louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05783947: Diagnostic Performance of a Commercial Assay for the Detection of Neuronal Antibodies
Official title: Diagnostic Performance of a Commercial Indirect Immunofluorescence Assay for the Detection of Neuronal Antibodies in Auto-immune Encephalitis and Paraneoplastic Neurological Syndromes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paraneoplastic Neurological Syndrome
Autoimmune Encephalitis
Keywords: autoantibodies
diagnostic
paraneoplastic
encephalitis
neuronal
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a suspicion of autoimmune encephalitis or paraneoplastic neurological syndrome

Brief summary: Detection of autoantibodies targeting neuronal surface or intracellular antigens is a keystone for the diagnosis and the treatment of auto-immune encephalitis and paraneoplastic neurological syndromes. A strategy commonly used for their detection is to perform a screening with a tissue-based immunofluorescence assay or immunohistochemistry assay and a second line test to confirm and identify the autoantibody. Since several years, commercial kits are used by a growing number of laboratories to screen the presence of these autoantibodies. However, the diagnostic performance of these commercial kits is highly variable and several studies reported a high prevalence of false-positive and false-negative results with commercial immunodots and cell-based assays. It is therefore essential to explore commercial kits limitations in order to avoid false-positive and false-negative results that could lead to misdiagnosis and/or to delay the treatments.

To assess the diagnostic performance of commercial kits, the investigators performed a prospective study in which the investigators screened patients neuronal autoantibodies in cerebrospinal fluid and sera using commercial tissue-based indirect immunofluorescence assay and CBAs in comparison with an in-house tissue-based indirect immunofluorescence assay.


Eligibility criteria: * Inclusion Criteria \* : Sera and/or CSF with sufficient volume to perform both in-house and commercial assays
* Exclusion Criteria \* : Sera and/or CSF with insufficient volume to perform both in-house and commercial assays

Primary outcomes:
measure: Number of discrepant results between commercial and in-house assays
timeFrame: at the baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospice Civils de Lyon
city: Pierre-Bénite
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Jérome HONNORAT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00559247: A Single Ascending Dose Study of BMS-650032 in HCV Infected Subjects
Official title: Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BMS-650032 in Subjects Chronically Infected With Hepatitis C Virus Genotype 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2007-11-16
Enrollment: 24
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 primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-650032 in subjects with chronic hepatitis C infection


Eligibility criteria: Inclusion Criteria:

* Chronically infected with HCV genotype 1
* Treatment naive or treatment non-responders or treatment intolerant
* HCV RNA viral load of ≥10\*5 IU/mL
* BMI 18 to 35kg/m²

Exclusion Criteria:

* Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection
* Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
* Co-infection with HIV or HBV
* Women of childbearing potential

Primary outcomes:
measure: Safety Outcome Measures
timeFrame: Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose
Secondary outcomes:
measure: Pharmacokinetic Measures
timeFrame: Pharmacokinetic assessments will be done for a period of 72 hours following administration of a single oral dose
measure: Pharmacodynamic Measures
timeFrame: Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels for a period of 7 days after dosing
Other outcomes:
Locations:
city: Cypress
country: United States
facility: West Coast Clinical Trials, Llc
state: California
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Baltimore
country: United States
facility: Parexel International Corporation
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00576277: Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AV411 in Neuropathic Pain
Official title: A Prospective, Double-Blind, Randomized, Placebo-Controlled Trial of AV411 to Assess Its Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy in the Treatment of Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetic Neuropathy
Lead sponsor: Avigen
Sponsor class: INDUSTRY
First posted: 2007-12-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 determine the safety, tolerability and pharmacokinetics of AV411 after single and multiple doses in patients with chronic neuropathic pain due to diabetes.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of diabetic neuropathy or complex regional pain syndrome of at least 6 months duration
* VAS score of 4 cm or higher at Screening
* No clinical abnormality in laboratory and urine analyses
* Electrocardiogram within normal limits at Screening
* Negative pregnancy test on Study Day 1 for female subjects of childbearing potential
* On stable doses of medications, analgesic or others for at least 8 weeks prior to study enrollment
* Willing to use barrier contraceptive during the period of the study

Exclusion Criteria:

* Known hypersensitivity to AV411 or its components
* Conditions which might affect drug absorption, metabolism or excretion
* Untreated mental illness, current drug addiction or abuse or alcoholism
* Donated blood in the past 90 days or have poor peripheral venous access
* Platelets \<100,000mm3 or a history of thrombocytopenia
* Known or suspected chronic liver disease
* GFR \<=90mL/min/1.73m2 (Cockcroft-Gault)
* Female subjects who are pregnant or nursing mothers
* Received an investigational drug in the past 90 days
* Unable to swallow large capsules

Primary outcomes:
measure: Safety
measure: Tolerability
measure: Pharmacokinetic profile
measure: Pharmacodynamic profile
Secondary outcomes:
measure: Brief Pain Inventory
measure: Visual Analog Scale
measure: Clinical Global Impression of Change
measure: Use of analgesic or adjuvant medications for neuropathic pain
measure: Correlation between plasma concentrations of AV411 and pain intensity assessments
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: University of Adelaide
city: Kipparing
country: Australia
facility: Peninsular Specialist Centre
Study officials:
References:
Clinical trial NCT00912977: Prospective Evaluation of Forceplate Measured Levodopa-Induced Dyskinesia
Official title: Prospective Evaluation of Forceplate Measured Levodopa-Induced Dyskinesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Parkinsons disease
dyskinesia
measurement
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2009-06-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinsons disease patients with levodopa-induced dyskinesia

Brief summary: Nearly all Parkinson's disease (PD) patients eventually develop abnormal and unwanted movements (dyskinesias; LID) caused by the gold standard treatment, Levodopa. The severity of these movements can range from subtle to extremely debilitating and may or may not interfere with normal activities such as putting on a coat or brushing ones teeth. The purpose of this study is to demonstrate the validity and reliability of objectively measuring dyskinesia with a forceplate.

Detailed description: The main outcome measure of this study are measurements taken every half hour during an inpatient study visit. These measurements include standing on a forceplate for 1 minute while performing a mental task such as reciting the alphabet backwards. During this forceplate stance, a rater will visually score your movements. All participants must be eligible for another Parkinson's disease study at Oregon Health and Science University.

Eligibility criteria: Inclusion Criteria:

* Parkinsons disease
* Older than 18

Exclusion Criteria:

* Must be participating in a Parkinsons disease study at Oregon Health \& Science University

Primary outcomes:
measure: Forceplate Measure
timeFrame: Every 1/2 hour
Secondary outcomes:
measure: Visual Rating Scale
timeFrame: every 1/2 hour
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Kathryn Chung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Durif F, Debilly B, Galitzky M, Morand D, Viallet F, Borg M, Thobois S, Broussolle E, Rascol O. Clozapine improves dyskinesias in Parkinson disease: a double-blind, placebo-controlled study. Neurology. 2004 Feb 10;62(3):381-8. doi: 10.1212/01.wnl.0000110317.52453.6c.
citation: Hagell P, Widner H. Clinical rating of dyskinesias in Parkinson's disease: use and reliability of a new rating scale. Mov Disord. 1999 May;14(3):448-55. doi: 10.1002/1531-8257(199905)14:33.0.co;2-0.
citation: Durif F, Vidailhet M, Debilly B, Agid Y. Worsening of levodopa-induced dyskinesias by motor and mental tasks. Mov Disord. 1999 Mar;14(2):242-5. doi: 10.1002/1531-8257(199903)14:23.0.co;2-w.
Clinical trial NCT04240977: Feasibility of HOBSCOTCH Telehealth Intervention in Refractory Epilepsy
Official title: Feasibility and Single-arm Trial of HOBSCOTCH Telehealth Intervention in Refractory Epilepsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Refractory Epilepsy
Keywords: Refractory epilepsy, self-management
Quality of life
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: NYU Langone Health
First posted: 2020-01-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study utilizes a single-arm pre/post experimental design with an additional 3-month maintenance assessment.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to see whether a phone-intervention called HOBSCOTCH will improve health, daily functioning and quality of life among patients with refractory epilepsy. HOBSCOTCH stands for "Home-Based Self-Management and Cognitive Training Changes Lives." This study will also help to find the best ways of integrating this telehealth intervention to routine clinic use.

Detailed description: The proposed project will assess the efficacy of an 8-week phone-delivered, experimental treatment called "Home-Based Self-Management and Cognitive Training Changes Lives" (HOBSCOTCH) on sixty patients with refractory epilepsy (PWRE). The investigators will employ a prospective, single blind randomized clinical trial design with wait-list controls to examine both objective and subjective measures of daily life, daily functioning, cognition, and emotional well-being. Investigators will also assess the impact of HOBSCOTCH on employment and work productivity using the Lam Employment absence and Disability Scale (LEAPS) and the Sheehan Disability Scale (SDS). Lastly, the investigators will examine whether changes in these domains are maintained three months after completion of the intervention. The study will expand the efficacy literature for HOBSCOTCH and further refine its use in a busy clinical environment, and therefore has potential to benefit the patient population (PWRE), who currently lacks treatment options besides the pharmacological and surgical care currently available.

Eligibility criteria: Inclusion Criteria:

* Patient is able to read and speak English.
* Patient has a reliable telephone connection and a private place they can use during the course of this study
* They do not have any treatment or intervention plan in place for the next 6 months. They may be on an anti-epileptic drug regimen that has not been changed in the past 3 months.

Primary outcomes:
measure: Change in Quality of Life in Epilepsy - 31 score
timeFrame: baseline & 8-10 weeks after baseline
Secondary outcomes:
measure: Feasibility of HOBSCOTCH in the clinical setting
timeFrame: baseline
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References:
Clinical trial NCT00626977: Labor Analgesia With Ropivacaine and Clonidine
Official title: Labor Analgesia With Ropivacaine Added to Clonidine. A Randomized Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labor Pain
Keywords: Analgesia
Obstetrical
Anesthesia
Epidural
Newborn
Anesthetics, local
Clonidine
Pregnant women
Infant, newborn
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
Collaborators: name: Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2008-02-29
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women having requested epidural analgesia for labor and hers newborns

Brief summary: The aim of the present study was to examine, for pain relief during labor, the efficacy of two pharmacological approaches - the 0.125% ropivacaine alone and the 0.0625% ropivacaine added to 75 ug clonidine, both by epidural administration. The effect of the drugs on mother and newborn was also determined.


Eligibility criteria: Inclusion Criteria:

* Singleton healthy
* Full-term pregnancy
* American Society of Anesthesiologists physical status I or II

Exclusion Criteria:

* Patients who had received opioids
* History of hypersensitivity to local anesthetic or to clonidine
* Fetus showed signs of possible intrauterine suffering
* Fetus showed signs of possible neurological deficit

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: College of Medicine of Botucatu
state: São Paulo
Study officials:
affiliation: College Study of Medicine
name: Giane Nakamura, MD PHd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nakamura G, Ganem EM, Modolo NS, Rugolo LM, Castiglia YM. Labor analgesia with ropivacaine added to clonidine: a randomized clinical trial. Sao Paulo Med J. 2008 Mar 6;126(2):102-6. doi: 10.1590/s1516-31802008000200007.
Clinical trial NCT00504777: A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Agents.
Official title: An Open Label Study to Evaluate the Safety, and Effect on Treatment Response, of MabThera in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One or More Anti-TNF Agents.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-07-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will assess the safety and efficacy of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response or intolerance to one or more anti-TNF agents. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v. prior to infusion of MabThera. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* active rheumatoid arthritis;
* receiving outpatient treatment;
* an inadequate response, or intolerance, to \>=1 anti-TNF agent.

Exclusion Criteria:

* other rheumatic autoimmune disease or inflammatory joint disease;
* concurrent treatment with any anti-TNF-alpha therapy;
* joint or osseous surgery during 8 weeks prior to recruitment.

Primary outcomes:
measure: Change From Baseline in Disease Activity Score Based on 28-Joint Count (DAS28)
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology (ACR) Response
timeFrame: Week 24
measure: Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Category
timeFrame: Week 24
measure: Change From Baseline in HAQ-DI Score
timeFrame: Week 24
Other outcomes:
Locations:
city: Changhua
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Taichung
country: Taiwan
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
city: Tapei
country: Taiwan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06506877: A Cognitive Risk Calculator and Screening Tool for Primary Care Settings
Official title: A Cognitive Risk Calculator and Screening Tool for Primary Care Settings
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cognitive Risk Assessment
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-07-18
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This mixed-methods pragmatic trial will use a stepped wedge cluster randomized design to implement a cognitive risk-calculator and automated cognitive screening tool (BACH) in eight internal medicine clinics in the Cleveland Clinic Health System. Administrative and EHR data will provide quantitative metrics of adoption (tool use) and effectiveness (change in provider behavior) while observations, interviews, and questionnaires will assess fidelity, acceptability, and feasibility for all stakeholders. Analyses will consider provider characteristics, clinic attributes, and regional variations in patient characteristics (e.g., SES, race/ethnicity).


Eligibility criteria: Provider Inclusion Criteria:

* Must see adults aged 60 years or older in their practice.
* Must be a prescribing provider.

Exclusion Criteria:

* Provider sees patients at more than one participating study site.

Primary outcomes:
measure: Adoption of RC and BACH: Frequency of Cognitive Screening
timeFrame: Monthly assessment over the study duration (up to 1 year)
measure: Adoption of RC and BACH: Frequency of BACH Orders
timeFrame: Monthly assessment over the study duration (up to 1 year)
measure: Effectiveness of RC and BACH: Frequency of MCI/ADRD, Sleep Disorders, and Depression Diagnoses
timeFrame: Monthly assessment over the study duration (up to 1 year)
measure: Effectiveness of RC and BACH: Frequency of Referrals to Neuropsychology, Geriatrics/Neurology, Psychiatry/Psychology, and Sleep Medicine
timeFrame: Monthly assessment over the study duration (up to 1 year)
measure: Effectiveness of RC and BACH: Prescription Rates for Related Medications
timeFrame: Monthly assessment over the study duration (up to 1 year)
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References:
Clinical trial NCT04974177: A Study to Determine the Role of Physician Gestalt in Predicting COVID-19 in Patients
Official title: A Prospective Observational Study to Determine the Role of Physician Gestalt in Clinical Prediction of COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: All Patients Undergoing COVID 19 Specific Testing
Lead sponsor: Jubilee Mission Medical College and Research Institute
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 876
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting to ED, who undergo COVID 19 specific testing.

Brief summary: THIS IS A PROSPECTIVE OBSERVATIONAL STUDY TO DETERMINE THE ROLE OF PHYSICIAN GESTALT IN CLINICAL PREDICTION OF COVID 19.

Detailed description: Among patients attending the Emergency Department, prompt identification of possible cases of COVID 19 is important to avoid the spread. An immediate clinical diagnosis is important for point of care decision making on choice of treatment facility as well as for triaging, testing and to quarantine patients admitted to the hospital from emergency room. Hence this study attempts to find out the role of physician gestalt in early diagnosis and differentiation of COVID 19.

Eligibility criteria: Inclusion Criteria:

* All patients presenting to ED, who undergo COVID 19 specific testing.

Exclusion Criteria:

* Patients with active COVID 19 disease diagnosed outside All brought dead cases. All patients not consenting to take part in the study.

Primary outcomes:
measure: Sensitivity, specificity, positive and negative likelihood ratio of physician gestalt in diagnosis of COVID 19 in patients presenting to ED who are being sent for COVID 19 specific testing.
timeFrame: march 2021- september 2022
Secondary outcomes:
measure: Sensitivity, specificity, positive and negative likelihood ratio of clinical and epidemiological variables in patients presenting to ED who are being sent for COVID 19 specific testing.
timeFrame: march 2021- september 2022
Other outcomes:
Locations:
city: Thrissur
country: India
facility: Jubilee Mission Medical College
state: Kerala
Study officials:
References: