linjc16/ctgov huggingface dataset:
TKI258 in Subjects With Refractory or Relapsed Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), and safety profile of CHIR-258 when administered to subjects with refractory or relapsed multiple myeloma (MM).

Official Title
-----------------
Phase 1 Dose Escalating Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TKI258 in Subjects With Refractory or Relapsed Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: TKI258


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of multiple myeloma Evidence of relapsed or refractory disease Exclusion Criteria: Intracranial disease or epidural disease Clinically significant cardiac disease Diabetes mellitus

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: TKI258|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose |  |  | 
| Dose limiting toxicity |  |  | 
| Safety profile |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pharmacokinetics and pharmacodynamics |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Refractory Multiple Myeloma or, Relapsed Multiple Myeloma
Patients Attitude Towards Physicians and Health Screening Issues Among First Generation Asian-Indian Immigrants to United States.

Study Overview
=================
Brief Summary
-----------------
Aim - To better understand expectations and attitudes of first generation immigrants from India to USA. Background - The is large difference in healthcare system as practiced in India and in USA. Most people who have lived in India for certain period of their life have basic understanding of health-care system in India. In general it is the physician who makes choices for patients there , also the concept of health screening is less prevalent. After immigrating to USA these immigrants are exposed to new healthcare system. We donot have any data showing their attitudes to some specific questions and physician preference in general. We also have significant concentration of these ethnic group in the central valley. With this questionnaire study we hope to get better understanding of their beliefs and expectations. We have tried to keep the questions simple and straightforward.

Conditions
-----------------
Health Screening

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First generation immigrants from India to USA Currently living in USA Planning to live in USA and utilize local healthcare facilities Exclusion Criteria: Age < 18 People born in USA

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
CHIPS (Control of Hypertension in Pregnancy Study): A Pilot Trial

Study Overview
=================
Brief Summary
-----------------
Prior to undertaking CHIPS which will be a large and difficult trial, we believe we need to first determine whether clinicians will comply with the interventions of 'less tight' and 'tight' control of dBP, and whether the interventions will result in differences in mean dBP between groups. A pilot will also allow us to confirm the ability of centres to identify eligible women and the willingness of women to join CHIPS.

Detailed Description
-----------------
To determine whether 'less tight' control of mild-moderate non-proteinuric maternal hypertension, aiming for a diastolic blood pressure (dBP) of 100mmHg, can decrease the risks of adverse perinatal outcome without increasing maternal risk compared with 'tight' control, aiming for a dBP of 85mmHg.

Official Title
-----------------
Control of Hypertension in Pregnancy Study: A Pilot Trial

Conditions
-----------------
Transient Hypertension, Pregnancy

Intervention / Treatment
-----------------
* Procedure: Randomized to either a 'less tight' group or a 'tight' group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: dBP 90-109mmHg due to pre-existing or gestational hypertension; live fetus(es); and 20-33+6 weeks. Exclusion Criteria: dBP consistently < 85mmHg by home BP monitoring; severe systolic hypertension; proteinuria; contraindication to either arm of the trial or to prolongation of pregnancy; or known lethal/major fetal anomaly.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 48 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

| Intervention/Treatment |
| --- |
|Procedure: Randomized to either a 'less tight' group or a 'tight' group|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean dBP at 28, 32 and 36 weeks gestation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician compliance with treatment protocols; women's satisfaction with care. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, blood pressure, pregnancy
Spironolactone and Prevention of Peritoneal Fibrosis in Peritoneal Dialysis

Study Overview
=================
Brief Summary
-----------------
This is a double blind randomized controlled study to evaluate the effect of aldactone on peritoneal fibrosis on incident peritoneal dialysis patients. The study would include a total of 40 incident peritoneal dialysis patients. Peritoneal biopsy would be made at randomization and 6 months after the intervention to evaluate the effect of renin angiotensin blockade on peritoneal fibrosis.

Official Title
-----------------
Role of Renin Angiotensin Blockade in Peritoneal Fibrosis in Peritoneal Dialysis Patients

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* Drug: spironolactone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Hospitalized for peritoneal catheter placement for peritoneal dialysis Exclusion Criteria: Pregnancy Hiperkalemia (K> 5.5meq/l) Intolerance to spironolactone

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Peritoneal Dialysis patients on aldactone for 6 months | Drug: spironolactone<br>* 25 mg daily of spironolactone given for 6 months in the peritoneal dialysis patients<br>|
| Placebo Comparator: 2<br>Peritoneal dialysis Patients on the placebo arm for 6 months | Drug: Placebo<br>* Placebo, given daily for 6 months to Peritoneal Dialysis Patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peritoneal fibrosis |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spironolactone, peritoneal fibrosis, peritoneal dialysis
REmote MOnitoring Transmission Evaluation of IPGs

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the potential clinical and economic benefits of using CareLink remote management for pacemaker follow-up. Study Objectives include: To determine clinician perceived quality of care for CareLink remote follow-up. To determine patient satisfaction with CareLink follow-up. To estimate the time required to perform patient follow-up via CareLink remote transmissions. To determine the percentage of regular CareLink follow-ups that do not require further in-clinic review of the patient. To estimate potential patient cost avoidance for one year of follow up incorporating CareLink. To evaluate compliance to scheduled CareLink transmissions with the remote management system This is a non-randomized, multi-center, prospective study in which 120 patients who have a pacemaker are enrolled into the study and receive a CareLink monitor. Patients will replace their regularly scheduled pacemaker clinic follow-up visits with a CareLink remote transmission for 12months. Patients will require a test transmission within 1 month after they receive their CareLink monitor. Afterwards, patients are followed via CareLink transmissions as per their usual clinic schedule for 12 months.

Official Title
-----------------
REmote MOnitoring Transmission Evaluation of IPGs

Conditions
-----------------
Pacemaker

Intervention / Treatment
-----------------
* Other: CareLink Remote Monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have received a market released Medtronic pacemaker with automatic threshold management features for all active leads. Patients who have been implanted with their current pacemaker for at least 3 months. Patients who are willing, or who have caregivers willing, to use the Medtronic CareLink Monitor. Patients who are willing and able to sign an IRB/MEC approved patient informed consent. Exclusion Criteria: Patients participating in another study that would affect the objectives of this study Patients who have already previously used a Medtronic CareLink Monitor.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Pacemaker Patients | Other: CareLink Remote Monitoring<br>* Substitution of CareLink Remote Monitoring of Pacemakers for in-clinic pacemaker follow-up visits<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparison of Diagnostic Performance of Medical Monitor and Medical Augmented Reality Glasses in Endoscopy: Observation Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to compare the outcomes of medical augmented reality glasses and general monitors when distinguishing mucosal lesions from submucosal lesions in endoscopic diagnosis for early gastric cancer.

Official Title
-----------------
Comparison of Diagnostic Performance of Medical Monitor and Medical Augmented Reality Glasses in Endoscopy: Observation Study

Conditions
-----------------
Early Gastric Cancer

Intervention / Treatment
-----------------
* Other: application of medical augmented reality glasses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with early gastric cancer who are scheduled for endoscopic submucosal dissection Age 19 or more Patients who voluntarily participated in this clinical study and signed a written informed consent Exclusion Criteria: Patients with poor general medical condition which does not allow them to understand and submit a informed consent Patients who do not agree with this study

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: application of medical augmented reality glasses|Endoscopic images from medical monitor and medical augmented reality glasses will be collected and reviewed. Outcomes from both series of images will be compared|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consistency between the result from medical monitor and that from medical augmented reality glass | All series of images will be reviewed by several endoscopists by evaluation of several endoscopic findings. Then, concordance rate between the result from medical monitor and that from medical augmented reality glass will be assessed. More specifically, % of patients that does not show the same results (m cancer, sm cancer, or indeterminate) between medical monitor and medical augmented reality will be assessed. | Image review will be conducted after full collection of both series of images. Review process will be done within 3 months after acquision of images. The time for study completion is aimed at 1 year from the start date. |
Clinical Effectiveness of Obturator Externus Muscle Injection in Chronic Pelvic Pain Patients

Study Overview
=================
Brief Summary
-----------------
Obturator externus (OE) muscle has the possibility as a pain generator, considering its anatomical and functional aspects, but this muscle as a possible target for therapeutic intervention is currently understudied in pain practice.

Conditions
-----------------
Chronic Pelvic Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. 20-75 adults/ 2. Chronic pelvic pain patients who required the interventional procedures/ 3. patients with a localized tenderness on inferolateral side of the pubic tubercle Exclusion Criteria: 1. Severe cardiovascular disease /2. Coagulation abnormality /3. Patient denial

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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 |
| --- | --- |
| Obturator externus muscle injection<br>patients were treated with obturator externus injection | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-injection pain score | Before and after the OE muscle injection, patients were asked to rate their pain score using a 10-point numeric rating scale (NRS; 0=no pain, 10=worst possible pain). We also assessed the degree of patient satisfaction as excellent, good, fair, and bad during 2 weeks after injection. In this period, any analgesic medications did not change in all patients. Complications associated with OE muscle injection were investigated. | at 2 weeks after injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obturator externus
Efficacy of Choleretics in Acalculous Gallbladder in Situ After Endoscopic Removal of Biliary Stones

Study Overview
=================
Brief Summary
-----------------
In patients with gallbladder in situ after complete removal of common bile duct (CBD) stones, there is no definite guideline for the management of remnant acalculous gallbladder. This study was planned to evaluate the efficacy of choleretic agents in those patients comparing with non-treatment group during short (2 years) and long-term (5 to 10 years) period. So that, the investigators want to establish the treatment guideline in gallbladder in situ without definite stones following complete removal of CBD stones. Second, the protective or preventive effect of choleretics may be defined.

Official Title
-----------------
A Prospective Multicenter Comparative Study for Efficacy of Choleretics in Acalculous Gallbladder in Situ After Endoscopic Removal of Biliary Stones

Conditions
-----------------
Common Bile Duct Stones, Gallbladder in Situ, Choleretics, Biliary Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Complete clearance of CBD stones No definite GB stones Agree with the study protocol Exclusion Criteria: < 18 years of age Concomitant IHD stones Combined malignancy with a limted life span Prior cholecystectomy state refusal to agree to the study protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Wait-and-see group<br>After endoscopic clearance of their bile duct stones, this group of patients will be follow up without additional managements | |
| Choleretics group<br>After endoscopic clearance of their bile duct stones, this group of patients receives choleretic agents during 3 months | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | The primary outcome is biliary complications between two groups during follow-up. | two year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural outcomes | Other outcome measures included adverse events after choleretics and natural clinical courses of gallbladder in situ. | two year | 
| Other adverse events | Other outcome measures included adverse events after choleretics and natural outcomes of gallbladder in situ. | two year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Common bile duct stone, Gallbladder in situ, Choleretics
Compression Bandage in Local Infiltration Analgesia Afte Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
purpose: to determine wether a compression bandage prolongs analgesia of local infiltration analgesia after total knee arthroplasty

Detailed Description
-----------------
patients are randomised to receive a compression bandage or a non-compression bandage

Official Title
-----------------
The Effect of a Compression Bandage in Local Infiltration Analgesia After Total Knee Arthroplasty

Conditions
-----------------
Total Knee Arthroplasty

Intervention / Treatment
-----------------
* Device: compression bandage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scheduled for total knee arthroplasty speak and understand Danish Exclusion Criteria: severe obesity allergies to local anaesthetics
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

| Intervention/Treatment |
| --- |
|Device: compression bandage|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain, Visual Analogue Scale |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative pain
Using Phenazopyridine for In-office Cystoscopy

Study Overview
=================
Brief Summary
-----------------
The investigators propose to conduct a randomized controlled trial to evaluate whether administration of phenazopyridine prior to the procedure decreases office cystoscopy time. Women undergoing in-office cystoscopy at Boston Urogynecology will be recruited.

Detailed Description
-----------------
All potentially eligible participants will have had a complete history, physical examination, urinalysis and urine culture for clinical purposes. After eligibility is confirmed and written, informed consent is obtained, participants will be randomized to one of the two study arms. Participants randomized to phenazopyridine arm will receive 200 mg by mouth approximately 60 minutes prior to the scheduled cystoscopy. During the cystoscopy, at various time points, the time will be recorded.The color of the efflux will also be documented.

Official Title
-----------------
Using Phenazopyridine for In-office Cystoscopy

Conditions
-----------------
Cystoscopy, Phenazopyridine

Intervention / Treatment
-----------------
* Drug: Phenazopyridine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients undergoing in-office diagnostic cystoscopy at Boston Urogynecology Associates Exclusion Criteria: Women who have taken vitamin B the day of the cystoscopy Cystoscopy with concurrent treatments such as botulinum toxin or periurethral bulking injections Allergy to phenazopyridine

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Phenazopyridine before cystoscopy<br>This group will not receive phenazopyridine prior to cystoscopy | |
| Experimental: Phenazopyridine before cystoscopy<br>This group will receive 200mg of phenazopyridine prior to cystoscopy | Drug: Phenazopyridine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cystoscopy time | The total time of cystoscopy will be measured | at time of cystoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to visualization of ureteral jets | The time to visualization of the first ureteral jet will be recorded | at time of cystoscopy |