louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05766423: Phenotyping Adherence Through Technology-Enabled Reports and Navigation
Official title: Phenotyping Adherence Through Technology-Enabled Reports and Navigation: The PATTERN Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: The Claude D. Pepper Older Americans Independence Centers
name: National Institute on Aging (NIA)
First posted: 2023-03-13
Enrollment: 73
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is being conducted to adapt and pilot test a technology-enabled, primary care strategy for routinely monitoring medication use and adherence among older adults with multiple chronic conditions and polypharmacy.

Detailed description: Our study aims are to:

Aim 1: Adapt the PATTERN intervention for use in primary care using input from key stakeholders. During Aim 1, the Northwestern research team will solicit opinions from key informants (patients, clinicians, practice administrators) to ensure PATTERN meets the needs of primary care.

Aim 2: Assess the PATTERN intervention's feasibility and acceptability for use in primary care. During Aim 2, the investigators will conduct a 2-arm, patient-randomized controlled trial at a Northwestern Medicine primary care practice. Participants will be recruited and randomly assigned, using a random number generator application, to either the PATTERN intervention or usual care. Usual care refers to the normal standard clinical practices at the participating practice. Participants will be followed for 6 months.

Eligibility criteria: Inclusion Criteria:

Each participant must:

* Be an adult aged 65 or older
* Speak English as their primary language
* Have multiple chronic conditions
* Be prescribed 8 or more medications
* Be primarily responsible for administering own medication
* Receive medical care at the participating primary care practice
* Have access to the internet and an active email address
* Be signed up for the patient portal (MyChart)

Exclusion Criteria:

No participant can:

* Have severe, uncorrectable visual, hearing or cognitive impairments that would preclude study consent or participation

Primary outcomes:
measure: Medication Adherence
timeFrame: About 2-4 Weeks
Secondary outcomes:
measure: Fidelity
timeFrame: By the scheduled clinic visit (baseline)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Allison Pack, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00805623: Sucking and Sucrose as Pain Relief for Infants
Official title: Partial Blinded Controlled Study to Compare SucroseVs Water, With and Without Pacifier as Pain Reliever During Venous Puncture in Infants 3-12 Months Old
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain
Keywords: sucrose
sucking
pain relief
infant
require venous puncture
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2008-12-09
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sucking and sucrose have been shown to reduce pain during venous puncture in neonates. Our study is designed to see if sucking and sucrose relieve pain during venous puncture in infants age 3-12 months.

Detailed description: 100 infants age 3-12 months old without neurologic, developmental or cardio-respiratory impairment, needing venous puncture for IV access, or blood aspiration, will be randomly assigned to one of 2 groups - with or without pacifier. During the puncture, each patient with pacifier will receive either 1 cc of water or 1 cc of sucrose (the solutions prepared and marked blindly) . Each patient without pacifier 2 will receive 1 cc of water without pacifier,will receive either 1 cc of water or 1 cc of sucrose (the solutions prepared and marked blindly). FLACC pain score will be used for apin assessment before, during and after the puncture.Comparison of the four groups will be done after the end of the study.

Eligibility criteria: Inclusion Criteria:

* age 3-12 months
* hospitalized in pediatric ward B
* need venous puncture

Exclusion Criteria:

* neurological deficit
* developmental delay
* Cyanotic heart disease
* symptomatic respiratory disease
* known problematic venous access

Primary outcomes:
measure: reduced pain scoring
timeFrame: 10 minutes
Secondary outcomes:
measure: better Parent's scoring to the child's behavior
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Schneider Children's Medical Center of Israel
Study officials:
affiliation: Schneider Children's Medical Center, Israel
name: Rachel Efrat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04216823: Perfusion Index as an Objective Measure for Supraclavicular Brachial Plexus Block in Pediatric Patients
Official title: Evaluation of Perfusion Index as an Objective Measure for Supraclavicular Brachial Plexus Block in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Supraclavicular Brachial Plexus Block
Keywords: perfusion index
supraclavicular brachial plexus block
children
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 104
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ASA physical status I-II,Age 1 month-12 year,Children undergoing Upper limb surgery.

Brief summary: The aim of the present study is to evaluate the effects of supraclavicular brachial plexus block using perfusion index in pediatric patients undergoing Upper limb surgery.

Detailed description: The role of perfusion index in the prediction of peripheral block success was previously reported for infraclavicular brachial plexus block, axillary brachial plexus block, interscalene brachial plexus block, and supraclavicular brachial plexus in adult patients. The aim of the present study is to assess the effects of perfusion index on success of supraclavicular brachial plexus block in pediatric patients.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I-II
* Children undergoing Upper limb surgery.
* Parents' agreement.

Exclusion Criteria:

* Parents' refusal.
* Children with behavioral changes
* Children with physical developmental delay
* Children on treatment with sedative or anticonvulsant.

Primary outcomes:
measure: perfusion index
timeFrame: the time span between 1 day preoperative and 24 hours after surgery
Secondary outcomes:
measure: mean arterial blood pressure
timeFrame: the time span between 1 day preoperative and 24 hours after surgery
measure: heart rate
timeFrame: the time span between 1 day preoperative and 24 hours after surgery
measure: PI ratio
timeFrame: up to 10 minutes
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Huazhong university, Tongji medical college
name: Hong Liu, Dr.
role: STUDY_CHAIR
References:
citation: Wang J, Deng L, Xu A. Evaluation of prediction effect of perfusion index for supraclavicular brachial plexus block in children: protocol for a randomized trial. Trials. 2022 Aug 4;23(1):629. doi: 10.1186/s13063-022-06597-y.
Clinical trial NCT03341923: Clinical Evaluation of DAILIES TOTAL 1® Multifocal Compared to 1-Day Acuvue® Moist® Multifocal in a Japanese Population
Official title: Clinical Evaluation of DAILIES TOTAL 1® Multifocal Compared to 1-Day Acuvue® Moist® Multifocal in a Japanese Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Presbyopia
Keywords: contact lenses
lens centration
multifocal
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2017-11-14
Enrollment: 151
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is to evaluate DAILIES TOTAL1® Multifocal (DT1MF) contact lenses compared to 1-DAY ACUVUE® Moist® Multifocal (AMMF) contact lenses for investigator-graded lens centration in a Japanese population.

Detailed description: Subjects will be randomly assigned to one of two sequences of investigational product wear ((DT1MF→AMMF, AMMF→DT1MF). Each product will be worn in both eyes for at least 11 days.

Eligibility criteria: Inclusion Criteria:

* Sign informed consent
* Habitually wear multifocal soft/ silicone hydrogel contact lenses
* Require a near spectacle ADD of +0.50 diopters (D) to +2.50D (inclusive)
* Correctable to 20/30 Snellen or 0.2 logarithm minimum angle of resolution (logMAR) or better in each eye at distance
* Willing to wear contact lenses and attend all study visits

Exclusion Criteria:

* Currently wearing DAILIES TOTAL 1® Multifocal or 1-DAY ACUVUE® Moist® Multifocal contact lenses
* Any eye condition that would make contact lens wear unadvisable
* Any use of medication that would make contact lens wear unadvisable
* Prior refractive surgery

Primary outcomes:
measure: Percentage of Subjects With Investigator-graded Lens Centration of "Optimal"
timeFrame: Day 14, each product
Secondary outcomes:
Other outcomes:
Locations:
city: Koto-Ku
country: Japan
facility: Alcon Investigative Site
state: Tokyo
city: Nakano-ku
country: Japan
facility: Alcon Investigative Site
state: Tokyo
city: Shinagawa-Ku
country: Japan
facility: Alcon Investigative Site
state: Tokyo
city: Taitō
country: Japan
facility: Alcon Investigative Site
state: Tokyo
Study officials:
References:
Clinical trial NCT04592523: A Study of Usage of Brigatinib in the Treatment of Adult Participants for Approved Indications In South Korea
Official title: Post-Marketing Surveillance (Usage Results Study) of Brigatinib in the Treatment of Adult Patients for Approved Indications in South Korea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carcinoma, Non-Small-Cell Lung
Anaplastic Lymphoma Kinase
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2020-10-19
Enrollment: 257
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with ALK-positive advanced or metasatatic NSCLC who initiate treatment for the first time with brigatinib in a routine clinical practical setting will be observed prospectively.

Brief summary: The purpose of this study is to estimate the proportion of all adverse events (AEs) including serious adverse events (SAEs) occurring with the use of brigatinib among adult participants who have been administered brigatinib as per the approved indications.

Detailed description: This is a prospective observational post-marketing surveillance study of participants with ALK-positive NSCLC who initiate treatment for the first time with brigatinib in a routine clinical practical setting. The study will characterize the safety and effectiveness of brigatinib for its approved indications under real world use.

The study will enroll approximately 257 participants. The data will be prospectively collected, at the centers from routinely scheduled and emergency visits until end of follow up, and recorded into electronic case report forms (e-CRFs). All participants will be assigned to a single observational cohort.

This multi-center study will be conducted in the South Korea. The overall duration of this study is approximately 6 years. Data will be collected over and up to a 24 month-surveillance period (per participant) once enrolled.

Eligibility criteria: Inclusion Criteria:

1. With ALK-positive advanced or metastatic NSCLC.
2. Who initiate brigatinib for the first time.

Exclusion Criteria:

1. Treated with brigatinib outside of the locally approved label in Korea.
2. Whom brigatinib is contraindicated as per product label.
3. Participating in other clinical trials of NSCLC treatment.

Primary outcomes:
measure: Percentage of Participants with AEs and SAEs
timeFrame: Up to 30 days after the end of treatment (up to 24 months)
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 24 months
measure: Duration of Response (DOR)
timeFrame: Up to 24 months
measure: Progression Free Survival (PFS)
timeFrame: From first administration of study drug to the date of disease progression or death due to any cause (up to 24 months)
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01765738: Comparison of an Antibiotic Impregnated PICC Catheter Versus a Regular PICC Catheter in a Tertiary Care Setting
Official title: Randomized Double Blind Comparison of an Antibiotic Impregnated PICC Catheter Versus a Regular PICC Catheter in a Tertiary Care Setting
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Peripherally Inserted Central Catheters
Keywords: PICC
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2013-01-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine whether antibiotic impregnated PICC catheters have a lower infection rate than a conventional PICC catheter in a tertiary care patient population. Secondary goals will be to determine if there is a difference between the two catheters with early and late infections, to determine the cost comparison including extra cost of treatment for a line related infection, to determine if there are any non-infectious related complication differences between the two catheters.

Detailed description: All patients who are referred to VIR for a PICC line will be evaluated to see if they satisfy the inclusion/exclusion criteria. The study will be discussed with those who do and informed consent will be obtained from those wishing to participate. The patient will then be randomized to one of two types of PICC lines. All lines will be placed by identical technique. This will include sterile technique, placement via a vein of the upper arm using ultrasound guidance, and positioning of the catheter tip under fluoroscopic guidance. A database of all catheters placed will be kept. Records will be reviewed at 1 week, 30 days, and 60 days by the Interventional Radiology Fellow.Review will include length of time catheter was in place, whether treatment was completed, whether catheter was removed prematurely, the clinical reason for removal, results of other imaging tests, and results of cultures on any catheters removed for suspicion of infection. Any non-infectious complications related to the catheter will also be noted. The reviewer will be blinded to which catheter was used during the procedure.

Eligibility criteria: Inclusion Criteria:

* Greater than or equal to 18 years of age
* Have been scheduled for a medically necessary PICC placement

Exclusion Criteria:

* Less than 18 years of age

Primary outcomes:
measure: Infection rate
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: J. Bayne Selby, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02008838: Effects of Synbiotic Supplementation in Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Metabolic Syndrome
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 38
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: To evaluate the effects of synbiotic supplementation on insulin resistance, and lipid profile in subjects with metabolic syndrome, in a randomized, double-blind, placebo-controlled pilot study, 38 subjects with metabolic syndrome will be supplemented with either synbiotic or placebo capsules twice/day for 28 weeks. Both the synbiotic (G1) and the placebo (G2) groups will be advised to follow an energy balanced diet and physical activity recommendations. Parameters related to metabolic syndrome and insulin resistance will be measured every 7 weeks during the study course.


Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* having three of the following five features: Increased waist circumference (≥102 cm in men and ≥88 cm in women), elevated TG (≥150 mg/dl), reduced HDL-C (≤40 mg/dl in men and ≤50 mg/dl in women), elevated blood pressure (≥130/85 mm Hg or on treatment for hypertension) and elevated glucose (≥100 mg/dl), according to the National Cholesterol Education Program Adult Treatment Panel III report
* BMI : 25≥ BMI ≥ 40

Exclusion Criteria:

* Use antibiotic 2 weeks before recruitment to the study
* A history of alcohol consumption
* Pregnancy \& Breast feeding , Professional athelets
* A history of Cardiovascular disease, Pulmonary disease, Renal disease \& Celiac disease

Primary outcomes:
measure: HOMA-IR
timeFrame: 28 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00119938: An Online System to Improve Diabetes Self-Care
Official title: D-STAR (Diabetes-System To Access Records): An Online Patient Portal to Improve and Sustain Diabetes Self-Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Disease management
Patient access to records
Medical records systems, computerized
Questionnaires
Physician-patient relations
Medical records
Lead sponsor: Robert Wood Johnson Foundation
Sponsor class: OTHER
First posted: 2005-07-14
Enrollment: 331
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to see if an online program for patients with diabetes helps patients improve their self-care (how they take their medications, what they eat, how much they exercise, and whether they smoke).

Detailed description: Patient portals are online programs that can provide a number of functions for patients, among them:

* Ability to request appointments, referrals, and medication refills;
* Ability to send secure electronic messages to medical staff, and to receive replies;
* Access to the medical record;
* Disease management

We are comparing two patient portals with different sets of features to determine if personalized information and guidance can improve self-care and measures of diabetes-related health. Self-care measures will be assessed using standardized questionnaires at baseline, 3, and 6 months. Chart review will be used to assess measures of diabetes-related health.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Type 2 diabetes mellitus
* Has access to Internet
* Has e-mail address
* Established patient at one of four participating practices at University of Colorado Hospital

Exclusion Criteria:

* Non-English speaking

Primary outcomes:
measure: Composite measure of diabetes self-care activities, developed from the Summary of Diabetes Self-Care Measure
timeFrame: Surveys at baseline, 3 months, and 6 months
Secondary outcomes:
measure: Qualitative assessment of the program by patients and medical staff
timeFrame: Interviews after 9 months of deployment
measure: Biological markers of diabetes care (hemoglobin A1c, blood pressure, LDL cholesterol)
timeFrame: Incidentally obtained over 9 months of care
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Stephen E Ross, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01873638: Comparing Minilaparotomy and Laparoscopic Cholecystectomy as a Day Surgery Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gallstone Disease
Keywords: 5-year outcome after cholecystectomy
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2013-06-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Minlaparotomy (MC) and laparoscopic cholecystoctomy (LC) are commonly applied surgical techniques for the management of symptomatic gallstone disease and both techiques have shown to be feasible for day surgery. However, to our knowledge the long-term outcome between these approaches has not been compared in randomised trials as day surgery procedures.


Eligibility criteria: Inclusion Criteria:

* Cholelithiasis confirmed by preoperative ulrasound
* No significant co-morbidities
* The ASA physical status classification 1 or 2
* Age 18 to 65 yrs.
* BMI less than 35
* Less than a one hour journey from hospital to home
* Patient´s own motivation to daysurgery

Exclusion Criteria:

* Elevated liver laboratory tests
* Earlier jaundice
* A suspicion or verified stones in the common bile duct
* Acute cholecystitis
* A history of pancreatitis
* Hepatic cirrhosis
* Suspicion of cancer
* Previous open upper abdominal surgery
* Asthma
* Peptic ulcer
* Bleeding disorders

Primary outcomes:
measure: Chronic post-surgical pain
timeFrame: Five year outcome
Secondary outcomes:
measure: Quality of life
timeFrame: Five year outcome
Other outcomes:
measure: Cosmetic satisfaction
timeFrame: Five year outcome
measure: Residual abdominal symptoms
timeFrame: Five year outcome
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: Northern Savo
Study officials:
References:
Clinical trial NCT06226038: Effect of Static Magnetic Field on Dental Implant Stability.
Official title: Effect of the Modified Magnetic Interim Denture on Dental Implant Stability and Marginal Bone Level: a Double-blind Randomized Controlled Trial Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Implant Site Reaction
Keywords: Static magnetic field
Dental implant
Bone healing
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of static magnetic field on dental implant to bone integration.

Detailed description: Bone to implant integration depend on bone healing. Magnetic field was proved to promote and make bone to implant integration happen faster. We decided to investigate by placing 2 dental implants in lower jaw of complete edentulous patients with specialised temporary dentures. Said denture will have neodymium magnet on one side, completely embedded in acrylic mass.

Eligibility criteria: Inclusion Criteria:

* healthy, complete edentulous area

Exclusion Criteria:

* uncontrolled NCDs patients

Primary outcomes:
measure: Implant stability quotient
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Mahidol university
state: Payatai
Study officials:
References: