linjc16/ctgov huggingface dataset:
Treatment of Vasomotor Symptoms in Korean Post Menopausal Women

Study Overview
=================
Brief Summary
-----------------
Study to demonstrate that the therapeutic efficacy of Angeliq® is better than placebo in Korean postmenopausal women with hot flushes and other climacteric symptoms. Safety and tolerability of Angeliq.

Official Title
-----------------
A Double-blind, Randomized, Placebo-controlled, Multicenter Study Investigating the Efficacy and Tolerability of Angeliq(drospirenon2mg and Estradiol 1mg) in Postmenopausal Korean Women With Vasomotor Symptoms Over 3, 28 Day Treatment Cycle

Conditions
-----------------
Vasomotor Symptoms

Intervention / Treatment
-----------------
* Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal Korean women suffering from hot flushes Exclusion Criteria: Standard exclusion criteria for HRT clinical trials had to be obeyed, including current or history of hormone dependent malignant disease, thromboembolic disorders, abnormal cervical smear, undiagnosed vaginal bleeding.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* Placebo treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.<br>|
| Experimental: Arm 1<br> | Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)<br>* Treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hot flush (frequency and severity) |  | Daily in pre-treatment and treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menopausal symptoms |  | Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment | 
| Urogenital symptoms |  | Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment | 
| Assessment of bleeding |  | daily in pre-treatment and treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vasomotor symptoms, Vasomotor System
Gut Hormones After Oral Versus Intravenous Amino Acids

Study Overview
=================
Brief Summary
-----------------
The study hypothesis is that gut hormones are released after oral but not intravenous amino acids which result in stimulation of insulin secretion.

Detailed Description
-----------------
Amino acid mixture is given orally or intravenously to match total concentrations of amino acids in healthy subjects. Samples are taken regularly for 300 min after administrations. Plasma levels of the gut hormones glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1)and determined and related to plasma levels of insulin and glucagon.

Official Title
-----------------
Release of Gut Hormones After Oral Versus Intravenous Amino Acids

Conditions
-----------------
Normal Non-fluency

Intervention / Treatment
-----------------
* Other: Oral amino acid mixture
* Other: Intravenous amino acid administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects Exclusion Criteria: Diabetes Liver disease Kidney disease Thyroid disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral amino acid mixture<br>Oral administration of amino acid mixture in healthy volunteers | Other: Oral amino acid mixture<br>* Amino acid mixture 2,93 ml/kg<br>* Other names: Amino acid mixture;|
| Experimental: Intravenous amino acid administration<br>Intravenous infusion of amino acid mixture in healthy volunteers | Other: Intravenous amino acid administration<br>* Amino acid mixture 2,93 ml/kg<br>* Other names: Amino acid mixture;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut hormone secretion |  | 300 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin secretion |  | 300 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gut hormones, Insulin secretion, Normal physiology
CrescNet - Growth Monitoring Network

Study Overview
=================
Brief Summary
-----------------
CrescNet is a network of primary care physicians and pediatricians (n=219) and endocrinological treatment centers (n=33), established in Leipzig in 1998, whose aim is to improve the early detection of growth disorders. Secondary to this clinical aim, epidemiological analyses, for example on secular trends of growth data of children, are performed.

Detailed Description
-----------------
Pediatricians participating in CrescNet provide pseudononymized data on patients' height, weight, and head circumferences to the CrescNet registry. Growth data are evaluated by automatized filter algorithms and by a pediatric endocrinologist. CrescNet does not have access to patients or personal patient data. Each participating pediatrician receives a quarterly screening report with recommendations for the work-up of children with abnormal growth or abnormal development of weight or body mass index. The data registry is used for scientific purposes.The collection of data from healthy children allows the generation of evidence based statements about prevalence rates of growth disorders and also about the rates in disorders of weight development. For this, data are provided completely anonymized without allowing conclusions on personal patient data.

Official Title
-----------------
CrescNet - Computer-guided, Population-based Surveillance System for Growth Disorders

Conditions
-----------------
Obesity, Child Development, Growth Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Population based sample with inclusion of any patient seen by primary care or institutional physician/pediatrician, regardless of the objective for the visit (well child visits, acute visits or special requests) Exclusion Criteria: none

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| growth disorders | Early detection of growth disorders in childhood and adolescent development. For this, not only absolute data but also growth velocity data are evaluated. | 18 years | 
| obesity | detection of critical age periods for the development of obesity. For this, not only absolute data but also growth velocity data are evaluated. | 18 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
growth, BMI, obesity, childhood, adolescence, development
Determinants of Efficacy of EsophyX Treatment in Gastro-Esophageal Reflux Disease

Study Overview
=================
Brief Summary
-----------------
EsophyX is a promising endoscopic treatment for gastro-esophageal reflux disease. It is not known whether there are some pre- or per-operative anatomic or pathophysiological findings which may influence outcome. The aim of this trial is to study a series of parameters acquired during the pre-therapeutic work-up or during the procedure and their influence on the outcome of the procedure.

Official Title
-----------------
Determinants of Efficacy of EsophyX Treatment in Gastro-Esophageal Reflux Disease

Conditions
-----------------
Gastroesophageal Reflux Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients being considered for EsophyX treatment of GERD

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
Oral Glyceryl Triacetate (GTA) in Newborns With Canavan

Study Overview
=================
Brief Summary
-----------------
Canavan disease is caused by Aspartoacylase deficiency. There is no treatment for the disease, but there is a food additive that includes acetate . We suggest an early treatment with acetate and a neurologic evaluation, including MRI, after 4 months of treatment. In any case the treatment will be stopped at the age of 22 months, when myelinization is ended.

Official Title
-----------------
Oral Glyceryl Triacetate (GTA) in Newborns With Canavan

Conditions
-----------------
Canavan Disease

Intervention / Treatment
-----------------
* Dietary Supplement: GTA (Glyceryl triacetate)
* Drug: GTA glyceryl triacetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of Canavan disease Exclusion Criteria: Age above 18 months

Ages Eligible for Study
-----------------
Maximum Age: 18 Months

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

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

| Intervention/Treatment |
| --- |
|Dietary Supplement: GTA (Glyceryl triacetate)|0.5 gr/kg x2/day syrup two times a day with increasing dose each 3 days till max 5gr /kg each day for 6 months|
|Drug: GTA glyceryl triacetate|0.5 gr/kg twice a day with increase of 0.5 gr/kg every 3 days up to 5 gr/kg|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| brain MRI at the end of the study |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
babies with canavan disease
BRacelet And Physical actiVity Evaluation (BRAVE)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to quantify pre- and postoperative physical activity of patients operated on colorectal surgery. Daily physical activity (No. of footsteps) is going to be recorded from 15 days before surgery to the end of hospitalization after surgery in a prospective cohort of consecutive colorectal patients by use of an attached strap. Then, the investigators will propose physical activity thresholds (adapted to the age, gender and patient comorbidities) to optimize the ERAS protocol (Enhanced Rehabilitation After Surgery). Thus, this analysis will allow the investigators to provide patients with physical rehabilitation programs a la carte during a hospitalization for colorectal surgery. Connected bracelets will directly involve patients in their care and rehabilitation.

Detailed Description
-----------------
Connected bracelet will be given to 50 consecutive patients undergone colorectal surgery 15 days before surgery. The investigators will measure pre- and postoperative physical activity. It is an observational activity of patient's physical activity during the perioperative period with no intervention.

Official Title
-----------------
Evaluation of Pre- and Post-operative Physical Activity on Postoperative Rehabilitation After Colorectal Surgery With a Connected Device

Conditions
-----------------
Physical Activity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patients with a colorectal surgery Exclusion Criteria: Limitation of linguistic or cognitive abilities, interfering with the understanding of the study protocol Lack of consent of the study form Emergency Surgery stoma closure

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 |
| --- | --- |
| Connected bracelet<br>Patients with a colorectal surgery planned will be included. Fifteen days before surgery, patients will have a connected bracelet permitting to quantify the number of steps and distance achieved each day before surgery. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre- and postoperative physical activity | Number of footsteps | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | score (number between 0 to 10) | 30 days | 
| Quality of sleep | Score (number between 0 to 10) | 30 days | 
| Pain | Score (number between 0 to 10) | 30 days | 
| Fatigue | Score (number between 0 to 10) | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
connected bracelets, footsteps
Comparison of the Effect of 4th Generation Fluoroquinolones, Gatifloxacin and Moxifloxacin, on Epithelial Healing Following Photorefractive Keratectomy (PRK), A Substudy of: Initial Evaluation of Excimer Laser Keratorefractive Surgery in U.S. Army Personnel (WU # 2335-99)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is a prospective,double-blinded, randomized trial to compare the rate of healing following PRK after the use of two commercially available 4th generation fluoroquinolones, moxifloxacin and gatifloxacin.

Conditions
-----------------
Epithelium, Corneal

Intervention / Treatment
-----------------
* Drug: Moxifloxacin
* Drug: Gatifloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Manifest refraction spherical equivalent (MSE) of up to -6.00 diopters (D) at the spectacle plane with refractive cylinder up to 3.00D. Exclusion Criteria: Concurrent topical or systemic medications that may impair healing including corticosteroids, antimetabolites, isotretinoin, amiodarone hydrochloride and/ or sumatripin. Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course. Anterior basement membrane dystrophy. History of recurrent epithelial erosion. Significant dry eye (symptomatic sith Schirmer <5mm at 5 minutes) Other corneal epithelial disorder or healing abnormality

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moxifloxacin<br>Moxifloxacin eye drops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery | Drug: Moxifloxacin<br>* 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery<br>|
| Experimental: Gatifloxacin<br>Gatifloxacin eyedrops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery | Drug: Gatifloxacin<br>* 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Epithelial Healing Time | patients' eyes will be observed daily after surgery until the corneal epithelium has completely healed (usually 3 to 4 days) | 3 to 4 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Removal of corneal epithelium followed by excimer laser treatment during prk
Intravitreal Bevasizumab Versus Intravitreal Triamcinolone in Branch Retinal Vein Occlusion

Study Overview
=================
Brief Summary
-----------------
This randomized clinical trial is conducted to evaluate the effect of three intravitreal injections of bevasizumab versus two intravitreal injections of triamcinolone in acute retinal vein occlusion. The outcomes are visual acuity and central macular thickness. The follow-up time is 6 months.

Official Title
-----------------
Three Injections of Intravitreal Bevasizumab Versus Two Injections of Intravitreal Triamcinolone in the Management of Branch Retinal Vein Occlusion

Conditions
-----------------
Branch Retinal Vein Occlusion

Intervention / Treatment
-----------------
* Drug: Bevacizumab
* Drug: Triamcinolone Acetonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recent onset (less than 3 months) BRVO Exclusion Criteria: Any previous intervention
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravitreal bevacizumab<br> | Drug: Bevacizumab<br>* Intravitreal, 1.25 mg, 3 times, one month apart.<br>|
| Active Comparator: Intravitreal triamcinolone<br> | Drug: Triamcinolone Acetonide<br>* Intravitreal, 2 mg, 2 times, two months apart.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| central macular thickness |  | 6 months |
T-cell Subsets in Rheumatoid Arthritis Patients on Long-term Anti-TNF or IL6-receptor-blocker Therapy

Study Overview
=================
Brief Summary
-----------------
Data on the impact of biological therapies, especially of IL6-blocker treatment, on the T-cell phenotype in rheumatoid arthritis (RA) are limited, inconclusive, and mainly involve short-term follow-up. Here, the investigator prospectively measure the percentages of 15 circulating T-cell subtypes using flow cytometry. The investigators aim to obtained transversal and longitudinal data in 30 anti-TNF responders, 19 secondary anti-TNF-non-responders, 43 IL6R-antagonist-responders before, 8 weeks and, after, at least, 6 months of biological therapy. These are then compared with results obtained in early, untreated RA patients and gender-and-age matched healthy controls.

Official Title
-----------------
T-cell Subsets in Rheumatoid Arthritis Patients on Long-term Anti-TNF or IL6-receptor-blocker Therapy

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for patients: Diagnosis of rheumatoid arthritis classified according to the 2010 ACR/EULAR classification criteria for RA Biological treatment with anti-TNF therapy (adalimumab or certolizumab pegol or etanercept or infliximab or golimumab) or anti-IL-6R agent (tocilizumab) Inclusion Criteria for healthy controls: negative history of RA symptoms negative status upon detailed physical and laboratory examination including normal CRP and ESR values Exclusion Criteria: other autoimmune comorbidity lack of informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Healthy control<br> | Other: No intervention<br>* Observational study<br>|
| RA patients on anti-TNF therapy<br> | |
| RA patients on anti-IL-6R therapy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow cytometry for the assessment of change in T cell subtypes | The percentages of 15 circulating T-cell subtypes were measured using flow cytometry. | Before, after 8 weeks and after at least 6 months of the initiation of biological therapy. |
Insulin Sensitivity of the Brain in Pathogenesis of Diabetes Mellitus Type 2

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate whether insulin sensitivity of the human brain correlates with insulin sensitivity of the liver.

Official Title
-----------------
Insulin Sensitivity of the Brain in Pathogenesis of Diabetes Mellitus Typ 2

Conditions
-----------------
Human Physiology of Energy Homeostasis

Intervention / Treatment
-----------------
* Drug: Human insulin
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-70 Risk factor(s) for type 2 diabetes (e.g. overweight, family history of diabetes) Exclusion Criteria: Type 2 diabetes pregnancy acute or chronic diseases

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: I<br> | Drug: Human insulin<br> <br> |
| Placebo Comparator: P<br> | Drug: Saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin effect on cortical function (spectral analysis) |  | 2 weeks |