louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05455177: Change in Patient Reported Outcomes and Wish for Joint Surgery
Official title: Within-person Change in Patient-reported Outcomes and Their Association With the Wish to Undergo Joint Surgery During a Digital First-line Intervention for Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee and Hip
Keywords: osteoarthritis
exercise
wish for surgery
digital intervention
PROMs
Lead sponsor: Joint Academy
Sponsor class: INDUSTRY
Collaborators: name: Lund University
First posted: 2022-07-13
Enrollment: 14018
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with osteoarthritis of the knee or hip ascertained by a clinicians who enrolled in a first-line digital intervention for OA including exercise and education.

Brief summary: Aim To investigate associations between within-person change in patient reported outcomes (PROMs) and wish for joint surgery during up to 12-month participation in a digital first-line intervention for knee and hip osteoarthritis (OA) comprising exercise and education.

Methods Retrospective observational registry data. All participants enrolling between June 1st 2018 and September 30th 2021 with follow-up data and with a change in their wish for surgery (dichotomous, becoming wishing or unwishing) were included. Analysed PROMS comprised pain (numeric rating scale (NRS), 0-10), 5 level EuroQol - 5-dimension (EQ5D-5L, 0.243-0.976), overall health (NRS, 0-10), activity impairment (NRS, 0-10), walking difficulties (yes/no), fear of movement (yes/no), function and quality of life subscales of Knee/Hip injury and Osteoarthritis Outcome Score 12 Items (KOOS-12/HOOS-12, both 0-100). To capture effects of changes in PROMs over time on probability of wish for surgery, the investigators used fixed effect (conditional) logistic regressions.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of knee or hip osteoarthritis
* Date of enrolment between June 1st 2018 and September 30th 2021 (study period)
* Consent to the use of the data at the moment of enrolment (not withdrawn during the study period)

Exclusion Criteria:

* No follow-up data
* No change in wish for surgery (participants remained either wishing or not wishing to undergo surgery for the whole treatment period). This exclusion was due to the focus of the present study on within-person relationships between PROMs and wish for surgery. In this scenario, those with no change in their wish for surgery do not provide any information to the analysis.

Primary outcomes:
measure: Wish for surgery at baseline
timeFrame: 0 months
measure: Wish for surgery at 3 months
timeFrame: 3 months
measure: Wish for surgery at 6 months
timeFrame: 6 months
measure: Wish for surgery at 9 months
timeFrame: 9 months
measure: Wish for surgery at 12 months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Joint Academy
state: Skåne
Study officials:
References:
Clinical trial NCT01089777: Monitoring and Characterization of Coronary Flow By Transthoracic Parametric Doppler (TPD) During Exercise Stress Test
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Artery Disease
Lead sponsor: Echosense Ltd.
Sponsor class: INDUSTRY
First posted: 2010-03-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Scheduled to exercise stress test

Brief summary: The study is an open prospective study of coronary flow preferably of the left anterior descending artery (LAD), by a Transthoracic Parametric Doppler (TPD) system during conventional exercise stress test. The system is a noninvasive non-imaging device designed to monitor coronary flow velocity and display the data continuously during exercise stress tests. The system enables continuous monitoring of coronary flow during resting, stress loading and recovery phases. The study intent is to improve the stress test predictive value for CAD.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Planned for ergometry test
* Signed informed consent

Exclusion Criteria:

* Excluded for stress test on a treadmill

Primary outcomes:
measure: Monitor coronary artery flow during exercise stress test.
timeFrame: 1-3 months following the stress test
Secondary outcomes:
measure: Improve CAD predictive power of stress testing
timeFrame: 1-3 months following the stress test
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Cardiovascular department, Carmel medical center
Study officials:
References:
Clinical trial NCT06721741: Clinical and Radiographic Success of Nusmile Bioflex Versus Stainless-Steel Crowns in Restoring Decayed Primary Molars with Modified Hall Technique
Official title: Clinical and Radiographic Success of Nusmile Bioflex Versus Stainless-Steel Crowns in Restoring Decayed Primary Molars with Modified Hall Technique:A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Restoration of Primary Molars with Bioflex Crowns
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 36
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot study aims to compare the clinical and radiographic success of Bioflex (Nusmile) crowns Versus Stainless-steel crowns in restoring decayed primary molars.

Detailed description: Decayed primary teeth must be treated promptly because they are crucial for chewing, speaking, and holding the space for permanent teeth. Losing primary teeth too early can cause various issues, including psychological problems. Hence, restoring decayed primary teeth is an essential aspect of pediatric dentistry Preformed metal crowns are a popular and affordable option as a treatment for dental caries. They offer full crown coverage and help to prevent recurrent caries. However, their aesthetic limitation is a notable drawback Parents are increasingly concerned about the appearance of dental restorations for their children and prefer tooth-colored options. To overcome this issue, Nusmile has introduced a new type of crown called "Bioflex". These crowns combine the best qualities of both stainless steel and zirconia crowns, as they are flexible, adaptable, and durable

Eligibility criteria: Inclusion Criteria:

* Clinical Criteria:

  1. Children from age 4-7.
  2. Cooperative children and willing for follow-up visits.
  3. Mandibular second Primary molars with multi-surface caries
* Radiographic criteria:

  1. Mandibular second Primary molars with at least two-thirds of the root remaining.

     Exclusion Criteria:
     * • General Criteria:

  <!-- -->

  1. •Unable to attend follow-up visits
  2. •Refuse to participate in the study
  3. •Uncooperative child
* Clinical Criteria:

  1. • Tooth with grade II or grade III mobility
  2. •Children with bruxism
  3. • Pulpally involved teeth
* Radiographic Criteria:

  1. •Tooth with pathological root resorption
  2. •Teeth with root caries

Primary outcomes:
measure: Patient relevant criteria
timeFrame: 1 Year
Secondary outcomes:
measure: Crown Relevant Criteria
timeFrame: 1Year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01777841: Mayo Clinic Health Connection Discovery Trial
Official title: Clinical Pilot:myCare
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Recovery
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-01-29
Enrollment: 250
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The MC Health Connection Discovery trial is designed to determine if a new health information system that delviers interactive care plans (delivered by mobile) to patients can impact post-surgical recovery.


Eligibility criteria: Inclusion Criteria:

Patients will be English speaking adults without visual or hearing impairments that would prevent use of the Ipad program. Target population will be older than 50 years of age. We will include patients who are undergoing coronary artery bypass grafting, valve repair or replacement or both at St. Mary's Hospital-Rochester, Minnesota. We will also be including family members 18 years of age and over, that may be the primary non-patient user of the iPad.

Exclusion Criteria:

Patients who do not meet inclusion criteria or who are predicted to have very short or very long hospital stays would not be candidates for the program which is designed for a standard 5, 6 or 7 day hospitalization.

Primary outcomes:
measure: Patient usability of IT platform: percent completion of care modules delivered
timeFrame: Day 1 to day 7 of hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
citation: Cook DJ, Manning DM, Holland DE, Prinsen SK, Rudzik SD, Roger VL, Deschamps C. Patient engagement and reported outcomes in surgical recovery: effectiveness of an e-health platform. J Am Coll Surg. 2013 Oct;217(4):648-55. doi: 10.1016/j.jamcollsurg.2013.05.003. Epub 2013 Jul 25.
Clinical trial NCT04217941: Effect of Practical Demonstration to Use Nasal Spray and Apply Intranasal Ointment on Epistaxis
Official title: Effect of Practical Demonstration to Use Nasal Spray and Apply Intranasal Ointment on Outcome, in Cases of Recurrent Pediatric Epistaxis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epistaxis
Keywords: Epistaxis
Randomized control trial
Health education
Lead sponsor: Combined Military Hospital, Pakistan
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the result of verbally educating the parents about method of intranasal antiseptic cream application versus practically educating and demonstrating how to apply cream intra nasally.

Detailed description: The primary outcome variables was control of epistaxis through history and clinical examination on follow up visits

Eligibility criteria: Inclusion Criteria:

* The children of age less than 12 years presenting with anterior recurrent epistaxis

Exclusion Criteria:

* o Children with bleeding disorders.

  * Children with liver and renal failure/dysfunction.
  * Children using anti-coagulants.
  * Those children who have gross deviated nasal septum or nasal polys etc.
  * Cases who had history of nasal injuries secondary to trauma.

Primary outcomes:
measure: number of epistaxis episodes
timeFrame: 0ne month
Secondary outcomes:
Other outcomes:
Locations:
city: Mardan
country: Pakistan
facility: CMH Mradan
state: KPK
Study officials:
affiliation: CMH Mardan
name: Ahmed Khan, MBBS, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03291041: A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder
Official title: A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Jet Lag Disorder
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2017-09-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder


Eligibility criteria: Inclusion Criteria:

* Ability and acceptance to provide written consent
* Men or women between 18-75 years
* Body Mass Index of ≥ 18 and ≤ 30 kg/m2

Exclusion Criteria:

* History (within the 12 months prior to screening) of psychiatric disorders
* Major surgery, trauma, illness or immobile for 3 or more days within the past month
* Pregnancy or recent pregnancy (within 6 weeks)
* A positive test for drugs of abuse at the screening visit
* Any other sound medical reason as determined by the clinical investigator

Primary outcomes:
measure: Total Sleep Time in the First Two-Thirds of the Night on the Night(s) Most Likely to be Disrupted
timeFrame: 4 days
Secondary outcomes:
measure: Patient Global Impression of Severity (PGI-S) Day 4
timeFrame: 1 Day
measure: Total Sleep Time in the First Two-Thirds of the Night (All 3 Nights)
timeFrame: 3 Days
measure: Subjective Total Sleep Time on Night 3
timeFrame: 1 Day
measure: Subjective Sleep Quality Night 3
timeFrame: 1 Day
measure: Subjective Sleep Latency Night 3
timeFrame: 1 Day
measure: Subjective Wake After Sleep Onset Night 3
timeFrame: 1 Day
measure: Karolinska Sleepiness Scale Day 4
timeFrame: 1 Day
Other outcomes:
Locations:
city: Alameda
country: United States
facility: Vanda Investigational Site
state: California
city: Santa Monica
country: United States
facility: Vanda Investigational Site
state: California
city: Chevy Chase
country: United States
facility: Vanda Investigational Site
state: Maryland
Study officials:
References:
Clinical trial NCT05796141: Becoming United in Lifestyle Decisions
Official title: Optimizing a Couples-Based mHealth Intervention for Weight Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Keywords: couples
mobile weight loss treatment
weight control
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-04-03
Enrollment: 736
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The goal of this project is to investigate how to enhance the effects of an online-only (mHealth) couples weight loss program. This study will use an innovative methodological framework, the Multiphase Optimization Strategy (MOST), to test four different strategies for weight loss and partner support in addition to a core intervention (i.e., dyadic action planning, joint feedback on goal progress, autonomy support training, and home environment modifications).


Eligibility criteria: Inclusion Criteria:

* Married/cohabitating couple - both partners must be eligible
* BMI between 25-55kg/m2
* English speaking/reading
* Have a smartphone and reliable internet access
* Have active email address
* Willing to videoconference

Exclusion Criteria:

* Report being unable to walk 2 blocks without stopping
* Are currently participating in weight loss treatment, have a history of bariatric surgery, or lost ≥5% in the past 6-months
* Are pregnant or plan to become pregnant during the study period
* Report chest pain or loss of consciousness on the Physical Activity Readiness Questionnaire
* Report a medical condition that could jeopardize their safety in a weight control program with diet and exercise guidelines
* Report conditions that, in the judgment of the PI, would render them unlikely to follow the protocol (e.g. dementia)

Primary outcomes:
measure: Body Weight (kg)
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Goal Coordination (Wingrove Goal Coordination Scale)
timeFrame: Baseline, 3 months, 6 months
measure: Transactive Density
timeFrame: Baseline, 3 months, 6 months
measure: Shared Goal Representation
timeFrame: Baseline, 3 months, 6 months
measure: Home Food Environment (Household Food Inventory)
timeFrame: Baseline, 3 months, 6 months
measure: Home Exercise Environment (Exercise Environment Questionnaire)
timeFrame: Baseline, 3 months, 6 months
measure: Dietary Intake
timeFrame: Baseline, 3 months, 6 months
measure: Physical Activity (Paffenbarger Physical Activity Questionnaire)
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Hartford
country: United States
facility: UConn's Weight Management Research Group
state: Connecticut
Study officials:
References:
Clinical trial NCT02951741: Revision Total Hip Replacement Arthroplasty and Hematologic Variables
Official title: Relations Between Hematologic Variables and Postoperative Bleeding and Transfusion in Revision Total Hip Replacement Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Avascular Necrosis of Hip
Degenerative Hip Joint Disease
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing revision total hip replacement

Brief summary: Revision total hip replacement arthroplasty is a surgery having intra- and postoperative substantial blood loss. The investigators will investigate the relationship between the various hematologic variables and postoperative bleeding volume.


Eligibility criteria: Inclusion Criteria:

* revision total hip replacement

Exclusion Criteria:

* hematologic disease
* anticoagulant medication
* American Society of Anesthesiologists physical status 4 and 5

Primary outcomes:
measure: Change of FIBTEM
timeFrame: 5 minutes before initiation of anesthesia and 5 minutes after finishing operation
Secondary outcomes:
measure: volume of infused fluid during operation
timeFrame: Period from starting to finishing the operation (During operation, an expected average of 3 hours)
measure: intraoperative urine output
timeFrame: Period from starting to finishing the operation (During operation, an expected average of 3 hours)
measure: transfusion units
timeFrame: Period from starting to finishing the operation (During operation, an expected average of 3 hours) and postoperative first day
measure: postoperative bleeding volume
timeFrame: postoperative 72 hours
measure: Hemoglobin
timeFrame: preoperative day 1
measure: Hemoglobin
timeFrame: postoperative day 4
measure: Hematocrit
timeFrame: preoperative day 1
measure: Hematocrit
timeFrame: postoperative day 4
measure: Platelet count
timeFrame: preoperative day 1
measure: Platelet count
timeFrame: postoperative day 4
measure: prothrombin time_international normalized ratio
timeFrame: preoperative day 1
measure: prothrombin time_international normalized ratio
timeFrame: postoperative day 1
measure: activated partial prothrombin time
timeFrame: preoperative day 1
measure: activated partial prothrombin time
timeFrame: postoperative day 1
measure: fibrinogen concentration
timeFrame: preoperative day 1
measure: fibrinogen concentration
timeFrame: postoperative day 1
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Hyo-Seok Na, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05592041: Studying of Natural Constituents' Treatment of Plantar Warts
Official title: In-vitro and Randomized Controlled Clinical Studying of Natural Constituents' Anti-HPV Potential for Treatment of Plantar Warts Supported With in Silico Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Plantar Wart
Lead sponsor: Deraya University
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Moringa banana nigella and Banna coat extract were prepared and formulated in the form of bi gel for transdermal delivery of these plant extracts. The formulation was prepared and charterized for organoleptic charters, morphology, and penetration efficacy. The optimised formulation was assessed clinically on patients suffering from plantar warts. The clinical study was phase 1 and interventional randomised allocation.


Eligibility criteria: Inclusion Criteria:

* Male or female patient aged 18 years or more.
* Clinical evaluation
* Number of warts lower than 10 on the 2 feet and total diameter of warts lower than 10 cm

Exclusion Criteria:

* Patient suspected to be immunocompromised
* Patient aged under 18 years
* Patient refusing to sign the consent
* Pregnant or lactating women

Primary outcomes:
measure: Complete clinical remission of the warts
timeFrame: 30 days
measure: Clinical assessment of warts curement
timeFrame: 30 days
Secondary outcomes:
measure: Pain asssesment
timeFrame: 30 days
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Soad A. Mohamad
Study officials:
References:
Clinical trial NCT03080441: Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention
Official title: Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Intradialytic Hypotension
Lead sponsor: Nimedical
Sponsor class: INDUSTRY
First posted: 2017-03-15
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a research study to test the application of FDA-approved, non-invasive device (NICaS) that measure the performance of your heart during HD treatment.

Detailed description: The incidence of intradialytic hypotension (IDH) events, reported to occur in 15% to 50% of hemodialysis (HD) treatments, is still high despite major technical advances in HD technology. By definition, excessive reduction in intravascular volume by ultrafiltration and limited vascular refilling from tissues into the vascular space is the cause of IDH. Chronic HD patients exhibit a high prevalence of peripheral vascular and cardiac abnormalities. Specifically, hemodynamic instability during HD can occur due to insufficient reduction in venous unstressed volume, poor diastolic filling under reduced atrial pressures associated with diastolic dysfunction, altered cardiac contractility, and impaired vascular reactivity. An IDH event can lead to myocardial cerebral and other organ ischemia. Long- and short-term adverse outcomes have been associated with IDH, a common HD complication and significant cause of morbidity.

Recent pilot studies suggest that in IDH-prone subjects, measurements of hemodynamic variables during HD can be used to categorize the hemodynamic response into three subgroups: cardiac power index (CPI) reduction with stable total peripheral resistance (TPR), TPR reduction with stable CPI, and reduction in TPR and CPI groups. It is hypothesized that targeted intervention for each subgroup can reduce IDH.

Eligibility criteria: Inclusion Criteria:

* 18 years old or older
* Have been on maintenance hemodialysis at the facility for at least six months
* Have not had un-excused missed treatments for six months
* Is symptomatic to HD treatments
* Males and non-pregnant/non-nursing females, as confirmed via urine pregnancy testing of women of child bearing potential

Exclusion Criteria:

* Patient refusal
* Currently on Midodrine at the start of the Phase 1, Observation period
* Any known contraindications to Midodrine

Primary outcomes:
measure: Hypotension
timeFrame: 6 weeks
measure: Weight
timeFrame: 6 weeks
measure: Cardiac Index
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: