louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00497068: Tobacco Use in Opioid Agonist Treated Pregnant Women
Official title: Tobacco Use in Opioid Agonist Treated Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Nicotine Dependence
Keywords: smoking
pregnancy
neonatal abstinence syndrome
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2007-07-06
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the proposed study is to evaluate the efficacy of tobacco abstinence-contingent voucher incentives versus non-tobacco abstinence-contingent incentives for reducing or eliminating tobacco use during pregnancy in methadone treated women. In addition, the impact that this intervention has in reducing the incidence and severity of methadone associated neonatal abstinence syndrome will also be examined.


Eligibility criteria: Inclusion Criteria:

* Confirmed pregnancy
* Treatment entry at or before 31 weeks EGA
* Expected to enter drug-free outpatient modality at CAP
* Placed on methadone pharmacotherapy
* Nicotine dependent
* Sufficient literacy and understanding for assessment procedures
* Expected availability for study duration (e.g., complete inpatient stay)
* Able and willing to provide informed consent
* At least 18 years of age
* Confirmed smoker of 10 or more cigarettes

Exclusion Criteria:

* Not pregnant
* EGA of 32 weeks or greater
* 17 years of age or younger
* Undergoing detoxification (non-methadone treatment)
* Unable to provide informed consent
* Currently receiving nicotine replacement products (NRT)
* Current diagnosis of alcohol or benzodiazepine dependence
* Severe medical or psychiatric concomitant conditions that would interfere with treatment or require extended hospitalization.

Primary outcomes:
measure: Percent of tobacco-free urine samples submitted and Neonatal Abstinence Score
timeFrame: from treatment entry until 6 weeks post-partum
Secondary outcomes:
measure: tobacco use measures • treatment compliance• Neonatal measures include:Birth parameters
timeFrame: from treatment entry to 6 weeks posrt-partum
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center, Center for Addiction and Pregnancy
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Hendree E Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tuten M, Svikis DS, Keyser-Marcus L, O'Grady KE, Jones HE. Lessons learned from a randomized trial of fixed and escalating contingency management schedules in opioid-dependent pregnant women. Am J Drug Alcohol Abuse. 2012 Jul;38(4):286-92. doi: 10.3109/00952990.2011.643977. Epub 2012 Feb 22.
Clinical trial NCT00822068: Improvement of Language Disturbances After Stroke by Intensive Training and Electrical Brain Stimulation
Official title: Improvement of Aphasia After Stroke by Intensive Training and Transcranial Direct Current Stimulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Aphasia
Stroke
Keywords: stroke
aphasia
rehabilitation
transcranial direct current stimulation
intensive training
chronic aphasia after stroke
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2009-01-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study aims to identify if intensive language training, consisting mainly of computer-based object naming, together with electrical brain stimulation, will lead to an improvement of language functions in patients that suffer from language disturbances after a stroke.


Eligibility criteria: Inclusion Criteria:

* chronic stroke (\> 1 year after event)
* aphasia due to stroke with naming impairment
* German as first language
* first-ever stroke

Exclusion Criteria:

* more than 1 stroke
* progressive stroke
* history of severe alcohol or drug abuse, psychiatric illnessess like severe depression, poor motivational capacity
* dementia
* contraindications for Magnetic Resonance Imaging

Primary outcomes:
measure: Number of words correctly named after training plus tDCS
timeFrame: 1 year
Secondary outcomes:
measure: Communicative-Activity-Log & Stroke-and-Aphasia-Quality-of-Life-Scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Muenster / Berlin
country: Germany
facility: Department of Neurology, University of Muenster; Department of Neurology, University of Berlin
state: NRW/Berlin-Brandenburg
Study officials:
affiliation: Department of Neurology, University of Muenster; Department of Neurology, University of Berlin, Germany
name: Agnes Floel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Floel A, Meinzer M, Kirstein R, Nijhof S, Deppe M, Knecht S, Breitenstein C. Short-term anomia training and electrical brain stimulation. Stroke. 2011 Jul;42(7):2065-7. doi: 10.1161/STROKEAHA.110.609032. Epub 2011 Jun 2.
Clinical trial NCT04127968: Efficacy and Safety of Vitamin A Treatment for Children With Sepsis
Official title: Efficacy and Safety of Vitamin A Treatment for Children With Sepsis: a Randomized Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vitamin A Deficiency
Pediatric
Sepsis
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 450
Sex: ALL
Minimum age (years): 0
Maximum age (years): 192
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The prevalence of vitamin A deficiency was found high in children with sepsis. Whether those patients will benefit from the vitamin A supplementation is unknown.

Detailed description: It was reported that the prevalence of vitamin A deficiency was highly as 58% in critically ill children with sepsis. However, whether those patients will benefit from the vitamin A supplementation is unknown. We design an randomized, double-blind, placebo-controlled, multi-center trial to investigate the effect of vitamin A supplementation on the outcome of critically ill children with sepsis.

Eligibility criteria: Inclusion Criteria:

1. age \< 18 years,
2. Expected to stay in the ICU for 48 hours or more,
3. Vitamin A deficiency (VA \< 0.2 mg/L)

Exclusion Criteria:

1. Severely impaired gastrointestinal function
2. Premature infants and low birth weight (LBW) infants
3. Condition of underlying organ dysfunction
4. Having received chemotherapy or radiotherapy
5. Hematological malignancies
6. Primary or acquired immunodeficiency

Primary outcomes:
measure: length of hospital stay
timeFrame: 2 years
Secondary outcomes:
measure: hospital mortality
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06241768: Feasibility of a Colorectal Cancer Screening Web App in Primary Care Patients
Official title: Feasibility of a Cloud-based Digital Health Navigation Program for Colorectal Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer Screening
Keywords: colorectal cancer screening
pragmatic clinical trial
randomized clinical trial
digital health
feasibility study
Lead sponsor: Digital Health Navigation Solutions, Inc
Sponsor class: INDUSTRY
Collaborators: name: Wake Forest University Health Sciences
name: National Cancer Institute (NCI)
First posted: 2024-02-05
Enrollment: 921
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The goal of this clinical trial is to test the feasibility of a web app about colorectal cancer screening in patients with an upcoming primary care appointment. The main questions it aims to answer are:

* Among patients who use the web app, what proportion will request a colorectal cancer screening test via the program?
* How many patients will respond to a text message intervention to use the web app?

Participants will receive a text message informing them of the value of colorectal cancer screening, and inviting them to click a hyperlink to learn more. The hyperlink will take participants to the web app. The web app: 1) asks questions and use algorithms to determine if routine colorectal cancer screening is needed, and 2) if screening is indicated, shows a brief educational video about colorectal cancer screening and allows participants to request a screening test via the program.

Researchers will compare four different versions of the text message invitation to see if some messages result in higher program completion rates than others.


Eligibility criteria: Inclusion Criteria:

* Have a phone number listed in the electronic health record
* Language preference of English in the electronic health record
* Have a scheduled primary care appointment within the next 15 days

Exclusion Criteria:

* Prior diagnosis of colorectal cancer
* Prior diagnosis of inflammatory bowel disease
* Have a record in the electronic health record of completing a colonoscopy within the last 10 years, a FIT-DNA test within the last 3 years, or a fecal immunochemical test (FIT) within the last 1 year
* Have an electronic Charlson Comorbidity Index \> 2

Primary outcomes:
measure: Number (and Proportion) of Participants Who Request a Colorectal Cancer (CRC) Screening Test
timeFrame: 28 days
Secondary outcomes:
measure: Number (and Proportion) of Participants Who Complete the mPATH-CRC Web App
timeFrame: 28 days
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
Study officials:
affiliation: Digital Health Navigation Solutions, Inc
name: David Miller, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05671068: EMOTION & COGNITION in MYOCLONUS DYSTONIA (AGENT10-ECODYST)
Official title: CEREBELLAR INVOLVEMENT in MOTOR, COGNITIVE and EMOTIONAL PROCESSES in MYOCLONUS DYSTONIA
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Myoclonus-Dystonia
DYT11
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: Assistance Publique - Hôpitaux de Paris
First posted: 2023-01-04
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll patients with DYT-SGCE and Healthy Volunteers (HVs).

Brief summary: Background:

Myoclonus dystonia (DYT-SGCE) is characterized by myoclonus and dystonia. Such condition is associated with a high prevalence of psychiatric symptoms which are part of the phenotype. The mechanisms underlying these non-motor symptoms are still poorly understood.

Objective:

To investigate the neural correlates of cognition and emotion in DYT-SGCE.

Design:

Participants will have 1 - 2 visits at the clinical center. The total participation time is less than 24 hours.

Participants will have a medical interview and a neurological exam. They may give a urine sample before MRI.

Participants will have a short neuropsychologic and psychiatric interviews. Participants will have MRI scans. They will do small tasks or be asked to imagine things during the scanning.

Detailed description: Eligibility:

DYT-SGCE patients and healthy volunteers (HV) between 15 and 60 years old.

Eligibility criteria: Inclusion Criteria:

For all participants:

* Age between 15-60 years
* Able to give informed consent.

For patients:

* An established diagnostic of DYT-SGCE
* No change in medication (related to DYT-SGCE) for a month

For controls:

* No neurological symptoms
* No medication except oral contraception

Exclusion Criteria:

* No deprivation of liberty
* Inability to give a consent
* Established cognitive alteration
* Contraindication to MRI (per MRI safety checklist)
* Severe chronic psychiatric illness

Primary outcomes:
measure: BOLD signal derived from the functional magnetic resonance imaging
timeFrame: 46 month
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Brain Institute
Study officials:
affiliation: Department of neurology, Pitié-Salpêtrière Hospital, Paris
name: Emmanuel Roze, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roze E, Lang AE, Vidailhet M. Myoclonus-dystonia: classification, phenomenology, pathogenesis, and treatment. Curr Opin Neurol. 2018 Aug;31(4):484-490. doi: 10.1097/WCO.0000000000000577.
citation: Peall KJ, Dijk JM, Saunders-Pullman R, Dreissen YE, van Loon I, Cath D, Kurian MA, Owen MJ, Foncke EM, Morris HR, Gasser T, Bressman S, Asmus F, Tijssen MA. Psychiatric disorders, myoclonus dystonia and SGCE: an international study. Ann Clin Transl Neurol. 2015 Nov 20;3(1):4-11. doi: 10.1002/acn3.263. eCollection 2016 Jan.
Clinical trial NCT01518868: A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens
Official title: A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2012-01-26
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the product performance of the investigational multifocal high add soft contact lens compared with PureVision Multi-focal contact lens on a daily wear basis.


Eligibility criteria: Inclusion Criteria:

* Have physiologically normal anterior segments
* Be adapted wearers of soft contact lenses and wear a lens in each eye.
* Be presbyopic and require near add correction in each eye.
* Be an adapted monovision or multifocal contact lens wearer or be an adapted spherical lens wearer who also uses spectacles for near vision correction.
* Have no active ocular disease or allergic conjunctivitis.
* Must not be using any topical ocular medications.
* Must habitually use a lens care product for lens cleaning, disinfecting, and storage.

Exclusion Criteria:

* Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Anisometropia (spherical equivalent) of greater than 2.00 D.
* Any systemic disease affecting ocular health.
* Using any systemic or topical medications that will affect ocular physiology or lens performance.
* Allergic to any component in the study products.
* Ocular astigmatism of greater than 1.00 D in either eye.
* Have had any corneal surgery (ie, refractive surgery).
* Uses AMO Ultra Care as their habitual lens care regimen.
* Is a toric contact lens wearer.
* Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
* An active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications.

Primary outcomes:
measure: Visual Acuity
timeFrame: At 2 weeks follow up
Secondary outcomes:
measure: Symptoms/Complaints
timeFrame: At 2 weeks follow up
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb, Incorporated
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Beverly J Barna, CCRA
role: STUDY_DIRECTOR
References:
Clinical trial NCT02109068: Lifestyle, Exercise and Nutrition Study 1
Official title: Lifestyle, Exercise and Nutrition (LEAN) Study 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Weight Loss
Keywords: Breast Cancer
Survivorship
Weight Loss
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 100
Sex: FEMALE
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: The specific aims of this study are to determine the efficacy and cost-effectiveness of a weight loss program compared with usual care (control) treatment on 6-month changes in body weight, body fat, and serum hormones in breast cancer survivors.

Detailed description: Proposed is a three-arm randomized controlled trial of 6-months of weight loss counseling (i.e., dietary-induced caloric restriction and physical activity) on clinically meaningful endpoints in 100 breast cancer survivors . The three arms will be: 1. In-person counseling, 2. Telephone-based counseling, 3. Usual care. Women will be randomized into one of 3 study arms using a random permuted block design. Research staff collecting body composition data, as well as reviewing forms and entering data, will be blinded to the participant's study group.

Eligibility criteria: Inclusion Criteria:

* American Joint Committee on Cancer (AJCC) Stages 0-IIIC Breast Cancer
* BMI \>25 kg/m2
* Completed surgery, chemotherapy and radiation at least 2 months ago
* Physically able to exercise
* Agrees to be randomly assigned to either weight loss or control
* Gives informed consent to participate in all study activities
* Able to come for baseline and 6-month clinic visits
* Mentally competent

Exclusion Criteria:

-

Primary outcomes:
measure: Change in Body Mass Index (BMI)
timeFrame: 6 months
measure: Change in body weight in kilograms (kg)
timeFrame: 6 months
measure: Change in percent body fat
timeFrame: 6 months
Secondary outcomes:
measure: Change in fasting insulin
timeFrame: 6 months
measure: Change in Insulin-like growth factor 1 (IGF-1)
timeFrame: 6 months
measure: Change in Leptin
timeFrame: 6 months
measure: Change in C-reactive protein
timeFrame: 6 months
measure: Skin Carotenoids Assessment
timeFrame: 6 months
measure: Maintenance of Weight Loss
timeFrame: 12 months
Other outcomes:
measure: Change in Physical Activity
timeFrame: 6 months
measure: Change in Dietary Intake
timeFrame: 6 months
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Melinda L Irwin, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06770868: A Novel Alloplastic Patient Specific Temporalis Tendon Enthesis
Official title: A Novel Alloplastic Patient Specific Temporalis Tendon Enthesis for Mandibular Resection with Coronoidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mandibular Resection
Keywords: mandibular resection
coronoid
computer assisted
computer-aided design,
computer-aided manufacturing
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: mandibular resection with coronoidectomy managed with patient specific reconstruction plate with custom made temporalis tendon enthesis
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Mandibular reconstruction of segmental defects is an arduous surgical procedure that requires an utmost degree of surgical fidelity. Whether primary bone reconstruction is feasible or not, alloplastic bridging between the remaining bone stumps is mandatory to achieve functional, aesthetic, and symmetrical demands of the lower third of the face. Mandibular reconstructive surgery should be directed toward the maintains of the normal orthognathic centric condylar position, mandibular kinematics, and muscles of mastication function. Mandibular resection with coronoid removal cause imbalance in the attachment of one of the large muscles of mastication, the temporalis muscle. The use of computer-aided surgery allowed the creation of custom made fixation plates with a plethora of advantages over the conventional plates.

the study aims to introduce a novel plate design, which creates an enthsis for the reattachment of the temporalis muscle tendon.


Eligibility criteria: Inclusion Criteria:

* Patients with mandibular lesion that require segmental resection.
* Patients required coronoid processes resection within the safety margin of the lesion.
* Brown Class I cases with preservation of the condyle process and no need for alloplastic TMJ replacement.
* Complaisant patient that is able to complete at least 1 year follow up.

Exclusion Criteria:

* Composite mandibular defect.
* Malignant lesions that required postoperative adjunctive therapies (CT or RT).

Primary outcomes:
measure: Mandibular Kinematics assessment
timeFrame: 6 months
Secondary outcomes:
measure: Postoperative temporalis muscle activity
timeFrame: 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
References: