cyrilzakka/clinical-trials huggingface dataset:
Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological Effects

Lennox-Gastaut syndrome is a severe epileptic encephalopathy of childhood. In that syndrome, various type of seizure occur, mainly tonic seizures, atonic seizures and atypical absences. The tonic seizure occur mostly at night.

The hypothesis is that the melatonin could have a positive effect in that syndrome, by reducing the epileptic activity (assessed in the polysomnographic record by counting the number of interictal and ictal discharges) and stabilizing the structure of sleep.

The study is double blind, randomised, cross-over designed.

The aim of the trial is to study the efficacity of melatonin in the Lennox-Gastaut syndrome, by assessing the reduction of the seizure/interictal discharges in polysomnography and assessing the sleep structure.

After initial recruitment, the baseline visit includes a polysomnography. The patients will then be randomised in two groups: melatonin (1 cp containing melatonin 2 mg 1x/d 1h before sleep) vs placebo (1 cp 1x/d 1h before sleep). The treatment (melatonin or placebo) will be given for 1 month.

After 1 month, the treatment will be stopped and another polysomnography will be recorded.

The patients will take no treatment (wash-out period) for 15 days. The second treatment phase is cross-over: the group that had melatonin in the first phase will take placebo for one month, and the group that had placebo in the first treatment phase will take melatonin for one month. A last polysomnography will be recorded after the second treatment phase.

The other medications (antiepileptic drugs) taken by the patients before the trial will not be modified.

Eligibility Criteria:
Inclusion Criteria:

* Lennox-Gastaut syndrome (based on ILAE classification, 1989)
* light mental retardation (QI 50-69)
* french mother tongue
* having someone helping the patient (parent and/or referent educator)
* informed consent have been given by the patient / guardian
* absence of concomitant evolutive affection or associated sleep pathologies
* collaboration of the patient, ability to complete all aspects of the trial.

Exclusion Criteria:

* epileptic syndrome other than Lennox-Gastaut, other neurologic and/or psychiatric disease
* moderate to severe mental retardation (QI \< 50)
* psychiatric disease that could interfere with the diagnostic procedure
* specific sleep disorder (anamnestic and diagnosed on the polygraphic record), for example: sleep apnea syndrome, narcolepsy, restless legs syndrome, periodic legs movements, etc...
Movement Disorders in Multiple Sclerosis Patients

The aim of this study is to determine the prevalence of movement disorders in MS patients.

Also,To know the clinical type of movement disorders occurring with multiple sclerosis patients and the MRI finding of those patients. Moreover, to find the correlation between the movement disorder and the different types of MS.

A randomized cross-sectional study will be conducted on diagnosed multiple sclerosis patients who were diagnosed according to McDonald criteria of MS 2017 (Thompson et al. 2018).

The investigators will study the prevalence of movement disorders in M.S patients, clinical type of movement disorder and the MRI findings. Data collected from patients admitted or following at Al-Azhar university hospitals at Al-Hussein and El-Sayed Galal hospitals. The included eligible patients should fulfil the following inclusion criteria:

i. Full clinical history and neurological assessment. ii. Detailed multiple sclerosis history according to MS unit history sheet. iii. Detailed history of movement disorder which include clinical type of movement disorder and medication taken (or not).

iv. MRI Brain and spine of the included patient will be photographed.

Exclusion criteria:

1. Patients with multiple sclerosis mimics which can cause movement disorders e.g., systemic disease or overlap syndromes including systemic lupus, vasculitis, hepatic failure, renal failure, hyperthyroidism, electrolyte disturbances, Behcet's disease or CNS infection.
2. patients with primary movement disorders or related to other neurodegenerative diseases.

Eligibility Criteria:
Inclusion Criteria:

- We will study the prevalence of movement disorders in M.S patients, clinical type of movement disorder and the MRI findings. Data collected from patients admitted or following at Al-Azhar university hospitals at Al-Hussein and El-Sayed Galal hospitals. The included eligible patients should fulfil the following inclusion criteria: i. Full clinical history and neurological assessment. ii. Detailed multiple sclerosis history according to MS unit history sheet. iii. Detailed history of movement disorder which include clinical type of movement disorder and medication taken (or not).

iv. MRI Brain and spine of the included patient will be photographed.

Exclusion Criteria:

- 1-Patients with multiple sclerosis mimics which can cause movement disorders e.g., systemic disease or overlap syndromes including systemic lupus, vasculitis, hepatic failure, renal failure, hyperthyroidism, electrolyte disturbances, Behcet's disease or CNS infection.

2-patients with primary movement disorders or related to other neurodegenerative diseases.
Prospective Stuy in Evaluating Hepatic Fibrosis Related to Hepatitis B Virus Using Non-invasive Parameters

The aim of our prospective study is to construct and validate a non-invasive model consisting biochemical markers, FibroScan, and radiological parameters for evaluating liver fibrosis caused by hepatitis B virus in mainland China.

Up to Oct, 2015,total of 1800 patients with chronic HBV infection were enrolled. Paired blood and liver biopsy samples were collected. Blood samples stored at -80 degree Celsius. Liver biopsy samples were judged by three pathology experts.

Eligibility Criteria:
Inclusion Criteria:

1. HBsAg positive for at least 6 months
2. agree to have liver biopsy
3. Male or female aged 18 to 65 years old

Exclusion Criteria:

1. Patients with alcoholic liver disease, autoimmune liver disease, heretic liver disease, drug induced liver disease,nonalcoholic liver disease or other chronic liver disease
2. platelet count \< 80000/L
3. prothrombin activity ≤ 60%
4. patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
The Anatomical Localization of the Inferior Mesenteric Artery in Relation to the Left Colonic Artery

1. To observe and measure the distance between the origin of LCA (left colonic artery，LCA) and IMA (inferior mesenteric artery，IMA) root and the distance between IMA and IMV (inferior mesenteric vein，IMV) at the origin of LCA in rectal cancer patients. Statistical analysis of intraoperative measured data, on the basis of the original anatomical relationship, to achieve anatomical localization of quantitative and accurate, for the preservation of LCA laparoscopic radical resection of rectal cancer to provide a strong anatomical basis.
2. The operation time, 253 lymph node dissection time, intraoperative blood loss, postoperative anal exhaust time, postoperative feeding time, postoperative hospital stay, postoperative ischemic colitis rate and postoperative anastomotic leakage rate of patients with laparoscopic radical resection of rectal cancer with preservation of LCA were recorded. The surgical efficacy and clinical significance of laparoscopic radical resection of rectal cancer with preservation of LCA were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of rectal cancer (T2-4a, N- / +, M0) ; Laparoscopic radical resection of rectal cancer and preservation of LCA Patients and their families agree to participate in the clinical study

Exclusion Criteria:

* Those who had a history of lower abdominal surgery and could not undergo laparoscopic surgery LCA vascular absence was found during operation combined with other malignant tumors pregnant or lactating patients Combined with severe mental illness Severe diseases of the blood system, coagulation dysfunction ; Preoperative assessment of heart, lung and brain function, unable to tolerate surgery.
Metabolic Effects of Subchronic Dopamine D2 Receptor Blockade by Haloperidol in Healthy Humans

We hypothesized that short-term treatment with haloperidol induces insulin resistance through a mechanistic route that is independent of weight gain. We therefore treated healthy non-obese men with haloperidol for 8 days, and studied the impact of these intervention on glucose and lipid metabolism by hyperinsulinemic euglycemic clamp, isotope dilution technology and indirect calorimetry.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men
* 20 kg/m2 \< BMI \< 26 kg/m2
* Age 20-40 years
* FPG \< 6 mmol/L

Exclusion Criteria:

* FPG \> 6 mmol/L
* BMI \> 26 kg/m2
* Psychiatric disorders and/or use of antipsychotic or antidepressants drugs at present or in the past.
* A positive family history of schizophrenia
* Any significant chronic disease
* Renal, hepatic or endocrine disease
* Use of medication known to influence lipolysis and/or glucose metabolism
* Total cholesterol \> 7mmol/L and/or triglycerides \> 2 mmol/L
* Recent weight changes or attempts to loose weight (\> 3 kg weight gain or loss, within the last 3 months)
* Difficulties to insert an intravenous catheter
* Smoking (current)
* Severe claustrophobia (ventilated hood)
* Recent blood donation (within the last 2 months)
* Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year
* Extensive sporting activities (more than 10 hours of exercise per week)
Evaluating the Effect of Laser Vision Surgery, Phakic Intraocular Lens Implantation, Cataract Surgery, and Pupil Dilation on the Iris Recognition Scanner Function of Smartphone

This study included patients who visit for refractive surgery (photorefractive keratectomy, photorefractive keratectomy with with corneal collagen cross linking, laser in situ keratomileusis, small incision lenticule extraction), phakic Intraocular Lens implantation (Implantable Collamer Lens, artiflex), and cataract surgery. Patients will be examined whether iris recognition scanner of smartphone works before and after surgery. In addition, before and after pupil dilation (5mm, 6mm, 7mm, 8mm), patients will be examined whether iris recognition scanner of smartphone works well.


Eligibility Criteria:
Inclusion Criteria:

* Patients who visit for refractive surgery (photorefractive keratectomy, photorefractive keratectomy with with corneal collagen cross linking, laser in situ keratomileusis, small incision lenticule extraction)
* phakic Intraocular Lens implantation (Implantable Collamer Lens, artiflex)
* cataract surgery.
* age of 20\~90

Exclusion Criteria:

* history of previous ocular or intraocular surgery
* glaucoma or ocular hypertension, ocular infection, non-dry eye ocular inflammation, ocular allergy, autoimmune disease
* history of iris damage during ocular surgery or previous trauma
* wearing contact lenses during the study period
* presence of current punctal occlusion
* pregnancy, lactating women, and children
Evaluating a Web-Based Ventilator Management Educational Program for Clinicians (The Lung Injury Knowledge Network [LINK] Study)

Acute lung injury/acute respiratory distress syndrome (ALI/ARDS) is a severe lung condition that causes respiratory failure. Individuals with ALI/ARDS often require the use of a respirator or artificial breathing machine, known as a mechanical ventilator, while in an intensive care unit (ICU). Research has shown that lung protective ventilation (LPV), a type of mechanical ventilation technique, is an effective way to reduce the number of deaths due to ALI/ARDS. This study will evaluate the effectiveness of a Web-based educational program that aims to educate ICU clinicians about the use of LPV in patients with ALI/ARDS.

ALI/ARDS is a life-threatening condition that involves inflammation of the lungs and fluid accumulation in the air sacs, leading to low blood oxygen levels and respiratory failure. Common causes include pneumonia, septic shock, and lung trauma, and most patients require immediate care in an ICU. The main form of treatment for ALI/ARDS is the delivery of oxygen and a continuous level of pressure to the damaged lungs through mechanical ventilation. Each year, 74,500 people die due to ALI/ARDS and 22% of these deaths could be prevented with the use of LPV. LPV is a mechanical ventilation technique in which lower volumes of oxygen are administered. The purpose of this study is to implement and evaluate a Web-based educational program that will provide educational and instructional resources about ALI/ARDS and LPV to ICU clinicians, including physicians, nurses, and respiratory therapists.

Hospitals participating in this study will be randomly assigned to access the Web site at either the beginning of the study period or a later time. Participating clinicians at each hospital will access the Web site as often as necessary for a 6-month period. The Web site will contain background and educational information on ALI/ARDS and LPV, including how to recognize ALI/ARDS and how to implement LPV in patients. Scholarly articles and other materials, including a chart to help clinicians determine appropriate ventilator settings for each patient, will be available to download. Clinicians will also be able to email questions to critical care experts. At the end of the 6-month study period, study staff will compare the number of patients receiving LPV to the number of patients who received LPV prior to the start of the study.

Eligibility Criteria:
Inclusion Criteria for Hospitals:

* Between 10 and 20 ICU beds with 5 to 10 ALI/ARDS patients cared for each month
* Provide critical care services
* Keep electronic medical records on ICU patients
* ICU staff must have access to computers with Intranet or Internet

Inclusion Criteria for Clinicians:

* Provide care for mechanically ventilated patients in ICUs
* Willing to participate by viewing Web site

Exclusion Criteria for Hospitals:

* Cardiac, cardiothoracic, neurosurgical, neonatal, or pediatric ICUs
* Residents and fellows must provide care to majority of critically ill patients
* Fewer than 5 to 10 ALI/ARDS patients cared for each month
Resection of Pulmonary Metastasis in Clear Cell Renal Cell Carcinoma +/-Adjuvant Sunitinib Therapy (SMAT)

The aim ist to identify biomarkers in the blood, to indicate early response or early treatment resistance.

Prospective randomized multi-center Phase II trial for resection of metastases from pulmonary metastases (poor prognosis) in clear cell renal cell carcinoma + / - adjuvant sunitinib therapy over one year

Eligibility Criteria:
Inclusion Criteria:

* \>/= 2 synchronous or within 24 Months after Nephrectomy occured pulmonary metastases. Patients in whom more back than 2 years of a solitary lung metastasis, bone metastasis or brain metastasis was resected, may also be included in the study.
* Aged 18 to 75 years
* functionally acceptable surgical risk
* Women in conceptional age: negative pregnancy test and adequate contraception
* Adequate hematologic, renal, hepatic and coagulation-physiological functions
* Amylase/ Lipase \< 1,5 x upper limit of normal
* Informing the patient about the study and the present written consent to participate after clarification in accordance with the stipulations of AMG(german drug law), and the principles of GCP ("informed consent")
* Patient compliance and geographic proximity to allow adequate follow-up

Exclusion Criteria:

* Presence of other metastases outside the lung
* progress in the 12-week sunitinib therapy before resection of metastases
* R1 or R2-finding in resection of metastases
* Dialysis after nephrectomy
* Previous or existing serious cardiovascular (grade III - IV according to NYHA(New York Heart Association)) disease, active angina pectoris or ischemia, myocardial infarction within previous 6 months , uncontrolled hypertension(RR diastolic 120 mmHg(Millimeters of mercury))
* serious hematopoetic (e.g. serious Bone marrow aplasia), pulmonary, hepatic or renal Disease
* Stroke within the previous six months
* Patients with poorly controlled diabetes mellitus
* Serious bacterial or fungal infections
* chronic hepatitis B or C, HIV(human immunodeficiency virus) infection
* autoimmune disease
* prior organ transplantation
* prior autologous bone marrow transplant or stem cell transferred within the last 4 months before study
* Neuropsychiatric diseases that affect patient compliance
* Manifesto, second malignancy or other malignancy within the past 5 years (except basal cell carcinoma, carcinoma in situ of the cervix, incidental prostate carcinoma, superficial urothelial Ca pTaG1-2 and pT1G1)
* Therapy with immunotherapeutic agents including monoclonal antibodies, cytotoxic drugs or hormones (other than bisphosphonates and oral contraceptives) within the last 4 weeks prior to enrollment. Previous use of inhibitors of Ras/Raf-, MEK kinase, AKT kinase and mTOR inhibitors or induction of Farnesyltransferase
* Previous use of angiogenesis inhibitors such as VEGF / VEGFR, PDGF / PDGFR and other key molecules of angiogenesis
* parallel treatment with rifampicin
* Participation in other treatment studies in the last 4 weeks
Impact of Training Status on Bioavailability of Flavanones

Flavonoids are compounds that have been proven to have a beneficial effect on health, such as reducing the risk of developing cardiovascular disease and, in some cases, cancer. Citrus juices have a high flavonoid content. However, the absorption of flavonoids into the body is limited. This study will investigate whether being physically active improves the absorption of flavonoids.

Endurance trained athletes will be invited to participate. Following screening procedures (a. Health Screening Questionnaire; b. height and weight measurement for calculation of Body Mass Index; c. maximal oxygen consumption (VO2max) uptake test, eligible participants will undertake two experimental tests; one during a period of normal training, the other immediately following 1 week of detraining.

In the morning of the experimental trial participants will consume 500 mL of orange juice. Blood samples and urinary fractions will be collected prior (base line) to and for 24 hours after orange juice consumption. Participants will be asked to follow a special polyphenol-free diet and record weighed dietary intake for 2 days preceding each trial and during the day of the experimental trial.

The study aims to:

1. Determine the effects of training status of endurance athletes on bioavailability of flavanones in endurance trained individuals
2. Determine whether changes in bioavailability of flavanones are related to changes in biomarkers of inflammation, oxidative stress, plasma lipids and insulin sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* trained regularly for at least 4 years and typically perform at least 5 hours of endurance training per week (distance runners, triathletes, cyclists)
* healthy
* normotensive
* non-smokers
* not taking any drug therapies
* VO2 max \>50 ml/kg body mass

Exclusion Criteria:

* history of gastrointestinal disease
* vegetarian
* unstable food habits
* VO2 max \< 50 ml/kg body mass
More Fresh Fruit and Vegetable Prescription Program for Families with Type 2 Diabetes Mellitus

Rady Children's Hospital San Diego (RCHSD), UCSD Division of Child and Community Health and the Center for Community Health, and Northgate Gonzalez (NG) Markets will collaborate to create a Produce Prescription Program (Fruit and Vegetable Prescription Program) to be implemented in the RCHSD Diabetes Clinic. We will provide families on Medi-Cal who have a child with T2DM with a fruit and vegetable prescription (FVRx) which will enhance their ability to purchase GusNIP-eligible fresh fruits and vegetables (FV). These prescriptions will be delivered in the form of an electronic voucher that can be filled at any NG Markets throughout San Diego and Riverside counties. The goal of this program is to increase the purchase and consumption of fresh fruits and vegetables, decrease food insecurity, and improve metabolic outcomes for children with type 2 diabetes mellitus (T2DM).

Participants upon enrollment will be randomized into two groups, either to immediately receive nutrition incentive vouchers for 12 months (intervention group) or to receive nutrition incentive vouchers for 12 months after a 6-month delay (delayed-intervention group). To evaluate the implementation and outcomes of this program, we will collect fruit and vegetable prescription (FVRx) voucher data in addition to standardized laboratory studies, (hemoglobin A1c (HbA1c), total cholesterol, HDL cholesterol and liver function tests (LFTs)) and physiologic assessments (height, weight) at the child's follow-up appointments through the Diabetes Clinic. These markers will be evaluated at baseline, 6-, 12- and 18-months. Additionally, we will ask participants to complete online or phone surveys including the Dietary Screener Questionnaire (DSQ) for youth and parents and the 18-item US Household Food Security Survey Module every 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Age \< 18 years old
* Diagnosis of type 2 diabetes mellitus
* Hemoglobin A1c greater than or equal to 6.5
* Receiving care at the Rady Children's Hospital Diabetes Clinic

Exclusion Criteria:

* Another immediate family member living in the same household who is already recruited into the study