linjc16/ctgov huggingface dataset:
Effects of Pregnane X Receptor (PXR) Activation on Human Glucose, Lipid and Hormone Homeostasis

Study Overview
=================
Brief Summary
-----------------
This clinical trial is designed to study the effects of pregnane X receptor activator rifampicin on the glucose, lipid and hormone homeostasis in healthy volunteers. The main hypothesis is that rifampicin raises postprandial glucose studied with oral glucose tolerance test. The study is a non-randomized, one-phase, open-label trial. Twelve subjects will be given 600 mg of rifampicin a day for a week. The main outcome measures are the changes in the glucose and insulin levels during oral glucose tolerance test.

Official Title
-----------------
PXR-aktivaation Vaikutukset Sokeri-, Kolesteroli- ja Hormonitasapainoon

Conditions
-----------------
Glucose Metabolism

Intervention / Treatment
-----------------
* Drug: Rifampicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteer Age 18-45 years Body mass index 19-28 Exclusion Criteria: Any continuous medication Any significant disease Allergy to rifampicin Pregnancy and breast feeding Fear of needles and previous difficult blood samplings Substance abuse Participation in another clinical drug trial within 1 month of enrollment Use of soft contact lenses

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rifampicin<br> | Drug: Rifampicin<br>* Rifampicin 600 mg daily for a week<br>* Other names: Rimapen, ATC J04AB02;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose levels during oral glucose tolerance test |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PXR, glucose, cholesterol
Metabolomics of Liver Regeneration Following Partial Hepatectomy in Healthy Living Liver Donors

Study Overview
=================
Brief Summary
-----------------
The PI will study metabolism during liver regeneration in living liver donors

Detailed Description
-----------------
Samples of blood and urine will be collected from study participants at defined timepoints. The samples will be evaluated to study the metabolism of the regenerating liver after a portion of the liver has been donated from a living donor.

Official Title
-----------------
Metabolomics of Liver Regeneration Following Partial Hepatectomy in Healthy Living Liver Donors

Conditions
-----------------
Liver Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Potential donor must be in excellent medical and psychological health. Potential donor must be between the ages of 18 and 60. Must have a compatible blood type to the recipient. Must have health care coverage for non-donor related health issues that arise post donation Recipient and donor must have compatible body size. Donors Body Mass Index (BMI) must be less than 30. All previous donor abdominal surgeries will be reviewed on a case by case basis by the surgeon. Exclusion Criteria: Positive blood test for Human Immunodeficiency Virus, Hepatitis C virus, Hepatitis B virus The size of the donor liver is not large enough to safely resection and still retain enough volume to function normally after the surgery. Liver biopsy show liver cirrhosis or early stages of HCC. - -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| Characterized Metabolic Changes during liver regeneration |  | one year after donation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Living liver donor
Post Marketing Surveillance of MENOPUR

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of highly purified (HP) menotrophine to Korean women.

Official Title
-----------------
Post Marketing Surveillance of MENOPUR

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anovulation in women (WHO group II) Controlled ovarian hyperstimulation cases for ART Exclusion Criteria: Hypersensitivity to MENOPUR Pregnancy, lactation or contraindication to pregnancy Ovarian cysts not related to polycystic ovarian syndrome Abnormal uterine bleeding Tumors in uterus, ovaries and breasts Ovarian hyperstimulation syndrome Thromboembolism or history of it Infertile due to other reason than anovulation High FSH level indication primary ovarian failure

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

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

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 |
| --- | --- | --- |
| Number of follicles per cycle | An ART cycle: From ovulation (number and size) to when chemical pregnancy test results are recorded | Up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events | An ART cycle: From ovulation (number and size) to when chemical pregnancy test results are recorded | Up to 6 weeks |
A Phase I Study of BMS-690514 in Patients With Advanced or Metastatic Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to determine the highest dose of the drug (BMS-690514) that can be safely given to patients with advanced cancer.

Official Title
-----------------
A Phase I Dose Escalation Study of BMS-690514 in Patients With Advanced or Metastatic Solid Tumors

Conditions
-----------------
Cancer, Tumor

Intervention / Treatment
-----------------
* Drug: BMS-690514


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women 18 and older Diagnosis of any solid tumor ECOG performance status score 0-1 Prior chemo-therapy, immunotherapy or radiotherapy with at least 4 weeks since the last treatment Treatment with VEGFR2 or HER1 TKI allowed but not both (for instance Avastin or Tarceva, but not both) Exclusion Criteria: Treatment with other TKIs within the past 4 weeks Patients with brain metastasis Patients with centrally located squamous cell carcinoma of the lung Major gastrointestinal surgery which may affect absorption of the drug Any surgery within last 4 weeks History of thromboembolism Severe unmanageable diarrhea Subjects in Part B will have Non-Small Cell Lung Cancer (NSCLC) Part B/Cohort I erlotinib-naive subjects Part B/Cohort II subjects who have experienced disease progression while receiving erlotinib (erlotinib-resistant subjects)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: BMS-690514<br>* Tablets, Oral, up to 300 mg, once daily, up to 24 mos<br>* Other names: panHER;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | results of weekly vital sign measurements, ECGs, laboratory tests and physical exams, echocardiograms every 8 weeks | 
| Highest dose tolerated |  | continuous medical review of adverse event reports | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective dose or doses of BMS-690514 |  | tumor measurement by imaging every eight weeks. Continuous medical review of adverse event reports | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Solid Tumors
Adiponectin Gene and Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
Genetic studies of coronary artery disease, restenosis after angioplasty or stenting, focusing on renin-angiotensin system genes and adiponectin gene, and their interactions.

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving angiography Exclusion Criteria: Patients receiving angioplasty and reluctant for the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Bariatric Surgery and Pharmacokinetics of Ramipril

Study Overview
=================
Brief Summary
-----------------
Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study we investigate the pharmacokinetic effects of bariatric surgery on ramipril.

Official Title
-----------------
Bariatric Surgery and Pharmacokinetics of Ramipril: BAR-MEDS Ramipril

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Drug: Ramipril


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway Being a Norwegian citizen Exclusion Criteria: Having previously undergone resections in the GI-tract

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

| Intervention/Treatment |
| --- |
|Drug: Ramipril|Patients are tested for their normal prescription ramipril medication|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ramipril concentration in blood serum (area under curve (AUC)) |  | From baseline to 1 year postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric surgery, Gastrointestinal tract, Biological availability, Pharmacokinetics, Ramipril
Evaluation of Smile Esthetics in Orthodontically Treated Patients With Bimaxillary-dentoalveolar Protrusion

Study Overview
=================
Brief Summary
-----------------
Evaluation of Smile Esthetics in Orthodontically Treated Adult Female Patients with Bimaxillary-dentoalveolar Protrusion. A Retrospective Cohort Study.

Official Title
-----------------
Evaluation of Smile Esthetics in Orthodontically Treated Adult Female Patients With Bimaxillary-dentoalveolar Protrusion: A Retrospective Cohort Study

Conditions
-----------------
Bimaxillary Protrusion

Participation Criteria
=================
Eligibility Criteria
-----------------
The selected records should meet the following inclusion criteria: Pre treatment: Full permanent dentition No dental nor any craniofacial anomalies Molar Class I with bimaxillary-dentoalveolar protrusion No excessive over jet or overbite Treatment mechanics: All patients treated with extraction of four 1st premolars Retraction of anterior teeth using maximum anchorage mechanics Post treatment: Canine 1 relation Molar I relation Exclusion criteria : Any orthodontic records without the previously mentioned pre and posttreatment inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 24 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival display | Amount of maxillary gingival exposure between inferior border of upper lip and marginal gingiva of maxillary central incisors. | Change from Baseline gingival display, at an average 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lateral negative space | The buccal corridor between the posterior teeth and the corner of the mouth in smiling. | Change from Baseline lateral negative space, at an average 24 months | 
| Smile arc | Relationship between a hypothetical curve drawn along The edges of the maxillary anterior teeth and the inner contour of the lower lip in the posed smile. | Change from Baseline smile arc, at an average 24 months | 
| Lip line | The height of the upper lip relative to the maxillary central incisors. | Change from Baseline lip line, at an average 24 months | 
| Smile width | The distance between the most medial points on the lips at the angles of the mouth (Left to right cheilion, CHR to CHL). | Change from Baseline smile width, at an average 24 months | 
| Smile height | Distance from the most inferior point on the upper lip between the maxillary central inciors to the most superior point on the lower lip on a perpendicular vertical line from the upper point (upper stomion to lower stomion,UST to LST). | Change from Baseline smile height, at an average 24 months |
Long-Term Extension Study of Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: HEADWAY-DLB Extension

Study Overview
=================
Brief Summary
-----------------
This 6-month extension study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) in subjects with Dementia with Lewy bodies (DLB) who have participated in the double-blind, placebo-controlled, lead-in study RVT-101-2001.

Detailed Description
-----------------
This 6-month, double-blind,extension study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) in subjects with DLB who have participated in the double-blind, placebo-controlled, lead-in study RVT-101-2001. The study duration for subjects in study centers in the USA will be 12 months. Subjects who were randomized to the RVT-101 35-mg and RVT-101 70-mg treatment groups in lead-in study RVT-101-2001 will remain in the same treatment groups for this study; subjects who were randomized to the placebo treatment group in the lead-in study will be assigned to the RVT-101 70-mg treatment group in this study. Various background therapies, including acetylcholinesterase inhibitors and memantine, will be allowed.

Official Title
-----------------
A Long-Term Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)

Conditions
-----------------
Dementia With Lewy Bodies

Intervention / Treatment
-----------------
* Drug: RVT-101 35 mg
* Drug: RVT-101 70 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participated in the lead-in study RVT-101-2001. Exclusion Criteria: Any clinically relevant concomitant disease, which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 86 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RVT-101 35 mg<br>RVT-101 35 mg once daily | Drug: RVT-101 35 mg<br>* once daily, oral, 35-mg tablets<br>|
| Experimental: RVT-101 70 mg<br>RVT-101 70 mg once daily | Drug: RVT-101 70 mg<br>* once daily, oral, 35-mg tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events and changes in physical examinations, vital sign measurements, electrocardiograms (ECGs), and clinical laboratory assessments |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dementia with Lewy bodies, dementia, RVT-101, intepirdine, Lewy bodies
HORIZON-PFT: Pivotal Fracture Trial

Study Overview
=================
Brief Summary
-----------------
HORIZON-PFT (Pivotal Fracture Trial) will study the effect of zoledronic acid, given once per year, on the treatment of osteoporosis in women past menopause. Hip and vertebral fractures are the most devastating consequences of osteoporosis. HORIZON-PFT is designed to determine the benefits of zoledronic acid in fracture reduction at both the hip and spine.

Official Title
-----------------
HORIZON-PFT: Pivotal Fracture Trial

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

Intervention / Treatment
-----------------
* Drug: Zoledronic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female, 65-89 years old No history of severe liver, kidney or eye disease Exclusion Criteria: Current bisphosphonate users such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel® (risedronate), Skelid® (tiludronate) Using hip protectors Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 89 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zoledronic Acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hip fxs |  |  | 
| Incidence of new vertebral fxs |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in hip BMD |  |  | 
| New and/or worsening vertebral fxs |  |  | 
| All clinical fxs |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bisphosphonate,BMD,Height loss, Hip protectors,HRT,, Osteoporosis
Efficacy and Safety of the ACAT Inhibitor CS-505 (Pactimibe) for Reducing the Progression of Carotid Artery Disease. This Study is Also Known as CAPTIVATE.

Study Overview
=================
Brief Summary
-----------------
The effects of pactimibe versus placebo on the progression of atherosclerosis in the carotid arteries will be assessed using standard ultrasound techniques.

Official Title
-----------------
A Randomized, Double-blind, Stratified, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of the ACAT Inhibitor CS-505 for Reducing the Progression of Atherosclerosis in Subjects With Heterozygous Familial Hypercholesterolemia and Carotid Atherosclerosis Using Carotid Ultrasound (CUS)

Conditions
-----------------
Atherosclerosis, Heterozygous Familial Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Pactimibe sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of heterozygous familial hypercholesterolemia Ambulatory male (40 to 75 years, inclusive) or female (45 to 75 years, inclusive) subjects Calculated LDL-C level greater than or equal to 100 mg/dL (or 2.5 mmol/L) and triglycerides less than 500 mg/dL (5.65 mmol/L) while on usual and stable lipid-lowering therapy Exclusion Criteria: Breast feeding or lactating women Previous organ transplantation High-grade stenosis (>75%) or the occlusion of any segment of either carotid artery History of carotid endarterectomy, or insertion of carotid artery stent or are scheduled to have either of these procedures

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pactimibe sulfate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate the effect of pactimibe versus placebo, when added to usual medical care, on the intima-media thickness (IMT) of the carotid arteries in subjects with heterozygous familial hypercholesterolemia (HeFH) and carotid atherosclerosis. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effects of pactimibe versus placebo, when added to usual medical care: |  |  | 
| - on the incidence and the time to first occurrence of |  |  | 
| cardiovascular events, |  |  | 
| - on inflammatory and oxidative markers, such as serum |  |  | 
| high-sensitivity C-reactive protein (hsCRP), plasma |  |  | 
| interleukin 6 (IL-6), plasma myeloperoxidase (MPO) and |  |  | 
| serum nitrotyrosine. |  |  | 
| To compare the safety of pactimibe versus placebo, when added to usual medical care, particularly with respect to the incidence of clincal and laboratory adverse events. |  |  |