cyrilzakka/clinical-trials huggingface dataset:
Music Training and Child Development Study

This proposed study aims to provide a definitive answer to whether music training benefits brain development, particularly brain inhibition control circuitry and its related health outcomes using a randomized control trial design.

In the study, 114 Hispanic children between ages 6-8 from underserved communities of LA will be randomly assigned to a 24-month:(1) community-focused after school music training group focused on a traditional strings curriculum at the Colburn school in Los Angeles (MG) or (2) a control group (CG) after-school program comprising of visual arts, book club, ethnic and cultural studies and theater without specific focus on systematic music training or sports. Imaging data will be collected at before and after the intervention (24 months), behavioral assessments will be conducted before the intervention and yearly afterwards, and mid-intervention evaluations will be performed every six months throughout the study.

The investigators will use an RCT design to investigate effects of a music training intervention on brain inhibition control circuitry. Throughout R61(N=40) and R33 (N=74) phases, 114 Hispanic children between ages 6-8 from under-served communities of LA will be randomly assigned to a 24-month: (1) community-focused after school music training group focused on a traditional strings curriculum at the Colburn school in Los Angeles (MG) or (2) a control group (CG) after-school program comprising of visual arts, book club, ethnic and cultural studies and theater without specific focus on systematic music training or sports. Imaging data will be collected at before and after the intervention (24 months), behavioral assessments will be conducted before the intervention and yearly afterwards, and mid-intervention evaluations will be performed every six months throughout the study.

The investigators anticipate that the R61 phase will take 2 years and R33 will take 3 years to complete. The goal of the R61 phase is to evaluate the feasibility of executing the RCT. Comprehensive behavioral and imaging data will be collected at pre- and post-intervention, and mid-intervention evaluations will be performed every six months throughout the study. The combined R61/R33 phases will include 114 participants and will ultimately provide much needed guidance on the development of larger trials in the field.

Eligibility Criteria:
Inclusion Criteria:

* normal IQ (standard score of \>85 in the Abbreviated Wechsler's Scale of Intelligence)
* Hispanic/Latino living in LA within 2 miles radius of the location of the music and the afterschool programs
* low SES as defined by Hollingshead Index cumulative score below 29
* ages 6-8

Exclusion Criteria:

* current diagnosis of neurological or psychiatric disorders
* prior engagement in formal and systematic music training for more than 6 months
* previous or current diagnosis of severe hearing loss defined as air conduction thresholds greater than 60 dB HL through 8 kHz or- severe vision loss that is not correctable with prescription eyeglasses or contact lenses
* non-removable, non-MRI compatible body parts
* Claustrophobia
Efficacy of a Gluten-free Diet in Difficult to Manage Nephrotic Syndrome: Utility of Plasma Zonulin Levels as a Predictive Biomarker

Elevated plasma zonulin levels, which are supportive of a diagnosis of CD (celiac disease) in children with gastrointestinal symptoms, may indicate patients with difficult-to-manage NS who will benefit from initiation of a GFD (gluten free diet). This pilot study will determine whether high plasma zonulin levels can be used as a screening tool to identify patients with NS (nephrotic syndrome) who are likely to demonstrate a beneficial response to a GFD. It will provide important information about the feasibility of testing the efficacy of a GFD for this condition and assist in the design and sample size calculation for a definitive trial to test the beneficial effect of this dietary intervention. Although NS is a rare condition in childhood, it is a chronic disease that can lead to short- and long-term disability especially in those with difficult-to-manage disease. There is an urgent need to develop safe and effective new therapies in this subgroup. This project may indicate the utility of a common dietary modification, a GFD, to treat these patients. The growing medical use of and greater access to gluten-free food items underscore the feasibility and timeliness of this approach.


Eligibility Criteria:
Inclusion Criteria:

* Steroid sensitive NS: complete remission of proteinuria in response to administration of a standard course of corticosteroids
* Difficult-to-manage NS: disease that cannot be controlled without incurring intolerable side effects from currently available immunosuppressive agents, namely corticosteroids, calcineurin inhibitors, mycophenolate mofetil, or rituximab. Patients with biopsy-proven MCD or FSGS will be eligible as long as they have steroid sensitive disease. However, a renal biopsy will not be required for enrollment into the trial.

Exclusion Criteria:

* Any patient diagnosed with nephrotic syndrome that is not considered steroid sensitive or frequently relapsing
* Pre-existing celiac disease or gastro-intestinal disorder that precludes use of a GFD
A Trial of Chronotherapy of Corticosteroids in Duchenne Muscular Dystrophy

Duchenne muscular dystrophy (DMD) is a progressive neuromuscular disease for which no curative treatment has yet been identified, making it important to slow progression and improve the quality of life among affected boys and young men. Treatment with corticosteroids is standard of care for patients with DMD five years old and older, due to the robust observation that this intervention lengthens the interval prior to loss of ambulation but is associated with many side effects. This clinical trial will be conducted in the youngest age group able to receive corticosteroids orally and on whom study outcomes are measurable, ages 3 to 7 years. This is a randomized, double blinded, double masked, placebo-controlled clinical trial that will explore whether better synchronization of corticosteroid administration with the circadian rhythm will provide improved tolerability and at least comparable efficacy to current standards in which corticosteroids are always given in the morning. Furthermore, the trial provides a unique opportunity to rigorously evaluate corticosteroid effects in the young DMD patient, both for efficacy as compared to placebo and as a study of the impact of corticosteroid chronotherapy, or delayed release, on increased tolerability over standard therapy. The main hypothesis is that synchronization of the timing of corticosteroid dosing will improve medication tolerability in children, while maintaining (non-inferiority) the efficacy of corticosteroid. The study also offers a unique opportunity to measure several biomarkers as well as novel genetic modifiers that may further impact the response to corticosteroid in DMD.


Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed dystrophin mutation compatible with DMD phenotype. Specifically, gene deletion test positive (missing one or more exons) in the central rod domain (exons 25-60) of dystrophin, where reading frame can be predicted as 'out-of-frame' OR showing complete absence of dystrophin by muscle biopsy.
* Ages between 3 years and \< 7 years
* Steroid-naïve
* Signed informed consent

Exclusion Criteria:

* Treatment with CoenzymeQ10, creatine, amino acid supplements within 3 months of study entry
* Treatment with cardiac medications: beta-blockers, digoxin, and carvedilol
* Existing medical condition or physical disability that would alter subject's motor development
* Existing medical condition that precludes the use of corticosteroids
* Inability to swallow sample tablet in bite of soft food\*
* Investigator assessment that participant or family will not be compliant with treatment or study procedures
* Been on investigational DMD medication for the past 6 months
Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes

In recent years, more and more attention has been paid to diabetes self-management. Glycemic control and self-management skills of patients with type 1 diabetes (T1DM) in China are poor. Artificial intelligence (AI) and the Internet offer a new way to improve the self-management skills of patients with chronic diseases. Few studies have combined AI technology with structured education intervention of type 1 diabetes. This study is innovative in that it compares the effectiveness of smartphone app between usual care, as well as automatic and individualized app education and standardized app education to explore whether the individualized treatment advocated by the latest guideline will bring any additional benefit to T1DM patients. The ultimate goal is to provide an effective and convenient approach for glycemic control of type 1 diabetes and reduce related disease burden in China.

This is a single-blinded, 1:1 paralleled group cluster randomized controlled trial (RCT). The intervention will last for 24 weeks. The laboratory staff who test the HbA1c level, the outcome assessor who collects the blood glucose data, and the statisticians will be blinded to the treatment allocation.

Sample size estimation: We propose to enroll 138 patients with type 1 diabetes (T1DM) by considering withdrawals, 69 in the smartphone app groups and 69 in the routine care group. Sample size estimation is based on hypothesized changes in the primary outcome HbA1c.

In order to ensure high quality data, two staff are responsible for the input of original data into the database to check and confirm the accuracy. When the data entered by two staff independently, the auxiliary staff decides which data to use.

Data analysis will be conducted under the intention-to-treat principle by including all the randomized patients in the data analysis. Missing data will be filled in with multiple imputation method. Any substantial difference in baseline characteristics will be adjusted with mixed-model regression analysis. Sensitivity analysis will be conducted by using per-protocol data by excluding those patients who drop out of the RCT.

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with Type 1 Diabetes according to the 1999 World Health Organization report
* Insulin dependence from disease onset
* Aged 18-50 years
* With a disease duration over 6 months
* With a HbA1c level over 7%
* Treated T1DM with multiple daily injections or insulin pump
* Individuals who own smartphone and are capable of using wechat or apps

Exclusion Criteria:

* Age below 18 years or above 50 years
* Being pregnant
* With mental disorders
* Have any other condition or disease that may hamper from compliance with the protocol or complication of the trial
* Already using a smartphone app for managing diabetes
* Having chronic complications including diabetic retinopathy, diabetic nephropathy or diabetic foot, diabetic neuropathy
Safety and Efficacy of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification

The purpose of this study is to determine the safety and efficacy of OMS302 (the study drug) for maintaining intraoperative mydriasis in individuals undergoing Intraocular Lens Replacement (ILR) surgery.


Eligibility Criteria:
Inclusion Criteria:

* Competent and willing to voluntarily provide informed consent
* 18 years of age or older
* In good general health needing to undergo cataract extraction or lens extraction with lens replacement surgery in one eye, under topical anesthesia

Exclusion Criteria:

* No allergies to the medications and/or the active ingredients of any of the study medications
* No medications with the same activities of the active ingredients in OMS302 for defined time intervals prior to and after surgery
* No other significant eye injuries, eye conditions or general medical conditions likely to interfere with the evaluation of the study medication
Neratinib and Trastuzumab Biosimilar in Patients with HER2 Mutated Advanced Solid Cancers

Prospective, Basket, Open-label, Multi-dose, Single-arm, Simon's two-stage, Multi-center trial

Study drug : neratinib + herzuma (trastuzumab biosimilar)

1. Primary objective Evaluate overall response rate (ORR) in HER2 mutated advanced solid cancer patients based on RECIST v1.1
2. Secondary objectives

(1) Evaluate clinical benefit rate (CBR) (2) Evaluate duration of response (DOR) (3) Evaluate progression free survival (PFS) (4) Evaluate overall survival (OS) (5) Evaluate compliance with oral administration 3) Safety evaluation

1. Evaluate the overall safety of the test drug
2. Evaluate the predefined adverse event (diarrhea)

Eligibility Criteria:
Inclusion Criteria:

* Patients who voluntarily decide to participate and give written consent after hearing the explanation of the clinical trial and investigational drugs.
* Adult men and women over 19 years old.
* Histological or cytological confirmed advanced solid tumor and confirmed to have HER2 known oncogenic mutations in tumor DNA by K-master panel test using tumor tissues or circulating tumor DNA in blood.
* Patients having at least 1 or more than 1 measurable lesion according to RECIST v 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status 0\~2.
* Patients whose life expectancy is more than 6 months.
* Metastatic/progressive solid cancer patients who have received one or more than one standard treatment or do not have any treatment option.
* Patients who have agreed to provide plasma/blood samples, the most recent metastatic/progressive tumor sample or new tumor biopsy for gene sequencing and other biomarker analysis.

Exclusion Criteria:

* Patients who received radiotherapy or surgical treatment within 2 weeks prior to the initiation of investigational product.
* Patients having symptomatic brain metastasis who needs treatment. Patients with stable brain metastasis who need no treatment including steroid are eligible
* Inappropriate HER2 mutation (e.g., non-Hot Spot mutation, variant of unknown siginificance, subclonal mutation, premature STOP codon or the Frame Shift mutation).
* Patients having difficulties in swallowing tablets.
* Patients with toxicities of prior treatment which are not recovered to baseline level or ≤ Grade 1.
* Inadequate organ functions:

  1. Hemoglobin (Hemoglobin) \< 8 .0g / dL
  2. Absolute neutrophil count (ANC) \< 1. 0 x10 ³ per mm³
  3. Platelet count \< 100 x10⁹/L (100 ,000/ mm³)
  4. Total bilirubin \> 1.5 x upper normal limits (UNL), (exclude Gilbert's syndrome)
  5. Alanine aminotransferase (ALT) or aspartate amino transferase (AST) \> 3 x upper normal limits (UNL) (in case of liver and bone metastases \> 5 x ULN)
  6. Serum creatinine \>1.5 x upper normal limits (UNL) or \< eGFR 30 mL/min/1.73 m² 7) Left ventricle ejection fraction \<50% by multi-gate obtaining method scan (MUGA) or echocardiogram.

  8) Chronic gastrointestinal disorders of which a main symptom is diarrhea (e.g., Crohn's disease, malabsorption, or grade 2 or more than grade 2 diarrhea according to the NCI CTCAE version 5.0 regardless of etiology).
Adjunctive Effect of Acupuncture for Advanced Cancer Patients With Palliative Care: a Three-arm Randomized Trial

The proposed study aims to evaluate the adjunctive effect of MA with standard care (ASC) for relieving cancer-related symptoms in a collaborative model of palliative care compared to sham MA plus standard care (SSC) or standard care alone (SC).

After being informed about the study plan, potential risk and benefits, all subjects will give written informed consent prior to participation and undergo eligibility screening. Eligible participants will be randomized into three arms, ASC, SSC, and SC, in a 2:1:1 ratio.

Eligibility Criteria:
Inclusion Criteria:

* All cases are subject to pathology and (or) cytology for a diagnosis of malignant tumour (pathological type is not restricted) at stage IIIB or IV;
* Aged 18 years or above;
* Expected survival time longer than 16 weeks;

Exclusion Criteria:

* Disseminated intravascular coagulation or severe thrombocytopenia with a bleeding tendency, i.e., low platelet count \< 35000/µL; INR \> 1.5; hemoglobin ≤ 90 g/dL; white blood cell count ≤ 4x109/L;
* Uncontrolled active skin infection;
* Needle phobia;
* Inability to read and understand Chinese;
* Not signed written informed consent.
* Receiving surgery during the whole study period;
* Receiving acupuncture treatment in the last 3 months
Trial of a Non-pharmacological Intervention to Prevent Delirium Among Elderly In-patients

This study evaluates the effect of earplugs and eyemask for delirium prevention among elderly in-patients. Half of patients will receive earplugs and eyemask for use during the night and information about orientation to time and space every night, while the other half will receive only the time and space orientations.

Delirium is an acute neuropsychiatric syndrome usually associated with a general medical condition. Its prevalence is high among hospitalized elderly patients and is generally underdiagnosed. Delirium is associated with prolonged hospitalization, increased mortality, institutionalization, falls, cognitive and functional decline and also with higher economic costs. The etiology of delirium is multifactorial, including excessive sensorial stimulation and disruption of the sleep-wake cycle as triggering factors.

The aim of this study is evaluate the effect of earplugs and eyemask for delirium prevention among elderly in-patients of a brazilian university hospital. This will be a partially blinded clinical trial, in wich both control and intervention group will receive information about orientation to time and space every evening, and intervention group will also receive earplugs and eyemask for use during the night. The primary outcome will be the occurrence of delirium.

Eligibility Criteria:
Inclusion Criteria:

* In-patients, expected to stay for at least 24 hours.
* Understand and consent in participating in the study and sign the consent form.
* 60 years of age, or older.
* Visual and auditory acuity sufficient to perform cognitive tests.

Exclusion Criteria:

* Diagnosis of delirium in the selection visit.
* Glasgow Coma Scale less than 15 in the selection visit.
* PRISMA-7 ≤3 patient will be excluded.
Graft Take and Microbiology in Burns

SPLIT-THICKNESS SKIN GRAFT TAKE AND MICROBIOLOGICAL EVALUATION IN BURNED PATIENTS

INTRODUCTION: Infection is cause of increased morbidity and mortality in burn patients, and its control is a major challenge also for skin graft integration. Wound and soft tissue infection rates are higher than microbiological diagnosis rates.

PURPOSE: To evaluate partial skin graft integration in relation to microbiological analysis of wounds in burn patients.

METHODS: This project will be a transversal, prospective, analytical, controlled study in humans, conducted in a single center, at Burn Care Unit of Department of Plastic Surgery at Federal University of São Paulo from October, 2010 to October, 2011. Data will be collected to characterize demographic and clinical aspects. Data analysis will be performed using Student's t-test and Friedman analysis of variance.

SPLIT-THICKNESS SKIN GRAFT TAKE AND MICROBIOLOGICAL EVALUATION IN BURNED PATIENTS

INTRODUCTION: Early excision and partial skin graft is state-of-the-art in burns treatment. Otherwise, infection is cause of increased morbidity and mortality in burn patients, and its control is a major challenge also for skin graft integration. Wound and soft tissue infection rates are higher than microbiological diagnosis rates. This difference is related to moderate sensibility of cultures in general. Precise bacterial diagnostic and its susceptibility to specific antibiotics are prerequisite for adequate treatment of burn patients and skin graft integration.

PURPOSE: To evaluate partial skin graft integration in relation to microbiological analysis of wounds in burn patients.

METHODS: This project was approved at Ethics Committee at Federal University of São Paulo (1272/10). It will be a transversal, prospective, analytical, controlled study in humans, conducted in a single center, at Burn Care Unit of Department of Plastic Surgery at Federal University of São Paulo from October, 2010 to October, 2011. Thirty patients will be included in this study after reading and signing a consent form. Data will be collected using an evaluation sheet to characterize demographic and clinical aspects, including partial skin graft integration, use of topical and systemic antibiotics and infection rates in all sites (blood, urine, skin, tracheal aspirate and bronchial lavage). Data analysis will be performed using Student's t-test and Friedman analysis of variance.

Eligibility Criteria:
Inclusion Criteria:

* Both gender
* More than 18 years of age
* Burned patient
* Inpatient of Burn Center of Federal University of São Paulo
* Upper 5% of TBSA
* Debridement and skin graft indication and procedure realization

Exclusion Criteria:

* Not interest in participating in research
* Not have debridement or graft indication
* Under 5% of TBSA
* Skin disease
* Clinical disease that contraindication procedure
* Clinical disease that directly interferes with infectious process and wound healing
Pennisetum Purpureum in Sarcopenia Patients

The purpose of this study was to investigate the effects of Pennisetum purpureum health food supplementation on muscle mass and muscle strength.

All participants performed anthropometric measurements (body height, body weight, BMI, blood pressure, body composition, upper arm circumference, and lower thigh circumference), blood collection (hormones, liver function, and kidney function), exercise test (grip strength and 10-m walking test), as well as questionnaire survey before supplementation. Participants were assigned to either the experimental (n=20) or placebo (n=20) group according to their body composition, upper arm circumference, and lower thigh circumference. The definition of insufficient muscle mass was based on the Asian working group for sarcopenia (AWGS) that skeletal muscle mass in extremities by dual-energy X-ray absorptiometry less than 7.0 kg/m2 in men and less than 5.4 kg/m2 in women is a necessary condition, and one of the following criteria were met: (1) handgrip strength less than 28 kg in men and less than 18 kg in women and (2) 5-time chair stand test over than12 seconds. The anthropometric measurements (body height, body weight, BMI, blood pressure, body composition, upper arm circumference, and lower thigh circumference), blood collection (hormones, liver function, and kidney function), exercise test (grip strength and 10-m walking test), as well as questionnaire survey, were collected after 8 weeks and 12 weeks of supplementation.

Eligibility Criteria:
Inclusion Criteria:

1. adult between 18-75 years old
2. skeletal muscle mass in extremities by dual-energy X-ray absorptiometry less than 7.0 kg/m2 in men and less than 5.4 kg/m2 in women
3. one of the following criteria were met: (1) handgrip strength less than 28 kg in men and less than 18 kg in women and (2) 5-time chair stand test over than 12 seconds

Exclusion Criteria:

1. The volunteers have history of cardiovascular, liver, kidney, and diabetes mellitus
2. acute sport injury
3. participated in any clinical trials or experimental research in the last 3 months before our experiment
4. taking supplement during the experimental period
5. did not maintain their regular eating habit or drink alcohol