linjc16/ctgov huggingface dataset:
Vascular Function, Fish Protein Hydrolysates and Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease of abnormal carbohydrate metabolism which is related with high morbidity and mortality rates caused by its complications. One of the major diabetes-related arterial phenotypes thought to be responsible for development of cardiovascular disease is endothelial dysfunction. Nitric oxide (NO) is a potent molecule derived of endothelium, which plays key role in control of vascular tone. In T2DM present endothelial dysfunction due to reduced NO bioavailability. Fish protein hydrolysates (FPH) have been showed to present antioxidant peptides (and high value of ACE inhibition activity. Therefore, the present study aimed to examine whether single dose of FPH ingestion would reversal macro- and microvascular endothelial dysfunction in T2DM.

Official Title
-----------------
Effect of Acute Fish Protein Hydrolysates Ingestion on Vascular Function of the Type 2 Diabetes Subjects

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Other: Placebo
* Other: Fish protein hydrolysates


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus Exclusion Criteria: History of symptomatic coronary artery disease; Stroke or other known atherosclerotic disease; Cancer; HIV positive; Alcohol or drug abuse within the past 6 months previous the visit 1; use any antioxidant supplementation

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Health control<br>Health young subjects free of diabetes mellitus and nutritional intervention | |
| Placebo Comparator: DM Placebo<br>Sucralose | Other: Placebo<br>* 5g of the sucralose administered as white plastic capsules<br>|
| Active Comparator: DM FHP<br>Fish protein hydrolysates | Other: Fish protein hydrolysates<br>* 5g of the FPH dissolving in 100 mL of water<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow-mediated dilation | macrovascular endothelial function | 60 min after nutritional intervention | 
| Near infrared spectroscopy | microvascular endothelial function | 70 min after nutritional intervention | 
| High performance liquid chromatography | serum amino acids | 75 min after nutritional intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vascular function, Type 2 diabetes mellitus, Fish protein hydrolysates
Quality of Life in Men Undergoing Robotic Assisted Laparoscopic Radical Prostatectomy Versus Radical Retropubic Prostatectomy

Study Overview
=================
Brief Summary
-----------------
This study is prospective evaluation of quality of life in men undergoing robotic assisted laparoscopic radical prostatectomy versus radical retropubic prostatectomy.

Detailed Description
-----------------
Preoperatively, enrolled patients will complete questionnaires called EPIC that will ask about urinary, sexual, bowel and hormonal function At 1, 3,6,9 and 12 months after surgery, pateints will complete the questionnaires again. All will be enrolled at Samsung Medical Center

Official Title
-----------------
Prospective Evaluation of Quality of Life in Men Undergoing Robotic Assisted Laparoscopic Radical Prostatectomy Vs. Radical Retropubic Prostatectomy

Conditions
-----------------
Prostatic Neoplasms, Quality of Life

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologic diagnosis of prostate adenocarcinoma Clinical stage: AJCC (VI) stage T1-T2 N0M0 Primary treatment at Samsung Medical Center for prostate cancer using: radical retropubic prostatectomy, robotic prostatectomy Exclusion Criteria: Clinical Stage: T3, T4, nodal or distant metastasis All kind of neoadjuvant, concurrent and adjuvant treatment poor health forced a patient into dropout

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
D-dimer In Patients With atRial Fibrillation rEceiving antiCoagulation Therapy

Study Overview
=================
Brief Summary
-----------------
This is a sigle-center, prospective study to evaluate the role of D-Dimer testing in patients with atrial fibrillation receiving Dabigatran or warfarin anticoagulation therapy.

Detailed Description
-----------------
Patients with atrial fibrillation receiving Dabigatran or warfarin anticoagulation therapy was screened and signed to two group: Dabigatran group and Warfarin group. D-dimer test was analyzed before and 3 months after anticoagulation starting specificly. Patients were followed-up for at least 12 months,and clinical outcomes, including thrombotic events major bleeding events and all-cause deaths were recorded during follow-up period.

Official Title
-----------------
The Role of D-dimer in Patients With Atrial Fibrillation Receiving Anticoagulation Therapy

Conditions
-----------------
Atrial Fibrillation, Strokes Thrombotic

Intervention / Treatment
-----------------
* Drug: Dabigatran Etexilate 110mg
* Drug: Warfarin Sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-valvular atrial fibrillation Receiving oral anticoagulation therapy and have good compliance Exclusion Criteria: Life expectancy less than 1 year Thrombosis or major bleeding history within 3 months Refusal to Participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dabigatran Group<br>Patiets with atrial fibrillation received dabigatran (110mg, bid). | Drug: Dabigatran Etexilate 110mg<br>* Dabigatran Etexilate 110mg, BID<br>* Other names: Pradaxa;|
| Warfarin Group<br>Patiets with atrial fibrillation received warfarin (110mg, bid).The target international normalized ratio (INR):1.6-3.0 | Drug: Warfarin Sodium<br>* Target INR:1.6-3.0<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular events | Thrombotic events, cardiovascular deaths, major bleeding events | 12 months |
Oxytocin Levels in Typically Developing Boys

Study Overview
=================
Brief Summary
-----------------
Measuring basal levels of plasma oxytocin in individuals with typical development across childhood and adolescence using both extracted and unextracted EIA methods.

Detailed Description
-----------------
Measuring basal levels of plasma oxytocin in individuals with typical development across childhood and adolescence using both extracted and unextracted EIA methods. This study is necessary since there is great variability in reported plasma oxytocin in typically developing children from other studies as well as up to 1000 fold variability in such levels using different assay procedures. Further existing studies have not clearly described variation in levels with age. all samples will be taken in the afternoon.

Official Title
-----------------
Ontogenic Measurement of Plasma Oxytocin in Typically Developing Boys Using Extracted and Unextracted EIA Methods

Conditions
-----------------
Healthy Boys

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 3 and 17 years old, inclusive Consent of parent or guardian. Exclusion Criteria: Exclusion Criteria for Healthy Control Participants: Female gender Evidence of a mental health diagnosis Evidence of significant medical condition (ie: renal, cardiovascular or genetic disease) First degree family member with an ASD diagnosis

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 17 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 |
| --- | --- |
| Age 3-6<br>This will include 10 typically developing boys age 3-6 | |
| Age 7-12<br>This will include 10 typically developing boys age 7-12 | |
| Age 13-17<br>This will include 10 typically developing boys age 13-17 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Oxytocin Levels | 20 children in each of 3 age cohorts 3-6, 7-12, and 13-17 will participate. Plasma oxytocin levels will be taken at the screening appointment. | Baseline oxytocin level at visit 1 (time zero) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory markers | C reactive protein and cytokine panel | at single time point | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy boys, plasma oxytocin, pediatric
Occipital Nerve Stimulation in Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate whether greater occipital nerve stimulation is effective in the treatment of fibromyalgia related pain. The study uses sub sensory threshold stimulation and placebo stimulation in order to investigate whether sub-threshold stimulation is feasible in a placebo controlled study.

Official Title
-----------------
Subcutaneous C2 Stimulation: Treatment of Fibromyalgia

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Device: Occipital nerve stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed according to the criteria of the American College of Rheumatology (ACR-90) Minimally treated with adequate trials during 3 months Insight of the patient in her disease and capable of understanding and signing an informed consent Exclusion Criteria: History of severe illness or suffering from severe chronic disease History of substance abuse, unless treated and in remission during 6 months Cardiac disease History of epileptic insults Psychiatric disorders with psychotic symptoms Pace maker / defibrillator Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Effective stimulation<br>Effective stimulation at sub-threshold level | Device: Occipital nerve stimulation<br> <br> |
| Placebo Comparator: Placebo stimulation<br>Stimulation at non-effective strength | Device: Occipital nerve stimulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores on Visual Analogue Scale (VAS), pain Catastrophizing Scale (PCS), pain vigilance and awareness questionnaire (PVAQ) |  | at a weekly base during 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on Fatigue and Mood |  | at a weekly base, during 10 weeks |
Wilson France Register

Study Overview
=================
Brief Summary
-----------------
This registry concerns adults and children with Wilson's disease. The collection of a large amount of data will allow a better understanding of the epidemiology of this rare disease, in particular the age of onset according to the hepatic or hepato-neurological forms, but also the geographical distribution of patients consulting in France. This database will also make it possible to know all the therapies prescribed to Wilsonian patients. The genetic study of these patients will make it possible to specify the various genetic mutations involved in Wilson's disease. The information (clinical, biological, radiological and genetic) relating to the disease will be entered by a doctor or a professional specialising in Wilson's disease.

Official Title
-----------------
Registre Wilson France

Conditions
-----------------
Wilson Disease

Intervention / Treatment
-----------------
* Other: Recording of pathology-related information on the Wilson Register


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients suffering from Wilson disease Exclusion Criteria: Lack of written consent from the patient or their legal representative

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Recording of pathology-related information on the Wilson Register|Age, gender, date of diagnosis, clinical symptoms, ethnic charateristics and family tree will be collected and recorded on the Wilson Register during routine clinical care|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recording of pathology-related information on the Wilson Register | The patient's age, sex, date of diagnosis, clinical symptoms, family tree and ethnic characteristics are collected by a physician or professional specialising in Wilson's disease during a routine care consultation. | 1 hour |
An Integrative Approach for Idiopathic Granulomatous Mastitis.

Study Overview
=================
Brief Summary
-----------------
Collaboration is established between Turkish Holistic & Integrative Medicine Association and Traditional & Complementary Medicine Society of Istanbul Medipol University. Study is carried out on idiopathic granulomatous mastitis patients who are followed in the Breast Clinic at Istanbul Medipol University Hospital for between September 2015 and September 2019. Hirudotherapy and medical cupping therapy were applied as traditional and complementary medicine integratively. Following initial radiological imaging, microbiological- and histological testing, side effects and relapses are analyzed. Follow-up examination is also carried out at the end of the treatment, which consisted of clinical breast exam and radiological imaging.

Official Title
-----------------
Traditional and Complementary Medicine: a Cure for Idiopathic Granulomatous Mastitis?

Conditions
-----------------
Idiopathic Granulomatous Mastitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IGM patients, either ones newly diagnosed or had previously received different types of treatments, currently refusing conventional treatments with immunosuppressives etc, or/and surgical management, and now und Exclusion Criteria: Patients currently using any conventional treatment, and/or contraindication to hirudotherapy and cupping.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Breast Mass Size | Ultrasonic scan at 6 months | Up to 12 months | 
| Change of Breast Mass Size | Ultrasonic scan at 12 months | Up to 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Breast Mass Size | MRI scan at 12 months, if prompted by ultrasonic scan | Up to 48 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Integrative Medicine, Ethnomedicine, Hirudotherapy, Idiopathic Granulomatous Mastitis, Medical Cupping Therapy, Traditional and Complementary Medicine
Evaluation of the Influence of Output on Skin Covered by Newly Developed Adhesives

Study Overview
=================
Brief Summary
-----------------
The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive and a standard adhesive.

Conditions
-----------------
Ileostomy - Stoma

Intervention / Treatment
-----------------
* Other: Standard adhesive strip
* Other: New adhesive strip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have given written informed consent Be at least 18 years of age and have full legal capacity Have had an ileostomy for more than one year Have intact skin on the area used in the evaluation Has an ileostomy with a diameter up to (≤) 35 mm Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist) Exclusion Criteria: Currently receiving or have within the past 2 month received radio- and/or chemotherapy Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment. Are pregnant or breastfeeding Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist) Participating in other interventional clinical investigations or have previously participated in this evaluation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 4<br>This is a sub-study testing the effect of real output applied under two adhesive strips on the skin at two different time points (4 and 24 hours). There are two visits: Visit 1: Two adhesive strips (standard adhesive strip and new adhesive strip)contaminated with the subjects own output are applied on the peristomal skin and allowed to sit for 4 hours before being removed Visit 2: Two adhesive strips (standard adhesive strip and new adhesive strip)contaminated with the subjects own output are applied on the peristomal skin and allowed to sit for 24 hours before being removed | Other: Standard adhesive strip<br>* This is a standard adhesive strip (hydrocolloid)<br>Other: New adhesive strip<br>* This a newly developed adhesive strip.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trans epidermal water loss | The condition of the skin (transepidermal water loss) is measured after removing the adhesive by TE | 4-24 hours |
ETT Cuff Leak: TV Ratios

Study Overview
=================
Brief Summary
-----------------
In the past 5 years cuffed endotracheal tubes (ETT) have become the standard of care in pediatrics. However, hyperinflation of the cuff can compromise the tracheal mucosal perfusion while an inadequate seal may impact ventilation and potentially increase the risk of aspiration. Hence, the goal after placement of a cuffed ETT is to create a safe and effective tracheal seal. The two ways to measure that are to hold CPAP while listening for an audible leak and measuring the difference between the inspired and expired tidal volumes (TV). This is a prospective study to compare these two methods used to create a tracheal seal and measure the intracuff pressure after a satisfactory tracheal seal is established.

Official Title
-----------------
Minimal Occlusive Pressure With Cuffed ETTs: A Comparison of Two Different Techniques to Ensure a Tracheal Seal

Conditions
-----------------
Surgical Procedures, Operative

Intervention / Treatment
-----------------
* Other: CPAP
* Other: Tidal volume


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children who are scheduled to undergo GA with a cuffed ETT in place. Exclusion Criteria: Any children with pre-existing tracheal/bronchial anomalies, patients with Down syndrome, patients with C-spine issues.
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 |
| --- | --- |
| Experimental: Cuffed ETT<br> | Other: CPAP<br>* Sealing the airway by holding CPAP of 20 cmH2O in the anesthesia circuit and slowly inflating the cuff until no air leak is heard with a stethoscope placed in the suprasternal notch.<br>Other: Tidal volume<br>* The ratio of the inspired to expired tidal volume will be determined using the following formula: (TVinspired - TV¬expired)/TVinspired. The peak inflating pressure (PIP) required to achieve the set TV will be noted. The air in the cuff will then be increased or decreased as needed to achieve a set delivered ratio of 0.9-1.0.<br>* Other names: TV;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracuff pressure | Difference in intracuff pressure measured after inflation with CPAP and inflation with TV. | Immediately following intubation |