louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01245478: DePuy Revision TKA Implant 5yr Survivorship
Official title: Clinical Outcome and 5-year Implant Survival Rate Among Adult Revision Total Knee Arthroplasty Patients With DePuy Implant Components
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Complications; Arthroplasty, Mechanical
Keywords: Surgical Procedures, Elective
Lead sponsor: The New England Baptist Hospital
Sponsor class: OTHER
Collaborators: name: Depuy, Inc.
First posted: 2010-11-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any NEBH patients who received DePuy implant components during a Revision TKA procedure, performed by either:

* Dr. Geoffrey Van Flandern
* Dr. David Mattingly
* Dr. James Nairus
* Dr. James Bono
* Dr. Daniel Ward
* Dr. Carl Talmo

Brief summary: This will be a retrospective chart review of 200 charts of adult patients who have undergone a revision TKA at New England Baptist Hospital and who received implant component(s) manufactured by DePuy Orthopedics. The data will be collected retrospectively after patients are seen clinically for a minimum of five years after surgery to answer:

1. What is the five-year survivorship of revision a knee prosthesis containing components manufactured by DePuy Orthopedics among adult revision TKA patients?
2. What patient factors are associated with the need for re-operation after revision TKA among patients receiving DePuy implant components? How do clinical outcomes change from baseline over the five-year follow-up after revision TKA surgery?

Data collection will include patient-reported and clinician-reported measures.


Eligibility criteria: Inclusion Criteria:

* Received a Revision TKA (must have been initial revision)

  --Received J\&J/DePuy implant components for initial revision
* Procedure performed at New England Baptist Hospital

Exclusion Criteria:

* 2nd Revision TKA on knee
* Received femoral or tibial components not of DePuy manufacture

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: New England Baptist Hospital
name: John Richmond, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05164978: DEP Combine With PD-1 Antibody as an Treatment for EBV-HLH
Official title: DEP Combine With PD-1 Antibody as an Treatment for EBV Associated Hemophagocytic Lymphohistiocytosis (HLH)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemophagocytic Lymphohistiocytosis
Keywords: Hemophagocytic Lymphohistiocytosis
DEP
PD-1 antibody
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients with EBV- HLH receive DEP combine with PD-1 antibody as an treatment.
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the efficacy and safety of DEP (liposomal doxorubicin, etoposide and methylprednisolone) together with PD-1 antibody as an treatment for EBV associated hemophagocytic lymphohistiocytosis.

Detailed description: PD-1 antibody added to the DEP regimen （with or without asparaginases） in EBV-HLH,

Eligibility criteria: Inclusion Criteria:

1. Meet hemophagocytic lymphohistiocytosis (HLH)-04 diagnostic criteria; EBV-DNA in peripheral blood or EBER in tissue were positive, patients were diagnosed with EBV associated HLH (EBV-HLH).
2. . The expected survival time is more than 1 month.
3. Age \>18 years old, gender is not limited.
4. Serum creatinine ≤ 1.5 times normal；
5. Serum human immunodeficiency virus(HIV) antigen or antibody negative； Hepatitis C virus (HCV) antibody is negative, or HCV antibody is positive, but HCV RNA is negative；HBV copies less than 1E+03 copies/ml.
6. No thyroid dysfunction. The left ventricular ejection fraction (LVEF) was normal.
7. No uncontrollable infection.
8. Contraception for both male or female.

8. Informed consent obtained.

Exclusion Criteria:

1. Allergic to doxorubicin, etoposide and sintilimab Injection
2. Serious immunoreaction: myocardial damage, hepatitis, pneumonia
3. Central nervous system symptoms
4. Serious mental illness;
5. Central nervous system symptoms
6. Serious mental illness;
7. Accumulated dose of doxorubicin above 300mg/m2 or epirubicin above 450mg/m2；
8. Pancreatitis history. Patients unable to comply during the trial and/or follow-up phase;
9. Participate in other clinical research at the same time.

Primary outcomes:
measure: Evaluation of treatment response
timeFrame: Change from before and 2,4,6 and 8 weeks after initiating DEP combine with PD-1 antibody therapy
Secondary outcomes:
measure: EBV-DNA
timeFrame: Change from before and 2,4,6 and 8 weeks after initiating DEP combine with PD-1 antibody therapy
measure: Survival
timeFrame: 3 months after the intervention
measure: Adverse events that are related to treatment
timeFrame: 2,4,6 and 8 weeks after initiating DEP combine with PD-1 antibody therapy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
Study officials:
affiliation: Beijing Friendship Hospital
name: Zhao Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00490178: Acceptability Study of a New Fixed Combination of Fenofibrate 80 mg BID and Metformin 1000 mg BID in Type 2 Diabetes and Dyslipidemia
Official title: An Open Label, Multicenter Trial Assessing the Acceptability of a New Fixed Combination of Fenofibrate 80 mg BID and Metformin 1000 mg BID in Patients With Type 2 Diabetes and Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Dyslipidemia
Keywords: Type II diabetes
dyslipidemia
metformin
fenofibrate
synordia
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-06-22
Enrollment: 29
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The present study aims to assess the acceptability of a 4 week treatment of a new fixed-dose combination of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia


Eligibility criteria: Inclusion Criteria:

1. Male or female patients aged from 20 to 80 years (at inclusion visit).
2. Type 2 diabetes treated with a stable dose of metformin for a minimum of 3 months either alone or in combination with another oral hypoglycaemic agent.
3. Dyslipidemia treated with 160 mg fenofibrate (or bioequivalent formulations) for a minimum of 3 months either alone or in combination with a statin.
4. And having signed a written informed consent.-

Exclusion Criteria:

1. Known Type 1 Diabetes, uncontrolled type 2 diabetes \[HbA1c \> 9.5 %, Fasting plasma glucose (FPG) \> 240 mg/dL (\> 13.4 mmol/L) on the last performed blood sample (within the last 3 months)\].
2. TG \> 500 mg/dL (\> 5.65 mmol/L) on the last performed blood sample (within the last 3 months).
3. Women who are not surgically sterilized (i.e. bilateral tubal ligation, bilateral or two unilateral oophorectomies, hysterectomy) or not using adequate contraceptive methods (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide) or not postmenopausal (\> 1 year since their last menstrual period).
4. Pregnant or lactating women.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Site 3
city: Nantes
country: France
facility: Site 1
city: Tours
country: France
facility: Site 2
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
Clinical trial NCT03896178: Prostate Cancer in Firemen: Early Diagnosis Because of Increased Diagnostic Pressure?
Official title: Early Detection of Prostate Cancer in Firefighters - a Register-based Study of Prognostic Factors and Survival
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Institute of Public Health
name: Extrastiftelsen
name: The National Institute of Occupational Health
name: Norwegian Confederation of Trade Unions
name: Fagforbundet
name: Gjensidige Foundation
name: Norwegian Cancer Society
name: Norwegian Firefighters Fight Cancer
name: Norwegian Labour Inspection Authority
First posted: 2019-03-29
Enrollment: 137536
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All men registered in the Cancer Registry of Norway with prostate cancer. Analysis of firefighters, pilots, police, military personnel and a matched group of other workers.

Brief summary: Firefighters, police, military personnel and pilots are all shown to have a higher incidence of prostate cancer than the general population. A possible explanation for this is that these four groups of employees need regular mandatory health-checkups. If these checkups increase the chances of having a PSA or DRE performed one could expect the workers in question to have a higher probability than the general population of being diagnosed with prostate cancer. If this is the case the four groups should have cancers that are lower grade and have better survival. The investigators wish to examine this by comparing the four groups with a control group made up of all other workers with regards to prognostic factors at the time of diagnosis and survival rates. This will be done by extracting data from the Cancer Registry of Norway, coupled with employment data from Statistics Norway. This study is also a part of a project on cancer in firefighters. If the prostate cancers in firefighters differ significantly from the other three specified groups, this could point to an exposure specific for firefighters, e.g. fire smoke, as an etiologic factor.


Eligibility criteria: Inclusion Criteria:

* All cases of prostate cancer as registered by the Cancer Registry of Norway

Exclusion Criteria:

* None

Primary outcomes:
measure: Cause-specific mortality rate for prostate cancer
timeFrame: From January 1st 1960 until December 31st 2018
Secondary outcomes:
measure: TNM staging
timeFrame: January 1st 1960 until December 31st 2018
measure: Gleason score
timeFrame: January 1st 1960 until December 31st 2018
measure: PSA at time of diagnosis
timeFrame: January 1st 1960 until December 31st 2018
measure: Functional status at time of diagnosis (WHO classification)
timeFrame: January 1st 1960 until December 31st 2018
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Cancer Registry of Norway
Study officials:
References:
Clinical trial NCT02906878: Platelet Kinetics After Platelet Transfusion for the Placement of a Central Venous Catheter
Official title: Evaluation of the Effectiveness and Security of the Prophylactic Platelet Transfusion in Thrombocytopenic Patients Requiring the Placement of a Central Venous Catheter
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thrombopenia
Central Venous Catheter Placement
Keywords: Intensive Care
Haematology
Platelets prophylactic transfusion
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2016-09-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Haematology patients who needs a central venous catheter and with a non-auto immune thrombopenia

Brief summary: PLATCAT study's purpose is to evaluate platelet kinetics after platelet transfusion


Eligibility criteria: Inclusion Criteria:

* Admission en haematology unit
* Need for a central venous catheter
* Thrombopenia \< 50 G/L

Exclusion Criteria:

* Patient protected by law
* Pregnant or breastfeeding women
* Peripheral thrombopenia
* Patient admitted in Intensive Care Unit

Primary outcomes:
measure: 72 hours thrombocythemia kinetics after a platelet transfusion
timeFrame: 72 hours post transfusion
Secondary outcomes:
measure: Transfusion Safety - assessed by Troubles during process
timeFrame: One day after transfusion
measure: Transfusion Efficacy
timeFrame: One month after transfusion
measure: Description of patients treatment
timeFrame: One week before and one month after transfusion
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Angers
name: Nicolas LEROLLE, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00232778: A Multicenter Trial of Localized Radiation Therapy to Inhibit Restenosis (GAMMA V)
Official title: A Multicenter Trial of Localized Radiation Therapy to Inhibit Restenosis (GAMMA V)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Coronary Artery Disease
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2005-10-05
Enrollment: 579
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objectives of this study are:

1. To show a reduction in the late thrombosis (LT) rate following percutaneous revascularization using current interventional techniques with new stent placement and intravascular radiation therapy (IRT) with a long-term antiplatelet regimen (12 months) compared to the stented patients on short-term antiplatelet regimen (2 months) from the IRT arm of GAMMA I Trial.
2. To show equivalence in the LT rate following percutaneous revascularization using current interventional techniques without new stent placement and IRT with a long-term antiplatelet regimen (6 months) compared to non-stented patients on short term antiplatelet therapy (2 months or less) from a pooling of the IRT arms of the GAMMA I, SCRIPPS, and WRIST Trials.


Eligibility criteria: Inclusion Criteria:

1. The patient has a restenosis of \>60% (by subjective angiographic determination of the minimal luminal diameter compared to the distal reference diameter) within a native coronary artery which has previously undergone stent placement.
2. The patient has a history, signs of, or laboratory studies that suggest coronary ischemia attributable to the target stenosis.
3. The study target lesion must be located in a restenotic native coronary artery measuring \>2.75 and \<4.0 mm in diameter and 45 mm in length. The target lesion must have undergone coronary interventional treatment \>4 weeks previously.
4. The vessel 1 cm distal to the target lesion is \>2.5 mm in diameter.

5 Patients age must be \>18 years and \<85 years.

Exclusion Criteria:

1. Attempts to treat lesions in other vessels during the procedure were unsuccessful.
2. The patient sustained a recent (\<72 hours) myocardial infarction defined as a serum CK 2x the upper limit of normal and elevated MB.
3. Serum creatinine \>2.0 mg/dl.
4. The left ventricular ejection fraction is \<40%.

Primary outcomes:
measure: The primary effectiveness parameters will be late thrombosis of the target lesion at
measure: 9 months for non-stented patients and late thrombosis of the target lesion at
measure: 15 months for stented patients.
measure: The safety criteria will include post-procedure Q-wave myocardial infarction, non-Q-wave myocardial infarction, death, need for bypass surgery, need for emergency bypass surgery,or need for repeat coronary angioplasty.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01595971: Distance Education Versus Usual Care Qualification in Asthma Care
Official title: Distance Education Versus Usual Care in the Qualification of Asthma Care: A Cluster Randomized Clinical Trial - RESPIRANET
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Continuing education
Primary health care
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
First posted: 2012-05-10
Enrollment: 467
Sex: ALL
Minimum age (years): 5
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate the effectiveness of multifaceted educational interventions in the care of asthma, conducted remotely over the platform TelessaúdeRS in teams of the Family Health Strategy and the consequent clinical improvement patients.

Detailed description: Cluster-randomized trial with follow-up of 6 months. The aim of this study is to determine whether multifaceted interventions performed at a distance for the care of asthma symptoms reduce overhead, improve asthma control and qualify the care provided to patients.

Eligibility criteria: Inclusion Criteria:

* Practice:Participate in the Telessaúde/RS. Minimal staff consisting of a general practitioner, nurse, nurse and community health agents (CHA), ability to give at least ten patients diagnosed with asthma, located in a municipality to make available for free inhaled medication (short-acting bronchodilators and corticosteroids ) for the treatment of asthma and willingness to participate in the study.
* Patients: 5 to 45 years with a diagnosis of asthma made by a physician and register at least one consultation for asthma or an asthma-related hospitalization during the year preceding the beginning of the study.

Exclusion Criteria:

* Patients with other chronic diseases with pulmonary complications such as tuberculosis, cancer and cystic fibrosis or those with severe mental illness

Primary outcomes:
measure: Symptom burden, measured as the number of self-reported asthma symptom days (ASD). ASD is based on 2 week recall.
timeFrame: six months
Secondary outcomes:
measure: Asthma control
timeFrame: 6 months
measure: Health care utilization
timeFrame: 6 meses
measure: Proportion of patients in use inhaled corticosteroids
timeFrame: 6 meses
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de clínicas de Porto Alegre
state: Rio grande do sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Erno Harzheim, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT05193071: Early Antiplatelet for Minor Stroke Following Thrombolysis (EAST)
Official title: Early Antiplatelet for Minor Stroke Following Thrombolysis (EAST): a Prospective, Random, Double Blinded and Multi-center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemic Stroke
Keywords: thrombolysis
minor stroke
early antiplatelet
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 1022
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current guideline recommends to give antithrombotic treatment 24 hours after intravenous thrombolysis in acute ischemic stroke. However, early neurological deterioration will occur in some patients due to no antithrombotic treatment, which is closely associated with poor outcome. The current trial aims to investigate the effectiveness and safety of early antithrombotic treatment after intravenous thrombolysis in minor stroke.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old;
* Acute ischemic stroke patients who received intravenous thrombolysis within 4.5 hours of onset;
* NIHSS ≤ 5 within 6 hours after the end of intravenous thrombolysis, and no bleeding transformation was found in head CT examination;
* Premorbid mRS ≤ 1;
* Signed informed consent.

Exclusion Criteria:

* Premorbid mRS≥2;
* Uncontrolled severe hypertension (systolic pressure \>180 mmHg or diastolic pressure \>110 mmHg after drug treatment);
* Antithrombotic treatment within 24 hours before randomization;
* Significant dysphagia and inability to take the experimental drug orally;
* Allergy or contraindication to study drugs;
* Comorbidity with any serious diseases and life expectancy is less than half a year;
* Participating in other clinical trials within three months;
* Patients not suitable for this clinical study considered by researcher

Primary outcomes:
measure: The proportion of excellent prognosis
timeFrame: Day 90
Secondary outcomes:
measure: The proportion of favorable prognosis
timeFrame: Day 90
measure: Distribution of modified Rankin Score (mRS)
timeFrame: Day 90
measure: Changes in National Institute of Health stroke scale (NIHSS)
timeFrame: 24 hours, 48 hours, and 10 days
measure: Occurrence of early neurologyical deterioration (END)
timeFrame: 24 hours
measure: The incidence of symptomatic intracerebral hemorrhage
timeFrame: 36 hours
measure: The incidence of any intracerebral hemorrhage
timeFrame: 36 hours
measure: The incidence of stroke recurrence and other vascular events
timeFrame: Day 90
measure: The death due to any cause
timeFrame: Day 90
Other outcomes:
Locations:
city: ShenYang
country: China
facility: Hui-sheng Chen
state: None Selected
city: Shenyang
country: China
facility: Department of Neurology, General Hospital of Northern Theater Command
Study officials:
References:
Clinical trial NCT02260271: Florida Neonatal Neurologic Network
Official title: Florida Neonatal Neurologic Network
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hypoxic-Ischemic Encephalopathy
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2014-10-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants diagnosed with hypoxic-ischemic encepholopathy (HIE) at birth

Brief summary: Create a database with selected medical information on infants born with hypoxic-ischemic encephalopathy (HIE). In addition, the following samples will be collected in a bio-repository for future studies: blood, urine, and buccal samples.

Detailed description: The purpose of this study is to create a detailed medical and sample database of infants born with HIE. Both the medical information and the samples are de-identified. Any future studies performed with the data and samples will receive Institutional Review Board (IRB) approval.

Eligibility criteria: Inclusion Criteria:

* Gestational Age greater than or equal to 35 weeks gestation
* Birth weight greater than or equal to 1.8 kg
* Less than or equal to 6 hours since insult occurred
* Severe hypoxic-ischemic encepholopathy (HIE)

Exclusion Criteria:

* Presence of lethal chromosomal abnormalities
* Severe IUGR
* Significant intracranial hemorrhage with a large intracranial hemorrhage (Grade III or intraparenchymal echodensity (Grade IV))

Primary outcomes:
measure: Measurement of blood-based biomarkers of neonatal Hypoxic Ischemic Encephalopathy (HIE)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Michael D Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References: