linjc16/ctgov huggingface dataset:
A Safety Study of ARRY-502 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This is a Phase 1 study, involving a 14-day dosing period, designed to test the safety of investigational study drug ARRY-502 in healthy subjects. Approximately 32 healthy subjects from the United States will be enrolled in this study.

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

Intervention / Treatment
-----------------
* Drug: ARRY-502
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Healthy male or female between the ages of 18 and 50 years. Females must be of nonchildbearing potential. Body mass index (BMI) of 18 to 32 and a total body weight > 50 kg (110 lbs) and < 114 kg (250 lbs). Additional criteria exist. Key Exclusion Criteria: Evidence or history of clinically significant disease (excepting allergic rhinitis). Evidence of hepatitis B, hepatitis C or human immunodeficiency virus (HIV). Gastrointestinal surgery that may interfere with motility or absorption. Serious illness requiring hospitalization within the previous 6 months. A positive test for drugs or alcohol. Recent use of tobacco- or nicotine-containing products. Use of any medications, grapefruit or supplements within the previous 14 days. Use of corticosteroids within the previous 28 days. Recent history of blood, plasma or platelet donation. Treatment with a small-molecule investigational drug within the previous 30 days or any biologic therapy within the previous 6 months. Prior exposure to investigational study drug ARRY-502. Additional criteria exist.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARRY-502<br> | Drug: ARRY-502<br>* Oral; multiple dose, escalating<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral; matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the safety profile of the study drug as determined by adverse events, clinical laboratory tests, electrocardiograms and vital signs. |  | 3 weeks | 
| Characterize the pharmacokinetics of the study drug and metabolite as determined by plasma concentrations. |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the pharmacodynamics of the study drug as determined by laboratory assays. |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety
Association of Preoperative Sarcopenia and Intraoperative Hypotension in Patients Undergoing Minimally Invasive Pylorus Preserving Pancreaticoduodenectomy : Prospective Observational Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine whether preoperative sarcopenia (low muscle strength/muscle mass) is correlated with time weighted average intraoperative hypotension in patients undergoing minimally invasive pylorus preserving pancreaticoduodenectomy.

Official Title
-----------------
Association of Preoperative Sarcopenia and Intraoperative Hypotension in Patients Undergoing Minimally Invasive Pylorus Preserving Pancreaticoduodenectomy : Prospective Observational Study

Conditions
-----------------
Patients Undergoing Minimally Invasive Pylorus Preserving Pancreaticoduodenectomy

Intervention / Treatment
-----------------
* Device: Hand grip test, computed tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. patients 20 years or older who undergo minimally invasive pylorus preserving pancreaticoduodenectomy Exclusion Criteria: emergency surgery patients who cannot read consent forms(e.g., illiterate, foreigner, etc.) patients with cognitive dysfunction pregnant, lactating women When hand grip test cannot be performed patients with atrial fibrillation, moderate or severe valvular heart disease, left ventricular ejection fraction less than 35%

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| patients undergoing minimally invasive pylor-preserving pancreaticoduodenectomy<br>Adult patients aged 20 years or older and who underg minimally invasive pylor-preserving pancreaticoduodenectomy | Device: Hand grip test, computed tomography<br>* A hand grip test, abdominal computed tomography are performed before surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time weighted average intraoperative hypotension | 1) Intraoperative hypotension is defined as a mean blood pressure < 65 mmHg. | Procedure (From the induction of anesthesia to the end of anesthesia) |
ATG5 as a Serum Marker of Autophagy in Psoriatic Patient

Study Overview
=================
Brief Summary
-----------------
it will be of interest to know the ATG 5 as a serum marker of autophagy in serum of psoriasis vulgairs patients and explore its relationship with psoriasis severity.

Official Title
-----------------
Evaluation of ATG5 as Aserum Marker of Autophgy in Psoriasis Vulgaris Patients

Conditions
-----------------
Psoriasis Vulgaris, Autophagy

Intervention / Treatment
-----------------
* Diagnostic Test: serum ATG5


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Psoriasis vulgaris of both sex, age 18-55 years Exclusion Criteria: i. Patients with other types of psoriasis ii. Pregnant or lactating women iii. patients with hepatic or renal diseases iv. patients receive any systemic treatment in last 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| psoriasis vulgaris patients<br>psoriasis vulgaris patients , both sex , 18,55 years old | Diagnostic Test: serum ATG5<br>* This kit is used to assay the Autophagy protein 5(ATG5) in the sample of human's serum, blood plasma, and other related tissue Liquid<br>* Other names: human autophgy protien 5 ELISA kit;|
| healthy participants<br> | Diagnostic Test: serum ATG5<br>* This kit is used to assay the Autophagy protein 5(ATG5) in the sample of human's serum, blood plasma, and other related tissue Liquid<br>* Other names: human autophgy protien 5 ELISA kit;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum level of ATG5 in psoriatic patients | evaluation of serum ATG5 in psoriasis vulgaris patients by ELISA | Within 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
serum marker, ATG5
Molecular Characteristics of the Persistent Intestinal Fistulae After Glue Application

Study Overview
=================
Brief Summary
-----------------
For non-healing ulcers, abnormal periods of wound healing processes: inflammation, proliferation and remodelling, are believed to lead to chronic wounds. As a chronic stalled wound, investigators hypothesized that these glue-assisted closure (GAC)-failed enterocutaneous fistula (ECF) might have a prolonged inflammatory phase modulated by excessive pro-inflammatory cytokines or proteases. The aim of this study was to analyze the chemicals in ECF wounds in order to determine patients' condition and fitness for GAC.

Conditions
-----------------
Enterocutaneous Fistulas

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: above 18 years old; single tubular (tract length >2 cm) ECF; low output volume (<200 ml/24h); Exclusion Criteria: fistulas of cancer-infiltrated; associated abscess; foreign bodies; distal bowel obstruction;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Fistula closure after glue application | No fistula output | 7 days |
Thoracic Fluid Content and Acute Lung Injury

Study Overview
=================
Brief Summary
-----------------
To study the association of the thoracic fluid content and acute lung injury during liver transplantation.

Detailed Description
-----------------
Acute lung injury is not uncommon after liver transplantation. A new monitor non-invasive cardiac output monitor (NICOM) is designed to measure thoracic fluid content. The investigators attempt to use the parameter thoracic fluid content to investigate its relationship with acute lung injury in liver transplant recipients.

Official Title
-----------------
The Association of Thoracic Fluid Content and Acute Lung Injury in Liver Transplantation

Conditions
-----------------
Acute Lung Injury

Intervention / Treatment
-----------------
* Device: NICOM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: end stage liver disease scheduled for liver transplantation in National Taiwna University Hospital. Exclusion Criteria: allergic reaction history of aortic regurgitation pre-existing pulmonary disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| NICOM<br> | Device: NICOM<br>* NICOM monitoring thoracic fluid content at baseline(T1), anhepatic phase(T2), 30 mins after reperfusion(T3) and 2 hrs after reperfusion(T4).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac index | Participants will be followed for the duration the operation. Cardiac index was measured by non-invasive cardiac output monitor at different time points as baseline(T1), anhepatic phase(T2), 30 mins after reperfusion(T3) and 2 hrs after reperfusion(T4) | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thoracic fluid content | Participants will be followed for the duration the operation.Thoracic fluid content was measured in liver transplant recipients at different time points as baseline(T1), anhepatic phase(T2), 30 mins after reperfusion(T3) and 2 hrs after reperfusion(T4). | one day |
Drug Interaction Between Ritonavir And Sitaxsentan

Study Overview
=================
Brief Summary
-----------------
The study is to assess if sitaxsentan and ritonavir will affect the blood levels of each other when coadministered.

Official Title
-----------------
A Phase 1, Open Label, Randomized, Multiple Dose Study To Assess The Two-Way Drug Interaction Between Sitaxsentan And Low Dose Ritonavir In Healthy Subjects

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: Sitaxentan
* Drug: Ritonavir
* Drug: Sitaxsentan
* Drug: Ritonavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects and/or women of non-child bearing potential. Subjects (because of teratogenic risk of sitaxsentan) between the ages of 21 and 55 years, inclusive. Signed informed consent. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. History of significant alcohol and drug use. Has hepatic dysfunction.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 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 |
| --- | --- |
| Active Comparator: Treatment A<br> | Drug: Sitaxentan<br>* Sitaxsentan Tablet, 100 mg, q24h (once daily) for 5 days.<br>|
| Active Comparator: Treatment B<br> | Drug: Ritonavir<br>* Ritonavir Capsule, 100 mg, q12h (twice daily) for 5 days (morning dose only on Day 5).<br>|
| Experimental: Treatment C<br> | Drug: Sitaxsentan<br>* Sitaxsentan Tablet, 100 mg, q24h (once daily) for 5 days<br>Drug: Ritonavir<br>* Ritonavir Capsule, 100 mg, q12h (twice daily) for 5 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The comparison of peak plasma concentration of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone. |  | 24 hours | 
| The comparison of area under the curve of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone. |  | 24 hours | 
| The comparison of peak plasma concentration of ritonavir when coadministered with sitaxsentan versus ritonavir administered alone. |  | 24 hours | 
| The comparison of area under the curve of ritonavir when coadministered with sitaxsentan versus ritonavir administered alone. |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sitaxentan, ritonavir, drug interaction, pharmacokinetics
Acute Respiratory Distress Syndrome in Taiwan

Study Overview
=================
Brief Summary
-----------------
The study enrolls ARDS patients in medical ICUs in 11 Hospitals in Taiwan. The epidemiology and long-term outcomes of the patients will be recorded.

Official Title
-----------------
Epidemiology and Long-term Outcomes of Patients With Acute Respiratory Distress Syndrome in Taiwan

Conditions
-----------------
Acute Respiratory Distress Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Patients in medical intensive care unit in Sep., 2017 and Jan., 2018. Exclusion Criteria: Age less than 18 years. 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epidemiology | The incidence of ARDS in intensive care unit | two months | 
| Mortality | The mortality rate of patients in hospital | 90 days | 
| Long-term outcome | Performance status of live patients discharged. | 5 years |
Measuring the Balance Improvement on Multiple Sclerosis Patients After a Short Training Period With an APOS (All Phase Of Step Cycle) Kit

Study Overview
=================
Brief Summary
-----------------
Randomised double blind study of two parallel groups,one of the groups trained with the full APOS kit (a shoe with an additional bio mechanical device) The control group trained with the Apos shoe without the bio mechanical device. both groups will be checked at the beginning of the study, one month later and at the end of the study after two months. The tests include neurological test, functional test(FSST,up and go test and berg balance test) gate analysis and quality fo life (rays) test.

Conditions
-----------------
Multiple Sclerosis, Balance, Cerebelar Impairment

Intervention / Treatment
-----------------
* Device: APOS shoe kit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of Multiple sclerosis Cerebellar impairment EDSS under 4.5 age 18-65 years signed informed consent form Exclusion Criteria: pregnancy coronary event in last 6 month 30 days or less after acute attack steroidal treatment in the last 60 days alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: APOS shoe kit|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional tests |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gait analysis |  |  |
Observational Study of Outcomes After EchoMark and EchoSure-based Free Flap Monitoring

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the performance of the EchoMark and EchoSure as an ultrasound-based method of monitoring the viability of free flaps and patency of at-risk vessels.

Official Title
-----------------
Observational Study of Outcomes After EchoMark and EchoSure-based Free Flap Monitoring

Conditions
-----------------
Free Flap Transfer, Malignant Neoplasm

Intervention / Treatment
-----------------
* Device: EchoMark
* Device: EchoSure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Patients presenting for microvascular tissue transfer procedures where the surgeon has selected EchoMark and EchoSure as the optimal method of vascular monitoring based on clinical assessment and plan Patient is able to sign informed consent and able to participate in all testing associated with this clinical investigation Women of childbearing potential have a negative pregnancy test Exclusion Criteria: Age <18 years old Patient unable to sign informed consent Patient participating in another investigational device or pharmacological study Prisoner or patient from vulnerable populations as defined in 45 CFR 46.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: EchoMark|EchoMark is implanted during surgery to mark the at-risk blood vessels to enable EchoSure ultrasound-based monitoring|
|Device: EchoSure|EchoSure ultrasound scans are performed to monitor the free flap|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgeon evaluation of improved monitoring ability via questionnaire with likert scale |  | Through study completion, an average of 1 year | 
| Surgeon evaluation of satisfaction via questionnaire with likert scale |  | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flap failure rate |  | Through patient stay, up to 5 days post-op | 
| Flap takeback rate |  | Through patient stay, up to 5 days post-op | 
| Flap salvage rate |  | Through patient stay, up to 5 days post-op | 
| Total cost of hospitalization |  | Through patient stay, up to 5 days post-op | 
| Time from OR departure to return to OR |  | Through patient stay, up to 5 days post-op | 
| Nurse evaluation of improved monitoring via questionnaire with likert scale |  | Through study completion, an average of 1 year |
Measuring and Predicting Glycemic Response to Food in Patients With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
Personalized medicine methods in the management of type 1 diabetes

Detailed Description
-----------------
This proposal joins together clinical practitioners, biologists, and computer scientists to set up the infrastructure for research that will facilitate, for the first time, the use of big-data, machine-learning approaches in the application of personalized medicine methods in the management of type 1 diabetes mellitus. We will model the clinical, microbial, and nutritional factors underlying the variability in glycemic response to food in this population; develop algorithms for prediction of this response and for the accurate administration of insulin, assisting the clinical management of the disease and discover intervention targets in the gut microbiome aimed at improving glycemic control.

Official Title
-----------------
Measuring and Predicting Glycemic Response to Food in Patients With Type 1 Diabetes

Conditions
-----------------
Personalized Medicine in Type 1 Diabetes

Intervention / Treatment
-----------------
* Other: non-Interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over one year of diagnostic with T1DM. Exclusion Criteria: Drug related diabetes. genetical diabetes.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: non-Interventional|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood glucose |  | 2 weeks |