linjc16/ctgov huggingface dataset:
Do You Arthroscopic Repair for Subscapularis Tendon Tear, Which Accounts for More Than Half of the 1st Facet? Or do You Perform Debridement?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to randomly classify the upper third of the subscapularis in 1/2 of the rupture patients as preoperative group (arthroscopic and arthroscopic debridement group) and the difference between clinical and clinical scores.

Detailed Description
-----------------
The degree of rupture that is an adaptation of arthroscopic surgery is now known to be about one-third to one-half of a rupture. However, the most controversial case is the one-third to one-half of the upper tear attached to the tendinous portion of the subscapularis. Currently, debridement or repair is under way. But evidence-based studies are lacking and no clear treatment guidelines are available.

Official Title
-----------------
Prospective Randomized Clinical Trial of Arthroscopic Repair Versus Debridement for Subscapularis Tendon Tear More Than 1/2 to Entire 1st Facet (Representing 1/3 to More Than 1/3 Tear of Subscapularis Entire Footprint)

Conditions
-----------------
Subscapularis Tendon Tear, Arthroscopic Repair, Arthroscopic Debridement

Intervention / Treatment
-----------------
* Procedure: arthroscopic repair
* Procedure: arthroscopic debridement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subscapularis tendon tear from more than 1/2 to entire of 1st facet found during routine arthroscopy with 70 degree scope Isolated or combined with Supraspinatus and/or Infraspinatus tear (SS/IS tear less than 3 cm) Combined biceps lesion Combined acromial clavicle (AC) arthritis Exclusion Criteria: Revision case or previous surgical history of the index shoulder Any open surgery, including open repair of the subscapularis tendon Compensation case Combined severe arthritis of the glenohumeral joint Patient who selects one's own surgical method, i.e. not randomized Infection, tumor, etc
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients included in inclusion criteria<br> | Procedure: arthroscopic repair<br> <br> Procedure: arthroscopic debridement<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion (ROM) |  | 2 year postoperatively | 
| Pain Visual Analogue Scale (PVAS) |  | 2 year postoperatively | 
| American Shoulder and Elbow Surgeons' score |  | 2 year postoperatively | 
| Constant score |  | 2 year postoperatively | 
| Korean Shoulder Score (KSS) score |  | 2 year postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| repair integrity analysis using postoperative MRI |  | 6 months |
Open, Randomized, Two Way Crossover Study Comparing the Effect of Esomeprazole Adminstered Orally and iv

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effects of Nexium at a dose of 20mg administered orally compared to intravenously on the maximum acid output in subjects with symptoms of Gastroesophageal reflux disease (GERD).

Official Title
-----------------
An Open, Randomised Two Way Crossover Study Comparing the Effects of 20mg of Esomeprazole Administered Orally and Intravenously as a 3 Minute Injection on Basal and Pentagastrin-stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)

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

Intervention / Treatment
-----------------
* Drug: Esomeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heartburn on 2 out of the last 7 days prior to screening or a diagnosis of GERD (with or without a diagnosis of Erosive eosphagitis) or a documented diagnosis of GERD within 6 months prior to screening, with or without a history of EE. Body Mass Index within the limits specified in the protocol. Exclusion Criteria: History of esophageal, duodenal or gastric surgery History of severe liver disease. Any other significant disease or pathology judged to be clinically significant by the investigator.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>20mg oral | Drug: Esomeprazole<br>* Oral and Intravenous<br>* Other names: Nexium;|
| Experimental: 2<br>20mg IV | Drug: Esomeprazole<br>* Oral and Intravenous<br>* Other names: Nexium;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the maximum acid output during pentagastrin stimulation after 10 days of Nexium dosing administered orally with 10 days dosing via intravenous administration. |  | Every 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare basal acid output at steady state and when switching between Oral and IV administration of Nexium. |  | Post Day 10 | 
| To compare maximum acid output when switching between Oral and IV adminstration of Nexium |  | Post Day 10 | 
| Safety assessment via adverse event recording. |  | At each visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nexium, Gastroesophageal reflux disease, Esomeprazole, Administration methods.
Comparison of Resilience Between ADHD and Controls.

Study Overview
=================
Brief Summary
-----------------
To explore if resilience serves as a mediator between adverse life events and emotional and behavioral problems, and compare the difference of resilience and its mediating effects between children and adolescents with and without ADHD.

Official Title
-----------------
Resilience as a Mediator Between Adverse Life Events and Emotional Behavioral Problems in Children and Adolescents and Comparison Between Individuals With Attention-Deficit /Hyperactive Disorder and Controls

Conditions
-----------------
ADHD; Resilience; Stress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ADHD; Control without ADHD Exclusion Criteria: ASD, other major physical and psychiatric diseases

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 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 |
| --- | --- | --- |
| comparison of resilience between ADHD and controls | We will use SPSS and SPSS PROCESS to analyze the data. The t-test will be used to compare the difference of resilience performance between child and adolescents with and without ADHD. Pearson correlation analyses will be adopted to calculate the relationships between all variables. Moreover, the bias-corrected method was used to estimate the 95% bootstrap confidence interval (CI)of the mediating and moderating effects of resilience between adverse life events and emotional and behavioral problems. Finally, we would compare if there is difference between the mediating effect of resilience in group with ADHD and control group. | up to 1 month |
Vitamin D3 Supplementation in Dialysis Patients

Study Overview
=================
Brief Summary
-----------------
Vitamin D deficiency is highly prevalent among dialysis patients, and has been associated with cardiovascular risk factors such as increased aortic pulse wave velocity, blood pressure, inflammation, and brain natriuretic peptide. This study will evaluate the effect of 26 weeks of vitamin D3 supplementation in patients with end stage renal disease.

