linjc16/ctgov huggingface dataset:
An Affect Management Intervention for Juvenile Offenders

Study Overview
=================
Brief Summary
-----------------
Adolescents are at risk for HIV because of sexual and drug behavior initiated during this developmental period. Adolescents in the juvenile justice system are at increased risk for HIV due to higher rates of substance use and psychopathology than their non-offending peers. Juvenile justice youth may therefore also be less likely to benefit from frequently used skills based interventions. It appears that emotional lability, frequently found in this population, disrupts skills learned. This project will implement and evaluate an affect management HIV prevention intervention for adolescents in a juvenile drug court program. Affect management and general health promotion interventions will be compared to determine which intervention best reduces risk behavior among adolescents in the drug court.

Official Title
-----------------
An Affect Management Intervention for Juvenile Offenders

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

Intervention / Treatment
-----------------
* Behavioral: Affect Management
* Behavioral: General Health Promotion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescents enrolled in the juvenile drug court program Exclusion Criteria: Adolescent is HIV positive Adolescent is pregnant Adolescent is developmentally delayed Adolescent has history of sexual crime

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Behavioral: Affect Management<br>* 5 session group intervention that focused on teaching affect management skills and included HIV prevention and sexual health training<br>|
| Active Comparator: 2<br> | Behavioral: General Health Promotion<br>* 5 session group focused on delivering general health promotion information in didactic format<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adolescent-reported sexual activity and condom use |  | 3 month post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adolescent substance use (self-report and urine toxicology screen results) |  | 3 months post-intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV prevention, HIV seronegativity
Identifying Saliva Markers of Patients With Stomach, Colorectal (Including Pre-cancer Polyp) and Pancreatic Cancers

Study Overview
=================
Brief Summary
-----------------
Colorectal cancers account for 783,000 new cases and cause 437,000 deaths per year across the world. Diagnosis in the early stages improves survival rates. Up to now, these cancers are mostly diagnosed only at later stages of the disease's course through histoimmune staining and molecular biology processes on the tissues biopsied from the gastrointestinal system under invasive diagnostic procedures of colonoscopy. Oral fluid presents a large protein complexity and has been recently used as a diagnostic biofluid for oral, as well as systematic diseases. Using oral fluid as a bio-marker for the colorectal cancer can be advantageous as it contains gastrointestinal fluids, in addition to bacteria and bacteria lysate, which can also serve as a bio-markers' source for colorectal cancers. Proteomic technologies provide the tools needed to discover and identify disease-associated biomarkers. The aim of the present study is to identify salivary bio-markers in patients suffering from colorectal cancers.

Conditions
-----------------
Gastric Cancer, Colorectal Cancer and Pre-cancer Polyps, Pancreatic Cancer

Intervention / Treatment
-----------------
* Other: Salivary samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has not yet started treatment for the identified cancer Exclusion Criteria: medically compromised patients congenital syndromes being treated with radiotherapy or chemotherapy.

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 |
| --- | --- |
| Control<br>Healthy adults above the age of 18 years | Other: Salivary samples<br>* Each participant will give a sample of saliva through spitting for 10 minutes in a sterile tube.<br>* Other names: Salivary Analysis;|
| Study<br>Adult patients above the age of 18 years with gastric, colorectal (including pre-cancer polyps) or pancreatic cancer | Other: Salivary samples<br>* Each participant will give a sample of saliva through spitting for 10 minutes in a sterile tube.<br>* Other names: Salivary Analysis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Acute Lower gastroIntestinal BleedIng (ALIBI Study) in Italy

Study Overview
=================
Brief Summary
-----------------
Unlike upper GI bleeding, for LGIB there is still a paucity of data on clinical presentation, patient characteristics, pathways of care and outcomes for LGIB patients. In-hospital mortality ranges from 1.2% to 8.8% (2-4), according to retrospective studies, but data from prospective series are still limited (5). Present multicentre, prospective, observational study was designed to explore these areas, to assess variations in practice management and to identify factors associated with patient outcomes.

Official Title
-----------------
Acute Lower gastroIntestinal BleedIng (ALIBI Study): a Multicentre Prospective, Cohort Study

Conditions
-----------------
Lower GI Bleeding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients with acute lower GI bleeding Exclusion Criteria: age below 18 years bleeding patients with an upper GI source

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 |
| --- | --- | --- |
| Mortality rate in patients admitted for acute lower GI bleeding | Number of deaths among the study cohort | 4 weeks |
A Randomized, Double-blind, Placebo-controlled, Sequential Ascending, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2212 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This study is designed as a single ascending dose study in healthy subjects to evaluate safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) in plasma and Cerebrospinal (CSF) following single oral doses of E2212.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Sequential Ascending, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2212 in Healthy Subjects

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: E2212
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and women of non-child bearing potential age 18 and 55 years old at the time of Screening; Body mass index (BMI) 18 and 30 kg/m2 at Screening; Are willing and able to comply with all aspects of the protocol; and Provide written informed consent. Exclusion Criteria: Clinically important abnormalities on physical examination, vital signs or clinical laboratories. History of serious medical illness Smoking or use of tobacco-containing products within past 3 months History of alcohol or drug abuse within past 2 years

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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug E2212<br> | Drug: E2212<br>* single ascending doses ranging from 10mg to 250mg<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* a single dose of matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of single ascending oral doses of E2212 in healthy subjects. |  | 21 days |
Arterial Spin Labeling Perfusion Magnetic Resonance (MR) Imaging in Pediatric Brain Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to get information regarding the usefulness and accuracy of this new magnetic resonance imaging (MRI) technique - termed arterial spin labeling (ASL) - in the diagnosis of pediatric brain tumors.

Detailed Description
-----------------
The purpose of this study is to get information regarding the usefulness and accuracy of this new MRI technique - termed arterial spin labeling (ASL) - in the diagnosis of pediatric brain tumors. This technique can non-invasively measure the blood flow to the brain during MRI examination. Because aggressive brain tumors require new blood vessels and a high level of blood supply to support its growth, we believe the tumor blood flow measured using ASL is a reliable indicator of tumor grade. This information may be useful for doctors to make treatment decisions and to monitor patients' response to treatment.

Official Title
-----------------
CHP-901:Arterial Spin Labeling Perfusion MR Imaging in Pediatric Brain Tumors

Conditions
-----------------
Brain Tumors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 0-18 years Primary brain tumor (newly diagnosed or recurrent) with measurable disease (at least 1cm2) Exclusion Criteria: Patients with cardiac pacemaker or ferrous metal foreign bodies Patients with medical problems contradictive to receiving MRI scans. Patients requiring general anesthesia or sedation for their MRI scan. Patients with a history of cerebrovascular disorders (stroke, moya moya) that may alter cerebral perfusion.

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
Phase II Gallium Nitrate in Relapsed or Refractory Non-Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
Eligible patients will have low- or intermediate-grade Non-Hodgkin's Lymphoma (NHL) that has progressed after standard chemotherapy. Patients will receive gallium nitrate 300 mg/m2/day by continuous IV infusion for 7 consecutive days using a portable infusion pump. Hospitalization is not required. Stable or responding patients will receive additional gallium nitrate infusions every 3 weeks until the time of disease progression, for a maximum total of 8 infusions, or 2 cycles after complete remission has been documented.

Detailed Description
-----------------
This study seeks to define the role of gallium nitrate in a specific population of patients who are expected to have received prior therapy. Preliminary clinical studies have suggested substantial evidence of antitumor activity in patients with relapsed or refractory non-Hodgkin's Lymphoma treated with gallium nitrate.

Official Title
-----------------
A Phase II Multicenter Study of Gallium Nitrate in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Conditions
-----------------
Non-Hodgkin's Lymphoma, Relapsed Lymphoma, Refractory Lymphoma, Low-Grade Lymphoma, Intermediate-Grade Lymphoma

Intervention / Treatment
-----------------
* Drug: gallium nitrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Low- or intermediate-grade NHL using the International Working Formulation, subtypes IWF A-G: Using the Updated REAL/WHO Classification, the following pathologic subtypes are eligible: Small lymphocytic lymphoma Lymphoplasmacytic lymphoma/immunocytoma Follicular lymphoma Diffuse large B-cell lymphoma Peripheral T-cell lymphoma, not otherwise characterized Progression of disease following treatment with standard chemotherapy Bi-dimensionally measurable disease Performance Status: ECOG < = 2 Patients with mantle cell lymphoma or mycosis fungoides are not eligible Patients with known history of CNS metastasis are not eligible

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: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gallium nitrate|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
-----------------
Gallium Nitrate, Ganite, NHL, Relapsed
Microvascular Reactivity.

Study Overview
=================
Brief Summary
-----------------
This study attempts to test capillary responses to various challenges without the need for iontophoresis (electrical current).

Detailed Description
-----------------
Studies of microvascular responsiveness often employ iontophoresis to fascilitate drug absorption. Iontophoresis is a confounding stimulus in such studies, and we are attempting to create tests of the microvasculature that do not require iontophoretic drug delivery.

Official Title
-----------------
Transdermal Application of Acetylcholine and Nitroglycerin Without Iontophoresis.

Conditions
-----------------
Diabetes, Retinopathy, Vascular Pathology

Intervention / Treatment
-----------------
* Device: Laser Doppler Flowmetry with topical acetylcholine and nitroglycerin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetic. - Exclusion Criteria: not on nitrates or mydriatic eye drops within 48 hours. -

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

| Intervention/Treatment |
| --- |
|Device: Laser Doppler Flowmetry with topical acetylcholine and nitroglycerin|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
-----------------
endothelium, iontophoresis, acetylcholine, nitroglycerin, vasodilation
Diagnostic Imaging of Lymph Nodes in Gynaecologic Oncology

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the diagnostic accuracy of a new magnetic resonance imaging (MRI) technique, the diffusion weighted imaging with body background signal suppression (DWIBS) in the detection of lymph node pathology in patients with gynaecologic malignancies.

Detailed Description
-----------------
The presence of lymph node metastases indicates a poor prognosis, with a marked decrease in 5-year survival rate. Lymph node involvement is an important factor in the choice of adjuvant treatment in gynaecological malignancies. Surgical lymphadenectomy is the gold standard for the diagnosis of lymph node metastases. This is a highly specialized procedure with increase in operative time and cost, and risk of surgery-related morbidity. Therefore, a non-invasive technique that accurately identifies lymph node metastasis would be beneficial. Diffusion Weighted whole body Imaging with Background Signal suppression (DWIBS) is a new imaging technique, which lightens lymph nodes and possibly differentiates normal and hyperplastic from metastatic lymph nodes. Cancer metastases in lymph nodes may be associated with alterations in water diffusivity and microcirculation within the node. It is also likely that cell density might play an important role. So far, no feasibility studies have will be evaluated for its accuracy, effectiveness, and feasibility in detecting lymph node metastases in gynaecological malignancies, as a possible alternative for the surgical staging method. The accuracy of a pelvic lymph node dissection (reference test) will also be evaluated by performing a post-operative DWIBS scan.

Official Title
-----------------
The Diagnostic Accuracy of Non-invasive Lymph Node Imaging in Gynaecologic Malignancies

Conditions
-----------------
Cervix Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms, Vulvar Neoplasms, Lymphatic Metastasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Cervical cancer stage Ia2-Ib, IIa Endometrial cancer stage I (high risk), II Ovarian cancer stage I, IIa-IIa Vulvar cancer stage I, II Age > 18 years Karnofsky score > 70 Exclusion Criteria: Eligible for the PORTEC II trial Contra-indications to the MRI: surgical clips in the brain, a pacemaker and claustrophobia

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

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

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
-----------------
Gynaecological malignancy, Diagnostic Accuracy, DWIBS, Lymph Nodes, Metastasis
Trends in Modern Phase 1 Oncology Trials

Study Overview
=================
Brief Summary
-----------------
Overview of response rate published in recent oncology phase I trials

Detailed Description
-----------------
Critics have raised a fundamental ethical challenge about phase 1 cancer research. They point to an expected paucity of benefits, since approximately 5% of patients in phase 1 trials are reported to have tumor shrinkage. Objective was to conduct a search of the literature using PubMed to identify articles about phase 1 trials that were published from January 1, 2014, through June 30, 2015. The primary end point was the response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Clinically relevant trials' characteristics were investigated as candidate factors associated with the RR: Funding source (Academic / Industrial), First-in man trial (Yes / No), Expansion cohort (Yes / No), Number of targeted organs (Single / Multiple), Therapy (Single / Combination), Treatment (MAB-Immuno / ITK / Chimioth-HT-other), Biological eligibility criterion (Yes / No), as well as the number of assessable patients, which for ease of clinical interpretation was transformed into a qualitative variable (0-25 / 26 - 50 / 51+). The RR was described according to the individual trials' characteristics. Associations with trials's characteristics were investigated using statistical modeling.

Official Title
-----------------
Trends in Modern Phase 1 Oncology Trials

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: Phase I


Participation Criteria
=================
Eligibility Criteria
-----------------
Trials based on the following eligibility criteria: cancer phase 1 trials published from January 1, 2014, through June 30, 2015

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: Phase I|Chemotherapy, ITK, Hormotherapy, Immunotherapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate | Number of reported responses (complete [CR] and partial [PR]) divided by the number of reported assessable patients | up to 6 months after treatment initiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Phase I trials, Review
Follow Up Study of Tear in the Rotator Culf

Study Overview
=================
Brief Summary
-----------------
Rotator culf tears are common in the aging population and are a significant morbidity source. The common knowledge is that the major tears do not heal and constantly expanding.Still since the majority of the patients are old the acceptable therapy is conservative treatment. Our objective is to estimate the accuracy of rotator culf tear utilizing an ultrasound.

Official Title
-----------------
Follow Up Study of Tear in the Rotator Culf

Conditions
-----------------
Rotator Culf Tear

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Was diagnosed with shoulder tear Size of the tear till 2.5 cm The opposite tendon-normal Exclusion Criteria: systematic Diseases . Injury to the shoulder after the previous US. Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 65 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<br> | |

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

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