louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06568250: Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention - UG3 Pilot
Official title: Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: chronic pain
mindfulness
complementary therapies
models, biopsychosocial
rural Veterans health
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2024-08-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This project addresses the significant challenge of providing evidence-based non-pharmacologic pain management to rural-dwelling Veterans in the VA healthcare system who have chronic pain. For this preparatory phase (UG3) the investigators will conduct a pilot study of 40 rural VA patients with chronic pain to assess the feasibility of delivering RAMP (experimental intervention for the UH3 trial) in terms of recruitment and engagement, intervention fidelity and adherence, data collection, and other key metrics.


Eligibility criteria: Inclusion Criteria:

* Veteran participants must be rural dwelling
* Patient's Veterans Affairs (VA) primary care provider is in the Southeast region of the US
* Email address in the VA electronic health record (EHR)
* Report pain at least most days in the past 3 months
* Brief Pain Inventory (BPI) Pain Interference subscale score of 4 or greater
* Willingness and ability to complete study activities including meeting remotely via videoconferencing when program sessions are held

Exclusion Criteria:

* Participation in a prior project conducted by the study team on mindfulness for pain (NCT0456158) or an engagement activities advisor for the current project
* Current enrollment in a research study for pain
* Current enrollment in a similar facilitated, multi-week, multi-modal CIH program
* Severe, poorly controlled psychiatric or substance use disorder (based on chart review using structured checklists, conducted by trained staff who are trained and supervised by a clinical psychologist)

Primary outcomes:
measure: Number of Participants Recruited
timeFrame: 3 months
measure: Percentage of Female and Racial/Ethnic Minoritized Participants Recruited
timeFrame: 3 months
measure: Percentage of Participants Who Report Being "Somewhat Satisfied" or "Very Satisfied" with the Program on a 7-point Scale
timeFrame: 3 months
measure: Percentage of Participants Who Attend/Engage with Recommended Number of Sessions
timeFrame: 3 months
measure: Intervention Fidelity Based on Observation By Trained Raters
timeFrame: 3 months
measure: Percentage of Participants Who Complete Post-Treatment Data Collection
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VAMC
state: Minnesota
Study officials:
References:
Clinical trial NCT02655250: Neonatal Microbiome Validity Study
Official title: The Neonatal Microbiome Study: Validity of Biologic Sample Collection Methods
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gut Microbiome
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2016-01-14
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A convenience sample of men/women willing to provide a stool sample and/or breast milk sample.

Brief summary: This is a validation study to compare proposed field collection methods with a gold standard collection technique for microbiome analysis of stool and breast milk samples.

Detailed description: In order to conduct a future study of the gut microbiome in a population living in a rural, low income setting, this validation study will be conducted to verify the validity of our proposed field collection methods for stool and breast milk samples. We will compare the microbial diversity and abundance in the biologic samples using various proposed field collection methods to an immediately frozen sample. The proposed field collection methods are feasible for use in a community-based study in a low income setting with limited access to cold storage.

Eligibility criteria: Inclusion Criteria:

* Lactating women (for breast milk sample)

Exclusion Criteria:

* None

Primary outcomes:
measure: Difference in intestinal microbiome between gold standard and proposed field protocol
timeFrame: Baseline
measure: Difference in breast milk microbiome between gold standard and proposed field protocol
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: State University of New York at Buffalo, Farber Hall
state: New York
Study officials:
affiliation: State University of New York at Buffalo
name: Amy E Millen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01810250: Endurant for Challenging Anatomy: Global Experience Registry
Official title: EVAR Treatment With the Endurant Stent Graft of Challenging Anatomy in Experienced Hands, the Real World Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysms With Challenging Anatomy
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
First posted: 2013-03-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with abdominal aortic aneurysms (AAAs) with challenging anatomy defined by having one or more of the following measurements:

* Proximal necks 5 - 10mm in combination with \< 60 degrees infrarenal AND \< 45 degrees suprarenal angulation
* Proximal necks 10 - 15mm in combination with 60 degrees - 75 degrees infrarenal AND \< 60 degrees suprarenal angulation OR in combination with \< 75 degrees infrarenal AND 45 degrees - 60 degrees suprarenal angulation
* Proximal necks \> 15mm in combination with 75 degrees - 90 degrees infrarenal AND \< 75 degrees suprarenal angulation OR in combination with \< 90 degrees infrarenal AND 60 degrees - 75 degrees suprarenal angulation

Brief summary: The Department of Vascular Surgery at Catharina Hospital Eindhoven, The Netherlands initiates the Endurant for Challenging Anatomy: Global Experience (EAGLE) Registry. The aim of this study is to collect clinical information on the performance of the Endurant Stent Graft System for endovascular repair in anatomically challenging aneurysms, and to critically assess whether the current guidelines for anatomic eligibility to endovascular treatment with this system are still applicable. This study aims at creating a database that can be pooled/ compared with the ENGAGE database.

This study aims at answering two major questions:

1. Is the technical success rate of successful delivery and deployment of the Endurant (II) similar in anatomically challenging aneurysm?
2. Is the successful treatment rate comparable in anatomically challenging aneurysms, or does treatment of these aneurysms lead to more complications and reinterventions?


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years or minimum age as required by local regulations
* Indication for elective EVAR
* Challenging AAA anatomy
* Intention to electively implant the Endurant or Endurant II Stent Graft System©
* Signed informed consent form

Exclusion Criteria:

* Subjects with intolerance to contrast media
* Chimneys or fenestrated device procedures
* High probability of non-adherence to physician's follow-up requirements
* Current participation in a concurrent trial that may confound study results

Primary outcomes:
measure: Clinical success
timeFrame: 12 months
Secondary outcomes:
measure: Helath Related Quality of Life Scores
timeFrame: 12 months
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
state: Noord-Brabant
Study officials:
References:
Clinical trial NCT00872950: 3,4-Diaminopyridine Use in Lambert-Eaton Myasthenic Syndrome(LEMS) and Congenital Myasthenic Syndromes (CMS)
Official title: Open Label Trial Of 3,4-Diaminopyridine In Lambert-Eaton Myasthenic Syndrome (LEMS) and Congenital Myasthenic Syndromes (CMS)
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Lambert-Eaton Myasthenic Syndrome
Congenital Myasthenic Syndrome
Keywords: LEMS
CMS
3,4 DIAMINOPYRIDINE
3,4 DAP
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
First posted: 2009-04-01
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to determine the effectiveness and adverse effects of 3,4-diaminopyridine for the treatment of the Lambert-Eaton Myasthenic Syndrome (LEMS) and Congenital Myasthenic Syndromes (CMS).

Detailed description: This is an open-label, non-randomized, non-comparative expanded access study. Up to 25 patients with clinically proven paraneoplastic or primary autoimmune LEMS per EMG and positive voltage-gated calcium channel antibody serology, OR patients with clinically proven CMS per electromyogram (EMG), biopsy or genetic testing who meet the selection criteria outlined in sections 3.1 and 3.2 will be enrolled in this study. Subjects will receive 3,4-diaminopyridine (3,4-DAP) starting with a low dose and titrating up per efficacy and patient tolerance to a maximum daily dose of 100mg . Treatment will continue until the subject experiences a treatment-limiting toxicity, voluntarily withdraws consent, transfers to another site, dies, becomes lost to follow-up, is no longer receiving clinical benefit from 3,4-DAP (in the opinion of the subject and/or the investigator), or the Jacobus Pharmaceuticals or the FDA discontinues the study.

Eligibility criteria: Inclusion Criteria:

* LEMS diagnosis OR Pre or Post Synaptic CMS diagnosis
* 18 years or older
* Females must have negative pregnancy test and be willing to practice an effective form of birth control
* No prolonged QT syndrome as indicated by baseline EKG

Exclusion Criteria:

* Known sensitivity to 3,4-DIAMINOPYRIDINE
* History of seizures and/or severe asthma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
Study officials:
affiliation: Lahey Clinic
name: Jayashri Srinivasan, MD,MCRP,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05871450: Legacy of the Special Olympics World Games Berlin 2023
Official title: Legacy of the Special Olympics World Games Berlin 2023
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inclusion, Social
Lead sponsor: German University of Health and Sports
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This research aims to evaluate the impact of the project "170 Nations - 170 Inclusive Communities" of the Special Olympics World Games 2023 (SOWG 23) on sustain inclusive structures for people with intellectual disabilities (ID). The research utilizes a quasi-experimental research design and a qualitative research design and will synthesize qualitative and quantitative data to display successful and non-successful interventions for more inclusive communities. The research will target 56 host communities of SOWG 23 and 56 non-host communities, interviewing 200 people with ID and a minimum of 400 key stakeholders, as well as conducting qualitative interviews and focus groups.


Eligibility criteria: Inclusion Criteria:

* legal age

Exclusion Criteria:

* none

Primary outcomes:
measure: ATTID-Questionnaire
timeFrame: Change from baseline (T1) attitudes toward people with intellectual disability (ATTID-Questionnaire) at 3-4 month (T2) and 8-9 month (T3)
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: German University of Health and Sport
Study officials:
affiliation: German University of Health and Sports
name: Wolfgang Ruf, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02600650: EndogenousTestosterone Response to a Testosterone Boosting Supplement
Official title: EndogenousTestosterone Response to a Testosterone Boosting Supplement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Testosterone
Lead sponsor: Canadian Memorial Chiropractic College
Sponsor class: OTHER
Collaborators: name: Iovate Health Sciences International Inc
First posted: 2015-11-09
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether a proprietary 'testosterone-boosting' supplement, when used as recommended by the manufacturer, results in an increase in testosterone levels as measured by a salivary free testosterone assay.

Detailed description: The experimental intervention in this study is the daily administration of a testosterone boosting supplement or sham supplement for 4 weeks. The supplement will be administered daily in capsule form. The control group will be given a sham capsule containing the carrier components of the supplement. Participants will be asked not to modify their current lifestyle. Salivary testosterone levels will be assessed prior to the intervention to collect a baseline measurement for each subject, and following the intervention to evaluate any changes in hormone levels.

Eligibility criteria: Inclusion Criteria:

* Adult male aged 20 to 40 years.
* Fluent in English.

Exclusion Criteria:

* Currently receiving hormonal therapy or testosterone boosting supplement.
* Has received hormonal therapy or testosterone boosting supplement within 3 months prior to study.
* Has experienced adverse event following previous exposure to testosterone boosting supplements.

Primary outcomes:
measure: Change in concentration of salivary free testosterone from baseline measured by ELISA
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Canadian Memorial Chiropractic College
state: Ontario
Study officials:
affiliation: Canadian Memorial Chiropractic College
name: brian budgell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01270750: Bosentan for Severe Mitral Valve Dysfunction
Official title: Pilot Trial of Bosentan for Secondary Pulmonary Hypertension Due to Severe Mitral Valve Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: SECONDARY PULMONARY HYPERTENSION
MITRAL STENOSIS
CHILDHOOD RHEUMATOID FEVER
CONGESTIVE HEART FAILURE
Keywords: ENDOTHELIN RECEPTOR ANTAGONIST
BOSENTAN
SECONDARY PULMONARY HYPERTENSION
RHEUMATOID FEVER
CONGESTIVE HEART FAILURE
SECONDARY PULMONARY HYPERTENSION DUE TO MITRAL STENOSIS
Lead sponsor: General Hospital of Chalkida
Sponsor class: OTHER_GOV
First posted: 2011-01-05
Enrollment: 10
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Vasoconstrictive signaling via endothelin receptors is not limited to primary pulmonary arterial hypertension, but has also been documented in secondary pulmonary hypertension due to congestive heart failure, including cardiac valve disease. The investigators aim to examine the clinical and physiologic effects of bosentan therapy in patients with secondary pulmonary hypertension due to severe, inoperable cardiac valve disease, using a single-center, prospective, open-label, non-randomized study of oral bosentan in outpatients with severe mitral stenosis due to childhood rheumatoid fever. Primary end-point will be exercise capacity at six months determined by six-minute walking distance and cardiopulmonary exercise testing. Secondary end-points will be symptomatic relief, echocardiographic left ventricular function and pulmonary pressure, serum pro-brain natriuretic peptide, and adverse events at six months.


Eligibility criteria: Inclusion Criteria:

* Outpatient
* \> 60 Yrs Old
* \< 85 Yrs Old
* Stable disease
* Congestive heart failure NYHA IIIB/V
* Inoperable mitral stenosis due to childhood rheumatoid fever
* Mean pulmonary artery pressure \> 40 cm H2O

Exclusion Criteria:

* Prior treatment with endothelin receptor antagonist(s)
* Hospitalization (exacerbation)
* Cardiac valve surgery

Primary outcomes:
measure: SIX MINUTE WALKING DISTANCE
timeFrame: SIX MONTHS
measure: MAXIMAL OXYGEN UPTAKE
timeFrame: 6 MONTHS
Secondary outcomes:
measure: ECHOCARDIOGRAPHIC PULMONARY PRESSURE
timeFrame: 6 MONTHS
measure: ECHOCARDIOGRAPHIC LEFT VENTRICULAR FUNCTION
timeFrame: 6 MONTHS
measure: SERUM PRO-BNP
timeFrame: 6 MONTHS
measure: DYSPNEA
timeFrame: 6 MONTHS
Other outcomes:
Locations:
city: Chalkida
country: Greece
facility: General Hospital of Chalkida
state: Evoia
Study officials:
affiliation: GENERAL HOSPITAL OF CHALKIDA, GREECE
name: GEORGE VLACHOGIORGOS, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01892150: Histologic Response to UVA and UVB Exposure During the Use of Sunscreen
Official title: Histologic Response to UVA and UVB Exposure During the Use of Sunscreen With Anti-inflammatory and Anti-oxidant Properties - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solar Elastosis
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2013-07-04
Enrollment: 2
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Anti-inflammatory and anti-oxidant agents have become the important ingredients in sunscreen. However, there is no histologic study about the effects of anti-inflammatory and anti-oxidative properties of sunscreen to prevent premature aging from UVA and UVB.

Detailed description: Premature aging can be prevented by using sunscreen. Currently, anti-inflammatory and anti-oxidant agents have become the important ingredients in sunscreen. However, there is no histologic study about the effects of anti-inflammatory and anti-oxidative properties of sunscreen to prevent premature aging from UVA and UVB.

Eligibility criteria: Inclusion Criteria:

* subjects aged 35-65 years who were scheduled for abdominoplasty
* the excised area should be larger than 18x10 cm2
* no skin diseases or lesions on the excised area
* no topical treatment on excised area more than 1 month prior to this study

Exclusion Criteria:

* pregnancy
* lactation
* have tattoo or striae distensae on abdomen

Primary outcomes:
measure: H&E Staining
timeFrame: 2 Months
Secondary outcomes:
measure: Tyrosinase Staining
timeFrame: 2 Months
Other outcomes:
measure: 8-OH-dG Staining
timeFrame: 2 Months
measure: MMP1 Staining
timeFrame: 2 Months
Locations:
city: Bangkok
country: Thailand
facility: Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Rungsima Wanitphakdeedecha, MD, MA, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lavker RM, Gerberick GF, Veres D, Irwin CJ, Kaidbey KH. Cumulative effects from repeated exposures to suberythemal doses of UVB and UVA in human skin. J Am Acad Dermatol. 1995 Jan;32(1):53-62. doi: 10.1016/0190-9622(95)90184-1.
Clinical trial NCT01073150: Tea Tree Oil in the Treatment of Chronic Blepharitis
Official title: Tea Tree Oil in the Treatment of Chronic Blepharitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Blepharitis
Keywords: Tea Tree Oil
Chronic Blepharitis
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2010-02-23
Enrollment: 34
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:

* The prevalence of Demodex sp. in chronic blepharitis.
* The efficacy of the treatment of topical Tree Tea Oil in chronic blepharitis for Demodex sp.

Detailed description: Patients with clinical diagnosis of chronic blepharitis were included in this study. A check list of symptoms and an ophthalmologic examination including best corrected visual acuity and biomicroscopy were performed.

Under a slit lamp visualization, three lashes with cylindrical dandruff of each eyelid were epilated by fine forceps. The lashes were immersed in fluorescein dye and examined under a light microscope at a 20-times magnification. The mites were detected based on its morphological characteristics and movement.

The patients with chronic blepharitis who had Demodex were randomly divided in two groups. The treatment group was prescribed lid hygiene with Tea Tree Oil shampoo 0.25% and ointment 5% daily and Tea Tree Oil oily solution 50% once a week - produced by Ophthalmos, São Paulo. The control group used the same posology of placebo similar products.

After six weeks, all subjects underwent the initial clinical and laboratory examination. The symptoms and the quantity of mites (mites/eye) were compared before and after the treatment in both groups.

Eligibility criteria: Inclusion Criteria:

* Chronic Blepharitis with out treatment previously

Exclusion Criteria:

* Patients under 18 y.o.
* Pregnant woman
* Others Ocular Surface Disease (Severe Dry Eye, Lagoftalmo, Entropium, Ectropium)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Nahin Geha
role: PRINCIPAL_INVESTIGATOR
References: