linjc16/ctgov huggingface dataset:
Measure of Engagement of Epilepsy Patients in Messaging Groups

Study Overview
=================
Brief Summary
-----------------
This study will measure the engagement of people with epilepsy in a mobile phone based messaging platform as well as understand if there is an impact on their self-management

Detailed Description
-----------------
The primary purpose of this study is to assess a person with epilepsy's level of usage of a mobile messaging application for peer support. The secondary purpose is to understand what characteristics of their group drive different levels of usage and improvements in self-management. Participants can participate as much or little as they want for a minimum of six weeks. Participants will complete an initial and a final questionnaire.

Official Title
-----------------
Measure of Engagement of Epilepsy Patients in Messaging Groups and Group Characteristics That Influence Engagement.

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Behavioral: Facilitator support and education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age, diagnosis of epilepsy, have access to a smartphone capable of running messaging application Exclusion Criteria: A diagnosis of learning disability/difficulty, significant mental health conditions; those in care, bereaved, or prisoners. Any other vulnerable individuals (individuals unable to protect themselves against significant harm or exploitation)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>The Experimental Group will be placed in a group using the matching algorithm. Facilitator support and education intervention | Behavioral: Facilitator support and education<br>* Group engaged with facilitator support and education<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engagement | Average participant number of posts over time frame assessed by tracking number of participant entries | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epilepsy self-management | Patient activation measure based on self-reported questionnaire | Change in Baseline to 6 weeks | 
| Epilepsy medication adherence | Medication adherence based on self-reported questionnaire | Change in Baseline to 6 weeks | 
| Epilepsy quality of life | Quality of life in epilepsy metric based on self-reported questionnaire | Change in Baseline to 6 weeks |
Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Cholecalciferol (vitamin D3) prevent respiratory tract infections in patients with primary immunodeficiency.

Official Title
-----------------
A Placebo Controlled Double Blinded Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency

Conditions
-----------------
Primary Immune Deficiency Disorder

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-75 Increased number of respiratory tract infections At least 42 days of infections during 2008 or 2009 S-25 OH vitamin D3 < 250 nM Not planning a pregnancy during the coming year Accepting the use of contraceptives during 1 year Exclusion Criteria: Continuous antibiotic treatment Hypercalcemia Sarcoidosis Kidney disease Tuberculosis Pregnancy Kidney stone Heart medication (glycosides)

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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|
| Active Comparator: Vitamin D<br>Vigantol (cholecalciferol) 4000 IE/day | Drug: Vigantol<br>* Vigantol 4000IU/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infectious score |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antimicrobial peptide expression in nasal fluid |  | 12 months | 
| Serum levels of 25-OH Vitamin D3 |  | 12 months | 
| Consumption of antibiotics |  | 12 months | 
| Number of positive bacterial cultures in nasal swabs |  | 12 months |
Clip Closure of Mucosal Defects After Endoscopic Mucosal Resection.

Study Overview
=================
Brief Summary
-----------------
An simple-blind, randomized study, to evaluate the efficacy and safety of complete closure with clips of mucosal defects after endoscopic mucosal resection (EMR) of large non-pedunculated colorectal lesions (≥ 2 cm) as prophylaxis of delayed bleeding.

Official Title
-----------------
Clip Closure of Mucosal Defects After Endoscopic Mucosal Resection of Large Colorectal Lesions as Prophylaxis of Delayed Haemorrhage.

Conditions
-----------------
Endoscopic Resection, Clip, Haemorrhage, Non-pedunculated Lesions

Intervention / Treatment
-----------------
* Device: Clip closure
* Procedure: No clip closure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older Clinical indication of endoscopic mucosal resection for large-sized (≥ 2cm) non-pedunculated colorectal lesions. Medium-high risk of delayed bleeding (DB risk score ≥ 4) Informed consent. Exclusion Criteria: Patients with colorectal non-pedunculated lesions without endoscopic mucosal resection indication. Lesions resected by endoscopic submucosal resection. Incomplete resections. Resections with suspected deep submucosal invasion. Mucosal defects treated with clips for known or suspected damage to the muscle layer. Lesions with low risk of delayed bleeding (DB risk score ≤3). Patients with any other medical, geographic or social condition, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clip<br>Clip closure of mucosal defects after endoscopic mucosal resection. | Device: Clip closure<br>* Complete clip closure of secondary lesions after the endoscopic mucosal resection<br>|
| Active Comparator: No clip<br>No clip closure of mucosal defects after endoscopic mucosal resection. Observation. | Procedure: No clip closure<br>* Observation: no clip closure of secondary lesions after the endoscopic mucosal resection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delayed hemorrhage |  | 15 days post-EMR |
Predictive Factors of Obesity-hypoventilation Syndrome (OHS) Among Obese Subjects- ETUDE COHYPOB -

Study Overview
=================
Brief Summary
-----------------
Investigate whether the course of an isolated nocturnal alveolar hypoventilation can predict the future occurrence of obesity-hypoventilation syndrome (OHS) in obese subjects

Official Title
-----------------
Predictive Factors of Obesity-hypoventilation Syndrome (OHS) Among Obese Subjects- ETUDE COHYPOB -

Conditions
-----------------
Obesity-hypoventilation Syndrome, Nocturnal Alveolar Hypoventilation

Intervention / Treatment
-----------------
* Other: Annual visits among 3 years. During each visit different testings are performed in order to detect an obesity-hypoventilation syndrome (OHS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Obese volunteer Subject (BMI> 30 kg/m2) Adults of either sex Social security affiliation Written informed consent Exclusion criteria: Confirmed OHS at baseline defined by a daytime hypercapnia with PaCO2> 45mmHg Any cause of chronic respiratory failure other than obesity such as COPD, chest deformation, phrenic nerve paralysis, pulmonary fibrosis, neuromuscular disease, a history of mutilating thoracic surgery ... Obstructive ventilatory defect with FEV1/ FVC <70% post-bronchodilator Long term oxygen therapy, noninvasive ventilation, continuous positive airway pressure Any serious illness involving life-threatening within 3 years after inclusion Drug or alcohol abuse Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Obesity: BMI > 30 kg/m2<br>Annual visits among 3 years. During each visit different testings are performed in order to detect an obesity-hypoventilation syndrome (OHS) Polygraphy/Polysomnography, Blood sampling, EKG, Lung function testing, Arterial blood gases, Thoracic radiography, Six-minute walk test, Respiratory questionnaires | Other: Annual visits among 3 years. During each visit different testings are performed in order to detect an obesity-hypoventilation syndrome (OHS)<br>* Polygraphy/Polysomnography,Blood sampling, EKG,Lung function testing,Arterial blood gases,Thoracic radiography,Six-minute walk test,Respiratory questionnaires<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of obesity-hypoventilation syndrome | partial pressure of carbon dioxide in the arterial blood > 45mmHg | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OHS
Study of KRN951 in Patients With Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and tolerability of KRN951 administered to patients with solid tumors. In the single dose period, patients in each cohort will receive one oral dose of KRN951 in the first day, followed by a 6-day rest period during which no treatment is received. After that, patients in each cohort will receive one oral dose of KRN951 daily over a 21-day treatment period, followed by a 7-day rest period during which no treatment is received. Treatment will be continued in the absence of disease progression or unacceptable adverse events.

Official Title
-----------------
An Open-label, Non-randomised Dose Escalation Study of KRN951 Administered Orally to Patients With Solid Tumors

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Drug: KRN951


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent Solid tumors to be unresponsive to, or untreatable by standard therapies ≥ three-month life expectancy Eastern Cooperative Oncology Group Performance Status score of 0, 1 or 2 Exclusion Criteria: Hematologic abnormality Myocardial infarction or clinically symptomatic left ventricular failure Active hypertension or controllable hypertension more than 3 antihypertensive medications Symptomatic CNS metastasis Unhealed wounds Active infections Hepatic or renal functional disorder Any of the HBs antigen, HCV antibody and HIV antibody positivity Prior use of any chemotherapy, radiotherapy, immunotherapy or surgery within four weeks previous to first dose of study drug Pregnant or lactating women Women of childbearing potential and fertile men, unless willing to use adequate contraceptive protection

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

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KRN951<br> | Drug: KRN951<br>* Orally once daily administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To define the maximum tolerated dose (MTD) of KRN-951 when administered orally for 21 days followed by a 7-day rest period. |  |  | 
| To evaluate the safety profile and the tolerability of KRN951 throughout the study period by assessing adverse events and laboratory values recorded during treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the pharmacokinetics of KRN951 in serum |  |  | 
| To describe biological and clinical anti-tumor activity |  |  |
Pharmacokinetic Study of Spironolactone 25 mg, 50 mg and 100 mg Tablets

Study Overview
=================
Brief Summary
-----------------
Objective is to investigate pharmacokinetics and to estimate the level of dose linearity of spironolactone and its metabolites canrenone and 7α-thiomethylspirolactone from Spironolactone 25 mg, 50 mg and 100 mg Tablets

Official Title
-----------------
Pharmacokinetic Study of Spironolactone 25 mg, 50 mg and 100 mg Tablets in Healthy Subjects Under Fasting Conditions.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Spironolactone
* Drug: Spironolactone
* Drug: Spironolactone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with normal findings as determined by baseline history, physical examination and vital signs, haemogram, biochemistry, infectious disease screening, urinalysis, 12 lead ECG Exclusion Criteria: Any condition requiring regular concomitant medication or likely to need any concomitant medication during the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Order of strenghts; 25 mg, 50 mg, 100 mg<br> | Drug: Spironolactone<br>* single dose of one tablet; 25 mg tablet<br>Drug: Spironolactone<br>* single dose of one tablet; 50 mg tablet<br>Drug: Spironolactone<br>* single dose of one tablet; 100 mg tablet<br>|
| Experimental: Order of strenghts; 50 mg, 100 mg, 25 mg<br> | Drug: Spironolactone<br>* single dose of one tablet; 25 mg tablet<br>Drug: Spironolactone<br>* single dose of one tablet; 50 mg tablet<br>Drug: Spironolactone<br>* single dose of one tablet; 100 mg tablet<br>|
| Experimental: Order of strenghts; 100 mg, 25 mg, 50 mg<br> | Drug: Spironolactone<br>* single dose of one tablet; 25 mg tablet<br>Drug: Spironolactone<br>* single dose of one tablet; 50 mg tablet<br>Drug: Spironolactone<br>* single dose of one tablet; 100 mg tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax, AUC0-t and AUC0-inf of Spironolactone and its metabolites canrenone and 7α-thiomethylspirolactone in plasma |  | up to 72 h after the study drug administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spironolactone, linearity of pharmacokinetics, Healthy volunteers
Pressure Dependent Tracheal Obstruction in Copd Patients

Study Overview
=================
Brief Summary
-----------------
Background. Do pressure dependent tracheal obstructions (PDTO) often seen during bronchoscopy in COPD patients affect pulmonary function tests and breathing symptoms? Method. Model study. A garden hose was compressed from one side to simulate the posterior wall of the trachea bulging into the lumen. For two obstruction lengths - 3 cm and 12 cm, the hose was increasingly compressed in eight steps. Resistance was measured at each step for airflows 1 l/s through 9 l/s, and digital photos of the luminal area were taken which were used by a computer to estimate the cross sectional area reduction and the corresponding distance between the bulging (posterior)and the opposite (anterior) wall (AP-distance). Patient study. 104 stable COPD patients studied by pulmonary function tests and bronchoscopy. The tracheal obstruction was observed during forced expiration and cough, and the cross sectional area reduction was estimated using the results from the model study.

Official Title
-----------------
Pressure Dependent Tracheal Obstruction in Copd Patients

Conditions
-----------------
Tracheobronchomalacia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: copd Exclusion Criteria: clinical evidence of malignant disease not able to be subjected to bronchoscopy
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
-----------------
copd, airway obstruction, Tracheobronchomalacia
Out-patient Discharge Management After General Intravenous Anesthesia

Study Overview
=================
Brief Summary
-----------------
The lower limit of time for postoperative observation and discharge criteria for diagnostic or operational tests program in outpatient under general intervenous anesthesia/sedation

Detailed Description
-----------------
When is it considered safe for an outpatient to leave after a advanced procedure of general anesthesia/sedation

Official Title
-----------------
Out-patient Discharge Management After General Intravenous Anesthesia

Conditions
-----------------
Evaluation, Outpatient Surgery

Intervention / Treatment
-----------------
* Other: assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged from 18 years with American Society of Anesthesiologists (ASA) physical status I to II were selected. The adaptation and contraindications of the Chinese expert consensus on sedation/anesthesia in digestive endoscopy will be used Exclusion Criteria: The inclusion criteria were the patient underwent general anesthesia with endotracheal intubation or patients with systemic comorbidities or unable to walk independently or those who suffered from severe adverse events that required in-hospital observation after diagnosis and treatment or the patients with no available assistance after discharge or the emergency endoscopy patients

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

| Intervention/Treatment |
| --- |
|Other: assessment|An exit evaluation was initiated immediately upon recovery from anesthesia|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of discharge | From the time the patient enters the resuscitation room at the end of the session until the patient leaves the resuscitation room | mo more than 60 mintues | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Adverse reactions (Nausea, vomiting, pain, bleeding, fatigue, dizziness, or readmission for any related reason ) | 24 hours after surgery |