louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06147713: Vibrotactile Foot Device for Freezing of Gait in Parkinson's Disease
Official title: Vibrotactile Foot Device for Freezing of Gait in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Freezing of Gait
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Freezing of gait (FOG) is a common, disabling symptom of later stage Parkinson's disease (PD), and can induce significant morbidity and mortality by increasing risk of falls as the disease progresses. Despite optimum medical management and deep brain stimulation therapy, many patients with PD are incapacitated by FOG and gait disorders. Non-invasive vibrotactile stimulation has been reported to potentially improve FOG of patients with PD. However, results of studies were variable, and there is a lack of convenient vibrotactile devices ready for daily use with reliable clinical trial data. In the proposed study, the investigator will test the effect of a newly developed vibrotactile foot device (Smart shoe) on participants diagnosed with PD and FOG. EEG and fMRI are obtained in order to investigate the underlying neurological mechanism.


Eligibility criteria: Inclusion Criteria:

* Age 30-80 years
* Diagnosed with Parkinson's Disease according to MDS Clinical Diagnostic Criteria
* Stable drug therapy without any change in the past one month
* Subjective presence of FOG more than once per day
* Objective presence of FOG by provoking tasks, e.g., gait initiation, rapid full turn, et al.
* Able to walk unaided at least 20 meters
* Provide written informed consent

Exclusion Criteria:

* Stroke and other diseases interfering ambulation
* Severe foot sensory impairments disabling the individual to perceive vibratory stimulation
* History of deep brain stimulation surgery

Primary outcomes:
measure: New Freezing of Gait Questionnaire (NFOGQ)
timeFrame: 2 weeks
measure: Freezing severity
timeFrame: 2 weeks
Secondary outcomes:
measure: Quantitative Gait parameters
timeFrame: 2 weeks
measure: MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III
timeFrame: 2 weeks
measure: Berg Balance Scale
timeFrame: 2 weeks
measure: Number of falls and near falls
timeFrame: 2 weeks
measure: 39-item Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: 2 weeks
measure: Clinical Global Impressions Scale (CGI-I)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital
Study officials:
References:
Clinical trial NCT00408213: A Continuation Study to Assess the Effect of CellCept in Patients With Myasthenia Gravis.
Official title: A Randomized, Double-Blind Study to Evaluate the Safety of Continued Treatment With CellCept in Patients With Well-Controlled Myasthenia Gravis Receiving a Stable Dose of Prednisone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myasthenia Gravis Generalised
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Aspreva Pharmaceuticals
First posted: 2006-12-06
Enrollment: 136
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: This 2 arm study will provide optional continuation of double-blind treatment with CellCept or placebo, in patients with myasthenia gravis who have achieved good symptom control in study WX17798. Patients who have completed 36 weeks of treatment in study WX17798, with stable prednisone dosing for the last 4 weeks, can continue on blinded treatment with CellCept (1g bid) or placebo until the database for WX17798 is locked and unblinded. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* subjects who have completed 36 weeks of treatment in study WX17798, and who have demonstrated good symptom control with a stable prednisone dose for the final 4 weeks of that study.

Exclusion Criteria:

* regularly scheduled plasma exchange or intravenous immunoglobulin treatment;
* medical condition, adverse event or intolerance of double-blind treatment which would preclude continuation.

Primary outcomes:
measure: AEs, laboratory parameters, vital signs.
timeFrame: Throughout study
Secondary outcomes:
Other outcomes:
Locations:
city: Sun City
country: United States
state: Arizona
city: Sacramento
country: United States
state: California
city: Upland
country: United States
state: Pennsylvania
city: Belgrade
country: Former Serbia and Montenegro
city: Bordeaux
country: France
city: Nice
country: France
city: München
country: Germany
city: Regensburg
country: Germany
city: Milano
country: Italy
city: Roma
country: Italy
city: Kharkov
country: Ukraine
city: Kiev
country: Ukraine
city: Zaporozhye
country: Ukraine
city: Liverpool
country: United Kingdom
city: Oxford
country: United Kingdom
city: Salford
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01764113: Effect of Mindful Eating on Body Mass Index in Obese Adolescents
Official title: Effect of Mindful Eating on Body Mass Index and Cardiovascular Risk Markers in Obese Adolescents: A Pilot Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Adolescent Obesity
Keywords: Obesity
Adolescence
Mindful Eating
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-01-09
Enrollment: 21
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to study the effect of a family based mindfulness training program with special focus on diet and nutrition on weight and cardiovascular risk markers in obese adolescents.

Detailed description: 40 obese adolescents would be randomized into either a mindfulness based behavioral modification program or standard dietary counseling. At least one parent would be expected to attend the counseling sessions. Patients would be followed for a period of 6 months. Anthropometric parameters, questionaiires relating to quality of life and blood tests would be drawn at baseline and and at 6 months.

Eligibility criteria: Inclusion Criteria

* BMI at or greater than the 95th percentile for age and gender

Exclusion Criteria

Primary outcomes:
measure: Body Mass Index
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Quality of Life
timeFrame: Baseline and 6 months
Other outcomes:
measure: Fasting glucose
timeFrame: 6 months
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Seema Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05361213: Is There Any Correlation Among Neonates Anthropometry and Neuromotor Behaviour
Official title: Association Among Anthropometric Parameters and Neuromotor Behaviour in Neonates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy, Autism or Other Neuromotor Behavior Abnormalities Correlation With Anthropometry
Keywords: Correlation; infants; muscles; weight; length
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 54
Sex: ALL
Minimum age (years): 28
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both term and preterm neonates from level III B NICU

Brief summary: To explore the association among anthropometric parameters and neuromotor behaviour in neonates for early identification and prediction of later neuromotor deficit.

Detailed description: The association between anthropometric (birth weight, length and occipitofrontal circumference) measurement and hands-on measurement of above mentioned anthropometric dimensions and demographic dimension (bilateral forearm, midarm, calf and thigh) with neuromotor behaviour were explored.

Eligibility criteria: Inclusion Criteria:

* Neonates born between ≥28 weeks and ≤ 42 weeks of gestation
* Birth weight between 1500 and 3000 grams
* Neonates are born under all the classifications of Fenton growth charts (SGA, AGA and LGA)
* Stable Hemodynamics
* Free from infection
* Stable vitals

Exclusion Criteria:

* Dermal conditions
* Chromosomal abnormalities
* History of surgery
* Neural tube defect
* Cardiac abnormally

Primary outcomes:
measure: Neuromotor behaviour
timeFrame: at the baseline, single time on day first of assessment
measure: Demographic dimension
timeFrame: at the baseline demographic dimension measured, single time on day first
measure: Demographic dimensions
timeFrame: at the baseline demographic dimension measured, single time on day first
measure: Anthropometric measurement
timeFrame: Anthropometry was documented single time on same day
Secondary outcomes:
Other outcomes:
Locations:
city: Ambala
country: India
facility: Jaishree
state: Haryana
Study officials:
affiliation: Maharshi Markandeshwar institute of physiotherapy and rehabilitation, mullana, ambala, india
name: Asir John Samuel, PhD
role: STUDY_DIRECTOR
affiliation: Maharshi Markandeshwar institute of physiotherapy and rehabilitation, mullana, ambala, india
name: Sunanda Bhowmik, MPT
role: STUDY_CHAIR
affiliation: Maharshi Markandeshwar institute of physiotherapy and rehabilitation, mullana, ambala, india
name: Jaishree Rai, (MPT)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06620913: Clinico-immunological Characterization and Immune Tolerance Breakdown in CV2-autoimmunity
Official title: Clinico-immunological Characterization and Immune Tolerance Breakdown in CV2-autoimmunity
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: CV2 Autoimmunity
Keywords: Paraneoplastic neurological disorders, lung cancer, CV2 autoimmunity, immune tolerance breakdown
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients harboring CV2 Abs in serum and/or CSF with or without cancer.

Brief summary: Paraneoplastic neurological syndromes are rare syndromes caused by the remote effects of cancer. They have an immune-mediated pathogenesis, yet the underlying mechanisms are not fully elucidated. CV2/Collapsin response-mediator protein 5 (CRMP5)-IgG paraneoplastic neurological syndrome is characterized by heterogeneous clinical presentations, affecting both central and peripheral nervous system, and the most frequently associate tumor is small cell lung carcinoma. Central nervous system involvement along with CSF and neuroimaging findings have not been fully described in the literature in CV2/CRMP5 patients. Unraveling the complexities of CV2/CRMP5 paraneoplastic neurological syndrome is critical to improve diagnosis, treatment, and patients' care. Our intention is to perform a comprehensive analysis of the clinical characteristics and instrumental investigations of a large cohort of CV2/CRMP5 patients.


Eligibility criteria: Inclusion Criteria:

* Patient with paraneoplastic neurological syndromes
* Patient with CV2 antibody in sera and/or CSF

Exclusion Criteria:

* Patient with no data
* Patient without neurological disorder
* Patient without CV2 antibody in sera/CSF

Primary outcomes:
measure: Modified Rankin Scale (mRs)
timeFrame: At baseline, 3, 6, 12, 18 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Neurologique Pierre Wertheimer / Groupement Hospitalier Est
Study officials:
affiliation: Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes, Lyon, France.
name: Pr Jérôme Honnorat, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00990613: A Study Evaluating The Absorption Of Dimebon Into The Body From A Dimebon Solution Applied To The Skin
Official title: A Phase 1, Fixed Sequence, Cross-Over Study To Investigate The Single Dose Pharmacokinetics Of A Dimebon (Latrepirdine) Transdermal Solution Relative To The Immediate Release Formulation In Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Huntington's Disease
Keywords: percutaneous transcutaneous dimebon transdermal pharmacokinetics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Medivation, Inc.
First posted: 2009-10-07
Enrollment: 19
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To estimate the absorption, safety, and tolerability of a dimebon transdermal solution relative to the dimebon immediate release oral formulation.


Eligibility criteria: Inclusion Criteria:

* Caucasian, male or females, 50 to 85 years inclusive.
* Subjects must have adequate space available on each side of the upper or middle back that is free from excessive hair, broken or irritated skin, tattoos, scars, moles, acne, and sunburn.

Exclusion Criteria:

* Evidence or history of any major medical or psychiatric illness or unstable medical condition within six months of Screening that may increase the risk associated with study participation.
* Subjects with any central nervous system disease including Alzheimer's disease, Parkinson's disease, Huntington disease, or any form of dementia.
* Subjects with any history of stroke, known cerebrovascular disease or subjects with any history of structural brain disease.
* Any history of epilepsy, seizure disorder (i.e., including febrile seizures) or convulsion.
* Subjects with any skin disorders that might prevent application of the dimebon solution including, but not limited to, any known sensitivity to adhesives.

Primary outcomes:
measure: Pharmacokinetic endpoints include dimebon area under the curve from 0 to the last quantifiable concentration (AUClast) and dimebon area under the curve from 0 to infinity (AUCinf) as permitted by data
timeFrame: 4 to 6 days
Secondary outcomes:
measure: Safety endpoints include subjective symptoms/objective findings (including skin irritation), clinical safety laboratory assessments, 12 lead ECGs, and supine vital signs.
timeFrame: 4 to 6 days
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Chew ML, Mordenti J, Yeoh T, Ranade G, Qiu R, Fang J, Liang Y, Corrigan B. Minimization of CYP2D6 Polymorphic Differences and Improved Bioavailability via Transdermal Administration: Latrepirdine Example. Pharm Res. 2016 Aug;33(8):1873-80. doi: 10.1007/s11095-016-1922-4. Epub 2016 Apr 12.
Clinical trial NCT04322513: Biomarkers for Identification of COVID-19 Infection
Official title: Biomarkers Identification for Diagnosis and Treatment of SARS-COV-2 Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus
Lead sponsor: University of Catanzaro
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera Pugliese Ciaccio
name: Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
First posted: 2020-03-26
Enrollment: 110
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of both sexes and \> 18 years with and without covid-19 infection that came in hospital for flu-like syptoms: cough fever and dyspnea

Brief summary: Acute lung injury represents the most severe form of the viral infection sustained by coronavirus disease 2019 (Covid-19) also named as SARS-CoV-2, a new virus emerged in December 2019 in Wuhan (China). The diagnosis is clinical and patients develop flu-like syndrome with fever and cough; patients with clinical symptoms can perform a swab test, including molecular and/or antigen swab, for diagnosis of positivity to Covid-19. Even if diagnosis and treatment are well described, to date, this viral pandemic infection induces an increased mortality in the world. The aim of the present project is to evaluate specific biomarkers that could be used for patient stratification and for tailor therapy in COVID-19 infected patients.


Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 75 years, extremes included, male or female In conscious patients, ability to understand and the willingness to sign a written informed consent document; in unconscious patients informed consent will be signed from parents or legal tutors.

Exclusion Criteria:

* Patients that don't sign the informed consent

Primary outcomes:
measure: Biomarkers expression
timeFrame: up to 30 days
measure: Liver Biomarkers expression
timeFrame: up to 30 days
Secondary outcomes:
measure: biomarkers expression (microRNAs, oxidative stress, Neuron-Specific Enolase, IL-2, IL-6, TNF-alfa, leukocytes, subtypes lymphocytes) after treatment
timeFrame: 60 days
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Luca Gallelli
Study officials:
References:
Clinical trial NCT02532413: Antiviral Efficacy of the Combination Treatment With Poly IC and Entecavir for Chronic Hepatitis B
Official title: Comparison of Antiviral Efficacy of Entecavir Monotherapy and Combination Treatment With Poly IC for Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Hepatitis B
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2015-08-25
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate antiviral efficacy of the combination treatment with Poly IC and Entecavir and compare with the efficacy of Entecavir mono-therapy for chronic hepatitis B.

Detailed description: In this study, the patients with chronic HBV infection will be divided into two groups: HBeAg (+) and HBeAg (-) group. Each group will be divided into two subgroups, which are treated with combination treatment of Entecavir and Poly IC and Entecavir monotherapy respectively. All the patients will be followed up for one year. From this study, the investigators want to study if Poly IC can enhance antiviral efficacy of Entecavir for chronic hepatitis B.

Eligibility criteria: Inclusion Criteria:

* HBsAg positive for more than 6 months.
* Having been treated wit Entecavir and the level of HBV DNA is under 1000 copies/ml.
* ALT ≤10×ULN， TB \<2ULN .

Exclusion Criteria:

* Previous antiviral treatment for HBV.
* Co infection of HIV, HCV, HEV, HAV, or HAV.
* Evidence of hepatic carcinoma.
* Evidence of autoimmune disease.
* Evidence of thyroid disease.
* History of mental sickness.

Primary outcomes:
measure: Proportion of patients with HBsAg serological response
timeFrame: at week 48 of treatment
Secondary outcomes:
measure: Changes in serum HBV DNA levels
timeFrame: at week 4，12，24，36，48，72，96 of treatment
measure: Biochemical Response （the serum levels of ALT and AST） Biochemical Response
timeFrame: at week 1，2，4，8，12，16，20，24，36，48，72，96 of treatment
measure: Proportion of patients with HBeAg serological response
timeFrame: at week 48 of treatment
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Infectious Disease of Wu Han Union Hospital
state: Hubei
Study officials:
affiliation: Huanzhong University of Science and Technology
name: Liang D Yang, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05079113: Leveraging ctDNA Analysis to Improve Early Detection of Cancer Recurrence in the High-Risk Melanoma Setting
Official title: Leveraging ctDNA Analysis to Improve Early Detection of Cancer Recurrence in the High-Risk Adjuvant Melanoma Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stage III Melanoma
Stage IV Cutaneous Melanoma
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Retrospective biobanking samples collected at baseline, 3 months, 6 months and 18 months.

Brief summary: To generate meaningful data regarding ctDNA that would infer risk of recurrence in stage III melanoma patients.

Detailed description: Cancer cells harbor and can acquire potentially hundreds of mutations, many of whom are found in the ctDNA. Circulating tumor DNA (ctDNA) holds the promise for the 50% of participants who do not need adjuvant therapies - participants could be monitored to ensure no increase in ctDNA. Participants treated could then be followed for the earliest possible blood level signs of recurrence (incr. ctDNA) and more quickly be switched to more effective therapies. Further, the treating physician could hold therapy until the first signs of ctDNA based recurrence for those participants that would benefit.

Blood sample from a biobank will be used to identify to monitor ctDNA. These blood samples were drawn at baseline, 3 months, 6 months and 18 months.

Eligibility criteria: Inclusion Criteria:

* Age ≥18
* Confirmed fully resected Stage IIIb-IV cutaneous melanoma; including patients treated neoadjuvantly within three months prior to resection.

Exclusion Criteria:

• Treatment plan inconsistent with the standard of care systemic adjuvant therapies 4.0 Study Design

Primary outcomes:
measure: Identify a pattern for gene recognition of cancer recurrence earlier than standard of care.
timeFrame: samples taken at baseline, 3 months, 6 months and 18 months.
Secondary outcomes:
measure: Analyze the genetic pathway associated with cancer recurrence and biologic information.
timeFrame: samples taken at baseline, 3 months, 6 months and 18 months.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer center
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: James Isaacs, MD
role: PRINCIPAL_INVESTIGATOR
References: