louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00674037: Efficacy of Monetary Incentives for Primary Care Physicians on Patients
Official title: Efficacy of Monetary Incentives for Primary Care Physicians on Patients' Recruitment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Recruitment
Keywords: recruitment
physicians participating in the recruitment of patients
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-05-07
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Patients' recruitment is difficult in clinical trial. Financial incentives are frequently proposed to clinicians in private funded trials. However, the effect of these financial incentives has never been evaluated.

The purpose of this study is to evaluate the effect of financial incentive on the rate of recruitment of patients in a cohort study.

Detailed description: Context: Patients' recruitment is difficult in clinical trials. Financial incentives are frequently proposed to clinicians in private funded trials. However, the effect of these financial incentives has never been evaluated.

Objective: to evaluate the effect of financial incentive on the rate of recruitment of patients in a cohort study.

Design: randomized controlled trial Setting: primary care Participants: physicians (GP and cardiologists) participating in the recruitment of patients in a cohort study (the COFRASA study). The COFRASA cohort study is including aortic stenosis aging patient.

Intervention:75 euros for each patient included Main outcome: percentage of physician including at least one patient at 3 months Secondary outcome: mean number of patients included at 6 months. Sample size 270 physicians

Eligibility criteria: Inclusion Criteria:

* Physicians participating in the COFRASA cohort study
* informed consent

Exclusion Criteria:

- None

Primary outcomes:
measure: number of patient included
timeFrame: 3 months
Secondary outcomes:
measure: number of patient included
timeFrame: 6 month
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe hospitalier Bichat-Claude Bernard
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Isabelle BOUTRON, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01067937: Study for a Rational Management of Appendicitis in Children
Official title: Multicenter Prospective Study for a Rational Management of Appendicitis in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis
Keywords: Appendicitis
children
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2010-02-12
Enrollment: 891
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no

Brief summary: Despite the fact that appendicitis is one of the most frequent surgical pathology in children, its clinical management is still debated. Previous reports have shown rate of appendectomy in children without appendicitis up to 30 %. Morbidity, due to infectious complications or intestinal obstruction, is often between 5 and 10 % of published cases, and increase medical and social costs. Evidence-based medicine concept could therefore be worthwhile in that context, in order to promote rational diagnosis and treatment of that frequent medical condition.An algorithm describing management of children with suspicion of appendicitis was established, based on recent published data, in order to reduce delay between first clinical signs and confirmation of the diagnosis, and to define therapeutic indication such as conservative management and interval appendectomy or patient requiring laparoscopic approach. The main objective of the study is to decrease morbidity and unnecessary appendectomy rates, and secondly to decrease costs, by the use of that algorithm.


Eligibility criteria: Inclusion Criteria:

* male and female children, between 4 and 15 years-old, with more than 37,5°C of body temperature during the 3 days before hospital admission, and with abdominal pain located in right or median lower quadrant

Exclusion Criteria:

* children coming from another hospital, children with septic choc, children with co-morbidity in interaction with algorithm (antibiotics allergy, mellitus diabetes, haemostasis disturbance, ...)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: WEIL Dominique
city: Brest
country: France
facility: DE VRIES Philine
city: Caen
country: France
facility: PETIT Thierry
city: Nantes
country: France
facility: PODEVIN Guillaume
city: Poitiers
country: France
facility: MCHEIK Jiad
city: Rennes
country: France
facility: AZZIS Olivier
city: Saint-Brieuc
country: France
facility: GARIGNON Cynthia
city: Tours
country: France
facility: LARDY Hubert
Study officials:
References:
Clinical trial NCT00120237: Misoprostol for the Prevention of Postpartum Hemorrhage in Rural Pakistan
Official title: A Placebo-Controlled Randomized Trial of Misoprostol in the Management of the Third Stage of Labor in the Home Delivery Setting in Rural Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Anemia
Keywords: Postpartum hemorrhage
Misoprostol
Maternal morbidity
Developing countries
Traditional birth attendants
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Aga Khan University
name: Aga Khan Health Services
name: The Aga Khan Foundation
name: Family Care International
First posted: 2005-07-15
Enrollment: 1600
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This community-based trial will study misoprostol for the prevention of postpartum hemorrhage in rural Pakistan. Traditional birth attendants assisting home deliveries will administer study tablets (600 mcg oral misoprostol or placebo) in the third stage of labor to women participating in the trial. Blood loss, hemoglobin levels, side effects, and other variables will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Pregnant women in general good health, home delivery
* Must live in one of 78 study villages

Exclusion Criteria:

* Hypertension
* Non-cephalic presentation
* Polyhydramnios
* Previous cesarean section
* Suspected multiple pregnancy
* Suspected still birth
* Antepartum hemorrhage
* Previous complication in 3rd trimester
* Anemia of \<8 g/dl

Primary outcomes:
measure: Postpartum hemorrhage (blood loss >or= 500 mL)
timeFrame: Measured at 1 hour postpartum or until active bleeding has stopped
measure: Drop in hemoglobin > 2 g/dL from pre to post-delivery
timeFrame: Hemoblobin (Hb) level measured 3-5 days after delivery
Secondary outcomes:
measure: Intermediate and severe PPH (blood loss >or=750 mL and >or= than 1000 mL)
timeFrame: Blood loss measured at 1 hr postpartum or until active bleeding stopped
measure: Mean blood loss
timeFrame: blood loss measured at 1 hr postpartum or until active bleeding stopped
measure: Side effects experienced among recently delivered mothers
timeFrame: Interviews conducted 1 day post-delivery
measure: Anemia (<9 g/dL and <11 g/dL)
timeFrame: Postpartum hemoglobin assessed 3 days post-delivery
Other outcomes:
Locations:
city: Chitral
country: Pakistan
facility: Home delivery setting
state: Chitral District
Study officials:
affiliation: Aga Khan Health Services
name: Gijs Walraven, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aga Khan University
name: Juanita Hatcher, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aga Khan University
name: Naushaba Mobeen, MD
role: STUDY_DIRECTOR
affiliation: Gynuity Health Projects
name: Jennifer Blum, MPH
role: STUDY_DIRECTOR
affiliation: Aga Khan Health Services
name: Zafar Ahmad, MD
role: STUDY_DIRECTOR
affiliation: Aga Khan University
name: Nadeem Zuberi, MD
role: STUDY_DIRECTOR
affiliation: Gynuity Health Projects
name: Jill Durocher
role: STUDY_DIRECTOR
References:
Clinical trial NCT05793437: Effects of Permissive Hypercapnia on Concentration of Postoperative Plasma Neurofilament Light
Official title: Effects of Permissive Hypercapnia on Concentration of Postoperative Plasma Neurofilament Light in Elderly Patients Undergoing Laparoscopic Surgery:A Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercapnia
Keywords: Neurofilament light
Hypercapnia
Lead sponsor: Affiliated Hospital of Jiaxing University
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 84
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to conduct a prospective, single-center randomized controlled study to investigate the changes of plasma NFL concentration in patients undergoing laparoscopic surgery with mild hypercapnia, and further explore its impact on the central nervous system.

Detailed description: Plasma NFL concentrations were measured preoperatively and 1 day postoperatively.

Secondary endpoints:CAM (Confusion Assessment Method) is conducted to check the subjects' baseline cognitive function preoperative day and 1 day postoperatively to assess whether delirium occurs.

Eligibility criteria: Inclusion Criteria:

* age over 60 years
* duration of pneumoperitoneum greater than 60 minutes
* American Society of Anesthesiology (ASA) status Ⅱ-Ⅲ
* undergoing laparoscopic surgery under general anesthesia with endotracheal intubation

Exclusion Criteria:

* history of mental or neurological disorders
* preoperative use of antipsychotic drugs
* American Society of Anesthesiology (ASA) status Ⅳ
* severe abnormalities in heart, lung, liver, kidney, and coagulation function
* Intracranial space-occupying lesions or major cerebrovascular diseases (such as carotid atherosclerosis and cerebral aneurysm)
* Severe hypertension or hypotension
* Severe metabolic acidosis or hypercapnic respiratory failure before surgery

Primary outcomes:
measure: Changes in plasma Neurofilament Light levels
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Jiaxing
country: China
facility: Affiliated Hospital of Jiaxing University
state: Zhejiang
Study officials:
affiliation: Affiliated Hospital of Jiaxing University
name: Qinghe Zhou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04324970: Does the "TOOKIE Vest" Reduce Line Fall Out Rate in Children?
Official title: A Prospective Study to Assess Whether the "Tookie Vest for Oncology" Reduces Central Line Fall Out Rate in the Paediatric Oncology Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Cancer
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2020-03-27
Enrollment: 40
Sex: ALL
Minimum age (years): 0
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of the trial is to assess whether the TOOKIE vest is an effective intervention in reducing line fall out. All oncology patients with a tunneled central line will be approached to participate in this study. Following informed consent they will be issued with a TOOKIE vest.

Detailed description: All oncology patients with a tunneled central line will be approached to participate in this study. Following informed consent they will be issued with a TOOKIE vest. Lines will be studied for the duration they are in situ. This will vary depending on the underlying diagnosis and treatment regime. One hundred central line insertions for oncology patients will be prospectively identified and be given the "TOOKIE Vest" to wear. Data will be collated for each group regarding age, gender, diagnosis, type of central access inserted, duration of line, reason for removal, in cases of infection the infected organism will be documented, date of each fall out.

Eligibility criteria: Inclusion Criteria:

* Any child receiving treatment for malignancy at Royal Manchester Children's Hospital
* Patients with a tunnelled central line inserted for treatment of their malignancy

Exclusion Criteria:

• Any child having a portacath inserted as their mode of central access

Primary outcomes:
measure: Central line fall out rate
timeFrame: approximately 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
Study officials:
affiliation: Manchester University NHS Foundation Trust
name: Ross Craigie
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02068170: Risk of QT-prolongation and Torsade de Pointes in Patients Treated With Acute Medication in a University Hospital
Official title: Risk of QT-prolongation and Torsade de Pointes in Patients Treated With Acute Medication in a University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
QT-prolongation
Keywords: QT-prolongation
Torsade de Pointes
QT-prolonging drugs
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Agentschap voor Innovatie door Wetenschap en Technologie
First posted: 2014-02-21
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated with acute potentional QT-prolonging medication. In a university hospital.

Brief summary: A prospective, observational study in a university hospital (UZ Leuven). Patients are included when they are treated with a potentional QT-prolonging drug: haloperidol for delirium, antibiotics (moxifloxacin, levofloxacin, azithromycin, clarithromycin, erythromycin, co-trimoxazole), antimycotics (ketoconazole, itraconazole, fluconazole, voriconazole), methadone, tacrolimus and oral oncolytics.

An ECG is taken before the administration of the drug and 3-5 days after starting the drug to investigate the change in duration of the QTc-interval. Risk factors for developing QT-prolongation will be documented. Together with ECG2, an additional blood sample will be collected to measure the blood concentration of the drug.


Eligibility criteria: Inclusion Criteria:

* treatment with a potentional QT-prolonging drug of our list
* inpatient of UZ Leuven, admitted on one of the participating wards

Exclusion Criteria:

* \< 18 years old
* DNR-code 3
* not possible to take an ECG before the start of haloperidol

Primary outcomes:
measure: change in QTc-interval (corrected for heart rate)
timeFrame: before and 3-5 days after the start of a potentional QT-prolonging drug
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: KU Leuven
name: Eline Vandael, PhD-student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vandael E, Vandenberk B, Vandenberghe J, Spriet I, Willems R, Foulon V. Development of a risk score for QTc-prolongation: the RISQ-PATH study. Int J Clin Pharm. 2017 Apr;39(2):424-432. doi: 10.1007/s11096-017-0446-2. Epub 2017 Mar 9.
Clinical trial NCT01019070: Hepatic Impaired Subjects Compared to Healthy Subjects Receiving Multi-dose BMS-650032
Official title: Multiple-Dose Pharmacokinetics of BMS-650032 in Subjects With Hepatic Impairment Compared to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Insufficiency
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-11-25
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to assess the effects of hepatic impairment on the multiple dose pharmacokinetics of BMS-650032.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects aged 18 to 70, with hepatic impairment conforming to Child-Pugh class A,B or C
* Each matched control subjects determined to be healthy

Exclusion Criteria:

* History of esophageal and gastric bleeding within the past 6 months
* Primarily cholestatic liver disease
* Active alcoholic hepatitis
* Stable encephalopathy of ≥Stage 2
* Presence of severe ascites or edema
* Presence of hepatopulmonary or hepatorenal syndrome
* Positive for HIV
* Positive for HCV, unless HCV RNA is undetectable

Primary outcomes:
measure: Pharmacokinetics parameters including Cmax, Tmax,AUC(TAU),Vss/F, T-Half, CLT/F and AI
timeFrame: Day 10
Secondary outcomes:
measure: Assess the safety and tolerability of BMS-650032 in subjects with hepatic impairment and in healthy subjects. This will be measured by: blood chemistries, hematology, urinalysis and ECGs
timeFrame: Day 10
measure: Assess the relationship between the Child-Pugh classification (including its components) and BMS-650032 PK parameters. This will be measured by frequent pharmacokinetics blood samples.
timeFrame: Day 10
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Clinical Res Inst
state: California
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Eley T, He B, Chang I, Colston E, Child M, Bedford W, Kandoussi H, Pasquinelli C, Marbury TC, Bertz RJ. The effect of hepatic impairment on the pharmacokinetics of asunaprevir, an HCV NS3 protease inhibitor. Antivir Ther. 2015;20(1):29-37. doi: 10.3851/IMP2773. Epub 2014 Apr 7.
Clinical trial NCT01472770: A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer
Official title: A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: Colorectal cancer
Metastatic
Treatment resistant
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2011-11-16
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The present study aims to investigate the efficacy and safety of the combination of capecitabine and gemcitabine in heavily pre-treated, treatment resistant metastatic colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically verified colorectal adenocarcinomas
* Age \> 18 years
* Metastatic colorectal cancer refractory to 5-FU, oxaliplatin, irinotecan and relevant biological agents.
* Measurable disease according to RECIST 1.1
* ECOG performance status 0, 1 or 2
* Adequate renal, hepatic and haematological function
* Consent to blood samples and available paraffin embedded tumour material for translational research studies
* Fertile males and females (\<2 years after last period for women) must use effective birth control.
* Signed Informed consent

Exclusion Criteria:

* Clinically significant concurrent disease.
* Other malignant diseases within 5 years of inclusion in the study, except squamous cell carcinoma of the skin and cervical carcinoma-in-situ.
* Other experimental therapy within 30 days of treatment initiation.
* Patients who are breast feeding, childbearing or of childbearing potential without using dual effective contraception.
* Clinical or radiological evidence of CNS metastasis.
* Planned radiation therapy against target-lesions.
* Known allergy to 5FU/capecitabine or gemcitabine.

Primary outcomes:
measure: Rate of patients progression free at 3 months
timeFrame: 3 months after start of treatment
Secondary outcomes:
measure: Progression free survival
timeFrame: Every 12 weeks
measure: Overall survival
timeFrame: Every 12 weeks
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Department of Oncology, Vejle Hospital
Study officials:
References:
Clinical trial NCT03486470: Comparison of Two Radial Artery Segments Related to "Old-Fashioned" Radial and New Snuff Box Vessel Approach by US
Official title: Comparison of Two Radial Artery Segments Related to "Old-Fashioned" Radial and New Snuff Box Vessel Approach. Ultrasound Study of Both Arms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Diseases
Lead sponsor: Dr. Stephan Cherkezov Hospital
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the Cardilogy Department

Brief summary: The purpose of this study is to determine if there is a difference in the size and the depth of the radial artery at the access points for established radial and new distal radial approach for the arteries of both arms

Detailed description: Radial approach for coronary and peripheral procedures is now well established due to both patient and operator preference and carries a lower risk of bleeding and mortality. The most lasting consequence of transradial procedures remains radial artery occlusion, which is mainly influenced by the artery diameter and the size of the sheath. As a new, more distal approach looms on the horizon, it is plausible to determine factors that could impact its feasibility. Since the success rate for artery cannulation depends to a great extent on the size and the depth of the artery, the current study examines both parameters, as well as whether they are influenced by variables such as sex, body mass index, handedness, or comorbidities i.e. diabetes mellitus and hypertension.

Eligibility criteria: Inclusion Criteria:

* Patients \>18 years old admitted to the Cardiology Department

Exclusion Criteria:

* Previous transradial procedures
* Arm AV fistula for dialysis access
* History of upper limb peripheral arterial disease
* Hemiparesis
* Hemodynamic instability

Primary outcomes:
measure: Comparison of ultrasound derived diameters of radial artery measured at sites related to two different transradial arterial approaches for catheterization
timeFrame: 1 day
Secondary outcomes:
measure: Comparison of ultrasound derived depth of radial artery measured at sites related to two different transradial arterial approaches for catheterization
timeFrame: 1 day
measure: Impact of sex, BMI, hand-dominance or comorbidities on the size and the depth of the arterial segments
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Dr. Stephan Cherkezov Hospital
name: Valentin Krastev, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr. Stephan Cherkezov Hospital
name: Haralamby Benov, MD
role: PRINCIPAL_INVESTIGATOR
References: