cyrilzakka/clinical-trials huggingface dataset:
Effect of EPA-DHA Supplement, Life Style Modification Standard Treatment on Clinical Outcome Lipid Membrane Composition in Type 2 Diabetes

The aim of the present study is: to examine some of the mechanisms by which a change in life style alone or supplemented with a diet supplemented in n-3 PUFA, and associated with this computerized life style regulation reduces the development of diabetic complication in a small population based study.

(The NewMe™ / Eco-fusion, Ltd is a science-driven lifestyle change program for better living -www.eco-fusion.com)


Eligibility Criteria:
Inclusion Criteria:

1. Participants between 18-80 years of age.
2. Have been diagnosed with type 2 diabetes more than nine months before study entry, and, despite having been given standard dietary advice by dietitian, doctor, or nurse and prescribed oral hypoglycaemic agents, insulin, or both.
3. Have persistent unsatisfactory glycaemic control defined as HbA1c more than 7%.
4. Participants should have at least two of the following three characteristics:

   1. Overweight or obesity (body mass index ≥25),
   2. Hypertension (currently prescribed antihypertensive drugs or blood pressure \>140/90 mm Hg despite optimized antihypertensive drug treatment),
   3. Dyslipidaemia (currently prescribed lipid modifying drugs) or one or more of:

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   1. total cholesterol \>5.2 mmol/l,
   2. low density lipoprotein cholesterol \>3.5 mmol/l,
   3. triglycerides \>2.0 mmol/l,
   4. high density lipoprotein cholesterol \<1.0 mmol/l (despite optimised lipid modifying drug treatment).

Exclusion Criteria:

1. Pregnancy
2. Serious chronic illness.e.g cancer
3. End stage renal failure
4. Amputation
5. Stroke
6. Severe retinal microangiopathy
7. Pancreas transplantation
8. HbA1c \<7%
9. Requires diet only treatment
10. They are too busy with work
A 6-Week Multicenter Trial Of Varenicline Tartrate For Cognitive Impairment In Subjects With Schizophrenia

The primary objective of this protocol is to assess the efficacy of two dose strengths of varenicline (0.5 mg BID and 1mg BID) as adjunctive treatment for cognitive impairment in symptomatically stable outpatient schizophrenic subjects who are receiving treatment with atypical antipsychotic medications.

A secondary objective is to evaluate the safety and tolerability of two doses of varenicline in symptomatically stable schizophrenic subjects who are receiving treatment with atypical antipsychotic medications.


Eligibility Criteria:
Inclusion Criteria:

* Have a current diagnosis of schizophrenia
* Subjects must be on ongoing maintenance antipsychotic monotherapy or combination therapy with risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, or paliperidone.
* Evidence of stable symptomatology ≥3 months (eg, no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of symptoms of schizophrenia).

Exclusion Criteria:

* Subjects with a current DSM-IV axis I diagnosis other than schizophrenia.
* Current treatment with conventional antipsychotics (e.g. fluphenazine, haloperidol) or clozapine, or the use of adjunctive anticholinergic treatment.
Study of the Safety, Tolerability and Analgesic Efficacy of Multiple Doses of Ketorolac Tromethamine (IN) for Postoperative Pain

This was a randomized, double blind, placebo-controlled study in subjects who have undergone major surgery. Each subject's study participation consisted of a screening visit, a 2-day treatment period, and a follow-up visit. Following surgery, subjects were randomly assigned to receive intranasally (IN) ketorolac 10 mg, IN ketorolac 30 mg, or placebo when the pain intensity (PI) rating equaled at least 40 on a 100-mm visual analog scale (VAS). Thereafter, subjects received study drug every 8 hours, with the last dose given at 40 hours. For pain not relieved by the study drug, the subjects had access to morphine sulfate (MS) administered via patient controlled analgesia (PCA).

The primary objective was to evaluate the analgesic efficacy of multiple intranasal (IN) doses of ketorolac over 2 days. The secondary objective was to evaluate the safety and tolerability of this dosing regimen.


Eligibility Criteria:
Inclusion Criteria:

* Men or women, age 18 years or older
* Body weight \> or = 100 pounds (45.4 kg) and \< or = 300 pounds (136.1 kg)
* Women of childbearing potential must have had a negative serum pregnancy test result prior to entry into the study
* Able to provide written informed consent
* At least moderate pain as determined by a PI score of \> or = 40 mm on a 100-mm VAS
* Expected to remain in the hospital for at least 48 hours
* Willing and able to comply with all testing and requirements defined in the protocol
* Willing and able to complete the posttreatment visit

Exclusion Criteria:

* Allergy or sensitivity to ketorolac or ethylene diamine tetraacetic acid (EDTA)
* Allergic reaction to aspirin or other nonsteroidal anti-inflammatory drug (NSAIDs)
* Current upper respiratory tract infection or other respiratory tract condition that could interfere with the absorption of the nasal spray or with the assessment of adverse events
* Use of any IN product within 24 hours prior to study entry
* Clinically significant abnormality on screening laboratory tests
* History of cocaine use resulting in nasal mucosal damage
* Active peptic ulcer disease, recent (defined as within 6 months) gastrointestinal bleeding or perforation, or a history of peptic ulcer disease or gastrointestinal bleeding
* Advanced renal impairment or a risk for renal failure due to volume depletion
* A history of any other clinically significant medical problem, which in the opinion of the investigator would interfere with study participation
* Participation within 30 days of study entry or within 5 times the half-life, whichever is longer, in another investigational drug study
* Allergy or significant reaction to opioids
* Pregnancy or breastfeeding
* Previous participation in this study
Effects of a Fasting Mimicking Diet on Sperm Quality

This study investigates the effect of repetitive cycles of a Fasting Mimicking Diet (3x5 days in six months) on sperm quality in men

This 2-arm, randomized, controlled exploratory clinical trial aims to explore fasting as a novel supportive treatment in male infertility due to reduced sperm quality according to WHO5-criteria. The participants will be randomized in two groups. The intervention group follows a regime of a periodic fasting mimicking diet (3x5 days in six months, every 6-8 weeks, accompanied via a mobile application), whereas the patients on the waiting list continue their normal diet. Spermiograms are taken about every 2 months following the WHO-5 criteria. In addition, qualitative interviews will be conducted including individual and focus group interviews with a subgroup of participants.

Eligibility Criteria:
Inclusion Criteria:

* Men aged between 18 and 60 years
* Unfulfilled desire to have a child \> 1 year
* reduced sperm quality (proven via spermiogram according tho WHO-5 criteria)
* informed consent
* 20 kg/m² \<= BMI \<= 35 kg/m²

Exclusion Criteria:

* No sufficient communication possible
* severely impairing cognitive illness
* serious mental illness
* Patients with anatomical/organic damage of reproductive organs
* Eating disorders in the medical history
* Serious internal diseases
* Lack of internet access
* No consent to randomisation
* Participation in other studies
Magnetic Resonance Imaging (MRI) Study of the Hippocampus After Infarction in the Territory of the Middle Cerebral Artery

The purpose of this study is to observe delayed neuronal death of hippocampus after middle cerebral artery infarction in human beings.

40 patients with middle cerebral artery infarction and 40 healthy volunteers will be observed. All of them will receive MRI scan and the assessment of the neuropsychological function (MMSE, AVLT, HAMD) intending to observe delayed neuronal death of hippocampus after middle cerebral artery infarction in human beings.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of middle cerebral artery infarction
* At least six months from the stroke
* Must be able to measure his(her) neuropsychologic function (by MMSE, AVLT)

Exclusion Criteria:

* Unable to undergo examinations due to disturbances of consciousness or medical conditions
* Severe dementia, apraxia, disturbances of sensation or perception
* Serious complications including severe heart failure, hepatic dysfunction, renal insufficiency,or shock
* Parkinson's disease, malignant tumor, autoimmune diseases
Growth Hormone Treatment of Women With Turner Syndrome

Growth hormone treatment is used in girls with Turner syndrome to increase final height. The aim of this study is to evaluate the effect of growth hormone treatment on body composition and heart function in adult women with Turner syndrome. The hypothesis is that the fat mass will decrease and lean body mass will increase. There is only very limited documentation of the effect on the heart in this study population.

This study is a randomised, double-blinded, controlled clinical trial to evaluate the effect of growth hormone (GH) treatment on adult women with Turner syndrome. The endpoints will be changes in body composition and heart function evaluated by echocardiography (ECHO) and positron emission tomography (PET).

Phase one: 6 months of GH or placebo treatment. Phase two: "open label" all participants are treated with GH for 12 months. At baseline, healthy controls will be examined, but will not receive any treatment

Eligibility Criteria:
Inclusion Criteria:

* Turner syndrome
* Age 20-40

Exclusion Criteria:

* Symptomatic heart disease
* Anti hypertensive treatment
* Untreated thyroid disease
* Adipositas (BMI \> 35)
* Treatment with glucocorticoids
* Pregnancy
Prevalence of Heterozygote Mothers for Pompe's Disease Among Mothers Having Delivered in French Guiana

Given the high incidence of Pompe's Disease in French Guiana (100 times higher than in mainland France) the aim is to determine the prevalence of heterozygotes among women having just delivered in French Guiana who accepted that their newborn child enters the depipomp1 study. In these women the specific mutations p.Gly648Ser and p.Arg854X will be sought using PCR in order to calculate the prevalence of these mutations and estimate the risk factors associated with them in order to improve genetic counselling.


Eligibility Criteria:
Inclusion Criteria:

* women having delivered in French Guiana whose child was enroled in the depipomp1 study

Exclusion Criteria:

* refusal to participate
Using SMART Experimental Design to Personalize Treatment for Child Depression

The purpose of the study is:

1. To conduct a pilot SMART (Sequential, Multiple Assignment, Randomized) study with the long-term goal of developing a personalized treatment for child depression.
2. To collect pilot data on ways to personalize treatment for child depression using cognitive behavioral therapy (CBT), caregiver-child treatment, or both.

Child depression is among the most prevalent and impairing pediatric conditions and constitutes a major public health concern. Unfortunately, treatment benefits are relatively modest and short-lived with sizeable percentages of children who maintain depressive symptoms following treatment. This problem may be addressed in part by personalizing treatment, including determining which children will benefit from CBT, which children will benefit from caregiver-child treatment, and which children will benefit from both. The goal of the current study is to pilot test an innovative experimental design called Sequential, Multiple Assignment, Randomized Trial (SMART), which is used for development of personalized treatments, collect pilot data, and assess the acceptability and feasibility of using this design, in preparation for a full-scale SMART in a larger clinical trial and for the development of personalized treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Current diagnosis of Major Depressive Disorder (MDD), Dysthymic Disorder (DD), or Depressive Disorder Not Otherwise Specified (NOS).
2. If receiving psychiatric medication, dose should be stable for at least three months at enrollment.

Exclusion Criteria:

1. A disorder other than depression as primary diagnosis.
2. Autism Spectrum Disorders and Pervasive Developmental Delay or Disorder.
3. Mental Retardation.
4. Psychotic Disorders and Schizophrenia.
5. Mania or Hypomania disorders.
6. Acute suicidal behavior and/or acute plan that require higher level of care, and being hospitalized over the past year for a suicide attempt or for threatening to commit suicide.
7. Participation in additional psychotherapy.
8. Caregiver and/or children do not speak English.
Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing/Absence of the Right Heart

The purpose of the study is to monitor the clinical safety and performance of the EXCOR Venous Cannula in context of an EXCOR VAD therapy to ensure continued acceptability of identified risks, to enable detecting emerging risks and to assess clinical improvement on both short- and long-term.

The registry study has an observational, prospective, international, multi-center, non-randomized design.

The registry is planned for 42 months (3.5 years), with an enrollment period of 28 months, the follow-up of up to 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patient or his/her parent/guardian or legally authorized representative has given the consent by means of a written, signed and dated informed consent form,
* The indications on RVAD and BVAD use of the EXCOR VAD apply,
* Patient shall be on transplant list or at least eligible for HTx,
* BSA (body surface area) greater than or equal to 1.2 m².

Exclusion Criteria:

* Patient or his/her parents/legal guardian or legally authorized guardian has not given the consent,
* The contraindications of EXCOR VAD apply.
Esomeprazole in PPI Failures - IMPROVE

The purpose of this study is to assess how PPI treated GERD patients with insufficient symptom control will benefit from a change in management by providing a more efficient acid secretion inhibition during 4 weeks, by evaluation of esomeprazole 40 mg compared to pre-study PPI treatment.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Male or female, aged 18-65 years
* History of GERD symptoms during, at least, six months prior to enrolment
* PPI as maintenance treatment during the last 30 days prior to enrolment
* Heartburn as predominant GERD symptom, as judged by the investigator
* Persisting GERD symptoms during the past 7 days prior to visit 1, judged by the patient as either: 4 days with mild symptoms (i.e. awareness of sign or symptom, but easily tolerated)or 2 days with moderate (i.e. discomfort sufficient to cause interference with normal activities) to severe symptoms (i.e. incapacitating, with inability to perform normal activities)

Exclusion Criteria:

* Any treatment with esomeprazole during 30 days prior to enrolment History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer
* Current or historical evidence of the following diseases/conditions, as judged by the investigator:Zollinger-Ellison syndrome,Primary esophageal motility disorder, i.e. achalasia, scleroderma, primary esophageal spasm,
* Gastric or duodenal ulcers within the last three months, Malabsorbtion
* Malignancy or other concomitant disease with poor prognosis or which may interfere with the assessments in the study
* Unstable diabetes mellitus. Stable diabetes controlled by diet, oral agents or insulin is acceptable
* Patients with severe diseases or disorders which may interfere with the conduct of the study
Low Glycemic Index (GI) Diet Management for Pregnant Woman With Overweight

The study is a randomized, single-blinded, controlled intervention trial to compare the effect of a low glycemic index diet versus diet recommended by the Chinese Dietary Guide for Pregnant Women on maternal and neonatal insulin resistance and adverse gestational events.

Overweight in pregnant women increases maternal insulin resistance and risk of adverse pregnancy outcomes. Recent evidence from both animal studies and human subject studies shows that adverse environmental exposures during pregnancy result in adverse influence on offsprings. The hypothesis of the current study is that the healthy intervention during pregnancy to overweight pregnant women--low glycemic diet, may improve the maternal and neonatal insulin resistance at birth.

The current study adopts randomized, single-blinded, controlled intervention trial, gives low glycemic index diet intervention based on the national diet and physical activity recommendations for pregnant women to the intervention group and only national diet recommendations to the control group. Four diet consultation interviews will be done,at baseline (first prenatal examination), the end of the 1st trimester, the 2nd trimester and the 3rd trimester respectively, including diet assessment and diet consultation specifically to adopting low glycemic diet. Glycemic load of diet will be calculated based on 24 hour diet recall data for each individual at every visit to help to lower their diet glycemic load by modifying some daily foods. The effect of intervention is investigated by comparing the insulin resistance levels between the two arms at birth and when infants are at age 2. For discrete traits, such as incidence of gestational diabetes and gestational hypertension, Person's chi-square tests were used. For continuous traits, such as insulin resistance index, maternal weight gain and neonatal birth weight, we use t-tests for comparisons between two groups. The study expects that long-term low GI diet intervention have beneficial effects on controlling maternal and neonatal insulin resistance to overweight women and long term health.

Eligibility Criteria:
Inclusion

* Singleton pregnancy;
* Pregnant women with BMI≥24 kg/m2 at first antenatal examination;
* aged 18 years to 45 years;
* The week of first prenatal examination equal to or less than 12 weeks;
* Take routine prenatal examination;
* Willing and able to give informed consent. Exclusion
* Artificial impregnation;
* History of hypertension, diabetes, coronary heart disease or mental disorder;
* With Special diet habit(e.g. vegetarianism/ veganism).
A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient Department

This is an open-label, multicenter and observational study in China, which is designed to record the data of RA \& AS patients within 52 weeks after rheumatologists decided to prescribe etanercept, and evaluate the safety and efficacy of the treatment. All eligible subjects agreed to be recruited in the study and can withdraw anytime if they choose so.

Patients with RA or AS are typically managed by rheumatologists. As this study seeks to record the data of RA \& AS patient in etanercept and evaluate the safety and efficacy of the treatment, patients will be recruited from Rheumatic department. Rheumatologist will be asked to build up the database for RA \& AS patient surveillance prospectively in outpatient dept, which benefits for the patient treatment outcomes evaluation and clinical management.

The primary objective of this non-interventional study is to evaluate the safety of etanercept in Chinese RA and AS subjects. Total of 600 subjects (300 RA subjects and 300 AS subjects) will be enrolled in the study. If the true rate of an adverse event is no less than 0.5%, with sample size of 600 subjects, this study will have 95% probability to detect at least one occurrence of the adverse event. The study prematurely discontinued on January 15, 2013 due to slow enrollment and low adherence of etanercept. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a confirmed diagnosis of rheumatoid arthritis or ankylosing spondylitis.
* Subject has accepted physician's prescription of etanercept in rheumatology department.
* Subject agreed to be enrolled in the observational study and sign the ICD.
* Subject is≥18 years of age at the time of consent.
* Subject is willing and able to understand and complete questionnaires

Exclusion Criteria:

* Presence of active or suspected latent infection including HIV, or any underlying disease, including open cutaneous ulcers that could predispose the subject to infections.
* Immunodeficiency syndromes including Felty syndrome or large granular lymphocyte syndrome.
* Active tuberculosis (TB) or a history of TB, or findings consistent with previous exposure to TB on a chest x-ray (CXR). Investigators must follow China's guidelines for appropriate screening and treatment of TB.
* History of hypersensitivity to any of the ingredients in either preparation.
A Study to Assess the Effectiveness and Safety of Ozanimod in Chinese Adults With Relapsing Multiple Sclerosis

The purpose of this study is to assess the effectiveness and safety of ozanimod in Chinese adults with relapsing multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria

* Participants must have Multiple Sclerosis (MS) as diagnosed by the 2017 revision of the McDonald criteria.
* Participants must be exhibiting a relapsing clinical course consistent with Relapsing Multiple Sclerosis (RMS) and history of brain MRI lesions consistent with MS.
* Participants must have an EDSS score between 0 and 5.0 (both inclusive) at baseline.

Exclusion Criteria

* Participants must not have primary progressive MS at screening.
* Participants must not be diagnosed with, or suspected to have neuromyelitis optica spectrum disorder (NMOSD) by clinical symptoms, MRI appearance, and/or supportive serologies according to international consensus criteria.28 A positive test for aquaporin-4 (AQP4) by history or at screening is exclusionary.
* Participants must not have clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the participant at risk by participating in the study in the opinion of the Investigator.
* Specific cardiac conditions are excluded, including history or presence of:.

  i) Recent (within the past 6 months) occurrence of myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, New York Heart Association (NYHA) Class III/IV heart failure, or severe untreated sleep apnea.

ii) Second-degree (Mobitz type II) atrioventricular (AV) block, third-degree AV block, sick sinus syndrome, or sino-atrial block unless participants have a pacemaker in place.

iii) Prolonged corrected QT interval by Fredericia's formula (QTcF; \> 450 msec males and \> 470 msec females), or participants at additional risk for QT prolongation.

* Participants must not have diabetes mellitus type 1 or uncontrolled diabetes mellitus type 2 with hemoglobin A1c \> 9%, or diabetic participants with significant comorbid conditions such as retinopathy or nephropathy.
* Participants must not receive a live vaccine or a live-attenuated vaccine within 4 weeks prior to first dose or planning to receive a live vaccine or a live-attenuated vaccine during the study or within 28 days after discontinuation from study intervention.
* Participants must not have a history of any significant drug allergy (such as anaphylaxis or hepatotoxicity).
* Other protocol-defined Inclusion/Exclusion criteria apply.
Electroencephalogram Dynamics in Children <=1 Year During Anesthetic Procedures

As part of the clinical routine of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin at Campus Virchow-Klinikum intraoperative electroencephalography data and clinical routine data are recorded and evaluated in surgical children (\<=1 year).


Eligibility Criteria:
Inclusion Criteria:

• Children \<= 1 year undergoing surgery procedure

Exclusion Criteria:

* Incomplete patient record documentation
* Pre-existing neurological/psychological conditions