linjc16/ctgov huggingface dataset:
A Study of LY2157299 in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
Participants in this study will receive two oral doses of 150 milligram (mg) LY2157299 taken at least 4 days apart. One dose will be given without food. One dose will be given with a high fat meal. The study will evaluate the effect of a high fat meal on how much of the drug gets into the blood stream. Side effects will be documented. This study will last approximately 15 days not including screening. Screening is required within 30 days prior to the start of the study.

Official Title
-----------------
Effect of Food on the Pharmacokinetics of LY2157299 Monohydrate in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: LY2157299


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy sterile males or females Are able to eat a high fat meal No abnormal heart function or high blood pressure No participation in a clinical trial within 30 days No evidence of human deficiency virus (HIV), hepatitis C or hepatitis B Exclusion Criteria: Have a clinically significant abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY2157299 (Fasted)<br>Single dose of 150 mg LY2157299 administered orally in fasted state in one of two study periods. | Drug: LY2157299<br>* Administered orally<br>|
| Experimental: LY2157299 (Fed)<br>Single dose of 150 mg LY2157299 administered orally in fed state in one of two study periods. | Drug: LY2157299<br>* Administered orally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2157299 |  | Pre-dose through 72 hours post-dose in each study period | 
| Pharmacokinetics: Time of Maximum Observed Concentration (tmax) of LY2157299 |  | Pre-dose through 72 hours post-dose in each study period | 
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2157299 |  | Pre-dose through 72 hours post-dose in each study period |
Job Strain, Ambulatory Blood Pressure and Hypertension

Study Overview
=================
Brief Summary
-----------------
To analyze the association between an objective measure of job strain and risk of stroke, and change in ambulatory blood pressure.

Detailed Description
-----------------
BACKGROUND: Cardiovascular disease accounts for 43 percent of all deaths in the United States. Hypertension affects as many as 50 million Americans, however the causes of essential hypertension are not well known. A new CVD risk factor (job strain) has emerged as a potential major cause of essential hypertension. By 1995, over 20 studies had found significant positive relationships between job strain and CVD, coronary heart disease, all-cause mortality or hypertension. Job strain is defined as high psychological workload demands combined with lowdecision latitude. An expanded concept of job strain which included low workplace social support (iso-strain) was developed and examined in the study. Important questions remained to be answered about job strain, CVD and hypertension. In most studies, job strain was only measured at one point in time, while, in fact, cumulative exposure to job strain was believed to be the risk factor. In addition, most studies relied on self-report measures of job strain. Also, no studies specifically examined risk of stroke and job strain. DESIGN NARRATIVE: Data from the Cornell University cohort study of Psychosocial Factors and Cardiovascular Disease and the Columbia University-Northern Manhattan Stroke Study were analyzed. The study had five specific aims, including to determine whether: blood pressure levels were associated with cumulative exposure to job strain; differences in blood pressure increases were associated with an objective measure of job strain; increased risk of stroke was associated with an objective measure of job strain; changes in psychological variables over time were associated with job characteristics; changes in CVD risk factors (other than hypertension) were associated with job characteristics. Paul Landsbergis also constructed measures of cumulative exposure to job strain and determined their association with blood pressure, and analyzed the association between job characteristics and change in psychological variables and cardiovascular disease (CVD) risk factors. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Cerebrovascular Accident, Hypertension, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Comparison of Remifentanil With Dexmedetomidine or Midazolam in Regards of Sedation Effectivity and Postoperative Cognitive Functions in Cystoscopies

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to compare the effects of remifentanil-dexmedetomidine and remifentanil-midazolam with mini-mental state examination (MMSE) in monitored anesthesia care (MAC) patients undergoing cystoscopy.

Detailed Description
-----------------
Forty patients undergoing cystoscopy receiving remifentanil infusion of 0.05 microgram per kg-1 min-1 were randomized into two groups: Either dexmedetomidine 1 microgram per kg -1 (GroupD) or midazolam 0.2 mg kg-1h-1 (GroupM) were administered intravenously for the first 10 minutes. Subsequently anesthesia was maintained by using the bispectral index(BIS) as a continuous infusion of dexmedetomidine 0.2-0.7 microgram per kg-1h-1 or midazolam 0.05-0.15 mgkg-1h-1. Heart rate, mean arterial pressure, MMSE, sedation and the patient's and surgeon's satisfaction were determined.

Conditions
-----------------
Postoperative Cognitive Functions

Intervention / Treatment
-----------------
* Drug: Remifentanil
* Drug: Midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with indication of cystoscopy must be able to have sedation Exclusion Criteria: hypersensitivity to drugs used morbid obesity coronary disease diabetes mellitus and other endocrinologic diseases pregnancy psychomotor diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Remifentanil|IV infusion|
|Drug: Midazolam|IV infusion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of sedative efficiency | Bispectral Index (BIS) was used. | During cystoscopy procedure | 
| Degree of cognitive functions | mini-mental state examination(MMSE) test was used. | Postoperative 60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dexmedetomidine, midazolam, remifentanil, mini-mental state examination, monitored anaesthesia care, cystoscopy, sedation
Long-Term Multicenter Evaluation of the E1® Tibial Bearing

Study Overview
=================
Brief Summary
-----------------
This study has been designed to document the long-term outcome of the E1® Tibial Bearings used with the Vanguard® Knee System in 500 patients receiving total knee arthroplasty. All patients will receive the E1® Tibial Bearing in a Vanguard® knee replacement. Radiographic analysis and patient reported outcomes will be used as follow-up measures to track wear, mechanical performance, and patient satisfaction.

Official Title
-----------------
Long-Term Multicenter Evaluation of the E1® Tibial Bearing

Conditions
-----------------
Osteoarthritis of the Knee, Traumatic Arthritis of the Knee

Intervention / Treatment
-----------------
* Procedure: Total knee arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female 20 to 75 years of age Subjects requiring total knee replacement Subjects with the diagnosis of osteoarthritis, or traumatic arthritis Subjects who demonstrate the ability to return to Massachusetts General Hospital for follow-up for the next 10 years Exclusion Criteria: Subjects with osteoporosis, osteomalacia, or neuromuscular disease Incomplete or insufficient soft tissue around the knee Subjects with a limited life span Subjects who have difficulty comprehending the study protocol for any reason Subjects with disorders which may impair bone formation Subjects whose bony structure deviates substantially from the general norm Female subjects that are, or may become, pregnant while participating in this study

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E1 Tibial bearing<br>All patients undergoing primary total knee replacement surgery will receive a tibial bearing made of E1 polyethylene, which is the material being monitored in this study. | Procedure: Total knee arthroplasty<br>* Primary total knee arthroplasty surgery for the treatment of osteoarthritis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship, as determined by the implant remaining within the patient. |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clinical outcomes, radiographic outcomes, total knee arthroplasty, survivorship
A Study of DTC in Patients With AIDS and AIDS Related Complex

Study Overview
=================
Brief Summary
-----------------
To determine if ditiocarb sodium (sodium diethyldithiocarbamate; DTC) restores immune and host defense function; if DTC ameliorates the AIDS related complex (ARC) symptoms in patients with AIDS and ARC; if DTC prevents progression from ARC to AIDS or progression of AIDS; and if DTC prolongs survival in AIDS.

Official Title
-----------------
A Study of DTC in Patients With AIDS and AIDS Related Complex

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Ditiocarb sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Zidovudine (AZT). Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Active opportunistic infection or progressive Kaposi's sarcoma (KS). Dementia. Lymphoma. Concurrent Medication: Excluded within 3 weeks of study entry: Other experimental AIDS therapy. Patients with the following are excluded: Active opportunistic infection or progressive Kaposi's sarcoma (KS). Patients must be either HIV seropositive or have AIDS or AIDS related complex (ARC) and have life expectancy of at least 6 months.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ditiocarb sodium|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
-----------------
Ditiocarb, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
Mutation Analysis of 17βhydroxysteroid Dehydrogenase 3 Deficiency

Study Overview
=================
Brief Summary
-----------------
To disclose the molecular pathology of our 3 families with 17βHSD3 deficiency.

Detailed Description
-----------------
17βhydroxysteroid dehydrogenase 3 (17βHSD3) deficiency is a rare cause of male pseudohermaphroditism. The incidence is reported to be 1: 147,000 in the Netherlands. Fewer than one hundred affected 46, XY males were reported in the literature, and no such case has been reported in Taiwan before. The 46, XY patients have ambiguious or complete female external genitalia. They are mostly unrecognized at birth and reared as female. They often draw medical attention when they receive operation for inguinal hernia or during puberty, clitoromegaly and musculization were noticed. However, the homozygous or compound heterozygous genetic females are asymptomatic. The 17βHSD3 catalyze the conversion of androstenedione to testosterone, the last step in the synthesis of testosterone. Therefore, the serum levels of androstenedione are elevated and testosterone or dihydrotestosterone are in the low range in these affected 46, XY individuals. The clinical diagnosis is made by HCG stimulation test, because androstenedione-to-testosterone ratio is abnormally elevated in these patients. But the molecular basis of 17βHSD3 deficiency was not determined till recent decade. The HSD17B3 gene was elucidated in 1994, and composed of 11 exons. Several missence mutation and splice mutation were identified. But the precise action and tissue distribution of 17βHSD3 still need to be clarified. The Wölffian ducts virilze normally in the embryonic stage and the serum concentration of testosterone achieve to the normal range in the pubertal stage. The exact mechanism is not understood clearly and peripheral conversion under other isozymes was suggested in some studies. The purpose of this study is to disclose the molecular pathology of our 3 families with 17βHSD3 deficiency.

Conditions
-----------------
Pseudohermaphroditism

Intervention / Treatment
-----------------
* Procedure: blood drawing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with 17β-hydroxysteroid dehydrogenase 3 deficiency and their family

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: blood drawing|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Alterations of Immunologic Mediators During Severe Sepsis

Study Overview
=================
Brief Summary
-----------------
Severe sepsis induces significant changes in expression of insulin- and toll-like receptors, cytokines, markers of apoptosis, and activation of t- and b-lymphocytes.

Detailed Description
-----------------
In patients at early stage of severe sepsis, we investigate the expression of pro- and anti-inflammatory cytokines, chemokines, adhesion-molecules, toll-like receptors, insulin-receptors, markers of apoptosis und of t- and b-cell-activation on a mRNA level.

Official Title
-----------------
Alterations of Immunologic Mediators During Severe Sepsis

Conditions
-----------------
Severe Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >= 18 y agreement with study procedures 3 of 4 SIRS-criteria proven or highly suspected infection 2 or more sepsis-induced organ failures start of first sepsis-induced organ failure within the last 36 hours Exclusion Criteria: non-agreement with study procedures signs of severe sepsis with organ failure > 36 hours chronic immuno-compromising diseases chronic therapy with anti-inflammatory drugs non-curable cancer chronic renal failure with hemodialysis pregnancy or breast-feeding

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 |
| --- | --- | --- |
| severity of sepsis | SOFA-Score | 96 hours after diagnosis of sepsis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sepsis, Early Stage, Immune System, Receptors, Cytokines
Abdominal Cutaneous Nerve Entrapment Syndrome

Study Overview
=================
Brief Summary
-----------------
Nerve entrapment as a cause of chronic abdominal pain is frequently overlooked. A series of nerves pass through the muscles of the abdomen before reaching the skin to carry sensations. They can get trapped within the muscles leading to severe pain resulting in a condition known as Abdominal Cutaneous Nerve Entrapment Syndrome (ACNES). ACNES affects between 10-30% of patients with chronic abdominal wall pain. A definitive diagnosis of ACNES is obtained by anaesthetising these nerves. Initial management includes education and avoidance of known triggers. It is common practice to inject steroid with local anaesthetic during the diagnostic injections itself to prolong pain relief. Like other nerve entrapment conditions, this is also refractory to medical treatment. Hence repeated injections and nerve entrapment release surgery are commonly carried out. In Aberdeen, a number of patients have been treated for this condition. A cohort of patients have benefitted with injection alone while recurrence has been noted in patients who have undergone surgery. This project aims to gain more understanding about the clinical course of patients with suspected ACNES by evaluation of the clinic progress.

Official Title
-----------------
The Management of Abdominal Cutaneous Nerve Entrapment Syndrome

Conditions
-----------------
Abdominal Pain, Abdominal Cutaneous Nerve Entrapment Syndrome

Intervention / Treatment
-----------------
* Procedure: Injection to or release of anterior cutaneous nerves


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In order to be eligible for inclusion, all patients must: Be aged 16 or over Be able to understand English Be able to give informed consent Be able to report on their health and pain status (neurologically stable) Should have undergone either injection or surgery for suspected ACNES Exclusion Criteria: Patients will be excluded if they: Are not able to understand what is required of them Are not able to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Injection to or release of anterior cutaneous nerves|Patients who have undergone at least one injection to the nerves|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of intervention | An intervention either injection or surgery is classed as success when there is either a 2 point difference in the average pain scores pre and post intervention or more than 30% improvement as rated by the participant in the Brief Pain Inventory used for evaluating the pain baseline and follow-up. | 3 months |
Exploring Liver and Muscle Fat Content Using MRI

Study Overview
=================
Brief Summary
-----------------
The aim of our study was to compare the difference of fatty infiltration in liver and muscle using magnetic resonance imaging (MRI) between overweight as well as obese polycystic ovary syndrome (PCOS) cases and body mass index (BMI)-matched women without PCOS, identifying the possible influence factors.

Official Title
-----------------
Exploring Liver and Muscle Fat Content in Overweight and Obese Polycystic Ovary Syndrome Using Magnetic Resonance Imaging Technique

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Radiation: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) subjects with a body mass index (BMI) ≥ 24 kg/m2; (2) subjects aged between 18 and 40 years; (3) subjects who had not received any prescription or non-prescription drugs that affect insulin sensitivity or ovarian function, including hormonal contraceptives and metformin, within three months before the trial; (4) PCOS diagnosis fulfills the Rotterdam 2003 criteria phenotype B with hyperandrogenism (HA) and oligo-/anovulation [29]; (5) subjects who had not received medication that impacts lipid metabolism (fibrates, statins, antioxidants and diuretic) in the recent 3 months; (6) subjects who did not intend to become pregnant and use barrier contraception; (7) subjects who did not change their lifestyle, including physical activity and eating habits, during the study period. Exclusion Criteria: -

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pcos<br> | Radiation: MRI<br>* MRI-mDIXON-Quant examinations, anthropometric measures, body composition, hormonal and biochemical assays were performed in all participants, and the liver fat fraction (LFF) and muscle fat fraction (MFF) represented the fat content in the liver and skeletal muscle, respectively.<br>|
| non-pcos<br> | Radiation: MRI<br>* MRI-mDIXON-Quant examinations, anthropometric measures, body composition, hormonal and biochemical assays were performed in all participants, and the liver fat fraction (LFF) and muscle fat fraction (MFF) represented the fat content in the liver and skeletal muscle, respectively.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver fat fraction | liver fat fraction (LFF) represented the fat content in liver. | 1 year |