louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01125527: Immunogenicity and Safety of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children
Official title: A Phase III Observer-blind, Randomized, Controlled, Single-coordinating Center Study to Investigate Immunogenicity and Safety of a Monovalent Glycoprotein-conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children in China, According to the Recommended Regimen of 1 Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Haemophilus Influenzae Type b (Hib) Infection
Keywords: Haemophilus influenzae type b (Hib)
Vaccine
Anti PRP antibody
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-05-18
Enrollment: 700
Sex: ALL
Minimum age (years): 13
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the safety and immunogenicity of single dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 13-59 months of age.


Eligibility criteria: Inclusion Criteria:

* Infants 13-59 months of age.

Exclusion Criteria:

* Prior Hib vaccine administration.
* History of serious reaction(s) following vaccination.
* Any vaccination within 7 days of study vaccination.
* Known or suspected immune impairment.
* Premature (before 37th week of gestation) or birth weight less than 2500g
* For additional entry criteria please refer to the protocol.

Primary outcomes:
measure: Anti-PRP antibody levels at day 31 post last vaccination
timeFrame: 30 days after last vaccination
Secondary outcomes:
measure: Solicited local and systemic reactions, AEs, and SAEs
timeFrame: 30 days post last vaccination
Other outcomes:
Locations:
city: Hebei Province
country: China
Study officials:
References:
Clinical trial NCT01982227: Monocentric Prospective Pilot Study Evaluating the Value of Indocyanine Green (ICG, Indocyanine Green) During a Surgical Resection of Cancerous Lesions Peritoneal Colorectal Origin.
Official title: Monocentric Prospective Pilot Study Evaluating the Value of Indocyanine Green (ICG, Indocyanine Green) During a Surgical Resection of Cancerous Lesions Peritoneal Colorectal Origin.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer Metastatic
Keywords: colorectal cancer metastatic
indocyanine green
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with progressive colorectal cancer in intra-abdominal surgery requiring resection +/- Chemotherapy Hyperthermic Intraperitoneal

Brief summary: Between 30% and 40% of patients with colorectal cancer develop metastatic disease intraperitoneally. The optimal treatment of this disease combines surgery and chemotherapy but requires resection of all lesions larger than 2mm.

Indocyanine green has an affinity for tumor tissues and the interest of its use has been demonstrated for the detection of sentinel lymph node and some liver surgeries.

The ability of indocyanine green to detect peritoneal carcinomatosis in humans has never been evaluated.

This study aims to evaluate the diagnostic performance of fluorescence in the detection of malignant cells in peritoneal carcinomatosis of colorectal origin compared with pathological analysis.


Eligibility criteria: Inclusion Criteria:

* Patient with progressive colorectal cancer in intra-abdominal surgery requiring resection + / - Chemotherapy Hyperthermic Intraperitoneal
* Aged 18 to 70 inclusive
* Signature information form and consent by the patient

Exclusion Criteria:

* Pregnant women, a urine pregnancy test or blood will be realized within 72 hours before surgery
* Contraindication to surgery
* Diagnosis not confirmed colorectal adenocarcinoma
* Persons major subject of legal protection or unable to consent

Primary outcomes:
measure: Sensitivity (true positive) of the fluorescence ex vivo compared to histological analysis s detected by fluorescence ex vivo
timeFrame: At the end of the surgery
Secondary outcomes:
measure: Specificity (true negative) of the in-vivo fluorescence compared to histological analysis s detected by fluorescence ex vivo peritoneal cancer index (PCI) score with and without fluorescence
timeFrame: At the end of the surgery
measure: Specificity (true negative) of the in-vivo fluorescence compared to histological analysis s detected by fluorescence ex vivo PCI score with and without fluorescence
timeFrame: At de begining of the surgery
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Gabrielle BARABINO, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01160627: Prevention of Contrast-induced Nephropathy in Patients With Acute Myocardial Infarction
Official title: Prevention of Contrast-induced Nephropathy in Patients With Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contrast Induced Nephropathy
Keywords: CIN STEMI
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2010-07-12
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: OBJECTIVE: To evaluate the efficacy of prevention of contrast induced nephropathy in patients with ST segment elevation myocardial infarction treated with primary percutaneous coronary intervention.

DESIGN: Prospective study. SETTING: Three-center study Acute kidney injury was defined as a rise in creatinine \>25% from baseline Serum creatinine will be measured at baseline and each day for the following 3 days and at 30 days.

Patients will be randomised to:

1. Standard treatment
2. Standard treatment + acetylcystein for 2 days
3. Standard treatment + Sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours
4. Standard treatment + acetylcystein for 2 days + Sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours


Eligibility criteria: Inclusion Criteria:

* STEMI patients treated with primary PCI

Exclusion Criteria:

* Cardiogenic shock

Primary outcomes:
measure: Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI
timeFrame: from baseline to day 3
Secondary outcomes:
measure: Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI
timeFrame: from baseline to day 30
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Per Thayssen, MD DMSci
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thayssen P, Lassen JF, Jensen SE, Hansen KN, Hansen HS, Christiansen EH, Junker A, Ravkilde J, Thuesen L, Veien KT, Jensen LO. Prevention of contrast-induced nephropathy with N-acetylcysteine or sodium bicarbonate in patients with ST-segment-myocardial infarction: a prospective, randomized, open-labeled trial. Circ Cardiovasc Interv. 2014 Apr;7(2):216-24. doi: 10.1161/CIRCINTERVENTIONS.113.000653. Epub 2014 Apr 8.
Clinical trial NCT04320927: Iatrogenic Withdrawal Symptoms in Severe Traumatic Brain Injury
Official title: Iatrogenic Withdrawal Symptoms in Severe Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Iatrogenic Withdrawal Symptomes
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Severe TBI defined as traumatic brain injury that required admission to the neuro-ICU.

Brief summary: Iatrogenic withdrawal symptomes has been associated with prolonged mechanical ventilation and the and the derived symptoms such as fever and agitation has been shown to cause significantly prolonged ICU and hospital length of stay. The incidence of IWS in the adult general ICU ranges from 16,7-55%. To this date, the incidence of IWS has not been studied in patients with TBI.


Eligibility criteria: Inclusion Criteria:

* adult patients suffering from severe TBI and were mechanical ventilated and received continuous infusions of opioids, benzodiazepines and neuromuscular blocking agents for 72ours or more

Exclusion Criteria:

* age \<18 years, patients who died before discharge, chronic alcohol abuse, regular use of heroin, cocaine and amphetamines, chronic use of opioids, patient that were primary admitted to other ICUs and patients that were moved to other ICUs with ongoing infusions.

Primary outcomes:
measure: proportion of patients with positive IWS diagnosis
timeFrame: 20-6-2019
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Neuroanaesthesiology
state: Capital Region
Study officials:
References:
Clinical trial NCT04489927: Validation of the Measurement Accuracy of the Tcore Thermometer
Official title: Validierung Der Messgenauigkeit Des Tcore Thermometers in Der Anwendung Nicht-invasiver Temperaturmessung gegenüber herkömmlicher Invasiver Messung Auf Der Intensivstation Bei Wachen Patienten
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Temperature Change, Body
Lead sponsor: Drägerwerk AG & Co. KGaA
Sponsor class: INDUSTRY
First posted: 2020-07-28
Enrollment: 75
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 in the ICU of the University Hospital Schleswig-Holstein

Brief summary: The aim of the study conducted at the UKSH is to investigate the measuring accuracy of the body core temperature thermometer Tcore®. Therefore the bias of the measurements to the reference measurements of the bladder catheter thermometer is determined.

Detailed description: The aim of the study conducted at the UKSH is to investigate the measuring accuracy of the body core temperature thermometer Tcore®. Therefore the bias of the measurements to the reference measurements of the bladder catheter thermometer is determined.

Patients included are in the ICU of the UKSH and awake. They already have the reference thermometer in the catheter. The patient investigation time is limited to maximum 2 hours, SAEs will be recorded for 24 hours. The temperature of the two temperature sensors will be compared on three timepoints.

Eligibility criteria: Inclusion Criteria:

* Body temperature \> 34 °C
* Signed consent
* Bladder catheter with temperature sensor

Exclusion Criteria:

* Inflammation of the frontal sinus or the measuring point of the reference measurement (bladder)
* Skin irritation to the adhesive or other materials used
* medication that locally affects the body temperature or the temperature of the reference body site (barbiturates, thyroid preparations, antipsychotics, new vaccines, aspirin, acetaminophen, ibuprofen, or similar)
* Taking antipyretics in the last 120 minutes before measurement

Primary outcomes:
measure: Temperature
timeFrame: within 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: University Schleswig-Holstein
Study officials:
affiliation: University Schleswig-Holstein Lübeck
name: Tobias Graf, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01815827: A Study of Single Dose Inclacumab in Japanese Healthy Volunteers Compared to Caucasian Healthy Volunteers
Official title: An Open-label, Parallel Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of Inclacumab in Japanese Healthy Volunteers Compared to Caucasian Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-03-21
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This open-label, parallel group study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of inclacumab in Japanese healthy volunteers compared to Caucasian healthy volunteers. Subjects will receive a single intravenous dose of inclacumab. Follow-up will be for up to 197 days.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female volunteers, 18 to 55 years of age, inclusive Healthy status as defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
* Japanese subjects must have Japanese parents and grandparents who were born in Japan
* Caucasian subjects must have Caucasian parents and grandparents
* Body mass index (BMI) 18 - 30 kg/m2 inclusive

Exclusion Criteria:

* Clinically significant abnormalities in laboratory test results (including positive test for HIV, hepatitis B and/or C), vital signs or ECGs
* Any confirmed significant allergic reactions against any drug, or multiple allergies (non-active hay fever is acceptable)
* Smokes more than 5 cigarettes per day during the three months prior to study conduct
* Participation in an investigational drug or device study within 30 days or 5 half-lives prior to screening
* Positive test for drugs of abuse
* Any suspicion of or history of alcohol and/or other substance abuse or addiction
* Pregnant or lactating women

Primary outcomes:
measure: Pharmacokinetics: Area under the concentration-time curve (AUC)
timeFrame: up to 197 days
measure: Pharmacokinetics: Maximum plasma concentration (Cmax)
timeFrame: up to 197 days
Secondary outcomes:
measure: Pharmacodynamics: Blood platelet leukocytes aggregation (PLA)
timeFrame: up to 197 days
measure: Pharmacodynamics: Plasma (free and total) soluble P-selectin
timeFrame: up to 197 days
measure: Safety: Incidence of adverse events
timeFrame: approximately 10 months
Other outcomes:
Locations:
city: Anaheim
country: United States
state: California
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Morrison M, Palermo G, Schmitt C. Lack of ethnic differences in the pharmacokinetics and pharmacodynamics of inclacumab in healthy Japanese and Caucasian subjects. Eur J Clin Pharmacol. 2015 Nov;71(11):1365-74. doi: 10.1007/s00228-015-1938-4. Epub 2015 Sep 12.
Clinical trial NCT02043327: Simulation Based Training in Colonoscopy
Official title: Simulation-based Training for Colonoscopy: Establishing Criteria for Competency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Group Identification
Keywords: Colonoscopy
assessment
certification,
simulation,
standard setting
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 25
Sex: ALL
Minimum age (years): 28
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Experienced: 10 consultants of gastroenterology with experience in Colonoscopy (\>350 procedures) Novices: 15 fellows of gastroenterology with limited experience in Colonoscopy (\<2 procedures)

Brief summary: The aim of this study is to create simulation-based tests with credible pass/fail-standards for two different fidelities of colonoscopy models

1. virtual reality simulator
2. physical model simulator To create pass/ fail standards for certification

Detailed description: Twenty-five physicians (10 consultants with endoscopic experience and 15 fellows in the first year of fellowship without endoscopic experience) will be tested twice on each of the two different simulator models.

Metrics with discriminatory ability will be identified for both modalities. Reliability will be determined A pass/ fail standard will be determined and the concequences explored.

Eligibility criteria: Inclusion Criteria: For the two groups

Experienced endoscopists :

Having performed \>350 colonoscopy procedures

Novice endoscopists:

First or second year of fellowship in gastroenterology Having performed less than 3 colonoscopies

Exclusion Criteria: For the two groups

Experienced endoscopists:

Prior simulator training

Novice endoscopists:

Prior simulator training

Primary outcomes:
measure: Metrics with discriminatory ability measuring colonoscopy competence
timeFrame: tests were carried out in one day per participant
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet; CEKU
Study officials:
affiliation: Rigshospitalet, Copenhagen, University of Copenhagen
name: Louise Preisler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00496327: Safety,Tolerability and Immunogenicity of Vaccination With VARIVAX in Healthy Indian Children (V210-056)
Official title: Evaluation of Safety,Tolerability and Immunogenicity of Vaccination With VARIVAX (V210)in Healthy Indian Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Varicella
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-07-04
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To observe the safety and tolerability of the administration of VARIVAX in varicella history negative Indian children 12 months to 12 years of age.


Eligibility criteria: Inclusion Criteria:

* Healthy Children, Between 12 Months And 12 Years Of Age
* Parent Or Legal Guardian Should Be Willing And Able To Sign The Informed Consent Form Prior To Entry Into The Study

Exclusion Criteria:

* Any Immune Impairment Or Deficiency, Neoplastic Disease, Or Depressed Immunity, Including That Resulting From Corticosteroid Or Other Immunosuppressive Therapy
* Any Immunoglobulin Or Blood Products 5 Months Prior To Or Expected Within 3 Months After Enrollment In This Study

Any Medical Condition Which, In The Opinion Of The Investigator May Interfere With The Evaluation Of Teh Study Objectives

* Any Other Inactivated Vaccine Administered Within 14 Days Before Or Expected Within 42 Days After Administration Of The Study Vaccination
* Any Other Live Vaccine Administered Within 30 Days Before Or Expected Within 42 Days After Administration Of The Study Vaccination
* Female Subjects Who Are Pregnant Or Nursing
* History Of Anaphylactic Or Other Immediate Allergic Reactions
* Hypersensitivity To Any Of The Components Of The Vaccine Administered Under This Protocol Such As Gelatin Or Neomycin
* Past History Of Varicella
* Previous Vaccination With Any Varicella Vaccine In Either Monovalent Or Combination Form
* Recent Household, Daycare, Or School Exposure(In The Last 4 Weeks) To Varicella

Primary outcomes:
measure: Percent of subjects with VZV specific antibody titre>= 5gp ELISA units/ml 6 weeks post-vaccination
timeFrame: 6 weeks post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Subba Rao SD, Panday S, Maiya PP, Samdani PG, Lokeshwar MR, Bhave S, Bafna S. Immunogenecity and safety of Oka varicella-zoster virus vaccine (VaripedTM) in Indian children. New Indian Journal of Pediatrics. 2018;7.1(Jan-Mar):7-14. https://nijp.org/immunogenicity-and-safety-of-oka-varicella-zoster-virus-vaccine-varipedtm-in-indian-children/
Clinical trial NCT05623527: Clinical Characteristics and Prognosis of Acute Cerebrovascular Events Secondary to Patients Receiving Cardiac Electronic Implants
Official title: Clinical Characteristics and Prognosis of Acute Cerebrovascular Events Secondary to Patients Receiving Cardiac Electronic Implants (SOS-CARE) - A Multicenter Real-world Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Atrial Fibrillation
Pacemaker
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 13324
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: From January 2012 to September 2022, any patients with cardiac implantable electronic device

Brief summary: To investigate the incidence, clinical characteristics and prognosis of acute ischemic and hemorrhagic cerebrovascular disease secondary to the implantation of cardiovascular implantable electronic devices, so as to provide a basis for subsequent treatment strategies and risk factor stratification.

This study intends to retrospectively collect the incidence and case characteristics of acute cerebral infarction, cerebral embolism, transient ischemic attack and cerebral hemorrhage in CIED patients admitted to the First Affiliated Hospital of Xi 'an Jiaotong University and other centers from January 2012 to September 2022. Then, the incidence of poor prognosis and related factors of patients within 3 months were followed up by telephone to provide a basis for subsequent treatment strategy and risk factor stratification.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute cerebrovascular disease secondary to cardiac electronic device implantation.
* Hospitalized from January 2012 to September 2022.

Exclusion Criteria:

* Patients were absent of cranial CT/MRI scan data.
* Patients refuse to take follow-up interviews.

Primary outcomes:
measure: The incidence of acute cerebrovascular disease
timeFrame: About 4 weeks after the enrollment
Secondary outcomes:
measure: In-hospital mortality
timeFrame: About 4 weeks after the enrollment
measure: All-cause mortality
timeFrame: 3 months after the enrollment
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Guoliang Li
state: Shannxi Province
Study officials:
affiliation: Xi'an Jiaotong University First Affiliated Hospital
name: Guoliang Li
role: PRINCIPAL_INVESTIGATOR
References: