linjc16/ctgov huggingface dataset:
Dexmedetomidine on Segmental EEG Power Spectra

Study Overview
=================
Brief Summary
-----------------
To compare the EEG power spectra activity during propofol-based anesthesia in the presence or absence of dexmedetomidine in patients undergoing hysteroscopic examination and surgery to determine whether the addition of dexmedetomidine will induce better sleep-like anesthesia status.

Detailed Description
-----------------
Three groups of patients undergoing hysteroscopic examination and surgery will be studied: 1) control group, patients will receive propofol intravenous infusion to provide anesthesia; 2) dexmedetomidine 0.5 microgram/kg group. This dexmedetomidine dose is infused within 10 min and then the use of propofol for anesthesia; and 3) dexmedetomidine 1 microgram/kg group. This dexmedetomidine dose is infused within 10 min and then the use of propofol for anesthesia. Each group will have 20 patients. General conditions including blood pressure, respiration, and heart rates will be recorded. EEG power spectra activity will be recorded no-invasively by a Narcotrend EEG monitor.

Official Title
-----------------
The Effects of Dexmedetomidine on Segmental EEG Power Spectra Activity Under Propofol-based Anesthesia

Conditions
-----------------
Anesthesia, EEG Power Spectra

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists Physical status I to II grade. body mass index 18 to 25 kg/m2 no vision or hearing impairment will receive general anesthesia Exclusion Criteria: with psychological or mental diseases with neurological diseases treating with steroids or with alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Control<br>Patients will receive intravenous propofol infusion. | |
| Dexmedetomidine 0.5 microgram/kg group<br>Patients will receive dexmedetomidine 0.5 microgram/kg and then intravenous propofol infusion. | |
| Dexmedetomidine 1 microgram/kg group<br>Patients will receive dexmedetomidine 1 microgram/kg and then intravenous propofol infusion. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG power spectra | EEG power spectra monitored no-invasively by Narcotrend | From prior to anesthesia to 10 min after anesthesia. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Blood pressure monitored no-invasively | From prior to anesthesia to 10 min after anesthesia. | 
| Respiration | Monitored no-invasively | From prior to anesthesia to 10 min after anesthesia. | 
| Heart rates | Monitored no-invasively | From prior to anesthesia to 10 min after anesthesia. |
Confocal Microscopy in Barrett's Esophagus

Study Overview
=================
Brief Summary
-----------------
This data review will be done to evaluate the use of confocal microscopy imaging in patients who were seen for clinically indicated endoscopic surveillance and biopsies of Barretts Esophagus

Detailed Description
-----------------
This retrospective chart review will be done to evaluate the use of confocal microscopy imaging in patients who were seen at Mayo Clinic for clinically indicated endoscopic surveillance and biopsies of BE. Endoscopy reports and pathology results will be reviewed from 100 patients who have undergone endoscopy. These results will be correlated with images obtained with confocal microscopy at the time of the endoscopy. There will be no patient contact.

Official Title
-----------------
The Use of Confocal Microscopy in Barrett's Esophagus

Conditions
-----------------
Barrett's Esophagus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have undergone confocal microscopy at the time of surveillance endoscopy for Barrett's Esophagus

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 |
| --- | --- |
| 1<br>patients who were seen clinically indicated endoscopic surveillance and biopsies of BE and confocal microscopy was performed. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Confocal Microscopy, Barrett's Esophagus
Muscle Mass Loss in Critically Ill Patients.

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to describe the change in muscle mass in critically ill patients. The study will examine rectus femoris cross sectional area with ultrasound and identify risk factors of this changes.

Detailed Description
-----------------
The study will commence following the Approval by The Ethics Research Committee. All patients admitted to our ICU from the 1st of March 2019 to the 31st of August 2019 will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. Informed consent will be requested. Ultrasound measurement of rectus femoris cross sectional area will be performed in first 24 hours after admission to ICU. Study data will be entered in study form. The ultrasound measurement will be repeated on day 7 of hospitalisation. Changes in rectus femoris cross sectional area and potential risk factors will be analysed. The length of ICU length of stay and 28-day mortality will be also monitored.

Official Title
-----------------
Muscle Mass Loss in Critically Ill and Its Risk Factors. A Prospective Observational Study.

Conditions
-----------------
Muscle Loss

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥18 years mechanical ventilation expected for at least 48 hours Exclusion Criteria: Clinical Frailty Score above 7 prior admission neuromuscular disease in previous medical history amputated lower extremities trauma of lower extremities involving tights age under 18 years inability to perform ultrasound examination death or discharge prior completion of protocol full verticalization prior completion of protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Muscle mass loss | Change in cross sectional area of rectus femoris muscle estimated by ultrasound | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 day mortality | mortality 28 days after enrolment | 28 days after enrolment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Critical Care, Muscle loss, Rectus femoris cross sectional area, Muscle ultrasound
Angiotensin Converting Enzyme Inhibitors and Periprocedural Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
Metabolic syndrome (MS) has been reported as a risk for cardiovascular events. The aim of the present cohort study is to investigate whether ACEi therapy reduces the rate of periprocedural myocardial injury (PPMI) after elective percutaneous coronary intervention (PCI) among patients with metabolic syndrome.

Official Title
-----------------
Angiotensin Converting Enzyme Inhibitor Therapy and Periprocedural Myocardial Infarction in Patients With Metabolic Syndrome

Conditions
-----------------
Metabolic Syndrome, Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: metabolic syndrome elective percutaneous coronary intervention with angiographically successful stent implantation Exclusion Criteria: acute coronary events renal failure needed the use of IV glycoprotein IIb/IIIa receptor inhibitors were excluded left main coronary artery disease chronic total occlusion high levels of baseline CKMB or troponin any contraindication of aspirin, clopidogrel or ACEi treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Periprocedural myocardial injury (MI) | Periprocedural MI was defined as cardiac Troponin I release [5 times ULN] 24 hours after percutaneous coronary intervention | 24 hours after (percutaneous coroary intervention) PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periprocedural myonecrosis | Peri-procedural myonecrosis was defined as troponin I release of >1×ULN 24 hours after the intervention. | 24 hours after PCI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Angiotensin converting enzyme inhibitor, inflammation, metabolic syndrome, myonecrosis, percutaneous coronary intervention, periprocedural myocardial injury
Compliance With The European Society Of Cardiology Prevention Guidelines In Patients at High Cardiovascular Disease Risk

Study Overview
=================
Brief Summary
-----------------
Patients with coronary or other atherosclerotic cardiovascular disease and those at high risk of developing cardiovascular disease have been defined as the highest clinical priorities for prevention

Detailed Description
-----------------
Cardiovascular disease prevention programs are designed to reduce patients' morbidity and mortality.the European society of cardiology with other partner societies has engaged in a comprehensive programme of cardiovascular disease prevention in clinical practice aimed to improve practice of preventive cardiology by encouraging the development of national guidance on cardiovascular disease prevention

Official Title
-----------------
Compliance With The European Society Of Cardiology Prevention Guidelines In Patients at High Cardiovascular Disease Risk in Assiut University

Conditions
-----------------
Hypertension, Diabetes, Dyslipidemias

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having signed an informed Consent Patients aged from 18 to 80 years old at the time of identification At least six and at most 24 months elapsed between the index event (the recruiting diagnostic or treatment criteria below) and the date of interview Patients meeting the recruiting diagnostic or treatment criteria: High CVD risk patients: patients free of CVD, who have been prescribed one or more of the following treatments: blood pressure and/or lipid-lowering and/or glucose lowering (diet and/or oral hypoglycaemic agents) Exclusion Criteria: Patients living outside defined geographical area (Assiut Governorate)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| the incidence of Cardiovascular disease | occurrence of any cardiovascular affection | 18 months |
Subcutaneous Administration of Teplizumab in Adults With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of subcutaneously administered teplizumab in adults with relatively recent onset T1DM, greater than 12 weeks and less than 52 weeks of presentation of first signs and symptoms of disease to a physician prior to randomization.

Official Title
-----------------
A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Subcutaneously Administered Teplizumab (MGA031) in Adults With Type 1 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: teplizumab or placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Randomization after 12 weeks but within 12 months from first doctor visit for symptoms or signs of diabetes Diagnosis of type 1 diabetes mellitus Currently receiving insulin therapy Detectable fasting or stimulated C-peptide level at screening One positive autoantibody test result at screening: Islet-cell autoantibodies (ICA512)/islet antigen-2 (IA-2),Glutamic acid decarboxylase (GAD) autoantibodies, or Insulin autoantibodies Exclusion Criteria: Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial Previous treatment with monoclonal antibody Current treatment with oral antidiabetic agents Evidence of active infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Segment 1: 3 Arms<br> | Drug: teplizumab or placebo<br>* infusion or injection<br>|
| Experimental: Segment 2: 4 Arms<br> | Drug: teplizumab or placebo<br>* infusion or injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose regimen | Define and evaluate dose regimen based on AEs, PD response and drug levels. | 91 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 1 Diabetes Mellitus, T1DM
The Effects of Intraoperative Dexmedetomidine Infusion on Postoperative Bowel Movement in Patients Undergoing Laparoscopic Gastrectomy

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesized that sympatholytic effect of dexmedetomidine would attenuate the hemodynamic instability and decrease in the splanchnic blood flow caused by pneumoperitoneum during laparoscopic surgery. This study is to investigate the effect of intraoperative dexmedetomidine infusion on postoperative bowel movement in patients undergoing laparoscopic gastrectomy.

Conditions
-----------------
Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy

Intervention / Treatment
-----------------
* Drug: the dexmedetomidine group
* Drug: the control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient between 20 and 65 of age with ASA physical status Ⅰ-Ⅲ gastric cancer patient undergoing laparoscopic gastrectomy Exclusion Criteria: ASA physical status Ⅳ bradycardia (< 60 bpm), arrhythmia uncompensated heart failure hepatic failure (Child-Pugh score B 이상) renal failure (eGFR MDRD < 60 ml/min/1.73m2)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexmedetomidine group<br> | Drug: the dexmedetomidine group<br>* the dexmedetomidine group: dexmedetomidine infusion from induction of anesthesia to end of surgery<br>|
| Placebo Comparator: control group<br> | Drug: the control group<br>* saline infusion from induction of anesthesia to end of surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gas passing | To evaluate the postoperative bowel movement, we will assess the time to first gas passing | up to 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sips of water time | To evaluate the postoperative bowel movement, we will assess the time to resume water intake | up to 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative bowel movement, laparoscopic gastrectomy, dexmedetomidine
System Accuracy of a Blood Glucose Monitoring System GlucoSpark/GlucoScore

Study Overview
=================
Brief Summary
-----------------
This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO 15197

Detailed Description
-----------------
This study assesses the system accuracy the blood glucose monitoring systems for personal use GucoSaprk/GlucoScore as outlined in DIN EN ISO 15197:2015.

Official Title
-----------------
Evaluierung Der Systemgenauigkeit Des Blutglucosemonitoring Systems GlucoSpark / GlucoScore gemäß DIN EN ISO 15197:2015.

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Diagnostic Test: Glucometer Test
* Diagnostic Test: blood glucose measurement, laboratory reference device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients with clinical indication for blood glucose testing Signed form of consent Minimum age of 18 years Subjects are legally competent and capable to understand character, meaning and consequences of the study Exclusion Criteria: Pregnancy or lactation Severe acute disease (at study physician's discretion) Acute or chronic diseases with inherent risk of aggravation by the procedure (at study physician's discretion) Current constitution that does not allow participating in the study (e.g. hematocrit out of the devices's specifications, medication known to influence blood glucose measurements; Appendix A of ISO 15197) Being unable to give informed consent Age younger than 18 years Legally incompetent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: Subject glucometer measurement<br> | Diagnostic Test: Glucometer Test<br>* measurement of the blood glucose concentration using the blood glucose monitor for personal use<br>Diagnostic Test: blood glucose measurement, laboratory reference device<br>* measurement of the blood glucose concentration using a laboratory reference device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of system accuracy based on DIN EN ISO 15197 | Assessment of the analytical measurement performance of the blood glucose monitor based on procedures defined in DIN EN ISO 15197 | Day 1 |
Safety and Efficacy Study of Imexon for Treatment of Multiple Myeloma Patients

Study Overview
=================
Brief Summary
-----------------
AMP-007 is a Phase 1/2 study for the treatment of advanced, previously treated multiple myeloma. The first phase of the study is designed to determine a safe dose of imexon that can be given to patients with advanced, previously-treated multiple myeloma. The Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether imexon can improve the outcome for patients with multiple myeloma

Official Title
-----------------
A Phase 1/2 Trial of Amplimexon® (Imexon, Inj.) for Patients With Previously Treated Multiple Myeloma

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

Intervention / Treatment
-----------------
* Drug: imexon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced myeloma, with measurable disease as defined in the protocol. Prior treatment, at least 2 prior regimens are required. This may include prior treatment with investigational products. Able to perform the activities of daily living. Off prior therapy for at least 2-4 weeks depending on the drug. Blood counts and blood chemistries in or near normal range. If female, neither pregnant nor nursing. Willing to use contraceptives to prevent pregnancy. No other serious illnesses. No other active malignancy. No serious infections. No current other drug therapy for the myeloma except for steroid therapy under certain circumstances. Biphosphonate therapy is permitted. Prior radiation is permitted. Exclusion Criteria: Use of corticosteroids for amyloid disorders, or high dose chronic steroids.

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

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the maximally tolerated dose of imexon in multiple myeloma patients |  |  | 
| evaluate the toxicity of imexon |  |  | 
| Preliminarily evaluate efficacy in terms of response and progression free survival. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate biomarker responses. |  |  |