linjc16/ctgov huggingface dataset:
Retrospective Study of Patients With Type 2 Diabetes Mellitus on Dapagliflozin Therapy in Taiwan

Study Overview
=================
Brief Summary
-----------------
Retrospective Study of Patients With Type 2 Diabetes Mellitus on Dapagliflozin Therapy in Taiwan.

Official Title
-----------------
Retrospective Study of Patients With Type 2 Diabetes Mellitus on Dapagliflozin Therapy in Taiwan

Conditions
-----------------
Type II Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatient equal to or more than 20 years of age. T2DM patient initiated dapagliflozin after May 1st 2016 as a second line or third line oral anti-diabetic therapy, either as add-on or switching from one to another. Or initiating dapagliflozin as adjunctive therapy for T2DM subjects treated with insulin. Completed follow-up of at least 6 months regardless of continuation on dapagliflozin therapy. Will provide completed and signed written informed consents. Exclusion Criteria: Subjects with a history of SGLT2 inhibitor therapy other than dapagliflozin prior to Baseline. Subjects with Type 1 diabetes. Treatment with other investigational drugs concurrently during the retrospective data collection period.

Ages Eligible for Study
-----------------
Maximum Age: 99 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 |
| --- | --- | --- |
| Change in HbA1c | To assess the change from baseline (time to initiate dapagliflozin*) in HbA1c at 6 months | 6 months |
A Study to Evaluate ICU Simulation Experience in the Cardiothoracic Surgical Population to Reduce Post-operative Delirium

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of a pre-ICU admission virtual reality ICU simulation on post-operative delirium in the elective cardiothoracic surgical population while in the intensive care unit.

Official Title
-----------------
Pre-operative, Multi-sensory ICU Simulation Experience to Reduce Post-operative Delirium in the Cardiothoracic Surgical Population

Conditions
-----------------
Post-Operative Delirium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Baseline normal neurological function pre-operatively. Planned use of mechanical ventilator with endotracheal tube post-operatively after planned cardiothoracic surgical procedure. Exclusion Criteria: Chronic dementia, Alzheimer's disease, or other chronic neurological disease (i.e., Bi-Polar). Chronic use of neurological altering medications such as benzodiazepines, psychotropic, anti-depressants, anxiolytics. Patient undergoing emergent surgery. Use of post-operative cardiopulmonary support devices such as ECMO (extracorporeal membrane oxygenation), intra-aortic balloon pump, total artificial heart, or other similar device.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAM-ICU | Confusion Assessment Method for the ICU - Metric of delirium in the intensive care unit. | Once, during ICU admission within 24 hours of ICU admission. | 
| Subjective experiential outcome after ICU simulation | Survey questions to understand patient's subjective experience during the virtual reality ICU simulation session. | Once, immediately following the virtual reality ICU simulation session. | 
| Subjective experiential outcome after ICU admission | Survey questions to understand patient's subjective experience in the intensive care unit. | Once, up to 3 days after transfer out of the Intensive Care Unit. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of ICU admission | Number of hours in the intensive care unit | During ICU admission; average 2 days | 
| Duration of intravenous sedation in the ICU | Number of hours of intravenous sedation in the ICU | During ICU admission; average 2 days | 
| Duration of mechanical ventilation in the ICU | Number of hours of mechanical ventilation in the ICU | During ICU admission; average 2 days | 
| Use of anti-psychotic medications | Number of administrations of anti-psychotic medications in the ICU | Throughout ICU admission; average of 5 days | 
| Cardiopulmonary Bypass | Number of hours of use of cardiopulmonary bypass in the operating room | During OR case; average 12 hours |
Immature Myeloid Cells in Respiratory Syncytial Virus Bronchioliltis

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that Respiratory Syncytial Virus (RSV) infection may influence the population of lung immature myeloid cells and dendritic cells in a way that will impair their ability to invoke an effective immune response and lead to prolonged inflammation, angiogenesis and scarring. This may lead in turn to disturbed lung function. Our aim is to determine the presence and phenotype of immature myeloid cells present in respiratory secretions of children with RSV bronchiolitis as compared to non-RSV bronchiolitis and healthy controls.

Conditions
-----------------
Bronchiolitis

Intervention / Treatment
-----------------
* Other: Respiratory secretions obtained


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bronchiolitis Exclusion Criteria: Chronic disease

Ages Eligible for Study
-----------------
Maximum Age: 2 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children Suffering From Bronchiolitis<br>Respiratory secretions obtained from children suffering from Bronchiolitis | Other: Respiratory secretions obtained<br> <br> |
| Healthy Children<br>Respiratory secretions obtained from children with no respiratory infection | Other: Respiratory secretions obtained<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Immature Myeloid Cells in Respiratory Secretions | Respiratory secretions obtained from child presenting with bronchiolitis will be examined for the presence of immature myeloid cells | Participants will be followed for the duration of hospital stay, an expected average of one week |
Abdominal Drainage During Appendicectomy - Resources Down the Drain: A Retrospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
The investigators performed a retrospective review of all patients undergoing appendicectomy from March-November 2018 using the online theatre database and discharge letters. CA was defined as patients with perforated or gangrenous appendicitis on histology. Patients were divided into 2 groups; Group 1 (G1) included patients with CA who had a drain inserted; Group 2 (G2) included patients with CA and no drain.

Official Title
-----------------
Abdominal Drainage During Appendicectomy - Resources Down the Drain: A Retrospective Cohort Study

Conditions
-----------------
Appendicitis

Intervention / Treatment
-----------------
* Procedure: Abdominal drain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients over the age of 16 with complicated appendicitis (CA) were included Exclusion Criteria: Patients with evidence of caecal/ appendicular malignancy were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Patients with complicated appendicitis who had a drain inserted | Procedure: Abdominal drain<br>* A latex-free drain (size 20F)<br>|
| Group 2<br>Patients with complicated appendicitis who did not have a drain inserted | Procedure: Abdominal drain<br>* A latex-free drain (size 20F)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-abdominal abscess |  | Up to 6 months post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Number of days patient in hospital since admission | 8 months - March to November 2018 |
The Prevention of Thromboembolic Complications Associated With Coil Embolization

Study Overview
=================
Brief Summary
-----------------
Clopidogrel has been to be reported to be superior to aspirin for the prevention of thromboembolic complications associated with coil embolization in patients with ruptured aneurysms.

Official Title
-----------------
Coil Embolization and Thromboembolic Complications in Patients With Ruptured Aneurysms

Conditions
-----------------
Clopidogrel, Thromboembolic Stroke, Aspirin, Coil Embolization, Prevention

Intervention / Treatment
-----------------
* Drug: Aspir-Low Pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All the patients enrolled in the study underwent MRI and Angiography. Participants included in the study were confirmed on assessment, and verified for ruptured aneurysm by imaging using either computed tomography (CT) or MRI. Exclusion Criteria: Patients with any history of sensitivity or reaction to aspirin, or any contraindication for MRI, were excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aspirin Group<br>patients were prescribed 75 mg/day of either aspirin for 6 months | Drug: Aspir-Low Pill<br>* patients were prescribed 75 mg/day of either aspirin<br>|
| Clopidogrel Group<br>75mg/day prescribed for 6 months | Drug: Aspir-Low Pill<br>* patients were prescribed 75 mg/day of either aspirin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High Intensity Areas | post procedural | at 24 hours | 
| High Intensity Areas | Post Procedural | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High Intensity Areas | Post procedural | at 6 months |
Study of CP-675,206 in Refractory Melanoma

Study Overview
=================
Brief Summary
-----------------
CP-675,206 is a fully human monoclonal antibody (mAb). It binds to the CTLA4 molecule, which is expressed on the surface of activated T lymphocytes. CP-675,206 is thought to stimulate patients' immune systems to attack their tumors. CP-675,206 is not expected to have a direct effect on tumor cells. CP-675,206 been shown to induce durable tumor responses in patients with metastatic melanoma in Phase 1 and Phase 2 clinical studies.

Official Title
-----------------
A Phase 2, Open Label, Single Arm Study To Evaluate The Efficacy, Safety, Tolerability And Pharmacokinetics Of CP-675,206 In Patients With Advanced Refractory And/Or Relapsed Melanoma

Conditions
-----------------
Refractory Melanoma

Intervention / Treatment
-----------------
* Drug: CP-675,206


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgically incurable Stage III or IV melanoma One prior systemic treatment for metastatic melanoma Measurable disease Eastern Cooperative Oncology Group (ECOG) PS = 0 or 1 Exclusion Criteria: Melanoma of ocular origin Received prior vaccine Received prior CTLA4-inhibiting agent History of, or significant risk for, chronic inflammatory or autoimmune disease Potential requirement for systemic corticosteroids

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: 15 mg/kg CP-675,206<br> | Drug: CP-675,206<br>* 15 mg/kg Q12W dosing regimen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the anti-tumor efficacy, as determined by objective response rate, of intravenous CP-675,206 administered at a dose of 15 mg/kg every 90 days to patients with relapsed or refractory advanced melanoma |  | Tumor response is assessed every 2-3 months until disease progression | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug | 
| Pharmaco Kinetic |  | At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug | 
| Survival |  | At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug | 
| Health-related QoL |  | At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
refractory melanoma, malignant melanoma
The Effect of Occupational Therapy Intervention in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the effect of person-centre occupational therapy intervention on activity performance and quality of life in hemodialysis patients. The results of the study will guide the intervention programs for prevention, coping and improving the quality of life of HD patients.

Official Title
-----------------
The Effect of Person-Centered Occupational Therapy Intervention on Occupational Performance and Quality of Life in Hemodialysis Patients

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Behavioral: Awareness Training and Person-Centered Occupational Therapy Intervention
* Behavioral: Awareness Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed as chronic renal failure. between 18-65 years undergoing HD treatment for at least 1 year Exclusion Criteria: Beck Depression Scale score of 17 or higher

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>Awareness Training | Behavioral: Awareness Training<br>* Exp. General information about HD Approaches to Coping with HD Symptoms Self care skills (eg hygiene)<br>|
| Experimental: Intervention group<br>Awareness Training Person-Centered Occupational Therapy Intervention | Behavioral: Awareness Training and Person-Centered Occupational Therapy Intervention<br>* Exp. identifying the activities the person wants to do, suggestions to facilitate the activity, arranging the activity according to the needs of the person, arranging the environment so that the environment can be a facilitating factor in the activities the person wants to do.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (with a quality of life scale specific to renal patients). | The KidneyDisease Quality of Life (KDQOL-36) consists of the SF-12, which measures physical and mental functioning, Burden of Kidney Disease subscale, Symptoms and Problems subscale, and Effects of Kidney Disease on Daily Life subscale. The scores of theKDQOL-36 questionnaire are transformed into 0 to 100, with higherscores indicating better quality of life.combines the generic SF-36 Health Survey instrument and disease-specific components for assessing the health-related quality of life of | 1st day of study |
Appendectomy in Children Performed by Residents in the Era of Laparoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
Introduction: An increasing proportion of childhood appendicitis is treated with laparoscopic appendectomy (LA). The investigators wanted to elucidate the outcome of childhood appendicitis treated primarily by residents in a university hospital. Material and methods: All children (age<16 years) treated surgically with appendectomy in our department between January 2006 and January 2011 were retrospectively identified. Readmission, reoperation or postoperative length of stay (LOS) exceeding five days were considered as non-satisfactory outcomes.

Official Title
-----------------
Appendectomy in Children Performed by Residents in the Era of Laparoscopic Surgery

Conditions
-----------------
Intraabdominal Abscess, Wound Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age below 16 years. operated on suspicion of appendicitis Exclusion Criteria: appendectomy for causes other than suspicion of appendicitis

Ages Eligible for Study
-----------------
Maximum Age: 15 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 |
| --- | --- |
| open appendectomy<br> | |
| laparscopic appendectomy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical complications |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LOS, Ileus, Fever, reoperation
A Study to Evaluate the Real-world Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B

Study Overview
=================
Brief Summary
-----------------
Elocta (rFVIIIFc) and Alprolix (rFIXFc) are recombinant extended half-life coagulation factor products. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Elocta and Alprolix in the prophylactic treatment of haemophilia A and B.

Official Title
-----------------
A 24-month Prospective, Non-interventional, Multicentre Study to Evaluate the Real-World Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B

Conditions
-----------------
Haemophilia A, Haemophilia B

Intervention / Treatment
-----------------
* Drug: ELOCTA
* Drug: ALPROLIX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a diagnosis of haemophilia A or B and previously treated with factor Product Have started prophylactic Elocta/Alprolix treatment prior to enrollment visit, or at enrollment prescribed prophylactic treatment with Elocta or Alprolix regardless of participation in the study Signed and dated informed consent provided by the patient, or the patient's legally acceptable representative for patients under the legal age, Before any study-related activities are undertaken. Assent should be obtained from paediatric patients according to local regulations. Exclusion Criteria: Participation in an investigational medicinal product trial, from four weeks prior to first injection with Elocta or Alprolix to enrollment visit.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Haemophilia A patients<br>Elocta will be prescribed according to local practice and administered by patients with haemophilia A for prophylactic treatment | Drug: ELOCTA<br>* Extended half-life factor VIII product<br>* Other names: Eloctate, efmoroctocog alfa, rFVIIIFc;|
| Haemophilia B patients<br>Alprolix will be prescribed according to local practice and administered by patients with haemophilia B for prophylactic treatment | Drug: ALPROLIX<br>* Extended half-life factor IX product<br>* Other names: Eftrenonacog alfa, rFIXFc;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualised bleeding rate (ABR) | Based on bleeding episodes assessed by local practice | 24 months | 
| Annualised injection frequency | Assessed by prescription | 24 months | 
| Annualised factor consumption (IU) | Assessed by dispensed factor product | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood Coagulation Disorder, Hematologic Diseases, Coagulation Protein Disorder, Hemorrhagic Disorder, Genetic Diseases, Inborn