linjc16/ctgov huggingface dataset:
Clinical Outcomes and Costs Analyses in Use of Goal Directed Therapy

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate clinical and economic impact of Goal Directed Fluid Therapy according to NICE haemodynamic protocol. Haemodynamic parameters were assessed using automated pulse contour analysis (Flotrac/Vigileo®). A specific dedicated software has been developed to perform clinical and expenditures data collection, both retrospective and prospective data are archived.

Conditions
-----------------
Postoperative Complications

Intervention / Treatment
-----------------
* Device: Goal Directed Fluid Therapy FloTrac/Vigileo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients selected for major abdominal surgery Exclusion Criteria: •Patients under the age of 18, patients with hemodynamically significant aortic regurgitation and heart rhythm disorders

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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional Intravenous Fluid therapy<br>Basal infusion of crystalloid (normal saline,Ringer's lactate,Ringer's solution)variable from 4 to 12 ml/kg/hour | |
| Experimental: GDT<br>Basal infusion of crystalloids (normal saline,Ringer's lactate,Ringer's solution) at 2,5 ml/kg/h and boluses of crystalloids for values of stroke volume (SV) < SV TRIGGER. Every additional infusion of colloids, blood derivates, drugs must be recorded | Device: Goal Directed Fluid Therapy FloTrac/Vigileo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of reduction of postoperative spending |  | 30 day postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fluid Therapy, Cost-Benefit Analysis, Hemodynamics, Cost Control
Retention of Bone Marrow Donors in a National Registry

Study Overview
=================
Brief Summary
-----------------
To identify factors that affected the National Marrow Donor Program's (NMDP) success in retention of bone marrow volunteers.

Detailed Description
-----------------
BACKGROUND: As bone marrow transplantation becomes one of the preferred treatments for life-threatening diseases of the blood, increasing numbers of patients must seek compatible marrow from unrelated donors. The low probability of finding a good patient-donor marrow match means that between one- to two-thirds of ill patients never locate a donor with perfectly compatible marrow. Furthermore, once volunteers are identified as a preliminary match for a patient, 30 to 40 percent are either unwilling or medically unable to actually donate marrow. Thus, volunteer attrition contributes significantly to the problems already inherent in finding a suitable donor candidate. DESIGN NARRATIVE: The study examined the relationship of volunteer characteristics and donor center factors to volunteer psychological outcomes during two critical stages in the blood testing process and to donor center rates of volunteer cooperation at these stages. Longitudinal and cross-sectional survey data were gathered from a total of over 2,900 potential marrow donors who were at one of two critical decision points in the process leading to donation (DR-blood-typing, CT-blood-typing), and from personnel at the 100 NMDP donor centers. These data allowed the investigators to (a) describe the distribution and interrelationships between donor center structural characteristics and the strategies centers utilize for volunteer recruitment and retention, (b) determine which donor center factors (both structural and tactical) and volunteer background characteristics best predict positive volunteer-specific psychological outcomes at later typing stages, and examine and revise models of individual volunteer-specific outcomes and aggregate across-center retention rates. 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
-----------------
Bone Marrow Transplantation, Blood Disease

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

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Stroke COunseling for Risk REduction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the efficacy of the Stroke Counseling for Risk Reduction (SCORRE) intervention in increasing accuracy of perceived stroke risk and promoting lifestyle behavior change to reduce stroke risk in young adult African Americans.

Official Title
-----------------
Stroke Counseling for Risk Reduction in Young Adult African Americans

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Behavioral: SCORRE
* Behavioral: Attention-Control Activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: self-identify as African American/Black age 20-35 years able to complete two study visits lasing 1 1/2- 2 hours and a brief daily diary for 8 weeks has a cell phone or email address to receive weekly reminders and tips has at least one modifiable risk factor for stroke identified during study visit one screening

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 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: Parallel Assignment
Interventional Model Description: randomized controlled two-group pre-post test design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCORRE group<br>Stroke risk factor brochure, stroke champions video, counseling on accuracy of perceived stroke risk and strategies to reduce stroke risk, weekly motivational health behavior tips (for physical activity, diet, or smoking cessation) text messages for 8 weeks. | Behavioral: SCORRE<br>* 3 components based on the Health Belief Model<br>|
| Sham Comparator: Attention Control Group<br>Sexual health education brochure and Safe in the City video, weekly sexual health tips text messages for 8 weeks. | Behavioral: Attention-Control Activity<br>* sexual health education<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of perceived stroke risk | Comparison of perceived versus actual stroke risk | immediately post-intervention | 
| Targeted health behaviors | Improvements in targeted health behavior (physical activity, diet, or cigarette smoking) | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Stroke Prevention, Risk Factors for Stroke
Accuracy of Different Scoring Systems for Predicting Successful Induction of Labor

Study Overview
=================
Brief Summary
-----------------
Induction of labour (IOL) nowadays is a common procedure in obstetric practice. Presently, IOL is done for 20% of pregnancies for various maternal and fetal indications and nearly 20% of labour inductions end up in caesarean deliveries. The success of IOL mainly depends upon favourability of the cervix which is usually assessed by manual examination and Scored as Bishop Score. However, this method is limited by subjectivity and reproducibility and though done in all the patients prior to IOL, several studies have demonstrated poor correlation between Bishop Score and outcome of IOL

Official Title
-----------------
Accuracy of Different Scoring Systems for Predicting Successful Induction of Labor: a Cross-sectional Study

Conditions
-----------------
Induction of Labor Affected Fetus / Newborn

Intervention / Treatment
-----------------
* Procedure: Manipal ultrasound scoring system
* Procedure: Levine scoring system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnancy. Pregnant ≥ 37 weeks gestation. Fetus with longitudinal lie and vertex presentation. Intact membranes. No vaginal bleeding. Exclusion Criteria: Patients with previous cesarean delivery. Previous uterine surgery. Antepartum hemorrhage. Cephalopelvic disproportion. Category II or III non-stress test. Malpresentation. Intrauterine fetal death. Fetal growth restriction. Fetuses with major congenital malformations
Sexes Eligible for Study
-----------------
Female

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| study group<br>All pregnant women who will attend the labor unit for induction of labour due to different indications during the study period will be invited to participate in the study. | Procedure: Manipal ultrasound scoring system<br>* length of the cervix from the internal to external os, presence or absence of funneling and if present width and length of funneling at internal os were measured. Distance between presenting part to external os will be measured and position of the cervix i.e. whether curved or straight will also noted.<br>Procedure: Levine scoring system<br>* maternal height, parity, body-mass index (BMI) at delivery and the results of modified Bishop's score in calculation of probability of CS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of successful induction of labor | an ability to achieve the active phase of labor corresponding to a cervical dilatation of ≥4 cm within 12 h of initiating oxytocin on the first day of induction | 24 hours |
Influence of Painphysiolgy Education on the Pain Inhibition in Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether education about the neurophysiology of pain is able to improve central pain inhibition in patients with Fibromyalgia.

Official Title
-----------------
Influence of Painphysiolgy Education on the Pain Inhibition in Fibromyalgia

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Behavioral: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnose fibromyalgia Widespread pain Dutch speaking

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Education|Education about the neurophysiology of pain|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diffuse noxious inhibitory control |  | baseline, 14 days and 3 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain pressure thresholds |  | baseline, 14 days and 3 months follow-up |
Celecoxib for Reducing Morphine Requirement After Thyroid Surgery: A Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether celecoxib is effective in the treatment postoperative pain after thyroidectomy. The research hypothesis: There is a difference in postoperative morphine consumption in the first 24 hours after thyroidectomy between patients who received celecoxib or placebo.

Detailed Description
-----------------
Postoperative pain has been concerned in the past few years by both the anesthesiologists ans the surgeons. COX2-inhibitors have played an important roles in postoperative pain with minimal side effects. Comparison(s): There is a difference in postoperative morphine consumption in the first 24 hours after thyroidectomy between patients who received celecoxib and placebo.

Official Title
-----------------
Celecoxib for Reducing Morphine Requirement After Thyroid Surgery: A Randomized Controlled Trial

Conditions
-----------------
Postoperative Pain, Thyroidectomy, Cyclooxygenase 2 Inhibitors

Intervention / Treatment
-----------------
* Drug: celecoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient ASA physical status I-III. Scheduled for an elective thyroidectomy. Body weight > or = 40kg Can operate a patient-controlled analgesia (PCA) device. Exclusion Criteria: History of asthma, acute rhinitis, nasal polyps, angioneurotic edema or urticaria following the administration of aspirin or other NSAIDs. Known hypersensitivity to morphine or sulfonamides. History of hepatic dysfunction. Creatinine clearance < 30ml/min. History of bleeding tendency. History of gastrointestinal bleeding or active peptic ulcer. Known case of inflammatory bowel disease. Patient with severe heart failure.

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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br>placebo celecoxib | Drug: celecoxib<br>* placebo celecoxib 400 mg oral single dose<br>* Other names: celebrex;|
| No Intervention: 1<br>1 placebo | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The patients' total amount of morphine requirement in the first 24 hour. |  | 24 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
celecoxib, postoperative pain, thyroidectomy
Impact of Body Mass Index on Positive End-expiratory Pressure Guided by Electrical Impedance Tomography for Patients Under General Anaesthesia

Study Overview
=================
Brief Summary
-----------------
The induction of general anaesthesia is associated with a fall in lung volume due in particular to a decrease in muscle tone and the formation of denitrogenation atelectasis. Many recent studies insist on the need to apply a so-called protective strategy of intraoperative ventilation, which combines the use of recruitment manoeuvres, reduced tidal volume (Vt) (6-8ml/kg) and positive expiratory pressure (PEEP) to prevent these phenomena. However, the setting of PEEP remains debated and several authors agree on the need to individualize ventilatory parameters, particularly in obese patients, without describing the individualization tools. In the ICU, it has been shown that electrical impedance tomography (EIT) can be used to individualise the PEEP level in a simple and non-invasive way. Therefore, we wish to determine whether the use of this technique during general anaesthesia allows for the individualization of PEEP, and whether the value determined is correlated with the body mass index (BMI).

Official Title
-----------------
Impact of Body Mass Index on Positive End-Expiratory Pressure Guided by Electrical Impedance Tomography for Patients Under General Anesthesia: A Retrospective Observational Study

Conditions
-----------------
General Anesthetic, Positive Expiratory Pressure, Obesity

Intervention / Treatment
-----------------
* Other: regional ventilation monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient Patient who received general anesthesia with orotracheal intubation. Patient who has undergone surgery of the following types: : abdominal surgery by laparotomy or laparoscopy, emergency or scheduled Exclusion Criteria: NA

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 |
| --- | --- |
| patient undergoing surgery under general anaesthesia<br> | Other: regional ventilation monitoring<br>* regional ventilation monitoring<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| electrical impedance tomography |  | Through study completion, an average of 1 year |
Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of CHF5074 in young healthy male volunteers.

Official Title
-----------------
Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: CHF5074 1x
* Drug: CHF5074 2x
* Drug: CHF5074 3x
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is judged to be in good health on the basis of medical history, complete physical examination including vital signs, 12-lead electrocardiogram (ECG) and standard laboratory tests. Exclusion Criteria: Medical history (within the last 10 years) of major cardiovascular, hepatic or renal disease. Abnormal results of liver function tests, renal function tests or thyroid tests performed at screening. Significant allergic conditions that require medical treatment Use of any psychoactive, recreational or prescription drug within the 4 weeks prior to study drug administration. Use of ibuprofen, sulindac sulfide, indomethacin, flurbiprofen within 2 weeks prior to study drug administration.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHF5074 1x<br>oral tablet, multidose | Drug: CHF5074 1x<br>* oral tablet, 1x, once a day in the morning for 14 days<br>|
| Experimental: CHF5074 2x<br>oral tablet, multidose | Drug: CHF5074 2x<br>* oral tablet, 2x, once a day in the morning for 14 days<br>|
| Experimental: CHF5074 3x<br>oral tablet, multidose | Drug: CHF5074 3x<br>* oral tablet, 3x, once a day in the morning for 14 days<br>|
| Placebo Comparator: Placebo<br>placebo, oral tablet, multidose | Drug: Placebo<br>* oral tablet, placebo, once a day in the morning for 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | from Screening through Day 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose linearity of CHF5074 plasma levels (Cmax) |  | Day -1 through Day 18 | 
| Dose linearity of CHF5074 plasma levels (AUC 0-t) |  | Day -1 through Day 18 |
Deep Phenotyping of Rosacea and Migraine

Study Overview
=================
Brief Summary
-----------------
This study aims to deep phenotype patients with rosacea and migraine

Detailed Description
-----------------
Rosacea and migraine are common disorders that overlap in epidemiology, symptoms, trigger factors, and distribution in the trigeminal area. Recent studies establish a connection between the two disorders, which needs to be investigated. The purpose of this study is investigate the link between the two disorders by deep phenotyping through semi-structured interviews.

Official Title
-----------------
Deep Phenotyping of Rosacea and Migraine

Conditions
-----------------
Migraine, Rosacea

Intervention / Treatment
-----------------
* Diagnostic Test: No intervention apart from tests, including interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis with either rosacea and/or migraine Exclusion Criteria: does not want to participate cannot co-operate to investigation

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rosacea<br>Patients who have been diagnosed with rosacea | Diagnostic Test: No intervention apart from tests, including interview<br>* No interventions<br>|
| Migraine<br>Patients who have been diagnosed with migraine | Diagnostic Test: No intervention apart from tests, including interview<br>* No interventions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of migraine in rosacea cohort | Prevalence of patients in rosacea cohort who fulfill diagnostic criteria for migraine | 60 minutes | 
| Prevalence of rosacea in migraine cohort Prevalence of rosacea in migraine cohort | Prevalence of patients in migraine cohort who fulfill diagnostic criteria for rosacea | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of migraine subtypes in rosacea cohort | Prevalence of patients in rosacea cohort who fulfill diagnostic criteria for subtypes of migraine according to international headache society classification | 60 minutes | 
| Prevalence of rosacea subtypes in migraine cohort | Prevalence of patients in migraine cohort who fulfill diagnostic criteria for subtypes of rosacea | 60 minutes |