louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00875290: The Effectiveness of Continuous Glucose Monitoring in Diabetes Treatment for Infants and Young Children
Official title: Gerber Pump Trial: Effectiveness of Continuous Subcutaneous Insulin Infusion (CSII) and Real-Time Sensor Augmentation (RTSA) in 0-3 Years Old Diabetes Patients; A One Year Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetes Mellitus, Type I
Keywords: Diabetes Mellitus, Type I
Children
Insulin pump therapy
Continuous glucose monitor
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: The Gerber Foundation
name: Medtronic
First posted: 2009-04-03
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if the use of a real-time glucose sensor improves diabetes control in young children (less than 4 years old) with Type I diabetes when they are initiated on insulin pump therapy.

Detailed description: A randomized controlled clinical trial involving patients 0-3 yrs old with type 1 diabetes. After successful screening the subjects will be randomized into one of two groups: a CSII group alone and a CSII group + Real Time Sensor Augmentation group (RTSA) group. The CSII group will serve as the control for the CSII+RTSA group. The trial will last for one year.

Eligibility criteria: Inclusion Criteria:

* Children less than 4 years of age with Type I diabetes for at least 3 months

Exclusion Criteria:

* Children greater than 4 years of age
* Monogenic diabetes

Primary outcomes:
measure: Reduce blood glucose variability among 0-3 year old children with type I diabetes.
timeFrame: 1 year
Secondary outcomes:
measure: Number of adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Patricia Fechner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00298090: Evaluation of a Radial Arterial Line's Effect on StO2 Monitoring
Official title: An Evaluation of a Radial Arterial Line's Effect on StO2 Monitoring Using the InSpectra® Tissue Spectrometer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxygenation
Keywords: Oxygenation
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2006-03-01
Enrollment: 47
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: ICU patients wiht arterial lines

Brief summary: Measuring tissue oxygen saturation (St02) in the thenar eminence is emerging as a measurement of resuscitation. However, no study to our knowledge has evaluated the effects of an arterial line in the radial artery supplying this muscle bed on St02. This study will attempt to address the interaction between an arterial line and St02 monitoring in the thenar eminence. As most patients who require aggressive resuscitation will have an arterial line, it is important to understand what if any impact this will have on St02 in the same extremity.


Eligibility criteria: Inclusion Criteria:

* Standard of care placement of arterial line
* 18 years of age or older

Exclusion Criteria:

* Pregnant females
* Nursing mothers
* Prisoners

Primary outcomes:
measure: Tissue Oxygen Saturation (StO2) Measurement on the Extremity With a Radial Arterial Line
timeFrame: up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University Hospital
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Lopez P Peter, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02509390: Hyperfibrinogenemia After Major Trauma
Official title: Hyperfibrinogenemia Within the First Days After Major Trauma : Kinetic, Functionality, Impact of Fibrinogen Replacement Therapy and Trauma, Thrombosis Risk
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Trauma
Keywords: Fibrinogen level
Hyperfibrinogenemia
Trauma
Thrombosis risk
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2015-07-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Assessment of the evolution of fibrinogen plasma level within the first ten days after major trauma in order to determine prevalence of hyperfibrinogenemia (Fg \> 4 g/L) and its time to onset.

Detailed description: In this study, investigators daily investigate fibrinogen plasma levels and fibrinogen antigen in severe trauma patients (Injury severity score \> 15) within the first ten days. Investigators then modelize hyperfibrinogenemia profiles according to severity of injuries and physiopathologic mechanisms. Finally, investigators determine predisposing risk factors to develop hyperfibrinogenemia and assess the impact of fibrinogen replacement therapy in initial phase of management of major trauma.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years old.
* Polytrauma with ISS Score \> 15
* Hospitalized patients in reanimation unit \< 4h after trauma
* Informed consent

Exclusion Criteria:

* Patients in another study
* Pregnant or lactating women

Primary outcomes:
measure: daily fibrinogen level >4 g/L
timeFrame: 10 days
Secondary outcomes:
measure: assessing predisposing risk factors of hyperfibrinogenemia (> 4 g/l)
timeFrame: 10 days
measure: plasmatic fibrinogen level evolution
timeFrame: 10 days
Other outcomes:
Locations:
city: Montpellier Cedex 5
country: France
facility: Department of Anesthesiology and critical care, Lapeyronie University Hospital
Study officials:
affiliation: Regional Trauma Center, Department of Anesthesiology and critical care, Lapeyronie University Hospital, Montpellier
name: Pauline PD DERAS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01361490: Rehabilitating Overweight People Back to Working Life
Official title: Rehabilitating Overweight People Back to Working Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2011-05-26
Enrollment: 405
Sex: ALL
Minimum age (years): 19
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese people where the obesity is the reason they are not actively taking part in working life.

