louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05623735: Comparison of the Effects of Instrument Assisted Soft Tissue Mobilization Techniques Low Back Pain
Official title: Comparison of the Effects of Two Different Instrument Assisted Soft Tissue Mobilization Techniques in Individuals With Chronic Non-Specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: IASTM
chronic pain
flexibility
disability
mobility
muscular endurance
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine whether the effectiveness of instrument-assisted soft tissue mobilization technique is different from passive prone lying when performed with a functional exercise in individuals with chronic nonspecific low back pain.

Detailed description: Individuals participating in the study will first be divided into two groups by randomization. While IASTM (Instrument Assisted Soft Tissue Mobilization Techniques) will be applied to one group in the prone position, IASTM will be applied to the other group with functional exercise. The pain, mobility, flexibility, disability and endurance parameters of the individuals assigned to the groups after randomization will be determined just before the application, immediately after the 1st application and immediately after the 6th application. The study will last for a total of 6 sessions, with two sessions per week for 3 weeks.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with non-specific low back pain by a specialist physician
* 18-45 years old
* Having 3 or more pains on VAS for the last 3 months.
* Those who do not use analgesic drugs
* Not taking physiotherapy for the last 6 months.

Exclusion Criteria:

* Those with orthopedic, neurological, psychiatric and systemic diseases (such as fracture, osteoporosis, scoliosis, kyphosis, stenosis, cauda equina, myositis ossificans, severe nerve compressions, rheumatoid arthritis, cancer)
* Those with a history of spinal surgery
* Pregnant and lactating
* Open wound, infection, serious kidney disease
* Those who have limited hip joint movements

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 3 Weeks
Secondary outcomes:
measure: Mobility (Modified Schober Test)
timeFrame: 3 Weeks
measure: Flexibility (Sit and Reach Test)
timeFrame: 3 Weeks
measure: Flexibility (Maximal Hip Flexion Active Knee Extension (MHFAKE))
timeFrame: 3 Weeks
measure: Disability (Oswestry Disability İndex)
timeFrame: 3 Weeks
measure: Trunk Extensors Muscle Endurance (Biering-Sorenson Test)
timeFrame: 3 Weeks
Other outcomes:
Locations:
city: Famagusta
country: Cyprus
facility: Süleyman Güzelşemme
Study officials:
affiliation: Eastern Mediterranean University
name: Süleyman Güzelşemme, Res. Asst.
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastern Mediterranean University
name: Sevim Öksüz, Asst. Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06834035: Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa
Official title: Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Epidermolysis Bullosa
Epidermolysis Bullosa Acquisita
Dystrophic Epidermolysis Bullosa
Recessive Dystrophic Epidermolysis Bullosa
Keywords: Epidermolysis Bullosa
Epidermolysis Bullosa Acquisita
Dystrophic Epidermolysis Bullosa
Recessive Dystrophic Epidermolysis Bullosa
Collagen 7
C7
Col7
EB
EBA
DEB
RDEB
Antibodies
Collagen VII
IV IgG
IgG
IVIgG
C7 Antibodies
Collagen 7 Antibodies
Collagen VII Antibodies
Vyjuvek
B-VEC
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Epidermolysis Bullosa Research Partnership
First posted: 2025-02-19
Enrollment: 8
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study objective is to see if IV IgG treatment in Recessive Dystrophic Epidermolysis Bullosa (RDEB) skin in conjunction with VYJUVEK treatment improves wound healing and affects the levels of C7 and HSV-1 antibody levels in serum.

Fewer wounds, more rapidly healing wounds, and decreased C7 and HSV-1 antibodies could improve quality of life.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations.
2. Diagnosis of EBA demonstrated by the presence of levels of serum C7 antibodies above the normal ELISA range
3. Baseline skin blistering greater than 5% total body surface area
4. 1 wound at least 20 cm\^2 able to be entirely treated with Vyjuvek weekly
5. 1 wound at least 20 cm\^2 that has never been treated with Vyjuvek
6. Ongoing VYJUVEK treatment.

Exclusion Criteria:

1. History of thrombotic event(s)
2. History of cardiac failure
3. History of renal failure
4. IgA deficiency

Primary outcomes:
measure: Adverse Events and Effects
timeFrame: 9 Months
measure: Percent Change in Wound Area
timeFrame: 9 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Associate Professor of Dermatology
name: Matt P Marinkovich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06627335: An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis
Official title: Pregnancy Outcomes Study of Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy Related
Atopic Dermatitis
Keywords: ruxolitinib
Atopic Dermatitis
pruritus
eczema
topical therapy
JAK inhibitor
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2024-10-04
Enrollment: 5621
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Exposure cohort study of women within the US with atopic dermatitis (AD) who were exposed to ruxolitinib cream at any time during their pregnancy period.

Brief summary: This study is to assess infant outcomes of women with AD who were exposed to ruxolitinib cream during pregnancy compared with a control cohort of women with AD who were exposed to a topical corticosteroid (TCS) during pregnancy.


Eligibility criteria: Inclusion Criteria:

* Women aged 14 years or older at pregnancy outcome.
* Pregnancy following FDA approval of ruxolitinib cream for AD on 21 SEP 2021.
* At least 1 pharmacy-dispensing claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort).
* A diagnosis of AD prior to or on the day of the first pharmacy claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort) from 6 months before the estimated date of conception.
* Continuous enrollment in the database from 6 months before the estimated date of conception through the end of pregnancy.
* For infant outcomes only, linkage of mother and infant data will be required (ie, pregnancies that cannot be linked to an infant will be excluded for infant outcomes but not for pregnancy outcomes). Infants will be followed for as long as they are continuously enrolled in the database up to 1 year after birth (ie, variable follow-up for each infant). A 1-year fixed period of continuous enrollment after birth will not be imposed so as not to introduce survival bias.

Exclusion Criteria:

• One or more pharmacy claims for oral ruxolitinib or other JAK inhibitors in the exposure window for a given outcome.

Primary outcomes:
measure: Number of major congenital malformation (MCM)s
timeFrame: Up to 12 months after birth
Secondary outcomes:
measure: Number of small-for-gestational age (SGA) births
timeFrame: At time of delivery
measure: Number of Pregnancy outcomes
timeFrame: Up to birth
Other outcomes:
Locations:
city: Morrisville
country: United States
facility: Syneos Health (remote site)
state: North Carolina
Study officials:
affiliation: Incyte Corporation
name: Incyte Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01359735: Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients
Official title: A Phase II Randomized, Open-label Study Investigating the Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-melanoma Skin Cancer
Keywords: Wound
non-melanoma skin cancer
Mohs micrographic surgery
Head or neck
Lead sponsor: Healthpoint
Sponsor class: INDUSTRY
First posted: 2011-05-25
Enrollment: 8
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: This study compares HP802-247 versus an antibiotic ointment for healing the wound after Mohs surgery.


Eligibility criteria: Inclusion Criteria:

* Provide informed consent.
* Age ≥ 18 years and of either sex.
* Type I, II, or III skin as assessed by the Fitzpatrick Scale.
* Willing to comply with protocol instructions, including allowing all study assessments.
* Scheduled to have head or neck non-melanoma skin cancers removed by Mohs micrographic surgery with final wound size of 8 mm to 20 mm in diameter or with 8 mm to 20 mm long axis if not circular.
* Acceptable state of health and nutrition, in the opinion of the Investigator.

Exclusion Criteria:

* History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, or amphotericin B.
* Therapy with blood-thinning agents including aspirin within 14 days of the Baseline Visit (these may be resumed post-surgery).
* Subjects with platelet or coagulation disorders.
* Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
* Current systemic therapy with cytotoxic drugs.
* Current therapy with chronic (\> 10 days) oral corticosteroids.
* In the opinion of the Investigator the subject has a current life expectancy of less than 1 year.

Primary outcomes:
measure: The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH).
timeFrame: 13 weeks- The IGAH was measured at study Weeks 4 and 13
Secondary outcomes:
measure: The Number of Subjects With Complete Wound Closure at Each Evaluation Visit.
timeFrame: Over 12 weeks or until wound closure, which ever occurred first. Following completion of treatment subjects were followed for a further 4 weeks
measure: Time in Days to Wound Closure
timeFrame: Over the 12 week treatment period
measure: Investigator Reported Signs and Symptoms
timeFrame: At each evaluation visit: Weeks 3 and 12 post-surgery.
measure: Subject Reported Signs and Symptoms
timeFrame: At each evaluation visit: Weeks 3, and 12 post-surgery.
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Derm Research PLC
state: Kentucky
Study officials:
affiliation: Healthpoint
name: Herbert B Slade, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04832035: Integration of Refugees Into Public Mental Health Care
Official title: Integration of Refugees With Mental Disorders Into the Public Psychotherapeutic Health Care Services - a Model Project With Trained Peers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychiatric Disorders From Chapters 3 and 4 of ICD10
Lead sponsor: University of Konstanz
Sponsor class: OTHER
Collaborators: name: Vivo international e.V.
First posted: 2021-04-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: There are specific barriers to utilise psychotherapeutic services for refugees with mental health problems in the German public health care system. This study aims to evaluate additional organisational components that are hypothesised to improve service utilisation.

In a randomised controlled trial, refugees with mental health problems are identified by peers, subsequently assessed by professional staff and referred to public psychotherapeutic health services who offer standard care. Participants are assigned to care as usual or to "coordinated and peer supported mental health care"; the latter includes several additional organisational assistance components, i.e. a coordination center, trained peers to support treatment utilisation, a support and training center for therapists, and a interpreter pool. Measures include service utilisation and symptom change after 6 months. Furthermore the study evaluates whether trained peers can correctly identify participants with mental health problems.


Eligibility criteria: Inclusion Criteria:

* Psychiatric diagnosis from Chapters 3 and 4 of ICD10
* Participant applied for asylum in Germany
* Entry to Germany after 2012
* Participants is motivated to utilise psychotherapeutic services
* Patient speaks one of the languages in which services are offered (i.e. German, English, French, Arabic, Kurdish, Dari, Farsi, Urdu, Pashto, Tirginya, Somali)

Exclusion Criteria:

* Mental disorder that requires inpatient treatment

Primary outcomes:
measure: Service utilisation
timeFrame: 6 months after study inclusion
measure: Psychiatric symptom change
timeFrame: assessments 6 and 12 months after study inclusion
Secondary outcomes:
measure: Percentage correctly identified refugees with mental health problems
timeFrame: two weeks
Other outcomes:
Locations:
city: Konstanz
country: Germany
facility: University of Konstanz, Psychotherapy Outpatient Clinic
Study officials:
References:
Clinical trial NCT02095535: Chlorhexidine Drying Time
Official title: The Minimum ChloraPrep Drying Time Before Neuraxial Anesthesia in Elective Cesarean Delivery Patients - Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drying Time
Keywords: obstetric patients
chloraprep
chlorhexidine
drying time
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2014-03-24
Enrollment: 20
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elective cesarean patients at BC Women's Hospital

Brief summary: Before a patient gets a spinal/epidural, their lower back is cleaned with an antiseptic solution diluted in alcohol called ChloraPrep. ChloraPrep must completely dry before starting the anesthetic procedure. It is not known how much time is needed for the solution to completely dry. The investigators aim to determine this.

As the ChloraPrep dries, the alcohol is converted into vapour. The investigators will be using a PPBRae 3000 device to detect small amounts of vapours in the air. As the ChloraPrep dries it gives off less and less vapour. The investigators will use this diminishing vapour concentration to determine when drying is complete.


Eligibility criteria: Inclusion Criteria:

* Pregnant
* At full term
* Due to have a cesarean section under spinal or epidural anesthesia
* 19 to 40 years of age

Exclusion Criteria:

* Allergy to certain antiseptic solutions
* Not suitable for a spinal/epidural anesthetic
* Have a significant amount of hair on lower back

Primary outcomes:
measure: Length of Drying Time
timeFrame: At Chloraprep application
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Women's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Vit Gunka, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02524535: Alliance With Therapeutic Entourage in Support of Young Suicidal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 292
Sex: ALL
Minimum age (years): 13
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Regardless of age, the quality of hospital care, the confidence that the young can have in the health care team, joining parents are pivotal elements and influence followed. Family support is all the more important as 14% of young people realize a new suicidal act within three months of hospitalization for attempted suicide, and that the essential predictors appear to be the young age and quality of intra-family relationships.

The main objective of this study is to determine, through the construction of an instrument to quantify the therapeutic alliance, defined by the characteristics of the mobilization of the entourage and the mutual commitments in the care of nursing teams and the entourage, the role of early therapeutic alliance with the entourage of suicidal youth 13-40 years, whether primosuicidants or repeat offenders, on short and medium term recurrences and early mortality.


Eligibility criteria: Inclusion Criteria:

* Patient aged 13-40 years
* From male or female
* Supported the waning of a suicidal gesture.
* speaking and writing fluent French
* living in Upper or Lower Normandy
* signed informed consent form, and at least one of his parents after oral and written information about the study for minors.

Exclusion Criteria:

* Age \<13 years or \> 40 years
* Do not live in the Upper and Lower Normandy regions
* Detained patient
* forced hospitalization
* Patient under guardianship
* Patient with severe somatic pathology (cancer, heart failure, kidney or respiratory, central neurological disorder), scalable, or likely to be life-threatening within a period of less than one year
* Refusal to participate in the study
* Inability to respond

Primary outcomes:
measure: characteristics of the mobilization of the entourage evaluated with Family Assessment Device
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: service de pédopsychiatrie, CHU de Caen
Study officials:
References:
Clinical trial NCT06789835: Automated Quantification of Dental Plaque
Official title: Automated Quantification of Dental Plaque
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Plaque
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: 3Shape A/S
name: National and Kapodistrian University of Athens
First posted: 2025-01-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults

Brief summary: The study generates data that contribute to the development and validation of an automated approach to full-mouth quantification of dental plaque, based on fluorescence images and intraoral scans of teeth with disclosed and undisclosed plaque.


Eligibility criteria: Inclusion Criteria:

Males and females ≥ 18 years old Presence of at least one tooth Anatomically possible to perform intraoral imaging Subjects need to be able to understand and follow instructions, as well as to read and sign the informed consent form

Exclusion Criteria:

History of allergies towards any of the ingredients in the disclosing agents Self-reported serious medical conditions

Primary outcomes:
measure: Planimetric plaque index
timeFrame: 1 day
Secondary outcomes:
measure: Turesky modification of the Quigley and Hein Plaque Index
timeFrame: 1 day
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Dentistry and Oral Health, Aarhus University
Study officials:
affiliation: University of Aarhus
name: Sebastian Schlafer, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04347135: Evaluating Endometriosis With 16α-(18)F-fluoro-17β-estradiol ([F-18] FES) PET/MRI
Official title: Pilot Study Evaluating Endometriosis With 16α-(18)F-fluoro-17β-estradiol ([F-18] FES) PET/MRI
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Endometriosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 0
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: Researchers are trying to improve the detection of endometriosis using F-18 FES PET/MRI imaging.


Eligibility criteria: Inclusion Criteria:

- Premenopausal women (18-50) with endometriosis

Exclusion Criteria:

* Postmenopausal women
* AP diameter when lying supine greater than 32 cm (too large for PET/MRI)
* Unable to undergo PET/MRI for any reason (metal implants, severe claustrophobia)
* Unable to receive IV Gadolinium contrast for any reason (renal failure eGFR \< 60, contrast allergy)
* Pregnant (Urine test will be provided for all patients)

Primary outcomes:
measure: Detection of Endometriosis
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ann Packard, MD
role: PRINCIPAL_INVESTIGATOR
References: