linjc16/ctgov huggingface dataset:
Effect of Pioglitazone on Cardiovascular Outcome on Higashi-Saitama Trial in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
We want to investigate the effects of pioglitazone on cardiovascular events in Japanese patients with type 2 diabetes.

Detailed Description
-----------------
Primary composite endpoints: Cardiovascular death Non-fatal myocardial infarction and angina Non-fatal stroke Renal failure (hemodialysis/doubling of serum creatinine) Secondary endpoints: urinary albumin excretion diabetic retinopathy hyperlipidemia hypertension gout

Conditions
-----------------
Type 2 Diabetes, Hypertension, Dyslipidemia, Diabetic Nephropathy

Intervention / Treatment
-----------------
* Drug: pioglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes HbA1c: more than 7% and less than 9% Exclusion Criteria: insulin treatment

Ages Eligible for Study
-----------------
Minimum Age: 20 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: pioglitazone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Expanded Access of Pemigatinib to Treat a Single Patient With Metastatic Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
Expanded access of Pemigatinib to treat a single patient with metastatic pancreatic cancer.

Intervention / Treatment
-----------------
* Drug: Pemigatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Patients Who Die Within Emergency Department

Study Overview
=================
Brief Summary
-----------------
Emergency services are a crowded and chaotic environment.

Detailed Description
-----------------
Emergency services are a crowded and chaotic environment. Aim of this study is to investigate the clinic features of emergency patients who die after brought to emergency service. This retrospective study will be conducted on patients who die within Emergency Department a tertiary hospital over between 01 January 2013 and 31 December 2015.

Official Title
-----------------
Demographic Characteristics of Patients Who Die Within Emergency Department

Conditions
-----------------
Emergencies, Death

Intervention / Treatment
-----------------
* Other: patients who die


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who die within emergency department Exclusion Criteria: patients who die outside emergency department patients who die before they were admitted to emergency department

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: patients who die|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients who die within Emergency department | patients who die by data obtained from medical records | two years |
Aerobic Exercise and Blood Biochemical Factors in Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
Background: Patients with spinal cord injury (SCI) have a higher prevalence of cardiovascular diseases compared to the healthy population. Aerobic exercise training is one of the recommended treatments. However, literature regarding the effect of aerobic training on patients with SCI is scarce. This study evaluated changes in parameters of exercise physiology and serum myokines immediately after exercise and after a training program among patients with SCI. Method: Male patients with SCI and age- and sex-matched healthy individuals were recruited. Cardio-pulmonary exercise testing (CPET) was used to determine oxygen uptake at peak exercise and anaerobic threshold in both groups. The patients with SCI attended aerobic exercise training for 36 sessions within 12-16 weeks. Basic data, hemodynamic and exercise physiology parameters, and serum myokine (myostatin, insulin like growth factor, and follistatin) concentrations were measured pre- and post-exercise in both groups, and were repeated in patients with SCI post-training.

Detailed Description
-----------------
The patients with SCI were invited to undergo a 12- to 16-week exercise training by arm ergometry. The exercise physiology and measurements of hemodynamic parameters and cytokines were repeated after completion of the training.

Official Title
-----------------
Effect of Aerobic Exercise Training on the Blood Biochemical Factors and Peripheral Hemodynamics in Person With Spinal Cord Injury

Conditions
-----------------
Spinal Cord Injury

Intervention / Treatment
-----------------
* Other: aerobic exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >20 years, male sex, and onset of injury more than one year Exclusion Criteria: known heart disease, atrial fibrillation/flutter, ventricular bigeminy, active inflammatory disease, malignancy, and cardiac pacemakers

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal cord injury<br>Cardio-pulmonary exercise testing and aerobic exercise training | Other: aerobic exercise training<br>* aerobic exercise training for 36 sessions within 12-16 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum myokines |  | 12-16 weeks |
Mild Head Trauma in the Emergency Room: Assessment of the Risk of Intracranial Hemorrhage in Patients Receving Platelet Inhibitors.

Study Overview
=================
Brief Summary
-----------------
The clinical signs presented by a patient with a mild head injury are highly variable but remain strongly predictive of brain damage. The reference examination for the diagnosis of post-traumatic intracranial hemorrhage is currently the cerebral scanner without injection of contrast medium. Magnetic resonance imaging (MRI) tends to surpass CT in equipped centers, except for suspected bone lesions. The time required to perform brain imaging depends on the patient's clinical condition, comorbidities and treatments. The responsibility of antiplatelet agents in post-traumatic intracranial hemorrhage is currently discussed, particularly with aspirin. The hypothesis is that there is no significant difference in the proportion of intracranial hemorrhage in patients on antiplatelet agents after mild head trauma, in the absence of other factors favoring the occurrence of intracranial hemorrhage.

Official Title
-----------------
Mild Head Trauma in the Emergency Room: Assessment of the Risk of Intracranial Hemorrhage in Patients Receving Platelet Inhibitors.

Conditions
-----------------
Head Trauma Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Adult patient (≥18 years old) Visit to the emergency room of the Strasbourg University Hospital during 2017 Victim of mild head trauma Patient who has given their consent to the reuse of their data for the purposes of this research. Non-inclusion criteria Patient who expressed their opposition to participating in the study Subject under safeguard of justice Subject under guardianship or curatorship Patient on anticoagulant Non-isolated head trauma (AVP, fall greater than 6 meters, etc.)

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 |
| --- | --- | --- |
| Propensity score on the factors influencing the taking of antiplatelet agents. |  | Files analysed retrospectively from January 01, 2017 to December 31, 2017 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Head Trauma Injury, Head Trauma, Traumatic Intracranial Hemorrhage, Antiaggregants, Platelet
Intervening With Children/Adolescents With FAS/ARND

Study Overview
=================
Brief Summary
-----------------
Children diagnosed through the FAS DPN clinic (who receive non-study services through the clinic/referrals) will receive baseline assessment. The baseline assessment for the child will include: medical issues (including medication), intellectual assessment, academic achievement, language, social functioning, executive functioning, neurological assessment, perceived self-confidence, and behavioral observation of parent-child interactions (videotaped and coded). For caregivers, baseline assessment will include: demographics, medical histories, educational history, current services, satisfaction with services, knowledge of FAS, stress, parenting competence, and family functioning.

Detailed Description
-----------------
Functional analysis of challenging behaviors will be conducted. Intervention will be an individualized, multimodal, behavioral consultation. The consultation will include: FAS education, emotional/practical support, and teaching child management strategies specific to children with FAS/ARND, advocacy assistance, and school consultation. Specific procedure will be based on previous findings and experience. In particular, specialized Behavior Support Plans will be developed for each child with input from parents, teachers, and clinicians. Team consultations at the child's home during weekly visits. Instruction will include information on FAS, behavioral strategies, and information for advocating with service systems. Evaluation Plan: Both interventions: Treatment and control groups will be compared using pre- and post-tests measures. Post-tests will be at the conclusion of the intervention and at a 9-month follow-up (end of school year).

Official Title
-----------------
Intervening With Children/Adolescents With FAS/ARND

Conditions
-----------------
Control, Treatment

Intervention / Treatment
-----------------
* Behavioral: Positive Behavior Support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children 5 to 12 years of age Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Positive Behavior Support|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| behavior |  |  |
Same Day Discharge After Laparoscopic Hysterectomy

Study Overview
=================
Brief Summary
-----------------
Patients who are scheduled for laparoscopic hysterectomy will be included in the study. After the operation, those who are well and without major distress will be discharged from the hospital before 24 hours. Those who have pain or have additional health problems will be observed further. Our aim is to compare these two groups in terms of early complications and operation characteristics.

Official Title
-----------------
Same Day Discharge After Laparoscopic Hysterectomy vs Late Discharge

Conditions
-----------------
Surgery--Complications

Intervention / Treatment
-----------------
* Procedure: Early discharge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients Scheduled For Hysterectomy Exclusion Criteria: Diagnosis of Malignancy Those with intraoperative complication

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early Discharge<br>< discharge before 24 hours | Procedure: Early discharge<br>* Early discharge<br>|
| Late Discharge<br>discharge after 24 hours | Procedure: Early discharge<br>* Early discharge<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication in 30 days | Number of patients with surgical complications, postoperative complications, wound complications | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postop hb | Number of patients whose hemoglobin value declined beyond two parameters. (mg/dL) | 30 day | 
| Postop htc | Number of patients whose hematocrit value declined more than 5 percent (%) | 30 day |
Influence of Drug Transporter Expression on the Pharmacokinetics of the HIV Protease Inhibitor Kaletra

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the pharmacokinetics of Kaletra™ (HIV protease inhibitors lopinavir and ritonavir) in different body compartments and to assess the role of four different drug transporters (MDR, MRP1, MRP2 and BCRP) in the tissue distribution of the two protease inhibitors. The latter will be studied by comparing intracellular concentrations of peripheral blood mononuclear cells (PBMCs) with total and free plasma concentrations in healthy individuals. These effects will be studied after single dose (day 1), during steady state (day 3), and during chronic treatment (day 14).

Detailed Description
-----------------
Objective: Measurement of AUC, Cmax, tmax, t1/2 and clearance (Cl) of the protease inhibitor Kaletra™ (lopinavir and ritonavir) each in the plasma of healthy individuals establish free and total plasma - blood cell concentration-relationship establish free and total plasma - saliva concentration-relationship establish blood cell concentration - drug transporter expression-relationship

Official Title
-----------------
Influence of Drug Transporter Expression on the Pharmacokinetics of the HIV Protease Inhibitor Kaletra (Lopinavir/Ritonavir) and on the Concentration Relations Between Plasma, Blood Cells, Saliva and Urine

Conditions
-----------------
Healthy, Pharmacokinetics

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good state of health Exclusion Criteria: Drug treatment with known inhibitors or inducers of cytochrome P450 isozymes or ABC-transporters within the preceding 2 months Any acute or chronic illness Smoking Pregnancy Alcohol or drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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
-----------------
ritonavir, lopinavir, HIV Infections
Safety and Effectiveness of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis During One Year Treatment (BY9010/M1-404)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of perennial allergic rhinitis.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial to Assess the Long Term Safety of Ciclesonide, Applied as a Nasal Spray (200 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 12 Years and Older

Conditions
-----------------
Perennial Allergic Rhinitis, Allergic Rhinitis, Hay Fever

Intervention / Treatment
-----------------
* Drug: Ciclesonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: General good health, other than perennial allergic rhinitis History and diagnosis of perennial allergic rhinitis by skin prick test Main Exclusion Criteria: Participation in any investigational drug trial within the 30 days preceding the Screening Visit A known hypersensitivity to any corticosteroid or any of the excipients in the formulation Use of any prohibited concomitant medications as defined by the study protocol

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Single Group Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Total Nasal Symptom Scores. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in symptoms, quality of life, safety. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergy, Perennial Allergic Rhinitis, Allergic Rhinitis, Hay Fever
A Pilot Study of Bone Mineral Density in Postmenopausal Women After Treatment for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to see what levels of Bone Mineral Density post-menopausal women with breast cancer have, and to see if the level of Bone Mineral Density changes during a women's treatment after her surgery. This trial studies changes in Bone Mineral Density and markers of of bone activity in post-menopausal women receiving treatment for early stage breast cancer.

Official Title
-----------------
A Pilot Study of Bone Mineral Density in Postmenopausal Women After Treatment for Breast Cancer

Conditions
-----------------
Breast Cancer, Postmenopausal Bone Loss

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of breast cancer Last menstrual period occurring more than 5 years ago Non-metastatic breast cancer tumor with the diagnosis of Tis, Tl-T4, N0-3, M0 DCIS is allowed, but LCIS (only) is not Exclusion Criteria: Any metabolic bone disease other than postmenopausal osteoporosis or osteopenia Use of systemic gonadal hormonal medications or supplements within the past 24 months Prior use of tamoxifen or raloxifene is permitted if the medication was discontinued more than 24 months prior to the diagnosis of breast cancer. No adjuvant antiestrogen, antineoplastic, therapies are permitted on study. Chronic use of systemic steroids for disease process other than breast cancer chemotherapy premedication or antiemetics History of rheumatoid arthritis, ankylosing spondylitis, hyperparathyroidism, renal osteodystrophy, moderate to severe inflammatory or autoimmune disease or newly diagnosed thyroid condition requiring titration of medications. Lobular carcinoma in situ or Stage IV breast cancer and patients with a concurrently active second malignancy other then adequately treated non-melanoma skin cancers or in situ cervical cancer. participation in other clinical trials that are measuring BMD as a study parameter Patients with conditions that are expected to distort BMD reading and make DEXA results unreliable Patients with concurrent medical or psychiatric conditions that would keep them from understanding and complying with this clinical trial.

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

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

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 |
| --- | --- | --- |
| Changes in bone mineral density in post-menopausal women receiving treatment for early stage breast cancer. |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post menopause women receiving adjuvant care