linjc16/ctgov huggingface dataset:
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314

Study Overview
=================
Brief Summary
-----------------
A Double-blind, Multi-center, Multi-regional, Randomized controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed with COVID-19

Detailed Description
-----------------
To evaluate the efficacy and safety of CKD-314 by comparing the study group and control group in hospitalized adult patients diagnosed with COVID-19 pneumonia

Official Title
-----------------
A Double-blind, Multi-center, Multi-regional, Randomized Controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed With COVID-19

Conditions
-----------------
COVID-19 Pneumonia

Intervention / Treatment
-----------------
* Drug: CKD-314+SOC
* Drug: CKD-314 Placebo+SOC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged ≥ 18 years Patients diagnosed with COVID-19 infection and pneumonia Patients who have voluntarily decided to participate in the study and signed the informed consent form If a patient cannot provide consent on his or her own, informed consent by a legally authorized representative may be obtained. Exclusion Criteria: Patients with history of hypersensitivity to the study drug Female patients, either who are or may be pregnant or who are breastfeeding, or female patients of child-bearing potential who are unable to use adequate contraception during the study Patients who are deemed to ineligible to participate in the study for other reasons by the investigator

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKD-314<br>Treatment with CKD-314 + SOC | Drug: CKD-314+SOC<br>* CKD-314 is administered intravenously and standard of care is also performed.<br>|
| Placebo Comparator: CKD-314 Placebo<br>Treatment with CKD-314 Placebo + SOC | Drug: CKD-314 Placebo+SOC<br>* CKD-314 placebo is administered intravenously and standard of care is also performed..<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recovery | Day of recovery is defined as the first day on which the subject meets the criteria | From day1 to day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to clinical improvement: Time to clinical improvement (TTCI) | as time (days) from randomization to a decline of 2 categories on the 8-category ordinal scale of clinical status | From day1 to day 28 |
EBUS-TBNA-RTE VS Radiography in Staging of NSCLC

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to make a qualitative and quantitative analysis of the intrathoracic lymph nodes by CP-EBUS elastography for the first time, and to make a benign and malignant diagnosis.

Detailed Description
-----------------
The newly developed convex array can be used to identify the hardness of the lymph nodes and estimate the benign and malignant lymph nodes indirectly through the quantitative and visualized analysis of the elastic coefficient of the bronchus through the CP-EBUS elastography mode. The purpose of this study is to make a qualitative and quantitative analysis of the intrathoracic lymph nodes by CP-EBUS elastography for the first time, and to make a benign and malignant diagnosis. 120cases will be enrolled.Compared with the commonly used methods to evaluate intrathoracic lymph node metastasis, the accuracy of chest CT and PET-CT were compared. The lymph node staging method and the final pathological gold standard of the three groups were compared, so as to verify the accuracy and clinical popularization of the bronchial ultrasound elastography mode.

Official Title
-----------------
A Control Study of Intrathoracic Lymph Node in NSCLC Staging by EBUS-TBNA-RTE and Radiography

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

Intervention / Treatment
-----------------
* Device: EBUS-TBNA-RTE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intrathoracic lymph node enlargement EBUS-TBNA operation can be performed Exclusion Criteria: 1. Unable to cooperate with the experiment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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: EBUS-TBNA-RTE<br>Patients do CT、 PETCT examination and EBUS-TBNA-RTE | Device: EBUS-TBNA-RTE<br>* Every patient will do CT、 PETCT and EBUS-TBNA-RTE.These three kind of examination will have their own result.The three methods of inspection will be compared by diagnostic rate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effectiveness of EBUS-TBNA-RTE | By comparison of the diagnostic accuracy of CT ,PET-CT and EBUS-TBNA-RTE | 1year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CP-EBUS, EBUS-TBNA, Real time elasticity, Staging of lung cancer
Predictors of Attempted Inferior Vena Cava Filters Retrieval.

Study Overview
=================
Brief Summary
-----------------
The InferiorVena Cava (IVC) with filters has been recommended when there is a contraindication or a failure of anticoagulation. Due to the side effects related to the filters, it is recommended to remove them as soon as possible. It's a retrospective study in a French hospital to evaluate the retrieval rate and predictors of filter removal. All the data of consecutive patients who had a retrievable InferiorVena Cava Filter (IVCF) inserted in the investigator center between April 2012 and November 2019 are included.

Official Title
-----------------
Predictors of Attempted Inferior Vena Cava Filters Retrieval.

Conditions
-----------------
Venous Thromboembolic Disease

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who had a cave filter placement at Saint-Etienne Hospital between april 2012 and november 2019. 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 |
| --- | --- |
| Retrievable Inferior Vena Cava Filters (IVCF)<br>The population study includes patients with a Retrievable Inferior Vena Cava Filters (IVCF) inserted between April 2012 and November 2019. Follow up data is collected up to July 2020. | Other: Data collection<br>* Collect in medical records : Filter's retrieval rate Complications of vena cava filters Predictive factors of attempted inferior vena cava filters retrieval: age, the distance between the patient's home and the hospital, the indication or not given by the therapeutic medicine department, patients referred by external structures, patients whose filter was installed during the medical on-call period, the absence of a written request for filter placement, the presence of active neoplasia at the time of filter placement, a peri-surgical context.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Filter's retrieval rate (%) | Collect in medical records. | Month: 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive factors of attempted inferior vena cava filters retrieval | Collect in medical records. | Month: 2 | 
| Adverse event of vena cava filters | Collect in medical records. | Month: 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inferior vena cava filter, inferior vena cava filter retrieval, inferior vena cava filter complications, deep vein thrombosis (DVT), pulmonary embolism, venous thromboembolism event (VTE)
NEW DAY: Nutrition, Exercise, Weight Loss, Diabetes And You

Study Overview
=================
Brief Summary
-----------------
This clinical trial examines whether the addition of individual sessions of a motivational intervention to a state-of-the art behavioral group weight loss intervention for overweight women with Type 2 diabetes improves the weight losses and glycemic control outcomes.

Detailed Description
-----------------
The multi-disciplinary behavioral, group-based intervention focuses on dietary and exercise changes, with group meetings over an 18-month period. Participants are assessed at 6-month intervals (for a total of 18 months) to examine the impact of the interventions on body weight and blood sugar control (primary outcomes), as well as on blood pressure, cholesterol, quality of life and attitudes (secondary outcomes). All enrolled participants receive group-based weight loss intervention. Half the women enrolled also receive several individual sessions of motivational interviewing and the other half of enrolled women receive the same number of individual sessions of health education, which focus on issues relevant to women (e.g., mammography, sleep hygiene, menopause, etc).

Official Title
-----------------
Obesity Treatment and NIDDM in Black and White Women

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

Intervention / Treatment
-----------------
* Behavioral: Behavioral Group Weight Loss Intervention
* Behavioral: Motivational Interviewing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index of 27 - 50 Type 2 diabetes currently treated with oral medications Ability to walk for exercise Exclusion Criteria: Use of insulin Current pregnancy Presence of debilitating disease, psychotic condition or any other condition that might interfere with participation Failure to complete self monitoring diary for 1 week Plans to move out of the area in the upcoming 18 months

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Behavioral Group Weight Loss Intervention|nan|
|Behavioral: Motivational Interviewing|nan|

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
-----------------
obesity treatment, non insulin dependent diabetes, type 2 diabetes, behavioral weight control, motivational interviewing, motivational enhancement
Bariatric Surgery and Pharmacokinetics of Losartan

Study Overview
=================
Brief Summary
-----------------
Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on losartan are investigated.

Official Title
-----------------
Bariatric Surgery and Pharmacokinetics of Losartan: BAR-MEDS Losartan

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Drug: Losartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway Being a Norwegian citizen Exclusion Criteria: Having previously undergone resections in the GI-tract

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Losartan|Patients are tested for their normal prescription losartan medication|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Losartan concentration in blood serum (area under curve (AUC)) |  | From baseline to 1 year postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric surgery, Gastrointestinal tract, Biological availability, Pharmacokinetics, Losartan
Study of the Bioequivalence of the 20% and 30% Etoricoxib Tablet Formulations (0663-070)

Study Overview
=================
Brief Summary
-----------------
This study will establish the bioequivalence of the 20%, milled, roller compaction final market image (FMI) etoricoxib tablets and 30% unmilled, roller compaction (UMC) etoricoxib tablets.

