linjc16/ctgov huggingface dataset:
Walk With a Doc: Enhanced Recovery Walking Program for Surgical Inpatients and Wellness Program for Surgical Residents

Study Overview
=================
Brief Summary
-----------------
Program studying the number of steps post-operative patients need to take to prevent post-operative complications. Also studying surgical resident wellness program that provides extra time to ambulate with inpatients.

Detailed Description
-----------------
Program studying the number of steps post-operative patients need to take to prevent post-operative complications. Patients receive a pedometer while inpatient to measure their daily steps, which is recorded in the electronic medical record.

Official Title
-----------------
Walk With a Doc: Enhanced Recovery Walking Program for Surgical Inpatients and Wellness Program for Surgical Residents

Conditions
-----------------
Complication of Surgical Procedure, Resident Physicians

Intervention / Treatment
-----------------
* Other: Measuring number of post-operative steps


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post-operative surgical patient with an over 24 hour post-operative stay in the hospital Safe to ambulate with/without assistance Exclusion Criteria: Unable to ambulate Bedbound

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Measuring number of post-operative steps|Measuring the number of post-operative steps that inpatients take.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of steps | Total number of steps ambulated by the patient as measured by a pedometer | From index surgery to initial post-operative office visit, up to 3 weeks | 
| 30 day Post-operative complications | 30 day Post-operative complications | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resident physician wellness, Post-operative walking program
Music Listening to Reduce Pain and Anxiety During LEEP

Study Overview
=================
Brief Summary
-----------------
Loop electrosurgical excision procedure (LEEP) is the primary diagnostic and therapeutic procedure employed in women with high-grade intraepithelial neoplasia of the cervix. The procedure usually performed in the outpatient setting under local anesthesia. However, it could be associated with significant pain and anxiety. The aim of this study is to examine the effects of listening to music during the procedure in reducing pain and anxiety.

Official Title
-----------------
Effects of Music Listening During Loop Electrosurgical Excision Procedure on Anxiety, Pain, and Satisfaction: a Randomized Controlled Trial

Conditions
-----------------
Cervical Intraepithelial Neoplasia

Intervention / Treatment
-----------------
* Behavioral: Music listening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with confirmed or suspected high-grade intraepithelial neoplasia of the cervix Exclusion Criteria: Allergy to local anesthetic agent (lidocaine) Pregnancy Previous major surgical procedures on cervix (conization, LEEP, laser therapy, cryotherapy) or uterus Using cardiac pacemaker or history of cardiac arrhythmia Neurological disorder affecting perception of pain History of lower urinary tract cancer Coagulation defects History of drug dependence Lower genital tract infection Apparent invasive cancer of the cervix Hearing difficulty

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music<br>Listening to relaxing music for the entire period starting from waiting period in the surgical waiting area until the end of the LEEP procedure Undergoing LEEP according to the usual protocol | Behavioral: Music listening<br> <br> |
| No Intervention: Control<br>- Undergoing LEEP according to the usual protocol without listening to music | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure-related pain, as measured by Visual Analog Scale |  | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure-related anxiety, as measured by Visual Analog Scale |  | During the procedure | 
| Procedure-related satisfaction, as measured by Visual Analog Scale |  | During the procedure |
The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery

Study Overview
=================
Brief Summary
-----------------
Peritoneal perfusion during laparoscopic surgery is quantified by video recording after intravenous injection of indocyanine green at a pneumoperitoneum pressure of 8, 12 and 16 mmHg.

Official Title
-----------------
The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery: a Pilot Study

Conditions
-----------------
Laparoscopic Surgery, Pneumoperitoneum

Intervention / Treatment
-----------------
* Other: Intra-abdominal pressure during laparoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (≥ 18 years old) Scheduled for robot-assisted colorectal laparoscopic surgery Exclusion Criteria: Severe liver- or renal disease Pregnancy or lactation Planned diagnostics or treatment with radioactive iodine < 1 week after surgery BMI >35 kg/m2 Known or suspected hypersensitivity to indocyanine green, sodium iodide or iodine Hyperthyroidism or thyroid adenomas Use of medication interfering with ICG absorption as listed in the summary of product characteristics.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intra-abdominal pressure of 8 mmHg<br>The laparoscopy insufflator is set to a pressure of 8 mmHg | Other: Intra-abdominal pressure during laparoscopy<br>* Insufflation pressure of the abdomen during laparoscopy<br>|
| Experimental: Intra-abdominal pressure of 12 mmHg<br>The laparoscopy insufflator is set to a pressure of 12 mmHg | Other: Intra-abdominal pressure during laparoscopy<br>* Insufflation pressure of the abdomen during laparoscopy<br>|
| Experimental: Intra-abdominal pressure of 16 mmHg<br>The laparoscopy insufflator is set to a pressure of 16 mmHg | Other: Intra-abdominal pressure during laparoscopy<br>* Insufflation pressure of the abdomen during laparoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peritoneal perfusion | Perfusion is quantified by video recording of the parietal peritoneum using the Firefly fluorescence module of the DaVinci surgical robot after intravenous injection of 0.2mg/kg indocyanine green. Fluorescent intensity in [-] over time is plotted in MATLAB, maximum fluorescent intensity and time to reach maximum fluorescent intensity are extracted. | 3 minutes after intravenous injection of indocyanine green | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopic surgery, Pneumoperitoneum, Peritoneal perfusion, Intra-abdominal pressure
Routine Clinical Screening for Substance Use Disorders in the Emergency Room Setting

Study Overview
=================
Brief Summary
-----------------
To ensure consistent documentation of alcohol and substance use, the emergency medicine is initiating a new standard of care for substance use screening: the use of a brief self-evaluation questionnaire on alcohol, tobacco and illicit substance use to be completed in triage. This questionnaire will allow emergency medicine patients presenting to the emergency room. This study will also review medical records after one year of the index emergency room visit to establish rates or re-presentation and hospitalization correlated with different substance use.

Detailed Description
-----------------
Screening for alcohol use and substances of abuse in the emergency and trauma settings is critical for both effective current treatment of the presenting clinical issue and prevention of future incidents. Identification, engagement and treatment of substance use disorders decreased trauma and emergency department visits and medical comorbidities (Bertholet et al., 2005; Kaner et al., 2007). To ensure consistent documentation of alcohol and substance use, the emergency medicine is initiating a new standard of care for substance use screening: the use of a brief self-evaluation questionnaire on alcohol, tobacco and illicit substance use to be completed in triage. This questionnaire will allow emergency medicine patients presenting to the emergency room. This research study will perform a chart review on all self-evaluation questionnaires on alcohol, tobacco and substance use to determine the prevalence of use of specific substances in this patient population and associated demographic predictors and medical comorbidities. This study will also review medical records after one year of the index emergency room visit to establish rates or re-presentation and hospitalization correlated with different substance use.

Official Title
-----------------
Routine Clinical Screening for Substance Use Disorders in the Emergency Room Setting

Conditions
-----------------
Substance Use

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to complete a questionnaire Exclusion Criteria: Younger than 19 Unable or unwilling to complete a self-assessment form written in English Prisoners

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Percent of subjects with re-presentation of drug or alcohol abuse 1 year after initial presentation to Emergency Department |  | baseline to 12 months |
Management of Index Episode in Patients With Bipolar Disorder Treated by Seroquel XR

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the study is to explore management of symptomatology in patients with bipolar disorder that experience a new manic,depressive or mixed episode and are treated with Seroquel XR monotherapy/adjuctive, in routine clinical practice in Romania

Official Title
-----------------
Non-interventional Study to obSERve currENt Management of Index Episode in Patients With Bipolar Disorder Treated bY Seroquel XR

Conditions
-----------------
Bipolar Disorder, New Occurred Episode

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients eligible for entry into the study, male and females, will have a diagnosis of bipolar disorder, as defined by DSM-IV-TR and the current episode, whether it is manic, depressed or mixed will be treated with Seroquel XR since 1 week before entering the programme. All eligible patients will be included in the programme provided they will receive information in advance and will sign consent to grant access to the data collected with regard to their condition during the observation interval proposed. Exclusion Criteria: All the patients who have a known hypersensitivity to Seroquel XR/quetiapine or any of its excipients will not be included in this study. Concomitant medication, that could result in drug interactions and could jeopardize patient safety will be carefully considered before having the patient enrolled. Additionally, all precautions applicable for special category patients will be taken into account, as detailed in current valid Romanian SmPC.

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 |
| --- | --- |
| 1<br>Bipolar patients that experience a new episode of any type | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms severity |  | 10 weeks ( 4 times:baseline; at 2 weeks; 6 weeks;10 weeks ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoL/ quality of life |  | twice in 10 weeks ( v1 and v4) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar disorder, New occured episode: manic depressive or mixed
Total Hip Registry

Study Overview
=================
Brief Summary
-----------------
Objective Describe the clinical and demographic characteristics of patients who undergo hip arthroplasty and document post operative outcomes. Examine the relationship between processes of care, hospital and surgeon associated outcomes Provide expanded data to characterize existing and evolving practice patterns, delivery of care, and resource utilization in the management of knee arthroplasty patients. Analyze and design ancillary studies to address unanswered questions. Disseminate findings through publication in peer-reviewed scientific journals.

Official Title
-----------------
Total Hip Registry

Conditions
-----------------
Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient requires total hip Arthroplasty Patient has signed IRB approved informed consent Exclusion Criteria: Less than 21 years of age Patient is a prisoner

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 93 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 |
| --- | --- |
| Total hip<br>all consented patients receiving total hip arthroplasty | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score |  | 2 weeks, 6 weeks, 3 months, 6 months, 1, 2, 5, 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
total hip
Clinical Research on Bowel Symptoms of Patient With Pelvic Organ Prolapse

Study Overview
=================
Brief Summary
-----------------
To study the prevalence of bowel symptoms in patients with pelvic organ prolapse.

Official Title
-----------------
Clinical Research on Bowel Symptoms of Patients With Pelvic Organ Prolapse

Conditions
-----------------
Bowel Symptoms

Intervention / Treatment
-----------------
* Procedure: Pelvic floor reconstruction（with or without mesh）


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients with stage>2 POP are recruited.The patients are all received surgeries, which include transvaginal synthetic mesh surgery, the sacral fixation, tissue repair surgery and colpocleisis. Exclusion Criteria: Gestation； Inflammatory bowel disease； Slow transit constipation diagnosed by Colonic transit test； Unable to follow up.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesh repairment<br>patients undergoing pelvic floor Reconstruction using mesh | Procedure: Pelvic floor reconstruction（with or without mesh）<br> <br> |
| Active Comparator: Tradition Neoplasty<br>patients undergoing traditional surgical approaches | Procedure: Pelvic floor reconstruction（with or without mesh）<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the prevalence of bowel symptoms |  | baseline,1,3,6,12 months after operation. | 
| change in the severity of intestinal symptoms | assessed by Birmingham Bowel and Urinary Symptoms Questionnaire | baseline,1,3,6,12 months after operation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the quality of life | assessed by international consultation on incontinence questionnaire short form | baseline,1,3,6,12 months after operation. | 
| length of the high-pressure zone recorded by anorectal manometry |  | baseline and 12 months after operation | 
| rectoanal inhibitory reflex recorded by anorectal manometry |  | baseline and 12 months after operation | 
| Rectal-Vaginal pressure interval during maximum Vasalva | Measured by Peritron manometer | baseline and 6 months after operation |
Safety and Performance Evaluation of the Rapid Ring Device

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the safety, performance and initial efficacy of the RapiDx device.

Detailed Description
-----------------
The study will be a single center, open label, prospective, non-comparative, randomized trial and assess the safety and performance of the Rapid Ring device. In order to assess pain reduction, a comparative study will be performed and each subject will serve as his/her own control. Clinical assessment for all 100% patients will occur at baseline. All participants will be men and women above the age of 18. The trial will be conducted at a Medical Center.

Official Title
-----------------
Single Center, Open Label, Prospective, Non-comparative, Non-randomized Study to Assess the Safety and Performance of the Rapid Ring Device (Comparative Study to Assess the Pain Reduction)

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

Intervention / Treatment
-----------------
* Device: Rapid Ring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is healthy Subject's age is between 18 to 70 years old Subject must be capable of providing informed consent Exclusion Criteria: Clotting disorders Subject has a clinically significant untreated chronic disease which may unable him/ her to participate in the study. Subject is taking anti-coagulant medication Non-intact finger tip (left middle/ring finger) Skin disease on the subject finger Abnormal blood pressure Pregnant or lactating women Menstrual period Previous diagnosis of HIV or Hepatitis Participation in other clinical investigations within previous 30 days Peripheral blood vessels diseases Diabetes Neuropathic pain

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Rapid Ring|Rapid Ring is a ring-shaped device that encircles the distal phalanx of the middle finger and blocks the arterial blood to quickly and passively withdraw blood following a finger stick, and to reduce the pain of the lancet.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of at least 2 drops (approximately 50microliter) of blood within one minute. |  | approximately 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in pain |  | approximately 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Finger sticks, Rapid Ring, Finger sticks method of obtaining blood for diagnostic testing
Enhancing Heart Failure Self-Care

Study Overview
=================
Brief Summary
-----------------
To test the effectiveness of a motivational intervention compared with standard patient education in improving economic and clinical outcomes in patients enrolled in an existing heart failure (HF) disease management program.

Official Title
-----------------
Enhancing Heart Failure Self-Care

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Other: telephone management plus a motivational intervention
* Other: telephone management with standard patient education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic heart failure, hospitalized for heart failure or hospitalized for heart failure within the past 30 days, speak and read English Exclusion Criteria: Severe renal failure requiring dialysis, HIV-AIDS, psychosis, uncorrected hearing loss

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- |
| Other: 1<br>Telephone management plus a motivational intervention | Other: telephone management plus a motivational intervention<br>* heart failure intervention<br>|
| Other: 2<br>Telephone management with standard patient education | Other: telephone management with standard patient education<br>* heart failure intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test the effectiveness of a motivational intervention compared with standard patient education in improving economic and clinical outcomes in patients enrolled in HF disease management. |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
motivational therapy