louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01502813: Citicoline, Creatine, and Omega-3 Effects in Middle Age Women
Official title: Citicoline, Creatine, and Omega-3 Effects in Middle Age Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Benefits
Keywords: Neuropsychological testing
Dietary supplements
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2012-01-02
Enrollment: 40
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the functional effects of a citicoline, creatine, and omega-3 fatty acids combination when administered for a duration of four weeks (28 days) to non-psychiatric adult female participants.

Detailed description: Standard clinical measures for mood and neuropsychological measures of attention, cognitive inhibition and memory will be applied before, during, and after a course of a daily supplementation of citicoline, creatine and omega-3 for 28 days to non-psychiatric adult female participants. We hypothesis that the combination of supplements will improve memory and attention in healthy adult women.

Eligibility criteria: Inclusion Criteria:

* Female
* Age 40-60 years

Exclusion Criteria:

* Significant medical condition
* History of co-morbid psychiatric disorders
* Current Axis I or II diagnosis
* Past participation in a pharmacotherapeutic trial
* Head injury with LOC\>5 minutes
* Use of psychotropic medication
* History of fish allergies
* Medical condition associated with clinically significant decreases in coagulability
* Use of anticoagulant medication

Primary outcomes:
measure: Change From Baseline in California Verbal Learning Test (CVLT) That Measure Attention and Memory at 14 Days
timeFrame: Baseline and 14 days from baseline
measure: Change From Baseline in WAIS-IV Block Design Subtest A That Measures Attention and Memory at 28 Days
timeFrame: Baseline and 28 days from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: The Brain Institute
state: Utah
Study officials:
affiliation: The Brain Institute, University of Utah
name: Deborah Yurgelun-Todd, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02355613: Comparative Evaluation of Two Different Radiosurgery
Official title: Comparative Evaluation of Two Different Radiosurgery Modalities in Brain Metastatic Patients From Several Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastases to Brain
Keywords: Radiosurgery, brain, metastases
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2015-02-04
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized double arm phase III study to evaluate feasibility and safety of Gamma Knife radiosurgery and Linac Based (Edge) radiosurgery in brain metastatic patients

Detailed description: This is a prospective double arm phase III study to evaluate cerebral side effects following radiosurgery delivered by Gamma Knife Perfexion and Linac Based EDGE. In particular our primary objective is to evaluate rate of symptomatic radionecrosis from the two different modalities of radiosurgery.

Eligibility criteria: Inclusion Criteria:

* Age 18 - 85 years
* 1 - 4 brain metastases
* Karnofsky performance status (KPS) ≥70
* RPA 1 or 2
* Histopathologically confirmation of primary solid tumor
* Estimated survival ≥ 3 months as GPA score
* Written informed consent

Exclusion Criteria:

* Prior WBRT
* Age \> 85 years
* KPS \< 70
* RPA 3
* Diagnosis of small cell lung cancer (SCLC) or Lymphoproliferative disease
* Use of Avastin for at least 2 months after radiosurgery
* Pregnant women

Primary outcomes:
measure: Incidence of symptomatic radionecrosis
timeFrame: two years
Secondary outcomes:
measure: Local Control of Brain Metastases
timeFrame: two years
measure: Disease Free survival
timeFrame: two years
measure: Overall survival
timeFrame: two years
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: MI
Study officials:
affiliation: Istituto Clinico Humanitas
name: Marta Scorsetti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04843813: Effects of Lutein Supplementation on Cognition and MPOD in Multiple Sclerosis Patients-
Official title: Lutein and Multiple Sclerosis Experimental Study (LuMES)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Cognitive Function
Lutein
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: Division of Nutritional Sciences, University of Illinois at Urbana-Champaign
name: National Institutes of Health (NIH)
First posted: 2021-04-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A 2-group parallel design will be employed to collect feasibility data on daily lutein supplementation over 4 months.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The central hypothesis is that lutein supplementation will improve MPOD and cognition. Accordingly, the specific aims are to 1) to determine the process feasibility associated with participating in 4-month lutein supplementation trial; and 2) to investigate the scientific feasibility of 4-month daily lutein supplementation on biological markers of lutein status and cognitive function among persons with MS.

Detailed description: A two-group parallel design will be employed whereby participants will be randomly assigned to one of 2 groups. The supplementation doses 20mg/d (Group 1), and placebo (Group 2) will be consumed daily by the participant for a 4-month period. Pre-test and follow-up measures of lutein status and cognitive function will be assessed at baseline and at 4-month follow-up via laboratory visits.

Eligibility criteria: Inclusion Criteria:

* 18-64.9 years
* Self-reported relapsing-remitting MS (RRMS) diagnosis
* Expanded Disability Status Scale (EDSS) score between 0-3.5
* Macular Pigment Optical Density at baseline (MPOD ≤0.35)
* Score ≤55 during the Symbol Digit Modalities Test (SDMT)
* 20/20 or corrected vision
* No presence of color blindness
* No history of age-related macular degeneration
* No history of epileptic seizures

Exclusion Criteria:

* Under 18 years or over 64.9 years
* MS diagnosis other than RRMS
* Pregnancy
* Uncorrected vision
* Presence of color blindness
* PDDS score of 7 or more
* Prior diagnosis of age-related macular degeneration
* History of epileptic seizures

Primary outcomes:
measure: Macular Pigment Optical Density
timeFrame: 4 months (baseline vs. follow-up)
measure: Attentional Accuracy
timeFrame: 4 months (baseline vs. follow-up)
measure: Attentional Reaction Time
timeFrame: 4 months (baseline vs. follow-up)
measure: Attentional Resource Allocation
timeFrame: 4 months (baseline vs. follow-up)
measure: Attentional Processing Speed
timeFrame: 4 months (baseline vs. follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois Urbana Champaign
name: Naiman Khan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03056313: The Proactive Support of Labor Study
Official title: The Proactive Support of Labor Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstetric Labor Complications
Keywords: Delivery, Obstetric
Uterine Contraction
Cervix Uteri
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2017-02-17
Enrollment: 347
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The duration of labor is decisive for maternal and fetal health. Poor progression often results in tired mothers, bad experience, delivery complications and a demand for cesarean section in next pregnancy. Proactive support of labor is a method originally from the Netherlands.

The main idea is to define start of active labor earlier than the traditional "3-4 cm opening of the cervix and regular contractions" to be cervix \< 0.5 cm in length, and 1 cm opening and painful contractions. From this point, it is expected to be a progress of 1cm/hour opening of cervix. If not, progress is supported by amniotomy or stimulation of contractions.

This method is embraced by several clinics with great enthusiasm. However, there are no randomized controlled trials to prove that this method is better than others.


Eligibility criteria: Inclusion Criteria:

* spontaneous start of labor
* nulliparous
* term pregnancy
* cephalic presentation

Exclusion Criteria:

* twins
* breech presentation
* given birth earlier
* known uterine anomaly
* insulin treated diabetes
* preeclampsia
* other serious medical conditions in mother or fetus

Primary outcomes:
measure: number of pathological deliveries
timeFrame: 2 days
measure: maternal satisfaction with deliver
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Eszter Vanky, md prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brenne Fehn M, Dahlo R, Nielsen R, Laache I, Vanky E. Proactive versus standard support of labour in nulliparous women; study protocol for a randomized, controlled trial. Trials. 2020 Apr 23;21(1):358. doi: 10.1186/s13063-020-4191-9.
Clinical trial NCT00010413: Phase II Study of High-Dose Cyclophosphamide in Patients With Refractory Pemphigus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pemphigus
Keywords: immunologic disorders and infectious disorders
pemphigus
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
First posted: 2001-02-02
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Determine the response rate and 1-year event-free survival of patients with refractory pemphigus treated with high-dose cyclophosphamide.

Detailed description: PROTOCOL OUTLINE: Patients receive cyclophosphamide IV on days 1-4 and filgrastim (G-CSF) beginning on day 10 and continuing until blood counts recover.

Patients are followed monthly for 6 months, every 2 months for 6 months, every 4 months for a year, and then annually thereafter.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Definitive diagnosis of pemphigus, including all of the following: Typical clinical lesions Histologically proven by skin or mucous membrane biopsy Pemphigus IgG autoantibodies in skin or mucous membrane by direct immunofluorescence (IF) Circulating pemphigus IgG autoantibodies in serum by indirect IF

Dependence on high-dose corticosteroids

Persistent disease activity despite treatment with mycophenolate mofetil or azathioprine, or inability to tolerate these drugs (for paraneoplastic pemphigus, persistent disease activity despite treatment with cyclosporine)

--Prior/Concurrent Therapy--

No concurrent cytotoxic therapy

--Patient Characteristics--

Performance status: Karnofsky 20-100%

Renal: Creatinine no greater than 2.5 mg/dL

Cardiovascular: LVEF at least 40%

Pulmonary: FVC, FEV1, or DLCO at least 50% predicted

Other: Not pregnant Fertile patients must use effective contraception during and for 9 months after study Not preterminal or moribund

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Grant J. Anhalt
role: STUDY_CHAIR
References:
Clinical trial NCT05314218: The Objective of This Multicentre Study is to Collect Operative Data on the Related Clinical Functional Outcomes and Complications and of Market Approved Alcis Electrophysiology Catheters to Demonstrate Safety and Performance of These Devices in a Real-world Setting
Official title: EPICADIA - Electrophysiologic Performance Investigation for CArdiac DIAgnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrhythmia
Lead sponsor: Alcis
Sponsor class: INDUSTRY
First posted: 2022-04-06
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have to undergo diagnostic procedure or ablation procedure (Cardiac arrythmias).

Brief summary: The objective of this multicentre study is to collect operative data on the related clinical functional outcomes and complications and of market approved Alcis electrophysiology catheters to demonstrate safety and performance of these devices in a real-world setting.

Detailed description: Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR), Clinical Evaluation Report (CER) on Alcis devices and support peer-reviewed publications on products performance and safety.

Eligibility criteria: Inclusion Criteria:

To be included, patients must be:

* 18 to 90 years old
* Patient who have to undergo diagnostic procedure or ablation procedure (Cardiac arrythmias)
* Informed and willing to sign an informed consent for approved by EC
* Affiliation to the social security or foreign regime recognized in France

Exclusion Criteria:

A patient will not be eligible to participate in the study if any of the following conditions are present:

* Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times).
* Any medical condition that could impact the study at investigator's discretion (e.g. allergy...).
* Pregnant women
* Adult subject to legal protection measure

Primary outcomes:
measure: Signal quality
timeFrame: Through study completion, an average of 4 hours
Secondary outcomes:
measure: Micro-stimulation
timeFrame: Through study completion, an average of 4 hours
measure: Manoeuvrability
timeFrame: Through study completion, an average of 4 hours
measure: Bending
timeFrame: Through study completion, an average of 4 hours
measure: Imaging
timeFrame: Through study completion, an average of 4 hours
measure: Diagnosis
timeFrame: Through study completion, an average of 4 hours
Other outcomes:
Locations:
city: Créteil
country: France
facility: Hôpital Henri-Mondor AP-HP
state: Ile De France
city: Avignon
country: France
facility: Clinique Rhône Durance
Study officials:
References:
Clinical trial NCT06943118: Comparison of Efficacy of 35% Glycolic Acid vs 20% Salicylic Acid Peel in the Treatment of Post Acne Scars
Official title: Comparison of Efficacy of 35% Glycolic Acid vs 20% Salicylic Acid Peel in the Treatment of Post Acne Scars
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Post Acne Scars
Lead sponsor: Hayatabad Medical Complex
Sponsor class: OTHER_GOV
First posted: 2025-04-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the effectiveness of two drugs in patients that presents with scars on face after acnes. The effectiveness will be measured by a goodman and baron scale. One group of patients will receive 35% glycolic acid while other group of patients will receive 20% salicylic acid and both groups will be followed by 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18-45 years with mild to moderate atrophic post acne scars
* Fitzpatrick skin type 2-4
* No active acne or ongoing systemic acne treatment

Exclusion Criteria:

* Pregnancy and breast feeding
* History of keloid or hypertrophic scars
* Use of retinoids or chemical peel in last 3 months
* Active skin infections
* History of hyperpigmentation after any procedure
* Hypersensitivity to aspirin

Primary outcomes:
measure: improvement in acne scars as per Goodman and baron scale
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Hayatabad Medical Complex
state: KPK
Study officials:
affiliation: Hayatabad Medical Complex Peshawar, KPK pakistan
name: khizar hayat, MBBS
role: STUDY_CHAIR
References:
Clinical trial NCT03790618: Effect of Stimulant Drugs on Social Perception
Official title: Effect of Stimulant Drugs on Social Perception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
MDMA ('Ecstasy')
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2018-12-31
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study will improve our understanding of the "prosocial" effects of ± 3,4-Methylenedioxymethamphetamine (MDMA), relative to a prototypical stimulant, methamphetamine (MA). The investigators seek to characterize the "uniquely social" effects of MDMA.


Eligibility criteria: Inclusion Criteria:

* High school degree
* English fluency
* Healthy
* Has used MDMA

Exclusion Criteria:

* Pregnant or trying to become pregnant
* Any medical or psychiatry condition

Primary outcomes:
measure: Responses to Affective Touch
timeFrame: End of study (time 0 and approximately six weeks later)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
References:
Clinical trial NCT02936518: Anterior Lingual Frenectomy is Inadequate in Improving Breastfeeding Outcomes: a Prospective Cohort Study
Official title: Anterior Lingual Frenectomy is Inadequate in Improving Breastfeeding Outcomes: a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankyloglossia
Breastfeeding
Keywords: ankyloglossia
breastfeeding
lip tie
Lead sponsor: The Oregon Clinic
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 55
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A previously published study (https://www.ncbi.nlm.nih.gov/pubmed/27641715) identified breastfeeding improvements following lingual frenotomy and/or maxillary labial frenectomy. In the previous cohort, babies were excluded from the study if they had previously undergone an attempted frenotomy prior to seeing the P.I. in the office. The proposed study will only look at those babies who did undergo a previous frenotomy to determine:

1. the presence of continued problematic breastfeeding symptoms
2. if further tongue tie or lip tie release improves those outcomes


Eligibility criteria: Inclusion Criteria:

* Healthy babies who are breastfeeding
* Had a previous frenotomy prior to presenting to the P.I.

Exclusion Criteria:

* Twins, triplets
* Maternal breast surgery or IGT
* Premature birth
* Significant heart/lung/brain disease of infant

Primary outcomes:
measure: Nipple pain
timeFrame: 1 week post-procedure
measure: Reflux (i-GERQ-R)
timeFrame: 1 week and 1 month post-procedure
measure: Maternal breastfeeding self-efficacy (BSES-SF)
timeFrame: 1 week and 1 month post-procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: O'Callahan C, Macary S, Clemente S. The effects of office-based frenotomy for anterior and posterior ankyloglossia on breastfeeding. Int J Pediatr Otorhinolaryngol. 2013 May;77(5):827-32. doi: 10.1016/j.ijporl.2013.02.022. Epub 2013 Mar 22.
citation: Geddes DT, Langton DB, Gollow I, Jacobs LA, Hartmann PE, Simmer K. Frenulotomy for breastfeeding infants with ankyloglossia: effect on milk removal and sucking mechanism as imaged by ultrasound. Pediatrics. 2008 Jul;122(1):e188-94. doi: 10.1542/peds.2007-2553. Epub 2008 Jun 23.
citation: Ghaheri BA, Cole M, Fausel SC, Chuop M, Mace JC. Breastfeeding improvement following tongue-tie and lip-tie release: A prospective cohort study. Laryngoscope. 2017 May;127(5):1217-1223. doi: 10.1002/lary.26306. Epub 2016 Sep 19.
Clinical trial NCT01214018: Evaluation of Post-traumatic Stress Among the Nearest Relatives of Brain-dead Organ Donors
Official title: Evaluation of Post-traumatic Stress Among the Nearest Relatives of Brain-dead Organ Donors: Comparison With the Nearest-relatives of Brain-dead Patients Who Were Not Organ Donors for Medical or Legal Reasons, or Because of Donation Opposition
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Stress Disorders, Post-Traumatic
Tissue Donors
Tissue and Organ Procurement
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2010-10-04
Enrollment: 91
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants are the nearest relatives of brain-dead patients

Brief summary: The goal is to compare post tramautic stress between the nearest relatives of brain-dead patients who are organ donor to those of brain-dead patients who are not organ donors for medical, legal or opposition reasons.


Eligibility criteria: Inclusion Criteria:

* must be one of the following: person-of-trust previously designated by the deceased, a spouse, sibling, parent, or child of the deceased

Exclusion Criteria:

* refusal to participate
* does not speak French
* deaf/mute
* adult, but under guardianship

Primary outcomes:
measure: Proportion of participants with an IES score > 37
timeFrame: 2 hours
Secondary outcomes:
measure: The IES score
timeFrame: 2 hours
measure: Hospital Depression and Anxiety Score (HDAS)
timeFrame: 2 hours
Other outcomes:
Locations:
city: Avignon
country: France
facility: CH Henry Duffaut
city: Beziers
country: France
facility: Centre Hospitalier Général
city: Montpellier Cedex 05
country: France
facility: Hôpital Guy de Chauliac, CHU de Montpellier
city: Nimes
country: France
facility: Centre Hospitalier Universitaire de Nîmes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Caroline Boutin, MD
role: PRINCIPAL_INVESTIGATOR
References: