linjc16/ctgov huggingface dataset:
Effects of the Örebro Prevention Program on Youth Drinking

Study Overview
=================
Brief Summary
-----------------
The Örebro prevention program is a brief (6 x 30 minutes)program administered to parents of 13-16 year old youths in regular parental meetings. The program aims to encourage parents to maintain a restrictive attitude towards youth drinking throughout their children's teenage years, and thereby postpone and reduce youth drinking. A previous quasi-experimental study by the program developers showed a sustained alcohol-specific restrictivity among parents exposed to the program, and also a reduction on drinking measures among the youths of the exposed parents (Koutakis, Stattin & Kerr, 2008). This study aims to investigate whether these effects are sustained also when the program has gone into wide dissemination in Sweden.

Conditions
-----------------
Youth Drinking

Intervention / Treatment
-----------------
* Behavioral: Örebro prevention program
* Behavioral: Business as usual


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Municipal schools in counties with local ÖPP program presenters, comprising grades 7-9, with at least two 7th grade classes in parallel, and with no previous experience of the Örebro prevention program. - Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 16 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: Örebro prevention program<br> | Behavioral: Örebro prevention program<br>* 6 presentations on alcohol-specific parenting practices to parents of 13-16 year olds youth<br>|
| Active Comparator: Control<br>Business as usual | Behavioral: Business as usual<br>* Regular alcohol prevention activities and curricula in Swedish schools<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported drunkenness | Self-reported drunkenness among youth | 12 months | 
| Self-reported drunkenness | Self-reported drunkenness among youth | 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported alcohol consumption | Self-reported alcohol consumption among youth | 12 months | 
| Self-reported alcohol consumption | Self-reported alcohol consumption among youth | 30 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Örebro prevention program, Youth drinking
Nutritional Status and Barriers to Dietary Intake in Head and Neck Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The investigators hope to learn more about how side-effects of RT or RTchemo affect food intake and nutrition status.

Detailed Description
-----------------
Head and neck cancer patients often have difficulty meeting their nutritional needs while undergoing radiation therapy (RT) and/or chemotherapy (RTchemo). Tumor locations and side effects of RT or RTchemo, including dry mouth, mouth sores, difficulty chewing and swallowing, changes in taste and smell, and loss of appetite, lead to poor food intake and weight loss. The investigators hope to learn more about how side-effects of RT or RTchemo affect food intake and nutrition status.

Official Title
-----------------
Nutritional Status and Barriers to Dietary Intake in Head and Neck Cancer Patients Prior to, on Completion of and Six Weeks After Oncology Treatment

Conditions
-----------------
Head and Neck Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Diagnosed with head and neck cancer including the lip, oral cavity, salivary glands, paranasal sinuses, oropharynx, nasopharynx, hypopharynx, larynx, and thyroid All histological types of cancer All tumour stages according to American Joint Committee for Cancer (AJCC) Staging All forms of RT including standard or investigational and/or concurrent standard or investigational chemotherapy for head and neck cancers Alert and mentally competent English speaking Exclusion Criteria: Unwilling to participate

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
food, diet, mucositis, xerostomia, dysphagia, taste, smell, head and neck, radiation, chemotherapy
Hypertension in Families of African Origin

Study Overview
=================
Brief Summary
-----------------
To investigate familial patterns of hypertension and related cardiovascular (CV) risk factors in the United States and Nigeria.

Detailed Description
-----------------
BACKGROUND: It has been known for many years that African Americans experience twofold higher rates of hypertension than do whites. The underlying biological mechanisms which lead to this differential are still not understood, however. Despite widespread speculation that persons of African descent are genetically susceptible to hypertension, few direct studies have been carried out. Rates of hypertension remain low in West Africa, and this study will provide a contrast between populations of similar genetic background in a low versus high risk environmental setting DESIGN NARRATIVE: A total of 240 families were identified from completed community surveys in Maywood, Illinois and Ibadan, Nigeria. Probands were ages 45-55 and equally divided between males and females. A minimum of five first-degree relatives were examined in each family to obtain information on the following variables: blood pressure (BP), obesity, urinary sodium and potassium, socioeconomic status and physical activity. In addition, plasma and DNA were collected and stored for future studies of relevant physiologic intermediate phenotypes and candidate genes for hypertension in the two contrasting populations. These data provided the basis for examining familial aggregation of blood pressure/hypertension and related CV risk factors. Three primary goals were addressed: 1) to determine whether the familial aggregation of blood pressure in Black populations was influenced by the overall distribution of environmental factors at the population level, by contrasting the distribution of familial correlations of blood pressure and the familial aggregation of hypertension, in Nigeria and the United States; to determine the significance of measured environmental correlates of blood pressure by comparing the magnitude of variance components for probands and relatives in each setting; and 3) to use path analysis to obtain estimates of genetic and cultural heritability of blood pressure, controlling for clustering environmental factors at the household level. Plasma and DNA samples collected in this study provided additional valuable resources for future molecular research. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Cap-assisted Sigmoidoscopy - Influence on Pain, Duration and Rate of Success

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the attachment of a transparent hood (cap) on the sigmoidoscope. The investigators hypothesis is that this will reduce pain, reduce investigation time, and increases the success rate of the sigmoidoscopy. The study focus on the less-experienced endoscopist.

Detailed Description
-----------------
The investigators randomize study subject to sigmoidoscopy +/- the attachment of the cap. Using a 100mm VAS scale the investigators record pain when the sigmoidoscopy reaches its intubation end-point (60cm from anus). The investigators also register the time spent to this point and the rate of examinations not achieving this endpoint.

Official Title
-----------------
Cap-assisted Sigmoidoscopy - Reduction in Pain, Reduction in Investigation Time and Increased Rate of Success, When Examined by the Less-experienced Endoscopist. A Prospective Randomized Clinical Trial

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Device: Disposable distal attachment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: planned to undergo sigmoidoscopy informed consent Exclusion Criteria: use of iv medication for pain and/or anxiety immediately before the endoscopy lack of indication for a full sigmoidoscopy (eg just need to investigate the rectum) lack or improper administration of standard bowel preparation

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cap<br>Sigmoidoscopy with cap | Device: Disposable distal attachment<br> <br> * Other names: Dimentions: Ø15,0mm;|
| No Intervention: No cap<br>Sigmoidoscopy without cap | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS recording of pain | the registration is performed when the endoscopist has advanced the scope to the 60 cm mark. | During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time | Recording of the time it takes from the introduction of the endoscopy through anus until it reaches 60 cm intubation mark. | During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sigmoidoscopy with or without cap, Pain during sigmoidoscopy, Sigmoidoscopy and time
BIO|STREAM.ICM Obesity

Study Overview
=================
Brief Summary
-----------------
The aim of the submodule study is to assess whether a high BMI may influence the sensing performance and the sECG quality of the BIOMONITOR.

Detailed Description
-----------------
This submodule of the BIO|STREAM.ICM registry specifically investigates the performance of the BIOMONITOR in a subset of obese patients with a BMI >30 kg/m2 in order to exclude any concerns regarding impaired ICM sensing performance. These concerns are founded in the increased distance between heart and device electrodes due to fat layers that may attenuate signal detection and therefore sensing performances of the ICM.

Official Title
-----------------
BIO|STREAM.ICM Obesity, Submodule of the BIO|STREAM.ICM Registry

Conditions
-----------------
Atrial Fibrillation, Syncope, Bradycardia, Cryptogenic Stroke, Tachycardia Atrial

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is already enrolled in the BIO|STREAM.ICM registry Patient BMI > 30 Exclusion Criteria: Patient clinically indicated for or already implanted with another cardiac active device

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 |
| --- | --- | --- |
| R-wave amplitude | R-wave amplitude at 3-month Home Monitoring observation in patients with a BMI > 30 | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of 'noise burden' | Measurement of amount of 'noise burden' during the study period | 3 month | 
| P-wave visibility | Measurement of the P-wave visibility at 1- and 3-month Home Monitoring observation | 1 month and 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, BIOMONITOR, BIOMONITOR III, Syncope, Cryptogenic stroke, Atrial Fibrillation
Study of Cerebrospinal Fluid Samples in Diagnosing Carcinomatous Meningitis in Patients With Cancer or Meningeal Syndrome

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of cerebrospinal fluid from patients with cancer or meningeal syndrome may help doctors identify biomarkers related to cancer. PURPOSE: This clinical trial is studying cerebrospinal fluid samples in diagnosing carcinomatous meningitis in patients with cancer or meningeal syndrome.

Detailed Description
-----------------
OBJECTIVES: Primary Evaluate the validity of determining CA 15-3 levels in the cerebrospinal fluid (CSF) using automated immuno-enzymatic methods. Secondary Determine the sensitivity and specificity of these assays in assessing CA 15-3 in CSF. Assess favorability of intrathecal production of CA 15-3. Determine threshold interpretations of CA 15-3 levels in CSF. OUTLINE: This is a multicenter study. Within 15 days of suspected meningeal involvement, blood and cerebrospinal fluid samples are collected. Samples are examined by immunoenzyme assays. Patients with suspected cases of carcinomatous meningitis undergo cerebrospinal MRI.

Official Title
-----------------
Interest of the Dosage of CA 15-3 in CSF for Diagnosing Carcinomatous Meningitis in Breast Cancer

Conditions
-----------------
Brain and Central Nervous System Tumors, Breast Cancer, Metastatic Cancer

Intervention / Treatment
-----------------
* Other: diagnostic laboratory biomarker analysis
* Other: immunoenzyme technique
* Procedure: magnetic resonance imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Meets 1 of the following criteria: Diagnosis of metastatic breast cancer with evidence suggestive of carcinomatous meningitis, with or without brain metastasis Other type of cancer with evidence suggestive of carcinomatous meningitis Meningeal syndrome without context of cancer PATIENT CHARACTERISTICS: No other prior cancers Not pregnant or nursing PRIOR CONCURRENT THERAPY: No prior intrathecal treatment At least 4 weeks since prior interferon No concurrent participation in another clinical trial

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: Diagnostic
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: diagnostic laboratory biomarker analysis|nan|
|Other: immunoenzyme technique|nan|
|Procedure: magnetic resonance imaging|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CA 15-3 levels in cerebrospinal fluid |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
leptomeningeal metastases, male breast cancer, stage IV breast cancer, tumors metastatic to brain, adult meningioma
Reproducibility and Method Comparison Studies of the Quo-Test™ A1C System and the Quo-Lab A1C Test and CLIA Waiver Study of the Quo-Test™ A1C System

Study Overview
=================
Brief Summary
-----------------
The Quo-Test A1C Analyzer and Reagent Test System (Quo-Test A1C System) are intended for the in-vitro quantitative determination of glycated hemoglobin in whole blood samples obtained from fingerstick or venous samples for point-of-care testing. The Quo-Test A1C System is indicated in the management and treatment of diabetes and for monitoring long term glycemic control by diabetics. It is for multiple patient use. Only auto-disabling, single use lancing devices should be used with this system.

Official Title
-----------------
Reproducibility and Method Comparison of the Quo-Test™ A1C System and the Quo-Lab A1C Test and CLIA Waiver of the Quo-Test™ A1C System

Conditions
-----------------
Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years or over Able to read English Read, understood and signed the Informed Consent Form Agrees to participate and does not withdraw\ Either healthy (without diabetes) or has Type 1 or Type 2 diabetes Exlcusion Criteria: • Declines participation or withdraws before study completion

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The objective is to conduct reproducibility testing using duplicates of each of 3 levels of HbA1C | The objective is to conduct a method comparison between both the Quo-Test and Quo-Lab investigational devices and the reference method [Tosoh G8 (K071132)]. The reference method also serves as the predicate for the premarket notifications for both investigational devices. Both capillary and venous samples will be tested on the Quo-Test A1C System and Quo-Lab A1C Test, while only venous samples will be tested on the reference method. | 10 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obtain CLIA Waiver Status for the Quo-Test |  | 10 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type I Diabetes, Type II Diabetes, HbA1C
Aquacel Compared to Traditional Post Surgical Wound Dressing in Vascular Surgery Patients

Study Overview
=================
Brief Summary
-----------------
The study is a prospective randomised, controlled study of 136 patients undergoing vascular surgery. Their closed wounds were covered with either aquacel, a hydrofiber dressing, or a traditional gauze dressing.Number of changes, patient comfort,number of infections, length of hospital stay and wound complications were compared between the two groups.

Conditions
-----------------
Wound Healing, Patient Comfort

Intervention / Treatment
-----------------
* Procedure: wound dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing elective vascular surgery, with an expected hospital stay of at least 4 days. informed consent Exclusion Criteria: known hypersensitivity to the dressing materials. age under 18 years. dementia, insufficient danish language understanding, pregnancy

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 |
| --- |
|Procedure: wound dressing|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
-----------------
Patient comfort, Wound dressings, infection, vascular surgery
Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture

Study Overview
=================
Brief Summary
-----------------
Comparing injectable collagenase and percutaneous needle fasciotomy for Dupuytren's contracture affecting proximal interphalangeal joints. An open label, medico-independent randomized controlled trial.

Official Title
-----------------
Comparing Injectable Collagenase (CI) and Percutaneous Needle Fasciotomy (PNF) for Dupuytren's Contracture (DC) Affecting Proximal Interphalangeal Joints (PIP). A Randomised Controlled Trial

Conditions
-----------------
Dupuytrens Contracture

Intervention / Treatment
-----------------
* Drug: Xiapex
* Procedure: Percutaneous needle fasciotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DC affecting PIP joint with Passive Extension Deficit (PED) more than 20 degrees Clearly defined strings Exclusion Criteria: Allergies to used medication International Normalised Ratio more than 2.0 Pregnancy and breastfeeding Previous treatment for DC in affected finger Former inclusion in the study with another string Activity in disease at time of study PED more than 20 degrees for Metacarpophalangeal or Distal Interphalangeal joint in affected digit

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Collagenase injection<br>Injection of collagenase obtained from Clostridium Histolyticum in contracture string | Drug: Xiapex<br>* Collagenase Clostridium Histolyticum<br>* Other names: XIAPEX® - Pfizer UK;|
| Active Comparator: Percutaneous needle fasciotomy<br>PNF ad modum Lermusiaux and Debeyre | Procedure: Percutaneous needle fasciotomy<br>* Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement | Clinical improvement is defined as a contracture reduction 50% or more from baseline. | 2 years |