linjc16/ctgov huggingface dataset:
Improvement of Sleep Quality by RePneu® Coils in Advanced Pulmonary Emphysema

Study Overview
=================
Brief Summary
-----------------
Improvement of sleep quality in emphysema patients is desirable. Yet, there are no data of patients treated with RePneu coils. This monocenter prospective study investigates the effect on sleep quality of RePneu coils for reduction of dynamic hyperinflation in advanced disease stages of pulmonary emphysema. Patient's sleep will be studied in three Polysomnography measurement nights, one prior to Coil Treatment, one six months after, and one twelve month after. Primary objective is to investigate differences in sleep quality 6 and 12 months after Coil Treatment. Further endpoints are changes in daily activity and sleep (actigraphy), 6MWT, lung function parameters, and questionnaires (SGRQ, mMRC dyspnoe scale).

Official Title
-----------------
Verbesserung Der Schlafqualität Durch RePneu® Coils Zur Behandlung Des Fortgeschrittenen Lungenemphysems

Conditions
-----------------
COPD, Emphysema

Intervention / Treatment
-----------------
* Other: Polysomnographic diagnostic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written consent RePneu Coil treatment according to clinical criteria Exclusion Criteria: Pregnancy or nursing period Participation in another clinical trial within the last 4 weeks Incapable of giving consent Known OSA (AHI>10)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: RePneum coils<br>Patients who needed lung volume reduction with RePneum coils | Other: Polysomnographic diagnostic<br>* Polysomnographic diagnostic performed one prior to Coil Treatment, one six months after and one twelve month after Coil Treatment<br>* Other names: PSG;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep efficiency, measured in baseline and 6 and 12 month after coil treatment. | Sleep Efficiency is evaluated by the ratio of WASO (Time wake after sleep onset) to Sleep Period Time (SPT). | 3 times in one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life Questionnaire | The St. George Respiratory Questionnaire (SGRQ) is designed to capture the health related quality of life. | 3 times in one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep, emphysema, coils, lung volume reduction
Evaluation of Intervention on Impaired Glucose Tolerance(IGT) in Patients With Coronary Heart Disease.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether therapeutic intervention on impaired glucose tolerance in patients with coronary heart disease can decrease the incidence of new onset DM.

Official Title
-----------------
Evaluation of Lifestyle and Therapeutic Intervention on Impaired Glucose Tolerance(IGT) in Patients With Coronary Heart Disease.

Conditions
-----------------
Coronary Heart Disease, Impaired Glucose Tolerance

Intervention / Treatment
-----------------
* Drug: Voglibose tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with coronary heart disease Impaired Glucose Tolerance Exclusion Criteria: Age < 40yr or > 75yr Diabetes Mellitus Scr > 2.0 mg/dL（176 μmol/L） ALT or AST > 2.5 ULN Hb < 90g/L Heart Failure Infection Undergo other interventional clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Placebo with lifestyle intervention | |
| Experimental: Drug<br>Voglibose tablets with lifestyle intervention | Drug: Voglibose tablets<br>* 0.2mg Tid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TypeⅡDiabetes Mellitus |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Cardiovascular Events |  | 2 years |
Clinical Utility of the Alaris MidLatencyAuditoryEvoked Potentials Monitor to Titrate the Anesthetic-Hypnotic Component of Anesthesia

Study Overview
=================
Brief Summary
-----------------
Index computed in real time from Auditory Evoked Potentials have been described parallel to depth of anesthesia. The goal of the study was to compare general anesthesia guided on Auditory Evoked Potentials monitoring to standrad practice in order to assess if AEP monitoring can improve recovery delay (main criteria) or intraoperative hemodynamic stability (secondary criteria). Patients were randomized in 2 groups, stratified by center. Group I : AEP guided anesthesia, Group II: Blind AEP record, standard practice.

Official Title
-----------------
Clinical Utility of the Alaris MidLatencyAuditoryEvoked Potentials Monitor to Titrate the Anesthetic-Hypnotic Component of Anesthesia

Conditions
-----------------
Scheduled General Anesthesia

Intervention / Treatment
-----------------
* Device: Alaris AEP monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA status I-II patients aged 18 - 65 years scheduled for general surgery (except laparoscopic interventions) lasting longer than 1 hour. Exclusion Criteria: Body weight < 70% or > 150% ideal body weight neurological disorder and hearing disorders (being not able to communicate with the patient in a normal tone) use of any medication interfering with pharmacological effect of the study including alcohol misuse or drugs.

