linjc16/ctgov huggingface dataset:
Evaluation of the Reliability and Usability of the Reusable BrownieForSymphony Pump Set

Study Overview
=================
Brief Summary
-----------------
The primary objectives of this study is to evaluate how professionals rate the reliability and usability of the reusable BrownieForSymphony pump set.and the current used Symphony pump set 4.2 Secondary Objectives The secondary objectives of this study are: to evaluate the rate of usability problems with the BrownieForSymphony pump set to evaluate the pragmatic quality (task/goal fulfilment) of the BrownieForSymphony pump set to evaluate first impression of lactating woman regarding pumping with the BrownieForSymphony pump set

Detailed Description
-----------------
This is a 5 day case study to evaluate the reliability and usability of the BrownieForSymphony pump set. The study consists of two different participant groups, professionals (e.g. lactation consultants, nurses) and lactating women.

Official Title
-----------------
ESP Evaluation of the Reliability and Usability of the Reusable BrownieForSymphony Pump Set

Conditions
-----------------
Lactation

Intervention / Treatment
-----------------
* Device: BrownieForSymphony use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized lactating woman >18 years which are pumping breast milk Exclusion Criteria: hospitalized lactating woman has a medical indication for pumping (e.g. Mastitis, cracked nipples) lactating woman used a breast shield size >27 and <24

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: BrownieForSymphony use<br>Each participant will use the BrownieForSymphony pumpset | Device: BrownieForSymphony use<br>* Professional will use the BrownieForSymphony Pumpset in their daily work. hospitalized lactating woman will pump with the BrownieForSymphony Pumpset<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability Scale (SUS) Symphony Pumpset usability | Rating of the Usability of the Symphony Pumpset | day at inclusion | 
| Usability Scale (SUS) BrownieForSymphony Pumpset usability | Rating of the Usability of the BrownieForSymphony Pumpset | after 5 days |
Imatinib + MTC in Relapsed / Refractory Acute Myeloid Leukemia (AML)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to show superiority in complete responses of combination therapy MTC plus Glivec in patients with refractory or relapsed AML compared to a historical control which was treated with MTC alone.

Official Title
-----------------
Open-label Multicenter Trial of Glivec® (Imatinib Mesylate, Formerly Known as STI571) in Combination With Chemotherapy (MTC) in Patients With Refractory or Relapsed Acute Myeloid Leukemia (AML)

Conditions
-----------------
AML

Intervention / Treatment
-----------------
* Drug: Glivec
* Drug: Mitoxantrone
* Drug: Topotecan
* Drug: AraC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Refractory AML after primary therapy First relapse after a safe previous diagnosis of de novo or secondary AML Age > 18 years Serum bilirubin < 2.0 mg/dl Serum creatinine < 1.5 times the normal value or a creatinine clearance > 60 ml/min ECG and heart echography prior to start of therapy without severe findings Overall condition < 2 according to ECOG criteria Life expectancy > 6 weeks Written informed consent by patients with full legal capacity Exclusion Criteria: Serious secondary disease (clinically relevant cardiac disease, chronic- obstructive pulmonary disease, hepatic dysfunction, renal insufficiency) Active secondary neoplasia (exception: adequately treated basalioma or epidermoid cancer and cervical carcinoma) Known hypersensitivity to topoisomerase-I inhibitors Overall condition > 2 according to ECOG criteria Pregnant/breast feeding women Serious intercurrent infections

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: Glivec|nan|
|Drug: Mitoxantrone|nan|
|Drug: Topotecan|nan|
|Drug: AraC|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To show superiority in complete responses of combination therapy MTC plus Glivec in patients with refractory or relapsed AML compared to a historical control which was treated with MTC alone. |  |  |
Complicated Appendicitis During the COVID-19 Pandemic in Jordan

Study Overview
=================
Brief Summary
-----------------
Comparing the incidence of complicated appendicitis between two groups, the pandemic and pre-pandemic groups.

Detailed Description
-----------------
The investigators have retrospectively investigated data on acute appendicitis cases. Two groups were established, the first group was the pandemic group, which included patients who presented to the hospital during the period of acute restrictions and shutdowns extending from the 17th of March to the 6th of June 2020, and the pre-pandemic group which represents the same period in the previous year, the aim was to assess the incidence of complicated appendicitis during the COVID-19 pandemic in Jordan University Hospital

Official Title
-----------------
Impact of the COVID-19 Pandemic on the Incidence of Complicated Appendicitis in a Tertiary Medical Center, Amman, Jordan: A Retrospective Cohort

Conditions
-----------------
COVID-19, Complicated Appendicitis

Intervention / Treatment
-----------------
* Other: Observational Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient that presented with appendicitis and underwent an appendectomy at the university of Jordan hospital during the specified time periods (March 2019-December 2020) Exclusion Criteria: Incomplete data record.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pandemic group (2020)<br>includes patients who presented to the hospital during the period of acute restrictions and shutdowns extending from the 17th of March to the 6th of June 2020 | Other: Observational Study<br>* Observational Study; the study did not involve any interventions<br>|
| pre-pandemic group (2019)<br>which represents the same period in the previous year | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of postoperative complications | To determine if there were any complications, this was detected by reviewing the histopathology report | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of in-hospital stay | How many days did the patient spend in the hospital until discharged. | Up to 2 years | 
| Imaging method used for diagnosis (CT or US) | How was appendicitis diagnosed, either by using Computed Tomography (CT) Scan or Ultrasound. | Up to 2 years | 
| Type of operation (open or laparoscopic) | We reported what type of operation the patient underwent to treat appendicitis. | Up to 2 years |
Multi-Center Registry Trial of EXCEL Biodegradable Polymer Drug-Eluting Stent

Study Overview
=================
Brief Summary
-----------------
The trial aims to evaluate 12-month long-term efficiency of Excel stent in the treatment of coronary heart disease and inhibition of restenosis after coronary artery stenting as well as a 12 months' long-term safety after the cessation of clopidogrel as an anti-platelet drugs used for 6 months after the implantation of degradable drug coating stent.

Official Title
-----------------
Multi-Center Registry Trial of EXCEL Biodegradable Polymer Drug-Eluting Stent

Conditions
-----------------
AMI

Intervention / Treatment
-----------------
* Device: Excel drug-eluting coronary artery stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who should be full fill the criteria of using Excel stent. Each included patient should allowed to use Excel stent. Complete revascularization can be achieved through one invasive operation. Exclusion Criteria: Patient do not suitable to use Excel stent, for example, not tolerant to anti-platelet drug or undergo cardiac/non-cardiac surgery recently. Patient with multiple branch lesions, thus the single Excel stent cannot resolve the condition. NYH Cardiac functional grading>3 or Echocardiography LVEF<0.3. Patient with complete revascularization cannot be resolved by one operation.
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 |
| --- |
|Device: Excel drug-eluting coronary artery stent|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE(Major adverse cardiac events) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE |  | 30 days and 6 months |
BRInging the Diabetes Prevention Program to GEriatric Populations - PILOT

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to test the feasibility of implementing a telehealth adaption of the Diabetes Prevention Program (DPP) intervention among 30 NYC senior center members. The intervention will be conducted through 6 weekly webinars with a certified DPP coach. Participants will receive a binder and physical activity tracker to complete self-monitoring of diet and physical activity. The primary outcome is feasibility and acceptability of the intervention measured by workshop attendance and focus group feedback. Secondary outcomes include changes in diet, physical activity, and weight.

Official Title
-----------------
BRInging the Diabetes Prevention Program to GEriatric Populations(BRIDGE): a Pilot Study to Test the Usability and Effectiveness of a Telehealth Adaption of the Diabetes Prevention Program (DPP) in a Community of Older Adults

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Behavioral: 6 Week Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women age ≥ 60 years Diabetes Risk Score >=5 Exclusion Criteria: Decisional incapacity to consent

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetes Prevention Program (DPP)<br>Live stream the first six sessions of the Diabetes Prevention Program (DPP) curriculum to Senior Planet on a weekly basis, The webinars will be about 1 hour long, led by a certified DPP educator, and live-streamed to the senior center. Participants will have weekly weigh-ins and meet with a research assistant led focus group following two out of the six sessions to discuss program acceptability. | Behavioral: 6 Week Intervention<br>* Weekly interactive webinars based on the DPP curriculum at senior center.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Program engagement | calculated by subtracting attending study visits from those enrolled | 8 Weeks |
A Research Study to Compare the Treatments of a Combination of Elzasonan With Zoloft, to Zoloft Alone, or Placebo in People With Major Depressive Disorder (MDD)

Study Overview
=================
Brief Summary
-----------------
The major purpose of the study is to help determine whether giving the combination of Elzasonan with Zoloft to people with depression is a better treatment than taking Zoloft alone. This study will also compare the safety and tolerability of Elzasonan and Zoloft combination to Zoloft alone or placebo.

Official Title
-----------------
An Eight-Week, Double-Blind, Group-Sequential Design, Placebo Controlled Trial To Evaluate The Safety And Efficacy Of The Co- Administration Of Sertraline And Elzasonan (CP-448,187) In Outpatients With Major Depressive Disorder

Conditions
-----------------
Depressive Disorder, Major

Intervention / Treatment
-----------------
* Drug: Sertraline and Elzasonan Combination
* Drug: Sertraline
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult subjects, 18 years of age or older with a diagnosis of recurrent, moderate-to-severe MDD without psychotic features (DSM-IV 296.3x, with a HAMD17 score >= to 22 and CGI-S >=4. MDD must be the primary psychiatric disorder that motivated the subject to seek treatment and the current episode must be at least 1 month in duration but no longer than 6 months in duration. Exclusion Criteria: Subjects who, in the investigator's judgement, would require treatment with electroconvulsive therapy (ECT), or antipsychotics, or would require a change in intensity of psychotherapy, or subjects who would require treatment with any other psychotherapeutic drugs during the course of the trial. Subjects who have ever been diagnosed with Panic Disorder, Post-Traumatic Stress Disorder, Obsessive-Compulsive Disorder, Bipolar Affective Disorder, Schizophrenia, Schizoaffective Disorder or othe Psychotic Disorder, MDD with a seasonal pattern, or Dissociative Disorders per DSM-IV criteria.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sertraline and Elzasonan Combination|nan|
|Drug: Sertraline|nan|
|Drug: Placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The estimated treatment difference (elzasonan plus sertraline - sertraline monotherapy) in MADRS (Montgomery-Asberg Depression Rating Scale) remission rates at Week 8 in patients with MDD. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in: MADRS, CGI-I, CGI-S, HAMA, HAMD17, CSFQ, SOS-10 and PGID-D total scores at Week 8. Treatment differences in MADRS response rates at Week 8. |  |  |
Mathematical Modeling and Risk Factor Analysis for Mortality of Sepsis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate the risk factors for mortality of sepsis and to create mathematical models to predict the survival rate based on electronic health records that extracted from hospital information system. More than 1000 records should be collected and used to data analysis. Univariate and multivariable logistic regression model were applied to risk factors analysis for the outcome, and machine learn algorithms were employed to generate predictive models for the outcome.

Official Title
-----------------
Mathematical Modeling and Risk Factor Analysis for Mortality of Sepsis Based on Real World Data in China

Conditions
-----------------
Morality, Risk Factor, Sepsis, Predictive Model

Intervention / Treatment
-----------------
* Other: regular medical treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all records with sepsis in emergence department of hospitals Exclusion Criteria: subjects with major missing data

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 99 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 |
| --- | --- |
| mortality of sepsis<br>the study sample would be extracted from electronic health records in emergence departments. risk factor analysis and mathematical modeling would be performed to evaluate the significant and independent risk factors and predictive models. | Other: regular medical treatment<br>* regular medical treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality of sepsis | mortality of sepsis | 4 weeks |
Safety and Tolerability of ASA404 Administered in Combination With Docetaxel in Japanese Patients With Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This study will assess the tolerability of combination therapy with ASA404 and docetaxel in Japanese patients with advanced or recurrent solid tumors.

Official Title
-----------------
A Safety, Tolerability Study of Intravenous ASA404 Administered in Combination With Docetaxel in Japanese Patients With Advanced or Recurrent Solid Tumors

Conditions
-----------------
Advanced or Recurrent Solid Tumors

Intervention / Treatment
-----------------
* Drug: vadimezan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with confirmed solid tumors whose disease has progressed or recurred after treatment at lease one therapy, except docetaxel WHO Performance Status of 0-1 Exclusion Criteria: Patients having symptomatic CNS tumor/metastasis and requiring treatment Patients who have received prior therapy with ASA404 or other vascular disrupting agents Patients with systolic BP > 160mmHg and/or diastolic BP > 90mmHg Patients with fluid retention Patients with any one of cardiotoxicities Concomitant use of drugs with a risk of prolonging the QT interval Known allergy or hypersensitivity to taxane or polysorbate 80 Other protocol-defined inclusion/exclusion criteria may apply

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASA404<br> | Drug: vadimezan<br> <br> * Other names: ASA404;|

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
-----------------
ASA404,, vadimezan,, docetaxel
Mitral Doppler as a Predictor of Respiratory Worsening After Vascular Filling

Study Overview
=================
Brief Summary
-----------------
Interventional study of the accuracy of a non-invasive testing by echocardiography to predict respiratory worsening after vascular filling.

Detailed Description
-----------------
Mitral Doppler will be performed before vascular filling. Patients will be classified in two groups (normal or high cardiac filling pressure). The evolution of the respiratory data (SpO2/FiO2) of the two groups of the patients before and after vascular filling will be compared.

Official Title
-----------------
Assessment of Mitral Doppler as a Predictor of Respiratory Worsening After Vascular Filling for ICU Patients With Mechanical Ventilation. The EVALDM Study

Conditions
-----------------
Respiration, Artificial, Vascular Filling, Echocardiography

Intervention / Treatment
-----------------
* Diagnostic Test: mitral doppler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mechanical ventilation And hemodynamic failure And decision of the attending physician to perform a vascular filling Exclusion Criteria: Pregnancy and breast-feeding women Patients deprived of their administrative or judicial freedom

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: Mitral doppler<br>Mitral doppler before and after vascular filling | Diagnostic Test: mitral doppler<br>* Mitral doppler before and after vascular filling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of the occuring of premature degradation respiratory | definied by a reduction of at least 15% of the SpO2/FiO2 ratio in the 30min following the vascular filling | 30 minutes after vascular filling |