louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07014592: Characterization and Analysis of Evoked Cortical Responses in Participants With Medication-intractable Epilepsy
Official title: Characterization and Analysis of Evoked Cortical Responses in Participants With Medication-intractable Epilepsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intractable Epilepsy
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 5
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this project is to study how the brain reacts to a small electrical signal. Researchers will be using a novel combination of recording electrodes. The researchers will measure the brain response from these electrodes.


Eligibility criteria: Inclusion Criteria:

* Patients with medication intractable epilepsy who are recommended to undergo brain surgery to remove a "seizure" focus
* Can provide informed consent for the study and willing to participate

Exclusion Criteria:

* Presence of a permanent electronic implant
* Any chronic medical conditions that prevent safe placement of electrodes

Primary outcomes:
measure: Characterization of time-frequency data
timeFrame: During a 20 minute research phase of a clinically indicated surgery
measure: Characterization of local field responses (LFPs)
timeFrame: During a 20 minute research phase of a clinically indicated surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Matthew Willsey, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00099892: Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes
Official title: Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: type 2 diabetes
vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-12-22
Enrollment: 544
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, when added to metformin in people with type 2 diabetes who are not at target blood glucose levels on metformin alone.


Eligibility criteria: Inclusion Criteria:

* Blood glucose criteria must be met
* On a stable dose of metformin as defined by the protocol
* Body mass index (BMI) in the range 22-45

Exclusion Criteria:

* Type 1 diabetes
* Pregnancy or lactation
* Evidence of serious diabetic complications
* Evidence of serious cardiovascular complications
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in HbA1c after 24 weeks
Secondary outcomes:
measure: Change from baseline in fasting plasma glucose at 24 weeks
measure: Patients with endpoint HbA1c <7% after 24 weeks
measure: Patients with reduction in HbA1c >/=to 0.7% after 24 weeks
measure: Change from baseline in body weight at 24 weeks
measure: Change from baseline in fasting lipids at 24 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Bosi E, Camisasca RP, Collober C, Rochotte E, Garber AJ. Effects of vildagliptin on glucose control over 24 weeks in patients with type 2 diabetes inadequately controlled with metformin. Diabetes Care. 2007 Apr;30(4):890-5. doi: 10.2337/dc06-1732. Epub 2007 Feb 2.
Clinical trial NCT01340092: Use of a Family Navigator in Families With Children Newly Diagnosed With Autism Spectrum Disorder
Official title: Use of a Family Navigator in Families With Children Newly Diagnosed With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autistic Disorder
Keywords: Family Navigator
Autistic Disorder
Early Intervention
Developmental Disabilities
Child Development Disorders
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2011-04-22
Enrollment: 192
Sex: ALL
Minimum age (years): 15
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to see whether or not Family Navigators, who 1 ) help families after their child is diagnosed with autism and help them get autism specific services for their child 2) help families identify barriers to obtaining these services and 3) help families problem solve to overcome these barrier, are helpful to parents of a child newly diagnosed with an Autism Spectrum Disorder.


Eligibility criteria: Inclusion Criteria:

* Child with a new confirmed diagnosis of Autism Spectrum Disorder
* Child is under 8 years of age
* Parent is the mother, father and/or legal guardian of the child and identifies themselves as the primary caregiver
* Primary caregiver speaks English, Spanish, Haitian Creole, Somali, Vietnamese, Portuguese or Chinese

Exclusion Criteria:

* Parent or legal guardian has psychosis
* Parent or legal guardian endorses suicidal ideation
* Parent or legal guardian actively using illicit drugs
* Parent or legal guardian expected to leave area within 6 months

Primary outcomes:
measure: Hours of Services
timeFrame: 6 months after enrollment
measure: Receipt of adequate services
timeFrame: 6 months after enrollment
measure: Time to Receipt of Services
timeFrame: 6 months after enrollment
Secondary outcomes:
measure: Family Psychological Functioning
timeFrame: 6 months after enrollment
measure: Family Psychological Functioning
timeFrame: Baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Marilyn Augustyn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00760292: Genetic Variants and Phenotypic Characteristics of Patients With T2DM
Official title: Genetic Variants and Phenotypic Characteristics of Patients With T2DM
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Genetic Variants
SNP
DNA microarray
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Danish PhD schools of Molecular Metabolism and Endocrinology
name: University of Southern Denmark
First posted: 2008-09-26
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Diabetic Patients from Dept. of Endocrinology, Odense University Hospital
2. Non-diabetic volunteers found from advertising at Odense University Hospital

Brief summary: Background: Genetic risk-markers associated with T2DM are thoroughly studied. So far, only a few genetic variants, also termed single nucleotide polymorphisms (SNP's), have been replicated in several studies and each of them gives only limited explanation for the growing incidence of T2DM. The hypothesis of the present study is that determination of combinations of genetic variants by SNP-chip technology may improve the prediction of T2DM, complications and efficacy of treatment compared to the methods previously used including genome wide association (GWA) studies. The SNP-chip/ DNA microarray makes it possible to study several SNP's association with T2DM, one by one but also in combination.

Aims: To study whether specific genetic variants, and combinations of these, 1) are present with higher prevalence in patients with T2DM than in the normal population, 2) are associated with specific diabetes-related complications and 3) the effect of the anti-diabetic treatment.

Methods: During the next three years 1000 patients with T2DM and 1000 healthy, non-diabetic persons will be included in the study, and examined by blood samples, a questionnaire and clinical evaluation, all in one visit. Initially, we will perform DNA analyses on blood samples from 372 patients included in another clinical study from our department. Description of genetics will be done by a DNA-chip with approximately 70 SNP's, which have previously been reported to be associated with T2DM.

Results and conclusions: It is expected that the result of this project can help us predicting T2DM, diabetes-related complications and individualizing treatment to the individual patient with T2DM.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes Mellitus
* \> 18 years and

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Dept. of Endocrinology, Odense University Hospital
state: Funen
Study officials:
References:
Clinical trial NCT02503592: Vestibular Function After Cochlear Implantation Using Soft Surgery Techniques
Official title: Vestibular Function After Cochlear Implantation Using Soft Surgery Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Function in Cochlear Implant Patients
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2015-07-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will measure the effects of soft surgical techniques on vestibular function and quality of life in patients pre- and post-cochlear implant (CI) surgery. Additionally, the investigators will attempt to systematically evaluate the utility of different electrophysiological measures of vestibular system function in surgical ears.

Vestibular system function in CI patients will be evaluated pre-surgically and twice post-surgically, at 3 months and again at 1 year post-surgery. Traditional test techniques - such as VNG, rotational testing, and air conduction VEMPs - will be compared to and cross-checked with newer techniques including video head impulse testing (vHIT) and bone conduction VEMPs.

Detailed description: Design \& Procedures: The current standard of care for CI patients includes a pre-op evaluation of the vestibular system. For this study, the investigators will compare subjects' routine pre-op test results to two additional post-op assessments performed for study purposes: one in the short term (\~3 months post-op) and one in the long-term (\~1 year post-op).

Eligibility criteria: Inclusion Criteria:

* \> 18 years of age
* Only patients implanted with the MED-EL CI device within the last 90 days will be eligible for this study.

Exclusion Criteria:

* Patients \< 18 years of age
* Patients implanted with a cochlear implant device other than MED-El CI

Primary outcomes:
measure: Change in Vestibular function in Cochlear Implant Patients
timeFrame: Pre-Operatively, and then 3 months and 12 months post-operatively
measure: Change in Quality of Life by questionnaire
timeFrame: 3 months and 12 months post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Erin Piker, AuD, PhD,
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00519792: Phase 1b Study of Omega DUROS® in Patients With Chronic Hepatitis C Who Relapsed After Prior Treatment
Official title: Phase Ib Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Omega DUROS® and Ribavirin in Subjects With Chronic Hepatitis C Previously Treated With Pegylated Interferon and Ribavirin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis C
Keywords: Relapse
HCV
Hepatitis C
Interferon
Ribavirin
Lead sponsor: Intarcia Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-08-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Omega DUROS® is an implantable drug delivery system designed to deliver omega interferon subcutaneously at a constant rate for 90 days.

This study is being performed to evaluate the safety and antiviral effects of omega interferon delivered by the Omega DUROS® device in combination with ribavirin in subjects with chronic Hepatitis C genotype 1.


Eligibility criteria: Inclusion Criteria:

* Chronic Hepatitis C with HCV genotype 1 infection
* Relapse following an end of treatment response after treatment with a pegylated interferon and ribavirin.

Exclusion Criteria:

* Presence or history of non-HCV chronic liver disease
* Treatment with any interferon subsequent to the relapse with pegylated interferon-alpha and ribavirin
* Decompensated liver disease

Primary outcomes:
measure: Safety
timeFrame: Week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: St Louis
country: United States
facility: St. Louis University
state: Missouri
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Dallas
country: United States
facility: The Liver Institute at Methodist Dallas
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
Study officials:
References:
Clinical trial NCT03205592: Ultrasound Assessment of Residual Gastric Content in Critically Ill Patients
Official title: Ultrasound Assessment of Residual Gastric Content in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critically Ill Patients
Lead sponsor: Hôpital Edouard Herriot
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 61
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: Critically ill patients hospitalized in 3 critical care units (Groupement hospitalier Sud Lyon, Saint Etienne, Marseille)

Brief summary: This prospective observational study aims to assess whether ultrasound assessment of gastric content may be useful for the monitoring of the gastric residual content in critically ill patients


Eligibility criteria: Inclusion Criteria:

* Critically ill patients under mechanical ventilation and enteral feeding through a gastric tube since \>48 h

Exclusion Criteria:

* Digestive hemorrhage Contra-indication to prokinetic drugs Enteral feeding through jejunostomy or gastrostomy Pregnancy

Primary outcomes:
measure: change in antral cross sectional area measured by ultrasonography after suctioning gastric volume
timeFrame: prior to and immediately after suctioning of gastric content volume through a gastric tube
measure: Change in antral area after administration of prokinetic drug
timeFrame: Ultrasound assessment of gastric content after reinjection of suctioned gastric content and 1h30 later (1 h after the end of the infusion of prokinetic drug)
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital Nord
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Saint-Étienne
country: France
facility: CHU Saint Etienne
Study officials:
affiliation: Hospices Civils de Lyon
name: Lionel BOUVET, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bouvet L, Zieleskiewicz L, Loubradou E, Alain A, Morel J, Argaud L, Chassard D, Leone M, Allaouchiche B; AzuRea CAR'Echo collaborative networks. Reliability of gastric suctioning compared with ultrasound assessment of residual gastric volume: a prospective multicentre cohort study. Anaesthesia. 2020 Mar;75(3):323-330. doi: 10.1111/anae.14915. Epub 2019 Dec 4.
Clinical trial NCT00870792: Physician Focused Intervention to Improve Adherence With HIV Antiretrovirals
Official title: Physician Focused Intervention to Improve Adherence With HIV Antiretrovirals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
HIV Infections
Keywords: HIV
antiretroviral therapy
medication adherence
Treatment Experienced
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2009-03-27
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: We hypothesized that providing physicians treating with HIV disease, at the time of a routine outpatient visit, with a detailed report describing patients' adherence with HIV antiretroviral medications, would improve the quality of the physician-patient interaction, and also patients' subsequent adherence.


Eligibility criteria: Inclusion Criteria:

* on ART
* willing to use MEMS cap
* speaks and reads English
* detectable viral loads

Exclusion Criteria:

* uses a pill box

Primary outcomes:
measure: Antiretroviral medication adherence as assessed by electronic pill cap monitoring.
timeFrame: 6 months
Secondary outcomes:
measure: Self-reported medication adherence
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Ira B. Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lu M, Safren SA, Skolnik PR, Rogers WH, Coady W, Hardy H, Wilson IB. Optimal recall period and response task for self-reported HIV medication adherence. AIDS Behav. 2008 Jan;12(1):86-94. doi: 10.1007/s10461-007-9261-4. Epub 2007 Jun 19.
citation: Vranceanu AM, Safren S, Cowan J, Ring D. The development of the negative pain thoughts questionnaire. Pain Pract. 2008 Sep-Oct;8(5):337-41. doi: 10.1111/j.1533-2500.2008.00213.x. Epub 2008 May 23.
Clinical trial NCT00509392: ClosureFAST vs. Laser Ablation for the Treatment of GSV Disease: A Multicenter, Single-Blinded, Randomized Study.
Official title: Radiofrequency Endovenous ClosureFAST vs. Laser Ablation for the Treatment of Great Saphenous Reflux: A Multicenter, Single-Blinded, Randomized Study (RECOVERY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Venous Reflux
Keywords: Varicose veins, venous reflux, GSV disease
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
Collaborators: name: VNUS Medical Technologies, A Covidien Company
First posted: 2007-07-31
Enrollment: 69
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: The objective of this post-market study is to compare the post-procedure recovery between two types of minimally invasive catheter treatments for venous disease in the Great Saphenous Vein.

Detailed description: Comparison of the post-procedure recovery of radiofrequency (RFA) treatment vs. laser treatment.

Eligibility criteria: Inclusion Criteria:

* All subjects must provide written informed consent.
* Must be a candidate for either treatment with Radiofrequency Ablation (RFA) or endovenous laser.

Exclusion Criteria:

* Subjects who require additional treatments in either leg within 30 days before or after the study procedure.
* Subjects who are participating in another investigational study.

Primary outcomes:
measure: Pain
timeFrame: 48 Hour
measure: Pain
timeFrame: 1 Week
measure: Pain
timeFrame: 2 Weeks
measure: Pain
timeFrame: 1 Month
measure: Tenderness
timeFrame: 48 Hour
measure: Tenderness
timeFrame: 1 Week
measure: Tenderness
timeFrame: 2 Weeks
measure: Tenderness
timeFrame: 1 Month
measure: Ecchymosis
timeFrame: 48 Hours post treatment (no baseline)
measure: Ecchymosis
timeFrame: 1 Week post treatment (no baseline)
measure: Ecchymosis
timeFrame: 2 Weeks post treatment (no baseline)
measure: Ecchymosis
timeFrame: 1 Month post treatment (no baseline)
measure: Complications
timeFrame: 1 month
Secondary outcomes:
measure: VCSS
timeFrame: 48 Hours
measure: VCSS
timeFrame: 1 Week
measure: VCSS
timeFrame: 2 Weeks
measure: VCSS
timeFrame: 1 Month
measure: Change in CIVIQ QOL
timeFrame: 48 Hours
measure: Change in CIVIQ QOL
timeFrame: 1 Week
measure: Change in CIVIQ QOL
timeFrame: 2 Week
measure: Change in CIVIQ QOL
timeFrame: 1 Month
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health Sciences
state: Oregon
Study officials:
affiliation: VNUS Medical Technologies, A Covidien Company
name: Lian Cunningham, MD
role: STUDY_DIRECTOR
References:
citation: Almeida JI, Kaufman J, Gockeritz O, Chopra P, Evans MT, Hoheim DF, Makhoul RG, Richards T, Wenzel C, Raines JK. Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY study). J Vasc Interv Radiol. 2009 Jun;20(6):752-9. doi: 10.1016/j.jvir.2009.03.008. Epub 2009 Apr 22.