louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01613443: Ex-vivo Effect of New Oral Anticoagulants on Point-of-care Devices
Official title: Time-dependent ex Vivo Influence of Rivaroxaban on Point-of-care Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Effect of NOAC on POCT
Keywords: Dabigatran, Rivaroxaban, Point of Care-testing
Lead sponsor: Cardioangiologisches Centrum Bethanien
Sponsor class: OTHER
First posted: 2012-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients indicated for NOAC-therapy

Brief summary: Concentration determinations of anticoagulants require plasma instead of whole blood, and results are not immediately available to clinicians. Monitoring anticoagulants concentration along with bedside methods may provide an alternative guide for administration of the NOAC.

The purpose of this investigation is to compare bedside coagulation assays in whole blood with plasma concentrations of the new oral anticoagulants (NOAC) in patients treated with therapeutic dosis of NOAC.

Detailed description: This open-label study will be performed by ex vivo investigations. Patients receiving the NOAC as dabigatran or rivaroxaban in therapeutic doses are recruited and informed consent of two blood sampling times will be obtained in correlation to the time of drug intake (two and 24 hours after drug intake). The bedside measurements will be performed and compared directly with the concentrations determined by plasma concentration assays. These investigations will be performed at the department of Angiology at the university hospital Frankfurt.

Eligibility criteria: The indication for the use of NOAC is provided by the attending physician. The criteria for inclusion and exclusion criteria for the use of the new oral anticoagulants must meet appropriate eligibility criteria and the clinical guidelines that are described in the SOPs.

Patients treated with dabigatran 2x150mg / d for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation are included.

Moreover, patients treated with rivaroxaban 20 mg / d for DVT prophylaxis and treatment of recurrent DVT or PE are included.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Mani H, Herth N, Kasper A, Wendt T, Schuettfort G, Weil Y, Pfeilschifter W, Linnemann B, Herrmann E, Lindhoff-Last E. Point-of-care coagulation testing for assessment of the pharmacodynamic anticoagulant effect of direct oral anticoagulant. Ther Drug Monit. 2014 Oct;36(5):624-31. doi: 10.1097/FTD.0000000000000064.
Clinical trial NCT00599443: Safety and Tolerability of a Cell-Derived Influenza Vaccine in Healthy Adults Aged ≥18 Years and ≤ 49 Years
Official title: Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of a Cell-Derived Influenza Vaccine in Healthy Adults Aged ≥18 Years and ≤ 49 Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Cell-derived subunit influenza vaccine
Safety
Reactogenicity
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-01-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A controlled, double blinded study to determine the safety and reactogenicity in healthy adults of a single dose of a trivalent cell-derived influenza vaccine administered by intramuscular injection.


Eligibility criteria: Inclusion Criteria:

* Healthy female or male subjects aged ≧18 and ≦49 years
* Willing and able to give informed consent

Exclusion Criteria:

* Influenza vaccination of laboratory confirmed influenza infection within six months of informed consent,
* presence of any significant medical condition,
* a serious adverse reaction after a previous (influenza) vaccination,
* underlying medical conditions for which annual influenza vaccine is recommended by the Advisory Committee on Immunization Practices (ACIP),
* chronic diseases requiring long-term immunosuppressive therapy

Primary outcomes:
measure: Safety and tolerability of one dose of cell-derived influenza vaccine in healthy adults aged ≧18 years and ≦ 49 years after vaccination.
timeFrame: 3 weeks
measure: Long-term safety
timeFrame: 6 months
Secondary outcomes:
measure: HI antibody titers
timeFrame: 3 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
Clinical trial NCT02493543: Autoantibodies on Spinal Cord Injury
Official title: Role of Autoantibodies in Spontaneous Functional Recovery After Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Cord Injuries
Keywords: autoantibodies
Lead sponsor: Hospital Nacional de Parapléjicos de Toledo
Sponsor class: OTHER
Collaborators: name: Fundación Mutua Madrileña
First posted: 2015-07-09
Enrollment: 110
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 acute spinal cord injury admitted to the Spanish National Hospital for Paraplegics

Brief summary: The purpose of this study is to determine the autoantibody profiles after spinal cord injury and their role in spontaneous functional recovery.

Detailed description: Most patients experience variable degrees of functional recovery after spinal cord injury (SCI), predominantly in the first months after lesion. In SCI animal models, autoantibodies are pathogenic and their titers rise up at the time when spontaneous recovery stops. The aim of this study is to determine the autoantibody profiles after SCI and to infer their relation with functional recovery. To achieve this, autoantibody profiles, biochemical, hematological and immune-related parameters (cytokines, chemokines and growth factors) will be determined from a serum blood sample and functional recovery will be evaluated accordingly to standardized scales.

Eligibility criteria: Inclusion Criteria:

* Traumatic or non-progressive vascular SCI
* Less than 45 days after lesion
* Any neurological level
* Complete and incomplete lesions
* If patient has been treated with glucocorticoids, it should have passed at least 7 days from the end of the treatment

Exclusion Criteria:

* Cauda equina syndrome
* Autoimmune disorder
* Tumor (even if benign)
* Neurodegenerative disease

Primary outcomes:
measure: Changes in ASIA scores
timeFrame: 4 months
Secondary outcomes:
measure: Change in neurological level of injury
timeFrame: 4 months
measure: Change in ASIA impairment scale (AIS)
timeFrame: 4 months
Other outcomes:
measure: Spinal cord independence measure (SCIM)
timeFrame: Until discharge from the hospital (6-12 months)
Locations:
city: Murnau Am Staffelsee
country: Germany
facility: Berufsgenossenschaftliche Unfallklinik Murnau
city: Toledo
country: Spain
facility: Hospital Nacional de Parapléjicos, SESCAM
Study officials:
affiliation: Hospital Nacional de Parapléjicos, SESCAM
name: Angel Arevalo-Martin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02028143: ICE: Intracardiac Ultrasound Within the Left Atrium During Radiofrequency Ablation of Nonvalvular Atrial Fibrillation
Official title: ICE: Intracardiac Ultrasound Within the Left Atrium During Radiofrequency Ablation of Nonvalvular Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Lead sponsor: Wellmont CVA Heart Institute
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2014-01-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Imaging Real Time within the Left atrial chamber Enhances safety and efficacy of Radiofrequency Ablation of Atrial Fibrillation

Detailed description: Atrial fibrillation is the most common rhythm disturbance affecting the human population.

1. Its prevalence increases with age and can be found in \>8% of humans over the age of eighty;
2. Radiofrequency ablation for drug refractory nonvalvular atrial fibrillation has become a common therapy available to patients. It has been shown to be both efficacious and cost effective;
3. The standard approach to atrial fibrillation involves electrical isolation of the pulmonary veins (PVI) from the rest of the atrium chamber. This involves moving a 3.5mm tip ablation catheter point to point around the PV structures until an encircling ablation line is formed. This can be made difficult by not knowing if the tip is in good contact with the atrial tissue. In addition the esophagus is a posterior lying structure and injury to the esophagus by ablating the overlying tissue has been reported, at times fatal;
4. Currently, intracardiac imaging of the left atrium has FDA approval in the right atrial chamber. This leads to difficulty in visualizing tip tissue interface, and important left sided structures such as carina, ligaments, and esophagus. By placing the tip of the ICE catheter in the left atrium, enhanced visualization of the tip tissue interface may lead to more effective ablation points, fewer needed ablation points, and enhanced safety by avoiding placement over adjacent noncardiac structures.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 80 years
* Recommended for radiofrequency ablation of nonvalvular atrial fibrillation

Exclusion Criteria:

* none

Primary outcomes:
measure: number of lesions requiring ablation to obtain Electrical Isolation PV System
timeFrame: during procedure
Secondary outcomes:
measure: to assess number of lesions to obtain Electrical Isolation PV system
timeFrame: during procedure
Other outcomes:
measure: Safety-Cardiac perforation, emboli, fistula formation
timeFrame: during procedure
Locations:
city: Kingsport
country: United States
facility: Wellmont CVA Heart Institute
state: Tennessee
Study officials:
affiliation: Wellmont CVA Heart Institute
name: Gregory Jones, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03023943: The Effects of IASTM and Proprioception
Official title: The Effects of Instrument Assisted Soft Tissue Mobilization on Proprioception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Youngstown State University
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The research design will be single group pretest-posttest design. The subject will be instructed to position the knee joint to a position previously set by the experimenter. Intervention will be 10 minutes of GT1 instrument application at anterior thigh using sweep technique.


Eligibility criteria: Inclusion Criteria:

* male or female, age 18 to 65.

Exclusion Criteria:

* sensory impairments or a present contraindications to IASTM which include cancer, burn scars, kidney dysfunction, pregnancy, varicose veins, osteoporosis, body art, chronic regional pain syndrome, polyneuropathies, fractures, autoimmune disorders, diabetes, vitamin C \& D/Calcium deficiencies, rheumatoid arthritis, ankylosing spondylitis, congestive heart failure, acute inflammation, lymphedema, flu or illness with flu-like symptoms, and medications (anticoagulant, steroids, hormone replacements, NSAIDS, fluoroquinolone antibiotics, herbal supplements).

Primary outcomes:
measure: Proprioception determined using the reposition error
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Youngstown
country: United States
facility: Youngstown State University
state: Ohio
Study officials:
affiliation: Youngstown State University
name: Michael Hripko
role: STUDY_DIRECTOR
References:
Clinical trial NCT01284543: Study Comparing Tan EndoGlide With the Busin Glide for Insertion of the Donor Graft in DSAEK
Official title: Randomized Prospective Study Comparing Tan EndoGlide With the Busin Glide for Insertion of the Donor Graft in Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endothelial Cell Loss With Different Insertion Devices
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2011-01-27
Enrollment: 42
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 Tan EndoGlide device results in less endothelial cell trauma during insertion of the donor corneal graft indicated by reduced endothelial cell loss at 1 year follow-up compared to the Busin glide.


Eligibility criteria: Inclusion Criteria:

* Patients presenting with corneal decompensation requiring DSAEK with or without cataract surgery for visual rehabilitation.
* Clinical diagnosis include endothelial cell dysfunction secondary to Fuchs endothelial dystrophy, pseudophakic or aphakic bullous keratopathy, failed penetrating keratoplasty or DSAEK, iridocorneal endothelial syndrome or trauma.
* Ability to understand the nature of the procedure and give full informed consent.
* Patients who are able to comply with the standard DSAEK follow-up protocol at the Toronto Western Hospital.

Exclusion Criteria:

* Patients with late stage corneal decompensation with stromal scarring unsuitable for DSAEK and therefore requiring penetrating keratoplasty.
* Patients with complex anterior segment pathology precluding successful DSAEK procedure.
* Patients not giving full informed consent to participate in the trial

Primary outcomes:
measure: Endothelial cell counts at 1, 3, 6 and 12 months postoperatively
timeFrame: 1 year
measure: Best corrected visual acuity at 1, 3, 6, and 12 months postoperatively
timeFrame: 1 year
Secondary outcomes:
measure: Complications of surgery
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT00836043: Safety, Effectiveness and Patient Acceptance of the Treatment With MabCampath in Chronic Lymphocytic Leukemia
Official title: Safety, Effectiveness and Patient Acceptance of the Treatment With MabCampath in Chronic Lymphocytic Leukemia (CLL)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Lymphocytic Leukemia
Keywords: CLL
alemtuzumab
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-02-04
Enrollment: 6
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 suffering from chronic lymphocytic leukemia (CLL) and are treated with alemtuzumab (MabCampath)

Brief summary: This study will collect data on safety, effectiveness and patient acceptance of MabCampath treatment under daily life conditions.

Detailed description: As of 29 May 2009, the clinical trial sponsor is Genzyme Corporation. NOTE: This study was originally posted by sponsor Schering AG, Germany, which was subsequently renamed to Bayer Schering Pharma AG, Germany.

Eligibility criteria: Inclusion Criteria:

In- and outpatients suffering from CLL, who are treated with Mab Campath, and are routinely monitored with PCR (Polymerase Chain Reaction) for CMV infection during MabCampath treatment and for at least 2 months following completion of treatment.

Exclusion Criteria:

In accordance with Summaries of Product Characteristics (SPC).

Primary outcomes:
measure: Efficacy related variables are patient's condition, physician's assessment of efficacy and tolerability, information whether application could be completed, clinical and laboratory findings. Safety Variables.
timeFrame: After first cycle of treatment, e.g. 12 weeks, then after 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Many Locations
country: Bosnia and Herzegovina
city: Many Locations
country: Israel
city: Many Locations
country: Macedonia, The Former Yugoslav Republic of
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03449043: BECOME PATIENTS IN THE EMERGENCIES OF UHC POITIERS
Official title: ANALYSIS OF THE BECOME OF THE PATIENTS ADDRESSED BY THEIR GENERAL PRACTITIONER TO EMERGENCIES OF UHC POITIERS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Emergencies
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient coming to emergency for all types of pathologies with general practitioner letter

Brief summary: The number of consultations in the emergency services has continued to increase with 19.7 million passages in 2014, an increase of 4% compared to 2013. Among these admissions, many patients come spontaneously to the emergency department and others are sent by the general practitioner who remains the first resort in the care of the patient.

Faced with this massive influx to emergency services, the investigator will see what is the future of these. Are they more likely to be hospitalized than patients presenting to emergencies on their own?


Eligibility criteria: Inclusion Criteria:

* Major patient
* View by a general practitioner whether he is their doctor or a substitute
* Addressed with a mail
* All types of pathologies are taken into account

Exclusion Criteria:

* Minor patient

Primary outcomes:
measure: Concordance rate between the general practitioner request and the patient's actual care path.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01625143: Studying Genes in Samples From Younger Patients With Relapsed Acute Lymphoblastic Leukemia
Official title: Molecular Taxonomy of Pediatric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: B-cell Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Lymphoblastic Leukemia
Untreated Childhood Acute Lymphoblastic Leukemia
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-06-21
Enrollment: 40
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of B-cell acute lymphoblastic leukemia

Brief summary: This laboratory study is looking into genes in samples from younger patients with relapsed acute lymphoblastic leukemia. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

Detailed description: OBJECTIVES:

I. To identify global changes in the epigenome and various underlying histone modifications that characterize relapsed acute lymphoblastic leukemia (ALL).

II. To identify specific transcription factor-binding sites associated with histone alterations.

III. To correlate gene expression changes of differentially regulated genes at relapse with underlying chromatin modifications.

OUTLINE:

Archived bone marrow samples, collected at the time of diagnosis and relapse, are analyzed for gene expression and histone modifications by microarray, chromatin immunoprecipitation (ChIP) sequencing, and quantitative real-time polymerase chain reaction (qRT-PCR).

Eligibility criteria: Inclusion Criteria:

* Diagnosis of B-cell acute lymphoblastic leukemia

  * Paired diagnosis-relapse primary patient samples obtained from the Children's Oncology Group (COG) cell bank

Primary outcomes:
measure: Cellular origins of relapse and the underlying epigenetic mechanisms associated with drug resistance
timeFrame: 1 month
measure: Genes associated with histone modification
timeFrame: 1 month
measure: Biological pathways involved in relapse
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Arcadia
country: United States
facility: Children's Oncology Group
state: California
Study officials:
affiliation: Children's Oncology Group
name: William Carroll, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04107038: Monitored Anesthesia Care vs. General Anesthesia for Transcatheter Aortic Valve Replacement
Official title: A Randomized Controlled Trial Comparing Monitored Anesthesia Care Versus General Anesthesia With Transesophgeal Echocardiography for Transcatheter Aortic Valve Replacement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transcatheter Aortic Valve Replacement
Keywords: Anesthesia, TAVR, Cardiothoracic, Cardiology
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being done to evaluate the impact that monitored anesthetic care (MAC) versus general endotracheal anesthesia (GETA) has on hospital length of stay, rate of ICU admission, and procedural mortality for patients undergoing Transcatheter Aortic Valve Replacement (TAVR). Also, the investigators hope to determine if the use of Transesophageal Echocardiography (TEE) during GETA impacts device success. Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis may be eligible candidates for this study.


Eligibility criteria: Inclusion Criteria:

* Adult patients ≥ 18 years old
* Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis
* Adult patients who are medically eligible to receive both anesthetics (GA and MAC)

Exclusion Criteria:

* Inability to speak English
* Body Mass Index (BMI) \> 37 kg/m2
* History of difficult airway requiring fiberoptic intubation
* Inability to lie flat
* Women who are pregnant
* Patients who have contraindications to either anesthetic, such as an allergy or history of malignant hyperthermia, will also be excluded from the study.
* Inability or unwillingness of subject to give informed consent based on any reason
* Patients with any of the following absolute contraindications to TEE:
* Perforated Viscus
* Esophageal Stricture
* Esophageal Tumor
* Esophageal Perforation
* Esophageal Diverticulum
* Active upper GI Bleed

Primary outcomes:
measure: Hospital Length of Stay
timeFrame: Up to 1 month
measure: ICU Admission Rate
timeFrame: Up to 48 hours
measure: Procedural Mortality
timeFrame: Up to 30 days
Secondary outcomes:
measure: Paravalvular Regurgitation
timeFrame: For GETA cases, will be recorded after valve implantation. For all cases, will be recorded from a TTE report that is completed on post-operative day 1 or 2 and at 1 year.
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina - Department of Anesthesia
name: George Whitener, M.D.
role: PRINCIPAL_INVESTIGATOR
References: