linjc16/ctgov huggingface dataset:
A Phase I Study in Healthy Volunteers to Assess Safety of BMS747158

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to learn the safety and biodistribution of BMS747158 in normal, healthy volunteers.

Official Title
-----------------
A Single-Dose, Phase I, Dosimetry, Biodistribution, and Safety Trial of BMS 747158 in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: BMS747158


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-40 BMI 18-30 kg/m2 No active or chronic illnesses If female: not pregnant, use of birth control or not of child-bearing potential Exclusion Criteria: Significant active or chronic illness Any neurological disorder GI disease within 3 months Recent infection Major surgery within 4 weeks Donation of blood within 4 weeks Blood transfusion within 4 weeks Recent history drug/alcohol abuse Head trauma Significant screening ECG, EEG, lab tests, physical exam and vital signs abnormalities Prescription or OTC drugs within 2 weeks Exposure to any other investigational drug/device within 6

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: BMS747158<br>* Single dose administration.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosimetry analysis following whole body imaging after resting injection |  | Imaging takes place 0 - 310 minutes post injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety analysis following vital signs, ECGs, EEG, neuro and physical exams, telephone and visit follow up, and blood draws for chemistry and hematology post injection of BMS747158 at rest |  | Screening (14 days prior to dosing) through 14 days post dose administration |
Epidemiology of Sepsis at Yuetan Subdistrict in Beijing

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the epidemiology and outcome of sepsis at Yuetan subdistrict in Beijing in mainland China).

Detailed Description
-----------------
Questionnaires were used to collect the characteristic information of people living in Yuetan subdistrict in Beijing and select people who had been hospitalized because of any reasons between July 2012 and June 2014. Data were collected on all patients admitted into different hospitals during the study period. The following information was recorded:demographic characteristics and admission category (whether medical, scheduled surgery, nonoperative trauma, or unscheduled surgery), presence of preexisting organ insufficiency,using definitions included in the Acute Physiology and Chronic Health Evaluation (APACHE) II score11; co- morbidities and the estimated prognosis of any preexisting underlying disease, following the classification of McCabe and Jackson. Patients were included in the study cohort when having, in association with a documented or strongly suspected infection and fullfil the diagnostic criteria of sepsis according to the Surviving Sepsis Campaign: International guidelines for management of severe sepsis and septic shock:2012.

Official Title
-----------------
Epidemiology of Sepsis at Yuetan Subdistrict in Beijing

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age≥18 years; Having lived in Yuetan Subdistirct for at least 1 year Having, in association with a documented or strongly suspected infection and fullfil the diagnostic criteria of sepsis according to the Surviving Sepsis Campaign:International guidelines for management of severe sepsis and septic shock:2012 Exclusion Criteria: Age<18 years Lived in Yuetan Subdistrict less than 1 year

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of sepsis of people living in Yuetan subdistrict in Beijing |  | 2012-7-1 2014-6-30, up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sepsis, Severe sepsis, septic shock, epidemiology, outcome
Mandibular Movement Test as a Screening Tool for Polysomnography Candidates

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine the technical failure and inconclusive test rates when using the Brizzy device for mandibular movement tracking.

Official Title
-----------------
A Mandibular Movement Test as a Screening Tool for Polysomnography Candidates Among Patients With Sleep Apnea: a Retrospective Feasibility Study

Conditions
-----------------
Sleep Apnea Syndromes

Intervention / Treatment
-----------------
* Device: Mandibular movement tracking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient included in the Brizzy register Mandibular movement test prescribed by practitioner Patient performed a mandibular movement test (ambulatory setting) using a magnetic sensor (Brizzy, Nomics, Liege, Belgium) Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The study population<br>The study population is comprised of all patients included in the Brizzy register, Belgium. | Device: Mandibular movement tracking<br>* Patients wore the Brizzy device while sleeping. Mandibular movements (A mid-sagittal mandibular movement magnetic sensor measured the distance in mm between two parallel, coupled, resonant circuits placed on the forehead and chin.) were tracked during sleep.<br>* Other names: Brizzy (Nomics, Liege, Belgium);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The exploitable data rate | The number of usable tests / the number of tests performed. | Day 0 (retrospective cross-sectional study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory disturbance index based on mandibular movements | Respiratory disturbance index based on mandibular movements (Brizzy, Nomics, Liege, Belgium) | Day 0 (retrospective cross-sectional study) | 
| Minimal estimated total sleep time | Minimal estimated total sleep time | Day 0 (retrospective cross-sectional study) | 
| ODI | The oxygen desaturation index (ODI) from oximetry. | Day 0 (retrospective cross-sectional study) | 
| Type of prescriber (qualitative) | Was the prescriber a (choose one from among the following): cardiologist, general practitioner otorhinolaryngologist pneumologist orthodontist other | Day 0 (retrospective cross-sectional study) | 
| Identification of reasons why a given test was unusable |  | Day 0 (retrospective cross-sectional study) | 
| age | age in years | Day 0 (retrospective cross-sectional study) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mandibular movements
Effects of Calcium and Phytate on Zinc Absorption

Study Overview
=================
Brief Summary
-----------------
This study is determine the effects of dietary calcium and phytate on zinc absorption.

