cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Balance Board and Perceptual Motor Therapy in Children With Cerebral Palsy.

Various studies have worked on the sitting balance of cerebral palsy (CP) with Gross Motor Function Classification System (GMFCS) level I-III with a sample greater than 30, there is no data available to compare the effect of a balance board and perceptual motor therapy to improve sitting in GMFCS level IV and V with a sample greater than 30. This study will add the authenticity to literature with a large sample size and affect the severity of the condition.

This study will compare the effect of balance board therapy and Perceptual motor therapy to improve sitting in children with Cerebral palsy. Previous studies have worked on the sitting balance of cerebral palsy (CP) with Gross Motor Function Classification System (GMFCS) level I-III with a sample greater than 30, there is no data available to compare the effect of a balance board and perceptual motor therapy to improve sitting in GMFC level IV and V with a sample greater than 30. This study will add the authenticity to literature with large sample size and affect the severity of the condition. In addition, the patients with diagnosed Cerebral Palsy with GMFCS levels IV and V will be benefited from this study; an exercise program will help them to improve their sitting ability. A total of 88 Cerebral palsy patients will be included by dividing them into two groups (A, B). 1 hour of exercise session will be performed three times per week for 12 weeks with a total of 36 sessions. Both groups will receive 30 minutes of conventional physical therapy. In addition, group A will receive balance board therapy in the remaining 30 minutes while Group B will receive Perceptual motor therapy in the remaining 30 minutes. Data will be collected at baseline, at 4 weeks, at 8 weeks and at 12 weeks after intervention from both groups. The sitting balance will be measured by using Gross Motor Function Measure Scale (GMFM 88) and Trunk Control Motor Scale (TCMS).

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been diagnosed with CP GMFC level IV and V
* Both Male/Female
* Participants with the age ranges from 1.5 years to 5 years

Exclusion Criteria:

* Patients diagnosed with GMFC level I, II and III
* Participants taking botulinum toxin
* Participants diagnosed with auditory and visual impairments
* Participants diagnosed with mental impairments/ unable to understand the commands
* Participants diagnosed with any other comorbid conditions like (obesity, cardiovascular impairments)
* Participants who are not willing to participate
Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Phase III Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients.


Eligibility Criteria:
Inclusion Criteria:

\[Visit 1\]

1. Male Aged of 45 or above
2. Patients must have a diagnosis of Benign Prostatic Hyperplasia
3. IPSS(International Prostate Symptom Score) questionnaire total score ≥ 13
4. Signed and dated informed consent document indicating that the patient

\[Visit 2\]

1. IPSS(International Prostate Symptom Score) questionnaire total score ≥ 13
2. 15mL/s ≥ Qmax ≥ 4mL/s, if voided volume ≥ 120ml
3. PVR(post-void residual urine volume) ≤ 250ml

Exclusion Criteria:

1. Patients have ever taken Finasteride in 3 months or Dutasteride in 6 months
2. Patients with prostate cancer or PSA \> 10ng/ml
3. Patients with other disease which could have influence on urine flow rate except BPH(benign prostatic hyperplasia )
4. Patients with a history of operation on prostate which could have influence on the result and need to have surgery.
5. Patients with acute urinary retention in 3months
6. Patients with a history of drug or alcohol abuse within 6 months
7. Patients have cardiovascular disease or associated disease which is not controlled.
8. Patients who need to take Nitrates, alpha blocker, Nitric Oxide Donor
9. Patients with orthostatic hypotension
10. Patients with a history micturition syncope
11. Patients with severe or malignant retinopathy
12. Patients have a visual disturbance by Non-arteritic anterior ischemic optic neuropathy
13. Patients with a congestive disease like galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
14. Serum creatinine \> upper Normal Limit\*2, AST/ALT \> upper Normal Limit\*3
15. Patient with uncontrolled diabetes(HbA1C\>9%)
16. Patients have a history of malignant tumor within 5 years
17. Patients have hypersensitivity reaction on this drug.
18. Patients treated with other investigational product within 4 weeks at first time taking the investigational product
19. Not eligible to participate for the study at the discretion of investigator
Application of Artificial Intelligence in Precision Medicine and Healthcare

This study aims to propose an intelligent health robot that utilizes remote intelligent robots to assist patients with disease-related issues, enabling them to address their problems promptly.

Utilizing an information architecture system, a voice-based artificial intelligence program will be developed. The symptoms of major diseases and related knowledge will be input into this system to construct a dedicated disease platform. This platform will allow patients to remotely access it, enabling them to promptly understand and address disease-related issues, thereby improving convenience for patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with myasthenia gravis by a physician.
2. Age 20 years and above.
3. Able to use a smartphone.

Exclusion Criteria:

1. Individuals not diagnosed with myasthenia gravis.
2. Individuals who do not use smartphones or tablets.
3. Individuals who withdraw from the group midway.
4. Individuals unwilling to participate in interviews.
Reoperation Rate Versus Clinical Recurrence After Ventral Hernia Repair

The risk for recurrence after ventral hernia repair is often based on reoperation rates with short follow-up rather than recurrences identified by clinical examinations.

The purpose of current study is find the real incidence of recurrences 3 years after ventral hernia repair and to compare with the reoperation rate.

all patients in a restricted area (all patients in the part of Denmark called Zealand) who had a ventral hernia repair in 2007 (appr. 1200 patients). The patients will be sorted by a questionnaire and if the patients are suspicious for recurrence they will be offered a clinical examination.

Eligibility Criteria:
Inclusion Criteria:

* Primary ventral hernia repair performed in the region of Zealand in Denmark

Exclusion Criteria:

* Patients who died and patients not resident in region Zealand
Defibrotide in Children With High Risk Kawasaki Disease

This study evaluates the safety of defibrotide with IVIG in children with high risk Kawasaki disease.


Eligibility Criteria:
Inclusion Criteria:

* Kawasaki disease presumptive diagnosis defined according AHA criteria;
* Signed informed consent and patient assent (if applicable)
* Diagnosis of KD and initiation of defibrotide within 96 hours from the conclusion of IVIG treatment
* Age: 0 - 11 years old
* High risk category defined as patient meeting ≥2 of the following criteria: male, age \<6 months or \>8yrs, IVIG-resistance, Fever lasting greater than 10 days, prior to diagnosis, Coronary artery aneurysms, and/or Laboratory tests indicating worse systemic inflammation
* PT and PTT within institutional normal limits
* Platelet count ≥100,000/mm3

Exclusion Criteria:

* History of Grade III or IV hemorrhage or active bleeding;
* Previous Grade II-IV hypersensitivity to defibrotide
* Current systemic anti-coagulant therapy and/or fibrinolytic therapy, excluding aspirin (5 mg/kg/dose maximum).
* Patients on an active experimental trial for Kawasaki disease
Relative Bioavailability of a Fentanyl Patch

Tohe purpose of this study is to demonstrate the bioequivalence of a fentanyl patch transdermal delivery system.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on physical exam, medical history or clinical laboratory tests on screening.

Exclusion Criteria:

* Negative test for HIV and hepatitis B and C
* No history of drug or alcohol treatment
* No allergies to opiates
The Effects of Sorafenib on Molecular Barrett's Esophagus Cancer

To determine whether sorafenib is able to change pre-cancerous cells in a way that we believe is important in the progression of cancer.

To characterize the effects of sorafenib on specific molecular markers in patients with Barrett's esophagus and high grade intraepithelial neoplasia (HGIN) or carcinoma in situ (CIS).

Eligibility Criteria:
Inclusion Criteria:

* ECOG performance status 0-2
* Life expectancy of greater than 12 months
* No prior history of esophageal surgery or endoscopic treatment of dysplasia
* No prior exposure to sorafenib
* Patients may not be receiving any other investigational agents or any concomitant antineoplastic therapy, with the exception of androgen ablating agents (for patients with prior prostate cancer)
* Age 18 years.
* Patients must have adequate organ and marrow function as defined below:

  * hemoglobin: 8.5 g/dL
  * absolute neutrophil count: 1,500/L
  * platelets: 100,000/L (greater than 35,000/L without transfusion for less than 1 X the institutional upper limit of normal)
  * creatinine less than 1.5 X institutional upper limit of normal
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* A patient will be withdrawn from the study if any of the following events occur while on therapy:

  * Interruption of scheduled therapy for greater than 7 days
  * Intolerable adverse effects which are judged by the investigator to be either physically or psychologically detrimental to the patient
  * Patient decision to discontinue treatment
  * Pregnancy
  * Patient non-compliance with therapy administration
  * Grade 3 or 4 NCI-CTC toxicity attributable to sorafenib
  * Treatment with other chemotherapeutic or investigational anti-neoplastic drugs
  * Disease progression
* HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with sorafenib.Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
Modified Atkins Diet for Overweight and Obesity

The aim of the study is to investigate dynamic changes in biochemical metabolism, gut microbiome and its metabolites among overweight and obese participants while they are on a modified Atkins Diets.

The mechanisms of obesity are complex, involved in genes, environment, life style, and systemic and adipose tissue inflammation. Dysbiosis of gut microbiome is considered to make a difference in obesity. On the other hand, both long-term and short-term dietary interventions can induce changes in the body composition and structure and function of gut microbiome. However, it is not really clear how gut microbiome changes along with weight loss in overweight or obese.

In the present study, investigators aim to characterize the gut microbiome among overweight or obese participants on a modified Atkins diets. The stool and blood samples were collected by an interval of every 5% and 10% of weight loss, respectively. Data collecting mainly covers: 1) body composition analysis ; 2) obesity related biochemical metabolism; 3) measurement of gut microbiome using metagenome and 16S rRNA sequencing techniques; 4) metabolomics of serum and gut microbiome; 5) measurement of physical activity and diets using questionnaires.

Eligibility Criteria:
Inclusion Criteria:

1. 18-55 years old;
2. BMI \> 23.9kg/m2;
3. being willing and able to receive guidelines to a modified Atkins diet;
4. signed informed consent.

Exclusion Criteria:

1. patients with serious physical and mental diseases (including cardiovascular and cerebrovascular diseases, liver and kidney diseases, respiratory diseases gastrointestinal diseases, mental diseases, etc.);
2. patients with malignant tumor;
3. pregnant and lactating women;
4. those with recent relocation plans.
Study of the Efficacy and Safety of Kalinox® 170 Bar for the Performance of Care Procedures in Children With Burns

The purpose of this study is to assess the efficacy and the safety of Kalinox® 170 bar, over a period of three consecutive care procedures in burned children. It's a international (Spain, France, Tunisia and Belgium) study with 8 investigator centers.

Pain due to burns is one of the most intense and persistent types of pain. This pain consists of a permanent background pain, overlaid by episodes of temporary exacerbations triggered by treatment procedures or burn-care procedures.

Care procedures, such as changing the dressings or cleaning the wounds, make it necessary to handle the painful areas, and this causes transient intense pain.

Analgesia with a 50/50 mix of nitrous oxide and oxygen is a simple and effective technique, which induces a state of light sedation during which verbal contact is not lost, which is rapidly reversible and is devoid of any major side effects. This gas is used in paediatrics for carrying out painful procedures of a short duration, such as lumbar puncture and minor surgery.

The nitrous oxide/oxygen mix has also been used to treat the pain induced by care procedures in children with burns for more than 30 years.

The objective of our study is to obtain qualitative and quantitative data about the efficacy of Kalinox® 170 bar in care procedures in children with burns.

Eligibility Criteria:
Inclusion Criteria:

* Child between 5 and 15 years of age , burned for many days and who has to undergo at least 3 procedures of care

  * potentially mildly to moderately painful
  * lasting for at least 15 minutes and for less than 30 minutes
  * eligible to receive short-term prophylactic analgesic treatment
  * for whom the consent form has been signed (parent and child)

Exclusion criteria:

* Child treated under general anaesthesia
* Child physically or mentally incapable of responding to an assessment of his/her pain on a visual scale.
* Child suffering from moderate to severe pain when beginning the care procedure (FPSr \> 4)
* Exclusion criteria linked to the product
Nutritional Outcomes After Vitamin A Supplementation in Subjects With SCD

This study establishes the safety and efficacy of vit A supplementation doses (3000 and 6000 IU/d) over 8 weeks in children with SCD-SS, ages 9 and older and test the impact of vit A supplementation on key functional and clinical outcomes. Additionally, vitamin A status is assessed in healthy children ages 9 and older to compare to subjects with SCD-SS.

Suboptimal vitamin A (vit A) status is prevalent in children with type SS sickle cell disease (SCD-SS) and associated with hospitalizations and poor growth and hematological status. Preliminary data in children with SCD-SS show that vit A supplementation at the dose recommended for healthy children failed to improve vit A status, resulting in no change in hospitalizations, growth or dark adaptation. This indicates an increased vit A requirement most likely due to chronic inflammation, low vit A intake and possible stool or urine loss. The dose of vit A needed to optimize vit A status in subjects with SCD-SS is unknown.

Eligibility Criteria:
Inclusion Criteria:

* Sickle cell disease, SS genotype (subjects with sickle cell disease only)
* Usual state of good health (no hospitalizations, emergency room visits, or unscheduled acute illness clinic visits for two weeks prior to screening)
* Commitment to a 119-day study (subjects with sickle cell disease only), or a 4-day study (healthy volunteers only)

Exclusion Criteria:

* Hydroxyurea initiated within the previous 6 weeks (subjects with sickle cell disease only)
* History of stroke (subjects with sickle cell disease only)
* Other chronic conditions that may affect growth, dietary intake or nutritional status
* Retinoic acid (topical or oral), weight loss medication and/or lipid lowering medications
* Subjects with a BMI greater than 98th percentile for age and sex
* Pregnant or lactating females (subjects who become pregnant during the course of the study will not continue participation)
* Liver function tests \>4 x upper limit of reference range
* Participation in another study with impact on vitamin A status (subjects with sickle cell disease only)
* Use of multi-vitamin or commercial nutritional supplements containing vitamin A (those who are willing to discontinue these supplements, with the approval of the medical care team, will be eligible for the study after a 1 month washout period. Subjects taking nutritional products without vitamin A will be eligible)
* Inability to swallow pills (subjects with sickle cell disease only)
Comparison of the Methylation Pattern of DNA in Buccal Swabs From Different Time Points

A buccal swab will be taken using a cotton stick by rubbing it against the buccal mucosa. Samples will be taken from the same participant at different timepoints.

DNA will be extracted from the buccal cells on the swabs using a commercial extraction kit and will be quantified by a nano-drop spectrophotometer.

We will determine global and gene-specific methylation and hydroxymethylation alterations by UPLC/MS/MS. Hydrolyzed DNA into individual nucleosides will be analyzed for the quantitative measurement of 5-methylCytosine and 5-hydroxymethylCytosine on Triple Quadrupole UPLC/MS/MS platform. Secondly, specific methylation in the CpG islands of tumor suppressor and promoter genes, and genes involved in the oxidative stress pathways will be assessed by PCR-pyrosequencing.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian

Exclusion Criteria:

-
Physical and Psychological Changes in CRPS Patients Undergoing Multimodal Rehabilitation

The goal of this clinical trial is to learn about cognitive changes during rehabilitation in CRPS patients. The main questions it aims to answer are:

* What are the cognitive changes in CRPS?
* Do cognitive functions change during multimodal rehabilitation in CRPS?
* What is the effect of multimodal rehabilitation on pain, functioning, mood, active range of motion, cognitive functions.

Participants will undergo a 4-week program of multimodal rehabilitation of physical therapy, education and Graded Motor Imagery. Assessment will be made at baseline and after 4 weeks.

Researchers will compare the interventional arm with healthy control to see if the observed psychological results are exclusive to CRPS group.

There is no expanded access scheduled for this study.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of CRPS (or equivalent);
* MMSE \>24 points;
* Has signed an informed consent to the study.

Exclusion Criteria:

* MMSE ≤24 points;
* Inability to perform scheduled tasks (multimodal rehabilitation program).
Chemotherapy and Tislelizumab With Split-course HFRT for Locally Advanced Rectal Cancer

The question of how to administer adequate chemotherapy and immunotherapy to synchronise hypofraction radiotherapy （HFRT） treatment strategy to maximise the benefits of neoadjuvant therapy for the improved prognosis of patients with locally advanced rectal cancer (LARC).We aimed to study whether chemotherapy and tislelizumab plus split-course HFRT results in better outcomes in LARC patients.

Prior to analyzing continuous variables, the statistical normality of the data will be determined. The differences between the main variables will be compared by using the analysis of variance. A comparison of data on categorical variables will be carried out by χ2 tests or Fisher's exact tests. The OS and PFS was estimated using the Kaplan-Meier method. PFS and OS will be compared using the log-rank test. In cases where variables must be adjusted, we will use the proportional hazard Cox regression model. P values for all analyses will be based on using a significance level of 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Treatment-naïve patients with operable locally advanced cancer (LARC, T3-4 and/or N+)
* Pathologically diagnosed as rectal adenocarcinoma
* Male or non-pregnant female
* Age: 18-70 years old
* Hematology examination：I. White blood cell count ≥4×10\^9/L;II. Neutrophils ≥1.5×10\^9/L;III. Platelet count ≥100×10\^9/L;IV. Hemoglobin ≥9g/L
* Blood biochemical examination: total bilirubin, AST, ALT≤2.0×upper limit of normal; creatinine≤1.5×upper limit of normal
* Functional status: ECOG score 0-1 points or KPS score ≥70 points
* Obtain the patient's informed consent

Exclusion Criteria:

* Pathologically diagnosed as non-adenocarcinoma
* Age\> 70 years old
* Patients with recurrence and distant metastasis
* Have a history of other malignancies
* Have had radiotherapy and/or chemotherapy
* Pregnant or breastfeeding women
* Mentally disordered
* Patients with severe heart, liver, and kidney damage
* Non-compliance or the investigator believes that the patient cannot complete the entire trial treatment
Phase 1 XG005-03 Topical Study

Phase 1, randomized, single-blinded, placebo-control, ascending single and multiple dose of the PK, safety, and tolerability of XG005-03 topical formulation in Healthy Volunteers.

This is a single-blind, placebo-controlled study which will investigate the PK, safety and tolerability of XG005-03 topical formulation, in three ascending concentrations after single and multiple topical applications in healthy subjects. The trial consists of two parts: a single ascending dose (SAD; Part 1) and a multiple ascending dose (MAD; Part 2). The MAD study will begin after the SAD portion of the study is complete.

The study will consist of 4 weeks of screening period, treatment period (1 day of dosing for SAD and 6.5 days for MAD), and 14 days of safety follow-up period. Each subject will serve as his/her own control, as the XG005-03 and placebo will be applied on contralateral legs. Application of XG005-03 or placebo to a particular leg will be randomly assigned.

Approximately 36 healthy subjects will be enrolled. Eighteen healthy subjects (3 alternates per dose group) in Part 1 (SAD) and Part 2 (MAD), who fulfill eligibility criteria will receive the study drug: XG005-03 (1%, 5%, and 10%) and placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy males or females between 18 and 55 years of age
2. BMI 18.0 to 30.0 kg/m2
3. Non-pregnant, non-breastfeeding female subjects

Exclusion Criteria:

1. Unstable or severe illness
2. Skin infection or lesion
3. Subjects with scars, moles, tattoos at application site
4. Expose to excessive UV
5. Hypersensitivity or allergy to NSAID