louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02870049: Study to Increase Colorectal Screening
Official title: A RCT of Outreach and Inreach Strategies for Boosting CRC Screening in a Federally-Qualified Health Center
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: early detection
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: San Diego State University
First posted: 2016-08-17
Enrollment: 673
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

Brief summary: The purpose of this study is to determine whether inreach and outreach strategies will be superior to usual care, and combination of both will be superior to either strategy alone.

Detailed description: Colorectal cancer (CRC) screening saves lives, but screening rates are low among underserved populations, particularly Latinos. The screening rate in the predominantly Latino population served by San Ysidro Health Center (SYHC, a Federally Qualified Health Center (FQHC)), is just 31%, similar to that reported for Latinos nationally, but lower than the overall national average of 65%. Previous research has demonstrated that inreach interventions at point of medical care such as patient navigation after screening referral, and outreach outside of usual medical care (such as with mailed invitations) can increase screening rates among underserved populations. However, since these have undergone limited evaluation among low income predominantly Spanish-speaking Latinos, it is unclear which approach is best, and whether implementing both approaches would be synergistic for optimizing screening rates. We hypothesize that two culturally and linguistically tailored interventions: a) an inreach strategy (IR, consisting of community health worker-delivered in clinic education regarding CRC screening and other components), and b) an outreach strategy (OS, consisting of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) and telephone reminders) can substantially increase screening, and further, that the two interventions together will be substantially better than either alone. To test these hypotheses, we propose a randomized trial comparing usual care, IR, OS, and IR+OS for CRC screening.

Eligibility criteria: Inclusion Criteria:

* Individuals age 50 to 75 years,
* One or more SYHC visits in the last year,
* Not uptodate with CRC screening

Exclusion Criteria:

* Individuals with personal history of CRC or colorectal polyps

Primary outcomes:
measure: Screening completion rate
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Diego
name: Samir Gupta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Diego State University
name: Sheila Castaneda, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03465449: Feasibility of Enhanced Dialysis Education (EDU) Intervention for Chronic Kidney Disease (CKD) Patients
Official title: Feasibility of Enhanced Dialysis Education (EDU) Intervention for Chronic Kidney Disease (CKD) Patients ≥ 75 Years of Age and Their Caregivers (CKD-EDU Study) - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2018-03-14
Enrollment: 58
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators are studying the feasibility, acceptability, and outcomes of an intervention called Enhanced Dialysis Education (EDU) Intervention. CKD-EDU is a palliative care-based dialysis decision-making intervention that involves educating patients and caregivers about dialysis and engaging them in shared decision-making. Half of the enrolled patients will receive CKD-EDU and the other half will receive Usual Care.


Eligibility criteria: Inclusion Criteria:

1. Age ≥75 years old
2. Presence of advanced CKD stage 4 or 5 (i.e. e GFR ≤ 25 ml/min)
3. Patient's nephrologist is enrolled in the study and has seen that nephrologist at least once
4. Speaks English
5. Have not attended a dialysis education class or met with the dialysis education coordinator.
6. Have not made a dialysis decision

Exclusion Criteria:

1. Patient has already been seen by a palliative care clinician or is enrolled in hospice
2. Is already on dialysis
3. Hospitalized at the time of recruitment

Primary outcomes:
measure: Number of participants receiving the intervention
timeFrame: 24 months
measure: Acceptability of the intervention
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT05585749: Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients
Official title: The Effect of Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Virtual Reality
Anxiety
Pain
Endoscopy Patients
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Virtual Reality Based Relaxation Program
Primary purpose: SUPPORTIVE_CARE

Brief summary: With the virtual reality application in patients with bronchoscopy, it is aimed to reduce the fear, stress and tension arising from the possibility of the development of pain and complications in the patients. The research will be carried out in the form of pretest-posttest application with 30 experimental and 30 control groups. The researcher aims to minimize the fear and stress in the patient by applying the virtual reality application to the patient in the experimental group 10 minutes before the procedure and 5-10 minutes during the procedure.

Detailed description: This study includes the examination of the effect of applying virtual reality interventions, which are used for the treatment of anxiety problems, to patients who will undergo bronchoscopy. For this purpose, first of all, a relaxation intervention will be designed in a virtual reality environment. The virtual reality environment will be organized on the basis of relaxation exercise. In this direction, first of all, an image will be created by taking 3D modeling service and the text of the relaxation exercise prepared in the presence of a professional sound artist will be transferred to the image with sound.

Eligibility criteria: Inclusion Criteria:

* be18 years and over
* Ability to communicate adequately
* Absence of psychiatric problems
* Those who are determined by the physician that they do not have a physical disability in exercising
* Volunteering to participate in the research
* Individuals who have the ability to use technological tools

Exclusion Criteria:

Those who have communication problems

• Those with psychiatric problems

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 1 hours later
measure: Anxiety Assessment Scale
timeFrame: 1 hours later
measure: Physiological Symptoms of Anxiety Follow-up Form
timeFrame: 1 hours later
Secondary outcomes:
Other outcomes:
Locations:
city: Elazığ
country: Turkey
facility: Firat University
Study officials:
affiliation: Firat University
name: Gülcan Bahçecioğlu Turan, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04296149: Beta- Probe and Surgery in GEP NET: Evaluation of a New Probe
Official title: Studio Esplorativo Monocentrico Non Controllato, in Aperto, Volto a Sviluppare e Valutare l'Applicazione di Una Tecnica Innovativa di Rimozione Radioguidata Dei Tumori Neuroendocrini Gastro-entero-pancreatici
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuroendocrine Tumors
Keywords: beta- probe
radioguided surgery
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Radioguided surgery (RGS) with beta- radioisotopes is a novel approach focused on developing a new probe which, detecting electrons and operating with low background, provides a clearer delineation of the margins of lesions with low radiation exposition for surgeons.

To validate this procedure, ex vivo specimens of tumours expressing somatostatin receptors, as small-intestine neuroendocrine (SI-NET), will be tested

Detailed description: Small Intestinal neuroendocrine patients, with a positive Ga-68-DOTATOC PET/CT, will receive a small amount of beta- radiopharmaceutical (Y-90-DOTATOC), and then operated, as clinical indicated.

Tissue samples will be tested ex-vivo with a beta-probe prototype

Eligibility criteria: Inclusion Criteria:

* SI NET patients, Ga-68-DOTATOC PET/CT positive, proposed for surgery

Exclusion Criteria:

* negative PET/CT; pregnancy

Primary outcomes:
measure: Evaluation of sensitivity of a beta- probe
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Chiara Maria Grana
Study officials:
References:
Clinical trial NCT04580849: Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease
Official title: Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 24
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: individuals with parkinson's disease and healthy control individuals will be assigned to the same online dance class via zoom platform.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to verify the feasibility of a telerehabilitation approach with dance in people with parkinson's disease.

Detailed description: This is a feasibility study that aims to investigate the safety and efficacy of dance classes via an online platform in people with and without Parkinson's Disease. The intervention will last 2 months and the classes will be conducted twice a week (60 minutes) using the Zoom platform. Evaluations will be performed before and after the intervention by means of the Zoom platform as well and will include questionnaires of quality of life, depression, anxiety, and activities of daily living.

Eligibility criteria: Inclusion Criteria:

* Individuals with and without parkinson's disease according London Brain Bank Criteria
* Minimal cognitive ability to understand commands (MMSE)
* Able to stand at least 10 minutes with or without support
* Dopamine medication stable at least 6 weeks before the beginning of the study
* Portable device and internet connection

Exclusion Criteria:

* Severe visual or auditive disturbances
* Neurological disease (other than parkinson's for those included) or severe neuromuscular disorders that prejudice the proposed activities

Primary outcomes:
measure: feasibility (adherence rates)
timeFrame: 10 weeks
Secondary outcomes:
measure: feasibility (patients opinions)
timeFrame: 10 weeks
measure: feasibility (safety and usability)
timeFrame: 10 weeks
measure: Parkinson's Disease Questionnaire-8 (PDQ-8)
timeFrame: Change from Pre to Post treatment (10 weeks)
measure: 36-Item Short Form Survey (SF-36)
timeFrame: Change from Pre to Post treatment (10 weeks)
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from Pre to Post treatment (10 weeks)
measure: Unified Parkinson's Disease Rating Scale (UPDRS) Part I
timeFrame: Change from Pre to Post treatment (10 weeks)
measure: Activities-Specific Balance (ABC) Scale
timeFrame: Change from Pre to Post treatment (10 weeks)
measure: Five Times Sit to Stand Test (FTSTS)
timeFrame: Change from Pre to Post treatment (10 weeks)
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Universidade Federal de Ciências da Saúde de Porto Alegre
state: Rio Grande Do Sul
Study officials:
References:
Clinical trial NCT01433549: Lens Wear Schedules and End-of-Day Comfort
Official title: Effect of Recovery Periods on Ocular Comfort During Daily Lens Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
Collaborators: name: University of Waterloo
First posted: 2011-09-14
Enrollment: 44
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study was to assess the impact of lens-free (recovery) intervals of varying lengths on end-of-day comfort and tear film changes with daily contact lens wear.

Detailed description: This study was conducted in a cross-over design with two phases. Each phase consisted of four cycles approximately 12 hours in length. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear. A 12-hour lens-free wear period preceded each phase.

Eligibility criteria: Inclusion Criteria:

* Is at least 17 years of age and has full legal capacity to volunteer.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Has had an ocular examination in the last two years.
* Is an adapted soft contact lens wearer.
* Experiences a decrease in ocular comfort through a lens-wearing day.
* Has a current pair of spectacles.
* Has a distance contact lens prescription of +6.00 diopters to -10.00 diopters and an acceptable fit with the study lenses.
* Has astigmatism less than or equal to -1.00 DC.
* Achieves visual acuity of 6/9 or better with the study lenses and with habitual spectacles.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Has any ocular disease.
* Has a systemic condition that may affect a study outcome variable.
* Is using any systemic or topical medications that may affect ocular health.
* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean End-of-Day Comfort
timeFrame: Hour 12
Secondary outcomes:
measure: Mean Non-Invasive Tear Film Break-Up Time (NITBUT)
timeFrame: Hour 12
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: University of Waterloo Centre for Contact Lens Research
state: Ontario
Study officials:
affiliation: Centre for Contact Lens Research, School of Optometry, University of Waterloo
name: Lyndon Jones, PhD FCOptom FAAO, Director
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stahl U, Keir NJ, Landers A, Jones LW. Effect of Short Recovery Periods on Ocular Comfort During Daily Lens Wear. Optom Vis Sci. 2016 Aug;93(8):861-71. doi: 10.1097/OPX.0000000000000912.
Clinical trial NCT02125149: The Expecting Study
Official title: Prenatal Physical Activity Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pregnancy
Obese
Keywords: pregnancy
obese
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2014-04-29
Enrollment: 284
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to determine how a mother's health and physical activity may influence her child's growth and development.


Eligibility criteria: Inclusion Criteria:

* BMI \>30
* \>18 years of age
* Singleton pregnancy
* Less than 12 weeks gestation
* Sedentary
* Conceived without assisted fertility treatments
* Cleared by physician to exercise

Exclusion Criteria:

* Women with pre-existing medical conditions as determined by the PI to affect the outcomes of interest
* Women who are using recreational drugs, tobacco, or alcohol during pregnancy
* Women with contraindications to exercise during pregnancy

Primary outcomes:
measure: Risk of obesity in infants and children
timeFrame: 2 years
Secondary outcomes:
measure: Maternal insulin sensitivity
timeFrame: 9 months
measure: Maternal inflammation
timeFrame: 9 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
affiliation: UAMS
name: Aline Andres, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saben JL, Sims CR, Piccolo BD, Andres A. Maternal adiposity alters the human milk metabolome: associations between nonglucose monosaccharides and infant adiposity. Am J Clin Nutr. 2020 Nov 11;112(5):1228-1239. doi: 10.1093/ajcn/nqaa216.
Clinical trial NCT02824549: An Evaluation of the FreeStyle Flash Glucose Monitoring System
Official title: An Evaluation of the Usability, Skin Reactions and Accuracy of the FreeStyle Libre Flash Glucose Monitoring System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Flash Glucose Monitoring
Skin Reactions
Keywords: Flash glucose monitoring
skin reactions
usability
accuracy
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with type 1 diabetes mellitis using the FreeStyle Libre Flash glucose monitoring system

Brief summary: The usability, skin reactions and accuracy of the FreeStyle Libre glucose monitoring system in children will be evaluated by questionnaires, pictures of the insertion site and comparison of the glucose results with capillary blood glucose determinations.


Eligibility criteria: Inclusion Criteria:

* type 1 diabetes mellitus
* being followed in the Pediatric Diabetes Unit of the Jessa Ziekenhuis

Exclusion Criteria:

-

Primary outcomes:
measure: Usability of the FreeStyle glucose monitoring systeem
timeFrame: 0.5 year follow-up
Secondary outcomes:
measure: Skin reactions to the sensor : e.g. allergic reaction, red mark, blister
timeFrame: 0.5 year follow-up
measure: Accuracy of the FreeStyle Libre glucose monitoring system
timeFrame: 0.5 year follow-up
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
Study officials:
affiliation: Department of Pediatric Diabetology, Jessa Ziekenhuis, Stadsomvaart 11, B3500 Hasselt, Belgium
name: Guy Massa, MD, PhD
role: STUDY_DIRECTOR
affiliation: Department of Pediatric Diabetology, Jessa Ziekenhuis, Stadsomvaart 11, B3500 Hasselt, Belgium
name: Renate Zeevaert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06603506: Collection of Endometrial Cancer-derived Organoids to Evaluate the Efficacy of PARP Inhibitors: PENDOR Pilot Study
Official title: Collection of Endometrial Cancer-derived Organoids to Evaluate the Efficacy of PARP Inhibitors: PENDOR Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometrial Cancer
Keywords: endometrial cancer
organoide
PARP inhibitor
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 16
Sex: FEMALE
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: Patient with localized endometrial cancer

Brief summary: This study comprises 3 stages:

1. Collection of tumor and blood samples.
2. Creation of organoid models based on tumor samples.
3. Development of functional tests to predict clinical response to treatment.


Eligibility criteria: Inclusion Criteria:

* Patient aged 18 years or more
* Patient with histologically confirmed, localized endometrial cancer, candidate for surgical treatment.
* Patient with localized endometrial cancer, presenting:

  * A high-grade endometrioid histological type and/or
  * P53 mutation and/or
  * a non-endometrioid histological type regardless of P53 status.
* Patient affiliated to a social security scheme
* Information and signature of informed consent prior to any specific study procedure

Exclusion Criteria:

* Other active cancer less than 6 months old (with the exception of treated basal cell carcinoma of the skin).
* Patient deprived of liberty, under guardianship, or subject to a legal protection measure, or unable to express consent.

Primary outcomes:
measure: Rate of establishment of exploitable tumor organoid lines
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
Study officials:
References:
Clinical trial NCT04589806: Change in Mandibular Bone Width Using Two Stages Splitting Approach
Official title: Evaluation of Bone Width Change Using a Two-stage Ridge Splitting Approach in Narrow Posterior Mandibular Ridge (Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Narrow Mandibular Ridge
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Alveolar ridge splitting technique is a commonly used procedure for horizontal ridge augmentation of narrow ridges to allow placement of implants. However, the commonly used one-stage technique can cause malfracture and subsequent necrosis of the fractured part.

Detailed description: Twelve patients were selected randomly having posterior mandibular narrow edentulous ridge. The sample were selected to match a list of inclusion and exclusion criteria. In the first stage, all patients will underwent a mandibular ridge splitting technique using piezotomes. In the second stage, ridge expansion and implants were placed with only envelope flap. Assessment were included measurement of the buccal and lingual bone surrounding the implants and amount of increase in the bone width from the cone beam computed tomography.

Eligibility criteria: Inclusion Criteria:

* Adult patients aged 18-60 years old with no gender predilection.
* Patients presenting with posterior mandibular (premolar-molar area) narrow alveolar ridge
* that requires dental implantation.
* Minimum bone width of 3 mm
* Minimum bone height of 10 mm
* Proper inter-occlusal space

Exclusion Criteria:

* Uncontrolled diabetes.
* Heavy smokers.
* Current chemotherapy or radiotherapy.
* Alcohol or drug abuse.
* Pregnant women.
* Active infection.
* Inter-occlusal space not less than 7-8 mm.
* Parafunctional habits.

Primary outcomes:
measure: change in the width of the alveolar bone
timeFrame: at the 1st week and the 4th month
measure: Bone density
timeFrame: at the 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
affiliation: Researcher
name: Ahmed M Eid, BDS
role: PRINCIPAL_INVESTIGATOR
References: