linjc16/ctgov huggingface dataset:
Prevention of Ileus After Gynecologic Surgery Using Chewing Gum

Study Overview
=================
Brief Summary
-----------------
This study will attempt to determine if the use of chewing gum can cause the early return of bowel function after gynecologic surgery.

Official Title
-----------------
Prevention of Post-Op Ileus After Gynecologic Surgery Using Chewing Gum

Conditions
-----------------
Ileus

Intervention / Treatment
-----------------
* Other: chewing gum - Extra Winterfresh
* Other: Standard Post-Op Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All female patients 18 years of age or older undergoing surgery for any gynecologic procedure which the peritoneum is entered and general anesthesia is administered. Disease State will not affect inclusion in the study. Women with previous surgeries or other medical conditions will be included as will those undergoing an initial operation. Exclusion Criteria: Patient deemed legally incompetent to sign their own consent Women under the age of 18 Patients lacking their own or a false set of teeth

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients are given standard post-op care with clear liquid diet as tolerated plus chewing gum q8 for 30minute chewing intervals. | Other: chewing gum - Extra Winterfresh<br>* Patients are given standard post-op care with clear liquid diet as tolerated plus chewing gum q8 for 30minute chewing intervals.<br>|
| Sham Comparator: 2<br>Patients are given standard post-op care with clear liquid diet as tolerated . | Other: Standard Post-Op Care<br>* Patients are given standard post-op care with clear liquid diet as tolerated.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ileus |  | Until ileus formation or first flatus post-op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ileus,, Gynecologic surgery,, Post-operative,, Flatus
Study to Compare the Pharmacokinetics and Pharmacodynamics of 6 mg RGB-02 to 6 mg Neulasta

Study Overview
=================
Brief Summary
-----------------
Single-centre, double-blind, randomised, two-period, two-way crossover study to investigate the pharmacokinetics and pharmacodynamics of RGB-02 as compared to Neulasta® administered as a single subcutaneous injection in healthy adult subjects.

Official Title
-----------------
Randomised, Double-Blind, Single, 6 mg Fixed Dose, Two Treatment, Two-Period, Two-Sequence, Two-Way Crossover Comparative Pharmacokinetic and Pharmacodynamic (Phase I) Study of RGB-02 Compared to Neulasta® in Healthy Adult Subjects

Conditions
-----------------
Bioequivalence

Intervention / Treatment
-----------------
* Drug: RGB-02 or Neulasta® (pegfilgrastim)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males or non-pregnant, non-lactating healthy females aged 18 to 55 years Body mass index ≥19.0 to ≤30.0 kg/m2 Body weight >55 kg Exclusion Criteria: Prior exposure to filgrastim, pegfilgrastim or lenograstim (Period 1 only) Subjects who have received any IMP in a clinical research study within the previous 3 months History of any drug or alcohol abuse in the past 2 years Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine) Current smokers who smoke more than 10 cigarettes per day Positive drugs of abuse test result Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RGB-02 6 mg SC (test product)<br> | Drug: RGB-02 or Neulasta® (pegfilgrastim)<br>* Pre-filled syringe containing 6 mg RGB-02 or Neulasta® in 0.6 mL, administered as subcutaneous injection into the abdominal area<br>|
| Active Comparator: Neulasta®<br> | Drug: RGB-02 or Neulasta® (pegfilgrastim)<br>* Pre-filled syringe containing 6 mg RGB-02 or Neulasta® in 0.6 mL, administered as subcutaneous injection into the abdominal area<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameter: AUC0-inf | Area under the serum concentration vs time curve from dosing to the last measured time point | 67 days | 
| Pharmacokinetic parameter: Cmax |  | 67 days | 
| Pharmacodynamic parameter: ANCmax |  | 67 days | 
| Pharmacodynamic parameter: ANC AOBEC0-tlast |  | 67 days |
After Eighty Study

Study Overview
=================
Brief Summary
-----------------
The rationale of the present clinical trial is to study whether an invasive strategy in clinical stable patients over 80 years with NSTEMI/UAP may improve rates of death, reinfarction, stroke, need of urgent revascularisation, myocardial function and quality of life. The invasive approach involves coronary angiography with immediate evaluation for three different treatment options; 1. Percutaneous coronary intervention (PCI), 2. Coronary artery bypass graft (CABG) or 3. medical treatment. Clinical practice shows that older patients are commonly treated less vigorously than younger patients and the present guidelines are based on a considerably younger population.

Official Title
-----------------
A Randomised Prospective Study of an Invasive Strategy Versus Medical Therapy in Patients Over 80 Years With Non ST-Elevation Myocardial Infarction (NSTEMI) or Unstable Angina Pectoris (UAP)

Conditions
-----------------
Coronary Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 80 years. Acute coronary syndrome (NSTEMI/UAP) with chest pain > 10 minutes, with or without ST-segment depression in ECG, and normal or elevated levels of troponin T or I. Elevated troponin levels are defined as values exceeding the 99 percentile of a normal population at the local laboratory at each participating site. Clinical stable Exclusion Criteria: Age < 80 years. ST-segment elevation in ECG (STEMI) Clinical unstable with ongoing chest pain or other ischaemic symptoms/signs. Cardiogenic shock. Short life expectancy due to extra cardiac reason, ie. COPD, disseminated malignant disease, or other reason. Anamnestic indications for significant mental disorder, including dementia. Any condition which interferes with patients possibility to comply with protocol.

Ages Eligible for Study
-----------------
Minimum Age: 80 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 |
| --- | --- | --- |
| Composite endpoints. | Does an invasive strategy in clinical stable patients over 80 years with NSTEMI/UAP improve rates of death, reinfarction, stroke and need of urgent revascularisation? | One year follow up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death of any cause |  | One year from randomization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary heart disease in patients over, 80 years of age.
Differential Expression and Analysis of Peripheral Plasma Exosome miRNA in Patients With Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the miRNA expression profile in peripheral blood exosomes of patients with myocardial infarction and to investigate its relationship with myocardial infarction.

Detailed Description
-----------------
Collect exosomes in peripheral blood of patients with myocardial infarction, compare the expression of miRNA with healthy volunteers, find out the miRNAs with significant differences, and explore its relationship with the development of myocardial infarction.

Official Title
-----------------
Differential Expression and Analysis of Peripheral Plasma Exosome miRNA in Patients With Myocardial Infarction

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Other: exosome


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years ST elevation by ECG diagnostic of STEMI Evidency of coronary occlusion in coronariography Signed informed consent Exclusion Criteria: Patients who will undergo immediate PCI Pregnant and lactating women Patients with mental disorders Patients are using other experimental drugs; Refusal to provide informed.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| myocardial infarction group<br>Patients admitted with the diagnosis of myocardial infarction. | Other: exosome<br>* Collect exosomes in peripheral blood of patients and extract miRNAs from them.<br>|
| Blank control group<br>Patients admitted without the diagnosis of myocardial infarction. | Other: exosome<br>* Collect exosomes in peripheral blood of patients and extract miRNAs from them.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of differential expression of miRNA by second-generation sequencing technology |  | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic value of the differential microRNAs evaluate by qPCR in patients of myocardial infarction |  | Day 7 |
PK and Safety Study of HCP1102, HGP0813 and HGP1408

Study Overview
=================
Brief Summary
-----------------
This study is a randomized, open label, single dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety/tolerability of HCP1102 in comparison to HGP0813 and HGP1408 administered in healthy male volunteers.

Official Title
-----------------
A Randomized, Open Label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of HCP1102 in Comparison to HGP0813 and HGP1408 Administered in Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: montelukast and levocetirizine FDC
* Drug: Singulair + xyzal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19 45 years in healthy male volunteers BMI is more than 19kg/m^2 , no more than 28.0 kg/m^2 Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing Exclusion Criteria: Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system Subjects who judged ineligible by the investigator

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

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

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: Group 1<br>Reference Drug → Test Drug | Drug: montelukast and levocetirizine FDC<br>* HCP1102<br>Drug: Singulair + xyzal<br>* HGP0813 + HGP1408<br>|
| Experimental: Group 2<br>Test Drug → Reference Drug | Drug: montelukast and levocetirizine FDC<br>* HCP1102<br>Drug: Singulair + xyzal<br>* HGP0813 + HGP1408<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast of Montelukast |  | 1 Day 0 hour, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hour, 2 Day 0 hour, 3 Day 0 hour | 
| Cmax of Montelukast |  | 1 Day 0 hour, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hour, 2 Day 0 hour, 3 Day 0 hour | 
| AUClast of Levocetirizine |  | 1 Day 0 hour, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hour, 2 Day 0 hour, 3 Day 0 hour | 
| Cmax of Levocetirizine |  | 1 Day 0 hour, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hour, 2 Day 0 hour, 3 Day 0 hour |
Indocyangreen Elimination in Cirrhosis and Acute Liver Failure

Study Overview
=================
Brief Summary
-----------------
Indocyangreen (ICG)is totally biliary eliminated and corresponds to hepatocyte function and liver perfusion. The ICG-clearance will be evaluated as a prognostic marker in liver disease.

Detailed Description
-----------------
patients with acute liver failure or advanced liver disease will be studied. ICG-clearance will be correlated with established clinical scores and outcome.

Official Title
-----------------
Evaluation of the Indocyangreen Elimination as a Prognostic Marker in Decompensated Cirrhosis and Acute Liver Failure

Conditions
-----------------
Acute Liver Failure, Liver Cirrhosis

Intervention / Treatment
-----------------
* Procedure: Indocyangreen (ICG) clearance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute liver failure OR end-stage liver disease normal hepatic perfusion by doppler ultrasound Exclusion Criteria: portal vein thrombosis allergy to ICG or iodine thyroid disease

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Indocyangreen (ICG) clearance|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
-----------------
ICG clearance, liver cirrhosis, acute liver failure, prognosis
The Safety/Tolerability and Pharmacokinetics (PKs) of Naftopidil in Korean Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
The safety/tolerability and pharmacokinetics (PK) of Naftopidil (commercial name: Flivas) after oral administration will be investigated in Korean healthy male volunteers. All volunteers will be assigned to 2 groups and administered a lower single dose tablet (Period 1). After one week's wash-over period, the volunteers take higher dosages (Period 2).

Official Title
-----------------
A Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics of Naftopidil After Oral Administration in Korean Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: Naftopidil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males subjects, 20-45 years inclusive Weight over 55 kg inclusive and Ideal Body Weight (IBW) between -20% and +20% inclusive Written informed consent given Exclusion Criteria: Hypersensitivity to drugs(aspirin, antibiotics and so on) including naftopidil History or presence of any clinically significant liver or kidney disease, gastrointestinal, cardiovascular, respiratory, endocrinal, musculoskeletal, neurologic/psychiatric, urinary, hematological, oncological pathology Have a history of drug abuse, or show positive for drug abuse at urine screening Have participated in another clinical study within 2 months prior to entering inth the study Are considered ineligible by the investigator due to clinical laboratory results or any other relevant reasons

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naftopidil<br> | Drug: Naftopidil<br>* 25mg/ 50 mg/ 75mg dosage tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of naftopidil |  | Dec. 2009 (anticipated) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, Safety, tolerability
Lipoarabinomannan (LAM) Enzyme-Linked Immunosorbent Assay (ELISA) in Diagnostics of Childhood Tuberculosis (TB)

Study Overview
=================
Brief Summary
-----------------
In children, it remains quite difficult even in developed countries, to prove a diagnosis of Tuberculosis (TB). New means for diagnosis of this disease are currently being researched. One candidate test is Lipoarabinomannan ELISA from Urine, which has shown good sensitivity of up to 80% in adults. Our study aims to evaluate this test in the diagnosis of children with TB.

Detailed Description
-----------------
Among candidate new diagnostics for TB, a test for mycobacterial Lipoarabinomannan (LAM) excretion in urine has shown promising results in one Tanzanian study: The sensitivity for detecting TB culture-positive patients was 80.3%. Of 103 healthy volunteers, only one gave a false positive result (Boehme, 2005). Until now, there are only data concerning this test for diagnosis of adult disease. For evaluation of routine use in children in countries like Malawi, we are starting a prospective study. Children 0-14 years of age with suspected TB will be investigated using TB culture as the gold standard. In sputum samples, microscopy will be done. Simultaneously, LAM Elisa from the patient´s urine will be done.

Official Title
-----------------
Evaluation of Urine Lipoarabinomannan ELISA In Diagnostics of Childhood Tuberculosis

Conditions
-----------------
Tuberculosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 0-14 years suspicion of active TB or TB contact Exclusion Criteria: no informed consent

Ages Eligible for Study
-----------------
Maximum Age: 14 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
childhood, tuberculosis, diagnostic, lipoarabinomannan, ELISA, Tuberculosis in Childhood
Prednisolone Novel Endpoint Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
Prednisolone will be used as a model medication to identify new clinical outcomes for future evaluation of new therapies in short-term studies (up to 4 weeks) in patients with Chronic Obstructive Pulmonary Disease (COPD).

Official Title
-----------------
A Randomized, Double-blind Study of Treatment With a Known Anti-inflammatory (Prednisolone) to Evaluate Novel Endpoints in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Prednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An established clinical history of COPD Evidence of bronchitis Current or ex-smoker Exclusion Criteria: COPD exacerbation requiring steroid and/or antibiotics in the last month Taking oral or inhaled steroids for more than 14 days in the last 6 months Unable to withhold salbutamol/albuterol for a 6 hour period History of alcohol, substance or drug abuse within the last year. Other significant medical condition e.g. diabetes Cancer that has not been in complete remission for at least 5 years As a result of the medical interview, physical examination or screening investigations, that the doctor considers the subject unfit for the study.

Ages Eligible for Study
-----------------
Minimum Age: 40 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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lung function tests using a system called Impulse oscillometry (IOS). CT scans to measure the thickness of the tubes in the lungs Blood, sputum and breath samples to measure chemical products in the lungs and body that relate to COPD |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Traditional lung function tests & Symptom Questionnaires |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CT scan, breathing tests, lung function tests, biomarkers, prednisolone, IOS, COPD, clinical outcomes