linjc16/ctgov huggingface dataset:
Treatment of Screen-detected Celiac Disease

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to evaluate the natural history of celiac disease in asymptomatic, screen-detected subjects having positive endomysial antibodies and the effects of an intervention with a gluten-free diet. The investigators hypothesize that these subjects may have decreased general health and benefit of the dietary treatment regardless of the small-bowel mucosal structure.

Detailed Description
-----------------
Asymptomatic, endomysial-antibody positive adults will be randomized to either continue with a normal, gluten-containing diet or start an intervention with a gluten-free diet irrespective of the small-bowel mucosal morphology. Several celiac-disease associated histological, serological and clinical markers will be evaluated both at baseline and after one year on trial.

Official Title
-----------------
Treatment of Screen-detected Celiac Disease in Adults

Conditions
-----------------
Celiac Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Gluten-free diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive endomysial antibodies Adults Exclusion Criteria: Previous celiac disease diagnosis Significant clinical symptoms Suspicion of any serious celiac disease-associated complication Suspected or diagnosed severe illness other than celiac disease Consuming oral corticosteroids or immune suppressants Marked laboratory abnormalities

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: gluten-containing diet<br> | |
| Active Comparator: Active comparator, gluten-free diet<br> | Dietary Supplement: Gluten-free diet<br>* gluten-containing cereals removed from diet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Small-bowel mucosal morphology and inflammation |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endomysial antibodies |  | one year | 
| Tissue transglutaminase antibodies |  | one year | 
| Antibodies to deamidated gliadin |  | one year | 
| Intestinal tissue transglutaminase-specific IgA deposits |  | one year | 
| Bone mineral density |  | one year | 
| Body composition |  | one year | 
| Health-related quality of life |  | one year | 
| Laboratory parameters |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Celiac disease, Endomysial antibodies, Gluten-free diet, Screen-detected, Asymptomatic, Bone mineral density
A Study to Evaluate the Efficacy and Safety of CJC-1134-PC in Patients With Type 2 Diabetes Mellitus Who Are Currently on Metformin Monotherapy

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, randomized, placebo-controlled, double-blind, Phase II study. The objective of this study is to evaluate the efficacy and safety of 12 weeks of treatment with CJC-1134-PC in patients with type 2 diabetes mellitus who are currently on metformin monotherapy.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Multiple-dose, Phase II Study to Evaluate the Efficacy and Safety of 3 Months of Weekly Injections of CJC-1134-PC in Patients With Type 2 Diabetes Mellitus on Metformin Monotherapy

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

Intervention / Treatment
-----------------
* Drug: CJC-1134-PC
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Major Inclusion Criteria: BMI: 27 to 45 kg/m2 Stable Type 2 diabetes mellitus for at least 3 months, as defined by the Investigator Stable life-style, i.e. diet & physical activity, as determined by the Investigator Stable metformin daily dose ≥1000 mg for at least 3 months Glycosylated hemoglobin (HbA1c) at screening ≥ 7.1% and ≤ 11%

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>12 weekly doses of 1.5 mg CJC-1134-PC | Drug: CJC-1134-PC<br>* 1.5 or 2.0 mg CJC-1134-PC<br>|
| Experimental: 2<br>4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC | Drug: CJC-1134-PC<br>* 1.5 or 2.0 mg CJC-1134-PC<br>|
| Placebo Comparator: 3<br>12 weekly doses of placebo | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of HbA1c From Baseline | Change from Baseline | Screening and Day 85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in FPG From Baseline | Change from Baseline | Screening and Day 85 | 
| Reduction in Fasting Body Weight From Baseline | Change from Baseline | Screening and Day 85 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes Mellitus, incretins, GLP-1, HbA1c, metformin
Effect of the Natural Sweeteners Erythritol and Xylitol on Vascular Function in Obese Volunteers

Study Overview
=================
Brief Summary
-----------------
Sugar alcohols such as xylitol and erythritol are increasingly popular as sugar substitutes in the food industry and are also recommended to diabetic patients. Both substances are already in use in the food industry and are freely available. Since the 1970s, beneficial effects on oral health could be demonstrated as oral bacteria were influenced positively. A pilot study recently undertaken in the US (Flint N, 2014) has shown that diabetics profit from a daily intake of erythritol, as this natural sweetener enhances the elasticity of the blood vessels. In this trial, investigators aim to examine whether this effect can be found in a non-diabetic but obese cohort, and whether also xylitol improves vascular function.

Official Title
-----------------
Effect of the Natural Sweeteners Erythritol and Xylitol on Vascular Function in Obese Volunteers: A Pilot Study

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: E967-Xylitol
* Dietary Supplement: E968-Erythritol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese volunteers (BMI > 30kg/m2) Aged 18- max. 55 years Otherwise healthy. Exclusion Criteria: Known cardiovascular disease Diabetes mellitus Smoking and drug abuse Arterial hypertension with antihypertensive treatment Dyslipidaemia with statin therapy Known chronic hepatic disease (NASH, hepatitis). Known renal disease: kidney failure Pregnancy Chronical diseases of the gastrointestinal tract, history of gastrointestinal surgery with major changes to the gastrointestinal tract Substance abuse, alcohol abuse. Inability to follow procedures due to psychological disorders, dementia or insufficient knowledge of project language (German).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>no treatment | |
| Active Comparator: E967-Xylitol<br>24g xylitol/d | Dietary Supplement: E967-Xylitol<br>* 24g xylitol/d<br>|
| Active Comparator: E968-Erythritol<br>36g erythritol/d | Dietary Supplement: E968-Erythritol<br>* 36g erythritol/d<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central arterial stiffness measured by sonography |  | Change from baseline to 5 weeks after intake of polyol | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose tolerance measured by oral glucose tolerance test |  | Change from baseline to 5 weeks after intake of polyol |
Concentration of S-1 Metabolites in Tear and Plasma of Patients Receiving TS-1

Study Overview
=================
Brief Summary
-----------------
S-1 has been also shown to be an effective drug for palliative chemotherapy in Eastern and Western GC patients. Recently, some case and small-sized studies have been reported on lacrimal drainage obstruction(LDO)caused by S-1.Suggested mechanism of LDO involves direct secretion of S-1 into the tear; thus the concentration of S-1 metabolite in tear is expected to be high in patients who developed LDO than in patients without LDO. We investigate the concentration of S-1 and its metabolites in tear and plasma and find out its correlation with side effects such as LDO. These results will also help us identify patients who are at high risk of developing S-1-associated side effects.

Detailed Description
-----------------
S-1 metabolites concentration in plasma factors affecting plasma concentration surgery subtype serum creatinine systemic adverse effects of S-1 and its correlation with plasma S-1 metabolites concentration enteritis fatigue S-1 metabolites concentration in tears correlation of tear concentration with plasma concentration lacrimal drainage obstruction caused by S-1 administration, and its correlation with tear S-1 metabolites concentration lacrimal drainage obstruction caused by S-1 administration, and its correlation with plasma S-1 metabolites concentration

Official Title
-----------------
Concentration of S-1 Metabolites in Tear and Plasma and Correlation With Its Side Effects in Patients Receiving S-1 Adjuvant Chemotherapy

Conditions
-----------------
Gastric Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received radical surgery for gastric cancer Patients who receiving S-1 adjuvant chemotherapy Patients who administrated S-1 for more than 7 days Exclusion Criteria: who using eyedrop medication who has dry eye that tear cannot be sampled

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 |
| --- | --- | --- |
Methotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
To investigate whether cyclosporine, added to methotrexate and steroid, increases the possibility of inflammatory management early in the disease; furthermore to investigate the possible steroid-sparing effect of cyclosporine in patients with recently diagnosed rheumatoid arthritis.

Detailed Description
-----------------
Design: Multicentre, prospective, randomised, double-blind study with parallel design. Selection of patients: Patients with recently diagnosed rheumatoid arthritis (less than 6 months of persistent synovitis).

Official Title
-----------------
Combination Treatment With Methotrexate and Cyclosporine in Early Rheumatoid Arthritis.

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

Intervention / Treatment
-----------------
* Drug: Methotrexate
* Drug: Intraarticular betamethasone
* Drug: Cyclosporine/placebo-cyclosporine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Synovitis in at least 2 joints. Compliance with the ACR criteria for RA. Duration of no more than 6 months (from the first anamnestic non-traumatic synovitis of at least 6 weeks' duration). Informed consent. Exclusion Criteria: Age less than 18 years or more than 75 years Lack of co-operability. Previous treatment with DMARD Corticosteroid treatment during the preceding 4 weeks. Contra indications for the treatments (awaiting the recommendations from Novartis) Previous or present malignant or premalignant disease Poorly regulated hypertension Impaired renal function Immuno defective diseases, including HIV Cardiac or pulmonary insufficiency Serious arteriosclerosis Serious granulocytopenia or thrombocytopenia Impaired liver function (liver enzymes more than twice the highest normal limit). Alcohol consumption of more than 3 drinks a week. Poorly controlled epilepsy Lack of contraception in fertile patients Pregnancy and lactation Psoriasis Poorly regulated diabetes Anticoagulant treatment Known allergy to the medicine Medicamental interactions Other inflammatory rheumatic diseases

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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Methotrexate|nan|
|Drug: Intraarticular betamethasone|nan|
|Drug: Cyclosporine/placebo-cyclosporine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR20 response |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR remission (modified) |  |  | 
| Cumulated dose of glucocorticoids |  |  | 
| Development of erosions |  |  | 
| Development of osteopenia |  |  |
Effect of Intensive Motor Rehabilitation in Subacute Stroke Patient

Study Overview
=================
Brief Summary
-----------------
Early stroke rehabilitation is known to be an effective and essential therapy in gaining functional independence and preventing complications. However, there was no consensus of proper amount of motor rehabilitation in stroke patients. In this study, the investigators investigated the effects of the intensive motor rehabilitation during subacute phase to improve motor function at 6 months after onset in patients with first-ever strokes.

Detailed Description
-----------------
Intensive cognitive rehabilitation group - physical and occupational therapy for 3 hours on every working day for 2 weeks

Official Title
-----------------
Effect of Intensive Motor Rehabilitation in Subacute Stroke Patient

Conditions
-----------------
Stroke, Rehabilitation, Motor Function

Intervention / Treatment
-----------------
* Procedure: Intensive motor rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute first-ever stroke Upper limb score of Fugl-Meyer assessment at 7 days after onset : 25 84 Exclusion Criteria: Transient ischemic stroke Joint contracture of affected upper extremity

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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
Interventional Model Description: Intenstive motor rehabilitation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive motor rehabilitation group<br> | Procedure: Intensive motor rehabilitation<br>* Intensive motor rehabilitation during subacute stroke phase<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper limb score of Fugl-Meyer assessment |  | Change of upper limb score of Fugl-Meyer assessment after intensive motor rehabilitation for 4 weeks |
Evaluation of Interference Between Bioelectrical Impedance Analysis and Implantable Cardioverter Defibrillators

Study Overview
=================
Brief Summary
-----------------
Evaluation of electromagnetic interference between Bioelectrical Impedance Analysis (BIA) and implantable cardioverter defibrillators (ICDs).

Detailed Description
-----------------
Electrograms of ICDs will be analyzed during wireless telemetry and during body composition measurement using BIA. ICD therapy will have been temporarily inactivated before the measurement to avoid inappropriate shocks, and the sensitivity level of the ICD will be set to maximum. Body composition will be measured at three frequencies (5 khz, 50 khz and 100 khz). Interference will be assessed by the presence of visible artefacts on the real-time electrogram, with ICD marker annotations showing atrial and/or ventricular sensed episodes. The outcome measure will be the number and proportion of patients who have electromagnetic interferences of the ICD when BIA is done. The procedure will take approximately 5-10minutes, with reprogramming of the device at the end of the test. No further follow-up in the context of the study will be performed.

Official Title
-----------------
Use of Bioelectrical Impedance Analysis in the Nutritional Assessment of Patients With CHF Equipped With Implantable Cardioverter Defibrillators

Conditions
-----------------
Electromagnetic Interference

Intervention / Treatment
-----------------
* Other: Exposure to BIA interference with the ICD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Implantation with a wireless-enabled ICD Exclusion Criteria: Age <18yrs Inability to sign an informed consent Pacemaker dependancy

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 |
| --- | --- |
| Electromagnetic Interference<br> | Other: Exposure to BIA interference with the ICD<br>* Exposure to BIA interference with the ICD<br>* Other names: Study group;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who have electromagnetic interference of the ICD when exposed to BIA. |  | 5-10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICD, Bioelectrical Impedance Analysis, Body composition
Trans-perineal Repair With or Without Limited Internal Sphincterotomy for Treatment of Type I Anterior Rectocele

Study Overview
=================
Brief Summary
-----------------
Comparison between transperineal repair of rectocele with or without posterior internal sphincterotomy.

Detailed Description
-----------------
Transperineal repair of anterior rectocele is performed in two groups of patients, the first will undergo limited posterior internal sphincterotomy, the second group will not have internal sphincteroromy. The two groups are compared regarding recurrence of rectocele and improvement of symptoms.

Official Title
-----------------
Comparative Study Between Trans-perineal Repair With or Without Limited Internal Sphincterotomy in Treatment of Type I Anterior Rectocele: A Randomized Controlled Trial

Conditions
-----------------
Rectocele

Intervention / Treatment
-----------------
* Procedure: Transperineal repair with PIS
* Procedure: Transperineal repair without PIS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with anterior rectocele Exclusion Criteria: Pregnant females Rectocele with pelvic organ prolapse Any patient with previous anorectal surgery Pudendal nerve neuropathy Anal fistula and sepsis Patients with sphincter defect proved by endo-anal sonography Patients proved to have colonic inertia either by colon transit time and/or history Patients with defecography anomalies causing obstructed defecation other than rectocele (e.g. Anismus). Also patients with vascular diseases, scleroderma, malnutrition, and coagulopathy were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Active Comparator: Transperineal repair with PIS<br>transperineal repair of anterior rectocele with limited internal sphincterotomy | Procedure: Transperineal repair with PIS<br>* Repair of anterior rectocele via transperineal approach followed by limited internal sphincterotomy at 6 o'clock.<br>|
| Active Comparator: Transperineal repair without PIS<br>transperineal repair of anterior rectocele only | Procedure: Transperineal repair without PIS<br>* Repair of anterior rectocele via transperineal approach without performing limited internal sphincterotomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of recurrence | Number of patients presenting with recurrent or persistent symptoms during follow up | 18 months |