louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06668870: Electronic Health Record-Integrated Patient-Generated Data
Official title: Electronic Health Record-Integrated Patient-Generated Data to Support Clinical Care and Research
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sepsis
Keywords: patient-generated data collection
electronic health record monitoring
transitional care
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2024-11-01
Enrollment: 200
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 purpose of this study is to find out if patients that receive supportive messaging with response adaptation are more likely to adhere to patient-generated data collection and electronic health record integration, compared to patients that do not receive supportive messaging.

Detailed description: This project will directly inform re-usable strategies to support the integration of important patient-generated data (PGD) into the electronic health record to improve clinical care and research. For this application, investigators propose to develop and test the PGD translational science innovation in patients recovering from sepsis. This diverse patient population frequently suffers from long-term complications that are ideally suited for development and demonstration of strategies to collect, integrate, and examine PGD and builds directly on the study team's robust research portfolio on improving sepsis recovery.

Eligibility criteria: Inclusion Criteria:

* Discharged alive from the hospital without hospice care who meet clinical criteria for infection and organ dysfunction consistent with sepsis
* Enrolled into the Sepsis Transition and Recovery program
* Enrolled or willing to enroll as an Epic MyChart user

Exclusion Criteria:

* Discharged from the hospital with hospice care

Primary outcomes:
measure: Proportion of Completed Versus Requested Patient-Generated Data
timeFrame: 90 days post hospital discharge
Secondary outcomes:
measure: Number of Readmissions
timeFrame: 90 days post hospital discharge
measure: Number of Deaths
timeFrame: 90 days post hospital discharge
measure: Number of Emergency Department Visits
timeFrame: 90 days post hospital discharge
measure: Number of Outpatient Clinic Visits
timeFrame: 90 days post hospital discharge
measure: Number of Hospital-Free Days
timeFrame: 90 days post hospital discharge
Other outcomes:
Locations:
Study officials:
affiliation: Atrium Health Wake Forest Baptist
name: Marc Kowalkowski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02350270: Gait, cOgnitiOn & Decline (GOOD)
Official title: Gait, cOgnitiOn & Decline (GOOD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mild Cognitive Impairment
Mild Dementia
Moderate Dementia
Healthy
Keywords: cognitively healthy individuals
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Biomathics
First posted: 2015-01-29
Enrollment: 2800
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were recruited in each memory clinic by a physician

Brief summary: The main objective of the GOOD initiative was to determine which spatio-temporal gait parameters and/or combination(s) of spatio-temporal gait parameters best differentiate between cognitively healthy individuals (CHI), patients with mild cognitive impairment (MCI) and those with mild and moderate dementia.

Detailed description: Gait disorders are frequent in individuals with cognitive disorders. However, the profile of spatio-temporal gait parameters in the different cognitive status in aging (from normal cognition to dementia) has been poorly studied. Determining this profile associated with the severity of cognitive disorders may be helpful to understand the complex interplay between gait and cognitive disorders and, thus, may have important implication for the diagnosis process of patients with and without dementia. For instance, defining a motor phenotype of the severity of cognitive disorders by using quantitative gait measurements could be used to improve the prediction and the diagnosis of dementia.

The investigators hypothesized that, compared to CHI, people with MCI and mild dementia could be characterized by specific phenotypes of spatio-temporal gait parameters measured with the GAITRite® system, and that these profiles could be explained by declines in domain-specific cognitive performance.

Eligibility criteria: Inclusion Criteria:

* Being 60 years old and older
* Ability to answer questions

Exclusion Criteria:

* Opposition to the use of information collected for research purposes

Primary outcomes:
measure: Spatio-temporal gait parameters
timeFrame: This outcome is assessed at inclusion
Secondary outcomes:
measure: Clinical assessment
timeFrame: This outcome is assessed at inclusion
measure: Cognitive status
timeFrame: This outcome is assessed at inclusion
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
Study officials:
affiliation: Angers University Hospital
name: Olivier Beauchet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01724970: Laryngeal Masks for Bariatric Surgery
Official title: A Randomized Comparative Study on Proseal LMATM and Supreme LMATM for Bariatric Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Morbid Obesity
Keywords: anesthesia
postanesthetic recovery
ventilation
bariatric surgery
Lead sponsor: University of Padova
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera di Padova
First posted: 2012-11-12
Enrollment: 80
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: Obese people pose specific problems as far as the management of airway during surgery. The study aims to compare efficacy and safety of two LMA devices.

Detailed description: The study will investigate two types of LMA devices endowed of different constructive features. The two devices share common features as far as providing access to the stomach and reducing morbidity of the upper airway. The two device differ in regard to ease of insertion and sealing of the airway and these features are particularly important in the obese patient.

Eligibility criteria: Inclusion Criteria:

* ASA class I-III
* candidates to bariatric surgery

Exclusion Criteria:

* uncontrolled psychiatric symptomatology
* known or presumed pregnancy
* history of surgery on the airway or esophagus
* gastroesophageal reflux

Primary outcomes:
measure: oropharyngeal leak pressure
timeFrame: intraoperatively, up to 3 hours
Secondary outcomes:
measure: total anesthetic and analgesic drug dosages
timeFrame: intraoperatively and postoperatively, up to 24 hours from end of surgery
measure: pulse oximetry saturation
timeFrame: intraoperatively and postoperatively, up to 24 hours from end of surgery
measure: time to post-anesthetic discharge scoring system (PADSS) > 8
timeFrame: in PACU up 72 hours
measure: EKG monitoring
timeFrame: postoperatively up to 72 hours
measure: satisfaction of the surgeon (ad hoc questionnaire)
timeFrame: day 1
measure: satisfaction of the patient (Iowa Satisfaction with Anesthesia Scale)
timeFrame: day 1
measure: gastric distension
timeFrame: intraoperatively up to 3 hours
measure: levels of pain and nausea (Visual Analogue Scale)
timeFrame: postoperatively up to 24 hours
measure: metilen's blue
timeFrame: before end of surgery up to 3 hours
measure: total dosage of analgesic and antihemetic drugs
timeFrame: intra and postoperatively up to 24 hours
Other outcomes:
measure: insertion time
timeFrame: up to 10 minutes
Locations:
city: Padua
country: Italy
facility: University of Padua
state: PD
Study officials:
affiliation: University of Padova
name: Michele Carron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01381770: Platelet-derived Factors for Treatment of Muscular Lesions
Official title: Platelet-derived Factors for Treatment of Muscular Lesions: a Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Muscle Lesions
Keywords: muscular lesions grade 2
muscular lesions grade 3
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate that platelet-derived repairing factors are effective and safe in the treatment of muscular lesion grade 2 or 3, a Phase II, open-label, single arm, single centre has been designed. Sample size will be 25.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years old
* if woman, no pregnancy ongoing
* muscular lesion grade 2 or 3 in a lower limb muscular group

Exclusion Criteria:

* no hematological conditions
* no anticoagulation in the two preceding weeks

Primary outcomes:
measure: number (and proportion with 95% CI) of patients able to return to sport activity (i.e. training) at 21 days from muscular injury.
timeFrame: 21 days from enrollment
Secondary outcomes:
measure: Time-to-return to sport activities
timeFrame: within 4 months from lesion
measure: Side effects
timeFrame: within 4 months from treatment
measure: time-to-healing at ultrasound
timeFrame: within 4 months from treatment
measure: side effects
timeFrame: within 4 months from treatment
measure: side effects
timeFrame: within 4 months from treatment
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Clinica Ortopedica Fondazione IRCCS Policlinico San Matteo
Study officials:
References:
Clinical trial NCT00466570: Prospective Randomized Comparison of Zymar(Gatifloxacin) and Vigamox (Moxifloxacin) in Killing Conjunctival Bacterial Flora Following a One-hour Application
Official title: Prospective Randomized Comparison of Zymar(Gatifloxacin) and Vigamox (Moxifloxacin) in Killing Conjunctival Bacterial Flora Following a One-hour
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Conjunctical Flora
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2007-04-27
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Topical ophthalmic antibiotics are common prescribed just prior to eye surgery to lower the risk of infection. Previous studies have suggested that antibiotics containing a preservative (Zymar) kill bacteria much quicker than those without a preservative (Vigamox). The purpose of this research is to compare how quickly to the two commonly prescribed antibiotics eliminate bacteria from the eye surface.


Eligibility criteria: Inclusion Criteria:

* Age- older than 50 years of age
* Diagnosis- Cataract or had cataract surgery

Exclusion Criteria:

* Systemic or topical antibiotic treatment within 30 days
* Use of systemic or topical steroids
* Active ocular infection
* Ocular surgery in the past 6 months
* Allergy to fluoroquinolones

Primary outcomes:
measure: Antibiotic killing of conjunctival bacterial flora 1 hour after application
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Christopher Ta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ta CN, He L, Nguyen E, De Kaspar HM. Prospective randomized study determining whether a 3-day application of ofloxacin results in the selection of fluoroquinolone-resistant coagulase-negative Staphylococcus. Eur J Ophthalmol. 2006 May-Jun;16(3):359-64.
citation: Mino de Kaspar H, Koss MJ, He L, Blumenkranz MS, Ta CN. Antibiotic susceptibility of preoperative normal conjunctival bacteria. Am J Ophthalmol. 2005 Apr;139(4):730-3. doi: 10.1016/j.ajo.2004.10.007.
citation: de Kaspar HM, Kreidl KO, Singh K, Ta CN. Comparison of preoperative conjunctival bacterial flora in patients undergoing glaucoma or cataract surgery. J Glaucoma. 2004 Dec;13(6):507-9. doi: 10.1097/01.ijg.0000137872.19942.cf.
citation: Ta CN, Chang RT, Singh K, Egbert PR, Shriver EM, Blumenkranz MS, Mino de Kaspar H. Antibiotic resistance patterns of ocular bacterial flora: a prospective study of patients undergoing anterior segment surgery. Ophthalmology. 2003 Oct;110(10):1946-51. doi: 10.1016/s0161-6420(03)00735-8.
citation: Ta CN, Egbert PR, Singh K, Shriver EM, Blumenkranz MS, Mino De Kaspar H. Prospective randomized comparison of 3-day versus 1-hour preoperative ofloxacin prophylaxis for cataract surgery. Ophthalmology. 2002 Nov;109(11):2036-40; discussion 2040-1. doi: 10.1016/s0161-6420(02)01236-8.
Clinical trial NCT05104970: Comparative Pharmacokinetics of Two Different Oral Delivery Systems of Cholecalciferol
Official title: Comparative Pharmacokinetics of Two Different Oral Delivery Systems of Cholecalciferol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Vitamin D Deficiency
Keywords: Vitamin D
Lead sponsor: Scotmann Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Rawalpindi Medical College
First posted: 2021-11-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to adapt the gold standard of research and to explore the comparative bioavailability and clinical efficacy of the two most commonly used forms of Cholecalciferol i.e. ampoules and softgel capsules.

Detailed description: Deficiency of Vitamin D is highly prevalent in all sectors and regions of Pakistan. Its effects encompass multiple pluripotent physiological impacts on human body, including its classical action on bone health and immune modulation. Health care workers are routinely prescribing supplementations to correct the deficiencies. Different forms of Cholecalciferol are available in the market. It ranges from absorba liquids, drops, tablets, softgels to injectable and oral ampoules. Different delivery systems offer different advantages, challenges and efficacies specific to their specific pharmacokinetics. The aim of this study is to adapt the gold standard of research and to explore the comparative bioavailability and clinical efficacy of the two most commonly used forms of Cholecalciferol i.e. ampoules and softgel capsules.

Eligibility criteria: INCLUSION CRITERIA:

1. Adult (20-70 years of age)
2. Vitamin D deficiency (serum 25(OH)D \< 20 ng/ml)
3. Permanent employees of Medicine ward of Holy Family Hospital, DHQ, BBH hospitals and RMU for easy follow up throughout the study duration
4. Willingness and availability to show-up in the follow up visit and serum testing throughout the study period as needed

EXCLUSION CRITERIA:

1. Vitamin D sufficiency or moderate deficiency (serum 25(OH)D \> 20 ng/ml)
2. Pregnant ladies
3. Participants already taking Vitamin D supplementation, anti-convulsants, barbiturates or steroids
4. Subjects with granulomatous conditions, liver disease, kidney disease, or diabetes

Primary outcomes:
measure: Area Under Curve (AUC)
timeFrame: 70 days
Secondary outcomes:
measure: Serum 25(OH)D level
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Rawalpindi Medical College
name: Muhammad Umar, MBBS,FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01550770: Exploratory Study of Propofol and Fentanyl Pharmacodynamics
Official title: An Open Label, Exploratory Study of Propofol and Fentanyl Pharmacodynamics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: General Anesthesia
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2012-03-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Exploration of the hypothesis that general anesthesia is not a singular threshold but is a continuum of central nervous system depression dependent on interpretation of nociceptive stimuli.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesia (ASA) classification score I-II male and female volunteers
* Normal healthy individual by medical history and physical examination
* Uncomplicated airway anatomy
* Body Mass Index (BMI) between 18-29
* Subject willing to give consent and comply with evaluation and treatment schedule
* 18-55 years of age (inclusive)
* Negative durg screen for marijuana, cocaine, ecstasy, phencyclidine (PCP), amphetamines, benzodiazepines, opiates and methamphetamines
* Woman of childbearing age byst be utilizing reliable means of contraception
* Able to read, speak and understand English

Exclusion Criteria:

* Physical of psychological condition which would impair study participation as determined by the principal investigator
* Known or suspected neurological pathologies as assessed by the principal investigator
* History of significant alcohol or drug abuse, a history of allergy to opioids or propofol, or a history of chronic drug requirement or medical illness that is known to alter pharmacokinetics or pharmacodynamics of fentanyl and/or propofol
* Known or suspected hypersensitivity to any study drug
* Taken any medication within 2 days prior to study drug administration, with the exception of oral contraceptives
* Baseline tolerance above 50 mA on TES
* Pregnancy or lactation
* Consumed food within 8 hours or liquids within 4 hours prior to study drug administration
* Participation in any other investigational device or durg study within 30 days of enrollment
* Diagnosis of sleep apnea
* Current prescription to anti-depressant or anti-anxiety medication

Primary outcomes:
measure: Difference between Modified Observers Assessment of Alertness (MOAAS) and transdermal electrical stimulation (TES)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Talmage Egan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02928770: A Disposable Device NAS to Treat Obstructive Sleep Apnea and Snoring
Official title: A Disposable Device NAS to Treat Obstructive Sleep Apnea and Snoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Snoring
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Seven Dreamers Laboratories
First posted: 2016-10-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to test a new approach for treating patients with obstructive sleep apnea and/or snoring. The new nasal device, nastent (NAS: nasal airway stent), appears to be a useful alternative or additive treatment.

Detailed description: The nasal stent basically helps to splint the soft palate open. Subjects have a baseline (diagnostic) sleep study without wearing the device. Subjects are then fitted with the device and then subjects wear the device for at least 7 nights during their sleep while at home. Subjects then return for a repeat in-laboratory sleep study while wearing the device. The primary outcome is to assess the effectiveness of the device by change in the apnea-hypopnea index (number of sleep-related abnormal breathing events per hour of sleep) while wearing the device compared to baseline.

Eligibility criteria: Inclusion Criteria:

* Adults that are 18 years of age or older who had a prior sleep-study within the past 6 months that confirmed a diagnosis of obstructive sleep apnea, and with body mass index less than 30 kg/m2.

Exclusion Criteria:

* Children, pregnant women, homeless, economically disadvantaged individuals, and those who are unable to comprehend or understand English, or follow instructions were excluded. Persons with body mass index equal or greater than 30 kg/m2 were excluded.

Primary outcomes:
measure: Apnea-Hypopnea Index (AHI)
timeFrame: In-lab sleep study obtained at least 7 nights following use of the device at home
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Sleep Medicine
state: California
Study officials:
affiliation: Stanford University
name: Clete A Kushida, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03067870: Transplantation of Autologous Bone Marrow Derived Stem Cells in Patients With Rheumatoid Arthritis
Official title: Transplantation of Autologous Purified Bone Marrow Derived Specific Populations of Stem Cells and Mesenchymal Stem Cells in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: RheumatoId Arthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Keywords: Stem cells
Rheumatoid arthritis
Lead sponsor: Stem Cells Arabia
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 100
Sex: ALL
Minimum age (years): 17
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Rheumatoid arthritis is a chronic systemic disease, which is characterized by chronic inflammation in the synovial tissue. Rheumatoid arthritis ultimately results in the destruction of cartilage, bone and ligaments and joint deformity. The underlying hypothesis is that autologous bone marrow-derived mesenchymal and specific populations of stem cells has anti-inflammatory and regenerative effects and thus potentially alleviates the progression of rheumatoid arthritis. The study is to explore the safety and efficacy of BM-SC transplantation in treatment of rheumatoid arthritis.

Detailed description: Rheumatoid arthritis (RA) is a chronic autoimmune disorder that primarily affects joints. It typically results in swollen and painful joints. Pain and stiffness often worsen after rest. Most frequently, the wrist and hands are involved, with the same joints typically involved on both sides of the body. RA affects between 0.5-1% of adults in the developed world with between 5-50 per 100,000 people newly developing the disease each year. Onset is most frequent during middle age and women are affected 2.5 times as frequently as men. The goal of treatment is to reduce pain, decrease inflammation, and improve a person's overall functioning and quality of life.

Herein, the investigators study the safety and efficacy of the immunomodulatory effects of bone marrow-derived stem cells administered intravenously and the regenerative and repair potential of bone marrow-derived stem cells transplanted into the joints of patients with RA.

Eligibility criteria: Inclusion Criteria:

* 17-75 years old
* The presence of osteoarthritis based on MRI and American Rheumatism Association criteria since 6 months before treatment.

Exclusion Criteria:

* Subjects with addition major health condition/disease diagnoses
* Subjects that are pregnant or breastfeeding

Primary outcomes:
measure: Evaluation of Pain Reduction measured by VAS scaling
timeFrame: 1 month
Secondary outcomes:
measure: Evaluation of the Physical Activity measure by WOMAC scoring
timeFrame: 1 month
measure: Evaluation the resurfacing of articular cartilage by MRI
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: