linjc16/ctgov huggingface dataset:
Designated Drug Use Investigation 1 of Follistim Injection (Study P06130)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
To evaluate dosage and administration method, efficacy and safety of Puregon and the relationship between background factors of patients and dose and administration method. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Official Title
-----------------
Designated Drug Use Investigation 1 of Follistim Injection

Conditions
-----------------
Fertilization in Vitro

Intervention / Treatment
-----------------
* Drug: Follitropin beta


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent IVF Exclusion Criteria: Patients with tumors of ovary, breast, uterus, pituitary or hypothalamus Pregnant or possible pregnant women, or lactating women Patients with undiagnosed atypical vaginal bleeding Patients with a history of hypersensitivity to any of the ingredients of this product. Patients with ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients who underwent IVF | Drug: Follitropin beta<br>* Normally, Follistim Injection 150 or 225 IU will be administered (s.c. or i.m.) once a day for 4 days as follitropin beta (genetical recombination). The dosage will be adapted to growth of follicles (75-375 IU for 6-12 days, in general). If more than 3 follicles of mean diameter 16-20 mm are confirmed by ultrasound tomography, ovulation will be stimulated by using Human Chorionic Gonadotropin (hCG) drugs.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of retrieved oocytes |  | 2 months, from initiation of treatment to confirmation of pregnancy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy outcome |  | 2 months, from initiation of treatment to confirmation of pregnancy. |
Interaction Study in Patients With Pulmonary Hypertension and Stable Treatment of Sildenafil 20 mg TID

Study Overview
=================
Brief Summary
-----------------
This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic effect of BAY63-2521 in patients with pulmonary hypertension and stable treatment of sildenafil 20 mg.

Official Title
-----------------
Interaction Study to Investigate Safety, Tolerability, Pharmacokinetics and the Impact on Pulmonary and Systemic Hemodynamics of Single Doses of 0.5 and 1 mg of BAY 63-2521 in Patients With PAH and Stable Treatment of Sildenafil 20 mg TID in a Non-randomized, Non-blinded Design

Conditions
-----------------
Hypertension, Pulmonary

Intervention / Treatment
-----------------
* Drug: Riociguat (Adempas, BAY63-2521)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pulmonary hypertension stable for the last 6 weeks Treated with Sildenafil 3 × 20 mg Undergoing routine invasive diagnostics. Exclusion Criteria: Pre-existing lung disease other than pulmonary arterial hypertension, Acute or severe chronic left heart failure, Severe coronary artery disease, Uncontrolled arterial hypertension; Congenital or acquired valvular or myocardial disease except acquired tricuspid valve insufficiency due to pulmonary hypertension, Systolic blood pressure < 100 mmHg, heart rate < 55 bpm or >105 bpm, PaO2/FiO2 < 50 mmHg, PaCO2 > 55 mmHg, Severe hepatic insufficiency, Severe renal insufficiency, Administration of strong CYP3A4 inhibitors or inductors

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Riociguat (Adempas, BAY63-2521)<br>* The investigational drug will be given twice per subject, as single dose administration of BAY 63-2521 (0.5 mg and 1.0 mg) during the hemodynamic investigation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of a single dose of BAY63-2521 on pharmacodynamic parameters of the pulmonary system, on safety, tolerability and pharmacokinetics. |  | At baseline, throughout study days 1 and 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary hypertension
Sentinel Node Mapping in Women With Cervical and Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the effect of SLN mapping on the incidence and severity of lymphedema in women with early stage cervical and endometrial cancer.

Official Title
-----------------
Sentinel Node Mapping With Robotic Assisted Near Infra-red Fluorescent Imaging in Women With Cervical and Endometrial Cancer

Conditions
-----------------
Uterine Cervical Neoplasms, Uterine Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Study IA: Cervical carcinoma, FIGO stage IB1, cervical tumour size < 2 cm Study IB: Endometrial adenocarcinoma, presumed FIGO stage I, low- and intermediate risk: Type 1 grade 1 + 2, > 50% myometrial invasion Exclusion Criteria: Prior PL Known allergy towards ICG and/or iodine (ICG contains 5% sodium iodine) Women included in other studies affecting outcome-measures of the present study

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with cervical cancer<br>All patients receive sentinel node mapping as the conventional treatment. | |
| Patients with endometrial cancer<br>All patients receive sentinel node mapping as the conventional treatment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of lymphedema | Incidence of lymphedema will be assessed using patient reported outcome measures. | 3 years | 
| Severity of lymphedema | Severity of lymphedema will be assessed using patient reported outcome measures. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate of sentinel lymph node | Detection of sentinel lymph node per patient, per heme-pelvis and bilaterally | 2 years | 
| Mapping of SLN in different types of lymph node stations | Mapping of SLN in areas outside the normal area of pelvic lymphadenectomy | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
robotic surgery procedure, indocyanine green, sentinel lymph node mapping
The Use of Capnography as a Guide for Oral Intubation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess if capnography can be utilized to assist in the process of endotracheal intubation; specifically, in locating the glottic opening. Ultimately this would result in a new use of capnography to aid in securing normal and difficult airways. Currently capnography is only utilized for the confirmation of endotracheal tube placement. If successful, this study will provide information, and allow for the development of instrumentation that will assist in difficult airway management; specifically, in locating the glottic opening when visualization may be impaired. Ultimately, this technique will be useful for routine and emergency airway management.

Detailed Description
-----------------
The purpose of this study is to assess if capnography can be utilized in the process of endotracheal intubation; specifically, in locating the glottic opening. Ultimately this would result in a new use of capnography to aid in securing normal and difficult airways. Currently capnography is only utilized for the confirmation of endotracheal tube placement. If successful, this study will provide information, and allow for the development of instrumentation that will assist in difficult airway management; specifically, in locating the glottic opening when visualization may be impaired. Ultimately this technique will be useful for routine and emergency airway management.

Official Title
-----------------
Assessing the Use of Capnography as a Guide for Endotracheal Intubation

Conditions
-----------------
Measurement

Intervention / Treatment
-----------------
* Procedure: Capnography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients for elective surgery, requiring general endotracheal anesthesia Exclusion Criteria: Patients with a known or suspected difficult intubation Patients requiring specialized endotracheal tubes Patients with a history of tracheostomy Airway tumor or airway pathology

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All comers<br>capnography used for all consenting subjects | Procedure: Capnography<br>* device which measures carbon dioxide at intubation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful intubation |  | at intubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intubation, capnography
Comparison Between Fixed- Versus Mobile-bearing TKA

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to analyse the clinical and radiological results of a postero-stabilized TKA by using a mobile bearing versus fixed. Only patients with medial femorotibial arthritis will be included. The consequences on the patellofemoral joint will be thoroughly analysed on skyline view.

Official Title
-----------------
Comparison Between Fixed- Versus Mobile-bearing TKA : a Randomized Prospective Study

Conditions
-----------------
Knee Arthritis

Intervention / Treatment
-----------------
* Device: mobile-bearing TKA
* Device: fixed- bearing TKA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medial medial femorotibial arthritis requiring an arthroplasty Age between 50y and 90y Exclusion Criteria: Lateral femorotibial arthritis Inflammatory disease Stiff knee with flexion under 90° Revision TKA Previous surgery (except meniscectomy)

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mobile-bearing TKA<br> | Device: mobile-bearing TKA<br> <br> |
| Active Comparator: fixed- bearing TKA<br> | Device: fixed- bearing TKA<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Knee Society Score |  | 2, 6 and 12 monthes after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patellofemoral tilt on skyline view, measurement of two angles : |  | 2 and 12 monthes after surgery | 
| patellar tilt |  | 2 and 12 monthes after surgery | 
| patellar displacement from the center of the trochlear groove |  | 2 and 12 monthes after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mobile-bearing, arthroplasty, fixed-bearing, knee, patella, posterior stabilized TKA
Effect of Aerobic or Resistance Exercise on the Endothelial Response in Post-acute Myocardial Infarction Patients Submitted to Angioplasty

Study Overview
=================
Brief Summary
-----------------
Cardiac Rehabilitation, as art and acting science multiprofessional, is based on the training with exercises that provides the post-infarct patients to satisfactorily re-establish the patient's clinical condition and that improve the functional capacity of these individuals. Evidence shows that aerobic exercise training provides improvements in the endothelial function of this population. However, we do not yet have strong evidence of other modalities of exercise in these parameters in post-infarction patients treated with angioplasty.

Official Title
-----------------
Effect of Aerobic or Resistance Exercise on the Endothelial Response in Post-acute Myocardial Infarction Patients Submitted to Angioplasty: Randomized Clinical Trial

Conditions
-----------------
Cardiac Rehabilitation, Aerobic Exercise, Resistance Exercise

Intervention / Treatment
-----------------
* Other: Resistance exercise session


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post-acute myocardial infarction patients Ergometric test 30 days after the infarction Ejection fraction> 40% (Simpson's method) Regular use of optimized drugs Exclusion Criteria: Unable to perform the randomized exercise

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resistance exercise session<br>Acute isometric session, about 20 minutes. | Other: Resistance exercise session<br>* Acute isometric exercise session performed with handgrip Jamar about 20 minutes monitored.<br>* Other names: Aerobic exercise session;|
| Active Comparator: Aerobic exercise session<br>Acute aerobic session, about 20 minutes. | Other: Resistance exercise session<br>* Acute isometric exercise session performed with handgrip Jamar about 20 minutes monitored.<br>* Other names: Aerobic exercise session;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function | Flow-mediated dilatation technique | Pre and post 5 minutes exercise session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial stiffness | Pulse wave velocity technique | Pre and post 5 minutes exercise session |
Electrical Interactions in Heart Disease

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the relationship of markers of cardiac activation and their determinants. The hypothesis is that these markers will be interrelated.

Conditions
-----------------
Cardiomyopathy, Dilated

Intervention / Treatment
-----------------
* Other: Observational study, no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ventricular dysfunction Exclusion Criteria: normal ventricular function

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiomyopathy<br> | Other: Observational study, no intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pulsatility Aneurysmal Evaluation Process by Cerebral Dynamic CTA (Computed Tomography Angiography)

Study Overview
=================
Brief Summary
-----------------
Intracranial aneurysm are frequent with a prevalence estimated over 2-5% in the general population. These are focal dilatations occuring in the cerebral vessels. They usually remain silent until complications occur. Complications associated with intracranial aneurysms include mass effect on adjacent structures and rupture. Rupture is the most severe complication with a mortality rate of 35-50% and a high rate of morbidity including long-term disability. It incidence is estimated about 1% per year for aneurysm smaller than 1 cm. However, preventative treatments have their own risk of complication and morbi-mortality rate including stroke and hemorrhage. Actual guidelines for treatment planning are mainly designed with the size, the location and the age of the patient. This is why working on the identification of imaging markers of aneurysmal instability is relevant. Dynamic CTA (Computed Tomography Angiography) acquisition allow to study the variation of metrics such as dome height, dome length, ostium width, ostium area, and volume during the cardiac cycle. The goal of this study is to assess different aneurysmal metrics to determine those which may vary the most during the cardiac cycle and to assess it as an imaging marker of aneurysmal instability.

Official Title
-----------------
Pulsatility Aneurysmal Evaluation Process by Cerebral Dynamic CTA (Computed Tomography Angiography)

Conditions
-----------------
Aneurysm, 4D CT Scan

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with an intracranial aneurysm assessed with a 4D CTA Exclusion Criteria: Minor Refusal to participate

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 |
| --- | --- | --- |
| Assess the variation of different aneurysmal metrics (dome height, dome length, ostium width, ostium area, and volume) during the cardiac cycle. | Is there a difference between the maximum and the minimum values ? Measurements are realised with a 4D computed tomography angiography. | 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate among different aneurysmal metrics (dome height, dome length, ostium width, ostium area, and volume) the most relevant ones. | Evaluate among different aneurysmal metrics (dome height, dome length, ostium width, ostium area, and volume) for a composite endpoint including those which may vary the most during the cardiac cycle (maximum minus minium values) and which have the best reproducibilities over one (intrareader agreement) and multiples cardiac cycles. | 6months |
A Study to Compare the Pharmacokinetic Characteristics of CJ-12420

Study Overview
=================
Brief Summary
-----------------
To compare the pharmacokinetics after administration of different formulation of CJ-12420

Detailed Description
-----------------
The purpose of this study is to compare the pharmacokinetics after a single dose administration of CJ-12420 formulation 1 and formulation 2.

Official Title
-----------------
A Randomized, Open-label, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics of CJ-12420 in Healthy Male Volunteers

Conditions
-----------------
Erosive Esophagitis

Intervention / Treatment
-----------------
* Drug: CJ-12420 formulation 2
* Drug: CJ-12420 formulation 1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male aged 19 to 45 years at the screening Subject who is over 50kg with BMI between 19 kg/m2 to 28 kg/m2 (inclusive) Subject who fully understood after being informed detailed description of clinical trial, written informed consent voluntarily to observe the precautions. Exclusion Criteria: Subject who fall under the criteria below in laboratory test. AST, ALT, ALP, GGT, total bilirubin, BUN, creatinine > UNL x 1.5 Subject who with low blood pressure with clinical significance at screening test. (systolic blood pressure is less than 90 mmHg or over 140 mmHg, and diastolic blood pressure is less than 50 mmHg or over 90 mmHg) Subject who has a medical history of symptomatic GERD, erosive esophagitis or duodenal ulcer, gastric ulcer, barrett's esophagus or zollinger-ellison syndrome.

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CJ-12420 formulation 1<br>CJ-12420 formulation 1 | Drug: CJ-12420 formulation 2<br>* CJ-12420 formulation 2<br>|
| Active Comparator: CJ-12420 formulation 2<br>CJ-12420 formulation 2 | Drug: CJ-12420 formulation 1<br>* CJ-12420 formulation 1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the AUClast |  | Up to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the AUCinf |  | Up to 48 hours | 
| Tmax |  | Up to 48 hours | 
| t1/2 |  | Up to 48 hours | 
| Vd/F |  | Up to 48 hours |