louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06800053: FOCUS ON US: Adapting the FOCUS Program for Sexual and Gender Minority (SGM) Cancer Patients and Caregivers
Official title: FOCUS ON US: Adapting the FOCUS Program for Sexual and Gender Minority (SGM) Cancer Patients and Caregivers
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Cancer Support
Oncology Patients
Caregivers
Keywords: Cancer Patients and Caregivers
LGBTQ+
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Wayne State University
name: National Cancer Institute (NCI)
First posted: 2025-01-29
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Our aim for this study is to assess the feasibility and acceptability and explore potential outcomes of the adapted FOCUS On Us intervention in a two-arm pilot trial. The investigators will randomize 80 sexual and/or gender minority (SGM; e.g., lesbian, gay, bisexual, transgender, queer, etc.) cancer patients and their ≥80 informal caregivers (total N≥160) to either FOCUS On Us (adapted from the evidence-based FOCUS program) or a waitlist control.


Eligibility criteria: Inclusion Criteria:

Patients must:

1. have been diagnosed or had a biochemical recurrence or progression of any invasive (e.g., Stage ≥1) cancer within the past 24 months;
2. have at least one informal (unpaid) caregiver willing to participate in the program;
3. identify as a sexual and/or gender minority (SGM) OR have a caregiver who identifies as SGM (e.g., either the patient or caregiver(s) must be SGM);
4. be age 18 or older;
5. be able to complete all written and oral components of the study in English;
6. provide informed consent;
7. live in the United States.

Caregivers must:

1. self-report having provided support for a cancer patient as an informal (unpaid) caregiver;
2. have a cancer patient for whom they provided support willing to participate in the program;
3. identify as a sexual and/or gender minority (SGM) OR have provided support to a patient who identifies as SGM (e.g., either the patient or caregiver(s) must be SGM);
4. be age 18 or older;
5. be able to complete all written and oral components of the study in English;
6. provide informed consent;
7. live in the United States

Primary outcomes:
measure: Feasibility of Intervention
timeFrame: 3 months after randomization
measure: Acceptability
timeFrame: 3 months after randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Rochester
country: United States
facility: University Of Rochester
state: New York
Study officials:
References:
Clinical trial NCT00599053: Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates
Official title: Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Bacteria Infection
Respiratory Tract Infections
Keywords: Ureaplasma
Bronchopulmonary dysplasia
very low birthweight
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2008-01-23
Enrollment: 7
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Our hypothesis is that treatment of known Ureaplasma spp. infection of the airways in very low birth weight (VLBW) infants with azithromycin will eradicate the organisms and lessen the proinflammatory state caused by infection that puts them at risk for Bronchopulmonary Dysplasia (BPD). We propose to conduct a randomized trial of early (less than 3 days of age) treatment with intravenous azithromycin versus expectant management for VLBW infants with Ureaplasma spp. respiratory tract infection with the following specific aims: (1) Determine microbiological efficacy, pharmacokinetics, and safety of azithromycin treatment for eradication of Ureaplasma spp. in preterm infants, (2) Determine the respiratory outcomes of infants in the two treatment groups and those without respiratory tract Ureaplasma spp. infection


Eligibility criteria: Inclusion Criteria:

* Infants weighing \<1250 grams at birth with respiratory distress syndrome who have respiratory infection with Ureaplasma sp organisms.

Exclusion Criteria:

* Severe respiratory distress syndrome with survival unlikely \>7 days, Congenital malformations

Primary outcomes:
measure: Microbiological Efficacy of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants
timeFrame: 100 days or discharge from hospital
measure: Pharmacokinetics (PK) of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants
timeFrame: 100 days or discharge from hospital
measure: Safety of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants
timeFrame: from day 1 of study drug through 100 days or discharge from hospital, which ever comes first
Secondary outcomes:
measure: Respiratory Outcomes as Determined by Subjects Without Respiratory Tract Ureaplasma Spp Infection in Subjects in the Two Treatment Groups
timeFrame: from baseline to 100 days or discharge from Hospital, which ever comes first
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birminham
name: Robert L Schelonka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03417453: Eye Drop Dispensers: Safety, Efficacy and Comfort.
Official title: Eye Drop Dispensers: Safety, Efficacy and Comfort.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma
Cataract
Healthy Subjects
Keywords: normal patients
eye drops dispensers
aids
glacuoma
cataract
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-01-31
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: One aspect to eye drop adherence is successful instillation of the drops; however, it is well known that many patients struggle with this task. Difficulties may include aiming their drops,extending their neck, preventing excess drop leakage, avoiding contamination of the bottle tip and generating enough force to expel a drop from the bottle. Instillation aids are devices that aim to ameliorate one or more of these barriers.

Several eye drop dispensers had been developed in order to improved outcomes of eye drop instillation, including improved rates of successful administration and increased patient satisfaction compared to standard eye drop bottles.

In this study we aim to compare the eye drops various installation aids

Detailed description: subject will evaluate 2 dispensers by questioners. efficacy and safety of each one will be evaluated.

Eligibility criteria: Inclusion Criteria:

* glaucoma patients

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of correct application of eye drops to the eye without missing conducted by questioners.
timeFrame: 5 seconds after instillation of eye drops
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-aviv
country: Israel
facility: Asaf Achiron
Study officials:
References:
Clinical trial NCT05594953: Outcomes Using MARS for Patients With ALF
Official title: Outcomes Using MARS: A Single Center Experience
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alcoholic Hepatitis
Acute Liver Failure
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients meeting the inclusion criteria (Alcoholic hepatitis, AoCLF; or ALF who underwent at least one round of dialysis using plasma exchange or MARS from January 1, 2019 to December 15, 2020 will be included in the analysis.

Brief summary: Retrospective chart review will be conducted on patients at Methodist Dallas Medical Center, meeting the inclusion criteria from January 1, 2019 to December 15, 2020 to determine the transplant free survival and overall survival and other secondary outcome measures.

Detailed description: Retrospective chart review will be conducted on patients at Methodist Dallas Medical Center, meeting the inclusion criteria from January 1, 2019 to December 15, 2020 to determine the transplant free survival and overall survival and other secondary outcome measures. Patient's charts will be accessed on EPIC by the PI or delegated study personnel. The investigator's anticipate completion of this study by January 31, 2022.

Eligibility criteria: Inclusion Criteria:

• The patient was diagnosed with: Alcoholic hepatitis; AoCLF; OR Acute fulminant liver failure

• The patient underwent at least one round of dialysis using plasma exchange or MARSTM

Exclusion Criteria:

* Patient not meeting the inclusion criteria will be excluded.

All patients who underwent MARS at MDMC will be included in the study population.

Primary outcomes:
measure: Transplant free survival mortality
timeFrame: Rate at 30 days
measure: Difference in Demographics
timeFrame: Rate at 30 days
measure: Improvement in Transplant
timeFrame: Rate at 30 days
Secondary outcomes:
measure: Demographics
timeFrame: January 1, 2019 to January 31, 2022
measure: Hepatorenal syndrome
timeFrame: (in hospital [date of death or discharge or transplant]) and at 30 days
measure: Need for vasopressor support
timeFrame: (in hospital [date of death or discharge or transplant]) and at 30 days
measure: Sepsis (as measured by by QSOFA criteria):
timeFrame: (in hospital [date of death or discharge or transplant]) and at 30 days
measure: Need for CRRT as documented in the chart:
timeFrame: (in hospital [date of death or discharge or transplant]) and at 30 days
measure: ICU duration
timeFrame: date of ICU admission and date of discharge (or death)
measure: long term dialysis
timeFrame: (in hospital [date of death or discharge or transplant]) and at 30 days
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Methodist
name: Parvez Mantry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01099553: Improving Bowel Preparation With an Educational Video
Official title: Improving Bowel Preparation With an Education Video
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bowel Preparation
Keywords: Educational video
colonoscopy
bowel preparation
Bowel preparation for colonoscopy
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2010-04-07
Enrollment: 2000
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 investigators goal is to improve bowel preparations with an educational video on the Center for Digestive Disorders (CDD) website that explains the steps required for bowel preparation for those patients undergoing screening colonoscopies. The video will focus on explaining the purpose of a screening colonoscopy, the rationale for bowel preparation, the pre-colonoscopy diet, and the instructions for completing the laxative. In a randomized fashion, patients in the control group will receive the standard written bowel preparation instructions, while patients in the intervention group will receive standard written instructions plus a link to watch the instructional video. The investigators hypothesize that an educational tool that provides visual examples of a good and poor preparation, examples of the pre-colonoscopy diet, and an explanation of how to administer the laxative will lead to improved patient compliance and a better bowel preparation. In addition, the investigators hypothesize that a better quality bowel preparation will improve detection of colonic polyps and fewer recommendations for repeat colonoscopy based solely on inadequate bowel preparation.


Eligibility criteria: Inclusion Criteria:

* all outpatients
* age \>18
* referred and scheduled for an elective screening colonoscopy

Exclusion Criteria:

* inpatients
* prisoners
* patients allergic to PEG-ELS based laxatives

Primary outcomes:
measure: Quality of bowel preparation
timeFrame: Day of colonoscopy only
Secondary outcomes:
measure: Histology of polyp
timeFrame: one week after colonoscopy
measure: Colonoscope insertion and withdrawal times
timeFrame: Day of colonoscopy only
measure: Patient compliance
timeFrame: Day of colonoscopy only
measure: Preparation associated side effects
timeFrame: Day of colonoscopy only
measure: Patient satisfaction
timeFrame: Day of colonoscopy only
measure: Number of repeat colonoscopies due to inadequate bowel preparation
timeFrame: Day of colonoscopy only
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Brian C Jacobson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04961853: Diagnostic Value of Hand Ultrasound Versus MRI in Rheumatoid Arthritis
Official title: Diagnostic Value of Hand Ultrasound Versus MRI in Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient's With Rheumatoid Arthritis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Rheumatoid arthritis (RA) is one of the most common autoimmune rheumatic diseases, affecting one in 100 individuals worldwide. It is considered a complex systemic multifactorial inflammatory process in which the immune system targets synovial joints and causes mild to severe joint destruction with extra-articular manifestations.

If left untreated, RA leads to deformity, considerable disability, and major comorbid conditions, including cardiovascular disease and increased mortality.

Early treatment with targeted therapies can alter long-term outcomes by minimizing disease activity, preventing joint damage and disability, and improving patients' quality of life.


Eligibility criteria: Inclusion Criteria:

1. Adult-onset disease.
2. Patients who fulfill the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis.

Exclusion Criteria:

1. Any patient with any collagen disease rather than Rheumatoid arthritis.
2. Patients with joints deformities.
3. Patient's with implanted metal clips or wires or artificial pacemaker.

Primary outcomes:
measure: Diagnostic performance of Ultrasound and MRI in Rheumatoid Arthritis of the hand
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Kaeley GS, Bakewell C, Deodhar A. The importance of ultrasound in identifying and differentiating patients with early inflammatory arthritis: a narrative review. Arthritis Res Ther. 2020 Jan 2;22(1):1. doi: 10.1186/s13075-019-2050-4.
citation: Tan YK, Ostergaard M, Conaghan PG. Imaging tools in rheumatoid arthritis: ultrasound vs magnetic resonance imaging. Rheumatology (Oxford). 2012 Dec;51 Suppl 7:vii36-42. doi: 10.1093/rheumatology/kes329.
citation: Hodgson RJ, O'Connor P, Moots R. MRI of rheumatoid arthritis image quantitation for the assessment of disease activity, progression and response to therapy. Rheumatology (Oxford). 2008 Jan;47(1):13-21. doi: 10.1093/rheumatology/kem250. Epub 2007 Nov 28.
citation: Rowbotham EL, Grainger AJ. Rheumatoid arthritis: ultrasound versus MRI. AJR Am J Roentgenol. 2011 Sep;197(3):541-6. doi: 10.2214/ajr.11.6798.
Clinical trial NCT03020953: The Anabolic Effects of Estrogen on Skeletal Muscles
Official title: The Anabolic Effects of Estrogen on Skeletal Muscles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Estrogen Supplementation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 31
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Purpose: to study the effect of estrogen replacement on muscle hypertrophy in response to 12 weeks resistance training in postmenopausal women Hypothesis: Transdermal administration of 17-β estradiol enhance the anabolic effect of resistance training on muscle mass, strength in postmenopausal women Primary outcome: Muscle hypertrophy (muscle CSA, muscle fiber type specific CSA) Secondary outcome: Messenger RiboNucleic Acid (mRNA)(real-time PCR), protein (western blotting), satellite cell proliferation and activation, Strength, functional test, muscle protein synthese.

Design: Two groups of healthy postmenopausal women (½-5 years after menopause) who have not performed regular resistance exercise (\<1 times per week) the last two years. Randomized, controlled intervention study +/- transdermal administration of estrogen (17-β estradiol). Both groups perform 12 weeks of supervised progressive resistance training (3/week) aiming to induce muscle hypertrophy in the legs.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women, more than 6 months, but less than 5 years since last menstruation.

Exclusion Criteria:

* Less than 2 hours exercise with moderate to high intensity per week the last year, no regular resistance exercise the last 2 years (less than 5 exercise bouts during the last year)
* No previous or present lower limb injuries which may hinder participation in strength training
* No use of medicine which may influence the adaptation to strength training such as regular use of nonsteroidal anti-inflammatory drugs and use of statins, no muscle
* Joint or metabolic diseases or other chronic diseases that would affect the results of the investigation, high blood pressure (\>140/90), smoking

Primary outcomes:
measure: Muscle hypertrophy
timeFrame: 12 weeks
Secondary outcomes:
measure: Muscle fiber hypertrophy
timeFrame: 12 weeks
measure: Muscle strength
timeFrame: 12 weeks
measure: tendon size
timeFrame: 12 weeks
measure: Fat cell size
timeFrame: 12 weeks
measure: Fat mass
timeFrame: 12 weeks
measure: Fat free mass
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Sport Science, Department of Public Health, Aarhus University
Study officials:
affiliation: University of Aarhus
name: Mette Hansen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00298753: Urinary Aquaporine 2 in Patients With Syndrome of Inappropriate ADH-secretion Caused by Treatment With Antiepileptic Medicine
Official title: Urinary Aquaporine 2 in Patients With Syndrome of Inappropriate ADH-secretion Caused by Treatment With Antiepileptic Medicine
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Syndrome of Inappropriate ADH-secretion
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2006-03-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: Patients treated with the antiepileptic drug Oxcarbazepine often develop syndrome of inappropriate secretion of antidiuretic hormone(SIADH)We want to test the hypothesis, that these patients have a higher reabsorption of water during the Aquaporine2 water channels,a higher concentration of Vasopressine (AVP), and a lower clearance of water.This situation will tend to normalize, when the patients are treated with fluid restriction

Detailed description: The purpose of the study is to determine the amount of Aquaporine2(AQP2)in the urine in patients treated with the antiepileptic drug Oxcarbazepine before and after the administration of fluid restriction

Eligibility criteria: Inclusion Criteria:

Age more than 18 years, both men and women, patients with epilepsia treated with Oxcarbazepine, and a Sodium content in plasma lower than 130 mmol/liter

Exclusion Criteria:

severe diseases in the heart, lungs or liver;diabetes mellitus, other not-well treated diseases in endocrine organs, cancer; unwillingness to participate

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of Medicine, Holstebro Hospital
state: Jutland
Study officials:
affiliation: Holstebro Hospital, Denmark
name: Erling B Pedersen, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT03473353: Doctor-Parent Interactions With Medical Scribes
Official title: Doctor-Parent Interactions With Medical Scribes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout, Professional
Keywords: Medical Scribe
Outpatient
EHR
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 732
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of the study is to collect outcomes related to a quality improvement project assessing the feasibility and effectiveness of a medical scribe program in which medical scribes accompany clinicians during their visits with patients. The medical scribes involved in the project are professional scribes and medical students who will accompany clinicians during patient visits and takes notes, enabling the clinician to engage more directly with the patient.

Detailed description: The study has several specific objectives. This study aims to examine the impact of using medical scribes on (1) patient experience (e.g. patient satisfaction) (2) clinician experience (e.g. stress load, burnout, evaluation of the visit, amount of time spent after hours inputting notes), and (3) clinician-patient interaction (e.g. patient and clinician engagement during the visit).

Eligibility criteria: Provider Participants

Inclusion Criteria:

1. Attending clinicians with privileges at Penn State Hershey Children's Hospital and/or the Penn State Hershey Internal Medicine. This may include attending MDs or DOs and Nurse Practitioners (NPs).
2. Voluntary participation in the medical scribe QI project.
3. Consents to participate in the study.

Exclusion Criteria:

1. Clinician is not participating in the scribe project.
2. Clinician does not consent to participate in the research portion of this project.

Patient Participants

Inclusion Criteria:

1. Patient (if 18 years or older) or parent/guardian (P/G) of patient being seen by a participating clinician.
2. Patient was not seen by a resident or medical student prior to meeting with clinician.
3. English speaking/reading.
4. Patient or P/G has capacity to consent.

Exclusion Criteria:

1. Patient is seeing a clinician who has not consented to participate in the research portion of the study.
2. Non-English speaking/reading.
3. Patient or P/G lacks capacity to consent.

Primary outcomes:
measure: Clinician Burnout
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Hope Drive Pediatric Clinic
state: Pennsylvania
Study officials:
affiliation: Departments of Humanities & Pediatrics
name: Benjamin Levi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: