louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03134573: Medication Usage and Patient Reported Outcomes Evaluation Via myBETAapp in Patients With Multiple Sclerosis Treated With Betaferon: a Pilot Study
Official title: PROmyBETAapp: Ascertaining Medication Usage & Documentation of Patient Reported Outcomes Utilizing the myBETAapp® in Patients With Multiple Sclerosis Treated With Betaferon®: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Relapsing Remitting Multiple Sclerosis (RRMS),
Clinically isolated Syndrome (CIS),
Secondary Progressive Multiple Sclerosis (SPMS)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-05-01
Enrollment: 96
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: The study population will consist of patients with multiple sclerosis who are treated with Betaferon and who are using the myBETAapp.

Brief summary: The planned study will be a prospective, non-interventional, observational cohort study using the structure of a registry. Medication usage behavior will be observed for 6 months, while documentation behavior on the wellness tracker in the myBETAapp will be observed for 3 months.


Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 18 years.
* Patients on treatment with Betaferon (every Betaferon box contains a "Mixject" number, which is a product specific number unrelated to the study. Only patients prescribed Betaferon for their MS will be able to use the myBETAapp and participate in the study).
* Patients must be using the myBETAapp.
* Electronic informed consent must be obtained.

Exclusion Criteria:

-There are no exclusion criteria for participation in this study.

Primary outcomes:
measure: Compliance to therapy (%)
timeFrame: 6 months
measure: Persistence of therapy (yes, no)
timeFrame: 6 months
measure: Adherence to therapy (yes, no)
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of patients consenting to participate in this study among those using the myBETAapp
timeFrame: 3 months
measure: Proportion of patients volunteering to record wellness related data in each of the following categories on the "Wellness chart" on the myBETAapp
timeFrame: 3 months
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Many locations
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Limmroth V, Hechenbichler K, Muller C, Schurks M. Assessment of Medication Adherence Using a Medical App Among Patients With Multiple Sclerosis Treated With Interferon Beta-1b: Pilot Digital Observational Study (PROmyBETAapp). J Med Internet Res. 2019 Jul 29;21(7):e14373. doi: 10.2196/14373.
Clinical trial NCT01929473: Seroepidemiological Study of Pertussis and Other Infectious Diseases
Official title: Seroepidemiological Study of Pertussis and Other Infectious Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pertussis Infection
Keywords: Pertussis infection
Risk factors
Lead sponsor: Gifu Prefecture Medical Association
Sponsor class: OTHER
Collaborators: name: Sanofi Pasteur S.A.
First posted: 2013-08-28
Enrollment: 3830
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Students of junior high school, high school or college

Brief summary: Serum samples will be corrected twice from the same youth subjects with one year interval.

Seroincidence of pertussis will be estimated by the elevation of Ig-G-PT in paired sera from an identical individual.

The relationship between the incidence and the demographic data or medical history of the subjects will be discussed.


Eligibility criteria: Inclusion Criteria:

* Students of junior high school, high schools or college in Gifu prefecture
* Students who can have the second blood drawing one year later
* Students (and their parent when students are underage) whose written consent is obtainable.

Exclusion Criteria:

* None

Primary outcomes:
measure: IgG
timeFrame: 0 day, 365 day (2 points)
Secondary outcomes:
measure: Incidence of Pertussis
timeFrame: 0 day
measure: Antibodies of Varicella, Mumps and Rubella
timeFrame: 0 day
measure: Infection Risk Factors Including Family Numbers, Living Space, With or Without a Cough Patient in the Surroundings, Medical History and Hospitalization
timeFrame: 365 day
Other outcomes:
Locations:
city: Gifu
country: Japan
Study officials:
affiliation: Gifu Prefecture Medial Association
name: Naoki Kawai
role: STUDY_CHAIR
References:
Clinical trial NCT02571673: Feasibility Study of the Head and Neck Survivorship Tool: Assessment and Recommendations (HN-STAR)
Official title: Feasibility Study of the Head and Neck Survivorship Tool: Assessment and Recommendations (HN-STAR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Keywords: Survivorship
Quality of Life
HN-STAR web-based
15-245
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Columbia University
name: Hartford Hospital
First posted: 2015-10-08
Enrollment: 65
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: Clinics

Brief summary: This study is being done to understand how survivors of head and neck cancer think they can make HN-STAR (the Survivor Self-Assessment, the survivorship clinic experience, and the Survivorship Care Plan the best it can be. Once the investigators have your input and input from other survivors, they can make changes to HN-STAR, so that they can test this tool in a larger study. The larger study will tell them whether using HN-STAR improves the care of head and neck cancer survivors.


Eligibility criteria: Inclusion Criteria:

Aim 1: Part 1

* Have completed treatment for head and neck cancer at least 1 year prior to survivorship visit and have no evidence of disease
* Have a primary care provider
* Be able to provide informed consent
* Be able to speak and read English
* Be at least 18 years old

Aim 1: Part 2

* Have completed treatment for head and neck cancer at least 1 year prior to survivorship visit and have no evidence of disease
* Have a primary care provider
* Be able to provide informed consent
* Be able to speak and read English
* Be at least 18 years old

Exclusion Criteria:

Aim 1: Parts 1 and 2 is the same

* Patients or providers who cannot speak or read English
* Patients with cognitive, visual, or motor impairment such that they cannot complete the Survivor Self-Assessment as assessed by the research team.

Primary outcomes:
measure: Recommendations for Cancer Surveillance (Patient-reported Outcomes From the Survivor Self-Assessment)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Healthcare Cancer Institute @ Hartford Hospital
state: Connecticut
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Talya Salz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salz T, McCabe MS, Oeffinger KC, Corcoran S, Vickers AJ, Salner AL, Dornelas E, Schnall R, Raghunathan NJ, Fortier E, Baxi SS. A head and neck cancer intervention for use in survivorship clinics: a protocol for a feasibility study. Pilot Feasibility Stud. 2016 May 5;2:23. doi: 10.1186/s40814-016-0061-3. eCollection 2016.
Clinical trial NCT04478773: Adverse Events of MRI With Abandoned Leads
Official title: Evaluating MRI Scanning in Patients With Fractured or Abandoned Endocardial Leads
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pacemaker Electrode Lead Fracture
ICD
Keywords: abandoned lead
fractured lead
Lead sponsor: Lancaster General Hospital
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this study is to determine the safety and efficacy of MRI scanning in patients with fractured or abandoned endocardial leads. Specifically, the investigators aim to provide community-acquired data that can be used in Medicare and Medicaid coverage determinations and to investigate whether patients with fractured or abandoned leads can safely be scanned using an MRI and to evaluate the impact of MRI availability on patient care in this population. This study also aims to validate similar studies conducted by Mayo Clinic, the Hospital of the University of Pennsylvania and Johns Hopkins Medicine that employ MRI in the abandoned lead patient population.


Eligibility criteria: Inclusion criteria:

* Patients implanted with or without an ICD or pacemaker and with a fractured or an abandoned or non-functional endocardial lead, and who have a clinical need for MR imaging
* Patients are English or Spanish speaking and able to review and sign the consent

Exclusion criteria:

* Patients who complete the MRI standard screening form and are deemed inappropriate for MRI for any reason other than abandoned or fractured endocardial, or epicardial lead.
* Patients less than 18 years of age

Primary outcomes:
measure: Incidence of Adverse Events related to Magnetic Resonance Imaging (MRI) in patients with abandoned or fractured pacemaker or implantable cardioverter defibrillator (ICD) leads
timeFrame: 2 hours
Secondary outcomes:
measure: Understand longitudinal utilization and safety of subsequent MRIs
timeFrame: 7 years
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Lancaster General Health
state: Pennsylvania
Study officials:
affiliation: The Heart Group
name: Sandeep Bansal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00881231: To Demonstrate the Relative Bioavailability of Cilostazol 50 mg Tablets Under Fasting Conditions
Official title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Eon and Otsuka (Pletal) 50 mg Cilostazol Tablets In Healthy Adults Volunteers Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-04-15
Enrollment: 26
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability of Cilostazol 50 mg tablets under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: MDS Pharma Services
name: Gaetano Morelli, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01510431: Safety and Treatment Outcome Study of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease
Official title: An Open-label Compassionate Treatment Protocol to Evaluate the Safety and Treatment Outcomes of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Crohn's Disease
Lead sponsor: Mesoblast, Ltd.
Sponsor class: INDUSTRY
First posted: 2012-01-16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Protocol 620 provides PROCHYMAL(R) adult human mesenchymal cells to specifically chosen Crohn's disease patients at participating centers who typically have already demonstrated good response in another PROCHYMAL study, are not eligible for other PROCHYMAL studies, and in the view of the investigator, would not benefit significantly from other Crohn's therapies but would benefit from use of PROCHYMAL.

The study is not placebo-controlled or randomized.


Eligibility criteria: Inclusion Criteria:

* currently active moderate-to-severe Crohn's disease
* exhausted standard-of-care options
* age 18 to 70 inclusive
* body weight between 30 and 150 kg
* adequate renal function
* not at risk for tuberculosis (TB) activation or re-activation

Exclusion Criteria:

* biologic therapy for Crohn's within last 8 weeks
* confirmed adverse reactions during prior PROCHYMAL study participation
* alcohol or substance abuse, current or within past 6 months
* active HIV or hepatitis B or C infection
* surgery or trauma with 6 weeks
* allergy to bovine or porcine products
* elevated serum liver enzymes
* elevated serum bilirubin
* active malignancy within 5 years (other than some resected skin cancers)
* bacteremia or other serious bacterial or fungal infection within 3 months
* colonic dysplasia
* unstable arrhythmia or serious heart condition

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Unviersity of California, San Francisco
state: California
city: Topeka
country: United States
facility: Stormont-Vail
state: Kansas
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Mesoblast, Inc.
name: Mahboob Rahman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01812031: Benefits Study of Respiratory-gated PET Acquisition in Lung Disease
Official title: Benefits Study of a Respiratory Gating Protocol for Positron Emission Tomography: Application on the Lungs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Non Small Cell Lung Cancer
Chronic Obstructive Pulmonary Disease
Keywords: PET/CT
18F-fluoro-2-deoxyglucose
lung neoplasms
respiratory motion
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2013-03-15
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Fluorodeoxyglucose (FDG) positron emission tomography (PET) is now widely used for cancer imaging purpose, notably for preoperative work-up. It aims at visualizing organs metabolism. In case of cancer, metabolism is, classically, increased and some hot spots are visible on PET images. Because of respiratory motion some lung tumours (especially the smallest ones) can be falsely interpreted by the clinician.

The investigators developed a respiratory-gated PET method in order to reduce the motion issue. The investigators designed a study to investigate its effect on lung cancer (primary or metastasis) to check if it improves the sensitivity/specificity of PET imaging of the lungs.

To that aim, patients presenting a lung nodule on a CT examination can be proposed to participate this study. After the standard PET acquisition (acquired in free-breathing), an additional 10 minutes respiratory-gated PET acquisition is performed without additional injection. After that, a breath-hold (\~10s) CT is performed.


Eligibility criteria: Inclusion Criteria:

* patient has one or more lung lesion(s) less than 35 mm visible on a CT image
* age : over 18 years
* patients gave their written informed consent

Exclusion Criteria:

* pregnancy
* patient has at least one lesion more than 35 mm in its great axis

Primary outcomes:
measure: Lesion SUVmax
timeFrame: Day 1
Secondary outcomes:
measure: Lung function test
timeFrame: Day 0
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
state: Picardie
Study officials:
affiliation: CHU Amiens
name: Marc-Etienne MEYER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Daouk J, Leloire M, Fin L, Bailly P, Morvan J, El Esper I, Saidi L, Moullart V, Francois G, Jounieaux V, Meyer ME. Respiratory-gated 18F-FDG PET imaging in lung cancer: effects on sensitivity and specificity. Acta Radiol. 2011 Jul 1;52(6):651-7. doi: 10.1258/ar.2011.110018. Epub 2011 Apr 21.
citation: Daouk J, Bailly P, Kamimura M, Sacksick D, Jounieaux V, Meyer ME. Positron emission tomography-based evidence of low-amplitude respiratory motion in patients with chronic obstructive pulmonary disease. Ann Nucl Med. 2015 May;29(4):319-24. doi: 10.1007/s12149-014-0945-3. Epub 2015 Jan 8.
Clinical trial NCT02866331: G-CSF and Autologous Cord Blood Infusion in Cerebral Palsy
Official title: Phase II, Randomized, Double-blind Clinical Trial for Efficacy of G-CSF and Autologous Cord Blood Infusion in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cerebral Palsy
Lead sponsor: Hanyang University Seoul Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health & Welfare, Korea
First posted: 2016-08-15
Enrollment: 88
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is performed to reveal the safety and feasibility of combination therapy with autologous cord blood mononuclear cells (CB) and G-CSF as well as repeated administration of G-CSF for children with cerebral palsy. The evaluation tools are as follows: (1) Developmental tests (DDST, PEDI, GMFM, GMFCS, MACS, QUEST), (2) Neurocognitive function test (WPPSI-IV), (3) Brain MRI-DTI, (4) Peripheral blood CD34+ cell counts, (5) Neurotrophic factors/anti-inflammatory cytokines.


Eligibility criteria: Inclusion Criteria:

* Ages from 2 years to 10 years at the time of enrollment
* Non-severe type of cerebral palsy
* Willing to comply with all study procedures

Exclusion Criteria:

* Previous participation within 1 year in a clinical study with stem cell therapy including cord blood, G-CSF, and erythropoietin
* Presence of chromosomal abnormalities
* Unwillingness to participate clinical trial
* Presence of hypersensitivity reaction to G-CSF
* Evidence of hepatic, renal, cardiac dysfunctions

Primary outcomes:
measure: Confirm the safety of autologous cord blood infusion and repeated injection of G-CSF in children with cerebral palsy by repeated follow-up every 3 months over 18 months with clinical and laboratory evaluations
timeFrame: For 18 months from date of randomization
Secondary outcomes:
measure: Confirm the efficacy of autologous cord blood infusion and/or G-CSF in children with cerebral palsy using standardized Gross Motor Function Measure evaluation.
timeFrame: Every 6 months from date of randomization up to 18 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
Study officials:
References:
Clinical trial NCT00163631: Relationship of Vasoactive Peptide Levels to Portal Pressure and Patient Outcomes in Patients With Hepatic Cirrhosis
Official title: Relationship of Vasoactive Peptide Levels to Portal Pressure and Patient Outcomes in Patients With Hepatic Cirrhosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Portal Hypertension
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
First posted: 2005-09-14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Investigate vasoactive medicators in portal hypertension on stored sera


Eligibility criteria: Inclusion Criteria:

* portal hypertension

Exclusion Criteria:

* Nil

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
Study officials:
affiliation: The Alfred
name: William W Kemp, MBBS FRACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004731: Parkinson's Disease Treatment With Coenzyme Q10
Official title: Effects of Coenzyme Q10 in Early Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
coenzyme Q10
Lead sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Sponsor class: NIH
First posted: 2000-02-28
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects of varying dosage of coenzyme Q10 (CoQ10) versus a placebo in the treatment of Parkinson's disease (PD) in patients with early, untreated PD.

Detailed description: Four groups of 20 subjects/group of subjects will be randomly assigned to receive CoQ10 (at doses of 300, 600 or 1200 mg/day) or matching placebo. A subject must have early PD that does not require treatment. A subject will be evaluated at a Screening Visit, a Baseline Visit (after which the subject begins to take the study drug) and visits at 1, 4, 8, 12, and 16 months after the baseline visit. The subject will be followed until she/he needs treatment with levodopa or for a maximum of 16 months. Because CoQ10 is a component of the mitochondria (the part of a cell that makes energy), blood samples will be taken at the baseline visit and the last visit to study mitochondrial function.

Eligibility criteria: Inclusion Criteria:

* The subjects must have the three cardinal features of PD: slowness of movement, resting tremor and rigidity. The signs of PD must be greater on one side.

Exclusion Criteria:

* Disorders that mimic PD.
* Other serious medical problems.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of California, San Diego
name: Clifford W. Shults, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04386031: Fungal Infection After Oral Cavity Surgeries
Official title: Fungal Infection After Oral Cavity Surgeries
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prevalence of Fungal Infection in Patients Undergoing Oral Cavity Surgery Without Treatment With Antifungal Drug
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients \> 18 years old, undergoing oral cavity surgery at ENT department and maxillofacial surgery department, Rambam medical center between May 2019-May 2021

Brief summary: this prospective study we will examine the prevalence of fungal infection in patients undergoing oral cavity surgery without treatment with antifungal drug


Eligibility criteria: Inclusion Criteria:

* Age over 18

Exclusion Criteria:

* Previous oral cavity surgery.

  * Previous radiotherapy to the head and neck.
  * Previous treatment with antifungal drugs in the 30 days preceding the surgery Immunocompomised state at the date of surgery.
  * Pregnancy
  * Lack of follow-up

Primary outcomes:
measure: prevalence of fungal infection in patients undergoing oral cavity surgery without treatment with antifungal drug.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: