linjc16/ctgov huggingface dataset:
Study Comparing Standard Dose and Reduced Dose Tacrolimus With Sirolimus in Renal Transplant Patients

Study Overview
=================
Brief Summary
-----------------
The study evaluated renal graft function (based on the calculated creatinine clearance) 6 months after kidney transplantation in patients receiving either a regimen of 'reduced-dose' tacrolimus + sirolimus + corticosteroids or a regimen of 'standard-dose' tacrolimus + sirolimus + corticosteroids.

Detailed Description
-----------------
The study evaluated renal graft function (based on the calculated creatinine clearance) 6 months after kidney transplantation in patients receiving either a regimen of 'reduced-dose' tacrolimus + sirolimus + corticosteroids or a regimen of 'standard-dose' tacrolimus + sirolimus + corticosteroids. The two treatment groups were also compared with respect to the incidence of acute graft rejection at 6 months and patient and graft survival at 6 months after transplantation.

Official Title
-----------------
An Open-label, Concentration-controlled, Randomized, 6-month Study of 'Standard Dose' Tacrolimus + Sirolimus + Corticosteroids Compared to 'Reduced-dose' Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: Rapamune® (Sirolimus)
* Drug: Tacrolimus
* Drug: Perioperative Corticosteroids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: At least 18 years of age End-stage renal disease in patients receiving a primary or secondary renal allograft from a cadaveric, living-unrelated, or living-related mismatched donor Patients with a secondary transplant must have maintained a primary graft for at least 6 months Exclusion criteria: Planned antibody induction Multiple organ transplants History of malignancy within five years of enrollment

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

| Intervention/Treatment |
| --- |
|Drug: Rapamune® (Sirolimus)|nan|
|Drug: Tacrolimus|nan|
|Drug: Perioperative Corticosteroids|The corticosteroids use was left up to the investigators decision.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculated creatinine clearance at month 6 post transplantation |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and graft survival at 6 months post transplantation; the safety of sirolimus + corticosteroids given concomitantly with reduced or standard dose tacrolimus |  | 6 months |
A Study in Children With Different Formulations of GSK Biologicals' 11 Valent Pneumococcal Conjugate Vaccine

Study Overview
=================
Brief Summary
-----------------
Three dose primary vaccination with 11-valent pneumococcal conjugate vaccine administered concomitantly with Infanrix™ hexa to healthy infants between 8 to 16 weeks of age at the time of first vaccination.

Detailed Description
-----------------
Test groups: 9 groups receiving different formulations of 11PN-PD-DiT vaccine + DTPa-HBV-IPV/Hib (Infanrix™ hexa) Comparator: 11Pn-PD + Infanrix™ hexa Control: Prevenar® + Infanrix™ hexa

Official Title
-----------------
A Randomized, Controlled, Phase II Study to Evaluate the Safety and Immunogenicity of Different Formulations of GlaxoSmithKline Biologicals' 11-valent Pneumococcal Conjugate Vaccine, When Administered Intramuscularly as a 3-dose Primary Immunization (2-3-4 Month Schedule) Before 6 Months of Age

Conditions
-----------------
Streptococcal Infections

Intervention / Treatment
-----------------
* Biological: Pneumococcal (vaccine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Male or female aged 8-16 weeks at the time of first vaccination, written informed consent obtained from the parent/guardian of subject. Exclusion criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceeding the first dose of study vaccine, or planned use during the study period. Planned administration/ administration of a licensed vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of vaccine(s) and ending 30 days after the last dose.

Ages Eligible for Study
-----------------
Minimum Age: 8 Weeks
Maximum Age: 16 Weeks

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Pneumococcal (vaccine)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 month after d3, antibody concentrations to pneumo. serotypes 1,3,4,5,6B,7F,9V,14,18C,19Fand23F.Occurrence of: solicited local and general symptoms within 8 days after each vaccination; unsolicited adverse events within 31 days after each vaccination |  | 1 Month after dose 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 month post d3: For pneumo.serotypes 1,3,4,5,6B,7F, 9V,14,18C,19F,23F:Opsono titres;antibody concentrations (AbC) >= 0.20 µg/mL;AbC to protein D and seropositivity (S+)status; S+/seroprotection status to antigens in Infanrix hexa. |  | 1 Month after dose 3 |
Blood Endothelium Progenitor Cells and Dendritic Cells as Predictive Biomarkers of In-stent Restenosis

Study Overview
=================
Brief Summary
-----------------
clinically relevant in stent restenosis occurs in 5-10% of the non-diabetic patients treated with a coronary bare metal stent. Recent research has identified endothelial progenitor cells as well as dendritic cells as components of neointima. Numerical and functional evaluation of endothelial progenitor and dendritic cells at the time of coronary stent implantation is assessed and the relation with clinical and/or angiographic restenosis at 6 months post-stent implantation is evaluated.

Official Title
-----------------
Blood Endothelium Progenitor Cells and Dendritic Cells as Novel Predictive Biomarkers of In-stent Restenosis After Percutaneous Coronary Intervention.

Conditions
-----------------
Atherosclerosis, Restenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>18 years old Scheduled for PCI Candidate for CABG if necessary Clinical evidence of ischemic heart disease and/or abnormal functional study New native coronary artery lesion >50%-<100% stenosis Lesion length<30 mm, treatment with a single bare metal stent planned Reference diameter 2.5-3.5 mm Informed consent explained, red, understood and signed by the patient Exclusion Criteria: Pregnancy, birth or lactation period <6 months ago Women of childbearing age who do not intend to use accepted anticonceptive measures or who wish to get pregnant Left ventricular ejection fraction <30% Acute myocardial infarction (ST-elevation, Q-wave evolution or CK-MB >2x upper limit of normal)in the past month Contra-indication to PCI Diabetes mellitus Planned drug eluting stent implantation Total occlusion (TIMI 0 or 1) Ostial localisation (<3.0 mm of the coronary ostium) of the lesion Bifurcational lesion with side branch >2.0 mm or side branch which will be recanalised at occlusion due to PCI Lesion in arterial or venous bypass or anastomosis with coronary Angiographic contra-indication to IVUS Severe renal insufficiency (creatinine clearance <30 mL/') Severe hepatic insufficiency Systemic inflammatory pathology of any kind Uncorrected hyperthyreosis Hematologic or other malignancy, prior radio- or chemotherapy Severe peripheral artery disease (accesproblem via groin) Use of corticosteroïds or immune suppression therapy Contrastallergy Life expectancy <1 year Participation in other clinical study which has not ended yet

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atherosclerosis, Restenosis, EPC, DC
Nabilone & Marijuana Addiction

Study Overview
=================
Brief Summary
-----------------
Safety of Nabilone in reducing marijuana craving

Detailed Description
-----------------
Randomized double blind trial into the safety and efficacy of Cesemat for the treatment of marijuana use

Official Title
-----------------
A Double-Blind Placebo Control Study on the Use of Nabilone for Outpatient Management of Acute Marijuana Withdrawal

Conditions
-----------------
Marijuana Smoking

Intervention / Treatment
-----------------
* Drug: Cesemat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19 years or older History of marijuana use

Ages Eligible for Study
-----------------
Minimum Age: 19 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cesemat<br> | Drug: Cesemat<br>* 1 mg capsule per day for 21 days<br>* Other names: Nabilone;|
| No Intervention: Placebo<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability to Nabilone |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marijuana craving questionnaire |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Efficacy, Marijuana, Reduction, Craving
The Use of Propranolol for the Prevention of Worsening of Esophageal Varices in Patients With Isolated Gastric Varices

Study Overview
=================
Brief Summary
-----------------
Balloon-occluded retrograde transvenous obliteration (BRTO) has been effective method to manage gastric varices. However, more than one third of patients after BRTO treatment experienced worsening of esophageal varices. The present study was designed to evaluate the effect of post-BRTO propranolol adminstration on the change of esophageal varices.

Official Title
-----------------
Post-balloon Occluded Retrograde Transvenous Obliteration Use of Propranolol for the Prevention of Worsening of Esophageal Varices in Patients With Isolated Gastric Varices

Conditions
-----------------
Liver Cirrhoses, Portal Hypertension, Gastric Varix

Intervention / Treatment
-----------------
* Drug: Propranolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of liver cirrhosis Clinical diagnosis of isolated gastric varices The presenec of spontaneous portosystemic shunt Exclusion Criteria: Contradictions to Propranolol Balloon occluded retrograde transvenous obliteration was failed

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propranolol group<br>Propranolol was given after patients with cirrhosis and isolated gastric varices underwent balloon occluded retrograde transvenous obliteration successfully. | Drug: Propranolol<br>* Propranolol was given after patients with cirrhosis and isolated gastric varices underwent balloon occluded retrograde transvenous obliteration successfully.<br>|
| No Intervention: control group<br>Propranolol was not given after patients with cirrhosis and isolated gastric varices underwent balloon occluded retrograde transvenous obliteration successfully. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Worsening of esophageal varices rate | Analysis | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variceal rebleeding rate | Analysis | 3 years | 
| Mortality rate | Analysis | 3 years | 
| Worsening of ascites rate | Analysis | 3 years |
Congenital Syphilis Prospective Cohort With Retrospective Evaluation

Study Overview
=================
Brief Summary
-----------------
Syphilis is an infectious disease caused by Treponema pallidum. In children, there are two different forms of this disease; acquired syphilis and congenital syphilis, which results from transplacental transmission of spirochetes. The worldwide incidence of congenital syphilis has increased in past years, probably due to inadequate control of pregnant women and lack of early diagnose and treatment in acute infected adults. This infection can have numerous and non-specific manifestations at all stages, and may simulate other diseases, which can delay diagnose if not suspected. A high number of newborns can be asymptomatic, so diagnose is confirmed or discharged by serologic testing after 6 to 10 months of age. This study will observe the clinical presentation and the laboratory of patients with CS treated.

Official Title
-----------------
Congenital Syphilis at Third-level Pediatric Hospital. A Prospective Cohort With Retrospective Evaluation Study of the Last Three Decades.

Conditions
-----------------
Syphilis, Congenital

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants with reactive VDRL /RPR of mothers with positive serology without confirmed treatment or incomplete. Patients with compatible clinical signs of syphils. Exclusion Criteria: Patients with diagnosis of acquired syphilis Patients whose medical records are missing

Ages Eligible for Study
-----------------
Minimum Age: 0 Days
Maximum Age: 1 Year

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 |
| --- | --- | --- |
| Analyze the number of cases of congenital syphilis according to the years surveyed at the Ricardo Gutierrez Children's Hospital | By examining clinical records we will describe prevalence of congenital syphilis through last 30 years. | Past 30 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the clinical presentation -symptoms and image findings - in children diagnosed with CS. Symptoms will be measured as present or not and described. | By looking at clinical records we will describe the number of children presenting with symptoms and number of asymptomatic. We will also describe the most frequent symptoms found and other test findings. | Past 30 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congenital syphilis, VDRL, CSF, Clinical manifestations
Effect of Spiriva® 18 Microgram on Health-related Quality of Life and Physical Functioning in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Proven Hyperinflation

Study Overview
=================
Brief Summary
-----------------
Primary objective of this observational study was to gain insights into the effects of therapy with Spiriva® (tiotropium bromide) 18 microgram on the health-related quality of life and physical functioning in patients with chronic obstructive pulmonary disease (COPD) and demonstrated hyperinflation. Secondary objective was to obtain safety data regarding adverse events.

Official Title
-----------------
Effect of Spiriva® 18 Microgram on Health-related Quality of Life and Physical Functioning in Patients With COPD and Proven Hyperinflation

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

Intervention / Treatment
-----------------
* Drug: Tiotropium bromide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women and men with diagnosis of chronic obstructive pulmonary disease (COPD) with a thoracic gas volume (TGV) > = 120% as measured by body plethysmography Only patients who have not yet been treated with Spiriva® 18 micrograms can be included in the study. Exclusion Criteria: Patients who presenting the general and specific contraindications mentioned in the Patient Information and Prescribing Information
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COPD and proven hyperinflation<br>Patients with COPD and proven hyperinflation receiving tiotropium bromide 18 microgram | Drug: Tiotropium bromide<br>* Tiotropium bromide18 micrograms by oral inhalation (1 x daily) with the HandiHaler®<br>* Other names: Spiriva®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline for assessment of the health-related euro quality of life 5 dimensions questionnaire (EQ-5D) time trade off (TTO) score |  | At baseline (visit 1) and after 4 weeks (visit 2) | 
| Change from baseline for assessment of the health-related EQ-5D questionnaire linear rating scale |  | At baseline (visit 1) and after 4 weeks (visit 2) | 
| Change from baseline for assessment of physical functioning in every day life (PF-10) |  | At baseline (visit 1) and after 4 weeks (visit 2) |
A Study to Evaluate the Effect of Increased Stomach pH on Evacetrapib in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of increased stomach pH on how much evacetrapib is found in the blood stream and how long the body takes to get rid of it when given to healthy participants. Information about any side effects that may occur will also be collected. There are two parts to the study. Participation in both parts will be required. The study will last approximately 30 days, not including screening.

Official Title
-----------------
Evaluation of the Impact of Increased Gastric pH Following Omeprazole Administration on the Pharmacokinetics of Evacetrapib in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: Evacetrapib
* Drug: Omeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overtly healthy participants, as determined by medical history and physical examination Females must be of non-child-bearing potential Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2) Exclusion Criteria: Have known allergies to evacetrapib, omeprazole, related compounds, or any components of the evacetrapib or omeprazole formulations

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evacetrapib<br>Single oral dose of evacetrapib administered alone on Day 1 of Period 1. | Drug: Evacetrapib<br>* Administered orally<br>* Other names: LY2484595;|
| Experimental: Omeprazole + Evacetrapib<br>In Period 2, participants will receive 40 mg oral dose of Omeprazole once daily (QD) on Days 8 through 20. Evacetrapib will be co-administered once, orally on Day 14. | Drug: Evacetrapib<br>* Administered orally<br>* Other names: LY2484595;Drug: Omeprazole<br>* Administered orally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib |  | Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8,12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose | 
| Pharmacokinetics (PK): Time of Maximum Observed Concentration (Tmax) of Evacetrapib |  | Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose | 
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) |  | Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose |