louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01824979: Pilairo Lab Market Research
Official title: Pilairo Lab Market Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2013-04-05
Enrollment: 100
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 the study is to observe the Pilairo mask in a lab setting.

Detailed description: The purpose of the study is to observe the Pilairo mask in a lab setting, compared to other commercially available masks for continuous positive airwary pressure (CPAP) therapy.

Eligibility criteria: Inclusion Criteria:

* Apnea Hypopnea Indea \>15 from diagnostic study
* Minimum 18 years of age

Exclusion Criteria:

* Inability ot give informed consent
* History of intolerance to CPAP
* Anatomical or physiological conditions making CPAP therapy inappropriate

Primary outcomes:
measure: Technician Experience With Mask
timeFrame: One night
Secondary outcomes:
measure: Number of Mask Interventions During the Night
timeFrame: One night
Other outcomes:
Locations:
city: Burlingame
country: United States
facility: Peninsula Sleep Center Inc
state: California
Study officials:
References:
Clinical trial NCT05865379: Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
Official title: Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease: a Non-inferiority Investigation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dry Eye Disease
Lead sponsor: TRB Chemedica International SA
Sponsor class: INDUSTRY
First posted: 2023-05-18
Enrollment: 80
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 goal of this interventional investigation is to compare BUFY01 with SVS20 in the treatment of patients with dry eye disease. The main questions it aims to answer are:

* Is BUFY01 non-inferior to SVS20 in terms of signs of DED?
* Is BUFY01 non-inferior to SVS20 in terms of symptoms of DED?

Participants will be asked to:

* Visit the trial site at 4 different timepoints
* Use the allocated study treatment everyday until the end of the study (during 3 months)
* Be examined by the investigator
* Complete several questionnaires
* Return unused study treatment.

Researchers will compare BUFY01 to SVS20 to see if both study treatments provide similar effects on signs and symptoms of the disease, together with comparable safety.


Eligibility criteria: Inclusion Criteria includes:

* At least a 3-month documented history of bilateral dry eye syndrome needing artificial tears;
* At least one eye with Oxford score ≥ 4 and ≤ 9;
* At least one objective sign of tear deficiency (in at least one eligible eye);
* Having a health insurance.

Exclusion Criteria includes:

* Wear of contact lenses starting within the last 2 months;
* Best-corrected visual acuity (BCVA) \< 1/10;
* Severe DED with one of the listed conditions:
* Severe blepharitis;
* Seasonal allergy;
* Any issues of the ocular surface not related to DED;
* History of ocular trauma, infection or inflammation not related to DED;
* History of ocular surgery, including laser surgery;
* Unstable glaucoma;
* Use of artificial tears with preservative within the last 2 weeks;
* Systemic (enteral or parenteral) or local (topical) use of one of the listed medications:
* Known hypersensitivity to any constituent of the study treatments;
* Pregnancy or breastfeeding;
* Participation in another clinical study within the last 90 days;
* Legally restricted autonomy, freedom of decision and action.

Primary outcomes:
measure: Signs
timeFrame: Day 28
Secondary outcomes:
measure: Symptoms
timeFrame: Day 28
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02667379: Skin Tests in Cat Allergic Patients With Cat Dander Samples Obtained Before and After Vaccinating the Cat
Official title: Evaluation of Skin Prick Tests in Cat Allergic Patients With Cat Dander Samples Obtained Before and After Vaccinating the Cat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypersensitivity
Keywords: Cat
allergy
dander
Fel d 1
Felis domesticus
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Determination of allergenicity of cat dander samples obtained before and after vaccinating the cat


Eligibility criteria: Inclusion Criteria:

* Informed Consent as documented by signature (Appendix Informed Consent Form)
* Male or female between 18 years to 65 years
* Confirmed cat allergy (positive skin prick test)

Exclusion Criteria:

* Diseases or medications, influencing the skin tests or impairing the correct conduct and evaluation of the study
* History of anaphylactic reaction
* Pregnancy
* Skin irritations in test area
* Participation in another clinical trial within the last 30 days and during the present study

Primary outcomes:
measure: Wheal size of allergic skin reaction in mm² measured 15 minutes after application of test substance
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Dept of Dermatology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Dept Dermatology
name: Thomas Kuendig, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02776579: Effect of a Female Strength & Conditioning Specialist on High School Girls' Health
Official title: Girls in the Weight Room: Assessing the Influence of a Female School-based Strength & Conditioning Specialist on the Health of High School Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
Low Physical Fitness
Keywords: Resistance Training; Muscle Strength
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2016-05-18
Enrollment: 31
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The majority of today's youth do not engage in enough physical activity (PA) to maintain good health. Low PA levels are associated with poor health (e.g. diabetes, high blood pressure) and early mortality. Girls are less likely than boys to be active, and their rates of participation drop off more steeply during adolescence. Girls report many barriers to exercise, including transportation issues and feeling self-conscious about their appearance and abilities. School-based PA programs that try to improve health, mainly through aerobic exercise and education, have had a small effect to date. However, the few programs that included resistance training as the focus showed strong improvements in health related measures. In this project, we will examine the effect of a female strength and conditioning specialist on decreasing barriers and increasing the overall health of high school girls, with the delivery of in-school, girls-only resistance training programs. We will see if physical and mental health changes with the training, and how the presence of the S \& C specialist affects the girls' social interactions within the school. The results will help individuals in the education sector plan programs and services to improve overall youth and school health.


Eligibility criteria: Inclusion Criteria:

* Grades 7 to 12 at Grant Park High School
* do not participate on organized sports teams
* self-report as not meeting the recommended amount of 60 min of Moderate-Vigorous Physical Activity per day

Exclusion Criteria:

* engaged in regular resistance training activities within the previous 6 months
* health condition or injury that would put them at risk during testing/training

Primary outcomes:
measure: 1 Repetition Maximum leg press
timeFrame: Change from Baseline and at 8 weeks
Secondary outcomes:
measure: 1 Repetition Maximum bench press
timeFrame: Baseline and at 8 weeks
measure: Grip strength dynamometry
timeFrame: Baseline and at 8 weeks
measure: mCAFT for aerobic fitness
timeFrame: Baseline and at 8 weeks
measure: Physical activity levels
timeFrame: Baseline and at 8 weeks
measure: Physical Self-Perception Profile
timeFrame: Baseline and at 8 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Joanne Parsons, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03780179: MMR at 6 Months Trial
Official title: Measles-mumps-rubella Vaccine at 6 Months of Age, Immunology, and Childhood Morbidity in a High-income Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meales-mumps-rubella Vaccine
Keywords: measles-mumps-rubella vaccine
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 6540
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to intervention: MMRvaxpro at 6 months of age, or placebo-vaccine (solvent only)
Primary purpose: PREVENTION

Brief summary: Randomised, double-blind clinical trial to test humoral and cellular immunogenicity, and potential in-direct beneficial effect of the MMRvaxpro-vaccine administered at 6 months of age


Eligibility criteria: Inclusion Criteria:

* Gestational age of 32+ weeks.
* Birth weight of 1000+ grams.
* Signed informed consent from the parents.

Exclusion Criteria:

* Immune-deficiency (primary or acquired) or -suppression.
* Intake of immune modulating medicine (including high doses of corticosteroids) (M-M-RVAXPRO is not contraindicated in individuals who are receiving topical or low-dose parenteral corticosteroids, e.g. for asthma prophylaxis or replacement therapy).
* Signs of severe illness or major malformation.
* No Danish-speaking parent.
* Children with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g., hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion are excluded.
* Children with known fructose intolerance, thrombocytopenia or any coagulation disorder will be excluded.
* Children who received blood or plasma transfusions, or administration of human immune serum globulin within the last 3 months will be excluded.
* Further, children are excluded from the trial if any contraindication is suspected: history of hypersensitivity to any measles, mumps, or rubella vaccine, or to any of the excipients, including neomycin.
* Children with active untreated tuberculosis, blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems will be excluded.

Primary outcomes:
measure: Humoral immunogenicity
timeFrame: 1 months after intervention
measure: Hospitalisation for infection
timeFrame: 6-12 months of age
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Copenhagen Ø
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
References:
Clinical trial NCT06441279: Treatment of Tempromandibular Joint Anterior Disc Displacement With Different Materials
Official title: Hyaluronic Acid Versus Platelet Lysate in The Treatment of Temporomandibular Joint Anterior Disc Displacement With Reduction: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TMJ Disc Disorder
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: comparing the clinical efficacy of intra-articular injection of platelet lysate (PL), versus Hyaluronic Acid after arthrocentesis in the management of patients with anterior disc displacement with reduction.


Eligibility criteria: Inclusion Criteria:

* Patients that will be diagnosed with anterior disc displacement with reduction (ADDWR) both clinically and through magnetic resonance imaging scan (MRI).
* Patients who will not respond to a previous conservative therapy.
* Patients with pain in temporomandibular joints.
* Patients with normal or limitation in mouth opening.
* Patients with clicking sound.

Exclusion Criteria:

* Patients with previous invasive TMJ surgical procedures.
* Patients with inflammatory or connective tissue diseases.
* Patients with neurologic disorders.
* Patients with history of bony or fibrous adhesion.
* Patients having gross mechanical restrictions and condylar fractures.
* Patients with psychological problems.
* Patients receiving anti-coagulation treatment, non-steroidal anti-inflammatory drugs within 48 hours pre-operatively, corticosteroid injection at the treatment site within one month or systemic use of corticosteroids within 2 weeks.

Primary outcomes:
measure: Maximum inter-incisal opening
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura, Egypt
country: Egypt
facility: Heba Elsheikh
Study officials:
References:
Clinical trial NCT00714779: Fluoxetine vs. Brief Psychotherapy for Major Depression
Official title: Fluoxetine vs. Brief Psychotherapy in the Treatment of Major Depression - a Randomized Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Major depressive Disorder
fluoxetine
short-term psychodynamic psychotherapy
PET
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: KELA
name: Finnish State Grant
First posted: 2008-07-14
Enrollment: 85
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study we compare two treatments for major depression - fluoxetine and brief psychodynamic psychotherapy. In addition to more traditional outcome measures, we also measure the densities of 5HT-1A and D-2 receptors before and after the treatment. The main hypothesis is that brief psychotherapy is as effective as fluoxetine.

Detailed description: This study is a randomized comparison of two treatments for major depression - fluoxetine and brief psychodynamic psychotherapy. The patients are recruited from occupational health services and suffer from mild to moderate major depressive disorder. The treatments last for 16 weeks. The main outcome measures include HAM-D, BDI, SOFAS, Rand-36. In addition to more traditional outcome measures, we also measure the densities of 5HT-1A and D-2 receptors before and after the treatment using Positron Emission Tomography (PET) . The main hypothesis is that brief psychotherapy is as effective as fluoxetine, but differences between the treatments are seen in PET scanning.

Eligibility criteria: Inclusion Criteria:

* MDD (mild to moderate)
* HDRS 15 or more, age 20-60 years
* No treatment for preceding 4 months
* No DSM-IV axis I or II comorbidity
* No severe somatic illness
* No contraindications for fluoxetine treatment

Primary outcomes:
measure: HAM-D
timeFrame: 0, 16 weeks, one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Helsinki
name: Hasse Karlsson, MA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02911779: The Optimal Angle of Mediolateral Episiotomy at Crowning of the Head During Labor
Official title: The Optimal Angle of Mediolateral Episiotomy at Crowning of the Head During Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor, Obstetric
Episiotomy
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-09-22
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In order to determine the optimal angle to perform an episiotomy, the investigators assessed the angle of marked episiotomy lines at the first stage of labor and at the time of crowning of the head.

Incision lines for mediolateral episiotomy were pre-marked on the perineal skin at 30°, 45°, and 60° angles from the midline, at the first stage of labor, in women with singleton pregnancies. The angles of the marked lines were measured again at crowning of the head. Mediolateral episiotomy was performed only for obstetric indications.


Eligibility criteria: Inclusion Criteria:

* women during labor above 37 weeks, Occiput presentation

Exclusion Criteria:

* cesarean section, vacuum or forceps deliver, breech deliver, below 37 weeks

Primary outcomes:
measure: Change of medilateral angle line during crowning of the head
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfson Medical Center
Study officials:
References:
Clinical trial NCT06073379: Efficacy of Korean Manupuncture on Pain in Women With Endometriosis: a Parallel-group Randomized Controlled Trial
Official title: Efficacy of Korean Manupuncture on Pain in Women With Endometriosis: a Parallel-group Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometriosis
Pain
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Endometriosis is defined as the presence and development of hormone-dependent endometrial tissue comprising both glands and stroma outside the endometrium and myometrium.

It affects 10-15% of women of childbearing age; of these, 25% are diagnosed following a consultation for infertility, and 25% following a consultation for pelvic pain.

This disease has a strong functional (pain and infertility) and organic impact, its numerous symptoms can have a considerable effect on quality of life.

Individualized analgesic management with multidisciplinary care (medical, surgical and psychological) can improve quality of life for women with endometriosis, but current treatment remains insufficient.

Korean manupuncture is a complementary treatment technique that does not interact with current treatments. It's a holistic discipline that draws up a highly detailed map of the body's correspondence on the hand. Each body zone corresponds to a zone on the hand.

The aim of this research is to evaluate the effect of Korean manupuncture on endometriosis-related pain.

Patients will be randomly assigned to 2 groups, 30 to the "Korean manupuncture" group and 30 to the "placebo/control" group. Patients will be blinded to their assigned group.


Eligibility criteria: Inclusion Criteria:

* Person having given oral consent
* Woman of legal age
* Woman diagnosed with endometriosis consulting for pain management

Exclusion Criteria:

* Not affiliated to the national health insurance system
* Person under legal protection (curatorship, guardianship)
* Person under court order
* Pregnant or breast-feeding women
* Menopausal women (menopause is defined as amenorrhea lasting more than 12 consecutive months)
* An adult unable to give consent
* Women who have had a hysterectomy
* Women who cannot speak or read French
* Hands not accessible for treatment
* Inability to follow the entire protocol
* Cognitive impairment

Primary outcomes:
measure: Variation in the Visual Analog Scale (VAS)
timeFrame: Between Day 1 and Day 29
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References:
Clinical trial NCT02741479: The Effectiveness of Kinesio® Tex Tape on Gluteus Medius Activation in Dancers
Official title: The Effectiveness of Kinesio® Tex Tape on Gluteus Medius Activation in Dancers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gluteus Medius Activation
Keywords: dancers
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research is to determine if a specific type of elasticated athletic tape (Kinesio Tex Tape) increases muscle activation among professional level dancers. Investigators will determine if changes in muscle activation with the elasticated tape differ from changes experienced with no tape and/or sham tape, and if it coincides with subjective sense of muscle activation.


Eligibility criteria: Inclusion Criteria:

* Uninjured professional level dancers

Exclusion Criteria:

* Non-professional level of dance or non-dancer; obesity (body mass index greater than 30 kg/m²)
* A history of major back, abdominal, or lower extremity surgery
* A history of muscle diseases; a history of serious cardiovascular diseases (e.g., cardiac insufficiency, arrhythmia, severe hypertension, vascular insufficiency)
* A history of serious respiratory diseases; major fractures of the lower extremities; lower extremity or trunk injury within the last year; a history of surgery within the last year, a history of stroke, acute, or chronic infections; serious metabolic diseases
* Glaucoma
* Structural disease or severe congenital deformities of the spine of a high degree
* Inguinal, femoral, or umbilical hernia; or diseases related to body equilibrium.

Primary outcomes:
measure: Change in Muscle Activity measured via electromyography
timeFrame: Baseline and 1.5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Donald Rose, MD
role: PRINCIPAL_INVESTIGATOR
References: