louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05073393: Effect of Probiotics on Oral Homeostasis During Sugar Stress
Official title: Effect of Probiotics on Oral Homeostasis During Sugar Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Probiotics
Gingivitis
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Deerland Probiotics and Enzymes
First posted: 2021-10-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded randomized clinical trial with a test and placebo group
Primary purpose: PREVENTION

Brief summary: The present study is a double-blinded randomized clinical trial with a duration of 28 days.

Detailed description: The present study is a double-blinded randomized clinical trial with a duration of 28 days.

80 orally and systemically healthy participant will be allocated in the test (probiotic) and the control (placebo) group at baseline.

The intervention is sugar stress, which will be applied at baseline and continue through day 14, followed by 14 days without sugar stress.

Clinical measurements and sampling will be performed at baseline, day 14 and day 28

Primary endpoint: Changes in microbial composition.

Secondary endpoints: Changes in clinical and immunological parameters

Eligibility criteria: Inclusion Criteria:

* age \> 18 yrs.

Exclusion Criteria:

* Presence of oral diseases i.e. gingivitis, periodontitis and dental caries
* Current smokers
* Any systemic diseases and current use of any medication with known effect on oral health
* Use of systemic antibiotics within the latest three months.
* Age \< 18 yrs., and age \> 30 yrs.

Primary outcomes:
measure: Changes in microbial composition in dental plaque
timeFrame: Baseline vs. Day 14 and Day 28
Secondary outcomes:
measure: Changes in clinical parameters
timeFrame: Baseline vs. Day 14 and Day 28
measure: Changes in salivary levels of inflammatory cytokines
timeFrame: Baseline vs. Day 14 and Day 28
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen, Department of Odontology
Study officials:
References:
Clinical trial NCT03331393: The Value of Orencia in Rapidly Progressing Rheumatoid Arthritis
Official title: The Value of Orencia in Rapidly Progressing Rheumatoid Arthritis: A Chart Review Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rapidly-progressing RA patients initiating treatment with abatacept or TNFi at approximately 10 rheumatology practices across the US.

Brief summary: The purpose of this study is to investigate the value of Orencia in rapidly progressing Rheumatoid Arthritis (RA).


Eligibility criteria: Inclusion Criteria:

* 18 years of age at enrollment
* Confirmed diagnosed with RA
* Initiated first-line treatment with abatacept, adalimumab, etanercept, or infliximab with a record of the start date at the practice site

Exclusion Criteria:

* Does not have at least 1 or more poor RA prognostic factor: Evidence of joint erosions, Positive anti-CCP autoantibodies, Positive RF autoantibodies, Increased CRP levels, Increased ESR levels
* Was followed at the site for less than 1 year since biologic treatment initiation
* Patients with autoimmune diseases: Crohn's, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis, anal fistula

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: number of patients discontinuing treatment before completing 12 months of therapy
timeFrame: approximately 1 year
measure: time from treatment initiation to discontinuation
timeFrame: approximately 1 year
Secondary outcomes:
measure: Distribution of Healthcare Resource Utilization (HCRU)
timeFrame: approximately 1 year
measure: Disease Activity Score
timeFrame: approximately 1 year
measure: Health Assessment Questionnaire
timeFrame: approximately 1 year
measure: C-reactive Protein Levels
timeFrame: approximately 1 year
measure: Erythrocyte Sedimentation Rate
timeFrame: approximately 1 year
measure: Joint Erosions
timeFrame: approximately 1 year
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Local Institution
state: California
city: Gainesville
country: United States
facility: Local Institution - 0005
state: Georgia
city: Coeur d'Alene
country: United States
facility: Local Institution
state: Idaho
city: Eagan
country: United States
facility: Local Institution - 0007
state: Minnesota
city: Greensboro
country: United States
facility: Medication Management, LLC
state: North Carolina
city: Myrtle Beach
country: United States
facility: Local Institution
state: South Carolina
city: Richland
country: United States
facility: Local Institution
state: Washington
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03543293: Imaging Perilymphatic Fistulas After Barotrauma
Official title: Fast and Accurate Diagnosis of an Oval or Round Window Perilymphatic Fistula on CT and MRI, Without Injection, on 101 Patients With Surgical Confirmation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perilymphatic Fistulas
Keywords: perilymphatic fistulas
magnetic resonance imaging (MRI)
surgery
round window
vertigo
tinnitus
cophosis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient having undergone a rock scan or MRI of the middle ear at the Strasbourg University Hospital with surgical confirmation of the diagnosis (or reversal)

Brief summary: Our objective is to validate the CT / MRI combination of non-injected rock for the rapid positive diagnosis of perilymphatic fistulas.


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18
* Clinical suspicion of perilymphatic fistula
* Patient having undergone a rock scan or MRI of the middle ear at the Strasbourg University Hospital with surgical confirmation of the diagnosis (or reversal)

Exclusion Criteria:

- Refusal of the patient to participate in the study

Primary outcomes:
measure: Diagnosis of perilymphatic fistula
timeFrame: 1 hour after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Imagerie 1
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Francis VEILLON, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06997393: Prevention of Hand Eczema Among Workers in the Fishing Industry in Greenland
Official title: Prevention of Hand Eczema Among Workers in the Fishing Industry in Greenland: an Intervention Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hand Eczema
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: LEO Foundation
name: University of Copenhagen
name: Greenland University
name: Government of Greenland, Agency for Health and Prevention
First posted: 2025-05-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to investigate the effect of a prevention programme on hand eczema among workers in the Greenlandic fishing industry. This is a non-randomised clinical trial including employees at approximately three of Royal Greenland's fish processing facilities in Greenland.


Eligibility criteria: Inclusion Criteria:

* Employee in Royal Greenland, a state-owned company and one of the largest seafood enterprises in the world
* Written informed consent

Exclusion Criteria:

* Age below 18 years
* Inability to understand the Greenlandic, Danish or English language
* Pregnancy
* Other chronic skin diseases on the hands
* Receiving immunomodulatory therapies

Primary outcomes:
measure: Change from baseline in knowledge of hand eczema at 3 months
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Change from baseline in clinical severity of hand eczema at 3 months
timeFrame: From enrollment to the end of intervention at 12 weeks
Secondary outcomes:
measure: Change from baseline in patient-reported quality of life at 3 months
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Change from baseline in Patient Global Assessment of Disease Severity (PaGA) at 3 months
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Change from baseline in the number of self-reported days with absence from work due to hand eczema at 3 months
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Change from baseline in the number of participants being forced to change their job due to hand eczema at 3 months
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Change from baseline in the availability of protective equipment at 3 months
timeFrame: From enrollment to the end of intervention at 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06539793: Effect of Neuromodulation on Pain Biomarkers and Functional Outcome in Patients With Fibromyalgia Syndrome
Official title: Effect of Neuromodulation on Pain Biomarkers and Functional Outcome in Patients With Fibromyalgia Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia Syndrome
Keywords: Fibromyalgia
NEUROMODULATION
Centralization
PAIN BIOMARKERS
FUNCTIONAL OUTCOME
Lead sponsor: AlRyada University for Science & Technology
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Fibromyalgia is the third most common musculoskeletal condition in terms of prevalence, after lumbar pain and osteoarthritis. Its prevalence is around 2-4 % and is more frequent in women than in men; the prevalence is highest in age the range of 40-60 years.

Detailed description: Group A (Control Group): Patients will receive exercises, and sham Non-Invasive Neuromodulation, 3 sessions per week (one hour for each session) for 4 weeks.

Group B (Study Group): Patients will receive exercises as in group (A) in addition to Non-Invasive Neuromodulation 3 sessions per week (one hour for each session) for 4 weeks.

Eligibility criteria: Inclusion Criteria:

1. Patients fibromyalgia from both genders.
2. The duration of fibromyalgia is more than 6 month (all patients with history of cervical or lumbar pain) and following diagnosis of FM using the 2016 revised FM criteria, on the basis of the ACR-2010 criteria.
3. Their ages will be ranged from 25-35 years old.
4. They will be medically stable and have sufficient cognitive abilities that enable them to understand and follow instruction according to Montreal Cognitive Assessment (MoCA) \>26.

Exclusion Criteria:

1. Other Neurological diseases as stroke , multiple sclerosis, Parkinson's disease and motor neuron disease
2. Pacemaker
3. Spinal fusion-cervical or lumbar
4. Metal implants in the spine
5. Pregnancy
6. Epilepsy
7. Severe psychiatric disorder or alcohol and drug abuse.
8. Unstable medical condition which could compromise the participant's welfare or confound the study results.
9. Uncontrolled blood pressure or diabetes
10. Visual or auditory problems.
11. Active inflammatory conditions

Primary outcomes:
measure: Pain Numeric Pain Rating Scale
timeFrame: 4 weeks
measure: Biochemical analysis
timeFrame: 4 weeks
measure: Fibromyalgia Impact Questionnaire
timeFrame: 4 weeks
measure: Pressure Pain Thresholds
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sadat
country: Egypt
facility: Al Ryada University for Science and Technology
state: Menoufia
Study officials:
References:
Clinical trial NCT01552993: Registration and Treatment of Pain During Eye Examination of Prematurity
Official title: Registration and Treatment of Pain During Eye Examination of Prematurity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infant, Premature
Retinopathy
Keywords: prematurity
retinopathy
pain
acetaminophen
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2012-03-13
Enrollment: 5
Sex: ALL
Minimum age (years): 31
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to see if paracetamol has a pain-relieving effect during eye examination in premature infants.

Detailed description: Retinopathy of prematurity (ROP) is a feared complication of premature birth. If discovered in time, the disease can be treated, and impaired vision or blindness can be reduced. Premature infants are therefore examined regularly after birth. However, the examination is painful and stressful for the infant. Painful experiences might lead to a pathological stress response later in life and should therefore be prevented.

This is a double blinded, controlled and randomized study where the infants are examined and assessed either with or without the use of paracetamol.

Eligibility criteria: Inclusion Criteria:

* Infants \< 32 weeks of gestational age (\< 31+6 weeks)

Exclusion Criteria:

* Infants with ongoing analgesic treatment

Primary outcomes:
measure: pain
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St.Olavs University Hospital
state: Trondelag
Study officials:
affiliation: St.Olavs University Hospital
name: Hakon Bergseng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03209193: Effect of Anesthetics on Microcirculation in Patients Undergoing Off-pump Coronary Artery Bypass Surgery
Official title: Effect of Anesthetics on Microcirculation in Patients Undergoing Off-pump Coronary Artery Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Microcirculation
Anesthetic Complication Spinal
Keywords: off-pump coronary artery bypass
sevoflurane
desflurane
tissue oxygen saturation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Volatile anesthetics, such as sevoflurane and desflurane, are commonly used in patients undergoing cardiac surgeries including off-pump coronary artery bypass. However, the effect of volatile anesthetics on microcirculation in patients undergoing off-pump coronary artery bypass has not been well conducted.

Detailed description: This is a prospective randomized clinical trial investigating the effect of sevoflurane vs. desflurane on tissue microcirculation in patients undergoing off-pump coronary artery bypass surgery. Eligible patients are going to be randomized to receive sevoflurane or desflurane, as a maintenance anesthetic, during the surgery. Tissue oxygen saturation and microcirculatory changes, such as an occlusion and recovery slope, during vascular occlusion test will be recorded during the surgery. The primary end point of the study is the difference in tissue oxygen saturation between the groups.

Eligibility criteria: Inclusion Criteria:

* scheduled for off-pump coronary artery bypass surgery

Exclusion Criteria:

* any deformity or vascular abnormalities on upper arms
* cannot receive sevoflurane or desflurane for any reason (muscular diseases, etc)
* uncontrolled diabetes
* peripheral vascular disease
* severe renal dysfunction (end-stage renal disease)
* refuse to enroll
* pregnant

Primary outcomes:
measure: Tissue oxygen saturation measured at thenar eminence by Hutchinson(R) tissue oximeter during off-pump coronary artery bypass surgery
timeFrame: Before induction of anesthesia to the end of the surgery, an average 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Youn Joung Cho, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cho YJ, Yoo SJ, Nam K, Bae JY, Lee SH, Jeon Y. Effects of anesthetics on microvascular reactivity measured by vascular occlusion tests during off-pump coronary artery bypass surgery: a randomized controlled trial. J Clin Monit Comput. 2021 Oct;35(5):1219-1228. doi: 10.1007/s10877-020-00587-8. Epub 2020 Sep 11.
Clinical trial NCT00823693: Safety and Efficacy Study of Bimosiamose Cream to Treat Psoriasis
Official title: Multi-center, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Safety and Efficacy of Bimosiamose 5% Cream for the Treatment of Patients With Chronic Plaque Type Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Revotar Biopharmaceuticals AG
Sponsor class: INDUSTRY
First posted: 2009-01-16
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Bimosiamose Cream is safe and effective in the treatment of plaque type psoriasis.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of plaque type psoriasis PASI score of 5-15
* At least 18 years of age
* Written informed consent

Exclusion Criteria:

* Active skin infection
* More than 20% Body Surface Area (BSA) affected by psoriasis
* Use of certain anti-psoriasis medication or treatments

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Campus Mitte, Klinik für Dermatologie, Venerologie und Allergologie
Study officials:
References:
Clinical trial NCT02283593: Self-help Internet-based Relapse Prevention for Problematic Alcohol Use
Official title: Self-help Internet-based Relapse Prevention for Problematic Alcohol Use: A Naturalistic Study Among Internet Help-seekers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Problematic Alcohol Use
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 4165
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Internet help-seekers with problematic alcohol use.

Brief summary: The purpose of this study is to observe and evaluate the use of a relapse prevention program over time among internet help-seekers. Participants are recruited via a nationally known portal for assisting anonymous individuals with changing their problematic alcohol use in a healthier direction (alkoholhjalpen.se). The intervention offered lasts 10 weeks and includes 7 relapse prevention modules, with a three-week pause between the 6th and 7th modules. Baseline data are collected regarding substance use and psychosocial health and follow-up takes place 10 weeks after recruitment. The study is observational.


Eligibility criteria: Inclusion Criteria:

* AUDIT \>5 points for women
* AUDIT \>7 points for men

Exclusion Criteria:

* AUDIT \<6 points for women
* AUDIT \<8 points for men

Primary outcomes:
measure: Timeline Follow Back (TLFB)
timeFrame: 10 weeks
measure: The Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: 10 weeks
Secondary outcomes:
measure: The Drug Use Disorders Identification Test (DUDIT)
timeFrame: 10 weeks
measure: The Hospital Anxiety and Depression Scale (HADS)
timeFrame: 10 weeks
measure: The Readiness to Change Questionnaire (RTCQ)
timeFrame: 10 weeks
measure: The Readiness Ruler
timeFrame: 10 weeks
measure: The World Health Quality of Life - shorter version (WHOQOL - BREF)
timeFrame: 10 weeks
measure: EQ-5D-5L
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet, Department of Clinical Neuroscience
Study officials:
affiliation: Karolinska Institutet
name: Anne H Berman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sinadinovic K, Wennberg P, Johansson M, Berman AH. Targeting individuals with problematic alcohol use via Web-based cognitive-behavioral self-help modules, personalized screening feedback or assessment only: a randomized controlled trial. Eur Addict Res. 2014;20(6):305-18. doi: 10.1159/000362406. Epub 2014 Oct 4.
Clinical trial NCT06262893: Effect of Dexamethasone Adjuvant in Combined Supraclavicular Block and Suprascapular Block Versus Interscalene Block in Patients Undergoing Shoulder Arthroscopy
Official title: Effect of Dexamethasone Adjuvant in Combined Supraclavicular Block and Suprascapular Block Versus Interscalene Block in Patients Undergoing Shoulder Arthroscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Arthroscopy Blocks
Dexamethasone
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study the investigators aim to compare the effect of the suprascapular- supraclavicular nerve block in association with dexamethasone to that of the interscalene brachial plexus block on analgesic effect during arthroscopic shoulder surgery, as postoperative pain scores ,postoperative consumption of analgesic rescue medications and diaphragmatic excursion assessment.


Eligibility criteria: Inclusion Criteria:

* ASA status 1,2.

  * Age 18 years or older
  * Elective shoulder arthroscopic surgery under general anesthesia and nerve block performed preoperatively.

Exclusion Criteria:

* • Patient refusal

  * Serious cardiac arrhythmias (including atrial fibrillation) or unstable coronary artery disease.
  * Use of drugs that act on the autonomic nervous system (including β- blockers).
  * Coagulation disorders..
  * Anatomical disorders and/or neuropathic disease.
  * BMI above 40.
  * History of substance abuse.
  * Chronic use of psychotropic and/or opioid.
  * History of psychiatric diseases needing treatment.
  * Allergy to any drug in the study protocol.
  * Failure of nerve block performed in the preoperative block room when tested prior to entering the operating room (i.e. lack of loss of sensation to ice at the shoulder incision level).

Primary outcomes:
measure: Postoperative analgesia by visual analog scale (VAS).
timeFrame: 48 hours
Secondary outcomes:
measure: Diaphragmatic excursion
timeFrame: 1hour postoperatively
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References: