linjc16/ctgov huggingface dataset:
Single Incision Versus Conventional Laparoscopic Appendectomy

Study Overview
=================
Brief Summary
-----------------
This is a randomized prospective study comparing single incision versus conventional laparoscopic appendectomy for management of acute appendicitis.

Conditions
-----------------
Acute Appendicitis

Intervention / Treatment
-----------------
* Procedure: single incision laparoscopic appendectomy
* Procedure: conventional laparoscopic appendectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute appendicitis Exclusion Criteria: perforation with peritonitis lower abdominal scar contraindications to laparoscopy

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 80 Years

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: single incision laparoscopic appendectomy<br> | Procedure: single incision laparoscopic appendectomy<br> <br> |
| Placebo Comparator: conventional laparoscopic appendectomy<br> | Procedure: conventional laparoscopic appendectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
ICU Patient and Family Comfort Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate family-led interventions for Intensive Care Unit (ICU) patients' symptoms (i.e., pain and thirst) that will involve ICU patients' family members in the non-pharmacological management of these symptoms. This family involvement may help to ameliorate not only patients' symptoms but also the families' symptoms and promote family satisfaction with ICU care.

Conditions
-----------------
Pain, Thirst, Anxiety, Satisfaction

Intervention / Treatment
-----------------
* Behavioral: mouth care
* Behavioral: pain intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient: in ICU for at least 24 hours; adult; able to self-report; pain and thirst greater than 3 on 0-10 numeric rating scale; English-speaking. Family member: 18 years or older; visits patient more than other family members; closest person to patient (can be non-biological). Exclusion Criteria: Patient: in ICU for at less than 24 hours; non-adult; unable to self-report; no pain and thirst greater than 3 on 0-10 numeric rating scale; non-English-speaking. Family member: younger than 18 years; visits patient less than other family members; not closest person to patient.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pain intervention<br>music and massage for 30 minutes | Behavioral: pain intervention<br>* music and massage<br>|
| Experimental: thirst intervention<br>sterile water mouth spray, lip moisturizer,mouth swab | Behavioral: mouth care<br>* mouth spray, mouth swab, moisturizer<br>|
| No Intervention: control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient-reported pain |  | immediately after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient-reported thirst |  | immediately after intervention | 
| Family-reported anxiety |  | at end of study | 
| Family-reported satisfaction |  | end of study |
Placebo Controlled Dose-Response Study of Rivoglitazone in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy response of rivoglitazone HCl on the change in HbA1c after 12 weeks of treatment in patients with type 2 diabetes.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled 12-Week Dose-Response Study of Rivoglitazone (CS-011) in Patients With Type 2 Diabetes.

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Rivoglitazone HCl
* Drug: rivoglitazone HCl
* Drug: rivoglitazone HCl
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes mellitus HbA1c >6.5% and <10% FPG >126 mg/dL (7mmol/L) and <270 mg/dL (15 mmol/L) Exclusion Criteria: history of type 1 diabetes history of ketoacidosis current insulin therapy C-peptide <0.5ng/mL impaired hepatic function CHF or history of CHF (NYHA stage I - IV) uncontrolled hypertension

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>rivoglitazone HCl 0.5 mg tablets once daily for 12 weeks | Drug: Rivoglitazone HCl<br>* 0.5 mg tablets once daily for 12 weeks<br>|
| Experimental: 2<br>rivoglitazone HCl 1 mg tablets once daily for 12 weeks | Drug: rivoglitazone HCl<br>* 1.0 mg tablets once daily for 12 weeks<br>|
| Experimental: 3<br>rivoglitazone HCl 1.5 mg tablets once daily for 12 weeks | Drug: rivoglitazone HCl<br>* 1.5 mg tablets once daily for 12 weeks<br>|
| Placebo Comparator: 4<br>Matching placebo tablets once daily for 12 weeks | Drug: Placebo<br>* Matching placebo tablets once daily for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from baseline for rivoglitazone compared to placebo |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fasting Plasma Glucose from baseline for rivoglitazone HCl compared to placebo |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rivoglitazone HCl, thiazolidinedione, peroxisome proliferator-activated receptor gamma (PPARgamma), diabetes mellitus, type 2
Clinical Observational Study Investigating the Role of Diastolic Dysfunction in Determining Abnormal Cardiorespiratory Exercise Testing Parameters in Patients Undergoing Major Surgery

Study Overview
=================
Brief Summary
-----------------
REASON FOR STUDY Major non-cardiac surgery has a high degree of morbidity and mortality. Recently, suitable measurements of a patient's preoperative cardiorespiratory reserve, performed non-invasively by cardiopulmonary exercise testing, have been shown to be predictive of outcome following non-cardiac surgery. Although the exact mechanisms behind poor reserve in this population are unknown, poor cardiac function and particularly diastolic dysfunction are likely to be important. AIMS The aim of the present study is to investigate the role of diastolic dysfunction in determining poor cardiorespiratory reserve in elderly patients undergoing major non-cardiac surgery. This will provide suitable information to inform a further therapeutic preoperative interventional study. OBJECTIVES AND METHODS To determine the presence and severity of diastolic dysfunction, measured by preoperative transthoracic echocardiogram, in a series of elderly surgical patients undergoing major elective non-cardiac surgery To investigate the relationship between diastolic dysfunction and poor cardiorespiratory function during and following exercise measured by non-invasive testing including cardiopulmonary exercise testing, non-invasive blood pressure measurements and biochemical analysis To determine whether patients with poor diastolic dysfunction are likely to have worse outcomes following major surgery compared with those who show no evidence of diastolic dysfunction. Outcomes will be measured in terms of length of hospital stay and early postoperative morbidity (validated scoring system) and mortality.

Conditions
-----------------
Diastolic Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing major surgery Low functional capacity Exclusion Criteria: Unable to give consent

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| All patients undergoing major surgery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Chronic Kidney Disease - REAL Life Study in Alsace

Study Overview
=================
Brief Summary
-----------------
Chronic kidney disease (CKD) is a public health problem and affects about 10% of the world's adult population with a constantly increasing incidence. The approach to CKD in France is centered on access to replacement therapy (dialysis, renal transplantation), the cost of which amounts to 4 billion euros (data from the REIN registry). Real-life data are essential to specify the characteristics of patients with chronic kidney disease and the factors associated with the evolution of CKD and the occurrence of complications in order to improve the management of CKD before the suppletion stage. Since October 2019, CKD at the severe stage (stage 4) and at the non-dialysis end stage (stage 5) is subject to an annual flat fee (Article L. 162-22-6-2 of the Social Security Code). The reimbursement of these lump sums by the health insurance is subject to the collection and transmission of certain medical data by the establishments.

Official Title
-----------------
Chronic Kidney Disease - REAL Life Study in Alsace

Conditions
-----------------
Chronic Kidney Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subject (≥18 years) Subject included in the MRC package (GFR <30 ml/min/1.73 m2) Subject who has not expressed opposition, after information, to the reuse of his or her data for the purpose of this research Exclusion criteria: - Subject having expressed his opposition to participate in the study

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retroanalysis of the risk factors in patients with severe chronic kidney disease | Analysis of risk factors in patients with severe chronic kidney disease by retrospectively analyzing health data contained in patient medical records | Files analysed retrospectively from October 01, 2019 to February 31, 2027 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney, Chronic Disease, Chronic Kidney Disease
Effect of Cumulative Chloride Dose on Development of Acute Kidney Injury in Critically Ill Children

Study Overview
=================
Brief Summary
-----------------
The investigators would like to investigate the effect of chloride dosing on the development of acute kidney injury in critically ill patients. The investigators hypothesis is that administering intravenous fluids with higher chloride content are more likely to lead to acute kidney injury.

Detailed Description
-----------------
Retrospective chart review from 2008-2012 evaluating chloride dosing and serum chloride levels and their effects on acute kidney injury in the pediatric ICU. Patients will be included for the first seven days of their PICU stay.

Official Title
-----------------
Retrospective Investigation of Chloride Dosing and Its Effect on Acute Kidney Injury

Conditions
-----------------
Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age less than 18 years PICU admitting diagnosis of sepsis, respiratory failure, or hepatic failure. Exclusion Criteria: hyponatremia or hypernatremia at PICU admission preexisting diagnosis of End-stage renal disease or renal transplant presence of neurologic comorbidities.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum 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 |
| --- | --- |
| High Chloride Dose<br>Patients receiving high dosing of chloride | |
| Low Chloride Dose<br>Patients receiving low dosing of chloride | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Kidney Injury | or sooner if death or discharged | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PICU length of stay |  | 7 days | 
| Hospital length of stay |  | 7 days | 
| Number of ventilator days |  | 7 days | 
| Mortality |  | 7 days |
Clitoris Potential Analgesic Function Research by Pregnant Women : Feasibility Study

Study Overview
=================
Brief Summary
-----------------
Assessment of the acceptability by pregnant women on the research of the potential analgesic function of the clitoris.

Official Title
-----------------
Clitoris Potential Analgesic Function Research by Pregnant Women : Feasibility Study

Conditions
-----------------
Pregnancy Related

Intervention / Treatment
-----------------
* Other: Vibrating Relaxation Tool


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant woman, whatever the term, primiparous or multiparous Age ≥ 18 years old Patient having read and understood the information letter and signed the consent form Patient affiliated to Social Security Exclusion Criteria: Inability to understand French or information, Person deprived of their liberty by an administrative or judicial decision Person placed under the protection of justice Person under guardianship or curatorship

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vibrating Relaxation Tool<br>Use of a Vibrating Relaxation Tool in case of pain during pregn | Other: Vibrating Relaxation Tool<br>* Use of a Vibrating Relaxation Tool in case of pain during pregnancy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability | Among patients who had the information visit, proportion of those who were included and applied the procedure at least twice | through study completion, an average of 15 months |
The Effects of Nicotine Chewing Gum in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The objective of this experiment is: To determine if nicotine chewing gum will improve acute episodes of orthostatic hypotension in PD subjects.

Detailed Description
-----------------
Subjects will be asked to sit and rest for 10 minutes. Blood pressure will be taken in this resting position after the 10 minutes. After all inclusion criteria has been met, subjects will then wear an automated BP cuff and be administered 4mg of nicotine gum (Nicorette™). They will be instructed to use it according to manufacturer's directions and remain chewing the gum for 30 minutes. The subject will remain in a seated position and BP and HR will be recorded every 5 minutes for 30 minutes. After 30 minutes the gum will be removed and subjects will still have HR and BP monitored in the seated position for another hour every 10 minutes. All values will be compared to pretreatment values. After 120 minutes if the subject is non-symptomatic, they can go home.

Official Title
-----------------
The Effects of Nicotine Chewing Gum on Acute Low Blood Pressure in Parkinson's Disease

Conditions
-----------------
Low Blood Pressure, Parkinsons Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Nicotine gum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a diagnosis of PD a diastolic BP less than 90 mmHg and/or a systolic BP lower than 100mHg. Exclusion Criteria: current tobacco users in all forms of tobacco severe dysphasia (difficulty swallowing) previous tobacco users who might be at risk for re-addiction.
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicotine Gum<br>Nicotine chewing gum administered for 30 minutes | Dietary Supplement: Nicotine gum<br>* Nicotine chewing gum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure |  | 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate |  | 90 Minutes |
Association of Plasma PTX3 Concentration and Outcomes of STEMI

Study Overview
=================
Brief Summary
-----------------
335 of patients with STEMI treated by primary PCI were assayed for PTX3 measurement by ELISA method. The angiographic and clinical outcomes were evaluated according to the PTX3 concentration.

Detailed Description
-----------------
335 of patients with STEMI treated by primary PCI were assayed for PTX3 measurement by ELISA method using human PTX3 kit. Blood was drawn at the emergency department before primary PCI. The angiographic and clinical outcomes were evaluated and analyzed according to the PTX3 concentration. The angiographic outcome were thrombus grade on initial angiogram and final TIMI flow. The clinical outcome were ECG resolution after primary PCI and all-cause death at 30 days. The plasma PTX3 concentration was then compared based on the outcomes.

Official Title
-----------------
Association of Plasma Pentraxin 3 Concentration With Angiographic and Clinical Outcomes in STEMI Treated by Primary Angioplasty

Conditions
-----------------
STEMI, Coronary; Ischemic

Intervention / Treatment
-----------------
* Other: Plasma PTX3 concentration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acute STEMI with symptom onset <12 h undergoing primary PCI Exclusion Criteria: Acute STEMI patients who received fibrinolytic therapy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PTX3 concentration<br>First quartile, second quartile, third quartile and fourth quartile of PTX3 in ng/mL | Other: Plasma PTX3 concentration<br>* Long pentraxin 3, thrombus burden, final TIMI flow, ST segment resolution, STEMI, primary PCI<br>* Other names: PTX3;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of thrombus grade 4&5 and final TIMI flow <3 | PTX3 concentration was compared based on the outcome | Intraprocedure |
Role of Dietary Habits in Efficacy of Bariatric Surgery - Study A

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate how dietary habits in the post-surgical year impact outcomes of bariatric surgery.

Detailed Description
-----------------
The obesity epidemic is a major public health concern with a significant economic burden in the USA. Bariatric surgery is the most effective and durable weight loss treatment, with long-term cardiometabolic health benefits. Among different types of bariatric procedures, sleeve gastrectomy (SG) has become the most commonly performed in USA. While SG is expected to result in a 50-60% excess weight loss, inter-individual differences in weight loss are large and approximately 25% of patients can be considered poor weight-loss responders who either do not lose a substantial amount of weight or regain the lost weight afterwards. The mechanisms underlying this clinical variation remain unknown and interventions to improve on these outcomes critically lacking. Of interest, altered daily dietary habits are experienced by a substantial proportion of bariatric surgery candidates, raising the question whether such alterations may contribute to inter-individual differences in weight loss success. Therefore, the purpose of this study is to evaluate how dietary habits in the post-surgical year impact outcomes of bariatric surgery.

Official Title
-----------------
Role of Dietary Habits in Efficacy of Bariatric Surgery - Study A

Conditions
-----------------
Obesity, Bariatric Surgery, Sleeve Gastrectomy

Intervention / Treatment
-----------------
* Other: Dietary habits


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bariatric surgery (sleeve gastrectomy) patients Exclusion Criteria: Prior bariatric surgical procedures

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sleeve gastrectomy patients<br>Patients electing to undergo sleeve gastrectomy will monitor their dietary habits. | Other: Dietary habits<br>* Sleeve gastrectomy patients will be asked to monitor dietary habits before surgery and at 2, 6, and 12 months after surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI at 1-year post-surgical | Body mass index at one year after surgery compared to baseline | Baseline and one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diet, Dietary Habits, Weight changes