linjc16/ctgov huggingface dataset:
Prospective Evaluation of Biliary Tissue Sampling With ERCP

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety, outcomes and performance characteristics of multiple biliary sampling techniques including but not limited to: single operator cholangioscopy (SOC) directed biopsies, transpapillary biliary biopsies (TPBx), brushings and bile aspiration for cytology and FISH in patients undergoing ERCP.

Official Title
-----------------
Prospective Evaluation of Biliary Tissue Sampling With ERCP

Conditions
-----------------
Cholangiopancreatography, Endoscopic Retrograde, Biliary Stricture, Biliary Tract Diseases, Cholangiocarcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults > 18 years Diagnosis of indeterminate biliary stricture Scheduled clinically indicated ERCP procedure Exclusion Criteria: • Adults <18 years, Children

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 |
| --- | --- | --- |
| Performance characteristics | Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value for the detection of malignancy with each sampling technique | 1 year after ERCP procedure | 
| Number of adverse events | Adverse events after biliary sampling | Within 30 days of ERCP procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare Utilization | Number of ERCPs, Radiological studies etc needed before accurate diagnosis | through study completion, an average of 2 years |
A Comparison of Olopatadine and Fluticasone in Patients With Allergic Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
To compare the clinical efficacy of olopatadine and fluticasone in a 3-week single center, double-masked, randomized, placebo controlled parallel treatment conjunctival allergen challenge (CAC) study in patients with allergic conjunctivitis

Detailed Description
-----------------
Study will evaluate the efficacy of nasal anti-allergic therapy compared to ocular anti-allergic therapy in the prevention of ocular allergic symptoms.

Official Title
-----------------
A Comparison of Olopatadine Versus Fluticasone Nasal Spray in the Prevention of the Signs and Symptoms of Allergic Conjunctivitis

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

Intervention / Treatment
-----------------
* Drug: Olopatadine
* Drug: Fluticasone
* Drug: Saline
* Drug: Artificial tears


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age & either sex, any race Willing and able to follow all instructions and attend all study visits Positive history of ocular allergies Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge Exclusion Criteria: Have planned surgery during trial period Female currently pregnant, planning a pregnancy, or lactating Use of disallowed medications

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Olopatadine | Drug: Olopatadine<br>* Ophthalmic solution<br>|
| Active Comparator: 2<br>Fluticasone | Drug: Fluticasone<br>* Nasal spray<br>|
| Placebo Comparator: 3<br>Placebo nasal spray | Drug: Saline<br>* Nasal spray<br>|
| Placebo Comparator: 4<br>Placebo Eyedrops | Drug: Artificial tears<br>* Ophthalmic Solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular itching |  | Minutes following CAC | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular redness |  | Minutes following CAC | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic conjunctivitis, Allergic rhinoconjunctivitis
Efficacy of NIV Masks in COPD

Study Overview
=================
Brief Summary
-----------------
A randomized controlled pilot study to compare the efficacy and tolerability of a two different NIV masks on carbon dioxide in participants with stable chronic obstructive pulmonary disease (COPD) with chronic type II respiratory failure.

Official Title
-----------------
Efficacy of NIV Masks in COPD Patients With Chronic Respiratory Failure: A Randomized Controlled Cross Over Pilot

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Device: Investigation Mask
* Device: Comparator Mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A doctor's diagnosis of COPD PtCO2 ≥45mmHg on transcutaneous monitor at baseline measure Oxygen saturation measured by pulse oximetry (SpO2) ≥85% Fits the study mask Can tolerate the therapy Exclusion Criteria: FEV1/FVC ≥70% Body mass index >35 Hypercapnia considered to be primarily due to Obesity Hypoventilation syndrome and/or Obstructive Sleep Apnea Any condition which makes NIV contra-indicated as per BTS guidelines based on clinical judgement

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigation Mask<br>Bi Level CPAP Mask | Device: Investigation Mask<br>* Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff<br>Device: Comparator Mask<br>* Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff<br>|
| Active Comparator: Comparator Mask<br>Bi Level CPAP Mask | Device: Investigation Mask<br>* Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff<br>Device: Comparator Mask<br>* Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transcutaneous Carbon Dioxide | mmHg | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen Saturation | Percentage | 60 minutes | 
| Minute Ventilation | Litres | 60 minutes | 
| Heart Rate | Beats per minute | 60 minutes | 
| Respiratory Rate | Breaths per minute | 60 minutes | 
| Borg Dyspnoea Score | 1-6 Ranking, with 1 being best and 6 being worst | 60 Minutes |
Serum Proteomic Profiling for the Early Diagnosis of Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
No ideal serum biomarker currently exists for the early diagnosis of colorectal cancer (CRC). Therefore, it is urgent that accurate and reliable serum biomarkers be identified.

Detailed Description
-----------------
Magnetic bead-based fractionation coupled with matrix-assisted laser desorption/ionization-time-of-flight mass spectrometry (MALDI-TOF MS) was used to screen serum samples from CRC patients and healthy controls.

Official Title
-----------------
Serum Proteomic Profiling for the Early Diagnosis of Colorectal Cancer

Conditions
-----------------
Colorectal Neoplasms

Intervention / Treatment
-----------------
* Other: Serum proteomics


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with colorectal cancer Inclusion criteria histologically confirmed colorectal cancer aged 18 years or older have provided written informed consent Exclusion criteria refusal to participate Healthy controls Inclusion criteria no cancer history aged 18 years or older have provided written informed consent Exclusion criteria refusal to participate have first-degree relative with a known history of colorectal cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Colorectal Cancer Patients<br>Patients with histologically confirmed colorectal cancer | Other: Serum proteomics<br>* magnetic bead-based fractionation coupled with matrix-assisted laser desorption/ionization-time-of-flight mass spectrometry<br>* Other names: MB coupled with MALDI-TOF MS;|
| Healthy Controls<br>Healthy volunteers | Other: Serum proteomics<br>* magnetic bead-based fractionation coupled with matrix-assisted laser desorption/ionization-time-of-flight mass spectrometry<br>* Other names: MB coupled with MALDI-TOF MS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum peptide mass fingerprinting (PMF) | Compare PMF of the colorectal caner group and control group, and then build the model to distinguish patients with colorectal cancer and controls | 2010.03-2012.05 (2 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expressed peptide peaks | Find differentially expressed peptide peaks from the model and identify some ideal serum biomarkers for the early diagnosis of colorectal cancer | 2010.03-2012.05 (2 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
proteomics, serum peptides, colorectal cancer, MALDI-TOF MS
Efficacy of Pancrelipase on Postprandial Belching and Bloating.

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this study is that the administration of pancrelipase with meals will benefit symptoms of post-prandial bloating, pain and eructation.

Detailed Description
-----------------
Subjects will complete a double-blind crossover study in which, for one week periods, they will receive two pancrelipase tablets with each of the three major meals or a similarly administered identical placebo. Three times daily, subjects will rate the severity of belching, epigastric discomfort, epigastric fullness, bloating, and nausea.

Conditions
-----------------
Postprandial Bloating, Postprandial Belching, Postprandial Eructation

Intervention / Treatment
-----------------
* Drug: Pancrelipase (Creon) 2 tablets with each meal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects will have either bothersome upper abdominal discomfort, bloating (feeling of abdominal distention) or belching following meals for at least 12 month's duration. Subjects must have had a normal upper gastrointestinal endoscopy and/or upper GI series during the preceding three years. Exclusion Criteria: Individuals with a history suggestive of organic disease such as recent weight loss, nausea, vomiting, GERD, recent changes in bowel habits will be excluded from the study.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pancrelipase (Creon) 2 tablets with each meal|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal bloating |  |  | 
| Abdominal pain |  |  | 
| Eructation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancrelipase, Abdominal bloating, Abdominal pain, Eructation
Effect of Ivabradine on Heart Rate & Effort Tolerance in Mitral Stenosis in Sinus Rhythm

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the effect of Ivabradine vs Atenolol on heart rate and effort tolerance in patients with mild to moderate mitral stenosis and normal sinus rhythm.

Official Title
-----------------
Effect of Ivabradine vs Atenolol on Heart Rate and Effort Tolerance in Patients With Mild to Moderate Mitral Stenosis and Normal Sinus Rhythm

Conditions
-----------------
Mitral Stenosis

Intervention / Treatment
-----------------
* Drug: Ivabradine
* Drug: Atenolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild to moderate mitral stenosis (Mitral valve area: 1.0 cm2 - 2.0 cm2 on echocardiography) with normal sinus rhythm Age >18 years Need for rate control therapy for symptoms Exclusion Criteria: Atrial fibrillation Other significant valvular lesions (More than mild AS/AR/MR) Denial of consent Unable to do TMT/Contraindication for TMT Need for surgical treatment or BMV Presence of significant non-cardiac co-morbidities Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Active Comparator: Ivabradine<br>Crossover study to compare ivabradine and atenolol | Drug: Ivabradine<br>* Ivabradine 5 mg BId for 4 weeks<br>Drug: Atenolol<br>* 50 mg od for 4 weeks<br>|
| Placebo Comparator: Atenolol<br> | Drug: Atenolol<br>* 50 mg od for 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in effort tolerance ( in minutes/Mets) from baseline with the study drugs at the end of stipulated 4 weeks |  | 4 weeks |
Measurement of Hormonal Concentration in Chylothorax Fluid in Infants With Congenital Chylothorax

Study Overview
=================
Brief Summary
-----------------
Late onset Hypothyroidism was found in infant with congenital hypothyroidism. The hypothesis is that infants with congenital hypothyroidism may lose thyroxin and other hormones via the chylothorax fluid causing transient hypothyroidism. In this study hormonal concentration will be measured in the chyle as well as hormonal serum level.

Detailed Description
-----------------
Late onset Hypothyroidism was found in infant with congenital hypothyroidism. The hypothesis is that infants with congenital hypothyroidism may lose thyroxin and other hormones via the chylothorax fluid causing transient hypothyroidism. In this study hormonal concentration will be measured in the chyle as well as hormonal serum level.

Conditions
-----------------
Congenital Chylothorax

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants with congenital chylothorax requiring thorax drain Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 1 Hour
Maximum Age: 10 Weeks

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 |
| --- | --- | --- |
The Effects of a Weight Management Program on Body Weight and Quality of Life

Study Overview
=================
Brief Summary
-----------------
Evaluate the impact of a 12-week behavioral weight management program on body weight and quality of life. We hypothesize that participants will lose body weight and see improved quality of life after program completion.

Detailed Description
-----------------
This study will evaluate weight change and quality of life among individuals after completion of a 12-week comprehensive group weight management program. Findings from this study will also help with program development and improvement within our center. The already established weight management program is called Healthy Habits for Life (HHL) and includes a total of 14 visits (one individual visit both before and after the 12 group sessions). All patients who are enrolled in the Healthy Habits for Life group program at the Weight Center have an individual visit with a registered dietitian prior to beginning the group as part of standard care. At this visit the dietitian will obtain informed consent for participation in the research study and provide subjects consenting to participate in the study with the IWQOL-lite quality of life questionnaire. After completion of the 12 HHL group sessions, all patients at the Weight Center have another individual visit with the dietitian to review weight and behavior changes since the initial evaluation. At this visit, subjects participating in the research study will again be provided with the IWQOL-lite questionnaire to fill out.

Official Title
-----------------
A Longitudinal Study to Investigate the Effects of a 14-visit Comprehensive Lifestyle Weight Management Program on Body Weight and Quality of Life

Conditions
-----------------
Overweight, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking adults aged 18 or older BMI ≥ 25 Enrolled in HHL program at the MGH Weight Center Exclusion Criteria: Non-English speaking patients

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 |
| --- | --- | --- |
| Weight Change | The primary outcomes will be change in body weight comparing body weight at the start of the behavior change program and at the end. This includes weight at the initial individual visit, weights at each of the 12 group visits and body weight at the end of the group program. | Approximately 4 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Quality of life will be assessed with a validated questionnaire at the start of the group and after completion of the group program. | Approximately 4 months after enrollment |
Stroke Prognosis in Intensive CarE

Study Overview
=================
Brief Summary
-----------------
The S.P.I.C.E registry is an investigator-initiated prospective multicenter cohort study which will be conducted in 35 ICUS in the Paris area.The aim of the study is to determine the trajectory of acute stroke patients requiring invasive mechanical ventilation, focusing on functional outcomes at 3 months and 1 year following ICU admission. This project is funded by the French Agence Régionale de Santé (ARS).

Official Title
-----------------
Stroke Prognosis in Intensive CarE - The SPICE Registry

Conditions
-----------------
Acute Stroke Patients Requiring Invasive Mechanical Ventilation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age>18 years Acute stroke (acute ischaemic stroke, brain hemorrhage, subarachnoid hemorrhage). The stroke diagnosis date is defined by the date of the initial brain imaging (TDM or MRI). Admitted to ICU within 7 days before or after the diagnosis of stroke. Requiring invasive mechanical ventilation in ICU for more than 24 hours. Exclusion criteria: Traumatic causes of stroke Refusal of the patient, or his reliable person, to participate in the study. Privation of liberty by administrative or judicial decision

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Functional outcome | Score on the modified Rankin scale (a disability score that ranges from 0 [no symptoms] to 6 [death]). Patients will be classified as good outcome (score of 0-3) or poor outcome (score of 4-6, indicating severe disability or death). | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mechanical invasive ventilation, course of the care, prognosis, stroke