linjc16/ctgov huggingface dataset:
A Genotype Stratification Study for Pharmacokinetics and Pharmacodynamics of Amitriptyline in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
A total of 24 healthy Korean male subjects will receive a single oral dose of amitriptyline, 25 mg. Subjects will be enrolled in this study based on their cytochrome P450 2D6 and cytochrome P450 2C19 genotypes, and serial blood sampling will be done for plasma concentrations of amitriptyline, nortriptyline, and their metabolites. Various pharmacodynamic markers related to the adverse event of amitriptyline will be measured serially during the study.

Official Title
-----------------
A Single Dose, Double-blind, Genotype-based Stratification Study to Explore the Pharmacokinetics and Pharmacodynamics of Amitriptyline According to CYP2D6 and CYP2C19 Polymorphisms in Healthy Korean Male Adult Subjects

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: Amitriptyline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteer, age 19 45 years The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 28 kg/m2 Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial. Voluntarily signed the informed consent form Exclusion Criteria: Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study History of relevant drug allergies or clinically significant hypersensitivity reaction. Smoked more than 10 cigarettes a day for past 3 months Not eligible due to other reasons including laboratory results

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amitriptyline<br>Single oral dose of amitriptyline, 25 mg | Drug: Amitriptyline<br>* Single oral dosing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under curve (AUC) of Amitriptyline, 10-Hydroxy-amitriptyline, Nortriptyline, and 10-Hydroxy-nortriptyline |  | 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hour | 
| Maximum concentration (Cmax) of Amitriptyline, 10-Hydroxy-amitriptyline, Nortriptyline, and 10-Hydroxy-nortriptyline |  | 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
amitriptyline, cyp2d6, cyp2c19
Lung Cancer Location: a Repository

Study Overview
=================
Brief Summary
-----------------
The purpose of this repository is to prospectively examine subjects with known or suspected lung cancer to determine the extent of mediastinal lymph node involvement with respect to primary lung cancer location. The data collected in this repository may be used to influence our current standard of care and streamline indications for EUS.

Official Title
-----------------
Lung Cancer Location: A Prospective Repository

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects undergoing EUS evaluation of a mediastinal mass, or suspected/known lung cancer Subjects with a prior history of lung cancer Subjects referred to thoracic surgery for evaluation of a suspected/known lung cancer Exclusion Criteria: Altered mental status that would prohibit the giving and understanding of informed consent Dementia Psychiatric illness that would preclude adequate compliance with communication for this protocol Prisoners

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 |
| --- | --- |
| surgery<br>those subjects who went to surgery to treat their lung cancer | |
| no surgery<br>those subjects who did not go to surgery for their lung cancer | |
| NSCLC<br>subjects with NSCLC | |
| Small cell lung cancer<br>those with small cell lung cancer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| examine subjects with known or suspected lung cancer to determine the extent of mediastinal lymph node involvement with respect to primary lung cancer location |  | ongoing-database |
Shalamar Institute of Health Sciences

Study Overview
=================
Brief Summary
-----------------
Effect of Didactic intervention regarding Dietary Approach to Stop Hypertension (DASH) on Hypertensive Patients Blood Pressure, Knowledge and Attitude at a Tertiary Hospital of Lahore

Detailed Description
-----------------
Objective: To explore the effect of didactic intervention regarding dietary approach to stop hypertension (DASH) on hypertensive patients blood pressure, knowledge and attitude. Study Design: Randomized controlled trial Place and Duration of Study: Punjab Institute of Cardiology (PIC) Lahore. From June 2018 to Oct 2018. Methodology: Seventy volunteers aged 20-60 years attending regularly outpatient department at Punjab institute of cardiology Lahore, with systolic > 130 mm hg, diastolic > 80 mm hg were selected and assigned into 2 groups, i.e. Intervention and control, by simple random lottery method. For twelve weeks, only intervention group were given DASH education. Both groups were checked for DASH knowledge, attitude, and systolic diastolic blood pressure, before and after education session. Pre-tested questionnaire was used for demographic, attitude and knowledge data collection.

Official Title
-----------------
Shalamar Institute of Health Sciences

Conditions
-----------------
Effect of Didactic Intervention Regarding (DASH) on Hypertension

Intervention / Treatment
-----------------
* Other: DASH Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertensive patient aged 20-60 years attending regularly at Punjab institute of cardiology outpatient department Lahore systolic > 130 mm hg diastolic > 80 mm hg. Exclusion Criteria: Less than 20 years age patient diagnosed with secondary hypertension any mental and physical ailment that may interfere the intervention like deafness and blindness.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>For twelve weeks, only intervention group were given DASH education | Other: DASH Education<br>* DASH health education about general knowledge of DASH diet Plan and lifestyle modification<br>|
| No Intervention: Controlled<br>Controlled group not received DASH education | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-tested questionnaire was used | 10 knowledge questions were asked with minimum score 0 and maximum 10. Attitude assessment consisted of 4 questions and score range was 0-4. | 1 month |
Validation and Standardisation of a Pool of Simplified Evaluation Aimed to the Diagnoses of Aphasic Disorders and Adapted to the Patients Suffering an Acute Phase of Stroke

Study Overview
=================
Brief Summary
-----------------
Every year in France, from 100 000 to 145 000 people are affected by a stroke. 75% patients survived with aftereffects, in particular aphasic disorders. A sketch of a new tool called BESTA aiming to a rapid handover to the acute phase post stroke had been worked out. After a meeting, 13 multidisciplinary experts have discussed, adjusted and a new complete tool (BESTA) had been created in order to evaluate the different states of aphasia. The goal of this study is the validation and the standardization of this new BESTA tool.

