linjc16/ctgov huggingface dataset:
Study to Evaluate the Value of the Follow-up of CALCIneurin Activity to MOdulate Calcineurin Inhibitors-induced Immunosuppression in Lung Transplantation

Study Overview
=================
Brief Summary
-----------------
The study is an interventional, multicentre, prospective, randomized, controlled, single-blind, comparative trial of two processes for adjusting the inhibitor of calcineurin (CNI) dosage in lung transplant recipients. Recipients will be stratified by transplant center and according to the underlying lung disease (affected with cystic fibrosis or not) and will be randomized to either evaluation of calcineurin activity (CN-a) in combination with CNI blood levels versus CNI blood levels alone in a 1:1 ratio. The objective is to compare the proportion of acute rejection that has required a specific curative treatment at 6 months after transplantation between patients in the two groups.

Conditions
-----------------
Lung Diseases

Intervention / Treatment
-----------------
* Biological: levels of CNI in whole blood
* Biological: Calcineurin activity (CN-a) in peripheral blood mononuclear cells (PBMCs)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient placed on the national waiting list for lung transplantation First de novo lung transplantation (single or double LTx) Prevention of allograft rejection by a usual immunosuppressive regimen including CNI (cyclosporine or tacrolimus) Exclusion Criteria: Previous lung transplantation or other solid organ transplantation Combined lung transplantation with either liver or renal transplantation

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: new strategy of immunosuppression monitoring<br>evaluation of calcineurin activity (CN-a) in combination with CNI blood levels | Biological: levels of CNI in whole blood<br> <br> Biological: Calcineurin activity (CN-a) in peripheral blood mononuclear cells (PBMCs)<br> <br> |
| Active Comparator: strategy of reference<br>CNI (inhibitor of Calcineurin) blood levels alone | Biological: levels of CNI in whole blood<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of episodes of acute rejection after LTx |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung transplantation in end-stage lung diseases
A Phase 2, 12-Week, Double-Blind, Efficacy and Safety of GX-G6 in Patients With Uncontrolled Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
GX-G6-002 is a Phase 2, 12-week, randomized, parallel group, multi-centre, double blind, placebo-controlled and an open-label active comparator study.

Detailed Description
-----------------
This study aims to establish the dose-response relationship of 4 dose cohorts of GX-G6 compared with double-blind placebo. These treatment cohorts will also be compared with open-label active control.

Official Title
-----------------
A Phase 2, 12-Week, Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate Efficacy and Safety of GX-G6 on Glycaemic Control Versus Placebo and Open-Label Dulaglutide in Patients With Uncontrolled Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: GX-G6
* Drug: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of T2DM ≥ 6 months prior to screening HbA1c level of 7-10% (inclusive) Exclusion Criteria: Have known type 1 diabetes mellitus (T1DM) History of severe hypoglycaemia defined as ≥ 2 episodes of severe hypoglycaemia within 6 months prior to screening Have had ≥ 2 episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization in the 6 months prior to screening Has fasting serum TG ≥ 500 mg/dL or 9 mmol/L at screening. Patients receiving lipid-lowering therapy must have been on the same dose of therapy for the past three months

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose level 1<br> | Drug: GX-G6<br>* long acting anti-diabetic drug<br>|
| Experimental: Dose level 2<br> | Drug: GX-G6<br>* long acting anti-diabetic drug<br>|
| Experimental: Dose level 3<br> | Drug: GX-G6<br>* long acting anti-diabetic drug<br>|
| Experimental: Dose level 4<br> | Drug: GX-G6<br>* long acting anti-diabetic drug<br>|
| Placebo Comparator: Placebo<br> | Drug: Control<br>* Control<br>|
| Active Comparator: Dulaglutide<br> | Drug: Control<br>* Control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | Week 12 |
Intravenous Administration of Metoprolol Versus Biatrial Pacing in the Prevention of Atrial Fibrillation After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare the effectiviness of biatrial pacing versus intravenous administration of metoprolol in the prevention of atrial fibrillation after cardiac surgery

Official Title
-----------------
Intravenous Metoprolol Versus Biatrial Pacing in the Prevention of Atrial Fibrillation After Cardiac Surgery

