louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06568900: Randomized Controlled Trial to Evaluate the Impact of ZYN Nicotine Pouch Products on Cigarette Usage and BoExp in Adult Smokers Over a 12-week Period
Official title: A Randomized Controlled Trial to Evaluate the Impact of ZYN Nicotine Pouch Products on Cigarette Usage and Biomarkers of Exposure in Adult Smokers Over a 12-week Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Keywords: nicotine
tobacco
nicotine containing products
Lead sponsor: Swedish Match AB
Sponsor class: INDUSTRY
First posted: 2024-08-23
Enrollment: 450
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To verify whether unrestricted access to flavored products is likely to lead to greater reductions in combustible cigarette smoking and decreased exposure to smoking related toxicants.

Detailed description: US adult smokers will be randomized into three groups (Group I: (control) continue smoking their usual brand of CC; Group II: provided with tobacco flavor and unflavored options of ZYN; Group III: provide with unrestricted flavor options of ZYN) to evaluate the impact of availability of different ZYN products on cigarette usage patterns and biomarkers of exposure over a 12-week study period, followed by an 6-week extension for some participants.

Eligibility criteria: Inclusion Criteria:

* Healthy adult smokers 22 to 65 years of age (inclusive) at screening.
* Smokes an average of at least 10 commercially available cigarettes per day for the last 12 months.
* Interested in switching from combustible cigarettes to nicotine pouch products.

Exclusion Criteria:

* Participants of childbearing potential (CBP) who are breast-feeding or have a positive pregnancy test.
* Participants who currently use nicotine pouches.
* Participants with known heart disease or medical condition that may adversely affect participant safety

Primary outcomes:
measure: Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL) in urine
timeFrame: Measured from baseline to week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: Rose Research Center
state: North Carolina
Study officials:
affiliation: Swedish Match
name: Brian E Erkkila, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01063400: Feasibility Study: Comparison of Performance Status With Objective Physical Activity Monitors
Official title: OS09328 Feasibility Study: Comparison of Performance Status With Objective Physical Activity Monitors
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non Small Cell Lung Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2010-02-05
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-small cell lung cancer patients receiving chemotherapy.

Brief summary: The purpose of this research is to examine the relationship between performance status rating and the actual amount of physical activity a subject does when it is measured by an activity monitor.


Eligibility criteria: Inclusion Criteria:

* Worst Daily Pain rating of \< 4/10
* ECOG Performance Status of 0, 1, or 2
* Prior malignancy is allowed as long as it is inactive or well-controlled without current anti-tumor therapy required

Exclusion Criteria:

* Known brain metastasis
* Use of assistive devices (cane, crutch)
* No concurrent radiotherapy: all radiotherapy must be completed 4 weeks prior to enrollment in this study
* Patients receiving only targeted therapy are not eligible(e.g.erlotinib)

Primary outcomes:
measure: To determine the feasibility of examining physical activity (through objective measurement devices) and performance status in a 14-day study of lung cancer patients.
timeFrame: 14 days
Secondary outcomes:
measure: To determine the number of days of monitoring necessary to reliably estimate energy expenditure (steps/day, and % of time spent sedentary) in lung cancer patients undergoing chemotherapy.
timeFrame: 14 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: UW Madison
name: Toby Campbell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01398800: Early Clinical Results of Mobile-Bearing Revision Total Knee Arthroplasty
Official title: Early Clinical Results of Mobile-Bearing Revision Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty, Replacement, Knee
Lead sponsor: Colorado Joint Replacement
Sponsor class: OTHER
Collaborators: name: DePuy Orthopaedics
First posted: 2011-07-21
Enrollment: 340
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients of Colorado Joint Replacement

Brief summary: Long term follow-up is needed to determine whether current Mobile Bearing revision Total Knee Arthroplasty (TKA) designs will improve implant longevity. The potential advantages of mobile bearings in the revision TKA setting include reduction in polyethylene wear, decreasing fixation stresses, and protection of the constraining mechanisms. Several studies have reported satisfactory clinical results after revision total knee arthroplasty but no study with a large number has specifically addressed the clinical outcomes after revision total knee arthroplasty using the mobile bearing design

Detailed description: Failure modes of revision total knee arthroplasty (TKA) that include prosthetic loosening and damage to constraining mechanisms often require revision TKA. Mobile bearing revision TKA components have been developed in hopes of lessening these failure mechanisms. Our purpose is to evaluate the use of mobile bearings in revision TKA.

Retrospective clinical and radiographic evaluation of 340 revision mobile bearing TKAs using the PFC Sigma and LCS posterior stabilized rotating platform implants (Depuy, Warsaw, IN) will be performed. Indications for revision include instability, loosening, arthrofibrosis, chronic hemarthrosis, failed patellofemoral replacement, failed unicompartmental knee replacement, infection reimplantation, and supracondylar fracture nonunion.

Eligibility criteria: Inclusion Criteria:

Requiring a revision of a primary knee replacement. Indications for revision include instability, aseptic loosening, failed unicompartmental knee replacement, infection reimplantation, arthrofibroisis, chronic hemarthrosis, failed patellofemoral replacments, and non union of a supracondylar femur fracture.

Exclusion Criteria: None since they have all required a revision.

Primary outcomes:
measure: Function and knee score of the knee society scoring at every 2 years until 10 years.
timeFrame: 1-10 years post operative of revision
Secondary outcomes:
measure: Radiographic analysis by our orthopedic clinician to determine component failure or loosening.
timeFrame: Post op - 1-10 years or revision surgery
Other outcomes:
Locations:
city: Denver
country: United States
facility: Colorado Joint Replacement
state: Colorado
Study officials:
affiliation: Colorado Joint Replacement
name: Raymond Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03391700: Effect of Intraoperative Muscle Relaxation Depth on Postoperative Sore Throat and Hoarseness After General Anesthesia
Official title: Effect of Intraoperative Muscle Relaxation Depth on Postoperative Sore Throat and Hoarseness After General Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sore Throat
Keywords: muscle relaxant
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 206
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigators assess and compare postoperative sore throat and hoarseness in the group maintaining moderate relaxation and deep relaxation during operation.

Detailed description: In this sturdy, the deep block is applied when the surgeon requests for deep muscle relaxation to improve surgical field condition in the surgery such as laparotomy known that the deep block is helpful and in the other surgeries, the moderate block is maintained. The investigators assess the postoperative sore throat and hoarseness and compare the effect of muscle relaxation depth in the deep block group and moderate block group in terms of the incidence and severity of postoperative sore throat and hoarseness.

Eligibility criteria: Inclusion Criteria:

* Requirement for mechanical ventilation under general anesthesia

Exclusion Criteria:

* Hoarseness and sore throat existed before surgery
* Upper respiratory infection
* Known or predicted difficult airway
* Liver, renal disease
* Requirement of postoperative ventilator care
* the operation within 2hrs
* Laparoscopic surgery
* Other positions except supine during surgery

Primary outcomes:
measure: Overall incidence of postoperative sore throat
timeFrame: Within 24 hrs after operation
Secondary outcomes:
measure: The incidence of postoperative sore throat
timeFrame: At 1,6, and 24 hrs after operation
measure: The severity of postoperative sore throat
timeFrame: At 1,6, and 24 hrs after operation
measure: Incidence and severity of postoperative hoarseness
timeFrame: At 1,6, and 24 hrs after operation
measure: Postoperative analgesic consumption
timeFrame: Within 24 hrs after operation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jee-Eun Chang
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Jee-eun Chang, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00773500: Impact of Vendor Systems on Ambulatory Medication Safety
Official title: Impact of Vendor Systems on Ambulatory Medication Safety
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medication Errors
Keywords: Medication Errors
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2008-10-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our study will take place in 2 NYS communities. We will select 2 communities in order to assemble a study population with the following characteristics: use of at least 2 different vendor-based systems, different implementation times (with some communities being early adopters and others experienced users), and inclusion of urban underserved and federally defined rural areas.

We will select the following 2 communities/organizations: the community health centers implementing electronic prescribing with the New York City Department of Health (NYC DOH) and the Taconic Health Information Network and Community (THINC) in the Hudson Valley of New York. Both communities have expressed their interest in participating in this study.

Brief summary: Our objective is to determine the effects of electronic prescribing on medication safety including medication errors, near misses and preventable adverse drug events in the ambulatory setting. Study design will be a longitudinal evaluation of errors early after implementation and after sustained use.

Detailed description: We will compare the effects of different vendor-based electronic prescribing systems on ambulatory medication safety in various settings, including rural and underserved areas and determine the effects of electronic prescribing systems on ambulatory medication safety over time.

Eligibility criteria: Inclusion Criteria:

* \>=0.75 FTE providers

Exclusion Criteria:

* \<0.75 FTE providers

Primary outcomes:
measure: prescribing error
timeFrame: 1 year
Secondary outcomes:
measure: near misses
timeFrame: 1 year
measure: preventable adverse drug events
timeFrame: 1 year
Other outcomes:
Locations:
city: Fishkill
country: United States
facility: Taconic IPA
state: New York
city: New York
country: United States
facility: New York City Department of Health and Mental Hygiene
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Rainu Kaushal, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abramson EL, Pfoh ER, Barron Y, Quaresimo J, Kaushal R. The effects of electronic prescribing by community-based providers on ambulatory medication safety. Jt Comm J Qual Patient Saf. 2013 Dec;39(12):545-52. doi: 10.1016/s1553-7250(13)39070-9.
Clinical trial NCT00003000: Morphine for the Treatment of Pain in Patients With Breast Cancer
Official title: Peripheral Effects of Opioid Analgesia in Patients Undergoing Axillary Node Dissection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: pain
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2004-07-30
Enrollment: 18
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast Cancer Patients

Brief summary: RATIONALE: Morphine helps to relieve the pain associated with cancer surgery. Giving morphine in different ways may offer more pain relief.

PURPOSE: This randomized clinical trial is studying how well morphine injected directly into the underarm area works compared with morphine injected into the back of the shoulder in treating pain in patients who have breast cancer and who are undergoing axillary lymph node dissection.

Detailed description: OBJECTIVES: I. Determine whether morphine injected at the site of surgery can control pain from surgery.

OUTLINE: This is a prospective, double blind, randomized study. Patients are randomized into 3 groups with 6 patients in each group. Group 1 receives morphine diluted in normal saline (NS), which is administered in the axillary region at the completion of surgery before surgical closure. The area is flooded and the solution is allowed to remain in the wound for 5 minutes. Group 2 (control group) receives NS only, administered in the same fashion as group 1. Group 3 receives morphine subcutaneously in the deltoid area, ipsilateral to the site of surgery, at the beginning of wound closure. Postoperatively, patients self-administer IV fentanyl analgesia through a patient controlled analgesia pump. Comparisons of daily IV fentanyl utilization is done among the three groups. Quality of pain is assessed via visual analog pain scores four times a day at 2, 4, 6, and 24 hours postoperatively.

PROJECTED ACCRUAL: A total of 18 patients will be accrued over a period of 2 years.

Eligibility criteria: DISEASE CHARACTERISTICS: Patients with breast cancer who are scheduled to undergo axillary node dissection

PATIENT CHARACTERISTICS: See General Eligibility Criteria

PRIOR CONCURRENT THERAPY: No oral-equivalent doses of morphine greater than 10 mg a day -- Patient Characteristics-- Age: Not specified Sex: Not specified Other: Not allergic to morphine

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
References:
Clinical trial NCT04799600: The Effect of the Severity of COVID-19 Disease on the Incidence of Acute Renal Failure in ICU
Official title: The Effect of the Severity of COVID-19 Disease on the Incidence of Acute Renal Failure in ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID19
Acute Renal Failure
Keywords: COVID19
Acute Renal Failure
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 158
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalized in the intensive care unit diagnosed with COVID-19 will participate in the study.

Brief summary: Aim of the study is to determinate the frequency of acute renal failure in COVID-19 patients, its relationship with the severity of COVID-19 disease in ICU, and the ability to take precautions against these factors.


Eligibility criteria: Inclusion Criteria:

Patients hospitalized in the intensive care unit diagnosed with COVID-19 will include in the study.

Exclusion Criteria:

there is no exclusion criteria

Primary outcomes:
measure: KDIGO criteria
timeFrame: 6 months
measure: BRESCIA-COVID RESPIRATORY SEVERITY SCALE (BCRSS) scores
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
affiliation: ankara ch bilkent
name: betül aytaç, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kellum JA, Lameire N; KDIGO AKI Guideline Work Group. Diagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (Part 1). Crit Care. 2013 Feb 4;17(1):204. doi: 10.1186/cc11454.
citation: Wang L, Li X, Chen H, Yan S, Li D, Li Y, Gong Z. Coronavirus Disease 19 Infection Does Not Result in Acute Kidney Injury: An Analysis of 116 Hospitalized Patients from Wuhan, China. Am J Nephrol. 2020;51(5):343-348. doi: 10.1159/000507471. Epub 2020 Mar 31.
citation: Rodriguez-Nava G, Yanez-Bello MA, Trelles-Garcia DP, Chung CW, Friedman HJ, Hines DW. Performance of the quick COVID-19 severity index and the Brescia-COVID respiratory severity scale in hospitalized patients with COVID-19 in a community hospital setting. Int J Infect Dis. 2021 Jan;102:571-576. doi: 10.1016/j.ijid.2020.11.003. Epub 2020 Nov 9.
Clinical trial NCT01952600: Empowering Patients On Choices for Renal Replacement Therapy (Aim 1)
Official title: Empowering Patients On Choices for Renal Replacement Therapy (Aim 1)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease
Hemodialysis
Peritoneal Dialysis
Lead sponsor: Arbor Research Collaborative for Health
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: Henry Ford Health System
name: National Kidney Foundation, United States
name: American Association of Kidney Patients
name: Patient-Centered Outcomes Research Institute
First posted: 2013-09-30
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients residing in the United States with advanced chronic kidney disease or on dialysis.

Brief summary: The EPOCH-RRT study seeks to fill knowledge gaps by gaining more understanding of chronic kidney disease (CKD) patients' priorities; assessing the comparative benefits of hemodialysis (HD) versus peritoneal dialysis (PD), with respect to these priorities; and providing tailored information to assist patients with identifying the best dialysis modality fit for their own unique circumstances and perspectives.

The outcomes most relevant to patients ("patient-centered") extend beyond those traditionally assessed in clinical research, with the relative importance varying across patient groups. A tailored decision aid based on these findings can improve patient decision-making processes regarding choice of dialysis modality.

Detailed description: Empowering Patients On Choices for Renal Replacement Therapy (EPOCH-RRT)study seeks to identify factors that matter the most to patients with kidney disease and study how they are impacted by different types of dialysis. The inclusion of patients, caregivers, and patient advocacy organizations as research partners will assure that the study addresses questions of greatest relevance to patients facing the need for dialysis.

Aim One of EPOCH-RRT identifies outcomes that are most important to different groups of advanced CKD and dialysis patients through qualitative methods applied for conducting in-depth interviews.

Eligibility criteria: Inclusion Criteria:

* Individuals 18 years of age or older.
* Individuals with advanced chronic kidney disease or on dialysis (in-center, hemodialysis, or peritoneal dialysis) for at least three months.

Exclusion Criteria:

* Individuals under 18 years of age.
* Individuals unable to provide informed consent.
* Individuals who do not have chronic kidney disease.

Primary outcomes:
measure: Factors That Are Most Important to Patients
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Arbor Research Collaborative for Health
state: Michigan
Study officials:
affiliation: Arbor Research Collaborative for Health
name: Francesca Tentori, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05124600: An Individualized-health eLibrary App for People With Multiple Sclerosis
Official title: An Individualized-health eLibrary App for People With Multiple Sclerosis: Testing Feasibility and Effectiveness of a Brief Education Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: eHealth
mHealth
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the effectiveness after using a new individualized-health e-library app named SavvyHealth among people with multiple sclerosis.

Detailed description: Participants will use our developed app for 21 days and take a before-use survey and a post-use survey.

Eligibility criteria: Inclusion Criteria:

* diagnosed with MS;
* 18 years or older;
* one comorbidity evaluated by a validated comorbidity questionnaire for people with MS;
* willing to take a survey;
* willing to use the app for 21 days;
* willing to be assigned to either the intervention or control group.

Exclusion Criteria:

-

Primary outcomes:
measure: MS Self-management Scale
timeFrame: Through study completion, an average of 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Champaign
country: United States
facility: University of Illinois Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Chungyi Chiu
role: PRINCIPAL_INVESTIGATOR
References: