linjc16/ctgov huggingface dataset:
Plaque Burden Pre- Myocardial Revascularisation

Study Overview
=================
Brief Summary
-----------------
The study is a prospective-observational, explorative single-centre cohort study aimed to examine the influence of the peripheral atherosclerotic plaque volume on short and long term morbidity and mortality in patient after coronary artery bypass grafting (CABG). Atherosclerotic disease (IMT, plaque volume) will be measured with a ultrasound system (IMT measurements and 3D quantitative plaque volumetric). Hemodynamic and flow profiles of the internal thoracic arteries will be evaluated additionally with US. These parameters will be measured pre-CABG. Morbidity will be evaluated using quality of life questionnaires (EQ-5D-3L, IPAQ). Major adverse cardiovascular events (MACE) will be the primary endpoint. The atherosclerotic burden will be compared with established risk scores (EuroSCORE, STS-Score, SYNTAX Score, FORECAST.

Official Title
-----------------
Association of Peripheral Atherosclerotic Burden With the Short-term and Long-term Outcome in Patients With Elective Myocardial Revascularisation

Conditions
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Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pre CABG Exclusion Criteria: no consent, prior carotid intervention

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Association of MACE rates with peripheral atherosclerotic volume |  | 5 years | 
| Association of morbidity with peripheral atherosclerotic volume | Morbidity will be evaluated with quality of life assessment (EQ-5D-3L, IPAQ | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of predictive value of peripheral atherosclerotic volume with established risk scores for cardiovascular operations and interventions | Risk scores include STS Score and Euro Score | 1 year | 
| Association of the duration of the operation with peripheral atherosclerotic volume |  | 30 days | 
| Association of flow profiles of internal mammary artery with LIMA/RIMA graft patency rates |  | 5 years | 
| Association of the aortic clamp time with peripheral atherosclerotic volume |  | 30 days | 
| Association of the ICU stay with peripheral atherosclerotic volume |  | 30 days | 
| Association of the hospitalization duration with peripheral atherosclerotic volume |  | 30 days |
Early Conversion of Dasatinib in CML-CP Patients

Study Overview
=================
Brief Summary
-----------------
Chronic myeloid leukemia (CML) is a malignant disease of acquired hematopoietic stem cells. The BCR-ABL fusion gene is the pathogenic basis of CML. Tyrosine kinase inhibitors (TKIs) are targeted drugs for this fusion protein. With the wide clinical application of TKIs, the efficacy of CML patients has been greatly improved. However, there are still a significant number of patients who have poor response to the first generation of TKI drugs, imatinib, most of them have early molecular response failures (BCR-ABL（IS）>10% at 3 or 6 months) ，which means lower rates of molecular response, increased risk of progression, and higher overall survival. For them, the early conversion of dasatinib might be a better choice.

Official Title
-----------------
A Prospective Study on Early Conversion of Dasatinib in CML-CP Patients Who Have Not Early Molecular Response on Imatinib

Conditions
-----------------
Validity and Safety

Intervention / Treatment
-----------------
* Drug: Dasatinib 100 MG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.18-65 years old； 2.CML-CP,and Imatinib treatment longest for 6 months ； 3.Q-pcr monitoring of BCR/ABLIS failed to achieve the best therapeutic effect（BCR/ABLIS>10.00% in 3m or BCR/ABLIS>1.00% in 6m）； 4.No previous history of malignant tumor; 5.Informed consent of the patient or his legal representative Exclusion Criteria: History of CML-CP or CML-AP; Resistant to dasatinib,or treatment with imatinib more than 6 months; Received allogeneic hematopoietic stem cell transplantation,or immunotherapy; woman who is pregnant or nursing Combined with other serious organic diseases, serious arrhythmia, pulmonary hypertension, cardiomyopathy, serious autoimmune diseases.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dasatinib group<br> | Drug: Dasatinib 100 MG<br>* The CML-CP patients with early(3m to 6m) molecular response failure on imatinib,Conversion dasatinib group or Imatinib group<br>|
| Imatinib group<br> | Drug: Dasatinib 100 MG<br>* The CML-CP patients with early(3m to 6m) molecular response failure on imatinib,Conversion dasatinib group or Imatinib group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MMR in 1 year | MMR(BCR/ABL(IS)<0.1%) at 12 months after switching to dasatinib for patients who did not achieve optimal treatment with imatinib for 3 to 6 months. | 1 year |
Support Group Surveys for Individuals Who Have Type 1 Diabetes and an Eating Disorder

Study Overview
=================
Brief Summary
-----------------
We propose to conduct a monthly group of persons with type 1 diabetes who also withhold insulin. Subjects will be asked to complete a 2-page survey (check-in sheet) at the beginning of each session and a 5-page survey (Diabetes and Eating Disorders Survey) on their first session and at their last session of their group.

