louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02625402: Pilot RCT Comparing Effectiveness of Two Decision Aids for Hip and Knee Osteoarthritis
Official title: Pilot RCT Comparing Effectiveness of Two Decision Aids for Hip and Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Knee Osteoarthritis
Keywords: decision making
decision aids
decision quality instruments
osteoarthritis
shared decision making
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Newton-Wellesley Hospital
First posted: 2015-12-09
Enrollment: 58
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This pilot RCT study is to examine the comparative effectiveness of two decision aids for hip and knee osteoarthritis.

Detailed description: This pilot RCT study is to examine the comparative effectiveness of two decision aids for hip and knee osteoarthritis. The vendors employ different design features (e.g. use of video for patient narratives, interactive values clarification exercise) and the study will examine the relative impact of the different features on decision quality. Eligible subjects will be randomly assigned to receive one of two decision aids before their upcoming clinic visit with a participating provider. Immediately before the visit, participants will complete a short questionnaire about the decision aid. This pilot study will assist with determining the potential difference between these two decision aids on improving knowledge and use of decision aids.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of either hip or knee osteoarthritis
* Scheduled visit with participating orthopedic surgeon

Exclusion Criteria:

* Prior partial or total knee or hip replacement surgery
* Hip fracture or aseptic necrosis in the last 12 months
* Rheumatoid arthritis or psoriatic arthritis
* Unable to read or speak English

Primary outcomes:
measure: Hip and Knee Decision Quality Instruments Knowledge Subscale Scores
timeFrame: In clinic, immediately before the first visit with surgeon
Secondary outcomes:
measure: Percentage of Participants Who Used the Decision Aid
timeFrame: In clinic, immediately before the first visit with surgeon
measure: Percentage of Participants With a Clear Treatment Preference
timeFrame: In clinic, immediately before the first visit with surgeon
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Newton
country: United States
facility: Newton Wellesley Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Karen R Sepucha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sepucha K, Feibelmann S, Chang Y, Clay CF, Kearing SA, Tomek I, Yang T, Katz JN. Factors associated with the quality of patients' surgical decisions for treatment of hip and knee osteoarthritis. J Am Coll Surg. 2013 Oct;217(4):694-701. doi: 10.1016/j.jamcollsurg.2013.06.002. Epub 2013 Jul 25.
Clinical trial NCT05202002: Decrease Type II Diabetes in Gestational Diabetes Population
Official title: Decreasing the Incidence of Post-partum Type II Diabetes Mellitus in Gestational Diabetes Population- Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes
Diabetes Mellitus, Type 2
Breastfeeding
Diabetes Mellitus, Type 1
Impaired Glucose Tolerance
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of the study is to examine the impact of an educational video on the rate of breastfeeding in mothers who had gestational diabetes mellitus, and the rate of type-II diabetes mellitus diagnosed postpartum.


Eligibility criteria: Inclusion Criteria:

* Pregnant individuals aged over 18 years old
* Diagnosed with Gestational Diabetes Mellitus (GDM) by 100gm oral glucose tolerance test (OGTT) done between week 24-28 of gestation, or by other criteria (50gm glucose challenge test (GCT) \>200 mg/dl22 or having one abnormal value in OGTT )
* Having pregestational diabetes (DM-I or DM-II)
* Can read and understand Hebrew

Exclusion Criteria:

* Delivery of a non-viable fetus

Primary outcomes:
measure: Rate of type II Diabetes Mellitus (DM) diagnosis, as diagnosed by the 75gm oral glucose tolerance test (OGTT)
timeFrame: A phone call at 6 weeks postpartum.
Secondary outcomes:
measure: Rate of OGTT performance
timeFrame: A phone call at 6 weeks postpartum.
measure: Rate of impaired glucose tolerance (IGT)
timeFrame: A phone call at 6 weeks postpartum.
measure: Rate of exclusive breastfeeding
timeFrame: A phone call at 6 weeks postpartum.
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel MC
Study officials:
affiliation: Carmel MC
name: Nadav Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gunderson EP, Hedderson MM, Chiang V, Crites Y, Walton D, Azevedo RA, Fox G, Elmasian C, Young S, Salvador N, Lum M, Quesenberry CP, Lo JC, Sternfeld B, Ferrara A, Selby JV. Lactation intensity and postpartum maternal glucose tolerance and insulin resistance in women with recent GDM: the SWIFT cohort. Diabetes Care. 2012 Jan;35(1):50-6. doi: 10.2337/dc11-1409. Epub 2011 Oct 19.
citation: McFadden A, Gavine A, Renfrew MJ, Wade A, Buchanan P, Taylor JL, Veitch E, Rennie AM, Crowther SA, Neiman S, MacGillivray S. Support for healthy breastfeeding mothers with healthy term babies. Cochrane Database Syst Rev. 2017 Feb 28;2(2):CD001141. doi: 10.1002/14651858.CD001141.pub5.
Clinical trial NCT03405402: Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization
Official title: Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Keywords: Sickle cell disease
Allo-immunization
Blood transfusion
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 173
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Sickle cell patients have a high prevalence of alloimmunization. This high rate of alloimmunization can be partially explained by the existence of an antigenic difference between the predominantly Caucasian donor population and the sickle cell patients of African origin. Genetic and environmental risk factors have also been described.

The main risk factors that have been shown in retrospective or cross-sectional studies are some HLA alleles, the age of the patient, the number of leukocyte-depleted erythrocyte concentrates (CED) transfused, the number of transfusion episodes, the age of the CEDs, the existence of an inflammatory event at the time of transfusion and the presence of anti-erythrocyte autoantibodies.There is also evidence of an impaired TH response but the underlying immunological mechanism is not fully understood.

The aim of this study is to study the prevalence and the risk factors for anti-erythrocyte alloimmunization and to try to understand the immunological mechanisms.


Eligibility criteria: Inclusion Criteria:

Sickle cell disease patients treated within the CHU Brugmann or Queen Fabiola Children's Hospital

Exclusion Criteria:

None

Primary outcomes:
measure: Irregular antibodies
timeFrame: 1 hour before blood transfusion
measure: Irregular antibodies
timeFrame: Between 2 to 4 weeks after blood transfusion
measure: C-reactive protein (CRP)
timeFrame: 1 hour before blood transfusion
measure: Cytokine
timeFrame: 1 hour before blood transfusion
measure: Cytokine
timeFrame: Between 2 to 4 weeks after blood transfusion
measure: Heme oxygenase
timeFrame: 1 hour before blood transfusion
measure: Heme oxygenase
timeFrame: Between 2 to 4 weeks after blood transfusion
measure: Lymphocyte typing
timeFrame: 1 hour before blood transfusion
measure: Lymphocyte typing
timeFrame: Between 2 to 4 weeks after blood transfusion
Secondary outcomes:
measure: Sex
timeFrame: 1 hour before blood transfusion
measure: Chronic or acute blood transfusion
timeFrame: 1 hour before blood transfusion
measure: Blood transfusion indication
timeFrame: 1 hour before blood transfusion
measure: Blood donor ethnicity
timeFrame: 1 hour before blood transfusion
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
city: Brussel
country: Belgium
facility: HUDERF
Study officials:
affiliation: CHU Brugmann
name: Marie Deleers, Ph Biol
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06634602: The Effect of Sports and Arts on Job Engagement Among Physicians
Official title: The Effect of Sports and Arts on Job Engagement Among Physicians: A Descriptive Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Job Engagement
Leisure Activities
Keywords: job engagement
dedication
concentration
leisure activities
healthcare professionals
Lead sponsor: Marmara University Pendik Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All resident physicians, specialist physicians, and academic staff actively working at Marmara University School of Medicine in Istanbul.

Brief summary: The goal of this observational study was to learn about the relationship between the sociodemographic characteristics or leisure time activities of physicians and their job engagement.

The main question it aims to answer was: Do sports or artistic activities increase job engagement among physicians? A survey was administered to physicians, to collect sociodemographic and professional characteristics (including sports and artistic activities), followed by a face-to-face application of the Utrecht Work Engagement Scale (UWES-17).


Eligibility criteria: Inclusion Criteria:

* All physicians who agreed to participate in the study were included.

Exclusion Criteria:

* Those who did not complete the questionnaires were excluded.

Primary outcomes:
measure: Evaluation of the Utrecht Work Engagement Scale (UWES-17) scores among physicians based on their engagement in sports activities
timeFrame: january 2024- april 2024
measure: Evaluation of the Utrecht Work Engagement Scale (UWES-17) scores among physicians based on their engagement in artistic activities
timeFrame: january 2024- april 2024
Secondary outcomes:
measure: Evaluation of the Utrecht Work Engagement Scale (UWES-17) scores among physicians based on their sociodemographic characterictics
timeFrame: january 2024- april 2024
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine
Study officials:
References:
citation: Verweij H, van Hooff MLM, van der Heijden FMMA, Prins JT, Lagro-Janssen ALM, van Ravesteijn H, Speckens AEM. The relationship between work and home characteristics and work engagement in medical residents. Perspect Med Educ. 2017 Aug;6(4):227-236. doi: 10.1007/s40037-017-0364-y.
citation: Solms L, van Vianen AEM, Theeboom T, Koen J, de Pagter APJ, de Hoog M; Challenge & Support Research Network. Keep the fire burning: a survey study on the role of personal resources for work engagement and burnout in medical residents and specialists in the Netherlands. BMJ Open. 2019 Nov 5;9(11):e031053. doi: 10.1136/bmjopen-2019-031053.
Clinical trial NCT03886402: Adipose-derived SVF for Treatment of Erectile Dysfunction (ED)
Official title: Use of Autologous Adipose-derived Stromal Vascular Fraction to Treat Erectile Dysfunction - A Safety and Feasibility Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Erectile Dysfunction
Lead sponsor: GID BIO, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-22
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, non-randomized, non-blinded, interventional, consecutive series, single site study
Primary purpose: TREATMENT

Brief summary: This study will examine the safety and feasibility of a single injection of autologous adipose-derived stromal vascular fraction to treat erectile dysfunction.


Eligibility criteria: Inclusion Criteria:

* history of ED of at least 3 months' duration
* have been taking a Phosphodiesterase type 5 (PDE5) inhibitor for at least 1 month prior and willing to stop taking any PDE5 inhibitor for duration of study
* have an IIEF-EF domain score that is ≥11 and ≤25
* have the same sexual partner for the duration of the study
* subject and partner willing to voluntarily give consent
* speak, read and understand English

Exclusion Criteria:

* non-responders to PDE5 inhibitor
* radical prostatectomy or other pelvic surgery or penile implant
* currently taking blood thinners, cancer drugs or HIV drugs
* allergic to lidocaine, epinephrine, valium
* diminished decision-making capacity
* use of tobacco
* previous pelvic or abdominal radiation therapy
* anti-androgen therapy
* untreated hypogonadism
* uncontrolled hypertension or hypotension
* unstable cardiovascular disease
* systemic autoimmune disorder

Primary outcomes:
measure: Adverse Events
timeFrame: 1 year
Secondary outcomes:
measure: International Index of Erectile Function (IIEF)
timeFrame: Pre-treatment, 30 days, 3 months and 6 months
Other outcomes:
measure: Partner Satisfaction Questionnaire
timeFrame: Pre-treatment and 30 days, 3 months and 6 months
Locations:
city: Charlotte
country: United States
facility: David Matthews MD
state: North Carolina
Study officials:
References:
Clinical trial NCT05966402: Evaluation of Immersion in Virtual Reality in the Management of Anxiety, Then Pain, of Patients in Interventional Imaging.
Official title: Evaluation of Immersion in Virtual Reality in the Management of Anxiety, Then Pain, of Patients in Interventional Imaging.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interventional Imaging
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Investigators propose to use static VR scenarios, adapted to the patient's preferences (sea, mountain, countryside...) to immerse them in an emotionally positive environment. The objective is to reduce the anxiety and pain associated with IR acts in the operating room.

Hypothesis tested:

The use of the 3D immersion of an oculus rift DK2 virtual reality headset during an interventional radiology intervention would reduce the anxiety felt by patients by 25%, evaluated by the STAI YB scale. The correlation between the STAI YB and the APAIS and HAD scales will also be tested.


Eligibility criteria: Inclusion Criteria:

* Patients (18-80 years old) with an indication for performing one of the following interventional radiology procedures, according to HAS recommendations: Liver biopsy puncture, embolization of varicoceles, embolization of pelvic varices, embolization of uterine fibroids, Hepatic arterial chemoembolization for hepatocellular carcinoma, radioembolization.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Minor or age \> 80 years.
* People suffering from psychiatric pathologies, chronic depressive syndrome or chronic anxiety disorder.
* People with a high risk of motion sickness during virtual reality immersion (MMSQ and VIMSSQ \> 80th percentile).

Primary outcomes:
measure: anxiety measured with STAI Y-B
timeFrame: once (as close as possible to the interventional gesture, i.e. just after it.)
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CAEN University Hospital
Study officials:
References:
Clinical trial NCT04849702: Comparison of the Clavien-Dindo and Comprehensive Complication Index
Official title: Comparison of the Clavien-Dindo and Comprehensive Complication Index Systems for Grading of Surgical Complications After Colorectal Resections.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication of Surgical Procedure
Colorectal Disorders
Clavien Dindo
Comprehensive Complication Index
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data of patients in which complications occurring after surgical procedures, performed between October 2012 and September 2013, were recorded.

Brief summary: Our aim was to compare 2 postoperative complication scoring systems in predicting length of hospital stay and in-hospital costs after colorectal resections.

Detailed description: Introduction: Postoperative complications are associated with prolonged hospital stay and rise in costs of treatment. The Comprehensive Complication Index (CCI) was developed as a scoring system that does not only take the most severe complication into account, but all complications after surgery. Our aim was to compare the Clavien-Dindo scoring system with the CCI in predicting length of hospital stay (LOHS) and in-hospital costs after colorectal resections.

Eligibility criteria: Inclusion Criteria:

* Only patients that underwent a colorectal resection were included

Exclusion Criteria:

-

Primary outcomes:
measure: Length of hospital stay
timeFrame: 1 year
measure: Total in-hospital costs
timeFrame: 1 year
Secondary outcomes:
measure: Length of ICU stay
timeFrame: 1 year
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
affiliation: Jessa hospital, Hasselt
name: Karel MC Smeyers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01770002: Eversion in Dermatologic Surgery: Is Cosmetic Appearance Improved?
Official title: Eversion in Dermatologic Surgery: Is Cosmetic Appearance Improved?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Basal Cell Carcinoma
Squamous Cell Carcinoma
Melanoma
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2013-01-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators hypothesize that everting wound edges while suturing surgical sites will result in more aesthetic scars. Additionally, we also hypothesize that small to moderate wound irregularities present at 3 months will resolve by 6 months after surgery with no intervention


Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Able to give informed consent themselves
* Willing to return for follow up visits

Exclusion Criteria:

* Mentally handicapped
* Unable to understand written and oral English
* Incarceration
* Under 18 years of age
* Unwilling to return for follow up
* Pregnant Women
* Wounds less than 3 cm in length

Primary outcomes:
measure: Everted versus non-everted suturing techniques
timeFrame: 3 and 6 months
measure: Mean score of sum of 2 blinded observers POSAS scores
timeFrame: 3 and 6 months
measure: Scar measurements (height, width, length)
timeFrame: 3 and 6 months
measure: Scar induration
timeFrame: 3 and 6 months
measure: Scar erythema
timeFrame: 3 and 6 months
measure: Wound contour irregularities
timeFrame: 3 and 6 months
measure: Stand cone volume
timeFrame: 3 and 6 months
measure: Uneven edge measurement
timeFrame: 3 and 6 months
measure: Hyperpigmentation area
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Infection
timeFrame: up to 6 months
measure: wound dehiscence
timeFrame: up to 6 months
measure: spitting sutures
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis, Department of Dermatology
state: California
Study officials:
affiliation: University of California, Davis
name: Daniel Eisen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03631602: Posaconazole vs Itraconazole in Preventing IFD Post-HSCT
Official title: Posaconazole Oral Suspension and Itraconazole Oral Solution in Preventing Invasive Fungal Disease (IFD) in Patients With Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: IFD Post-HSCT
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 120
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Invasive Fungal Disease (IFD) after haematopoietic stem cell transplantation (HSCT) remain a clinical challenge.The studay aims to compare the efficacy and safety of posaconazole oral suspension vs itraconazole oral solution in preventing IFD post-HSCT.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent Aged ≥13 years Patients undergoing hematopoietic stem cell transplantation. Cardiac: Left ventricular ejection fraction ≥ 50% Adequate renal and hepatic function Performance status: Karnofsky ≥ 70%

Exclusion Criteria:

* Pregnant or lactating females Any co-morbidity precluding the administration ofposaconazole or itraconazole

Primary outcomes:
measure: Incidence of breakthrough IFD
timeFrame: 1 year
Secondary outcomes:
measure: Overall survival
timeFrame: 1 year
measure: treatment-related mortality
timeFrame: 1 year
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References: