linjc16/ctgov huggingface dataset:
Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fasted Conditions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the relative bioequivalence of oxymorphone hydrochloride extended-release tablets (Sandoz) with Opana extended release oxymorphone hydrochloride tablets.

Detailed Description
-----------------
Bioequivalence based on FDA Criteria.

Official Title
-----------------
A Study to Evaluate the Relative Bioavailability of Oxymorphone 40 mg Extended-Release Tablets (Sandoz, Inc.) Compared to Opana ER (Oxymorphone Hydrochloride) Extended-Release Tablets, 40 mg (Endo Pharmaceuticals, Inc.) in Healthy Volunteers Under Fasted Conditions

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: oxymorphone
* Drug: Oxymorphone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on physical exam, medical history or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C Treatment for drug or alcohol dependence

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Oxymorphone ER 40 mg tablets Sandoz | Drug: oxymorphone<br>* Tablets<br>* Other names: Opana;|
| Active Comparator: 2<br>Opana ER 40 mg tablets Eon Pharmaceuticals | Drug: Oxymorphone<br>* 40 mg tablets<br>* Other names: Opana;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on Cmax and AUC |  | Four Weeks |
Ridge Preservation After Tooth Extraction Using Cortical Versus Cancellous Freeze Dried Bone Allograft

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare cortical and cancellous freeze-dried bone allograft (FDBA) materials in the preservation of alveolar bone following extraction of non-molar teeth. The primary objective is to histologically evaluate and compare the healing of extraction sockets of non-molar teeth grafted with cortical FDBA versus cancellous FDBA for ridge preservation.

Official Title
-----------------
Histological Comparison of Healing Following Tooth Extraction With Ridge Preservation Using Cortical Versus Cancellous Freeze Dried Bone Allograft

Conditions
-----------------
Tooth Extraction

Intervention / Treatment
-----------------
* Device: cortical FDBA
* Device: Cancellous FDBA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: single rooted tooth requiring extraction with future dental implant placement Exclusion Criteria: smoking > 10 cigarettes per day poorly controlled diabetes

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 99 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: cancellous FDBA (LifeNet)<br>grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health) | Device: Cancellous FDBA<br>* CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)<br>|
| Experimental: cortical FDBA (LifeNet)<br>CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health) | Device: cortical FDBA<br>* cortical mineralized freeze-dried bone allograft<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histologic Percentage of Vital Bone Formation | Histologic percentage of vital bone formation in bone cores | 18-20 weeks after grafting | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tooth extraction, bone grafting
Significance of Fluorescence Colposcopy With Autofluorescence Imaging for Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
Clinical Trial to access Significance of fluorescence colposcopy with autofluorescence imaging for the screening of cervical cancer

Detailed Description
-----------------
Perform pelvic vaginal exam of the subjective to know symptom, illness history, physical exam and basal state before fluorescence colposcopy. Observe acetowhite epithelium and perform biopsy at suspicious lesion during fluorescence colposcopy. Perform fluorescence colposcopy again after biopsy and confirm extraordinary reaction. After 1 2weeks follow up the subjective at opd and confirm biopsy result.

Official Title
-----------------
Clinical Trial to Access Significance of Fluorescence Colposcopy With Autofluorescence Imaging for the Screening of Cervical Cancer

Conditions
-----------------
Cervical Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age : 20-65 years abnormal cervical papanicolaou smear , no other specific cervical disease subject to colposcopic biopsy or LEEP signed voluntarily to informed concents with full knowledge after explanation abot objective, method, contents Exclusion Criteria: pregnant women porphyria severe cervical bleeding genital chlamydia, gonorrhea infection other drug user with possible interaction (e.g. photosensitizer) no informed consent

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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 |
| --- | --- | --- |
| fluorescence colposcopic result |  | 2weeks after fluorescence colposcopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fluorescence colposcopy, cervical cancer
KTP Green Light Prostatectomy Compared With TUR-P in High Risk Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare safety and efficacy of Green Light PVP (Photoselective Vaporization of the Prostate) compared to TUR-P in high risk patients

Official Title
-----------------
The Effect of KTP (Potassium-titanyl-phosphate) Green Light Prostatectomy (120W) Compared With TUR-P When Treating Benign Prostatic Hyperplasia in High Risk Patients, A Prospective Randomized Study

Conditions
-----------------
BPH (Benign Prostatic Hyperplasia)

Intervention / Treatment
-----------------
* Procedure: KTP laser
* Procedure: TUR-P


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men with anticoagulant medication undergoing surgery for BPH Exclusion Criteria: Previous prostate surgery Carcinoma of the prostate Neurogenic bladder Bladder carcinoma

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

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

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: KTP laser<br>device | Procedure: KTP laser<br> <br> * Other names: Green laser;|
| Active Comparator: TUR-P<br>device | Procedure: TUR-P<br>* device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-bleeding rate requiring hospitalization |  | two months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IPSS (International Prostate Symptom Score) | symptom score | 0, 3, 6 and 12 months | 
| DAN-PSS (Danish Prostate Symptom Score) |  | 0, 3, 6 and 12 months | 
| Maximum flow rate (Qmax) |  | 0, 3, 6 and 12 months | 
| Residual urine |  | 0, 3, 6 and 12 months | 
| Length of catheterization |  | Participants will be followed for the duration of hospital stay, an expected maximum of one week | 
| Length of hospital stay |  | Participants will be followed for the duration of hospital stay, an expected maximum of one week | 
| Perioperative bleeding |  | Time of operation | 
| IIEF (International Index of Erectile Function) questionnaire |  | 0,12 months | 
| TRUS (transrectal ultrasound) |  | 0, 12 months |
Time-dependent Improvement of Functional Outcome Following LCS Rotating Platform TKR

Study Overview
=================
Brief Summary
-----------------
The objective of this prospective study is to determine (1) the time course of patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome Score (KOOS) and (2) the time course of range of motion (ROM) the first four years following TKR using the LCS rotating platform prosthesis. Improvement of patient self-reported pain and daily function during the study period, are of particular interest.

Official Title
-----------------
Time-dependent Improvement of Functional Outcome Following LCS Rotating Platform TKR - A Prospective Longitudinal Study With Repetitive Measures of KOOS

Conditions
-----------------
Osteoarthritis, Total Knee Replacement

Intervention / Treatment
-----------------
* Device: Total Knee Replacement (LCS rotating platform)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with knee osteoarthritis admitted for total knee replacement no rheumatoid arthritis no previous knee infection age 40-85 years Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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 knee osteoarthritis<br> | Device: Total Knee Replacement (LCS rotating platform)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee injury and Osteoarthritis Outcome Score |  | Preoperative and 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion (ROM) |  | Preoperative and 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years postoperatively | 
| Knee injury and Osteoarthritis Outcome Score |  | 10 years postoperatively |
Bicuspid Echocardiac Study Team（BEST）

Study Overview
=================
Brief Summary
-----------------
The Chinese Bicuspid Aortic Valve (BAV) Ultrasound imaging cohort study is a Chinese BAV ultrasound imaging cohort study. At present, a retrospective study cohort involving more than 30 hospitals has been established. The prospective multi-center study of BAV is expected to include and follow up 200 outpatients and inpatients with BAV. The clinical, ultrasound imaging and treatment parameters of the patients are collected and the patients are followed up for 2 years. To analyze the prognostic characteristics of BAV patients and establish a Chinese BAV database. The primary endpoint was all-cause death, and the secondary endpoints were heart failure, angina, severe aortic stenosis, severe aortic insufficiency, ascending aortic diameter ≥50mm, and surgery (surgical and interventional). According to the different pathological types of aortic valve in different types of BAV, ultrasound imaging was used to evaluate the different forms of valvular leaflet lesions and prognosis. Finally, it provides a basis for the prognosis, treatment method, treatment timing and treatment plan selection of BAV patients, and lays a foundation for the mechanism study of BAV arterial lesions and the establishment of risk model for the prognosis of BAV patients.

Official Title
-----------------
Prospective Cohort Study on Imaging Genetics of Bicuspid Aortic Valve

Conditions
-----------------
Bicuspid Aortic Valve Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ultrasound or other imaging tests to diagnose patients with BAV Exclusion Criteria: Patients with TAV or/and have significant aortic valve calcification Those deemed unsuitable for enrollment by clinicians (e.g., end-stage patients, mentally ill patients, non-cooperating patients, etc.) Those who do not agree to be included
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 |
| --- | --- | --- |
| Diameter of ascending aorta | Diameter of ascending aorta shall be taken using leading edge-to-leading edge convention at end diastole. | baseline; once a year; through study completion. |
To Evaluate the Hormonal Response to Low Blood Sugar After a Single Oral Dose of AZD1656 Suspension

Study Overview
=================
Brief Summary
-----------------
To evaluate the hormonal response to low blood sugar after a single oral dose of AZD1656 suspension.

Official Title
-----------------
A Randomized, Open, Two-Way Cross-Over, Single-Centre, Phase I Study to Assess the Counter Regulatory Response During Hypoglycaemia in Healthy Male Volunteers After a Single Oral Dose of AZD1656 Suspension in Comparison With Insulin Infusion

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Insulin
* Drug: AZD1656


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers. Clinically normal physical findings (incl. Electrocardiogram (ECG)) and laboratory values as judged by the investigator. Have a body mass index (BMI) ≥19 and ≤30 Exclusion Criteria: Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the investigational product Intake of any prescribed medicine and OTC drugs (including herbals, vitamins and minerals), except for occasional paracetamol or nasal spray for nasal congestion, within two weeks before the first administration of the investigational product. Daily use of nicotine containing substances.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>AZD1656 | Drug: AZD1656<br>* Single dose oral suspension given at one occasion.<br>|
| Active Comparator: 2<br>Insulin | Drug: Insulin<br>* Insulin infusion given during 3 hours at one occasion.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic variables |  | Blood samples taken repeatedly up to 6 hours during study days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables |  | Blood samples taken repeatedly during 24 hours on study day sessions | 
| Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables) |  | Taken repeatedly during treatment periods | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, hormonal response
Surveillance For New Lung Primaries

Study Overview
=================
Brief Summary
-----------------
This clinical research protocol proposes to perform low dose helical computed tomographic (CT) scanning in 250 high-risk patients (125/year for two years) in order to detect lung carcinomas when they are small and subject to effective curative therapies.

Official Title
-----------------
Low Dose Helical Computed Tomographic (CT) Screening Followed by Anatomic Co-Registered Computed Tomography With Positron Emission Tomography (CT/PET) for Patients With Indeterminate (5-9 mm) Nodules

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asymptomatic Exclusion Criteria: 20 pack year history

Ages Eligible for Study
-----------------
Minimum Age: 50 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
-----------------
surveillance for lung cancer
Evoke Data Collection Study Germany

Study Overview
=================
Brief Summary
-----------------
The objective of this multicentre study is to collect electrophysiological and device data from the Evoke Closed-Loop SCS system in the treatment of chronic pain of the trunk and/or limbs, in a real world setting under normal conditions of use.

Official Title
-----------------
Prospective Data Collection to Evaluate the Feedback Control of the Saluda Medical's Evoke Spinal Cord Stimulation System in the Treatment of Patients With Chronic Pain of the Trunk and/or Limbs

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Device: Evoke Spinal Cord Stimulation (SCS) System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient approval for data collection and transfer of de-identified data to sponsor. Exclusion Criteria: No further exclusion criteria.

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 |
| --- | --- |
| ECAP-controlled, closed-loop SCS<br>Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude | Device: Evoke Spinal Cord Stimulation (SCS) System<br>* A spinal cord stimulation system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECAP Measurement in Microvolts | Evoked Compound Action Potentials (ECAPs) as a measure of spinal cord activation | through 6 months post-implant |
Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients

Study Overview
=================
Brief Summary
-----------------
Demonstrate feasibility of detection of EML4-ALK fusion transcripts and T790M EGFR mutation from exosomes in the circulation of Non-Small Cell Lung Cancer (NSCLS) patients.

Detailed Description
-----------------
The goal of this study is two-fold: 1) Demonstrate feasibility of detection of EML4-ALK fusion transcripts in the circulation of NSCLC patients positive for ALK on tissue analysis, using an institutionally accepted assay; 2) Demonstrate feasibility of detection of T790M EGFR mutation in the circulation of NSCLC patients positive for T790M on tissue analysis, using an institutionally accepted assay.

Official Title
-----------------
Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must have histologically confirmed NSCLC, stage IIIB- IV, and have tested positive for the presence of EML4-ALK on tissue specimen, fresh or archived, using an institutionally accepted assay. Age of 18 years or older. Participants are being considered for ALK-directed therapy or have progressed on EGFR TKI treatment. Participants must have hemoglobin > 10 mg/dL. Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: Hepatitis (all types) in patient's medical record HIV documented in patient's medical record Hemoglobin < 10 mg/dL Less than 18 years of age Histologically confirmed NSCLC Stage I-IIIA Tested negative for the presence of EML4-ALK and T790M EGFR on tissue

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 |
| --- | --- |
| EML4-ALK<br>ALK positive patients | |
| T790M EGFR<br>T790M positive patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ALK mutation by tissue assay. | Patients found to be positive for ALK mutation by tissue assay. ALK fusions in samples will be considered binary - positive or negative/ not assessable. 2x2 table will be constructed to determine concordance with tissue testing. | Two years | 
| T790M EGFR mutation by tissue assay | Patients found to be positive for T790M EGFR mutation by tissue assay. ALK fusions in samples will be considered binary - positive or negative/ not assessable. 2x2 table will be constructed to determine concordance with tissue testing. | Two years |