linjc16/ctgov huggingface dataset:
Allogeneic Tumor Cell Vaccination in Patients With Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to apply allogeneic tumor cell vaccination for immunotherapy in patients with micro-metastatic disease and/or in patients at high risk disease progression. The present study will use allogeneic tumor cell lines for tumor cell vaccines that share MHC determinants with the patient aiming to overcome possible restriction of antigen presentation.

Official Title
-----------------
Allogeneic Tumor Cell Vaccination in Patients With Solid Tumors

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

Intervention / Treatment
-----------------
* Biological: Tumor Cell Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with measurable metastatic disease or disease resistant to chemotherapy or with minimal residual disease at high risk to relapse. Exclusion Criteria: Karnofsky less than 60%. Unrelated condition requiring the use of any cytotoxic agents or immunosuppressive agents which may interfere with optimal immune response.

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Tumor Cell Vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the feasibility of anti-tumor immune response by allogeneic tumor cell vaccine using tumor cells that share MHC determinants with the patient. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the feasibility of immune responses against cancer cells by combining allogeneic TCV with indomethacin, cimetidine, tetanus and rIL-2. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tumor cell vaccine
MyHealthCheckup Wellness Program Among Canadian Forces Military Personnel

Study Overview
=================
Brief Summary
-----------------
This research is collecting data to determine the benefits of a web-based wellness program designed to improve the health and well-being of individuals in the workplace. Participants will be invited to participate in a web-based Healthy Weight Program. The program is designed to optimize health and wellbeing by promoting physical activity and healthy eating.

Official Title
-----------------
The Effectiveness of the MyHealthCheckup Wellness Program Among Canadian Forces Military Personnel

Conditions
-----------------
Overweight

Intervention / Treatment
-----------------
* Behavioral: Web-based weight loss program
* Behavioral: On-line health coaching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A military member of the Canadian Forces Base in Halifax Exclusion Criteria: -

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Web-based weight loss program<br>Subjects will have access to a web-based weight loss program for an 8-week period. | Behavioral: Web-based weight loss program<br>* A 4-week web-based wellness program.<br>|
| Experimental: On-line health coaching in addition to web-based program<br>Subjects will have access to the web-based wellness program and will also receive weekly personalized health coaching emails. | Behavioral: Web-based weight loss program<br>* A 4-week web-based wellness program.<br>Behavioral: On-line health coaching<br>* A 4-week web-based wellness program with weekly personalized on-line health coaching.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body weight | Body weight | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Waist circumference | Waist circumference measured at the umbilicus | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
weight loss, healthy weight, overweight, body mass index greater that 25 kg/m2
VIBATIV Pregnancy Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to evaluate the outcome of pregnancy in women exposed to VIBATIV at any time during pregnancy. There are no mandated physician visits for the registry.

Official Title
-----------------
VIBATIV (Telavancin Hydrochloride) Pregnancy Exposure Registry

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Drug: VIBATIV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients who were exposed to VIBATIV at any time during pregnancy Outcome of pregnancy is unknown at the time of enrollment
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VIBATIV treated pregnant women<br>Women treated with telavancin (any dose or duration) during pregnancy. | Drug: VIBATIV<br>* Observational<br>* Other names: TD-6424;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcomes of pregnancy in women exposed to VIBATIV at any time during pregnancy |  | Once per trimester, 6-7 months gestation, and within 4 weeks after the estimated due date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of fetal exposure to VIBATIV on pregnancy outcomes |  | Within 4 weeks after the estimated due date and if a live infant birth is reported, at 3, 6, 9, and 12 months of age. | 
| Fetal/neonatal outcomes |  | Within 4 weeks after the estimated due date and if a live infant birth is reported, at 3, 6, 9, and 12 months of age. | 
| Infant development and milestones through 12 months of age |  | Within 4 weeks after the estimated due date and if a live infant birth is reported, at 3, 6, 9, and 12 months of age. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VIBATIV, telavancin, Pregnancy, Registry
Rainbow Acoustic Monitoring (RAM) in Patients Weighing up to 10kg Comparison Study

Study Overview
=================
Brief Summary
-----------------
The objective of this clinical investigational study is to compare the acoustic respiration rates (RRa) obtained using the INVSENSOR0004 sensor in the subjects up to 10 kg with the respiration rates determined by manual annotations (RRref), and when applicable with capnography respiration rate (RRcap).

Official Title
-----------------
Rainbow Acoustic Monitoring (RAM) in Patients Weighing up to 10kg Comparison Study

Conditions
-----------------
Respiration Rate

Intervention / Treatment
-----------------
* Device: INVSENSOR00004


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects weighing up to 10kg Subjects will be inpatients and/or outpatients admitted to the NICU (Neonatal Intensive Care Unit) or PICU (Pediatric Intensive Care Unit) or PACU (Post-Anaesthesia Care Unit) The parent/legal guardian has given written informed consent/assent to participate in the study. Exclusion Criteria: Subjects with underdeveloped skin Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, infections, abnormalities, etc. Subjects deemed not suitable for the study at the discretion of the investigator.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INVSENSOR00004<br>All enrolled subjects will receive the INVSENSOR00004 sensor. The INVSENSOR00004 rainbow acoustic monitoring (RAM) acoustic respiration sensor is designed to noninvasively convert acoustical airflow patterns into respiratory rate (RRa). | Device: INVSENSOR00004<br>* The INVSENSOR00004 will be placed on the subject's neck or chest to provide acoustic respiration rate.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Acoustic Respiration Rate (RRa) | Acoustic respiration rate (RRa) as determined by the INVSENSOR00004 will be compared to measurements of actual respiration rates as determined by manual annotation of recorded respiration waveform (RRref) data. Evaluation of the RRa measurements will be reported as bias between the RRa and the RRref. | One study visit lasting up to 60 minutes. |
LARS for Chinese Patients

Study Overview
=================
Brief Summary
-----------------
Low anterior resection syndrome (LARS) frequently occurs in patients undergoing low anterior resection (LAR). However, the incidence, exact mechanism and risk factors of major LARS largely variate in different studies. Considering varieties and differences of patient characteristics between Chinese patients and the western ones, this retrospective study aims to investigate the incidence of LARS in Chinese patients undergoing laparoscopic LAR, and to explore perioperative risk factors that might be associated with major LARS. Consequent patients undergoing laparoscopic LAR and free from disease recurrence from January 2015 to May 2021 were issued with LARS questionnaire. Incidence of LARS and patient data were collected and analyzed.

Official Title
-----------------
The Incidence and Risk Factors of Low Anterior Resection Syndrome: Basing on Data of Chinese Patients From a Single Center

Conditions
-----------------
Incidence and Risk Factors of Low Anterior Resection Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: LARS questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed as rectal cancer and underwent radical laparoscopic LAR and straight colorectal/coloanal anastomosis (with or without a protective stoma) by a same surgical team Exclusion Criteria: either local or distal recurrence, severe complications such as postoperative anastomotic leakage, failure of protective stoma closure, data missed and no responding to LARS questionnaire
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: LARS questionnaire|Eligible participants were issued with LARS questionnaire (Chinese version) by E-mail, message, phone or face to face interview.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of LARS | incidence of Low Anterior Resection Syndrome | at least 1 months postoperatively | 
| incidence of major LARS | incidence of major Low Anterior Resection Syndrome | at least 1 months postoperatively |
Study Evaluating DVS-233 SR in Adult Outpatients With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to compare the antidepressant efficacy and safety of DVS-233 SR versus placebo in adult outpatients with Major Depressive Disorder.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy And Safety Study of a Flexible Dose of DVS-233 SR in Adult Outpatients With Major Depressive Disorder

Conditions
-----------------
Depression, Depressive Disorder, Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: DVS-233 SR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients Men and women age 18 years of age and older Women of childbearing potential participating in the study must have a negative serum pregnancy test result at screening and use a medically acceptable form of contraception Exclusion Criteria: Treatment with DVS-233 SR at any time in the past Treatment with venlafaxine (immediate release [IR] or extended release [ER]) within 90 days of study day 1 Known hypersensitivity to venlafaxine (IR or ER) Significant risk of suicide based on clinical judgment, including common

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DVS-233 SR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical Outcomes Related to Cardiac Resynchronization Therapy Deactivation of Super Responders

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine clinical outcomes related to deactivation of Cardiac Resynchronization Therapy device in subjects with super response.

Official Title
-----------------
Midterm Clinical Outcomes Related to Cardiac Resynchronization Therapy Deactivation of Super Responders

Conditions
-----------------
Cardiomyopathy

Intervention / Treatment
-----------------
* Device: Cardiac Resynchronization Therapy Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: super response to Cardiac Resynchronization Therapy near normal Left ventricular ejection fraction >99% pacing Exclusion Criteria: <99% pacing atrial fibrillation ischemic cardiomyopathy

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Off-pace group<br>Deactivated device group | Device: Cardiac Resynchronization Therapy Device<br>* Cardiac Resynchronization Therapy Device pacing activity, on or off<br>|
| No Intervention: On-Pace group<br>Ongoing device activity group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical/Echocardiographic outcome | Clinical/Echocardiographic outcome including New York Heart Association class, 6-min walk test, Left ventricular ejection fraction, Left ventricular end- diastolic diameter, Left ventricular end-systolic volume, and Left ventricular end-systolic diameter. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Number of participants experiencing mortality | 12 months | 
| Heart failure hospitalization | Number of participants experiencing heart failure hospitalization | 12 months | 
| Cardiac Resynchronization Therapy Device intervention | Heart failure hospitalization Cardiac Resynchronization Therapy Device intervention for detected episodes. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure, Super responder
Magnetic Resonance Imaging and Spectroscopy Biomarkers for Facioscapulohumeral Muscular Dystrophy

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to identify and study changes in muscle in people with facioscapulohumeral muscular dystrophy using magnetic resonance imaging and spectroscopy.

Detailed Description
-----------------
This research study is being done to study changes in muscle imaging over time in people with facioscapulohumeral muscular dystrophy (FSHD). Whole-body magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) will be used to evaluate skeletal muscle in study participants. This research is being done to assess how changes in muscle imaging correspond to muscle strength and function. Qualified participants will be asked to complete 5 study visits over 21 months. Each visit will include muscle strength and function testing in addition to the MRI/MRS scan. The investigators plan to use MRI and MRS in developing outcome measures that can be used in future clinical trials for FSHD.

Official Title
-----------------
Magnetic Resonance Imaging and Spectroscopy Biomarkers for Facioscapulohumeral Muscular Dystrophy

Conditions
-----------------
Facioscapulohumeral Muscular Dystrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to give written informed consent for study participation (a parent or guardian will be asked to provide informed consent for participants younger than 18 years old) Confirmed diagnosis of FSHD through genetic testing (participants will be asked to provide copies of genetic testing results) Exclusion Criteria: Any contraindication to MRI scanning Inability to complete a physical examination, including strength measurements

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- | --- |
| Intramuscular fat infiltration on MRI | Intramuscular fat infiltration on MRI | Baseline, 3 months, 9 months, 15 months, and 21 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intramuscular edema on MRI | Intramuscular edema on MRI | Baseline, 3 months, 9 months, 15 months, and 21 months | 
| Muscle strength testing | Muscle strength testing | Baseline, 3 months, 9 months, 15 months, and 21 months | 
| Timed function testing | Timed function testing | Baseline, 3 months, 9 months, 15 months, and 21 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FSHD, magnetic resonance imaging, magnetic resonance spectroscopy
The Treatment Challenges and Limitation in High-Voltage Pediatric Electrical Burn at Rural Area

Study Overview
=================
Brief Summary
-----------------
A case of high-voltage pediatric electrical burn involving a fully conscious 13-year old boy who was admitted to the emergency room after being electrocuted by high-voltage power cable, with superficial partial thickness burn over right arm, trunk, and left leg (26% of total body surface area) with cardiac abnormality e.g. tachycardia and non-specific ST depression. Treatments were based on Australian New Zealand Burns Association algorithm with several modifications, i.e. administering lower concentration of oxygen with nasal cannula instead of non-rebreathing mask and intravenous Ketorolac and Metamizole as analgesic instead of morphine due to limitation in infrastructure and knowledge. The patient underwent surgical debridement and strict observation with no signs of abnormality found during hospital stay. Wound dressing consisted of silver sulfadiazine, Sofra-tulle® and dry sterile gauze were used until epithelialization. After the wound healed, the patient resumed wearing elastic bandage and moisturizer on the wound area. The patient was observed daily through 7 days of hospitalization and followed-up for 1 year, achieving normal physiologic function of the affected area but unsatisfactory esthetic result. This case report showed that there is still a lack of burn prevention programs in the rural area, resulted in inadequate first aid application for electrical burn. There is a need for acknowledging and maximizing the implementation of available standardized guidelines e.g. Australian New Zealand Burns Association by giving homogenized training to personnel as well as providing feasible equipment, and then followed by strict monitoring for the patient. The focus of the burn program should also include burn rehabilitation, psychosocial needs and any complaints needing expert opinion in an outpatient setting in addition to adequate burn management for life saving and good wound healing.

Official Title
-----------------
The Treatment Challenges and Limitation in High-Voltage Pediatric Electrical Burn at Rural Area: A Case Report

Conditions
-----------------
Burns, Electrical Burn, Burn Degree Second, Burn Scar

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with acute electrical burn wound Exclusion Criteria: patient does not want to participate
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| Wound healing | The healing rate of burn wound | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burn Scar | The appearance and function of the scar and the affected areas | 1 year |