Detailed Description
-----------------
Zinc absorption is tested from 2 days of consuming each of four diets with zinc-65 isotope, followed by retention monitoring in a whole body scintillation counter for 4 weeks. All four 4 experimental diets are tested with each subject, in randomized order, for a total of 16 weeks.

Official Title
-----------------
Effects of Calcium and Phytate on Zinc Absorption

Conditions
-----------------
Dietary Zinc Absorption

Intervention / Treatment
-----------------
* Dietary Supplement: Moderate Calcium, Low phytate Diet
* Dietary Supplement: Moderate Calcium, High Phytate Diet
* Dietary Supplement: High Calcium, Low Phytate Diet
* Dietary Supplement: High Calcium, High Phytate Diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Average weight for height Exclusion Criteria: Medications other than birth control pills or hormone replacement therapy, Pregnancy within last 6 months

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Overall Study<br>Participants consumed 4 experimental diets for 4 weeks each in randomized order | Dietary Supplement: Moderate Calcium, Low phytate Diet<br>* Participants consumed diet containing 700 milligrams calcium and 440 milligrams of phytate for 4 weeks<br>Dietary Supplement: Moderate Calcium, High Phytate Diet<br>* Participants consumed diet containing 700 milligrams calcium and 1800 milligrams of phytate for 4 weeks<br>Dietary Supplement: High Calcium, Low Phytate Diet<br>* Participants consumed diet containing 1900 milligrams calcium and 440 milligrams of phytate for 4 weeks<br>Dietary Supplement: High Calcium, High Phytate Diet<br>* Participants consumed diet containing 1900 milligrams calcium and 1800 milligrams of phytate for 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Zinc Absorption | Retention of Zinc-65 was monitored for 28 days by whole body scintillation counting. The percentage of Zinc-65 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Zinc-65 retained versus time | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dietary zinc absorption, dietary phytic acid, dietary calcium
A Study to Assess the Bioequivalence of Aprepitant and Fosaprepitant and the Effect of Food on Aprepitant Bioavailability (0869-165)

Study Overview
=================
Brief Summary
-----------------
This study will assess the bioequivalence of single oral doses of aprepitant (MK0869) to a single intravenous infusion of fosaprepitant (MK0517) and also determine the effect of food on the bioavailability of oral aprepitant.

Official Title
-----------------
A Single-Dose Bioequivalence and Food Effect Study With Aprepitant and Fosaprepitant Dimeglumine in Healthy Young Adult Subjects

Conditions
-----------------
Chemotherapy-Induced Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: aprepitant 165 mg
* Drug: Comparator: aprepitant 185 mg
* Drug: Comparator: fosaprepitant 150 mg
* Drug: Comparator: aprepitant with food


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is in good health Subject is a nonsmoker Subject is willing to comply with the study restrictions Exclusion Criteria: Subject has a history of any illness that might confound the results of the study or might make participation in the study unsafe Subject has a history of stroke, seizures, or major neurological disorder Subject has a history of cancer Subject consumes more than two alcoholic drinks per day Subject consumes more than three caffeinated beverages daily

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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>aprepitant 165 mg | Drug: aprepitant 165 mg<br>* Single dose of aprepitant 165 mg tablet in the fasted state during treatment period 1,2, or 3.<br>|
| Active Comparator: 2<br>aprepitant 185 mg | Drug: Comparator: aprepitant 185 mg<br>* Single dose of aprepitant 185 mg tablet in the fasted state during treatment period 1, 2, or 3.<br>|
| Experimental: 3<br>fosaprepitant 150 mg | Drug: Comparator: fosaprepitant 150 mg<br>* Single dose of fosaprepitant 150 mg intravenous infusion in the fasted state during treatment period 1,2, or 3.<br>|
| Experimental: 4<br>aprepitant with food | Drug: Comparator: aprepitant with food<br>* Single dose of aprepitant 165 mg or 185 mg tablet in the fed state during treatment period 4.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg |  | Through 72 Hours Postdose | 
| Peak Plasma Concentration (Cmax) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg. |  | Through 72 Hours Postdose |
Relationship of Genes and Life Events to Blood Pressure

Study Overview
=================
Brief Summary
-----------------
Research suggests that blood pressure is influenced by both genetic and environmental factors. The goal of this study is to find genes that play a role in blood pressure and understand how they interact with life events (such as job stress) to influence blood pressure. We hypothesize that the gene for endothelin-1 is associated with increased blood pressure. Further, we predict that this genetic relationship is moderated by psychosocial stress factors, specifically job strain and marital cohesion.

Conditions
-----------------
Hypertension, Psychosocial Factors

Intervention / Treatment
-----------------
* Genetic: Cheek swab samples for DNA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous participation in a study of psychosocial stressors and blood pressure (Double Exposure Study) and agreement to participate in follow-up studies Exclusion Criteria: Withdrawal of consent
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: Cheek swab samples for DNA|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Blood Pressure, Psychosocial Factors
GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the duration of survival between GVAX® immunotherapy for prostate cancer and chemotherapy treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases, and who have not been treated with chemotherapy in the past.

Official Title
-----------------
A Phase III Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer Who Are Chemotherapy-Naïve

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

Intervention / Treatment
-----------------
* Biological: Immunotherapy with allogeneic prostate vaccine
* Drug: Chemotherapy (Taxotere and prednisone)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy Detectable metastases Any Gleason score ECOG performance status 0-2 Exclusion Criteria: Prior treatment with chemotherapy Prior Immunotherapy Prior treatment with gene therapy Significant cancer related pain

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 2<br>Standard of care - chemotherapy | Drug: Chemotherapy (Taxotere and prednisone)<br>* Chemotherapy (Taxotere and prednisone)<br>|
| Experimental: 1<br>Immunotherapy | Biological: Immunotherapy with allogeneic prostate vaccine<br>* Immunotherapy with allogeneic prostate vaccine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone pain and bone related events |  | 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate, Cancer, Metastatic, Hormone-refractory, GVAX, Chemotherapy, Taxotere, Docetaxel, Prednisone, Vaccine, Allogeneic cells, Advanced Prostate Cancer
A Study To Evaluate The Safety And Efficacy Of Atorvastatin In Patients With Diabetes And High Cholesterol

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of atorvastatin for the treatment of Taiwanese patients with diabetes and high cholesterol.

Official Title
-----------------
A Randomized, 12-Week, Open Labeled Study To Evaluate The Efficacy And Safety Of Once Daily Atorvastatin In Diabetes Mellitus Type 2 With Hyperlipidemia

Conditions
-----------------
Hyperlipidemias

Intervention / Treatment
-----------------
* Drug: atorvastatin
* Drug: atorvastatin
* Drug: atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Taiwanese outpatients with type 2 diabetes mellitus and high cholesterol Hemoglobin A1c levels of ≤10%, LDL-C levels of ≥130 mg/dL, and serum triglyceride levels of <400 mg/dL Exclusion Criteria: Type I diabetes mellitus Secondary causes of high cholesterol Elevated liver enzymes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br> | Drug: atorvastatin<br>* Atorvastatin calcium tablets 10 mg orally once daily in the evening for 12 weeks<br>|
| Experimental: Arm B<br> | Drug: atorvastatin<br>* Atorvastatin calcium tablets 20 mg orally once daily in the evening for 12 weeks<br>|
| Experimental: Arm C<br> | Drug: atorvastatin<br>* Atorvastatin calcium tablets 40 mg orally once daily in the evening for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in LDL-C levels from baseline to Week 12 |  | Week 12 | 
| Percentage of subjects with low-density lipoprotein cholesterol (LDL-C) levels of <100 mg/dL (LDL-C responders) at Week 12 |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change from baseline in TC, high-density lipoprotein cholesterol, triglycerides, and high sensitivity C-reactive protein at Weeks 4, 8, and 12 |  | Weeks 4, 8, and 12 | 
| Adverse events at Weeks 4, 8, and 12 |  | Baseline and at Weeks 4, 8, and 12 | 
| Clinical laboratory changes at Weeks 4, 8, and 12 |  | Screening and at Weeks 4, 8, and 12 | 
| Vital signs at Weeks 4, 8, and 12 |  | Screening and at Weeks 4, 8, and 12 | 
| Percentage change in LDL-C levels from baseline at Weeks 4 and 8 |  | Weeks 4 and 8 | 
| Percentage of LDL-C responders at Weeks 4 and 8 |  | Weeks 4 and 8 | 
| Percentage of subjects with total cholesterol (TC) levels of <160 mg/dL (TC responders) at Weeks 4, 8, and 12 |  | Weeks 4, 8, and 12 |