linjc16/ctgov huggingface dataset:
A Study of Motexafin Gadolinium for the Treatment of Relapsed or Refractory Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if the drug motexafin gadolinium will be an effective treatment for patients who have relapsed or refractory multiple myeloma.

Official Title
-----------------
An Open-Label Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Motexafin Gadolinium Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapsed or Refractory Multiple Myeloma ≥ 18 years old Able to provide consent for participation ECOG status 0-2 Lab values: ANC ≥ 1,000/µL WBC count ≥ 2.0/µL Hemoglobin ≥ 8.0 g/dL Platelet count ≥ 50,000/µL AST and ALT ≤ 2 x ULN Total Bilirubin ≤ 2 x ULN Creatinine ≤ 2.0 mg/dL and Not pregnant or lactating

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Motexafin Gadolinium Injection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complete response, partial response and stable disease (clinical benefit rate) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  |  | 
| Safety and tolerability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myeloma, Multiple Myeloma, Relapsed Multiple Myeloma, Refractory Multiple Myeloma
Microarray Analysis of Sinus Samples From Patients With and Without Chronic Rhinosinusitis.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the bacteria, fungi, and viruses that are present in the sinuses of patients with chronic rhinosinusitis to patients without sinus disease using a new technology, called a microarray, that will allow more accurate identification of microorganisms than current laboratory methods.

Official Title
-----------------
Microarray Analysis of Sinus Samples From Patients With and Without Chronic Rhinosinusitis.

Conditions
-----------------
Chronic Rhinosinusitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older History of chronic rhinosinusitis (CRS) Impaired CRS-specific quality of life Evidence of sinus disease on a CT scan Exclusion Criteria: Control patients with any evidence of CRS by history, survey, or imaging criteria

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 |
| --- | --- | --- |
Effective Endurance Training in Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
To see how fast and how much physical training can reduce risk factors related to metabolic syndrome

Official Title
-----------------
Effective Endurance Training in Metabolic Syndrome

Conditions
-----------------
Impaired Glucose Tolerance, Overweight, Hypertension, Dyslipidemia

Intervention / Treatment
-----------------
* Behavioral: exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: insulin resistance, impaired glucose tolerance or type 2-diabetes, including two or more of the following factors: Blood pressure ≥ 140/90 mm Hg, Triglycerides Fasting ≥ 1,7 mmol/l, and/or low HDL-cholesterol (≤ 0,9 mmol/l in men, ≤ 1,0 mmol/l in women) Obesity, Waist-hip ratio ≥ 0,9 in men, ≥ 0,85 in women or BMI (body mass index) ≥ 30 kg/m2 Microalbuminuria (albumin secretion ≥ 20 mg/l or 20 - 200 g per minute) Exclusion Criteria: -

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: exercise training|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To reduce risk factors related to metabolic syndrome |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve endothelial functions in patient with metabolic syndrome |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise, Exercise therapy
Assessment of Tele-expertise for Second Medical Opinion on Pathological Diagnosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether digitalizing pathological slides and let it accessible on a server for a second medical opinion (tele-expertise) would reduce the time to diagnosis.

Official Title
-----------------
Assessment of Tele-expertise for Second Medical Opinion on Pathological Diagnosis

Conditions
-----------------
Anatomical Pathological Condition

Intervention / Treatment
-----------------
* Device: During tele-expertise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients in need for a second medical opinion on a pathological sample 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 |
| --- | --- |
| Before tele-expertise<br>Usual second opinion with pathological slides sent by mailing | |
| During Tele-expertise<br>Second opinion with tele-expertise | Device: During tele-expertise<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delay of second medical opinion | Between preparation of the slide and the result | Up to 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of second medical opinion requested |  | During the whole study (around 8 months) | 
| Overall costs | Sum of the durations of the professionals immobilization for performing a diagnosis x wages + costs of the telemedicine solution development and implementation. | Within 6 months after the start of tele-expertise | 
| Number of times that the pathologist who gave the second opinion required the original material |  | During the whole study (around 8 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Second opinion
Evaluation of the Sleep Hygiene in the Lebanese Population During the COVID-19 Confinement Period.

Study Overview
=================
Brief Summary
-----------------
The term sleep hygiene refers to a series of healthy sleep habits that can improve the ability to fall asleep. These habits are the most effective long-term treatment for people with chronic insomnia. The Sleep Hygiene Index is a 13-item questionnaire that evaluates these habits. We are in the process of validation of this questionnaire in the arabic language. We will evaluate these habits in the Lebanese population during the COVID-19 confinement period.

Detailed Description
-----------------
The sleep hygiene will be evaluated during the COVID-19 confinement period. The Sleep Hygiene Index with other questions will be applied to the Lebanese population in english and arabic. It will be distributed by the means of WhatsApp and Facebook.

Official Title
-----------------
Evaluation of the Sleep Hygiene in the Lebanese Population During the COVID-19 Confinement Period.

Conditions
-----------------
Sleep Hygiene

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lebanese living in Lebanon, 18 YO and over, understanding written english or arabic. Exclusion Criteria: Not having the inclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Lebanese population<br>The Sleep Hygiene Index with other demographic questions will be applied to the Lebanese population. | Other: Questionnaire<br>* Sleep Hygiene Index and demographic questions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Hygiene |  | 30/04/2020 to 30/12/2020 |
Assessment of Utility of accelerateIQ in the Care of Patients Participating in a Pulmonary Rehabilitation Program

Study Overview
=================
Brief Summary
-----------------
The proposed study seeks to assess the performance of continuous biosensor data and machine learning analytics in assessment of health patient status in a pulmonary rehabilitation program. It is hypothesized that using continuous physiologic biosensor data and machine learning analytics to detect changes in physiology may play a role in managing patients in the pulmonary rehabilitation setting.

Official Title
-----------------
Assessment of Utility of accelerateIQ in the Care of Patients Participating in a Pulmonary Rehabilitation Program

Conditions
-----------------
COPD, Pulmonary Rehabilitation

Intervention / Treatment
-----------------
* Other: pinpointIQ


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, at least 40 years of age; Diagnosis of Chronic Obstructive Pulmonary Disease (COPD); Enrolled in the study site's 12-week pulmonary rehabilitation program; Capable of completing a 6-minute walk test; Willing and able to comply with scheduled protocol procedures and follow up; Signed and dated informed consent and HIPAA materials indicating that the patient has agreed to participate in this study and has been informed of all pertinent aspects of the trial. Exclusion Criteria: Patient has cognitive or physical limitations that, in the opinion of the investigator, limit the patient's ability to utilize the System as instructed; Patient is actively enrolled in another clinical investigation that, in the opinion of the investigator, interferes with or compromises either that patient's ability to participation in this study or the ability for the study to generate results; Patients who have implanted defibrillators or pacemakers; Patient is allergic to hydrocolloid adhesive; Patient does not speak English.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: pinpointIQ|The study will utilize physIQ's multivariate analytical methods that detect vital sign relationship changes compared to a patient's individual baseline. Changes in vital signs relationships may be indicative of current or future important clinical events. These changes are indicated through the Multivariate Change Index (MCI), which is a scalar index between 0 and 1, where values close to 0 indicate no significant change from baseline and values close to 1 indicated greater changes from baseline|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Utility | Correlation of reported health events with the multivariate change index | 90 days |
Telephone Enhancement Procedure for Continuing Care - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test a feasibility study of a telephone enhancement procedure (TELE) to improve participation in continuing care activities.

Official Title
-----------------
Telephone Enhancement Procedure (TELE) for Continuing Care

Conditions
-----------------
Substance-Related Disorders

Intervention / Treatment
-----------------
* Behavioral: Behavior Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Residential substance abuse treatment patients who reside within the pre-specified catchment area who complete continuing care plans prior to discharge. Voluntary admit to residential treatment center; substance abuse or dependence; reside in targeted counties; and may be reached by telephone.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Behavior Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment compliance, drug and alcohol astinence |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
behavioral intervention
Using ICDAS II and KaVo DIAGNOdent Pen Detecting Tooth Pit and Fissure Level Incipent Caries Progression

Study Overview
=================
Brief Summary
-----------------
The study was to monitor effectiveness of glass ionomer sealant and resin-based sealant in ICDAS, and to evaluat the correlation between ICDAS and DIAGNOdent over 24 months. Over 200 8-year-old children with at least 2 permanent molar with the International Caries Detection and Assessment System (ICDAS) scores 0-4 were placed glass ionomer sealant and resin-based sealant split-mouthed randomly, and examined with ICDAS and DIAGNOdent before sealents placement and 6, 12 and 24 months after.

Conditions
-----------------
Dental Caries on Pit and Fissure Surface

Intervention / Treatment
-----------------
* Other: glass ionomer sealants
* Other: resin-based sealant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects provided written informed consent; They were 7 to 9 years old; They have at least 2 permanent molar with the International Caries Detection and Assessment System (ICDAS) scores 0-4; They were generally heallthy Exclusion Criteria: They were allergic to the constituents in pit and fissure sealants

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 9 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: glass ionomer sealant<br> | Other: glass ionomer sealants<br> <br> |
| Active Comparator: resin-based sealant<br> | Other: resin-based sealant<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Decayed Surfaces (DS) of Different Fissure Sealants | Count of DS in different ICDAS cut-off( including D1-6S, D1-2S, D3-6S, D4-6S and D5-6S) in the baseline and 6-month, 12-month and 24-month follow-up. | Baseline, 6 months, 12 months and 24 months | 
| Change in Repaired Sealants by the baseline ICDAS | Evaluation the numbers of tooth surface in which the fissure sealants were in the status partially retained or completely lost, and ICDAS score were increasing from the baseline to the 3 follow-ups. | 6 months, 12 months and 24 months | 
| Change in DIAGNOdent Score | The peak value of DIAGNOdent was recorded after repeating it 3 times in the baseline and 3 follow-ups | Baseline, 6 months, 12 months and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICDAS, DIAGNOdent, glass ionomer sealant, resin-based sealant, pit and fissure sealants, effectiveness of preventing caries
The Correlation Between Hair Cortisol Level of Acute Stroke or Its Long Term Disability.

Study Overview
=================
Brief Summary
-----------------
In patients admitted to hospital with acute cerebrovascular stroke, we want to study the relationship between hair cortisol levels and biomarkers of inflammation and the clinical and radiological severity of the stroke and the degree of neurological disability being tested in three months and one year after.

Detailed Description
-----------------
The study will include patients hospitalized due to an acute cerebrovascular stroke. A number of 30 patients aged 40-70 will be included. Within 48 hours of the event, blood inflammatory biomarkers, and scalp hair sample for cortisol will be taken. All recruited patients will undergo full neurological examination and the severity of the stroke will be rated using NIHSS (National Institutes of Health Stroke Scale). 3 months and one year later neurological examination and rating of neurological disability will be determined using Rankin Scale.

Official Title
-----------------
The Correlation Between Hair Cortisol Level of Acute Stroke or Its Long Term Disability.

Conditions
-----------------
Cerebrovascular Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 40-80. Acute cerebrovascular stroke (symptoms that began no more than 72 hours before) Rankin 0-1 before the event Exclusion criteria: Suspicion or known Cushing's syndrome Known adrenal failure Chronic inflammatory disease Active malignancy Acute infectious disease within 4 months before enrollment

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Anti Tumor Necrosis Factor alpha | single blood sample will be drawn to measure Anti Tumor Necrosis Factor alpha levels (pg/ml). | 24 months | 
| C-reactive protein levels | single blood sample will be drawn to measure c-reactive protein levels (mcg/dl). | 24 months | 
| Hair Cortisol level | single hair sample will be drawn to measure cortisol levels (mcg/dl) | 24 months | 
| INL-6 | single blood sample will be drawn to measure INL-6 levels. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TSH | single blood sample will be drawn to measure Thyroid-Stimulating Hormone (mcIU/ml). | 24 months | 
| FT4 | single blood sample will be drawn to measure Free Thyroxine (pmol/L) . | 24 months | 
| FT3 | single blood sample will be drawn to measure Free Triiodothyronine (pmol/L). | 24 months | 
| Cortisol | single blood sample will be drawn to measure cortisol levels (mcg/dl). | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute cerebrovascular stroke
Validation of a Novel Non-invasive Continuous Blood Pressure Monitor in Children Ages 2- 17 Years-old

Study Overview
=================
Brief Summary
-----------------
This is a prospective observational study to investigate if a non-invasive blood pressure monitoring device, the CareTaker Pulse Decomposition Analysis (PDA), can accurately measure blood pressure in children when compared to an arterial line. Enrolled patients will have the CareTaker PDA device placed on their finger during their operation to collect data for 30 minutes. Blood pressure readings from the CareTaker PDA device will be compared to measurements from the patient's indwelling arterial line, which will be placed as part of the patient's clinical care plan.

Official Title
-----------------
Validation of a Novel Non-invasive Continuous Blood Pressure Monitor in Children Ages 2- 17 Years-old

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Device: CareTaker PDA Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Plan to receive an invasive arterial blood pressure monitor as part of their anesthesia care plan at the BCH Longwood campus Exclusion Criteria: Patients with vascular or congenital heart disease known to affect large and small arteries Patients who declined to participate.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 Years

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

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

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 |
| --- | --- |
| Other: All Enrolled Patients<br>Patients will wear the Caretaker Pulse Decomposition Analysis (PDA) Device, which will record the patient's blood pressure. | Device: CareTaker PDA Device<br>* Non-invasive blood pressure monitoring<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure Comparison | The accuracy of blood pressure measurements taken from the non-invasive blood pressure device will be compared to measurements taken from the patient's indwelling arterial line, which will be place as part of standard of care. | One hour during procedure |