Official Title
-----------------
Validation and Standardisation of a Pool of Simplified Evaluation Aimed to the Diagnoses of Aphasic Disorders and Adapted to the Patients Suffering an Acute Phase of Stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: BESTA scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with stroke: Every patient over 18, admitted among neuro-vascular unit, native french speaker, the level of vigilance is satisfactory in order to allow a speech therapy test. Healthy Volunteers: Every volunteers over 18, without any medical history of a stroke or any speech disorders, native french speaker. Exclusion Criteria: Patients with stroke and Healthy Volunteers : dementia disease psychiatric condition non-equipped deafness pregnant woman patient with medical histories of stroke

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 |
| --- | --- |
| BESTA scale<br>BESTA scale is administered at T0, T1 (3 months) and T2 (1 year) | Other: BESTA scale<br>* BESTA scale is administrated at T0, T1 and T2.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| validity of concomitant criterion at T0 versus LAST | T0: the gold standard was determined by the expert group is the LAST screening tool. The tool to be evaluated is the BESTA at T0. However, as written expression is not evaluated in the LAST, only the dimensions and Oral Expression Listening Comprehension of BESTA may actually be faced with LAST scale. | 1 day |
Discontinuation for Oral Anticoagulants in Patients With Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the discontinuation rates for vitamin K antagonists and for direct oral anticoagulants during their first year

Detailed Description
-----------------
The purpose of this study is to compare the discontinuation rates for vitamin K antagonists and for direct oral anticoagulants during their first year of use after their initiation during hospitalization in patients covered by our health insurance plan.

Official Title
-----------------
Discontinuation for Oral Anticoagulants During the First Year of Use in Patients With Atrial Fibrillation Covered by a Medical Insurance

Conditions
-----------------
Auricular Fibrillation, Anticoagulant Drugs

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient older than 18 years of age covered by our Health Care Insurance Plan. Indication for oral anticoagulation with an expected duration of use of no less than 1 year. Exclusion Criteria: Refusal to take part. Use of oral anticoagulants within 6 months prior to admission. Presence of mechanical prosthetic valve. Chronic renal failure with creatinine clearance <30 mL/min (estimated using the MDRD formula).

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 |
| --- | --- |
| DOAC<br>Direct oral anticoagulant | |
| OAC<br>Vitamin K anticoagulant | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anticoagulant Discontinuation Rate | Anticoagulant Discontinuation Rate | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discontinuation Predictors | Discontinuation Predictors | One year |
Undiagnosed Hepatitis C Infection in an Urban Hospital

Study Overview
=================
Brief Summary
-----------------
The Centers for Disease Control and Prevention estimates that there are approximately 3.2 million people in the United States infected with hepatitis C and a significant percentage of these patients are unaware of their diagnosis. This study will attempt to determine the point prevalence of undiagnosed hepatitis C infection in an urban hospital population. All patients admitted to the hospital on two separate days will have hepatitis C testing done on leftover serum and plasma that was collected as part of routine inpatient lab work. Our primary goal is to determine the number of undiagnosed hepatitis C infected patients in our hospitalized population. We will also compare these rates to specific demographic characteristics, such as age, race, gender, zip code and type of insurance to see if any associations exist between these demographics and undiagnosed hepatitis C infection.

Detailed Description
-----------------
De-identified study of Hepatitis C infection point prevalence in the inpatient setting of an inner city hospital.

Official Title
-----------------
Incidence of Undiagnosed Hepatitis C Infection in an Urban Hospital

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Other: observation only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient admitted to Temple University Hospital on either of the study dates Exclusion Criteria: Patients admitted on both study dates will only be counted once

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 |
| --- | --- |
| Hospitalized Patients<br>Observation only. All patients admitted to Temple University Hospital on the study day. Observational only, no intervention. | Other: observation only<br>* This is an observational only, nonintervention study. There will be no patient contact. This was a de-identified point prevalence study of hepatitis C infection in hospitalized patients in an inner city hospital.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Point Prevalence of Hepatitis C Infection | The point prevalence of hepatitis C infection in our hospitalized patients will be measured on a single day. All leftover plasma/serum samples will be de-identified and tested for hepatitis C antibody and if antibody positive will be tested for hepatitis C polymerase chain reaction. Results reported as percentage of subjects who are viremic. | Single 24 hour period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C
Post Market Clinical Follow-Up Study of Excia T® Hip Prosthesis

Study Overview
=================
Brief Summary
-----------------
Clinical and radiological 10 year results of Excia T® Hip Stem

Official Title
-----------------
Post Market Clinical Follow-Up Study of Excia T® Hip Prosthesis

Conditions
-----------------
Hip Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient gave written informed consent age ≥ 18 years Exclusion Criteria: pregnancy

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 |
| --- | --- |
| Excia T®<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival Rate of the Implant | Kaplan-Meier Survival Rate up to 10 years | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip disability and Osteoarthritis Outcome Score (HOOS) | Documentation of clinical outcome with HOOS Score | preoperatively, intraoperatively + discharge, after 3 and 12 months 3, 5 and 10 years | 
| Change of functional outcome over follow-up period (Harris Hip Score (HHS)) | The Harris Hip Score (HHS) is one of the most used scores in total hip arthroplasty, mainly combining range of motion questions with questions regarding daily life activities. | at discharge, after 3 and 12 months 3, 5 and 10 years | 
| Pain Assessment | Pain will be measured with a Visual Analogue Scale (VAS), at rest and when walking on flat ground. The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patients are asked to mark their current pain level on the line. | at 6 examinations during follow-up (discharge, after 3 and 12 months and 3, 5, and 10 years) | 
| Shaftposition ap and lateral | Radiological documentation of shaftposition in ap and lateral view discharge, after 3 and 12 months and 3, 5, and 10 years | 10 years | 
| Stress Shielding | Radiological documentation of stress shielding after 3 and 12 months and 3, 5, and 10 years | 10 years | 
| Hypertrophies | Radiological documentation of hypertrophies after 3 and 12 months and 3, 5, and 10 years | 10 years |
Comparison of Safety and Efficacy of Two Different Drug Eluting Stents Implanted Into Saphenous Vein Grafts

Study Overview
=================
Brief Summary
-----------------
Drug eluting stents significantly reduced the rate of in-stent restenosis in coronary arteries. There are several kinds of DES i.e. eluting the drug either from stable or biodegradable polymer. The type of the polymer may impact the clinical outcome. The aim of our study was to compare safety and efficacy of implantation of two different types of stents eluting paclitaxel from stable vs biodegradable polymer (TAXUS stent vs LUC-CHOPIN stent) into coronary artery by-pass graft.

Official Title
-----------------
Comparison of Safety and Efficacy of Drug Eluting Stents : TAXUS (Boston Scientific) vs. LUC-Chopin (Balton, Poland) Implanted Into Saphenous Vein Grafts. Study With Serial Intravascular Ultrasounds.

Conditions
-----------------
Stenosis in Saphenous Vein Graft, Drug Eluting Stent

Intervention / Treatment
-----------------
* Device: Taxus stent implantation
* Device: Luc-Chopin stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Atherosclerotic lesion in saphenous vein grafts causing angiographic stenosis ≥70% Stable coronary artery disease or non ST segment elevation acute coronary syndrome Reference segment diameter in range of 2.5-4.5mm Exclusion Criteria: Cardiogenic shock Contraindications to prolonged dual antiplatelet therapy Female of child birth potential unless on effective contraception Other medical condition that may limit survival

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T<br>Implantation of Taxus stent into saphenous vein graft | Device: Taxus stent implantation<br>* Patients will be treated with implantation of Taxus stent<br>|
| Experimental: C<br>Implantation of Luc-Chopin stent into saphenous vein graft | Device: Luc-Chopin stent<br>* Patients will be treated will implantation of Luc-Chopin stent<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neointima hyperplasia volume by Intravascular Ultrasound |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 5 years | 
| Cardiovascular mortality |  | 5 years | 
| Stent thrombosis |  | 5 years | 
| Target lesion revascularization |  | 5 years | 
| Angiographic late loss |  | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
saphenous vein graft, TAXUS stent, Chopin stent
A Study to Measure the Effect of Tolterodine Extended Release on the Thickness of the Bladder Wall in Patients With Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
The main aim of the study is to investigate whether taking Tolterodine for overactive bladder symptoms can reduce the thickness of the bladder wall, as measured by intra-vaginal ultrasound. This will help doctors to understand whether there is a link between changes in the thickness of the bladder wall and progression of symptoms.

Official Title
-----------------
A Multi-centre, Randomised, Placebo Controlled, Double Blind, Parallel Group Study in Female Patients to Evaluate Whether Tolterodine ER Can Reverse the Increased Bladder Wall Thickness in Patients With Overactive Bladder.

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Drug: Tolterodine ER
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptoms of overactive bladder (described as urinary urgency, with or without urge incontinence, usually with frequency and nocturia for more than 6 months Bladder wall thickness of 5mm or more Exclusion Criteria: Treatment in the previous four weeks with an anticholinergic drug or any drug for the treatment of overactive bladder. Significant stress incontinence - Urinary tract infection or a history of intermittent urinary tract infections (more than four episodes in the last two years). Conditions considered significant by the investigator (e.g. cystocoele, significant bladder prolapse, bladder stone, indwelling catheter etc)

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tolterodine ER|nan|
|Drug: Placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The main outcome will be the change in bladder wall thickness, as measured by intra-vaginal ultrasound from baseline to week 12. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes are the change in bladder wall thickness, as measured by intra-vaginal ultrasound from baseline to week 24 |  |  |