linjc16/ctgov huggingface dataset:
Reducing Musculoskeletal Stresses and Work-related Injuries Among Allied Health Professionals in Surgical Care

Study Overview
=================
Brief Summary
-----------------
What are the risk factors that contribute to musculoskeletal injuries and fatigue on allied health professionals in surgical care (e.g. scrub nurses, surgical assistants, and circulating nurses)? Can the investigators design wearable devices that the investigators can later evaluate?

Official Title
-----------------
Exposure Assessment and Intervention for Reducing Musculoskeletal Stresses and Work-related Injuries Among Allied Health Professionals in Surgical Care

Conditions
-----------------
Musculoskeletal Injury, Musculoskeletal Illness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years of age Employed at Mayo Clinic Rochester as Surgical Assistant, Circulating Nurse, and Scrub Nurse (Surgical Technicians) Exclusion Criteria, Aims 1 and 2: None

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| risk factors of musculoskeletal injuries<br>trainees for surgical assistants - determining the level of risk | |
| design wearable devices<br>Creating feedback mechanism to reduce surgical assistant musculoskeletal risk | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of awkward postures | Awkward postures will be quantified with motion tracking using an inertial measurement unit (IMU), a lightweight, small sensor. IMU data will be collected and transmitted wirelessly to a real time monitoring system. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Open-ended questionnaire on workflow and usability process to develop automated, unobtrusive, and cost-effective wearable device | Description: Open-ended questionnaire will present participants with the following questions after viewing a presentation on surgical ergonomics and vibrotactile feedback: Would this device interrupt your work; if so, in what ways, Are you concerned you may be distracted, Might it interfere with movement in any way, Could you provide feedback on the vibration settings, etc.time work postures and these data will control tactor activation. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ergonomic risk factors, allied health professionals, surgical care
Examination How the Administration Period of Teriparatide Affects Bone Metabolism and Bone Mineral Density Prior to Denosumab Therapy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine the efficacy and adverse events in the following 3 groups in osteoporosis patients: The administration period of teriparatide is less than 6 months and thereafter, denosumab for 24 months. The administration period of teriparatide is from 6 to 12 months and thereafter, denosumab for 24 months. The administration period of teriparatide is more than 12 months and thereafter, denosumab for 24 months.

Official Title
-----------------
Examination How the Administration Period of Teriparatide Affects Bone Metabolism and Bone Mineral Density Prior to Denosumab Therapy

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Teriparatide, Forteo® or Teribon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteoporotic patients who want to take teriparatide and denosumab Exclusion Criteria: Patients who are allergic to teriparatide or denosumab Patients who are pregnant or breast-feedin

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 120 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TPTD 6M<br> | Drug: Teriparatide, Forteo® or Teribon<br>* To examine the effects of terimaratide less than 6 months in osteoporosis<br>|
| Active Comparator: TPTD 6-12M<br> | Drug: Teriparatide, Forteo® or Teribon<br>* To examine the effects of terimaratide less than 6 months in osteoporosis<br>|
| Active Comparator: TPTD 12-24M<br> | Drug: Teriparatide, Forteo® or Teribon<br>* To examine the effects of terimaratide less than 6 months in osteoporosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density |  | Change from Baseline Values at 1 year |
Ultrasound Elastography in Diagnosing Patients With Kidney or Liver Solid Focal Lesions

Study Overview
=================
Brief Summary
-----------------
This clinical trial studies ultrasound elastography in diagnosing patients with kidney or liver solid focal lesions. New diagnostic procedures, such as ultrasound elastography, may be a less invasive way to check for kidney or liver solid focal lesions.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To determine the utility of ultrasound elastography in correlation with kidney or liver biopsy or magnetic resonance imaging (MRI) or computed tomography (CT) results. OUTLINE: Patients undergo ultrasound elastography.

Official Title
-----------------
US Elastography for Characterizing Focal Lesions in the Liver and Kidney

Conditions
-----------------
Adult Primary Liver Cancer, Kidney Tumor

Intervention / Treatment
-----------------
* Procedure: ultrasound elasticity imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: There are no restrictions on life expectancy Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status will not be employed Patients of any ethnic background Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Patients should not be taking other investigational agents No requirements due to co-morbid disease or intercurrent illness, as needed No restrictions on allergic reactions as no imaging agent will be used Concomitant medications for treatment of the target lesion Pregnant or nursing patients will be excluded from the study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (ultrasound elastography)<br>Patients undergo ultrasound elastography. | Procedure: ultrasound elasticity imaging<br>* Undergo ultrasound elastography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strain ratio for all lesions measured by comparing the lesion to the adjacent normal tissue | Suspicious liver and kidney lesions will be analyzed separately on a per-lesion basis. Within each population, the strain ratio of cases and controls will be compared using the Wilcoxon rank sum test, and the analysis will be illustrated using the non-parametric receiver operating characteristic (ROC). | Up to 36 months |
Aspergillus and Chronic Obstructive Pulmonary Disease Evolution

Study Overview
=================
Brief Summary
-----------------
This is a prospective multicenter cohort study which includes all consecutive COPD patients who come for a visit in one the participating pneumologist. They will have to do a sputum and to complete some questionnaries. Questionnaries will be redone by phone after 1 and 3 months and during the visit after 6 months. We will correlate aspergillus presence in sputum with quality of life (QoL), and COPD symptoms evaluated by questionnaires.

Detailed Description
-----------------
Aspergillosis disease is a growing problem. These diseases are not yet uncommon in chronic obstructive pulmonary disease patients. (COPD). Aspergillosis disease are very difficult to be diagnosed or treated. Isolation of aspergillus in sputum of patients is not always responsible of a real disease. Need of treatment is discussed. That is why, we will conduct a prospective cohort study to evaluate aspergillus rate in respiratory samples of COPD patients (GOLD stage III or IV)

Official Title
-----------------
Impact of Aspergillus on Chronic Obstructive Pulmonary Disease Evolution

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

Intervention / Treatment
-----------------
* Diagnostic Test: Questionnaries


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD patients GOLD stage III and IV Exclusion Criteria: Cystic fibrosis Pulmonary fibrosis hematological malignancy known aspergilloma allergic bronchopulmonary aspergillosis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COPD<br>COPD patients GOLD stage III and IV | Diagnostic Test: Questionnaries<br>* patients will have to do a sputum and to complete some questionnaries<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of aspergillus in sputum or respiratory samples | sputum examination | one year before inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea with MMRC score | Pulmonary function testing | day of inclusion |
Development and Validation of a Driving Simulator for Evaluating the Residual Effects of Drugs on Driving Performance - Sensitivity Analysis Using Zopiclone as a Positive Control

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm of assay sensitivity of Driving Simulator by positive control

Official Title
-----------------
Development and Validation of a Driving Simulator for Evaluating the Residual Effects of Drugs on Driving Performance - Sensitivity Analysis Using Zopiclone as a Positive Control

Conditions
-----------------
Healthy Participants

Intervention / Treatment
-----------------
* Other: Road-tracking test
* Other: Car-following test
* Other: Harsh-braking test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) ≥18.5 and <25.0 kg/m^2 at screening inspection No visual impairment (enable to correct the vision with eyeglasses or contact lens) Receive a prior explanation on the study, able to accept its content, and capable to provide voluntary written consent for participation in this study Other protocol defined inclusion criteria could apply Exclusion Criteria: History of drug and food allergy Hypersensitivity to zopiclone Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator Other protocol defined inclusion criteria could apply

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 64 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zopiclone<br> | Other: Road-tracking test<br>* Driving with simulator program for SDLP measurement<br>Other: Car-following test<br>* Intervention Description: Driving with simulator program for DCV measurement<br>Other: Harsh-braking test<br>* Driving with simulator program for BRT measurement<br>|
| Placebo Comparator: Placebo<br> | Other: Road-tracking test<br>* Driving with simulator program for SDLP measurement<br>Other: Car-following test<br>* Intervention Description: Driving with simulator program for DCV measurement<br>Other: Harsh-braking test<br>* Driving with simulator program for BRT measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard Deviation of Lateral Position (SDLP) |  | 60 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Coefficient of Variation (DCV) |  | 5 min | 
| Brake Reaction Time (BRT) |  | 5 min |
Inhaled Treprostinil Expanded Access Program in Pulmonary Hypertension Associated With Interstitial Lung Disease

Study Overview
=================
Brief Summary
-----------------
This is an Expanded Access Program (EAP) for eligible participants with Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD) designed to provide access to Inhaled Treprostinil. Availability will depend on territory elegibility.

Conditions
-----------------
Pulmonary Hypertension, Interstitial Lung Disease, Combined Pulmonary Fibrosis and Emphysema

Intervention / Treatment
-----------------
* Drug: Inhaled Treprostinil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient consent Males and females aged 18 years old or older PH-ILD diagnosis: Confirmed diagnosis of Group 3 PH by Right Heart Catheterization (RHC): - mPAP > 20 mmHg with PAWP ≤ 15 mmHg and PVR ≥ 2 WU and Confirmed diagnosis of diffuse parenchymal lung disease based on imaging (any form of ILD or CPFE) Exclusion Criteria: Diagnosis of PAH or PH for reasons other than Group 3 PH-ILD Use of concomitant PAH drugs contraindicated for PH-ILD (ambrisentan and riociguat) Use of any concomitant investigational drug

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Inhaled Treprostinil|nan|

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
-----------------
Inhaled Treprostinil, Tyvaso, EAP, Expanded Access, Early Access, Compassionate Use, Named Patient Program, NPP, PH-ILD
Clinical and Laboratory Characteristics of Patients Admitted With Syncope; Diagnosis and Follow up After These Patients

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesis is that a significant number of patients may remain without specific cause and have recurrent syncope with its associated physical and mental morbidity.

Detailed Description
-----------------
Patients with diagnosis of syncope who were admitted to the medical ward will be interviewed and their charts reviewed to rule in or out the diagnosis of syncope. Assess physical and mental injury as a result of syncope. The lab workup will be documented including; - Routine blood tests. troponin level. - ECG. Echocardiogram Brain CT. EEG. U/S doppler of carotids. Tilt tests. At the time of diagnosis the final diagnosis will be documented including recommendations for patients to prevent syncope after discharge. Follow up after patients by phone verifying recurrence of syncope and resulting physical and or mental injury if any.

Official Title
-----------------
Observational Study Following After Patients Admitted With Syncope

Conditions
-----------------
Diagnosis, Recurrence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with diagnosis of syncope on admission to the medical ward. Exclusion Criteria: patients with loss of consciousness due to other than low perfusion of the brain patients that can't sign a consent form patients that we can't get details about the episode of the syncope

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 |
| --- | --- | --- |
| diagnosis | Final diagnosis as a cause of syncope | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence | how many patients had recurrence of syncope and average number of syncope in these patients during the period of follow up of each patient. | 6 months | 
| physical injury | During this period of follow up of each patient, was there a physical injury, graded either none, mild, moderate or severe (bedridden) | 6 months | 
| Mental effect | fear of recurrent syncope affecting his mobility and graded from mild to severe where severe indicates fear of moving even one step without support. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
syncope, evaluation, recurrence, morbidity
Pregabalin Versus Celecoxib on Sevoflurane and Analgesic Consumption in Spine Fixation Surgery

Study Overview
=================
Brief Summary
-----------------
The anti-epileptic drugs such as gabapentin and other non-steroidal anti-inflammatory drugs (NSAID) such as celecoxib were used as a part of multimodal analgesia to control such pain. Gabapentin is an anticonvulsant drug that has analgesic effect in post-herpetic neuralgia, diabetic neuropathy, and neuropathic pain. Celecoxib is one of the NSAIDs, that its analgesic effect is reported in various studies by cyclooxygenase-2 (COX-2) inhibitor. The aim of this randomized double-blinded study was to asses and compare the efficacy of using gabapentin versus celecoxib as a part of multimodal analgesia in perioperative hemodynamic control and pain relief in patients underwent posterior approach lumbar spine disc fixation surgery.

Official Title
-----------------
Efficacy of Pre-emptive Different Doses of Oral Pregabalin Versus Celecoxib on Sevoflurane and Analgesic Consumption in Patients Subjected for Elective Lumbar Spine Fixation Surgery: a Randomized Controlled Trial

Conditions
-----------------
Post-Operative Pain

Intervention / Treatment
-----------------
* Drug: Celecoxib capsules
* Drug: Pregabalin 150mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American society of anesthesiologists (ASA) I and II, aged between 21-60 years old scheduled to undergo elective posterior approach lumbar spine disc surgery Exclusion Criteria: Patients with a known sensitivity to celecoxib or pregabalin, psychotic disorder or cognitive impairment, history of drug dependency or substance addiction, history of chronic medical disease, the presence of coagulation disorders or pregnancy, were excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group (G)<br>received gabapentin 300 mg capsule 2 hours preoperative and the same dose 6 hours postoperative. | Drug: Pregabalin 150mg<br>* received Pregabalin 150mg 2 hours preoperative and the same dose 6 hours postoperative.<br>|
| Active Comparator: Group (C)<br>received celecoxib 200 mg 2 hours preoperative and the same dose 6 hours postoperative. | Drug: Celecoxib capsules<br>* received celecoxib 200 mg 2 hours preoperative and the same dose 6 hours postoperative.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain control | Visual Analogue Scale for pain measurement. | Change from Baseline Visual Analogue Scale every 4 hours for 48 hours (0=no pain 10=most sever pain) |