linjc16/ctgov huggingface dataset:
Phase 2 Study of Vinblastine in Children With Recurrent or Refractory Low Grade Glioma

Study Overview
=================
Brief Summary
-----------------
This study is examining whether Vinblastine is an effective drug to shrink low grade glioma brain tumors in children, and what the side effects are.

Official Title
-----------------
A Phase 2 Study of Vinblastine Sulphate Injection in Children With Recurrent or Refractory Low Grade Glioma

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

Intervention / Treatment
-----------------
* Drug: vinblastine sulphate injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: < 21 years of age at original diagnosis histological verification of low grade glioma (glial tumors, neuronal tumors or chiasmatic-hypothalamic tumor) at original diagnosis evidence of tumor recurrence or progression by MRI or contrast CT Karnofsky and Lansky performance status of 0,1 or 2 life expectancy of greater than or equal to 2 months adequate organ and bone marrow function within 7 days of starting treatment with Vinblastine absolute neutrophil count (ANC)> 1000/uL platelet count > 100,000/uL (transfusion independent) serum creatinine < 1.5 x normal for age written informed consent signed by subject and/or subject's parent/legal guardian Exclusion Criteria: not recovered from the acute toxic effects of all prior chemotherapy, immunotherapy or radiotherapy chemotherapy within 2 weeks of entry in study (4 weeks if prior nitrosourea was used) less than 7 days since the completion of therapy with a biologic agent less than 2 months since cranial/spinal radiation receiving a stable dose of dexamethasone for less than one week

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 21 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: vinblastine sulphate injection<br>* Vinblastine dose: 6 mg/m^2 (10 mg max.) route intravenous administration once a week over a period of 10 weeks. If response at week 10 is greater than or equal to stable, weekly Vinblastine will be continued for 42 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the response rate to Vinblastine in recurrent low grade glioma of childhood |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To further assess the toxicity of weekly vinblastine in children treated at the currently defined maximally tolerated dose (MTD) of Vinblastine |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glioma, brain tumour, cancer, pediatrics, vinblastine sulfate
A See and Treat Paradigm for Cervical Pre-cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if the transvaginal colposcope produces similar results to colposcopy for the screening of cervical cancer. In this study the investigators are using an investigational device called the transvaginal colposcope. The word investigational means that the device is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA).

Official Title
-----------------
A See and Treat Paradigm for Cervical Pre-cancer

Conditions
-----------------
Cervical Pre-cancer

Intervention / Treatment
-----------------
* Device: transvaginal digital colposcope (TVDC)
* Other: Standard of care screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing cervicography OR colposcopy OR VIA OR patients undergoing LEEP for the treatment of cervical cancer. Age 25 and greater Patients of all ethnic backgrounds will be included. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Children and subjects under 25.

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: transvaginal digital colposcope (TVCD)<br>Each enrolled patient will undergo the standard of care for cervical cancer screening at her institution, and then the trans-vaginal colposcope will be used to collect digital images of the cervix. | Device: transvaginal digital colposcope (TVDC)<br>* TVDC is a miniature colposcope used to obtain images of cervical tissue.<br>|
| Active Comparator: standard of care screening<br>Each enrolled patient will undergo the standard of care for cervical cancer screening at her institution, and then the trans-vaginal colposcope will be used to collect digital images of the cervix. | Other: Standard of care screening<br>* Standard of care screening varies from institution to institution but is either visual inspection with the naked eye, colposcopy, or visual inspection with a camera or microscope<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants for Which the Standard of Care Diagnosis and the Diagnosis of the TVDC Image Agree |  | Up to approximately 10 minutes |
DNA Tests in Detecting Disseminated Disease in Tumor, Blood, and Bone Marrow Samples From Patients With Rhabdomyosarcoma

Study Overview
=================
Brief Summary
-----------------
RATIONALE: DNA analysis of tumor, blood, and bone marrow may help doctors predict if the disease has been disseminated. PURPOSE: This research trial studies DNA tests in detecting disseminated disease in tumor, blood, and bone marrow samples from patients with rhabdomyosarcoma.

Detailed Description
-----------------
OBJECTIVES: To establish a panel of hypermethylation assays for minimal disseminated disease analysis in rhabdomyosarcoma (RMS). To apply the hypermethylation assays to a series of bone marrow specimens from RMS patients. OUTLINE: Archived tumor, bone marrow, and peripheral blood samples are analyzed for DNA hypermethylation by PCR-based assays and microarray assays. Results are then compared with each patient's clinical and pathological characteristics, and outcomes. Patterns of locus hypermethylation in tumor and paired bone marrow samples are also compared.

