louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04970173: 1L-PEG-Asc Solution for Bowel Preparation in an "Open Access" Colonoscopy Booking System: Evaluation of Adverse Events
Official title: 1L-PEG-Asc Solution for Bowel Preparation in an "Open Access" Colonoscopy Booking System: Evaluation of Adverse Events
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bowel Preparation
Keywords: safety
Lead sponsor: Azienda USL Modena
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 5981
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only consecutive patients taking Plenvu (1L-PEG-Asc, Norgine, Harefield, UK) or Moviprep (2L-PEG-Asc, Norgine, Harefield, UK) were considered in our analyses, from January 2019 to September 2020

Brief summary: Several factors are considered as the key indicators of quality colonoscopy, including endoscopist experience, withdrawal time, and quality of bowel preparation (BP). A number of laxatives are currently used as BP, and these are mainly based on PEG agents that differ for the volume and the addition of adjuvants. Several trials have demonstrated the efficacy and safety of low volume 2L-PEG based regimens compared with high volume PEG regimens and non-PEG agents. However, for low-volume 1L-PEG plus ascorbate (1L-PEG-Asc) only the data from registration trials are available, and none of these have been performed in an "open access" colonoscopy booking system. The aim of our study was to evaluate the safety and tolerability of 1L-PEG-Asc compared to 2L-PEG plus ascorbate (2L-PEG-Asc) in an "open access" booking system.

Detailed description: All patients who underwent "open access" colonoscopy in our Unit from January 2019 to September 2020 were evaluated as part of a quality improvement project. Only patients taking 2L-PEG-Asc and 1L-PEG-Asc were enrolled in this study. Safety of BP was assessed by reviewing the number of admissions to the Emergency Department of our Hospitals and the main presentation symptom/diagnosis in the 7 days following the colonoscopy. Tolerability was evaluated as the compliance to full BP intake

Eligibility criteria: Inclusion Criteria:

* From January 2019 to September 2020, data from all consecutive adult (aged ≥ 18 years old) patients who underwent "open access" colonoscopy performed in our Digestive Endoscopy Unit (which is based in the Hospitals of Carpi, Castelfranco Emilia, Mirandola, Pavullo and Vignola) were collected using an electronic reporting system

Exclusion Criteria:

* Pregnant of breastfeeding patients

Primary outcomes:
measure: Safety of BP was assessed by reviewing the number of admissions to the Emergency Department of our Hospitals and the main presentation symptom/diagnosis in the 7 days following the colonoscopy.
timeFrame: from January 2019 to September 2020
Secondary outcomes:
measure: Tolerability was evaluated as the compliance to full BP intake.
timeFrame: from January 2019 to September 2020
Other outcomes:
Locations:
city: Carpi
country: Italy
facility: Azienda USL Modena
state: Modena
Study officials:
References:
Clinical trial NCT05617573: Synovitis in Patients With Osteoarthritis
Official title: Correlations Between Microscopic Features of Synovium and Clinical Parameters in Patients With Advanced Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 272
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced knee osteoarthritis

Brief summary: To study synovial membrane (SM) inflammation in suprapatellar fossa in advanced knee osteoarthritis (OA), and to correlate the pathological features with clinical findings.


Eligibility criteria: Inclusion Criteria:

* patients undergoing elective, unilateral, primary TKA for advanced osteoarthritis.

Exclusion Criteria:

- revisions, bilateral procedures, alcohol or medical abuse, administration of any glucocorticoids during the 3 months prior to surgery, and/or a history of serious cardiac or cerebrovascular problems, severe liver or kidney failure, and/or connective tissue disease including rheumatoid arthritis, ankylosing spondylitis, and systemic lupus erythematosus.

Primary outcomes:
measure: Correlation between pathological features and clinical scores
timeFrame: 1 day.
measure: Correlation between pathological features and laboratory index
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The affiliated hospital of Qingdao University
state: Shandong
Study officials:
References:
Clinical trial NCT04723173: Quality Control of CE-Certified Phonak Hearing Aids - 2020_43
Official title: Quality Control of CE-Certified Phonak Hearing Aids - 2020_43
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2021-01-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Detailed description: The study will compare different features of the Phonak behind the ear device activated and deactivated, for example the noise reduction feature. There shall be differences in listening effort, awareness and sound quality shown. The study shall show the advantages especially for people with severe to profound hearing losses. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Eligibility criteria: Inclusion Criteria:

* Adult hearing impaired persons (minimum age: 18 years, severe to profound Hearing loss)
* Good written and spoken (Swiss) German language skills
* Healthy outer ear
* Ability to fill in a questionnaire (p/eCRF) conscientiously
* willingness to wear Behind-the-ear hearing aids
* Informed Consent as documented by signature

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Known psychological problems

Primary outcomes:
measure: Subjective Listening Effort Scaling
timeFrame: 2 weeks
Secondary outcomes:
measure: Subjective Ratings of Speech and Music Samples (Part1: Sound Quality)
timeFrame: 4 weeks
measure: Measure of Detection Threshold (in dB) for Soft Sounds
timeFrame: 2 weeks
measure: Subjective Ratings of Speech and Music Samples (Part 2: Artefact Perception)
timeFrame: 2 week
Other outcomes:
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
state: Zürich
Study officials:
References:
Clinical trial NCT03092973: Carotid Intima Media Thickness (CIMT) in Epistaxis
Official title: Carotid Intima Media Thickness in Patients With Epistaxis: a Surrogate Marker for Generalised Atherosclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epistaxis
Atherosclerosis
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2017-03-28
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 50 patients with epistaxis and 50 healthy controls.

Brief summary: Epistaxis is a very frequent emergency among adults and often needs specialised treatment in an ENT-department. Among others, atherosclerosis is often named as a reason for an increased risk for Epistaxis. To evaluate whether or not this is the case, the investigators examined the carotid intima media thickness via ultrasound in patients who were treated in the ENT-department of the University Hospital of Zurich.


Eligibility criteria: Inclusion Criteria:

* active or very recently active anterior or posterior epistaxis
* at least 18 years old

Exclusion Criteria:

* posttraumatic or postoperative epistaxis

Primary outcomes:
measure: Carotid Intima Media Thickness in Epistaxis vs. Controls
timeFrame: June 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital of Zurich
state: ZH
Study officials:
affiliation: University of Zurich
name: Michael Soyka, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kunz SM, Holzmann D, Soyka MB. Association of epistaxis with atherosclerotic cardiovascular disease. Laryngoscope. 2019 Apr;129(4):783-787. doi: 10.1002/lary.27604. Epub 2018 Dec 13.
Clinical trial NCT02540473: Fostering Resilience in Physician Moms
Official title: Fostering Resilience: An Intervention for Women Physicians at Risk for Burnout
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Keywords: Resilience
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Arizona State University
First posted: 2015-09-04
Enrollment: 44
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Physicians in general are at risk for burnout, and this risk is heightened among women, particularly mothers. In a randomized design, central hypotheses in this study are that mothers who attend our 12-week Relational Psychotherapy Mothers Group (RPMG) intervention will show significantly greater decreases in stress, depression, burnout, and associated risk biomarker indices, as compared to comparison controls (who would meet in unstructured gatherings, for an hour a week for 12 weeks). Additionally the investigators hypothesize that the gains would be maintained three months after the intervention is completed.


Eligibility criteria: Inclusion of Women and Minorities:

* This study will be restricted to women physician mothers, who are the target of the manualized RPMG program.
* The study will not use race or ethnicity as a basis for selecting subjects.

Inclusion of Children:

* This study does not include children.

Exclusion criteria

* Participation in this study is open to all Mayo physician mothers with a child under the age of 18 years.
* As in past RPMG trials, the only exclusion criteria are if mothers were to indicate active suicidality, or meet criteria for psychoses, during initial assessments or during participation in this study.

Primary outcomes:
measure: level of depression
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: biomarker of stress
timeFrame: Baseline to 3 months
measure: biomarker of stress
timeFrame: Baseline to 3 months
measure: Professional functioning
timeFrame: Baseline to 3 months
measure: perceived social support
timeFrame: Baseline to 3 months
measure: Parenting stress
timeFrame: Baseline to 3 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Cynthia Stonnington, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kunzler AM, Helmreich I, Chmitorz A, Konig J, Binder H, Wessa M, Lieb K. Psychological interventions to foster resilience in healthcare professionals. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD012527. doi: 10.1002/14651858.CD012527.pub2.
citation: Luthar SS, Curlee A, Tye SJ, Engelman JC, Stonnington CM. Fostering Resilience among Mothers under Stress: "Authentic Connections Groups" for Medical Professionals. Womens Health Issues. 2017 May-Jun;27(3):382-390. doi: 10.1016/j.whi.2017.02.007. Epub 2017 Apr 14.
Clinical trial NCT02127073: Pilot Study of Oxytocin and microRNA Identification in NAF, Serum, and Tissue in Women With Breast Cancer
Official title: Identifying the miR Fingerprint in NAF, Serum, and Tissue in Patients With Ductal Carcinoma in Situ (DCIS) or Invasive Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Ductal Carcinoma in Situ
Keywords: Breast cancer
Ductal carcinoma in situ (DCIS)
Oxytocin
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2014-04-30
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine the genetic material called microRNA of three types of specimens from women with breast cancer. The study also seeks to examine the effectiveness of using a new agent called oxytocin to increase the amount of nipple fluid that can be collected during surgery.

Detailed description: Vast majority of breast cancers arise from ductal epithelium. Ductal cells can be collected through the nipple orifice very early in breast cancer development. The nipple aspirate ﬂuid (NAF) can be used to identify biomarkers that predict risk of breast cancer. To date, the biomarkers identified in nipple aspirate ﬂuid (NAF) have limited utility due to the large volume of NAF required for data analysis. Recent studies show intranasal oxytocin's utility in enhancing the yield of nipple aspirate ﬂuid (NAF) among healthy, non-lactating female patients as well as those at high risk for breast cancer. This capability is crucial for the analysis of various markers associated with breast disease and cancer such as microRNAs. The primary aim of the study is to determine whether the microRNA profile characterization is feasible with the collection of tissue, serum and NAF in patients with in situ and invasive breast cancer. Intranasal oxytocin will be used to enhance ﬂuid yielding of the NAF.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Ductal carcinoma in situ (DCIS) or invasive breast cancer
* Candidate for breast conserving surgery or mastectomy

Exclusion Criteria:

* Pregnant women
* Prior Breast Cancer diagnosis
* Adverse reaction to Oxytocin in the past

Primary outcomes:
measure: Percentage of Patients With Detection of microRNA in NAF, Serum, or Tissue
timeFrame: 3 years
Secondary outcomes:
measure: Percentage of Patients With Collection of ≥ 5 μL of Nipple Aspirate Fluid
timeFrame: 3 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Sheldon Feldman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04083573: Comparison of Diagnostic Performance of Medical Monitor and Medical Augmented Reality Glasses in Endoscopy: Observation Study
Official title: Comparison of Diagnostic Performance of Medical Monitor and Medical Augmented Reality Glasses in Endoscopy: Observation Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Early Gastric Cancer
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2019-09-10
Enrollment: 25
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with early gastric cancer who are scheduled for endoscopic submucosal dissection will be the study population

Brief summary: The purpose of this study was to compare the outcomes of medical augmented reality glasses and general monitors when distinguishing mucosal lesions from submucosal lesions in endoscopic diagnosis for early gastric cancer.


Eligibility criteria: Inclusion Criteria:

* Patients with early gastric cancer who are scheduled for endoscopic submucosal dissection
* Age 19 or more
* Patients who voluntarily participated in this clinical study and signed a written informed consent

Exclusion Criteria:

* Patients with poor general medical condition which does not allow them to understand and submit a informed consent
* Patients who do not agree with this study

Primary outcomes:
measure: Consistency between the result from medical monitor and that from medical augmented reality glass
timeFrame: Image review will be conducted after full collection of both series of images. Review process will be done within 3 months after acquision of images. The time for study completion is aimed at 1 year from the start date.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Yoon JW, Chen RE, Kim EJ, Akinduro OO, Kerezoudis P, Han PK, Si P, Freeman WD, Diaz RJ, Komotar RJ, Pirris SM, Brown BL, Bydon M, Wang MY, Wharen RE Jr, Quinones-Hinojosa A. Augmented reality for the surgeon: Systematic review. Int J Med Robot. 2018 Aug;14(4):e1914. doi: 10.1002/rcs.1914. Epub 2018 Apr 30.
citation: Takeshita H, Kihara K, Yoshida S, Higuchi S, Ito M, Nakanishi Y, Kijima T, Ishioka J, Matsuoka Y, Numao N, Saito K, Fujii Y. Clinical application of a modern high-definition head-mounted display in sonography. J Ultrasound Med. 2014 Aug;33(8):1499-504. doi: 10.7863/ultra.33.8.1499.
citation: Eckardt C, Paulo EB. HEADS-UP SURGERY FOR VITREORETINAL PROCEDURES: An Experimental and Clinical Study. Retina. 2016 Jan;36(1):137-47. doi: 10.1097/IAE.0000000000000689.
citation: Choi J, Kim SG, Im JP, Kim JS, Jung HC, Song IS. Endoscopic prediction of tumor invasion depth in early gastric cancer. Gastrointest Endosc. 2011 May;73(5):917-27. doi: 10.1016/j.gie.2010.11.053. Epub 2011 Feb 11.
Clinical trial NCT05219773: Clinic Versus Home Spirometry
Official title: A Comparison of Clinic-based Versus Home-based Spirometry.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Chronic Obstructive Pulmonary Disease
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2022-02-02
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study aims to assess the differences between spirometry performed with the NuvoAir Air Next spirometer in the clinic setting with both direct and virtual supervision via a video call, and in the home setting with virtual supervision. This is will be achieved by comparing lung function values, specifically the FEV1 and FVC measurements. We also wish to evaluate participant's perceptions of home spirometry, by using a survey.

This is a multi-centre, cross-over study. The study will enrol participants with a diagnosis of asthma and COPD, across participating study sites until 68 have completed the study.


Eligibility criteria: Inclusion Criteria:

* An ability to provide fully informed consent.
* A diagnosis of asthma or COPD.
* Male or female aged ≥18 and ≤ 80 years of age.

Exclusion Criteria:

* Symptoms suggestive of COVID-19.
* An exacerbation of asthma or COPD or symptoms of a respiratory infection within the 30 days prior to the first visit.
* Any other clinically significant medical disease or uncontrolled concomitant disease, that is likely, in the opinion of the Investigator(s), to impact on the ability to participate in the study.
* The presence of any contraindications to spirometry.

Primary outcomes:
measure: 1. To compare spirometric values obtained from the NuvoAir Air Next device, directly supervised in clinic and virtually supervised in clinic and at home.
timeFrame: 8 days
measure: 2. To compare spirometric values obtained from two virtually supervised tests performed at home, using the NuvoAir Air Next device.
timeFrame: 8 days
Secondary outcomes:
measure: To evaluate the participant's views of home spirometry via a survey.
timeFrame: 8 days
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Respiratory Research Unit
state: Nottinghamshire
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospitals NHS Foundation Trust
city: Rotherham
country: United Kingdom
facility: The Rotherham NHS Foundation Trust
Study officials:
affiliation: University of Nottingham
name: Professor Harrison
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03615573: Survey Study: Financial Impact of Breast Cancer Treatment
Official title: Determining the Financial Impact of Breast Cancer Treatment Over a One Year Period for Patients at a Rural Cancer Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: The Guthrie Clinic
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen at rural cancer center with diagnosis of breast cancer or a recurrence of breast cancer within the past 2 years

Brief summary: A survey study to evaluate the financial impact of breast cancer as self-reported by breast cancer patients over a period of 1 year. The study will also look at the health insurance literacy and patient's utilization of support services.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Diagnosed with breast cancer or a recurrence of breast cancer within the past 2 years
* Willing to sign consent
* Able to read and complete surveys in English

Exclusion Criteria:

* Cancer diagnosis other than breast cancer
* More than 2 years since diagnosis with breast cancer or recurrence

Primary outcomes:
measure: Change in level of self-reported financial burden
timeFrame: Baseline through 1 year
Secondary outcomes:
measure: Change in level of self-reported health insurance literacy
timeFrame: Baseline through 1 year
measure: Self-reported access and utilization of institutional support services
timeFrame: Baseline through 1 year
Other outcomes:
Locations:
city: Sayre
country: United States
facility: Guthrie Medical Group
state: Pennsylvania
Study officials:
affiliation: The Guthrie Clinic
name: Cynthia Perry-Keaty, RN FNP AOCNP
role: PRINCIPAL_INVESTIGATOR
References: