louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02841397: Validation of Noninvasive Hemoglobin, Comparison of PVI to Standard Methods, and Validation of Clinical Efficacy of ORI
Official title: Validation of a Pulse Oximetry Based Hemoglobin Measurement System. Comparison of Plethysmographic Variability Index to Standard Methods of Guiding Fluid and Transfusion Management in the Critically Ill Adult Patients. Validation of Clinical Efficacy of ORI for Supplemental Oxygen Titration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Surgery
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2016-07-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study goal is to establish the correlation of hemoglobin values determined by the noninvasive pulse oximetry-determined hemoglobin (SpHb) system with hemoglobin as measured by other validated devices. The study will also evaluation oxygen reserve index (ORI) to correlate with partial pressure of oxygen (PaO2), and to evaluate pleth variability index (PVI) with stroke volume variation (SVV) or pulse pressure variation (PPV) values.


Eligibility criteria: Inclusion Criteria:

* Admitted into the ICU
* Aged 18 years or older
* Mechanically ventilated
* Arterial line placed
* Vigileo/Flotrac System being used for guidance of fluid management

Exclusion Criteria:

* Pregnancy
* Prisoner status
* Extreme hemodynamic instability
* Multiple vasopressors in use with questionable peripheral blood flow
* Lack of appropriate sites for sensor placement
* Patient or patient's legal representative refusal

Primary outcomes:
measure: Noninvasive Pulse Oximetry-determined SpHb Bias
timeFrame: Duration of study participation is up to three days.
measure: Correlation of PVI Measurement Compared With PPV or SVV
timeFrame: Duration of study participation is up to three days.
measure: Correlation of "ORI" With Partial Pressure of Oxygen (PaO2) "PaO2" Measurement From Blood Gas Analysis
timeFrame: Duration of study participation is up to three days.
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
References:
Clinical trial NCT03422497: The Association of Sex With Guideline-based Perioperative Care in Hip Fracture Surgery
Official title: The Association of Sex With Provision of Guideline-based Perioperative Care for Hip Fracture Surgery Patients: a Population-based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fractures
Gender Bias
Surgery
Anesthesia
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 50000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Emergency hip fracture surgery patients

Brief summary: The investigators will use multilevel multivariable regression analysis to measure the association of sex with provision of guideline-based perioperative care for hip fracture surgery in Ontario.

Detailed description: In 2013, the Ontario Ministry of Health and Longterm Care published a 'Quality Based Procedures' guideline for care of hip fracture patients. The adjusted association of sex with receipt of 5 perioperative processes of care that can be accurately measured in health administrative data within this guideline will be investigated.

Eligibility criteria: Inclusion Criteria:

* Non-elective hospital admission
* Hip fracture diagnosis
* Hip fracture surgery

Exclusion criteria

-None

Primary outcomes:
measure: Perioperative geriatric medicine consult
timeFrame: Hospital admission to date of discharge from hospital, or 365 days after admission, whichever came first
Secondary outcomes:
measure: Preoperative anesthesiology consult
timeFrame: Hospital admission to date of surgery, or 365 days after admission, whichever came first
measure: Wait for surgery greater than 2 days
timeFrame: Hospital admission to date of surgery, or 365 days after admission, whichever came first
measure: Perioperative regional analgesia
timeFrame: Hospital admission to 3 days after surgery
measure: Neuraxial anesthesia
timeFrame: Day of surgery
Other outcomes:
Locations:
Study officials:
References:
citation: Cho N, Boland L, McIsaac DI. The association of female sex with application of evidence-based practice recommendations for perioperative care in hip fracture surgery. CMAJ. 2019 Feb 11;191(6):E151-E158. doi: 10.1503/cmaj.180564.
Clinical trial NCT03025997: Lipid Encapsulation for Ileal Brake Activation
Official title: The Effect of Orally Applied Encapsulated Lipids in Yoghurt on Satiety and Food Intake: a Randomized Single-blind Placebo-controlled Study With Cross-over Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetite Regulation
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Wageningen University and Research
First posted: 2017-01-20
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study evaluates the ability of encapsulation of orally applied lipids in a yoghurt snack to modify ad libitum food intake and satiety, without GI symptoms. Every subject receives two treatments (active, and placebo) on two different days, following a randomized cross-over design.


Eligibility criteria: Inclusion Criteria:

* BMI between 25-30 kg/m2
* Voluntary participation

Exclusion Criteria:

* Milk (-protein or lactose)- allergy/intolerance
* History of serious GI complaints/surgeries
* Pregnancy, lactation
* Excessive alcohol consumption (\>20 per week)
* Abnormal eating behaviour
* Intention to stop smoking
* Reported unexplained weight loss or gain in the month prior to screening
* Self-admitted HIV-positive state

Primary outcomes:
measure: ad libitum food intake
timeFrame: 2 hours after yoghurt snack
Secondary outcomes:
measure: Satiety feelings
timeFrame: Up to 3.5 hours on each of the 2 test days.
measure: occurrence and severity of GI symptoms
timeFrame: Up to 3.5 hours on each of the 2 test days.
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
affiliation: azM/UM
name: Adrian AM Masclee, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01714297: Preoperative Versus Postoperative Start With Thromboprophylaxis in THA (Total Hip Arthroplasty)
Official title: A Prospective Randomized, Double Blind Study to Evaluate Safety and Effect With Pre Versus Postoperative Start of Thromboprophylaxis With Dalteparin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthritis of the Hip
Transfusion Related Complications
Infection
Wound Discharge
Keywords: cemented total hip arthroplasty
blood loss
wound discharge
thromboprophylaxis
biomarkers
Lead sponsor: Martina Hansen's Hospital
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2012-10-25
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if there are differences in clinical events, i.e bleeding with associated morbidity, if thromboprophylaxis with LMWH (Low Molecular Weight Heparin) is initiated before or after surgery.


Eligibility criteria: Inclusion Criteria:

-patients 50 years or older undergoing cemented total hip arthroplasty for primary osteoarthritis

Exclusion Criteria:

* allergy to Low-Molecular-Weight -Heparin
* bleeding disorders
* renal failure
* hepatic disease
* active treatment for malignancy
* history of deep venous thrombosis or pulmonary embolism
* major operations,trauma,stroke or cardiac infarction the last 3 months before surgery.

Primary outcomes:
measure: total blood loss
timeFrame: during and after surgery
Secondary outcomes:
measure: transfusion requirements
timeFrame: during and after surgery
measure: incidence of bleeding events
timeFrame: during and after surgery
measure: other complications
timeFrame: during and after surgery
Other outcomes:
Locations:
city: Sandvika
country: Norway
facility: Martina Hansen's Hospital
state: Gjettum
Study officials:
affiliation: Oslo University Hospital
name: Olav Reikeras, MD, Phd
role: STUDY_CHAIR
References:
citation: Borgen PO, Dahl OE, Reikeras O. Blood loss in cemented THA is not reduced with postoperative versus preoperative start of thromboprophylaxis. Clin Orthop Relat Res. 2012 Sep;470(9):2591-8. doi: 10.1007/s11999-012-2320-9. Epub 2012 Apr 3.
Clinical trial NCT04156997: Extreme Lipids Repository
Official title: Extreme Lipids Repository
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lipoprotein Disorder
Keywords: Lipoproteins
Cholesterol
High Density Lipoproteins
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-11-08
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with lipid and metabolism disorders and up to 50 healthy volunteers (age 18 years or older) with a normal lipid metabolism.

Brief summary: This is a prospective, observational study to establish a repository of samples from patients with extreme lipid phenotypes including but not limited to hyperlipidemia, dyslipidemia, hyperlipoproteinemia, extreme low/high HDL levels and deranged lipoprotein metabolism. The investigators plan to conduct sophisticated composition and functional analyses as well as genetic analysis to better understand the determinants of extreme lipid derangements.

Detailed description: Participants will be recruited from clinical encounters within the University of Texas (UT) Southwestern Medical Center and Parkland Hospital by screening the Electronic Medical Record (EMR) for those with lipid labs and values that satisfy criteria for extreme values. Identified participants will be recruited to provide health information via survey, permission to extract clinical information from the EMR, and blood collection for future analyses. Measurements will span direct measurement of circulating species, genetic analyses, and analysis of circulating cells. The blood specimens will be stored for future studies and collaborations and thus, will constitute a blood-based repository. All study procedures are experimental but do not involve an actual intervention.

Eligibility criteria: Inclusion Criteria:

* adult patients (age 18 years or older) diagnosed with any lipid or metabolic disorder including hyperlipidemia, dyslipidemia, hyperlipoproteinemia, low HDL levels and deranged lipoprotein metabolism

Exclusion Criteria:

* Anyone under 18 years of age will be excluded from the study.

Primary outcomes:
measure: Biological sample collection for repository
timeFrame: Day 1
measure: Data collection for repository
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Health Hospital System
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center - Ambulatory Clinic
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Anand Rohatgi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00154297: Efficacy and Safety of Early Versus Delayed Administration of Everolimus in de Novo Renal Transplant Patients
Official title: A National Multicentre Randomized Study Comparing the Early Versus Delayed Administration of Everolimus in de Novo Kidney Transplant Recipients at Risk of Delayed Graft Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Transplantation
Keywords: Renal transplantation
everolimus
immunosuppressants
wound-healing
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate if the delayed administration of everolimus could reduce the everolimus associated "anti-proliferative complications" (e.g. wound healing disorder) while maintaining efficacy, when compared to the immediate administration of everolimus in de novo renal transplant patients.


Eligibility criteria: Inclusion Criteria:

* Recipients of cadaveric kidney transplants
* Patients at risk of DGF defined as one or more of the following:

  * Donor age \> 55 years
  * Cold ischemic time (CIT) ≥ 24 hours but \< 40 hours
  * Second or subsequent renal transplantation

Exclusion Criteria:

* Patients who have received an investigational drug within 4 weeks of baseline period
* Patients who are recipients of multiple organ transplants, including more than one kidney, or previous transplant with any organ other than kidney
* Patients with body mass index (BMI) \> 32 kg/m2

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months
timeFrame: Month 3
Secondary outcomes:
measure: Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation.
timeFrame: at 6 Month post-transplantation
measure: Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation.
timeFrame: at 12 Month post-transplantation
measure: Number of Participants Who Underwent Any Dialysis Within the 12-month Treatment Period
timeFrame: Month 12
measure: Duration of Dialysis
timeFrame: 12 months
measure: Number of Participants With Any Wound Healing Disorder During the 12-month Treatment Period
timeFrame: Month 12
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT03652597: Neuro-Cardiac-Guided Transcranial Magnetic Stimulation: Replication and Dose-response.
Official title: Neuro-Cardiac-Guided Transcranial Magnetic Stimulation: a Method to Probe the Depression Network. Replication and Dose-response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Target engagement
TMS
Heart-brain pathway
Depression
Neuromodulation
DLPFC
Heart rate
Lead sponsor: Utrecht University
Sponsor class: OTHER
Collaborators: name: Research institute Brainclinics
First posted: 2018-08-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Autonomic regulation is disturbed in patients with major depressive disorder (MDD), indicated by a higher heart rate (HR) and lower heart rate variability (HRV). Moreover, the heart seems to be functionally connected via the vagus nerve (VN) to other brain structures that are dysregulated in depression, such as the subgenual anterior cingulate cortex (sgACC), and the dorsolateral prefrontal cortex (DLPFC), suggesting dysregulated network function in MDD. In line with this network dysregulation hypothesis of MDD, optimal transcranial magnetic stimulation (TMS) sites are currently thought to be those that show functional connectivity to the sgACC such as the DLPFC and multiple studies have shown that stimulation of the DLPFC, sgACC and nervus vagus decreased heart rate, suggestive of parasymphatetic action. It is hypothesized that this influence on parasympathetic activity can be used as a functional outcome measure reflecting adequate targeting of the DLPFC-sgACC network, similar to the motor evoked potential (MEP) as functional key measure for primary motor cortex stimulation. Recently, a pilot study was conducted, proposing a new functional neuronavigation method for localizing the frontal area representation of DLPFC-sgACC connectivity using HR, called: Neuro-Cardiac-Guided TMS (NCG-TMS), which is being replicated in the current study. .


Eligibility criteria: Inclusion Criteria:

* Healthy
* Between ages 18-60

Exclusion Criteria:

* No prior experience with epilepsy
* No pregnancy
* No metal in the head
* No cochlear implants

Primary outcomes:
measure: Heart rate during stimulation, converted to RR intervals
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Research institute Brainclinics
state: Gelderland
Study officials:
affiliation: Research institute Brainclinics
name: Martijn Arns, Phd.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04968197: Vestibular Intervention Via Portable Electrical Stimulator (VIPES)
Official title: Vestibular Intervention Via Portable Electrical Stimulator (VIPES)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balance Disorder
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to develop a vestibular interventional approach using stochastic vestibular stimulation (SVS) through a small, lightweight device, and a comfortable electrode set on the back of the head that stimulates the vestibular system and produces immediate improvements in balance, gait, and overall vestibular function for patients will balance disorder.


Eligibility criteria: Inclusion Criteria:

* Participants must be able to consent to participate themselves.
* Must be able to attend in-person sessions at the Mayo Aerospace Medicine and - Vestibular Research Laboratory in Scottsdale, AZ.
* No racial/ethnic groups will be excluded.
* All participants must be fluent speakers of English.

Exclusion Criteria:

* Presence of peripheral vestibulopathy (cleared by Dix-Hallpike, vHIT as part of clinical evaluation).
* Women who are pregnant.
* Inability to complete testing (e.g., severe symptom burden, inability to stand unassisted).

Primary outcomes:
measure: Change in Balance Performance
timeFrame: Through study completion, approximately 1.5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Gaurav N Pradhan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01268397: Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly
Official title: Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly. A Randomized Comparison Between Operative Fixation and Plaster Cast Treatment.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fracture of the Distal Radius
Wrist Fracture
Keywords: elderly
wrist fracture
fracture of the distal radius
volar plate
plaster cast
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
Collaborators: name: Stockholm South General Hospital
First posted: 2010-12-30
Enrollment: 80
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine whether operation and fixation with a metal plate gives better result from the patient's perspective than plaster treatment in elderly patients with a displaced wrist fracture.

Detailed description: We will perform a prospective randomized clinical trial comparing open reduction and internal fixation with a volar plate with closed reduction and plaster treatment in elderly patients with a displaced Colles' fracture in order to test the null hypothesis that the patient-perceived result is equal after conservative or operative treatment. Secondary outcomes are objective physical measurements.

Eligibility criteria: Inclusion Criteria:

* Unilateral unstable dislocated dorsally angulated fracture of the distal radius (radial shortening ≥4 mm and/or dorsal angulation ≥20°).

Exclusion Criteria:

* Previous displaced fracture of the distal radius.
* Additional fractures of the upper extremities, an open fracture, terminal disease, patient not fit for surgery, unwilling or unable to co-operate with follow-up (advanced dementia (SPMSQ\<5), psychiatric illness, alcohol abuse).

Primary outcomes:
measure: patient-perceived disability measured by the PRWE and DASH questionnaires
timeFrame: one year after wrist fracture
Secondary outcomes:
measure: impairments (grip strength and range of motion compared with the uninjured wrist)
timeFrame: one year after wrist fracture
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Division of Orthopaedics Danderyd Hospital
Study officials:
affiliation: Karolinska Institute at Danderyd Hospital
name: Per Y Adolphson, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Sudow H, Severin S, Wilcke M, Saving J, Skoldenberg O, Navarro CM. Non-operative treatment or volar locking plate fixation for dorsally displaced distal radius fractures in patients over 70 years - a three year follow-up of a randomized controlled trial. BMC Musculoskelet Disord. 2022 May 12;23(1):447. doi: 10.1186/s12891-022-05394-7.