linjc16/ctgov huggingface dataset:
Postoperative Pain and Recovery Time After Pulpotomy

Study Overview
=================
Brief Summary
-----------------
The aim of this retrospective study was to compare immediate postoperative pain scores and the need for rescue analgesia in children who underwent pulpotomies and general restorative treatment and those who underwent general restorative treatment only, all under general anaesthesia.

Detailed Description
-----------------
Ninety patients aged between 3 and 7 years who underwent full mouth dental rehabilitation under general anaesthesia were enrolled in the study and reviewed. The experimental group included patients who were treated with at least one pulpotomy, and the control group was treated with dental fillings only. The Wong-Baker FACES scale was used to evaluate self-reported pain and the need for rescue analgesia. The data were analysed using the Kruskal-Wallis test, two sample t- tests, chi-square tests and Pearson's correlation analysis.

Official Title
-----------------
Immediate Postoperative Pain and Recovery Time After Pulpotomy Performed Under General Anaesthesia in Young Children

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

Intervention / Treatment
-----------------
* Procedure: pulpotomy
* Procedure: tooth filling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent full mouth dental rehabilitation under GA because of their lack of chairside cooperation Patients with at least 1 pulpotomy were included in the experimental group (n=45), and patients treated with dental fillings only were included in the control group (n=45); a total of 90 patients were eligible for the study. Exclusion Criteria: Children with special needs and those with any systematic problem (cardiac disease, diabetes, or intellectual disability) were excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 7 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Pulpotomy and tooth filling | Procedure: pulpotomy<br>* vital endodontic procedure<br>Procedure: tooth filling<br>* tooth filling<br>|
| Active Comparator: Control group<br>Tooth filling | Procedure: tooth filling<br>* tooth filling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores evaluation | Wong Baker Faces Scale | An average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative pain, child, pulpotomy, general anesthesia
Extracellular Vesicles and Particles (EVP) as Biomarkers of Recurrence in Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out if fluid rinsed from peoples' airways (bronchial washing samples) during routine surgery to remove (resect) their non-small cell lung cancer (NSCLC) tumors contains enough vesicles to do testing that may help the researchers learn more about their NSCLC.

Official Title
-----------------
Extracellular Vesicles and Particles (EVP) as Biomarkers of Recurrence in Non-Small Cell Lung Cancer

Conditions
-----------------
Non-Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients ≥ 18 years of age undergoing consideration of surgical resection, including lobar resections, sublobar resections, and pneumonectomies, for primary lung cancer will be eligible. Patients with previously resected disease and/or previous radiation therapy will be considered on a case by case basis. Exclusion Criteria: Patients with active infection or pneumonia which may impact exosome makeup Additionally, if at the discretion of the operating surgeon, obtaining bronchial washings would lead to undue morbidity, the patient would be excluded and replaced

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 |
| --- | --- | --- |
| to isolate exosomes from bronchial washings | every patient from whom the essential specimens have been acquired will be evaluated to determine if more than 100,000 microvesicles can be isolated for exosome purification | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extracellular Vesicles and Particles, Biomarkers, 22-155
High-protein and High-carbohydrate Diets' Effect on Urinary Concentrating Ability

Study Overview
=================
Brief Summary
-----------------
We wanted to test urinary concentrating ability and AQP-2 expression in kidney during high-protein and high-carbohydrate diet.

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

Intervention / Treatment
-----------------
* Behavioral: High Protein diet
* Behavioral: High carbohydrate diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) Genders; both mal and female (2) Age; 18- 65 years old (3) BMI; below 30 (4) Females had to bee in oral contraceptive treatment Exclusion Criteria: (1) Clinical signs or history of disease in the heart, lungs, kidneys or endocrine organs (2) Abnormal laboratory test (blood haemoglobin, white cell count, platelets, plasma sodium, plasma potassium, plasma creatinine, plasma albumin, plasma bilirubin, plasma alanine aminotransferase, plasma cholesterol and blood glucose) (3) Albuminuria or glucosuria (4) Cancer (5) Arterial hypertension (6) Alcohol abuse (7) Use of tobacco (8) Medical treatment, except oral contraceptives (9) Pregnancy or breast feeding (10) Medicine abuse (11) Donation of blood less than 1 month before the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: High Protein diet|nan|
|Behavioral: High carbohydrate diet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| u-AQP-2 |  |  | 
| FeNa+ |  |  |
Effect of Meal Texture on Glucose-metabolism and Gut Hormone Response After Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
The investigators want to evaluate the difference in glucose metabolism and intestinal hormonal response after a liquid meal versus a solid meal in patients after bariatric surgery.

Official Title
-----------------
Does Meal Texture Have Different Impact on Glucose Metabolism and Intestinal Hormone Response After Gastric Bypass and Sleeve Gastrectomy Operated Patients?

Conditions
-----------------
Glucose Metabolism Disorders, Obesity, Sleeve Gastrectomy, Gastric Bypass, Gut Hormones

Intervention / Treatment
-----------------
* Other: Liquid meal
* Other: Solid meal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years RYGB or SG operation > 12 months prior to inclusion Weight stable (± 3 kg during the last month) HbA1c < 48 mmol/mol before surgery, and no history of diabetes HbA1c < 48 mmol/mol and fasting plasma glucose < 6.1 mmol/l at inclusion Exclusion Criteria: Thyrotoxicosis or inadequately treated hypothyreosis Hemoglobin < 6.5 mmol/l at inclusion Pregnancy or breast feeding Medication affecting the planned examinations

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Gastric bypass operated patients<br>Two test days in a randomized, patient-blinded, cross-over design | Other: Liquid meal<br>* Four-hour liquid mixed meal test<br>Other: Solid meal<br>* Four-hour solid mixed meal test<br>|
| Other: Gastric sleeve operated patients<br>Two test days in a randomized, patient-blinded, cross-over design | Other: Liquid meal<br>* Four-hour liquid mixed meal test<br>Other: Solid meal<br>* Four-hour solid mixed meal test<br>|
| Other: Control arm<br>Two test days in a randomized, patient-blinded, cross-over design | Other: Liquid meal<br>* Four-hour liquid mixed meal test<br>Other: Solid meal<br>* Four-hour solid mixed meal test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GLP-1 response | GLP-1 response after a liquid meal test compared to a solid meal test | 240 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in gut hormone response after bariatric surgery |  | 240 minutes |
The Role of Fractional Vascular Laser Therapy in the Management of Burn Scars

Study Overview
=================
Brief Summary
-----------------
While the literature tends to support the use of laser therapy in the management of burn scars, there is a definite lack of appropriately powered, randomized controlled trials. Laser therapy can be quite expensive when compared to other treatment modalities for burn scars, and while promising, its true usefulness has yet to be conclusively demonstrated. For this reason, our assessing the effects of fractional vascular lasers on burn scars. It has been hypothesized that the fractional vascular lasers work on mature scars to decrease scar formation, and the fractional laser works on scar that is quiescent to promote remodelling. The retexturing/ resurfacing of the laser theoretically can decrease the visibility of the mesh pattern created by meshed split thickness skin graft). Objective: To determine the benefit of fractional vascular laser treatment in improving burn scar height, texture, vascularity and pliability in late burn scars.

Official Title
-----------------
The Role of Fractional Vascular Laser Therapy in the Management of Burn Scars

Conditions
-----------------
Burn Scar

Intervention / Treatment
-----------------
* Device: Fractional Vascular Laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: living in Winnipeg burn scar 6-12 months old Fitzpatrick skin type I-III thermal burn scar on trunk or extremities Exclusion Criteria: open wound

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Proximal<br>location of the scar proximal to heart | Device: Fractional Vascular Laser<br>* laser energy will be applied to one of 2 sites (proximal or distal) depending on randomization result<br>|
| Experimental: Distal<br>location of scar distal to heart | Device: Fractional Vascular Laser<br>* laser energy will be applied to one of 2 sites (proximal or distal) depending on randomization result<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in scar appearance | examine with modified Vancouver Scar Scale | every 3 weeks to 15 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
burn, scar, laser, fractional, vascular
Sequential Endoscopic Lung Volume Reduction

Study Overview
=================
Brief Summary
-----------------
Patients with heterogenous emphysema benefits from endoscopic lung volume reduction. Until now the technique is limited to one lobe. In case of collateral ventilation patients show no improvement. Between upper and middle lobe exists the highest collateral flow. The trial examine the hypothesis, that sequential ELVR help especially those patients, which have no benefit after lobar exclusion.

Detailed Description
-----------------
Patients with heterogenous emphysema undergo ELVR, target lobe is the upper lobe right. After 6 weeks the middle lobe will be block too. Follow-up period 6 months Primary end points: FEV 1, 6-Minute walk test Secondary endpoints. Safety, Symptom scores Number of patients planned 30

Official Title
-----------------
Sequential Endoscopic Lung Volume Reduction in Patients With Heterogeneous Lung Emphysema

Conditions
-----------------
Emphysema, COPD

Intervention / Treatment
-----------------
* Device: Zephyr endobronchial valve


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heterogenous emphysema FEV1 < 45% RV > 150% TLC > 100% TLCO < 40% Exclusion Criteria: Homogeneous emphysema Pregnancy PCO2 > 50 mmHg

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Zephyr endobronchial valve|Endobronchial valve system to redirect the airflow within the bronchial system|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV 1 6 Minute walk test |  | 6 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Symptom scores |  | 6 months after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endoscopic lung volume reduction, heterogeneous emphysema, interventional bronchoscopy
Age, Risk Factors for CVD and Cognitive Functioning

Study Overview
=================
Brief Summary
-----------------
To relate cardiovascular disease (CHD) risk factors to cognitive performance among middle-aged and elderly men and women over a 10 year longitudinal study period.

Detailed Description
-----------------
BACKGROUND: The Framingham Heart Study is a major epidemiological investigation of prospective relationships between risk factors for the development of cardiovascular disease (CVD risk factors) and CVD risk factor outcomes. The Framingham Study and other large, prospective studies have resulted in an extensive literature on the impact of CVD risk factors (including age) and CVD outcomes. Comparatively, there have been many fewer studies of the impact of CVD risk factors on cognitive functioning, and possibly no studies of the effect of objectively measured, competing risk factors on cognitive functioning. DESIGN NARRATIVE: Dr. Elias and colleagues used cardiovascular risk factor data from the Framingham Heart Study (N= 2,123) in a prospective design allowing them to relate CVD risk factors (including age and gender) to two outcome measures: (1) level of cognitive performance and (2) change in cognitive performance over a 10 year longitudinal study period. The overall goals were to determine the best multivariate combination of biological and psychosocial risk factors for the prediction of lowered cognitive ability in middle-aged and elderly men and women, and to evaluate the relative impact of age, gender, and other biological and psychosocial risk factors on cognitive functioning. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Neurologic Manifestations

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Using Videos to Improve Understanding of the Delivery of End-of-life Medical Care in Non-hospital Settings

Study Overview
=================
Brief Summary
-----------------
To compare the decision making of elderly subjects having a verbal advance care planning discussion compared to subjects using a video.

Detailed Description
-----------------
A.1. Aim 1: To recruit 101 subjects over the age of 64 who are newly admitted to a nursing home facility and randomly assign these subjects to one of two advance care planning (ACP) modalities: 1. a video visually depicting the Goals of Care (Life Prolonging Care, Limited Care, and Comfort Care) (intervention) or 2. a verbal narrative describing the Goals of Care (control) encountered if the subject becomes very ill. Hypothesis 1: It is feasible to recruit and randomize newly admitted elderly subjects to each of the ACP modalities. A.2. Aim 2: To compare the care preferences for their primary goal of care (i.e., life-prolonging care, limited care, or comfort care) among 101 subjects randomized to video vs. verbal narrative intervention for ACP. Hypothesis 2: Subjects randomized to the video intervention will be significantly more likely to opt for comfort care (vs. life-prolonging or limited care) as the primary goal of care compared to those randomized to the verbal narrative. A.3. Aim 3: To compare knowledge assessment of the Goals of Care of 101 subjects randomized to video vs. verbal narrative intervention for ACP. Hypothesis 3: When compared to subjects randomized to the verbal narrative arm, subjects in the video group will have higher knowledge assessment scores when asked questions regarding their understanding of the Goals of Care.

Conditions
-----------------
Elderly

Intervention / Treatment
-----------------
* Other: video decision aid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over age of 64 have decision making capacity Exclusion Criteria: do not speak English

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control subjects<br>verbal narrative of advance care planning | |
| Experimental: intervention group<br>video decision aid viewed by subjects | Other: video decision aid<br>* video<br>* Other names: film;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preference for medical care | preference for care at the end of life | 5 minutes after the survey | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nursing home, advance care planning
A Single Dose of a Marketed Drug Being Studied for a New Indication to Treat Surgical Site Infection Following Colorectal Surgery as Compared to a Marketed Drug Approved for This Indication (0826-039)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and efficacy of a one time dose of an intravenous marketed drug being evaluated for a new indication as compared to a marketed drug already approved for the prevention of surgical site infection following colorectal surgery.

Detailed Description
-----------------
The duration of treatment is 1 day.

Official Title
-----------------
A Prospective, Multicenter, Double-Blind, Randomized, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of a Single Dose of Ertapenem Sodium (MK0826) Versus Cefotetan for the Prophylaxis of Surgical Site Infection Following Elective Colorectal Surgery

Conditions
-----------------
Colorectal Surgery

Intervention / Treatment
-----------------
* Drug: MK0826, ertapenem sodium
* Drug: Comparator: cefotetan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients 18 years of age scheduled to undergo elective colon or colorectal surgery by laparotomy must meet the following criteria: Surgery must be scheduled in advance. There must be adequate time to complete preoperative bowel preparation

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0826, ertapenem sodium|nan|
|Drug: Comparator: cefotetan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection following elective colorectal surgery based on surgical site assessment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiology of surgical site infection in pts who fail prevention or have distant site infection; Safety profile based on AE monitoring and lab results. |  |  |