louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03366259: Prostaglandins Before Caserean Section
Official title: Does the Administration of Prostaglandins Before Cesarean Section Reduce the Amount of Blood Loss ?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Intrapartum Hemorrhage
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 160
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of our study is to assess the value of administration of prostaglandins before cesarean section to reduce the amount of blood loss

Detailed description: 160 full term pregnant patients candidate for elective cesarean section were randomly allocated into 2 groups ,80 patients will receive 200mcg of rectal prostaglandins before cesarean section and 80 patients are used as control receiving placebo

Eligibility criteria: Inclusion Criteria:pregnant patients full term elective cesarean section

-

Exclusion Criteria:

* medical disorder with pregnancy

Primary outcomes:
measure: amount of intraoperative blood loss
timeFrame: during cesarean section
measure: postpartum hemorrhage
timeFrame: 24 hour after cesarean section
Secondary outcomes:
measure: fetal condition
timeFrame: 5 minutes after cesarean section
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr El Ainiy Hospital
Study officials:
References:
Clinical trial NCT01369459: Medication Integration in Treatment of Comorbid Adolescent Substance Users/Attention Deficit Hyperactivity Disorder
Official title: Family-Based Protocol for Medication Integration in Treatment of Comorbid ASU/ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Attention Deficit Hyperactivity Disorder
Attention Deficit Disorder
Keywords: Comorbid
ADHD
SUD
ASU
Lead sponsor: The National Center on Addiction and Substance Abuse at Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-06-09
Enrollment: 14
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this project is to develop and test a brief protocol designed to systematically integrate pharmacological interventions for Attention Deficit Hyperactivity Disorder (ADHD) into behavioral treatment services for adolescent substance users with co-morbid ADHD in everyday care. Primary study aims will yield proof-of-concept data on MIP feasibility and fidelity in usual care and evidence of MIP impact on psychiatric and behavioral services utilization, medication acceptance and compliance, and satisfaction with treatment services.


Eligibility criteria: Inclusion Criteria:

* Age 13-17 years
* Caregiver able to participate in treatment
* One day of alcohol use to intoxication or illegal drug use in the past 30 days (or 30 days prior to living in a controlled environment)
* endorsement of one or more DSM-IV symptoms of Substance Use or Alcohol Dependence/Abuse
* meet ASAM criteria for outpatient substance use treatment
* meet DSM-IV criteria for ADHD (with or without onset prior to age 7)
* not enrolled in any behavioral treatment

Exclusion Criteria:

* MDD
* Bipolar Disorder
* Mental Retardation
* PDD
* medical or psychiatric illness requiring hospitalization
* current psychotic features
* currently suicidal

Primary outcomes:
measure: Mini International Neuropsychiatric Interview (MINI) Version 5.0
timeFrame: Follow-up in 3 months
Secondary outcomes:
measure: Behavior Rating Inventory of Executive Function (BRIEF)
timeFrame: Follow-up at 3-months
Other outcomes:
Locations:
city: New York
country: United States
facility: Roberto Clemente Center
state: New York
Study officials:
affiliation: The National Center on Addiction and Substance Abuse at Columbia University
name: Aaron T Hogue, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06224959: Migraine and Neuropathic Pain in Osteoarthritis
Official title: Prevalence of Migraine and Neuropathic Pain in Osteoarthritis: Multicenter, Multidisciplinary, Cross-sectional Epidemiological Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarthritis
Migraine
Neuropathic Pain
Keywords: osteoarthritis
migraine
neuropathic pain
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with articular and/or spinal osteoarthritis, under the care of the University Hospital of Clermont-Ferrand (Rheumatology, Physical Medicine and Rehabilitation, Sports Medicine, Occupational Health and Environment, Orthopedics), and/or managed by specialized professionals (general practitioners, sports physicians, rheumatologists, rehabilitation specialists, orthopedic surgeons) in private medical practice

Brief summary: The goal of this observational study is to estimate the frequency of neuropathic pain and migraines in a group of patients with osteoarthritis of the knees, hips, hands, spine or other joints. In addition to their usual care for osteoarthritis, participants will complete questionnaires to define migraine and neuropathic pain.

Detailed description: This study will be proposed to patients with osteoarthritis who come for their routine consultation. If the patient has no abjection to taking part in the study, the doctor will give them the questionnaires to fill in. The questionnaires are about: perception of pain , depression and anxiety, how patients manage their disease emotionally, migraine, neuropathic pain, functional ability, osteoarthritis assessment.

Eligibility criteria: Inclusion Criteria:

* patients over 18 years old
* patients with articular or/and spinal osteoarthritis
* affiliation to a social security system.
* able to read and understand french

Exclusion Criteria:

* patients who refuse to participate in the study
* patients unable to complete self-questionnaires
* minors or adults under the protection of the law or under the protection of justice

Primary outcomes:
measure: the presence of neuropathic pain in patients
timeFrame: 10 minutes
measure: the presence of migraine in patients
timeFrame: 10 minutes
Secondary outcomes:
measure: the presence of anxiety and depression symptoms in patients
timeFrame: 10 minutes
measure: measure the level of catastrophizing thoughts related to pain in patients
timeFrame: 10 minutes
measure: Impact of headhache in patients
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Sylvain MATHIEU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04429659: Changes in Refractive Error in Patients With Both Partially Refractive Esotropia and Amblyopia
Official title: Changes in Refractive Error in Patients With Both Partially Refractive Esotropia and Amblyopia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractive Errors
Esotropia
Amblyopia Strabismic
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 58
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: study population was composed of amblyopic children with partially refractive ET.

Brief summary: To investigate changes in refractive errors and evaluate clinical outcomes of strabismus surgery in patients with both amblyopia and partially refractive esotropia (PAET).Amblyopic patients with PAET were enrolled. Non-amblyopic patients with full refractive accommodative esotropia (RAET) were included in the study as a control group. Preoperative and postoperative best corrected visual acuity (BCVA), spherical equivalent (SE), astigmatism, stereoacuity and deviations at near and distance were evaluated and statistically compared in the patient group. The mean BCVA, SE, astigmatism were compared between the patient and the control groups.

Detailed description: Purpose: To investigate changes in refractive errors and evaluate clinical outcomes of strabismus surgery in patients with both amblyopia and partially refractive esotropia (PAET).

Material-Method: Amblyopic patients with PAET were enrolled. Non-amblyopic patients with full refractive accommodative esotropia (RAET) were included in the study as a control group. Preoperative and postoperative best corrected visual acuity (BCVA), spherical equivalent (SE), astigmatism, stereoacuity and deviations at near and distance were evaluated and statistically compared in the patient group. The mean BCVA, SE, astigmatism were compared between the patient and the control groups.

Eligibility criteria: Inclusion Criteria:

amblyopic children with partially refractive accommodative esotropia as study group non- amblyopic children with fully refractive accommodative esotropia as control group

-

Exclusion Criteria:

Systemic diseases Neurological disorders and diseases Additional ocular diseases

Primary outcomes:
measure: spherical equivalent
timeFrame: 36 months
measure: cylindirical error
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya University Ophthalmology Department
Study officials:
affiliation: Sakarya University
name: Burcin Cakir, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00228059: An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder.
Official title: A 52-week, Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 750- 2000 mg/Day in the Treatment of Manic Episodes of Bipolar I Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar I Disorder
Keywords: Bipolar disorder, manic episode/treatment/licarbazepine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-28
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This extension study is designed to investigate the long-term safety and tolerability of licarbazepine 750-2000 mg/day over 52 weeks in patients who completed the 3-week double-blind study CLIC477D2301.

Detailed description: A 52-week, open-label extension study to evaluate the safety and tolerability of licarbazepine 750- 2000 mg/day in the treatment of manic episodes of bipolar I disorder

Eligibility criteria: Inclusion Criteria:

1. written informed consent provided prior to participation in the extension study
2. successful completion of study CLIC477D2301
3. willingness and ability to comply with all study requirements

Exclusion Criteria:

1. premature discontinuation from study CLIC477D2301
2. failure to comply with the study CLIC477D2301 protocol

Primary outcomes:
measure: Safety and tolerability of licarbazepine with respect to adverse events, serious adverse events, changes in laboratory values, ECGs and vital signs.
Secondary outcomes:
Other outcomes:
Locations:
city: Cerritos
country: United States
facility: Investigational Site
state: California
Study officials:
affiliation: Novartis
name: Novartis Pharmcuticals
role: STUDY_CHAIR
References:
Clinical trial NCT01789359: Urinary Excretion of Anthocyanins During Long Term Blueberry Feeding
Official title: Urinary Excretion of Anthocyanins During Long Term Blueberry Feeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bioavailability
Keywords: anthocyanin
bioavailability
urine
long-term
Lead sponsor: Atlantic Food and Horticulture Research Center
Sponsor class: OTHER_GOV
First posted: 2013-02-12
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Essentially all of the published data on anthocyanin absorption in humans are from short term studies - a few days or less, most typically 24 h. However human studies demonstrating clinical effects are typically conducted for several weeks or even months. To examine how anthocyanin absorption and metabolism may be affected this study will examine urinary excretion of anthocyanins over one month, followed by a one week washout, and then one more dose of blueberry juice.


Eligibility criteria: Inclusion Criteria:

* Provided written consent (see: Information and Consent Form)
* Fluent in English
* Complete a confidential medical questionnaire (Appendix 6)
* Able and willing to abide by the dietary restrictions as described
* Able and willing to abide by the urine collection protocols as described

Exclusion Criteria:

* No written consent
* No confidential medical questionnaire
* Unable to comply with diet restrictions and other study requirements

Primary outcomes:
measure: Anthocyanins and Phase 2 anthocyanin conjugates in urine
timeFrame: 5 weeks
Secondary outcomes:
measure: White blood cell gene expression at start and end of study
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Kentville
country: Canada
facility: Atlantic Food & Horticulture Research Centre
state: Nova Scotia
Study officials:
affiliation: Research Scientist
name: Wilhelmina - Kalt, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kalt W, Liu Y, McDonald JE, Vinqvist-Tymchuk MR, Fillmore SA. Anthocyanin metabolites are abundant and persistent in human urine. J Agric Food Chem. 2014 May 7;62(18):3926-34. doi: 10.1021/jf500107j. Epub 2014 Jan 27.
Clinical trial NCT01529359: Irritable Bowel Syndrome and Lactibiane Tolerance
Official title: Effect of Lactibiane Tolerance on Symptoms Severity of Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome
Probiotics
Lead sponsor: Larena SAS
Sponsor class: INDUSTRY
First posted: 2012-02-08
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of a probiotic combination (Lactibiane Tolerance) on the severity of symptoms in patients with irritable bowel syndrome (IBS).

Detailed description: The primary purpose of this study is to evaluate the effects of a probiotic combination (Lactibiane Tolerance) on the severity of symptoms in patients with irritable bowel syndrome (IBS).

The secondary purposes are to evaluate the effects of the intervention on:

* quality of life
* severity of fatigue, anxiety and depression
* levels of inflammatory markers in blood and tools

Eligibility criteria: Inclusion Criteria:

* Irritable bowel syndrome according to the Rome II criteria
* 150\< Francis Score \< 300
* HAD score inferior or egal to 25

Exclusion Criteria:

* History of hypersensitivity to one of the composant of the product
* Use of probiotics or antibiotics last four weeks
* use of prohibited drugs
* bowel preparation for morphological examination last month
* pregnancy or lactation
* immundepressed or co-existing other serious illness or evolutive

Primary outcomes:
measure: Severity of bowel symptoms according to the Francis Score
timeFrame: After 6 weeks of complementation
Secondary outcomes:
measure: Quality of life
timeFrame: after 6 weeks of complementation
measure: Severity of Anxiety/Depression
timeFrame: after 6 weeks of complementation
measure: Impact of the complementation on fatigue
timeFrame: after 6 weeks of complementation
measure: Impact of the intervention on immunological parameters in stools
timeFrame: after 6 weeks of complementation
measure: Impact of the intervention on immunological parameters in blood
timeFrame: after 6 weeks of complementation
measure: Severity of bowel symptoms according to the Francis Score
timeFrame: after 2 weeks of wash-out
measure: Quality of life
timeFrame: after 2 weeks of wash-out
measure: severity of the anxiety/depression
timeFrame: after 2 weeks of wash-out
measure: Impact of the complementation on fatigue
timeFrame: After 2 weeks of wash out
measure: Impact of the intervention on immunological parameters in stools
timeFrame: after 2 weeks of wash out
measure: Impact of the intervention on immunological parameters in blood
timeFrame: after 2 weeks of wash-out
Other outcomes:
Locations:
city: Nice
country: France
facility: Chu L'Archet 2
state: Alpes Maritimes
Study officials:
name: Piche Thierry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04655859: Thiol/Disulfide and Oxidative Stress
Official title: Evaluation of Saliva Thiol/Disulfide Homeostasis and Oxidative Stress in Children With Severe Early Childhood Caries by a Novel Method- Part 1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Early Childhood Caries
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: the children with severe early childhood caries which are 3-5 years

Brief summary: The aim of this study was to evaluate the role of thiol/disulfide homeostasis and oxidative stress in the saliva of children with severe early childhood caries


Eligibility criteria: Inclusion Criteria:

* 3-5 years

Exclusion Criteria:

* the children with systemic illness, using anti-inflammatory drug

Primary outcomes:
measure: thiol/disulfide homeostasis
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Aslı Soğukpınar
Study officials:
References:
Clinical trial NCT01803659: Effect of Small Daily Doses of B-carotene on Breast Milk Retinol
Official title: Effect of Small Daily Doses of B-carotene or Vitamin A on Breast Milk Retinol Concentration in Lactating Filipino Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin A Status
Keywords: b-carotene
breastmilk
vitamin A
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Helen Keller International
First posted: 2013-03-04
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to determine whether breast milk retinol concentration increases in response to daily supplementation with small amounts of vitamin A (\~600 ug RAE/d), as either a b-carotene or retinyl palmitate, 6 d/week for 3 weeks. A secondary purpose is to evaluate sampling methods for collecting breast milk samples in a community setting. The results of this pilot study will allow us to determine whether milk retinol is a useful indicator for evaluating the impact of food-based interventions on the vitamin A status of lactating women.


Eligibility criteria: Inclusion Criteria:

* lactating women breastfeeding a single infant 4-12 months of age

Exclusion Criteria:

* chronic disease
* breastfeeding more than one infant
* severe anemia
* signs or symptoms of vitamin A deficiency

Primary outcomes:
measure: breast milk retinol concentration
timeFrame: 3 weeks
Secondary outcomes:
measure: plasma retinol concentration
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California, Davis
state: California
Study officials:
References:
Clinical trial NCT04974359: A Study to Evaluate Lu AG06466 in Participants With Fibromyalgia
Official title: Interventional, Randomized, Double-Blind, Crossover, Placebo-Controlled, Multiple-Dose Lu AG06466 Phase IB Study in Patients With Fibromyalgia Using Neuroimaging to Investigate Its Pharmacodynamic Effects on Central Pain Processing and Neuroinflammation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Fibromyalgia
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2021-07-23
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out the effect of Lu AG06466 on the body in participants with fibromyalgia by assessing pain levels, brain signal changes, and psychiatric (mental) assessments.

Detailed description: This study will include 2 treatment periods and will utilize a crossover study design with a 7- to 14-day washout period between each 22-day treatment period.

Eligibility criteria: Inclusion Criteria:

* The participant has a body mass index (BMI) of ≥18.5 and ≤38.0 kilograms (kg)/square meter (m\^2).
* The participant has a fibromyalgia diagnosis, with self-reported pain visual analogue scale (VAS) score \>4, based on a self-reported pain diary assessed for a minimum of 4 out of 7 days prior to the Baseline Visit.
* The participant is, in the opinion of the investigator, eligible based on medical history, a physical examination, a neurological examination, vital signs (including orthostatic vital signs), an electrocardiogram (ECG), and the results of the clinical chemistry, hematology, urinalysis, serology, and other laboratory tests.

Exclusion Criteria:

* The participant has a disease, including clinically significant liver disease of any origin, or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.
* The participant has any other disorder for which the treatment takes priority over the treatment of fibromyalgia in this study or is likely to interfere with the study treatment or impair treatment compliance.

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Blood Oxygene Level Dependent (BOLD) Response in the Evoked-Pain Test
timeFrame: Day 22 of each 22-day treatment period
measure: Change in Resting State fMRI (rsfMRI) Functional Connectivity, Assessed by Voxelwise Connectivity Maps Based in Seed Voxels
timeFrame: Day 22 of each 22-day treatment period
measure: fMRI Data: BOLD Percent Signal Change Under Conditions of Visual Stimulation Versus Fixation
timeFrame: Day 22 of each 22-day treatment period
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Collaborative NeuroScience Network LLC
state: California
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: