louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06323226: The Impact of Sepsis on Long-term Outcomes in Critical Ill Children With Sepsis
Official title: The Impact of Sepsis on Long-term Outcomes in Critical Ill Children With Sepsis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Children, Only
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 300
Sex: ALL
Minimum age (years): 0
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We included critically ill children with sepsis who successfully discharged from pediatric intensive care units and age \< 16 years. Age, sex, and illness severity matched critically ill children would be included as control group.

Children with underlying diseases, cancer, and hematologic malignancy would be excluded.

Brief summary: This study is conducted in critically ill children with sepsis with a five years follow-up. We aim to investigate the impact of sepsis on long-term outcomes including growth, neurodevelopment, survival rate, quality of life.


Eligibility criteria: Inclusion Criteria:

We included critically ill children with sepsis who successfully discharged from pediatric Intensive care units, age \< 16 years.

We also included age, sex, illness severity matched critically ill children as control group.

Exclusion Criteria:

We excluded children with underlying diseases, cancer, hematologic malignancy.

Primary outcomes:
measure: Mortality
timeFrame: Five years
Secondary outcomes:
Other outcomes:
Locations:
city: Chendu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References:
Clinical trial NCT00287326: Comparison of Low-dose Epidural With Intravenous Narcotic Versus Intravenous Narcotic Alone
Official title: Comparison of Epidural Bupivacaine-Clonidine With Intravenous Morphine Versus Intravenous Morphine Alone for Post-Operative Pain Relief in Pediatric Patients Undergoing Lower Extremity or Pelvic Osteotomy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pain
Keywords: Epidural
Bupivacaine
Clonidine
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2006-02-06
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine if a low-dose epidural drug mixture without narcotic will result in lower parenteral narcotic usage, and improved side-effect profile for post-operative pain in the pediatric population undergoing lower extremity or pelvic osteotomy.

Detailed description: Post-operative pain in patients undergoing osteotomy can be severe. Current methods of treatment involve parenteral narcotics and regional anesthesia. Several studies have looked at the efficacy of regional anesthesia with various combinations of local anesthetic and additives in different populations. However, to our knowledge there have been none that directly compare bupivacaine/clonidine epidural with supplemental narcotics to parenteral narcotics alone. Many studies substantiate the efficacy of bupivacaine and clonidine as effective drugs for epidural analgesia (1,2,3). Parenteral narcotic alone is associated with the possibility of significant side effects, overdose, and inadequate analgesia. Epidural analgesia has been shown to reduce postoperative pain scores more than parenteral narcotics (4). We believe that this study is important since the protocol allows additional parenteral narcotic in the epidural group if needed, and also allows for narcotic dosing prior to discontinuation of the epidural to compensate for rebound pain. Further, the prolongation of pain control shown with epidural clonidine may be beneficial during the transition (5,6).

Eligibility criteria: Inclusion Criteria:

* Age 4-16
* English speaking
* Elective lower extremity osteotomy
* Expected length of stay greater than 24 hours

Exclusion Criteria:

* History of previous spine surgery
* Current infection overlying catheter insertion site
* Coagulopathy

Primary outcomes:
measure: 24 hour recording of pain, sedation, narcotic usage, and satisfaction.
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Michael J Stella, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01323426: Treatment of Stress Urinary Incontinence by Injection of Autologous Muscle Fibers Into the Urethral Sphincter.
Official title: Autologous Muscle Fiber Transplantation for Repair of the Urethral Sphincter in Patients With Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Urinary Incontinence, Stress
Keywords: urinary incontinence, stress
autologous
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2011-03-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This pilot study examines safety and efficacy of a simple procedure for treatment of stress urinary incontinence. A muscle biopsy is taken from the thigh, minced and injected into the urethral sphincter.


Eligibility criteria: Inclusion Criteria:

* Stress urinary incontinence refractory to conservative treatment.

Exclusion Criteria:

* urge urinary incontinence
* Pregnancy
* Pelvic organ prolapse \> grade 1

Primary outcomes:
measure: Frequency of incontinence episodes
timeFrame: 12 months
Secondary outcomes:
measure: International Consultation on Incontinence (ICIQ)short form incontinence score
timeFrame: 12 months
measure: Intraurethral pressure measured by reflectometry
timeFrame: 12 months
measure: Uroflow
timeFrame: 12 months
measure: Adverse events peri- or postoperatively
timeFrame: 12 months
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: Herlev Hospital
name: Søren Gräs, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03893526: Effect of Neprilysin on Glucagon-Like Peptide-1 in Patients With Type 2 Diabetes
Official title: The Effect of Neprilysin on Plasma Concentrations of Glucagon-Like Peptide-1 in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type2 Diabetes
Keywords: GLP-1
Neprilysin
Diabetes
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
First posted: 2019-03-28
Enrollment: 12
Sex: MALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Glucagon-like peptide-1(GLP-1) is secreted during a meal and increases glucose induced insulin secretion. The enzyme dipeptidyl peptidase 4(DPP-4) cleaves intact GLP-1 within minutes and DPP-4 inhibitors are therefore used for treatment of diabetic hyperglycemia. A few animal studies have implicated the enzyme neutral endopeptidase 24.11 (24.11) in the degradation of GLP-1 but if this is the case in humans with type 2 diabetes is unknown.

We therefore administered a NEP inhibitor, 194mg sacubitril, a DPP-4 inhibitor (sitagliptin 100mg the night before and 100mg 2 hours before), both, or placebo, to patients with type 2 diabetes during a standardized meal and measured plasma concentrations of GLP-1


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes
* Oral Antidiabetics Medicine Only
* Body Mass Index of 25-35
* Type 2 Diabetes

Exclusion Criteria:

* acute diseases within the two weeks
* chronic diseases
* smoker
* alcoholism, drug addiction or recent weight loss
* blood donation within the last 3 months

Primary outcomes:
measure: Blood Glucose
timeFrame: 3 hours after treatment ( during the subsequent standardized meal)
Secondary outcomes:
measure: Plasma Concentrations of GLP-1
timeFrame: 3 hours after treatment ( during the subsequent standardized meal)
measure: Plasma Concentrations of GIP
timeFrame: 3 hours after treatment ( during the subsequent standardized meal)
measure: Plasma Concentrations of Glucagon
timeFrame: 3 hours after treatment ( during the subsequent standardized meal)
measure: Plasma Concentrations of Insulin
timeFrame: 3 hours after treatment ( during the subsequent standardized meal)
measure: Plasma Concentrations of C-Peptide
timeFrame: 3 hours after treatment ( during the subsequent standardized meal)
measure: Plasma Concentrations of Amino Acids
timeFrame: 3 hours after treatment ( during the subsequent standardized meal)
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
state: RegionH
Study officials:
References:
citation: Wewer Albrechtsen NJ, Moller A, Martinussen C, Gluud LL, Rashu EB, Richter MM, Plomgaard P, Goetze JP, Kjeldsen S, Hansen LH, Gustafsson F, Deacon CF, Holst JJ, Madsbad S, Bojsen-Moller KN. Acute effects on glucose tolerance by neprilysin inhibition in patients with type 2 diabetes. Diabetes Obes Metab. 2022 Oct;24(10):2017-2026. doi: 10.1111/dom.14789. Epub 2022 Jul 21.
Clinical trial NCT05314426: Mayo Clinic Phage Program Biobank
Official title: Mayo Clinic Phage Program Biobank
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Bacteriophage Therapy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mayo Clinic patients receiving bacteriophage therapy.

Brief summary: The purpose of this study is to help scientists and clinicians discover answers to research questions related to antibiotic-resistant bacterial infections, and the role that phage therapy plays as a possible treatment.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age.
* Able to provide informed consent.
* Individual must have a future treatment plan to receive or has historically received phage therapy.

Exclusion Criteria:

* Individuals , 18 years of age.
* Unwilling/unable to provide informed consent.

Primary outcomes:
measure: Enrollment of study participants
timeFrame: 5 years
measure: Collection of biospecimens
timeFrame: 5 years
measure: Medical record review
timeFrame: 5 years
measure: Increase treatment options and level of care for patients with bacterial infections
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Gina Suh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03940326: Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures
Official title: Comparison Study of Efficacy and Safety of Levetiracetam Versus Valproate in Treatment of Idiopathic Generalized Tonic-clonic Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy, Idiopathic Generalized
Lead sponsor: Mazandaran University of Medical Sciences
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 103
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is an open-label, active-controlled,non-inferiority trial comparing efficacy and safety of levetiracetam versus valproate in idiopathic generalized tonic-clonic epilepsy.


Eligibility criteria: Inclusion Criteria:

* Age≥16
* At least 2 unprovoked generalized tonic-clonic seizures in last 2 years with at least one in last 6 months
* Normal brain MRI or MRI without epileptogenic lesion
* Normal electroencephalography(EEG) or existence of generalized epileptiform discharges without any focal epileptiform discharges.
* Signing consent form

Exclusion Criteria:

* History of treatment by sodium valproate or levetiracetam
* History of treatment by any anti-epileptic drug in last 6 months
* Plan for pregnancy
* Using no certain contraceptive method
* History of past or current hepatic disease
* History of past or current renal disease
* History of past or current hematologic disease
* History of known psychiatric disease
* History of status epilepticus

Primary outcomes:
measure: Time to First Seizure
timeFrame: 6 months
measure: Seizure Freedom Rate
timeFrame: 6 months
Secondary outcomes:
measure: Withdrawal Rate
timeFrame: 6 months
measure: Time to Withdrawal
timeFrame: 9 months
Other outcomes:
Locations:
city: Sari
country: Iran, Islamic Republic of
facility: Bu Ali Sina Hospital
state: Mazandaran
Study officials:
affiliation: Neurology department, Mazandaran University of Medical Sciences, Sari, Iran.
name: Nasim Tabrizi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04222426: 89Zr-atezolizumab PET Scan and Lobular Breast Cancer
Official title: Can 89Zr-atezolizumab PET Scan Identify Patients With Metastatic Invasive Lobular Breast Cancer Who Will Respond to Chemotherapy-immune Checkpoint Inhibition?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lobular Metastatic Breast Cancer
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The exploratory single center feasibility ImaGelato study is conducted as an imaging side study to the Dutch GELATO trial (Assessing efficacy of carboplatin and atezolizumab in metastatic lobular breast cancer). Ten patients with lobular metastatic breast cancer, who are included in the GELATO trial at the UMCG, are eligible for the ImaGelato study.

All patients will undergo two Zirconium-89 (89Zr)-atezolizumab positron emission tomography (PET) scans, one at baseline and one after two doses carboplatin induction treatment. The 89Zr-atezolizumab PET scan will be performed 4 days after tracer injection. Procedures within the ImaGelato study will be completed after the two 89Zr-atezolizumab PET scans, but patients will continue treatment with carboplatin combined with atezolizumab in the GELATO trial.


Eligibility criteria: Inclusion Criteria:

1. A patient must meet the inclusion criteria of the GELATO trial
2. Able to give written informed consent and to comply with the ImaGelato protocol

Exclusion Criteria:

1. Contra-indication for 89Zr-atezolizumab PET scan
2. Any approved anti-cancer therapy, including chemotherapy or hormonal therapy within ≤14 days prior to the first 89Zr-atezolizumab injection. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to the first 89Zr-atezolizumab injection.

Primary outcomes:
measure: Change in tumor uptake between 89Zr-atezolizumab PET scan at baseline and after two carboplatin induction treatments, defined as decline or increase of standardized uptake value
timeFrame: 2 years
Secondary outcomes:
measure: The relation between standardized uptake value (SUV) on 89Zr-atezolizumab PET scan, to response to carboplatin-atezolizumab
timeFrame: 2 years
measure: The relation of 89Zr-atezolizumab tumor uptake at baseline and after two courses of carboplatin, with tumor biopsy assessments
timeFrame: 2 years
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: C. P. Schröder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01258426: Human Selenoprotein P Concentration With Glucose Tolerance Status
Official title: Human Selenoprotein P Concentration With Glucose Tolerance Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SEPP1 Levels in Differnet Glucose Tolerance Status
Lead sponsor: Korea University
Sponsor class: OTHER
First posted: 2010-12-13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Total 180 patients Normal 60-IGT 60-T2DM 60

Brief summary: Recently, seslenium(Se) has known as important regulator in metabolic status, lipid profile, atherosclerosis progression. SEPP1(selenoprotein P1)is a secreted protein from mainly liver. This protein is used as an index of selenium nutritional status. The association between the concentration of SEPP1(selenoprotein P1) in normal glucose tolerance,impaired glucose tolerance, type 2 diabetes is still a matter of debate. This cross sectional study will evaluate whether glucose status is matter in SEPP1 level.


Eligibility criteria: Inclusion Criteria:

* 20-80 years old
* Not severe medical condition

Exclusion Criteria:

* metformin, insulin using type 2 diabetes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00997126: Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation
Official title: Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sedation
Keywords: propofol
alfentanil
nitrous oxide
moderate procedural sedation
Moderate Procedural Sedation in the Emergency Department
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
First posted: 2009-10-19
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a clinical trial of propofol and alfentanil as agents for moderated procedural sedation in patients undergoing sedation in the emergency department (ED).

Detailed description: This was initially going to be a trial of propofol vs alfentanil vs nitrous oxide, but our use of nitrous oxide was discontinued before the trial began and the trial was conducted with only two arms

Eligibility criteria: Inclusion Criteria:

* Adults undergoing moderate procedural sedation in the Emergency Department

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* Intoxication
* Cannot give informed consent
* Allergy to any of the three study medications
* ASA physical status score \> 2
* Patients who require deep procedural sedation

Primary outcomes:
measure: Number of Participants With Sub-clinical Respiratory Depression and Clinical Events Associated With Respiratory Depression During the Sedation Procedure
timeFrame: From one minute prior to start of procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure (~3-60 minutes depending on procedure duration)
Secondary outcomes:
measure: Time to Return of Baseline Mental Status From Start of Procedure in Minutes
timeFrame: Single time point after completion of sedation procedure, measured from start of procedure until the patient returns to baseline mental status up to 24 hours
measure: Depth of Sedation Measured Using the OAAS Scale
timeFrame: Single measurement during sedation procedure
measure: Patient Reported Pain
timeFrame: Single measurement immediately after patient returns to baseline mental status after sedation procedure
measure: Patient Reported Recall of the Procedure
timeFrame: Single measurement immediately after patient returns to baseline mental status after sedation procedure
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin Healthcare Research Institute
name: James R Miner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00521326: Diagnosis and Characterization of Coronary Artery Stenosis by Doppler Ultrasound
Official title: Diagnosis and Characterization of Coronary Artery Stenosis by Transthoracic Doppler Ultrasound
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Stenosis
Keywords: doppler
coronary stenosis
non-invasive testing
A prospective study of a new diagnostic method.
Study consists of a transthoracic doppler of LAD.
Doppler to be performed prior to coronary angiography.
F/U doppler examination for those who undergo PCI.
Doppler results will be compared with coronary angiography.
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-08-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of this study is to evaluate the feasibility of acquisition of coronary blood flow velocity signals over the whole length of the LAD with transthoracic pulsed Doppler, and to evaluate the diagnostic power of the transthoracic Doppler analysis package for detecting and estimating the degree of coronary artery stenosis. Finally we hope to optimize the currently available analysis package on the basis of the comparison of the Doppler with the angiographic stenosis results and evaluation.


Eligibility criteria: Inclusion Criteria:

* Patients who are clinically suspected of having significant coronary artery stenosis.
* Patients with CAD.
* Patients who are scheduled to undergo coronary angiography.
* Signed informed consent.

Exclusion Criteria:

* Patients with arrhythmia / irregular pulse
* Patients with unstable conditions: unstable angina, uncontrolled CHF
* Patients with COPD
* Any physical or medical disability that prevent lying in supine position
* Patients with chest wall deformity

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Coronary Care Unit, Heart Institute, Hille Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Simcha R Meisel, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05298826: Recombinant Factor VII for Intractable Postpartum Haemorrhage
Official title: Recombinant Factor VII for the Conservative Management Trials of Intractable Postpartum Haemorrhage: is it a Drug Effect , Operator Experience or Inherent Result of the Aetiology.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Partum Hemorrhage
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women who has resistant postpartum hemorage

Brief summary: Postpartum haemorrhage remains at the top of the causes of maternal deaths in both developed and developing countries .

Detailed description: Major postpartum haemorrhage is a dangerous complication that accounts for the highest maternal morbidity rate

Eligibility criteria: Inclusion Criteria:

* Women with severe resistant postpartum hemorage

Exclusion Criteria:

* women without postpartum hemorage

Primary outcomes:
measure: The number of women who had hysterectomy
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Doaaa Alaa
Study officials:
References: