linjc16/ctgov huggingface dataset:
Does Obesity Increase the Risk of Conversion and Short Term Complications in Laparoscopic Rectal Surgery?

Study Overview
=================
Brief Summary
-----------------
Obesity is on the rise in the Western population and BMI has been shown to be associated with an increased risk of per- and postoperative complications. The investigators intend to study a population of more than 300 patients undergoing laparoscopic surgery for rectal cancer. The investigators main outcome measure will be the conversion rate, and the investigators also intend to study other indications of short term complications, such as peroperative bleeding, infection, re-operation and mortality. The investigators hypothesise that increased BMI does not increase the risk of conversion.

Official Title
-----------------
Does Obesity Increase the Risk of Conversion and Short Term Complications in Laparoscopic Rectal Surgery?

Conditions
-----------------
Rectal Cancer, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with rectal cancer undergoing laparoscopic surgery, Hvidovre Hospital, Denmark. Exclusion Criteria: No exclusion criteria
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rectal cancer<br>Patients undergoing laparoscopic surgery for rectal cancer at the Department of Gastrointestinal Surgery, Hvidovre Hospital, Copenhagen, Denmark. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion rate | Amount of patients undergoing conversion from laparoscopic to open surgery. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peroperative Bleeding | Peroperative blood loss measured in mL. | Day 1 | 
| Length of Hospital Stay | Days in hospital after surgery. | Time of Discharge (3-80 days after surgery, mean: 11 days) | 
| Short term complications | Complications at the time of discharge classified according to Clavien Dindo, groups 0-5. | Time of Discharge (3-80 days after surgery, mean: 11 days) | 
| Readmission within 30 days after surgery | +/- Readmission to the Gastrointestinal Surgical ward within 30 days after initial discharge. | 30 days after discharge | 
| 30-day mortality |  | 30 days after surgery | 
| Duration of surgery | Duration of surgery measured in minutes. | Day 1 |
HIS Bundle Pacing Synchrony Comparing HIS Pacing to Intrinsic Conduction While Using the Medtronic ECG Belt System

Study Overview
=================
Brief Summary
-----------------
The HBP Synchrony Using ECG Belt study is a prospective, non-randomized single site physician-initiated research study. The study will collect ECG Belt data from up to 30 subjects at one single center. The target population will include subjects with a currently implanted Medtronic cardiac implantable device who have a HIS placed lead. The purpose of the study is to characterize the electrical dispersion using the ECG Belt provided by Medtronic in patients who have a HIS placed lead and understanding the amount of synchrony with intrinsic conduction compared to HIS pacing.

Official Title
-----------------
HBP Synchrony Using ECG Belt

Conditions
-----------------
HBP

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has previously been implanted with a Medtronic IPG/ICD and a HIS placed RV lead Patient has intrinsic AV conduction Normal EF, defined as EF >50%, as shown on recent echo within last 12 months Patient is willing and able to comply with the protocol Patient is 18 years of age or older Exclusion Criteria: ●Patient is ventricular pacer dependent

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Characterize the electrical dispersion using SDAT | Characterize the electrical dispersion between intrinsic to both Selective HIS pacing and Non-Selective HIS pacing using Standard Deviation Activation Timing of the ECG Belt system. | 1 year |
Frequency and Origin of Dysnatremias in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
Hypo- and hypernatremia are the most frequent electrolyte disorders found in hospitalized patients. The increasing use of diuretics and other medications influencing the water and sodium homeostasis potentially lead to a rise in the prevalence of the electrolyte disorders. Only little data is available on the frequency and the mechanisms leading to hypo-/hypernatremia. Thus, the investigators aim to A.) determine the frequency of hypo- and hypernatremia in the emergency department of a large tertiary university hospital and B.) explore the mechanisms leading to the development of dysnatremias by detailed clinical and laboratory examinations.

Official Title
-----------------
Frequency and Origin of Dysnatremias in the Emergency Department

Conditions
-----------------
Hyponatremia, Hypernatremia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Serum sodium below 135 mmol/L (i.e. hyponatremia); serum sodium exceeding 145 mmol/L (hypernatremia) Exclusion Criteria: Patients below age 18 years; patients declining study participation.

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 |
| --- | --- |
| Hypernatremia<br>Patients admitted to the emergency department with a serum sodium exceeding 145 mmol/L. | |
| Hyponatremia<br>Patients admitted to the emergency room with a serum sodium below 135 mmol/L. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of hypo- and hypernatremia in the emergency department | The investigators aim to determine the frequency of hypo- and hypernatremia in the emergency department of a large tertiary university hospital. | approx. 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Origin of hypo- and hypernatremia in the emergency department | The investigators try to investigate the mechanisms leading to the development of hypo- and hypernatremia in patients admitted to the emergency department. | approx. 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sodium, Hyponatremia, Hypernatremia, Emergency department
A Controlled Study to Evaluate the Efficacy and the Tolerability of a Cosmetic Active Ingredient Intended for Subjects With Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
Evaluation of safety and clinical efficacy of an active ingredient versus placebo for the treatment of mild to moderate Atopic Dermatitis (AD) adults.

Official Title
-----------------
Randomized, Double Blind, Clinical Study for Evaluating the Efficacy and the Tolerability of a Cosmetic Active Ingredient Intended for Subjects With Atopic Dermatitis. Controlled Study vs Placebo

Conditions
-----------------
Mild to Moderate Atopic Dermatitis

Intervention / Treatment
-----------------
* Other: Isopentenyltheophylline 0.44% + Glycerin 4.56%
* Other: Glycerin 4.56%


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Good general health Phototype I to IV Mild to moderate SCORAD (between 15 and 25) Main Exclusion Criteria: Pregnant/breastfeeding female or who have planned a pregnancy during the study period Positive history for atopy or hypersensitive skin Subjects under systemically pharmacological treatment Subjects under locally pharmacological treatment on the skin area monitored during the test Subjects with congenital or acquired immunodeficiency Subjects under treatment with food supplements which could interfere with the functionality of the product under study Subjects which show other skin alterations on the monitored area except for acne lesions Subjects with known or suspected sensitization to one or more test formulation ingredients

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
Interventional Model Description: Single center, randomized, double-blind, placebo-controlled, parallel group study, carried on 2 groups of 22 subjects.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active ingredient<br>Isopentenyltheophylline 0.44% + Glycerin 4.56% | Other: Isopentenyltheophylline 0.44% + Glycerin 4.56%<br>* Application of topical cream twice a day on the area affected by Atopic Dermatitis<br>|
| Placebo Comparator: Placebo<br>Glycerin 4.56% | Other: Glycerin 4.56%<br>* Application of topical cream twice a day on the area affected by Atopic Dermatitis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in severity of Atopic Dermatitis as assessed using the SCORing Atopic Dermatitis (SCORAD) |  | 7, 14 and 28 days |
Establish Finite Element Mesh of the Numerical Models of the Thoracic Aorta

Study Overview
=================
Brief Summary
-----------------
This study will be using finite element meshes and averaged algorithms to create the numerical thoracic aorta at different ages.

Detailed Description
-----------------
This study will be using finite element meshes and averaged algorithms to create the numerical thoracic aorta at different ages.

Official Title
-----------------
Establish Finite Element Mesh of the Numerical Models of the Thoracic Aorta

Conditions
-----------------
Heart Diseases

Intervention / Treatment
-----------------
* Procedure: computed tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal thoracic aorta

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: computed tomography|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic accuracy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity |  |  | 
| specificity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thoracic aorta, finite element mesh
Iowa WISEWOMAN Project

Study Overview
=================
Brief Summary
-----------------
To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases.

Official Title
-----------------
Iowa WISEWOMAN Project

Conditions
-----------------
CVD Risk

Intervention / Treatment
-----------------
* Behavioral: Women's health


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NBCCEDP Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 64 Years

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Women's health|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Early Reversal of Defunctioning Stoma Trial

Study Overview
=================
Brief Summary
-----------------
In this trial will be investigated if a defunctioning loop stoma used in low anterior resection of the rectum for cancer can be reversed after 14 days instead of 3-12 months which is present clinical practise.

Detailed Description
-----------------
Patients undergoing low anterior resection of the the rectum for adenocarcinom (total mesorectal excision; TME) with a defunctioning loop stoma are assessed preoperatively and for 6 days postoperatively according to a trial protocol including daily clinical, physiological, and serological variables, and a rectal contrast study on day 6. If inclusion criteria are fulfilled, a decision is taken on day 7 to schedule reversal of the defunctioning loop stoma on postoperative day 14. This trial is considered a hypothesis generating pilot study of feasibility type and is no power calculation. The present trial will include 20 consecutive patients who accept participation.

Official Title
-----------------
Early Reversal of Defunctioning Stoma Trial

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Procedure: Reversal of defunctioning stoma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written consent and fulfilled inclusion criteria preoperatively and during postoperative day 1-6. Exclusion Criteria: Written consent and/or inclusion criteria not fulfilled preoperatively and during postoperative day 1-6.

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 |
| --- | --- |
| I<br>Twenty consecutive patients operated on with low anterior resection of the rectum for cancer with a defunctioning stoma who accept participation. | Procedure: Reversal of defunctioning stoma<br>* Reversal of defunctioning stoma<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reversal of defunctioning loop stoma on postoperative day 14 following low anterior resection of the rectum for cancer with or without preoperative adjuvant treatment |  | Preoperatively, postoperative day 7, postoperative day 30 and at 6 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative 30 day morbidity. Postoperative ano-rectal function at 1 and 6 months. |  | Postoperatively at 1 and 6 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Defunctioning stoma, Low anterior resection, TME surgery, Early stoma reversal
Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca

Study Overview
=================
Brief Summary
-----------------
This study evaluates the efficacy and safety of 2 doses of pimecrolimus (0.3% and 1%) ophthalmic suspension in a moderate to severe population of keratoconjunctivitis sicca (KCS, dry eye syndrome) patients.

Official Title
-----------------
A 24-week Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled Evaluation of the Safety and Efficacy of 0.3% and 1% Pimecrolimus Ophthalmic Suspensions Used Twice Daily in Patients With Moderate to Severe Keratoconjunctivitis Sicca

Conditions
-----------------
Keratoconjunctivitis Sicca

Intervention / Treatment
-----------------
* Drug: Pimecrolimus
* Drug: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of artificial tear use Moderate to severe signs of dry eye Moderate to severe ocular discomfort Exclusion Criteria: Patients with uncontrolled systemic or ocular diseases. Have any history of refractive surgery Use any topical ocular medications other than those dispensed for the study, during the study Other protocol-defined exclusion criteria may apply.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pimecrolimus 0.3%<br>ASM981 0.3% | Drug: Pimecrolimus<br> <br> * Other names: ASM981;|
| Experimental: Pimecrolimus 1%<br>ASM981 1% | Drug: Pimecrolimus<br> <br> * Other names: ASM981;|
| Placebo Comparator: Vehicle with carbopol<br> | Drug: Vehicle<br>* Placebo<br>|
| Placebo Comparator: Vehicle without carbopol<br> | Drug: Vehicle<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)in one sign and one symptom |  |  | 
| change from baseline in fluorescein corneal staining and ocular discomfort(worst symptom,VAS) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)on all signs and symptoms |  |  | 
| Global assessment of efficacy and tolerability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
KCS, dry eye, pimecrolimus, Keratoconjunctivitis sicca (dry eye syndrome)
Long-Term Outcomes of Alternative Brachytherapy Techniques for Early Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to assess outcomes of treatment for early prostate cancer. Current treatments for early (non-metastatic) cancer may cause long-term impairments in the patients quality of life. In this study we will compare the outcomes of patients treated with two alternative brachytherapy (seed implants) techniques using a series of questionnaires.

Detailed Description
-----------------
Participants will be asked to complete a questionnaire about their health prior to treatment, at 1, 3 and 12 months after treatment and then once a year 4 more times.

Official Title
-----------------
Long-Term Outcomes of Alternative Brachytherapy Techniques for Early Prostate Cancer

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

Intervention / Treatment
-----------------
* Radiation: brachytherapy
* Radiation: brachytherapy
* Radiation: brachytherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathological diagnosis of an adenocarcinoma of the prostate 18 years of age or older Prior choice of either standard brachytherapy or MRIGPB as primary treatment Exclusion Criteria: Prior primary therapy (surgery or external beam radiation) for prostate cancer Current hormone ablation therapy

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MRBT<br>MRI-assisted brachytherapy, the experimental arm | Radiation: brachytherapy<br>* An experimental arm using MRI imaging and excluding the transition zone from the target volume<br>|
| USBT1<br>Standard ultrasound-guided brachytherapy performed by group 1 (control arm 1) | Radiation: brachytherapy<br>* Standard ultrasound-guided brachytherapy with standard target volumes<br>|
| USBT2<br>Standard ultrasound-guided brachytherapy performed by group 2 (control group 2) | Radiation: brachytherapy<br>* Standard ultrasound-guided brachytherapy with standard target volumes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess changes in generic and disease specific quality of life over time after treatment with brachytherapy for early prostate cancer |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare these outcomes after two alternative brachytherapy techniques, standard ultrasound guided brachytherapy and MRI guided prostate brachytherapy (MRIGPB) |  | 10 years | 
| To identify factors associated with specific adverse outcomes. |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brachytherapy, radioactive seed implants
The Role of TextRAd on Detection of Liver Metastasis in Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
This is a retrospective analysis of all patients diagnosed with LARC who received NCRT and had MRI scans between 2003-2014 at East Suffolk and North Essex NHS Foundation Trust. Region of interest was drawn around the tumor or its location on T2 MRI images. Six texture parameters were systematically extracted from Textural histograms of post-treatment scans. These parameters were examined to determine their ability to predict local recurrence and distant metastases through Kaplan-Meier survival curves and log-rank tests.

Official Title
-----------------
The Role of TextRAd on Detection of Liver Metastasis in Rectal Cancer

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects must have MRI post-Chemotherapy treatment to detect the response to Neoadjuvant treatment and compare it to pre-treatment scans to easily determine if there were a posttreatment liver metastasis. Locally advanced rectal cancer (LARC) = MRI stage: T3/T4 and/or N1/N0. Exclusion Criteria: Distant metastases. Synchronous tumour.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: MRI|Texture analysis (TA) is a novel imaging biomarker that can assess heterogeneity in MRIs by measuring grey-level intensities distribution. This study hypothesizes that TA of MRI is an imaging biomarker that can predict local recurrence and distant metastasis.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local recurrence of rectal cancer |  | 120 months |