linjc16/ctgov huggingface dataset:
Health Status and Cardiovascular Stress of Veteran Soccer Players

Study Overview
=================
Brief Summary
-----------------
This study shall provide missing descriptive data on health status of veteran players and potential preventive effects of soccer at an age of 40 to 60 years. The investigation represents a cross-sectional examination of cardiovascular parameters and metabolic stress induced by training and competition. Additionally, orthopedic and other medical risks are to be revealed, and options should be developed to minimize these risks, e.g. by preventive measures included in training or rule modifications.

Detailed Description
-----------------
Facing the demographic trends in Western societies there is an expected increase in interest in soccer for males between 40 and 60 years. Positive effects of such an activity on health can be suspected based on some studies and analogous conclusions. However, no sufficient database is available yet. Moreover, the range of cardiovascular risk factors or pre-existing diseases for this specific population is not known. This study shall provide missing descriptive data on health status of veteran players and potential preventive effects of soccer at an age of 40 to 60 years. The investigation represents a cross-sectional examination of cardiovascular parameters and metabolic stress induced by training and competition. Additionally, orthopedic and other medical risks are to be revealed, and options should be developed to minimize these risks, e.g. by preventive measures included in training or rule modifications.

Official Title
-----------------
Health Status and Cardiovascular Stress of Veteran Soccer Players

Conditions
-----------------
Health Status, Stress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male veteran soccer players aged 40 years and older, who are member of a club veteran team Exclusion Criteria: Diseases or injuries which are contraindications for physical exercise

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| veteran soccer players from Saarland County, Germany<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive data from medical check up and physiological testing | The investigation represents a cross-sectional examination of cardiovascular parameters and metabolic stress induced by training and competition: resting ECG stress ECG blood sample VO2max visit of training and competition (including the measurement of heart rate and blood lactate) | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
soccer, prevention, veteran athletes, exercise, Cardiovascular
Monitoring Response to Antiplatelet Therapy

Study Overview
=================
Brief Summary
-----------------
Antiplatelet therapy plays a key role in the prevention of complications related to coronary angioplasty and stenting (PCI) including procedure related myocardial damage. Aspirin and clopidogrel are now universally prescribed in patients undergoing these procedures. However, loading and maintenance doses have not been established and variation in individual response is emerging. New tests to assess the effects of these drugs are being developed but have yet to be incorporated into routine clinical practice. We will assess the effects of aspirin and clopidogrel in a consecutive series of patients undergoing angioplasty using new assays which can be carried out at the bedside. We will compare the results with alternative laboratory based tests and look for an association between the results, peri-procedural myocardial necrosis and subsequent cardiovascular events.

Official Title
-----------------
Pilot Study Investigating the Use of a Variety of Assays to Detect Individual Response to Antiplatelet Therapy

Conditions
-----------------
Coronary Stenosis, Coronary Thrombosis, Angioplasty, Balloon

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18-80 undergoing intended PCI for conventional indications. Informed written consent. Exclusion Criteria: Administration of GPIIbIIIa therapy prior to PCI, Oral anticoagulation, ticlopidine, dipyridamole, NSAID therapy, Pregnancy, Troponin I >0.2mcg/l on day of procedure, Chest pain in the 24 hrs prior to PCI. Anaemia (Hb<10g/dl). Platelet Count <150 or >450 x10^9/l, Personal or family history of bleeding disorder.

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?
-----------------
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
-----------------
Aspirin, Clopidogrel, Balloon Angioplasty, Coronary Thrombosis
The Double Exposure Study: The Impact of Job Strain and Marital Cohesion on Blood Pressure

Study Overview
=================
Brief Summary
-----------------
Psychosocial and lifestyle stressors, such as job strain (JS) and marital factors have previously been associated with a sustained increase in blood pressure (BP). In a one-year longitudinal follow-up to the Baseline Double Exposure cohort study, we, the researchers at Sunnybrook and Women's College Health Sciences Centre, evaluated whether JS and marital cohesion continued to be associated with ambulatory blood pressure (ABP) in subjects enrolled with normal or untreated high BP.

Detailed Description
-----------------
Psychosocial and lifestyle stressors, such as job strain (JS) and marital factors have previously been associated with a sustained increase in blood pressure (BP). In a one-year longitudinal follow-up to the Baseline Double Exposure cohort study, we evaluated whether JS and marital cohesion continued to be associated with ambulatory blood pressure (ABP) in subjects enrolled with normal or untreated high BP.

Official Title
-----------------
The Impact of Job Strain and Marital Cohesion on Ambulatory Blood Pressure Over One Year: The Double Exposure Study

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Behavioral: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 40-65 Unmedicated for at least 6 months Living with spouse for at least 6 months Working for at least 6 months Exclusion Criteria: Working rotating or evening shifts

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Observational|nan|

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
-----------------
Hypertension; Job Strain; Marital Strain; Blood Pressure
Randomized Study of Tauroursodeoxycholic Acid in Prophylactic Therapy of Total Parenteral Nutrition Associated Cholestasis in Infants

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine whether infants treated with tauroursodeoxycholic acid (TUDCA) have a lower peak direct bilirubin, ALT, AST, glutamyltranspeptidase levels and a reduced duration of cholestasis compared to the nontreatment arm. II. Determine the significance of lower birth weight and longer duration of total parenteral nutrition (TPN) on increasing risk of TPN associated cholestasis and increasing benefit from TUDCA therapy. III. Determine whether TUDCA therapy leads to significant reduction in the appearance of biliary tract sludge and/or stone formation in these infants. IV. Determine whether TUDCA therapy leads to reduced urinary excretion of potentially hepatotoxic bile acids as compared to the untreated arm matched for birth weight and duration of TPN.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by birth weight. Patients are randomized in pairs by birth weight to receive either a placebo in arm I or tauroursodeoxycholic acid (TUDCA) in arm II. TUDCA is administered by mouth, nasogastric tube, or gastrostomy tube twice daily. After 2 weeks of therapy, a bile sample is obtained via a duodenal tube. An ultrasound examination of the liver and biliary tract is performed after 2 weeks and every 3 weeks thereafter until discontinuation of therapy or until presence of biliary tract sludge is noted on 2 consecutive examinations. Completion date provided represents the completion date of the grant per OOPD records

Conditions
-----------------
Cholestasis

Intervention / Treatment
-----------------
* Drug: tauroursodeoxycholic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Hospitalized infants who are anticipated to require total parenteral nutrition for greater than 2 weeks and have: Major gastrointestinal anomalies (gastroschisis, ruptured omphalocele) OR Resection (necrotizing enterocolitis, volvulus) No evidence of biliary tract abnormalities No evidence of other forms of cholestatic liver disease --Patient Characteristics-- Renal: No life threatening renal disease Cardiovascular: No life threatening cardiovascular disease Other: No multiple congenital abnormalities

Ages Eligible for Study
-----------------
Maximum Age: 20 Days

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: tauroursodeoxycholic acid|nan|

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
-----------------
cholestasis, gastrointestinal disorders, rare disease
A Worldwide Cancer Registry Enrolling Participants Profiled With a Next-Generation Sequencing Test

Study Overview
=================
Brief Summary
-----------------
WAYFIND-R is a registry that aims to capture high-quality real-world data linking next-generation sequencing, treatments and outcomes from cancer patients diagnosed with a solid tumour. The WAYFIND-R has three main overarching objectives: 1. To provide a platform to support the design and conduct of clinical and epidemiological research; 2. To develop an evidence-generation platform to better understand health outcomes and cancer care processes; and 3. To characterize the treatments and clinical course of solid tumor cancers in patients who have undergone NGS testing.

Official Title
-----------------
A Registry to Collect Characteristics and Outcomes From Patients With Solid Tumors Profiled With a Next-Generation Sequencing Test (WAYFIND-R)

Conditions
-----------------
Solid Tumours

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant is an adult (according to the age of majority as defined by local regulations) Participant is currently diagnosed with any type of solid tumour cancer, at any stage of the disease, at the enrollment date (informed consent date) Participant has undergone NGS testing, no longer than 3 months prior to the enrollment date, irrespective of the availability of test results Informed consent has been obtained from the participant or legally authorized representative, as per local regulations Exclusion Criteria: -Participant has a prior or current diagnosis of haematological malignancy

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 |
| --- | --- | --- |
| Overall Survival |  | From date of registry entry until death, for up to 5 years |
Safety and Pharmacokinetic Characteristics After Administration of HIP1503 and HGP1103 in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and pharmacokinetic characteristics after administration of HIP1503 and HGP1103 in healthy male volunteers.

Official Title
-----------------
A Randomized, Open-label, Single Dose, 2-way Crossover Study to Compare the Safety and Pharmacokinetic Characteristics After Administration of HIP1503 and HGP1103 in Healthy Male Volunteers

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Drug: HIP1503
* Drug: HGP1103


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers, age 19 to 45 years. The result of Body Mass Index(BMI) 17.5 kg/m2  30.5 kg/m2, body weight over 55kg. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing. Exclusion Criteria: Presence of medical history or a concurrent disease, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system. Medical history of Gastrointestinal Diseases that effects drug absorption (esophageal disease, chronic disease) or surgery( except appendectomy , herniolaparotomy) sit SBP > 140 mmHg, sit DBP > 90 mmHg Alcohol or Drug abuse within 1 year

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 |
| --- | --- |
| Experimental: sequence 1<br>HGP1103→HIP1503 | Drug: HIP1503<br> <br> * Other names: Solifenacin tartrate 10.66 mg;Drug: HGP1103<br> <br> * Other names: Solifenacin succinate 10 mg;|
| Experimental: Sequence 2<br>HIP1503→HGP1103 | Drug: HIP1503<br> <br> * Other names: Solifenacin tartrate 10.66 mg;Drug: HGP1103<br> <br> * Other names: Solifenacin succinate 10 mg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast |  | 0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14) | 
| Solifenacin Cmax |  | 0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solifenacin AUCinf |  | 0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14) | 
| Solifenacin Tmax |  | 0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14) | 
| Solifenacin t1/2 |  | 0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14) |
Dose Finding Confirmation of Atazanavir With Ritonavir and Efavirenz (ATV/RTV + EFV) in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the exposure of Atazanavir 400 mg with Ritonavir 100 mg and with Efavirenz 600 mg compared to Atazanavir 300 mg with 100 mg without Efavirenz in Healthy Subjects

Official Title
-----------------
Open-Label, Multiple Dose Study to Determine the Relative Bioavailability of Atazanavir (ATV) 400 mg Administered With Ritonavir (RTV) and Efavirenz (EFV) Compared to Atazanavir 300 mg Administered With Ritonavir Alone in Healthy Subjects

Conditions
-----------------
HIV Infections, Protease Inhibitor

Intervention / Treatment
-----------------
* Drug: Atazanavir Sulphate + Ritonavir
* Drug: Atazanavir Sulphate + Ritonavir + Efavirenz


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 18-30 Men and women who are not of childbearing potential, ages 18-50 years, inclusive Exclusion Criteria: History of seizures or other central nervous system disorders (including migraine headaches) history of diagnosed mental illness or suicidal tendencies positive screening for Hep B surface antigen Hep C antibody HIV-1, -2

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

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: Atazanavir Sulphate + Ritonavir<br>* Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 10 days.<br>* Other names: Reyataz;|
| Active Comparator: B<br> | Drug: Atazanavir Sulphate + Ritonavir + Efavirenz<br>* Capsules/Tablets, oral, ATV 400 mg + RTV 100 mg + EFV 600 mg, once daily, 14 days.<br>* Other names: Reyataz, Sustiva;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the comparability of atazanavir exposure when dosed in the evening as atazanavir 400 mg with ritonavir 100 mg and with efavirenz 600 mg relative to ATV 300 mg and RTV 100 mg alone in healthy subjects |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the PK of EFV when coadministered with ATV 400 mg and RTV 100 mg in the evening |  |  | 
| To assess the PK of RTV when dosed as ATV 400 mg with RTV 100 mg and with EFV 600 mg in the evening relative to ATV 300 mg with RTV 100 mg alone |  |  | 
| To assess the safety and tolerability of ATV and RTV alone and when coadministered with EFV in the evening in healthy subjects |  |  |
Improving Glare and Visual Comfort for Patients With Visual Impairment

Study Overview
=================
Brief Summary
-----------------
To assess the use of contact lenses with transitions technology to improve glare, light sensitivity and overall visual comfort in patients with visual impairment.

Detailed Description
-----------------
Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology can adapt to the amount of visible light in the environment, darkening the lenses in bright sunlight, and returning to regular tint in normal or dim environment. Purpose of this study is to assess whether individuals with visual impairment may benefit from these lenses to minimize glare, light sensitivity symptoms and improve the overall visual comfort.

Official Title
-----------------
Managing Visual Comfort and Function in Patients With Low Vision Using Acuvue Oasys

Conditions
-----------------
Photophobia, Visual Impairment, Low Vision

Intervention / Treatment
-----------------
* Device: Acuvue Oasys with Transitions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to give informed consent Able to speak and read English Experience glare and light sensitivity that impacts patient's daily living activities Have confirmed diagnosis of ocular condition including but not limited to Stargardt's, Cone dystrophy, Cone-rod dystrophy, Albinism, Retinitis Pigmentosa and Achromatopsia. Willing and able to wear the contact lenses as instructed Exclusion Criteria: Are pregnant, nursing or planning to become pregnant during the course of the study Have current/recent ocular infection, inflammation, surgery in the past 3 months that contraindicates contact lens wear

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>All participants will be fit with Acuvue Oasys with Transitions. | Device: Acuvue Oasys with Transitions<br>* soft contact lenses with darkening technology<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glare test | Measure visual acuity and contrast sensitivity with or without illumination source | Measure change from baseline at the 6 week follow-up visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Activities Questionnaire on Glare and Light sensitivity visual functions | Patient will rate 7 questions on scale ranges from 1-5, higher score indicates more symptoms related to glare and light sensitivity during daily living tasks. Max value 35 | Measure change from baseline at the 6 week follow-up visit |