linjc16/ctgov huggingface dataset:
Changes of the Hemodynamic Profiles on Bio Reactance Technique During TURP in Elderly Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the change of the hemodynamic profiles on bio reactance technique during TURP in elderly patients.

Conditions
-----------------
Benign Prostate Hyperplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) Twenty (ASA status I   III) patients, ages 65 to 80 yr old, who were scheduled for transurethral resection of the prostate under spinal anesthesia Exclusion Criteria: if there were contraindications for spinal anesthesia including hypersensitivity to any local anaesthetics, bleeding diathesis, infections at the puncture sites, or pre-existing neurological disease. history of coronary artery bypass surgery history of dementia have a difficulty in understanding informed consent or refuse to sign the informed consent patients height under 150 cm

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 80 Years

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

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 |
| --- | --- | --- |
| change of the hemodynamic profiles including cardiac index on NICOM during the TURP in elderly patients | (Cardiac output, stroke volume, Stroke volume index, Total peripheral resistance, heart rate, blood pressure) | change from baseline 1 min before the anesthesia, 10 min after anesthesia, 10 min after surgery, 20 min after surgery, 30 min after surgery, at the end of the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of the electrolyte |  | from expected up to 3 months before surgery for preoperative evaluation to expected up to 3 hours after the end of surgery | 
| change of the hemoglobin |  | from expected up to 3 months before surgery for preoperative evaluation to expected up to 3 hours after the end of surgery | 
| estimated absorbed irrigation fluid during the surgery | Fluid absorbed = % decrease in sodium x ECF (0.2 x body weight) | during the surgery | 
| incidence of TURP syndrome |  | followed for the duration of hospital stay, an expected average of 7 days. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elderly patient, NICOM, TURP
Quantification of Thrombocytes Number and Function in Patients Undergoing Prolonged Extracorporeal Circulation

Study Overview
=================
Brief Summary
-----------------
Prolonged extracorporeal circulation (ECC) for cardiac surgery results in coagulation abnormalities, most of which related to the direct, time dependent effect of the polymer tubing and the pump rollers on the thrombocytes. Significant evidence demonstrates the effect of the duration of cardiopulmonary bypass on thrombocytes number and function, as well as on postoperative coagulopathy

Detailed Description
-----------------
Quantification of the effect of ECC duration on blood coagulation and platelet number and function Observational study on 20 patients undergoing prolonged ECC Blood sampling every 30 minutes for platelet count, platelet adhesion markers and coagulation studies Blood test to be performed in Rambam Blood Bank Laboratory

Official Title
-----------------
Quantification of Thrombocytes Number and Function in Patients Undergoing Prolonged Extracorporeal Circulation for Cardiac Surgery

Conditions
-----------------
Coagulopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults over 18 yo scheduled for prolonged cardiac surgery requiring ECC time over 3 hours Exclusion Criteria: documented coagulopathy antiplatelet therapy other then aspirin

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 |
| --- | --- |
| Study group<br>patients scheduled for prolonged cardiac surgery (over 3 hours anticipated ECC time) with no known coagulation disorders | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Platelet function apoptosis markers | Platelet apoptosis by annexin V (Flow cytometry) | 1st sample - less than 10 minutes after induction of anesthesia, 2nd sample - less than 3 minutes after termination of CPB, 3rd sample - 10 minutes after protamine administration for heparin reversal, after termination of CPB | 
| Change in Platelet function activation markers | Platelet activation by P-selectin (Flow cytometry) | 1st sample - less than 10 minutes after induction of anesthesia, 2nd sample - less than 3 minutes after termination of CPB, 3rd sample - 10 minutes after protamine administration for heparin reversal, after termination of CPB | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in platelet count over time |  | Every 30 minutes - starting less than 10 minutes after induction of anesthesia, and for 7 hours or until termination of CPB and protamine administration - whichever comes first |
Evaluate Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs

Study Overview
=================
Brief Summary
-----------------
This study will evaluate long-term safety and tolerability of pasireotide LAR in combination with everolimus in advanced metastatic NET patients, who who have not progressed during 12 months of combination therapy with pasireotide LAR and everolimus

Official Title
-----------------
Extension Study to the Open-label Phase I Study Evaluating the Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs - The COOPERATE-1 Study

Conditions
-----------------
Neuroendocrine Tumors

Intervention / Treatment
-----------------
* Drug: RAD001
* Drug: SOM230


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion and Exclusion Criteria: Patients eligible for inclusion in this extension study have to meet all of the additional inclusion criteria: The patient must provide a signed Informed Consent Form (ICF) for the extension study prior to any study related procedures Completion of the whole treatment period of 15 months (3 months monotherapy with either pasireotide LAR or everolimus followed by a 12 months combination of pasireotide LAR/everolimus) in the CSOM230F2102 study No tumor progression during 12 months of combination therapy with pasireotide LAR and everolimus (checked via radiologically assessment). No intolerable toxicity during combination therapy with pasireotide LAR and everolimus

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RAD001 + SOM230<br> | Drug: RAD001<br> <br> * Other names: Everolimus;Drug: SOM230<br> <br> * Other names: Paseriotide;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events and Serious Adverse Enents as a Measure of Safety and Tolerability |  | up to 4 years | 
| Number of Participants with abnormal laboratory and ECG results as a Measure of Safety and Tolerability |  | up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| investigator-assessed progression free survival (PFS) |  | up to 4 years | 
| best overall response |  | up to 4 years |
Evaluation of Walk With Ease in Arthritis

Study Overview
=================
Brief Summary
-----------------
The overall goal of this study is to determine the whether the Walk with Ease (WWE) program in its 2 version (group-assisted and self-directed) can increase physical activity and fitness levels among individuals (18 years and older) with arthritis over the long-term. Participants will be approximately 657 subjects from 20-24 rural and urban communities across North Carolina. It is expected that participants in the WWE program will have reduced pain, improved function and increased activity levels after participation in this 6-week program.

Official Title
-----------------
Evaluation of the Walk With Ease Program Among People With Arthritis

Conditions
-----------------
Arthritis

Intervention / Treatment
-----------------
* Behavioral: Walk with Ease - Group
* Behavioral: Walk with Ease - Self


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Self-reported, doctor-diagnosed arthritis Ages 18+ Exclusion Criteria: Non-English speaking Severe impairment of physical or mental function Co-existing condition for which exercise is contraindicated

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group WWE<br>Subjects will participate in a group-assisted 6 week WWE program. | Behavioral: Walk with Ease - Group<br>* Participate in 6-week, 1 hour per week group assisted classes (with instructor).<br>|
| Experimental: Self-directed<br>Subjects will follow the self-directed WWE program. | Behavioral: Walk with Ease - Self<br>* SUbject will receive the WWE workbook and follow it without group/instructor assistance.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity Level |  | 6 weeks | 
| 6-minute walk |  | 6 weeks | 
| Walking behaviors |  | 6 weeks | 
| Exercise self-efficacy |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related Quality of Life (SF36) |  |  | 
| Health Assessment Questionnaire |  |  | 
| Arthritis Symptoms |  |  | 
| Senior Fitness Test (function) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthritis, osteoarthritis, rheumatoid arthritis, fibromyalgia, lupus
Comparison of Transparent Retractable Extension Device and Narrow Band Imaging on Colorectal Adenoma Detection

Study Overview
=================
Brief Summary
-----------------
The investigators previously reported that colonoscopy with a transparent retractable extension (TRE) device improved the adenoma detection rate without affecting intubation and withdrawal times. On the other hand, colonoscopy using narrow band imaging (NBI) is expected to lead to higher rate s of adenoma detection. The investigators compared the effects of TRE device on colorectal adenoma detection with those of NBI.

Conditions
-----------------
Colorectal Cancer Screening

Intervention / Treatment
-----------------
* Device: TRE vs. NBI


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria: Age less than 20 years old Pregnant American Society of Anesthesiologists class III and IV Overweight (body weight > 100 kg) Allergic to the drugs used or its components (soybeans or eggs) Poor bowel preparation Previous colorectal surgical resection

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 100 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>The investigators evaluate beneficial effect of colonoscopy using narrow band imaging (NBI) for colorectal adenoma detection. | Device: TRE vs. NBI<br>* TRE NBI<br>|
| Experimental: 1<br>The investigators evaluate the beneficial effect of colonoscopy with a transparent retractable extension (TRE) device on colorectal adenoma detection rate. | Device: TRE vs. NBI<br>* TRE NBI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colorectal adenoma detection rate |  | after colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time, complication |  | after colonoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonoscopy, hood, NBI
Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance

Study Overview
=================
Brief Summary
-----------------
The trial is aimed to investigate an orthodontic treatment with a new removable-part-time-wearing appliance, based on High-Tech technology. The appliance should be wear only 12-14 hours a day, and is made of a single silicone aligner, made specifically for the patient, using 3-D screening technology of the patient's malocclusion. The aligner has a designed pathway built-in for the tooth to move, from the original position of the malocclusion to the end point - the correct position. The force system, that is needed in order to generate tooth movement, is produced by tiny air-balloons which are incorporated in the aligner. The study hypothesis is, that an orthodontic treatment can be done successfully with this part-time wearing appliance.

Detailed Description
-----------------
The appliance include: silicone aligner (made specifically for the patient. simple air pump to blow air in the tiny balloons. The patient is guided to wear the appliance 12-14 hours a day, after filling air in the balloons, under the doctor's instructions. Clinical examination for follow-up will be done every 4 weeks.

Conditions
-----------------
Malocclusion

Intervention / Treatment
-----------------
* Procedure: orthodontic treatment with Rafenalign appliance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild to moderate class I malocclusion good general health good oral hygiene Exclusion Criteria: bad cooperation any mental or health problem severe class I malocclusion, class II or class III malocclusion

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 68 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: orthodontic treatment with Rafenalign appliance|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| study models |  | every 2 appointments (8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occlusal photographs |  | every 3 appointments (12 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
malocclusion, aligner, crowding, expansion, orthodontic treatment
Colorectal Emergencies in Elderly Patients.

Study Overview
=================
Brief Summary
-----------------
Colon diseases can turn in a clinical emergency with the onset of some important complications. Some critical conditions are more common in aged patients because they are more frails. The aim of this study is to examine ultra 80 patients, undergoing emergency colorectal surgery, evaluating the aspects associated with post-operative complications and other problems in the short term. From November 2020 to February 2022 we have included 32 consecutive patients older than 80 undergoing emergency surgery due to colon diseases. We have collected and analysed all demographic, and operative data and then applied CR-POSSUM score and correlated with postoperative hospital stay and the onset of postoperative complications according to Clavien Dindo classification. Postoperative factors were selectively evaluated based on the clinical scenario and different colic pathologies. There was no statistically significant differences, in terms of postoperative hospital stay, postoperative complications, reoperation rate and 30-day mortality. The number of cases of blood transfusions was significant, more numerous in case of intestinal perforation and bleeding cases. The value of Operative Severity Score in the Bowel Perforations, was significantly higher. The use of a score to stratify the risk is a useful tool especially in elderly patients to undergo emergency surgery. The CR-POSSUM score was important for predicting morbidity in our study. Emergency manifestations of colon diseases in the elderly show higher morbidity and mortality rates.

Official Title
-----------------
Emergency Surgery for Colon Diseases in Elderly Patients. Analysis of Complications, and Postoperative Course

Conditions
-----------------
Emergency Colorectal Surgery in Ultra 80 Patients

Intervention / Treatment
-----------------
* Procedure: colorectal surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age older than eighty emergency conditions Exclusion Criteria: trauma cases

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: colorectal surgery|we have included several types of colorectal surgery procedures, in emergency conditions|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative hospital stay |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications |  | 30 days |
Helping Hospitalized Patients Quit Smoking

Study Overview
=================
Brief Summary
-----------------
The study is being done to determine whether an in-hospital intervention using a brief intervention to facilitate quitline utilization will increase quitline utilization by hospitalized smokers, and will increase post hospital discharge smoking abstinence rates. Study participants will be randomized to receive either a brief quitline facilitation intervention , or a control intervention of a brief stop-smoking message. The study will also compare healthcare costs and utilization in the first six months following hospitalization between the two groups.

Official Title
-----------------
Helping Hospitalized Patients Quit Smoking

Conditions
-----------------
Tobacco Abuse Cigarette

Intervention / Treatment
-----------------
* Behavioral: Quitline facilitation intervention
* Behavioral: Brief stop-smoking intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current smoker, Resident of Olmsted County, Inpatient admission to St. Marys or Rochester Methodist Hospital, Able to participate fully in all study aspects, Available for follow-up Exclusion Criteria: Current active treatment for tobacco use initiated prior to hospitalization

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quitline facilitation intervention<br>brief quitline facilitation intervention given | Behavioral: Quitline facilitation intervention<br>* brief quitline facilitation intervention<br>|
| Active Comparator: Stop-smoking intervention<br>brief review of tips to maintain smoking abstinence, using brochure | Behavioral: Brief stop-smoking intervention<br>* brief review of tips to help maintain smoking abstinence, using brochure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day point prevalence tobacco abstinence at 6 months after hospitalization |  | 6 months after hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-efficacy | Use of Smoking Self-Efficacy Questionnaire 12 | Immediately after the delivery of the brief intervention (day of enrollment) |