linjc16/ctgov huggingface dataset:
Post-operative Haloperidol Versus Placebo for Prevention of Post-operative Delirium After Acute Hip Surgery

Study Overview
=================
Brief Summary
-----------------
In this study the investigators want to determine if treatment with haloperidol direct post-operatively after acute hip surgery in high risk patients protects against developing a post-operative delirium.

Detailed Description
-----------------
A post-operative delirium is a serious and frequent (35-65%) complication with high morbidity and mortality in high risk patients. In this study we investigate whether we can prevent a delirium from occuring after surgery in patients with a hip fracture of 75 years of age and older. It's a randomised double-blind single centre placebo-controlled study of haloperidol versus placebo.

Official Title
-----------------
Randomised Double-blind Placebo-controlled Study of Post-operative Haloperidol Versus Placebo for Prevention of Post-operative Delirium After Acute Hip Surgery

Conditions
-----------------
Post-Operative Delirium, Hip Fracture

Intervention / Treatment
-----------------
* Drug: Haloperidol
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hip fracture 75 years and older Exclusion Criteria: Contra-indications for the use of haloperidol Pre-operative delirium Pre-operative use of haloperidol

Ages Eligible for Study
-----------------
Minimum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Patients receiving blinded medication (Haloperidol or Placebo) | Drug: Haloperidol<br>* Haloperidol 1mg twice daily during 72hours<br>|
| Placebo Comparator: B<br>Patients receiving blinded medication (Haloperidol or Placebo) | Drug: placebo<br>* Placebo 1mg twice daily during 72hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post-operative delirium |  | 72 hours post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay |  | days | 
| Complications |  | during hospitalization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post-operative delirium, hip fracture
TARGETing Healthy Weight Loss in the Context of Food Insecurity

Study Overview
=================
Brief Summary
-----------------
This pilot and feasibility study will collect information from food insecure, as well as food secure, women with obesity to detail their desires and needs for healthy weight reduction. Up to 60 women with obesity will be enrolled. Pennington Biomedical Research Center will coordinate this qualitative study and use focus groups discussion to collect formative data.

Official Title
-----------------
TARGETing Healthy Weight Loss in the Context of Food Insecurity Pilot and Feasibility Trial I

Conditions
-----------------
Obesity, Food Insecurity, Food Security, Body Weight

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing to provide written informed consent Female 18 to 65 years of age BMI ≥ 30 kg/m2 Ability to read and write using English Willing to participate in focus group discussions Willing to be audio/video recorded Exclusion Criteria: Male Currently pregnant BMI <30 kg/m2

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Food Insecure Women with Obesity<br>4 focus groups with 6-8 participants each | |
| Food Secure Women with Obesity<br>3 focus groups with 6-8 participants each | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Desires and needs for weight loss | Via focus group discussions, we will elicit in-depth information from women with food insecurity and obesity to detail their desires and needs for weight loss. | Through study completion, up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Food Insecurity, Obesity, Weight Loss
AVANTI - Avelox® in Acute Exacerbations of chroNic bronchiTIs

Study Overview
=================
Brief Summary
-----------------
The objective of this global non-interventional study is to evaluate the impact of Acute Exacerbation of Chronic Bronchitis(AECB) on the patient and the community as well as the safety and effect of a treatment with Moxifloxacin tablets in daily life clinical practice. This includes data on the course of symptom relief, speed of return to normal daily life activities as well as records on adverse events. This study will be performed in accordance with international guidelines like EMEA (EMEA, EUDRALEX Volume 9A, Pharmacovigilance for Medicinal Products for Human Use) as well as local laws.

Official Title
-----------------
AVANTI - Avelox® in Acute Exacerbations of Chronic Bronchitis

Conditions
-----------------
Bronchitis, Chronic

Intervention / Treatment
-----------------
* Drug: Moxifloxacin (Avelox, BAY12-8039)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at least 35 years of age with a diagnosis of Acute Exacerbation of Chronic Bronchitis (AECB) and decision taken by the investigator to treat with Avelox. Exclusion Criteria: Exclusion criteria must be read in conjunction with the local product information.

Ages Eligible for Study
-----------------
Minimum Age: 35 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 |
| --- | --- |
| Group 1<br> | Drug: Moxifloxacin (Avelox, BAY12-8039)<br>* Patients with acute exacerbation of chronic bronchitis for whom the physician decided to prescribe moxifloxacin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time until improvement of acute exacerbation |  | End of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time until cure of acute exacerbation |  | End of study | 
| Severity of AECB according to Antonisen criteria |  | Baseline | 
| Impact of AECB on daily life activities |  | Baseline | 
| Safety of Avelox under daily life treatment conditions |  | Throughout treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Exacerbation of Chronic Bronchitis (AECB) patients
Safety and Tolerability of the First IV Dosing of SLV338 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study will investigate the safety and tolerability of the first IV dosing of SLV338 in healthy volunteers.

Official Title
-----------------
A Placebo-Controlled, Combined Single and Multiple Rising Dose Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV338 After Intravenous Administration in Healthy Male Subjects

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

Intervention / Treatment
-----------------
* Drug: SLV338
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy Exclusion Criteria: not healthy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: SLV338<br>* 5 - 1000 mg IV<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability parameters, including administration site tolerability, adverse events, clinical laboratory tests, vital signs and ECG |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters: AUC, Cmax, tmax, t½, λz, CL, CLR, Vz, Vss, MRT, Ae, and fe. |  | 48 hours | 
| Pharmacodynamic parameters: Plasma levels of ANP, cGMP, BNP, VIP, Big ET, ET-1, angiotensin II and aldosteron. Urinary volume and urine levels of cGMP, sodium, potassium, chloride, uric acid and creatinine, and creatinine clearance. |  | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SLV338, phase I, healthy volunteers
A Study of Prevalence of EGFR Mutations in Participants With NSCLC

Study Overview
=================
Brief Summary
-----------------
This is a non-interventional, local, multicenter, cross-sectional study to determine the prevalence of epidermal growth factor receptor (EGFR) mutations in participants diagnosed with non-squamous non-small cell lung cancer (NSCLC).

Official Title
-----------------
An Epidemiology Study of the Prevalence of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients Diagnosed With Non-squamous Non-small Cell Lung Cancer (NSCLC)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent form signature Jordanian male and female participants greater than or equal to (>=) 18 years of age Histologically confirmed NSCLC Not participating in a study that involves an investigational agent within 30 days prior to enrollment Exclusion Criteria: Other primary malignancy Fine needle aspiration samples

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 |
| --- | --- |
| NSCLC Participants<br>Participants with non-squamous NSCLC will be enrolled in this study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with EGFR mutations |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with types of EGFR mutations |  | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-small cell lung cancer (NSCLC)
Clinical Impact of Autonomic Modulation After Pulmonary Vein Isolation

Study Overview
=================
Brief Summary
-----------------
Pulmonary vein isolation (PVI) has become a standard therapy for atrial fibrillation (AF), however, there is still considerable AF recurrence after PVI. Except for PV-left atrium (LA) reconnection, the cause of recurrence has been not yet fully clarified. The alternation of autonomic tone plays an important role in initiation of paroxysmal AF. It was reported that there are multiple gangliated plexus (GP) around pulmonary veins, therefore the modulation targeting those GPs, resulting in modulations of cardiac autonomic tone, have been conducted. Some study showed the efficacy of GP ablation for AF patients. According to the previous reports, heart rate (HR) increased, and heart rate variability (HRV) reduced after PVI. These are considered to be due to autonomic denervation caused by catheter ablation of GP. For the best of investigators knowledge, there have been no data on heart rate turbulence (HRT) of baroreflex sensitivity (BRS) concerning PVI.

Official Title
-----------------
Clinical Impact of Autonomic Modulation After Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who undergo PVI for paroxysmal atrial fibrillation Patients in sinus rhythm at baseline Exclusion Criteria: prior left atrial Ablation left atrial diameter >55mm frequent atrial extrasystole, frequent ventricular Extrasystole Diabetes Mellitus sleep apnea syndrome

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| recurrence of AF | Time measured in days to recurrence of AF | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of PVI on cardiac autonomic system utilizing HRT measurement |  | 12 months | 
| effect of PVI on cardiac autonomic system utilizing BRS measurement |  | 12 months | 
| association between measured parameters (HRT, BRS) and the recurrence of AF |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, pulmonary vein isolation, heart rate turbulence, baroreflex sensitivity
Comparison of Extubation Time Between Total Intravenous Anesthesia With Spinal Anesthesia for Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
This study compares the extubation time between total intravenous anesthesia guided by Bispectral Index with spinal anesthesia with minimal opioid dose for cardiac surgery.

Detailed Description
-----------------
This study compares the time needed to extubate of two anesthesic techniques, 1) Total Intravenous Anesthesia guided by Bispectral Index (BIS), 2) Spinal Anesthesia with minimal opioid dose for cardiac surgery. Identify the best anesthesia technique to do ultrafast track extubation can minimize the risk of infection associated.

Official Title
-----------------
Comparison of Extubation Time Between Total Intravenous Anesthesia Guided by Bispectral Index With Spinal Anesthesia With Minimal Opioid Dose for Cardiac Surgery

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Procedure: Anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for cardiac surgery Physical Status Classification System of the American Society of Anesthesiologists (ASA) II-III Exclusion Criteria: Physical Status Classification System of the American Society of Anesthesiologists (ASA) IV-V Emergency cardiac surgery Spinal defect

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 Intravenous Anesthesia<br>Patients with total intravenous anesthesia during the cardiac surgery | Procedure: Anesthesia<br>* Different anesthesia technique will be compared to find out which one offers better outcome to perform ultrafast track extubation<br>|
| Spinal Anesthesia<br>Patients with spinal anesthesia with minimal opioid dose. | Procedure: Anesthesia<br>* Different anesthesia technique will be compared to find out which one offers better outcome to perform ultrafast track extubation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extubation time | The time from anesthesia emergence to extubation will be measured in minutes | Up to 1 hour after anesthesia emergence | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extubation, Cardiac Surgery
Bicentric Study on the Use of ECMO-VV or VA for Severe ARDS Associated With Covid-19

Study Overview
=================
Brief Summary
-----------------
Describes the cohort of patients receiving ECMO-VV or ECMO-VA in the management of severe ARDS refractory to SARS-CoV-2 in the Strasbourg and Louvain centres

Official Title
-----------------
Bicentric Study on the Use of ECMO-VV or VA for Severe ARDS Associated With Covid-19

Conditions
-----------------
Covid-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over the age of 18; Diagnostic COVID-19 by RT-PCR; Hospitalisation in resuscitation for the management of complications related to COVID-19 Implanted ECMO-VV or VA during hospitalisation; Patient agreeing to participate in the study Exclusion Criteria: Sujet who has expressed opposition to participating in the study. Sujet under guardianship or trusteeship Sujet under safeguard of justice

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 |
| --- | --- | --- |
| Retrospective description of effect of the ECMO-VV or ECMO-VA in the management of severe ARDS refractory in patients of the Strasbourg and Louvain centres with covid-19 |  | files analysed retrospectily from March 1st, 2020 to August 1st, 2020 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiratory Distress Syndrome, SARS-CoV-2, Extracorporeal membrane oxygenation, ECMO-VV, ECMO-VA, Veno-venous ECMO
Human Gut Microbiota and microRNA Expression

Study Overview
=================
Brief Summary
-----------------
In this study, stachyose was used as an intervention factor. We will evaluate changes in fecal gut microbiota and miRNA expression profiles in subjects under stachyose intervention

Detailed Description
-----------------
In the stachyose intervention group, each person in the stachyose intervention group took 5 g of stachyose daily before breakfast, and the administration method was 100 ml of drinking water dissolved and taken orally for two months. Each person in the placebo control group took the same amount of maltodextrin daily. Stool samples of the subjects were collected weekly.

Official Title
-----------------
Regulatory Effect of Stachyose on Gut Microbiota and microRNA Expression in Human

Conditions
-----------------
Gut Microbiota, microRNA

Intervention / Treatment
-----------------
* Dietary Supplement: stachyose
* Dietary Supplement: Maltodextrin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy human Exclusion Criteria: people who need intake antibiotics，probiotics or its product

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Normal Control group<br>Subjects with maltodextrin as intervention，5g/kg·bw/day. | Dietary Supplement: Maltodextrin<br>* Maltodextrin is a polysaccharide that is used primarily in foods and beverages as a thickener, sweetener, and/or stabilizer. It is a relatively short-chain polymer (some would call it an oligomer); commercial products contain an average of ≈3 to ≈17 glucose units per chain. It is manufactured by partially hydrolyzing grain starches, usually corn or wheat.<br>|
| Experimental: Stachyose intervention group<br>Subjects with stachyose as intervention，5g/kg·bw/day. | Dietary Supplement: stachyose<br>* Stachyose is a tetrasaccharide consisting of sucrose having an alpha-D-galactosyl-(1->6)-alpha-D-galactosyl moiety attached at the 6-position of the glucose.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| expression of microRNA | small rna sequencing valuated the microRNA expression in human | up to 4 weeks | 
| structure of gut microbiota | 16S rDNA sequencing valuated the gut microbiota composition in human | up to 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stachyose, gut microbiota, microRNA