linjc16/ctgov huggingface dataset:
Automated Parkinson's Disease (PD) Motor Symptom Assessment for Deep Brain Stimulation (DBS) Programming

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the utility of a portable motion sensor-based system designed to assist with deep brain stimulation (DBS) programming sessions for Parkinson's disease patients.

Conditions
-----------------
Parkinson's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hoehn and Yahr stage 2 or worse when off medications Average tremor and/or bradykinesia Unified Disease Rating Scale (UPDRS) score greater than 2 off meds L-dopa responsive with clearly defined on periods, UPDRS motor III average tremor and bradykinesia improves by 25% Stable on medical therapy for at least one month prior to study enrollment Clinical approval to undergo unilateral DBS surgery targeting the STN or GPi Available to participate for six months following DBS surgery Exclusion Criteria: Parkinson's plus syndromes, secondary, or atypical Parkinson's syndromes (e.g. progressive supranuclear palsy, striato-nigral degeneration, multiple system atrophy, post-stroke, post-traumatic, or post-encephalitic Parkinson's. These patients have cardinal symptoms characteristic of PD but with additional symptoms indicating other organic brain dysfunction, such as gaze palsies, autonomic dysfunction, lack of response to L-dopa, these individuals tend not to improve with standard treatments for PD) previous Parkinson's Disease surgery medical contraindications to surgery or stimulation (e.g. uncontrolled hypertension, advanced coronary artery disease, other implanted stimulation or electronically-controlled devices including cardiac demand pacemaker, aneurysm clips, cochlear implants, or a spinal cord stimulator) (Note: for the subject who receives either a pacemaker and/or defibrillator after this study enrollment, he/she will be allowed to continue the study if the neurostimulator system can be adequately programmed to permit system compatibility) contraindication to magnetic resonance imaging (e.g. indwelling metal fragments or implants that might be affected by MRI) neuropsychological dysfunction (e.g. dementia) that would contraindicate surgery intracranial abnormalities that would contraindicate surgery (e.g. stroke, tumor, vascular abnormality affecting the target area)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 90 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
deep brain stimulation, monopolar review, motion sensors, tremor, bradykinesia
PLAIAR-Trial: Platelets in Inflammation and Resolution

Study Overview
=================
Brief Summary
-----------------
Detection and determination of platelets in bronchoalveolar lavage fluid and blood in ARDS and non-ARDS-patients. Correlation with phenotype and inflammation parameters in blood and outcome parameters.

Official Title
-----------------
PlaIaR-Trial: Platelets in Inflammation and Resolution.

Conditions
-----------------
ARDS, Platelet Abnormality

Intervention / Treatment
-----------------
* Diagnostic Test: Bronchoscopy, blood sampling; testing.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Routine bronchoscopy Patient in perioperative setting Age >=18 years Consent Exclusion Criteria: Active or recent (in past 7 days) bleeding in upper airways Recent traumatic injury of the lung associated with (micro-)hemorrhage Blood aspiration Pregnancy Age<18 years Acute kidney injury / Chronic kidney failure / Dialysis Transplantation HIV Hematologic diseases Immunosuppression Anti-Platelet-Therapy

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pneumonia patients with ARDS<br>Patients in the perioperative/intensive care setting with pneumonia-induced ARDS requiring bronchoscopy. | Diagnostic Test: Bronchoscopy, blood sampling; testing.<br>* BAL and blood samples are measured by hematology analyzer, flow cytometry, western blot, RNAseq analysis and multiplex.<br>|
| Ventilated patients without ARDS<br>Patients without ARDS on mechanical ventilation. | Diagnostic Test: Bronchoscopy, blood sampling; testing.<br>* BAL and blood samples are measured by hematology analyzer, flow cytometry, western blot, RNAseq analysis and multiplex.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detectability and changes in platelets in BAL and blood |  | 5-7 days | 
| Organ failure, survival. |  | 1 Year | 
| Systemic platelet and leukocyte numbers |  | 5-7 days | 
| Systemic platelet and leukocyte phenotypes. |  | 5-7 days | 
| Systemic cytokine profiles. |  | 5-7 days |
Peer Debriefing Versus Instructor Debriefing for Interprofessional Simulation Based Education

Study Overview
=================
Brief Summary
-----------------
Crisis management is important for operating room practice and non-technical skills are acknowledged as key to ensure patient safety in these situations. Unfortunately, it can be difficult to find instructors with appropriate experience. A peer-led team debriefing is led by the team it self rather than an external expert instructor but remains a reflective process. Incorporating peer-led debriefing compared to expert-led debriefing may increase access to an interprofessional crisis resource management course using simulation. The goals of the study are to observe the effect of an interprofessional peer-led team debriefing in the change in performance of non-technical skills of team performance and to compare it with the gold standard of expert-led debriefing on the performance of non-technical skills during a simulated operating room crisis. The investigators hypothesize that interprofessional peer-led debriefing will improve the performance of non-technical skills of the team during simulated intraoperative crisis management and that this improvement will be equivalent to the gold standard expert-led debriefing.

Official Title
-----------------
Peer Debriefing Versus Instructor Debriefing for Interprofessional Simulation Based Education (PICS

Conditions
-----------------
Crisis Resource Management

Intervention / Treatment
-----------------
* Other: Peer-led debriefing
* Other: Expert instructor debriefing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Operating room (OR) nurses from St. Michael's Hospital and University of Toronto Anesthesia and Surgery Residents/Fellows Exclusion Criteria: OR nurses from other hospitals and Residents/Fellows from other programs

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Expert instructor debriefing<br>Expert instructor debriefing | Other: Expert instructor debriefing<br> <br> |
| Experimental: Peer-led debriefing<br>Peer-led debriefing | Other: Peer-led debriefing<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of non-technical skills of the teams. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interdisciplinary Health Team, Training
Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®

Study Overview
=================
Brief Summary
-----------------
The aim of this randomized trial is to compare the rate of radio-dermatitis grade 2+ (NCI-CTC V3.0) in patients receiving radiotherapy+Erbitux+placebo versus in patients receiving radiotherapy+Erbitux+OTD70DERM® for the treatment of head and neck carcinoma.

Official Title
-----------------
Placebo Controlled Randomized Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®

Conditions
-----------------
Head and Neck Carcinoma

Intervention / Treatment
-----------------
* Other: Radiotherapy + Erbitux® + placebo
* Other: Radiotherapy+Erbitux+OTD70DERM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Head and neck carcinoma treated by radiotherapy (70Gy) plus Erbitux Exclusion Criteria: IMRT; Concomitant chemotherapy

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Radiotherapy+Erbitux+Placebo | Other: Radiotherapy + Erbitux® + placebo<br>* 3D radiotherapy 70 Gy / 7 weeks (no IRMT); Erbitux once a week, 1 week before radiotherapy and during radiotherapy ; Placebo local application, once a day, every day during the radiotherapy<br>|
| Experimental: OTD70DERM<br>Radiotherapy+Erbitux+OTD70DERM® | Other: Radiotherapy+Erbitux+OTD70DERM<br>* 3D radiotherapy 70 Gy / 7 weeks (no IRMT); Erbitux once a week, 1 week before radiotherapy and during radiotherapy ; OTD70DERM local application, once a day, every day during the radiotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radio-dermatitis grade 2, 3, 4 (NCI-CTC V3) | Radio-dermatitis grade 2, 3, 4 (according to the NCI-CTC V3. Radio-dermatitis will be evaluated twice a week during radiotherapy and at M1, M2 and M3 after end of treatment. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Quality of life by the Dermatology Life Quality Index (DLQI) | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Head and neck carcinoma treated by radiotherapy plus erbitux
Prediction of Post-Cesarean Section Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if dynamic psychophysical testing along with genetic screening will allow to identify pre-operatively women who will suffer severe acute pain post-operatively and the subset who may experience chronic pain following cesarean section.

Official Title
-----------------
Prediction of Post-Cesarean Section Pain

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Other: Psychophysical testing, questionnaires, and genetics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women age 18-50 scheduled for an elective cesarean section (1st or 2nd cesarean section) Exclusion Criteria: Women who: have taken opioids, acetaminophen, or NSAIDs 48 hrs prior to psychophysical testing have had more than two previous cesarean sections have a vertical abdominal incision from a prior cesarean section are non-English speaking have mental health issues have a failure of spinal anesthetic and require conversion to general anesthesia have a vertical uterine incision performed during ongoing cesarean section have a previous vertical uterine scar discovered during ongoing cesarean section

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with a scheduled cesarean section<br> | Other: Psychophysical testing, questionnaires, and genetics<br>* pre-operative psychophysical testing of endogenous pain modulation, pre-operative questionnaires, peri- and post-operative data collection, long term follow-up assessing chronic pain, SNP association analysis, and whole genome scanning association studies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Product Validation Study of 2 New Devices, EZ-NG (RightSpot pH Indicator) and EZ-pH (RightLevel pH Indicator)

Study Overview
=================
Brief Summary
-----------------
EZ Holdco Inc. has developed two devices for the measurement of gastric content pH. The devices, EZ-NG and EZ-pH, rapidly check gastric pH by aspirating gastric contents into the device through a nasogastric (NG) tube and causing a color change in the device. The color change is then compared to the reference indicator on the device to determine a pH value of the aspirate. Currently there is no bedside rapid way to check gastric pH that protects the clinician from being exposed to the aspirate. Primary Objective To assess the accuracy of the pH measurement of gastric fluid on the devices by comparing the reading on the 2 devices to a standard clinically approved pH probe. Secondary Objective To determine what percentage of time the EZ-NG - RightSpot pH indicator could have been used to determine proper placement of the NG tube when initially placed.

Official Title
-----------------
Product Validation Study of 2 New Devices, EZ-NG (RightSpot pH Indicator) and EZ-pH (RightLevel pH Indicator)

Conditions
-----------------
Small Bowel Obstruction, Colectomy, Bowel Surgeries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consented elective surgical patient Exclusion Criteria: -
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 |
| --- | --- | --- |
| 1. Primary Objective To assess the accuracy of the pH measurement of gastric fluid on the devices by comparing the reading on the 2 devices to a standard clinically approved pH probe. |  | 60 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2. Secondary Objective To determine what percentage of time the EZ-NG - RightSpot pH indicator could have been used to determine proper placement of the NG tube when initially placed. |  | 60 min |
Safety and Efficacy Study of NovoRapid™ in Patients With Coexisting Diabetes and Kidney Disease

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this observational study is to investigate the clinical safety profile and effectiveness while using SC NovoRapid™ (insulin aspart) in patients with coexisting diabetes and kidney disease under normal clinical practice conditions in India.

Official Title
-----------------
A Multicenter, Open Label, Nonrandomized, Non Interventional, Observational, Safety and Efficacy Study of NovoRapid™(Insulin Aspart) in Patients With Coexisting Diabetes and Kidney Disease in India. The NovoRapid™ Nephropathy Study

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any subject with coexisting kidney disease and type 1 or type 2 diabetes is eligible for the study, including: newly-diagnosed subjects, insulin naïve and subjects who have received insulin or an insulin analogue before Subjects with kidney disease (stage I-IV) including transplant patients will be eligible for the study, if initiated with NovoRapid™ Exclusion Criteria: Subjects who are unlikely to comply with protocol requirements, e.g., uncooperative attitude, inability to return for the final visit Subjects with stage V of chronic kidney disease Subjects who previously enrolled in this study Known or suspected allergy to trial product(s) or related products

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 |
| --- | --- |
| A<br> | Drug: insulin aspart<br>* Safety and effectiveness data collection in connection with the use of the drug NovoRapid™ in patients with coexisting diabetes and chronic kidney disease in daily clinical practice.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major hypoglycaemic episodes |  | during 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of serious adverse events |  | during 26 weeks | 
| Number of serious adverse drug reactions |  | during 26 weeks | 
| Number of all daytime and nocturnal major hypoglycaemic events |  | during 26 weeks | 
| Number of major hypoglycaemic events related to omission of a meal after injection |  | during 26 weeks | 
| Number of all minor (daytime and nocturnal) hypoglycaemic events |  | during 4 weeks proceeding each study visits during Insulin Aspart (NovoRapidTM) therapy |
Can CT Enteroclysis Predict the Outcome of Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
Specific CT Enteroclysis findings with or without other clinical and laboratory variables, can identify Crohn's disease patients who will response to medical therapy versus those who will either fail and require surgery or have uncontrolled disease.

Official Title
-----------------
Can CT Enteroclysis Predict the Response to Therapy and Outcome in Patient With Crohn's Disease

Conditions
-----------------
Crohn's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Crohn's disease with CT Enteroclysis during symptomatic treatment Exclusion Criteria: Crohn's disease subjects who have had a follow-up less than 1 year, without surgery Crohn's disease subjects that were later diagnosed with a bowel malignancy

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 |
| --- | --- |
| CTE with CD<br>Crohn's disease patients who underwent a CT enteroclysis as part of their clinical evaluation for symptomatic Crohn's disease. | |

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
-----------------
Crohn's Disease, CT Enteroclysis
Reproducibility of Ankle Brachial Index After Maximal Exercise

Study Overview
=================
Brief Summary
-----------------
Hemodynamic changes in the lower limbs are very important and rapid after maximal exercise. The automatic method allows a fastest measurement of the Ankle-Brachial Index (ABI). Thus, it appears important to know whether automatic assessment of ABI is as reliable and reproducible as the manual method.

Detailed Description
-----------------
Two methods are mainly used to determine the blood pressure at rest, in a non-invasive way, in order to calculate the Ankle-Brachial Index (ABI). The first method, using a manual sphygmomanometer coupled with a Doppler probe, is considered as the reference method. The second method requires at least one automatic sphygmomanometer. Data from the literature show that these two methods are reproducible to assess ABI at rest. Some authors have reported a better reproducibility of measurements with automatic tool. Others consider that the current accuracy of automatic measurement is insufficient to replace the reference method Doppler. Thus, the aime of the present study is to evaluate whether automatic assessment of ABI is as reliable and reproducible as the manual method.

Official Title
-----------------
Reproducibility of the Ankle-Brachial Index Measurements After a Maximal Exercise

Conditions
-----------------
Normal Subjects

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant between 18 and 40 years old Informed consent signed Exclusion Criteria: Do not want to participate to the protocol Pregnant woman Adults to enhanced protection, deprived of their liberty by judicial or administrative authority, without consent hospitalized or admitted to a health facility or social purposes other than research Being in a period of exclusion from another biomedical study Amputee or with a member dysgenesis Not allowed to perform a maximal exercise

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test-retest difference in ankle to brachial pressure index | Comparison of differendces observed on test-retest measures with manual and automatic measurements | up to 2 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of recordings. | Comaprison of the time needed to complete the recording with automatic vs. manual techniques | up to 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ankle Brachial Index, Maximal exercise