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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Alaris AEP monitor|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of AEP guided anesthesia on recovery delay |  |  |
Safety and Efficacy of the Percutaneous Intervention Performed With Devices of a Single-brand

Study Overview
=================
Brief Summary
-----------------
The freedom of choice in medicine is based on the physician's ability to treat their patients with the best available therapy. The armamentarium for percutaneous intervention is frequently determined on the basis of subjective criteria and the experience of the interventional cardiologist. The evaluation of devices used in coronary intervention, especially angiography and its clinical outcomes, has rarely been investigated; the exceptions are studies on stents. Therefore, the freedom of choice for the interventional cardiologist has been challenged, especially because of cost restrictions. This way this study aims to assess the safety and efficacy of a device of a single brand in performing percutaneous transluminal coronary angioplasty (guide catheters, guidewires, balloons, and stents) in selected patients.

Official Title
-----------------
Safety and Efficacy of the Percutaneous Intervention Performed With Devices of a Single-brand

Conditions
-----------------
Atherosclerotic Heart Disease, Coronary Heart Disease

Intervention / Treatment
-----------------
* Device: Coronary stent - Tsunami


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study included both male and female patients for stent implantation referred for angioplasty of coronary arteries with more than 18 years. Exclusion Criteria: chronic total occlusion angioplasty, saphenous graft angioplasty, bifurcation angioplasty (lateral branch greater than 1.5 mm) plans to perform angioplasty on more than one vessel during the same procedure and primary angioplasty in acute myocardial infarction

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Coronary stent - Tsunami|A coronary angioplasty was done|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of: need to change the materials during the procedure (angioplasty). |  | 12 months |
Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the St. Jude Medical Transfemoral Delivery System

Study Overview
=================
Brief Summary
-----------------
Collect and evaluate the long term safety data.

Detailed Description
-----------------
The purpose of this study is to collect and evaluate the long term safety data of the 23mm Portico™ Transcatheter Heart Valve and the transfemoral Delivery System previously implanted in subjects with aortic valve disease.

Official Title
-----------------
Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the SJM Transfemoral Delivery System

Conditions
-----------------
Aortic Valve Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has given written study Informed Consent for participation prior to any study procedures. Subject is ≥ 18 years of age or legal age in host country at time of consent. Subject currently has a 23mm SJM Portico Transfemoral Transcatheter Heart Valve Exclusion Criteria: Subject currently participating in another investigational device or drug study. Subject is unable or unwilling to return for the required follow-up visits.

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 |
| --- | --- | --- |
| The objective of this study is to retrospectively and prospectively collect and evaluate the long term safety of the 23mm Portico Transcatheter Aortic Heart | Data will be collected at 3 months, 6 months, and 12 months post-implant. | 1 year |
Indocyanine Green Test in Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
Indocyanine green (ICG) can be injected into the human bloodstream and it allows us to show stomach vascularity in real time

Official Title
-----------------
Anastomotic Leak Test Using Indocyanine Green During Laparoscopic Roux-en-y Gastric Bypass

Conditions
-----------------
Obesity, Morbid, Surgery, Leak, Anastomotic

Intervention / Treatment
-----------------
* Drug: Indocyanine green solution
* Device: Gastric bypass


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI>40kg/m2 Exclusion Criteria: Non obese patients

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Indocyanine green solution|Adequate perfusion was defined as the direct and clear visualization of the fluorescence along the gastric tube, relative to the excised specimen, after an estimated time of 150-180 s after i.v. administration injection|
|Device: Gastric bypass|Roux and Y Gastric bypass|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Intraoperative Indocyanine green test | Intraoperative indocyanine green test was performed | During surgery (within 150-180 minutes) |
Active Surveillance on Papillary Thyroid Microcarcinoma

Study Overview
=================
Brief Summary
-----------------
The study is a multi-center prospective cohort study of active surveillance in papillary thyroid cancer with low risk. The purpose of the study is to observe natural course of low risk papillary thyroid cancer in Korean population, and comparison of prognosis between active surveillance group and conventional surgery group. Patient will be well informed about their choice of active surveillance or surgery.

Conditions
-----------------
Thyroid Cancer, Papillary Thyroid Microcarcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: who agreed to the agreement form who is older than 18 years old who was diagnosed by fine needle aspiration or needle biopsy of Bethesda category V or VI whose thyroid cancer is smaller than 1 cm length Exclusion Criteria: who cannot routinely follow-up according to the study schedule who was diagnosed by fine needle aspiration or needle biopsy of Bethesda category I, II, III, or IV. who have hyperthyroidism which needs treatment

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 |
| --- | --- |
| Active surveillance<br>Group with active surveillance of their PTC | |
| Surgery<br>Group who underwent surgery after diagnosis of PTC | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Progression of Thyroid Papillary Microcarcinoma | rate of progression: tumor size increase of ≥3 mm in at least one dimension, tumor size increase of ≥2 mm in at least two dimensions, suspected organ involvement during the follow-up, such as trachea, esophagus, nerves, vessels, or muscles in imaging study including high-resolution ultrasonography, or pathological diagnosis of lymph node/distant metastasis | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Progression Rate between Active Surveillance and Surgery Group | Which group had higher progression rate; progression defined as whether tumor size increases more than 3 mm in diameter, or tumor involves new lymph nodes, or metastasis occurs | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Active surveillance
Screening Hepatitis Positive Women for Congenital Anomalies

Study Overview
=================
Brief Summary
-----------------
Hepatitis C virus is one of the virulent viruses

Detailed Description
-----------------
Hepatitius positive women should be screened for congenital anomalies

Official Title
-----------------
Screening Hepatitis Positive Women for Congenital Anomalies During Pregnancy and Assessment of Liver Status of Women

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Diagnostic Test: ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women with hepatitis C virus received treatment during first trimester Exclusion Criteria: pregnant women with hepatitis C virus who didnot receive treatment during first trimester

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: ultrasound|screening of pregnant women with hepatitis c virus received treatment in first trimester for congenital anomalies|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of pregnant women who will be diagnosed to have fetuses with congenital anomalies | the number of pregnant women who will be diagnosed to have fetuses with congenital anomalies by us | within 6 months |
CTCs in Breast Cancer After Neoadjuvant Treatment and Surgery: a Multicenter, Prospective Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide, which is CE approved. This is a prospective, multicenter study to evaluate the prognostic value of circulating tumor cells in breast cancer patients who completed surgery after neoadjuvant treatment.

Official Title
-----------------
The Value of Circulating Tumor Cells in Patients With Breast Cancer Who Completed Surgery After Neoadjuvant Treatment: a Multicenter, Prospective Clinical Trial

Conditions
-----------------
Breast Cancer, Circulating Tumor Cell

Intervention / Treatment
-----------------
* Device: GILUPI CellCollector®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female, aged ≥18 and ≤70 years; Histologically confirmed invasive breast cancer (cT2-4N0-2M0 or cT1N1-3M0 before neoadjuvant treatment); Completed neoadjuvant treamtment and surgery (within 4 years after surgery); Administered neoadjuvant chemotherapy (regardless of chemotherapy regimen); ECOG 0-1 Exclusion Criteria: Metastatic disease (Stage IV); Female patients who are pregnancy or lactation; Uncontrollable puncture site infection or systemic infection;

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

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CTC positive<br> | Device: GILUPI CellCollector®<br>* Use of GILUPI CellCollector® to detect CTC<br>|
| Other: CTC negative<br> | Device: GILUPI CellCollector®<br>* Use of GILUPI CellCollector® to detect CTC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| invasive disease-free survival (iDFS) | Invasive disease-free survival time is defined as the time from date of randomization until the first occurrence of invasive disease recurrence, distant metastasis and death from any cause. | From surgery until time of event up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathological complete response (pCR) | ypT0 ypN0, ypT0/is ypN0, ypT0 or ypT0/is | at surgery | 
| overall Survival (OS) | Overall survival is defined as the time from randomization to death from any cause. | From surgery until time of event up to 3 years |
Multicenter Evaluation of Children and Young Adults With Genotype Positive Long QT Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to provide comprehensive follow-up in patients with Long QT Syndrome (LQTS) and gain additional information regarding genotype-phenotype correlation and effective management and treatment options.

Official Title
-----------------
Multicenter Evaluation of Children and Young Adults With Genotype Positive Long QT Syndrome

Conditions
-----------------
Long QT Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children and/or young adults diagnosed with heterogeneous repolarization disorder who have genotype positive Long QT, or Newly diagnosed mutation positive patients with a confirmed test Exclusion Criteria: Children who are phenotypically positive with no molecular testing Children that are phenotypically positive but genotype negative

Ages Eligible for Study
-----------------
Maximum Age: 20 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 |
| --- | --- | --- |
| Adverse Cardiac Events on patients with genotype positive LQT1 who have a normal EKG and absence of symptoms, but a molecular confirmation of LQT1. |  | Enrollment is expected to take approximately 5 years. The patients will be followed until they are no longer cared for by a pediatric cardiology facility (typically post-college) or approximately 21 years of age. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Cardiac Events on patients with both phenotype and genotype positive. |  | Enrollment is expected to take approximately 5 years. The patients will be followed until they are no longer cared for by a pediatric cardiology facility (typically post-college) or approximately 21 years of age. |