Official Title
-----------------
A Randomized, Placebo-Controlled, Double Blind Study Evaluating the Effect of Cholecalciferol on Vasoactive Hormones, Heart Function, Arterial Stiffness, and Blood Pressure in Dialysis Patients.

Conditions
-----------------
End-Stage Renal Disease

Intervention / Treatment
-----------------
* Drug: Cholecalciferol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemodialysis or peritoneal dialysis > 3 months Exclusion Criteria: Hypercalceamia Cancer Inability to give informed consent

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cholecalciferol<br> | Drug: Cholecalciferol<br>* 3 tablets of 1000 IU daily for 26 weeks<br>* Other names: Vitamin D3;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 3 tablets of 1000 IU daily for 26 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of NT-proBNP |  | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of ionized calcium |  | 4 weeks | 
| Plasma concentration of phosphate |  | 4 weeks | 
| Plasma concentration of PTH |  | 4 weeks | 
| Plasma concentration of 25-hydroxycholecalciferol |  | 4 weeks | 
| 24-hour blood pressure |  | 26 weeks | 
| Plasma renin concentration |  | 26 weeks | 
| Plasma concentration of angiotensin II |  | 26 weeks | 
| Plasma concentration of aldosterone |  | 26 weeks | 
| Arterial stiffness |  | 26 weeks | 
| Serum concentration of FGF-23 |  | 26 weeks | 
| Plasma concentration of AVP |  | 26 weeks | 
| Plasma concentration of ANP |  | 26 weeks | 
| Plasma concentration of TNF alpha |  | 26 weeks | 
| Heart Function |  | 26 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodialysis, Peritoneal dialysis, Vitamin D Deficiency, blood pressure, arterial stiffness, Heart function, Renin-angiotensin system, Calcium, FGF-23, Brain natriuretic peptide
Study of Individualized Physiotherapy for Airway Clearance in Cystic Fibrosis.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate individual efficacy in Physiotherapy for Airway Clearance, and to investigate user experience, i.e.utility value and preference.

Official Title
-----------------
Efficacy Study of Physiotherapy for Airway Clearance in Cystic Fibrosis. Randomized Controlled Trials in Single Subjects (N of 1 RCT's).

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Other: Physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis: CF Age >18 years Amount of sputum >5 ml/60 min Wet inhalation of saline/DNase/both Informed consent Exclusion Criteria: Respiratory failure Hemoptysis Bacteriology (burkholderia cephacia, multi-resistent pseudomonas aeruginosa, atypical mycobacteria, MRSA). Ongoing intravenous medication 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physiotherapy techniques<br>Cough Technique vs Forced Expiration Technique | Other: Physiotherapy<br>* Physiotherapy for Airway Clearance<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expectorated sputum (gram) | Total amount of expectorated sputum (g) will be collected and weighed wet after each intervention for eight weeks, using a Mettler TOLEDO Weighing Balance (EL 202, accuracy: 0.01 g). N of 1 trial design. Each trial consist of eight pairs (8 weeks) of treatment periods with two interventions each week (one with Cough Technique and one with Forced Expiration technique), 16 treatments for each participant. Outcome measure after each treatment. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's experience, i.e. perceived utility value and preference of technique. | Utility value: Measured by self-reported questionnaire after completion of each intervention in week 8. Preference: Measured by three self-reported questions after both interventions in week 8. | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adults
Instanyl® Non-Interventional Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to describe the use of Instanyl® (Intranasal fentanyl spray) in the treatment of breakthrough pain (BTP) in cancer patients by success of dose titration and distribution of dose strength. Data will be collected at three different time points over a 3 month period.

Official Title
-----------------
A 3 Month Observational Prospective Patient Cohort Study of the Treatment of Breakthrough Pain in Cancer Patients With Instanyl®

Conditions
-----------------
Breakthrough Cancer Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Adult cancer patients suffering from BTP Instanyl should be prescribed in accordance with the Summary of Product Characteristics (SPC) and none of the stated contradictions applies The decision to prescribe should be made independently of the study All patients must provide signed Informed Consent prior to inclusion

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 |
| --- | --- | --- |
| Success of titration (Y/N), defined as reaching a maintenance dose |  | At week 4 and month 3 after baseline | 
| Dose level of Instanyl® after titration, defined as the maintenance dose |  | At week 4 and month 3 after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Drug Reactions (ADR) |  | At week 4 and month 3 after baseline | 
| Reason and time for Instanyl® termination |  | At week 4 and month 3 after baseline | 
| Change in Instanyl® maintenance dose |  | At week 4 and month 3 after baseline | 
| Change in level of background medication (standardised daily dose) |  | At week 4 and month 3 after baseline | 
| Pain, pain relief and impact of pain of daily life |  | At baseline and week 4 | 
| Treatment satisfaction |  | At baseline and week 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Instanyl, non-interventional, breakthrough cancer pain, BTP, BTCP, Intranasal fentanyl spray
Study Evaluating rhIL-11 in Active Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the activity of multiple doses of oral rhIL-11 in patients with active Crohn's disease (Crohn's Disease Activity Index [CDAI] score from 220-400).

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of Orally Administered Recombinant Human Interleukin-11 (rhIL-11) for the Treatment of Patients With Active Crohn's Disease

Conditions
-----------------
Crohn Disease, Inflammatory Bowel Disease

Intervention / Treatment
-----------------
* Drug: Recombinant Human Interleukin-11 (rhIL-11)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented, signed and dated informed consent to participate in this trial prior to any study related procedures being performed. Men and women age 16 years and over. Diagnosis of Crohn's disease for at least 6 months that has been appropriately documented and confirmed by radiological studies, endoscopy (with histological examination preferred), or surgical pathology (Patients with a diagnosis of Crohn's disease for less than 6 months may be included if the diagnosis is confirmed by a biopsy characteristic of Crohn's disease) Exclusion Criteria: Use of the following medications within the specified time period prior to randomization: Nonsteroidal anti-inflammatory drugs (NSAIDs; including Cyclooxygenase-2 [COX-2] inhibitors and >500 mg/day acetylsalicylic acid) Codeine-containing compounds Corticosteroid enemas

Ages Eligible for Study
-----------------
Minimum 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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Recombinant Human Interleukin-11 (rhIL-11)|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
-----------------
Crohn's Disease, Active Crohns Disease
Angelman Syndrome Italian Registry

Study Overview
=================
Brief Summary
-----------------
The Italian Angelman Registry is a national registry for patients with Angelman Syndrome. No experimental intervention is involved in participation. The data provided are stored in the registry according the EU General Data Protection Regulation (GDPR, enforced on 25 May 2018), unless participants wish to withdraw their child/ adult's information from the registry.

Detailed Description
-----------------
Parents/caregivers of a child or an adult with Angelman Syndrome living in Italy are eligible to insert data in this registry. The individuals must have a diagnosis of Angelman Syndrome confirmed by genetic testing results. The registry has been launched in February 2018 in coincidence with the International Angelman Day and the recruitment will be open until February 2021.

Official Title
-----------------
Italian Angelman Syndrome Registry Protocol

Conditions
-----------------
Angelman Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Molecular diagnosis of Angelman syndrome Exclusion Criteria: Does not meet diagnostic criteria for Angelman Syndrome Other medical or genetic disorders (except autism)

Ages Eligible for Study
-----------------
Minimum Age: 1 Day

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 |
| --- | --- | --- |
| Medical and behavioral problems | Medical and behavioral problems associated with Angelman syndrome and their prevalence. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Angelman Syndrome, Caregivers, Parents, Rare diseases, Registries
Genetic Association Study Between Single Nucleotide Polymorphisms (SNPs) and Cognitive Performance in Young Bipolar Type I Patients: LICAVALGENE

Study Overview
=================
Brief Summary
-----------------
This is a genetic association study of cognitive impairment in young bipolar disease type I patients without medications in mania, depression, hypomania or mixed states.

Detailed Description
-----------------
Introduction: Cognitive impairment in bipolar disease (BD) patients is common and recent data suggests that it may be an endophenotype of the disease as it differs individually, persists during periods of euthymia and co segregates in families of BD patients. Cognition is a complex trait and is therefore likely to be underpinned by many genes, each with a relatively small effect. Performance in each domain of the neuropsychological assessment can be statistically linked to the functional activity of particular protein and by extension to the genetic variants accounting for theses functional differences. Methods: 80 patients with BD type I (SCID DSM-IV), age from 18 to 35 years old, currently on mania, depression, hypomania or mixed state after medication wash out will be submitted to complete neuropsychological evaluation and genotyped for COMT (val158met, rs165599, -287, rs737865), ApoE (epsilon 4) and BDNF (val66met)and 80 healthy controls.

Official Title
-----------------
Genetic Association Study Between Single Nucleotide Polymorphisms (SNPs) and Cognitive Performance in Young Bipolar Type I Patients: LICAVALGENE

Conditions
-----------------
Bipolar

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BD type 1 non euthymia 18-35 y.o. Exclusion Criteria: pregnancy organic disease use of drugs schizophrenia mental retardation illiterate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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 controls<br> | |
| BD type I patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive deficits in BD patients are associated with COMT, ApoE and BDNF polymorphisms |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COMT, ApoE, BDNF, executive function, bipolar, cognition, Cognitive deficits and Bipolar disease type I