linjc16/ctgov huggingface dataset:
Comparing Tai Chi Training to a Low-Stress Physical Activity to Enhance Sleep in Older Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effects of Tai Chi, in comparison to conventional exercise, on the quality of sleep among sedentary older adults.

Detailed Description
-----------------
Elderly individuals often suffer from sleep disturbances. Chronic sleep problems can cause significant medical, psychological, and social disruptions. Although many sleep-related studies exist, few studies have focused on improving quality of sleep. Tai Chi, an exercise that incorporates meditation and breathing with whole body movements, may improve the quality of sleep and health status of elderly individuals. Participants will be randomly assigned to either a Tai Chi group or a conventional exercise control group. Participants in each group will exercise for 60 minutes, 3 times per week, for 6 months. Assessment of sleep quality and health status will be done at study start, 3 months, 6 months, at the end of the study, and at a 3-month follow-up visit.

Official Title
-----------------
Tai Chi Training and Sleep Enhancement in the Elderly

Conditions
-----------------
Sleep Deprivation, Sleep Initiation and Maintenance Disorders

Intervention / Treatment
-----------------
* Behavioral: Tai Chi


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sedentary, as defined by a lack of regular exercise during the previous 6 months Healthy to the degree that participation in exercise testing and an exercise program would not exacerbate any existing disease condition Physician's clearance for participation Willingness to adhere to the conditions of the study Exclusion Criteria: Sleep medication or other psychotropic medication during the study Current sleep disorder treatment Significant cognitive impairment as indicated by a score of 3 on the Pfeiffer Mental Status Questionnaire More than 7 alcoholic beverages per week or use of alcohol close to bedtime Smoking more than 10 cigarettes per day Score of 5 or higher in the Pittsburgh Sleep Quality Index questionnaire Score of 3 or higher on 2 out of 3 sleep items drawn from the Sleep Questionnaire and Assessment of Wakefulness

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Tai Chi|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tai Ji
Acceptability of HIV Oral PrEP Among MSM and TGW

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the factors associated with acceptability to oral HIV pre-exposure prophylaxis (PrEP) among Thai men who have sex with men (MSM) and transgender women (TGW).

Official Title
-----------------
Acceptability of HIV Oral Pre-Exposure Prophylaxis (PrEP) Among Men Have Sex With Men (MSM) and Transgender Women (TGW)

Conditions
-----------------
Patient Acceptance of Health Care

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MSM or TGW at age18 years or older at enrollment Able to read and write effectively in Thai language Negative HIV testing (by assigned rapid tests) at enrollment Available to return for the study visits and willing to comply with study requirements Willing to provide reachable contact numbers and address Creatinine clearance ≥ 60 mL/min Negative urine protein Negative HBs Ag Exclusion Criteria: Symptoms suggestive for acute HIV seroconversion Participating in any interventional HIV research Has any physical or mental condition(s) that, in the opinion of the investigator(s), complicate interpretation of study outcome data

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability and factors affecting the decision to take oral PrEP | After receiving information about PrEP, the participants will have a chance to decide whether they want to take PrEP or not. The set of questions asking about reason(s) for taking (or not taking) PrEP are used to evaluated the acceptability. The questions will evaluate multiple aspects such as knowledge about PrEP (efficacy and medications side effect), personal belief about PrEP, sexual practice, social stigmata, and concern for HIV resistance. The participants will answer these questions via Computer-Assisted Self Interviewing (CASI). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to PrEP by self-report | Among the participants who decide to take PrEP, the adherence will be evaluate by self-report (directly to medical staff and via Computer-Assisted Self Interviewing). | 1 year | 
| Adherence to PrEP by pill count | Among the participants who decide to take PrEP, the adherence will be evaluate by pill count. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oral PrEP, TGW, Thai MSM
Incidence and Predictive Factor of Irritable Bowel Syndrome After Acute Diverticulitis in Korea

Study Overview
=================
Brief Summary
-----------------
The pathogenesis of irritable bowel syndrome (IBS) is considered immune reaction of gastrointestinal tract. Therefore there is growing evidence that IBS could occur after gastroenteritis. However, little is known about the incidence of IBS after acute diverticulitis. We thought that post diverticulitis status could induce IBS because diverticulitis was also bowel inflammatory disorder. This survey was designed to identify incidence of post-diverticulitis IBS and risk factor in Korea.

Conditions
-----------------
Diverticulitis and Irritable Bowel Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 years or over Patients who diagnosed diverticulitis by CT scan from 2006 to 2010 (Case) Patients who admitted to hospital because of non-gastrointestinal disorder (Control) Exclusion Criteria: Patients who diagnosed IBS before diverticulitis (Case) Patients who diagnosed IBS before admission (Control) Patients with bowel resection surgery except for laparoscopic appendectomy Pregnancy Do not agree the consent of this study Patients who dose not understand telephone survey such as foreigner, mental retardation.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diverticulitis patients (case)<br>Cases were the patients who admitted to hospital because of acute diverticulitis attack. | |
| Non-diverticulitis patients (control)<br>Controls were the patients who admitted to hospital due to non-gastrointestinal disorder. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The newly developed IBS | The primary outcome was newly developed IBS. This was checked by telephone survey from 15th July 2013 to 30th September 2013. IBS was diagnosed by Rome III criteria. | Survey was done from 15th July 2013 to 30th September 2013 |
Multicenter Validation of the PREDICT Score

Study Overview
=================
Brief Summary
-----------------
Even after adequate TME with grade III mesorectal grading, local recurrence remains a possible event. Several studies investigated different parameters and assessed their predictive power in regards to local recurrence after TME. These parameters included a variety of patient-related, tumor-related, and treatment-related factors. A recent meta-analysis reviewed the current literature for the predictors of local recurrence after TME for rectal cancer and developed a prognostic scoring system, the PREDICT score. The present study aimed to validate the PREDICT scoring system by applying it to a prospective cohort of patients with rectal cancer who underwent curative TME in three

Official Title
-----------------
Multicenter Validation of the PREDICT Score for Prediction of Local Recurrence After Total Mesorectal Excision of Rectal Cancer

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: PREDICT score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients of either sex with non-metastatic low or middle rectal cancer who underwent elective TME with curative intent Exclusion Criteria: Patients with recurrent or metastatic rectal cancer at the time of presentation Patients with synchronous colon cancer Patients with missing data on the outcome of TME.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with recurrence after TME<br>Patients who developed local recurrence after TME of rectal cancer | Diagnostic Test: PREDICT score<br>* Predictive score for local recurrence after TME for rectal cancer that includes 8 parameters<br>|
| Patients without recurrence after TME<br>Patients who did not develop local recurrence after TME of rectal cancer | Diagnostic Test: PREDICT score<br>* Predictive score for local recurrence after TME for rectal cancer that includes 8 parameters<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of PREDICT score | The ability of the score to predict actual cases of recurrence after TME | 36 months after surgery | 
| Specificity of PREDICT score | The ability of the score to predict patients who did not experience recurrence after TME | 36 months after surgery |
Determining Drug Levels of Beta-lactam Antibiotics in Severe Burned Patients

Study Overview
=================
Brief Summary
-----------------
At antibiotic stewardship of the University Hospital of Schleswig-Holsten it was noticed that there are much less studies measuring drug levels in severe burned patients than are required. Especially, severe burned patient developing a capillary leak might show lower drug levels than patients without a capillary leak. To compare drug levels of beta-lactam antibiotics, it is the aim of this study to measure pharmacokinetics of Piperacillin/Tazobactam in ICU patients with and without severe burns.

Official Title
-----------------
Determining Drug Levels of Beta-lactam Antibiotics in Severe Burned Patients

Conditions
-----------------
Antibiotics, Severe Burn, Intensive Care

Intervention / Treatment
-----------------
* Diagnostic Test: Drug Level Monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: General Adult Receiving beta-lactam antibiotic Piperacillin/Tazobactam Antibiotic therapy of 3 or more days Given informed consent Group 1 Severe Burn Group 2 No Severe Burn Exclusion Criteria: Already in another Study No useful blood sample

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICU Patients with Severe Burns<br>Patients suffering from severe burns treated on a burn unit - Drug Level Monitoring Piperacillin/Tazobactam | Diagnostic Test: Drug Level Monitoring<br>* Free (unbound) drug concentration 1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admission<br>|
| ICU Patients without Burns - Drug Level Monitoring<br>Patient suffering from disease treated on an ICU - Drug Level Monitoring Piperacillin/Tazobactam | Diagnostic Test: Drug Level Monitoring<br>* Free (unbound) drug concentration 1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admission<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Free (unbound) drug concentration 1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admission | Free (unbound) drug concentration 1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admission | 1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admission |
Ultrasound Guided Sacral Erector Spina Plane Block as a Main Anesthetic Method

Study Overview
=================
Brief Summary
-----------------
The goal of this retrospective observational study is to demonstrate investigators' experience of Ultrasound guided Sacral Erector Spina Plane Block as an anesthetic technique in patients underwent sacral plastic and reconstructive surgeries. The main question[s] it aims to answer are: block indication, level results, side effects and complications

Detailed Description
-----------------
Erector Spina Plane Block is an interfascial plane block that is performed by injecting the local anesthetic solution between transverse process of the vertebra and erector spina muscle. It is found to be an inexpensive,easily applied, effective and safe technique for chronic pain.(1) Ultrasound guided Erector Spina Plane Block(ESP) is getting more and more widely used for analgesia and as an anesthetic technique.(2,3) Regional anesthesia techniques provide safer, more stable and advantageous anesthetic management, especially in high-risk patients. Ultrasound guided Sacral ESP is described by Tulgar et all.in 2019 and can be used either for analgesia or as an anesthetic technique. (4) In this retrospective study investigators planed to demonstrate one year of experience of this block for sacral plastic and reconstructive surgery. Demographic data of patients who underwent sacral surgery with sacral ESP block, indication of block, level of block, drug dose concentration, effect, side effect and results that were recorded will be analyzed.

Official Title
-----------------
Ultrasound Guided Sacral Erector Spina Plane Block as a Main Anesthetic Method: Single Center Experience

Conditions
-----------------
Anesthesia, Local

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: being going for a sacral surgery American Society of Anesthesiology status (ASA) 1 - 4 Exclusion Criteria: emergency ASA-5

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Block success | Effectiveness of Sacral Erector Spinae Plane Block as an Anesthetic technique | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and amount of required perioperative analgesic/anesthetic drugs | The number and amount of drugs administered will be determined from the anesthesia file records when the patient feels pain or shows dissatisfaction with anesthesia. | up to 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ESP, Anesthesia, Sacral
Effects of Liquid Zinc Supplementation and Dispersible Zinc Tablets on Plasma Zinc Concentration

Study Overview
=================
Brief Summary
-----------------
The study aims to compare the effects of two different formulations of zinc supplements on plasma zinc concentrations among young Burkinabe children.

Detailed Description
-----------------
1) To investigate the effects of short-term zinc supplementation, provided either as a dispersible tablet containing zinc sulfate (ZinCfant, Nutriset Ltd; Malaunay, France) or as a liquid ZnSO4 solution, on changes in serum zinc concentration, compared with a placebo in young Burkinabe children; and 2) to assess the relationship between change in serum zinc concentration and the presence of altered intestinal permeability within each treatment group.

Official Title
-----------------
The Effect of Zinc Supplementation, Provided as Either a Liquid Zinc Solution or Dispersible Tablets, on Plasma Zinc Concentration Among Young Burkinabe Children

Conditions
-----------------
Zinc Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: Liquid zinc syrup
* Dietary Supplement: Zinc tablet
* Dietary Supplement: Liquid placebo supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: currently breast feeding informed consent of a parent or guardian. Exclusion Criteria: symptomatic acute or chronic febrile infections diarrhea within the past week consuming vitamin or mineral supplements or zinc-fortified infant formulas

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 23 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zinc syrup<br>Liquid Zinc Syrup (ZnSO4) solution provided daily | Dietary Supplement: Liquid zinc syrup<br>* Liquid zinc syrup containing 5 mg zinc as zinc sulfate<br>* Other names: Phytofla, Banfora, Burkina Faso;|
| Experimental: Zinc tablet<br>Dispersible zinc tablets provided daily | Dietary Supplement: Zinc tablet<br>* Dispersible zinc tablet containing 5 mg zinc<br>* Other names: Nutriset S.A.S., France;|
| Placebo Comparator: Placebo<br>Liquid placebo supplement provided daily | Dietary Supplement: Liquid placebo supplement<br>* Liquid placebo supplement containing 0 mg zinc<br>* Other names: Phytofla, Banfora, Burkina Faso;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma zinc concentration |  | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
zinc supplement, prevention, zinc deficiency, plasma zinc concentration
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, randomized, double-blind, placebo-controlled, sequential rising single-dose study in which approximately 56 subjects with SLE will be enrolled in 7 dosing cohorts

Official Title
-----------------
Randomized, Multicenter, Double-Blind, Placebo-Controlled, Rising Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Drug: AMG 557
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of SLE with positive ANA Stable disease with no change in SLE therapy within the previous 30 days BMI from 18 to 38 kg/m2 Exclusion Criteria: Have had signs or symptoms of a viral, bacterial or fungal infection within 30 days of study randomization Evidence of renal disease or liver disease Any history of granulomatous disease including autoimmune granulomatous vasculitis and sarcoidosis Prior administration of any other biologic that primarily targets the immune system

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMG 557<br>AMG 557 administered as subcutaneous and intravenous doses. | Drug: AMG 557<br>* AMG 557 is for the treatment of sybjects with systemic lupus erythematosus<br>|
| Placebo Comparator: Placebo<br>No active drug | Drug: Placebo<br>* contains no active drug<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability | Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory safety tests, and ECGs | From 29 days to 169 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile of AMG 557 including Tmax, AUClast and Cmax | Serum concentration and derived PK parameters including Tmax, AUClast and Cmax | From 29 days to 169 days |