Zoledronate After Vertebroplasty

Osteoporotic vertebral compression fracture (OVCF) patients had a proportion of secondary fractures after percutaneous vertebroplasty (PVP). Denosumab and zoledronate acid is both effective to prevent bone loss for OVCF postmenopausal women. However, trial evidence comparing effect of denosumab vs zoledronate after PVP was unknown. The study aims to assess the efficiency of denosumab vs zoledronate for OVCF patients bone mineral density (BMD), bone turnover markers (BTMs), secondary fracture and adverse events after PVP.

Whether denosumab was non-inferior than zoledronate in improving bone mineral density (BMD), bone turnover markers (BTMs), functional status questionnaires, and secondary fracture in elderly patients with OVCF after PVP remains unknown. A prospective, randomized, placebo-controlled clinical trial in OVCF patients with PVP was performed. This study aimed to investigate the efficiency of denosumab vs zoledronate on BMD, BTMs, functional status, secondary fracture rate, and adverse events in OVCF patients after PVP during a 12-month follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Must be age between 50 and 90 years old

  * X-ray diagnosis of 1 or 2 segment vertebral compression fractures from T4 to L5
  * Bone mineral density T value less than -1 via dual-energy X-ray
  * A recent fracture history less than 6 weeks
  * MRI show bone marrow edema of fractured vertebrae
  * low back pain, local paravertebral tenderness

Exclusion Criteria:

* Must be able to have no intervertebral fissure

  * Must be able to have no infection
  * Must be able to have no malignancy
  * Must be able to have no neurological dysfunction
  * Must be able to have no previous use of anti-osteoporosis drugs
  * Must be able to have no inability to perform magnetic resonance imaging
  * Must be able to have no prior back open surgery
  * Must be able to have no other established contraindications for elective surgery
Linezolid for Treatment of Nontuberculous Mycobacterial Diseases

A prospective open study to determine the efficacy and tolerability of oral linezolid 600mg./day for the treatment of 40 patients with nontuberculous mycobacterial diseases will be conducted at Siriraj Hospital, Mahidol University, Bangkok, Thailand.

This will be an open label clinical study of oral linezolid combination with another oral antimycobacterial drug as the maintenance treatment of nontuberculous mycobacterial diseases in adult.

The eligible patients will be treated and monitored for the efficacy and safety every 6 weeks until 6 months then every 3 months for a total duration of 18 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-tuberculous mycobacterial (NTM) diseases
* Active or stable diseases receiving either parenteral or oral antimycobacterial treatment
* Require at least more than 6 months of treatment from enrollment

Exclusion Criteria:

* Stable NTM diseases with a plan to discontinue treatment within 3 months
* History of allergy to linezolid
* Hemoglobin \< 7 g/dl) or total white blood count \< 3,000 /cu.mm. or thrombocytopenia \< 50,000 cells/cu.mm.
* Concomitant uses of serotoninergic drugs (SSRIs) or Monoamine oxidase inhibitor (MAOIs) within 30 days prior to enrollment
* Abnormal neurological findings such as numbness, abnormal vision etc.