linjc16/ctgov huggingface dataset:
Latin America Registry on WatchmanTM Outcomes in Real Life

Study Overview
=================
Brief Summary
-----------------
Left atrial appendage (LAA) occlusion with WatchmanTM has emerged as viable alternative to anticoagulation therapy in randomized controlled trials. The device has FDA approved since 2015 and the firsts Latin American cases were performed in 2012. However, there is no real world data from Latin American experience in terms of success and outcomes.

Detailed Description
-----------------
Approximately 450 subjects will be enrolled in the study. Up to 50 sites in Latin America will participate in the study. Primary analyses may include, but will not be limited to, the following: procedural complications, incidence of stroke and death. Descriptive statistics will be used for baseline, procedure and follow-up data collected through the registry. Clinical history of each patient will be analyzed for a period of 6 months after the procedure according the standard practice at the enrolling centers. There will be no additional visits, nor procedures, for subjects in the registry.

Official Title
-----------------
Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation: Latin America Registry on WatchmanTM Outcomes in Real Life

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Left atrial appendage closure with Watchman device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were eligible for a WatchmanTM device implantation according to current international and local guidelines and per physician and institution discretion. Exclusion Criteria: Patient who were currently enrolled in another investigational study or registry that would directly interfere with the current study aims.

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

| Intervention/Treatment |
| --- |
|Device: Left atrial appendage closure with Watchman device|Percutaneous left atrial appendage closure using Watchman device|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Periprocedural complications | Pericardial effusion, stroke, device embolization and bleeding | At implant | 
| Incidence of Stroke | Stroke | 6 months follow up | 
| Incidence of Death | Cardiovascular and no cardiovascular death | 6 months follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, Left atrial appendage, Stroke
Monitor Patients With Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to gather data to correlate physiological signals measured by the AVIVO™ Mobile Patient Management System with the patient's respiratory status, including apnea and hypopnea events, during polysomnography

Detailed Description
-----------------
Patients with suspected sleep disordered breathing will be monitored during polysomnography and the collected information will be used to assess patient's respiratory status.

Official Title
-----------------
Adherent Respiratory Monitoring for Apnea Detection and Evaluation Study

Conditions
-----------------
Sleep Apnea

Intervention / Treatment
-----------------
* Device: AVIVO system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is female or male, 18 years of age or older Undergoing polysomnography for suspected sleep apnea Is willing to provide written informed consent and comply with study guidelines

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

| Intervention/Treatment |
| --- |
|Device: AVIVO system|Non invasive external monitoring device|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Adolescent Vaccination in Pharmacies

Study Overview
=================
Brief Summary
-----------------
The study aims to expand the evidence supporting pharmacy provision of adolescent vaccines, including human papillomavirus (HPV) vaccine. In the first part of the study, we will characterize parents' attitudes and support for pharmacy provision of adolescent vaccines in a national survey. In the second part of the study, we will provide HPV vaccines and other vaccines (Tdap, meningococcal, varicella, influenza) to 200 adolescents in a local community pharmacy in Chapel Hill, North Carolina. This portion of the study will identify the systems and workflow needed to provide vaccines effectively and safely, characterize parents' and their adolescents' attitudes toward receiving vaccine services in a pharmacy, and characterize pharmacists' attitudes toward providing adolescent vaccine services in a pharmacy.

Official Title
-----------------
Building Evidence to Expand Adolescent Vaccination in Pharmacies

Conditions
-----------------
Evaluating Attitudes Toward HPV Vaccinations in Pharmacies, Evaluating the Provision of HPV Vaccines in a Pharmacy

Intervention / Treatment
-----------------
* Drug: HPV vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
NATIONAL SURVEY (probability sample) Inclusion Criteria: Being a member of the GfK Knowledge Panel Having a child age 11-18. Exclusion Criteria: ● None PHARMACY DEMONSTRATION PROJECT (convenience sample) Inclusion Criteria: Having an adolescent child, ages 11-18 years old, who is healthy, and for whom HPV vaccine is indicated Child is with the parent Exclusion Criteria: ● Being the parent of an adolescent who is immunocompromised, or has other chronic illness, has known anaphylactoid/hypersensitivity reactions to components of HPV vaccine used, or is pregnant or plan to be pregnant within a month of vaccination.

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 18 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 |
| --- | --- |
| Adolescents and their parents<br>Pharmacy demonstration project: HPV vaccine delivery | Drug: HPV vaccine<br> <br> * Other names: Gardasil;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parents' willingness to get their adolescent children HPV vaccine in pharmacy | Outcome is for the national survey of parents. | At time of study | 
| Parents' satisfaction with HPV vaccine vaccine administration in the pharmacy | Outcome is for demonstration study in a community pharmacy. | At time of vaccine administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adolescent vaccines, HPV vaccine, Pharmacies
Immune Checkpoint Inhibitor Therapy- Induced Endocrinopathy

Study Overview
=================
Brief Summary
-----------------
To review cases from NTUH who developed endocrinopathy and metabolic diseases after immunotherapy, and statistically analyzed their age, clinical presentation, image findings, treatment and its response.

Detailed Description
-----------------
Immune checkpoint blockade-based immunotherapy is a new modality of cancer treatment with a unique mechanism that has gained increased numbers of indication and is now used in several cancer types. However, immune-related adverse events (irAEs) emerge as a new entity of diseases involving one or multiple organ systems. irAEs could result in interruption of immunotherapy, morbidities of patients or even death. Among various manifestations of irAEs, endocrinopathy and metabolic diseases are rare but important, and require prompt diagnosis and treatment to avoid life-threatening conditions. Thus, we intend to review cases from NTUH who developed endocrinopathy and metabolic diseases after immunotherapy, and statistically analyzed their age, clinical presentation, image findings, treatment and its response. We will also review literatures to evaluate the difference and similarity from previous diagnostic and treatment experience.

Official Title
-----------------
Immune Checkpoint Inhibitor Therapy- Induced Endocrinopathy and Metabolic Diseases -a Case Series of Taiwanese Patients

Conditions
-----------------
Endocrinopathy

Intervention / Treatment
-----------------
* Drug: Immunotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who receive immunotherapy in NTUH and develop endocrinopathy after therapy Exclusion Criteria: Patients less than 20 years old. Patients who are pregnant

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 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 |
| --- | --- |
| Patient with endocrinopathy after immunotherapy<br>Patient with endocrinopathy after immunotherapy | Drug: Immunotherapy<br>* Patients receive immunotherapy for cancer treatment<br>* Other names: Immune blockade therapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of endocrine profiles | Changes of serum fT4 TSH Glucose A1C ACTH cortisol LH FSH estradiol progesterone GH IGF1 prolactin | 10 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment response of the cancer after immunotherapy | The changes of size and extent of the tumors | 10 years |
Effect of Changing the Activation Frequency of the Arch Wires on the Rate of Leveling and Alignment in Moderate Crowding Cases

Study Overview
=================
Brief Summary
-----------------
Leveling and alignment is the first stage in the orthodontic treatment, performed for every patient .The archwire are usually changed every 4 weeks for reactivation of the force on the teeth. However, this means that large number of appointments and archwires are required. On the other hand, there is a lack of evidence that less number of appointments with longer time intervals between the visits and less number of wires will give the same effect.

Official Title
-----------------
Effect of Changing the Activation Frequency of the Arch Wires on the Rate of Leveling and Alignment in Moderate Crowding Cases

Conditions
-----------------
Leveling and Alignment of Teeth

Intervention / Treatment
-----------------
* Other: 6 weeks changing of archwire
* Other: 4 weeks changing of archwire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients aged (18 33) CVMI = 6 Moderate crowding (4-8) as described by Laura mitchel No extractions required Exclusion Criteria: Growing patients Previous orthodontic treatment Missing teeth other than the wisdoms

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 33 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: control group<br> | Other: 4 weeks changing of archwire<br>* changing the archwire every 4 weeks<br>|
| Active Comparator: intervention group<br> | Other: 6 weeks changing of archwire<br>* changing the archwire after 6 weeks instead of 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of alignment of teeth | the teeth are aligned together by using Little irregularity index to measure the decrease in the discrepency in each digital model taken after changing of the wire | 5 months |
The Comparative Trial of UFT + TAM With CMF + TAM in Adjuvant Therapy for Breast Cancer (CUBC)

Study Overview
=================
Brief Summary
-----------------
This controlled study is designed to evaluate the relapse-free survival of UFT + TAM compared with CMF + TAM. Patients are randomly assigned to receive either CMF + TAM or UFT + TAM within 6 weeks after surgery. To assess treatment efficacy, data on recurrence and survival will be collected for 5 years after surgery. To evaluate the safety, data on adverse events will be collected during treatment. Patients'quality of life will be assessed by means of a questionnaire.

Official Title
-----------------
The Comparative Trial of UFT + TAM With CMF + TAM in Adjuvant Therapy for Breast Cancer (CUBC)

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: UFT (uracil, tegafur) and tamoxifen
* Drug: CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20 to 65 Hematopoietic WBC ≥ 4,000/mm^3 Platelet ≥ 100,000/mm^3 Hemoglobin ≥ 11.0 g/dL Hepatic AST and ALT ≤ 40 U/L Total bilirubin ≤ 1.5 mg/dL Renal BUN ≤ 25 mg/dL Creatinine ≤ 1.5 mg/dL

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>UFT (uracil, tegafur) and tamoxifen | Drug: UFT (uracil, tegafur) and tamoxifen<br>* UFT(uracil, tegafur:270 mg/m2/day (p.o.) for 2 years) and tamoxifen:20 mg/body/day(p.o.) for 2 years.<br>|
| Active Comparator: 2<br>CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen | Drug: CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen<br>* CMF 6 cycles(q28 days X 6 cycles of cyclophosphamide:65mg/m2/day(p.o.)day 1-14, methotrexate:40mg/m2(i.v.)day 1,8 and fluorouracil:500mg/m2(i.v.)day 1,8) and tamoxifen:20mg /body/day(p.o.) for 2 years.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free survival |  | recurrence and survival will be collected for 5 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival, adverse events, and the quality of life |  | adverse events will be collected during treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer
Identification of the Region of Vitamin D Responsiveness

Study Overview
=================
Brief Summary
-----------------
Hypothesis: low vitamin D status is associated with increased insulin resistance and increased blood pressure. Approach: Multiple regression analysis of information extracted from a large database accumulated by a Canadian health foundation, specifically evaluating statistical associations between serum 25(OH)D levels and insulin responsiveness measures as well as blood pressure, after adjusting these variables for BMI, age, sex, and waist circumference.

Detailed Description
-----------------
Data obtained from the entry records of 4,116 adult men and women in Calgary,Alberta previously enrolled in the Pure North S'Energy Foundation's health program. Individuals with a clinical diagnosis of diabetes mellitus or a HOMA-IR value above 16 were excluded. Standard statistical analyses carried out. An association between 25(OH)D and the endpoints of interest was first established. The residual values after adjusting HOMA-IR, serum insulin, QUICKI, and blood pressure for BMI, age, sex, and waist circumference were then regressed against serum 25(OH)D using 40-percentile data blocks, stepping upward from the lowest 25(OH)D values by 5 percentile increments through the 7th decile. Regression coefficients are then computed for each data block and each outcome variable. The location (along the 25(OF)D continuum) of the largest and most statistically significant coefficients is noted, and regions of null response noted as well.

Official Title
-----------------
A Novel Approach Localizes the Association of Vitamin D Status With Insulin Resistance to One Region of the 25(OH)D Continuum.

Conditions
-----------------
Diabetes, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Exclusion Criteria: Diabetes Elevated HOMA-IR (>16)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HOMA-IR | A composite measure of insulin resistance (HOMA-IR) | Observational/cross-sectional study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Blood Pressure | cross-sectional study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin D, Associational study
Butyrophilins Role in Colon Cancer

Study Overview
=================
Brief Summary
-----------------
quantification of BTNL molecules in colon cancer in order to determinate if their could be used as a prognostic marquer

Official Title
-----------------
Role of Butyrophilins in Colon Cancers Aggressiveness Evaluation

Conditions
-----------------
Colonic Cancer

Intervention / Treatment
-----------------
* Biological: analysis of BTN and BTNL status


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is older than 18 years old, Signed participation consent, Non-metastatic colon cancer immediately resectable or metastatic and liver synchronous for which it was decided a combined colic and liver surgery (metastatic patient at the outset) in multidisciplinary consultation meeting. Performance Status (PS) 0 or 1 affiliated to the social security or beneficiary Exclusion Criteria: Rectal cancer, colon cancer recurrence Emergency of colon cancer Surgery History of inflammatory disease of the digestive tract (Crohn's disease or ulcerative colitis) Patient who received neoadjuvant therapy other than chemotherapy Patient treated with immune-suppressors or long-course corticosteroids <12 months Pregnant women or likely to be pregnant (without effective contraception) or breastfeeding, Person in urgent situation, person under legal protection measure, or unable to express his / her consent, Impossibility of submitting to the medical examination of the test for geographical, social or psychological reasons

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: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: colon cancer patients and metastatic colon cancer patients will be included in this study. We expect that BTNL molecules expression is different depending of the aggressiveness of the illness
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: non-metastatic colon cancer<br> | Biological: analysis of BTN and BTNL status<br>* analysis of BTN and BTNL expression in colon cancer and hepatic metastasis<br>|
| Experimental: metastatic colon cancer<br> | Biological: analysis of BTN and BTNL status<br>* analysis of BTN and BTNL expression in colon cancer and hepatic metastasis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of BTNL3, BTNL8 and BTNL9 expression by transcriptomics and immunohistochemistry | healthy and cancerous colon ad metastasis (if applicable) will be analysed by | 8 years |