linjc16/ctgov huggingface dataset:
Risk Stratification of Nodal PTCL

Study Overview
=================
Brief Summary
-----------------
This study is to investigate the prognostic significance of enhanced International Prognostic Index (NCCN-IPI) and post-treatment PET results in patients with newly diagnosed nodal peripheral T-cell lymphoma (PTCL), and establish a risk stratification model for nodal PTCL patients.

Official Title
-----------------
Multicenter Study to Assess the Prognostic Significances of NCCN-IPI and Post-treatment PET Results in Patients With Newly Diagnosed Nodal PTCL

Conditions
-----------------
Peripheral T-Cell Lymphoma, Not Otherwise Specified, Angioimmunoblastic T-cell Lymphoma, Anaplastic Large Cell Lymphoma, ALK-negative

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with nodal PTCLs (PTCL, NOS; Angioimmunblastic T-cell lymphoma; anaplastic large cell lymphoma [ALCL], anaplastic lymphoma kinase [ALK]-negative) Patients diagnosed with between January 1, 2004 and April 30, 2016 initially treated with curative intent Patients with standard 18F-fluorodeoxyglucose (FDG) PET or PET-CT data at the time of diagnosis and at the end of primary treatment Exclusion Criteria: Patients diagnosed with extranodal PTCLs, including followings (extranodal NK/T-cell lymphoma, nasal type; enteropathy-associated T-cell lymphoma; hepatosplenic T-cell lymphoma; subcutaneous panniculitis-like T-cell lymphoma; EBV-positive T-cell lymphoproliferative childhood disorders, and primary cutaneous lymphomas) Patients with ALCL-ALK+ Patients who do not have 18F-FDG PET or PET-CT data either at diagnosis or at the end of treatment available for review

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nodal PTCL<br>newly-diagnosed, pathologically-proven nodal PTCLs (PTCL, NOS; Angioimmunblastic T-cell lymphoma; anaplastic large cell lymphoma [ALCL], anaplastic lymphoma kinase [ALK]-negative) between January 1, 2005 and Jun 30, 2016 initially treated with curative intent Standard PET or PET-CT data available at the time of diagnosis and at the end of primary treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | Time between the date of diagnosis and any kinds of death or disease relapse/progrression | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | Time between the date of diagnosis and any kinds of death | 5 year |
Phase II Study of Pandemic Influenza Vaccine

Study Overview
=================
Brief Summary
-----------------
The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza H5N1 virus strain is the leading candidate to cause the next influenza pandemic. This study will test the safety and immunogenicity of a H5N1 Pandemic Influenza Vaccine in healthy adults. The Study will also assess Lot to Lot consistency of the Pandemic Influenza Vaccine.

Official Title
-----------------
A Double-Blind, Randomised, Multi-Centre Study to Evaluate the Safety, Tolerability, Immunogenicity and Lot to Lot Consistency of Two Formulations of CSL Limited's Inactivated Prototype Pandemic Influenza Vaccine in a Healthy Adult Population (≤18 Years to ≥64 Years of Age).

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: Pandemic Influenza Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Adults Exclusion Criteria: Previous vaccination with an influenza Vaccine containing the H5N1 strain History of clinically significant medical conditions History of Guillian-Barre Syndrome or active Neurological disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Pandemic Influenza Vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Immunogenicity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lot to Lot Consistency |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pandemic, Influenza, Prevention, Vaccine, Prevention of Pandemic Influenza
The Relationship Between Osteoporosis and Chronic Oral Anticoagulation Therapy With Warfarin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if osteoporosis is an unrecognized complication of chronic anticoagulation with warfarin.

Official Title
-----------------
The Relationship Between Osteoporosis and Chronic Oral Anticoagulation Therapy With Warfarin

Conditions
-----------------
Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients on warfarin that have had BMD within a year Exclusion Criteria: Patients on bisphosphates, SERMS, anticonvulsants, estrogens, androgens, calcitonin, hctz and thyroid hormone replacement

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Bone Density | bone density as measured by xray to assess bone strength nd risk of fracture | 5 to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
warfarin use
The Feasibility and Advantages of Subxiphoid Uniportal Video-assisted Thoracoscopic Surgery in Pulmonary Lobectomy

Study Overview
=================
Brief Summary
-----------------
Uniportal video-assisted thoracoscopic surgery (VATS) lobectomy has emerged as a promising and exciting approach for minimally invasive thoracic surgery. However, nearly all reported uniportal VATS lobectomies have been performed via the intercostal route, and chest wall trauma has still occurred. Here,the investigators undertook novel uniportal VATS technique involving a subxiphoid route for pulmonary lobectomies to evaluate the feasibility and advantages.

Official Title
-----------------
The Feasibility and Advantages of Subxiphoid Uniportal Video-assisted Thoracoscopic Surgery in Pulmonary Lobectomy.A Retrospective Study

Conditions
-----------------
Lobectomy, Subxiphoid Uniportal Video-assisted Thoracoscopic Surgery

Intervention / Treatment
-----------------
* Procedure: Subxiphoid uniportal VATS
* Procedure: Three-port VATS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with lung cancer can be undertook the subxiphoid uniportal VATS or three-port VATS Exclusion Criteria: Contraindications in patients with lung cancer
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Subxiphoid uniportal VATS<br>retrospectively analyzed and compared perioperative data for patients who underwent subxiphoid uniportal and traditional three-port VATS lobectomies | Procedure: Subxiphoid uniportal VATS<br>* Patients were placed in a supine position, and the operating table was manipulated as needed to elevate the appropriate side of the body for surgery. The surgical procedures followed principles of pulmonary resections; in particular, similar to mediastinal lymphadenectomy for lung cancer, these procedures involved the individual dissection of veins, arteries and lobar bronchi.<br>|
| Other: Three-port VATS<br>retrospectively analyzed and compared perioperative data for patients who underwent subxiphoid uniportal and traditional three-port VATS lobectomies | Procedure: Three-port VATS<br>* The surgical procedures followed principles of pulmonary resections; in particular, similar to mediastinal lymphadenectomy for lung cancer, these procedures involved the individual dissection of veins, arteries and lobar bronchi<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment |  | 17 months |
Early Apical Release vs Classic Holmium Laser Enucleation of the Prostate: Randomized Controlled Trial Comparing Post-Operative Incontinence Rates and Surgical Outcomes

Study Overview
=================
Brief Summary
-----------------
To determine if early apical release holmium enucleation of the prostate (EAR HoLEP), as a surgical treatment for benign prostatic hyperplasia, reduces post-operative urinary incontinence compared to classic HoLEP.

Official Title
-----------------
Early Apical Release vs Classic Holmium Laser Enucleation of the Prostate: Randomized Controlled Trial Comparing Post-Operative Incontinence Rates and Surgical Outcomes

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Procedure: EAR HoLEP
* Procedure: Classic HoLEP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be 18 years of age or older Patients must present to clinic with a diagnosis of benign prostatic hyperplasia Patients must be scheduled to undergo a holmium laser enucleation of the prostate Exclusion Criteria: Patients with previous surgical management of BPH Patients with prostate biopsy revealing high risk prostate cancer Patients with a concomitant neurogenic bladder diagnosis (SCI, Parkinson, MS, cerebral palsy)

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

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- |
| Experimental: Early apical release holmium enucleation of the prostate<br>Early apical release holmium enucleation of the prostate (EAR HoLEP), as a surgical treatment for benign prostatic hyperplasia | Procedure: EAR HoLEP<br>* early apical release holmium enucleation of the prostate (EAR HoLEP), as a surgical treatment for benign prostatic hyperplasia<br>|
| Active Comparator: Classic holmium enucleation of the prostate<br>Classic holmium enucleation of the prostate (HoLEP), as a surgical treatment for benign prostatic hyperplasia | Procedure: Classic HoLEP<br>* classic holmium enucleation of the prostate as a surgical treatment for benign prostatic hyperplasia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Urinary Incontinence | to determine if patients who undergo early apical release HoLEP have reduced rates of post-operative urinary incontinence compared to classic HoLEP as measured by patient report of leakage | Twelve Months Post-operative |
Management of Advanced Non-Small Cell Lung Cancer (NSCLC) and Clinical Outcomes in Patients Who Received Gefitinib in Thailand

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine progression-free survival of lung cancer patients who received gefitinib in clinical practice in Thailand.

Official Title
-----------------
Management of Advanced Non-Small Cell Lung Cancer and Clinical Outcomes in Patients Who Received Gefitinib (IRESSA) in Tertiary Care Setting in Thailand

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed as having lung cancer based on histological/cytological findings Admitted to the hospital between January 2004 and December 2008 Treated with gefitinib for at least 3 months Exclusion Criteria: Involvement in the planning and/or conduct of the study Participation in another clinical study during the last 3 months
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 |
| --- | --- | --- |
| Progression-free survival |  | median time from the first date of treatment until date of disease progression during Jan 2004- Dec 2008 or 5 years approx. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to maximum response |  | Median time from the first date of treatment until the date that the disease can be maximum controlled during Jan 2004- Dec 2008 or 5 years approx. | 
| Overall survival |  | time from the first date of treatment until date of patients dead during Jan 2004- Dec 2008 or 5 years approx. | 
| Prevalence of EGFR & KRAS mutation from laboratory result |  | During Jan 2004- Dec 2008 or 5 years approx. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced NSCLC, Gefitinib, Thai patient
A Study of MK0431 in Patients With Type 2 Diabetes (0431-010)

Study Overview
=================
Brief Summary
-----------------
A dose-ranging study of MK0431 in patients with type 2 diabetes who have inadequate control of their blood sugar.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Placebo- and Active-Controlled Dose-Range Finding Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Conditions
-----------------
Diabetes Mellitus, Type II

Intervention / Treatment
-----------------
* Drug: MK0431, sitagliptin phosphate / Duration of Treatment: 21 Weeks
* Drug: Comparator: placebo (unspecified) / Duration of Treatment: 21 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 21 to 70, You are a man or non-pregnant woman Exclusion Criteria: Have a history of type I diabetes You are on a weight loss program with ongoing weight loss or taking weight loss medications You have a history of minor surgery You have received investigational drugs within 8 weeks of study start You have hepatitis B or C

Ages Eligible for Study
-----------------
Minimum Age: 21 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0431, sitagliptin phosphate / Duration of Treatment: 21 Weeks|nan|
|Drug: Comparator: placebo (unspecified) / Duration of Treatment: 21 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To asses the effectiveness of MK0431 compared to placebo |  | over 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test the safety and tolerability of MK0431 in patients with type 2 diabetes |  |  |
Psychosocial Factors Related to Compliance With Treatment With Biphasic Insulin Analogues

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this study is to investigate psychosocial factors related to compliance with treatment with biphasic insulin analogues.

Official Title
-----------------
Psychosocial Factors Related to Compliance With Treatment With Biphasic Insulin Analogues

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Other: No treatment given
* Other: No treatment given


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type 2 diabetes in whom therapy with biphasic insulin analogues was started
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 |
| --- | --- |
| Questionnaire responders<br> | Other: No treatment given<br>* Patients to complete the WHO-5 Well-being Index questionnaire<br>Other: No treatment given<br>* Physicians to complete two questionnaires, Demographic Data and Disease and Treatment Course and Questionnaire of Potential Difficulties in the Period of Treatment Switching from Insulin to Its Analogues<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and level of difficulty in introducing changes in compliance with the guidelines for biphasic insulin analogue use in subjects previously treated with biphasic human insulins |  | Up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlations between the difficulty in introducing changes in compliance with the guidelines for biphasic insulin analogue use in subjects previously treated with biphasic human insulins, and psychosocial factors |  | Up to 3 months |
Daptomycin in the Treatment of Patients With Renal Insufficiency and Complicated Skin and Skin Structure Infections

Study Overview
=================
Brief Summary
-----------------
This is a Phase 4, randomized, open-label, multicenter, comparative study designed to further evaluate the pharmacokinetics of intravenous (i.v.) daptomycin and the safety and efficacy of daptomycin relative to comparator in the treatment of complicated skin and skin structure infections in patients with renal impairment.

Official Title
-----------------
An Open Label Phase 4 Trial to Further Evaluate the Pharmacokinetic Profile of Intravenous Daptomycin, and a Comparison of the Safety and Efficacy of Daptomycin Versus Comparator in the Treatment of Adult Patients With Renal Impairment and Complicated Skin and Skin Structure Infections Due, at Least in Part, to Gram-positive Bacteria

Conditions
-----------------
Soft Tissue Infections

Intervention / Treatment
-----------------
* Drug: daptomycin (up to 14 days)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Moderate to end-stage renal impairment - A diagnosis of complicated skin and skin structure infection known or suspected to be due to susceptible Gram-positive bacteria based on positive Gram stain - A diagnosis of bacterial skin and skin structure infection in the presence of some complicating factor Exclusion Criteria: - Known bacteremia, osteomyelitis or endocarditis

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: daptomycin (up to 14 days)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To obtain additional pharmacokinetic data (on dosing days) on intravenous daptomycin in patients with complicated skin and skin structure infections and renal impairment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the safety and efficacy of daptomycin to comparator in patients with complicated skin and skin structure infections and renal impairment at 14 to 21 days after last dose |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal impairment, daptomycin, Cubist, complicated skin and skin structure infections
Turkish Version of F-2-MS

Study Overview
=================
Brief Summary
-----------------
The aims of this study were to perform cultural adaptation of the F-2-MS and provide information regarding the factor structure, reliability and validity of the instrument in Turkish speaking patients with Multiple Sclerosis.

Official Title
-----------------
Validity and Reliability of the Turkish Version of F-2-MS Scale

Conditions
-----------------
Cultural Adaptation, Reliability, Validity, Multiple Sclerosis, Fatigue

Intervention / Treatment
-----------------
* Other: Cultural adaptation, reliability and validity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals aged between 20-65 years, with an EDSS score of 0-5, who have not had an attack in the last 2 months, who have no cognitive problems (a score of 6 or more according to the Hodkinson Mental Test), who do not have additional neurological diseases other than MS, and who volunteer to participate in the study will be included. Exclusion Criteria: Individuals with an EDSS score greater than 5, who are in the attack period, who have vestibulosupressant or drug or alcohol use habits that cause neuropathy, and who have communication problems will be excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Cultural adaptation, reliability and validity|Cross-cultural Adaptation, Reliability and Validity of the Turkish Version of the F-2-MS|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| F-2-MS Scale | F-2-MS is a novel scale to assess fatigue and perceived fatigability in patients with MS | 10 minutes |