linjc16/ctgov huggingface dataset:
Measuring Alterations of DNA in Human Blood

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to evaluate an automated, laser-based technique for measuring DNA damge resulting from radiation. We want to use controlled exposure on cancer patients to help develop a measurement to test people who may have been accidentally exposed to radiation.

Conditions
-----------------
Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, age 21 to 70 years old. Patient undergoing with anti-neoplastic agent(s) known to have genotoxic activity (e.g., cyclophosphamide, 5-FU, cisplatin, Ara-C. X-irradiation may be considered, so long as a substantial fraction of red marrow is exposed (e.g., femur or chest/trunk region); treatment could be ongoing therapy or initial therapy.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia

Study Overview
=================
Brief Summary
-----------------
To investigate dose-response efficacy and safety in hemodialysis patients with hyperphosphatemia.

Conditions
-----------------
Chronic Kidney Disease Requiring Hemodialysis

Intervention / Treatment
-----------------
* Drug: PA21
* Drug: PA21
* Drug: PA21
* Drug: PA21
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients age 20 or older, regardless of gender. Receiving stable maintenance hemodialysis 3 times a week. Patients not having changed their phosphate binder agent dose, for 4 weeks or more before their observation period start. Exclusion Criteria: Patients having history of a pronounced brain / cardiovascular disorder. Patients having severe gastrointestinal disorders. Patients having severe hepatic disorders.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PA21 750 mg/day<br> | Drug: PA21<br> <br> |
| Experimental: PA21 1500 mg/day<br> | Drug: PA21<br> <br> |
| Experimental: PA21 2250 mg/day<br> | Drug: PA21<br> <br> |
| Experimental: PA21 3000 mg/day<br> | Drug: PA21<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment. | Changes in serum phosphorus concentrations from baseline to the end of treatment were adjusted by serum phosphorus concentration at baseline. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Serum Calcium Concentrations. |  | 6 weeks | 
| Change From Baseline in Serum Intact-PTH Concentrations. |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodialysis, Hyperphosphatemia
Childhood Body Composition and Brain Structure and Function

Study Overview
=================
Brief Summary
-----------------
The specific aim of this research project is to use MRI methods to evaluate and compare brain structure and function in normal weight and obese children age 8-10 years.

Official Title
-----------------
Childhood Body Composition and Brain Structure and Function

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy normal weight or obese children Parental report of full-term gestation Parental report of birth weight between 5th-95th percentiles Parental report of breastfeeding or cow's milk formula fed during infancy Right hand dominance Exclusion Criteria: Maternal diabetes Maternal alcohol, tobacco or drug use during pregnancy Chronic sleep disorder History of psychological or psychiatric diagnosis History of neurological impairment or injury Surgical implant or other foreign object in the body which may be a MRI safety concern Dental work which may cause artifacts in MRI Claustrophobia High likelihood of inability to tolerate loud noise from the MRI scanner

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 10 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 |
| --- | --- |
| Normal weight<br> | |
| Obese<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain structure | We will use high resolution volumetric MRI and DTIto measure the brain structure of these children | 8 - 10 years of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain Function | We will use high resolution fMRI to measure the brain function under different cognitive paradigms | 8-10 years of age |
MicroCutter in Surgical Stapling - European Trial I

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate safety of the Microcutter stapling /cutting device in patients requiring the transection, resection or anastomosis of gastrointestinal tissue in a post-market approval study.

Detailed Description
-----------------
A prospective, open label, multi-center non-inferiority safety study with an all-comers enrollment of patients requiring surgical stapling of the stomach and/or intestine according to the labeled indications contained in the approved labeling. Up to 178 subjects consented for a 1-month clinical follow-up evaluation will be enrolled. Primary endpoint is to statistical non-inferiority of composite major adverse event rate (composite of infection (non-dermal), dehiscence, bleeding, and strictures) in study patients when compared to composite major adverse event rate (composite of infection (non-dermal), dehiscence, bleeding, and strictures) as derived from a comprehensive analysis of the medical literature. The comparison will be performed for cumulative events up to 30 days postoperatively.

Official Title
-----------------
The Cardica MicroCutter in Surgical Stapling: A Prospective, Open-label, Multi-center Study

Conditions
-----------------
Thoracic

Intervention / Treatment
-----------------
* Device: Microcutter XPRESS and Microcutter XCHANGE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All patients requiring surgical treatment where the use of a surgical stapler is anticipated Exclusion Criteria: - None
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MicroCutter Stapling Device<br>Patients undergoing surgical treatment with the MicroCutter Stapling Device | Device: Microcutter XPRESS and Microcutter XCHANGE<br>* Surgical stapling devices<br>* Other names: MicroCutter XCHANGE30;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite adverse event rate | Composite event rate is a compilation of the following stapling related adverse event rates: bleeding, leakage, stricture and infection | up to 30 days postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgical tissue resection, Tissue dissection, Tissue transection, Anastomosis of gastrointestina tissue
Risk Factors for Mechanical Failure After Spinal Fusion : an Observational Study

Study Overview
=================
Brief Summary
-----------------
The aim of this of study is to identify the incidence of mechanical failures after spinal fusion within one year of surgery and to assess the related risk factors.

Official Title
-----------------
Risk Factors for Mechanical Failure After Spinal Fusion : an Observational Study

Conditions
-----------------
Spinal Fusion, Surgery--Complications, Spine Disease

Intervention / Treatment
-----------------
* Procedure: spinal fusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing spine fusion and followed up for clinical checks in the year following the surgery . Exclusion Criteria: patients undergoing spine surgery without the application of instrumentation
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: spinal fusion|patients undergoing spinal fusion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of mechanical failure | number of mechanical failure / total number of spinal fusion performed | up to 1 year from the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| deambulation performed during hospitalization | number of patients that are able to achieve ambulation after surgery | up to the first day(up to 1 day) for ambulation from the surgery |
Is There Room for Butter in a Healthy Diet?

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine the effects in humans of a moderate butter intake on risk markers of cardiovascular disease compared to a diet with the same amount of olive oil (refined and therefore without polyfenols). The primary parameters are total cholesterol, LDL- and HDL cholesterol and triglycerides. The secondary parameters are risk markers of diabetes type 2; plasma glucose and insuling as well as the inflammatory marker hs-CRP.

Official Title
-----------------
Is There Room for Butter in a Healthy Diet? - A Randomized Controlled Dietary Human Intervention

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Other: Danish butter
* Other: Olive oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sign written consent Age: 20-70 y BMI: 18.5 - 32 kg/m2 Healthy men and women (with no known diseases) Exclusion criteria Current or previously cardiovascular disease, high blood pressure Diabetes Mellitus or other severe chronic disease, including severe allergies Use of dietary supplements and blood donations prior to, and during the study Known or suspected abuse of alcohol, drugs or medication Pregnant or are planning pregnancy during the study period Extreme physical activity level (more than 10 hours tough physical activity pr. week) Participation in other research studies Inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the study staff

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Danish butter, dairy<br> | Other: Danish butter<br>* The effect of butter intake versus olive oil (refined) intake on blood lipids (primarily)<br>* Other names: butter, diary;|
| Active Comparator: Olive oil, refined<br> | Other: Olive oil<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol |  | 5 weeks | 
| LDL cholesterol |  | 5 weeks | 
| HDL cholesterol |  | 5 weeks | 
| Triglycerides |  | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin |  | 5 weeks | 
| Glucose |  | 5 weeks | 
| hs-CRP |  | 5 weeks |
Oxyntomodulin, Mechanisms of Action in Relation to Appetite, Food Intake, Gastric Emptying and Energy Expenditure.

Study Overview
=================
Brief Summary
-----------------
Tiny molecules (hormones) are released from the bowels and other organs to the bloodstream in response to meals in order to orchestrate the metabolism. Oxyntomodulin, GLP-1 and glucagon are all known to regulate parameters such as appetite, food intake and induce weight loss. Therefore we want to investigate mechanistic relations between the three hormones.

Conditions
-----------------
Incretin Action, Obesity

Intervention / Treatment
-----------------
* Other: GLP-1 infusion
* Other: Glucagon infusion
* Other: Oxyntomodulin infusion
* Other: GLP-1 and glucagon infusion
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal fasting plasma glucose Normal glucose tolerance Normal haemoglobin levels Informed content Exclusion Criteria: Diabetes Pre diabetes (impaired glucose tolerance or impaired fasting glucose) 1st degree relatives with diabetes Obesity (BMI > 30) Inflammatory bowels disease Bowels surgery Nephropathy Liver disease Medication which cannot be on hold for 24h

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy young males<br> | Other: GLP-1 infusion<br>* 1 pmol/kg/min<br>Other: Glucagon infusion<br>* 3ng/kg/min<br>Other: Oxyntomodulin infusion<br>* 3 pmol/kg/min<br>Other: GLP-1 and glucagon infusion<br>* 1 pmol/kg/min 3 ng/kg/min<br>Other: Placebo<br>* NaCl 9 g/L infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying | Assessed by the acetaminophen - method | 4 h | 
| Satiety | Assessed by VAS | 4 h | 
| Hunger | Assessed by an ad'libitum meal | 4 h | 
| basal energy expenditure | Assessed by indirect calorimetry | 2 x 30min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GLP-1 |  | 4 h | 
| Oxyntomodulin |  | 4 h | 
| Glucagon |  | 4 h | 
| GIP |  | 4 h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Incretin hormones, Glucagon, Satiety, Hunger, Energy expenditure
Validating NIAAA Screen Guide in YCMC

Study Overview
=================
Brief Summary
-----------------
Alcohol use is a serious health threat to the 26% youth in the US with chronic medical conditions. While alcohol use can significantly impact an underlying illness and its safe/effective management, medical specialists rarely screen their adolescent patients for alcohol use. The investigators will validate a new, brief alcohol- screening tool with 9-18 year old youth with chronic medical conditions. Comprehensive assessment information will be collected and analyzed to describe relationships between youth alcohol use, other substance use, and chronic disease outcomes and findings integrated into the validated screen as actionable clinician guidance and health advice.

Official Title
-----------------
Validating NIAAA's Brief Screening Guide in Youth With Chronic Medical Conditions

Conditions
-----------------
Alcohol Related Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 9-18 years of age duration of chronic illness of at least one year ability to speak/read English and use a computer keyboard and/or complete an interviewer-assisted questionnaire Exclusion Criteria: medically or emotionally unstable unable to assent/consent

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum 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 |
| --- | --- |
| YCMC<br>Youth ages 9-18 with one of four chronic medical conditions - asthma, diabetes, rheumatic or gastroenterologic conditions | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eGuide diagnosis of alcohol use disorder | We will evaluate the sensitivity and specificity of the eGuide to correctly identify the group of YCMC who have problem use/abuse or dependence, using the CIDI-SAM as the criterion standard. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of HgbA1c level with level of alcohol use |  | Baseline | 
| Correlation between score on the Asthma Control Test (ACT)and level of alcohol use |  | Baseline | 
| Correlation of score on The Childhood Health Assessment Questionnaire (CHAQ) with level of alcohol use |  | baseline | 
| Correlation between The Pediatric Ulcerative Colitis Activity Index (PUCAI)score and level of alcohol use |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alcohol related disorders
A Retrospective Review of the Seasonality of Pre-Eclampsia

Study Overview
=================
Brief Summary
-----------------
This retrospective review will will attempt to determine whether our data show a significant difference in number of deliveries of women with pre-eclampsia compared to deliveries without pre-eclampsia during certain months of the year.

Detailed Description
-----------------
This study is a retrospective review of obstetrics charts of women who gave birth at OSU Medical Center between January 01, 2005 and December 31, 2007. Included will be patient charts of women > 18 years old who were admitted to OSUMC for delivery (both cesarean and vaginal deliveries) between 1/1/05 and 12/31/07, with and without a diagnosis of pre-eclampsia. The data collected will be recorded in a spreadsheet by month/day of delivery, and whether pre-eclampsia was a diagnosis. Also included will be total number of deliveries per month and total number of pre-eclampsia diagnoses per month. The rate of pre-eclampsia will be calculated. A contingency table with corresponding chi square test will be performed to determine whether there is a significant relationship of the diagnosis of pre-eclampsia with seasonality, defined primarily by month. Certain data occurring during transition periods between seasons may be excluded from analyses.

Official Title
-----------------
A Retrospective Review of the Seasonality of Pre-Eclampsia

Conditions
-----------------
Preeclampsia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who gave birth at OSU Medical Center between January 01, 2005 and December 31, 2007 and were > 18 years old who were admitted to OSUMC for delivery (both cesarean and vaginal deliveries) between 1/1/05 and 12/31/07, with and without a diagnosis of pre-eclampsia. Exclusion Criteria: Females under age 18

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of women per month who had a diagnosis of pre-eclampsia at OSU Medical Center when they delivered a baby. |  | Data assessed from patient charts retrospectively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preeclampsia
Smoking Cessation in a Dentistry Setting

Study Overview
=================
Brief Summary
-----------------
Aim: to assess relative effectiveness of a high and a low intensity intervention for smoking cessation support in a dental clinic setting. Method: 300 smokers were randomly assigned to support with either low (LTI) or high treatment intensity (HTI). Main outcome measures were self-reported point-prevalence and continuous abstinence (≥183 days).

Official Title
-----------------
A Comparing Study of the Smoking Cessation Program NIX Individual and the Self-Help Program Fimpa Dig Fri

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Behavioral: Nix Individual
* Behavioral: Fimpa dig fri


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult daily smokers in the county of Västmanland Exclusion Criteria: Reading difficulties Not fluent in the Swedish language

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Active Comparator: 1 Nix Individual<br>High Treatment Intensity | Behavioral: Nix Individual<br>* Eight 40-minutes sessions at the local dental clinic during 4 months. Written material and counseling by a dental hygienist with special training in smoking cessation, according to a fixed program. A traditional smoking cessation program with a mixture of behavior therapy, coaching and pharmacological advises. Two questionnaires.<br>|
| Placebo Comparator: 2 Fimpa dig fri<br>Low Treatment Intensity | Behavioral: Fimpa dig fri<br>* One 30-minute counseling session at the local dental clinic, focusing on explaining the content of a traditional self-help program (Fimpa dig fri). The leaflet contains an 8-week program with instructions and tasks to perform. Two questionnaires.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Point prevalence abstinence |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous abstinence |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RCT, tobacco, treatment intensity, dentistry, follow-up, Smoking cessation, Cost effectiveness