louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00320346: Phase II Study of Pandemic Influenza Vaccine
Official title: A Double-Blind, Randomised, Multi-Centre Study to Evaluate the Safety, Tolerability, Immunogenicity and Lot to Lot Consistency of Two Formulations of CSL Limited's Inactivated Prototype Pandemic Influenza Vaccine in a Healthy Adult Population (≤18 Years to ≥64 Years of Age).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Pandemic
Influenza
Prevention
Vaccine
Prevention of Pandemic Influenza
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2006-05-03
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza H5N1 virus strain is the leading candidate to cause the next influenza pandemic. This study will test the safety and immunogenicity of a H5N1 Pandemic Influenza Vaccine in healthy adults. The Study will also assess Lot to Lot consistency of the Pandemic Influenza Vaccine.


Eligibility criteria: Inclusion Criteria:

* Healthy Adults

Exclusion Criteria:

* Previous vaccination with an influenza Vaccine containing the H5N1 strain
* History of clinically significant medical conditions
* History of Guillian-Barre Syndrome or active Neurological disease

Primary outcomes:
measure: Safety and Immunogenicity
Secondary outcomes:
measure: Lot to Lot Consistency
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX, a division of IDT Australia
state: South Australia
city: Melbourne
country: Australia
facility: Murdoch Childrens Research Institute
state: Victoria
city: Perth
country: Australia
facility: Princess Margaret Hospital for Children
state: Western Australia
Study officials:
affiliation: Princess Margaret Hospital for Children
name: Peter Richmond, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nolan TM, Richmond PC, Skeljo MV, Pearce G, Hartel G, Formica NT, Hoschler K, Bennet J, Ryan D, Papanaoum K, Basser RL, Zambon MC. Phase I and II randomised trials of the safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in healthy adults. Vaccine. 2008 Aug 5;26(33):4160-7. doi: 10.1016/j.vaccine.2008.05.077. Epub 2008 Jun 13.
Clinical trial NCT00139646: Parecoxib in Renal Colic
Official title: A Multicenter Single-Blind, Single Dose Efficacy and Safety Pilot Study Comparing Intramuscular Parecoxib and Diclofenac in Renal Colic
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Colic
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase III, multicenter, randomized, single blind study designed to evaluate the efficacy and tolerability of a single dose of parecoxib compared with diclofenac in the treatment of acute pain due to renal colic.

Detailed description: This study was prematurely discontinued May 3, 2004 due to slow recruitment. The decision to terminate the trial was not based on any safety concerns.

Eligibility criteria: Inclusion Criteria:

* diagnosis of renal colic;
* baseline pain \> 50 mm on VAS;

Exclusion Criteria:

* evidence of neoplasm or any other severe disease of any organ, including any psychiatric illness;
* active GI disease (e.g. Crohn's disease or ulcerative colitis) or any evidence of concomitant disease which may lead to early termination of the study

Primary outcomes:
measure: Evaluation of efficacy through: time to onset of pain relief and time to remedication.
Secondary outcomes:
measure: Evaluation of efficacy through: Pain Intensity (VAS), Pain Relief (PR) and several measurements of analgesia that will be derived from VAS and PR Physician's Global Evaluation at 12 hours Patient's Global Evaluation at 12 hours
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Pfizer Investigational Site
city: Grosseto
country: Italy
facility: Pfizer Investigational Site
city: Modena
country: Italy
facility: Pfizer Investigational Site
city: Pavia
country: Italy
facility: Pfizer Investigational Site
city: Siena
country: Italy
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05581446: Pain Types and Pain Severity in Chronic Neck Pain
Official title: The Effects of Pain Types on Pain Severity and Quality of Life in Chronic Neck Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Neck Pain
Lead sponsor: Konya Beyhekim Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-10-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients presenting with chronic neck pain

Brief summary: The aim of this study is to characterize the distribution of pain phenotypes in people with chronic neck pain and to determine the effects of pain phenotypes on pain severity, functional status and quality of life.

Participants will be examined to determine the type of pain and questions will be asked to assess pain severity and impact.


Eligibility criteria: Inclusion Criteria:

* having chronic neck pain
* be over 18 years old

Exclusion Criteria:

* those under the age of 18
* Those with major psychiatric illness,
* Those with communication problems

Primary outcomes:
measure: identification of pain types(determination of nociceptive, neuropathic, nociplastic pain rates)
timeFrame: 01.06.2023
measure: determination of pain intensity and effects(Pain severity,quality of life,disability,pain status)
timeFrame: 01.06.2023
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya Beyhekim Research and Training Hospital
state: Selçuklu
Study officials:
References:
Clinical trial NCT01782846: Trama-Code (Two Analgesics-comparative Study)
Official title: Double Blind-randomized Study Comparing the Efficacy of Two Analgesia (Ixprim® and Dafalgan-Codeine®) , in the Emergency Unit.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2013-02-04
Enrollment: 803
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Double-blind randomized study to compare the efficacy of two analgesic drugs(Ixprim®, Dafalgan-Codeine®) in the emergency unit.

The efficacy (relief of pain) would be assessed 2 hours after administration of one of the two drugs in a patient presented to the emergency unit with a moderate pain (4 to 6 on pain assessment score).


Eligibility criteria: Inclusion Criteria:

* Patients of 18 - 75 years of age
* Presented to the emergency unit of FOCH hospital
* Complaining of moderate pain (4-6 on pain assessment scale) evaluated by the reception nurse

Exclusion Criteria:

* Patient already had received another type 2 analgesia or already received one of the study drugs in the last 4 hours
* pregnant or lactating females
* Patient with one or more contraindication to one of the study drugs
* Patients for whom the pain assessment scale can not be performed (unconscious, confused ...)
* Patient cannot be included for legal reasons
* Patient required urgent management
* Patient for whom it is considered difficult to be reassessed 2 hours later
* Patient unable to swallow

Primary outcomes:
measure: pain improvement
timeFrame: 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital FOCH - Emergency unit
state: Ile de France
Study officials:
References:
Clinical trial NCT05720546: Young Adult Infusion Space Experience Satisfaction Survey
Official title: Young Adult Infusion Space Survey: Comparing Experiences of Adolescents and Young Adults in Infusion Spaces at North Carolina Basnight Cancer Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: Adolescent
survey
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A subject with a cancer diagnosis and receiving infusion in the study site

Brief summary: The purpose of this study is to compare the satisfaction of Adolescent and Young Adults (AYA) receiving treatment in two different infusion spaces at the North Carolina Basnight Cancer Hospital (NCBCH). A survey and semi-structured interviews will be administered to participants to compare the experience with the built environment, with mental health staff, and between outpatient infusion spaces at NCBCH.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information.
2. Subjects are willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
3. Age 18-39 years old at enrollment.
4. Receiving treatment for a cancer diagnosis in Adult Infusion Center or the Adolescent and Young Adult Infusion Center
5. English speaking.

Exclusion Criteria:

1. Dementia, altered mental status, or any psychiatric condition as determined by the clinical or study team that would prohibit the understanding or rendering of informed consent.
2. Current incarceration.

Primary outcomes:
measure: General satisfaction
timeFrame: Baseline (up to 1 month)
Secondary outcomes:
measure: Satisfaction with the built environment
timeFrame: Baseline (up to 1 month)
measure: Satisfaction with staff interaction
timeFrame: Baseline (up to 1 month)
measure: Satisfaction with mental health
timeFrame: Baseline (up to 1 month)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Jacob Stein
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00308646: Instrument Development of Screening Prediabetes Patients
Official title: Instrument Development of Screening Prediabetes Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prediabetic State
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2006-03-30
Enrollment: 3000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: OTHER

Brief summary: It will be more effective if we can work on the primary prevention for the high risk groups of diabetes and prediabetes such as the early detection.

Detailed description: During the past years, many efforts were put on the diagnosis and treatment of DM and its complications. It will be more effective if we can work on the primary prevention for the high risk groups of diabetes and prediabetes such as the early detection. As a first public health step, it is worthwhile to identify prediabetes people in community by screening program. Three thousand persons will be randomly selected from residents of Taichung city. All the participants will fulfill a structured questionnaire and 'Diabetes risk factor screening tool' which American Diabetes Association suggested in 2003. This project will estimate the prevalence of prediabetes in conventional hospital-base population as well as the validity of a screening questionnaire for prediabetes.

Eligibility criteria: Inclusion Criteria:

Residents aged 40 and over of Taichung city, Taiwan in October, 2004.

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: School of Medicine, China Medical University
name: Lin C Chieh, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03106246: Circulating Extracellular Vesicles Released by Human Islets of Langerhans
Official title: Immune Response to Extracellular Vesicles Released by Human Islets of Langerhans
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type1 Diabetes Mellitus
Type2 Diabetes
Islet Cell Transplantation
Keywords: Extracellular vesicles
Autoimmunity
Beta-cell injury
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: CHU de Quebec-Universite Laval
First posted: 2017-04-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmed Type I and Type II diabetes, patients undergoing islet transplantation and healthy volunteers.

Brief summary: Beta-cells release extracellular vesicles (EV) and exosomes under normal and pathophysiologic conditions. These EV contain beta-cell specific autoantigens which may trigger the immune response at the initiation of type 1 diabetes. In this study, beta-cell derived EV will be detected and characterized in human blood samples.

Detailed description: Adult subjects will be recruited with: new onset type 1 diabetes mellitus (T1DM), type 2 diabetes mellitus (T2DM) as well as islet transplant candidates. Blood samples will be collected at defined intervals to determine beta-cell specific EV and determine the utility of this biomarker as a measure of beta-cell stress or injury.

Eligibility criteria: Inclusion Criteria:

Age 18-70 Diagnosis of type 1 diabetes or type 2 diabetes or islet transplant recipient

Exclusion Criteria:

Unknown diagnosis of diabetes Active infection Immunocompromised Organ transplant recipients not including candidates for islet transplant HIV+ Hepatitis C+ Hepatitis B surface antigen+ Known concurrent malignancy Known pregnancy

Primary outcomes:
measure: Determine the levels of circulating EVs
timeFrame: 2 years
measure: Determine whether these EVs contain islet-specific antigens
timeFrame: 2 years
Secondary outcomes:
measure: Mutivariate analysis will be performed with patient parameters and EV parameters
timeFrame: 3 years
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
Study officials:
References:
Clinical trial NCT01637246: A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Who Were Insufficiently Responsive to Monotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-07-11
Enrollment: 4385
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Primary Open Angle Glaucoma or Ocular Hypertension

Brief summary: This is a retrospective chart review and will assess changes in IOP after treatment with any fixed combination in patients who previously received monotherapy.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of glaucoma or ocular hypertension
* Previously treated with monotherapy followed by fixed combination therapy for at least 12 weeks

Exclusion Criteria:

* None

Primary outcomes:
measure: Change From Baseline in Intraocular Pressure (IOP)
timeFrame: Baseline, 12 Weeks
Secondary outcomes:
measure: Patient Assessment of Tolerability Using a 4-Point Scale
timeFrame: 12 Weeks
measure: Physician Assessment of Tolerability Using a 4-Point Scale
timeFrame: 12 Weeks
measure: Percentage of Patients Who Maintained Better Compliance With Treatment
timeFrame: 12 Weeks
measure: Percentage of Patients Continuing on Therapy After 12 Weeks
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00620646: The Comparison of Effects Between Increased Dose of Clopidogrel and Addition of Cilostazol
Official title: The Comparison of Effects Between Increased Dose of Clopidogrel and Addition of Cilostazol in Clopidogrel Non-Responders After Drug-Eluting Stent Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clopidogrel Non-Responsiveness
Keywords: clopidogrel
platelets
percutaneous coronary intervention
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2008-02-21
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effect of increased dosing of clopidogrel and adding cilostazol to standard dose of clopidogrel after the insertion of drug-eluting stent in patients with clopidogrel resistance

Detailed description: Using dual antiplatelet agents with aspirin and clopidogrel is essential after drug-eluting stent implantation to prevent restenosis and stent thrombosis. However, variable platelet response and potential resistance to therapy have emerged with clopidogrel. Several studies showed that clopidogrel resistance is associated with increased cardiovascular events after coronary interventions. New antiplatelet therapeutic strategy of is needed in case of clopidogrel resistance. We started this study to compare the effect of double dosing of clopidogrel to 150mg per day and adding cilostazol to standard dose of clopidogrel after the insertion of drug-eluting stent in patients with clopidogrel resistance.

Eligibility criteria: Inclusion Criteria:

* Patient with clopidogrel resistance with treatment of dual antiplatelet agent, aspirin and clopidogrel, for more than 4 weeks after drug-eluting stent
* Clopidogrel resistance is defined as a patients with platelet inhibition less than 30% in platelet function test(VerifyNow-P2Y12 assayTM, Accumetrics, San Diego, CA, USA)

Exclusion Criteria:

* Acute myocardial infarction within 2 weeks
* Unstable angina within 2 weeks
* History of using glycoprotein IIb/IIIa inhibitor within 1 month
* Cerebral infarction within 3 months
* Bleeding diathesis like coagulation disorder, thrombocytopenia (platelet count \< 100,000/uL)
* history of gastrointestinal bleeding or genitourinary bleeding within 3 months
* needed oral anticoagulation
* aspirin, clopidogrel or cilostazol hypersensitivity
* congestive heart failure
* serum creatinine level \>2mg/dl
* malignancy
* using cytochrome P450 inhibitor (eg, itraconazole)

Primary outcomes:
measure: % platelet inhibition with VeryfyNow-P2Y12 assay, platelet function test
timeFrame: 4 weeks
Secondary outcomes:
measure: P2Y12 reaction unit (PRU)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Hyeon-Cheol Gwon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04664946: Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With No Reperfusion Therapy (INSIST-NRT)
Official title: Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With No Reperfusion Therapy (INSIST-NRT): One Single Center, Safety and Feasibility Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Neuroprotection
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 30
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: To explore the safety and feasibility of intra-arterial neuroprotective strategy in acute ischemic stroke patients who missed recanalization operation.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years;
2. Major neurologic deficits: 6≤NIHSS≤20;
3. Missing recanalization therapy (IVT or EVT) or progressive stroke, which was defined as symptoms worsen in 48 hours (an increase in NIHSS more than 4);
4. Premorbid mRS 0 or 1;
5. Signed informed consent.

Exclusion Criteria:

1. Modified Rankin Score \>2 caused by a history of prior stroke;
2. Patients who underwent intravenous thrombolysis or Endovascular treatment;
3. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ \<80000/mm3;
4. Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
5. Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
6. Unsuitable for this clinical studies assessed by researcher.

Primary outcomes:
measure: Proportion of server adverse events
timeFrame: 48 hours
Secondary outcomes:
measure: Proportion of patients with modified Rankin Score 0 to 1
timeFrame: 90 days
measure: Proportion of patients with modified Rankin Score 0 to 2
timeFrame: 90 days
measure: Modified Rankin Score
timeFrame: 90 days
measure: Decrease in national institutes of health stroke scale (NIHSS)
timeFrame: 48 hours
measure: Proportion of symptomatic intracranial hemorrhage (sICH)
timeFrame: 48 hours
measure: Proportion of intraparenchymal hemorrhage (PH1 and PH2)
timeFrame: 48 hours
measure: Changes in cerebral edema
timeFrame: 48 hours
measure: All causes of death within 48 hours after the treatment
timeFrame: 48 hours
measure: Differences in serum factors levels in different artery region
timeFrame: 0 hour
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Department of Neurology, General Hospital of Northern Theater Command
Study officials:
References: