linjc16/ctgov huggingface dataset:
Acclimatization Mechanisms During Ascent to 7500m

Study Overview
=================
Brief Summary
-----------------
The trial evaluates the role of ascent protocol on acute mountain sickness and cardio-respiratory physiology during an ascent to Muztagh Ata (7546m). Two groups of mountaineers ascend with different acclimatization time to the summit. The prevalence and severity of symptoms of acute mountain sickness are evaluated along with physiologic variables.

Official Title
-----------------
Acclimatization Mechanisms During Ascent to 7500m. Effects of Ascent Protocol on Acute Mountain Sickness and Cardiorespiratory Physiology

Conditions
-----------------
Acute Mountain Sickness

Intervention / Treatment
-----------------
* Behavioral: ascent protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, physically fit subject Mountaineering experience Exclusion Criteria: Any type of cardiac or respiratory disease Regular intake of any medication History of high altitude pulmonary oedema Severe acute mountain sickness at altitudes below 3500m or high altitude cerebral oedema.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>fast ascent | Behavioral: ascent protocol<br>* ascent protocol for the two groups has different acclimatization time<br>|
| Active Comparator: 2<br>slow ascent | Behavioral: ascent protocol<br>* ascent protocol for the two groups has different acclimatization time<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute mountain sickness |  | during ascent | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mountaineering success, oxygen saturation, breathing pattern |  | during ascent | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
altitude illness, hypoxia
Comparison of Inferior Oblique Muscle Recession and Myectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare muscle recession and myectomy on inferior oblique muscle overactivity.

Official Title
-----------------
Comparison of Inferior Oblique Muscle Recession and Myectomy

Conditions
-----------------
Inferior Oblique Muscle Overactivity

Intervention / Treatment
-----------------
* Procedure: Inferior Oblique Muscle Recession and Myectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overactivity of Inferior Oblique Muscle >= 2 Exclusion Criteria: Nystagmus History of vertical muscle operation Mechanical limitation Eye disease Paralysis
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 |
| --- | --- |
| Other: Inferior Oblique Muscle Recession and Myectomy<br> | Procedure: Inferior Oblique Muscle Recession and Myectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study of the Kinetics of a 13C-Cholesterol Infusate in Healthy Male Subjects (0000-108)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
This is a 2-part pilot study in healthy male subjects to evaluate plasma enrichment kinetics of [13C3,4]-cholesterol (Part I) and to assess the test-retest reproducibility (Part II) of Reverse Cholesterol Transport (RCT) measurements. The study will determine whether atom percent enrichment (% APE) at 18 hours can be extrapolated from the steady-state value and whether the mean difference in repeat Ra measurements is below is a prespecified level.

Official Title
-----------------
A Pilot Study to Evaluate the Plasma Enrichment Kinetics of a 13C-Cholesterol Infusate in Healthy Male Subjects

Conditions
-----------------
Dyslipidemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is male 18 to 45 years of age at screening Subject has a stable weight (± 2 kg) for more then 6 weeks prior to screening Exclusion Criteria: Subject has a history of ileal bypass, gastric bypass, or other significant condition associated with malabsorption Subject has an active or recent (<2 weeks) gastrointestinal condition (gastroenteritis, diarrhea, chronic constipation, irritable bowl syndrome, etc.) affecting bowel movements Subject has a known allergy to beans, peas, eggs or egg-derived products and/or soy or soy-derived products Subject has a history of plant sterol storage disease (sitosterolemia, cerebrotendinotic xanthomatosis) or a history of intolerance to plant sterols and/or plant sterol containing products Subject has a history of hepatic or gall bladder disease (including gallstones, cholecystectomy, etc.) Subject is currently taking psyllium, other fiber-based laxatives, phytosterol margarines, and/or over the counter (OTC) therapies that are known to affect serum lipids Subject has taken lipid-lowering agents within 6 weeks prior to screening Subject has previously been administered an intravenous infusion of [13C3,4]-cholesterol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| All Subjects<br>Healthy males | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| %APE (atom percent enrichment) for all study subjects in Part I at 18 hours |  | 18 hours | 
| Rate of appearance (Ra) of unlabeled cholesterol from the whole-body peripheral pool |  | Baseline and 4 weeks |
Impact of CYP2C19*17 on the Pharmacokinetics of Proguanil and Clopidogrel

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate if the genetic variant CYP2C19*17 affects the pharmacokinetics of proguanil and clopidogrel.

Official Title
-----------------
Impact of CYP2C19*17 on the Pharmacokinetics of Proguanil and Clopidogrel

Conditions
-----------------
CYP2C19 Genotypes

Intervention / Treatment
-----------------
* Drug: Proguanil
* Drug: Clopidogrel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Written consent Age 18-65 CYP2C19*1 and or CYP2C19*17 genotype. Exclusion Criteria: Daily medication Alcohol abuse Pregnancy Breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Period A: proguanil<br>Proguanil pharmacokinetics | Drug: Proguanil<br>* 2x350 mg Malarone followed by 3 days of blood- and urine sampling<br>|
| Active Comparator: Period B: clopidogrel<br>Clopidogrel pharmacokinetics | Drug: Clopidogrel<br>* 2x300 mg Plavix followed by 7 hours days of blood sampling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proguanil pharmacokinetics. Primary endpoint is cycloguanil formation clearance. | Based on blood- and urine-concentrations of proguanil and the metabolites cycloguanil and 4-chlorphenylbiguanid a comparison of the pharmacokinetic parameters (AUC, Cmax, Tmax, T1/2) between the three groups of genotypes (CYP2C19*1/*1, CYP2C19*1/*17 and CYP2C19*17/*17) will be made. | Hours after administration: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 10, 24, 31, 48, 55 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of the derivatised active clopidogrel metabolite. | Based on blood-concentrations of the derivatised active metabolite of clopidogrel a comparison of the pharmacokinetic parameters (AUC, Cmax, Tmax, T1/2) between the three groups of genotypes (CYP2C19*1/*1, CYP2C19*1/*17 and CYP2C19*17/*17) will be made. Secondly, a comparison of the platelet inhibitory of clopidogrel between the three groups of genotypes (CYP2C19*1/*1, CYP2C19*1/*17 and CYP2C19*17/*17) will be made using the VerifyNow® P2Y12 Test. | Hours after administration: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CYP2C19*17, Pharmacokinetics, Pharmacodynamics
Cell-free DNA: a Non-invasive Test for Assessing Embryo Quality

Study Overview
=================
Brief Summary
-----------------
In the present project we propose to deeply characterize nuclear and/or mitochondrial DNA in embryo culture medium, in order to investigate whether both cell-free nucleic acid types may provide additional, reliable, predictive parameters for embryo viability and implantation potential.

Official Title
-----------------
Cell-free DNA: a Non-invasive Test for Assessing Embryo Quality

Conditions
-----------------
DNA, Culture Media

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: We will enroll in the study only embryos obtained from fresh gametes. It is to note that we currently transfer more than one embryo (with a maximum of 3, according to patient's age) and we will follow such criteria alongside the project. Consequently, we will take into consideration this aspect in correlating DNA parameters with embryo's outcome. Exclusion Criteria: We will exclude cryopreserved embryos, in order to avoid potential biases due to cooling/defrosting procedures.

Ages Eligible for Study
-----------------
Minimum Age: 2 Days
Maximum Age: 7 Days

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 |
| --- | --- | --- |
| Isolation and characterization of nuclear and/or mitocondrial DNA into embryo culture medium |  | Month 6 of the project | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of high quality embryos according to molecular profiling of cell-free DNA released into culture medium. |  | Month 12 of the project | 
| Publication of scientific reports. |  | Month 12 of the project | 
| Dissemination of results by participating at national and international meetings, workshops and specific courses. |  | Months 3-12 of the project | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Human embryo, Culture media, Cell-free DNA, In vitro fertilization, Infertility
Defining the Extent and Grade of Prostate Cancer Using Dynamic Contrast Enhanced Diffusion Weighted and BOLD MRI

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the ability of functional MRI techniques to detect, measure and locate intra-prostatic cancer.

Detailed Description
-----------------
The purpose of this study is to determine the ability of functional MRI techniques [High Resolution Dynamic Contrast Enhanced MRI (HR-DCE-MRI), diffusion weighted MRI (DWI) and BOLD MRI] to detect, measure and locate intra-prostatic cancer. 70 patients undergoing MRI for staging of prostate cancer prior to radical prostatectomy will be studied. Results of MRI obtained prior to surgery will be correlated with pathologic specimens to determine MRI accuracy.

Official Title
-----------------
Defining the Extent and Grade of Prostate Cancer Using Dynamic Contrast Enhanced Diffusion Weighted and BOLD MRI

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: MRI Prostate


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients will be recruited from the University Health Network (UHN). Eligible patients will be undergoing radical prostatectomy for prostate cancer at UHN. Patients with a contraindication to MRI or MRI contrast agents, claustrophobia, renal failure, allergy to MRI contrast agents, or prior hormonal therapy or radiation therapy for prostate cancer, a biopsy within 3 weeks of the surgical date or active prostatitis will be excluded.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MRI - pathology<br> | Procedure: MRI Prostate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent and Grade of Prostate Cancer Using MRI | Before undergoing surgery, all patients were examined with MR imaging | Imaging followed by pathology analysis |
Evaluation of the Prevalence of anomalIes of Glucose Metabolism in Patients Undergoing a Coronary Artery Bypass Graft (CABG)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the prevalence of diabetes and non-diabetic glucose metabolism anomalies (glucose intolerance, non-diabetic fasting hyperglycaemia in patients about to undergo coronary artery bypass grafting (CABG). In addition, the effect of these anomalies on post CABG morbi/mortality in the short term will be evaluated.

Official Title
-----------------
Evaluation of the Prevalence of anomalIes of Glucose Metabolism in Patients Undergoing a Coronary Artery Bypass Graft, Consequences for Morbi/Mortality in the Short and Medium Term

Conditions
-----------------
Anomalies in Glucose Metabolism, Coronary Artery Bypass Graft

Intervention / Treatment
-----------------
* Other: Collection of biological data
* Other: Collection of clinical data


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: persons who have provided oral consent patients about to undergo coronary artery bypass grafting age >18 years Exclusion Criteria: persons without national health insurance cover Adults under guardianship Pregnant or breast-feeding women

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 |
| --- | --- |
| CAD patients<br> | Other: Collection of biological data<br> <br> Other: Collection of clinical data<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of glucose anomalies (non-diabetic fasting hyperglycaemia, glucose intolerance, diabetes) in CAD patients about to undergo coronary artery bypass grafting. |  | Change from inclusion to week 2 and up to month 3 |
Ultra-rapid Opiate Detoxification Using Deep Sedation and Prior Oral Buprenorphine Preparation.

Study Overview
=================
Brief Summary
-----------------
The methods of detoxification under general anesthesia have been criticized because of limited data on safety and long-term follow-up. Premedication with buprenorphine has been advocated to improve safety. In current study we want to evaluate the importance of buprenorphine preparation in rapid opioid detoxification process, under general anesthesia.

Conditions
-----------------
Opioid Addiction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Opioid addiction Exclusion Criteria: Age < 18 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 |
| --- | --- |
| without buprenorphine preparation<br> | |
| with buprenorphine preparation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand the pharmacokinetics of sirolimus tablets in different regimens in newly renal transplant patients, and the effect of dosage form conversion on the concentration of sirolimus in stable renal transplant patients. So that we can design a better tacrolimus or cyclosporine/sirolimus/steroid dose regimen for Taiwanese.

Detailed Description
-----------------
Sirolimus tablets will be available more than one year after the launch of sirolimus solution. Most patients on sirolimus solution will use sirolimus tablet instead. The purpose of this study is to understand the pharmacokinetics of sirolimus tablets in different regimens in newly renal transplant patients, and the effect of dosage form conversion on the concentration of sirolimus in stable renal transplant patients. So that we can design a better tacrolimus or cyclosporine/sirolimus/steroid dose regimen for Taiwanese.

Official Title
-----------------
Effects of Conversion From Sirolimus Oral Solution to Tablets in Renal Transplant Recipients.

Conditions
-----------------
Transplantation, Kidney Transplantation, Immunosuppression

Intervention / Treatment
-----------------
* Drug: sirolimus, cyclosporine, tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages of 18 and 65, renal transplant patients Exclusion Criteria: pregnancy, tuberculosis, hepatitis B or C carrier status, human immunodeficiency virus-positive status, retransplantation or multiorgan transplantation, or history of rheumatoid arthritis before transplantation

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sirolimus, cyclosporine, tacrolimus|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of sirolimus tablets in different regimens in de novo renal transplant patients |  |  | 
| Effect of dosage form conversion on sirolimus concentration in stable renal transplant patients. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of different sirolimus dose regimens in rejection prevention |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, Sirolimus, Cyclosporine, Tacrolimus, Immunosuppressive Agents, Immunosuppression, Transplantation, Kidney Transplantation
Platelet Kinetics After Platelet Transfusion for the Placement of a Central Venous Catheter

Study Overview
=================
Brief Summary
-----------------
PLATCAT study's purpose is to evaluate platelet kinetics after platelet transfusion

Official Title
-----------------
Evaluation of the Effectiveness and Security of the Prophylactic Platelet Transfusion in Thrombocytopenic Patients Requiring the Placement of a Central Venous Catheter

Conditions
-----------------
Thrombopenia, Central Venous Catheter Placement

Intervention / Treatment
-----------------
* Procedure: Platelets transfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admission en haematology unit Need for a central venous catheter Thrombopenia < 50 G/L Exclusion Criteria: Patient protected by law Pregnant or breastfeeding women Peripheral thrombopenia Patient admitted in Intensive Care Unit

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

| Intervention/Treatment |
| --- |
|Procedure: Platelets transfusion|Prophylactic platelet transfusion in thrombocytopenic patients for the placement of a central venous catheter|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 72 hours thrombocythemia kinetics after a platelet transfusion | Blood drawing a H-1:00, H+0:10, H+1:00, H+4:00, H+24h00, H+72:00 Evaluation of platelets count on sodium citrate tube. | 72 hours post transfusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusion Safety - assessed by Troubles during process | Troubles during process (pneumothorax, laying failure, hematoma) Hematoma at H+24:00 Immunisation anti HLA,HPA | One day after transfusion | 
| Transfusion Efficacy | Number of blood or platelets transfusion | One month after transfusion | 
| Description of patients treatment | Type of received chemotherapy | One week before and one month after transfusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intensive Care, Haematology, Platelets prophylactic transfusion