Official Title
-----------------
Support Group Surveys for Individuals Who Have Type 1 Diabetes and an Eating Disorder

Conditions
-----------------
Eating Disorder, Type 1 Diabetes

Intervention / Treatment
-----------------
* Behavioral: ED/DM Support Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have an eating disorder Have type 1 diabetes Withhold their insulin 18 years or older Actively being treated at EDI Committed to at least one appointment each month with each member of their individual EDI team (RD, CDE or RN, CDE; LP; and MD) Approval of participation by EDI/DM team (RD; RN; LP; MD) Able to attend 66% of group sessions Exclusion Criteria: Psychologically not ready for this group therapy Have additional eating disorder issues that would make attendance in this group inappropriate Not committed to continuing treatment at PN's EDI Not being actively treated at PN's EDI Has type 2 diabetes

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 |
| --- | --- |
| eating disorder, type 1 diabetes<br>Individuals diagnosed with type 1 diabetes and an eating disorder who withhold their insulin. | Behavioral: ED/DM Support Group<br>* The ED/DM Recovery Group focuses on assisting individuals with diabetes and an eating disorder - specifically the struggle of withholding insulin. The group utilizes strategies and tools that have been taught in other EDI programs, and also builds on the strengths of a group. The group is a means for learning and support as the individuals continue a regular schedule of school, work, and/or family life.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to insulin regimen. |  | Monthly |
Impact of Sub-anesthetic Dose of Ketamine on Post Spinal Hypotension in Caesarean Delivery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of sub anesthetic dose of ketamine on vasopressor (Ephedrine) requirement to prevent maternal hypotension after spinal anesthesia in caesarean section.

Official Title
-----------------
Impact of Sub-anesthetic Dose of Ketamine on Post Spinal Hypotension in Caesarean Delivery :Prospective , Randomized Double- Blinded Study

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Drug: Ketamine
* Drug: isotonic saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physical status American Society of Anesthesiologist(ASA) I or II. Full term pregnancy Exclusion Criteria: ,Pre-eclampsia. Chronic hypertension. Cardiovascular troubles. any contraindications to spinal anesthesia as back infection , coaguolopathy , patient refusal

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketamine<br>sub- anesthetic dose of ketamine 0.5 mg/kg will be given in 3 ml volume | Drug: Ketamine<br>* patients will receive sub- anesthetic dose of ketamine 0.5 mg/kg in 3 ml of isotonic saline after spinal anesthesia<br>* Other names: general anesthetic;|
| Placebo Comparator: isotonic saline<br>isotonic saline 3 ml volume will be given | Drug: isotonic saline<br>* patients will receive 3 ml of isotonic saline after spinal anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of hypotension | after spinal anesthesia sub- anesthetic dose of ketamine will be given and blood pressure will be recorded every 2 minutes till delivery , every 5 minutes till end of surgery | 5 hours |
A Long-Term Study of MP-214 in Patients With Chronic Phase or Elderly Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with chronic phase or elderly schizophrenia.

Official Title
-----------------
A Long-term Study of MP-214 in Patients With Chronic Phase or Elderly Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: MP-214
* Drug: Risperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent obtained from the patient before the initiation of any study-specific procedures Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia Patients who meet at least one of the following: current diagnosis of schizophrenia of chronic phase between 65 and 74 years of age Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG) Exclusion Criteria: Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 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 |
| --- | --- |
| Experimental: MP-214 1.5-9mg<br> | Drug: MP-214<br>* Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg or 6mg) of MP-214 for four weeks, then flexible dose (1.5-9mg) of MP-214<br>|
| Active Comparator: Risperidone 2-12mg<br> | Drug: Risperidone<br>* Patients who meet eligibility criteria will be administered a once daily oral fixed dose (4mg) of risperidone for two weeks, then flexible dose (2-12mg) of risperidone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability |  | Up to 60 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Risperidone, Central Nervous System Agents, Schizophrenia, Antipsychotic Agents, Mental Disorder, Psychotropic Drugs, Dopamine Agents
Gastric Ultrasound in Tube Fed Intubated Patients

Study Overview
=================
Brief Summary
-----------------
This study will use point of care (POC) gastric ultrasound to confirm that nasojejunal tube (NJ) feeds result in minimal to no gastric content and therefore are low risk for aspiration and should be allowed at the very least to decrease the time that enteral feeds need to be held prior to a procedure or if they need to be held at all. This would allow critically ill children to receive the nutrition that they need to heal for longer periods of time. Using ultrasound would also potentially eliminate the need for exposure to x-rays to confirm tube placement. Most ICUs have a POC ultrasound machine so this would be any easy tool to access to improve patient care.

Official Title
-----------------
Utility of POC Gastric Ultrasound in Confirming Stomach is Empty in Intubated Patients Fed Gastrically (NG) Versus Transpylorically (NJ) to Ensure Low Risk of Aspiration.

Conditions
-----------------
Critical Illness

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all PICU patients intubated < 7 days that are receiving NJ or NG feeds Exclusion Criteria: patients that cannot be moved patients with significant GI conditions affecting motility patients intubated for more than seven days

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NJ tube fed<br>Critically ill children receiving nutrition via a nasojejunal feeding tube. | Diagnostic Test: Ultrasound<br>* Point of care ultrasound to measure gastric contents.<br>|
| NG tube fed<br>Critically ill children receiving nutrition via a nasogastric feeding tube. | Diagnostic Test: Ultrasound<br>* Point of care ultrasound to measure gastric contents.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric contents | Amount of gastric contents measured by ultrasound. | Baseline (Day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric contents | Amount of gastric contents measured by ultrasound. | Day 2 (if still intubated & being tube fed) | 
| Gastric contents | Amount of gastric contents measured by ultrasound. | Day 3 (if still intubated & being tube fed) | 
| Gastric contents | Amount of gastric contents measured by ultrasound. | Day 4 (if still intubated & being tube fed) | 
| Gastric contents | Amount of gastric contents measured by ultrasound. | Day 5 (if still intubated & being tube fed) |
The Role of Macular Pigment in Patients With Age-related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
In the industrialised world age-related macular degeneration (ARMD) is the leading cause for legal blindness beyond the age of 50 years. Recent studies indicate that the amount and status of the macular pigment (MP) may play a central role in the development and progression of the disease. It has been demonstrated that the MP density can be increased by dietary supplementation. First results of MP density measurements with a modified confocal laser scanning ophthalmoscope show that this method allows to quantify the MP in a clinical setting. The aim of this study is to assess the peak MP density as well as the MP distribution in relation to the risk for ARMD. We will establish reference values for MP density distribution in a normal population and compare these to values obtained from patients with age related maculopathy in a cross-sectional study. For all MP density measurements we will use a modified scanning laser ophthalmoscope and dietary intake of macular pigment will be assessed using a Food Frequency Questionnaire. Clinical examinations will include ETDRS visual acuity, binocular ophthalmoscopy, colour fundus photography and autofluorescence imaging. The results of our study will help assess the relationship of macular pigment density and distribution with ARMD. Additionally, we will be able to identify patients with low MP density, and probably improve the early diagnosis of patients at high risk for developing ARMD. This will be the basis for dietary supplementation of lutein and/or zeaxanthin in patients with high risk for ARMD due to low macular pigment values.

Official Title
-----------------
The Role of Macular Pigment in Patients With Age-related Macular Degeneration

Conditions
-----------------
Age Related Maculopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age related maculopathy Exclusion Criteria: other macular diseases

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of development of late AMD |  | End of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
age related maculopathy, macular pigment
NIRF Trial: Near-Infrared Spectroscopy for Intraoperative Restriction of Fluids Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate if the InSpectra StO2 Monitor can safely guide the amount of fluid needed during colorectal surgery. The study hypothesis is that intraoperative fluid limitation can be safely accomplished when guided by StO2 monitoring, and that this fluid restriction regimen will result in a reduction in postoperative morbidity when compared to standard monitoring and fluid therapy.

Official Title
-----------------
Near-Infrared Spectroscopy for Intraoperative Restriction of Fluids Trial A Prospective Randomized Study of Near-infrared Spectroscopy Directed Fluid Therapy vs Standard Fluid Therapy in Patients Undergoing Open Elective Colorectal Surgery

Conditions
-----------------
Colorectal Surgery

Intervention / Treatment
-----------------
* Procedure: Restricted intraoperative fluid management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for elective open colorectal surgery Age greater than or equal to 18 years Low to moderate risk colorectal surgery patients Exclusion Criteria: Unacceptable Baseline vital sign measurements High risk colorectal surgery patients Jehovah's Witness

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard<br>Standard intraoperative fluid management | |
| Experimental: Restricted<br>Restricted intraoperative fluid management | Procedure: Restricted intraoperative fluid management<br>* Intraoperative fluid management guided by Sto2.<br>* Other names: InSpectra StO2;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major postoperative complications |  | within the first 30 days of the postoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| StO2 changes during intraoperative fluid management, hospital-free days, surgical site infections, time to first bowel movement, total fluid and total intraoperative fluid volumes, daily fluid volumes through 3 days postoperative, daily weights |  | within the first 30 days of the postoperative period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Near-Infrared Spectroscopy, Intraoperative Care