Official Title
-----------------
DNA Methylation-based Assays for Detecting Disease Spread in Rhabdomyosarcoma

Conditions
-----------------
Sarcoma

Intervention / Treatment
-----------------
* Genetic: DNA methylation analysis
* Genetic: microarray analysis
* Genetic: polymerase chain reaction
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosed with rhabdomyosarcoma (RMS) Tumor, bone marrow, and peripheral blood samples from the Children's Oncology Group D9803 trial of intermediate-risk RMS PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: DNA methylation analysis|nan|
|Genetic: microarray analysis|nan|
|Genetic: polymerase chain reaction|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Panel of hypermethylation assays for minimal disseminated RMS |  |  | 
| Detection of RMS cells in bone marrow |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alveolar childhood rhabdomyosarcoma, embryonal childhood rhabdomyosarcoma, embryonal-botryoid childhood rhabdomyosarcoma, mixed childhood rhabdomyosarcoma, pleomorphic childhood rhabdomyosarcoma, previously untreated childhood rhabdomyosarcoma, nonmetastatic childhood soft tissue sarcoma
Efficacy of Atomoxetine Therapy Versus Placebo for Cognitive Late Effects

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the effectiveness and safety of atomoxetine in enhancing attention and concentration among childhood survivors of cancer.

Detailed Description
-----------------
In previous years, it had often been assumed that cognitive and behavioral declines in children who survived cancer therapy were largely a function of the prophylactic therapies (e.g., radiation, chemotherapy) that these children had received. Regardless of the etiologies of these specific late effects, the data regarding the long-term outcome of these children are strikingly consistent. Generally, the studies to date suggest significant impairments in attention and concentration that result in marked declines in academic performance and social and behavior difficulties. Despite the clear evidence of problems with attention and concentration, as well as associated fucntional impairments (e.g., poor academic achievement and poor peer relationships), there have been few clinical trials designed to manage the cogntive late effects and neurological toxicities associated with radiation therapy and chemotherapy for children and adolescents who have survived cancer.

Official Title
-----------------
Efficacy of Atomoxetine Therapy Versus Placebo For Ameliorating Cognitive Late Effects Among Survivors of Childhood Cancers

Conditions
-----------------
Cancer, Cognitive Late Effects

Intervention / Treatment
-----------------
* Drug: Atomoxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 6-18 Patient has received chemotherapy, radiation, or a combination of both. Patient is at least 12 months post-competion of therapy but no more than five years post-completion of therapy. Exclusion Criteria: No ongoing pharmacological management of ADHD Not currently pregnant

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conner's Parent Rating Scale (CPRS) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conner's Teacher Rating Scale (CTRS) |  |  | 
| Continuous Performance Test (CPT) |  |  | 
| Side Effects Rating Scale |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Cognitive Late Effects, Stimulants, Atomoxetine, Attention, Children
A Study of Insulin Peglispro in Healthy Male Japanese Participants

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to evaluate how the body processes the study drug known as insulin peglispro and how the study drug affects blood sugar in healthy male Japanese participants. This study will also evaluate safety of the study drug. The study will last up to 46 days for each participant, not including screening.

Official Title
-----------------
A Single Dose Study to Evaluate the Pharmacokinetics and Glucodynamics of Insulin Peglispro (LY2605541) in Healthy Male Japanese Subjects

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Insulin Peglispro


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants are overtly healthy male Japanese. Participants have Body Mass Index (BMI) between 18.5 and 25.0 kilograms per square meter (kg/m^2), inclusive. Exclusion Criteria: Participants have known allergies to insulin peglispro or related compounds. Participants have a fasting venous blood glucose >108 milligrams per deciliter (mg/dL) (>6 millimoles per liter [mmol/L]).

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin Peglispro<br>Single subcutaneous dose of 1.3 Units per kilogram (U/kg) insulin peglispro on Day 1. | Drug: Insulin Peglispro<br> <br> * Other names: LY2605541;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Observed Maximum Concentration (Cmax) of Insulin Peglispro |  | Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose | 
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of Insulin Peglispro | AUC from time zero to infinity (AUC[0-∞]) of insulin peglispro was evaluated. | Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose | 
| Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Insulin Peglispro |  | Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose | 
| Glucodynamics: Maximum Glucose Infusion Rate (Rmax) |  | Predose up to 36 hours post clamp procedure | 
| Glucodynamics: Total Amount of Glucose Infused (Gtot) |  | Predose up to 36 hours post clamp procedure. |
Consortium of Early Arthritis Cohorts USA

Study Overview
=================
Brief Summary
-----------------
Rheumatoid arthritis (RA) is the most common form of inflammatory arthritis. In the US, it is estimated that as many as 3 million adults may suffer from the disease. Fortunately in the last few years, a shift in strategy toward the earlier institution of disease modifying drugs and the availability of new classes of medications have greatly improved the outcomes that can be expected by most patients. The goal of treatment now aims toward achieving the lowest possible level of arthritis disease activity and even remission, if possible as early on as possible. Research has shown that this translates into minimized joint damage and enhanced physical function and quality of life for the RA patient. This also requires that a diagnosis of RA be made as early on as possible, and herein lies the challenge, i.e. identifying the RA patient early on in the course of their disease.

Official Title
-----------------
Consortium of Early Arthritis Cohorts USA - A Prospective Cohort Study of Adults With New Consent Inflammatory Arthritis Symptoms to Understand Predictors of Optimal Outcomes

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient was 18 years of age or over at time of referral Joint symptoms for < 12 months 2+ swollen joints OR 1 swollen joint with one of the following: Rheumatoid Factor > 20 IU, (+) anti-CCP antibody, morning stiffness > 45 minutes, responded to NSAIDs, (+) MTP squeeze test

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 |
| --- | --- | --- |
| Rapidity and sustainability of SDAI remission as achieved over a one year period |  | 3 months, 6 months, 9 months and 12 months of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients achieving DAS28 remission and CDAI remission twice |  | 3 months, 6 months, 9 months and 12 months of follow-up | 
| Rapid radiographic progression, as measured by a van der Heijde Sharp Score change of 5 point or more |  | 2 months and 24 months of follow-up |
Impact on Patient Outcome of Cardiac Implantable Electronic Device Complications

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to evaluate the impact on patient outcome and on healthcare utilization of cardiac implantation electronic device complications during a long-term follow-up.

Detailed Description
-----------------
Multicentric, observational, prospective registry enrolling consecutive patients underwent pacemaker or defibrillator implantation, aimed to evaluate the impact of cardiac implantable device complications requiring surgical revision on healthcare utilization (number and length of hospitalizations), and on patient outcome (all-cause mortality and cardiac mortality), during a long-term follow-up.

Official Title
-----------------
Impact on Patient Outcome and Healthcare Utilization of Cardiac ImplaNTable Electronic Devices Complications

Conditions
-----------------
Cardiac Implantable Electronic Device Complications

Intervention / Treatment
-----------------
* Device: Implantation of a cardiac implantable electronic device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients underwent cardiac implantable electronic device implantation according to current guidelines during the enrollment period. Exclusion Criteria: patients already carriers of a cardiac implantable electronic device underwent replacement or upgrading of device.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Implantation of a cardiac implantable electronic device|All patients enrolled in the registry underwent cardiac implantable electronic device implantation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause Death (dead/alive status assessment during follow-up) | Evaluation of all-cause mortality during follow-up | An average of 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of hospitalizations related to cardiac implantable electronic device complications | Evaluation of hospitalizations related to cardiac implantable electronic device complications | An average of 48 months |
Capsaicin-Evoked Pain in Patients With CRPS

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of capsaicin in patients with Complex Regional Pain Syndrome.

Detailed Description
-----------------
Primary outcome parameters: Capsaicin-induced pain and inflammation. Secondary outcome parameters: Peripheral sensory and autonomic function.

Official Title
-----------------
Capsaicin-Evoked Pain in Patients With Complex Regional Pain Syndrome

Conditions
-----------------
CRPS (Complex Regional Pain Syndromes)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18 or older. Pain in arm or hand > 3 months. Diagnosed with CRPS acc. to diagnostic research criteria (Harder et al., 2005) Inclusion of healthy subjects: age-, gender-, and BMI-matched. Exclusion Criteria: Other significant disease affecting the parameters measured, including cardiovascular disease. Treatment with anticholinergics, sympathomimetics and parasympathomimetics, and alpha- and beta-adrenergics.

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 |
| --- | --- | --- |
Rapid 10-Minute Liver MRI Protocol in Patients With Suspected Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study to assess the image quality of the rapid magnetic resonance imaging (MRI) compared to the standard MRI.

Detailed Description
-----------------
This is a pilot study to compare a rapid 10-minute liver magnetic resonance imaging (MRI) protocol to standard MRI in participants with suspected hepatocellular carcinoma.

Official Title
-----------------
Rapid 10-Minute Liver MRI Protocol in Patients With Suspected Hepatocellular Carcinoma: A Pilot Study to Assess the Image Quality (Multitransmit Body MRI Program)

Conditions
-----------------
Underlying Liver Disease, Hepatitis, Fibrosis of Liver, Cirrhosis With Suspicion of Liver Cancer, Lesion on a Prior Ultrasound, CT or Outside MRI

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: underlying liver disease have a lesion on a prior imaging study must have prior standard MR Exclusion Criteria: Contra-indication for MR imaging including pacemaker, claustrophobia, pregnancy, electronic or vascular devices that are contraindicated; patients with severe kidney dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| subjects with an underlying liver disease<br>(1)underlying liver disease; (2) have a lesion on a prior imaging study; (3) must be prior standard MR | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| image quality outcome | Two MRI exams will be evaluated by two radiologists based on a number of items. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver disease, hepatocellular carcinoma