louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06650462: Evaluating a Community-Led COVID-19 Testing Intervention to Address Mistrust
Official title: Evaluating a Community-Led COVID-19 Testing Intervention to Address Mistrust
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COVID-19
Trust
Keywords: community-led
COVID-19
trust
vaccine hesitancy
peer mentor
community advisory board
Lead sponsor: Old Dominion University
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants randomly assigned to intervention or control group; repeated measure assessments at 0 months, 3 months, 6 months
Primary purpose: PREVENTION

Brief summary: The goal of this study is to assess how community-led group discussions about health-related topics may alter beliefs and intentions regarding healthcare recommendations, such as COVID-19 testing and vaccination.

Detailed description: Eligible participants will be randomized to intervention or control group. Intervention group participants will meet virtually with other community member participants in small discussion groups once a week for one hour over the course of 12 weeks. The online discussion groups will be led by peer mentor facilitators and supported by a research team member. Discussion topics will include current events, COVID-19, and other health related topics. Control group participants will not meet in weekly discussion groups. At approximately the 0 month, 3 month, and 6 month time points, all participants will answer online surveys about health related topics. At the 3 month and 6 month time points, all participants will also be asked to self-administer a COVID-19 test that investigators provide. Finally, around the fourth month, intervention group participants will be invited to an online feedback session with the research team about participants' experiences in the study.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Resident of one of the 9 housing authority agencies
* Willing to participate in Zoom meetings and complete online assessments at baseline, 3-month, and 6-month timepoints
* Ability to read, speak, and understand English

Exclusion Criteria:

* None

Primary outcomes:
measure: Openness to COVID-19 testing
timeFrame: 0 months, 3 months, 6 months
measure: COVID-19 Testing Efficacy
timeFrame: 0 months, 3 months, 6 months
measure: COVID-19 Trust
timeFrame: 0 months, 3 months, 6 months
measure: Qualitative feedback
timeFrame: 4 months
Secondary outcomes:
measure: COVID-19 Vaccine Hesitancy
timeFrame: 0 months, 3 months, 6 months
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Macon & Joan Brock Virginia Health Institute at Old Dominion University
state: Virginia
Study officials:
affiliation: Old Dominion University
name: Kelli J England, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06253962: Carotid Atherosclerosis in Predicting Coronary Artery Disease
Official title: Carotid Atherosclerosis in Predicting Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carotid Atherosclerosis
Coronary Atheroscleroses
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 14
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to receive coronary angiography. Carotid ultrasound performed before angiography.

Brief summary: Carotid plaque burden and composition features, particularly lipid necrotic core, are significantly associated with severity of CAD stenosis. This study aims to explore the relationship between various phenotypic patterns of carotid atherosclerosis with the prevalence, phenotype, and severity of coronary atherosclerosis. The patients with chest tightness or chest pain will receive carotid artery ultrasonography before coronary angiography so as to explore the relationship between them.


Eligibility criteria: Inclusion Criteria:

* patients receive carotid ultrasound and coronary angiography

Exclusion Criteria:

* None

Primary outcomes:
measure: MACE
timeFrame: two years after angiography
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
Study officials:
References:
Clinical trial NCT05722262: Study to Demonstrate the Bioequivalence of Single Oral Administration of K-001 Relative to Single Oral Coadministration of Separate Tablets of K-877-ER and CSG452
Official title: A Randomized, Open-Label, Six-Sequence, Three-Period Crossover Study to Demonstrate the Bioequivalence of Single Oral Administration of K-001 Relative to Single Oral Coadministration of Separate Tablets of K-877-ER Plus CSG452 in Healthy Adult Volunteers, and to Characterize the Food Effect on the Pharmacokinetics of K-001
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Randomized, open-label, six-sequence, three-period, crossover study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to demonstrate the bioequivalence of single oral administration of K-001 relative to single oral co-administration of separate tablets of K-877-ER and CSG452 in healthy adult volunteers, and to characterize the food effect on the Pharmacokinetics(PK) of K-001.


Eligibility criteria: Inclusion Criteria:

* Participant provides written informed consent before any study-specific evaluation is performed.
* Participant is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.
* Participant has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
* Participant meet all other inclusion criteria outlined in the clinical study protocol.

Exclusion Criteria:

* Participant has clinically significant abnormalities at Screening or at Check-in assessments, in the opinion of the investigator.
* Participant is pregnant or breastfeeding or intends to become pregnant within 30 days after the last dose of study drug.
* Participant meets any other exclusion criteria outlined in the clinical study protocol.

Primary outcomes:
measure: Cmax of K-877 and CSG452
timeFrame: 1 hour before dosing and at multiple time points (up to 48 hours) post dose
measure: AUC0-t of K-877 and CSG452
timeFrame: 1 hour before dosing and at multiple time points (up to 48 hours) post dose
measure: AUC0-inf of K-877-and CSG452
timeFrame: 1 hour before dosing and at multiple time points (up to 48 hours) post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD - Austin Research Unit
state: Texas
Study officials:
References:
Clinical trial NCT02528162: Evaluation of Education for Gestational Diabetes
Official title: Evaluation of Knowledge Regarding Gestational Diabetes and Evaluation of (Group) Education for Gestational Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes
Keywords: gestational diabetes
education
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women diagnosed with GDM based on the IADPSG criteria

Brief summary: Prospective observational cohort study of women with gestational diabetes (GDM) based on the 'International Association of Pregnancy Study Groups' (IADPSG) criteria. The overall aim is to evaluate the knowledge regarding GDM of women with GDM and to evaluate the satisfaction of women with GDM about the education they receive (given in group or individually). Normal routine care is followed and evaluated.


Eligibility criteria: Inclusion Criteria:

* Women ≥ 18 years diagnosed with GDM in the university hospital Leuven.

Exclusion Criteria:

* Women who received bariatric surgery.
* Women with pregestational diabetes or diagnosed with diabetes during early pregnancy.

Primary outcomes:
measure: Evaluation of the knowledge regarding GDM with a self-designed questionnaire
timeFrame: over a 2-4 week period
measure: Scale (0 to 3) with questionnaire on depression (CES-D )
timeFrame: over a 2-4 week period
measure: Evaluation of satisfaction with education and Diabetes Treatment Satisfaction Questionnaire
timeFrame: over a 2-4 week period
measure: Scale (1-4) with questionnaire on anxiety (six-item short form STAI)
timeFrame: over a 2-4 week period
Secondary outcomes:
measure: The prevalence of GDM based on the IADPSG criteria
timeFrame: at 24-28 weeks of pregnancy
measure: Composite endpoint of glycaemic control, weight, gestational weight gain and pregnancy outcomes
timeFrame: over a period of 16 weeks
measure: The frequency of insulin therapy for GDM
timeFrame: over a period of 16 weeks
measure: The time between the glucose challenge test and oral glucose tolerance test
timeFrame: at 24-28 weeks of pregnancy
measure: The frequency of an HbA1c ≥6.5%
timeFrame: at 24-28 weeks of pregnancy
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
Clinical trial NCT00562562: A Pilot MRI Study of Osteopathic Manipulative Treatment of Acute Low Back Pain
Official title: A Pilot MRI Study of Osteopathic Manipulative Treatment of Acute Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Ohio University
Sponsor class: OTHER
Collaborators: name: Osteopathic Heritage Foundations
First posted: 2007-11-22
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a pilot project intended to determine the feasibility of detecting soft tissue changes in response to osteopathic manipulative treatment (OMT). MRIs of the lumbar and pelvic regions of low back pain (LBP) patients will be taken once before and at two different time points after OMT. Images obtained will be quantitatively analyzed for changes in the volumes of back muscles and for changes (T2 signals) indicative of activity levels or pathological conditions. Electromyography (EMG) will be used as an independent measure of back muscle activity for comparison with MRI results.


Eligibility criteria: Inclusion criteria:

* Adult patients (18-55)
* Patients with LBP with acute symptoms (within last 3 weeks)
* Test positive for lumbar somatic dysfunction

Exclusion criteria:

* History of any spinal injuries/surgeries
* Positive findings of frank neurological signs during physical exam
* Any other orthopedic or neurological impairment
* Unsuitable for MRI imaging:

  * Cardiac pacemaker or defibrillator
  * Severe Claustrophobia
  * Injured by a metallic object that was not removed
  * Cochlear (ear) implants
  * Surgery involving a metallic implant (e.g. knee replacement)
  * Weight more than 300 lbs/136 kg (weight limit for scanner bed)

Primary outcomes:
measure: MRI T2 signal changes
timeFrame: within 72 hours
Secondary outcomes:
measure: MRI anatomic changes and EMG changes
timeFrame: within 72 hours
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ohio University
state: Ohio
Study officials:
affiliation: Ohio University
name: John N Howell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04086862: Effect of Ultrasound Therapy on Bilateral Masseter Myalgia: Comparison of 1 Megahertz Versus 3 Megahertz
Official title: Effect of Ultrasound Therapy on Bilateral Masseter Myalgia: Comparison of 1 Megahertz Versus 3 Megahertz
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Females
Bilateral Masseter Myalgia
Keywords: temporomandibular disorders
masseter myalgia
adult female
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized to double-blind treatment with 1 MHz or 3 MHz therapeutic ultrasound.
Primary purpose: TREATMENT

Brief summary: Temporomandibular disorders (TMD) are a group of musculoskeletal and neuromuscular conditions that involve the temporomandibular joints, the masticatory muscles, and all associated tissues. These disorders are characterized by regional pain and limitation of mandibular range of motion. Pain-related TMD affects approximately 5% to 12% of the population and can affect individual's quality of life. The incidence is about 4 percent. Therapeutic ultrasound is a type of physical therapy that delivers energy via propagation of ultrasonic waves. One gap in knowledge is whether 1 megahertz (MHz) treating frequency has the same efficacy as treating with 3 MHz. This research proposes to test that.

Detailed description: See brief summary.

Eligibility criteria: Inclusion Criteria:

* Adult females
* Bilateral myalgia based on Diagnostic Criteria for TMD (DC-TMD) criteria
* An average pain of 5 or more on a 0 to 10 scale over the last 30 days.

Exclusion Criteria:

* A history or diagnosis of systemic musculoskeletal disorders or rheumatologic diseases (e.g. fibromyalgia, muscular atrophy).
* Certain conditions such as neoplasms or fractures.
* Neuropathies or neurological disorders.
* Currently taking muscle relaxants or analgesics.
* Undergone any form of physical therapy within the last 60 days.
* Severe bruxism requiring mouth-guard treatment.

Primary outcomes:
measure: Reduction in masseter pain by visual analog pain scale.
timeFrame: Baseline to fifth week.
measure: Reduction in masseter pain by pressure pain threshold.
timeFrame: Baseline to fifth week.
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: School of Dental Medicine
state: New York
Study officials:
affiliation: State University of New York at Buffalo
name: W. D. McCall, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06467162: Usage of Spacers and the Relationship With Symptoms Severity in COPD Elderly Patients
Official title: The Usage of Spacers and the Relationship With Symptoms Severity in Chronic Obstructive Pulmonary Disease Elderly Patients: A Correlational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease
Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease
Spacer
Symptom severity
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 164
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic obstructive pulmonary disease aged 65 years or over at thoracic medicine outpatient clinics.

Brief summary: The goal of this observational study is to investigate the usage of spacers and their relationship with symptom severity in chronic obstructive pulmonary disease elderly patients. Patients with chronic obstructive pulmonary disease aged 65 years or over at thoracic medicine outpatient clinics were recruited in this study. Research participants were interviewed using structured questionnaires, including demographic characteristics information, clinical characteristics information, and the chronic obstructive pulmonary disease assessment test.

Detailed description: The goal of this observational study is to investigate the usage of spacers and their relationship with symptom severity in chronic obstructive pulmonary disease elderly patients. A convenience sample was used to recruit patients with chronic obstructive pulmonary disease aged 65 years or over at thoracic medicine outpatient clinics from a teaching hospital in Taiwan. Research participants were interviewed using structured questionnaires, including demographic characteristics information, clinical characteristics information, and the chronic obstructive pulmonary disease assessment test.

Eligibility criteria: Inclusion Criteria:

* Individuals aged 65 or above diagnosed with COPD by a pulmonologist.
* Clear consciousness and communication abilities in Mandarin or Taiwanese.
* Consent to participate in this study and sign the informed consent form.

Exclusion Criteria:

* Patients who are blind, deaf, unable to express themselves, and unable to understand the study explanation.

Primary outcomes:
measure: Symptoms severity
timeFrame: Immediately after the outpatient department visit
Secondary outcomes:
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Wan-Ting Huang
Study officials:
affiliation: Da-Yeh University
name: Wan-Ting Huang, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06247891: Endocytoscopy of Upper Gastrointestinal Tract in Acute Graft-versus-host Disease: a Pilot Study
Official title: Endocytoscopy of Upper Gastrointestinal Tract in Acute Graft-versus-host Disease: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endocytoscopy
Keywords: Endocytoscopy
acute graft-versus-host disease
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 14
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to test the assess the diagnostic effectiveness of endocytoscopy in patients with underlying UGI aGvHD. The main question it aims to answer is: the effectiveness of ECS for diagnosing UGI aGvHD. Participants will undergo endoscopy, endocytoscopic evaluation and biopsy simultaneously. If there is a comparison group: Researchers will compare endoscopic, endocytoscopic and pathologic findings of these patients.


Eligibility criteria: Inclusion Criteria:

* aged ≥ 14 years
* developed UGI symptoms within first three months after engraftment or during the tapering of immunosuppressive agents

Exclusion Criteria:

* \< 14 year
* with underlying gastrointestinal disease before allo-HSCT
* incomplete medical information

Primary outcomes:
measure: the effectiveness of endocytoscopy for diagnosing UGI aGvHD
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ye Zhao
Study officials:
References:
Clinical trial NCT04574791: Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty
Official title: Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, cluster-randomized, two-arm, comparative study aimed at determining whether addition of tizanidine ( an oral muscle relaxant) to a multimodal pain regimen following primary TKA reduces opioid consumption.


Eligibility criteria: Inclusion Criteria:

* - Patients undergoing unilateral primary TKA with underlying diagnosis of osteoarthritis.
* ASA I - III
* Spinal anesthesia
* All patients will have a total knee arthroplasty utilizing a medial parapatellar approach with cruciate sacrificing implants and patellar resurfacing. A tourniquet will be used in all cases.
* Men and women between 18 and 80 years who are willing and able to provide informed consent

Exclusion Criteria:

* Opioid use greater than 10 mg/day morphine equivalents continuously for one month within 3 months preoperatively
* Inability to take/allergy to the protocol medications
* Contraindication to regional anesthesia
* Non-English speaking
* ASA IV or greater
* Psychiatric or cognitive disorders
* Allergy/contraindications to protocol medications.
* Renal insufficiency with Cr \> 2.0 or hepatic failure
* Sensory/motor disorder involving the operative limb
* PCS score \>20
* Patients with severe cardiac or neurological conditions precluding the use of study medications
* Patients using anticoagulation other than aspirin for the 14-day period after discharge

Primary outcomes:
measure: opioid consumption (MME) postoperatively
timeFrame: the first 14-days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References: