linjc16/ctgov huggingface dataset:
Study to Determine the Efficacy, Safety, Tolerability & Pharmacokinetics of RO 205-2349 in Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to determine the dose(s) of Ro 205-2349 which, when compared to placebo, are efficacious, safe and tolerable in improving glycemic control in patients with type 2 diabetes. Doses of 2 to 5 mg/day will be studied.

Official Title
-----------------
A Phase II Randomized, Double-Blind, Dose-Ranging Study to Determine the Efficacy, Safety, Tolerability & Pharmacokinetics of RO 205-2349 in Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Drug: RO 205-2349


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 35 to 75 Type 2 diabetes for longer than 3 months HbA1c (glycosylated hemoglobin A1c) greater than 7.0% at screening FPG (fasting plasma glucose) greater than 126 mg/dL at screening BMI (body mass index) less than 40 kg/square meter Exclusion Criteria: Type I diabetes Type 2 diabetes patients currently treated with insulin Type 2 diabetes patients currently or previously treated with Actos, Avandia or Rezulin FPG (fasting plasma glucose) greater than 270 mg/dL at baseline Impaired liver or kidney function Triglycerides greater than 600 mg/dL Uncontrolled hypertension Pregnant or lactating women Women not using adequate contraception

Ages Eligible for Study
-----------------
Minimum Age: 35 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All potential participants entered the placebo run-in phase. At the end of the placebo run-in phase, eligible participants who met the final inclusion/exclusion criteria were randomized to the double-blind treatment period. treatment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RO 205-2349 2 mg QD<br>RO 205-2349 2 mg was taken once daily (QD) for 16 weeks during the double-blind treatment period. | Drug: RO 205-2349<br> <br> * Other names: Edaglitazone;|
| Experimental: RO 205-2349 5 mg QD<br>RO 205-2349 5 mg was taken once daily (QD) for 16 weeks during the double-blind treatment period. | Drug: RO 205-2349<br> <br> * Other names: Edaglitazone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study of Cesium-131 Brachytherapy Following Sub-Lobar Resection for Early Stage Non Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
For patients diagnosed with early (Stage I) non-small cell lung cancer, a lobe of lung is usually removed at surgery to treat the cancer. For some patients, the removal of a lobe of lung may leave too little lung behind for easy breathing. For some of these patients, it may be possible to perform a smaller-scale surgery (sub-lobar resection) and place a radioactive implant behind to prevent the cancer from growing back. This study will see how these patients do in terms of controlling their disease treated with a radioactive implant called Cesium-131.

Official Title
-----------------
Outcome Study of Cesium-131 Brachytherapy Following Sub-Lobar Resection for Early Stage NSCLC

Conditions
-----------------
NSCLC, Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Radiation: Cesium-131 Brachytherapy Seed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have suspicious lung nodule for clinical stage I/recurrent non-small cell Lung Cancer Mass Tumor size < 7 cm Patient must have a CT scan of the chest with upper abdomen within 90 days prior to date of pre-registration. Patient must have ECOG/Zubrod performance status 0,1, or 2. Exclusion Criteria: Patient has already received high dose radiation to the area Cancerous nodule is very close to the esophagus or spinal cord, thereby increasing the risk of radiation treatment Pregnancy or unwillingness to practice a form of birth control (i.e. abstinence, oral contraceptives, etc.)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sub-lobar resection with Cesium-131<br>All enrolled patients will undergo sub-lobar resection and brachytherapy implant with Cesium-131 in an effort to study and quantify recurrence/control patterns. | Radiation: Cesium-131 Brachytherapy Seed<br>* 85 Gray Dose<br>* Other names: Sealed Brachytherapy Source CS-1 (IsoRay Medical);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Recurrence | Cancer regrowth in the area where it was surgically removed | 3 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Using questionnaires, data will be collected related to the sense of well-being experienced by the patient after treatment. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brachytherapy, Lung Brachytherapy, NSCLC, Sub-lobar resection
Urine Interleukin-37 as a Biomarker of Mortality Risk in Patients With Sepsis

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the efficacy of IL-37 as a biomarker to predict mortality risk in adults with sepsis.

Detailed Description
-----------------
Sepsis patients admitted in the Department of Critical Care Medicine, Zhongnan Hospital will be included. There are three groups of patients in this study: control group, sepsis group and septic shock group. The interleukin-37 (IL-37) concentration in urine was analyzed in the day 1, 2, 4, 6. Additionally, IL-37 concentration between blood stream infection groups and non-infection groups were analyzed. IL-37 concentration between survivors and non-survivors were also compared. IL-37 concentration were followed from day 1, 2, 4, 6.The correlation between the concentration of IL-37, IL-1β, IL-6、IL-10 and TNF-α were analyzed. Furthermore, the investigators will determine the correlation between the concentration of IL-37, sepsis associated organ dysfunction, 28-day mortality. Lastly, the predictive value of IL-37 to sepsis associated organ dysfunction and prognosis were explored.

Official Title
-----------------
Urine Interleukin-37 as a Biomarker of Mortality Risk in Patients With Sepsis

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Expected length of stay>24 hours in intensive care unit (ICU) Sequential organ failure assessment (SOFA) score ≥ 2 on ICU admission with a suspicion of infection Exclusion Criteria: anuria ICU readmission in 28 days

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| 28-day all-cause mortality | Number of patients who were confirmed to be dead within 28-day from enrollment onto the study | 28 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU all-cause mortality | Number of patients who were confirmed to be dead in ICU from enrollment onto the study | 28 day | 
| ICU length of stay | Length of intensive care unit stay | 28 day | 
| Hospital length of stay | Length of hospital stay | 28day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, interleukin-37, biomarker
The Effect of Plant Sterol Supplement on Blood Cholesterol

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether supplement of plant sterol could lower blood cholesterol.

Official Title
-----------------
A Single Centre, Randomized Crossover Double-Blind Placebo-Controlled Study to Measure the Effect of Plant Sterol Supplement on Blood Cholesterol

Conditions
-----------------
High Blood Cholesterol Level

Intervention / Treatment
-----------------
* Behavioral: Intake of plant sterols


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women 18-80 years old Total cholesterol: 4.5-7.5 mmol/l Triglycerides at or below 4.0 mmol/l Exclusion Criteria: BMI at or above 35 kg/m2 Secondary hyperlipidemia, included diabetes Hypertension (at og higher than 170/110) Coronar, perifery or cerebral vascular disease last 3 months Familial hypercholesterolemia Change in dose of statins, oestrogen or contraceptives last 3 months Taking drugs which are known to interfere with the plasma level of cholesterol Chronic rheumatoid diseases or other diseases known to affect c-reactive protein Pregnancy Lactation Planning to reduce weight Taking plant sterols

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Intake of plant sterols|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Optimal Analgesia in Acute Gastroenteritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out an optimal way of analgesia in case of acute infectious gastroenteritis the investigators are going to compare two medicines that are used on everyday basis (without being ever before subject to scientifical study): Dipyrone and papaverine The study is done in the Emergency Department setting. Thus, only first 6 hours of treatment is included in study

Official Title
-----------------
Optimal Analgesia in Acute Gastroenteritis in Emergency Department Setting: Dipyrone Versus Papaverine

Conditions
-----------------
Gastroenteritis

Intervention / Treatment
-----------------
* Drug: Dipyrone
* Drug: Papaverine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute gastroenteritis VAS scale of pain perception at least 4 Exclusion Criteria: pregnancy allergy to any one of study preparations blood pressure less than 85 on admission surgical condition (acute abdomen) suspected or diagnosed

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dipyrone<br> | Drug: Dipyrone<br>* 1 gram by slow IV infusion<br>* Other names: Optalgin;|
| Active Comparator: Papaverine<br> | Drug: Papaverine<br>* 80 mg by slow intravenous infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain assessment (VAS) as opposed the pain assessment on admission |  | 30 min, 1 hour, 2 hours, on discharge (up to 24 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for second analgesic medicine |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastroenteritis, Analgesia, Emergency department
Phase 1 Study of the Effect of Ketoconazole on the PK of Multiple Doses of Cediranib in Patients With Solid Tumours

Study Overview
=================
Brief Summary
-----------------
Phase I, open study to assess the effect of ketoconazole, a marketed drug, on the way the body handles the experimental drug cediranib, in patients with advanced cancer.

Official Title
-----------------
A Phase I, Open Label, Non-Randomised Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Multiple Oral Doses of Cediranib (AZD2171, RECENTINÔ), in Patients With Advanced Solid Tumours

Conditions
-----------------
Advanced Solid Tumors

Intervention / Treatment
-----------------
* Drug: cediranib (RECENTIN TM, AZD2171)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Histological or cytological confirmation of advanced solid tumour (with the exception of prostate cancer), which is refractory to standard therapies or for which no standard therapy exists. Estimated life expectancy of at least 8 weeks WHO performance status (PS) 0-2. Exclusion Criteria: Unstable brain/meningeal metastases Biochemistry/haematology results outside of required ranges History of significant GI impairment Inadequate bone marrow reserve

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cediranib alone, followed by cediranib plus ketoconazole, followed by cediranib alone | Drug: cediranib (RECENTIN TM, AZD2171)<br>* 20 mg cediranib once daily from Days 1 to 7; then 20 mg cediranib plus 400 mg ketoconazole from Days 8-10; then 20 mg cediranib once daily from Days 11-23. At Day 24 patients may dose escalate to 30 mg tablet once daily providing the treatment is well tolerated (this may be escalated up to 45 mg if the 30mg dose is tolerated for a minimum of 14 days)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the steady-state PK parameters of cediranib in the presence and absence of ketoconazole. |  | PK assessments to be taken until Day 42. Days 7 and 10 PK parameters used to assess the primary variables. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of cediranib in the presence of ketoconazole by assessment of Adverse events (AEs) Laboratory findings,Vital signs, physical examination and Electrocardiogram. |  | Until study drug is discountinued | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
advanced cancer,, metastatic, ketoconazole, pharmacokinetics, Phase I
Association Between Low Dose Acetylsalicylic Acid (ASA) and Proton Pump Inhibitors and Risk of Acute Myocardial Infarction or Coronary Death

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to estimate the risk of myocardial infarction (MI)/coronary death associated with use of monotherapy low dose ASA (single antiplatelet) as well as concomitant use of monotherapy low dose ASA and proton pump inhibitors (PPIs) in first- time users of low dose ASA for secondary prevention using a UK primary care database.

Detailed Description
-----------------
Number of Anticipated Subjects: In case-control analysis 5.000-10.000

Official Title
-----------------
Association Between Low Dose Acetylsalicylic Acid (ASA) and Proton Pump Inhibitors and Risk of Acute Myocardial Infarction or Coronary Heart Disease Death - Nested Case Control Analyses in a Cohort of First-time Users of Low Dose ASA for Secondary Prevention of Cerebrovascular and Cardiovascular Outcomes.

Conditions
-----------------
Nonfatal Myocardial Infarction, Coronary Death

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: As above (study population description). All individuals aged 50-84 years with at least two year of enrolment with the primary care physician (PCP) and a computerized prescription history of at least one year before the start of the study. Exclusion Criteria: Recorded diagnosis of cancer prior to study start. Alcohol abuse or alcohol-related disease prior to study start. Patients aged ≥ 70 years with a follow-up longer than one year if having fewer than two recorded consultations with a primary care physician (PCP) during their entire follow-up (proxy for incomplete and invalid data recording) which for some individuals will be close to 8 years.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 84 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 |
| --- | --- |
| Cases<br>Cases with nonfatal MI or coronary death | |
| Controls<br>Age, sex, and calendar-year matched controls sampled from the original study cohort to be a round number of at least four times the number of cases | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nonfatal MI or coronary death |  | Up to eight years from entry into study cohort | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MI, low dose aspirin, PPI, epidemiology
Characteristics of Neonatal Covid-19 in Turkey

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to investigate the clinical and epidemiological characteristics of neonates who will be born to Covid-19 positive mothers in Turkey. It is a multicentric prospective cohort study designed and destined only in Turkey. The investigators are planning to admit more than 20 Neonatal Intensive Care Units into the survey; nevertheless, the total number may change according to the prevalence of Covid-19 in neonates. The investigators will also inquire into vertical transmission by collecting cord blood, placental, and postnatal serum samples to test for Covid-19 PCR and Covid-19 Ig M and IgG values from the neonates.

Detailed Description
-----------------
The patients will be recruited by a secure database of Trials Network with individualized accounts. Plexus Corporation will hold data monitoring and primary analysis.

Official Title
-----------------
Clinical and Epidemiological Characteristics of COVID-19 Infection on Babies of Prenatal COVID-19 Positive Women in Turkey

Conditions
-----------------
COVID-19, Neonatal Disease, Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants born to mothers with Covid-19 infection Exclusion Criteria: If PCR values of mother negative, even though the clinic is preferable for Covid-19, the infant will not be recruited.

Ages Eligible for Study
-----------------
Maximum Age: 28 Days

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 |
| --- | --- | --- |
| Vertical Transmission | Vertical transmission will be investigated by obtaining neonatal PCR samples in blood, stool and mother milk as well as Neonatal Covid-19 Ig M and Ig G values | First 28 days of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay | Hospital span time of the neonates in NICU | First 28 days of life | 
| Early neonatal sepsis rate | Early neonatal sepsis rate | First 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vertical Transmission
Study for Safety and Efficiency of Therapeutic Angiogenesis for Patients With Limb Ischemia by Transplantation of Human Cord Blood Mononuclear Cell

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyze the safety and efficiency of therapeutic angiogenesis for patients with limb ischemia by transplantation of human cord blood mononuclear cells.

Conditions
-----------------
Ischemia

Intervention / Treatment
-----------------
* Other: Study for safety and efficiency of therapeutic angiogenesis for patients with limb ischemia by transplantation of human cord blood mononuclear cell


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Patients with ischemic symptoms such as claudication, rest pain or nonhealing ischemic wound Without evidence of improvement in response to conventional medical therapy Not candidates for surgical intervention or radiologic intervention Exclusion Criteria: Malignant disease More than 60 years old Other significant medical conditions, including diabetes mellitus, hypertension, hyperlipidemia, etc.

Ages Eligible for Study
-----------------
Maximum Age: 60 Years

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Study for safety and efficiency of therapeutic angiogenesis for patients with limb ischemia by transplantation of human cord blood mononuclear cell|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
-----------------
Safety and efficiency of angiogenesis for patients with limb, ischemia by transplantation of human cord blood mononuclear, cells