linjc16/ctgov huggingface dataset:
Transfusing Neonates Based on Platelet Mass

Study Overview
=================
Brief Summary
-----------------
Thrombocytopenia (low platelet count) is common in the neonatal intensive care unit. Commonly, the decision of when to transfuse platelets is based on platelet number. Recently, Christensen et al (2006) proposed using transfusion guidelines based on platelet mass rather than platelet number. By using platelet size as a guide of when to give platelets, we may be able to decrease the amount platelet transfusions needed. This study is investigating using platelet size rather than platelet number as a guideline for transfusing platelets in infants who are hospitalized in a NICU (neonatal intensive care unit). After obtaining parental informed consent, thrombocytopenic infants will be randomized to one of two groups. 1: Transfusion based on platelet number; 2: transfusion based on a combination of platelet number and platelet mass. In each group the decision to transfuse platelets will be made using a slightly different, yet strict set of transfusion rules. The objective is to determine the feasibility, rate of bleeding complications and compliance of transfusing neonates based on platelet mass rather than platelet number. The investigators hypothesize that transfusing platelets based on platelet mass will not increase bleeding complications and will reduce the number of transfusions in thrombocytopenic neonates.

Official Title
-----------------
Transfusing Neonates Based on Platelet Mass in the Neonatal Intensive Care Unit: A Randomized Pilot Study

Conditions
-----------------
Thrombocytopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thrombocytopenic infants Exclusion Criteria: Major congenital anomalies

Ages Eligible for Study
-----------------
Maximum Age: 12 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Platelet Number<br>Infants randomized to this group will be transfused based on a specific set of transfusion guidelines pertaining to the total number of platelets | |
| Platelet Mass<br>Infants randomized to this group will be transfused based on a specific set of transfusion guidelines pertaining to a combination of platelet number and platelet size (mass) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of transfusions |  | During NICU hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding outcomes |  | While the infant is thrombocytopenic | 
| Compliance with transfusion guidelines |  | During NICU hospitalization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thrombocytopenia, Platelet transfusion
Topical Calcipotriol Versus Narrowband Ultraviolet B in Treatment of Alopecia Areata

Study Overview
=================
Brief Summary
-----------------
Alopecia Areata is a common condition. This study investigated the efficacy of calcipotriol versus Narrow Band Ultraviolet B in treatment of Alopecia areata and their effects on serum vitamin D3 levels.

Official Title
-----------------
Topical Calcipotriol Versus Narrowband Ultraviolet B in Treatment of Alopecia Areata: A Randomized Controlled Trial

Conditions
-----------------
Alopecia Areata

Intervention / Treatment
-----------------
* Drug: Calcipotriol
* Device: Narrow Band UVB
* Diagnostic Test: vitamin D3 level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Alopecia Areata of scalp Exclusion Criteria: Other causes of alopecias including scarring alopecia, androgenic alopecia, telogen effluvium autoimmune diseases, pregnant and lactating females

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 40 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 |
| --- | --- |
| Active Comparator: Group I<br> | Drug: Calcipotriol<br>* Calcipotriol ointment (0.005%)<br>Diagnostic Test: vitamin D3 level<br>* vitamin D3 (ng/ml)<br>|
| Active Comparator: Group II<br> | Device: Narrow Band UVB<br>* NB-UVB (311nm) phototherapy<br>Diagnostic Test: vitamin D3 level<br>* vitamin D3 (ng/ml)<br>|
| Active Comparator: Group III<br> | Drug: Calcipotriol<br>* Calcipotriol ointment (0.005%)<br>Device: Narrow Band UVB<br>* NB-UVB (311nm) phototherapy<br>Diagnostic Test: vitamin D3 level<br>* vitamin D3 (ng/ml)<br>|
| Placebo Comparator: Group IV<br> | Diagnostic Test: vitamin D3 level<br>* vitamin D3 (ng/ml)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement of Alopecia Areata After treatment As assessed by Severity of Alopecia tool (SALT) score | calculation of SALT score before and after treatment | 3 months | 
| Improvement of serum Vitamin D levels in (ng/ml) after treatment | measurement of serum vitamin D before and after treatment | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alopecia Areata, Calcipotriol, Narrow Band-UVB, Vitamin D3
Study of the Enterprise Self-Expanding Stent System With Endovascular Coil Embolization of Wide- Neck Saccular Intracranial Artery Aneurysms

Study Overview
=================
Brief Summary
-----------------
Cordis Self Expanding Stent for use with embolic coils for the treatment of wide-neck, intracranial, saccular aneurysms arising from a parent vessel

Official Title
-----------------
Cordis Neurovascular Feasibility Study of the Enterprise Self-Expanding Stent System to Facilitate Endovascular Coil Embolization of Wide- Neck Saccular Intracranial Artery Aneurysms

Conditions
-----------------
Intracranial, Wide-Neck, Saccular Aneurysms

Intervention / Treatment
-----------------
* Device: Cordis Neurovascular Self-Expanding Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pts with intracranial, wide-neck, saccular aneurysms Exclusion Criteria: Subject with Hunt and Hess Grade IV or V subarachnoid hemorrhage.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cordis Neurovascular Self-Expanding Stent|nan|

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
-----------------
Wide-neck, Saccular, Intracranial, Aneurysms
Education of Parents About Discipline in a Way That is Culturally Sensitive

Study Overview
=================
Brief Summary
-----------------
To determine if a brief primary care intervention can educate under-resourced and minority parents about discipline in a way that is culturally sensitive.

Official Title
-----------------
Education of Parents About Discipline in a Way That is Culturally Sensitive

Conditions
-----------------
Violence, Parenting

Intervention / Treatment
-----------------
* Behavioral: Play Nicely


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents presenting with their children to a pediatric clinic. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention parents<br>Parents were asked to view 5-10 minutes of a program designed to educate about discipline. | Behavioral: Play Nicely<br>* Play Nicely is a multimedia program that teaches parents about appropriate methods to discipline.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cultural Sensitivity | Parents were asked to view 5-10 minutes of an educational program. Following the clinic visit, parents were asked several questions about whether the program was culturally sensitive. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in discipline questionnaire | Parents were asked if they planned to make any changes in how they discipline at home. | baseline |
Comparison of the Efficacy and Safety of Cresnon® and Crestor® in Patients With Hyperlipidemia

Study Overview
=================
Brief Summary
-----------------
Comparison of the efficacy and safety of Cresnon® and Crestor® in patients with hyperlipidemia - 8-week, active-controlled, open-label, randomized, parallelgroup, fixed-dose, noninferiority, multicenter, phase 4 design

Conditions
-----------------
Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: Rosuvastatin(Cresnon®)
* Drug: Rosuvastatin(Crestor®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 20 Persons who have not reached LDL-C targeted level in accordance with the treatment guidelines for dyslipidemia released by Korean Society of Lipidology and Atherosclerosis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cresnon®<br>Rosuvastatin 10mg, tablet, q.d. | Drug: Rosuvastatin(Cresnon®)<br>* 10mg<br>|
| Active Comparator: Crestor®<br>Rosuvastatin 10mg, tablet, q.d. | Drug: Rosuvastatin(Crestor®)<br>* 10mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent change in LDL-C |  | After taken medication for 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent change in total cholesterol, Triglyceride, HDL-C, non-HDL-C, and non-HDL-C/HDL-C |  | After taken medication for 8 weeks | 
| The proportion of subjects reaching LDL-C targeted level in accordance with the treatment guidelines for dyslipidemia released by Korean Society of Lipidology and Atherosclerosis |  | After taken medication for 8 weeks |
Detection of Chromosomal Aberrations in Non-small Cell Lung Cancer (NSCLC) Using Fluorescent in Situ Hybridization (FISH) (ALK Test)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is the identification of chromosomal aberrations in non-small cell lung cancer (NSCLC) . The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying ALK FISH stained lung samples.

Detailed Description
-----------------
The ALK Break Apart FISH test detects chromosomal aberrations via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens. The FDA approved ALK kit is designed to detect rearrangements involving the ALK gene (2p23). Results from the ALK Kit are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for the pathologist in the identification of patients eligible for treatment with XALKORI® (crizotinib).

Official Title
-----------------
Concordance Study for Detection of Chromosomal Aberrations Using FISH (ALK Test)in Non-small Cell Lung Cancer (NSCLC)

Conditions
-----------------
Non-small Cell Lung Cancer (NSCLC)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Well stained slides with bright FISH signals Exclusion Criteria: Very old slides that were already bleached

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IVD study |  | 1 Day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-small cell lung cancer (NSCLC), ALK probe, FISH, Chromosomal aberrations
Phase II Clinical Study of Imatinib Mesylate in Patients With Malignant Gastrointestinal Stromal Tumors (Extension Study)

Study Overview
=================
Brief Summary
-----------------
This is a extension study of CSTI571B1201 study

Official Title
-----------------
Phase II Clinical Study of Imatinib Mesylate in Patients With Malignant Gastrointestinal Stromal Tumors (Extension Study)

Conditions
-----------------
Gastrointestinal Stromal Tumors

Intervention / Treatment
-----------------
* Drug: Imatinib Mesylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients who completed the CSTI571B1201 study Exclusion Criteria: - Other protocol-defined inclusion / exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 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: Imatinib Mesylate<br>400 mg once daily | Drug: Imatinib Mesylate<br>* once daily<br>* Other names: STI571;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the antineoplastic effect of the investigational drug. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the safety and pharmacokinetics of the investigational drug. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GIST, Imatinib, STI571, Gastrointestinal Stromal Tumors
Pharmacist Discharge Medication Reconciliation Study

Study Overview
=================
Brief Summary
-----------------
Adverse drug events can occur commonly due to medication errors during the transition of care in a health care facility. Medication reconciliation is the process of comparing medications and providing an accurate medication list as a resource for prescribers, which is currently only being done upon inpatient admission at the CCI. The purpose of this study is to see if pharmacist medication reconciliation at discharge reduces unintentional medication discrepancies for inpatient discharges.

Official Title
-----------------
The Impact of Pharmacist Discharge Medication Reconciliation on Unintentional Medication Discrepancies From Inpatient Discharges at the Alberta Cancer Board Cross Cancer Institute

Conditions
-----------------
Medication Reconciliation

Intervention / Treatment
-----------------
* Procedure: MRS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cancer inpatients under the care of Dr. Follett or Dr. Candler Cancer inpatients to be discharged from the CCI Patients >18 years of age Patients that are taking >1 medications or herbals total at home. Exclusion Criteria: Cancer inpatients that are considered radioactive or in hot rooms (ie. Selectron patients or patients receiving radiation treatment for thyroid) Patients that do not remain in hospital >72 hours Patients without a home phone number or equivalent contact number. Language barrier (patients unable to speak or understand English). Patients that are readmitted and already included into the study.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: MRS|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRS Correlation with Treatment Response. | The percentage of patients with at least one unintentional medication discrepancy after discharge from the Cross Cancer Institute | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation with Tumor Stage | The amount of medication discrepancies after discharge that has the potential to cause moderate harm to severe harm. | up to 1 year | 
| The frequency of each type of unintentional medication discrepancies. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer cancer, MRS, Treatment response, Histologically confirmed diagnosed Breast cancer., Patient is 18 years or older., Karnofsky performance score is equal to or greater than 70., No previously irradiated or recurrent breast., No contraindication to MRS/MRI.
Graft Patency as a Predictor of Health-related Quality of Life.

Study Overview
=================
Brief Summary
-----------------
The health-related quality of life questionnaire EQ-5D has been collected in connection with several interventional and observational studies where the no-touch vein harvesting technique in CABG has been used. The results of the questionnaires will be compiled and reported in this study.

Official Title
-----------------
Graft Patency as a Predictor of Health-related Quality of Life in Coronary Artery Bypass Patients.

Conditions
-----------------
Ischemic Heart Disease, Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Operated at our department for a coronary artery bypass surgery with either the no-touch harvesting technique of conventional harvesting technique. Completed the EQ-5D questionnaire. Signed and dated consent. Exclusion Criteria: Substantial missing data from the EQ-5D questionnaire. Unable to comprehend the different inquiries in the questionnaire.
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 |
| --- | --- |
| No touch vein grafts<br>The grafts were harvested with there surrounding tissues. | |
| Conventional vein grafts.<br>The grafts were stripped from surrounding tissue. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The health-related quality of life. | EQ-5D is a generic measure of health. The instrument can be used to measure quality of life change in a population over time and to compare the quality of life among different groups in the population such as different socio-economic groups. EQ-5D is constructed of five dimensions: mobility, care, usual activities, pain / discomfort and anxiety / depression. Each dimension is answered on a three-point scale (none, moderate or severe symptoms). With this instrument, it can theoretically be 243 possible health conditions. Health condition can also be described as an index value between 0 corresponding to death and one equivalent full health. Some negative values corresponding a state worse than death can occur. Moreover consists EQ-5D of a VAS scale (Visual Analogue Scale), a thermometer-like scale, with 0 being the worst possible health status and 100 representing full health. | 5-15 years postoperatively. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary artery bypass grafting, saphenous vein, no-touch technique