linjc16/ctgov huggingface dataset:
32 Week, Open, Randomized, 2 Way Cross Over Multicentre Trial to Compare Safety & Efficacy of Combination of HOE901 Insulin Analogue Once Daily at Bedtime + Lispro Insulin Before Meals vs NPH Insulin (Twice a Day) + Regular in Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy (in terms of metabolic control evaluated through HbA1c levels) of treatment with insulin glargine as basal insulin and insulin analogue (insulin lispro) as mealtime insulin with a regimen of insulin NPH as basal insulin with regular insulin, as mealtime insulin, after a 16 week treatment phase with each regimen and to compare the safety of both treatments, evaluated through hypoglycemic rates.

Detailed Description
-----------------
Multicenter, open-label, randomized (allocation ratio 1:1), cross-over with two treatment phases of 16 weeks each in two treatment groups: Study arm with insulin glargine + insulin lispro (phase 1) and insulin NPH + regular insulin (phase 2) Insulin NPH + regular insulin (phase 1) and insulin glargine + insulin lispro (phase 2)

Official Title
-----------------
32-Week, Open, Randomized, Cross-Over, Local, Multicenter Clinical Trial Comparing Insulin Glargine in Combination With Insulin Analogue (Insulin Lispro) to NPH Insulin in Combination With Regular Insulin in Type 1 Diabetes Mellitus Patients in an Intensified Insulin Regimen.

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: Insulin glargine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with type 1 diabetes mellitus 18-65 years of age C-Peptide negative Treated at least for 6 months with multiple daily doses of insulin and with HbA1c greater than or equal to 7.0% and less than or equal to 9.5% and a BMI less than or equal to 35 kg/m². Women of childbearing potential must have a negative pregnancy test in visit 1 and must use an effective contraceptive method during the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Insulin glargine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare efficacy of insulin glargine & short acting insulin (Lispro), NPH insulin regime as basal insulin and regular insulin for meal insulin for metabolic control, evaluated by means of HbA1c . |  | after 16 weeks of treatment with each treatment regime |
Ultra-low-dose Whole-body CT Using AI-based CT Reconstruction in Patients With Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
This prospective study aims to perform intra-individual comparison of the image quality between ultra-low-dose whole-body CT with deep learning reconstruction and conventional low-dose whole-body CT with iterative reconstruction in patients with suspected multiple myeloma.

Official Title
-----------------
Noise Reduction and Image Quality Improvement in Ultra-low-dose Whole-body CT Scans Using AI-based CT Reconstruction Program (ClariCT.AI) in Patients With Multiple Myeloma: A Prospective, Single-center Study

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Diagnostic Test: noncontrast-enhanced whole-body CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: signed informed consent patients with suspected multiple myeloma and scheduled for noncontrast-enhanced low-dose whole-body CT patients who have no previous history of chemotherapy for multiple myeloma Exclusion Criteria: patients who do not agree to the protocol non-Korean patients pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Multiple myeloma<br>Patients with suspicion of multiple myeloma and scheduled for CT | Diagnostic Test: noncontrast-enhanced whole-body CT<br>* noncontrast-enhanced low-dose whole-body CT using dual-source CT scanner using A-tube (75% radiation) and B-tube (25% radiation). conventional low-dose CT data (A +B tubes, 100% dose) are reconstructed with iterative reconstruction ultra-low dose CT data (B-tube only, 25% dose) are reconstructed with deep learning commercially available software.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast-to-noise ratio | Contrast-to-noise ratio (CNR) of the vertebral body and paraspinal muscle obtained at L1 vertebra level | 3 months after the CT scan |
Emergency Department MCG for Suspected Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to assess a new non-invasive computerized, multiphase, resting electrocardiogram analysis device in early identification of patients at risk for acute coronary syndrome. The overall objective is to assess the association between the results from a resting MCG and 30-day cardiovascular outcome in patients presenting to the emergency department with suspected coronary disease.

Official Title
-----------------
Emergency Department MCG for Suspected Acute Coronary Syndrome

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Device: Multifunction Cardiogram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 and over. Symptoms consistent with a possible acute coronary syndrome per the treating emergency physician. Has an electrocardiogram performed while in the ED. Exclusion Criteria: Acute ST-segment elevation MI. Patient unable or unwilling to complete follow-up.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multifunction Cardiogram<br>non-invasive computerized, multiphase, resting electrocardiogram analysis device | Device: Multifunction Cardiogram<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of MCG as assessed by the development of major adverse cardiac events (MACE). | MACE will be defined as the composite of cardiac death, myocardial infarction (MI), or coronary revascularization. 2.2 Seco11dary | 30 days |
Perioperative Coagulation Management in Cardiac Surgery.

Study Overview
=================
Brief Summary
-----------------
Cardiac surgery is bleeding requiring transfusion surgery . The haemorrhagic is related to the need to use high doses of anticoagulants to prevent thrombosis of blood . Moreover, this type of surgery is platelets and coagulation factors consumming despite conducting a thorough anticoagulation. All these changes contribute to increase the need for transfusions during heart surgery. The main objective of this study is to compare the need for transfusions in patients suffering from bleeding complications after cardiac surgery with a therapeutic algorithm based on the use of ROTEM ® versus standard tests based solely on standard laboratory tests. 100 pateinst (50 in each arm) should be included in this trial.

Official Title
-----------------
Perioperative Coagulation Management in Cardiac Surgery. Rotem Versus Standard Pratctice. A Randomized Trial.

Conditions
-----------------
Cardiac Surgery, Bleeding

Intervention / Treatment
-----------------
* Device: Rotation thromboelastometry (ROTEM)
* Procedure: Standard coagulation managment procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults> 18 years Cardiac surgery or heart transplantation with abnormal bleeding regardless the etiology given informed consent Exclusion Criteria: Patient supported by a pre or postoperative circulatory technical assistance

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rotem<br>ROTEM: Rotation thromboelastometry | Device: Rotation thromboelastometry (ROTEM)<br>* Coagulation measurement<br>|
| Active Comparator: S<br>Standard coagulation managment procedure | Procedure: Standard coagulation managment procedure<br>* Standard coagulation managment procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of different blood transfusion |  | during cardiac surgery management | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coagulation Management, Cardiac surgery, Bleeding, Rotem
Pilot Test for a Newly Developed Nutrition Screening Method: Pediatric Subjective Global Assessment

Study Overview
=================
Brief Summary
-----------------
Researchers are studying ways to predict if cancer patients are at risk for poor nutrition during their chemotherapy treatment. They hope to identify children with nutrition problems early in treatment. This may help prevent weight loss and other nutrition problems later in treatment.

Detailed Description
-----------------
The PEDSGA is a newly developed nutrition tool that includes a training manual that be used to teach health care professionals to identify at-risk patients by doing a nutrition physical exam. The PEDSGA also includes questions that the patient/caregiver answers regarding appetite, recent treatment, and activity level. This method of screening is new and may be able to identify at-risk patients better than the standard method. This study will use both methods and evaluate the two, in hope of determining which method works best to identify at-risk patients.

Official Title
-----------------
Pilot Test for a Newly Developed Nutrition Screening Method: Pediatric Subjective Global Assessment

Conditions
-----------------
Compare Two Nutrition Screening Tools

Intervention / Treatment
-----------------
* Other: Nutritional Screening Tools


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: St. Jude Children's Research Hospital patient between 2 and 16 years of age who is actively receiving treatment for a hematologic or solid tumor malignancy Patient is not admitted to the transplant service Patient is able to read English or Spanish

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 16 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 |
| --- | --- |
| 1<br> | Other: Nutritional Screening Tools<br>* To compare the nutrition risk identification abilities of two nutrition screening tools: PEDSGA tool and the standard assessment tool.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the ability of two nutrition screening tools to identify nutritionally at risk patients |  | Within 90 days of study completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
All Malignancies
Impact of Enhanced External Counterpulsation (EECP) on Cardiac Force Index