Conditions
-----------------
Atrial Fibrillation, Biatrial Pacing, Metoprolol

Intervention / Treatment
-----------------
* Other: metoprolol, biatrial pacing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective CABG and aortic valve cardiac patients, previous use of beta blocker Exclusion Criteria: Previous episodes of Atrial fibrillation or flutter, II or II degree atrioventricular block, uncontrolled heart failure Sick sinus syndrome
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: metoprolol<br> | Other: metoprolol, biatrial pacing<br>* Prevention, atrial fibrillation, cardiac surgery, biatrial pacing, metoprolol<br>|
| Active Comparator: biatrial pacing<br> | Other: metoprolol, biatrial pacing<br>* Prevention, atrial fibrillation, cardiac surgery, biatrial pacing, metoprolol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biatriac pacing |  | 48 hours | 
| Incidence of atrial fibrillation |  | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevention
Evaluate Efficacy and Safety Of Tolterodine Extended Release Capsule Compared With Tolterodine Immediate Release Tablet

Study Overview
=================
Brief Summary
-----------------
To evaluate efficacy of tolterodine extended release formulation compared with immediate release formulation in subjects with symptoms of overactive bladder

Official Title
-----------------
A Phase III Randomized, Double-Blind, Double Dummy, Multi-Center Study To Compare The Efficacy, Safety And Tolerability Of Tolterodine Extended Release Capsule With Tolterodine Immediate Release Tablet In Subjects With Symptoms Of Overactive Bladder

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Drug: tolterodine extended release capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with a diagnosis of overactive bladder. Exclusion Criteria: Subjects with significant stress incontinence as determined by the investigator. Subjects with recurrent urinary tract infections defined as treated for UTI; 5 times in the last year.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: tolterodine extended release capsule|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of tolterodine extended release formulation compared with immediate release formulation after 8 weeks of treatment in subjects with symptoms of overactive bladder |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of tolterodine extended release formulation compared with immediate release formulation after 8 weeks of treatment in subjects with symptoms of overactive bladder. |  |  |
Effectiveness, Safety & Nurse Management Study of MabThera SC in Patients With Non-Hodgkin's Lymphoma: Real-Life Setting

Study Overview
=================
Brief Summary
-----------------
This prospective, open-label, multicenter, observational study will investigate the effectiveness and safety of MabThera SC (rituximab, subcutaneous) induction therapy in patients with non-Hodgkin's lymphoma, following a first initial treatment of MabThera IV (rituximab, intraveneous). Induction treatment period in the study is estimated to be 8 months.

Official Title
-----------------
A NON-INTERVENTIONAL STUDY TO EVALUATE THE EFFECTIVENESS, SAFETY AND NURSE MANAGEMENT DURING INDUCTION TREATMENT WITH MABTHERA S.C. FOLLOWING A FIRST INITIAL MABTHERA I.V. TREATMENT, IN PATIENTS WITH NON-HODGKINS LYMPHOMA IN A REAL-LIFE SETTING

Conditions
-----------------
Non-Hodgkin's Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication according to the Summary of Product Characteristics (SPC) for MabThera SC formulation: As treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy As treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with chemotherapy At least 4 treatment cycles with MabThera is planned Patients >/= 18 years at inclusion Patients written informed consent Treatment decision to prescribe MabThera SC has been taken by the physician prior to recruitment into the study Exclusion Criteria: Contraindications according to SPC for MabThera SC formulation: Hypersensitivity for the active substance or murine antibodies, hyaluronidase or any other excipients Active and severe infections Patients with severe immunsuppression Patient included in clinical trials with experimental pharmaceuticals Pregnancy

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate using the International Working Group criteria |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | Through to end of study, up to approximately 1 year | 
| Incidence of administration related reactions during induction therapy in patients who have previously received at least one dose of MabThera IV |  | Through to end of study, up to approximately 1 year | 
| Incidence of serious adverse events |  | Through to end of study, up to approximately 1 year |
Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent

Official Title
-----------------
A Multi-Center, Randomized, Controlled Study to Investigate the Safety and Tolerability of a Single Dose of Intravenous Ferric Carboxymaltose (FCM) vs. Standard Medical Care in Treating Iron Deficiency Anemia in Subjects Who Are Not Dialysis Dependent

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: Ferric Carboxymaltose
* Drug: Standard Medical Care (SMC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects ≥18 years of age and able to give informed consent Iron deficiency is the primary etiology of anemia Screening Visit central laboratory Hgb indicative of anemia ≤12 g/dL Screening Visit ferritin indicative of iron deficiency anemia ≤100 ng/mL or ≤300 when TSAT was ≤30% Exclusion Criteria: Previous participation in a FCM trial Known hypersensitivity reaction to FCM Requires dialysis for treatment of chronic kidney disease Current anemia not attributed to iron deficiency Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase Anticipated need for surgery requiring general anesthesia 30 days prior to screening or during the study period AST of ALT greater than 1.5 times the upper limit of normal Received an investigational drug within 30 days of screening Pregnant or sexually-active females who are not able to use an effective form of birth control

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ferric Carboxymaltose (FCM)<br>15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0. | Drug: Ferric Carboxymaltose<br>* 15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0.<br>|
| Active Comparator: Standard Medical Care<br>Per product label | Drug: Standard Medical Care (SMC)<br>* Per product label<br>* Other names: Ferrous Sulfate, Venofer, Ferrlecit, Infed, Dexferrum;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-emergent Serious Adverse Events (SAE's) |  | through 30 days after the last dose of study drug (FCM or SMC for the treatment of IDA) |
A Human Factor Study To Asses The Usability And Feasibility Of The Peritron+ During Intended Use

Study Overview
=================
Brief Summary
-----------------
In a hospital setting, the self-measurement of intravesical pressure (SMIP) assessment will be conducted at full and empty bladder using the Peritron+ and a ruler-based manometry method. In the home setting a human factor/usability study will be conducted to measure the subject's ability to perform a successful SMIP assessment at full and empty bladder with the Peritron+. This study involves the use of the Peritron+, Air-Trap Tubing, a ruler and a clean intermittent catheter (CIC).

Conditions
-----------------
Urology

Intervention / Treatment
-----------------
* Device: Peritron+


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children (2 to 18 years old) Subjects who perform CIC regularly Must be able to understand English instructions (written or oral) Exclusion Criteria: Subjects suffering from symptomatic bladder infection

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peritron+<br>SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter | Device: Peritron+<br>* Peritron+ device to measure intravesical pressure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability Factors; Simple, Doable, and is Comparable to the Ruler-based Manometry Method Using a Questionnaire and Patient Diary. | Each participant could score between 0 and 39 and the total score range for group is 0 to 195. All questionnaires and patient diary questions were summed across the board for patients to derive a total score for the Arm/Group | Through study completion, an average of 4 days |
Evaluation of EGFR TKI Resistance Mechanism Using Plasma DNA Analysis

Study Overview
=================
Brief Summary
-----------------
To detect resistance gene from serially collected plasma DNA in non-small cell lung cancer harbouring EGFR activating mutation who are being treated with EGFR TKIs by using castPCR method.

Official Title
-----------------
Detection of Resistance Genes From Serially Collected Plasma DNA in Non-small Cell Lung Cancer Patients Harboring EGFR Activating Mutation Who Are Being Treated With EGFR TKIs

Conditions
-----------------
EGFR Mutation Positive Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: EGFR TKIs (gefitinib, erlotinib, afatinib, et al)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Histologically confirmed NSCLC 2. Aged of or older than 20 years 3. ECOG performance status 0-2 4. Adequate hematological, renal, hepatic function 5. Patients with tumors harboring EGFR mutation (del 19 or L858R mutation) 6. Patient who are about to be treated with EGFR TKI (gefitinib, erlotinib or other EGFR TKI) 7. At least more than one measurable disease 8. Informed consent Exclusion Criteria: 1. Active infection 2. Active bleeding

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EGFR positive arm<br>Patients with NSCLC harboring activating EGFR mutation (deletion in exon 19, L858R mutation in exon 21) | Drug: EGFR TKIs (gefitinib, erlotinib, afatinib, et al)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection of resistant gene | To evaluate the efficiency of castPCR method for detection of resistance genes, especially, T790M mutation from serially collected plasma DNA in non-small cell lung cancer patients harboring EGFR activating mutation who are being treated with EGFR TKIs | 24 months |
T-score Comparability Between GE Lunar Prodigy and Norland Excel Densitometers

Study Overview
=================
Brief Summary
-----------------
Differences in determining bone density scores have been found when comparing different bone density machines. Reducing differences between machines will improve diagnostic agreement for patients measured at different clinics. This study will test if this difference exists between the Norland Excel, such as the one at Wildwood Clinic, and the GE Healthcare Lunar Prodigy at the UW Osteoporosis Clinical Research Center.

Official Title
-----------------
T-score Comparability Between GE Lunar Prodigy and Norland Excel Densitometers

Conditions
-----------------
Bone Densitometry

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ambulatory women age 40 years and older Recent spine and hip DXA at Wildwood clinic in Madison, WI

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>diagnosed with normal bone density by Norland Excel | |
| 2<br>diagnosed with osteopenia by Norland Excel densitometer | |
| 3<br>diagnosed with osteoporosis by Norland Excel densitometer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spine and hip BMD and T-score measurements will be compared between densitometry machines. |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone density diagnostic equipment discrepancies