cyrilzakka/clinical-trials huggingface dataset:
Prevalence of the Metabolic Syndrome in SPR Taking Antipsychotics

The purpose of this study is to assess the cross-sectional prevalence of the metabolic syndrome in patients with schizophrenia taking antipsychotics.

Schizophrenic patients taking any kind of antipsychotics for at least 1 year at the Seoul National Hospital will be participated in this study.

we are planning to enroll approximately 1000 patients with schizophrenia.

For each subject

* abdominal circumference
* body mass index
* lipid profile : TG, HDL-chlo, total chol
* systolic/diastolic blood pressure
* fasting blood glucose will be measured.

we will calculate the rates of patients who meet the criteria for the Metabolic syndrome.

1. Abdominal obesity : absolute criteria
2. 2 or more of followings

   1. Triglyceride ≥ 150mg/dL or ongoing treatment
   2. HDL-cholesterol \< 40mg/dL (men) HDL-cholesterol \< 50mg/dL (female) or ongoing treatment
   3. Hypertension 130mmHg ≥ systolic 85mmHg ≥ diastolic or ongoing treatment
   4. FBS ≥ 100mg/dL or previous diagnosis of type II DM

Eligibility Criteria:
Inclusion Criteria:

* Patients taking a same antipsychotics at least more than one year
* schizophrenia or schizoaffective disorder

Exclusion Criteria:

* none
Harmonized Micronutrient Project

The purpose of this trial is to better define how individuals with different genetic make-ups will require different interventions to improve their methylation potential and nutrient status.

Despite the increasing incidence of overweight and obesity among children, nutritional deficiencies are still a concern.

A low intake of vitamins and minerals is associated with a reduction in the antioxidant capacity. Some vitamins are associated with chronic diseases including overweight and obesity.

S-adenosylmethionine (SAM) and S-adenosylhomocysteine (SAH) are the substrate and product of essential reactions; the SAM:SAH ratio has been associated with health and is an indicator of cellular DNA methylation potential.

Low level of this ratio may affect short and long term health. In this explorative knowledge building open interventional study, subject to be enrolled are children or adolescents 9 to 13 years of age per year (n=180 per year, over 2 years). The study consists of 6 weeks nutritional intervention followed by a 6 weeks follow up.

In this study, genomics, proteomics, lipidomics analysis will be performed, in addition to biochemistry, hematology and vitamins analysis.

Eligibility Criteria:
Inclusion Criteria:

* Children or adolescents 9 to 13 years of age.
* Clinically stable.
* Normal weight, overweight and obese.

Exclusion Criteria:

* Disease diagnosis.
* At least one episode of axillary temperature \>37°C over the prior 15 days.
* Three or more episodes of liquid or semi-liquid stools over the prior 24 hours.
* Supplementation with vitamins and/or minerals.
* On a supervised diet for reducing weight or any other type of diet restriction.
* Currently participating or having participated in another clinical study during the last 4 weeks prior to the beginning of this study.
Investigating the Effects of Krill Oil and Krill Protein on Post-exercise Muscle Protein Metabolism

The aim of the current study is to find out if krill oil can increase muscle building processes in response to resistance (weightlifting) type exercise. Others aim are to determine the effects of krill protein, and the interaction of krill oil and protein, on muscle building processes in response to resistance (weightlifting) type exercise.


Eligibility Criteria:
Inclusion Criteria:

* Be 60 years old or older
* Have a BMI of less than 35kg/m2
* Be participating in structured exercise for less than 2h per week

Exclusion Criteria:

* Diabetes
* Severe cardiovascular disease
* Seizure disorders,
* Uncontrolled hypertension (\>150/90mmHg at baseline measurement)
* Cancer or cancer that has been in remission \<5 years
* Ambulatory impairments which would limit ability to perform assessments of muscle function
* Dementia
* Taking medication known to affect muscle (e.g., steroids)
* Have an implanted electronic device (e.g., pacemaker/defibrillator/insulin pump),
* Anticoagulant therapy
* Allergies to seafood
* Regular consumption of more than 1 portion of oily fish per week.
Comparison of Preoperative Screening Score for Obstructive Sleep Apnea (OSA)

Comparison of preoperative screening score for OSA. In a preoperative population, comparison of the STOP-BANG, DES-OSA, P-SAP and OSA50 score.