Study Overview
=================
Brief Summary
-----------------
Regular exercise can prevent cardiovascular disease, but there is also a risk of sudden cardiac death. Exercise-related sudden death often occurs unconsciously and there is no relevant monitoring mechanism. The patent of the Cardiac Force Index (CFI), invented by Professor Chu, is a method to detect the state of cardiac motion. Recent studies have confirmed Enhanced External Counterpulsation (EECP) can increase cardiopulmonary fitness and maximal oxygen consumption. Our aim is to investigate the differences and effects of CFI between two groups with and without 4 weeks of EECP intervention, therefore, to find out the relationship between CFI and maximum oxygen consumption (VO2max). Methods: A pre and post-test control group was designed. A total of 53 military students (33 males and 20 females) were recruited and divided into intervention and control groups. A 2000-meter running and maximum oxygen consumption tests were performed pre and post-test. The intervention group was conducted a 4 week (3 times per week/30 minutes) EECP intervention.

Official Title
-----------------
Impact of Enhanced External Counterpulsation (EECP) on Cardiac Force Index

Conditions
-----------------
Enhanced External Counterpulsation (EECP), Cardiac Output, Cardiac Force Index

Intervention / Treatment
-----------------
* Device: Enhanced External Counterpulsation (EECP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: can walk. Exclusion Criteria: disabilities.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Enhanced External Counterpulsation (EECP)|Enhanced External Counterpulsation (EECP)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enhanced External Counterpulsation (EECP) on cardiac force index | Enhanced External Counterpulsation (EECP) on cardiac force index | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac force index, Cardiac Output, Enhanced External Counterpulsation (EECP)
Clinical Interest of a Genetic Diagnosis in Early Infant Epilepsy, Paraclinical and Therapeutic Management, and Psychological Impact of Families

Study Overview
=================
Brief Summary
-----------------
To determine the paraclinical and therapeutic interest of genetic diagnosis in early onset epilepsy.

Official Title
-----------------
Clinical Interest of a Genetic Diagnosis in Early Infant Epilepsy, Paraclinical and Therapeutic Management, and Psychological Impact of Families

Conditions
-----------------
Early Infant Epilepsy

Intervention / Treatment
-----------------
* Other: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged ≤ 12 years, hospitalized or followed at the Hautepierre Hospital of the University Hospitals of Strasbourg for primary epilepsy having started in the first 5 months of life, from 2010 to 2021. Exclusion Criteria: - Children with secondary epilepsy (with infection trauma)

Ages Eligible for Study
-----------------
Maximum Age: 12 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaires|Sends and returns questionnaires to families.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of event densities | The frequency of events (crises, going to the emergency room, hospitalizations) before and after genetic diagnosis. | 4 month |
Retrospective Clinical Outcome of Parotid Tumor Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to determine the histopathological results of parotid tumors and postoperative complications after partial superficial or total parotidectomy with facial nerve dissection and superficial musculoaponeurotic system reconstruction.

Official Title
-----------------
Retrospective Clinical Outcome of Parotid Tumor Surgery

Conditions
-----------------
Parotid Tumors, Postoperative Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Clinical diagnosis of parotid tumor Patients received the surgery of parotid tumor at NTUH by single surgeon ( Prof. Lou) from 2004/01 to 2012/12 Exclusion criteria: -Inflammation or infection disease of parotid gland

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 84 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial palsy | Record the grade of facial palsy in patients receiving the surgery of parotid tumor | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parotid tumor, Partial superficial parotidectomy, Facial palsy
Sleep Disordered Breathing and Alzheimer's Disease Biomarkers in Normal Aging and Mild Cognitive Impairment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the sleep patterns of subjects with or without sleep disturbances (insomnia, sleep apnea) and compare these findings with their previous FDG/PIB PET, structural MRI and brain blood flow scams performed during their participation in the Following studies 'Alzheimer's Disease Core Center (ADCC) Clinical Evaluation' (IRB: 2942), MRI Progression Markers of Cognitive Decline in the Elderly' (IRB:09-0586), or 'Imaging Neuro inflammation in Alzheimer's Disease with [11C] Arachidonic Acid (AA) and PET'(IRB: 10-00442).

Official Title
-----------------
Sleep Disordered Breathing and Alzheimer's Disease Biomarkers in Normal Aging and Mild Cognitive Impairment

Conditions
-----------------
Sleep Disorder

Intervention / Treatment
-----------------
* Diagnostic Test: Structural 3T MRI
* Diagnostic Test: MRI Based Perfusion Imaging
* Diagnostic Test: VR-CO2 MRI Scans


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects will have participated in prior CBH studies and have agreed to an FDG, PIB and MRI scans. Exclusion Criteria: Diagnosis of sleep apnea and under treatment with a continuous positive airway pressure (CPAP) machine. Active depressive episode during the evaluation with a Geriatric Depression Scale score >7 and/or a Clinical Global Impression scale for depression score >4. Moderate Cognitive decline (GDS >3). Severe primary or secondary insomnia except insomnia due to SDB.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 90 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 |
| --- | --- |
| Mild Cognitive Impairment (MCI)<br>Patients with clinical dementia rating of 0.5 or a global deterioration scale of 3. | Diagnostic Test: Structural 3T MRI<br>* measures of global and hippocampal atrophy)<br>Diagnostic Test: MRI Based Perfusion Imaging<br>* brain blood flow<br>Diagnostic Test: VR-CO2 MRI Scans<br>* reduced vaso reactivity to carbon dioxide<br>|
| Normal Cognition (NL)<br>Clinical Dementia Rating [CDR] of 0 or Global Deterioration Scale [GDS] of 1-2 | Diagnostic Test: Structural 3T MRI<br>* measures of global and hippocampal atrophy)<br>Diagnostic Test: MRI Based Perfusion Imaging<br>* brain blood flow<br>Diagnostic Test: VR-CO2 MRI Scans<br>* reduced vaso reactivity to carbon dioxide<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased cerebral blood flow (CBF) | Measured by perfusion MRI | 1 Week | 
| Measure of vasoreactivity to CO2 (VRCO2) | subjects will breath through a respiratory tube and CO2 will be meaured | 1 Week | 
| Increase in cortical AB plaque burden | Measured by PIB PET | 1 Week |
Laparoscopic Transvaginal Hybrid Cholecystectomy: a Prospective Data Collection.

Study Overview
=================
Brief Summary
-----------------
Transvaginal hybrid procedures especially the transvaginal hybrid cholecystectomy are of interest as an available NOTES-Procedure for the clinical routine. Few authors have demonstrated the feasibility and safety in a selected patient collective. The aim of this prospective data collection is to evaluate the feasibility in the clinical routine in a non select patient collective. Therefore all patients giving the informed consent to the transvaginal hybrid cholecystectomy will be included and assessed concerning feasibility to perform the transvaginal approach and complete the operation transvaginally.

Conditions
-----------------
Cholecystolithiasis, Cholecystitis

Intervention / Treatment
-----------------
* Procedure: transvaginal hybrid cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: given informed consent for transvaginal hybrid cholecystectomy Exclusion Criteria: pregnancy malignoma present choledocholithiasis

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Given indication for cholecystectomy<br> | Procedure: transvaginal hybrid cholecystectomy<br>* transvaginal hybrid cholecystectomy: using one trans-umbilical 5mm trocar and 2 (one 12mm trocar, one 5-mm trocar)inserted through the posterior colpotomy. Removal of the gallbladder through the transvaginal access.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and safety of the transvaginal operation |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term life quality and sexual dysfunction |  | 3 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
symptomatic cholecystolithiasis