linjc16/ctgov huggingface dataset:
Strategies to Improve Asthma and Treatment of Asthma in Canadians

Study Overview
=================
Brief Summary
-----------------
Our study will enroll 644 randomly-selected Canadians who have been diagnosed with asthma by a physician within the previous five years. It will be determined what diagnostic tests were initially performed to make this diagnosis. Participants will undergo lung function testing over 6-8 weeks to determine their respiratory status and to confirm they have asthma. Participants may be followed up to one year depending on their test results.

Official Title
-----------------
Strategies to Improve Diagnosis and Treatment of Asthma in Canadians

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must have a recent diagnosis of asthma by a physician. Diagnosis of asthma must have occurred within 5 years prior to entry into the study. Patient must be at least 18 years old. Exclusion Criteria: Patients in whom methacholine challenge is contraindicated Patients using chronic oral prednisone. Patients with heart attack or stroke within three previous months, and those with known aortic or cerebral aneurysms. Pregnant patients (unknown effect of methacholine on the fetus) and breastfeeding patients (unknown whether methacholine is excreted in breast milk). Patients unable to provide informed consent. Patients not able to perform spirometry and/or methacholine challenge testing. Patients who have a greater than 10 pack-year smoking history (this will exclude patients with possible COPD). Patients who currently have active pulmonary Tuberculosis Patients who have had eye surgery in the past 3 months or who have a detached retina Patients involved in another interventional asthma study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
Multi-organ Transit Time Acquisition Using Contrast Ultrasound

Study Overview
=================
Brief Summary
-----------------
Echocardiographic contrast will be administered to volunteers for the purpose of measuring transit time through various organs/vascular beds

Official Title
-----------------
Multi-organ Transit Time Acquisition Using Contrast Ultrasound

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

Intervention / Treatment
-----------------
* Drug: Definity Suspension for Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 18 years old able to give informed consent Exclusion Criteria: Known allergic reaction to Definity ultrasound contrast Pregnancy/Nursing - as assessed/disclosed by the participant

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 |
| --- | --- |
| Contrast administration<br> | Drug: Definity Suspension for Injection<br>* Administration of Definity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transit time | time it takes for contrast to traverse an organ | during procedure |
A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to assess bioequivalence of a potential generic 1 mg granisetron tablet formulation compared with Roche Laboratories' 1 mg granisetron tablet, Kytril, following a single 1 mg dose, under fed conditions.

Official Title
-----------------
A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fed Conditions

Conditions
-----------------
Nausea, Vomiting

Intervention / Treatment
-----------------
* Drug: Granisetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to granisetron or any other comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Granisetron|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, 4-period, 7 day washout | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevention of nausea and vomiting associated with radiation or chemotherapy
Developing Derived Induced Pluripotent Stem Cells as a Model to Understand Imprinted Disorders

Study Overview
=================
Brief Summary
-----------------
Fetal and postnatal growth is finely regulated by genetic, epigenetic and environmental mechanisms. Parental imprinting is a regulatory mechanism that allows monoallelic expression of certain genes from a single parental allele through differential DNA methylation. Imprinted genes play a very important role in the control of fetal and postnatal growth. The pathophysiological mechanisms of these epimutations are largely unknown. Studying the consequences of these epimutations on the molecular signature of the imprinted gene network in these patients would provide a better understanding of the epigenetic mechanisms regulating fetal growth. As these genes are weakly expressed in fibroblasts, these studies will be carried out on pluripotent stem cells or IPSCs (Induced Pluripotent Stem Cells).

Official Title
-----------------
Developing Derived Induced Pluripotent Stem Cells From Blood as a Model for the Study to Understand Imprinted Disorders

Conditions
-----------------
Induced Pluripotent Stem Cells

Intervention / Treatment
-----------------
* Other: Diagnostic Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minor or young adult patients treated in the department, suffering from rare growth diseases: Silver-Russell syndrome (SRS), Beckwith-Wiedemann syndrome (BWS) and Temple syndrome (TS) For minors, the patient's weight must be ≥ 5 kg Exclusion Criteria: Patients unable to express their opposition to the use of their personal data.

Ages Eligible for Study
-----------------
Minimum Age: 3 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Silver-Russell Syndrome<br> | Other: Diagnostic Test<br>* Molecular diagnosis carried out in the context of care<br>|
| Beckwith-Wiedemann Syndrome<br> | Other: Diagnostic Test<br>* Molecular diagnosis carried out in the context of care<br>|
| Temple Syndrome<br> | Other: Diagnostic Test<br>* Molecular diagnosis carried out in the context of care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The objective of the study is to understand the consequences of epimutations found | The objective of the study is to understand the consequences of epimutations found at 11p15 or 14q32 in these three syndromes (SRS, BWS and TS) on the network of genes subject to parental imprinting, in order to progress in the understanding of the mechanisms governing the epigenetic regulation of fetal growth. | 1 day |
Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON

Study Overview
=================
Brief Summary
-----------------
Development of a bio-mathematical model of the human female cycle

Detailed Description
-----------------
From hormonal measurements throughout 1-2 menstrual cycles in women with and without endocrinological pathology a mathematical model of the human menstrual cycle will be generated. The model will serve to predict development of the cycle including ovulation as well as to better understand the pathophysiology of endocrinological disorder. In a second step current treatment protocols for fertility treatment will be integrated into the model in order to optimize treatment outcome.

Official Title
-----------------
Model Driven Computation for Infertility Related Endocrinological Diseases - PAEON

Conditions
-----------------
Polycystic Ovary Syndrome, Endometriosis, Hyperprolactinemia

Intervention / Treatment
-----------------
* Other: Fertility treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Women during their reproductive phase, no hormonal therapy Exclusion criteria: - Amenorrhoae

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 43 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal, pathological cycle, infertility<br>healthy women PCOS Endometriosis hyperprolactinemia fertility treatment | Other: Fertility treatment<br>* Fertility treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormonal parameters | Development of a mathematical model of the menstrual cycle | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamics of fertility treatment | Mathematical model to improve fertility treatments | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
menstrual cycle dynamics, PCOS, hyperprolactinemia, endometriosis, infertility
Liraglutide Efficacy on Glucocorticoid Induced Hyperglycemia in Patients High Risk for Diabetes

Study Overview
=================
Brief Summary
-----------------
Glucocorticoids therapy exposes the patient to an increased risk for diabetes morbidity. However, there is no proven preventive therapy. GLP-1-RA has shown to improve glucose metabolism in healthy volunteers treated with glucocorticoids. We assume that GLP-1-RA will improve glucose metabolism in patients with high risk for diabetes morbidity, treated with glucocorticoids.

Conditions
-----------------
Glucocorticoid Induced Hyperglycemia

Intervention / Treatment
-----------------
* Drug: Liraglutide
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Planned treatment with T. Prednisone in dosage >0.5 mg/kg for two weeks or more. Age >18 years Body mass index >27 kg/m2 OR 1st degree relative with type 2 diabetes mellitus OR hypertension OR hyperlipidemia OR gestational diabetes in the past OR diagnosis of polycystic ovary syndrome. Exclusion criteria: Glycosylated hemoglobin A1c >6.5% Diagnosis of diabetes mellitus or treatment with anti-glycemic drug Pancreatitis (acute or chronic) in the past Active malignancy Medullary thyroid carcinoma or multiple endocrine neoplasm type 2 of the patient or of 1st degree relative 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?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |
| Active Comparator: Intervention<br>Liraglutide, tapered from 0.6 mg/day to 1.8 mg/day. | Drug: Liraglutide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose levels 2 hours after 75 gr OGTT |  | 6 weeks |
Pharmacokinetic Study of Daptomycin in Healthy Chinese Subjects Living in China

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to characterise the pharmacokinetics and dose proportionality of daptomycin after single and multiple (once daily) 4mg/kg and 6 mg/kg doses of daptomycin in healthy Chinese volunteers.

Official Title
-----------------
A Two Cohort, Open Label, Single and Multiple Dose Pharmacokinetic Study of 4mg/Kg and 6mg/Kg Doses of Daptomycin in Healthy Chinese Subjects Living in China

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

Intervention / Treatment
-----------------
* Drug: Daptomycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women (not of childbearing potential) of Chinese ethnicity Weight between 55Kg to 90Kg and have a Body Mass Index (BMI) between 18 and 25 kg/m2 Have a calculated creatinine clearance within range from 80 to 120 ml/min inclusive Exclusion Criteria: Unable to discontinue use of HMG-CoA reductase inhibitor therapy within 7 days prior to first dose of study drug through discharge from unit CPK > 2X ULN (upper limit of normal)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Daptomycin|4mg/kg and 6 mg/kg dissolved in 0.9% sodium chloride for injection, administered intravenously over 30 minutes.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic data will be obtained from the analysis of blood and urine samples that will be obtained at specific time points throughout the study. The pharmacokinetic samples will be collected on days 1, 4 through 8 and 9. |  | On therapy evaluation on Day1 9. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety parameters (Incidence of AEs and SAEs, Deaths, Premature discontinuation due to an AE, regardless of relationship to study medication; Clinical lab data; Vital signs; ECG; Physical exam findings; Concomitant medications and adjunctive procedures). |  | On therapy evaluation on Day1 9. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cubicin, PK, China Registration, Pharmacokinetics
Monitoring of Tissue Transfer Flaps by Modulated Imaging

Study Overview
=================
Brief Summary
-----------------
Tissue transfer flaps are a method of moving tissue from a donor location to a recipient location. In the case of a free tissue transfer flaps, the blood vessels to the transferred tissues are detached and then re-attached to different arteries and veins at the recipient site. The process of reconstructive surgery using tissue transfer flaps is not without complications. These complications may include acute arterial or venous occlusion, as well as the development of late complications such as fat necrosis and flap atrophy.

Detailed Description
-----------------
The researchers developed a safe, non-contact, intra-operative and post-operative device called Modulated Imaging, can detect changes in a flap's optical properties and can correlate with arterial or venous occlusion or with the development of fat necrosis or flap atrophy.

Official Title
-----------------
Non-contact, Intra-operative & Post-operative Device, Evaluation of Tissue Transfer Flaps After Reconstructive Surgery.

Conditions
-----------------
Other Reconstructive Surgery

Intervention / Treatment
-----------------
* Device: Modulated Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult 18 years and older planned to undergo reconstructive surgery Exclusion Criteria: All emergency reconstructive surgery

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 |
| --- | --- |
| Tissue transfer skin flap<br>Modulated Imaging Spectroscopy | Device: Modulated Imaging<br>* Modulated Imaging Spectroscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfer Skin flap |  | up to 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tissue transfer
Effectiveness of Intracavitary Manual Lymphatic Drainage

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to determine the effectiveness of Intracavitary Manual Lymphatic Drainage (IMLD) in the reduction of the perineal trauma and the symptoms of vaginal edema, the prevention of complications during the expulsive and the improvement in the postpartum recovery, compared to conventional treatment during the gestation, in women with the second partum. The weekly treatment is performed from the 25th gestational week in women with vulvar edema.

Official Title
-----------------
Effectiveness of Intracavitary Manual Lymphatic Drainage Versus Conventional Treatment in the Prevention of Perineal Trauma During Labor.

Conditions
-----------------
Lymphatic Diseases

Intervention / Treatment
-----------------
* Other: Intracavitary Manual Lymphatic Drainage
* Other: Conventional treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A sample of 49 second-trimester pregnant women with gestational edema with more than 18 years of age Exclusion Criteria: Primiparous women

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intracavitary Manual Lymphatic Drainage<br>Intracavitary Manual Lymphatic Drainage technique. | Other: Intracavitary Manual Lymphatic Drainage<br> <br> |
| Active Comparator: Conventional treatment<br>Conventional treatment active comparator | Other: Conventional treatment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity assessed by the Visual Analogue Scale |  | 5 weeks |
The Effects of Normobaric Hypoxia on Blood Glucose Levels.

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to observe whether there is a change in blood glucose levels in response to a 2 hour oral glucose tolerance tests (OGTT) during acute normobaric hypoxia (short term low oxygen levels at normal ambient air pressure).

Official Title
-----------------
The Effects of Normobaric Hypoxia on Blood Glucose Levels.

Conditions
-----------------
Glucose

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (non-diabetics): Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB 5 males with a BMI < 25; 5 males with a BMI > 25 at least 18 years of age (MOFH personnel and DoD beneficiaries). 5 females with a BMI < 25; 5 females with a BMI > 25 at least 18 years of age (MOFH personnel and DoD beneficiaries). Exclusion Criteria (non-diabetics): History of abnormal fasting glucose. Pulmonary disease. Any medications that change glucose control to include systemic steroid and diabetic medications. History of claustrophobia. Pregnant or breast feeding. Non-English speaking. Physical inability to wear/use the ROBD2 Inclusion Criteria (diabetics): -5 males and/or females, at least 18 years of age, that are type 2 diabetics (MOFH personnel and DoD beneficiaries). Exclusion Criteria (diabetics): Pulmonary disease. History of claustrophobia. Pregnant or breast feeding. Non-English speaking. Physical inability to wear/use the ROBD2

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glucose levels at altitude | Subjects will be placed on a Reduced Oxygen Breathing Device (ROBD2) to simulate 3 different altitudes at three separate and distinct time periods (ground, 8,000 feet and 12,000 feet) then obtain c-peptide and 2-hour OGTT to determine blood glucose changes during acute normobaric hypoxia. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Altitude, Glucose