linjc16/ctgov huggingface dataset:
Influence of SLCO2B1 Polymorphism on the PK of Voriconazole in CYP2C19 PM

Study Overview
=================
Brief Summary
-----------------
A clinical trail to investigate the influence of SLCO2B1 polymorphism on the pharmacokinetic characteristics of voriconazole in CYP2C19 poor metabolizers

Official Title
-----------------
A Clinical Trail to Investigate the Influence of SLCO2B1 Polymorphism on the Pharmacokinetic Characteristics of Voriconazole in CYP2C19 Poor Metabolizers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Vfend (voriconazole) intravenous infusion
* Drug: Vfend (voriconazole) tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteer who is a CYP2C19 Poor metabolizer with rs3781727 SNP wild or variant genotype Exclusion Criteria: History of clinically significant respiratory, cardiovascular, renal, hepatic, hematologic, neurological disorder

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SLCO2B1 wild type<br>Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h (Day 1) - washout period - Vfend (voriconazole) 200 mg tablet once (Day 8) | Drug: Vfend (voriconazole) intravenous infusion<br>* Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h<br>* Other names: IV;Drug: Vfend (voriconazole) tablet<br>* Vfend (voriconazole) 200 mg tablet once<br>* Other names: Oral;|
| Experimental: SLCO2B1 variant<br>Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h (Day 1) - washout period - Vfend (voriconazole) 200 mg tablet once (Day 8) | Drug: Vfend (voriconazole) intravenous infusion<br>* Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h<br>* Other names: IV;Drug: Vfend (voriconazole) tablet<br>* Vfend (voriconazole) 200 mg tablet once<br>* Other names: Oral;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic outcome - Maximum plasma concentration (Cmax) |  | predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose | 
| Pharmacokinetic outcome - Area under the plasma concentration versus time curve (AUC) |  | predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose |
Unilateral Blindness/ Unilateral Deafness-relation to Neck Pain

Study Overview
=================
Brief Summary
-----------------
Neck pain is a common complaint in the general population affecting 10-15% of the general population. females more than men. Known risk factors are: Trauma, Repetitive lifting of heavy objects at work, driving vibrating vehicles, frequents diving from boards and smoking. No study dealt with the possible role of unilateral loss of vision or hearing as a risk factor for the development of neck pain. Intuitively, one might suspect that unilateral blindness or deafness will lead to a tilted position of the head, in order to cover a better visual/audio field. This position, in time, might lead to the development of neck pain. Our hypothesis is that patients with unilateral blindness/deafness will suffer from neck pain more frequently than the general population.

Official Title
-----------------
Unilateral Blindness/ Unilateral Deafness-relation to Neck Pain

Conditions
-----------------
Neck Pain, Unilateral Blindness, Unilateral Deafness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Men and women suffering from unilateral blindness or deafness Men and women visiting the ophthalmology or ENT clinics (general population) for reasons other than unilateral blindness/deafness and agreeing to participate in the study. Over 18 years of age Signed informed consent Exclusion criteria: Subjects suffering from neck pain as a result of fractures, infection, or metastatic disease. Inability to understand or fill out the questionnaire/informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 65 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 |
| --- | --- | --- |
| neck pain |  | two weeks |
Health Benefits of Chronic vs. Acute Exercise in Overweight Adults

Study Overview
=================
Brief Summary
-----------------
Compare the effects of single session of exercise vs. chronic exercise training on key risk factors associated with Metabolic Syndrome (e.g., glucose tolerance, blood lipid profile, and blood pressure) in overweight adults.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index: 27-34 kg/m2; Regular exercisers(≥4 days/wk of aerobic exercise; 30-60min/session at moderate and vigorous intensities); Non-exercisers (no regularly planned exercise/physical activity); Women must have regularly occurring menses and must be premenopausal. Exclusion Criteria: Pregnant or lactating; Evidence/history of cardiovascular or metabolic disease; Currently taking medications known to affect lipid or glucose metabolism.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Exercise Session<br>Subjects will exercise on a treadmill for 1 hour at moderate intensity (i.e., 90% of the exercise intensity found to elicit their ventilatory threshold during the preliminary testing, which is equivalent to approximately 60% of their maximal predicted heart rate). | Other: Exercise<br>* Subjects will exercise on a treadmill for 1 hour at moderate intensity (i.e., 90% of the exercise intensity found to elicit their ventilatory threshold during the preliminary testing, which is equivalent to approximately 60% of their maximal predicted heart rate).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oral glucose tolerance test |  | 2 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting Metabolic Rate |  | 20-30 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insulin sensitivity, exercise
Beta-Cell Function After Near-Normalisation of Blood Glucose

Study Overview
=================
Brief Summary
-----------------
The incretin effect is attenuated in patients with type 2 diabetes mellitus partly due to impaired potentiation of beta-cell responsiveness to glucose by glucose dependent insulinotropic polypeptide and glucagon-like peptide-1 respectively. The aim of the present study was to investigate whether 4 weeks of near-normalization of blood glucose could improve the insulin responses to GIP and GLP-1 in patients with type 2 diabetes.

Official Title
-----------------
Four Weeks of Near Normalisation of Blood Glucose Improves the Insulin Response to GLP-1 and GIP in Patients With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: glucagon-like peptide-1,
* Drug: glucose dependent insulinotropic polypeptide
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-70 years Type 2 diabetes diagnosed after 30 years of age BMI > 25 Exclusion Criteria: Severe complications to diabetes Abnormal liver and kidney function Haemoglobin below the lower limit Macroalbuminuria Systemic disease Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLP-1<br> | Drug: glucagon-like peptide-1,<br>* GLP-1:continuous infusion of ½ pmol/kg/min for a total time of 120 minutes.<br>|
| Experimental: GIP<br> | Drug: glucose dependent insulinotropic polypeptide<br>* continuous infusion of GIP (1½ pmol/kg/min) for 120 min.<br>|
| Placebo Comparator: saline<br> | Drug: Saline<br>* continuous infusion of Saline for 120 min<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2.phase insulin response measured as incremental area under the curve from 10-120 minutes |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2.phase insulin response measured as incremental area under the curve from 10-120 minutes, after 4 weeks of insulin treatment |  | 2 hours |
Prevention of Coronary Heart Disease in Morbidly Obese Patients

Study Overview
=================
Brief Summary
-----------------
The changes in risks of developing coronary heart disease in patients with morbid obesity after different weight loss interventions have not been extensively studied. The primary objective of this study is to investigate whether an intensive lifestyle intervention program in a tertiary care clinic (Spesialsykehuset for Rehabilitering) is comparable with a 7-week low-energy-diet followed by bariatric surgery in decreasing the risk of cardiovascular disease in these patients.

Detailed Description
-----------------
Patients matching the eligibility criteria were divided into two groups (not randomized). One group underwent a 7 weeks Low-Energy-Diet before bariatric surgery, the other group participated in an intensive lifestyle intervention program for 3 months. Data on arterial stiffness, body weight, body composition, blood pressure, blood samples, vital parameters are registered in the both groups at baseline, 7 weeks and after 1 year.

Official Title
-----------------
Prevention of Coronary Heart Disease in Morbidly Obese Patients. Lifestyle Intervention, Low Energy Diet or Bariatric Surgery.

Conditions
-----------------
Morbid Obesity, Hypertension, Type 2 DM, Obstructive Sleep Apnea, Osteoarthrosis

Intervention / Treatment
-----------------
* Procedure: Bariatric Surgery
* Behavioral: Conservative Treatment:


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Morbidly Obese patients with BMI > 40, or BMI > 35 with comorbidity such as Hypertension, Obstructive Sleep Apnea, Weight Related Osteoarthrosis, Type 2 DM. Exclusion Criteria: Participation in other weight loss program the last 12 months. Serious psychiatric conditions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lifestyle or bariatric surgery<br>Morbid Obesity with BMI >= 40 kg/m2 or BMI >= 35 with Comorbidity | Procedure: Bariatric Surgery<br>* Bariatric Surgery Treatment: Duodenal Switch, Gastric Sleeve or Gastric bypass.<br>Behavioral: Conservative Treatment:<br>* Intensive Lifestyle Intervention Program<br>* Other names: Conservative;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial stiffness | Pulse wave velocity and augmentation index | 7 weeks and 1 year | 
| Cardiovascular risk factors | Several biomarkers will be examined | 7 weeks and 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arterial stiffness, PulseWave velocity, Body composition, Bioimpedance, Morbid Obesity, APO A, APO B, Framingham risk score, Prevention of Coronary Heart Disease, Lifestyle Intervention, Bariatric Surgery, Low Energy Diet
Automated Ultrasound Cardiac Guidance Tool

Study Overview
=================
Brief Summary
-----------------
This research examines echocardiography images taken from cardiac patients in relation to the guidance tool developed

Detailed Description
-----------------
The study is an open label, single arm prospective study. This goal of the study is to learn about echocardiography images in relation to the developed guidance tool software in cardiac patients population. Participants will undergo one session of transthoracic echocardiography exam. The ultrasound will be performed by a sonographer for images acquiring purposes

Official Title
-----------------
Optimization of an Ultrasound Cardiac Guidance Tool

Conditions
-----------------
Ultrasound Imaging

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females, aged 18 years and older Subject willing and able to give written informed consent Exclusion Criteria: Emergency (non-elective) admission within 24 h prior to participating in the study Female subjects who are pregnant (women of childbearing potential will provide a statement that they are not pregnant incorporated in the ICF Unable to lie as required in all the classic positions for standard TTE exam: supine on back / left decubitus Subjects who currently participate in a clinical trial, involving interventional cardiac devices. Subjects who have prior Echo exam with description of Low/Poor quality exam in the echo report. Subjects with BMI above 40. Subjects experiencing a known or suspected acute cardiac event. Subjects with severe chest wall deformity as per previous medical records and physical examination. Subjects who have undergone pneumonectomy. Subjects whose anatomy does not lend itself to yield diagnosable standard echocardiography clips (i.e., situs inversus with dextrocardia, single ventricle anatomy due to congenital heart disease, etc.).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 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 |
| --- | --- | --- |
| Acquisition of transthoracic echocardiography media from up to 200 subjects | Several echocardiography views will be acquired from the participants, with in several acoustic windows and views | up to 5 year |
Comparison of Absorbability Between Calcium Tablet and Calcium Ion Water

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the absorbability of calcium tablet and calcium ion water.

Official Title
-----------------
A Randomized, Double-blind, Crossover Study to Compare the Absorbability Between Calcium Tablet and Calcium Ion Water

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Calcium tablet
* Dietary Supplement: Calcium ion water (250mg)
* Dietary Supplement: Calcium ion water (125mg)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal females Exclusion Criteria: Taking medicines or functional food that affect serum calcium levels Diseases that affect bone Renal or hepatic dysfunction Heart disease Participation in any clinical trial within 90 days of the commencement of the trial

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Calcium tablet<br>250 mg calcium/tablet | Dietary Supplement: Calcium tablet<br> <br> |
| Experimental: Calcium ion water (250mg)<br>250 mg calcium in 200 ml water | Dietary Supplement: Calcium ion water (250mg)<br> <br> |
| Experimental: Calcium ion water (125mg)<br>125 mg calcium in 200 ml water | Dietary Supplement: Calcium ion water (125mg)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum calcium profile (including AUC, Cmax, and Tmax) |  | Overall 2 hours |
The Effect of Virtual Reality Exercises on Balance in Patients With Osteoporosis

Study Overview
=================
Brief Summary
-----------------
Osteoporosis is a systemic disease characterized by low bone mass and increased bone fragility and increased fracture likelihood as a result of deterioration of the bone tissue microstructure.One of the important conditions determining the fracture risk in osteoporosis patients is fall. Balance exercises are perform to reduce the risk of falling.Virtual reality games are used in balance studies in many rehabilitation areas. The aim of this study is to investigate the effect of virtual reality exercises on balance.

Detailed Description
-----------------
Osteoporosis is a systemic disease characterized by low bone mass and increased bone fragility and increased fracture likelihood as a result of deterioration of the bone tissue microstructure.One of the important conditions determining the fracture risk in osteoporosis patients is fall. Balance exercises are perform to reduce the risk of falling.Virtual reality games are used in balance studies in many rehabilitation areas. The aim of this study is to investigate the effect of virtual reality exercises on balance patients with osteoporozis.

Official Title
-----------------
The Effect of Virtual Reality Exercises on Balance in Patients With Osteoporosis

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Other: Virtual Reality


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with primary osteoporosis Exclusion Criteria: history of inflammatory rheumatic disease history of vestibular and cerebellar disease diseases affecting the central and peripheral nervous system (Parkinson's, stroke, ataxia, dementia, multiple sclerosis, peripheral neuropathy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Realty<br>Microsoft Xbox Kinect® was used for virtual reality exercises | Other: Virtual Reality<br>* Microsoft Xbox Kinect® was used for virtual reality exercises<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static balance index | Postural balance was measured using the Biodex Balance System (BBS) (Biodex Medical Systems, Shirley, NY), a movable balance platform that provides up to 20 of surface tilt in a 360 range of motion. The platform is interfaced with computer software (Biodex, Version 3.1, Biodex Medical Systems) that enables the device to serve as an objective assessment of balance | 4th week |
Adding Insulin to IVF Culture Media Significantly Improve Outcome

Study Overview
=================
Brief Summary
-----------------
Add insulin to a single step culture media for IVF embryo culture from day 0 to day 5/6 of In Vitro culture and detect the the effect upon embryo quality and implantation potential.

Detailed Description
-----------------
The IVF culture media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding insulin as a hormon and growth factor might improve embryo development in vitro so we decide to design a trial to compare the embryogenesis by sibling Oocytes of the same patient between to arm of the same culture media and yhe same culture condition but with one arm with insulin and the other is traditional one and closely monitor the outcome within the 2 arms abd record the results

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: Adding insulin to In Vitro culture media


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal responder PCOS Tubal factor infertility mild asthenozoospermia Exclusion Criteria: patient over 40

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: In Vitro culture media with insulin<br>We will add insulin to the single step culture media to monitor the embryogenesis | Other: Adding insulin to In Vitro culture media<br>* We will add insulin for in vitro culture of human embryos<br>|
| No Intervention: In Vitro culture media without insulin m<br>The embryos will be cultured in the media without insulin and compare this arm as the control arm with the interventional one. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical Pregnancy rate ( % ) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blastocyst rate ( % ) |  | 6 months | 
| Blastocyst quality rate ( % ) |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
In Vitro, embryo quality, Intracytoplasmic sperm injection