linjc16/ctgov huggingface dataset:
Cardiac Vulnerability in Potentially Susceptible Patients

Study Overview
=================
Brief Summary
-----------------
This project is part of a program project directed toward assessing cardiac effects of particulate and other ambient air pollutants. In this project patient who have recently suffered a cardiac event are being monitored with cardiac monitors for 24 hours up to 4 times during the year following their cardiac event. Similarly a second group of patients with moderate to severe heart failure will undergo similar cardiac monitoring for 24 hours, twice a week separated by 3 months. In both sets of patients home indoor pollution measures will be continuously made and used to correlate with measures of heart rate variability.

Detailed Description
-----------------
Approximately 50 patients in each group will be studied. In addition to cardiac monitoring for 24 hours at each session, overnight respiratory pattern and oxygen saturation will be monitored in both groups. The exposure monitoring will include both particle mass of PM2.5 along with detailed assessment to determine that portion of the particulate exposure from outdoor vs. indoor sources.

Conditions
-----------------
Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
For the cardiac event cases patients are selected from the Brigham and Women's Hospital cardiac services at the time of discharge, aged 45-74, having suffered a cardiac event resulting in either an infarct or need for a cardiac procedure (angioplasty, stint, etc). For the CHF patients they are selected from the BWH cardiac clinics where they have been identified and classified as stage 3 or 4 CHF. For both groups residence requirements are that they reside within the Greater Boston Area as defined by an outer ring road (Route 495) and are willing to be visited at home and have the exposure assessment equipment set up in their home as well as be monitored personally.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 74 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac event, Heart disease, Particulate Matter
Cyanide Poisoning in Fire Victims

Study Overview
=================
Brief Summary
-----------------
Aim: To determine the incidence of cyanide poisoning in fire victims. 20 consecutive patients will have the rest of their blood sample analyzed for cyanide.

Conditions
-----------------
Carbon Monoxide Poisoning

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Exposed to smoke from fire and admitted to hospital Exclusion Criteria: None

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 |
| --- | --- |
| Cases<br>Cases would have had their blood cyanide concentration measured | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cyanide concentration |  | baseline |
To Evaluate the Long-Term Safety of Pregabalin in Refractory Partial Epilepsy.

Study Overview
=================
Brief Summary
-----------------
To evaluate the long-term safety of pregabalin in refractory partial epilepsy.

Official Title
-----------------
Pregabablin Open-Label, Follow-On Safety Trial In Patients With Refractory Partial Epilepsy.

Conditions
-----------------
Epilepsy, Partial

Intervention / Treatment
-----------------
* Drug: Pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have met the inclusion criteria for preceding double-blind study. Have received double-blind study medication and wish to receive open-label pregabalin. Exclusion Criteria: Pregnant or considering becoming pregnant. Receiving any concomitant medication that could alter the effectiveness of their medication response or seizure frequency.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pregabalin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  |
Shift to Everolimus (RAD) Kidney Sparing Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to verify if the combination of Everolimus with a very low dose of cyclosporine is more effective than the combination of mycophenolate mofetil with low-dose of cyclosporine in reducing the progression of kidney dysfunction in patients with heart transplantation.

Official Title
-----------------
Safety and Efficacy of Low-dose Cyclosporine in Association With Everolimus to Minimize Renal Dysfunction in Heart Transplant Recipients

Conditions
-----------------
Kidney Dysfunction, Heart Transplantation

Intervention / Treatment
-----------------
* Drug: cyclosporine
* Drug: cyclosporine
* Drug: Mycophenolate mofetil
* Drug: Everolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heart Transplant with 1 to 4 years of follow-up GFR between 20 and 60 ml/min (calculated with Colkoroft-Gault formula) Exclusion Criteria: Acute rejection in the previous 6 months Contraindications to statin therapy Ongoing infection Ongoing heart failure Myocardial infarction or myocardial revascularization after transplant Malignancy

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mycophenolate<br>Mycophenolate mofetil with cyclosporine trough levels between 100 and 150 | Drug: cyclosporine<br>* cyclosporine trough levels between 100 and 150<br>Drug: Mycophenolate mofetil<br>* mycophenolate with low doses<br>|
| Active Comparator: Everolimus<br>Everolimus with cyclosporine trough levels between 40 and 90 ng/ml | Drug: cyclosporine<br>* cyclosporine trough levels between 40 and 90 ng/ml<br>Drug: Everolimus<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculated GFR |  | One year after randomization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney, Heart Transplantation, Creatinine, Glomerular Filtration Rate
An Open Label Treatment Use Protocol for Ibrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide patients who have relapsed or refractory Mantle Cell Lymphoma (MCL) with early access to an investigational medication called ibrutinib (PCI-32765) and to collect safety information about the drug.

Official Title
-----------------
An Open-Label Treatment Use Protocol for Ibrutinib (PCI-32765) in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

Conditions
-----------------
Relapsed or Refractory Mantle Cell Lymphoma

Intervention / Treatment
-----------------
* Drug: Ibrutinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients, 18 years of age and older, with Mantle Cell Lymphoma who have relapsed or refractory disease after prior therapy are eligible. Exclusion Criteria: Patients eligible for enrollment in any other ongoing clinical study of ibrutinib are not eligible. Patients previously treated with ibrutinib are not eligible. Patients enrolled in another interventional clinical study with therapeutic intent are not eligible.

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 |
| --- |
|Drug: Ibrutinib|Ibrutinib|

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
-----------------
Mantle Cell Lymphoma, Ibrutinib
Predictors for Admission to Emergency Department More Than 48 Hours

Study Overview
=================
Brief Summary
-----------------
In Demark acutely admitted patients are supposed to stay in the Emergency Department (ED) bed ward if the anticipated duration of stay is less than 48 hours. However, it is not a trivial matter to estimate duration of stay for emergency patients. a number of factors affect this, eg. social background, disease, hospital organisation. The aim of this study is to analyse whom are the best among the health staff to predict the length of stay: ED nurses, admitting doctors og the specialist, and to analyse if a number of variables can be used to improve the prediction.

Conditions
-----------------
Length of Admission

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients admitted to the Emergency Department - Exclusion Criteria: Children less than 15 years patients transferred from other hospitals -

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- | --- |
| length of admission in hours | participants will be followed for the duration of hospital stay, an expected average of 76 hours | admission to discharge |
Text-message Program to Reduce Risky Sexual Behavior in Young Adult Female Emergency Department (ED) Patients

Study Overview
=================
Brief Summary
-----------------
The US preventative services task force (USPSTF) recommends behavioral counseling in the primary care setting for prevention of sexually transmitted diseases, however, screening and counseling rarely occur. Text messaging (TM) is increasingly being used as a tool to affect behavior change in patients, but its effect on patients that report at-risk sexual behavior in the emergency department (ED) is unknown. The investigators seek to assess the feasibility of ED-based screening of young adult females for at-risk sexual behavior and enrolling them in a 3 month trial using TM to deliver information and skill building to improve health behavior.

Official Title
-----------------
Mobile Phone Text-message Program to Reduce Risky Sexual Behavior in Young Females Discharged From the Emergency Department

Conditions
-----------------
Education, Sex

Intervention / Treatment
-----------------
* Behavioral: Lifestyle counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Age 18-25 years AUDIT-C score > 2 (Drugs or alcohol prior to last sex OR No condom with last sex OR > 1 partner in last 3 months) Exclusion Criteria: No personal cell phone with SMS features Prisoner Pregnant or planning in next 3 months Current or past drug/alcohol treatment or psychiatric treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

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

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: Lifestyle counseling<br>Weekly SMS assessing risky sexual encounters and providing feedback including concern, goal-setting and tools to reduce risk | Behavioral: Lifestyle counseling<br>* Weekly SMS assessments of risky sexual encounters with feedback<br>|
| No Intervention: Usual care<br>Usual care includes ED provider counseling as per normal clinical care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sex without condom | Participants will be called for phone follow-up at 12 weeks post-ED discarge | 3 months after ED discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of unprotected vaginal sexual encounters | Participants will be called for phone follow-up at 12 weeks post ED discharge | 3 months post-ED discharge |
Pilot Study of NKG2D CAR-T in Treating Patients With Recurrent Glioblastoma

Study Overview
=================
Brief Summary
-----------------
This is a pilot phase I study to evaluate the safety and efficacy of NKG2D CAR-T cell therapy in patients with relapsed and/or refractory glioblastoma

Official Title
-----------------
Pilot Study of UWNKG2D CAR-T in Treating Patients With Recurrent Glioblastoma

Conditions
-----------------
Recurrent Glioblastoma

Intervention / Treatment
-----------------
* Biological: NKG2D CAR-T


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed glioblastoma multiforme (GBM) and are at first or second relapse. Hemoglobin ≥ 9.0 g/dl, absolute neutrophil count (ANC) ≥ 1,000 cells/µl, platelets ≥ 125,000 cells/µl No active infection of HIV, HTLV and Syphilis Adequate renal function Adequate hepatic function Adequate cardiac function Adequate venous access for apheresis, and no other contraindications for leukapheresis Voluntary informed consent is given. Exclusion Criteria: Pregnant or lactating women. Uncontrolled active infection. History of hepatitis B or hepatitis C infection. Previously treatment with any gene therapy products or cell therapy product in past 28 days. Cannot undergo MRI with contrast or SPECT/CT HIV infection. Have autoimmune disorders Have active infection or inflammatory disorders Prescreening test results in expansion rate less than 5 folds An allergy to gentamycin and/or streptomycin

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UWN2D CAR-T<br> | Biological: NKG2D CAR-T<br>* The NKG2D CAR-T will be administrated via intracerebroventricular injection through an Ommaya catheter. Standard treatments such as temozolomide will be stopped during the infusion of NKG2D CAR-T.<br>* Other names: UWN2D;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants who experience a Dose-Limiting Toxicity (DLT) | Defined as the dose safely administered Intratumoral for the treatment of patients with GBM | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | Defined as the proportion of subjects with overall response of either complete response (CR) or partial response (PR) | 1 year | 
| Progression-free survival | Defined as date of the first NKG2D CAR-T infusion to the date of disease progression per RANO Response Criteria or death | 1 year |
The Influences of Long Periods of Pneumoperitoneum and Head up Position on the Variation of Heart-rate Corrected QT Interval During Robotic-assisted Laparoscopic Gastrectomy - Observational Study

Study Overview
=================
Brief Summary
-----------------
Sympathetic activity could be increased during robot-assisted laparoscopic gastrectomy, which is performed in a head up position under CO2 pneumoperitoneum. Stimulation of the sympathetic nervous system prolongs the QT interval and can increases the susceptibility to life threatening cardiac arrhythmias. Thus the investigators decided to evaluate the heart-rate corrected QT interval (QTc interval) during robotic-assisted laparoscopic gastrectomy.

Conditions
-----------------
Stomach Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA class I-II obtaining written informed consent from the patients who were undergoing robot- assisted laparoscopic gastrectomy. Exclusion Criteria: emergency operation cardiac disease (unstable angina, congestive heart failure, valvular heart disease) ventricular conduction abnormality prior pacemaker insertion abnormal electrolyte values patients who take antiarrythmic agent hepatic or renal failure drug hyperactivity neurological or psychiatric illnesses

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Evaluate the heart-rate corrected QT (QTc) interval (msec) during robotic-assisted laparoscopic gastrectomy | (T0: Pre-induction T1: 10min after anesthetic induction T2: 1min after CO2 pneumoperitoneum T3: 5min after CO2 pneumoperitoneum T4: 30min after steep trendelenburg position T5:60min after steep trendelenburg T6: 90min after steep trendelenburg T7: Supine positon following end of pneumoperitoneum T8: 5 min after end of pneumoperitoneum T9: End of surgery T10: 10min after extubation) | through study completion, an average of 5 hours |
DP-R212 Pharmacokinetic Study Phase I

Study Overview
=================
Brief Summary
-----------------
An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of DP-R212

Detailed Description
-----------------
An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of DP-R212, a fixed dose combination compared with coadministration of separate constituents in healthy adult volunteers

Official Title
-----------------
DP-R212 Pharmacokinetic Study Pharmacokinetic Characteristics of DP-R212 in Comparison to Each Component Coadministered in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: DP-R212
* Drug: Amlodipine
* Drug: Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 17.5 30.5 signed the informed consent form prior to the study participation Exclusion Criteria: Clinically significant disease Previously donate whole blood within 60 days or component blood within 30 days Clinically significant allergic disease Taken IP in other trial within 90 days An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 Years

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

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

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 |
| --- | --- |
| Experimental: A group<br>Amlodipine and Rosuvastatin, DP-R212 | Drug: DP-R212<br>* Investigational product is prescribed to all of randomized subjects<br>Drug: Amlodipine<br>* Investigational product is prescribed to all of randomized subjects<br>Drug: Rosuvastatin<br>* Investigational product is prescribed to all of randomized subjects<br>|
| Experimental: B group<br>DP-R212, Amlodipine and Rosuvastatin | Drug: DP-R212<br>* Investigational product is prescribed to all of randomized subjects<br>Drug: Amlodipine<br>* Investigational product is prescribed to all of randomized subjects<br>Drug: Rosuvastatin<br>* Investigational product is prescribed to all of randomized subjects<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast |  | 0,0.5,1, 2, 3, 4, 5, 6, 8, 10, 12, 24,48,72 hr | 
| Cmax |  | 0,0.5,1, 2, 3, 4, 5, 6, 8, 10, 12, 24,48,72 hr |