linjc16/ctgov huggingface dataset:
Postmarketing Surveillance to Investigate the Safety and Efficacy Information of Alesion® Tablet

Study Overview
=================
Brief Summary
-----------------
Study to investigate the safety and efficacy information of Alesion® Tablet under the proper use in daily clinical practice after new treatment guideline for allergic rhinitis, bronchial asthma, eczema, dermatitis, urticaria, pruritus, prurigo and psoriasis vulgaris with itching

Official Title
-----------------
Post Marketing Surveillance of Alesion® (Epinastine Hydrochloride) Tablet

Conditions
-----------------
Rhinitis, Allergic, Perennial

Intervention / Treatment
-----------------
* Drug: Alesion®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All the patients who: haven't treatment experience of epinastine product; have at least one out of following diseases. allergic rhinitis, eczema, dermatitis, pruritus, prurigo, urticaria, psoriasis with itching, bronchial asthma Exclusion Criteria: Alesion® Tablet is contraindicated for the patients with history of hypersensitivity to any ingredients of Alesion® Tablet in package insert. However, it is unknown whether a patient is hypersensitive to the ingredients of the product in almost cases. And this survey is drug utilization study to observe actual use in any patients. Therefore exclusion criteria is not set in the protocol
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients without experience in treatment with epinastine<br> | Drug: Alesion®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions | classified by Medical Dictionary for Regulatory Activities (MedDRA) | up to 24 months | 
| Incidence of adverse drug reactions classified by patient's background/treatment factors |  | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall assessment of efficacy by investigator on a 3-point scale |  | after 24 months |
Bioequivalency Study of 100 mg Cilostazol Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol Tablets, 100 mg, to PLETAL® Tablets, 100 mg (OTSUKA Pharmaceuticals) under fasting conditions using a single-dose, randomized, 3-treatment, 3-period, crossover design.

Official Title
-----------------
A Single Dose, Randomized, Three-Period, Three-Treatment, Crossover Bioequivalency Study of Cilostazol 100 mg Tablets Under Fasting Conditions

Conditions
-----------------
Intermittent Claudication

Intervention / Treatment
-----------------
* Drug: Cilostazol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Cilostazol or any comparable or similar product.

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two period, Seven day washout |
Clinical Study for Patients With Hypertension Associated With Dyslipidemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of DWJ1276

Official Title
-----------------
Multi-institutional, Randomized, Double-Blind, Placebo-Control, Factorial Design, 4-arms, 8 Week Administration, Phase 3 Clinical Study for Patients With Hypertension Associated With Dyslipidemia

Conditions
-----------------
Hypertension, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: DWJ1276
* Drug: Olmesartan
* Drug: Rosuvastatin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male and female in between ages of 20 and 80 at the time of screening Subject who can understand information provided and who can sign written consent voluntarily Exclusion Criteria: Patients with hypersensitivity to olmesartan and rosuvastatin Pregnant or lactating women and fertile women who is not using proper contraceptive method Patient with history of drug or alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWJ1276<br>Once daily, administered orally, 8 week | Drug: DWJ1276<br> <br> |
| Active Comparator: Olmesartan<br>Once daily, administered orally, 8 week | Drug: Olmesartan<br> <br> |
| Active Comparator: Rosuvastatin<br>Once daily, administered orally, 8 week | Drug: Rosuvastatin<br> <br> |
| Placebo Comparator: Placebo<br>Once daily, administered orally, 8 week | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-C percent change of DWJ1276 from baseline |  | 8weeks | 
| DBP change of DWJ1276 from baseline |  | 8weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who reached LDL-C treatment goal defined by NCEP ATP III guideline |  | 8weeks | 
| Proportion of subjects who reached blood pressure treatment goal defined by JNC VII report |  | 8weeks |
Nelfinavir and M8 Drug-level Monitoring in HIV-1 Infection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the impact of prospective drug level monitoring and dose-adjustment of nelfinavir (NFV) on the clinical and virologic outcomes in a group of HIV-infected patients who have achieved virologic success while receiving a nelfinavir containing highly active antiretroviral therapy (HAART) regimen.

Official Title
-----------------
Nelfinavir and M8 Drug-level Monitoring in HIV-1 Infection

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Nelfinavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Antiretroviral naive or currently taking a nelfinavir containing HAART regimen where nelfinavir is the first protease inhibitor Patients willing to comply with the protocol Age greater than or equal to 18 years Virologically successful if already on an established regimen Exclusion Criteria: Prior use of a protease inhibitor exclusive of nelfinavir Required use or concomitant use of drugs that may interact with or are contraindicated with nelfinavir Use of immunomodulators or vaccines for HIV disease Intercurrent illness at the time of enrollment that, in the clinician's judgement, could influence the HIV RNA concentration Baseline ALT levels greater than five times the upper limit of normal

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virologic response |  |  | 
| Nelfinavir pharmacokinetics |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of nelfinavir and M8 pharmacokinetics on virologic response |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV
Impact of Race and Re-Transplantation

Study Overview
=================
Brief Summary
-----------------
For children who develop graft failure following cardiac transplantation, retransplantation is often considered. While some centers have reported equivalent results for retransplantation as compared to primary transplantation, this strategy remains controversial. We seek to examine outcomes following re-transplantation in children and identify risk factors for mortality. In addition, adult African-Americans have been reported to have lower survival following heart and other solid-organ transplantation. The relationship of recipient race to survival following pediatric heart transplantation has not previously been reported.

Detailed Description
-----------------
Objective 1: For children who develop graft failure following cardiac transplantation, retransplantation is often considered. While some centers have reported equivalent results for retransplantation as compared to primary transplantation, this strategy remains controversial. We seek to examine outcomes following re-transplantation in children and identify risk factors for mortality. Objective 2: Adult African-Americans have been reported to have lower survival following heart and other solid-organ transplantation. The relationship of recipient race to survival following pediatric heart transplantation has not previously been reported. Methods: We would like to review the United Network for Organ Sharing database. We plan on reviewing database records of heart transplantation subjects <18 years of age from 1987 to 2004. Indications for retransplantation and patient race characteristics will be collected and evaluated. Analysis will be performed using proportional hazards regression controlling for other potential risk factors. The contribution economic disparity, insurance status and HLA mismatching to disparities in outcome will also be explored.

Official Title
-----------------
Impact of Race and Re-Transplantation in Childhood: Analysis of Data From the United Network of Organ Sharing

Conditions
-----------------
Orthotopic Heart Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: orthotopic heart transplantation < 18 years of age Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 18 Years

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
orthotopic heart transplantation
Intermittent Mechanical Compression For Peripheral Arterial Disease

Study Overview
=================
Brief Summary
-----------------
The study tests the use of a portable mechanical compression device (FM220, Flowmedic, USA) for the treatment of claudication and peripheral arterial disease. Major endpoints are improved exercise tolerance and relevant blood pressure ratios

Official Title
-----------------
Intermittent Mechanical Compression For Peripheral Arterial Disease

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Device: Intermittent Mechanical Compression
* Drug: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable claudication with an absolute claudication distance >40 meters but <300 resting ABI in the affected limb <0.8 Exclusion Criteria: presence of diabetes

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Active group receiving intermittent compression | Device: Intermittent Mechanical Compression<br>* FM220 device<br>|
| Active Comparator: Control<br>Standard Medical Treatment | Drug: Control<br>* Standard medical treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exercise tolerance |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ankle-brachial index |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Claudication, Peripheral Arterial Disease, Intermittent Compression, Mechanical Compression, Flowmedic
Does Ascorbic Acid Reduce Sympathoexcitation in CHF?

Study Overview
=================
Brief Summary
-----------------
In CHF central sympathetic activity is increased. ROS formation seems to play a role in this process. This study analyzes the effect of vitamin C as an antioxidant on central sympathetic activity in CHF

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Drug: vitamin C
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heart failure of at least New York Heart Association (NYHA) class II Left ventricular ejection fraction (LVEF) <= 40% Age 20-80 years Exclusion Criteria: Necessity of short-term PCI, CABG or heart transplantation, Chronic disease of the autonomic nervous system, diabetes mellitus, use of tricyclic antidepressant drugs and/or a-adrenergic receptor antagonists.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: vitamin C<br> <br> |
| Placebo Comparator: 2<br> | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in central sympathetic output after vitamin C vs. placebo |  |  |
Extension Study of 1.0mg Dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
- To investigate the safety of letrozole monotherapy at a dose 1.0 mg/day or fadrozole monotherapy at a dose 2.0mg in Japanese postmenopausal patients with advanced breast cancer which participated in double blind study.

Official Title
-----------------
Extension Study of 1.0mg Dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer

Conditions
-----------------
Postmenopausal Women With Advanced Breast Cancer

Intervention / Treatment
-----------------
* Drug: Letrozole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients which participated in double blind study Exclusion Criteria: Patients with intolerable toxicity. Patients which confirmed progressive disease during double blind study. Patients which have received concurrent anti-cancer therapy during double blind study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Letrozole<br> | Drug: Letrozole<br> <br> * Other names: FEM345;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety during treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No secondary outcomes/objectives planned |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aromatase inhibitor, letrozole, breast cancer
Evaluation Genotypic, Phenotypic and Prognosis APECED Syndrome

Study Overview
=================
Brief Summary
-----------------
The objective of the study will define the mutational spectrum in this French cohort, in patients with APECED syndrome genetically authenticated

Official Title
-----------------
Evaluation Genotypic, Phenotypic and Prognosis Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED) Syndrome

Conditions
-----------------
APECED

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with at least 2 major criteria out of the following 3: hypoparathyroidism of autoimmune origin, adrenal insufficiency of autoimmune origin, chronic cutaneous and mucosal candidiasis. patients with only 1 of the 3 major criteria, associated with at least 2 of the following minor criteria: hypergonadotropic hypogonadism of autoimmune origin, atrophic gastritis, malabsorption, autoimmune hepatitis, vitiligo, alopecia, chronic keratoconjunctivitis, hypoplasia of dental enamel. patients whose molecular diagnosis has been established or who will be established during the inclusion visit with the genetic sample. Exclusion Criteria: -
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 |
| --- | --- | --- |
| allelic frequency of the mutation c.967-979del13 of the AIRE gene |  | Baseline: one session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total number of cases recognized APECED syndrome regardless of the diagnostic criteria used. |  | Baseline: one session | 
| correlations between the clinical phenotype and the autoantibodies on all cases with APECED syndrome. |  | Baseline: one session | 
| correlations between the mutations of the AIRE gene and the HLA genotyping on all cases with APECED syndrome. |  | Baseline: one session | 
| prevalence of types of antibodies found on APECED syndrome. |  | Baseline: one session | 
| the distribution of lymphocyte subpopulations on the whole cases with APECED syndrome. |  | Baseline: one session | 
| proportion of patients with a molecular diagnosis of positive APECED syndrome, among patients presenting our new diagnostic criteria (a major criterion and at least 2 criteria |  | Baseline: one session |
Pancreatic Islet Function, Insulin Sensitivity, and Chronic Complications in Pre-Diabetes

Study Overview
=================
Brief Summary
-----------------
We, the investigators at National Taiwan University Hospital, want to compare patients' islet cell function, insulin sensitivity and risk of chronic complications with normal subjects. Moreover, we want to examine whether they are at a higher risk of having metabolic syndrome and to answer whether we should screen the phenotypes of metabolic syndrome in impaired fasting glucose (IFG) and impaired glucose tolerance (IGT) patients. Then, we want to examine the association between insulin sensitivity and islet functions.

Detailed Description
-----------------
We, the investigators at National Taiwan University Hospital, want to compare patients' islet cell function, insulin sensitivity and risk of chronic complications with normal subjects. Moreover, we want to examine whether they are at a higher risk of having metabolic syndrome and to answer whether we should screen the phenotypes of metabolic syndrome in impaired fasting glucose (IFG) and impaired glucose tolerance (IGT) patients. Then, we want to examine the association between insulin sensitivity and islet functions.

Conditions
-----------------
Prediabetic State, Obesity, Metabolic Syndrome X

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fasting glucose 100-125 mg/dl OR oral glucose tolerance test (OGTT) 2 hour glucose 140-199 mg/dl Diabetes mellitus Exclusion Criteria: Pregnancy Children < 18 years old

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

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

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