louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01893879: Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema
Official title: Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema in High Risk Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lymphedema
Unspecified Adult Solid Tumor, Protocol Specific
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2013-07-09
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized clinical trial studies an investigational drug in preventing lymphedema in patients at high risk after undergoing axillary lymph node dissection. The study drug may prevent lymphedema in patients undergoing axillary lymph node dissection.

Detailed description: PRIMARY OBJECTIVES:

I. To evaluate the efficacy of study drug in improving chronic lymphedema while further elucidating the role of inflammatory and lymphangiogenic processes in the pathogenesis of this disease.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive study drug orally (PO) thrice daily (TID) for up to 1 year in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 5 years.

Eligibility criteria: Inclusion Criteria:

* Axillary lymph node dissection within the preceding 12 months

Exclusion Criteria:

* Patients with active cancer
* Patients with lymphedema
* Infection or bleeding tendency
* Patients with medical contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs), including history of allergies, know gastrointestinal intolerance
* Other serious systemic illness (e.g., renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would impair the patients' ability to participate
* Persons not competent to consent
* Patients on aspirin therapy
* Minors (\< 18 years of age)
* Pregnant and/or lactating women
* Males

Primary outcomes:
measure: Number of Participants With Incidence of Lymphedema
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Hospitals and Clinics
state: California
Study officials:
affiliation: Stanford University Hospitals and Clinics
name: Stanley Rockson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01034579: The REbif® vs Glatiramer Acetate in Relapsing Multiple Sclerosis Pharmacogenetics Trial
Official title: A Multinational, Multicenter, Single Blood Sampling Exploratory Pharmacogenetic Study of the REGARD (the REbif® vs Glatiramer Acetate in Relapsing MS Disease) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Relapsing Multiple Sclerosis
Keywords: Biomarkers
Genetic markers
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
First posted: 2009-12-17
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study, REbif® vs Glatiramer acetate in relapsing multiple sclerosis (MS) disease - pharmacogenetic(s) (REGARD-PGx) is a single blood sampling exploratory pharmacogenetic study of the REGARD trial.

The aim of this trial is to provide additional data on the factors influencing interferon (IFN) beta response.

This is a Phase 4 trial involving subjects who previously participated in the REGARD trial. To address the trial objectives, a single visit follow-up trial will be performed during which a blood sample will be collected.


Eligibility criteria: Inclusion Criteria:

* Was randomized in the REGARD 24735 study
* Is willing and able to comply with the protocol
* Has given written informed consent before performing any trial-related activities

Exclusion Criteria:

* Is unwilling or unable to participate in the study
* Is already included in the initial REGARD 24735 PGx sub-study

Primary outcomes:
measure: Percentage of Responders as Defined by Single Nucleotide Polymorphism (SNP) Markers
timeFrame: Day 1 of EMR200136_023 study
Secondary outcomes:
measure: Number of Participants With Confirmed Expanded Disability Status Scale (EDSS) Progression as Defined by SNP2 Marker
timeFrame: Day 1 of EMR200136_023 study
measure: Change in Time Constant 1 Gadolinium (T1 Gd) Enhancing Lesion Volume as Defined by SNP3 and SNP4 Markers
timeFrame: Baseline (Day 1 of 24735 [NCT00078338] study) and Day 1 of EMR200136_023 study
measure: Change in Brain Volume as Defined by SNP2 Marker
timeFrame: Baseline (Day 1 of 24735 [NCT00078338] study) and Day 1 of EMR200136_023 study
measure: Mean Number of Time Constant 2 (T2) Active Lesions Per Subject Per Scan as Defined by SNP5 Marker
timeFrame: Day 1 of EMR200136_023 study
Other outcomes:
Locations:
city: Rockland
country: United States
facility: Please Contact U.S. Medical Information Located in
state: Massachusetts
Study officials:
affiliation: Merck Serono S.A., Geneva
name: Elisabetta Verdun di Cantogno, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03023579: The Star Excursion Balance Test: Analysis of Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Search MeSH
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 8
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: PURPOSE: The investigators estimated the reliability, standard error of measurement (SEM), and minimum detectable change (MDC) of the star excursion balance test (SEBT) in children with cerebral palsy (CP).

METHODS: Eight children with CP (four boys and four girls, sixteen legs) participated in this study. Each child carried out the SEBT and was assessed by two examiners. To determine intra-rater reliability, the investigators calculated the intra-class correlation coefficient (ICC) model (3,3). The investigators also calculated the ICC model (2,3) to determine the inter-rater reliability.


Eligibility criteria: Inclusion Criteria:

* were aged between 4 and 12 years,
* had a status above level II on the Gross Motor Function Classification System (GMFCS),
* were able to understand instructions from the rater, and

Exclusion Criteria:

* had history of fracture or sprain of the lower limbs over the previous 12 months.

Primary outcomes:
measure: The star excursion balance test
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04215679: Effect of Motor Imagery With Virtual Reality in Patients With Stroke
Official title: Comparison of Three Dimensional Virtual Reality Therapy and Motor Imaging in Functional Recovery of Upper Extremity After Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Virtual reality
Rehabilitation
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The first group of the study is immersive virtual reality therapy (IVR), the second group is motor imagery therapy (MI), and the third group is the conventional physiotherapy group (CG).
Primary purpose: TREATMENT

Brief summary: Virtual reality applications in hemiplegia rehabilitation are gaining popularity. It is claimed that, apart from implementing a function, imagining that function can trigger synaptic connections.

Detailed description: Although the effects of non-three-dimensional virtual reality and motor imagination on the brain have been investigated in a study, such comparison has not been made between the three-dimensional virtual reality and motor imagery.

Considering these situations, the aim of this study is to compare the effect of three-dimensional (immersive) virtual reality and motor imagery on upper extremity functional recovery after stroke.

Eligibility criteria: Inclusion Criteria:

* Diagnosed as stroke patient.
* Speaks, reads and writes in Turkish.
* Hand functions at 4, 5, 6 levels according to Brunnstrom.
* Mini mental test score to be at least 24.
* Volunteer for participation.

Exclusion Criteria:

* Neurological, orthopedic problems other than stroke.
* To have motion sickness that cannot continue 3D application.
* Individuals neglecting the affected side

Primary outcomes:
measure: Jebsen Hand Function Test
timeFrame: 6 weeks
measure: Action Reach Arm Test (ARAT)
timeFrame: 6 weeks
Secondary outcomes:
measure: Stroke impact scale (SIS)
timeFrame: 6 weeks
measure: Kinesthetic and visual imagery questionnaire
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal University
state: Merkez
Study officials:
affiliation: Bolu Abant Izzet Baylsa University
name: Mustafa Fatih Yaşar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bolu Abant Izzet Baylsa University
name: Ramazan KURUL, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Bolu Abant Izzet Baylsa University
name: Muhammed Nur Ögün, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bolu Abant Izzet Baylsa University
name: Şebnem AVCI, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT03431779: Lipofilling as a Treatment for Vestibulodynia
Official title: Adipose Derived Stem Cell Transplantation Via Lipofilling for Vestibulodynia: a Controlled Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibulodynia
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: However, subjects in the lipofilling group will be able to undergo surgery (excision) 3 months after the lipofilling of this intervention did not have the requested effect.
Primary purpose: TREATMENT

Brief summary: The investigators would like to investigate if lipofilling with its adipose derived stem cells (ADSC) could be a new, less invasive but equally or more effective therapeutic option for women with vestibulodynia than vestibulectomy. The investigators expect the study to be successful because of the anti-inflammatory effects of the ADSC and its effectiveness -although not thoroughly studied- in some neuropathic pain disorder like pudendal neuralgia or post mastectomy pain syndrome.

Method: A controlled intervention study: one group receiving golden standard therapy 'vestibulectomy' and one group receiving vestibular lipofilling.


Eligibility criteria: Inclusion Criteria:

* Vestibulodynia requesting surgery

Exclusion Criteria:

-

Primary outcomes:
measure: Q-tip scores (Cotton swab assessment of vaginal pain) 3 months after surgery
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
References:
Clinical trial NCT03906279: Choroidal Thickness Change in Response to Physiological and Refractive Changes
Official title: Automatic Measurements of Choroidal Thickness Change in Response to Physiological and Refractive Changes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Refractive Errors
Accommodation Disorder
Lead sponsor: Wrocław University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Wroclaw Medical University
First posted: 2019-04-08
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with refractive error

Brief summary: There is a great need for precise and repeatable measurements of the choroidal thickness. Including the diurnal physiological changes, accommodation and refractive error impact on those measurements.


Eligibility criteria: Inclusion Criteria:

* participants with refractive error
* willing and able to understand and sign an informed consent form

Exclusion Criteria:

* patient unable to participate in the study
* any disease that causes visual opacity of optic media that unable to perform OCT scanning
* current enrolment in another clinical trial/research project

Primary outcomes:
measure: Submacular choroidal thickness
timeFrame: 1 day
measure: Peripapillar choroidal thickness
timeFrame: 1 day
Secondary outcomes:
measure: Axial length of the globe
timeFrame: 1 day
measure: Anterior chamber depth - optical biometry
timeFrame: 1 day
measure: Phakic lens thickness
timeFrame: 1 day
measure: White to white diameter
timeFrame: 1 day
measure: Angle to angle diameter of anterior chamber
timeFrame: 1 day
measure: Anterior chamber depth - OCT
timeFrame: 1 day
measure: Corneal keratometry (steep meridian and its axis and flat meridian with its axis)
timeFrame: 1 day
measure: Spherical ametropia with cylindrical power of correcting lenses
timeFrame: 1 day
measure: Best-corrected visual acuity
timeFrame: 1 day
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Department of Optics and Photonics
Study officials:
affiliation: Wrocław University of Science and Technology
name: Joanna Przeździecka-Dołyk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06338579: Overview of Self-medication Among French Navy Personnel
Official title: Overview and Determinants of Self-medication Among Personnel Deployed on French Navy Surface Ships
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Self Medication
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteers, or participants with well-controlled chronic pathologies enabling them to be fit for embarkation, military personnel currently deployed for at least 4 weeks on a naval base surface ship

Brief summary: The goal of this cross-sectional descriptive observational study is to assess the extent of self-medication among the crews of surface ships at the Toulon naval base. This study could include healthy volunteers, or participants with well-controlled chronic pathologies enabling them to be fit for embarkation, who are currently being deployed for at least 4 weeks on a surface ship at the naval base.

Participants will tick and complete a questionnaire (between 15 and 30 minutes) after 4 consecutive weeks on the ship.


Eligibility criteria: Inclusion Criteria:

* French military personnel;
* age \> 18;
* embarked on a French navy vessel from the naval base;
* for a minimum 4-week mission;
* covered by social security.

Exclusion Criteria:

* Refusal to participate,
* Legionnaire
* Military Health Services member

Primary outcomes:
measure: percentage of patients who have self-medication
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03854279: Comparison of Bizact With Electroscissor for Tonsillectomy
Official title: Bizact Versus Electroscissor for Adult Tonsillectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Tonsillar Hypertrophy, Tonsillitis
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2019-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In a randomized, partly double-blind prospective setup we want to compare traditional adult electro-scissor tonsillectomy With ultrasound Technology, Bizact.


Eligibility criteria: Inclusion Criteria:

* planned elective tonsillectomy
* informed consent

Exclusion Criteria:

* regular use of analgesics pre-operatively
* known tendency of bleeding
* not able to communicate in Norwegian

Primary outcomes:
measure: Postoperative pain: Number of days With need of analgesics
timeFrame: 2 weeks
Secondary outcomes:
measure: Postoperative pain: Dose need of pain killers during first 24 hr postoperatively
timeFrame: 24 hrs
measure: Postoperative bleeding
timeFrame: 2 weeks
measure: Per-operative bleeding
timeFrame: per-operative
measure: Duration of surgery
timeFrame: 0 - 1 hr
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Dept of Anesthesiology, Oslo University Hospital, Ullevaal
Study officials:
References:
Clinical trial NCT05691179: COVID-19 Infection and Idiopathic Membranous Nephropathy
Official title: The Association of COVID-19 Infection and Relapse of Idiopathic Membranous Nephropathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Idiopathic Membranous Nephropathy
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Pinggu District Hospital
name: Beijing Fangshan District Liangxiang Hospital
First posted: 2023-01-19
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All eligible IMN patients with COVID-19 infection can be enrolled.

Brief summary: Infection is one of common risk factors for relapsing of idiopathic membranous nephropathy (IMN). However, it is still unclear wheather COVID-19 infection can induce the relapsing of IMN. Herein, in this prospective, multi-center, cohort study, the investigator enrolled the IMN patients with COVID-19 infection.

All subjects will be followed for three months with four visits at 1, 2 and 3 months. Then the investigator will compare the rate of replase of IMN in the two groups to evaluate the association of COVID-19 infection and replapse of IMN.


Eligibility criteria: Inclusion Criteria:

1. the status of nephrotic syndrome is complete remmision or partial remmision;
2. estimated glomerular filtration rate (eGFR according to the CKD-EPI formula) ≥60 mL/min per 1.73 m2;
3. patients with a moderate risk of IMN.

Exclusion Criteria:

1. secondary causes of MN;
2. the labarotary data two months before enrolement is absent.

Primary outcomes:
measure: primary outcome
timeFrame: 3 months
Secondary outcomes:
measure: secondary outcome
timeFrame: 0.5, 1, and 2 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friedship Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Pinggu Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Liangxiang Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01531179: Lactobacillus Reuteri for Prevention of Necrotizing Enterocolitis in Very Low-birth Weight Infants
Official title: Role Of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis in Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Necrotizing Enterocolitis
Very Low Birth Weight Infants
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2012-02-10
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in newborn infants whose birth weights are \< 1500 g. Although bifidobacterium and other lactobacilli spp. have been used to reduce the incidence of necrotizing enterocolitis in clinical trials, Lactobacillus reuteri has not been used in the prevention of necrotizing enterocolitis in very low birth weight infants yet. The objective of this study is to evaluate the efficacy of orally administered Lactobacillus reuteri in reducing the incidence and severity of necrotizing enterocolitis in very low birth weight infants.


Eligibility criteria: Inclusion Criteria:

* Very low birth weight infants \< 1500 gr
* Gestational age \< 32 weeks

Exclusion Criteria:

* Genetic anomalies
* Short bowel syndrome
* Not willing to participate
* Allergy to Lactobacillus reuteri components

Primary outcomes:
measure: Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants
timeFrame: up to 6 months
Secondary outcomes:
measure: Effect of Lactobacillus reuteri on culture proved sepsis
timeFrame: up to 6 months
measure: Effect of Lactobacillus reuteri on weight gain
timeFrame: up to 6 months
measure: Effect of Lactobacillus reuteri on length of hospital stay
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity Teaching Hospital, Neonatology Unit
Study officials:
affiliation: Neonatology
name: Mehmet Yekta Oncel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oncel MY, Sari FN, Arayici S, Guzoglu N, Erdeve O, Uras N, Oguz SS, Dilmen U. Lactobacillus Reuteri for the prevention of necrotising enterocolitis in very low birthweight infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F110-5. doi: 10.1136/archdischild-2013-304745. Epub 2013 Dec 5.