linjc16/ctgov huggingface dataset:
Ergonomics in Robotic Surgery

Study Overview
=================
Brief Summary
-----------------
This study is designed to answer if an ergonomist can configure a daVinci robot console to improve surgeon discomfort. Adjustments to the robot console will be surgeon specific as they are tailored to their individual body type. Measurements will be taken at the time of console configuration.

Official Title
-----------------
Ergonomics in Robotic Surgery

Conditions
-----------------
Musculoskeletal Strain, Ergonomics

Intervention / Treatment
-----------------
* Other: Ergonomist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fellowship trained, specialty board certified gynecologic surgeon. Robot used for hysterectomy until completion of vaginal cuff closure. Exclusion Criteria: - Any non-robotic method to perform hysterectomy (laparotomy, non-robotic laparoscopic, vaginal approach).

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study Arm<br> | Other: Ergonomist<br>* The intervention consists of each surgeon meeting with an ergonomist where the ergonomist will adjust the console settings and chair height to an ergonomically optimal position.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Nordic Upper Body Questionnaire Score | The Nordic upper body questionnaire will be one measure of upper body musculoskeletal discomfort following robotic hysterectomy. | Baseline, Immediately postoperative (approximately one hour) | 
| Change in Body Part Discomfort Questionnaire Score | The Body Part Discomfort Questionnaire will be one measure of upper body musculoskeletal discomfort following robotic hysterectomy | Baseline, Immediately postoperative (approximately one hour) | 
| Surgical Task Load Index Score | The surgical task load index score will be one measure of upper body musculoskeletal discomfort following robotic hysterectomy. | Immediately postoperative (approximately one hour) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in measurement of console settings (in cm) | Comparison between surgeon- and ergonomist-derived console settings | Baseline, up to 1 year | 
| Change in measurement of console head angle (in degrees) | Comparison between surgeon- and ergonomist-derived console settings | Baseline, up to 1 year |
Compounded Pain Preparation Absorption Study

Study Overview
=================
Brief Summary
-----------------
Single center, prospective, observational study to assess serum concentration of ingredients used in multi-ingredient, topical compounded medications from Medimix Specialty Pharmacy.

Detailed Description
-----------------
Single center, prospective, observational, open-label, cohort study of participants that receive a combination topical pain medication from Medimix Specialty Pharmacy with no comparator group designed to assess serum concentration of ingredients used in multi-ingredient, topical compounded medications.

Official Title
-----------------
Compounded Pain Preparation Absorption Study (ComPPAS)

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Multi-ingredient, topical compounded medications


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must apply and consistently use the supplied cream for 1 month at a prescribed Participants must be ≥ 30 and <65 years of age Participants must be able to provide sound written and verbal informed consent Participants must be diagnosed with an ICD9 code indicative of chronic pain Exclusion Criteria: Participants must not have prior hypersensitivity or adverse events to any of the components in the customized prescription Participants must not be pregnant or breastfeeding Participants must not have used any study drug greater than 180 days from the day of Screening Participants must not be utilizing medications that may interact with those being used in the topical formulation as determined by the PI Participants must not be using any systemic medications that may influence drug serum concentrations of ingredients being used in the topical compound. These include medications from the same class of studied drugs or drugs that may falsely increase or decrease serum levels of the study drugs

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 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 |
| --- | --- |
| Patients receiving a topical compounded medication<br> | Drug: Multi-ingredient, topical compounded medications<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentration of ingredients used in multi-ingredient, topical compounded medications |  | 1 Month |
Association Between Dental Implants Properties and Malodor Production

Study Overview
=================
Brief Summary
-----------------
Malodor production is bacterial in origin. The bacterial activity of anaerobic bacteria results in the breakdown of proteins and the production of foul smelling compounds. The aim of the study is to test the hypothesis that bacterial growth on dental implants contributes to malodor production and to see whether this contribution is associated with various properties of the dental implant such as: maker, type, depth ext.

Official Title
-----------------
Bacterial Accumulation and Malodor Production in Various Types of Dental Implants

Conditions
-----------------
Halitosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Dental patients that need dental implants - Exclusion Criteria:smokers -

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 75 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oral malodor, Dental implants
The Effects of Stress on the Clinical Performance of Residents in Simulated Trauma Scenarios

Study Overview
=================
Brief Summary
-----------------
Medical practice & training are inherently stressful situations. However, the effects of stress on educational & clinical performance are not well defined. The purpose of the current study is to examine the effects of stress on performance of residents in simulated trauma scenarios. The hypothesis is: 1) acutely stressful scenarios will be appraised as threat by residents and result in elevations of heart rate and salivary cortisol; 2) increased subjective & physiological stress will result in impairments in performance; and 3) greater stress responses will result in greater clinical impairments.

Official Title
-----------------
The Effects of Stress on the Clinical Performance of Residents in Simulated Trauma Scenarios

Conditions
-----------------
Trauma, Stress

Intervention / Treatment
-----------------
* Behavioral: stress


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: University of Toronto General Surgery & Emergency medicine residents Exclusion Criteria: No ATLS training Residents from other programs

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: stress|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| performance - global ratings |  |  | 
| performance - ANTS |  |  | 
| performance - checklists |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trauma, Stress, Simulation
Preload Dependence During Prone Position In ARDS Patients

Study Overview
=================
Brief Summary
-----------------
Preload dependence assessment is difficult during prone position, and to date, no hemodynamic parameters have been validated to rationalize fluid loading in that position. This study aims to validate several hemodynamic parameters, using continuous cardiac output by pulse contour analysis and transpulmonary thermodilution.

Official Title
-----------------
Evaluation of Performance Diagnosis of Hemodynamic Parameters of Preload Dependence in ARDS Patients During Prone Position

Conditions
-----------------
ARDS PATIENTS WITH HEMODYNAMIC INSTABILITY

Intervention / Treatment
-----------------
* Procedure: Trendelenburg position


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ARDS patient mechanically ventilated in prone position sedated and paralyzed with continuous cardiac output monitoring by transpulmonary thermodilution and pulse contour analysis fluid loading as indicated by attending physician Exclusion Criteria: Age below 18 no affiliation to social security Vena cava obstruction previous inclusion in protocol

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br> | Procedure: Trendelenburg position<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under ROC curve of the variation in continuous cardiac output during Trendelenburg position, to detect preload dependence | Preload dependence is assessed by the response in cardiac output to a 500 mL fluid loading, and is deemed positive if cardiac output increase by at least 15% | 1 minute after Trendelenburg position onset. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under ROC curve of the variation in continuous cardiac output during end-expiratory occlusion to detect preload dependence | Preload dependence is assessed by the response in cardiac output to a 500 mL fluid loading, and is deemed positive if cardiac output increase by at least 15% | 15 seconds after the onset of end-expiratory occlusion | 
| Area under ROC curve of the respiratory variation in pulse pressure to detect preload dependence | Preload dependence is assessed by the response in cardiac output to a 500 mL fluid loading, and is deemed positive if cardiac output increase by at least 15% | 1 minute after tidal volume increase to 8 ml/kg | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ARDS - FLUID LOADING - PRELOAD DEPENDENCE
University of Oklahoma Parenting Program Attrition

Study Overview
=================
Brief Summary
-----------------
The study will examine the extent to which a group motivational intervention (ME) impacts retention, treatment compliance, and long-term outcomes in families with a history of, or high risk for, child maltreatment.

Detailed Description
-----------------
The field of child abuse prevention faces not only the challenge of developing and disseminating effective treatments, but the problem of high attrition rates and treatment noncompliance. This study will compare the effects of a motivational intervention with a services as usual orientation group on program retention, treatment compliance, and long-term outcomes in families with histories of child maltreatment.

Official Title
-----------------
University of Oklahoma Health Sciences Center Parenting Program Attrition and Compliance Efficacy Trial

Conditions
-----------------
Child Abuse

Intervention / Treatment
-----------------
* Behavioral: Motivational intervention, parent training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Families referred to service agency for child maltreatment prevention services Families with children between 2-1/2 and 12 years of age Exclusion Criteria: Parents with cognitive, psychiatric, or social conditions that would limit their ability to provide voluntary consent or benefit from the intervention Parents who have sexually abused their children
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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Motivational intervention, parent training|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidents of child maltreatment 1-3 years post-treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parenting behaviors, attitudes, and functioning assessed during and post-intervention |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parent training, Child maltreatment, Motivation, Program attrition
Pilot Study of ORG 25935 Modulation of Ketamine-induced Behavioral and Cognitive Effects in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
Org 25935 is a new putative antipsychotic agent developed by N.V. Organon.The primary objective of this study is to investigate the effect of Org 25935 on ketamine-induced impairments in immediate recall.

Official Title
-----------------
Pilot Study of ORG 25935 Modulation of Ketamine-induced Behavioral and Cognitive Effects in Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Ketamine and Org 25935
* Drug: Placebo and Ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, 18 - 55 years Exclusion Criteria: History of sensitivity/idiosyncrasy to the drugs used in the study or chemically related compounds or excipients which may be employed in the study or to any other unknown drug used in the past.

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Ketamine and Org 25935<br>* Oral administration of Org 25935 16 mg and intravenous administration of ketamine (0.23 mg/kg bolus over 1 minute, followed by 0.58 mg/kg/hour x 30 minutes, followed by 0.29 mg/kg/hour x 69 minutes)<br>|
| Placebo Comparator: 2<br> | Drug: Placebo and Ketamine<br>* Oral administration of placebo and intravenous administration of ketamine (0.23 mg/kg bolus over 1 minute, followed by 0.58 mg/kg/hour x 30 minutes, followed by 0.29 mg/kg/hour x 69 minutes)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attenuation of ketamine-induced cognitive deficits by Org 25935 |  | +20 to +100 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attenuation of ketamine-induced schizophrenia-like psychotic symptoms, perceptual alterations, subjective high and deficits in attention and working memory by Org 25935. |  | 0 to +100 minutes | 
| Investigation of interaction of polymorphisms of candidate genes e.g., BDNF, COMT with the effect of Org 25935 on ketamine induced psychotomimetic and amnestic deficits. |  | 0 to +100 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ORG 25935, Ketamine, healthy subjects
Analysis of Effects and Side Effects in Patients Undergoing Radiation Therapy

Study Overview
=================
Brief Summary
-----------------
To collect and analyze effects and side effects in patients undergoing radiotherapy. This study investigates how analysis of effects and side effects will influence outcome of patients. These retrospectively collected data allow to adapt and improve radiotherapy treatment regimens .

Detailed Description
-----------------
Effects and side effects in patients undergoing radiotherapy will be collected over the next five years (2015-2020). It is planned to include 600 to 650 new patients referred for radiotherapy per calender year. It is estimated that 3000 patients will be included at the end of the study after five years. Patient Information on diseae and treatment will be collected and analyzed. Common statistical algorithms will be performed for outcome analysis.

Official Title
-----------------
Analysis of Effects and Side Effects in Patients Undergoing Radiation Therapy - Quality Control Using Clinical Database

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Radiation: Radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing radiotherapy at the Kantonsspital Graubuenden Exclusion Criteria: No radiotherapy at Kantonsspital Graubuenden Age: < 20 years, > 105 years

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 105 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Radiation|Radiation therapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects in patients undergoing radiotherapy (CTCAE v4.03) | acute and late side effects according to CTCAE | 5 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiotherapy, side effects
Urinary Biomarkers for AKI Diagnosis in Patients With SARS-CoV-2 (COVID-19)

Study Overview
=================
Brief Summary
-----------------
Among patients with SARS-CoV-2 pneumonia, approximately 20% have an acute kidney injury (AKI) and 5% require renal replacement therapy. Occurrence of AKI in patients with COVID-19 is associated with increased morbidity and mortality. Early detection of patients at risk of AKI would allow to prevent onset or worsening of AKI. The aim of this study is to determine if urine biomarkers of renal tubular damage such as TIMP-2 and IGFBP7 could early identify patients with SARS-CoV-2 pneumonia at risk of developing AKI.

Official Title
-----------------
Urinary Biomarkers (TIMP-2 and IGFBP7) for Early Diagnostic Assessment of Acute Kidney Injury in Patients With SARS-CoV-2 (COVID-19)

Conditions
-----------------
COVID-19, Renal Replacement Therapy, Acute Kidney Injury

Intervention / Treatment
-----------------
* Other: [TIMP-2]*[IGFBP-7]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age ≥ 18 years COVID-19 confirmed by positive SARS-CoV-2 PCR at least one urine sample Exclusion criteria: Persons under protection Paritcipation rejections

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| COVID-19 patients with urinary samples<br>COVID-19 patients with urinary samples | Other: [TIMP-2]*[IGFBP-7]<br>* [TIMP-2]*[IGFBP-7] mesurement in urine sample relicates of COVID-19 patients admitted to the Montpellier University Hospital<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensibility and specificity of urinary | Sensibility and specificity of urinary [TIMP-2]*[IGFBP-7] > 0,3 to predict AKI (KDIGO stage ≥ 1) in SARS-CoV-2 patients at day-7 after measurement | Occurence of AKI 7 days after urinary biomarkers measurement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensibility and specificity of urinary | Sensibility and specificity of urinary [TIMP-2]*[IGFBP-7] > 0,3 to predict AKI worsening, renal replacement therapy requirement or persistant AKI | Occurnce of AKI worsening, renal replacement therapy requirement or persistant AKI, 7 days after urinary biomarkers mesurement | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Kidney Injury, SARS-CoV-2, Renal Replacement Therapy
Evaluation of Lofexidine for Treatment of Opioid Withdrawal - 3

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety of lofexidine in the treatment of opiate withdrawal. Preliminary data will also be obtained to assess the ability of lofexidine to alleviate opiate withdrawal signs and symptoms.

Official Title
-----------------
Safety Evaluation of Lofexidine for Treatment of Opioid Withdrawal

Conditions
-----------------
Opioid-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: Lofexidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 59 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lofexidine|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
-----------------
opiate dependence