linjc16/ctgov huggingface dataset:
Korean Post-marketing Surveillance for Onglyza®

Study Overview
=================
Brief Summary
-----------------
The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Onglyza® so that the regulatory authority can manage the marketing approval properly.

Official Title
-----------------
Korean Post-marketing Surveillance for Onglyza®

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

Intervention / Treatment
-----------------
* Drug: No Intervention (subjects were previously treated with Onglyza®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female and male patients who are at least 18 years of age Patients with diagnosis of T2DM initiating Onglyza® treatment within the approved indications in Korea Exclusion Criteria: Indication which is not approved for Onglyza® in Korea Patients with contraindication for the use of Onglyza® (as clarified in Korean label)

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 |
| --- | --- |
| Patients with T2DM<br>Patients with diagnosis of type 2 diabetes mellitus (T2DM) initiating Onglyza® treatment within the approved indications will be enrolled | Drug: No Intervention (subjects were previously treated with Onglyza®)<br>* No Intervention<br>* Other names: saxagliptin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events occurrence |  | 30 days after last dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events and Serious Adverse Events |  | 30 days after last dose of study drug | 
| Effectiveness of Onglyza® measured by Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and 2-hr post-prandial glucose (2-hr PPG) comparing baseline data |  | Baseline (Week 0), 12 weeks and 24 weeks of registration |
Study to Assess the Efficacy and Safety of Meloxicam vs. Diclofenac SR in Patients With Osteoarthritis of the Knee

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy and safety of meloxicam 7.5mg once daily compared with diclofenac 100mg SR once daily over a treatment period of 8 weeks

Official Title
-----------------
Open Label Study to Assess the Efficacy and Safety of Meloxicam 7.5mg vs. Diclofenac 100mg SR in Patients With Osteoarthritis of the Knee

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Diclofenac
* Drug: Meloxicam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Osteoarthritis of the knee requiring the therapy with non-steroidal anti-inflammatory drugs (NSAIDs) 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meloxicam<br> | Drug: Meloxicam<br> <br> |
| Active Comparator: Diclofenac<br> | Drug: Diclofenac<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in pain on active movement assessed by a 100 mm visual analogue Scale (VAS) |  | Baseline, 8 weeks after first drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Lequesne index |  | Baseline, 8 weeks after first drug administration | 
| Change from baseline in global assessment by the patient and doctor on a 3-point scale |  | Baseline, 8 weeks after first drug administration | 
| Number of patients with significant changes from baseline in Laboratory values |  | Baseline, 8 weeks after first drug administration | 
| Number of patients with significant changes from baseline in physical examinations |  | Baseline, 8 weeks after first drug administration | 
| Number of patients with Adverse Events |  | Up to 8 weeks after first drug administration |
Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315 in Healthy Japanese Males

Study Overview
=================
Brief Summary
-----------------
To assess the safety and tolerability of ascending single oral doses of SAM-315, an investigational drug, in healthy Japanese male subjects.To obtain preliminary pharmacokinetic (PK) and pharmacodynamic (PD) profiles of SAM-315 in healthy Japanese male subjects.

Official Title
-----------------
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-315 Administered Orally to Healthy Japanese Male Subjects

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: SAM-315


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Men aged 20 to 45 years (inclusive) at the time of getting informed consent. Body mass index (BMI) in the range of 18.5 to 25.0 kg/m2 and body weight≥50 kg (BMI = [weight (kg)]/[height (m)]2). Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and digital 12-lead electrocardiogram (ECG). Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine levels must be within the upper limit of normal for eligibility. Exclusion criteria Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. Any clinically important deviation from normal limits in physical examination, vital signs, digital 12-lead ECGs, or clinical laboratory test results. Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or cola) or alcoholic beverages is prohibited from 48 hours and consumption of grapefruit or a grapefruit-containing products is prohibited from 72 hours before study day 1.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SAM-315|nan|

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics and pharmacodynamics |  |  |
Anxiety and Cardiovascular Autonomic Control

Study Overview
=================
Brief Summary
-----------------
To evaluate the hypothesis that chronic anxiety and/or anxiety disorders resulted in hyperkinetic cardiovascular autonomic regulation, often associated with increased coronary risk.

Detailed Description
-----------------
BACKGROUND: Prospective epidemiologic data indicate a strong relationship of chronic anxiety and/or anxiety disorders to risk of sudden cardiac death. Other studies have shown that cardiac autonomic mechanisms are altered among stably anxious individuals in the direction of reduced parasympathetic and elevated sympathetic control. The latter investigations, however, have been based on very small clinic samples and have been incomplete in their assessment of cardiovascular regulation in anxiety. This investigation was the first large-scale population-based research examining the cardiovascular physiology of anxiety, and helped to increase understanding of the reported association between anxiety and sudden cardiac death. This study also helped to identify groups in the general population at increased risk of sudden death. DESIGN NARRATIVE: The study used an ongoing well-characterized cohort, the VA Normative Aging Study (NAS), to recruit middle-aged and older community-dwelling men and women into the study. Using a variety of validated psychological and psychiatric screening instruments--including the Brief Symptom Inventory, the Composite International Diagnostic Interview, the Spielberger State-Trait Anxiety Inventory, and the Crown-Crisp Index--the study population was characterized in terms of symptoms of anxiety and diagnosis of anxiety disorders. Cardiovascular autonomic control was then assessed among anxious and non-anxious individuals using non-invasive time-domain and power-spectral measures of heart rate and blood pressure variability. Cardiac output, total peripheral resistance, and end-tidal pCO2 were simultaneously assessed. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Auto/Allo Tandem Transplant for Relapsed B-NHL

Study Overview
=================
Brief Summary
-----------------
The investigators plan to perform a retrospective review of patients with poor risk relapsed/refractory B-NHL having received HSCT and targeted immunotherapy at the Maria Fareri Children's Hospital between January 1, 2012 and June 1, 2015. The investigators will review the clinical records and collect the data with de-identified medical information from our HSCT clinical research database.

Detailed Description
-----------------
The investigators will obtain the following information from the patient's medical records: clinical factors including age at presentation, gender, clinical presentation, laboratory and pathology data, lymphoma diagnosis, clinical staging criteria, anti-cancer therapy as well as supportive care medicines, complications of therapy (adverse events graded from CTCAE v4.0), and hematopoietic stem cell transplantation therapy (chemotherapy, donor source, cell dose), course (engraftment, GVHD, chimerism), and follow-up (disease status).

Official Title
-----------------
MAC and autoHSCT, Targeted Immunotherapy and RIC alloHSCT in Children, Adolescents, and Young Adults (CAYA) With Poor-risk Refractory/Relapsed Mature B-NHL: A Retrospective Chart Review

Conditions
-----------------
Non Hodgkin Lymphoma

Intervention / Treatment
-----------------
* Procedure: auto transplant followed by allo transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This analysis will include all children, adolescents, and young adults less than 29 years old with a histologically confirmed diagnosis of B-NHL treated at the Maria Fareri Children's Hospital Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 29 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: auto transplant followed by allo transplant|patients who got MAC conditioning with auto SCT followed by RIC followed by alloSCT for mature B-NHL|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events related to study treatment (safety) | Adverse events (according to CTCAE 4.0) will be reviewed for all as well as outcome data retrospectively to determine if the treatment was equal or better than standard of care for relapse/refractory B-NHL in terms of the number of adverse events reported. Data reviewed will include laboratory values, radiology exams and disease evaluations. | 3 years |
Institut Paoli Calmettes Myelodysplastic Syndromes Database

Study Overview
=================
Brief Summary
-----------------
Database of Institut Paoli-Calmettes patients diagnosed with Myelodysplastic Syndromes

Official Title
-----------------
Institut Paoli Calmettes Myelodysplastic Syndromes Database

Conditions
-----------------
Myelodysplastic Syndromes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with a diagnosis of Myelodysplastic Syndromes 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of patients with myelodysplastic syndrome(MDS) | Overall survival of all patients with MDS who are taken in charge in Institut Paoli Calmettes Cancer Center | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of patients characteristics | Collection of characteristics of patients treated at Institut Paoli Calmettes in order to set up prospective and retrospective studies | 10 years |
Contraceptive Use and Respiratory Conditions Among Scottish Women

Study Overview
=================
Brief Summary
-----------------
Studies examining the sex differences in the epidemiology and morbidity patterns of asthma show that the rates of disease severity, healthcare utilisation, and poor quality of life are considerably higher in women than in men, and this has been attributed to endogenous and exogenous sex hormonal factors. Studies examining the impact of use of hormonal contraceptives on the risk of asthma and asthma-related conditions are few, yet findings are conflicting. In the present study, the investigators utilize data from the Scottish Health Survey, a national representative sample, to investigate the associations between current use of hormonal contraceptives and the prevalence of self-reported doctor-diagnosed current asthma and wheezing symptoms in Scottish women. The investigators hypothesize that while current use of any hormonal contraceptives and combined oral pills are associated with higher prevalence of asthma and asthma outcomes, current use of progesterone-only contraceptives is not associated with asthma. A secondary aim of the current study is to examine whether there is evidence of any biological interaction between use of hormonal contraceptives and BMI in relation to the risk of asthma and asthma outcomes.

Official Title
-----------------
Use of Hormonal Contraceptives in Relation to Asthma and Wheezing Disorders in Scottish Women: a Population-based Cross-sectional Survey

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-pregnant Woman 16-45 years old Exclusion Criteria: Pregnant Man Younger than 16 years or older than 45 years old

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 45 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-users of hormonal contraceptives<br> | |
| Users of hormonal contraceptives<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported doctor-diagnosed current asthma |  | During the past 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported wheezing symptom |  | During the past 12 months | 
| Self-reported current treatment for asthma/wheeze |  | During the past 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, hormonal contraceptives, combined pills, progesterone-only contraceptives, body mass index, Scotland, women
Treatment of Anemia and Neutropenia in HIV/HCV Coinfected Patients Treated With Pegylated Interferon and Ribavirin

Study Overview
=================
Brief Summary
-----------------
This study is designed to test two separate strategies for treatment of anemia (low hemoglobin) and neutropenia (low white blood cells) in HIV/HCV coinfected patients who are being treated with pegylated interferon and ribavirin.

Detailed Description
-----------------
This is a multi-center, randomized, open-labeled trial in subjects co-infected with hepatitis C (HCV) and human immunodeficiency virus type 1 (HIV-1) who are naïve to anti-HCV therapy. Subjects will receive PEG interferon alfa-2b (PEG-IFN) 1.5 mcg/kg/week administered once weekly plus ribavirin (RBV) 13 + 2 mg/kg/day. The goal of this study is to evaluate two different treatment options for anemia and neutropenia associated with the initiation of pegylated interferon and ribavirin. This will result in completion of therapy, and possibly a better viral sustained response.

Official Title
-----------------
A Randomized Clinical Trial Comparing Two Management Strategies for Treatment of Neutropenia and Anemia Associated With Pegylated Interferon Plus Ribavirin Treatment of Compensated Chronic Hepatitis C in Adult Subjects Infected With HIV.

Conditions
-----------------
Anemia, Neutropenia, Hepatitis C Virus, HIV Infections

Intervention / Treatment
-----------------
* Drug: erythropoietin, GCSF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hemoglobin > 11 absolute neutrophil count >1,200 naive to peg interferon and ribavirin Exclusion Criteria: Prior treatment for hepatitis C Pregnant or nursing

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: erythropoietin, GCSF|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in hemoglobin |  |  | 
| change in absolute neutrophil count |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV RNA |  |  | 
| depression |  |  | 
| fatigue |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anemia, dose reduction, neutropenia, hepatitis C virus, human immunodeficiency virus
Analgesia for Endometrial Scratching

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate whether Ibuprofen alone or combined with lorazepam reduce the pain associated with endometrial scratching/injury.

Official Title
-----------------
Analgesia for Endometrial Scratching in Subfertile Women: a Randomized Controlled Trial

Conditions
-----------------
Subfertility, Infertility

Intervention / Treatment
-----------------
* Drug: Ibuprofen 600 mg
* Drug: Lorazepam 1 mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged ≥ 18 years undergoing assisted reproduction (IUI, IVF/ICSI, frozen embryo transfer) Being submitted to endometrial scratching/injury with a Pipelle on the first four days of the menstrual cycle. Not have performed endometrial scratching in the last 90 days. Exclusion Criteria: - None

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibuprofen+Lorazepam<br>Oral ibuprofen (600 mg) + lorazepam (1 mg); one hour before endometrial scratching. | Drug: Ibuprofen 600 mg<br> <br> Drug: Lorazepam 1 mg<br> <br> |
| Active Comparator: Ibuprofen<br>Oral ibuprofen (600 mg) + Placebo; one hour before endometrial scratching. | Drug: Ibuprofen 600 mg<br> <br> Drug: Placebo<br> <br> |
| Placebo Comparator: Placebo<br>Placebo + Placebo; one hour before endometrial scratching. | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum pain during procedure | Evaluated by both visual analog scale (10 cm) and numeric verbal scale (0 to 10). | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain after the procedure | Evaluated by both visual analog scale (10 cm) and numeric verbal scale (0 to 10). | 5 minutes | 
| Rejection to a new procedure | Evaluated by a 5-point Likert scale, commenting on this sentence: I would repeat this procedure if it were indicated. 1 = I fully agree; 2 = I agree; 3 =Neither agree nor disagree; 4 = Disagree; 5 = Strongly Disagree. | 5 minutes |