Official Title
-----------------
An Open-Label, Randomized, 2-Period, Single-Dose, Balanced, Crossover Study in Healthy Subjects to Establish the Bioequivalence of the 20% and 30% Etoricoxib (MK0663) Formulations

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: etoricoxib
* Drug: Comparator: etoricoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is in good health Subject agrees to follow the study guidelines Exclusion Criteria: Subject is a smoker Subject has a history of adverse reactions caused by NSAIDs or allergies/intolerance to NSAIDs Subject is in a situation or has a condition/disease which may interfere with optimal participation in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: A<br>Etoricoxib, 20% tablet | Drug: etoricoxib<br>* Single dose etoricoxib 120 mg 20% final market image tablet in one of two treatment periods.<br>|
| Active Comparator: B<br>Etoricoxib, 30% tablet | Drug: Comparator: etoricoxib<br>* Single dose etoricoxib 120 mg 30% unmilled, roller compaction tablet in one of two treatment periods.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib | The area under the plasma concentration vs time curve. | Through 120 Hours Postdose | 
| Peak Plasma Concentration (Cmax) for Etoricoxib |  | Through 120 Hours Postdose |
Full Automaticity and Remote Follow-up

Study Overview
=================
Brief Summary
-----------------
With the expansion of Sudden Cardiac Death (SCD) primary prevention indications, the number of Implantable Cardioverter Defibrillators (ICD) implants has increased significantly in the recent years. This has resulted in an increase of the number of follow-up (FU) to be performed and a growing workload for centers. Remote FU system such as the Medtronic Carelink system allows to check remotely the proper functioning of self evaluating devices and give informations of some clinical events. The objective of this study is to define which patients with a remote follow-up need additional onsite visit and to assess to which extent remote FU can be an alternative to onsite visit.

Official Title
-----------------
Identification of Implantable Cardioverter Defibrillator Patients With Remote Follow up That Requires an Onsite Visit

Conditions
-----------------
Tachyarrhythmia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient older than 18, Patient implanted with a fully automatic ICD and remotely followed-up, Patient geographically stable and able to attend FU at investigative site Patient who signed a data release authorization form, Exclusion Criteria: Patient whose mental or physical capacity impedes to give an informed data release authorization, Patient already enrolled in a clinical study whose procedures may interfere with the results of the present study, Patients in New York Heart Association (NYHA) class IV

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 |
| --- | --- |
| ICD patients with remote follow-up<br>Patients implanted with a fully automatic ICD and remotely followed-up. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remote Follow-up as an Alternative to Onsite Visit | Evaluate the percentage of patients who had a successful remote follow up, as an alternative to onsite visit for patients implanted with a fully automatic ICD | 13 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICD, Remote follow-up
Surface Refractive Index Shift and Lens Absorption/Adsorption of Tear Components of Kalifilcon A Lenses vs Dailies Total1 and Precision1

Study Overview
=================
Brief Summary
-----------------
Approximately 10 habitual soft contact lens wearing participants will be enrolled in this bilateral, randomized, double-masked (participant and investigator masked) repeated measures insertion study. All participants will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If participants satisfy all eligibility criteria and none of the exclusion criteria, participants will insert study lenses in random, successive order according to unique randomization schedules that will be provided to each Investigator.

Official Title
-----------------
Evaluation of Surface Refractive Index Shift and Lens Absorption / Adsorption of Tear Components of Commercially Available Kalifilcon A Lenses Compared to Dailies Total1 and Precision1

Conditions
-----------------
Habitual Soft Contact Lens Use

Intervention / Treatment
-----------------
* Device: Kalifon A
* Device: Dailies Total1
* Device: Precision1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be 18 years or older and have full legal capacity to volunteer. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. Have no active ocular disease or allergic conjunctivitis. Not be using any topical ocular medications. Be willing and able to follow instructions. Have signed a statement of informed consent. Exclusion Criteria: Participating in a conflicting study in the opinion of the Investigator. Considered by the Investigator to not be a suitable candidate for participation.

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kalifilcon A lenses<br>Commercially available kalifilcon A lenses (Bausch + Lomb) | Device: Kalifon A<br>* Commercially available kalifilcon A lenses<br>|
| Active Comparator: Dailies Total1<br>Dailies Total1 (Alcon) | Device: Dailies Total1<br>* Dailies Total1<br>|
| Active Comparator: Precision1<br>Precision1 (Alcon) | Device: Precision1<br>* Precision1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surface refractive index shifts | Immediately following lens removal, the right eye worn lenses for each subject will be measured for surface refractive index on the refractometer. | 10 minutes |