louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00109655: Dose-Escalation Study of CG0070 for Bladder Cancer After BCG (Bacillus Calmette-Guerin) Failure
Official title: A Phase 1 Dose-Escalation Trial of Intravesical CG0070 for Superficial Transitional Cell Carcinoma of the Bladder After Bacillus Calmette-Guerin Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Carcinoma, Transitional Cell
Bladder Neoplasms
Keywords: Superficial Transitional Cell Carcinoma
Bacillus Calmette-Guerin (BCG)
Superficial Bladder Cancer
Gene Therapy
Vaccine
Adenovirus
Carcinoma in situ
Lead sponsor: Cell Genesys
Sponsor class: INDUSTRY
First posted: 2005-05-03
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this research study is to evaluate the safety and dosing of CG0070.

Detailed description: Cohorts of three to six patients will be assigned to receive intravesical (into the bladder) administration of CG0070 either Weekly or Every 4 Weeks for up to a total of 6 doses.

Eligibility criteria: Inclusion Criteria:

* High grade non-muscle invasive bladder cancer (stages Ta, T1 and/or CIS - carcinoma in situ). High grade being defined as G2 or G3 disease.
* Failure of at least one prior treatment with BCG, defined as evidence of TCC on cystoscopic exam and biopsy or cystoscopic exam and urine cytology at least 6 weeks from last BCG treatment
* ECOG performance status 0-1
* Adequate bone marrow, renal, liver and coagulation function

Exclusion Criteria:

* Pregnant or nursing
* HIV positive
* Use of anticoagulants such as coumadin or heparin
* History of bleeding disorder
* Active systemic autoimmune disease or chronic immunodeficiency
* Prior gene therapy
* Uncontrolled cystitis, bladder pain, bladder spasms, urinary incontinence, or reduced bladder volume

Primary outcomes:
measure: Maximum-tolerated or maximum feasible dose in single and multidose regimens of CG0070 by intravesical administration
timeFrame: Study End
Secondary outcomes:
measure: Assessment of the amount of CG0070 in the urine and blood over time by PCR
timeFrame: Study End
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: BCG Oncology
state: Arizona
city: San Francisco
country: United States
facility: UCSF Comprehensive Cancer Center
state: California
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Albany
country: United States
facility: New York Oncology Hematology
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Barrie
country: Canada
facility: Male/Female Health and Research Centre
state: Ontario
city: Oakville
country: Canada
facility: The Fe/Male Health Centre
state: Ontario
Study officials:
References:
Clinical trial NCT02935855: ORal anticoaGulants in diAbetic and Nondiabetic Patients With nOn-valvular Atrial fibrillatioN (ORGANON)
Official title: Efficacy and Safety of Non-vitamin K Oral Anticoagulants and Vitamin K Oral Anticoagulants on Some Metabolic and Coagulation Parameters in Diabetic and Nondiabetic Patients With First Diagnosis of Non-valvular Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Keywords: Diabetic patients
nondiabetic patients
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 300
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: Diabetic and nondiabetic patients will be evaluated if they had a first diagnosis of non-valvular atrial fibrillation and in therapy with non-vitamin K oral anticoagulants and with vitamin K oral anticoagulants.

Detailed description: Parameters evaluated:

* anthropometric indices
* glycated haemoglobin, basal and postprandial glycemia
* lipid profile
* small and dense LDL; oxidized LDL
* I troponin
* red and white cells count; platelets count
* creatinin, transaminases, iron
* fibrinogen, D-dimer, anti-thrombin III
* Hs-CRP, metalloproteinases 2 and 9
* incidence of bleeding

Eligibility criteria: Inclusion Criteria:

* non-valvular atrial fibrillation
* nondiabetic patients
* type 1 and 2 diabetic patients

Exclusion Criteria:

* patients with cancer
* patients with chronic inflammation diseases

Primary outcomes:
measure: Efficacy on coagulation parameters
timeFrame: 12 months
measure: Efficacy on coagulation parameters
timeFrame: 12 months
measure: Efficacy on coagulation parameters
timeFrame: 12 months
measure: Efficacy on coagulation parameters
timeFrame: 12 months
Secondary outcomes:
measure: Bleeding risk
timeFrame: 12 months
measure: Inflammation parameters
timeFrame: 12 months
measure: Inflammation parameters
timeFrame: 12 months
measure: Endothelial damage
timeFrame: 12 months
measure: Oxidative status
timeFrame: 12 months
measure: Heart damage
timeFrame: 12 months
measure: Safety and tolerability parameters
timeFrame: 12 months
measure: Safety and tolerability parameters
timeFrame: 12 months
measure: Safety and tolerability parameters
timeFrame: 12 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
Study officials:
affiliation: University of Pavia and IRCCS Policlinico San Matteo
name: Giuseppe Derosa, MD, PhD, FESC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01106755: Effects of Ground Level Gait Training With Body Weight Support (BWS) and Functional Electrical Stimulation (FES)
Official title: Ground-level Gait Training Combining Body Weight Support and Functional Electrical Stimulation in People Following Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiparesis
Stroke
Keywords: kinematic
hemiparesis
gait
Body weight support
Functional electrical stimulation
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2010-04-20
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate the effects of gait training on ground level, combining BWS and FES in people following chronic stroke.

Detailed description: The body weight support system (BWS) associated to a treadmill as well as to a functional electrical stimulation (FES) of the common peroneal nerve, has been proposed as a strategy for gait training in people following stroke. Moreover, it has also considered that the ground level is the most common locomotion surface, and that there is little information about the effects of gait training, on this kind of surface, in people with hemiparesis.

Eligibility criteria: Inclusion Criteria:

* Elapsed time since stroke longer than 6 months
* Spasticity classified under level 3 according to the Modified Ashworth Scale
* The ability to walk classified at levels 2, 3 or 4 according to the Functional Ambulation Category

Exclusion Criteria:

* Heart failure, angina pectoris, arrhythmias and other cardiovascular diseases
* Severe lung disease
* Orthopedic disorders
* Cognitive deficits

Primary outcomes:
measure: kinematic evaluation
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Carlos
country: Brazil
facility: Universidade Federal de Sao Carlos
state: Sao Paulo
Study officials:
affiliation: Universidade Federal de Sao Carlos (Sao Paulo - Brazil)
name: Tania F Salvini, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prado-Medeiros CL, Sousa CO, Souza AS, Soares MR, Barela AM, Salvini TF. Effects of the addition of functional electrical stimulation to ground level gait training with body weight support after chronic stroke. Rev Bras Fisioter. 2011 Nov-Dec;15(6):436-44. doi: 10.1590/s1413-35552011005000030. Epub 2011 Oct 27.
Clinical trial NCT04939155: Methylation Effects of COV-19 Infection and Vaccinations
Official title: Measuring the DNA Methylation Effects From COVID-19 Infection and COVID-vaccinations
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: TruDiagnostic
Sponsor class: INDUSTRY
Collaborators: name: Cornell University
First posted: 2021-06-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects that are healthy individuals and of any sex, ethnicity, and anyone above the age of 18 years old.

Brief summary: This is a retrospective non-randomized clinical study of 60 patients total to assess the effects of SARS-CoV-2 infection and the SARS-CoV-2 vaccination. This study will have 2 arms evaluating the epigenomes of patients pre and post-exposure to one of the interventions. The first arm of the study will analyze 40 patients' epigenomes whose DNA methylation was examined pre and post SARS-CoV-2 infection. The second arm of this study is analyzing 20 patients' epigenomes whose DNA methylation was examined pre and post-injection of the SARS-CoV-2 vaccine.


Eligibility criteria: Inclusion Criteria:

* Subjects that are healthy individuals and of any sex, ethnicity, and anyone above the age of 18 years old.

Primary outcomes:
measure: Methylation age clock testing
timeFrame: Change from baseline after COVID-19 infection
measure: Methylation age clock testing
timeFrame: Change from baseline after COVID-19 mRNA vaccination
Secondary outcomes:
measure: Overall state of health
timeFrame: Change from baseline after COVID-19 infection
measure: Overall state of health
timeFrame: Change from baseline after COVID-19 mRNA vaccination
Other outcomes:
Locations:
city: Lexington
country: United States
facility: TruDiagnostic
state: Kentucky
Study officials:
References:
citation: Bonek K, Roszkowski L, Massalska M, Maslinski W, Ciechomska M. Biologic Drugs for Rheumatoid Arthritis in the Context of Biosimilars, Genetics, Epigenetics and COVID-19 Treatment. Cells. 2021 Feb 4;10(2):323. doi: 10.3390/cells10020323.
citation: Cao X. COVID-19: immunopathology and its implications for therapy. Nat Rev Immunol. 2020 May;20(5):269-270. doi: 10.1038/s41577-020-0308-3.
citation: Corey L, Mascola JR, Fauci AS, Collins FS. A strategic approach to COVID-19 vaccine R&D. Science. 2020 May 29;368(6494):948-950. doi: 10.1126/science.abc5312. Epub 2020 May 11. No abstract available.
Clinical trial NCT04868955: Evaluation of Oral Screen Training With IQoro as Treatment for Dysphagia After Stroke
Official title: Evaluation of Oral Screen Training With IQoro as Treatment for Dysphagia After Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Dysphagia
Lead sponsor: Ostergotland County Council, Sweden
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 24
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: Purpose The purpose of the study is to evaluate if training with oral screen IQoro® improves swallowing in patients with dysphagia after stroke.

Method Inpatient from a stroke unit in Sweden who have been assessed with fiberoptic endoscopic evaluation of swallowing(FEES) which proves swallowing difficulties (dysphagia) were recruited. The participants were randomise to control- or intervention group. Both groups received usual care. The intervention group were instructed to oral screen (IQoro®) training for 13 weeks. Follow up with FEES was made 13 weeks post of recruitment. The assess with FEES was recorded and the recordings are going to be analyzed afterwards to compare the swallowing ability between baseline and follow up in group and between group.


Eligibility criteria: Inclusion Criteria:

* Inpatient at stroke unit at Vrinnevisjukhuset ward 1, due to stroke.
* Patient assessed to have dysphagia (score ≥1 on one of the studied parameters)according to FEES.
* Patient who is able to handle IQoro® according to instructions, independently or with support of assistance from relatives or staff.

Exclusion Criteria:

* Patients with dysphagia of a cause other than stroke.
* Patient with impaired cognitive skill, motor and / or language ability that prevents the possibility of performing training with IQoro®, despite possible support from assistance from relatives or staff.
* Patient who wishes training with the Muppy oral screen® related to saliva leakage.

Primary outcomes:
measure: Change in swallowing function due to secretion in the pharynx.
timeFrame: From baseline to follow up (13 weeks after baseline).
measure: Change in swallowing function due to aspiration and penetration.
timeFrame: From baseline to follow up (13 weeks after baseline).
measure: Change in swallowing function due to residual in the pharynx.
timeFrame: From baseline to follow up (13 weeks after baseline).
Secondary outcomes:
measure: The patient's experience of swallowing
timeFrame: From baseline to follow up (13 weeks after baseline)
measure: Change in swallowing function due to oral intake.
timeFrame: From baseline to follow up (13 weeks after baseline).
Other outcomes:
Locations:
city: Norrkoping
country: Sweden
facility: Vrinnevisjukhuset
state: Ostergotland
Study officials:
affiliation: Ostergotland County Council, Sweden
name: Rebecca U Norrman, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Ostergotland County Council, Sweden
name: Elin AM Rova, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00924755: Study of Surgical Mesh for Inguinal Hernia Repair
Official title: Early Outcome of Inguinal Hernia Repair With Biomerix Surgical Mesh Using the Lichtenstein Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hernia, Inguinal
Keywords: Surgical mesh
Lead sponsor: Biomerix
Sponsor class: INDUSTRY
First posted: 2009-06-19
Enrollment: 25
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the early outcomes when using the Biomerix Revive™ as a tension-free onlay patch, Lichtenstein-style, in patients who are candidates for primary, unilateral, open inguinal hernia repair.


Eligibility criteria: Inclusion Criteria:

* male ≥19 years old
* symptomatic and palpable inguinal hernia
* candidate for unilateral, primary, open inguinal hernia repair using the Lichtenstein technique
* will comply with required follow-up study visits
* willing and able to provide written informed consent

Exclusion Criteria:

* BMI ≥35
* life expectancy of \<3 years
* strangulated hernia
* urologic disorder and/or previous urologic surgery in the testicular area (with the exception of prostate surgery)
* active abdominal surgical condition such as bowel obstruction or perforation
* local or systemic infection or peritonitis
* known disease that impairs wound healing
* anti-platelet therapy (other than aspirin) for \>7 days preceding the surgical procedure
* previous ipsilateral groin incision
* receiving immunosuppressive therapy and/or has undergone radiation therapy to the affected groin area
* uncontrolled insulin-dependent diabetic with Hgb1Ac greater than 8
* advanced cirrhosis with Child-Turcott Class of C or higher
* severe COPD requiring home oxygen
* diagnosed with chronic pain syndrome or is undergoing treatment for pain management
* candidate for another major surgical procedure with the inguinal hernia repair
* enrolled in another investigational study that may confound the results of this study
* known drug abuser
* on anti-psychotic medications
* Worker's Compensation case

Primary outcomes:
measure: Technical success with no complications through 6 weeks.
timeFrame: 6 weeks
Secondary outcomes:
measure: Hernia recurrence
timeFrame: 1 year
measure: Pain and functional status
timeFrame: 10 day, 6 weeks, 6 months 1 year
measure: Incidence of complications
timeFrame: 10 days, 6 weeks, 6 months, 1 year
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: Houston
country: United States
facility: Michael E. DeBakey Veterans Affairs Medical Center
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Samir S Awad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00343655: Evaluation of Atorvastatin Treatment on Carotid Plaque.
Official title: A Randomized Clinical Trial Of Atorvastatin 10 Mg And 80 Mg In The Reversal Of Or Stabilization Of Carotid Atheroma Lipid Pool
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cardiovascular Diseases
Keywords: Hypercholesterolemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-06-23
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effect of 18 months treatment with atorvastatin 80mg or atorvastatin 10mg on the carotid vessel plaque morphology, in particular, the effect on evident necrotic lipid rich core of the plaque in patients.


Eligibility criteria: Inclusion Criteria:

* Subjects with measurable carotid plaque with lipid and are eligible for statin therapy.

Exclusion Criteria:

* Subjects at higher risk for cardiovascular disease with a screen LDL-cholesterol greater than 120 mg/dL,
* Subjects currently on high dose statin, and
* Subjects with contraindications for MRI or statin therapy.

Primary outcomes:
measure: Change in lipid pool volume from baseline to 18 months in response to atorvastatin 80mg.
measure: Comparison of effect of atorvastatin 80mg versus 10mg
Secondary outcomes:
measure: Correlation of MRI measure of carotid morphology with cIMT measured by B-mode US.
measure: Correlation of MRI measure of carotid morphology with DS-CT measure of coronary morphology.
measure: Correlation of biomarkers to carotid changes.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05543655: Impact of Simulation-Based Training on the Safety of Medication Administration
Official title: Impact of Simulation-Based Training on the Safety of Medication Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Nurse Training
Simulation
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2022-09-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 10 training courses including 4 nurses each are scheduled, i.e. 40 inclusions. The nurses will benefit from two half-days of simulation training three-months apart, dealing with the safety of medication administration. The training will include a high-fidelity scenario whose events will be adapted to medication administration in conventional care services.
Primary purpose: OTHER

Brief summary: Task interruption is part of professional life. The healthcare world is not exempt from this phenomenon. Task interruptions lead to errors and increase the risks in managing patients.

Medication administration is the critical step, in that it is the final step to stop medication errors produced upstream. It therefore requires the full attention of any healthcare professional.

In the field of health, simulation has become an innovative educational tool allowing experiential learning and reflective practice.

The general aim of this study is to objectivize the value of simulation-based training as regards medication administration when task interruptions occur.


Eligibility criteria: Inclusion Criteria:

* Nurses from conventional medical and surgical departments participating in the training
* people agreeing to participate in the study

Exclusion Criteria:

* Person refusing the processing of their data

Primary outcomes:
measure: The effectiveness of simulation-based training on safe drug administration for nurses in conventional services in terms of the number of good steps achieved among the 10 proposed by the HAS
timeFrame: three month
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Simulation center All'Sims; University Hospital of Angers
Study officials:
References:
Clinical trial NCT00845455: Personality Type as a Predictor to Develop Depression and Reduction in Quality of Life Among Stroke Survivals.
Official title: Personality Type as a Predictor to Develop Depression and Reduction in Quality of Life Among Stroke Survivals.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Depression
Quality of Life
Personality Type
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2009-02-18
Enrollment: 85
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke ( TIA, CVA, ICH ) patients

Brief summary: Personality type as a predictor to develop depression and reduction in quality of life among stroke survivals.


Eligibility criteria: Inclusion Criteria:

* any stroke,
* age 40-90,
* able to sigh informed concent,
* able to fill in the questionnaires.

Exclusion Criteria:

* non stroke,
* previous depression,
* not able to give consent or answer the questions.

Primary outcomes:
measure: Depression
timeFrame: 1-3 month post stroke
Secondary outcomes:
measure: QOL post stroke
timeFrame: 1-3 month post stroke
Other outcomes:
Locations:
Study officials:
name: David - Yarnitsky, Prof.
role: PRINCIPAL_INVESTIGATOR
References: