cyrilzakka/clinical-trials huggingface dataset:
Autologous Adipose Stem Cell Assisted Skin Graft

Skin graft is a commonly used method in wound repair. The long-term outcome of skin graft is unsatisfied because of the complications of contraction, pigmentation and stiffness. In our preclinical researches, we found that adipose stem cell can improve the texture of grafted skin and reduce contraction. In this trial, we will evaluate the efficiency and safety of autologous adipose stem cells in improving skin graft outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 6-70 years old;
2. Gender: male and female;
3. Scar, surface tumor or soft tissue defect evaluated to be suitable for skin grafting;
4. With two skin grafting areas and the edges more than 4cm apart;
5. Sign informed consent, participate in the study and be able to cooperate with the follow-up.

Exclusion Criteria:

1. Those who are not suitable for skin grafting;
2. There who are with local lesions in the operation area, such as infection, blood supply disturbance, delayed healing history, decreased soft tissue vitality, history of radiotherapy or going to receive radiotherapy, active ulcer, etc;
3. With severe medical diseases (such as diabetes, hepatitis, coronary heart disease, arteriosclerosis, glomerulonephritis, autoimmune diseases, etc.) were complicated;
4. Those who are receiving anticoagulant therapy and cannot suspend treatment;
5. Those who are with abnormal blood routine test, abnormal coagulation function, abnormal cardiac function, abnormal liver function or renal function evaluated by researchers according to the laboratory examination and other clinical signs and symptoms,
6. Those who can't tolerate the operation risk according to the surgeon's evaluation;
7. Pregnant and lactating women;
8. Those who have mental illness, have no insight, can not express and cooperate with each other;
9. Participant in other clinical trials within 30 days before the screen visit of this trial;
10. Those who have not signed the informed consent.
Exploration of Genotype Based Personalized Prescription of Valproate Sodium in Anti-epileptic Treatment

The purpose of this study is to investigate the relationship between the side effects of valproate sodium in the treatment of epilepsy in Han Chinese and the genetic polymorphisms of drug metabolizing enzymes and pharmacokinetics of valproate sodium.

Valproate sodium is a widely applied agent in the treatment of epilepsy. Although Valproate sodium is effective in clinic, it is able to induce several side effects, including weight gain, thinned hair, loss of appetite, nausea, vomiting, hepatotoxicity, hematotoxicity, thrill, etc. However, the remarkable variability of the reactions to the drug -- the incidence of side effect or the outcome of the treatment -- has been observed among patients. Valproate sodium is metabolized by some enzymes in the liver to transform it into several unreactive chemicals for excretion. Among them there are two toxic metabolites catalyzed by the specific metabolic enzymes. This study is designed to explore the genetic variation among individuals in the key processes of the deactivation and elimination of Valproate sodium in order to find out whether these genetic factors are associated to the side effects or efficacy. The further understanding into the factors concerning on the drug might imply possible solution to minimize the incidence of side effects in epileptic patients.

Eligibility Criteria:
Inclusion Criteria:

* The patients must have been diagnosed as epilepsy according to The International League Against Epilepsy (ILAE) criteria published in 2001.
* The patients must sign the informed consent. And for the patients who are under 18 years old, both the signatures of their legal guardians and that of the patients are required on the written informed consent.
* The patients are receiving the regimen of 15-30mg/kg valproate sodium given as daily oral administration.

Exclusion Criteria:

* Pregnant women, women in breast-feeding period and the women who refuse to take contraception measures during treatment.
* Patients with poor compliance.
* Patients who have blood transfusion during the therapy.
Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration

Dehydration due to vomiting is a common complication of acute gastroenteritis in children. Persistent vomiting following rehydration is a problem in outpatient management using oral rehydration therapy.

Four previous studies have examined the role of the medication, ondansetron, in treating nausea and vomiting in children with gastroenteritis and have suggested that it may be beneficial \[1-4\]. A previous study has also shown that the administration of intravenous fluid alone to children with dehydration due to gastroenteritis helps resolve nausea and vomiting in the majority of patients \[5\]. None of the previous studies compared the efficacy of intravenous ondansetron with that of intravenous fluid alone in the prevention of vomiting . In addition, the previous studies were limited by poorly defined inclusion criteria and outcome measures.

The proposed study seeks to more clearly define the role of intravenous ondansetron in the management of children suffering dehydration due to acute gastroenteritis. If ondansetron further reduces the incidence of vomiting compared with intravenous fluid alone, more children with dehydration due to acute gastroenteritis may be successfully discharged to home from the emergency department instead of admitted to the hospital. If it does not, the widespread use of ondansetron for such patients could be discouraged and money could be saved.

Hypothesis:

Patients receiving ondansetron in addition to intravenous fluids for the treatment of dehydration due to vomiting caused by gastroenteritis will not have a significant reduction in the occurrence of persistent vomiting as compared to those who receive only intravenous fluids.


Eligibility Criteria:
Inclusion Criteria:

* Age 6 months - 5 years
* Clinical diagnosis of acute gastroenteritis
* Mild or moderate dehydration as determined by validated clinical scale
* Clinical assessment to begin IV fluids
* Vomiting ≥ 2 episodes in past 4 hours

Exclusion Criteria:

* Severe dehydration
* History of significant gastrointestinal, metabolic, renal or cardiac disorder
* Ondansetron allergy
* Non-English language proficient parent/guardian
* Parent/guardian has no telephone
Efficacy and Safety of Sintilimab Plus Bevacizumab in Metastatic Nasopharyngeal Carcinoma After Failure of Platinum-based Chemotherapy: An Open-label Phase II Study

To evaluate the efficacy and safety of PD-1 immune checkpoint inhibitor combined with bevacizumab in the treatment of metastatic nasopharyngeal carcinoma after failure of platinum-based chemotherapy.

To evaluate the efficacy and safety of sintilimab combined with bevacizumab in the treatment of metastatic nasopharyngeal carcinoma (NPC) after platinum-based chemotherapy failure. The primary end point is objective response rate (ORR), the secondary end points are overall survival (OS), progression-free survival (PFS), duration of response (DOR), adverse effects and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with metastatic nasopharyngeal carcinoma are not suitable for radical local treatment.
* Previous failure of first-line platinum-containing chemotherapy (single drug or combination).
* Previously diagnosed WHO classification type II or III by histological pathology.
* At least one measurable lesion (according to RECIST1.1).
* Age between 18 and 70.
* Eastern Cooperative Oncology Group (ECOG) 0-1, and life expectation at least 3 months.
* Enough blood test.
* Participate voluntarily and sign the informed consent.

Exclusion Criteria:

* Previously diagnosed WHO classification type I by histological pathology.
* Prior exposure to anti-PD-1/PD-L1 antibodies plus anti-VEGF antibodies.
* Necrotizing lesions were found within the first 4 weeks, or the risk of massive bleeding.
* A history of interstitial pneumonia or other autoimmune diseases.
* Sever infection.
* Sever heart disease.
* HIV infection.
* Allogeneic organ transplantation
* Malignancy other than nasopharyngeal carcinoma.
* Pregnancy or breast feeding.
* Received other test drugs.
Automatic Urine Output Measuring Device Performance Validation and Efficacy.

To evaluate the efficacy of Serenno Medical Automatic Urine Output measuring device in patients with indwelling urinary catheter hospitalized in the cardiac surgery intensive care unit.

In order to evaluate the efficacy of Serenno Medical Automatic Urine Output measuring device we will perform a non inferiority of study device in compare with Urinometer (with acceptance of 3% standard deviation), in patients hospitalized in the intensive care unit after cardiac surgery.

Secondary endpoints are to attribute and Identify urine output changes prior to early stage acute renal failure, and identifying urine output changes prior to fluid overload or dehydration.

Eligibility Criteria:
Inclusion Criteria:

* Subjects, aged \>18 years
* Patients hospitalized in the intensive care unit requiring an indwelling urinary catheter for urine output monitoring for at least 24 hours.

Exclusion Criteria:

* Known urological pathology including but not limited to nephrolithiasis, polycystic kidney disease, congenital abnormalities of the kidneys and or urinary tract, history of obstructive uropathy, advanced chronic kidney disease (stage 4) of any cause.
* Known pregnancy or lactating women.
* Cognitive and/or psychiatric impairment which may not allow cognitive signing on the informed consent unless patient has a legal representative that was appointed prior to patient enrollment.
Augmented Posterior Oblique Sling Activation on Lumbopelvic Recruitment Pattern in Lumbosacral Radiculopathy

The current study aims to determine the impact of augmented posterior oblique sling activation on lumbopelvic recruitment pattern and functional outcomes in patients with unilateral lumbosacral radiculopathy.

Low back pain is now the leading cause of disability worldwide. Back pain and its related disability have a huge impact on individuals, communities, and healthcare systems. It reduces an individual's ability to participate in work which in turn negatively affects their quality of life. Also, it has major economic consequences through increasing the cost of health care and work absenteeism. Among the many differentials of low back pain, the most common cause is lumbosacral radiculopathy. Patients with low back pain showed uncontrolled lumbopelvic mobility while performing hip extension movement in functional activities. In patients with back pain, there is over-activation of the hamstrings and erector spinae and delayed or absent contraction of the gluteus maximus. Clinically, this pattern is observed as an anterior pelvic tilt with increased extension in the lumbar spine as the patient lifts the leg into extension. So, repetition of this abnormal pattern in patients with lumbosacral radiculopathy may result in mechanical and compressive stresses in the lumbar spine and magnify the patient's symptoms. Despite the role of POSM in improving spinal mobility and stability. And stabilizing the lumbopelvic joint, there are no previous studies investigating the impact of activation posterior oblique activation on this abnormal lumbopelvic recruitment and functional outcomes in patients with lumbosacral radiculopathy.

Eligibility Criteria:
Inclusion Criteria:

* Age ranges from 25 to 40
* L4/5 and L5/S1 disc herniation.
* Duration of pain will be more than three months.
* Normal body mass index (18.5 - 24.99Kg/m2)

Exclusion Criteria:

* 1. Red flags: spinal tumors, cauda equina syndrome, spinal fractures, osteoporosis, infection.

  2. Bilateral symptoms. 3. Spondylolisthesis, spondylitis, and spinal canal stenosis. 4. Previous lumbopelvic or hip surgery or injection 5. Any hip structural abnormality such as malformations, impingements and degeneration.

  6. Postural deviations such as scoliosis, kyphosis, lateral shift. 7. True leg length discrepancy. 8. Pregnancy and Gynecological problems.
Translation, Cross-cultural Adaptation and Validation of the MGQOL-15-F

The purpose of this study is to translate and culturally adapt the MGQOL-15 (health-related quality of life scale for myasthenia gravis) for use with French-speaking patients in France and to evaluate its psychometric properties to ensure reliability and validity.

It is a translation and validation of a quality of life scale.

Step 1: Translation and cultural adaptation (Forward and back translation, committee review, pre-testing with 10 patients for content and face validity).

Step 2 : Psychometric testing : Test-retest with a 2 day interval, correlation with clinical scores - the Myasthenic Muscle Score and the (MG-ADL) score and with a global quality of life score (WHOQOL-BREF).

Eligibility Criteria:
Inclusion Criteria:

* Auto-immune myasthenia gravis
* Age ≥ 18 years old
* Clinical Classification (MGFA) I-IV
* French speaking

Exclusion Criteria:

* cognitive or visual impairment which would limit the capacity to fill out the MGQOL-15-F
An Open Label Extension Study of STX209 in Subjects With Autism Spectrum Disorders

Study 22003, "An Open-Label, Flexible-Dose Evaluation of the Safety and Tolerability of STX209 for Treatment of Irritability in Subjects With Autism Spectrum Disorders(ASD)" currently is evaluating the efficacy of STX209 (R-baclofen) for management of typical problem behaviors, such as irritability and aggression, in subjects with ASD. This study (22007) will enter subjects who complete Study 22003 into a long-term, open-label study.The open-label extension protocol will provide necessary data on the long-term safety and tolerability of STX209 among subjects with ASD who receive treatment under conditions more closely reflective of their general medical care.


Eligibility Criteria:
Inclusion Criteria:

* Have completed all scheduled visits in protocol 22003 and have shown they can adequately follow the protocol, with sufficient medical justification to continue on open-label treatment with STX209, as assessed by the principal investigator

Exclusion Criteria:

* Subjects with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.
* The occurrence or continuation of any adverse event or condition during study 22003 that, in the opinion of the Investigator, should exclude the subject from participating in this open-label extension
Sirolimus Monotherapy in the Treatment of Antiphospholipid Antibody Related Thrombocytopenia

The goal of this clinical trial is to learn the efficacy and safety of sirolimus in the treatment of anti-phospholipid antibody associated thrombocytopenia. The patients would be followed at 2 weeks, 1 month, 3 months, and 6 months after the enrollment. The main questions it aims to answer are the differences between sirolimus and control group at below outcomes:

Primary outcome: the overall response rate at 6 months Secondary outcome: the complete response rate at 6 months the partial response rate at 6 months the change of anti-phospholipid antibody titers Participants will receive either sirolimus 1mg per day or placebo.

Complete response: the platelet count is more that 100×10\^9/L Partial response: If the platelet count is less than 100×10\^9/L, it should be more than 2 times of the baseline count Overall response: both complete and partial response

Eligibility Criteria:
Inclusion Criteria:

* persistent positive of antiphospholipid antibody (either lupus anticoagulant, anti-cardiolipin antibody, or anti-b2GP1 antibody, at least two times with 12 weeks apart)
* persistent thrombocytopenia (30-100×10\^9/L, at least for 2 weeks)
* prednisone or equivalent dose less than 10mg per day, and dose stable for more than 2 weeks
* hydroxychloroquine less than 400mg per day, and dose stable for more than 1 month
* strength of anti-platelet and/or anti-coagulant therapy is stable for 1 week

Exclusion Criteria:

* fulling the criteria of other connective tissue disease other than antiphospholipid syndrome
* received thrombopoietin or thrombopoietin receptor antagonist within 2 weeks before the enrollment; intravenous immunoglobulin within 1 month before the enrollment; immunosuppressants within 3 months before the enrollment; B cell inhibitors (Belimumab or Talitacicept) within 3 months before the enrollment; B cell depletion therapy (Rituximab) within 6 months before the enrollment.
* received oral/intravenous antibiotics within 2 weeks before the enrollment.
* new onset of thrombosis within 4 weeks before the enrollment.
* apparent bleeding tendency.
* life or organ threatening manifestations, includes but not limit to catastrophic antiphospholipid syndrome and thrombotic microangiopathy.
* liver and renal dysfunction: ALT or AST more than three times of upper limit of normal range; eGFR\<40mL/min/1.73m\^2
* hematocytopenia: WBC\<3.0×10\^9/L, Hb\<100g/L.
* uncontrollable hyperlipidemia: low density lipoprotein cholesterol\>3.1 mmol/L, triglycerides\>2.3 mmol/L after lipid lowering therapy.
* current active infection
* women in pregnancy and postpartum period
Early Commencement of Adjuvant Chemotherapy for Colon Cancer

This study sets up the final study end point and three detailed goals as the following.

The main objective of study: This trial is done to assess the safety and benefit of early adjuvant chemotherapy from 10 to 14 days after surgery compared with conventional commencement after 2weeks for treatment of patients with colon cancer.

Detailed goal of study:

The primary endpoint: This study is designed to assess whether early commencement of adjuvant chemotherapy improves the 3-year disease-free survival, overall survival and recurrence rate.

The secondary endpoint: This study aims to compare short-term cumulative complications between early and conventional commencement of adjuvant chemotherapy after laparoscopic resection of colon cancer. This study will also assess the quality of life and side effects of chemotherapy.

Chemotherapy regimen: FOLFOX-6, every 2weeks, total 12 cycles treatment

* day1: Oxaliplatin 85mg/m2
* day1: Leucovorin 200mg/m2
* day1: 5-FU 400mg/m2 IV bolus

  * 2,400mg/m2 over 46 hours

Eligibility Criteria:
Inclusion Criteria:

* Eligibility rule of enrollment
* Rectal adenocarcinoma that were 15 cm or more from the anal verge
* pathologically diagnosed stage II or III disease
* patients who meet the discharge criteria within 10days after surgery
* Patients with adequate hepatic, renal, and bone marrow function, and a left ventricular ejection fraction of 55% or higher measured by echocardiography

Exclusion Criteria:

* An ineligibility to participate in the clinical study based on the judgment of investigators from a legal perspective
* A past history of chemotherapy
* tumor with obstruction or perforation
* tumor with distant metastases
* synchronous tumor
* relative or absolute contraindications of chemotherapy
* Recent MI, CVA, nitrate medication
* Severe cardiovascular disease, psychiatric disease
* Severe hepatic dysfunction (GOT, GPT ≥100IU/L)
* Renal dysfunction (Cr ≥2mg/dl)
* The concurrent presence of other severe medical diseases
Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST)

This study is a pilot, randomized trial that will examine whether the Nintendo Wii virtual gaming system is safe and feasible for use in patients who have had a recent stroke.

A pilot, randomized (1:1) controlled trial to compare the safety and feasibility of Nintendo Wii gaming versus other recreational therapy activities (playing cards) in post-stroke patients. All patients will continue to receive all other standard medical and physiotherapy treatments while in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patient has provided written informed consent prior to entry into the study
* In-patient at one of the two study institutions at the time of randomization
* Males or females, aged over 18 and younger than 85
* Evidence of stroke confirmed by CT head (ischemic or hemorrhagic)
* Time: Onset of symptoms within 6 months prior to randomization
* Measurable Chedoke-McMaster scale stage of =\>4 on the "arm" item (10)
* Functional independence prior to present stroke (baseline mRS = 0-1)
* Patient is alert, medically stable according to the treating physician and able to follow simple verbal commands

Exclusion Criteria:

* Acute stroke onset more than 6 months ago
* Patient is unable to follow verbal commands or has global aphasia
* Severe illness with life expectancy less than 3 months (cancer, endocarditis, metastasis with an occult primary malignancy, coagulopathy).
* Uncontrolled hypertension according to the treating physician
* Unstable angina or recent myocardial infarction (within the last 3 months), current NY Heart Association Class III (marked limitation of physical activity; although patients are comfortable at rest, less-than-ordinary activity leads to fatigue, dyspnea, palpitations, or angina3) or IV (symptomatic at rest; symptoms of CHF are present at rest; discomfort increases with any physical activity) or symptomatic ventricular tachyarrhythmias, as per medical history (a baseline ECG will not be required.)
* Any history of seizure, except for febrile seizures of childhood
* Participation in another clinical trial involving rehabilitation (recreational therapy, occupational therapy, physiotherapy) or involving an investigational drug.
* Patient is unwilling or unable to comply with the protocol or can not/will not cooperate fully with the investigator or study personnel.
* Any condition(s) that, in the Investigator's opinion, would a) warrant exclusion from the study (i.e., participation in the study is not in the best interest of the patient) or b) prevent the patient from completing the study.
* Any medical condition that might confound the interpretation of results or put the patient at risk (amputation of one extremity).
Neuromuscular Electrical Stimulation: A Novel Treatment for Improving Metabolism

Once written consent is obtained, the participant will be provided with an accelerometer to be worn for 7 days to assess current physical activity levels. Subjects will be provided with a standardized diet (55/15/30% CHO/PRO/FAT) prior to collection of pre-intervention data of insulin sensitivity. Individuals will then participate in an 8-week electrical stimulation intervention (30min/day, 3x/week) and randomized into placebo/control, NMES, resistance training combined with NMES (RT +NMES), or resistance training (RT) group (n=20 per group), followed by collection of post-intervention data. The control group will receive electrical stimulation up to sensory level, the NMES group will receive stimulation up to tolerable intensity to induce visible muscle contraction, the RT+ NMES will receive stimulation up to tolerable intensity during resistance training, and the RT group will only receive exercise training. Control and NMES group will self administer stimulation at home. Pre-and post-intervention data includes measurements for body composition, resting metabolic rate, VO2max, insulin sensitivity, and comprehensive blood work.


Eligibility Criteria:
Inclusion Criteria:

* Overweight/Obese (BMI ≥25)
* Sedentary Lifestyle: Physical Activity Level\&lt;1.4
* Less than 150min/week of structured Exercise

Exclusion Criteria:

* Use of anti-hypertensive, lipid-lowering or insulin sensitizing medications
* Excessive alcohol, drug abuse, smoking
* Pregnant Women
* Unwilling to adhere to the study Intervention