linjc16/ctgov huggingface dataset:
Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® Tablet In Korea

Study Overview
=================
Brief Summary
-----------------
This is a non-interventional study of voriconazole tablet in Korea which is mandated by the Korean government agency.

Official Title
-----------------
Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® Tablet

Conditions
-----------------
Serious Fungal Infections

Intervention / Treatment
-----------------
* Drug: voriconazole tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are indicated for voriconazole table according to the drug package insert. Exclusion Criteria: None.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients who are indicated for use of voriconazole tablet. | Drug: voriconazole tablet<br>* 200 mg PO bid (orally, twice a day)<br>* Other names: Vfend;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable | Clinical response defined as: Cure=resolution of all baseline signs and symptoms of fungal infection(s); Improvement=lessening of baseline signs and symptoms or absence of one or more, but not all baseline findings; Failure=no improvement or deterioration of baseline condition; Unevaluable=incomplete therapy (efficacy could not be evaluated or discontinuation was not followed up). | Baseline (Day 1) up to 2.1 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable | In case cultivation performed, cultivated strain before and after Vfend administration recorded, and the improvement of mycological outcomes after administration evaluated. Mycological response defined as: Eradication=absence of signs and symptoms of fungal infection; Persistence=(no eradication) presence of fungal infection; Superinfection=existence of different strains from strains separated prior to study treatment; Not evaluable=a follow-up mycological cultivation not performed. | Baseline (Day 1) up to 2.1 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
voriconazole, Korea, invasive fungal infection
Neurobehavioral Mechanisms of Cocaine Choice

Study Overview
=================
Brief Summary
-----------------
The objective of this protocol is to use a drug-vs-money choice task, reinforcement learning modeling and fMRI to determine the neurobehavioral and neurobiological decision-making profile associated with the decision to take cocaine and the reduced cocaine choice that occurs during behavioral and pharmacological interventions.

Official Title
-----------------
Neurobehavioral Mechanisms of Cocaine Choice

Conditions
-----------------
Cocaine Use Disorder

Intervention / Treatment
-----------------
* Drug: Sustained Release d-amphetamine
* Behavioral: Money


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recent cocaine use, otherwise healthy Exclusion Criteria: Laboratory results outside of clinically acceptable ranges, history of or current serious physical or psychiatric disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A placebo-controlled, randomized, within-subjects design will be used to assess drug-vs-money choice in cocaine use disordered subjects as a function of alternative reinforcer value and d-amphetamine SR treatment.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Treatment<br>Cocaine choice during d-amphetamine maintenance | Drug: Sustained Release d-amphetamine<br>* Twice daily administration of active or placebo d-amphetamine<br>* Other names: Dexedrine Spansule SR;Behavioral: Money<br>* Three money values offered as alternatives to cocaine<br>|
| Placebo Comparator: Placebo Treatment<br>Cocaine choice during placebo maintenance | Drug: Sustained Release d-amphetamine<br>* Twice daily administration of active or placebo d-amphetamine<br>* Other names: Dexedrine Spansule SR;Behavioral: Money<br>* Three money values offered as alternatives to cocaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | The reinforcing effects of cocaine are determined using a reinforcement learning choice task. Subjects complete trials in which they could possibly receive the available cocaine dose or money. Reinforcing effects are measured for a fixed cocaine dose during both d-amphetamine and placebo maintenance and when three amounts of money are available as alternatives to cocaine. | Choices occur across a 40 minute session |
Sutureless Versus Conventional Thyroidectomy

Study Overview
=================
Brief Summary
-----------------
This study was prospective randomized double-blinded clinical trial on patients with thyroid disease who underwent thyroidectomy in the general surgery department, Mansoura university hospitals during the period of February 2017 to February 2018.Two techniques for vascular sealing were compared: conventional tying and harmonic scalpel

Official Title
-----------------
Sutureless Thyroidectomy Versus Conventional Thyroidectomy: Prospective Randomized Clinical Trial

Conditions
-----------------
Goiter

Intervention / Treatment
-----------------
* Procedure: Conventional thyroidectomy
* Procedure: Harmonic scalpel thyroidectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of both genders aging above 18 years presented with primary thyroid diseases requiring thyroidectomy including: Solitary thyroid nodule (STN) Multinodular goiter Controlled toxic goiter Inflammatory goiter (thyroiditis) Early-stage thyroid cancer. Exclusion Criteria: Patients unfit for surgery patients unwilling to participate in the study Pregnant women Thyroid cancer with lymph node or distant metastasis. Patients with psychiatric disturbances.

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional thyroidectomy<br>Thyroidectomy with ligation and division of thyroid vessels | Procedure: Conventional thyroidectomy<br>* Thyroid vessels are ligated with sutures and divided<br>|
| Active Comparator: Harmonic scalpel thyroidectomy<br>Thyroidectomy with sealing of thyroid vessels using harmonic scalpel | Procedure: Harmonic scalpel thyroidectomy<br>* Thyroid vessels are sealed using harmonic scalpel device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of postoperative drainage | The volume of fluid drained in the suction drain placed in the neck in milliliters | At 24 hours after surgery |
SARS-CoV-2 (COVID-19) Detection Using the Breath Analizer TeraSystem

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to verify the sensibility and accuracy of a rapid detection test for SARS-CoV-2 in breath samples analyzed by the breath detector analyzer TeraSystem, comparing with PCR tests.

Detailed Description
-----------------
BioSafety Technologies has developed a rapid detection test to clear people of COVID-19. A person can undergo an easy non-invasive test, to determine if they are: COVID-19 Clear (Negative) or Infected (Positive). The user-friendly process does not involve medically trained personnel. The study will compare TeraSystem test results against PCR test results. Persons participating will be persons having a PCR test as part of the Health System and consenting to participate.

Official Title
-----------------
SARS-CoV-2 (COVID-19) Detection Using the Breath Analizer TeraSystem

Conditions
-----------------
COVID19

Intervention / Treatment
-----------------
* Diagnostic Test: Breath sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 7 years odf age Able to provide informed consent Able to take the breath test Exclusion Criteria: Younger than 7 years of age Unable to provide informed consent Unable to take the breath test

Ages Eligible for Study
-----------------
Minimum Age: 7 Years

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 |
| --- | --- |
| Positive TeraSystem test<br>Patients having positive PCR tests will undergo TeraSystem test | Diagnostic Test: Breath sample<br>* Patient will blow into a tube 5 times.<br>|
| Negative TeraSystem test<br>Patients having negative PCR tests will undergo TeraSystem test | Diagnostic Test: Breath sample<br>* Patient will blow into a tube 5 times.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of disease | Established diagnosis | 1 minute | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-CoV-2, coronavirus testing
Involvement of Patients and Relatives in the Course of Cancer Disease

Study Overview
=================
Brief Summary
-----------------
The objective is to investigate a rehabilitation program (supportive conversations and a rehabilitation course for cancer patients and their relatives together). The study evaluate the effect of the program compared to no intervention (usual care)

Detailed Description
-----------------
The study aim to evaluate the effect and the benefit of the program. First the patients psychosocial well-being is assessed in a survey (EORTC, POMS, WHO-5 well-being index) Then their relatives psychosocial well-being is assessed in a survey (Ad hoc questions, POMS and WHO-5 well-being index) The effect is also assessed in qualitative interviews with patients and their relatives. The rehabilitation course is investigated in qualitative observations and interviews.

Official Title
-----------------
Involvement of Patients and Relatives in the Course of Cancer Disease With a Particular View to Rehabilitation and the Life With Cancer

Conditions
-----------------
Rehabilitation, Cancer, Relatives

Intervention / Treatment
-----------------
* Behavioral: Rehabilitation program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both the patient and their relative must agree to participate together Patient admitted to the Hospital Patient admitted with a lung cancer diagnosis or Patient admitted with a gynecological cancer diagnosis Exclusion Criteria: The cancer diagnosis was not verified.

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rehabilitation program<br>Counselling (supportive conversation with patient and their relatives together) Retreat Weekend (patient and their relatives together) | Behavioral: Rehabilitation program<br>* Patient and their relative receive three supportive, structured conversation with a trained nurse. Patient and their relative receive 4 days Retreat Weekend with supportive talk and activities<br>* Other names: KRIPP project;|
| No Intervention: Ususal treatment and support<br>Usual support and treatment at the hospital, no retreat Weekend. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life, |  | two months and one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, Rehabilitation program (patient and a relative together), counselling, retreat weekend
NPI-002 Intravitreal Implant for the Delay of Cataract Progression

Study Overview
=================
Brief Summary
-----------------
This study will examine the safety and efficacy NPI-002 intravitreal implants post vitrectomy.

Official Title
-----------------
Safety and Efficacy of NPI-002 Intravitreal Implant for the Delay of Cataract Progression in Patients Undergoing Vitrectomy

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Drug: NPI-002 Intravitreal Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indicated for vitrectomy Natural Lens in place at time of vitrectomy Some cataract present as assessed pre-operatively Exclusion Criteria: Previous intraocular surgery in study eye. Clear zonular weakness or defects / coloboma. Not on stable dose of medications for other conditions. Need for oral corticosteroids during study participation. Evidence or history of uveitis, or ocular ischemia. Current smoker Use of supplemental oxygen Evidence or history of proliferative diabetic retinopathy. Current lung disease (PU, COPD, Asthma) resulting in decreased oxygen saturation. Sensitivity to thiol compounds. Participation in another clinical trial.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single NPI-002 Intravitreal Implant<br>one NPI-002 implant inserted at the time of vitrectomy | Drug: NPI-002 Intravitreal Implant<br>* Implant inserted during vitrectomy.<br>|
| Experimental: Double NPI-002 Intravitreal Implant<br>two NPI-002 implants inserted at the time of vitrectomy | Drug: NPI-002 Intravitreal Implant<br>* Implant inserted during vitrectomy.<br>|
| No Intervention: Control<br>No implant inserted at time of vitrectomy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Densitometry | Change from Baseline | 6 months |
Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the safety and efficacy of FK614 in type 2 diabetic subjects receiving sulfonylurea (SU) monotherapy.

Detailed Description
-----------------
This is a prospective randomized, double-blind, placebo controlled, parallel group, Phase 2 study. Subjects meeting selection criteria will be randomly assigned to receive 12 weeks twice daily (BID) dosing with FK614 or placebo. Enrollment for this study will be approximately 200 patients.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: FK614


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Has history of type 2 diabetes mellitus for at least 1 year Has been taking current sulfonylurea (SU) for at least 3 months. Subjects currently taking metformin may be eligible to be switched. Has not received any oral antidiabetic medication other than an SU or taken regularly prescribed insulin for at least 3 months Exclusion Criteria Has type 1 diabetes mellitus Has uncontrolled hypertension, i.e., systolic BP >170 or diastolic BP > 95 mm Hg. History of congestive heart failure

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: FK614|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study Of BRL49653C For The Treatment Of Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the safety of BRL49653C administrated for 52 weeks

Official Title
-----------------
Clinical Evaluation of Rosiglitazone Malate (BRL49653C) in Patients With Type 2 Diabetes Mellitus -Long-term Study of Rosiglitazone Maleate-

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

Intervention / Treatment
-----------------
* Drug: rosiglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients with type 2 diabetes mellitus managed by diet therapy or one antidiabetic agent (sulfonylurea or alpha glucosidase inhibitor) will be candidates for this study. These candidates will be checked up on their clinical laboratory data, and must have adequate blood, liver and kidney function. Exclusion Criteria: - Patient with serious cardiovascular disease or serious hepatic disease will not be eligible.

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety profile (adverse events, laboratory parameters and other observations) of BRL49653C administered for 52 weeks will be evaluated. |  | 52 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy profile (HbA1c, FPG and Insulin) of BRL49653C administered for 52 weeks will be evaluated. |  | 52 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes mellitus;, diabetes;, rosiglitazone, Avandia;
The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids in Asthma

Study Overview
=================
Brief Summary
-----------------
We hypothesize that simvastatin in combination with ICS might have synergistic anti-inflammatory effects on airway inflammation in asthmatic patients

Detailed Description
-----------------
To determine the additive effect of simvastatin on airway inflammation in ICS-treated patients with persistent asthma by measuring eosinophil counts in induced sputum

Official Title
-----------------
The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids in Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: simvastatin
* Drug: B1-6-12


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: He or she has FEV1 > 60% of predicted He or she requires less than 1000 mcg daily of beclomethasone or equivalent Exclusion Criteria: He or she had previous history of renal disease or serum creatinine more than 2 mg/dL He or she had previous history of liver disease She is pregnant or during lactation He or she has already received statins or is allergic to statins or has developed myositis. He or she has an asthma exacerbation and requires treatment with oral corticosteroids during the 3 months prior to the commencement of study entry.

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: simvastatin<br>simvastatin in combination with budesonide | Drug: simvastatin<br>* 10 mg per oral once daily for 8 weeks<br>* Other names: zocor;|
| Placebo Comparator: B1-6-12<br>Budesonide in combination with B1-6-12 | Drug: B1-6-12<br>* 1 table per day for 8 weeks<br>* Other names: vitamin B1-6-12;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sputum eosinophil |  | 8 WEEKS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 |  | 8 WEEKS | 
| PC20 |  | 8 weeks |