linjc16/ctgov huggingface dataset:
Multi-center, Single Arm, Observational Study to Evaluate the Safety of Dapagliflozin in Type 2 Diabetes Mellitus Patients in China

Study Overview
=================
Brief Summary
-----------------
DONATE study is a multi-center, prospective cohort, single arm, observational study to be performed in 3000 Chinese type 2 diabetes mellitus (T2DM) patients recruited from 100 tier 2 or 3 hospitals, China.It is a drug intense monitoring study required by China Food and Drug Administration (CFDA) to assess the newly approved drug in at least 3000 patients within the first five years after commercial launch. The primary objective is to demonstrate the safety of dapagliflozin by assessment of the incidence of adverse events and serious adverse events during 6-month follow up in Chinese patients with T2DM.

Official Title
-----------------
Multi-center, Single Arm, Observational Study to Evaluate the Safety of Dapagliflozin in Type 2 Diabetes Mellitus Patients in China

Conditions
-----------------
Type 2 Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of subject informed consent prior to any study specific procedures. Chinese, Female or male. T2DM diagnosed by physicians according to 2013 Chinese Guideline for Diabetes, ie. 1) Patients with typical syndrome and with a FPG ≥ 7.0mmol/L and/or random plasma glucose ≥ 11.1mmol/L; and/or, 2) patients without typical syndrome and with repeated FPG ≥ 7.0mmol/L and/or 2 hour post challenged plasma glucose ≥ 11.1mmol/L. Subjects who already took at least one dose of dapagliflozin, which is prescribed by physicians based on their clinical practice. The prescription of dapagliflozin is separated from the decision to be included in the current study or not. Exclusion Criteria: Being unable to comply with study-specified procedures. Participating in any other clinical trial currently or during the last 3 months. Previous enrolment in the present study.
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 |
| --- | --- | --- |
| Incidence of adverse events | The adverse event will be collected and coded using latest version of MedDra. The incidence of adverse events will be presented using the number and percentages by System Organ Class and Preferred Term. | within 6-months |
Efficacy of Topiramate for Hospitalized Patients With Alcoholism

Study Overview
=================
Brief Summary
-----------------
This is a 12-Week, randomized controlled study of topiramate in hospitalized patients with alcoholism

Official Title
-----------------
Efficacy of Topiramate for Hospitalized Patients With Alcoholism: a 12-Week Randomized, Placebo-Controlled Trial

Conditions
-----------------
Alcohol Dependence

Intervention / Treatment
-----------------
* Drug: Topiramate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients hospitalized due to alcohol-related problem DSM-IV-TR alcohol dependence for male: history of alcohol drink >=35/week, female: history of alcohol drink >=28/week for at least 1 week during four weeks prior to the admission AUDIT score at least 8 mild or no alcohol withdrawal symptom BMI > 18 kg/m2 not pregnant and no plan for pregnancy intention to decrease or stop drinking Exclusion Criteria: severe psychiatric and cognitive disorders other substance dependence, except nicotine and caffeine dependence, during 6 months prior to enrollment taking antipsychotics, mood stabilizers, anticonvulsants, opioid analgesics, systemic steroids, carbonic anhydrase inhibitors, hydrochlorthiazide, metformin, pioglitazone, or disulfiram unstable medical condition medical history of narrow angle glaucoma, renal impairment, kidney stones, and seizures moderate to high risk of suicide under legal process plan to receive a formal treatment for alcoholism from other treatment settings pregnancy and nursing woman abnormal laboratory tests, including blood urea nitrogen, creatinine, electrolytes, and fasting blood sugar

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topiramate<br> | Drug: Topiramate<br>* Topiramate 100-300 mg/day orally twice per day<br>* Other names: Topamax;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol drink/day | Alcohol drink/day assessed by the use of time line follow back | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Common adverse effect | Common adverse effect will be assessed by the use of questionaire and self-report | 12 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alcohol dependence, Alcoholism, Topiramate
Martial Arts Therapy in Autism Spectrum Disorders

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study was to determine whether teaching Karate techniques training leads to reduction in communication deficit of children with autism spectrum disorders.

Official Title
-----------------
The Effect of Karate Techniques Training on Communication Deficit of Children With Autism Spectrum Disorders

Conditions
-----------------
Autism Spectrum Disorders

Intervention / Treatment
-----------------
* Other: physical exercise- based intervention (Karate techniques training)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals diagnosed as autism spectrum disorders according to the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition, Text Revision. Age range in 5 to 16. Exclusion Criteria: Not participating in up to 3 intervention sessions.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 16 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>physical exercise- based intervention (Karate techniques training) | Other: physical exercise- based intervention (Karate techniques training)<br> <br> |
| No Intervention: Control<br>Not participating in physical exercise- based intervention (Karate techniques training) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Raw score of communication subscale of Gilliam Autism Rating Scale-Second Edition (GARS-2) as the measure of communication deficit |  | within the first 30 days after termination of intervention |
The Psychological Effect of the Covid-19 Pandemic

Study Overview
=================
Brief Summary
-----------------
At the end of 2019, the novel coronavirus disease (Covid-19), which emerged in China, has become a public health emergency of international concern. Disease outbreaks both affect the physical and psychological health of individuals. The aim of this study was to investigate the levels of stress, anxiety, depression, and Covid-19 fear in health sciences intern students during the Covid-19 pandemic.

Official Title
-----------------
The Psychological Effect of the Covid-19 Pandemic on Turkish Intern Students

Conditions
-----------------
Psychological Distress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for students: be over 18 years old have taken the professional practice/internship lecture be practicing in the hospital not have any disease Inclusion Criteria for control: over the age of 18 without any disease who routinely work during the pandemic Exclusion Criteria: body mass index (BMI) <17 kg/m2 any chronic illness, psychological disorder, and perception problem be dental operation or significant damage to the teeth or oral mucosa

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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 |
| --- | --- |
| student group<br>have taken the professional practice/internship lecture and be practicing in the hospital | |
| control group<br>who routinely work during the pandemic | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Fear of Covid-19 Scale (FCV-19S) | FCV-19S is an assessment instrument developed to measure the fear levels of individuals due to Covid-19. | 5 minutes | 
| Depression Anxiety and Stress Scale (DASS) | DASS is a self-report scale that evaluates depression, anxiety, and stress state over the past week. | 10 minutes | 
| Saliva cortisol level | The solid-phase sandwich ELISA (Enzyme Linked-Immuno-Sorbent Assay) method was used with immunoassay kits to measure the cortisol level. | 15 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psychological distress, Covid-19, saliva cortisol
Urine pH and Urinary Tract Infection

Study Overview
=================
Brief Summary
-----------------
Urinary tract infections (UTI) affect the urine pH and may lead to salt precipitation such as struvite. Bacteria with urease activity are known to alkalinise urine, but not much is known on how pH is changing over time during UTI. This study aims at following urine pH progression at the time of diagnosis of UTI and during the treatment phase. Description of the change in urine pH over time will help understanding the risk of struvite formation and potential timing of intervention.

Detailed Description
-----------------
Adults presenting with UTI symptoms will be screened for infection and instructed to monitor urine pH during the course of treatment and 1 week after. Urine pH will be measured by the patients using calibrated pH-stix. Type of bacteria, antibiotics, and the type of diet will be monitored during the study.

Official Title
-----------------
Consequences of UTI on Urine pH

Conditions
-----------------
Urinary Tract Infections, Urinary Stone

Participation Criteria
=================
Eligibility Criteria
-----------------
Group 1. Cystitis Inclusion Criteria: Symptoms of dysuria, pollakiuria, no fever AND urine-stix positive for leucocytes OR positive culture (>10E5 cfu/ml) Group 2. Pyelonephritis Inclusion Criteria: Unilateral flank pain, pollakiuria, dysuria, fever (>38.5°C) AND urine-stix positive for leucocytes OR positive culture (>10E5 cfu/ml) Exclusion Criteria (both groups): known urinary tract anatomic abnormalities Presence of a urine catheter Sepsis - septic shock Patient taking drug interfering with urine pH (diuretics, citrate, acetazolamide, topiramate,...) Patients with UTI diagnosed in the preceding month Patients having received antibiotics during the preceding month Male patient with a diagnosis of prostatitis Presence of infected kidney cyst Patient with diabetes Pregnant female Patient with obstructive pyelonephritis

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cystitis<br>Patients with lower UTI will be included in this group | |
| Pyelonephritis<br>Patients with higher UTI will be included in this group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine pH | Urine pH is monitored by the patient every morning during the treatment phase and 7 days after the end of treatment | 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urine pH
OCT-A and Amblyopia

Study Overview
=================
Brief Summary
-----------------
Detect changes in retinal vessel density in the superficial and deep capillary plexuses using OCTA in children with anisometropic amblyopia

Official Title
-----------------
Assessment of Macular Microvascular Changes Following Amblyopia Treatment in Children With Anisometropic Amblyopia Using Optical Coherence Tomography Angiography

Conditions
-----------------
Amblyopia

Intervention / Treatment
-----------------
* Diagnostic Test: Optical Coherence tomography angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral anisometropia. Refractive error less than -6.00 D and +4.00 D. Age less than 12 years. No previous amblyopia treatments Exclusion Criteria: 1. High refractive error. 2. Bilateral amblyopia. 3. Age more than 12 years. -

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 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 |
| --- | --- |
| Amblyopic eye group<br> | Diagnostic Test: Optical Coherence tomography angiography<br>* Measurement retinal vessel density in the superficial and deep capillary plexuses using OCTA in children with anisometropic amblyopia<br>|
| Sound eye group<br> | Diagnostic Test: Optical Coherence tomography angiography<br>* Measurement retinal vessel density in the superficial and deep capillary plexuses using OCTA in children with anisometropic amblyopia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in retinal vessel density | Detect changes in retinal vessel density in the superficial and deep capillary plexuses using OCTA in children with anisometropic amblyopia and effect of treatment on the retinal vessel density | 3 months |
Renal Tubular Acidosis in Incident Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
Metabolic acidosis is a common complication in incident renal transplant recipients. Protracted acidosis may be associated with osteoporosis, inflammation, negative protein balance and malnutrition, and last but not least may cause renal dysfunction. Preliminary data indicate an increased prevalence of nephrocalcinosis in renal transplant biopsies of incident patients presenting with metabolic acidosis. The present study aims (1)evaluate the prevalence and type of renal tubular acidosis (RTA) in incident renal transplant recipients and to identify clinical correlates and (2) to find associations between RTA, nephrolithiasis and nephrocalcinosis

Official Title
-----------------
Renal Tubular Acidosis in Incident Renal Transplant Recipients

Conditions
-----------------
Renal Transplant Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recipient of a single kidney transplant included in the protocol biopsy program. eGFR > 30 ml/min Age ≥ 18 years Written informed consent Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
kidney, transplantation, metabolic acidosis, renal tubular acidosis, nephrocalcinosis
Improving Human Ovarian Transplantation

Study Overview
=================
Brief Summary
-----------------
we will perform xenotransplantation and in vitro culture of ovarian tissue from patients undergoing ovarian cortex cryopreservation.

Detailed Description
-----------------
Ovarian tissue is removed by laparoscopy and only in patients facing premature ovarian failure due to chemotherapy.Tissue for research will consist either of a small portion (<10%) of the cortex for preservation for young women. another source of ovarian tissue for research will be obtained following consent from family of patients who have died of the disease and have previously frozen ovarian tissue.

Official Title
-----------------
Phase 1 Study to Improve Results of Human Ovarian Transplantation

Conditions
-----------------
Fertility Preservation

Intervention / Treatment
-----------------
* Procedure: ovarian transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: tissue previously obtained Exclusion Criteria: no tissue available or no consent

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ovarian transplantation<br>tissue will be used for xenotransplantation or in vitro culture | Procedure: ovarian transplantation<br>* ovarian xenotransplantation or in vitro culture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improving folliculogenesis and oocuyte maturation after ovarian transplantation |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ovary, human, transplantaion, ovarian failure
Examination of the Pancreas in New-onset Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to create a prospective cohort of subjects with increased probability of being diagnosed with pancreatic cancer and then screen this cohort for pancreatic cancer

Detailed Description
-----------------
Compared to the general population, subjects >50 years of age with new-onset diabetes (DM) are 8-times more likely to have pancreatic cancer (PaC). The likelihood of PaC in new-onset DM is further increased in those who have weight loss or elevated CA19-9. In this study patients with newly diagnosed diabetes will be prospectively identified. Those with weight loss and/or elevated pancreatic cancer marker (CA 19-9) will undergo pancreatic imaging. All subjects will be followed up to 24 months. If successful in identifying surgically removable PaC, this study will fundamentally change our practice and will be a major breakthrough in PaC treatment and research.

Official Title
-----------------
Examination of the Pancreas in New-onset Diabetes (EXPAND Study)

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: medical chart review
* Other: survey administration
* Other: Specimen collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Patient Characteristics: --Suspected or definite new-onset diabetes based on recent blood sugar and hemoglobin A1c values No acute illness or steroid therapy No prior pancreas surgery

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: medical chart review|baseline, quarterly follow-up for 24 months|
|Other: survey administration|baseline|
|Other: Specimen collection|baseline|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To create a prospective cohort of subjects with increased probability of being diagnosed with pancreatic cancer and identify pancreatic cancer in this cohort. | We will prospectively identify patients with newly diagnosed diabetes and perform pancreatic imaging to identify pancreatic cancer | Follow subjects for 2 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreatic cancer, new-onset diabetic, diabetes