linjc16/ctgov huggingface dataset:
Old Blood and Postoperative Complications

Study Overview
=================
Brief Summary
-----------------
The investigators sought to examine the effects of 'old' red blood cells on mortality and morbidity of patients who undergoing revision hip replacement arthroplasty. The investigators hypothesis is that patients have an increased risk of mortality and infection after 'old' red blood cells transfusions compared with those who received 'new' transfusions.

Official Title
-----------------
The Effects of Old Red Blood Cell Transfusion on Morbidity in Patients Undergoing Revision Total Hip Arthroplasty: Retrospective Study

Conditions
-----------------
Orthopedics, Postoperative Complications, Red Blood Cells

Intervention / Treatment
-----------------
* Procedure: Old red blood cells transfusion
* Procedure: New red blood cells transfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent revision total hip replacement Exclusion Criteria: Patients who were not given red blood cells Patients who were given two units of which one unit was old and one was new

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 |
| --- | --- |
| RBC_old<br>shelf life of red blood cells of 15 or higher days | Procedure: Old red blood cells transfusion<br>* Red blood cells (shelf life > 14 days) transfusion during the operation (total hip replacement arthroplasty)<br>|
| RBC_new<br>shelf life of red blood cells 14 or lower days | Procedure: New red blood cells transfusion<br>* Red blood cells (shelf life =< 14 days) transfusion during the operation (total hip replacement arthroplasty)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | postoperative 7 days | 
| Sepsis |  | postoperative 7 days | 
| Wound infection |  | postoperative 7 days | 
| Postoperative delirium |  | postoperative 7 days | 
| Postoperative bleeding |  | postoperative 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusion related lung injury |  | postoperative 7 days | 
| Pulmonary edema |  | postoperative 7 days | 
| Pulmonary effusion |  | postoperative 7 days | 
| Myocardial ischemia |  | postoperative 7 days | 
| Pulmonary thromboembolism |  | postoperative 7 days | 
| Renal failure |  | postoperative 7 days | 
| Hepatic failure |  | postoperative 7 days |
Hospice Quality Score Assessment Post Pharmacist Intervention

Study Overview
=================
Brief Summary
-----------------
The study aims to investigate the impact of pharmacist delivered interventions on hospice patients quality metric scores.

Detailed Description
-----------------
The objective of this study is evaluate a program at a hospice involving activities designed to improve the site's National Quality Forum (NQF) and Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores. These scores are calculated by the hospice using existing patient satisfaction survey scores (HCAHPS). The institution quantifies their compliance with national quality metrics (NQF) and reports this existing data to the pharmacist providing counseling services to their patients. The pharmacist assesses for areas for improvement and provides additional counseling services to improve the continuity and quality of care. The pilot program is scheduled to launch April 2020 and the researchers will look to assess for changes in the NQF scores, HCAHPS scores, and time for their partnering pharmacy to refill the first set of prescriptions.

Official Title
-----------------
Assessing the Impact of Pharmacist Interventions on Hospice Quality Scores

Conditions
-----------------
Cancer, Respiratory Disease, Cardiovascular Diseases, Neurologic Disorder, Dementia

Intervention / Treatment
-----------------
* Other: Medication safety review


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients who were referred to hospice by a healthcare provider Exclusion Criteria: Patients 89 years or older

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 88 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention<br>Patients that receive pharmacist-delivered services in the pilot program | Other: Medication safety review<br>* Implementation of a medication safety review using a clinical decision support system<br>|
| Control<br>Patients that do not receive pharmacist-delivered services in the pilot program | Other: Medication safety review<br>* Implementation of a medication safety review using a clinical decision support system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Quality Forum Score | Performance metric used by hospice. Scale 0 - 100 (0=min; 100-high) | 6 months | 
| Consumer Assessment of Healthcare Providers and Systems | Performance metric used by hospice (0=min; 100-high) | 6 months | 
| Time to refill | Time to refill prescription from hospice organization (0=min; 100-high) | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
National Quality Forum Score, HCAHPS, Medication refill, Number medications
Study Comparing 2 New Formulations of HKI-272 in Healthy Adult Subjects

Study Overview
=================
Brief Summary
-----------------
To evaluate the comparative bioavailability of 2 new tablet formulations of HKI-272 with a reference capsule and an oral solution in healthy subjects.

Official Title
-----------------
A Single Dose Bioavailability Study of 2 New Formulations of HKI-272 (240 mg) Compared With a Reference Capsule and an Oral Solution in Healthy Adult Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: neratinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Criteria: Healthy male and female subjects aged 18 to 50 years. Women of nonchildbearing potential (WONCBP)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: neratinib|HKI-272|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The data from this study along with in vitro data will be used to explore in vitro/in vivo correlation for HKI-272 to support formulation development. |  |  |
Penetrating Cardiac Injuries: Outcome of Treatment From a Level 1 Trauma Centre in South

Study Overview
=================
Brief Summary
-----------------
Retrospective observational study design auditing the outcomes of cardiac injuries in a single centre

Detailed Description
-----------------
retrospective study over a two-year period. The demographics, injury sustained, clinical physiological parameters, mechanism of injury, injury site and patterns, outcomes and in-hospital mortality description of patients who were admitted at a single centre for further management of their cardiac injuries. Investigations performed, and procedures that were undertaken were also documented. Descriptive statistical analysis was performed. P-value of <0,05 was considered clinically significant.

Official Title
-----------------
Penetrating Cardiac Injuries: Outcome of Treatment From a Level 1 Trauma Centre in South

Conditions
-----------------
Penetrating Cardiac Trauma

Intervention / Treatment
-----------------
* Other: standards clinical management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All Priority one penetrating cardiac injuries seen at CMJAH in patients who were 18 years and older - Exclusion Criteria: Dead on arrival -

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: standards clinical management|outcomes seen in cardiac injuries post clincal care|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| List injury patterns | chamber involved | study period (Jan 2018-Dec 2019) | 
| List of Mechanisms seen | describe the type of mechanism involved in injury | study period (Jan 2016-Dec 2019) | 
| outcomes | overall inhospitable mortality and outcomes | study period (Jan 2016-Dec 2019) |
Evaluation of Topic Anaesthesia for Laryngoscopy With Fibroscopy During Paediatric Ear Nose Throat (ENT)Consultation

Study Overview
=================
Brief Summary
-----------------
The purpose of this work is to estimate the efficiency in terms of pain of the application of a local anesthetic (xylocaïne viscous 2%®) during the realization of an examination in naso-fiberscopy in consultation of ENT at the child from 3 to 7 years old.

Official Title
-----------------
Evaluation of Topic Anaesthesia for Laryngoscopy With Fibroscopy During Paediatric ENT Consultation

Conditions
-----------------
Nasofibroscopy

Intervention / Treatment
-----------------
* Drug: Indirect laryngoscopy in the flexible nasofibroscope
* Drug: Indirect laryngoscopy in the flexible nasofibroscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects from 4 to 7 years old (old enough to answer the test of self-assessment, the scale of faces) Appearing at the consultation of pediatric ENT, requiring an indirect laryngoscopy in the naso-fiberscope for a laryngeal evaluation. Subjects girls or boys Exclusion Criteria: All the criteria dissuading the employment of a local anesthetic Naso-fibroscopie realized within the framework of a nasal obstruction, or of a balance sheet of the gulp. Patients having already been examined by naso-fiberscopy, so that their reactions and their answers are not influenced by the previous experience of the examination. Not consent of one of both holders of the parental authority

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 7 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: group gel KY<br> | Drug: Indirect laryngoscopy in the flexible nasofibroscope<br> <br> |
| Experimental: group gel lidocaine<br> | Drug: Indirect laryngoscopy in the flexible nasofibroscope<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacity of local anesthetic | The purpose of this work is to estimate the efficiency in terms of pain of the application of a local anesthetic (xylocaïne viscous 2%®) during the realization of an examination in naso-fiberscopy in consultation of ENT at the child from 3 to 7 years old. |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain's scale | The child estimates his(her) own pain by postponing her(it) on a scale of more or less painful faces. |  |
To Examine the Lung When People With Diabetes Take an Inhaled Form of Insulin, Compared to Subcutaneous Insulin.

Study Overview
=================
Brief Summary
-----------------
To examine the lung when people with diabetes take an inhaled form of insulin, compared to subcutaneous insulin.

Official Title
-----------------
A Phase 2, Exploratory Study to Examine the Effects of Inhaled Insulin, Compared With Subcutaneously Administered Insulin, on Airway Lining Fluid Composition in Subjects With Type 2 Diabetes Mellitus.

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Inhaled insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes Mellitus Normal lung function Exclusion Criteria: Smokers

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 55 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: Inhaled insulin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess in patients with type 2 diabetes mellitus the effects, if any, on lung lining fluid cell count and differential within subjects after 12 weeks of inhaled insulin therapy compared to 12 weeks of subcutaneous short-acting therapy. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (1) Albumin and fibrinogen concentrations, and airway appearance in the above subjects. (2) routine safety, tolerance, and efficacy in the above subjects. |  |  |
PMS Retrospective Study of WIRION Performance in Patients Undergoing Saphenous Vein Graft (SVG) Intervention

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to collect data on the use of the WIRION system in Patients undergoing Percutaneous Intervention of Saphenous Vein Graft (SVG).

Detailed Description
-----------------
WIRION system is used as protection device in patients undergoing SVG stenting procedure. This retrospective study collects data on the usability of the WIRION during the procedure.

Official Title
-----------------
Post Marketing Surveillance (PMS) Retrospective Study of WIRION Performance in Patients Undergoing Saphenous Vein Graft (SVG) Intervention

Conditions
-----------------
Stenosis

Intervention / Treatment
-----------------
* Device: Saphenous vein graft (SVG) stenting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients underwent percutaneous intervention (PI) of SVG stenting in which the WIRIONTM system was used. Patient is greater than or equal to 18 years of age. Exclusion Criteria: Undergone cardiac surgery in the past 60 days before the procedure.

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

| Intervention/Treatment |
| --- |
|Device: Saphenous vein graft (SVG) stenting|Opening and stenting of blocked SVG with the use of the WIRION embolic protection filter|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events During the Procedure and up to 30 Days Following Procedure | Collect and analyse all adverse events occurred during and following the SVG procedure up to 30 days. | 30 Days | 
| Number of Patients That Undergo Successful SVG Procedure | Successful procedure is considered as a procedure in which no distal embolization, dissection, perforation, abrupt closure or no reflow occurred. | 30 Days |
Evaluation of Desloratadine When Used in Patients With Either Allergic Rhinitis or Chronic Idiopathic Urticaria

Study Overview
=================
Brief Summary
-----------------
Eligible patients will be prescribed Desloratadine 1 tablet of 5 mg once daily. Patients will be asked to follow-up for a final visit after 14 days (Day 15) where the safety, tolerability and clinical efficacy will be measured.

Official Title
-----------------
Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Desloratadine Tablet Among Filipino Patients

Conditions
-----------------
Rhinitis, Urticaria

Intervention / Treatment
-----------------
* Drug: Desloratadine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatient men or women, age 12 years and above. Diagnosis of Allergic Rhinitis or Chronic Idiopathic Urticaria Exclusion Criteria: Known hypersensitivity to Desloratadine. Pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Group<br>Patients diagnosed with Allergic Rhinitis or Chronic Idiopathic Urticaria | Drug: Desloratadine<br>* Desloratadine 5 mg once daily<br>* Other names: SCH 034117;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of adverse events reported | Final Visit (Day 15) |
HKT-500 in Adult Patients With Ankle Sprain

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to demonstrate the multiple-dose efficacy and safety of HKT-500 for the treatment of ankle sprain.

Detailed Description
-----------------
Randomized, double-blind, placebo-controlled, multicenter study in men and women 18 years of age or older who have a painful, acute, benign, ankle sprain of the lateral ligament(s) within the previous 48 hours.

Official Title
-----------------
Protocol HKT-500-US10: A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of HKT-500 in the Treatment of Pain Associated With Grade I or Grade II Ankle Sprain

Conditions
-----------------
Ankle Sprain

Intervention / Treatment
-----------------
* Drug: HKT-500 Ketoprofen Topical Patch
* Other: Placebo Patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Grade I or Grade II Ankle Sprain. Exclusion Criteria: The subject is a women of childbearing potential who has a positive urine pregnancy test, who is lactating, who is not surgically sterile (by tubal ligation or hysterectomy), or at least 2 years postmenopausal, and has not practice an acceptable form of birth control (defined as the use of an intrauterine device with spermicide, a barrier method with spermicide, condoms with spermicide, subdermal implant, oral contraceptives, or abstinence) for at least 2 months prior to Visit 1.

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HKT-500 Ketoprofen Topical Patch<br>Randomized, double-blind, placebo-controlled, multicenter study in men and women 18 years of age or older who have a painful, acute, benign, ankle sprain of the lateral ligament(s) within the previous 48 hours. | Drug: HKT-500 Ketoprofen Topical Patch<br>* HKT-500 Ketoprofen Topical Patch<br>* Other names: Ketoprofen Topical Patch;|
| Placebo Comparator: Placebo Patch<br>Treatment with placebo patch | Other: Placebo Patch<br>* Placebo Patch<br>* Other names: Sham treatment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Assessment |  | 2 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessment |  | 2 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sprain, ankle, pain
Sodium Tungstate in Obesity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy and safety of sodium tungstate versus placebo in patients with obesity (grade I and II).

Official Title
-----------------
Efficacy of Oral Sodium Tungstate (200 mg/Day)on Weight Loss in Subjects With Grade I-II Obesity

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: Sodium Tungstate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI: 30-39.9 Kg/m2 In case of male gender, 18 to 65 years old In case of female gender, diagnosis of menopause Body weight changes < 3 kg in the last 3 months In case of arterial hypertension or dyslipemia, no changes in dose in the last 2 months Exclusion criteria: In case of female gender, absence of menopause Evidence of secondary causes of obesity Diabetes, type II Concomitant treatment with drugs affecting body weight Previous surgical intervention of obesity

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Sodium Tungstate | Drug: Sodium Tungstate<br>* Sodium Tungstate, 200 mg BID, oral route during 6 weeks<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Placebo, BID, oral route during 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss |  | six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in lipids |  | 6 weeks | 
| changes in caloric intake and in hungry sensation |  | 6 weeks | 
| resting metabolic rate |  | 6 weeks | 
| changes in body composition |  | 6 weeks | 
| adverse events |  | 6 weeks | 
| changes in hormonal parameters |  | 6 weeks |