louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00316615: Safety and Immunogenicity of a Inactivated Influenza Vaccine When Administered to Non Elderly Adults and Elderly Subjects.
Official title: A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2005-2006, When Administered to Non-Elderly Adult and Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza Disease
Keywords: influenza
non elderly adult and elderly
vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2006-04-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate safety and immunogenicity of a single intramuscular (IM) injection of a Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2005-2006, when Administered to Non-Elderly Adults and Elderly Subjects


Eligibility criteria: Inclusion Criteria:

* subjects 18 years of age or older

Exclusion Criteria:

* Any serious disease such as: cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure
* hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine
* history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
* known or suspected (or high risk of developing) impairment/alteration of immune function

Primary outcomes:
measure: CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination
Secondary outcomes:
measure: Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.
measure: Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.
measure: Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: G. D'Annunzio University
city: Lanciano
country: Italy
facility: Office of Hygiene and Public Health, ASL Lanciano
Study officials:
affiliation: Novartis
name: Novartis Vaccines - Drug Information Services
role: STUDY_CHAIR
References:
Clinical trial NCT06353815: Clinical Evaluation of Anaesthetic Efficacy of 4% Articaine Buccal Infiltration Versus Inferior Alveolar Nerve Block
Official title: Clinical Evaluation of Anaesthetic Efficacy of 4% Articaine Buccal Infiltration Versus Inferior Alveolar Nerve Block for Restorative Dental Treatment in Mandibular First Permanent Molars: A Randomized Clinical Tria
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Restorative Dental Treatment by Buccal Infiltration Anaesthesia
Keywords: buccal infiltration
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 44
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Clinical evaluation of anaesthetic efficacy of 4% articaine buccal infiltration versus inferior alveolar nerve block during restorative dental treatment in mandibular first permanent molars


Eligibility criteria: Inclusion Criteria:

* Clinical Criteria:

  * Children aged between 6 years and 9 years having:
  * Mandibular first permanent molar with simple caries not involving pulp showing the following criteria: A. No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of the vestibule. B. Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test.

Radiographic criteria:

* No sign of radiolucency in periapical or furcation area.
* No widening of PDL space or loss of lamina dura continuity.
* No evidence of internal/external pathologic root resorption

Exclusion Criteria:

* • Uncooperative children.

  * Children with systemic disease.
  * Lack of informed consent by the child patient's parent.
  * Refusal of participation.
  * Allergy from anesthetic agent.
  * Acute infection

Primary outcomes:
measure: Success of local anesthesia
timeFrame: 10 minutes
Secondary outcomes:
measure: Child behavior during treatment
timeFrame: Intraoperative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01476215: A Pharmacokinetic Study Investigating the Rate and Extent of Paracetamol Absorption of Three Experimental Sustained Release Pediatric Suspensions
Official title: A Pharmacokinetic Study Investigating the Rate and Extent of Paracetamol Absorption of Three Experimental Sustained Release Pediatric Suspensions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: paracetamol
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-11-22
Enrollment: 18
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This proof of principle PK study will allow GSKCH to select the most favorable sustained release formulation among 3 prototypes to move to the next stage of drug development.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteer
* Body Mass Index between 19.0 - 28.0 (kg/m2) inclusive

Primary outcomes:
measure: Time to plasma level above therapeutic level
timeFrame: baseline to 8 hours
Secondary outcomes:
measure: General PK parameters (e.g. AUC, Tmax, Cmax)
timeFrame: baseline to 8 hours
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: MDS Pharma Services NEBRASKA
state: Nebraska
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00855985: Anastomotic Techniques in Pancreaticoduodenectomy
Official title: A Randomised Controlled Trial of Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Pancreaticoduodenectomy for Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Cancer
Pancreatic Fistula
Keywords: Pancreatic anastomosis
Whipple operation
Lead sponsor: Lakeshore Hospital
Sponsor class: OTHER
First posted: 2009-03-05
Enrollment: 312
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are two principal ways of draining the remnant of the pancreas back into the intestine after removal of the head of the pancreas for cancer. This can be performed either to the jejunum or to the stomach. The aim of this study is to randomly allocate consenting patients to one of the two arms to study whether the leak rates from the anastomosis and the outcomes after the surgery are affected.

Previous papers have shown similar results in both groups although non randomized data suggested that the Pancreaticogastrostomy (drainage into the stomach) may be superior


Eligibility criteria: Inclusion Criteria:

1. Pancreaticoduodenectomy for adenocarcinoma of the pancreatic head
2. resectable tumour

Exclusion Criteria:

1. chronic pancreatitis/benign tumours-
2. tumours extending into the body of the pancreas
3. tumours with metastasis beyond regional lymph nodes
4. requirement for sub total pancreatectomy
5. prolonged hypotension - \< 80 mm of hg for more than 30 min

Primary outcomes:
measure: pancreatic fistula rate
timeFrame: 30 days
Secondary outcomes:
measure: mortality
timeFrame: 90 days
measure: Hospital stay
timeFrame: 90 days
measure: need for postoperative intervention
timeFrame: 90 days
measure: major complication
timeFrame: 90 days
Other outcomes:
Locations:
city: Cochin
country: India
facility: Lakeshore Hospital & Research Center
state: Kerala
Study officials:
affiliation: Lakeshore Hospital
name: Hariharan Ramesh, MS MCh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03379285: Management of Digestive Haemorrhaging In CHRU of Brest During 2009 and 2014
Official title: Risk Factors for Further Bleeding in Patients Admitted to Intensive Care for Gastro Intestinal Bleeding
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastro Intestinal Bleeding
Keywords: Gastro Intestinal Bleeding;
Transfusion,
Outcomes
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to intensive care unit with the primary admission diagnosis of Gastro Intestinal Bleeding and who were not retrieved from another hospital.

Brief summary: Gastro intestinal (GI) bleeding is relatively frequent and may lead to intensive care unit admission. Although a restrictive strategy for red blood cell transfusion is supported by a large randomized controlled trial literature, less is known about the impact of transfusion strategy of other blood components and administration of anti fibrinolytic on clinical outcomes.

This study aims to identify parameters that may be associated with the risk of further bleeding in patients admitted to ICU for GI bleeding.


Eligibility criteria: Inclusion Criteria:

* Patients with Gastro Intestinal Bleeding admitted to either medical or surgical intensive care unit

Exclusion Criteria:

* patients retrieved from another hospital
* age \< 18 years consent withdrawal

Primary outcomes:
measure: Bleeding
timeFrame: within a week
Secondary outcomes:
measure: mortality
timeFrame: during hospitalisation (28 days)
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT04763785: Development of a Keratoconus Detection Algorithm by Deep Learning Analysis and Its Validation on Eyestar Images
Official title: Development of a Keratoconus Detection Algorithm by Deep Learning Analysis and Its Validation on Eyestar Images
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Keratoconus
Eye Diseases
Cataract
Corneal Ectasia
Keywords: Keratoconus
Eye Diseases
Cataract
Corneal Imaging
Corneal Topography
Corneal Tomography
Corneal Ectasia
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 4800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: retrospective part: anonymised picture-data of 4500 patients prospective part: 150 keratoconus patients and 150 healthy participants

Brief summary: Monocentric clinical study to develop an imaging analysis algorithm for the Eyestar 900 to identify keratoconus corneas and improve biometry for intraocular lens calculations

Detailed description: Keratoconus is a progressive corneal ectatic disorder, characterised by thinning, protrusion and irregularity. Corneal imaging is crucial in keratoconus detection and progression analysis. Detection of keratoconus in early stages is important and has therapeutic consequence, whether to plan a surgical intervention or calculating an intraocular lens, before cataract surgery, as standard lens calculation techniques may lead to wrong results in patients with a keratoconus.

The Eyestar 900 is a swept-source OCT biometer and has the potential to be used for early keratoconus identification and progression analysis.

Eligibility criteria: Inclusion Criteria:

1. Patients with all stages of keratoconus
2. Patients with healthy corneas

Exclusion Criteria:

1. Keratoconus patients with hydrops, status following hydrops
2. Patients with degenerative corneal diseases
3. Patients after corneal surgery

Primary outcomes:
measure: Keratoconus identification
timeFrame: 2.5 years
Secondary outcomes:
measure: Feasibility in clinical practice
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Universitätsklinik für Augenheilkunde, Inselspital
Study officials:
affiliation: Universitätsklinik für Augenheilkunde, Inselspital Bern
name: Früh Beatrice, Prof.Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00213785: A Study of Plasmatic Concentrations of Endothelin-1 (ET1), Atrial Natriuretic Peptide (ANP) and Brain Natriuretic Peptide (BNP) in Acute Ischemic Stroke.
Official title: A Study of Plasmatic Concentrations of Endothelin-1 (ET1), Atrial Natriuretic Peptide (ANP) and Brain Natriuretic Peptide (BNP) in Acute Ischemic Stroke.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: AreET1
ANP
BNP pronostic markers of stroke
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: A study of plasmatic concentrations of endothelin-1 (ET1), atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP) in acute ischemic stroke.


Eligibility criteria: Inclusion Criteria:

* male or female
* age \> 18
* with an ischemic stroke

Exclusion Criteria:

* cardiac failure
* renal failure

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Clinique neurologique - Service des maladies du système nerveux et du muscle - Hôpitaux Universitaires de Strasbourg, Hôpital Civil
Study officials:
affiliation: Hopitaux Universitaires de Strasbourg
name: Andoni Echanz-Laguna, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05928585: A Study of Safety and Drug Levels of HIB210 in Healthy Volunteers
Official title: Phase 1 Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HIB210 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Immune System Diseases
Autoimmunity
Keywords: C5aR1
C5a receptor
C5aR1 inhibition
CD88
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2023-07-03
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test safety of the investigational product in healthy volunteers. The main questions it aims to answer is when HIB210 is administered as multiple doses, is it:

1. Safe
2. Well tolerated
3. Does the body absorb and eliminate HIB210 as expected

Detailed description: Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.

Eligibility criteria: Key Eligibility Criteria:

* Healthy male and females between 19 to 65 years of age
* Normal or not significantly abnormal laboratory tests and EKG findings during Screening
* No significant medical conditions that might affect ability to participate in the study or present a safety risk
* No evidence of significant or recurrent infection or recent infection
* No history of cancer other than certain skin cancers and limited cancer of the cervix of the womb
* Willingness to comply with birth control requirements of the study (for both men and women)
* No recent major surgery or trauma or planned surgery during the study or within 1 month after the study
* Body mass index (BMI) between 18 and 32 kg/m2

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Baseline to End of Study (Up to Day 114)
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Baseline to End of Study (Up to Day 114)
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Baseline to End of Study (Up to Day 114)
measure: Number of participants with physical examination abnormalities
timeFrame: Baseline to End of Study (Up to Day 114)
measure: Number of participants with vital sign abnormalities
timeFrame: Baseline to End of Study (Up to Day 114)
Secondary outcomes:
measure: PK Parameters: Cmax
timeFrame: Baseline to Day 29
measure: PK Parameters: tmax
timeFrame: Baseline to Day 29
measure: PK Parameters: AUC
timeFrame: Baseline to Day 29
measure: Anti-drug Antibodies (ADA)
timeFrame: Baseline to End of Study (Up to Day 114)
Other outcomes:
Locations:
city: Hialeah
country: United States
facility: HI-Bio Investigational Site
state: Florida
Study officials:
affiliation: HI-Bio, A Biogen Company
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06573385: Reliability and Validity of Turkish Version of the Diabetes Education Questionnaire (DATE-Q)
Official title: Evaluation of Validity and Reliability of the Turkish Version of the Diabetes Education Questionnaire (DATE-Q) in Patients with Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Lead sponsor: Biruni University
Sponsor class: OTHER
Collaborators: name: Istanbul University
name: Istanbul Galata University
First posted: 2024-08-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are diagnosed with Diabetes

Brief summary: The Diabetes Education Questionnaire (DATE-Q) is a questionnaire that includes comprehensive care components of diabetes management and specifically questions the effect of exercise on blood glucose levels and the knowledge of the correct exercise intensity in patients with diabetes. It can be easily and rapidly applied. The aim of this study is to evaluate the translation into Turkish, validity and reliability of the DATE-Q, which questions the knowledge of diabetic patients about their disease.


Eligibility criteria: Inclusion Criteria:

. Age of 18 or above

* Those whose native language is Turkish
* Volunteer to participate in the study

Exclusion Criteria:

* Individuals who cannot cooperate (those who score below 24 points according to the Standardized Mini Mental Test)
* Those who have problems understanding and speaking Turkish
* Any visual or cognitive disorder that would prevent the participant from answering the survey

Primary outcomes:
measure: Diabetes Education Questionnaire (DATE-Q)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Biruni Üniversitesi
Study officials:
References:
Clinical trial NCT04446585: Cardiac Arrest in Residential Areas With Mobile First-responder Activation
Official title: A Cluster Randomized Clinical Trial of Strategic AED Deployment in High-risk Residential Areas Combined With Activation of Local Residents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Out-Of-Hospital Cardiac Arrest
Keywords: Suddan cardiac arrest
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Lead sponsor: Emergency Medical Services, Capital Region, Denmark
Sponsor class: OTHER_GOV
Collaborators: name: TrygFonden, Denmark
name: Zoll Medical Corporation
name: Danish Heart Foundation
First posted: 2020-06-25
Enrollment: 260
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to increase proportions of bystander defibrillation during out-of-hospital cardiac arrest (hereof referred to as cardiac arrest) in residential areas with a high density of cardiac arrests. The intervention consists of Automated External Defibrillators (AEDs) and residents' involvement in resuscitation through training and enrollment as citizen responders.

Detailed description: Survival decreases by 10% for every minute that passes after a cardiac arrest until defibrillation. Despite an increasing number of available AEDs, survival and defibrillation rates in residential areas remain poor. Efforts to increase bystander defibrillation has the potential to improve survival. Through the strategic deployment of AEDs, training, and recruitment of residents as citizen responders, we aim to improve proportions of bystander defibrillation and 30-day survival in densely populated residential areas with a high density of cardiac arrests.

Eligibility criteria: Inclusion Criteria:

* All witnessed cardiac arrests recognized registered in the Danish Cardiac Arrest Registry occurring within the study sites. This excludes non witnessed cardiac arrests.
* Witnessed cardiac arrest
* Non-traumatic etiology, this excludes intoxication, drowning or suicide.

Exclusion Criteria:

* Cardiac arrest occurring in a nursing home
* Cardiac arrest not treated by the EMS due to ethical reasons or obvious signs of death
* Not true cardiac arrest (suspected, but not verified)
* Cardiac arrests witnessed by the emergency medical personnel

Primary outcomes:
measure: Bystander defibrillation
timeFrame: Up to five years after implementation of the intervention
Secondary outcomes:
measure: 30-day survival
timeFrame: 30 days after date of cardiac arrest
Other outcomes:
Locations:
city: Ballerup
country: Denmark
facility: Emergency Medical Services Copenhagen
state: The Capital Region
Study officials:
affiliation: EMS Copenhagen
name: Fredrik Folke, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: EMS Copenhagen
name: Carolina M Hansen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: