linjc16/ctgov huggingface dataset:
Preliminary Survey in Preparation for the Implementation of ERAS at Dr Soetomo Hospital

Study Overview
=================
Brief Summary
-----------------
This study aims to analyze the readiness of the team that will support the ERAS application at Regional General Academic Hospital Dr Soetomo.

Detailed Description
-----------------
This is an observational analytic study with a cross-sectional design using a questionnaire. Patient baseline data were taken from the examination at the anesthesiology outpatient clinic. The patient's level of understanding was assessed by two investigators and rated on a scale of 1 to 5. Primary data and assessment of understanding of doctors and medical personnel were filled in independently by research subjects on online forms and rated on a scale of 1 to 5.

Official Title
-----------------
Preliminary Survey in Preparation for the Implementation of ERAS at Dr Soetomo Hospital

Conditions
-----------------
ERAS

Intervention / Treatment
-----------------
* Procedure: ERAS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with elective cesarean, urology, and simple orthopaedic surgery plans Patient with PS ASA 1-2 Exclusion Criteria: Patients with communication disorders / mental disorders Patients with outpatient surgery plans
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient<br>Patient baseline data were taken from the examination at the anesthesiology outpatient clinic. (N=41) | Procedure: ERAS<br>* This study is a cross-sectional observational study by distributing questionnaires regarding the readiness to implement ERAS at Dr Soetomo General Hospital to the subjects, so there is no treatment whatsoever on the subjects.<br>|
| Doctor<br>Consists of specialist and resident anesthesiology, orthopaedic surgery and traumatology, obstetrics and gynaecology, urology. (N=110) | |
| Healthcare worker<br>Consists of nutritionists, pharmacists, surgical nurses, anesthesiologists, and recovery room nurses.(N=56) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of understanding (using questionnaire) | This outcome is reported by a score on a scale. The minimum value is one, and the maximum value is five. Higher scores mean better outcomes. Scale title: Strongly don't understand Don't understand Neutral Understand Strongly understand | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ERAS, Intraoperative care, Perioperative care, Preoperative care, Surgery
Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies (Extension)

Study Overview
=================
Brief Summary
-----------------
The purpose of this extension study is to evaluate the potential inhibitory effects of patupilone on metabolism using midazolam and omeprazole as the respective probe drugs.

Official Title
-----------------
An Open Label Phase I Study to Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies (Extension)

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Drug: Patupilone
* Drug: Patupilone + Omeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Male or female patients 18 years or older Histologically documented advanced solid tumor, who have failed standard systemic therapy, or for whom standard systemic therapy does not exist Completed the Core study Completed all sampling in the core and not dose reduced Patients with adequate hematologic parameters Exclusion criteria: Female patients who are pregnant or breast-feeding. Patients with a severe and/or uncontrolled medical disease Patients with a known diagnosis of human immunodeficiency virus (HIV) infection Patients having received an investigational agent within 30 days prior to study entry Other protocol-defined inclusion/exclusion criteria may apply

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patupilone + Midazolam<br> | Drug: Patupilone<br> <br> |
| Experimental: Patupilone + Omeprazole<br> | Drug: Patupilone + Omeprazole<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety, tolerability and potential activity of patupilone once every 21 days in patients that completed the core study |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of objective response and tumor evaluation will be based on the response evaluation criteria in solid tumors (RECIST) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, EPO906, Patupilone
Subcutaneous Adaption and Cosmetic Outcome Following Caesarean Delivery

Study Overview
=================
Brief Summary
-----------------
This is a double blinded randomized study investigating if subcutaneous adaption has an impact on cosmetic outcome after Caesarean delivery.

Conditions
-----------------
Caesarean Delivery

Intervention / Treatment
-----------------
* Procedure: subcutaneous adaption


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women undergoing cesarean section for any indication literate in german language Exclusion Criteria: history of keloids previous transversal suprapubic scars known patient hypersensitivity to any of the suture materials used in the protocol a medical disorder that could affect wound healing (eg, diabetes mellitus, chronic corticosteroid use)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: wound closure with subcutaneous adaption<br> | Procedure: subcutaneous adaption<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective and subjective cosmetic appearance |  | after 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection and wound breakdown |  | within 30 days after surgery | 
| Haematoma |  | within 5 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cosmetic outcome, Wound closure
Frailty and the Elderly in Martinique

Study Overview
=================
Brief Summary
-----------------
This was a prospective multicenter cohort study of elderly people admitted to the acute care for elders in Martinique. They were followed up to 36 months. It aimed to study the adverse outcomes. In all, 287 subjects were included. They were 85+/-6 years, and mainly women (61%).

Detailed Description
-----------------
The SAFMA cohort was an ad hoc study formed into the recruitment of the acute care for elders in the geriatric department of Martinique university Hospitals. The inclusion of subjects ran from January 1st 2012 to June 30th 2012. To be eligible, patients had to be 75 or over and hospitalised for acute condition. Each patient was visited by a specialist in geriatrics familiar with the survey procedures. In the course of this interview, patients were informed about the study, prior to signing the consent form. If the clinical status and/or the cognitive status of the patient did not enable informed consent, the interviewer referred to the subject's representative. Follow-up was performed by visits and telephone interview till 36 months.

Official Title
-----------------
Frail Elderly Subjects Martinique: Adverse Outcome After Hospitalisation in Geriatric Department

Conditions
-----------------
Elderly People With Polypathology or Disabilities

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 75 years or over Admitted to acute care for elders Consent to participate Exclusion Criteria: Impossibility to perform the tests Refusals to participate

Ages Eligible for Study
-----------------
Minimum Age: 75 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 |
| --- | --- | --- |
| Mortality |  | 6 weeks | 
| Nursing home admission |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 6 month | 
| Mortality |  | 12 month | 
| Mortality |  | 24 month | 
| Mortality |  | 36 month | 
| Nursing home admission |  | 6 month | 
| Nursing home admission |  | 12 month | 
| Nursing home admission |  | 24 month | 
| Nursing home admission |  | 36 month |
Preoperative Use of Alprazolam and Hydroxyzine in Anxiety

Study Overview
=================
Brief Summary
-----------------
Patients will be divided into three groups. Group H patients will be given 100 mg Hydroxyzine orally 1 hour before surgery while group A patients will receive 0.5 mg Alprazolam orally. group P will be placebo group. Amsterdam Preoperative Anxiety and Knowledge Scale (APAIS) anxiety scores will be evaluated and recorded 1 hour before surgery. APAIS score will be evaluated again in the the operation room before surgery started. After base measurements of patients are recorded with standard monitoring, spinal block will be performed with 15 mg Heavy Bupivacaine from the L2-L3 or L3-L4 levels of spinal cord in sting position. When T10 level sensory block and Bromage 0-1 neuromusculer block will be occured , surgery will be started. Heart rate, non-invasive arterial blood pressure and the degree of peripheral O2 saturation will be measured at 5 minutes interval throughout the operation. IOWA anesthesia satisfaction scale will also performed to the patients the day after the surgery.

Official Title
-----------------
The Effect of Hydroxyzine and Alprazolam Premedication on Preoperative Anxiety and Patient Satisfaction

Conditions
-----------------
Agitation on Recovery From Sedation

Intervention / Treatment
-----------------
* Drug: Hydroxyzine Hydrochloride
* Drug: Alprazolam tablet
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sacrococcygeal dermoid cyst patients Saceptance of spinal anaesthesia between 18-60 years old patients ASA I-II Exclusion Criteria: drug allergy BMI>35kg/m2 psychiatric disorders serious renal and hepatic damage coagulation disorders serious cardiac and respiratory disorderders rejection of spinal anesthesia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: alprazolam<br> | Drug: Alprazolam tablet<br>* Alprozolam is given to the patient one hour before surgery.<br>|
| Experimental: hydroxyzine<br> | Drug: Hydroxyzine Hydrochloride<br>* Hyroxyzine hydrochloride is given to the patient one hour before surgery.<br>|
| Placebo Comparator: control<br> | Drug: Placebo<br>* Placebo candy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preopartive anxiety | Amsterdam Preoperative Anxiety and Information Scale (APAİS) (between 0-30) | 1 hour later orally admition of drugs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | IOWA pation satisfaction scale (between 9-54) | 24 hours after surgery |
A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Japan. The aim of this clinical trial is to investigate the effect of NN1250 (insulin degludec) in Japanese subjects with type 1 diabetes.

Official Title
-----------------
A Trial Investigating the Pharmacodynamic Properties of NN1250 in Japanese Subjects With Type 1 Diabetes

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

Intervention / Treatment
-----------------
* Drug: insulin degludec
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months Current daily basal insulin requirement above or equal to 0.3 (I)U/kg/day Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0% (one retest within a week is permitted with the result of the last test being conclusive) Exclusion Criteria: Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to screening Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period (only clamp period)

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: insulin degludec<br>* NN1250 (insulin degludec) injected s.c. (under the skin) once daily for 6 days<br>|
| Active Comparator: B<br> | Drug: insulin detemir<br>* Insulin detemir injected s.c. (under the skin) once daily for 6 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the NN1250 GIR (glucose infusion rate) curve |  | During one dosing interval at steady state | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin detemir concentration-time curve |  | During one dosing interval at steady state |
Combination With Treg Levels and CMR to Assess the Severity and Prognosis of Reperfusion Injury After PPCI in STEMI Patients

Study Overview
=================
Brief Summary
-----------------
This study aims to determine whether combination with regulatory T cell (Treg) levels and cardiac magnetic resonance imaging (CMR) are predictive of the severity of reperfusion injury following myocardial infarction and the prognosis in STEMI patients receiving primary percutaneous coronary intervention (PPCI).

Official Title
-----------------
Combination With Regulatory T Cell Levels and Cardiac Magnetic Resonance Imaging (CMR) to Assess the Severity and Prognosis of Reperfusion Injury After Primary PCI in STEMI Patients (TregCMRRS)

Conditions
-----------------
STEMI - ST Elevation Myocardial Infarction, Reperfusion Injury, Myocardial

Intervention / Treatment
-----------------
* Other: Treg levels and CMR results


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed STEMI diagnosis Undergoing primary percutaneous coronary intervention (presenting <12 hours after symptom onset) Patients were able to complete cardiac magnetic resonance imaging (CMR) and speckle tracking imaging echocardiogram (STE) examinations Patients agreed and provided informed consent Exclusion Criteria: Previous myocardial infarction or revascularization (PCI or CABG) Congestive heart failure with LVEF<40% Atrial fibrillation Renal insufficiency (GFR < 30 ml/min/1.73m^2) Acute infectious diseases within nearly 3 months Rheumatic immune system diseases Malignant tumors Claustrophobia Contraindicated to CMR Patients do not agree to be included in the study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participates<br> | Other: Treg levels and CMR results<br>* This is an observational study. Exposure: Different Treg levels and CMR results.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE (major adverse cardiovascular events) | nonfatal or fatal myocardial infarction, revascularization, cardiac death, nonfatal or fatal stroke, all cause of death | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse cardiac remodeling | a cut-off value of 12% change in left ventricular end-diastolic volume between the acute and follow-up magnetic resonance scans | 6 months |
Pathomolecular Analysis of Rare EGFR Mutations in Advanced NSCLC

Study Overview
=================
Brief Summary
-----------------
While current mutational analyses comprise exons 19 and 21 in which the majority of EGFR-mutations occur, this study aims at investigating the relevance of exon 18 and 20 mutations. Therefore, the investigators analyse 500 routine tumor samples with respect to the above mentioned exons and correlate the results to the clinical outcome. This approach will enable us to potentially identify patients that might in the future benefit from targeted therapy (EGFR-inhibition).

Conditions
-----------------
Mutations in Exons 18 to 21

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NSCLC Stadium III-IV Exclusion Criteria: no NSCLC or different stadium
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NSCLC Stadium III-IV<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Mechanistic Clinical Trial of Advanced Imaging for CRT

Study Overview
=================
Brief Summary
-----------------
This is a mechanistic clinical trial with randomization to guidance for the CRT procedure using cardiac magnetic resonance (CMR) and computed tomography angiography (CTA) versus a standard procedure.

Detailed Description
-----------------
At baseline, patients will have CMR, CTA, echocardiography, blood testing, and cardiopulmonary exercise testing. They will also complete a heart failure questionnaire. In patients randomized to CMR guidance for the CRT procedure, LV lead placement will be guided by the MRI information related to scar, activation and anatomy. Patients will have follow-up assessments at 6 and 12 months. There will also be clinical follow-up for survival free of appropriate ICD therapies over 3 years.

Official Title
-----------------
Advanced Imaging and Inflammatory Markers to Define Mechanisms of Response to CRT

Conditions
-----------------
Heart Failure, Systolic

Intervention / Treatment
-----------------
* Diagnostic Test: CMR/CTA Guidance for CRT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic systolic HF LVEF 35% or less Guideline-based class I or II indication for CRT Exclusion Criteria: Inability to provide informed consent Pregnancy Presence of metal embedded in the body due to prior accident or injury, as documented by skull films or other imaging Cerebral aneurysm clips Cochlear implants Other metallic implants known to be contraindications to CMR (does not include pacemakers and ICDs) Severe claustrophobia Acute kidney injury Acute renal failure or chronic kidney disease with GFR < 45 cc/min/1.73m2 Liver transplant Gadolinium allergy >10% premature ventricular contraction (PVC) burden; and 13) estimated >10% atrial fibrillation (AF) burden based on available clinical data.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>CMR-Guided CRT | Diagnostic Test: CMR/CTA Guidance for CRT<br>* The intervention is the use of CMR and CTA to determine the optimal pacing site in the left ventricle for cardiac resynchronization therapy (CRT) and guide left ventricular lead placement.<br>|
| No Intervention: Control<br>Standard CRT | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular end-systolic volume (LVESV) improvement | Change in LVESV with cardiac resynchronization therapy (CRT) | One Year |