louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00570843: Masked Comparison of a New PEG Based Artificial Tear and Optive for Comfort, Vision & Wear Time in Patients Wearing Contact Lenses
Official title: Phase 4 Masked Comparison of a New PEG Based Artificial Tear and Optive for Comfort, Vision & Wear Time in Patients Wearing Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Comfort, Vision and Wear Time
Lead sponsor: Bp Consulting, Inc
Sponsor class: NETWORK
First posted: 2007-12-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the effect of a new PEG based artificial tear as compared to Optive on comfort, wear time, and vision in patients wearing contact lenses.


Eligibility criteria: Inclusion Criteria:

* Use of soft contact lenses (e.g. silicone hydrogel lenses, daily disposables etc.) and multipurpose solution for cleaning, including enzyme-based cleaners (ClearCare etc.)
* Able to wear contact lenses for approximately 10-12 hours/day
* Willingness to complete entire length of trial and comply with subjective questionnaire.

Exclusion Criteria:

* Patients taking topical cyclosporine (Restasis)
* Patients currently using Optive for dryness relief.
* Patients wearing hard or rigid gas permeable lenses
* Patients with uncontrolled systemic disease which may confound the results of the trial.

Primary outcomes:
measure: Comfort
timeFrame: 1 month
Secondary outcomes:
measure: vision and wear time
timeFrame: 1 month
Other outcomes:
Locations:
city: New York
country: United States
facility: The New York Presbyterian Hospital-Weill Cornell Medical College
state: New York
Study officials:
affiliation: The New York Presbyterian Hospital Weill Cornell Medical College
name: Chris Starr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05747443: Multilevel Interventions to Increase Adherence to Lung Cancer Screening
Official title: Multilevel Interventions to Increase Adherence to Lung Cancer Screening
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Cancer
Lung Cancer Screening
Keywords: Lung Cancer
Low dose CT (LDCT)
Lung Cancer Screening
Stepped Reminders
Educational Video
User centered design
Stakeholders
Evaluation
Qualitative
Patient Partners
Adherence
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Fred Hutchinson Cancer Center
name: Hackensack Meridian Health
First posted: 2023-02-28
Enrollment: 1837
Sex: ALL
Minimum age (years): 50
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Screening for lung cancer has the potential for a profound public health benefit. Repeat annual screening is necessary for early detection of lung cancer. The investigators will test two interventions which include patient education and reminders to improve adherence to lung cancer screening.

Detailed description: Screening for lung cancer has the potential for a profound public health benefit.

Successful population-based screening requires continuous monitoring to adherence repeat screening in high risk adults to achieve similar results. Repeat annual screening is necessary for early detection of lung cancer. Baseline or first LDCT scans detect prevalent lung cancer, when subsequent screening detects new nodules. However, adherence to screening is low, ranging at 28-38% from centers nationally.

The investigators developed two novel, patient-centered interventions to address patient education and offering reminders for on-time screening. To address these goals, the specific aims are to: 1) Compare effectiveness of two multilevel interventions relative to usual care in improving (a) rates of adherence to lung cancer screening, (b) patient-centered outcomes; and (c) clinic outcomes; and 2) Determine the patient-, clinician-, and system-level factors that influence changes in adherence to inform lung cancer screening programs.

Eligibility criteria: Inclusion Criteria:

* KPWA members
* Aged 50-78 years
* Have a negative screening LDCT scan
* Speak English or Spanish
* Meet US Preventive Services Task Force guidelines

Exclusion Criteria:

* Patients who were previously diagnosed with lung cancer,
* Patients who have a positive scan,
* Patients who have an indicator for interpreter services, except for Spanish

Primary outcomes:
measure: Rate of repeat annual lung cancer screening
timeFrame: 9-15 months after index LDCT
Secondary outcomes:
measure: Knowledge of lung cancer screening
timeFrame: 8 weeks after index LDCT
measure: Attitudes and beliefs
timeFrame: 8 weeks after index LDCT
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Kaiser Permanente
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Karen Wernli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02282943: Carbon Dioxide-laser Versus Harmonic Scalpel in the Treatment of Pelvic Pain Due to Endometriosis
Official title: Carbon Dioxide-laser Versus Harmonic Scalpel in the Treatment of Pelvic Pain Due to Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Keywords: endometriosis
CO2 laser vapourisation
Harmonic scalpel
AFS stage I-III
Lead sponsor: Royal Surrey County Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare laser CO2 ablation/excision of Endometriosis (AFS stages 1-3) with excision of endometriosis using the Ethicon Harmonic ACE device. Pain scores at 6 months was the primary outcome, but secondary outcomes assessed pain scores at 1, 3 and 5 years as well as psychological state and quality of life.


Eligibility criteria: Inclusion Criteria:

* Endometriosis grade I-III by revised American Fertility Society Scoring
* Patients in whom laser treatment to the endometriosis is considered the treatment of choice.
* Patients having consented to participated in the trial
* Patient is 18 years old or greater
* Patients who have no contraindications to either of the treatment modalities proposed

Exclusion Criteria:

* Patients who do not wish to participate/have not signed the informed consent form
* Pregnancy of breast feeding
* Patients who are unable or unwilling to discontinue hormonal treatment for 6 months
* Patients who have received additional treatment for their endometriosis within 6 months of surgery
* Patients with documented painful conditions of the gastrointestinal or urinary system

Primary outcomes:
measure: Visual analogue pain score (VAS) change at 6 months compared to preoperative baseline
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life survey (Endometriosis Health Profile Questionnaire)
timeFrame: 0, 3, 6 months and 1,3,5 years
measure: Psychological state
timeFrame: 0, 3 ,6 months and 1,3,5 years
measure: Visual analogue pain score (VAS) change from baseline
timeFrame: 1,3 and 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Royal Surrey County Hospital NHS Foundation Trust
name: Andrew Kent, MD FRCOG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00903643: Sensory Processing in Subjects With Painful Bladder Syndrome
Official title: Sensory Processing in Subjects With Painful Bladder Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Painful Bladder Syndrome
Keywords: Painful Bladder Syndrome
Urinary Bladder
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Washington University Early Recognition Center
First posted: 2009-05-18
Enrollment: 34
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with condition will be from Kirklin Clinic Urology Clinic and the Highlands Pain Treatment Clinic. Healthy subjects will be recruited via advertisements.

Brief summary: The purpose of this study is to determine if clinically relevant subsets exist in patients meeting the diagnosis of Painful Bladder Syndrome (PBS). Subsets suggest differential responses to treatments and if verified, this will be important for the stratification of patients in clinical studies related to PBS.

Detailed description: Patients with the diagnosis of painful bladder syndrome (PBS) constitute two or more phenotypes that are distinguished by differential neurophysiological processing of sensory information. Further, these differing phenotypes can be predicted by the presence or absence of the co-morbidity fibromyalgia.

Eligibility criteria: Inclusion Criteria:

* NIDDK criteria for Painful Bladder Syndrome
* Age 19 years or older
* Must be able to read and speak English since testing materials are validated in English

Exclusion Criteria:

* PBS subjects must be independent of co-existing pain disorders or use of medications
* Uncontrolled hypertension or significant cardiopulmonary disease
* No chronic daily pain
* Older than 75 years of age

Primary outcomes:
measure: This study proposes to examine the sensations that are produced by warming the skin, poking the skin, pressure on muscles and by applying a blood pressure cuff.
timeFrame: One and half to two hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Kirklin Clinic Urology Clinic
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Timothy Ness, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05586243: MAGNETIC RESONANCE SPECTROSCOPY BIOMARKERS IN TYPE 3 GAUCHER DISEASE (GD3)
Official title: MAGNETIC RESONANCE SPECTROSCOPY BIOMARKERS IN TYPE 3 GAUCHER DISEASE (GD3)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gaucher Disease, Type 3
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with GD3

Brief summary: Recent studies have has shown that magnetic resonance spectroscopy (MRS) can provide validated neuronal markers in patients with Type 1 GD (GD1) who are on stable therapy. However, alterations in neurometabolites in adult patients with GD3, who have established neurological involvement, are not well understood. The goal of this study is to characterize neurometabolite profiles in adult patients with GD3 using MRS to identify novel biomarkers that can demonstrate treatment response. Additionally, a secondary aim is to evaluate relationships between neurometabolites and disease parameters, such as genotype, enzyme levels and Gaucher disease (GD) biomarkers.


Eligibility criteria: Inclusion Criteria:

* All participants must be 18 years or older.
* All enrollees must understand and cooperate with requirements of the study in the opinion of the investigators and must be able to provide written informed consent.
* Individuals with GD3 who are medically stable for participation in study in the opinion of the investigator.

Exclusion Criteria:

* Medically unstable conditions as determined by the investigators.
* Concurrent disease; medical condition; or an extenuating circumstance that, in the opinion of the investigator, might compromise subject safety, study compliance, completion of the study, or the integrity of the data collected for the study.
* Women who are pregnant or lactating or of child-bearing age that are not using acceptable forms of contraception.
* Patients enrolled in another interventional study.
* Patients who cannot or are unwilling to have blood drawn.
* Inability to undergo Magnetic Resonance Imaging (MRI) scanning, including but not limited to unable to remain still in an MRI scanner for more than 30 minutes, claustrophobia, presence of paramagnetic substances or pacemakers in body, weight over 300 lbs.
* Unable to adhere to study protocol for whatever reason.

Primary outcomes:
measure: Neurometabolite profile
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT01599143: Identifying Therapeutic Factors in an 8-Week (30 Hour) Mindfulness-Based Stress Reduction (MBSR) Program
Official title: Identifying Therapeutic Factors in an 8-Week (30 Hour) Mindfulness-Based Stress Reduction (MBSR) Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Diabetes
Hypertension
Keywords: Mindfulness
Pain Disorder (Chronic physical or mental health complaints:
Fibromyalgia; Migraines; Back Pain; etc)
Anxiety Disorder/Anxiety State
Lead sponsor: North York General Hospital
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Since it's introduction in 1979 at the University of Massachusetts Medical Center by Dr. Jon Kabat-Zinn, Mindfulness-Based Stress Reduction (MBSR) has become a respected adjunct to conventional treatment for patients suffering from many diverse chronic ailments. Three decades of research have documented it's benefits, but few papers have focused on identifying which particular aspect of MBSR directly correlates with it's degree of therapeutic efficacy. This study will use 7 well validated questionnaires to compare participants responses prior to, and following completion of an eight-week MBSR program at the North York General Hospital, as well as follow-up results at 1 month and 1 year post completion of the MBSR group.

Detailed description: As above

Eligibility criteria: Inclusion Criteria:

* over 18 years old
* suffer from a chronic health problem
* referred by their physician

Exclusion Criteria:

* acute illness (physical or psychiatric)
* suicidal
* problem use of alcohol or other substances
* inability to do one hour of daily homework
* inability to attend all 8 sessions

Primary outcomes:
measure: PSS-10
timeFrame: baseline, 8 weeks and follow-ups at 1 month and 1 year
Secondary outcomes:
measure: Toronto Mindfulness Scale (TMS)
timeFrame: Baseline, 8 weeks and follow up at 1 month and 1 year
Other outcomes:
Locations:
Study officials:
affiliation: North York General Hospital
name: Katalin J Margittai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02594943: Endodrill vs. Conventional Biopsy. Evaluation of Diagnostic Capacity in Diffuse Gastric Cancer
Official title: Endodrill vs. Conventional Biopsy. Evaluation of Diagnostic Capacity in Diffuse Gastric Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stomach Neoplasms
Keywords: Diagnostics
Biopsy
Diffuse gastric cancer
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Endodrill is a new instrument for biopsy sampling in the GI-channel. The purpose of this study is as follows:

* Compare the Endodrill instrument with conventional biopsy forceps in terms of ability to establish the correct diagnosis of diffuse gastric cancer based on collected biopsies from tumor tissue.

Detailed description: Endodrill is a newly constructed biopsy tool for flexible endoscopic use. It uses a drilling motion within a casing to harvest solid biopsies from tissue through the biopsy channel of a conventional flexible endoscope. It was originally designed for sampling of tissue from submucosal lesions. The investigators´ first study of the instrument is now finished. Endodrill is safe to use and generates more submucosal tissue compared to biopsies with a conventional biopsy forceps.

In this study, the investigators want to compare the Endodrill instrument´s ability to obtain representative tissue samples from a group of patients diagnosed with or suspected diffuse gastric cancer. 20 patients will be enrolled for this study. For each patient the investigators will collect 8 biopsies, 4 biopsies each with conventional biopsy and the Endodrill instrument respectively. The order will be randomized for each patient. For each specific biopsy the investigator will choose a particular site on the suspected tumor tissue without knowing which instrument that will be used for the biopsy. This procedure will be repeated for all 8 biopsies.

Eligibility criteria: Inclusion Criteria:

* Patients with suspected or with an established diagnosis of diffuse gastric cancer who are capable of stating a formal consent to participate in the study.

Exclusion Criteria:

* Mental illness
* Extreme co-morbidity (ASA\>3)

Primary outcomes:
measure: Highest proportion (number) of representative biopsies from tumors of diffuse gastric cancer
timeFrame: 24 months
Secondary outcomes:
measure: Amount of (mm2 and %) submucosal tissue within the biopsies.
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Region Skåne
name: Jan Johansson, SrConsultant
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04039243: Addressing Anxiety in 2-3-Year-Olds: A Pilot Intervention Study
Official title: Addressing Anxiety in 2-Year-Olds: A Pilot Screening and Intervention Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorder of Childhood
Fear
Shyness
Keywords: Anxiety disorders
Toddlers
Preschoolers
Cognitive-behavioral therapy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 47
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the feasibility and efficacy of intervening with 2-year-old children with elevated temperamental Fear and/or Shyness or 3-year-old children with elevated anxiety and their parents, using a parent-child Cognitive Behavioral Therapy (CBT) protocol to reduce anxiety disorders and maintain reduced anxiety at one-year follow-up. Before the COVID-19 pandemic, study visits and treatment sessions were conducted in office. Now all visits and treatment sessions are conducted remotely.


Eligibility criteria: Inclusion Criteria:

* The child scores \>1 Standard Deviation (SD) above reported means for the Fear or Shyness scales on the Early Childhood Behavior Questionnaire (ECBQ) (if child is 21-35 months) or the child scores \>1SD above reported means for the Total Anxiety, Generalized Anxiety, Social Anxiety, Physical Injury Fears, or Separation Anxiety scales on the Preschool Anxiety Scale (PAS) (if child is 36-47 months) as completed by a parent
* The parents are able to speak, understand, and read English
* The child must have a working knowledge of English.

Exclusion Criteria:

* Autism Spectrum Disorder (ASD) or global developmental delay in the child
* The child has disruptive behavior so severe as to interfere with participation in intervention sessions
* The child has a different primary disorder for which CBT for anxiety is inappropriate (e.g. severe depression, depression in the mother, significant medical disorder).

Primary outcomes:
measure: Response Rate (proportion of participants rated as 1 or 2 on Clinical Global Impression of Anxiety-Improvement Measure (CGI-I)
timeFrame: Baseline to four-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Dina Hirshfeld-Becker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06882343: Performance of Bioactive Low Viscosity Composite in Deep Marginal Elevation Restorations
Official title: Performance of Bioactive Low Viscosity Composite in Deep Marginal Elevation Restorations: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Deep Caries
Caries, Dental
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 50
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: The goal of this study is to evaluate the clinical, radiographic and periodontal performance of bioactive Giomer Shofu Flow Plus X F03 compared to nanohybrid resin composite restoration in deep subgingival proximal cavities over a period of 12 months.


Eligibility criteria: Inclusion Criteria:

* Adults patients (20-50)
* Good oral hygiene (plaque index 0 or 1 )
* Patient approving to participate in the study
* Absence of parafunctional habits and/or bruxism

Exclusion Criteria:

* Patients with known allergic or adverse reaction to the tested materials.
* Systematic disease that may affect participation.
* Xerostomic patients.
* Bad oral hygiene (plaque index 2 or 3 )
* Heavy smokers
* Patients undergoing or will start orthodontic treatment
* Patients with removable prothesis

Primary outcomes:
measure: Recurrent caries
timeFrame: 1 week, 6 months and 12 months
Secondary outcomes:
measure: Post-operative sensitivity
timeFrame: 1 week, 6 months and 12 months
measure: Fracture of the restoration
timeFrame: 1 week, 6 months and 12 months
measure: Bleeding on probing
timeFrame: 1 week, 6 months and 12 months
Other outcomes:
Locations:
Study officials:
References: