louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04256486: Family Model Diabetes Self-Management Education in Faith Based Organizations
Official title: Family Model Diabetes Self-Management Education in Faith Based Organizations
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Family Model
Marshallese
Pacific Islander
Diabetes Education
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2020-02-05
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: This study's objective is to conduct a cluster randomized control study that evaluates the effectiveness of F-DSME (Family Model Diabetes Self-Management Education) when delivered in a group setting in Marshallese Faith Based Organizations (FBO). The F-DSME has shown to be effective when delivered in patients' homes, and the proposed research will allow us to determine the F-DSME's effectiveness in a FBO setting.


Eligibility criteria: Inclusion Criteria:

* self-reported Marshallese
* 18 years of age or older
* have T2D (defined as having an HbA1c equal to or greater than 6.5)
* have at least one family member willing to take part

Exclusion Criteria:

* has received DSME in the past five years
* has a condition that makes it unlikely that the participant will be able to follow the protocol, such as terminal illness, non-ambulatory, severe mental illness, severely impaired vision or hearing, eating disorder
* plans to move out of the geographic region

Primary outcomes:
measure: Glycemic Control, Measured by Change in Adjusted Mean HbA1c(%) From Baseline at various time points
timeFrame: Baseline, Immediate Post-intervention, 6 Months Post-intervention, 12 Months Post-intervention, 18 Months Post-intervention, 24 Months Post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Springdale
country: United States
facility: UAMS Institute for Community Health Innovation
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Pearl McElfish, Phd, MDA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02454686: Fibroscan Predicts Complications After Hepatectomy
Official title: Role of Fibroscan in Predicting Complications After Hepatectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Neoplasms
Keywords: Complications after hepatectomy
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 240
Sex: ALL
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: A prospective cohort of patients scheduled for hepatectomy.

Brief summary: Most of the postoperative complications that may occur after hepatectomy are related to the underlying liver background, and the common preoperative tests do not completely predict such complications. Transient elastography by Fibroscan is used to calculate the stiffness and the steatosis of the liver, and it may be also used to predict postoperative complications after hepatectomy

Detailed description: A prospective cohort study on consecutive patients scheduled for hepatectomy was planned. Fibroscan was performed during the preoperative workup. Accuracy of the liver stiffness and steatosis measured by Fibroscan in predicting the presence of cirrhosis, of steatosis, and the development of postoperative complications was assessed by ROC curve, and multivariate analysis.

Eligibility criteria: Inclusion Criteria:

* Patients with primary and secondary tumors scheduled for hepatectomy at our Unit
* Written consent to get the Fibroscan during the preoperative workup

Exclusion Criteria:

* Refute to get the Fibroscan
* Loss of data

Primary outcomes:
measure: Accuracy of Fibroscan in predicting complication after hepatectomy
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Humanitas Research Hospital IRCCS, Rozzano-Milan
name: Guido Torzilli, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Donadon M, Fontana A, Palmisano A, Vigano L, Procopio F, Cimino M, Del Fabbro D, Torzilli G. Individualized risk estimation for postoperative morbidity after hepatectomy: the Humanitas score. HPB (Oxford). 2017 Oct;19(10):910-918. doi: 10.1016/j.hpb.2017.06.009. Epub 2017 Jul 22.
Clinical trial NCT03464786: A Clinical Study on the Efficacy and Safety of Lando® Absorbable Collagen Membrane in Oral Bone Repair
Official title: A Clinical Study on the Efficacy and Safety of Lando® Absorbable Collagen Membrane in Oral Bone Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Extraction
Lead sponsor: Shenzhen Lando Biomaterials Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Peking University
First posted: 2018-03-14
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, paralleled, control trial to validate the effectiveness and safety of Lando® absorbable collagen membrane for oral bone repair.


Eligibility criteria: Inclusion Criteria:

* 18\~65 years old;
* Subjects, whose single teeth (adjacent teeth intact) of incisor, canine or premolar is removed and bone graft is needed for alveolar ridge preservation, and need a delayed implant repair in more than 26 weeks.
* voluntary participation and sign on the informed consent form

Exclusion Criteria:

* Participated in other clinical trials in 90 days before joined in the trial
* Having received in 90 days before joined in the trial and / or will receive the head and neck radiation therapy or chemist during the study
* Having received in 90 days before joined in the trial and / or will receive any drug treatment that may affect bone metabolism;
* patients with heart disease;
* patients with abnormal liver and kidney function;
* poor diabetes control;
* low or abnormal immunity, anaphylaxis and the researchers judged to be of clinical significance;
* HIV infected patients;
* bleeding tendency or coagulation disorders and researchers judged to be of clinical significance;
* mental disorder;
* women who are pregnant or breast-feeding or preparing for pregnancy in the next 26 weeks;
* severe smokers;
* patients with periodontitis without basic periodontal treatment;
* the fracture of alveolar process after tooth extraction;
* The loss of bone wall on any side of alveolar fossa was more than 2/3.
* other cases that researchers believe not suitable for the participants of the trial

Primary outcomes:
measure: Change value of the width of alveolar ridge
timeFrame: 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Stomatological Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01453686: A Trial of Clobetasol Propionate Versus Hydrocortisone in Children With Alopecia Areata
Official title: A Randomized Controlled Trial of Clobetasol Propionate 0.05% Cream Versus Hydrocortisone 1% Cream in Children With Alopecia Areata
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alopecia Areata
Keywords: Alopecia Areata
Hydrocortisone
Clobetasol Propionate
Randomized Controlled Trial
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2011-10-18
Enrollment: 41
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of topical steroids in the treatment of alopecia areata in children is common practice. However, no particular potency of steroid is accepted as the standard treatment due to the paucity of high quality evidence in the dermatology literature to substantiate their use. Two randomized controlled trials exist assessing topical steroid efficacy in this disorder, both have methodological limitations. The question remains as to which topical steroid is safe and efficacious for use. We performed a double blinded controlled trial to assess the usefulness of a class 1 topical steroid (clobestasol proprionate 0.05%) compared with a class 7 topical steroid (hydrocortisone 1%) in children with alopecia areata.


Eligibility criteria: Inclusion Criteria:

* Age 2 to 16 years
* New patients presenting to The Hospital for Sick Children
* Clinical confirmation of alopecia areata
* Hair loss between 10 -75%

Exclusion Criteria:

* Skin or medical problems requiring use of oral steroids
* Immunosuppressants or PUVA for 4 weeks prior to the study
* Use of inhaled and or intranasal steroids for 14 days prior to trial
* Topical medicaments for 7 days prior to the trial

Primary outcomes:
measure: Change in scalp surface area affected over time
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in scalp surface area affected from baseline to end of study
timeFrame: 24 weeks
measure: Over 50% reduction in scalp surface area affected
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto, Canada
name: Colin Macarthur, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lenane P, Macarthur C, Parkin PC, Krafchik B, DeGroot J, Khambalia A, Pope E. Clobetasol propionate, 0.05%, vs hydrocortisone, 1%, for alopecia areata in children: a randomized clinical trial. JAMA Dermatol. 2014 Jan;150(1):47-50. doi: 10.1001/jamadermatol.2013.5764.
Clinical trial NCT04544163: Magnesium Versus High Dose Fentanyl in Endotracheal Intubation
Official title: Magnesium Versus High Dose Fentanyl in Attenuating Stress Response to Endotracheal Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Response
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this study is designed to assess the efficacy of MgSO4 versus high dose fentanyl compared to conventional anesthesia in attenuating stress response to intubation

Detailed description: to assess the effect of MgSO4 combined with fentanyl compared to high dose fentanyl in attenuating stress response in cancer patients undergoing surgeries under general anesthesia requiring endotracheal intubation

Eligibility criteria: Inclusion Criteria:

* Cancer patients undergoing surgery under general anesthesia requiring endotracheal intubation
* ASA I II
* 18 to 60

Exclusion Criteria:

* allergy to any of the used drugs
* renal or hepatic impairment
* hypertensive patients, patients with cardiovascular or cerebrovascular diseases

Primary outcomes:
measure: heart rate values
timeFrame: 5 minutes
Secondary outcomes:
measure: blood pressure
timeFrame: 5 minutes
measure: coughing during intubation
timeFrame: lntubation time
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Walaa Y Elsabeeny
Study officials:
affiliation: Lecturer
name: Walaa Y Elsabeeny, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer
name: Nahla N Shehab, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03431363: Medical Cannabis During Chemoradiation for Head and Neck Cancer
Official title: A Pilot Study to Assess the Role of Cannabis Added to the Supportive Care Regimen During Chemoradiation for Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Head and Neck Cancer
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 30
Sex: ALL
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: Patients with head and neck cancer that meet the eligibility criteria as described above

Brief summary: The primary purpose of the study is to observe the adherence and health seeking behavior of patients with Head and Neck cancer (HNC) certified to obtain medically certified cannabis as part of their supportive care regimen undergoing treatment with definitive or adjuvant concurrent chemoradiation (CRT).


Eligibility criteria: Inclusion Criteria:

* Patients must have histologically confirmed squamous cell carcinoma of the head and neck region planned for definitive or adjuvant treatment with concurrent radiation therapy and systemic therapy
* Patients may receive platinum-based chemotherapy or cetuximab concurrently with radiation therapy
* Age \>18 years and ECOG performance status \<2 (Karnofsky \>60).
* Patients must be willing to use medically certified cannabis as directed after study enrollment
* Patients must be able to read English, Spanish, or French fluently
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Prior diagnosis of cannabis use disorder as defined in the DSM-V
* Current opioid use disorder on maintenance opioid therapy
* Current active use of smoked cannabis or cannabis derivatives AND unwillingness to cease use of non-medically certified cannabis for the duration of study participation.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to cannabis derivatives
* Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Primary outcomes:
measure: Patients' adherence to registering for medically certified cannabis
timeFrame: Through study completion, an average of 12 months
measure: Patients' adherence to procuring medically certified cannabis
timeFrame: Through study completion, an average of 12 months
Secondary outcomes:
measure: Length of time for patients to obtain medically certified cannabis
timeFrame: Through study completion, an average of 12 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Rafi Kabarriti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05706363: Comparison of Two Graft Choices in Mediale Patellofemoral Ligament Reconstruction (MPFL)
Official title: Comparison of Two Graft Choices in Mediale Patellofemoral Ligament Reconstruction (MPFL) - A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patellar Dislocation
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 90
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Standard: Gracillis graft
2. Intervention: Quadriceps graft
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to elucidate surgical techniques for reconstructing MPFL in the treatment of chronic patella instability. The two techniques are conventional technique with the gracillis and screw fixation in the femur which is compared with new technique where the QT tendons and anchor fixation in the femur are used.

It would be investigated which technique provides the best stability with the least postoperative pain from the reconstruction and the lowest frequency of patellar reluxation.


Eligibility criteria: Inclusion Criteria:

* Patients between 15 and 40 years of age with chronic tendency to lateral patellar dislocation (defined as 2 or more verified dislocation cases)
* The growth zones must be found closed - verified by MRI scan

Exclusion Criteria:

* Patients with known rheumatoid arthritis.
* Patients with arthroscopically detected osteoarthritis (grade 3 cartilage lesion)
* Inability to follow a normal rehabilitation regime.
* Previous ligament surgery in injured knees.

Primary outcomes:
measure: Kujala (Anterior Knee Pain Scale)
timeFrame: 24 month
Secondary outcomes:
measure: Donor site morbidity score, 0=worst and 100=best
timeFrame: 24 month
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 24 month
measure: Lysholm-Tegner (Activity Score)
timeFrame: 24 month
measure: Numerical Rating Scale (NRS-pain score)
timeFrame: 24 month
measure: Knee pain
timeFrame: 24 month
measure: Patella Re-luxation sensation
timeFrame: 24 month
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Division of Sports Trauma, Palle Juul-Jensens Boulevard 99
Study officials:
References:
Clinical trial NCT00208663: Validation of an Instrument to Qualitatively and Quantitatively Profile Hospitalist Workflow
Official title: Validation of an Instrument to Qualitatively and Quantitatively Profile Hospitalist Workflow
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Physician Workflow
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physicians

Brief summary: The purpose of this study is to determine if a simple 'pick-list' menu applied to a handheld computer's time-motion program can be used to record reliably what a hospital-based doctor does while working a shift in the hospital. In this study reliability will be measured by comparing the data collected by at least two different observers recording data from the same hospitalist during the same period of time.

Detailed description: We were unable to configure the software to get started on this study.

Eligibility criteria: Inclusion Criteria:

* Must be a practicing hospitalist, defined as a physician working exclusively in a hospital settings

Exclusion Criteria:

* None

Primary outcomes:
measure: Elapsed time engaged in specific hospital work activities
timeFrame: 1 hospital workday
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory affiliated hospitals
state: Georgia
Study officials:
affiliation: Emory University
name: Jason M Stein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gillanders W, Heiman M. Time study comparisons of 3 intern programs. J Med Educ. 1971 Feb;46(2):142-9. doi: 10.1097/00001888-197102000-00005. No abstract available.
citation: Lurie N, Rank B, Parenti C, Woolley T, Snoke W. How do house officers spend their nights? A time study of internal medicine house staff on call. N Engl J Med. 1989 Jun 22;320(25):1673-7. doi: 10.1056/NEJM198906223202507.
citation: Parenti C, Lurie N. Are things different in the light of day? A time study of internal medicine house staff days. Am J Med. 1993 Jun;94(6):654-8. doi: 10.1016/0002-9343(93)90220-j.
citation: PAYSON HE, GAENSLEN EC Jr, STARGARDTER FL. Time study of an internship on a university medical service. N Engl J Med. 1961 Mar 2;264:439-43. doi: 10.1056/NEJM196103022640906. No abstract available.
Clinical trial NCT04988763: Challenges Faced By Neurophysiotherapist While Consultation Through Tele-rehabilitation
Official title: Challenges Faced By Neurophysiotherapist While Consultation Through Telerehabilitation Within Maharashtra State- A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Parkinson' s Disease, Neurological Impairments, Tele-rehabilitation
Lead sponsor: Mahatma Gandhi Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 103
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Neurophysiotherapist practicing within Maharashtra provenance

Brief summary: Being the most important stakeholder of such a vulnerable population, the neuro physiotherapist faced a lot of difficulties while consulting and assessing patients with neurological impairments. Up to our knowledge and search history, this is the first-ever study conducted by us which list out the challenges faced by neuro physiotherapist while teleconsultation mode among Indian population.

Detailed description: During the ongoing Covid-19 pandemic many Neurophysiotherapist opted for telerehabilitation to provide rehabilitation to the patients. This study aims to find out challenges faced by Neurophysiotherapist (NeuroPT) for consultation through telerehabilitation within Maharashtra provenance. A total of 103 NeuroPT within Maharashtra provenance were contacted through this online survey. A brief, structured and validated questionnaire was constructed as there is no gold standard questionnaire developed to obtain responses from the neuro physiotherapists opting for telerehabilitation mode for their consultations with their clients. The questionnaire was sent by What's app and email to gather basic information to describe the various challenges in consultation through telerehabilitation.

Eligibility criteria: Inclusion Criteria:- A cross-sectional study was carried out to obtain the responses from the neuro physiotherapist practicing within Maharashtra provenance.

Exclusion Criteria:

* Neurophysiotherapist practicing outside of Maharashtra provenance

Primary outcomes:
measure: Consultation Questionnaire
timeFrame: 1 Week
Secondary outcomes:
Other outcomes:
Locations:
city: Aurangabad
country: India
facility: MGM School Of Physiotherapy
state: Maharashtra
Study officials:
affiliation: MGM School Of Physiotherapy, Aurangabad
name: Nawaj M Pathan, MPT
role: STUDY_DIRECTOR
References: