linjc16/ctgov huggingface dataset:
A Study of Complete Molecular Response for Chronic Myeloid Leukemia in Chronic Phase Patients, Treated With Dasatinib

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate complete molecular response of Dasatinib in patients for Philadelphia chromosome-positive chronic myeloid leukemia

Official Title
-----------------
A Study of Complete Molecular Response for Chronic Myeloid Leukemia in Chronic Phase Patients, Treated With Dasatinib

Conditions
-----------------
Chronic Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: dasatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic Myeloid Leukemia in the Chronic Phase 20 years old over ECOG performance status (PS) score 0-2 Patients for major molecular response (MMR) with no CMR Adequate organ function (hepatic, renal and lung) Signed written informed consent Exclusion Criteria: A case with the double cancer of the activity Women who are pregnant or breastfeeding The case of Pleural effusion clearly Patients with complications or a history of severe or uncontrolled cardiovascular failure following have a Myocardial infarction within 6 months have an Angina within 3 months have a Congestive heart failure within 3 months have a suspected congenital QT syndrome have a QTc interval of more than 450msec at baseline A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy Prior treatment with dasatinib Subjects with T315I, F317L and V299L BCR-ABL point mutations

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dasatinib<br> | Drug: dasatinib<br>* 100mg QD<br>* Other names: BMS-354825;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complete molecular response (CMR) after treatment with dasatinib |  | at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dasatinib of dose intensity |  | at 12 months | 
| Expansions rate of large granular lymphocyte |  | at 12 months | 
| Progression free survival |  | at 12 months | 
| Number of Participants with Adverse Events |  | at 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic myeloid leukemia, dasatinib, complete molecular response
Treatment of Crohn's Fistula Using a Porcine Intestine Submucosa Graft

Study Overview
=================
Brief Summary
-----------------
Healing anal fistulas in Crohn's patients with an anal fistula plug.

Detailed Description
-----------------
The purpose of this study is to determine whether the Surgisis anal fistula plug is effective in healing anal fistulas in patients diagnosed with Crohn's Disease.

Official Title
-----------------
Treatment of Crohn's Fistula Using a Porcine Intestine Submucosa Graft (SurgiSIS AFP)

Conditions
-----------------
Anal Fistula, Crohn's Disease

Intervention / Treatment
-----------------
* Device: Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is diagnosed with Crohn's Disease Patient has a chronically draining anal fistula of Crohn's origin Patient is 18 years old or older Patient has signed an informed consent Exclusion Criteria: Patient is pregnant or lactating Patient has peri-anal drainage with originates from outside the anorectal tract

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AFP<br>Anal fistula plug placement performed during surgical procedure | Device: Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP)<br>* Surgical placement of the Surgisis AFP is performed under general anesthesia<br>* Other names: SurgiSIS Biodesign;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fistula Closure (Patient Based) | Fistula closure is defined as absence of drainage at the external fistula opening. | 12 months | 
| Fistula Closure (Tract Based) | Fistula closure is defined as absence of drainage at the external fistula opening. An anorectal fistula is an inflammatory tract or connection between the epithelialized surface of the anal canal and most frequently, the perianal skin or perineum. It is possible to have multiple fistula tracts present on a patient. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anal fistula, fistula in ano, anorectal fistula, Crohn's Disease
Study of UCART19 in Pediatric Patients With Relapsed/Refractory B Acute Lymphoblastic Leukemia

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the safety and feasibility of UCART19 to induce molecular remission in pediatric patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).

Official Title
-----------------
A Phase 1, Open Label, Non-comparative Study to Evaluate the Safety and the Ability of UCART19 to Induce Molecular Remission in Paediatric Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukaemia

Conditions
-----------------
Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed B-cell Acute Lymphoblastic Leukemia

Intervention / Treatment
-----------------
* Biological: UCART19


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with relapsed or refractory CD19-positive B-acute lymphoblastic leukaemia (B-ALL) who have exhausted alternative treatment options. Estimated life expectancy ≥ 12 weeks Lansky (age < 16 years at the time of assent/consent) or Karnofsky (age ≥ 16 years at time of assent/consent) performance status ≥ 50 Exclusion Criteria: Burkitt leukemia CD19-negative B-cell leukemia Active Central Nervous System (CNS) leukemia Active acute or chronic Graft-versus-Host Disease (GvHD) requiring systemic use therapy within 4 weeks before UCART19 infusion Patients with autoimmune disease requiring systemic immunosuppression therapy that cannot be stopped History of CRS grade 4 related to previous CAR T cell therapy Contraindication to Alemtuzumab administration

Ages Eligible for Study
-----------------
Maximum Age: 17 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: UCART19<br> | Biological: UCART19<br> <br> * Other names: S68587;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and Severity of Adverse Events | Adverse events assessed according to NCI-CTCAE v5.0 criteria | From inclusion to Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular Remission Rate | Proportion of patients in whom a molecular Complete Remission (CR) or a Complete Remission with incomplete blood recovery (CRi) is observed (i.e. a CR or CRi combined to a Minimal residual disease <10-4). | At Day 28 after the first UCART19 infusion |
Intrauterine Misoprostol Versus Intravenous Oxytocin Infusion During Cesarean Delivery

Study Overview
=================
Brief Summary
-----------------
Bleeding is still the major cause of mortality and morbidity in postpartum period. World health organization has reported 585000 deaths for pregnancy each year. Twenty five percent of cases die from post-partum bleeding. Mean amount of blood lost is 500 ml during normal vaginal delivery, 1000 ml in cesarean section, and 3500 ml during cesarean section with emergency hysterectomy

Official Title
-----------------
Intrauterine Misoprostol Versus Intravenous Oxytocin Infusion During Cesarean Delivery to Reduce Intraoperative and Postoperative Blood Loss: A Randomized Clinical Trial.

Conditions
-----------------
Post Partum Hemorrhage

Intervention / Treatment
-----------------
* Drug: Misoprostol
* Drug: Oxytocin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1-Uncomplicated pregnancy, 2-Had no hypersensitivity or contraindications to prostaglandins. 3-Had no history of coagulopathy. 4-Accepting to participate in the study. Exclusion Criteria: \1-women with anemia (Haemoglobin <8 gram ). 2 placental abnormality (e.g placenta previa,placenta abruption ) 3. History of complications at previous pregnancy especially postpartum hemorrhage. 4- Maternal hypertension , current or previous history of heart disease ,liver ,Renal disorders or known coagulopathy
Sexes Eligible for Study
-----------------
Female

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

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 |
| --- | --- |
| Experimental: misoprostol<br>intrauterine 400 microgram | Drug: Misoprostol<br>* intrauterine tablets<br>|
| Active Comparator: oxytocin<br>intravenous infusion 10 units | Drug: Oxytocin<br>* intravenous<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of intraoperative blood loss |  | 30 minutes |
Bioequivalency Study of 5 mg Pilocarpine Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine Tablets, 5 mg, to SALAGEN® Tablets, 5 mg (MGI Pharma) under fasting conditions using a single-dose, 2-treatment, 2-period, crossover design.

Official Title
-----------------
A Single Dose, Two-Treatment, Two-Period, Two Sequence Crossover Bioequivalency Study of 5 mg Pilocarpine Tablets Under Fasting Conditions

Conditions
-----------------
Dry Mouth

Intervention / Treatment
-----------------
* Drug: Pilocarpine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Pilocarpine or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pilocarpine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two period, Seven day washout |
Effects of Aromatherapy on Anxiety in Invasive Radiologic Procedure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if using aromatherapy (Lavender or Bergamot) will lower anxiety in patients having invasive Radiology procedures. First, the level of anxiety is assessed prior to the procedure using a questionnaire. Then, patients are given the aromatherapy treatment during the pre-procedure period. Then, the same questions are asked to determine how anxious the patient is after the aromatherapy and before going into the procedure room. After the procedure, patients are asked to evaluate the process of the study.

Official Title
-----------------
What is the Effect of Using Aromatherapy to Reduce Anxiety in Patients Undergoing Invasive Radiologic Procedures?

Conditions
-----------------
Anxiety, Anxiety Preoperative

Intervention / Treatment
-----------------
* Drug: Lavender Oil
* Drug: Bergamot Oil
* Other: Water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for Myelogram or IR invasive procedure at investigative site Exclusion Criteria: Incapable of giving informed consent Requiring pre-medication for scheduled procedure Allergy to lavender or bergamot Asthma (type of breathing related condition) COPD (Chronic Obstructive Pulmonary Disorder - breathing disease) Respiratory issues requiring oxygen therapy

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lavender<br>Lavender oil | Drug: Lavender Oil<br>* Lavender essential oil applied to cotton ball (3 drops) and placed in a medicine cup on bedside table<br>* Other names: Lavendula angustifolia;|
| Experimental: Bergamot<br>Bergamot oil | Drug: Bergamot Oil<br>* Bergamot essential oil applied to cotton ball (3 drops) and placed in a medicine cup on bedside table<br>* Other names: Citrus bergamia;|
| Placebo Comparator: Water<br>Water | Other: Water<br>* Tap water applied to cotton ball (3 drops) and placed in a medicine cup on bedside table<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety level of patients | Assessed with Amsterdam Preoperative Anxiety and Information Scale | Immediately prior to invasive radiologic procedure |
Postmarketing Surveillance Study to Assess Handling and Patient Satisfaction on Berodual® Respimat® Solution for Inhalation in Comparison to a Powder Inhaler in Patients With Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
New perceptions about handling and patient satisfaction of the everyday use of Berodual® Respimat® compared to a powder inhaler in patients with chronic obstructive lung disease (COLD). Moreover, further knowledge should be attained about the tolerability of Berodual® Respimat®

Official Title
-----------------
Berodual® Respimat® 20/50 Microgram/Dose Solution for Inhalation: Assessment of Handling and Patient Satisfaction in Comparison to a Powder Inhaler

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Berodual® Respimat® - inhaler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients aged at least 18 years Patients who are suffering from symptoms of a chronic obstructive lung disease (COLD) can be included in the PMS. To reduce influences caused by the use of a variety of different powder inhaler, only patients who are already regularly using Diskus® powder inhaler should be included, as the Diskus® as well as the Berodual® Respimat® are multiple dose devices During the PMS the Diskus® therapy is to be continued Exclusion Criteria: Patients who meet one or more of the general or specific contraindications mentioned in the Summary of Product Characteristics (SmPC) are excluded from the Postmarketing Surveillance (PMS)

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 |
| --- | --- |
| chronic obstructive pulmonary disease patients<br> | Drug: Berodual® Respimat® - inhaler<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events |  | up to 4 weeks | 
| Number of patients who prematurely discontinued therapy with Berodual® Respimat® |  | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of patient satisfaction with regard to handling of Berodual® Respimat® inhaler | by means of a patient satisfaction and preference questionnaire (PASAPQ) | up to 4 weeks | 
| Assessment of patient satisfaction with regard to handling of Diskus® inhaler | by means of patient satisfaction and preference questionnaire (PASAPQ) | Baseline |
Clinical Decision Unit (CDU) - Evaluation of a Novel Approach to Address Emergency Department Overcrowding

Study Overview
=================
Brief Summary
-----------------
This randomized controlled trial will introduce a Clinical Decision Unit (CDU) into the University of Alberta Hospital Emergency Department(ED)and assess the influence on ED length of stay, patients who leave without being seen, and other ED Overcrowding outcomes.

Detailed Description
-----------------
The study will take place over a 6-week period that will be spilt into three-two-week blocks. Using computerized blocks of 2 weeks, days of the week will be randomly allocated so that each day of the week receives one intervention (CDU) and one control day for the study period. The CDU involves transforming an ED bed location to a 6-chair internal waiting room with 2 adjacent beds assigned to act as assessment and treatment locations. Patients will transition between the chair and stretcher to optimize the use of ED space.

Official Title
-----------------
Clinical Decision Unit (CDU) - Evaluation of a Novel Approach to Address Emergency Department Overcrowding

Conditions
-----------------
Acute Illness

Intervention / Treatment
-----------------
* Behavioral: Clinical Decision Unit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only adult patients (>17 years of age) presenting to the University of Alberta Hospital Emergency Department (UAH ED), during the study interval will be included in the evaluation. Exclusion Criteria: Direct admits/Pediatric patients.

Ages Eligible for Study
-----------------
Minimum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>regular use of the 2-bed areas in the Emergency department | Behavioral: Clinical Decision Unit<br>* a dedicated 2-bed area to see patients and then rotate them back into the waiting room area for labs and diagnostic imaging.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total ED length of stay |  | in the Emergency Department | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left without being seen (LWBS) rates |  | in the Emergency Department | 
| nurse and physician satisfaction |  | following Emergency Department shift | 
| ambulance turnaround times (time |  | in the Emergency Department | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Emergency department, administration, overcrowding
Postencephalitic Symptoms After Tick Borne Encephalitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess clinical outcome in patients with tick borne encephalitis.

Official Title
-----------------
Postencephalitic Symptoms After Tick Borne Encephalitis

Conditions
-----------------
Central European Encephalitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: serologically proved tick borne encephalitis in patients > 15 years Exclusion Criteria: pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Patients with tick borne encephalitis.<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective sequelae and subjective symptoms in patients after tick borne encephalitis. |  | 1 year follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of subjective symptoms between patients after tick borne encephalitis and control subjects without a history of tick borne encephalitis. |  | 1 year follow-up. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tick borne encephalitis, clinical outcome, postencephalitic symptoms
Complementary and Alternative Medicine in Patients With Inflammatory Bowel Disease. A Cross Sectional Study in Norway.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the proportion of use of complementary and alternative medicine (CAM) in patients with inflammatory bowel disease (IBD). In addition, the reason for, and satisfaction with use of CAM.

Official Title
-----------------
Complementary and Alternative Medicine in Patients With Inflammatory Bowel Disease. A Cross Sectional Study in Norway.

Conditions
-----------------
Inflammatory Bowel Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients >18 years and with verified diagnosis of Crohn's disease or ulcerative colitis attending an outpatient clinic in a Norwegian hospital. Exclusion Criteria: Patients <18 years.

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Complementary and alternative medicine, HRQoL, Inflammatory bowel disease