linjc16/ctgov huggingface dataset:
Impact of Catch-up HPV Vaccination

Study Overview
=================
Brief Summary
-----------------
Each year in France, more than 6000 new cases of HPV inducted cancers are recorded. The vaccinal cover stays insufficient since less than 30% of the french population is vaccinated. Therefore french studies about vaccine efficacy and especially about the catch-up vaccine (done after 15years old) are needed. HPVAC2 is a prospective, analytic and monocentric study designed to learn the impact of the catch-up HPV vaccination. Women from 25 years old and born after 1984 may be included if they come to the Brest CHU to do their regular cervical smear. At this time, a survey will be given to know their vaccinal status. The aim of the study is to prove the efficacy of the catch up vaccination by analyzing the cervical smears results and by comparing the vaccinated group with the not-vaccinated group.

Official Title
-----------------
Impact of Catch-up HPV Vaccination on the Development of Cervical Lesions

Conditions
-----------------
HPV, HPV Vaccination, Vaccine Preventable Disease, Cervical Lesion, Cervical Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age limit Patient must have done a HPV or smear test during the study period Consent necessary Exclusion Criteria: Age limit No HPV or smear test done in the study period Patient not able to give her consent

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 38 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vaccinated<br>Patients who have been vaccinated against HPV virus. | |
| Not vaccinated<br>Patients who have not been vaccinated against HPV virus. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test HPV and smear test result. | Study the effectiveness of anti-HPV vaccine (done between 15 and 19 years old). | 13 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test HPV and smear test result. | Study the effectiveness of anti-HPV vaccine (done between 11 and 15 years old). | 13 months. | 
| Test HPV and smear test result. | Study the effectiveness of anti-HPV vaccine (not regarding the period of realization) | 13 months. | 
| Test HPV and smear test result. | Compare the effectiveness of anti-HPV vaccine done before and after 15 years old. | 13 months. | 
| Test HPV and smear test result regarding the cervical cancer risk factors. | Study the impact of the known cervical cancer risk factors on the smear results. | 13 months. |
A Trial of the ALK Grass Tablet in Subjects With Hayfever

Study Overview
=================
Brief Summary
-----------------
This trial is performed to assess the efficacy and safety of the ALK Grass tablet for treatment of grass pollen induced rhinoconjunctivitis (hayfever).

Official Title
-----------------
A Randomized, Parallel-group, Double-blind, Placebo-controlled Phase III Trial Assessing the Efficacy and Safety of ALK Grass Tablet in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Biological: ALK Grass tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Eligibility Criteria: A history of grass pollen induced rhinoconjunctivitis Positive skin prick test to grass Positive specific IgE to grass

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: ALK Grass tablet<br>* Tablets, 75,000 SQ-T or matching placebo. Daily administration for 3 years<br>|
| Placebo Comparator: 2<br> | Biological: ALK Grass tablet<br>* Tablets, 75,000 SQ-T or matching placebo. Daily administration for 3 years<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recording of rhinoconjunctivitis symptoms |  | Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009 | 
| Recording of use of rescue medication |  | Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | Weekly recordings during the entire grass pollen seasons 2007, 2008 and 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Grass pollen allergy, Hayfever, Allergen immunotherapy, Specific immunotherapy
Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-461

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish initial safety, tolerability, pharmacokinetics and pharmacodynamics of MYK-461 in human subjects. This is a sequential group, single ascending (oral) dose study in NYHA Class I, II, or III patient volunteers aged 18-65 years.

Official Title
-----------------
Safety, Tolerability, Preliminary Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of MYK-461 in Patient Volunteers With Hypertrophic Cardiomyopathy

Conditions
-----------------
Hypertrophic Cardiomyopathy

Intervention / Treatment
-----------------
* Drug: MYK-461


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with HCM Normal left ventricular ejection fraction (LVEF) NYHA class I, II or III Exclusion Criteria: Inherited metabolic disorders, myocardial infiltration or cardiofaciocutaneous syndrome (e.g., Noonan's, Fabry's). History of clinically important atrial or ventricular arrhythmias History of positive human immunodeficiency virus (HIV) test and/or seropositive for hepatitis C virus (HCV) or hepatitis B virus (HBV)..

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MYK-461<br> | Drug: MYK-461<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of pharmacokinetics parameters as measured by Cmax | maximum concentration (Cmax) | 28 Days | 
| Determination of pharmacokinetics parameters as measured by Tmax | time of the maximum measured concentration (Tmax) | 28 Days | 
| Determination of pharmacokinetics parameters as measured by AUC | area under the concentration-time curve (AUC) | 28 Days | 
| Determination of pharmacokinetics parameters as measured by t1/2 | half-life (t1/2) | 28 Days |
Study Evaluating BLI-489 and Piperacillin in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate how BLI-489 and piperacillin interact when given together to healthy subjects.

Official Title
-----------------
A Randomized, Open-label, Single-dose, 3-period Crossover Study to Describe the Pharmacokinetic Parameters of BLI-489 and Piperacillin When Administered Simultaneously Compared to When Each is Administered Alone.

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: BLI-489/Piperacillin
* Drug: BLI-489
* Drug: Piperacillin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women of non-childbearing potential, aged 18 to 50 years of age inclusive at screening. Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight greater than or equal to 50 kg. Healthy as determined by the investigator on the basis of the screening evaluations. Nonsmoker of smoker of fewer than 10 cigarettes per day as determined by history. Exclusion Criteria: Presence of history of any disorder that may prevent the successful completion of the study. History of drug abuse within 1 year.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: BLI-489/Piperacillin<br> <br> Drug: BLI-489<br> <br> Drug: Piperacillin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics as evaluated by drug concentrations in the blood and urine. |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured by the number of adverse events and serious adverse events. |  | 10 weeks |
Urinary Cytokine Levels as a Prognostic Marker for Kidney Scarring After Pyelonephritis

Study Overview
=================
Brief Summary
-----------------
The prevalence of kidney scarring after UTI is approximately 5-57%. UTIs are caused mainly by bacteria that cause local and systemic immunological reaction that are accompanied by cytokines. These cytokines are a main factor in the inflammatory process. They are produced by leukocytes, macrophages, fibroblasts, endothelial cells and epithelial cells in the kidney tissue. Interleukin 6 and 8 (IL-6 IL-8) were found in high levels in the urine of children and adults who suffer from UTIs. Other studies on animals have found a relationship between inflammatory reaction and scarring in the kidney. We hypothesize that we will find a similar relationship between the level of IL-6, IL-8 in the urine during acute pyelonephritis in children and the probability of kidney scarring.

Conditions
-----------------
Kidney Scarring Post-Febrile UTI

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 0-7 First episode febrile UTI Exclusion Criteria: Recurrent UTI

Ages Eligible for Study
-----------------
Maximum Age: 7 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 |
| --- | --- |
| Children with UTIs<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High prevalence of kidney scarring in children with high levels of urine interleukins |  | six months |
A Study of Peldesine (BCX-34) in HIV-Infected Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the highest amount of peldesine that is safe. This study will also see if this amount of peldesine is effective in lowering HIV levels in the blood.

Detailed Description
-----------------
Patients are given either BCX-35 or placebo for 14 or 28 days. Plasma viral load will be determined at the MTD.

Official Title
-----------------
Phase I Placebo-Controlled Study of Oral BCX-34 (Peldesine) in HIV-Infected Patients

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Peldesine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Documented HIV infection. CD4 cell count greater than or equal to 300 cells/mm3 on 3 occasions prior to protocol treatment. Plasma viral load by Roche Amplicor HIV Monitor assay greater than or equal to 2,000 RNA copies/ml and less than or equal to 50,000 RNA copies/ml on at least 2 occasions prior to protocol treatment. Normal or non-diagnostic electrocardiogram. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Severe opportunistic infection or any other medical condition which in the opinion of the investigators is a contraindication to enrolling in this trial. Severe lactose intolerance. Concurrent Medication: Excluded: Concomitant therapy with other medications having primary renal excretion (other than 3TC, ddC, and d4T). Prior Medication: Excluded: Ongoing dideoxyinosine or other antiretroviral therapy except ZDV, 3TC, ddC, d4T, saquinavir, ritonavir, indinavir, and nelfinavir within 2 weeks of study. Participation in a study of any systemic experimental drug within the last 2 months. Required: - Ongoing (at least 4 weeks) stable dosage of zidovudine (ZDV) and lamivudine (3TC), ZDV and stavudine (d4T), ZDV and zalcitabine (ddC), d4T and 3TC, ZDV alone, or ddC alone, or in combination with saquinavir, ritonavir, indinavir, or nelfinavir.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Peldesine|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
-----------------
Placebos, Administration, Oral, Anti-HIV Agents, Viral Load, peldesine
European Cardio Computer Tomography Registry

Study Overview
=================
Brief Summary
-----------------
The European Cardiac CT Registry has the unique potential to provide important data that will help to clarify the clinical role of cardiac computed tomography (CT), to create guidelines and recommendations for its use, and to identify the most important areas that require specific further research.

Official Title
-----------------
European Cardio CT Registry

Conditions
-----------------
Consecutive Patients Undergoing Computed Tomography of the Heart for Clinical Indications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion of all consecutive patients with accomplished or attempted CT imaging of the heart (whether imaging of the coronary arteries or other structures of the heart) Informed consent to be entered in the registry. Inclusion of all consecutive patients with accomplished or attempted coronary CT angiography. Inclusion of all patients who undergo coronary CT angiography for clinical indications, with separate analysis of patients with suspected coronary artery disease and previously known coronary artery disease. Exclusion Criteria: - Besides the absence of informed consent, and cardiac CT studies performed as part of a research protocol, no exclusion criteria exist.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| collect data | The general aim of the Registry is to collect data from a large number of patients regarding the indications, general use, safety, and therapeutic implications of cardiac CT in European clinical practice. | June 2009- | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of coronary CT angiography | A first specific aim of the Registry is the analysis of the effect of coronary CT angiography on downstream resource utilization, revascularization procedures, and prognosis in patients with known or suspected coronary artery disease | June 2009- | 
| analysis of radiation exposure during coronary CT angiography | The second specific aim is the analysis of radiation exposure during coronary CT angiography and the identification of parameters that influence radiation exposure, with the potential to provide specific guidance for interventions to lower radiation dose in the future | June 2009- | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clinical Practice Cardiac CT, Clinical Implications Coronary CT Angiography, Radiation Exposure of Coronary CT Angiography, Registry
Exploratory Study of Breast Cancer With ABY025

Study Overview
=================
Brief Summary
-----------------
The aim is to study if breast cancer metastases accumulate the newly developed HER2 binding molecule 111-In-ABY025 and if that shows whether the metastases express HER2.

Official Title
-----------------
An Exploratory Study to Evaluate the Distribution of [111In]ABY-025 Uptake for SPECT Imaging in Subjects With Metastatic Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: 111-In-ABY-025


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female age >20 years one or more known metastases localizations Exclusion Criteria: other critical disease than breast cancer age ≤ 20 years

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 111-In-ABY-025|Intravenous injection of the agent|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging of metastases | Imaging of breast cancer metastases using 111-In-ABY015 for SPECT | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Can the new molecule be used for imaging in extended studies |  | October 2010 - June 2011 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Diagnostics, HER2, Imaging, Metastases, SPECT, Imaging of metastases
Effects of Ketamine on Human Bladders and Its Possible Mechanisms

Study Overview
=================
Brief Summary
-----------------
This study is aimed to evaluate the relationship between ketamine abused and bladder dysfunction and its possible mechanisms.

Official Title
-----------------
Effects of Ketamine on Human Bladders and Its Possible Mechanisms

Conditions
-----------------
Cystitis

Intervention / Treatment
-----------------
* Other: ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male or female Cystitis (the clinicians ruled out the causes of bacterial infection) Frequent micturition The clinicians are willing to sign the ICF Exclusion Criteria: Suffers from the urinary system disease, is not suitable to carry on the urinary bladder biopsy sampling Suffers from other diseases, doctor recognized that is not suitable to carry on the sampling The clinicians are not willing to sign the ICF

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| case<br>ketamine + Cystitis | Other: ketamine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substance Abuse Situation Record | Substance abuse situation record: ketamine | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Bladder Capacity |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ketamine, bladder dysfunction, bladder mucosa, mechanisms
Pearl Index Study With Low Dose Combined Oral Contraceptive

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the contraceptive efficacy, bleeding pattern, and safety of SH D00342A. Subjects participating in the study will be treated with an oral contraceptive pill containing 0.03 mg ethinylestradiol and 0.125 mg levonorgestrel.

Detailed Description
-----------------
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Official Title
-----------------
Prospective, Multicenter, Open-label, Uncontrolled Study to Investigate the Contraceptive Efficacy, Bleeding Patterns, and Safety of an Oral Contraceptive Containing 0.03 mg Ethinylestradiol and 0.125 mg Levonorgestrel (SH D00342A) Applied for 13 Cycles to Healthy Female Volunteers

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: Minisiston (SH D00342A)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women requiring contraception Exclusion Criteria: Pregnant or lactating women, history or suspicion of hormone dependent tumor or any other conditions which forbid the participation.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Minisiston (SH D00342A)<br>* Daily oral administration in 21 days per cycle, followed by a 7-day pill-free interval<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unadjusted Pearl Index |  | After 13 cycles of intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted Pearl Index |  | After 13 cycles of intake | 
| Cumulative pregnancy rate |  | After 13 cycles of intake | 
| Bleeding pattern |  | After 13 cycles of intake | 
| Cycle control |  | After 13 cycles of intake | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contraception