linjc16/ctgov huggingface dataset:
Musculoskeletal Pain in Patients With Covid-19 Who Have Hospital Care

Study Overview
=================
Brief Summary
-----------------
Worldwide, the COVID-19 pandemic continues to grow. Although COVID-19 mainly affects the lungs and internal organs, musculoskeletal injury from this disease was reported with the presentation of marked elevation in creatine kinase and lactate dehydrogenase levels. Patients with post-acute COVID-19 are considered patients with a post-intensive syndrome (PICS) that results in loss of functional independence. In the physical and rehabilitation medical field, various modalities with therapeutic exercise can be used to manage pain by a physical therapist and psychiatrist. Pain management is particularly important during the COVID-19 pandemic because of the reduced accessibility to hospitals and medical resources.

Detailed Description
-----------------
The COVID-19 survivors with pain symptoms will participated. In this phase, a face-to-face interview will be conducted to collecting all outcomes about pain.

Official Title
-----------------
After the First and Second Wave in Italy: What Effects of Musculoskeletal Pain Did the Covid-19 in Patients Who Have Hospital Care?

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Other: Interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recovered from COVID-19 infection. COVID-19 survivors after hospitalization. Musculoskeletal pain. Exclusion Criteria: Participants will be excluded also if they score greater than 6 points on the Beck Depression Inventory (BDI) or more than 30 points in the State Trait Anxiety Inventory (STAI), dementia and not Italian speaking due to the high level of language skills required for questionnaires and quantitative sensory testing. Psychiatric or neurological disorders

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Interview|This interview will be conducted to collecting all outcomes about musculoskeletal pain in COVID-19 survivors|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported Version of the Leeds Assessment of Neuropathic Symptoms and Signs | the characterization of the pain. Total of 24. > 11 neuropathic pain. | Baseline | 
| PainDETEC | the characterization of the pain | Baseline | 
| EuroQol-5D | To measure quality of life, grade ranging from 0 (the worst possible health status) to 100 (the best possible health status) | Baseline | 
| The Hospital Anxiety and Depression Scale | To measure psychological status. 0-7 = Normal; 8-10 = Borderline abnormal (borderline case), 11-21 = Abnormal (case) | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid19, Pain, musculoskeletal
Open-Label Comparative Study of Risperidone Versus Olanzapine Versus Quetiapine for Mania in Children and Adolescents With Bipolar I and Bipolar II Disorder

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to compare the safety and effectiveness of Risperidone, Olanzapine, and Quetiapine in the treatment of mania in children and adolescents with Bipolar disorder over 8 weeks and then over an extension phase. This is an exploratory, open-label study, which seeks to determine if there is evidence for efficacy. The results of this study will be used to generate hypotheses for a larger study.

Conditions
-----------------
Bipolar Spectrum Disorder

Intervention / Treatment
-----------------
* Drug: Risperidone
* Drug: Olanzapine
* Drug: Quetiapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females age 6 to 18 years of age Patient must have a diagnosis of bipolar I or bipolar II disorder and currently displaying an acute manic, hypomanic, or mixed episode (with or without psychotic features) according to the DSM-IV based on clinical assessment and confirmed by structured diagnostic interview (Kidd Schedule of Affective Disorders). Patients must have an initial score on the Y-MRS total score of at least 15. Patient must be able to participate in mandatory blood draws. Patient must be able to swallow pills. Exclusion Criteria: Patients with chronic medical illness, DSM-IV substance dependence within the past 6 months, pregnant or nursing females, and those at serious risk of suicide will be excluded from the study

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Risperidone|Open treatment with Risperidone|
|Drug: Olanzapine|Open treatment with Olanzapine|
|Drug: Quetiapine|Open treatment with Quetiapine|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Young Mania Rating Scale | Improvement defined as score reduction of 30% or greater. | baseline to 8 weeks |
Impact of Infliximab in Fistulizing Crohn's Disease on Health Care Resources (Study P04204)(TERMINATED)

Study Overview
=================
Brief Summary
-----------------
A multi-centre retrospective review of fistulizing Crohn's disease (CD) patient charts will capture data to measure health care resource utilization associated with the use of Infliximab for treatment of CD. Three health science centres/hospitals from Ontario are targeted to participate in the study, each site is expected to provide 30-40 patient charts with a target of 108 charts total.

Detailed Description
-----------------
This study population was chosen from a non-probability sample.

Official Title
-----------------
Infliximab Use in Fistulizing Crohn's Disease: Impact on Health Care Resources

Conditions
-----------------
Crohn Disease

Intervention / Treatment
-----------------
* Biological: Infliximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment with infliximab for fistulizing CD. Administration of at least one infliximab infusion >=12 months before the chart review. 18 years of age or over (men and women). Exclusion Criteria: Subjects not followed for a full year after their first infusion of infliximab. Subjects not followed for a full year prior to their first infusion of infliximab. Subjects who had participated in clinical studies during the data collection timeframe.

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 |
| --- | --- |
| Infliximab<br>Because of the difficulty of finding subjects with exactly the same disease severity, information will be recorded for the time period for up to three years before and for one year after their initial infliximab infusion for comparison of health care costs and utilization prior to infliximab and post infliximab use. | Biological: Infliximab<br>* None available in the protocol. This was a chart review study, therefore no Infliximab provided during the study.<br>* Other names: SCH 215596;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To quantify the impact of infliximab therapy on the Canadian healthcare resource utilization as expressed as incidence per year. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To quantify the impact of infliximab therapy on healthcare resource utilization as expressed in Canadian dollars. |  | 1 year |
Evaluating Behavioral Treatments to Improve Adherence to CPAP in People With Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person repeatedly stops breathing or experiences shallow breathing for short periods of time during sleep. The most common treatment for OSA is the use of a continuous positive airway pressure (CPAP) machine, but many people have trouble adhering to the treatment schedule. This study will evaluate the effectiveness of two behavioral therapy programs used in combination with CPAP for improving treatment adherence in people with OSA.

Official Title
-----------------
Evaluating Behavioral Treatments to Improve Adherence to Continuous Positive Airway Pressure (CPAP) Therapy in People With Obstructive Sleep Apnea

Conditions
-----------------
Adherence to CPAP in Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Behavioral: Motivational Enhancement Therapy
* Behavioral: Educational Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OSA confirmed by polysomnography (PSG) CPAP is the prescribed form of treatment for OSA Judged by sleep physician to respond to CPAP Exclusion Criteria: Apnea/hypoxia index (AHI) less than 15 Diagnosis of another sleep disorder that causes arousals from sleep Past treatment for OSA Current substance abuse problem Diagnosis of a serious medical condition that would interfere with involvement in the study History of a major psychiatric disorder, other than depression Change in antidepressant medication in the 3 months before study entry

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Motivational Enhancement Therapy<br>MET will involve counseling sessions and phone calls, with a focus on building self-efficacy and providing personalized feedback on health and adherence patterns based on CPAP adherence monitoring. | Behavioral: Motivational Enhancement Therapy<br> <br> |
| Active Comparator: Educational Counseling<br>ED will involve sessions and phone calls that include educational information, problem-solving, and adherence feedback from study staff. | Behavioral: Educational Counseling<br> <br> |
| No Intervention: Standard Care<br> | |

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
-----------------
Obstructive Sleep Apnea, OSA, Adherence, CPAP, Cognition
Sudden Death Stratification

Study Overview
=================
Brief Summary
-----------------
Sudden cardiac death (SCD) risk stratification is a challenge in non-ischemic cardiomyopathy (NICM). The underlying mechanism of monomorphic ventricular tachycardia (VT) is mostly scar related. While electrophysiological mechanisms underlying ventricular arrhythmia are well known, late gadolinium enhanced (LGE) cardiac MRI-3D reconstructions are now able to guide VT ablation procedures. Such exam may help in identifying specific properties of scar at risk of malignant arrhythmia.

Official Title
-----------------
Channel Detection to Predict Ventricular Arrhythmia in Patients With Non-ischemic Cardiomyopathy

Conditions
-----------------
Non-ischemic Cardiomyopathy

Intervention / Treatment
-----------------
* Diagnostic Test: Cardiac MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult with NICM Previous history of ventricular tachycardia (VT) and no previous history of VT Exclusion Criteria: Inherited cardiomyopathies Previous history of myocarditis WITHOUT oedema/scar at the MRI
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ventricular tachycardia (VT) group<br>NICM patients admitted for a VT ablation with a pre-operative cardiac- MRI. | Diagnostic Test: Cardiac MRI<br>* Comparison of scar characteristics on cardiac MRI between the two groups.<br>|
| Control group<br>NICM patients without ventricular arrhythmia and a previous cardiac-MRI. The matching with the VT group was based on the age of the patients, the mean LVEF, the time between the initial diagnosis and the MRI examination, and the origin of the NICM. | Diagnostic Test: Cardiac MRI<br>* Comparison of scar characteristics on cardiac MRI between the two groups.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detect pro arrhythmogenic scar characteristics | The outcomes will aim to provide scar characteristics from 3D cardiac MRI reconstructions to detect pro arrhythmic properties in NICM patients. Comparisons between NICM patients who experienced VT ablation and NICM patients without history of ventricular arrhythmia will be made. In both groups, Primary outcome will aim to measure the number of the conducting channels into scars (n). | baseline : collected at the time of the cardiac MRI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LGE MRI, Ventricular tachycardia, sudden cardiac death, non-ischemic cardiomyopathy
The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This study is designed to estimate the effect of fluconazole (200 mg BID for 2 days), a moderate CYP3A4 inhibitor on the pharmacokinetics of a single 8 mg oral dose of fesoterodine in healthy adult subjects.

Official Title
-----------------
An Open-Label, Randomized, Two-Way Crossover Study To Evaluate The Effect Of Fluconazole, A Moderate CYP3A4 Inhibitor, On The Single-Dose Pharmacokinetics Of Fesoterodine In Healthy Subjects.

Conditions
-----------------
Overactive Bladder With Symptoms of Frequency, Urgency, and Urge Urinary Incontinence

Intervention / Treatment
-----------------
* Drug: Fesoterodine
* Drug: fesoterodine plus fluconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects between the ages of 18 and 55 years Exclusion Criteria: Not healthy subjects. subjects with acute or chronic medical or psychiatric condition or laboratory abnormality

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fesoterodine Alone<br>Reference treatment | Drug: Fesoterodine<br>* Single 8 mg oral dose of fesoterodine<br>|
| Other: fesoterodine plus fluconazole<br>Test treatment | Drug: fesoterodine plus fluconazole<br>* On Day 1, fluconazole (200 mg oral dose) will be given 1 hour before and approximately 11 hour following a single 8 mg oral dose of fesoterodine (fesoterodine SD). Fluconazole will also be administered 200 mg BID on the Day 2 (ie, at approximately 24 and 36 hours following the fesoterodine SD treatment given on Day 1)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf and Cmax of 5-HMT |  | 3 days per period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast, Tmax and half-life of 5-HMT as data permit. |  | 3 days per period | 
| Safety will be assessed by subjective symptoms/objective findings including physical examination findings, clinical safety laboratory assessments and adverse event monitoring. |  | 3 days per period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects
Validation of Noninvasive Blood Pressure Device

Study Overview
=================
Brief Summary
-----------------
This is a prospective, nonrandomized multi-center study for the investigation of noninvasive sphygmomanometers. The purpose of the study is to validate the clinical performance of the Masimo noninvasive blood pressure device compared to reference auscultatory measurements.

Official Title
-----------------
Validation of Noninvasive Blood Pressure Device

Conditions
-----------------
Healthy, Hypertension, Hypotension

Intervention / Treatment
-----------------
* Device: Masimo Noninvasive Blood Pressure Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years and older Site 1; Stage 1 only: Subjects with a history of hypertension (> 140/85 mmHg) or hypotension (< 100/60 mmHg) within the last 3 months. Stage 2 only: No criterion for blood pressure Site 2; Stage 1 and 2: Subjects with systolic blood pressure < 140/90 mmHg. Ability to provide informed consent Exclusion Criteria: Febrile subjects Subjects displaying respiratory symptoms, or with suspected respiratory illness Subjects whose skin is not intact, e.g. wounded, in or at the vicinity of the cuff placement site Subjects with removed axillary lymph nodes or mastectomies Subjects with peripheral artery disease Pregnant women (patient reported) Subjects deemed not suitable for the study at the discretion of the investigator

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test subjects<br>All subjects enrolled had blood pressure measurements taken using the noninvasive blood pressure device. | Device: Masimo Noninvasive Blood Pressure Device<br>* Non-invasive blood pressure device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean and Standard Deviation of Differences Between Masimo NIBP Device and Manual Sphygmomanometer Measurements. | Performance will be determined by calculating the mean and standard deviation of the differences between the systolic and diastolic blood pressure measurements obtained from Masimo NIBP device and manual sphygmomanometer. | 1 hour |
Post-marketing Surveillance of Donepezil Hydrochloride - Investigation of Long Term Safety and Efficacy of Aricept as Well as Its Proper Use Information in Patients With Dementia With Lewy Bodies (DLB).

Study Overview
=================
Brief Summary
-----------------
To investigate long term safety (especially about Parkinsonism) and efficacy of donepezil hydrochloride in clinical practice as well as its proper use information in participants with DLB.

Official Title
-----------------
Post-marketing Surveillance of Donepezil Hydrochloride - Investigation of Long Term Safety and Efficacy of Aricept as Well as Its Proper Use Information in Patients With Dementia With Lewy Bodies.

Conditions
-----------------
Dementia With Lewy Body Disease

Intervention / Treatment
-----------------
* Drug: Donepezil Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Naive participants diagnosed as DLB Exclusion Criteria: Participants with a history of donepezil hydrochloride product administration in the past Participants who have already been registered in this surveillance Participants with a history of hypersensitivity to any ingredients of donepezil hydrochloride or piperidine derivatives
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with DLB<br>Participants with DLB who will receive donepezil hydrochloride per approved label. | Drug: Donepezil Hydrochloride<br>* Initial dose for oral use is 3 mg once daily. The dose is increased to 5 mg after 1-2 weeks. Following at least 4 weeks of dosing at 5 mg, the dose is increased to 10 mg. The dose may be decreased to 5 mg depending on the symptoms of the participant.<br>* Other names: Aricept;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Mini-Mental State Examination (MMSE) score |  | At Week 12 | 
| Mean Mini-Mental State Examination (MMSE) score |  | At Week 24 | 
| Mean Mini-Mental State Examination (MMSE) score |  | At Week 52 | 
| Mean Revised Hasegawa's Dementia Scale (HDS-R) score |  | At Week 12 | 
| Mean Revised Hasegawa's Dementia Scale (HDS-R) score |  | At Week 24 | 
| Mean Revised Hasegawa's Dementia Scale (HDS-R) score |  | At Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) /adverse drug reactions (ADRs) |  | From Week 0 to Week 52 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Donepezil Hydrochloride, ARICEPT, Dementia, Lewy bodies, Dementia with Lewy bodies, Post-marketing surveillance