louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04684498: Open-label Study of Neuraminidase Inhibitor Treatment in STEMI Patients
Official title: An Open-label Study to Evaluate the Efficacy of Neuraminidase Inhibitor Treatment in ST-Elevation Myocardial Infarction (STEMI) Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: ST Elevation Myocardial Infarction
STEMI
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Neuraminidase-1 can cause the removal of terminal sialic acid residues from the cell surface or serum sialyloconjugates. The level of Neu5Ac was positively related to the activity of neuraminidase-1. Elevation of Neu5Ac was observed in myocardial ischemia animal model, as well as patients with coronary artery disease. It is interesting to note that Neu5Ac and its regulatory enzyme neuraminidase-1 seem to play a key role in triggering myocardial ischemic injury. Oseltamivir, a structural mimic of sialic acid, was widely used as anti-influenza drug. It suppressed neuraminidase-1 activity in the heart. Targeting neuraminidase-1 may represent a new therapeutic intervention for coronary artery disease. This project seeks to identify whether neuraminidase inhibitor (Oseltamivir) treatment could decrease the myocardial infarct size in STEMI patients and improve clinical outcomes.


Eligibility criteria: Inclusion Criteria:

1. Between the ages of 18 and 75, regardless of gender;
2. STEMI should be diagnosed by two attending physicians or above, including history, clinical symptoms and signs;
3. Participate voluntarily and sign informed consent, and can be followed up for more than one month.

Exclusion Criteria:

1. Allergic to oseltamivir;
2. Creatinine clearance rate less than 60%;
3. Severe liver insufficiency;
4. Female patients who have or plan to become pregnant;
5. Life expectancy less than one year;
6. Patients refused to comply with the requirements of this study;
7. According to the discretion of investigator, the patient was unable to complete the study or comply with the requirements of the study (for administrative or other reasons).

Primary outcomes:
measure: Myocardial infarct size at 1 week
timeFrame: 1 week
Secondary outcomes:
measure: Myocardial infarct size
timeFrame: 1 week
measure: Myocardial infarct size based on culprit vessel with TIMI 0-1 blood flow
timeFrame: 1 week
measure: The proportion of viable myocardium and ratio of myocardial reperfusion
timeFrame: 1 week
measure: Composite end point at 1 week
timeFrame: 1 week
measure: Myocardial infarct size at 3 month
timeFrame: 3 month
measure: Composite end point at 6 month
timeFrame: 6 month
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Dao Wen Wang, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01951898: Effects of Montelukast on Airway Regulatory T Cells in Asthma
Official title: Effects of Montelukast on Airway Foxp3+ and CTLA4+CD25highCD4+ T Cells in Asthmatics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Asthma
Keywords: asthma
regulatory T cells
leukotriene antagonist
Lead sponsor: Kurume University
Sponsor class: OTHER
First posted: 2013-09-27
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Montelukast is one of anti-inflammatory agents and a good controller for the patients with asthma. The hypothesis of the study is that the Montelukast will have airway anti-inflammatory effects and up-regulated regulatory T cells functions in asthma.


Eligibility criteria: Inclusion Criteria:

* asthma
* mild status
* stable status
* nonsmoker
* Positive of airway hyperresponsiveness (Methacholine-PC20\<16mg/mL)

Exclusion Criteria:

* taken other asthmatic medications such as oral, injective, and inhaled steroids, leukotriene antagonists, oral, inhaled, and transdermal beta-agonists, theophylline, anti-histamine agents, anti-IgE antibodies and long acting muscarinic receptor antagonists.
* respiratory tract infections within 4wks
* moderate to severe other organ disorders
* active malignancies
* past histories of side effects of leukotriene antagonists
* psychological disorders
* pregnancy or nursing

Primary outcomes:
measure: Montelukast will up-regulate airway regulatory T cell in the patients with asthma
timeFrame: 4wks of treatment period
Secondary outcomes:
measure: Montelukast will improve airway inflammation, lung function and hyperresponsiveness in the patients with asthma
timeFrame: 4wks of treatment periods
Other outcomes:
Locations:
city: Kurume
country: Japan
facility: Kurume University School of Medicine
Study officials:
References:
Clinical trial NCT02688998: REaCT-vascular Access Her2 Negative Vascular Access Strategies for (Neo) Adjuvant Breast Cancer Treatment Without Trastuzumab
Official title: Simple, Prospective and Randomized Trial to Obtain Answers to Questions of Standard of Care: Vascular Access Strategies for (Neo) Adjuvant Breast Cancer Treatment Without Trastuzumab: A Study From the REthinking Clinical Trials Program (REaCT-vascular Access Her2 Negative).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Cancer
Keywords: HER2 negative
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 150
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In the REaCT-Vascular Access Her2 negative study, the investigator will use a novel method to allow comparisons of established standard of care vascular access strategies using the "integrated consent model" as part of a pragmatic clinical trial.

Determining the optimal vascular access strategy remains an important medical issue for patients, nurses, physicians and society. A novel method to allow comparison of established standards of care is needed as part of an increasing internationally mandated incentive to perform more pragmatic clinic trials.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed primary breast cancer
* Planned to start either FEC-D, AC-D, dose-dense AC-T, TAC, or TC chemotherapy, in the adjuvant or neoadjuvant setting.
* ≥19 years of age
* Able to provide verbal consent

Exclusion Criteria:

• Contraindication to central line placement.

Primary outcomes:
measure: Accrual rates
timeFrame: One year
measure: Patient compliance
timeFrame: One year
Secondary outcomes:
measure: Physician engagement
timeFrame: One year
measure: Rates of thrombotic events
timeFrame: One year
measure: Number of attempts at cannulation
timeFrame: One year
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
Study officials:
References:
citation: Robinson A, Stober C, Fergusson D, Kehoe A, Bedard D, MacDonald F, Brunet MC, Saunders D, Mazzarello S, Vandermeer L, Joy AA, Awan A, Basulaiman B, Mallick R, Hutton B, Clemons M; REaCT investigators. A multicentre, randomized pilot trial comparing vascular access strategies for early stage breast cancer patients receiving non-trastuzumab containing chemotherapy. Breast Cancer Res Treat. 2019 Nov;178(2):337-345. doi: 10.1007/s10549-019-05388-5. Epub 2019 Aug 7.
Clinical trial NCT05538598: Dry Needling and Muscle Stiffness
Official title: Effect of Intramuscular Dry Needling on Soft Tissue Stiffness and Pressure-pain Thresholds
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Muscle Tightness
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Repeated measures design with pre-post measures
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to investigate the effect of intramuscular dry needling (IMDN) on muscle stiffness and pain. Research has suggested that IMDN can reduce muscle stiffness in needled areas. As well, IMDN may reduce mechanical pain sensitivity experienced by individuals.

IMDN will be performed at several anatomical locations. Muscle stiffness will be measured with a handheld probe, which measures contact force and displacement of soft tissue. Pressure-pain thresholds (PPT) will be discovered at each region of interest. Stiffness and pressure-pain thresholds will be collected before and after IMDN. The data collected from this research is important to understand the mechanism of IMDN and its relationship to pain.


Eligibility criteria: Inclusion Criteria:

* over the age of 18
* pain-free in your lower back and lower legs

Exclusion Criteria:

* unable to communicate in English
* surgery of any kind in the lumbar spine or lower legs.
* participants with a skin condition that does not allow for hypoallergenic tape to be attached to their skin.
* have a BMI\>25
* unable to hold your breath for 20 seconds
* contraindications to dry needling, i.e. pregnancy; fever or infection that is in your bloodstream; unstable compromised immune system; unstable bleeding disorders; presence at the site of DN of infection, an open wound , a burn, cellulitis, or an undiagnosed lump; post- mastectomy/lymph node removal in the affected limb; post-major surgery (3-6 month time period); presence of metal or plastic implant; absent sensation in area of planned DN; post-bacterial endocarditis or heart valve conditions/replacement without medical clearance for DN from medical doctor.

Primary outcomes:
measure: Effective stiffness of soft tissue
timeFrame: Within 10 minutes of intervention
measure: Pressure-pain threshold
timeFrame: Within 10 minutes of intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of British Columbia
name: Michael Koehle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02149498: Mapping Functional Networks of Brain Activity (Brain Network Activation, BNA) Based on Analysis of Evoked Response Potential (ERP) Signals for Healthy Controls Evoked Response Potential (ERP) Signals for Healthy Controls and Patients With Parkinson Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Keywords: Parkinson
EEG
BNA
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-05-29
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 patients with idiopathic Parkinson's disease (PD) 50 Healthy controls (HC)

Brief summary: A cornerstone in PD research is the investigation of neurophysiological changes as potential biomarkers that could help in tracking disease progression and response to therapies. Electroencephalography (EEG) could provide a non-invasive and relatively cheap tool for identification of such biomarkers. In this study we will use high-density electroencephalograph (EEG) recording, in order to develop a platform of biomarkers that could be more sensitive and reliable to disease progression and response to therapeutic intervention than standard clinical measures.


Eligibility criteria: Inclusion Criteria:

1. Idiopathic PD patients (according to the UK PD Society brain bank clinical diagnostic criteria (bradykinesia plus at least one other cardinal feature of PD, no atypical features or secondary cause) and HC aged 40-80 years
2. PD patients Hoehn and Yahr stages I to IVStable PD therapy

Exclusion Criteria:

* In the investigator's opinion, any unstable or clinically significant condition that would impair the participants' ability to comply with study requirements.
* Patients or HC with significant psychiatric symptoms or history
* BDI score \<14
* MMSE \<25
* Treatment with neuroleptics.
* For PD patients: Hoehn and Yahr Stage 5
* PD Patients with severe dyskinesia or tremor
* PD Patients with atypical Parkinsonism or secondary Parkinsonism
* History or evidence of neurological problems: cerebrovascular disease, previous head injury or neurosurgical interventions.
* Currently with lice or open wounds on scalp.
* Significant sensory deficits, e.g., deafness or blindness
* Current drug abuse or alcoholism.
* Pregnancy or not using a reliable method of birth control.
* Participation in current clinical study or clinical study within 30 days prior to this study.

Primary outcomes:
measure: Functional networks of brain activity in Idiopathic PD patients and healthy individuals measured using analysis of EEG Event Related Potential
timeFrame: 2 WEEKS
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sheba Medical Center
name: Sharon Hassin, Dr.
role: STUDY_DIRECTOR
affiliation: Sheba Medical Center
name: Oren Cohen, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01777698: Body Composition Analysis in Patients Undergoing Chemoembolization
Official title: Body Composition Analysis by Bioelectrical Impedance Vector Analysis in Patients With Hepatocellular Carcinoma Undergoing Chemoembolization.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: body composition
hepatocellular carcinoma
chemoembolization
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2013-01-29
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients will be recruited from the Radiology Department of a tertiary care center.

Brief summary: Hepatocellular carcinoma represents 80-90% of primary hepatic malignant tumors. 80% of patients with hepatocellular carcinoma are associated with cirrhosis.

Chemoembolization is a process in which a chemotherapeutic agent is deposited directly into the hepatic tumor where the principal artery is embolized.

Bioelectrical impedance bases its evaluation in a model where the body is conformed by two different compartments: fat mass and fat free mass.

Bioelectrical impedance is complemented by vectorial analysis, which is independent to the state of hydration and is helpful to monitor any changes in corporal composition. It can be used as a control for the interpretation of the bioelectrical impedance.


Eligibility criteria: Inclusion Criteria:

* Patients with hepato-renal disease
* Patients with hepatocellular carcinoma that are put down to radiofrequency ablation
* Patients with depression or any psiquiatric disease.
* Patients that don't agree to participate in the project.

Exclusion Criteria:

* Patients with hepatocellular carcinoma that are put down to radiofrequency ablation
* Patients with depression or any psiquiatric disease.
* Patients that don't agree to participate in the project.

Primary outcomes:
measure: Changes in body composition
timeFrame: 1 hour before treatment, 2 weeks after treatment, and 1 month after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
Study officials:
affiliation: Instituto Nacional de Nutrición y Ciencias Médicas "Salvador Zubirán"
name: Aldo Torre, M.D, M.Sc.
role: STUDY_CHAIR
References:
Clinical trial NCT00213798: Detection of Plasma DNA in Non Small Cell and Small Cell Lung Cancer Patients
Official title: Detection of Plasma DNA by Allelotyping in Non Small Cell and Small Cell Lung Cancer Patients. Evolution During Treatment and Follow-up.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Small Cell Lung Carcinoma
Small Cell Lung Cancer
Keywords: Lung cancer
plasma DNA
allelotyping
follow-up
Prospective Study
Non-Small Cell Lung Cancer
Small Cell Lung Cancer
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The majority of lung cancer patients have a tumor-derived genetic alteration in circulating plasma DNA that could be exploited as a diagnostic tool. The aim of this study is to evaluate if plasma DNA can be used as a valuable non invasive test to monitor disease progression without assessing the tumor.


Eligibility criteria: Inclusion Criteria:

* Presence of lung tumor to use fiberoscopy or surgical intervention for diagnosis.
* No lung instability.
* Individuals give all informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Pneumologie, Hôpital Lyautey
city: Strasbourg
country: France
facility: Service de Chirurgie Thoracique, Hôpital Civil
city: Strasbourg
country: France
facility: Service de Pneumologie, Hôpital Civil
city: Strasbourg
country: France
facility: Service de Pneumologie, Hôpital de Hautepierre
Study officials:
affiliation: Service de Pneumologie, Hôpital de Hautepierre
name: Michèle BEAU-FALLER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02321098: Antifungal Activity of Loceryl Nail Lacquer in Combination With a Cosmetic Varnish
Official title: Determination of Antifungal Activity of Loceryl Nail Lacquer 5% When Used Concomitantly With a Cosmetic Nail Varnish Compared to a Loceryl Nail Lacquer (NL) 5% Alone in Treatment of Toenail Distal Subungual Onychomycosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Foot Dermatoses
Keywords: Onychomycosis
antifungal
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2014-12-22
Enrollment: 50
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 main objective is to compare efficacy, in terms of antifungal activity of Loceryl Nail Lacquer associated with a Cosmetic Varnish and Loceryl Nail Lacquer alone, in the treatment of mild to moderate toenail Distal Subungual Onychomycosis.

The second objective of this study will be photographic follow-up of clinical improvement and cure after the initial treatment period of 12 weeks, for 15 additional months.

Detailed description: Study center:

A total of 50 subjects were to be included in 1 site in Iceland.

Methodology:

* Group Loceryl Nail Lacquer+ Cosmetic Varnish:

  * Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected toenails,
  * Cosmetic varnish to be applied once weekly for 12 weeks on all affected toenails and/or all toenails.
* Group Loceryl Nail Lacquer alone:

  - Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected toenails.
* All eligible subejct with no clinical sign of clinical aggravation of Onychomycosis at week 12, could continue to apply Loceryl Nail Lacquer alone, once a week for 15 additional months (or less in case of complete cure).

Eligibility criteria: Inclusion Criteria:

* Subjects with a mild to moderate Distal Subungual Onychomycosis (DSO) on at least 1 great toenail chosen as a Target nail
* Subjects must have maximum of 50% of nail distal edge involved
* Subjects with positive mycological results (direct microscopy and culture) of the Target nail for dermatophytes or Yeast (including Candida) at Screening

Exclusion Criteria:

* Subjects with clinically important abnormal physical findings at the Screening/Baseline visit
* Subjects with Lichen planus, eczema, psoriasis, or other abnormalities of the nail unit
* Subjects with known immunodeficiencies, radiation therapy, immune suppressive drugs

Primary outcomes:
measure: Measurement of Antifungal Activity of Loceryl Nail Lacquer
timeFrame: Week 12
Secondary outcomes:
measure: Absence of Dermatophytes in Nail Samples Culture
timeFrame: Week 12
Other outcomes:
Locations:
city: Reykjavik
country: Iceland
facility: Principal Investigator
Study officials:
References:
Clinical trial NCT02427698: Cyrolipolysis vs Cyrolipolysis and Subcision for Cellulite
Official title: Comparison of the Efficacy Between Cryolipolysis Versus Cryolipolysis Plus Subcision For Treatment of Cellulite: A Prospective Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cellulite
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Zeltiq Aesthetics
First posted: 2015-04-28
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized controlled study comparing the efficacy of cryolipolysis versus a combination of cryolipolysis and surgical subcision for the treatment of cellulite. The treatment sites are both outer thighs. One outer thigh will be randomized to receive one treatment of cryolipolysis, while the contralateral thigh will be assigned to receive the combination cryolipolysis plus surgical subcision. A live rating by a blinded dermatologist will evaluate the treatment and control areas using a cellulite severity scale at week 0 (before treatment) and at the 3-month follow up visit.


Eligibility criteria: Inclusion Criteria:

1. Healthy female subjects 18-65 years of age with at least a 5 on the CSS scale on both outer thighs.
2. All subjects must have the affected areas that show the mattress phenomenon spontaneously when standing or while both lying and standing (Stage 2 or 3 of Nurnberger-Muller grading scale of cellulite7).
3. Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.

Exclusion Criteria:

1. Subjects who are pregnant or lactating.
2. Subjects who are unable to understand the protocol or to give informed consent.
3. Subjects currently under treatment with an antiplatelet or anticoagulant for any medical problem or patients who have coagulation disorder.
4. Subjects who have a known history of cold-induced disease such as cryoglobulinemia, paroxysmal cold hemoglobulinuria, cold urticaria.
5. Subjects who have active skin disease or skin infection in the treatment area.
6. Subjects who are allergic to lidocaine or prilocaine.
7. Subjects who are allergic to both cephalexin (or penicillin) AND levofloxacin (or another quinolone antibiotic).
8. Subjects who have history of abnormal scarring.

Primary outcomes:
measure: Live rating by a blinded dermatologist using cellulite severity scale
timeFrame: Change from Baseline in cellulite severity scale at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References: