louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03631758: Evaluating the Impact of Evidence-based Information About Mammography on Breast Cancer Screening Decisions
Official title: McMaster Choices Study: Evaluating the Impact of Cancer Screening Patient Decision Aids on Breast Cancer Screening Decisions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Screening
Mammography
Patient Decision Aid
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
First posted: 2018-08-15
Enrollment: 209
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Patient decision aids are tools that help guide individuals through a healthcare-related decision making process. They help users combine evidence-based information and recommendations by a health care provider with their personal needs, values and preferences. Through this project, Dr. Dobbins and her research team will explore whether the use of patient decision aids with high-quality and user-friendly summaries of research evidence, or summaries of research evidence alone, help to improve the quality of decision making by women facing breast cancer screening decisions.

Detailed description: Guidelines for breast screening in Canada are based on low-moderate quality evidence of effectiveness and screening is associated with potential harms. Patient Decision Aids (PDAs) are tools that assist users to understand treatment options, risks and benefits to align decisions with values and preferences. The investigators would now like to know whether use of a PDA alongside evidence-based information provided through the McMaster Optimal Aging Portal, or simply access to evidence-based information alone, can help users to make informed decisions about breast cancer screening in women.

Eligibility criteria: Inclusion Criteria:

* English speaking women, 40-49 years old
* Residents of British Columbia, Nova Scotia, and Prince Edward Island

Exclusion Criteria:

* History of breast cancer or mammography in the last 12 months
* Classified as above-average risk for breast cancer (i.e., known genetic mutation linked to BC; no genetic testing, but a parent, sibling or child with a genetic mutation linked to BC; or received chest wall radiation before age 30)

Primary outcomes:
measure: Decisional Conflict Scale
timeFrame: Change from baseline to 6-mo
Secondary outcomes:
measure: Decision quality
timeFrame: Change from baseline to 6-mo
measure: Preparation for Decision Making Scale
timeFrame: Change from baseline to 6-mo
measure: Screening behaviour
timeFrame: Change from baseline to 6-mo
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Maureen Dobbins, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06626958: Stress Ball Used in the Active Phase of Labor on Labor Pain and Birth Comfort
Official title: The Effect of the Stress Ball Used in the Active Phase of Labor on Labor Pain and Birth Comfort
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Labor Pain
Birth Order
Stress
Keywords: Active phase of labor,
stress ball,
labor pain,
labor comfort
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled experimental trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the clinical trial is to examine the effect of a stress ball applied to pregnant women during the active phase of labor on labor pain and labor comfort. The effect of the stress ball used in the experimental group on labor pain and labor comfort will be evaluated. The stress ball applied to pregnant women during the active phase of labor minimizes labor pain and increases labor comfort H 0: The stress ball used during the active phase of labor has no effect on labor pain and labor comfort.

H 1: The stress ball used during the active phase of labor increases labor pain and labor comfort.

The researchers will monitor the pregnant women from the time the cervical dilation is 3-4 cm (from the active phase of labor) until the cervical dilation is 8-9 cm and the experimental group will be asked to use the stress ball. Routine application will be made to the control group. The pain during labor of the experimental and control groups will be evaluated with the VAS scale. After the birth, the labor comfort scale will be applied to measure labor comfort.


Eligibility criteria: Inclusion Criteria:

* Vaginal birth
* Pregnant women between the ages of 18-40

Exclusion Criteria:

* Risky pregnancy

Primary outcomes:
measure: Lapor Pain
timeFrame: First measurement: Within the first hour of labor Second Measurement: Within 10-12 hours of labor
measure: Labor Comfort
timeFrame: First measurement: Within the first hour of labor Second Measurement: Within 10-12 hours of labor
Secondary outcomes:
Other outcomes:
Locations:
city: Muş
country: Turkey
facility: Muş State Hospital Birth Hall
state: Merkez
Study officials:
affiliation: mihriban.elmas@icloud.com
name: Mihriban Elmas
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00667758: Gonadotropin-Releasing Hormone (GnRH)-Antagonist Therapy in Rheumatoid Arthritis
Official title: Antagonist to Gonadotropin-Releasing Hormone in Rheumatoid Arthritis (AGRA): A Double-blind, Randomized, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Betanien Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Foundation for Health and Rehabilitation
name: University of Oslo
First posted: 2008-04-28
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and efficacy of gonadotropin-releasing hormone (GnRH) antagonist therapy versus placebo in patients with moderate to severe rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Adult between 18 years and above
* Moderate to severe disease activity
* Negative pregnancy test for women of childbearing potential
* Use of reliable method of contraception (non-hormonal) by sexually active female patients

Exclusion Criteria:

* Patients who are pregnant or breastfeeding
* Patients taking biologic therapy or prednisolone \>7.5mg

Primary outcomes:
measure: Change in Disease Activity Score (DAS28CRP) in cetrorelix group versus placebo group
timeFrame: From baseline to day 5
Secondary outcomes:
measure: Change in DAS28 (CRP/ESR)
timeFrame: From baseline to day 2/5 /10/15
measure: Change in anti-CCP level
timeFrame: From baseline to day 2/5/10/15
measure: Change in cytokine level
timeFrame: From baseline to day 2/5/10/15
measure: Change in ACR core set measures
timeFrame: From baseline to day 2/5/10/15
measure: Proportion of patients with ACR 20/50/70/90 and EULAR good/moderate/none responders
timeFrame: Baseilne to day 2/5/10/15
measure: Adverse events
timeFrame: Baseline up to day 15
measure: Proportion of patients with DAS28low disease activity/remission
timeFrame: Baseline to day 2/5/10/15
measure: Change in HAQ scores
timeFrame: From baseline to day 5/10/15
measure: Correlation between percent changes in hormones, disease activity and biomarkers
timeFrame: By day 2, 5, 10 and 15
Other outcomes:
Locations:
city: Skien
country: Norway
facility: Deaprtment of Rheumatology, Betanien Hospital
Study officials:
affiliation: University of Oslo
name: Kåss
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kass A, Hollan I, Fagerland MW, Gulseth HC, Torjesen PA, Forre OT. Rapid Anti-Inflammatory Effects of Gonadotropin-Releasing Hormone Antagonism in Rheumatoid Arthritis Patients with High Gonadotropin Levels in the AGRA Trial. PLoS One. 2015 Oct 13;10(10):e0139439. doi: 10.1371/journal.pone.0139439. eCollection 2015.
Clinical trial NCT03769558: A Study of Juvenile Idiopathic Arthritis Patients Given Abatacept and the Number of Infections or Malignancies That Occur
Official title: Supplemental Data for the Juvenile Idiopathic Arthritis FDA Written Request
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Juvenile Idiopathic Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-12-07
Enrollment: 264
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include all patients with JIA who are treated with abatacept

Brief summary: This study will determine the incidences of infections and malignancies among JIA patients treated with abatacept


Eligibility criteria: Inclusion Criteria:

* Two diagnoses of JIA (ICD-9 code 714.3x) within 90 days
* Age less than 18 years at the time of second of the two diagnoses
* Index date is the date of initiating treatment with abatacept

Exclusion Criteria:

* Greater than or equal to 18 years of age

Primary outcomes:
measure: Incidence of infections
timeFrame: 110 months
Secondary outcomes:
measure: Incidence of malignancies
timeFrame: 110 months
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Local Institution
state: New Jersey
Study officials:
References:
Clinical trial NCT04910958: Impact of COVID-19 Pandemic on Early Spontaneous Abortions and Early Termination of Pregnancy
Official title: Impact of COVID-19 Pandemic on Early Spontaneous Abortions and Early Termination of Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Termination of Pregnancy
Covid19
Pregnancy Loss
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2021-06-02
Enrollment: 411
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women attending for early missed abortion or termination of pregnancy receiving treatment between March 11th - November 30th during the years 2017-2020 Gestational age until 12 weeks 6 days (1st trimester only)

Brief summary: To see the impact the COVID-19 pandemic has had on early spontaneous abortions and early termination of pregnancy in the first trimester

Detailed description: To date, the research has focused on the complications of SARS-CoV-2 in pregnant women. There is no research in the literature that has compared the rates and behavior of miscarriage during the time of the COVID-19 pandemic to before the time of the pandemic. As described in the literature, there is an established connection between COVID-19 and stress, anxiety, and depression. There is also an established connection between stress, anxiety, and depression and rates of miscarriage. The investigators hereby wish to analyze the effect of the COVID-19 pandemic on miscarriages.

In this study, The investigators will analyze the number of early missed abortions and number of termination of pregnancies in the first trimester before and during the COVID-19 pandemic. The investigators will also analyze the time interval between diagnosis of missed abortion and attendance to E.R in missed abortions during the COVID-19 pandemic. In addition, The investigators will be comparing the reasons for termination of pregnancy during this time, as well as analyzing age, religion, and demographic variables during the COVID-19 pandemic compared to years prior.

Eligibility criteria: Inclusion Criteria:

* All women attending for early missed abortion or termination of pregnancy receiving treatment between March 11th - November 30th during the years 2017-2020 Gestational age until 12 weeks 6 days (1st trimester only)

Exclusion Criteria:

* Incomplete and complete abortions
* Gestational age \>13 weeks

Primary outcomes:
measure: Number of early missed abortions
timeFrame: Two years
measure: Number of termination of pregnancies
timeFrame: Two years
Secondary outcomes:
measure: Time between discovery and attendance
timeFrame: 1 year
measure: Comparison of reasons for termination
timeFrame: 1 year
measure: Comparison of Age/Religion/Demographic variables
timeFrame: 1 year
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: omer.moore@gmail.com
name: Omer Mor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05337358: Clinical Performance of Fiber Reinforced FRC Base and Bonded CAD/CAM Resin Composite Endocrowns Versus Conventional Lithium Disilicate Endocrowns in Posterior Teeth (1y Randomized Clinical Trial).
Official title: Clinical Performance of Fiber Reinforced FRC Base and Bonded CAD/CAM Resin Composite Endocrowns Versus Conventional Lithium Disilicate Endocrowns in Posterior Teeth (1y Randomized Clinical Trial).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Clinical Performance
Keywords: Lithium dislocate
fiber reinforced composite
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In patients with endodontically treated molar teeth indicated for endocrown, will the fiber reinforced FRC base and bonded CAD/CAM resin composite endocrowns restorations have a similar clinical performance to the conventional lithium disilicate endocrown over one year?


Eligibility criteria: Inclusion Criteria:

* Patients with good oral hygiene
* Patients having one or more endodontically treated molars that need prosthetic restoration.
* Molars should have enough tooth structure for endocrown restoration with minimum 3 walls with thickness not less than 1.5 mm and gingival step placed supragingival
* Fully erupted molars
* Molars free of developmental defect
* Healthy periodontium
* Absence of periapical pathosis
* Acceptable endodontic treatment and proper bone support

Exclusion Criteria:

* Patients with bad oral hygiene
* Patients with active periodontal disease
* Patients with missing teeth opposing to the area intended for restoration
* Patients with parafunctional habits or psychiatric problems or unrealistic expectation.

Primary outcomes:
measure: clinical performance
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Lecturer of Fixed Prosthodontics
name: Sameh Sh Abou-steit, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06542458: Under-Represented Communities Diagnosed With SCD or MCI Through Tele-Cog
Official title: A Cohort Study of Older Adults From Under-resourced/Under-represented Communities Diagnosed With Subjective Cognitive Decline (SCD) or Mild Cognitive Disorder (MCI) Through Standard of Care Tele-Cog Visits (Tele-Cog)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Mild Cognitive Impairment
Subjective Cognitive Decline
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals will be recruited from the Tele-Cog clinic at The Ohio State University Wexner Medical Center.

Brief summary: Overall, this study's primary aim is to establish a prospective, longitudinal, observational cohort study of older adults at risk for dementia from under-resourced/underrepresented communities. More specifically, older adults diagnosed with subjective cognitive decline (SCD) or Mild Cognitive Impairment (MCI) during clinical care offered via the Tele-Cog clinic would be recruited for more comprehensive data collection to characterize the clinical presentation and course of illness over multiple timepoints spread out longitudinally.

Detailed description: Clinical data obtained as part of standard of care will be collected from the medical record (including clinical diagnosis, cognitive and other neuropsychological test scores, lab results, neuroimaging data, etc.) and additional data (neuropsychological test batteries and clinical questionnaires if not already obtained) would be obtained at research study visits.

Participants will be asked to participate in annual research visits for up to 5 years.

Eligibility criteria: Inclusion Criteria:

1. Adults ages 50 years and older
2. Diagnosed with subjective cognitive concerns (SCD) or objective cognitive decline with mostly intact functioning (MCI diagnosis) as part of clinical work up
3. Fluent in English
4. Able to provide voluntary informed consent
5. Willing and able to undergo all study procedures
6. Able to delegate, if possible, a study partner to contribute information regarding daily activities and cognition

Exclusion Criteria:

1. Diagnosis of dementia at baseline.
2. Inability to give informed consent.
3. High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, lack of meaningful social support).

Primary outcomes:
measure: Number of adults with Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI) at risk for dementia from under-resourced/underrepresented communities that we longitudinally collect clinical data, neuropsychology, neuroimaging, and biofluids
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
References:
Clinical trial NCT00750958: PREVENT - Prospective Rhythm Event Surveillance in the ER With NetGuard
Official title: PREVENT - Prospective Rhythm Event Surveillance in the ER With NetGuard
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Event
Keywords: cardiac rhythm changes
Lead sponsor: Datascope Patient Monitoring
Sponsor class: INDUSTRY
First posted: 2008-09-11
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine the incidence of clinically significant rhythm and rate changes in ED patients who are not placed on conventional telemetry, and to test the user-friendliness of a automated clinician alter device in hectic and noisy setting of a busy emergency room.


Eligibility criteria: Inclusion Criteria:

* \> 18 yes
* Agree to participate in study
* Telemetry not indicated
* Telemetry not available
* Willingness to complete a questionnaire-

Exclusion Criteria:

* Refusal to participate
* Know sensitivity to adhesive
* Language/communication barriers
* Perceived high risk for lack of study compliance

Primary outcomes:
measure: Incidence of clinically significant rhythm and rate changes in ED patients.
timeFrame: Patient ED stay
Secondary outcomes:
measure: Measure of user-friendliness of the device.
timeFrame: Patient ED stay
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Dr Charles Pollack
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Pennslvania Hospital
name: Charles Pollack, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02245958: A Retrospective Chart Review of BOTOX® and Xeomin® for the Management of Cervical Dystonia and Blepharospasm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Dystonia
Blepharospasm
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-09-22
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with cervical dystonia or blepharospasm previously treated with Xeomin® and BOTOX® in clinical practice.

Brief summary: This study is a retrospective chart review to evaluate the doses of botulinum Type A toxins BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used for the treatment of Cervical Dystonia and Blepharospasm in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Confirmed primary diagnosis of idiopathic cervical dystonia or blepharospasm for at least 2 years
* Treatment with Xeomin® and BOTOX® for at least 2 years each.

Exclusion Criteria:

* Having a neuromuscular junction transmission disorder or taking any medications that could affect neuromuscular junction transmission
* Previous surgical procedure involving bone or muscle for the management of cervical dystonia or blepharospasm.

Primary outcomes:
measure: Dose of Botulinum Toxin Used to Treat Cervical Dystonia
timeFrame: 4 Years
measure: Dose of Botulinum Toxin Used to Treat Blepharospasm
timeFrame: 4 Years
Secondary outcomes:
measure: Botulinum Toxin Inter-injection Intervals
timeFrame: 4 Years
measure: Number of Participants with Adverse Events
timeFrame: 4 Years
measure: Annual Botulinum Toxin Dose per Patient
timeFrame: 4 Years
Other outcomes:
Locations:
city: Colonia Roma Z.P.
country: Mexico
city: Wakefield
country: United Kingdom
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References: