linjc16/ctgov huggingface dataset:
SMART (School-aged Children Making Healthy Choices And Recognizing sTroke)

Study Overview
=================
Brief Summary
-----------------
A stroke awareness program for school-aged children to learn the signs/symptoms of stroke, teach their parents and make healthy life-style choices.

Detailed Description
-----------------
To educate school-aged children, grades 9th through 12th on the F.A.S.T. (Face, Arm, Speech and Time) acronym, additional signs and symptoms of stroke and the need for immediate activation of Emergency Medical Services (EMS) by calling 911. To improve adults' stroke literacy through educating their children in grades 9th through 12th.

Official Title
-----------------
SMART (School-aged Children Making Healthy Choices And Recognizing sTroke): A Pilot Trial of a Stroke Awareness Program

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: SMART Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High-school student Exclusion Criteria: Not a high-school student

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SMART<br>The intervention group of school-aged children will receive education on the F.A.S.T. (Face, Arm, Speech and Time) acronym, additional signs and symptoms of stroke and the need for immediate activation of Emergency Medical Services (EMS) by calling 911. | Other: SMART Education<br> <br> |
| No Intervention: Usual Care<br>This group will not receive stroke education. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Improved Stroke Literacy | A school-based stroke literacy program targeting children in grades 9th through 12th will be successful in improving stroke literacy. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adult Improved Stroke Literacy | If school-aged children, grades 9th through 12th are taught the F.A.S.T. acronym, additional signs and symptoms of stroke and the immediate activation of EMS by calling 911, they will improve the stroke literacy of their parents. | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Stroke Prevention, Children, Education
Meditation and Student Empathy

Study Overview
=================
Brief Summary
-----------------
Physician empathy and reducing stress are major factors in attaining positive clinical outcomes for patients. Fostering empathy in medical students is particularly important as they are the future of the healthcare workforce and a trend of declining empathy during medical education may lead to decreased health care quality outcomes. Meditation may be an avenue to promote positive student attitudes including empathy, though very few studies have examined this idea through empirical research. Using validated measures, the Jefferson scale of empathy and the perceived stress scale, we seek to investigate whether use of a meditation app will be associated with higher levels of self-rated empathy and lower self-rated stress.

Official Title
-----------------
Meditation and Student Empathy

Conditions
-----------------
Stress, Empathy

Intervention / Treatment
-----------------
* Behavioral: Meditation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Medical students from New York Institute of Technology Exclusion Criteria: -Not a medical student

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No meditation | |
| Experimental: Intervention<br>Meditate using headspace app 3 times a week | Behavioral: Meditation<br>* Meditate 3 times a week using headspace app<br>* Other names: MIndfullness;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived stress scale (PSS) | Perceived stress scale measures stress levels. 10 item scale where subjects are asked to indicate by circling how often they felt or thought a certain way on a scale of 1-4. Items are them added up- a higher score means higher stress. | 6 months | 
| Jefferson scale of empathy | Jefferson scale of Empathy measures empathy levels. 20 item scale where subjects are asked to indicate by circling how often they felt or thought a certain way about empathy related situations on a scale of 1-7. Items are them added up- a higher score means higher empathy. | 6 months |
Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in CSU Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of UB-221 as an add-on therapy in patients with Chronic Spontaneous Urticaria.

Detailed Description
-----------------
This is a phase I, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of UB-221 as an add-on therapy in patients with Chronic Spontaneous Urticaria.

Official Title
-----------------
A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of UB-221 as an Add-on Therapy in Patients With Chronic Spontaneous Urticaria

Conditions
-----------------
Urticaria Chronic

Intervention / Treatment
-----------------
* Biological: UB-221


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with age between 20 to 65 years old (inclusive). Subjects who are able and willing to provide the informed consent. Male subjects with body weight of 50 kilogram (kg) or above; female subjects body weight of 45 kilogram (kg) or above. Subjects diagnosed with chronic spontaneous urticaria (CSU). Exclusion Criteria: History of significant diseases (other than CSU) or major clinical conditions by the investigator's judgment, such as auto-immune disease or psychiatric and behavioral conditions from which the investigator considers the subject is not suitable to participate in this study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UB-221 (0.2 mg/kg)<br>Intravenous infusion | Biological: UB-221<br>* UB-221 (75 mg/ml)<br>|
| Experimental: UB-221 (0.6 mg/kg)<br>Intravenous infusion | Biological: UB-221<br>* UB-221 (75 mg/ml)<br>|
| Experimental: UB-221 (2 mg/kg)<br>Intravenous infusion | Biological: UB-221<br>* UB-221 (75 mg/ml)<br>|
| Experimental: UB-221 (6 mg/kg)<br>Intravenous infusion | Biological: UB-221<br>* UB-221 (75 mg/ml)<br>|
| Experimental: UB-221 (10 mg/kg)<br>Intravenous infusion | Biological: UB-221<br>* UB-221 (75 mg/ml)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event incidence | from the baseline to day 15 after IP infusion | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
UB-221, anti-IgE monoclonal antibody, chronic spontaneous urticaria (CSU)
Patients With Hemorrhoids Referred to a Surgical Specialist Department

Study Overview
=================
Brief Summary
-----------------
Hemorrhoids is the most common disease in rectum with a prevalence of 30 % of population. This means that many patients are referred to surgical specialist reception with diagnosis hemorrhoidal disease. The aim of this study is to describe population of patients with hemorrhoidal disease that are referred to a specialised colorectal unit and to determine what treatment they are given at a general practitioner as well as in colorectal unit.

Official Title
-----------------
Patients With Hemorrhoids Referred to a Surgical Specialist Department

Conditions
-----------------
Hemorrhoids

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with diagnosis hemorrhoidal disease that are referred to a surgical specialist department Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Hemorrhoids<br>Patient with hemorrhoids | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correct diagnosis? |  | patients visiting Ersta Hospital between 2007-2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment of hemorrhoids | Surgical or conservative treatment, results and number of patients in the groups | patients visiting Ersta Hospital between 2007-2009 |
Platelet Transfusion Refractoriness

Study Overview
=================
Brief Summary
-----------------
Platelet Transfusion Refractoriness is one of the severe complications after multiple transfusions in patients with severe thrombopenia. Platelet Transfusion Refractoriness is characterized by inefficient transfusion and arise from allo-antibodies specific of platelets antigenes, mostly carried by HLA-I molecules.

Detailed Description
-----------------
A preliminary study has shown different isotypes of anti-HLA I in patients with Platelet Transfusion Refractoriness. Our hypothesis is that the type of anti-HLA I antibodies (recognised epitope, quantity, isotype) should establish predictive and diagnostic criteria for Platelet Transfusion Refractoriness.

Official Title
-----------------
Characterization of Anti-HLA I Antibodies Involved in Platelet Transfusion Refractoriness: Optimization of the Transfusion Management of Patients With Severe Thrombocytopenia

Conditions
-----------------
Platelet Transfusion Refractoriness

Intervention / Treatment
-----------------
* Procedure: platelet transfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient with Hematopoietic stem cells graft (autograft or allograft) or with acute leukemia with the indication of platelet transfusion. Exclusion Criteria: Patient under guardianship Minor patient

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 |
| --- | --- |
| Patients with Platelet Transfusion Refractoriness<br> | Procedure: platelet transfusion<br>* platelet transfusion realised for Hematopoietic stem cells graft or for acute leukemia<br>|
| Patients without Platelet Transfusion Refractoriness<br> | Procedure: platelet transfusion<br>* platelet transfusion realised for Hematopoietic stem cells graft or for acute leukemia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Research of predictive criteria of Platelet transfusion refractoriness | Characterisation of anti-HLA I antibodies (recognised epitopes and isotypes) associated to Platelet transfusion refractoriness | blood samples before the transfusion of each chemotherapy cycle |
Bradycardia Following Intraoperative Administration of Dexmedetomidine

Study Overview
=================
Brief Summary
-----------------
This is a retrospective chart review to evaluate the postoperative course of all pediatric patients admitted to the hospital following adenotonsillectomy over the past 24 months to evaluate the incidence of bradycardia in children who received dexmedetomidine intraoperatively and identify confounding factors which may be precipitating the bradycardia or potentiating the negative chronotropic effects of dexmedetomidine.

Conditions
-----------------
Tonsillectomy, Adenotonsillectomy

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing adenontonsillectomy or tonsillectomy during 2011 and 2012. Exclusion Criteria: None.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dexmedetomidine patients<br>Patients that received dexmedetomidine during their surgery. | Drug: Dexmedetomidine<br> <br> * Other names: Precedex;|
| No Dexmedetomidine<br>Patients that didn't receive dexmedetomidine during surgery. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bradycardia |  | 24 hours |
Effects of Anthocyans on Cardiovascular and Sympathetic Function

Study Overview
=================
Brief Summary
-----------------
Anthocyans modify cardiovascular and sympathetic function

Official Title
-----------------
Effects of Anthocyans on Cardiovascular and Sympathetic Function

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Dietary Supplement: Anthocyans
* Other: placebo
* Dietary Supplement: Anthocyans


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 35 to 50 years old Males Hypertension

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Anthocyans | Dietary Supplement: Anthocyans<br>* Anthocyans<br>Dietary Supplement: Anthocyans<br> <br> |
| Placebo Comparator: B<br>no effective agent | Dietary Supplement: Anthocyans<br>* Anthocyans<br>Other: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic bloodpressure and heartrate |  |  |
Effects of Arm Cycling and Leg Cycling on Postprandial Blood Glucose Levels in Healthy Persons

Study Overview
=================
Brief Summary
-----------------
The literature has shown that exercise is effective in decreasing blood glucose levels. However, it remains less clear if there is any difference between muscle groups regarding the glucose-lowering effects of exercise. The purpose of this study is to examine the differences in blood-glucose level changes in response to exercise that involves different muscle groups.

Official Title
-----------------
A Comparison Between the Effects of Different Muscle Groups on Blood Glucose Levels at the Postprandial Status in College Students

Conditions
-----------------
Hyperglycemia, Postprandial

Intervention / Treatment
-----------------
* Behavioral: Arm Cycling
* Behavioral: Leg Cycling
* Behavioral: Sitting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Apparently healthy persons Age 18 years or above Exclusion Criteria: Cardiovascular diseases Pulmonary diseases Metabolic diseases Other contraindications to exercise

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

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

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

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: Arm Cycling<br>Arm cycling on an arm crank ergometer for 20 minutes at light to moderate intensity. 30 minutes before the exercise, participants will consume 60g of carbohydrates mixed with plain water. | Behavioral: Arm Cycling<br>* 20 minutes of arm cycling exercise at light to moderate intensity.<br>|
| Experimental: Leg Cycling<br>Leg cycling on a leg cycling ergometer for 20 minutes at light to moderate intensity. 30 minutes before the exercise, participants will consume 60g of carbohydrates mixed with plain water. | Behavioral: Leg Cycling<br>* 20 minutes of leg cycling exercise at light to moderate intensity.<br>|
| Placebo Comparator: Sitting<br>Participants will remain seated after carbohydrates consumption. | Behavioral: Sitting<br>* Remain seated for 20 minutes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial glucose levels |  | one hour after the carbohydrates intake |
Calquence CLL rr Japan PMS_Japan Post-Marketing Surveillance (PMS) Study - All Patient Investigation

Study Overview
=================
Brief Summary
-----------------
To understand the incidence of ADRs of Calquence 100 mg capsules (acalabrutinib) used in patients with relapsed or refractory chronic lymphocytic leukaemia (including small lymphocytic lymphoma) in a real-world post-marketing setting

Detailed Description
-----------------
To understand the incidence of ADRs of Calquence 100 mg capsules (acalabrutinib) used in patients with relapsed or refractory chronic lymphocytic leukaemia (including small lymphocytic lymphoma) in a real-world post-marketing setting. This investigation will be conducted for application for re-examination specified in Article 14-4 of the Pharmaceutical Affairs Law. In addition, after launch, the data for a certain number of all cases are collected and the survey is required to be conducted for all cases as conditions of approval.

Official Title
-----------------
Calquence 100 mg Capsules General Drug Use-Results Study; All Patient Investigation in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Lymphoma)

Conditions
-----------------
Relapsed or Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Lymphoma)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with relapsed or refractory chronic lymphocytic leukemia (small lymphocytic lymphoma) who are treated with the product - Exclusion Criteria: None -
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 |
| --- | --- | --- |
| Incidence of ADRs | the incidence of ADRs related to Calquence Safety specifications: Haemorrhage, infection, bone narrow depression, arrhythmia, ischemic heart disease, tumour lysis syndrome, interstitial lung disease, and second primary malignancy | 52weeks |
Sorry Not Sorry: Apologizing and Its Effect on Discomfort During Dressing Removal

Study Overview
=================
Brief Summary
-----------------
Use of dressing is common place following surgery, allowing for wounds to be covered and protected. Dressing material with adhesive contact layers or adhesive tape is integral to sealing off the wound. Mechanical stripping of stratum corneum during dressing removal causes pain and discomfort. During dressing removal, practitioners may at times apologize as a function of empathy. Previous study investigated speed of dressing removal and its effect on discomfort during dressing change. In this study, the investigators aim to investigate how empathy expressed in form of saying sorry affect the perception of pain during dressing change?

Official Title
-----------------
Sorry Not Sorry: Apologizing and Its Effect on Discomfort During Dressing Removal

Conditions
-----------------
Pain, Bandages, Empathy

Intervention / Treatment
-----------------
* Behavioral: Saying sorry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult volunteers, age >18. Exclusion Criteria: individuals with sensitivity to tape or dressing, anxiety disorders, or pain syndromes.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sorry<br>A small strip of self-adhesive dressing (3cm by 4cm) will be applied to the back of the patients' participants' hand and side of neck. After one minute of acclimatization, the dressing will be removed by the examiner. During the removal, the examiner will say sorry repeatedly. Following the dressing removal, participant will rate their pain with a 10 point visual analog scale. | Behavioral: Saying sorry<br>* The objective of this study is to investigate how empathy expressed in form of saying sorry affect the perception of pain during dressing change?<br>|
| No Intervention: Not Sorry<br>A small strip of self-adhesive dressing (3cm by 4cm) will be applied to the back of the patients' participants' hand and side of neck. After one minute of acclimatization, the dressing will be removed by the examiner. During the removal, the examiner will remain silent. Following the dressing removal, participant will rate their pain with a 10 point visual analog scale. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Based on self reported 10 point visual analog scale | Immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Empathy, Dressing change