linjc16/ctgov huggingface dataset:
An Assessment of Voluntary Adolescent Mental Health Screening and Referral in a Children's Hospital Emergency Department

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the TeenScreen intervention to usual care for adolescents who screen positive for mental health problems in a pediatric emergency department. It is anticipated that adolescents receiving the TeenScreen intervention will be more likely to attend a first session of outpatient mental health services within 60 days of the initial screening than those receiving the usual care.

Official Title
-----------------
An Assessment of Voluntary Adolescent Mental Health Screening and Referral in a Children's Hospital Emergency Department

Conditions
-----------------
Mental Health

Intervention / Treatment
-----------------
* Behavioral: TeenScreen Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between 11 and 17 years old Medically stable and presenting with a non-psychiatric complaint English speaking Parent/guardian present for consent Insurance coverage by Medicaid Hamilton County residents Not currently receiving mental health treatment Exclusion Criteria: Less than 11 years or greater than 17 years old Parent/guardian not present at time of visit Medically unstable Non-English speaking Insurance other than Medicaid Presenting complaint is a mental health problem Currently receiving mental health treatment

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 17 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: TeenScreen<br> | Behavioral: TeenScreen Program<br>* Adolescents who are randomized into the TeenScreen program and their parent/guardian will receive post-screening information, a facilitated referral, and case management services from a research social worker.<br>|
| No Intervention: Treatment As Usual<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verified mental health service use through clinical administrative data |  | 60 days after the initial mental health screening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of depressive symptoms and impairment of functioning utilizing the Center for Epidemiological Studies-Depressions Scale and Sheehan Disability Score |  | 60 days after the initial mental health screening | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TeenScreen, Mental Health, Adolescent Mental Health, Social Work
TOxicity After Radiotherapy in breAst CancEr Survivors (ThORACeS) - A Retrospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
Rationale: The number of breast cancer (BC) patients at risk for long-term radiation-induced health problems is increasing, as their outcome is improving due to intensified treatment regimens, such as new systemic approaches and radiotherapy. Therefore, identifying BC survivors with the highest risk for radiation-induced health problems is crucial for developing strategies for primary and secondary prevention, which may contribute to healthy ageing.

Official Title
-----------------
TOxicity After Radiotherapy in breAst CancEr Survivors (ThORACeS) - A Retrospective Cohort Study

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

Intervention / Treatment
-----------------
* Radiation: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female gender. Treated for stage I-III invasive adenocarcinoma of the breast or ductal carcinoma in situ (DCIS). Treated with curative breast-conserving surgery followed by radiotherapy of the breast, with or without irradiation of the regional lymph nodes. Start of radiotherapy is between 01-01-2005 and 31-12-2008. Available planning CT scan and dose distribution data of original breast cancer irradiation. Exclusion Criteria: Any prior malignancy other than non-melanoma skin cancer or breast cancer. Prior radiotherapy treatments in the thoracic region. Treated with neoadjuvant chemotherapy.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Radiotherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with cardiovascular events in relation with the received heart radiation dose |  | At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy | 
| Number of participants with secondary malignancies in relation with the received radiation dose |  | At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy | 
| Number of participants with radiation pneumonitis in relation with the received lung radiation dose |  | At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy | 
| Number of participants with hypothyroidism in relation with the received radiation dose |  | At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiation-induced health problems, Cardiovascular events, Lung toxicity
Circumcision and Breastfeeding

Study Overview
=================
Brief Summary
-----------------
1) To determine when the majority of male infants are being circumcised at 3 hospitals across the US (Brooke Army Medical Center, Naval Medical Center San Diego, and Dartmouth Hitchcock Medical Center. 2) To assess the breastfeeding patterns of circumcised male infants at the above-mentioned academic medical centers. Specifically, to determine if these babies are breastfeeding at the time of hospital discharge, at their newborn visit, their 2-week visit, and all subsequent well visits up until 6 months of age. 3) To determine if there is a significant relationship between the timing of newborn circumcision and breastfeeding initiation, establishment, and maintenance in the first 6 months of life. We hypothesize that the timing of circumcision will not be significantly associated with frequency of breastfeeding among mother-infant dyads during the initial months of life.

Official Title
-----------------
Timing of Circumcision and Breastfeeding Frequency: A Randomized Clinical Trial

Conditions
-----------------
Breastfeeding, Exclusive, Circumcision

Intervention / Treatment
-----------------
* Procedure: Circumcision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All male infants born at the 3 participating sites Exclusion Criteria: Gestational age <38 weeks, twin/multiple deliveries, NICU admission, mothers who are strictly formula feeding their newborns from the time of delivery, and mothers under 18 years of age.

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early Circumcision<br> | Procedure: Circumcision<br>* Early vs. Routine vs. Delayed Circumcision and their impact on exclusive breastfeeding rates<br>|
| Placebo Comparator: Routine Circumcision<br> | Procedure: Circumcision<br>* Early vs. Routine vs. Delayed Circumcision and their impact on exclusive breastfeeding rates<br>|
| Active Comparator: Delayed Circumcision<br> | Procedure: Circumcision<br>* Early vs. Routine vs. Delayed Circumcision and their impact on exclusive breastfeeding rates<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding Rates | Exclusive Breastfeeding Rates | From birth thru 6 months of age |
The Effect of a Diabetic- and a Kidney-like Environment on Gene and Protein Expression in Cultured EC and SMC

Study Overview
=================
Brief Summary
-----------------
This research is NOT part of an interventional trial, however the investigators use umbilical cord after birth for isolating endothelial and smooth muscle cells for academic research.

Detailed Description
-----------------
Isolation and culturing of endothelial and smooth muscle muscles for academic research

Official Title
-----------------
The Effect of a Diabetic- and a Kidney-like Environment on Gene and Protein Expression in Mono- and Co-cultured Endothelial and Smooth Muscle Cells

Conditions
-----------------
Endothelial Dysfunction, Disorder of Smooth Muscle

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal pregnancy Exclusion Criteria: -
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 |
| --- | --- | --- |
| The effect of a Diabetic- and a Kidney-like environment on gene and protein expression in mono- and co-cultured endothelial and smooth muscle cells |  | one year |
The Early Administration of Sodium Thiosulfate Should Help to Reduce the Mortality of Dialysis Patients With Calciphylaxis, From a National Cohort

Study Overview
=================
Brief Summary
-----------------
The national drug safety agency authorizes nominatively the use of sodium thiosulfate in dialysis patients with calciphylaxis. To date, it is the largest global cohort (more 600 patients from 2012 to 2016). We wanted to study retrospectively the fate of these patients at 6 months including mortality. Early use improves effectiveness.

Official Title
-----------------
National Follow-up of Dialysis Patients With Sodium Thiosufate-treated Calciphylaxis Under Temporary Use Authorization

Conditions
-----------------
Calciphylaxis, Renal Insufficiency, Chronic

Intervention / Treatment
-----------------
* Drug: Sodium Thiosulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All dialysis patients with calciphylaxis in France who have obtained a temporary use authorization for sodium thiosulfate by National Agency for the Safety of Medicines Exclusion Criteria: N/A

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 |
| --- |
|Drug: Sodium Thiosulfate|25g intravenously 3 times per week|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time factor on mortality |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney Failure, Chronic/complications, Renal Dialysis, Thiosulfates/therapeutic use, Time Factors, Calciphylaxis/complications
The Effectiveness of Influenza Vaccine Among Health Care Workers in a Hospital Setting.

Study Overview
=================
Brief Summary
-----------------
The study will be held in the winter of 2005-2007. The aim is to assess the effectiveness of the influenza vaccine in health care workers (HCW).

Detailed Description
-----------------
The study will be held in the winter of 2005-2006. Groups of vaccinated HCW and not vaccinated HCW will be followed for symptoms suggestive of influenza. For each event a quick through test for influenza A or B will be done and if positive will be confirmed by viral study. Data regarding days of illness, absence from work, therapy etc., will be collected. Effectiveness will be calculated as well as cost/effectiveness of vaccination.

Conditions
-----------------
Influenza Vaccines

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously healthy health care worker vaccinated or not Exclusion Criteria: Immunocompromised state

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

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
-----------------
influenza vaccine, effectiveness, health care worker, OBSERVATIONAL STUDY
Study of Nitazoxanide in the Treatment of Amebiasis in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of nitazoxanide suspension in treating diarrhea caused by Entamoeba histolytica in children.

Official Title
-----------------
Multi-Center, Double-Blind, Placebo-Controlled Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Entamoeba Histolytica in Children

Conditions
-----------------
Amebiasis

Intervention / Treatment
-----------------
* Drug: Nitazoxanide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 1 to 11 years. Patients with diarrhea (≥3 bowel movements/day) with one or more enteric symptoms such as bloody stools, rectal bleeding or enlarged colon. Positive stool ELISA test for Entamoeba histolytica within 7 days prior to enrollment. Exclusion Criteria: Patients with identified causes of diarrhea other than E. histolytica. Use within 2 weeks of enrollment of any drug or therapy with possible anti-protozoal activity. Females who are pregnant, suspected of being pregnant or breastfeeding. Serious systemic disorders incompatible with the study. History of hypersensitivity to nitazoxanide. Patients in whom the possibility of receiving placebo and not being able to receive immediately an effective treatment will be incompatible with the severity of the patient's illness. Patients with amebic liver abscess. Patients known to have or suspected of having AIDS. Patient with immune deficiencies.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 11 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: Single Group Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of clinical symptoms of amebiasis |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication of cyst or trophozoites of E. histolytica from post-treatment stool samples |  |  | 
| Time from initiation of treatment to passage of last unformed stool |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amebiasis, Entamoeba histolytica
Myocardial Infarction Register of the Saarland

Study Overview
=================
Brief Summary
-----------------
The Myocardial Infarction Register Saarland (MIR-SL), is intended to collect data about the treatment of patients suffering from ST-elevation myocardial infarction (STEMI). It aims to provide current data on the implementation of guidelines for both, the interventional and adjuvant drug therapy of STEMI in daily clinical practice in the Saarland.

Detailed Description
-----------------
The Myocardial Infarction Register Saarland (MIR-SL), is intended to collect data about the treatment of patients suffering from ST-elevation myocardial infarction (STEMI). It aims to provide current data on the implementation of guidelines for both, the interventional and adjuvant drug therapy of STEMI in daily clinical practice in the Saarland. In order to obtain representative data for the Saarland, preferably all consecutive patients should be documented comprehensively in the University Hospital of the Saarland, the non-university hospitals with cardiac catheterization laboratory as well as in hospitals without cardiac catheterization laboratory . MIR-SL is attended by all 22 hospitals in Saarland, that treat patients with acute STEMI. A follow-up will be carried out after three months, 12 months and five years.

Official Title
-----------------
Myokardinfarkt-Register Des Saarlandes (MIR-SL)

Conditions
-----------------
Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: signed informed consent Exclusion Criteria: age < 18 years missing informed consent

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 |
| --- | --- | --- |
| Rate of reperfusion therapies | Describe hospital daily routine in Germany | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time before reperfusion therapy | pre-hospital time, intrahospital time, transfer time | 24 hours | 
| In-hospital mortality | Describe mortality before discharge | 24 hours |
Effect of Diabetes Mellitus on Success of Spinal Anesthesia

Study Overview
=================
Brief Summary
-----------------
Some of the authors says that diabetes mellitus is a risk factor for spinal anesthesia failure. However, that opinion was not determined in a trial. Thus the investigators aimed to investigate the effect of diabetes mellitus on spinal anesthesia.

Detailed Description
-----------------
The investigators will include all of the patients who will undergo surgery with spinal anesthesia. The investigators will observe the patients with or without diabetes mellitus. And the investigators will examine the effect of diabetes mellitus on failure of spinal anesthesia.

Official Title
-----------------
Phase IV Study of Diabetes Mellitus for Spinal Anesthesia Failure

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: spinal anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: surgery with spinal anesthesia Exclusion Criteria: heart failure coronary artery disease

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| diabetes mellitus<br>spinal anesthesia | Other: spinal anesthesia<br>* non diabetes mellitus<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensorial loss with pin prick test |  | intraoperative 5 th minute | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
failure, spinal anesthesia
Product Surveillance Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.

Official Title
-----------------
Medtronic Product Surveillance Registry

Conditions
-----------------
Neurovascular, Cardiac Rhythm Disorders, Urological Disorders, Neurological Disorders, Cardiovascular Disorders, Digestive Disorders, Intracranial Aneurysm, Mechanical Circulatory Support, Respiratory Therapy, Aortic, Peripheral Vascular and Venous Disorders, Minimally Invasive Surgical Procedures, Diagnostic Techniques and Procedures, Surgical Procedures, Operative, Renal Insufficiency, Coronary Artery Disease, Ear, Nose and Throat Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements Patient has or is intended to receive or be treated with an eligible Medtronic product Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment Exclusion Criteria: Patient who is, or will be, inaccessible for follow-up Patient with exclusion criteria required by local law Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
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 |
| --- | --- | --- |
| Safety and Effectiveness of Market Released products |  | Every 6-12 months (Therapy-dependent) |