louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01990573: Methadone in Pediatric Anesthesiology II
Official title: Methadone in Pediatric Anesthesia II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: spinal surgery
Methadone
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2013-11-21
Enrollment: 51
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Three arm randomized controlled trial to evaluate the efficacy of a single dose of intraoperative methadone in reducing post-operative pain and opioid consumption in adolescents undergoing posterior spinal fusion. Our secondary goal is to determine the pharmacokinetics of IV methadone in children (0.3 and 0.4 mg/kg).

Detailed description: Randomized, controlled, modified dose-escalation design. Patients receive standard monitoring for anesthesia and postoperative care. Surgical and anesthesia (except for opioid use) care are not altered for study purposes. All patients are induced by propofol and muscle relaxants. In the first cohort (n=30 evaluable), subjects are randomized 1:2 to either control (standard intraop opioid at anesthesiologists' discretion) or methadone HCl (0.4 mg/kg ideal body weight, IBW). In the second cohort (n=30 evaluable), subjects are randomized 1:2 to either control (standard intraop opioid) or methadone HCl (0.3 mg/kg ideal body weight, IBW). Subjects in the study groups will receive methadone (IV bolus, after induction of anesthesia) as their primary intraoperative opioid, rather than leaving the choice of intraoperative opioid to the anesthesiologist. Intraoperative breakthrough pain will be treated at the discretion of the anesthesiologist with fentanyl. In the control groups, intraoperative opioid administration will be left at the discretion of the anesthesia providers. Patient controlled analgesia as prescribed by the clinical team, using hydromorphone or morphine, will be used to treat postoperative pain relief.

Eligibility criteria: Inclusion Criteria.

* Age 11-18 years
* Undergoing general anesthesia and idiopathic posterior spinal surgery with anticipated postop inpatient stay of \> 3 days
* Signed, written, informed consent from legal guardians and assent from patient

Exclusion Criteria.

* History of or known liver or kidney disease.
* Females who are pregnant or nursing.
* Children with developmental delay
* Children undergoing surgery for scoliosis of musculoskeletal origin

Primary outcomes:
measure: Total Opioid Consumption (Morphine Equivalent)
timeFrame: 6 days
measure: Pain Scores
timeFrame: 6 days
Secondary outcomes:
measure: Cmax of R and S Methadone
timeFrame: 96 hours
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Anshuman Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05763173: Evaluation of Lung Metastases Based on Ultrashort Echo Time MRI
Official title: The Diagnostic Value of Lung Ultrashort Echo Time MRI for Potential Lung Metastases in Children With Hepatoblastoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatoblastoma
Radiology
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 65
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children diagnosed as hepatoblastoma

Brief summary: Analyze the diagnostic efficiency (including performance, diameter, and location of nodules) of UTE-MRI in lung metastases of hepatoblastoma with chest CT as gold standard


Eligibility criteria: Inclusion Criteria:

* Children diagnosed as hepatoblastoma (including treated with neoadjuvant chemotherapy but not surgery)
* Recent chest CT scan (within 14 days)
* No MRI contraindications
* The guardian of the children are willing to undergo the examination after full communication and informed consent

Exclusion Criteria:

* MRI contraindications (including but not limited to: contrast medium allergy; Claustrophobia;Metal implants;chronic kidney disease≥stage 3 (glomerular filtration rate \< 60 mL min-1 (1.73 m2)-1))
* Patients with hepatoblastoma aged 14 years and above
* Children after surgery for hepatoblastoma
* Application of any contrast medium within 24 h before the MRI and/or CT examinations
* There is a concomitant medical condition (e.g. poorly controlled hypertension, severe diabetes, neurological or psychiatric illness, etc.) or any other condition that would seriously endangers the subject's safety, may confuse the study results, or may interfere with the subject's completion of the study according to the investigator's judgment.

Primary outcomes:
measure: UTE-MRI assessment of lung metastases with chest CT as gold standard
timeFrame: Baseline to 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Radiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University
state: Shanghai
Study officials:
References:
Clinical trial NCT04975373: Intrauterine Hyaluronic Acid Gel for Prevention of Intrauterine Adhesions
Official title: Reduction of Intrauterine Adhesions by Intrauterine Hyaluronic Acid Gel After Hysteroscopic Removal of Retained Products of Conception: Multicenter Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prevenetion of Intrauterine Adhesions by Hyaluronic Acid Gel
Keywords: retained placenta
operative hysteroscopy
intrauterine adhesions
hyaluronic acid
Lead sponsor: Barzilai Medical Center
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Women undergoing operative hysteroscopy for removal of retained placenta after delivery will be randomized into two groups.

1. study group - immediately after operative hysteroscopy 5 ml hyaluronic acid gel will be injected into uterine cavity
2. control group - no injection

4-8 weeks after operative hysteroscopy, participants will undergo diagnostic hysteroscopy with no anesthesia , as a part of routine evaluation after removal of retained placenta in Israel.

during diagnostic hysteroscopy the uterine cavity will be evaluated and the presence of adhesions and severity of adhesions will be recorded.


Eligibility criteria: Inclusion Criteria:

* Women undergoing hysteroscopic removal of retained placenta after delivery

Exclusion Criteria:

* Known adverse reaction or allergy to hyaluronic acid

History of intrauterine adhesions

Acute pelvic inflammatory disease

Primary outcomes:
measure: any adhesions
timeFrame: 4-8 weeks after intervention
Secondary outcomes:
measure: adhesion scorring
timeFrame: 4-8 weeks after intervention
Other outcomes:
Locations:
city: Ashkelon
country: Israel
facility: Barzilai University Medical Center
Study officials:
References:
Clinical trial NCT01916473: Epidural Versus Continuous Wound Ropivacaine Infusion Analgesia
Official title: Epidural Versus Continuous Wound Ropivacaine Infusion: Effect on Acute and Chronic Pain After Myomectomy or Total Abdominal Hysterectomy. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Analgesia
Keywords: Epidural analgesia
continuous wound infusion
ropivacaine
total abdominal hysterectomy
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2013-08-05
Enrollment: 80
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study Hypothesis: The analgesic requirements and pain scores postoperatively differ between the epidural and continuous wound infusion techniques.

Detailed description: The analgesic requirements and pain scores postoperatively differ between the epidural and continuous wound infusion techniques, in patients undergoing myomectomy or hysterectomy.

Eligibility criteria: Inclusion Criteria:

Patients ASA I-II scheduled for abdominal hysterectomy or myomectomy -

Exclusion Criteria:

Age older than 60 and younger than 25 years, body weight exceeding the 30% of the ideal, consumption of analgesics, sedatives, anxiolytics, antidepressants, calcium channel blockers, CNS disease or insulin dependent diabetes

-

Primary outcomes:
measure: Postoperative morphine consumption
timeFrame: 2 hours postoperatively
measure: Postoperative morphine consumption
timeFrame: 4 hours postoperatively
measure: Postoperative morphine consumption
timeFrame: 8 hours postoperatively
measure: Postoperative morphine consumption
timeFrame: 24 hours postoperatively
measure: Postoperative morphine consumption
timeFrame: 48 hours postoperatively
measure: Postoperative morphine consumption
timeFrame: 72 hours postoperatively
measure: Postoperative morphine consumption
timeFrame: 3 months postoperatively
measure: Postoperative morphine consumption
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: pain scores
timeFrame: 2 hours postoperatively
measure: pain scores
timeFrame: 4 hours postoperatively
measure: pain scores
timeFrame: 8 hours postoperatively
measure: pain scores
timeFrame: 24 hours postoperatively
measure: pain scores
timeFrame: 48 hours postoperatively
measure: pain scores
timeFrame: 72 hours postoperatively
measure: pain scores
timeFrame: 3 months postoperatively
measure: pain scores
timeFrame: 6 months postoperatively
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Aretaieio Hospital
Study officials:
affiliation: University of Athens
name: Argyro Fassoulaki, MD,PhD, DEAA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00242073: The Potential Use of BOLD MRI as a Noninvasive Measure of Tumor Hypoxia in Prostate Cancer
Official title: The Potential Use of BOLD MRI as a Noninvasive Measure of Tumor Hypoxia in Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2005-10-19
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Hypoxia (low oxygen level) is know to be present in many tumors and may strongly influence the success of treatment and the progression of disease in prostate cancer. The method used to measure tumor oxygen levels in prostate cancer is to place a needle in the prostate itself through the rectum. Blood oxygen level dependent imaging (BOLD MRI) is a special MRI technique that allows indirect assessment of oxygen levels in blood. This technique is non-invasive, involving no needles. BOLD has not been applied in humans in prostate cancer. The purpose of this study is to develop a MRI-BOLD technique that allows us to non-invasively measure changes related to tumor hypoxia in prostate cancer. This technique may provide information that will be an independent predictor of patient survival, tumor recurrence and likelihood of treatment response in prostate cancer

Detailed description: Hypoxia (low oxygen level) is know to be present in many tumors and may strongly influence the success of treatment and the progression of disease in prostate cancer. The method used to measure tumor oxygen levels in prostate cancer is to place a needle in the prostate itself through the rectum. Blood oxygen level dependent imaging (BOLD MRI) is a special MRI technique that allows indirect assessment of oxygen levels in blood. This technique is non-invasive, involving no needles. BOLD has not been applied in humans in prostate cancer. The purpose of this study is to develop a MRI-BOLD technique that allows us to non-invasively measure changes related to tumor hypoxia in prostate cancer. This technique may provide information that will be an independent predictor of patient survival, tumor recurrence and likelihood of treatment response in prostate cancer

Eligibility criteria: Inclusion Criteria:

* prostate cancer

Exclusion Criteria:

* contraindication to MRI

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Masoom Haider, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04395573: Real Time 3D Navigation and Traditional US to Identify Epidural Space Depth in Obese Pregnant
Official title: Real Time 3D Navigation and Traditional US to Identify Epidural Space Depth in Obese Pregnant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Obesity
Lead sponsor: European e-Learning School in Obstetric Anesthesia
Sponsor class: OTHER
Collaborators: name: University of Milano Bicocca
First posted: 2020-05-20
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant Patients undergoing elective cesarean section or requesting labor epidural analgesia

Brief summary: The aim of this study is to assess the accuracy of the Accuro Ultrasound Device in estimating the epidural space depth compared to the Standard Ultrasound Examination and with the measured needle depth during epidural and spinal insertion in pregnant obese patients

Detailed description: SpineNav3DTM technology facilitates image interpretation of individual 2D lumbar spine scans by automating spinal bone landmark detection and depth measurements and providing a real-time assessment of scan plane orientation in 3D.

All the subjects will have their lumbar area scanned for the measurements of the depth of the epidural space (recorded in cm) by two blinded anesthesiologists, one using standard ultrasounds and the other the Accuro Device.

All measurements will be performed either in the sitting or in the supine position at L1/L2, L2/L3 and L3/L4 levels. Neuraxial anesthesia will be performed by using the previously marked interspace by a blinded anesthesiologist who will measure the epidural space depth during epidural or spinal insertion by marking the needle.

Eligibility criteria: Inclusion Criteria:

* ASA Status \>III
* obese BMI\>30
* term gestatio \> 37 weeks
* singleton pregnancy
* undergoing elective cesarean section with spinal anesthesia
* requesting epidural labor analgesia

Exclusion Criteria:

* contraindications to neuraxial block
* severe scoliosis
* previous spine surgery

Primary outcomes:
measure: Epidural space depth
timeFrame: up to 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Monza
country: Italy
facility: ASST S Gerardo
Study officials:
affiliation: European e-Learning School in Obstetric Anesthesia
name: Giorgio Capogna, MD
role: STUDY_DIRECTOR
References:
citation: Seligman KM, Weiniger CF, Carvalho B. The Accuracy of a Handheld Ultrasound Device for Neuraxial Depth and Landmark Assessment: A Prospective Cohort Trial. Anesth Analg. 2018 Jun;126(6):1995-1998. doi: 10.1213/ANE.0000000000002407.
Clinical trial NCT01011673: Metoclopramide Versus Ketorolac for Tension-type Headache
Official title: An RCT of Metoclopramide/Diphenhydramine vs. Ketorolac Alone for Tension-type Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Headache
Keywords: headache
tension-type headache
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2009-11-11
Enrollment: 123
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Occasionally, episodic tension-type headache may be severe enough to require an emergency department (ED) visit. The purpose of this study is to compare two commonly used medications to see which is better for tension type headache. Patients who present to the ED with an acute tension-type headache requiring treatment with injectable medication will be randomized to metoclopramide or ketorolac.


Eligibility criteria: Inclusion Criteria:

* Acute tension type headache

Exclusion Criteria:

* Contraindications to investigational medications
* Secondary cause of headache

Primary outcomes:
measure: Change in Pain Score
timeFrame: Baseline, 60 minutes
Secondary outcomes:
measure: Satisfaction Scores
timeFrame: 24 hours
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
References:
citation: Friedman BW, Adewunmi V, Campbell C, Solorzano C, Esses D, Bijur PE, Gallagher EJ. A randomized trial of intravenous ketorolac versus intravenous metoclopramide plus diphenhydramine for tension-type and all nonmigraine, noncluster recurrent headaches. Ann Emerg Med. 2013 Oct;62(4):311-318.e4. doi: 10.1016/j.annemergmed.2013.03.017. Epub 2013 Apr 6.
Clinical trial NCT06263673: Anti-Diabetic Medications to Fight PD and LBD
Official title: Anti-Diabetic Medications to Fight Parkinson's Disease and Lewy Body Dementia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Lewy Body Dementia
Parkinson Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 18
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the hypothesis that DPP4 inhibitors and SGLT2 inhibitors are well tolerated and have beneficial neurological effects, specifically for Parkinson's disease and Lewy body dementia.


Eligibility criteria: Inclusion Criteria:

* Parkinson's disease or Lewy Body Dementia (diagnosis confirmed by neurologist at Mayo Clinic) with stable neurological treatment in the past approximately three months.
* Glucose intolerance or mild diabetes: The American Diabetes Association criteria for pre-diabetes/ glucose intolerance includes fasting glucose 100-125, random glucose 140-199, or hemoglobin A1C 5.7-6.4% and diabetes is \> 125 mg/dL, \> 200 mg/dL, and 6.5% or greater, respectively (40). It has been previously reported that 50-80% of individuals with Parkinson's disease have abnormal glucose tolerance (17), so this should not limit recruitment.

Exclusion Criteria:

* Use of insulin or other anti-diabetes medications other than metformin.
* Contraindication to taking a DPP4 inhibitor or SGLT2 inhibitor including: allergy, history of angioedema, pancreatitis, active gallbladder disease, renal impairment with EGFR \< 45).
* Bleeding disorder, use of anticoagulants, thrombocytopenia, or severe anemia.
* Use of high dose steroids.
* Current systemic chemotherapy.
* Pregnancy or breastfeeding.
* Recent (within 30 days) or recurrent (defined as more than one in the past 12 months) urinary tract infection or yeast infection.
* Other contraindication that would make study participation unsafe or make study related data unable to be interpreted.

Primary outcomes:
measure: Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: Baseline, 4 weeks
measure: Change in Mini Mental State Examination
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Glucose
timeFrame: Baseline, 4 weeks
measure: Supine blood pressure
timeFrame: Baseline, 4 weeks
measure: Standing blood pressure
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Jessica Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00442273: Comparison of Autologous Serum and Umbilical Cord Serum Eyedrops for Dry Eye Syndrome
Official title: Comparison of Autologous Serum and Umbilical Cord Serum Eyedrops for Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
First posted: 2007-03-01
Sex: ALL
Minimum age (years): 20
Maximum age (years): 61
Standard ages: ADULT
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the therapeutic effect between autologous serum and umbilical cord serum eyedrops in the treatment of severe dry eye syndrome.

Detailed description: Ninety-two eyes of 48 patients with severe dry eye syndrome (34 eyes of 17 patients with Sjögren's syndrome and 58 eyes of 31 patients with non-Sjögren's syndrome) were treated with either 20% autologous serum (41 eyes of 21 patients) or umbilical cord serum eyedrops (51 eyes of 27 patients). Symptom scoring, corneal sensitivity test, tear film break-up time (BUT), Schirmer test, tear clearance rate (TCR), corneal fluorescein staining, and conjunctival impression cytology were performed before and 1 month and 2 months after treatment.

Eligibility criteria: Inclusion Criteria:

* Patients with severe dry eye syndrome who were refractory to conventional treatments and had symptoms of dry eye for more than 3 months
* Low tear film break-up time (BUT, \< 5 sec)
* Low Schirmer test (5 mm)
* Positive fluorescein or rose bengal vital staining (≥ 3)

Exclusion Criteria:

* Active ocular infection or inflammation not associated with dry eye
* Contact lens wear
* Ocular allergy
* Ocular surgery within the recent 3 months
* Lid or lash abnormalities
* Pregnant or lactating women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam national university hospital
Study officials:
affiliation: Chonnam natianl university hospital
name: Kyung chul Yoon, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01089673: A Retrospective Study of the Effects of Molecular Diagnostics on Wound Care Outcomes
Official title: A Retrospective Study of the Effects of Molecular Diagnostics on Wound Care Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wounds
Keywords: retrospective data collection
Lead sponsor: Southwest Regional Wound Care Center
Sponsor class: OTHER
First posted: 2010-03-18
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient records would be extracted from the electronic health record system of Southwest Regional Wound Care Center.

Brief summary: A retrospective molecular diagnostic review on wound care outcomes between two time periods. The time periods include June, July, August of 2008 and June, July, August of 2009. The retrospective review would analyze the days of healing during those two timeframes, upon the introduction of molecular diagnostic testing.


Eligibility criteria: Inclusion Criteria:

* A patient record captured during June, July, August 2008 and June, July, or August of 2009.

Exclusion Criteria:

* A patient record captured outside the time frame of June, July August 2008 or June, July, August of 2009.

Primary outcomes:
measure: A retrospective molecular diagnostic review on wound care outcomes between two time periods.
timeFrame: The time periods include June, July, August of 2008 and June, July, August of 2009.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: