linjc16/ctgov huggingface dataset:
The Effect of Flooring on Office Workers' Health and Behaviors

Study Overview
=================
Brief Summary
-----------------
Researchers are trying to better understand how offices and workspaces influence people's performance, behavior and health during the course of weeks and over long periods of time.

Official Title
-----------------
The Effect of Flooring on Office Workers' Health and Behaviors

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

Intervention / Treatment
-----------------
* Other: Ergonomic flooring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide informed consent Must be adults between the ages of 18 and 60 Ability to relocate to the Well Living Lab for 9 consecutive weeks Full-time Mayo Clinic employees (35+ hours per week) Report working a sedentary job (e.g., sit for >= 50% of their work time). Have a working mobile phone that can receive text messages Must be present for 80% of the study (minimum of 4 days per week) Exclusion Criteria: Individuals who are shift-workers Individuals diagnosed with vascular diseases (i.e., Raynaud's disease, peripheral artery disease, etc.) Individuals with diagnosed neurological and psychiatric disorders that may have physical limitations Drug (illegal or prescription narcotic), nicotine, or alcohol dependency Women who are lactating, pregnant or intend to become pregnant during the duration of the study Individuals who are taking medications (either prescribed or over-the-counter) which may affect comfort levels (e.g., opiate based medications) Working in occupation requiring standing/stepping >50% of work time Report < 1 year at current job Hospitalization from either a physical or mental disorder in the past six months History of cardiovascular, pulmonary, metabolic, neurological, or orthopedic limitations that would prohibit occupational physical activity (e.g., standing, stepping, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Normal flooring<br>standard office flooring | |
| Experimental: Ergonomic flooring<br>Ergonomically designed flooring | Other: Ergonomic flooring<br>* Specially designed flooring system to optimize ergonomics of participants<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sickness, absence, presenteeism | Work Limitations Questionnaire | 9 weeks |
Association Between Dose Dialysis by Kt and Mortality

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess whether patients receiving current recommendations of an adequate dialysis dose by Kt adjusted for body surface area improved survival at 24 months compared to those who do not get it, as well as assess whether patients receiving a dose greater obtain more benefit.

Official Title
-----------------
Evaluation of the Association of Dialysis Dose Obtained by Kt and Mortality in Hemodialysis Patients

Conditions
-----------------
End Stage Renal Disease, Hemodialysis Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years old > six months on hemodialysis Receiving 3 sessions of dialysis per week Having 5 or more valid measures of Kt during the month Exclusion Criteria: active chronic inflammatory diseases Liver cirrhosis Neoplasms Chronic immunosuppression or use of anti-inflammatory

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 |
| --- | --- |
| Hemodialysis patients<br>Patients > 18y hemodialysis for at least 6 months at any center of Spain Fresenius Medical Care (FMC) meeting the inclusion criteria. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization |  | two years |
Continous Positive Airway Pressure (CPAP) Compliance Study

Study Overview
=================
Brief Summary
-----------------
Does an internet based text or email interaction and education improve CPAP compliance for patients with Obstructive sleep apnea (OSA) and reduce nursing intervention.

Official Title
-----------------
ICAN (Improvement in CPAP Adherence Via the Net) Study

Conditions
-----------------
Obstructive Sleep Apnea (OSA)

Intervention / Treatment
-----------------
* Behavioral: additional educational material
* Behavioral: Standard of care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (age 18 - 90 years of age) newly diagnosed with OSA who have been recommended CPAP therapy. Exclusion Criteria: Previously attempted CPAP, requires the use of bilevel positive airway pressure device, difficulty with English language such that they have difficulty understanding instructions given at high school equivalent, periodic limb movement associated arousals greater than 20/hour, primary complaint of insomnia, diagnosis of restless leg syndrome or periodic limb movement disorder

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

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: Standard of care<br>Participants randomized to this arm will have the usual follow up care without any additional information. | Behavioral: Standard of care<br>* participants will receive education from staff nurses as needed.<br>|
| Active Comparator: Additional Education<br>This arm will receive a weekly text message or e-mail asking participants to sign on to the web page that we will provide. Once they sign on, they will see additional educational materials and questions regarding their CPAP use. Based on their response, they will be directed to suggestion or sites to help improve their compliance with their CPAP. | Behavioral: additional educational material<br>* The internet-based intervention group would receive a weekly text or an email (based on the subject's preference). The content of the message asks about their approximate compliance over the past week. Based on their response, they will be directed to one of two internet web pages.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in mean number of nursing interventions at one month |  | baseline to one month after initiation |
Pain and Convalescence After Laparoscopic Groin Hernia Repair

Study Overview
=================
Brief Summary
-----------------
The investigators want to identify limiting factors for short convalescence after laparoscopic groin hernia repair. Before the operation patients are given intensive structured information about one day´s convalescence. Patients fill out questionnaire before operation about several clinically relevant parameters. This is also done first 3 days after operation and after 1 month and 6 months. The patients are seen for clinical control at 1 and 6 months.

Official Title
-----------------
Pain and Convalescence After Laparoscopic Groin Hernia Repair

Conditions
-----------------
Inguinal Hernia, Convalescence

Intervention / Treatment
-----------------
* Behavioral: Information


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: planned laparoscopic inguinal or femoral herniorrhaphy ASA class I-II speak and read danish Exclusion Criteria: converting to open operation low compliance (dementia, psychiatric disorder) use of morphine or similar drugs daily in the last month complications to the operation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| lap. inguinal herniorrhaphy<br>Patients undergoing planned lap. inguinal herniorrhaphy | Behavioral: Information<br>* Information on short convalescence (1 day). Example: Operated today and getting started with normal activities again tomorrow.<br>* Other names: Convalescence;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of convalescence |  | 3 weeks in average | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores on visual analog scale and verbal rating scale | daily first 4 days, after 1 and 6 months | 6 months | 
| fatigue scores on numeric rating scale (1-10) | daily first 4 days, 1 and 6 months | 6 months | 
| sexual dysfunction |  | 6 months | 
| nausea scores on verbal rating scale |  | 3 days | 
| vomiting |  | 3 days | 
| wellbeing scores on visual analog scale |  | 6 months | 
| Hospital anxiety and depression scale (HAD) |  | Baseline (before operation) | 
| Pain catastrophizing scale (PCS) |  | Baseline (before operation) | 
| Activity assessment scale (AAS) | Functional status | Baseline (before operation) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
convalescence, pain, nausea, vomiting, sexual dysfunction
Hypoglycemia Counterregulation and Symptom Perception With Insulin Detemir

Study Overview
=================
Brief Summary
-----------------
Hypoglycemia and unawareness of hypoglycemia are major problems of insulin therapy in patients with diabetes mellitus. The long acting insulin analogue Detemir has structural and physicochemical properties which differ from human insulin. The aim of the present study is to test whether this leads to altered hormone and symptom response during hypoglycemia.

Official Title
-----------------
Effects of Insulin Detemir Versus Regular Insulin (Actrapid) on Hormonal Counterregulation, Cognitive Function and Symptom Perception During Hypoglycemia

Conditions
-----------------
Diabetes Mellitus, Hypoglycemia

Intervention / Treatment
-----------------
* Drug: Detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects male or female Age 18-50 years Female subjects save contraception Ability to take part in the study Signed consent Exclusion Criteria: Chronic disease Acute disease during 4 weeks prior to the study Pregnancy Drug treatment other than hormonal contraception

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Crossover Assignment
Masking: Single


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormone response to hypoglycemia (Glucagon) |  |  | 
| Hormone response to hypoglycemia (glucagon) Symptom response to hypoglycemia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormone response to glucagon (epinephrine, growth hormne, cortisol) |  |  | 
| Hormone response (epinephrine, growth hormone, cortisol) to hypoglycemia |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
counterregulation, hypoglycemia unawareness, insulin therapy
Molecular Profiling of Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
In this translational research study, Formalin-Fixed-Paraffin-Embedded (FFPE) tumor tissue blocks from patients with early-stage (II-III) colorectal cancer will be assessed for a comprehensive cancer gene panel from NIPD Genetics (https://www.nipd.com/) targeting regions in 37 clinically relevant cancer genes. The colorectal cancer panel includes an extended list of clinically relevant genes, designed to target clinically actionable and clinically significant mutations that will provide physicians with genetic information regarding a) prediction of the patient's response to targeted therapy, b) prognosis, that is, prediction of clinical outcome, c) diagnosis and molecular classification of colorectal cancer.

Official Title
-----------------
Molecular Profiling of Colorectal Cancer: A Translational Research Study With a Next Generation Sequencing Panel.

Conditions
-----------------
Colorectal Cancer, Colon Cancer, Colon Adenocarcinoma

Intervention / Treatment
-----------------
* Diagnostic Test: Gene panel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgically resected early-stage (II-III) colorectal cancer Availability of biological material Exclusion Criteria: Metastatic disease (stage IV) at initial diagnosis

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 |
| --- |
|Diagnostic Test: Gene panel|comprehensive cancer gene panel targeting regions in 37 clinically relevant cancer genes in FFPE tumor tissue blocks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| association between gene mutational status and overall survival | the time from diagnosis to the date of death (from any cause). Alive patients and patients lost to follow-up will be censored at the date of last follow-up | 24 months | 
| association between gene mutational status and disease-free survival | the time from colorectal cancer diagnosis to the first date of documented disease progression, death or last contact, whichever occurs first | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptives | Association of any gene mutation tumor pathological stages. | 24 months | 
| Descriptives | Association of any gene mutation tumor budding. | 24 months | 
| Descriptives | Association of any gene mutation with microstatellite instability. | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colon, Translational research, Gene panel
The Role of Tomotherapy in Hypofractionated/Dose Escalated Conformal Radiation Treatment for High Risk Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Helical tomotherapy is being used to treat the prostate gland, local rates of spread and regional lymph nodes whilst sparing gross structures. The radiation to the gross disease in the prostate is hypofractionated and dose escalated. Magnetic resonance spectroscopic imaging (MRSI) is incorporated into pre- and post-treatment evaluation.

Official Title
-----------------
The Role of Tomotherapy (Dynamic IMRT and Megavoltage CT Scanning) in Hypofractionated/Dose Escalated Conformal Radiation Treatment Using Magnetic Resonance Spectroscopy (MRS) Scans to Predict and Document the Pattern of Local Failure for High Risk Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: Tomotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High risk localized prostate cancer Exclusion Criteria: Low/intermediate risk, metastatic cancer Patient refusal

Ages Eligible for Study
-----------------
Maximum Age: 75 Years

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

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

| Intervention/Treatment |
| --- |
|Procedure: Tomotherapy|Standard 45 Gy in 25 fractions in 5 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rectal Toxicity | Determine the acute and late rectal toxicity of high-dose short-course hypofractionated radiotherapy in five weeks in the treatment of high rish prostate cancer. | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prostate-specific antigen (PSA) and MRSI disease control | Determine the biochemical control (freedom from PSA failure) rate, overall and disease free survival. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tomotherapy, MRSZ, high risk prostate cancer
Calcium Concentration in Bicarbonate Hemodialysis (HD)

Study Overview
=================
Brief Summary
-----------------
The study was designed in order to investigate the effects of 3 different dialysate calcium concentrations may exert on mineral metabolism and hemodynamic stability in standard hemodialysis (hd).

Official Title
-----------------
Comparison Among Different Dialysate Calcium Concentrations in Bicarbonate Hemodialysis

Conditions
-----------------
Calcium Mass Balances and Serum Calcium Profiling in hd Patients

Intervention / Treatment
-----------------
* Other: Dialysate calcium concentration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bicarbonate hd since 6 months uncomplicated hd sessions Exclusion Criteria: Incident patients unstable hd patients patients aged less than 18 years

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevalent hd patients<br>Patients undergoing three consecutive cross-over hd session with 3 different dialysate calcium concentrations | Other: Dialysate calcium concentration<br>* Calcium dialysate concentrations: 1.25, 1.35 and 1.5 mmol/l<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum calcium concentrations | Evaluation of calcium mass balances and ionized calcium serum concentrations profiling during three hd sessions with different calcium concentrations in the dialysate | 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Serum calcium, Dialysate, Mass balance, Blood pressure
Coronary Angiography Before Elective Carotid Endarterectomy in Patients With Asymptomatic Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the potential benefit of systematic preoperative coronary angiography followed by selective coronary artery revascularization on the incidence of myocardial infarction (MI) in patients without a history of coronary artery disease (CAD) and undergoing carotid endarterectomy (CEA).

Detailed Description
-----------------
Patients candidates for CEA, with no history of CAD, a normal electrocardiogram (ECG), and a normal cardiac ultrasound were randomized in two groups. In group A (n = 216) all patients underwent coronary angiography before CEA +- coronary artery revascularization. In group B (n = 210) CEA was performed without coronary angiography.

Official Title
-----------------
Randomized Controlled Trial Analyzing the Role of Systematic Preoperative Coronary Angiography Before Elective Carotid Endarterectomy in Patients With Asymptomatic Coronary Artery Disease

Conditions
-----------------
Carotid Stenosis, Coronary Stenosis

Intervention / Treatment
-----------------
* Other: Preoperative coronary angiography
* Other: Standard cardiac workup


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication for carotid endarterectomy no clinical sign or history of ischemic heart disease no electrical signs of cardiac ischemia left ventricular ejection fraction >50% at transthoracic echocardiogram. Exclusion Criteria: disabling stroke (mRS ≥3) non atherosclerotic carotid disease severe intracranial carotid artery stenosis contra-indications to heparin, aspirin or clopidogrel.

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A - Coronary angiography<br>All the patients receive preoperative coronary angiography followed, if needed, by percutaneous intervention (PCI) or bypass (CABG) | Other: Preoperative coronary angiography<br>* If coronary disease is detected percutaneous intervention (PCI) or coronary artery bypass grafting (CABG) is applied<br>|
| Active Comparator: B - standard cardiac workup<br>Standard cardiac workup | Other: Standard cardiac workup<br>* EKG, transthoracic cardiac echocardiogram<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-fatal and fatal myocardial infarction |  | 30 days through year 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause and cardiovascular mortality |  | 30 days through year 3 |