linjc16/ctgov huggingface dataset:
Bioequivalence Study of Rivaroxaban in Japanese Healthy Adult Male Subjects

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to establish the bioequivalence between rivaroxaban tablet 10mg and rivaroxaban granule formulation 10mg, and to assess the safety and tolerability of rivaroxaban 10mg in healthy adult male subjects.

Official Title
-----------------
Randomized, Non-blinded, Two-way Crossover Study to Establish the Bioequivalence Between a Rivaroxaban Tablet 10 mg and a Rivaroxaban Granule 10 mg in Japanese Healthy Adult Male Subjects

Conditions
-----------------
Embolism, Atrial Fibrillation and Venous Thrombosis

Intervention / Treatment
-----------------
* Drug: Rivaroxaban (BAY 59-7939)
* Drug: Rivaroxaban (Xarelto, BAY 59-7939)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese healthy male subjects 20 to 40 years of age 17.6 to 26.4 kg / m² of body mass index (BMI) Exclusion Criteria: Subject with incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal Subject with a history of relevant diseases of vital organs, of the central nervous system or other organs, eg instable coronary heart disease, heart failure, liver failure, kidney failure, hypotension, or history of stroke or myocardial infarction Subject with known coagulation disorders (eg von Willebrand's disease, hemophilia) Subject with known disorders with increased bleeding risk (eg periodontosis, hemorrhoids, acute gastritis, peptic ulcer) Subject with known sensitivity to common causes of bleeding (eg nasal)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- |
| Experimental: BAY59-7939 granule<br> | Drug: Rivaroxaban (BAY 59-7939)<br>* Rivaroxaban granule 10mg for one day<br>|
| Active Comparator: BAY59-7939 tablet<br> | Drug: Rivaroxaban (Xarelto, BAY 59-7939)<br>* Rivaroxaban tablet 10mg for one day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (maximum observed drug concentration in measured matrix after single dose administration) |  | Multiple time point up to 3 day | 
| AUC(0-tlast) (AUC from time 0 to the last data point > LLOQ (lower limit of quantitation)) |  | Multiple time point up to 3 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety and tolerability |  | Up to 30 day |
Wrist Cartilage - High Resolution in Vivo MR T2 Mapping- a Feasibility Study

Study Overview
=================
Brief Summary
-----------------
Purpose:Evaluate the feasibility of T2 cartilage mapping on MRI of the wrist and correlate with T2 mapping of knee cartilage. Study protocol: Phase 1. 10 healthy volunteers, Phase 2. 10 volunteers with osteoarthritis of the wrist, Phase 3. 50 patients for studies for routine MR of the wrist. MRI protocol: 3 T unit((Signa EXITE HDx),T1, T2 and T2 mapping sequences on axial and coronal orientation.

Official Title
-----------------
Wrist Cartilage - High Resolution in Vivo MR T2 Mapping- a Feasibility Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Phase 1. Age:18-40 Phase 2: No age limit, known OA on pre-existing X-rays Phase 3: No age limit, routine MRI of the wrist Exclusion Criteria: Phase 1, 2: wrist trauma/surgery All phases: any contraindication for MR: eg metals, claustrophobia, etc.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| 1<br>healthy young volunteers Inclusion: age 18-40, Exclusion: wrist trauma/surgery | |
| 2<br>patients with know osteoarthritis wrist changes according to pre-existing x-rays No age limits exclusion: previous wrist surgery | |
| 3<br>Mixed group of 50 patients that perform routine MRI of the wrist for various indications | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wrist bone cartilage thickness can be measured and stratification can be observed on T2 mapping with correlation to T2 mapping of the knee cartilage |  | Within MRI completion (20 minutes) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cartilage, osteoarthritis, T2 mapping, MRI, Wrist
Effect of PUR003 on Asthma

Study Overview
=================
Brief Summary
-----------------
PUR003 is an inhaled substance that is proposed to assist in the treatment of asthma. Study objectives are to : to evaluate the safety of PUR003 in subjects with asthma, and to evaluate the efficacy of PUR003 in assisting the treatment of asthma.

Official Title
-----------------
Double-blind, Placebo-controlled Crossover Evaluation of the Effect of PUR003 on Subjects With Asthma

Conditions
-----------------
Asthma, Lung Diseases, Bronchial Diseases

Intervention / Treatment
-----------------
* Drug: PUR003
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent. Ability and willingness to return to the outpatient clinic for repeated clinic visits and complete all assessments. Adult male or female subject, 18-60 years of age. Stable, mild asthma not requiring any medical treatment other than short acting inhaled bronchodilators, as needed. No smoking within six months prior to entry Must be medically stable. Female subjects must have a negative pregnancy test Subjects of child bearing potential should be sexually inactive (abstinent) for 14 days prior to the first dose of study medication or using an acceptable form of birth control methods. Exclusion Criteria: History or presence of significant co-existing chronic diseases. History of asthma exacerbations or upper or lower respiratory illness (viral respiratory syndrome, bronchitis, pneumonia) within four weeks of first visit. Pregnancy, breastfeeding. Abused alcohol or illicit drugs that required treatment. Participated in any other investigational drug evaluation within last 30 days. Scheduled to have elective or invasive medical intervention, procedure, or surgery within 6 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>normal saline for inhalation | Drug: Placebo<br>* Normal saline for inhalation<br>|
| Active Comparator: PUR003<br>PUR003 for inhalation | Drug: PUR003<br>* PUR003 for inhalation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of PUR003 as determined by incidence of adverse events (AEs); changes in physical examination, chest examination; pulmonary function; vital signs; electrocardiogram (ECG) and clinical laboratory assessments. |  | after three doses | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, bronchial diseases, lung diseases, bronchitis, respiratory tract diseases
A Study on the Effect of Kidney Disease on a Diabetes Medication (0431-008)

Study Overview
=================
Brief Summary
-----------------
A study to evaluate the effect of kidney disease, from mild to severe disease, on a diabetes medication

Official Title
-----------------
An Open- Label, 2 Part Study to Investigate the Pharmacokinetics, Safety, and Tolerability of MK0431(Sitagliptin Phosphate) in Patients With Varying Degrees of Renal Insufficiency

Conditions
-----------------
Renal Insufficiency, Hemodialysis

Intervention / Treatment
-----------------
* Drug: MK0431, sitagliptin phosphate / Duration of Treatment : 1 Days


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : Male and non-pregnant females with a clinical diagnosis of renal insufficiency with mild, moderate, severe or end stage renal disease on hemodialysis A body mass index of less than 40 kg per meter squared (body weight in kg divided by height in meters squared) Smokes less than 10 cigarettes/day Exclusion Criteria : Patients with uncontrolled diabetes or uncontrolled congestive heart failure Patient has abnormal prestudy laboratory measurements including serum potassium or white blood counts Patient has systolic blood pressure below 100 mm Hg or above 180 mm Hg Patient has diastolic blood pressure less than 50 mm Hg systolic or above 100 mmHg

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0431, sitagliptin phosphate / Duration of Treatment : 1 Days|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the pharmacokinetics of MK0431 (sitagliptin phosphate) in patients with renal insufficiency compared to healthy volunteers |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability in patients with renal insufficiency |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mild, moderate, severe renal insufficiency, End stage renal disease
Study Comparing Pursestring Wound Closure vs Conventional Closure to Reverse Stoma of Colorectal Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Temporary stomas has been performed to reduce complications after colorectal cancer surgery, especially in high-risk anastomosis. Different closure technics showed different outcome. The aim of this study is to compare the scar length , surgical site infection and pain score of purse-string wound closure vs conventional closure.

Official Title
-----------------
Randomized Clinical Trial of Stoma Reversal Comparing Pursestring Wound Closure vs Conventional Closure to Eliminate the VSS Score of the Scar for Colorectal Cancer Patients

Conditions
-----------------
Colorectal Cancer, Stoma Closure Technic

Intervention / Treatment
-----------------
* Procedure: Pursestring Wound Closure
* Procedure: Conventional Wound Closure
* Device: prolene


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receiving temporary ostomy because of colorectal cancer at least 3 months ago; Age of≥18 and ≤80 Exclusion Criteria: Not willing or incapable to comply with all study visits and assessments Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that puts the patient at high risk for treatment-related complications

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

| Intervention/Treatment |
| --- |
|Procedure: Pursestring Wound Closure|Procedure: Pursestring Wound Closure|
|Procedure: Conventional Wound Closure|Procedure: Conventional Wound Closure|
|Device: prolene|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Phase II Exploratory, Multicentre, Open-label, Non-comparative Study of ZD1839 (Iressa) and Radiotherapy in the Treatment of Patients With Glioblastoma Multiforme

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the efficacy of gefitinib (IressaTM) in combination with radiotherapy on patients with glioblastoma multiforme.

Official Title
-----------------
A Phase II Exploratory, Multicentre, Open-label, Non-comparative Study of ZD1839 (Iressa™) and Radiotherapy in the Treatment of Patients With Glioblastoma Multiforme

Conditions
-----------------
Glioblastoma

Intervention / Treatment
-----------------
* Drug: Gefitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent histologically-or cytologically-confirmed glioblastoma multiforme age 18 years or older Exclusion Criteria: Have had prior radiation therapy, immunotherapy, gene therapy and/or chemotherapy for the glioblastoma co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ known severe hypersensitivity to ZD1839 or any of the excipients of this product.

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective tumour response at 6 months after the end of combination treatment by computerized tomography scan or magnetic resonance imaging of the brain according to Macdonald criteria. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate at 6 months after the combination treatment, clinical or radiological progression-free-survival, overall survival and safety of ZD1839 in combination with radiotherapy. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glioblastoma multiforme, Brain tumour
Evaluation of RTVue in Corneal Measurement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate RTVue measurement of the cornea in various ocular conditions to include normal, pathology, post refractive surgery and cataract.

Official Title
-----------------
Evaluation of RTVue in Corneal Measurement

Conditions
-----------------
Normal Cornea, Post Laser Refractive Surgery, Cornea Pathology, Cataract Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal cornea: 18 years of age or older No corneal pathology No prior ocular surgery and no prior laser refractive surgery Post laser refractive surgery: 18 years of age or older No corneal pathology No prior ocular surgery except laser refractive surgery At least 1 week post laser refractive surgery without complication Corneal pathology: 18 years of age or older Clinical diagnosis of one or more type of corneal pathologies, including corneal scar and keratoconus, etc., excluding eyes in which corneal power measurement are not clinically relevant (e.g., eyes requiring corneal transplant) No prior laser refractive surgery Cataract surgery: 18 years of age or older No corneal pathology No prior ocular surgery, no prior laser refractive surgery, and no prior cataract surgery Post surgery visit shall only include eyes without complication

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Normal cornea<br> | |
| Post laser refractive surgery<br> | |
| Cornea pathology<br> | |
| Cataract surgery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Biomarkers of Diabetic Retinopathy Progression

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate a predictive model of diabetic retinopathy progression in patients with diabetes mellitus type 2 patients to clinically significant macular edema (CSME) needing treatment either photocoagulation or intravitreal injections (ITV) using non-invasive techniques.

Official Title
-----------------
Biomarkers of Diabetic Retinopathy Progression.

Conditions
-----------------
Type 2 Diabetes Mellitus, Mild Nonproliferative Diabetic Retinopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus Age over 35 years-old Non-proliferative diabetic retinopathy (Levels 20 to 35, according the ETDRS criteria) Best Corrected Visual Acuity > 20/25 on the ETDRS chart Informed Consent Exclusion Criteria: Previous laser therapy Other retinal vascular disease Glaucoma Recent intraocular surgery (in the last 6 months) Inadequate ocular media and/ or pupil dilatation that do not permit good quality fundus photography (e.g. cataract) HbA1C > 11 % at the Screening Subject that has a condition or that is in a situation which may put him/her at significant risk, may confound the study results or may interfere significantly with his/ her participation in the study.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 100 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 diabetic retinopathy.<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CSME needing treatment either photocoagulation or ITV. |  | Months 0, 6, 12 and 24. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity. |  | Months 0, 6, 12 and 24. | 
| Vision loss of at least 2 lines documented in ETDRS charts |  | Months 0, 6, 12 and 24. | 
| Central retinal thickness |  | Months 0, 6, 12 and 24. | 
| Microaneurysm(MA) activity (number of MA, MA formation and MA disappearance rates and MA turnover) |  | Months 0, 6, 12 and 24. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes mellitus, nonproliferative diabetic retinopathy
PMCF Study to Evaluate Safety of TIPMED TPM08 Total Knee Prosthesis Systems and TPM Revision Knee Prosthesis Systems

Study Overview
=================
Brief Summary
-----------------
This is a observational multicenter study to assess the safety of TIPMED TPM08 Total Knee Prosthesis Systems and TPM Revision Knee Prosthesis Systems used for total knee arthroplasty or revision knee arthroplasty.

Detailed Description
-----------------
In this study, short term (12 months) safety data of TIPMED TPM08 Total Knee Prosthesis System and TPM Revision Knee Prosthesis System will be evaluated using Case Report Forms (CRF). A CRF should be completed at each control visit of the participants by investigator in order to assess safety of the TIPMED Knee Prosthesis Systems by success of operation, occurrence of adverse events during procedure or as the effects in 12 months period resulting from TIPMED Knee Prosthesis Systems. CRF will also include questions related to performance and effectiveness of TIPMED Knee Prosthesis Systems. Participants should be treated according to instructions-for-use of the implants and accessories and according to clinical routine. The devices must have been used exclusively by physicians who are experienced in knee arthroplasty techniques and who are experienced in using the products in operations.

Official Title
-----------------
Multicenter, Prospective, Observational Post Market Clinical Follow-up Study to Evaluate Safety of TIPMED TPM08 Total Knee Prosthesis Systems and TPM Revision Knee Prosthesis Systems

Conditions
-----------------
Knee Arthroplasty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects aged older than 18 years of age, The subjects with appropriate indication for primary total or revision knee arthroplasty, The subjects who used TIPMED TPM08 Primary Total or Revision Knee Prosthesis System in their surgery, Subjects not under legal disability, Subjects or guardian who is willing and able to sign the informed consent form. Exclusion Criteria: - Subjects in another interventional clinical trial will be excluded.

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 |
| --- | --- | --- |
| Safety data | Assessment of safety data during 12 months after surgery. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Revision Knee Arthroplasty, Knee Prosthesis, Total Knee Arthroplasty