Brief summary: Obesity may have implications on the individual's participation in working life through different mechanisms such as comorbidity and loss of functional level. The investigators also know that when exiting the working force, it is difficult to get back later. As rehabilitation back to working life is often not a very focused aim with weight loss treatment, this study sets this as a primary aim by involvement in a 4 week stay at a rehabilitation clinic followed by 48 weeks work practice programme at one of three different companies.


Eligibility criteria: Inclusion Criteria:

* BMI 30-47
* 19-67 years

Exclusion Criteria:

* Pregnancy
* Significant reduced physical function
* Drug use
* Serious mental illness

Primary outcomes:
measure: Participation in working life
timeFrame: 4 years
Secondary outcomes:
measure: Body weight
timeFrame: 4 years
Other outcomes:
Locations:
city: Valldal
country: Norway
facility: Muritunet Rehabiliteringssenter
Study officials:
affiliation: Norwegian University of Science and Technology
name: Bård Kulseng, phd prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT01304290: Glucose/Insulin Clamp on Solid Organ Transplant (Liver, Kidney, Pancreas and Heart) on Cadaveric Donors
Official title: Glucose/Insulin Clamp on Solid Organ Transplant (Liver, Kidney, Pancreas and Heart) on Cadaveric Donors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complication of Transplanted Organ, Nos
Keywords: inflammatory process
hyperglycaemia
inflammatory cytokine response
organ survival
hyperinsulinemic clamp
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2011-02-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Our objective in this study will be to determine if implementing the glucose/insulin clamp (GICT) on cadaveric organ donors can:

* Prevent hyperglycaemia
* Drop in the inflammatory cytokine response after brain death after a minimum of 6 hours therapy with the GICT prior to organ procurement.
* Assess organ (heart, liver, pancreas and kidney) survival at one year post-transplant
* Assess graft function by evaluating:

  * Liver: post-transplant liver function score (PTLF)
  * Kidney: graft function as defined by UNOS (immediate graft function IGF, slow graft function SGF and delayed graft function DGF and
  * Pancreas: 7 day post-transplant insulin requirement, C-peptide and C-RP levels at day one and seven post-transplantation


Eligibility criteria: Inclusion Criteria:

* Donors must be over 18 years of age
* Brain death donors only
* Getting consent prior to any specific protocol procedure under Transplant Quebec regulations.

Exclusion Criteria:

* Inability to obtain a research consent
* Time interval between the start of the study and cross-clamping less than 6 hours.
* No solid organs retrieved for transplantation
* Diagnosed with Type 1 Diabetes
* Donor has uncontrolled serum blood glucose levels (above 10 mmol/L) at time of inclusion

Primary outcomes:
measure: • Drop in the inflammatory cytokine response after brain death after a minimum of 6 hours therapy with the GICT prior to organ procurement.
timeFrame: during transplant
Secondary outcomes:
measure: Assess organ (heart, liver, pancreas and kidney) survival at one year post-transplant
timeFrame: 1 year post-transplant
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Dr. Peter Metrakos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01076790: Dexmedetomidine-propofol-remifentanil Anaesthesia and Reactivity to Noxious Stimuli
Official title: The Effect of Dexmedetomidine on Reactivity to Noxious Stimuli During Propofol-remifentanil Anaesthesia and Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anaesthesia
Keywords: Nociception
Dexmedetomidine
Electroencephalogram
Electromyogram
Entropy Index
Bispectral Index
Electrocardiogram
Plethysmogram
Heart
Heart rate
Heart rate variability
Surgery
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2010-02-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Dexmedetomidine acts at central nervous system (specifically: at locus caeruleus), providing sedative and analgesic effects. It is widely used in intensive care. Surgery-related interventions elicit arousal ('nociceptive') reactions. The effects of dexmedetomidine on the neurophysiological signs of arousal are studied in surgical patients. Brain waves, electrocardiogram, Entropy Index, Bispectral Index, and fingertip pulse waves are recorded and analyzed later on. The course of anaesthesia and surgery are recorded.

Detailed description: The patients are randomized to receive either dexmedetomidine or saline infusion before and during anaesthesia (dexmedetomidine 0.1 mcg/kg within 10 minutes, thereafter 0.7 mcg/kg/h until 30 min after skin incision).

Multi-channel EEG, Entropy, BIS, multi-channel EMG, ECG, and plethysmogram are recorded on computer. Anaesthesia and surgery associated events are annotated on computer.

Time points of endotracheal intubation, skin incision, and course of surgery well be analyzed in detail. Additionally, tetanic stimulus of ulnar nerve will be applied for each patient, and reactions to the stimulus will be analyzed.

Eligibility criteria: Inclusion Criteria:

* males or females giving informed consent
* age range 18-70 years
* elective surgery: laparoscopy, laparotomy, breast surgery
* general anaesthesia
* ASA classification 1 or 2

Exclusion Criteria:

* pregnancy
* body mass index 30.1 or more
* diseases affecting CNS, autonomic nervous system, heart, heart rate, or circulation
* chronic use of drugs affecting CNS, autonomic nervous system, heart, heart rate, or circulation; except antihypertensives, which are acceptable in this study
* chronic use of clonidine
* serious psychiatric disease or condition
* overuse of alcohol
* use of illicit drugs
* unability of understand, read or use Finnish language

Primary outcomes:
measure: Physiological reaction to noxious stimulus
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Arvi Yli-Hankala, MD
role: STUDY_CHAIR
affiliation: Tampere University Hospital
name: Arvi Yli-Hankala, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05771090: First Clinical Evaluation of a Novel Glucose Non-invasive Sensor Technology in Patients With Type 1 Diabetes
Official title: First Clinical Evaluation of a Novel Glucose Non-invasive Sensor Technology in Patients With Type 1 Diabetes: a Single-arm Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Volatile Organic Compounds
Hypoglycaemia
Lead sponsor: DCB Research AG
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
First posted: 2023-03-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Sokru device, prototype
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The primary aim of this clinical study is to find signal characteristics of VOCs detected by Sokru device during fasting, insulin injection and after glucose intake and to find the association with blood glucose variation in variant states of glycemia and hypoglycemia.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* T1D with MDI or CSII therapy \>1 year
* Age 18 - 50 (inclusive)
* Caucasian ethnicity
* BMI between 18.5 and 24.9 kg/m2 (inclusive)
* Usage of a continuous glucose monitoring (CGM)

Exclusion Criteria:

* Pregnancy or breastfeeding
* History of cardiovascular diseases
* Diabetes-related comorbidities
* HbA1c \>9 %
* Epilepsy
* Known sensitivity to medical grade adhesives or other skin-related complications, which might influence the outcome
* Known sensitivity to Latex
* Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation

Primary outcomes:
measure: Characteristics of volatile organic compound (VOC) signals measured by the Sokru device
timeFrame: During the study procedure (approximately 5 hours)
Secondary outcomes:
measure: Volatile Organic Compound Signals
timeFrame: During the study procedure (approximately 5 hours)
measure: Blood glucose concentration
timeFrame: During the study procedure (approximately 5 hours)
measure: Time of onset of subjective symptoms of hypoglycemia
timeFrame: During the study procedure (approximately 5 hours)
measure: Heart rate
timeFrame: During the study procedure (approximately 5 hours)
measure: Oxygen saturation
timeFrame: During the study procedure (approximately 5 hours)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM) Inselspital, Universitätsspital
Study officials:
affiliation: DCB Research AG
name: Derek Brandt
role: STUDY_CHAIR
References:
Clinical trial NCT01046890: Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir
Official title: Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: Darunavir
Echinacea purpurea
Interaction
Complementary Therapies
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
Collaborators: name: IrsiCaixa
name: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
First posted: 2010-01-12
Enrollment: 15
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 clinical trial is to characterize drug interactions between one medicinal herb widely used by HIV infected patients: Echinacea sp. and the protease inhibitor darunavir/ritonavir.

Detailed description: 15 patients on antiretroviral therapy with darunavir/ritonavir 600/100 mg twice a day during four weeks will be recruited. The patients will receive treatment with Echinacea purpurea for 14 days, 500 mg every 6 hours. A 12 hour pharmacokinetic curve will be obtained at baseline and on day 14.

Eligibility criteria: Inclusion Criteria:

1. Patients infected with HIV-1 (at least one documented positive Western-Blot).
2. Age =/+ 18 years.
3. Patients receiving antiretroviral therapy containing darunavir / ritonavir at the approved dose of 600/100 mg twice daily for at least 4 weeks
4. HIV viral load in plasma \<50 copies / mL
5. Absence of acute infections and / or tumors in the three months prior to inclusion.
6. Subject able to follow the treatment period, without suspicion of poor adherence in previous antiretroviral treatments.
7. Voluntary written informed consent.

Exclusion Criteria:

1. Any clinical or historical observation that could interfere with the pharmacokinetics of medications, such as gastrointestinal illness or surgery (except for herniotomy and appendectomy), changes in the composition of plasma proteins, some indication of hepatic or renal dysfunction.
2. Active alcohol consumption (\> 50 g / day) or illicit drugs (except cannabis).
3. Pregnancy or lactation

Primary outcomes:
measure: plasma concentration of darunavir and ritonavir
timeFrame: DAY 14
Secondary outcomes:
measure: Clearance (CL/F)
timeFrame: DAY 14
measure: Volume of distribution (V/F)
timeFrame: DAY 14
measure: Elimination half-life (t1/2)
timeFrame: DAY 14
measure: Area under the plasma concentration-time curve during the dosing interval
timeFrame: DAY 14
measure: Adverse events and laboratory alterations
timeFrame: DAY 14
measure: HIV Viral load in plasma
timeFrame: DAY 14
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Lluita contra la Sida Foundation, HIV Unit, Irsi Caixa Foundation
Study officials:
affiliation: Lluita contra la Sida Foundation, HIV Unit
name: Jose Moltó, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03727490: The Role of Subscapularis Repair in Reverse Shoulder Arthroplasty
Official title: The Role of Subscapularis Repair in Reverse Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Arthropathy Shoulder
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2018-11-01
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall goal of the study is to determine if repairing the subscapularis tendon during primary reverse shoulder arthroplasty effects short-term patient outcomes. The study is a patient blinded randomized controlled trial that is currently enrolling.


Eligibility criteria: Inclusion Criteria:

* Adults undergoing primary reverse shoulder arthroplasty

Exclusion Criteria:

* Adults without an intact subscapularis
* Inflammatory arthritis
* Revision surgery

Primary outcomes:
measure: American Shoulder and Elbow Surgeons Score
timeFrame: Two Years
Secondary outcomes:
measure: Simple Shoulder Test
timeFrame: Two Years
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University Department of Orthopaedic Surgery
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Alexander W Aleem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06651190: Pain Caregiver Resource (PainCaRe)
Official title: Building MHealth Parent Capacity to Manage Pain in Young Children with Cancer: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pediatric Cancer
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Pain is a problem for children with cancer, especially when they are outside of the hospital setting. Younger children with cancer are particularly vulnerable to undermanaged pain because of their inability to self-report pain and their reliance on parents for treatment. One method to help these children to get the best care possible is through the use of smartphone-based mHealth solutions. Smartphone apps can provide treatment advice to patients experiencing pain in real-time and in any environment. This research will use a phased and user-centered approach with family caregivers to co-design and co-evaluate the new cancer Pain Caregiver Resource (PainCaRe) app to achieve the following aims: (1) high-fidelity software development and usability refinement; (2) evaluation of trial feasibility and preliminary effectiveness in a pilot randomized controlled trial (RCT); and (3) systematic analysis of caregiver app usage patterns to refine PainCaRe for optimal engagement prior to a future RCT.


Eligibility criteria: 1. Be the primary caregiver, or person assuming the majority of care activities, for a child aged 2-11 years undergoing cancer treatment and experiencing above mild pain (≥3/10) in the week preceding study enrolment (pain measured by self or caregiver proxy using a validated numerical 11-point rating scale).
2. Be able to speak and read English.

Primary outcomes:
measure: Feasibility - attrition
timeFrame: 1 year
measure: Feasibility - accrual
timeFrame: 1 year
measure: Feasibility - adherence
timeFrame: 8 weeks
measure: Acceptability
timeFrame: 8 weeks
Secondary outcomes:
measure: Child pain intensity - parent report
timeFrame: 8 weeks
measure: Child pain intensity - child report
timeFrame: 8 weeks
measure: Child pain interference - parent report
timeFrame: 8 weeks
measure: Child pain interference - child report
timeFrame: 8 weeks
measure: Child health-related quality of life - parent report
timeFrame: 8 weeks
measure: Child health-related quality of life - child report
timeFrame: 8 weeks
measure: Parent quality of life
timeFrame: 8 weeks
measure: Parent pain management self-efficacy
timeFrame: 8 weeks
measure: Parent care satisfaction
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References: