linjc16/ctgov huggingface dataset:
Registry Study on Epidemiological and Biological Disease Profile as Well as Clinical Outcome in Patients With Low Grade Gliomas

Study Overview
=================
Brief Summary
-----------------
The LoG-Glio-Registry is based on a network of german hospitals gathering radiological, clinical, epidemiological and molecular data on all patients diagnosed with a low grade glioma.

Official Title
-----------------
Registry Study on Epidemiological and Biological Disease Profile as Well as Clinical Outcome in Patients With Low Grade Gliomas: The LOG-Glio-Project

Conditions
-----------------
Glioma

Intervention / Treatment
-----------------
* Other: no interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with radiological suspected diagnosis of a low grade glioma Age ≥ 18 years. There is no upper age limit. Exclusion Criteria: Severe neurological or psychiatric disorder interfering with ability to give an informed consent No consent for registration, storage and processing of the individual disease characteristics and course as well as information of the family physician about study participation No consent for bio-banking of patient's biological specimens and performance of analyses on stored material.

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

| Intervention/Treatment |
| --- |
|Other: no interventions|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) |  | 5yrs | 
| Overall survival (OS) |  | 15yrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of tumor resection | calculated based on volumetric assessement of tumor in cm³ and residual tumor in pre and postoperative MRI | 3yrs | 
| Quality of life (QoL) assessed by the EORTC QLQ C-30/BN-20. (European Organisation for Research and Treatment of Cancer Quality of Life Questionaire C-30 |  | 5yrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low grade glioma, registry, neurosurgery, brain tumor
Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess combining AF ablation, with AV node ablation and pacemaker implantation for patients suffering with 'irregular heartbeats' or atrial fibrillation. The study will last 13 months.

Official Title
-----------------
Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation

Conditions
-----------------
Persistent Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: AF ablation and AV node ablation
* Procedure: AV node ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with symptomatic drug refractory atrial fibrillation. Patients who have had pacemaker implantation and AV node ablation with ongoing symptoms. Patients will already be refractory to at least 2 rate or rhythm control drugs. Patients must be over 18 years old. Patients give informed consent form prior to participating in this study. Exclusion Criteria: Patient is suffering with unstable angina in last 1 week. Patient has had a myocardial infarction within last 2 months. Patient is expecting or has had major cardiac surgery within last 2 months. Patient is participating in a conflicting study. Patient is unable to perform exercise testing. Patient is mentally incapacitated and cannot consent or comply with follow-up. Patient has NYHA class III/ IV heart failure. Patient has LVEF <35% not secondary to tachycardia. Pregnancy. Patient suffers with other cardiac rhythm disorders. Recent coronary artery intervention or other factors suggesting clinical instability (ECG, clinical or laboratory findings).

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AF ablation and AV node ablation<br>Patients will receive the combined procedure of AF ablation as well as AV node ablation | Procedure: AF ablation and AV node ablation<br>* AF ablation and AV node ablation<br>|
| Active Comparator: AV node ablation<br>Patient will receive AV node ablation alone | Procedure: AV node ablation<br>* AV node ablation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the two treatment effects on VO2 max over time by means of cardiopulmonary exercise testing.To measure the two treatment effects on 6-minute hall walk distance.Echocardiographic parameters |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Fibrillation, Ablation
Imaging Modality Effects on the Multi-dimensional InfraRed Analysis (MIRA) Technology

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of everyday practice modalities (mammography, US) on the MIRA technology.

Detailed Description
-----------------
The objective of the current clinical study is to collect sufficient MIRA imaging data of subjects arriving for a routine screening mammography, before and after they undergo the mammography. This is in order to reach a conclusion whether the the firm breast compression involved in the mammography procedure affects the performance of the MIRA technology. At the current stage of the development of the device, the goal of this clinical trial is in no way to arrive at a statistical analysis.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gender: female Age: 50 years and older Subjects summoned for a routine screening mammography, ultrasound, diagnostic mammography or breast biopsy. Subject who have signed an informed consent form. Exclusion Criteria: Subjects who have had a mammography, ultrasound, and/or MRI examination performed on the day of the study, PRIOR to their FIRST imaging session with the RealImager. Subjects who have undergone any type of breast surgery throughout the 6 weeks preceding the study. Subjects who have had a breast biopsy performed throughout the 6 weeks preceding the study. Subjects who have undergone a mastectomy. Subjects who have undergone a lumpectomy. Subjects who have a large scar (causing breast deformation). Subjects who have previously undergone or are currently undergoing breast radiation therapy. Subjects who have previously undergone or are currently undergoing chemotherapy. Subjects with prior breast reduction surgery or breast augmentation surgery. Subjects who are pregnant. Subjects who are breast-feeding.

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

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

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 |
| --- | --- | --- |
Phase 1B Study of RiVax, a Vaccine to Prevent the Toxic Effects of Ricin

Study Overview
=================
Brief Summary
-----------------
Dose escalation study: 3 dose groups. 5 patients in each dose group, then 15 more patients in best group. 3 vaccinations in volunteers, at 0 6 and 16 weeks.

Detailed Description
-----------------
Final report was submitted to Dr. Karen Russell at FDA, Rockville on September 26, 2012.

Official Title
-----------------
Phase 1 Study of the Safety and Immunogenicity of RiVax With Alum in Healthy Adults

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

Intervention / Treatment
-----------------
* Biological: RiVax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers aged 18-31, m or f Exclusion Criteria: immunodeficiency pregnant chronic disease parental IgG abnormal labs drug use hiv hep c hep b

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 31 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: RiVax|vaccine|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess the safety of 3 dose levels |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine the immunogenicity of the 3 dose levels |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
volunteers
Clinical Trial To Evaluate ANT-1207 In Subjects With Acne

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of ANT-1207 in the treatment of acne.

Official Title
-----------------
Clinical Trial To Evaluate Botulinum Neurotoxin Type A (ANT-1207) In Subjects With Acne

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Biological: ANT-1207
* Biological: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of moderate to severe facial acne 15 to 40 papules and pustules, and 5 to 50 open and/or closed comedones no presence of nodules female subjects must be not pregnant and non-lactating Exclusion Criteria: presence of 1 or more nodules use of topical steroids on the face 4 weeks prior and during the study use of systemic corticosteroids 6 weeks prior and during the study topical or systemic acne treatment in the 4 weeks prior to Baseline

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>blank vehicle formulation | Biological: Vehicle<br> <br> * Other names: Placebo;|
| Experimental: Dose 1<br>Dose 1 | Biological: ANT-1207<br>* single dose application<br>|
| Experimental: Dose 2<br>Dose 2 | Biological: ANT-1207<br>* single dose application<br>|
| Experimental: Dose 3<br>Dose 3 | Biological: ANT-1207<br>* single dose application<br>|
| Experimental: Dose 4<br>Dose 4 | Biological: ANT-1207<br>* single dose application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy will be assessed by lesion count. | inflammatory lesion count (papules, pustules, and nodules) and non-inflammatory lesion count (open and closed comedones) | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Investigator Global Assessment Score |  | Week 1, 2, 4, 8, and 12 | 
| Change from Baseline in Lesion Count |  | Week 1, 2, 4, 8, 12 |
Estimate the Effect of Telaprevir and Boceprevir on Maraviroc Pharmacokinetics in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect that telaprevir and boceprevir has on the pharmacokinetics of maraviroc.

Official Title
-----------------
Open-Label, Randomized, Fixed-Sequence, Crossover Study to Estimate the Effect of Telaprevir and Boceprevir on Maraviroc Pharmacokinetics in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: Maraviroc
* Drug: Maraviroc + Boceprevir
* Drug: Maraviroc + Telaprevir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2. Total body weight >50 kg (110 lbs). Exclusion Criteria: Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day. Positive result for HIV-1, HIV-2, Hepatitis B serology (HbsAg, HbcAb) or anti hepatitis C virus serology (as determined by a multi antigen EIA).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Maraviroc<br> | Drug: Maraviroc<br>* Maraviroc 150 mg BID x 5 days with food<br>|
| Experimental: Maraviroc + Boceprevir<br> | Drug: Maraviroc + Boceprevir<br>* Maraviroc 150 mg BID + Boceprevir 800 mg TID x 10 days with food<br>|
| Experimental: Maraviroc + Telaprevir<br> | Drug: Maraviroc + Telaprevir<br>* Maraviroc 150 mg BID + Telaprevir 800 mg TID x 10 days with food<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maraviroc plasma pharmacokinetic parameters: AUC12, Cmax, and C12h on Period 1, Day 5 and Periods 2 and 3, Day 10 |  | 25 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maraviroc plasma pharmacokinetic parameters: Tmax on Period 1, Day 5 and Periods 2 and 3, Day 10 |  | 25 days | 
| Boceprevir plasma pharmacokinetic parameters: AUC8, Cmax, C8h, and Tmax on Period 2, Day 10 |  | 10 days | 
| Telaprevir plasma pharmacokinetic parameters: AUC8, Cmax, C8h, and Tmax on Period 3, Day 10 |  | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
maraviroc, boceprevir, telaprevir, drug interaction, pharmacokinetics, HIV
Evaluating the Relationship Between Blood Clotting Disorders, Inflammation, and Obesity in Individuals With Venous Disorders and Post-Thrombotic Syndrome

Study Overview
=================
Brief Summary
-----------------
Venous thrombosis is the development of a blood clot in a vein. Post-thrombotic syndrome (PTS) is a painful condition that can develop following a venous thrombosis in one of the deep veins of the leg. While PTS is mainly thought to occur because of damage to the vein, other factors may be responsible for the development of this condition. This study will analyze genetic and biologic samples from participants of a previous study to examine other possible causes of venous diseases and PTS.

Detailed Description
-----------------
The long-term effects of venous thrombosis, known collectively as PTS, include persistent swelling, pain, cramps, and numbness in the leg. These symptoms result from impaired return of blood through the veins of the lower leg to the heart. PTS is believed to occur as a result of direct damage to the valves and walls of the vein. There may be specific factors that make certain individuals more prone to PTS. Individuals who are obese, have a genetic predisposition to blood clotting disorders, or have high levels of inflammation biomarkers may have an increased risk of developing venous diseases. The purpose of this study is to investigate the possible link between these factors and the occurrence of chronic venous disease and PTS. The study's findings will be useful in developing new prevention and treatment strategies. This study will examine previously collected data from participants in the San Diego Population Study, a study that gathered information on the prevalence of chronic venous disease in a multi-ethnic group of individuals. There will be no study visits specifically for this study. Researchers will examine stored genetic and biologic samples of 370 control participants and 370 participants with chronic venous disease. Specifically, levels of inflammation biomarkers, levels of obesity-related biomarkers, and genetic predispositions for blood clotting disorders will be studied.

Official Title
-----------------
Association of Thrombophilia and Inflammation With Post-Thrombotic Syndrome

Conditions
-----------------
Venous Thrombosis, Venous Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participated in the San Diego Population Study

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 79 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Deep Vein Thrombosis, Chronic Venous Insufficiency, Post Thrombotic Syndrome, Blood Coagulation, Inflammation
Feasibility and Efficacy Study of Student Wellness Online Course for Medical Students

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the feasibility and efficacy of online student wellness courses for improving medical student mental health and well-being.

Official Title
-----------------
Evidence-Based Online Curriculum to Improve Sleep in Medical Students: A Multisite Trial to Assess Efficacy and Feasibility of RefreshMD

Conditions
-----------------
Student Wellness

Intervention / Treatment
-----------------
* Behavioral: RefreshMD
* Behavioral: Bond Between Us


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Full-time medical student at a participating medical school Will remain enrolled as full-time medical student throughout duration of study Exclusion Criteria: Not a full-time medical student at a participating medical school
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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RefreshMD<br>An online course for sleep improvement in medical students | Behavioral: RefreshMD<br>* Online Sleep Improvement Course<br>|
| Placebo Comparator: Bond Between Us<br>An online course covering communication skills and the physician-patient relationship | Behavioral: Bond Between Us<br>* Online Educational Course<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment numbers per course | # of participants who enroll / # of participants invited to enroll | 2 weeks | 
| Views per video |  | Throughout the course (6 weeks) | 
| Number of actively engaged students per course |  | Throughout the course (6 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment |  | Through study completion (4 months) | 
| PROMIS Sleep Disturbance |  | Through study completion (4 months) | 
| PROMIS Depression |  | Through study completion (4 months) | 
| Stanford Medical Student Burnout Questionnaire |  | Through study completion (4 months) |
Retrospective Review of FDG PET MRI Management of Patients With Muscle Invasive Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
Background: Bladder cancer is a common cancer in the U.S. Survival rates for metastatic bladder cancer have not gotten better for 15 years. Diagnosing and assessing the disease is important for treating it. The best way to tell what stage a cancer is in is computed tomography. This is also called CT. But it does not always give the best images of the bladder. Adding a test called positron emission tomography (PET) can help. Magnetic resonance imaging (MRI) is even better than CT for detecting bladder cancer. But it is not widely used. Some people with bladder cancer have already had MRI/PET and CT. Researchers want to study their records. They want to compare the different ways of assessing the disease. Objective: To evaluate the use of MRI/PET for diagnosing and treating metastatic bladder cancer. Eligibility: People 18 years and older who were in studies between 2013 and 2016 Design: Researchers will study existing records. There will be no active participants. The records will have no data that could identify the participants. Data will be stored on secure computers. No study participants will be contacted without approval from a review board.

Detailed Description
-----------------
This protocol is a chart review of the diagnostic imaging and management of patients with metastatic bladder cancer who have undergone PET MRI. The study will involve only review of patient records and will not use specimens or participant contact. The participants whose records will be reviewed in this protocol were enrolled on a number of different protocols between 2013 and 2016.

Official Title
-----------------
Retrospective Review of FDG PET MRI Management of Patients With Muscle Invasive Bladder Cancer

Conditions
-----------------
Bladder Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Patients with metastatic bladder cancer seen between 2013 and 2016 at the NIH Clinical Center. EXCLUSION CRITERIA: Patients who opted out of storage of specimens/data for future use on prior studies will be excluded from this study.

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 |
| --- | --- |
| 1/Patients medical records<br>Medical records of patients with metastatic bladder cancer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease burden | Comparison of measure of disease burden by PET/MRI versus traditional CT imaging | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diagnostic Imaging, Review of Patients Records, PET MRI, Treatment Responses