cyrilzakka/clinical-trials huggingface dataset:
Korean OBEsity Surgical Treatment Study

This trial is a multi-center, single-arm, prospective, observational cohort study of patients undergoing primary bariatric surgical procedures in Korea. A total of 100 patients will be recruited over a 1-year period from 2016 to 2017, and will be followed for a mean follow-up period of 1 year after surgery. The eligible subjects who have given their consent to participate will undergo one of two surgical procedures; sleeve gastrectomy and Roux-en Y gastric bypass.

The primary objective of this clinical trial is to measure the changes in body weight (kg) and waist circumference (cm) of the enrolled patients at postoperative 1 year. Secondary outcomes are improvement or remission rates of obesity-related co-morbidity (hypertension, type 2 diabetes, dyslipidemia, and sleep apnea), and the change in quality of life. Additionally, postoperative incidences of morbidity and mortality, micronutrient status, body composition, and cost-effectiveness of surgical intervention will be examined.


Eligibility Criteria:
Inclusion Criteria:

1. body mass index (BMI) ≥ 35 kg/m2 or BMI ≥ 30 kg/m2 with co-morbidities such as hypertension, glucose intolerance, dyslipidemia, and sleep apnea
2. being suitable for general anesthesia
3. being able to give informed consent and committed to follow-up
4. Female patients should have a negative urine pregnancy test at screening and agree to use reliable method of contraception for 1 year.

Exclusion Criteria:

1. prior bariatric surgery of any kind
2. being unable to understand the risks, benefits and compliance requirements of this trial
3. pregnancy or planning on being pregnancy
4. non-Korean speaker
5. American society of anesthesiology (ASA) class IV or higher
6. malignancy within 5 years.
The Impact of Tele-coaching on the Physical Activity Level

The study aims to test the benefits of a semi-automated tele-coaching program to coach adult participants with chronic lung disease towards a more active lifestyle.

The level of physical activity (PA) has been shown to be an important predictor for morbidity and mortality in individuals with chronic respiratory diseases, for instance Chronic Obstructive Pulmonary Disease (COPD) or Idiopathic Pulmonary Fibrosis (IPF). Physical inactivity and sedentary behavior is a common feature of patients with chronic respiratory diseases. Pulmonary rehabilitation is known as a beneficial intervention in exercise capacity, disease symptoms and quality of life in respiratory diseases. Despite the overall large benefits on exercise capacity and other variables described above, it does not automatically translate into increases in PA. Recent literature shows that coaching programs specifically aiming to increase PA are more likely to result in PA changes.

Therefore, this study was designed to investigate the impact of 3-month (12 weeks) tele-coaching intervention on PA level of adult participants suffering from a chronic lung disease.

Eligibility Criteria:
Inclusion Criteria:

* Stable patients, older than 18 years of age, with a diagnosis of interstitial lung disease
* Understands and is able to work with a smart phone application (judged by the investigator)
* On stable pharmacotherapy
* Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥30%predicted

Exclusion Criteria:

* On the waiting list for a lung transplantation
* Life expectancy below 3 months
* Respiratory tract infection or an exacerbation or change in maintenance medication within 4 weeks before study enrolment
* Extra pulmonary impairments, unrelated to the underlying lung disease, interfering with physical activity
Evaluation of a Diabetes Self-Management Education Program for Non-Intensified Insulin Therapy in Type 2 Diabetes

A new diabetes education program for the initiation of non-intensive insulin therapy in type 2 diabetic patients (MEDIAS 2 CT) was developed.

In the evaluation, this new developed program is compared with an education programs which is currently used for diabetes education. It is expected that the new developed program (MEDIAS 2 CT) can demonstrate non-inferiority with regard to the main outcome variable glycemic control. If non-inferiority can be demonstrated superiority of this program will be tested.

The MEDIAS 2 CT program is based on a self-management/empowerment approach. It is conducted as a group program comprising 6 lessons of 90 minutes each. MEDIAS 2 CT was designed to help patients perform conventional insulin therapy. In addition, MEDIAS 2 CT focused on controlling metabolic risk factors (elevated lipids and blood pressure), coping with the risk of late complications, and reducing the emotional burden of diabetes and its treatment.

The active comparator condition (ACC-CT) consisted of an established patient education program for type 2 diabetic patients with conventional insulin treatment. This education program was developed in the 1980s and 1990s and is more didactic-oriented, focusing primarily on the acquisition of knowledge, skills, and information about the correct treatment of diabetes. Both treatment arms (MEDIAS 2 CT and ACC) consisted of 6 lessons, which were conducted as group sessions.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* two years diabetes duration with oral treatment
* BMI \> 20 and \< 40 kg/m²
* written informed consent

Exclusion Criteria:

* current psychiatric disease
* dementia or other severe cognitive impairment
* severe complications
* severe conditions (e.g., cancer)
* gestational diabetes.
Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Acitretin Capsules

In an early clinical research, 138 patients completed the treatment of Psoriasis Vulgaris by Acitretin Capsules in 8 weeks, the results indicate 75 cases effectively (54.3%), 50 cases invalid(36.2%), 13 cases serious(9.4%). To investigate the influence of genetic factors on the curative effect and find the relationships between genetic variants and the response of Acitretin Capsules to treatment of Psoriasis Vulgaris.

Investigators analyzed the various levels of genetic factors, including: 1.To analysis the key gene variants which associated with ADME affect the efficacy of Acitretin Capsules; 2.Direct full genetic sequencing of MHC genes, to explore the genetic variations of efficacy and side effects; 3. Direct sequencing of all exons in the gene in the patients of the response of serious and effectively, to explores the rare genetic variation may cause deterioration of treatment by Acitretin Capsules.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed according to Classification criteria for Psoriasis vulgaris
2. Patients aged 18 to 70 years (to the date of screening)
3. PASI grade ≥7point
4. Not treatment in the Topical corticosteroids, Immunosuppression, Biologicals agents or Tretinoin cream, Phototherapy nearly one months before enrolled.
5. Total bilirubin \< 1.5 x ULN, AST(SGOT)/ALT(SGPT) \<2.5 x ULN if not liver metastases\<5 x ULN if known liver metastases, Creatinine clearance \<1.5 x ULN
6. Understanding the whole process of the study, voluntary participation and signed the informed consent

Exclusion Criteria:

1. Pregnant women, ready to pregnant or lactating women
2. Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history
3. Patients is liver function abnormal persons (ALT above the center laboratory normal limit) or hepatitis b patient grain carriers
4. Patients with chronic diarrhea, or peptic ulcer nearly 1 year
5. Patients suffering from malignant tumor
6. Patients suffering from acute and chronic infectious diseases
7. Mental disorders, history of alcohol abuse, drug or other substance abuse
8. Other cases which researchers believe that can not enroll
Survey of Procedures and Resources for Initiating Treatment of HIV in Africa-Malawi

In its 2017 revision of the global guidelines for HIV care and treatment, the World Health Organization (WHO) called for rapid or same-day initiation of antiretroviral treatment (ART) for eligible patients testing positive for HIV. However, to date neither the WHO nor the Malawi Ministry of Health has provided detailed guidance on how to implement this recommendation.

In sub-Saharan Africa, where most HIV patients are located, studies continue to document high losses of treatment-eligible patients from care before they receive their first dose of antiretroviral medications (ARVs). Among facility-level reasons for these losses are treatment initiation protocols that require multiple clinic visits and long waiting times before a patient who tests positive for HIV is dispensed an initial supply of medications. There is very little published evidence on the practical details of the process and the extent to which it varies by facility, setting, or country. Without a robust baseline evidence base, it is challenging to identify opportunities for making improvements. The SPRINT (Survey of Procedures and Resources for Initiating Treatment of HIV in Africa) study will begin to develop this evidence base. SPRINT will combine a facility-level description of the standard of care with a retrospective record review of patients who recently initiated ART at the study sites. Data will be collected from 12 health facilities in Malawi. The survey will elicit detailed information about current procedures through structured interviews with clinic staff at the selected health facilities. The record review for a retrospective cohort of patients eligible for ART will estimate actual numbers of clinic visits, services provided, and duration of the steps for treatment initiation from start to finish. SPRINT is expected to identify differences in approaches to treatment initiation and potential opportunities for improvement.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (at least 18 years old)
* Tested HIV-positive (or brought proof of positive HIV status) at a study site within the study period (1 July 2018 through 30 June 2019)

Exclusion Criteria:

* Pregnant
Comparision of M-TAPA Versus TAPB After Laparoscopic Cholecystectomy

This randomized controlled study is designed to evaluate the postoperative analgesic effect of the ultrasound-guided modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy. The investigators hypothesized that the US-guided M-TAPA would be more effective in postoperative pain control than the US-guided subcostal transversus abdominis plane block (TAPB).

Patients (Age\>18 years) undergoing elective laparoscopic cholecystectomy are randomly allocated to receive bilateral US-guided M-TAPA (n=30) or bilateral subcostal TAPB (n=30) using 0.375% ropivacaine 15ml (total 30ml) before surgical incision. The blinded investigator evaluates each patient's parameters (Numeric rating scale, nausea, vomiting, pruritis, and patient satisfaction) at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge. The primary outcome is pain severity evaluated by a NRS at 12hours postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo elective laparoscopic cholecystectomy
* American Society of Anesthesiologists (ASA) physical classification I-II

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) physical classification III or more
* Chronic pain, chronic analgesic or antidepressant or anticonvulsant use
* Allergies to anesthetic or analgesic medications used in the protocol
* Single port laparoscopic cholecystectomy
* Patients with infection at the abdominal wall
* Medical or psychological disease that can affect the treatment response
* Do not understand our study
Comprehensive Clinical Decision Support (CDS) for the Primary Care of Premature Infants

This study will use a rules-based expert system embedded in an electronic health record (EHR) to extract, interpret, and present salient facts and recommendations related to the healthcare of premature infants.

Premature infants are a vulnerable population with multiple inter-related health problems that put them at risk for poor outcomes. Electronic health records capture large amounts of information that may help guide decisions, but existing alert and reminder-based clinical decision support (CDS) frameworks do not adequately apply multiple overlapping care guidelines to complex patient histories to produce coherent clinical recommendations.

The primary objective of the study is to design and evaluate the usability of a CDS intervention to improve the quality of primary care for low birth weight (LBW) and very low birth weight (VLBW) premature infants from the time of intensive care nursery discharge through 24 months corrected gestational age

Eligibility Criteria:
Inclusion Criteria:

* All clinicians from participating practices.
* Premature Infants: Receive preventive healthcare from a participating practice at least twice during the study period; (2) age less than 24 months; and (3) birth weight less than 2000 g or gestational age at birth less than 35 weeks.

Exclusion Criteria:

-Residents will not eligible to participate in this study due to the fact that they receive significant ongoing education related to the inpatient and outpatient management of premature infants as part of their day-to-day training.
Adaptations of Exercise Energy Metabolism in Response to Weight Loss in Healthy Normal Weight People

More and more normal weight people are dieting in the general population. The NUTRILEX study aims to better understand the physiological adaptations in response to weight loss in healthy normal weight individuals.

After an inclusion visit to verify the eligibility criteria of the subjects, they will complete a "T0" control session. The subjects will then have to complete two phases. The first transversal phase consists of 4 randomized sessions with lunch ad libitum after a physical exercise: i) a control session (no exercise, CON); ii) an exercise session at initial body weight (BWT0); iii) an exercise session with a simulated weight loss of 3% performed on an anti-gravity treadmill (BW-3%) and; iv) an exercise session with a simulated weight loss of 6% performed on an anti-gravity treadmill (BW-6%).

During the second longitudinal phase, the participants will perform a dietary rebalancing and a slight caloric restriction (dietary intervention) in order to induce a weight loss of 6% of their initial body weight. Subjects will then perform an exercise session after losing 3% (T1) and then 6% (T2) of their initial body weight.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.5 and 24.9 kg/m²,
* Subjects abled to understand the information note and abled to sign the consent form,
* Subjects with stable body weight (variation \< 3% of body weight) until at least 6 months,
* Subjects subjected to a social security plan.

Non-Criteria:

* Have achieved a minimal BMI \< 18.5 or maximal BMI ≥ 25 kg/m² in adult life,
* Subjects with high levels of physical activity (\> 5 h of exercise per week),
* Presence of comorbidities or medical conditions that may interfere with study data,
* Subjects undergoing energy restriction or physical activity weight loss program at the time of inclusion or within the past 6 months,
* Taking medication that may interfere with study results,
* Surgery within the last 3 months,
* Person under guardianship, curatorship, or safeguard of justice; or not subject to a social security plan,
* Pregnant or breastfeeding women,
* Refusal to sign the consent form,
* Person in a period of exclusion from another study,
* Regular consumption of tobacco or alcohol,
* Voluntary weight loss in the last 6 months,
* Present or past eating disorders.
Effects of Experiential Learning on Vegetable Intake in Preschool Children

The aim of this cluster randomized control trial is to test the efficacy of providing experience of a target novel vegetable within the context of an interactive story time to increase intake of the target novel vegetable in preschool aged children (aged 2-5 years).

The aim of this study is to test the efficacy of providing experience of a target novel vegetable within the context of an interactive story time to increase intake of the target novel vegetable in preschool aged children (aged 2-5 years). In particular, the study will assess whether these strategies are effective to encourage intake of an unfamiliar vegetable in children who are fussy eaters.

There are two manipulations in this study - the provision of a story which features either a target vegetable (celeriac) or a control vegetable (carrot) and the presence of experiential learning (smelling, touching, looking at the vegetable) with either the target vegetable or the control vegetable.

Baseline consumption and familiarity of the target veg will be assessed for all children, before the intervention. The intervention consists of two familiarization trials, and 2-weeks of access to a story book featuring vegetables. Following the final familiarization trial, consumption and familiarity will be assessed again. Each familiarization trial consists of a story in class, and depending on condition, an experiential learning episode in class. During the 2 week interval between familiarization sessions nurseries will be requested to ready the story book 5 times in the preschool room (at times convenient to them).

Participants will be cluster randomized into 4 groups (2X2 between subjects design): 1) target vegetable narrative, 2) target vegetable narrative + experiential, 3) control vegetable narrative 4) control vegetable narrative + experiential

Child's food fussiness data will be collected by parents using the Food Fussiness sub scale of the Child Eating Behaviour Questionnaire. Their usual consumption of the target vegetable will also be measured using parent report.

Nursery staff will be requested to provide feedback to evaluate intervention feasibility, barriers and efficacy.

It is predicted that children's intake of the novel vegetable will vary by intervention. The primary hypothesis to be tested is that providing experience of a target novel vegetable within the context of an interactive story time will encourage preschoolers to taste, try and eat the target vegetable.

Eligibility Criteria:
Inclusion Criteria:

* 2 to 5 years old
* Attends nursery on selected test day

Exclusion Criteria:

* Relevant food allergy (celeriac / celery)
* Medical condition which would prevent them from eating the test vegetable
Exploring Life Experience and Lifestyle Intervention Program Among Patients With Chronic Kidney Disease: A Longitudinal Study

The lifestyle consulting program through one year follow-up could effective increase the scores of health responsibility and nutrition according to the past three-year study. Behavior change is a dynamic and complex process. Using a long-term follow up approach will be able to understand the trajectory of behavior change. The purpose of this study is to explore life experience and lifestyle intervention program for patients with chronic kidney disease using mixed methods with a longitudinal approach. The first year of this study will include a qualitative study with in depth interview of the subjects who attend previous study in the research team and have the scores of health promoting lifestyle among the highest 27% and lowest 27%. The life experience will be explored. The quantitative study will be an experimental design. Qualified subjects will be randomly assigned to intervention or control group. The intervention protocol is based on trans-theoretical model. Each subject will be followed every six months. The second and third year of studies will continue to use the qualitative and quantitative approach to understand the life experience and meaning among patients with chronic kidney diseases. The trajectory of life experience and life style changes will be explored. The method may strengthen the effectiveness of lifestyle program and may provide comprehensive understanding of the trajectory of behavior changes among patient with chronic kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Early Stages of Chronic Kidney Disease (GFR≧30ml/min/1.73㎡)
* Must be able to commmunicate in Chinese or Taiwanese
* Muse be voluntarily to attend
* Patient who does not exercise regularly
* Patient whose blood pressure higher than 140/90 mmHg
* Patient who is overweight or BMI\>25kg/㎡

Exclusion Criteria:

* Patient who limited to exercise
Safety Study of CNT-01 in Patients With Idiopathic TGCV

The purpose of this study is to assess the safety and to examine the index of the efficacy after repeated dosing of CNT-01 in patients with idiopathic triglyceride deposit cardiomyovasculopathy.


Eligibility Criteria:
Inclusion Criteria:

* Have a definite diagnosis of idiopathic triglyceride deposit cardiomyovasculopathy
* After receiving a sufficient explanation upon participation in this study, on a full understanding, patients who obtained the written informed consent from each patient
* More than 20 years old at the time of informed consent
* Is able to oral intake
* Must be willing to comply with protocol-required examination such as BMIPP myocardial scintigraphy

Exclusion Criteria:

* Have diabetic ketoacidosis
* Have a malignancy that is being treated by anticancer drug or anticipated survival is less than three years
* Female with pregnant or lactating
* Is not able to agree to using intrauterine device, oral contraceptive, condom or having sexual intercourse from the start of taking investigational product to 30 days after the end of the study
* Have a New York Heart Association functional classification IV
* Have a known history of drug dependence
* Is allergic to any component of the investigational product
* Is allergic to BMIPP or iodine
* Have a known history of clinically significant drug allergy
* Have a severe liver dysfunction (Child classification B and C)
* Participated in other clinical study within the past 3 months and received an investigational agent including placebo
* Being treated with diet containing medium chain fatty acid
* Is considered unfit for the study by the Investigator's medical decision