linjc16/ctgov huggingface dataset:
Evaluation of Glycemic Control Using Adjunctive Continuous Glucose Monitoring With the Dexcom G4 System

Study Overview
=================
Brief Summary
-----------------
This is a prospective, non-randomized, observational study conducted in the United States.Up to sixty (60) subjects will be enrolled. The purpose of the study is to evaluate long-term utility and usability of Dexcom G4 Continuous Glucose Monitoring (CGM) System. Subjects will be followed monthly over a period of one year.

Official Title
-----------------
Evaluation of Glycemic Control Using Adjunctive Continuous Glucose Monitoring With the Dexcom G4 System - GLYCOAIM Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Require intensive insulin therapy, defined as use of Continuous Subcutaneous Insulin Infusion (CSII) i.e. insulin pumps or multiple daily injections (MDI. Willing to refrain from use of any acetaminophen - containing (ACT) medication during the study, up to 24-hours before the initial sensor insertion. Exclusion Criteria: Have extensive skin changes/ diseases that preclude wearing the device. Dialysis.

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 |
| --- | --- | --- |
| Evaluate the Dexcom G4 system utility and usability during home use. | The primary object of the study is to evaluate the Dexcom G4 system utility and usability during home use. Variables to be evaluated are sensor used, length of use, and data capture during use. | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus
Early Intervention, Supervision, Quality and Outcome in ASD

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to examine the significance of knowledge of autism spectrum disorder (ASD), and early intensive behavioral intervention, as well as trust in EIBI, adequate assessment of EIBI quality, and EIBI supervision on EIBI intervention outcome in ASD.

Official Title
-----------------
Quality and Efficacy of Early Intensive Autism Intervention: a Matter of Trust, Knowledge, and Supervision?

Conditions
-----------------
Autism Spectrum Disorder

Intervention / Treatment
-----------------
* Behavioral: Early Intensive Behavioral Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of ASD (ICD-10), ongoing EIBI program Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic RCT
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Tailored supervision<br> | Behavioral: Early Intensive Behavioral Intervention<br> <br> * Other names: Applied Behavior Analysis;|
| Other: Regular supervision<br> | Behavioral: Early Intensive Behavioral Intervention<br> <br> * Other names: Applied Behavior Analysis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| York Measure of Quality of Behavioural Intensive Intervention (YMQI) |  | Change is assessed from baseline (probe 1) to probe 2 (2-3 months), and probe 3 (4-6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vineland Adaptive Behavior Scales (VABS) |  | Change is assessed from baseline (probe 1) to probe 2 (2-3 months), and probe 3 (4-6 months) | 
| Social Responsiveness Scale (SRS) |  | Change is assessed from baseline (probe 1) to probe 2 (2-3 months), and probe 3 (4-6 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allegiance, Knowledge, Supervision, Early intervention, Autism
Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate if retarded phosphatidylcholine is as effective as mesalazin in preventing an acute episode in ulcerative colitis. The hypothesis is, that ulcerative colitis is cuased by a defect in the barrier function of the colonic mucus. The background of the study is the finding that the phosphatidylcholine content of the colonic mucus is reduced in patients with ulcerative colitis, in both healthy and inflamed parts of the colon.

Official Title
-----------------
Prospektive, Randomisierte, Doppelblinde, Mesalazin-kontrollierte (Double-dummy Verfahren) Multizenter-Studie Zur Beurteilung Der Annahme Der äquivalenten Wirkung Von Intestinal Retardiert Freigesetztem Phosphatidylcholin gegenüber Mesalazin (Non-inferiority Study) in Der Remissionserhaltung Der Colitis Ulcerosa.

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: retarded release phosphatidylcholine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of ulcerative colitis in remission (CAI 3 or less) signed letter of content no steroids or immunosupressants in the last 6 weeks at least 5 relapses in the last 3 years last relapse was 8 months ago or less complete colonoscopy at entry Exclusion Criteria: pregnancy or breast feeding steroids or immunosuppressants acute episode of UC condition after complete or partial colektomy known intolerance to mesalazin severe medical disease other than colitis

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: retarded release phosphatidylcholine|2g daily, given orally QTD|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of relapses |  |  | 
| relapse is defined as an increase of the clinical Rachmilewitz index to 5 or more, but at least 3 points over a period of 14 days |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to the first relapse |  |  | 
| amount of relapses per year |  |  | 
| endoscopic index |  |  | 
| histolgical score |  |  | 
| life quality |  |  | 
| side effects |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
remission, mesalazin, non-inferiority study, relapse
Topical AS101 for Treatment of FAGA (Female Androgenetic Alopecia) in Menopause Women

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the safety and efficacy of topical AS101 as treatment for Female Androgenetic Alopecia (FAGA) in menopause women.

Official Title
-----------------
Phase 2 Study of Topical AS101 for the Treatment of FAGA (Female Androgenetic Alopecia) in Menopause Women

Conditions
-----------------
Alopecia

Intervention / Treatment
-----------------
* Drug: AS101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women in menopause, over 50 years of age. Clinically diagnosed for AGA, according to Ludwig scale I-II. Exclusion Criteria: Women treated with chronic medications. Use of Minoxidil within 3 months prior to entering study. Women who have underwent hair transplantation. Use of drugs with androgenic or anti-androgenic effects. Any other type of hair loss.

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

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

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

| Intervention/Treatment |
| --- |
|Drug: AS101|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hair density |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hair diameter, anagen/telogen ratio and hair growth rate,Global photographic assessment according to Female-Ludwig scale, |  |  | 
| Self-administered satisfaction questionnaire |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Androgenetic Alopecia, Telogen effluvium, Chronic telogen effluvium, Menopause, Female Androgenetic Alopecia (FAGA)
Topical Tacrolimus 0.03% Ointment for Intractable Allergic Conjunctivitis: An Open Label Pilot Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy, tolerance and safety of tacrolimus 0.03% ointment in the treatment of intractable allergic conjunctivitis.

Conditions
-----------------
Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Drug: Tacrolimus 0.03% ointment (Protopic)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects included if they were > 5 years old and suffered from intractable allergic conjunctivitis Exclusion Criteria: pregnancy or breastfeeding,history of herpetic eye disease,transplant patients concomitant administration of drugs inhibiting cytochrome CYP3A4, hypersensitivity to macrolides

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tacrolimus 0.03% ointment (Protopic)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Impact of Highest Drain Fluid Amylase Levels on Surgical Outcomes and Postoperative Interventions in Patients Undergoing Pancreaticoduodenectomy

Study Overview
=================
Brief Summary
-----------------
This study investigated the impact of highest drain fluid amylase (DFA) level on postoperative pancreatic fistula (POPF) severity and outcomes of patients undergoing pancreaticoduodenectomy (PD) with POPF. Patient demographics of biochemical POPF and clinically relevant POPF (CR-POPF) were compared. Predictive factors were assessed using binary logistic regression. Receiver operating characteristic curve analysis was performed to determine the optimal cutoff value of highest DFA (beyond 3 days post-PD). The investigators compared length of hospital stay, surgical mortality rates, and need for postoperative interventions by highest DFA level.

Official Title
-----------------
Significance of Drain Amylase Levels After Pancreaticoduodenectomy

Conditions
-----------------
Pancreas; Fistula

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: underwent PD from October 2010 to September 2018 in our institution Exclusion Criteria: younger than 20 years of age clinical information was unavailable due to private or legal issues receiving PD without pancreaticojejunostomy

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pancreatic fistula | fluid output of any measureable volume via an operatively placed drain with amylase activity greater than 3 times the upper normal serum value | through study completion, an average of 2 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative interventions | transarterial embolization, image-guided second drainage, and reoperation | through study completion, an average of 2 month | 
| length of hospital stay |  | through study completion, an average of 2 month | 
| 30-day mortality rates |  | 30 day |
Survey of Lipid Goal Attainment and Mortality in Patients With High Cardiovascular Risk in Thailand

Study Overview
=================
Brief Summary
-----------------
The first phase of the study is a hospital-based cross-sectional, epidemiological survey. The required sample size is 1,260 patients from 50 hospitals across Thailand. Each of the hospital will enroll 10 to 40 consecutive patients, depending on case availability on the date conducting the survey, with dyslipidemia and classified as high risk as defined by the protocol. Lipid levels will be based on serological analysis conducted by a local laboratory. For the second phase, each subject will be followed for survival status at 36 months after enrollment. Such follow-up will be done by searching the Thai National Vital Event Registration Database using subjects' Population Identification Number. All activities regarding case selection and data collection will be done by well trained clinical research associates (CRAs). The CRAs are from Khon Kaen University where the Statistical Coordinating Center (SCC) for this project is based and are independent of the investigator. Random auditing visits will also be performed by auditors independent of the SCC. These are to ensure not only high quality data but also protecting right and well being of subjects.

Official Title
-----------------
Lipid-lowering Therapy in Patients With High Cardiovascular Risk and Their 3-year Mortality Rate in General Practice in Thailand

Conditions
-----------------
Dyslipidemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Evidence of high cardiovascular risk Dyslipidemic currently being treated with the same therapy for at least 3 months Exclusion Criteria: Recent major trauma(within 12 weeks) Recent surgery requiring anesthesia including coronary bypass graft(within 12 weeks) Acute or abrupt change(within 1 month) in usual diet Pregnancy, breast-feeding currently, or postpartum within the last 6 months

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| 1<br>Patients with high cardiovascular risk who have been treated with lipid-lowering drugs at least 3 months | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-cholesterol |  | June2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | June 2011 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lipid-lowering
A Clinical Study Evaluating the Safety and Efficacy of SI-614 Ophthalmic Solution in Patients With Dry Eye.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and effectiveness of SI-614 solution compared with placebo solution in treating patients with dry eye.

Official Title
-----------------
A Multicenter, Randomized, Double-masked and Placebo-controlled Study Evaluating the Efficacy and Safety of SI-614 Ophthalmic Solution in Patients With Dry Eye

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Drug: SI-614
* Drug: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 18 years of age Have provided written informed consent Have dry eye in both eyes Exclusion Criteria: Use of contact lenses Have an uncontrolled systemic disease Have an uncontrolled psychiatric condition, or substance or alcohol abuse Women who is pregnant, nursing or planning a pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 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: SI-614<br> | Drug: SI-614<br>* 1 drop in each eye<br>|
| Placebo Comparator: Placebo Vehicle<br> | Drug: Vehicle<br>* 1 drop in each eye<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal staining score |  | Up to 28 days | 
| Symptom score |  | Up to 28 days |
Institut Paoli Calmettes Thyroid Cancer Database

Study Overview
=================
Brief Summary
-----------------
Database of Institut Paoli-Calmettes patients diagnosed with thyroid cancer

Official Title
-----------------
Institut Paoli Calmettes Thyroid Cancer Database

Conditions
-----------------
Thyroid Neoplasms

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of thyroid cancer Exclusion Criteria: Non applicable

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 thyroid cancer diagnosis<br> | Other: Data collection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of patients | Overall survival of all patients who come in the center | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of patients characteristics | Collection of characteristics of patients treated at Institut Paoli Calmettes in order to set up prospective and retrospective studies | 10 years |
Gene Polymorphism in Tinea Versicolor

Study Overview
=================
Brief Summary
-----------------
Blood samples will be taken from cases presenting with recurrent tinea versicolor , after confirmation of diagnosis by wood's light and KOH examination, for the detection of gene polymorphism in IL17 A and IL17 F. In addition , serum samples from patients and controls will be tested for 25(OH)2 D3

Official Title
-----------------
Detection of IL1-7A and IL-17F Gene Polymorphism in Pityriasis Versicolor and Its Relation to Susceptibility to Infections.

Conditions
-----------------
Recurrent Pityriasis Versicolor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients with recurrent pityriasis versicolor (active now) and not taking treatment for it. Patients of both genders. Age ≥18 years old. Exclusion Criteria: - Patients with other cutaneous diseases. Patient's having dandruff (scaly scalp) even if not symptomatizing. Pregnant and lactating females, children, prisoners, cognitively impaired or mentally disabled subjects. Patients with autoimmune diseases. Patients with immunodeficiency diseases. Immunosuppressed patients e.g. HIV, diabetics, organ transplant, malignancy, patients taking immunosuppressive drugs e.g. chemotherapy, cortisone.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with recurrent pityriasis versicolor<br> | |
| Healthy age and sex-matched controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL 17A gene polymorphism | IL 17A | 6months-1 year | 
| IL 17 F gene polymorphism | IL 17 F | 6months-1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D | Serum 25(OH)2 D3 | 6months-1 year |