linjc16/ctgov huggingface dataset:
Study of Oglemilast for the Treatment of Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether oglemilast is safe and effective in the treatment of allergen-induced asthma.

Official Title
-----------------
Efficacy and Safety of Oglemilast in the Prevention of Allergen-induced Bronchospasm

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Oglemilast
* Drug: Placebo then Oglemilast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild atopic asthma Hyperreactivity to methacholine Exhibit positive response to standard allergen skin prick test Exclusion Criteria: Pulmonary disease other than asthma Asthma exacerbation within 4 weeks History of substance abuse Active cardiac disease

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oglemilast followed by placebo<br> | Drug: Oglemilast<br>* Oglemilast, 15mg oral administration, once per day and then dose-matched placebo<br>|
| Experimental: Placebo followed by Oglemilast<br> | Drug: Placebo then Oglemilast<br>* Dose-matched placebo and then Oglemilast, 15mg, oral administration, once per day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of oglemilast in the prevention of bronchoconstriction after the administration of allergen, in comparison with placebo in patients with mild asthma |  | From Baseline to Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of oglemilast over 2 weeks as determined by adverse events,physical examinations, vital signs, electrocardiograms, and laboratory examinations |  | From Baseline to Day 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oglemilast, asthma, allergen, prevention, prophylaxis, Allergen-Induced Asthma
Early Detection of Lung Cancer and Mesothelioma in Workers Exposed to Asbestos

Study Overview
=================
Brief Summary
-----------------
This is a pilot study that aims to develop a lung cancer screening program for workers in British Columbia, Canada exposed to asbestos who are at risk of developing lung cancer/pleural mesothelioma. This is high risk population is at of respiratory system diseases as a result of their occupational exposures. Additionally, knowledge garnered from this study will allow us to develop other studies that will further our understanding of asbestos related lung cancer and mesothelioma.

Official Title
-----------------
Early Detection of Lung Cancer and Mesothelioma in Workers Exposed to Asbestos

Conditions
-----------------
Mesothelioma, Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women or men age 50 to 79 years history of exposure to asbestos at work and one or more of the following: lung cancer risk ≥2% over 3 years or asbestosis or pleural plaques on a chest x-ray or abnormal auto-antibodies level using the EarlyCDT test Capable of providing informed consent for screening procedures (low dose spiral CT, lung function, blood biomarkers). Exclusion Criteria: Any medical condition, such as severe heart disease (e.g. unstable angina, chronic congestive heart failure), acute or chronic respiratory failure, or any disorder, that in the opinion of the physician unlikely to benefit from screening due to shortened life-expectancy from co-existing illnesses Have been previously diagnosed with mesothelioma Have had other cancer within the past 5 years with the exception of the following cancers: non-melanomatous skin cancer,localized prostate cancer, carcinoma in situ (CIS) of the cervix, or superficial bladder cancer. Treatment of the exceptions must have ended >6 months before registration into this study Pregnancy Unwilling to have a low dose CT scan of chest Unwilling to sign a consent

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 79 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 |
| --- | --- |
| Workers exposed to asbestos<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of Model to Predict Workers at highest risk of lung cancer/mesothelioma |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung Cancer, Mesothelioma, Early Detection
Effects of Allium Hookeri on Blood Glucose

Study Overview
=================
Brief Summary
-----------------
The researchers investigated the anti-diabetic effects of Allium hookeri root extract for Korean prediabetic participants.

Detailed Description
-----------------
Allium hookeri root is widely consumed as a vegetable and herbal medicine in Asia. Although the antidiabetic activities of Allium hookeri have been documented in animal studies, the improved effects of Allium hookeri on human are not clear. Therefore, in this study, the researchers investigated whether Allium hookeri root extract could be effective in reducing the risk of type 2 diabetes in individuals with prediabetes.

Official Title
-----------------
An 8 Week, Randomized, Double-blind, Placebo-controlled Crossover Clinical Trial of Allium Hookeri Root Extract on Anti-diabetic Effects

Conditions
-----------------
PreDiabetes

Intervention / Treatment
-----------------
* Dietary Supplement: Allium hookeri extract
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fasting glucose 100 126 mg/dl Exclusion Criteria: Significant variation in weight (more 10%) in the past 3 months Treatment by hypoglycemic and hypolipidemic drug therapy within the past three months Type 1 diabetes or HbA1c>9.0% Cardiovascular disease Hypoglycemic agent, obesity medicine, and lipid lowering agent within past 6 months or blood sugar, obesity, and lipid improvement functional foods within past 2 monts Pregnancy or breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allium hookeri extract<br>take two capsules per day (486 mg/day) for 8 weeks | Dietary Supplement: Allium hookeri extract<br>* take two capsules per day (486 mg/day) for 8 weeks<br>* Other names: AH;|
| Placebo Comparator: Placebo<br>take two capsules per day for 8 weeks | Dietary Supplement: Placebo<br>* take two capsules per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of blood glucose during OGTT | Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of blood insulin | Changes of blood insulin were assessed before and after the intervention | 8 week | 
| Changes of C-peptide | Changes of C-peptide were assessed before and after the intervention | 8 week | 
| Changes of HbA1c | Changes of HbA1c were assessed before and after the intervention | 8 week |
Bioequivalency Study of Sertraline Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was the bioequivalence of a Roxane Laboratories' Sertraline Tablets, 100 mg, to Zoloft® Tablets, 100 mg (Pfizer) under fed conditions using a single-dose, 2-treatment, 2-period, crossover design.

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of Sertraline Tablets 100 mg Under Fed Conditions

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: Sertraline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. Treatment with any triptan within 30 days prior to or during the study. History of allergic or adverse response to sertraline or any comparable or similar product.

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two period, Fourteen day washout |
Serum Serotonin and Pruritus After Intrathecal Morphine in Cesarean Section

Study Overview
=================
Brief Summary
-----------------
Pruritus is the commonest side effect of intrathecal morphine especially in parturient, but the exact mechanism of pruritus is not clear. Many mechanisms have been suggested. Among these mechanisms is the activation of the 5-HT3 receptors by the intrathecally injected morphine.

Detailed Description
-----------------
Forty parturients underwent elective cesarean section under spinal anesthesia were divided into two groups of 20 each in this prospective randomized study. Group I received 100 µg of intrathecal morphine (ITM) mixed with 12 mg of 0.5% heavy bupivacaine (M100) while group II received 200 µg of ITM mixed with 12 mg of 0.5% heavy bupivacaine (M200). Two blood samples were taken from each patient for serotonin estimation, preoperatively and 4 hrs later. Postoperatively all patients were assessed for pruritus (incidence & severity), visual analog scale (VAS), first request of analgesia, and total analgesic dose required within 24 hrs.

Official Title
-----------------
Pruritus After Intrathecal Morphine in Cesarean Section: Incidence, Severity and Its Relation to Serum Serotonin Level

Conditions
-----------------
Pruritus

Intervention / Treatment
-----------------
* Drug: Morphine 100 μg
* Drug: Morphine 200 μg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I - II term pregnant patients scheduled for elective cesarean section Exclusion Criteria: patients with a known allergy to the study drugs significant cardiac, respiratory, renal, neurological, or hepatic disease; -coagulation disorders BMI > 30 kg/m2 any itchy skin diseases.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I<br>intrathecal injection of 100 μg morphine | Drug: Morphine 100 μg<br>* Intrathecal injection of morphine100 μg<br>* Other names: M100;|
| Active Comparator: Group II<br>iIntrathecal injection of 200 μg morphine | Drug: Morphine 200 μg<br>* Intrathecal injection of morphine 200 μg<br>* Other names: M200;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pruritus | incidence | 24 hours postoperative | 
| Pruritus | severity | 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serotonin | Serum level | preoperative | 
| serotonin | Serum level | 4 hours postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
morphine, pruritus, serotonin
A Study to Evaluate Combining Metformin With Muraglitazar or Pioglitazone in Type 2 Diabetics

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate if type 2 diabetics who have inadequate glycemic control on metformin alone, have a similar, or not inferior, glycemic response when treated with the combination of muraglitazar and metformin compared to pioglitazone and metformin.

Official Title
-----------------
A Phase 3, Randomized, Double-Blind, Active-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination With Metformin Compared to Pioglitazone in Combination With Metformin in Type 2 Diabetics With Inadequate Glycemic Control on Metformin Alone

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Muraglitazar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetics HbA1c ≥7.0% and ≤10.0%,currently receiving a stable dose of metformin 1500 to 2550 mg/day for at least 6 weeks prior to screening were enrolled in this study. Fasting C-peptide ≥1.0 ng/mL BMI≤41 kg/m2 mean fasting serum trig. ≤600 g/dL Exclusion Criteria: symptomatic type 2 diabetics with > 10% weight loss 3 months prior to study history of diabetic ketoacidosis, hyperosmolar nonketotic coma, insulin therapy, inability to take muraglitazar, pioglitazone, or metformin according to investigator brochure or labeling History of MI (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (TIA), cerebrovascular attack, or cerebrovascular accident (CVA) within 6 months, congestive heart failure (NYHA Class III and IV, uncontrolled hypertension, history of, or renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare change from basline in HbA1c after 24 weeks and 50 weeks of treatment with muraglitazar + metformin vs. pioglitazone + metformin |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FPG from basline to W24, proportion of subjects receiving therapeutic response at W24, percent change of fasting lipid levels from baseline to W11/12, change in |  |  | 
| hs-CRP from baseline to W24 |  |  |
Validity and Reliability of the Polar M200 Activity Monitor

Study Overview
=================
Brief Summary
-----------------
The aim of this study will be to investigate the validity of a consumer available activity tracker (Polar M200) in free-living conditions to measure sedentary time.

Detailed Description
-----------------
The aim of the present study is to evaluate the validity from a commercially available wearable Polar device. Consumer-based activity trackers are generally cheaper, designed for long-term wear and are less intrusive. Potentially, consumer-based activity trackers can be used for research purposes, but high-quality validation studies are needed. The aims of this study will be to assess validity of sedentary outcome measures of a Polar device during free-living conditions in comparison with the ActivPAL3TM activity monitor (AP; PAL Technologies Ltd, Glasgow, UK), which is considered the gold standard to measure sedentary time in free-living conditions.

Official Title
-----------------
Validity and Reliability of the Polar M200 Activity Monitor to Measure Sedentary and Active Time

Conditions
-----------------
Healthy Persons, Fitness Trackers

Intervention / Treatment
-----------------
* Device: Polar M200


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults Exclusion Criteria: /

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy adult group<br>Sixty healthy adults, aged 18-65 years, will be included following written informed consent. | Device: Polar M200<br>* Participants will have to wear the activity monitors (AP and Polar M200) for at least 7 days. Minutes spent in each activity type will be summed to a total day score. Participants will be instructed to do their regular daily life activities without limitation, but to note their main activity categories in an activity diary, with a main focus on cycling and participation in structured exercise.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedentary time | Sedentary time | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steps | Number of steps | 7 days | 
| Sleeping time | Sleeping time | 7 days | 
| Standing time | Standing time | 7 days | 
| Walking time | Walking and running time | 7 days |
Effectiveness of Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis in Intraocular Pressure (IOP) After Bevacizumab

Study Overview
=================
Brief Summary
-----------------
Purpose: To evaluate the effects of anterior chamber paracentesis, brimonidine and oral acetazolamide to reduce intra-ocular pressure (IOP) variations after intravitreal bevacizumab injection (IVBV). Methods: 47 patients scheduled for IVBV (1.5 mg / 0.06 ml) will be randomly assigned to a pre-treatment 1 hour before IVBV with either 250 mg oral acetazolamide (DIA, 9 eyes), anterior chamber paracentesis immediate after IVBV (PAR, 15 eyes), topic brimonidine tartarate 1 hour before IVBV (BRI, 14 eyes), or no pre-treatment IBVB (CTR, 9 eyes). IOP will be measured 90 minutes before injection (baseline), just before injection, and at 3, 10, 20 and 30 minutes after the procedure.

Official Title
-----------------
Effectiveness of Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis for Ocular Hypertension Control After Intravitreal Bevacizumab Injection: Preliminary Results

Conditions
-----------------
Macular Edema, Diabetic Retinopathy, Macular Degeneration

Intervention / Treatment
-----------------
* Drug: bevacizumab
* Procedure: anterior chamber paracentesis
* Drug: acetazolamide
* Drug: brimonidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: macular edema Exclusion Criteria: pulmonary chronic problems chronic renal failure intraocular inflammation drug or alcohol addiction

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bevacizumab|nan|
|Procedure: anterior chamber paracentesis|nan|
|Drug: acetazolamide|nan|
|Drug: brimonidine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-ocular pressure variation after intra-vitreous injection of bevacizumab |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bevacizumab, intra-ocular pressure, acetazolamide, anterior chamber paracentesis, brimonidine, macular edema secondary to diabetic retinopathy or macular degeneration
Observational Study of the Switch of Metformin Alone to Metformin Combined With Repaglinide in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this observational study is to investigate the switch from metformin alone to metformin combined with repaglinide in type 2 diabetic patients not achieving adequate glycaemic control on maximal dose of metformin given alone and to analyse different epidemiological parameters.

Official Title
-----------------
Observational Study Investigating the Efficacy of Switching From Metformin Monotherapy to a Dual Therapy of Metformin and Repaglinide on Glycaemic Control in Type 2 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: repaglinide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic patients with inadequate glycaemic control when received metformin alone on maximal dose Signed informed consent Treatment in accordance with the summary of product characterisation Exclusion Criteria: Any contraindication to metformin or repaglinide

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| A<br> | Drug: repaglinide<br>* Start dose and freqency to be prescribed by the physician at his discretion following clinical practice<br>* Other names: Prandin®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (number of hypoglycaemic incidents) |  | After 10-20 weeks | 
| HbA1C |  | After 10-20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety |  | After 10-20 weeks | 
| posology |  | After 10-20 weeks | 
| lifestyle |  | After 10-20 weeks | 
| FBG |  | After 10-20 weeks |