Comparison of preoperative screening score for OSA (Obstructive Sleep Apnea). In a preoperative population, comparison of the STOP-BANG, DES-OSA, P-SAP and OSA50 score.

Comparison between scores and if applied with the results of a polysomnography (PSG).

Eligibility Criteria:
Inclusion Criteria:

* All adults patients (\> 18 years) performing a preoperative assessment at the ASTES Doctor's Office (ASTES is an acronym with the name of Medical Doctors involved in this office)

Exclusion Criteria:

* Patients \< 18 years
A Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV)

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-072 and ribavirin (RBV) in treatment-naïve participants with genotype 1 chronic hepatitis C virus (HCV) infection.

This was a Phase 2a multicenter, open-label, single arm, combination treatment study of a regimen of ABT-450/r/ABT-072, and ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-(1a or 1b) infected treatment-naïve participants.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C, genotype 1 infection with interleukin 28B (IL28B) rs12979860 genotype C/C.
* Liver biopsy within 3 years with histology consistent with hepatitis C virus (HCV) - induced liver damage, with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV.
* Treatment naïve male or female between the ages of 18 and 65.
* Females must be postmenopausal for at least 2 years or surgically sterile.
* Be in a condition of general good health, as perceived by the investigator, other than hepatitis C virus infection.
* Body mass index 18 to \< 35 kg/m\^2 .

Exclusion Criteria:

* Significant sensitivity to any drug.
* Use of herbal supplements within 2 weeks prior to study drug dosing.
* Positive screen for certain drugs or alcohol.
* Positive hepatitis B surface antigen or anti-human immunodeficiency virus (HIV) antibody.
* Use of strong cytochrome P450 3A (CYP3A), cytochrome P450 2C8 (CYP2C8), and organic anion transporting polypeptide 1B1 (OATP1B1) enzyme inducers or inhibitors within 1 month of dosing.
* Prior treatment with any investigational or commercially available anti-hepatitis C virus agents.
* Abnormal laboratory tests.
* Cirrhosis or extensive bridging fibrosis.
* History of cardiac disease.
Small Changes Clinical Weight Loss Trial

The purpose of this study is to assess the effectiveness of the Small Changes program in facilitating weight loss and to assess treatment effects on body composition, blood markers of metabolic health, and blood pressure, and to assess attrition and compliance


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index greater than or equal to 25
* Stable weight with less than a 5% body weight change in the past 3 months.
* Willingness and ability to follow a written dietary plan.
* Ambulatory and capable of attending bi-weekly in-person and phone appointments.
* Must reside in the geographic area for the duration of the 12-week study.
* Clearance for weight loss by their health care provider.

Exclusion Criteria:

* Pregnant or lactating.
* Acute medical conditions such as kidney disease, liver disease, pancreatitis, or cancer.
* A history of bariatric surgery or gastrointestinal resection.
* Current use of anti-obesity medications or diabetes medications, such as Glucagon-like peptide-1 receptor agonists (GLP-1RAs), that induce weight loss.
* A history of commercial weight loss program participation within the last six months.
* A history of anorexia nervosa or other eating disorders.
* A history of anxiety or depression.
* Extreme dietary restrictions or allergies that limit the ability to follow the weight loss plan.
Effect of Exercise on Endothelial Injury in Hypertensive Patients

Introduction: Endothelial dysfunction precedes atherosclerosis being evidenced in patients with hypertension. Increasing physical activity levels and/or physical exercise are part of the recommendations of antihypertensive therapy. However, the effects of oscillations and/or increase the systemic blood pressure induced by exercise session on endothelial function has not been studied.

Objective: To evaluate the effect of aerobic exercise, resistance exercise and combined exercise on endothelial injury levels in patients with hypertension.

Methodology: Hypertensive (n = 51) and healthy subjects (n = 30) (30-59 years old) will perform at random 40 minutes of aerobic exercise (50-60% of heart rate reserve) or 40 minutes of resistance exercise (4 x 12 repetitions of exercises for lower limbs, 60-70% of one repetition maximum and 60-90 second interval) or 40 minutes of combined exercise (20 minutes of resistance exercise and 20 minutes of aerobic exercise, in that order). Blood will be collected 10 minutes before, 10 and 60 minutes after intervention for the quantification of endothelial microparticles (MPE) circulating (induced endothelial lesion) and endothelial progenitor cells (EPC) circulating (endothelial recovery capacity) by flow cytometry. Ambulatory blood pressure monitoring (ABPM) will be held before and after the intervention. Ultrasonography is used to measure the flow-mediated dilation of the brachial artery 10 minutes before, 10, 30 and 60 minutes after the intervention.

Statistics: generalized estimating equation (GEE) for repeated measurements and Person correlation, being significant p \< 0.05.

It is expected to show results to ensure cardiovascular protection in patients with hypertension caused by different types of exercise and consequent endothelial injury and release induced regenerative factors. Knowledge of the magnitude of injury and endothelial recovery provided by different types of exercise can contribute scientifically to health professionals aimed at prescribing exercise with a vascular protective vision in patients with hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Adults with hypertension;
* 30 to 59 years old.

Exclusion Criteria:

* Diabetes;
* Heart disease;
* Participating in any regular exercise program over the last six months;
* Orthopedic impairments or any physical or mental limitation that prevents - achievement of physical exercise;
* Body Mass Index in class II obesity or more (BMI ≥ 35 kg / m2);
* Smoking.
Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections

The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by immediate release (IR) guaifenesin (GGE) and do not match approved Mucinex labeling in the U.S. The purpose of this study is to determine whether Mucinex is effective and non-inferior as compared to placebo and immediate release guaifenesin in the treatment of symptoms of acute upper respiratory infections. This design was required based on EU regulatory guidance.


Eligibility Criteria:
Inclusion Criteria:

1. Has developed cold symptoms within 3 days prior to dosing on Day 1.

Exclusion Criteria:

1. Chronic illnesses.
2. Febrile illness \> 101 F within 7 days prior to Day 1,
3. Pregnant.
4. Known current malignancy.
Rural South and Southeast Asia Household Health Survey

A cross-sectional household survey with two-stage cluster-randomized sampling. This cross-sectional household survey design to recruit a random sample of households that is representative for each of the study sites. From the selected households, all consenting, household members will be included in the study.

This study is funded by the UK Wellcome Trust. The grant reference number is 215604/Z/19/Z

371 households will be randomly selected from each site in Bangladesh, Cambodia, Myanmar, and Thailand. Assuming each household has an average of 4.5 members and all members will be sampled, 1500 participants will be recruited per site. This sample size allows for the overall prevalence estimation of key survey indicators with 95% confidence and 5% degree of precision.

The survey components include questionnaire interview, physical examination, blood sample collection, and point of care (PoC) tests. The questionnaire interview will collect information on household characteristics, members' disability, presence or history of disease, risk factors, self-perceived quality of life, and health seeking behaviour. For women, questions about reproductive health and antenatal care, and for young children, vaccination coverage and achievement of child development goals, will also be assessed.

For physical examinations, tympanic temperature, weight and height will be measured in all household members, mid-upper arm circumference in young children, and blood pressure in adults. Blood sample will be collected from all participants aged 6 months and above. Venous blood samples will be collected from participants aged 5 years and older, and dried blood spot will be collected from children under 5 years. Samples will be shipped to a central laboratory and analysed. Haemoglobin PoC will be administered to all participants.

All data will be collected directly on an electronic case report form using tablets, and uploaded to an electronic database.

Eligibility Criteria:
Inclusion Criteria:

* All members of the selected households at the time of the survey; and able to provide informed consent.

Exclusion Criteria:

* Adults or children whose parent/guardian/ caretaker are unable or unwilling to provide informed consent.
Effects of Left Nostril Breathing in Young Females Having Cardiovascular Hyper Reactivity to Cold Pressor Test.

The purpose of this study is to evaluate the effects of left nostril breathing in young females having cardiovascular hyper reactivity to cold pressor test.Although,limited literature exist regarding hyper reactivity towards stress induced test in our youth and its effective and easy treatment in the form of left nostril breathing which could proves to be beneficial for our youth.

The Cold Pressor Test (CPT) was introduced as a standard incentive for studying the vasomotor response (Hines and Brown 1932). Hyper-reactors were the subjects in his study who responded more strongly to CPT, Participants who show hyper reactivity to Cold pressor test (i.e. subjects showing 25 mmHg increase in systolic blood pressure along with 20 mmHg increase in diastolic blood pressure).They proposed that these hyper reactive could be candidates for hypertension in the future. Increased occurrence of these diseases could be attributed to an asymmetry in sympathetic and parasympathetic stimulation. Control or adaptation of breathing or breathing workouts i-e yoga are thought to be beneficial in the treatment of such disease. Although Yoga techniques proven to be effective in treating stress related disorders but it is time consuming and young population because of their busy routine couldn't be able to take out time for their health related issues. This study introduces very simple exercise in the form of left nostril breathing which decreases sympathetic activity and increases parasympathetic activity. It is inversely proportional to stress induced response of the body, it is very easy to perform and can be done at any time, and if found significantly effective for stress disorder ,it could be used in daily routine by our youth to get themselves prevented from major risk factors of CVD's particularly hypertension. This study will identify participants with a high potential risk of developing hypertension in the future by administering Cold pressor test, additionally the effects of left nostril breathing intervention on hyper reactive participants would be observed and if found significant, it would be a major breakthrough in primary prevention of hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Participants falling in the following category would be recruited into the study:
* Females Age (18-25) years
* Participants who show hyper reactivity to Cold pressor test (i.e subjects showing 25mmHg increase in systolic blood pressure along with 20mmHg increase in diastolic blood pressure)
* Consenting participants.

Exclusion Criteria:

* The participants in the following category would be excluded from the study:
* Participants on antihypertensive drugs.
* Participants who are diagnosed with any cardiovascular, renal, hepatic or metabolic disease.
* Participants having malignant tumor.
* Participants with nasal blockages, polyps ,Raynaud phenomena
* Females during menstrual cycle, pregnancy or on oral contraceptives.
Time Restricted Feeding to Reduce Weight and Cardiometabolic Risk

The obesity rate in Malaysia is higher than the average world obesity rate. Central obesity is a component of metabolic syndrome (MetS) which is also made up of dyslipidemia, impaired glucose tolerance, and hypertension. MetS is a continuum in the risk of developing cardiometabolic complication. Time Restricted Feeding (TRF) involves an extended physiological overnight fast. Researchers believe that the timing of meal intake that matches with the circadian rhythms is as important as the calories intake to prevent obesity and its complications. The investigators hypothesize that TRF is effective in weight control and improvement of metabolic severity. Subjects will be randomized into either the control group, which practices QQH dietary plan or intervention group, which practices TRF as an adjunct to QQH dietary plan.

Subjects will be followed up at week 12 and week 24 to assess adherence, efficacy and safety of TRF.

This study intends to fill a few research gaps as follows:

1. Longer study duration of 6 months.
2. This is the first study amongst the Asian population.
3. Adherence level to TRF in real life setting is measured. This information can potentially predict the intensity level of TRF that are feasible for practice in real life and also its association with the efficacy of TRF.
4. TRF is defined as eating within a≤12-hour period and fasting for at least 12 hours per day. This is the shortest fasting window studied so far.


Eligibility Criteria:
Inclusion Criteria:

1. 20-59 years of age
2. BMI 27.5kg/m2 - 39.9kg/m2
3. Smart phone users
4. Willing to lose weight
5. Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in the protocol.

Exclusion Criteria:

1. Those with history of cardiovascular disease, cerebrovascular accidents, degenerative or inflammatory diseases of the nervous system; epilepsy, malignancy, gastrointestinal disorders, thyroid disorders, diabetes or medications which could have had metabolic effects.
2. Women who are pregnant or breastfeeding.
3. Those who are currently practicing any form of intermittent fasting or newly enrolled into a dietary or slimming program within the past 3 months.
4. Subjects with any medical condition, which in the investigator's judgment may be associated with increased risk to the subject or may interfere with study assessments or outcomes.
5. Those currently on medication for chronic illness.
6. Permanent night shift worker
7. Those who need to practise Ramadan fasting during the period of this study.
AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission

This phase III trial is conducted to evaluate if azacitidine in combination with venetoclax as maintenance therapy improves relapse-free survival (RFS) for younger adults with favorable-risk acute myeloid leukemia (AML) who remained in first complete remission (CR1) following intensive consolidation.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of favorable-risk acute myeloid leukemia (AML) according to revised 2017 European LeukemiaNet genetic risk stratiﬁcation and are not immediate candidates for allogeneic stem cell transplant.
2. Aged 18-64 years.
3. Patients who have received remission induction therapy and 3-4 HiDAC or medium-dose cytarabine-based consolidation and are in their first remission.
4. ECOG performance status of \< or = 3.
5. Adequate organ function as follows:

   1. Serum total bilirubin \< or = to 3 X the Upper Limit of Normal (ULN)
   2. Aspartate Transaminase and alanine transaminase \< or = to 3 x ULN
   3. Ccr（Creatinine Clearance Rate) \> or ＝60 ml/min
   4. Left ventricular ejection fraction \> or ＝50% determined by ultrasound.
6. For females of childbearing age, they should have a negative serum or urine pregnancy test within 10 to 14 days of enrolling.
7. For males of childbearing age, they should take effective contraceptive methods throughout the treatment period and up to 30 days after discontinuing treatment.
8. Ability to understand and sign informed consent.

Exclusion Criteria:

1. Acute promyeloid leukemia.
2. Patients with active central nervous system (CNS) leukemia.
3. Previously diagnosed with myelodysplastic syndrome (MDS) or myeloproliferative neoplasm(MPN) and progressed to AML.
4. Patients with other progressive malignancies.
5. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to uncontrolled and/or active systemic infection (viral, bacterial or fungal).
6. Patients who have participated in other trials within 30 days before signing the informed consent.
7. Females who are pregnant or lactating or intending to become pregnant during the study.
The Effects of Escitalopram on Cytokines

The association of cytokines with escitalopram has not been investigated in patients with major depressive disorder (MDD). Hence, the investigators will examine this association.

In addition to serotonin, inflammatory process has been suggested in the development of major depressive disorder (MDD) and in its associated treatment. Escitalopram is an antidepressant that has been widely used in patients with MDD because of the promising results. The association of cytokines with escitalopram has not been investigated in patients with MDD. Hence, the investigators will examine this association.

Eligibility Criteria:
Inclusion Criteria:

1. DSM-IV-defined Major depressive disorder, single episode
2. Age 20-65
3. Drug-naive
4. Hamilton Depression Rating Scale exceeding 14 scores

Exclusion Criteria:

1. Major medical disorders
2. Substance use
3. Pregnant
4. Allergy to escitalopram