louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06073015: Effect of Esketamine on Reducing Postoperative Anxiety and Depression in Adolescent Patients
Official title: Effect of Esketamine on Reducing Postoperative Anxiety and Depression in Adolescent Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Anxiety-depression
Lead sponsor: Henan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 200
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study intends to conduct a prospective, double-blind, randomized, controlled trial. Adolescents aged 8-17 years old are selected as subjects. Esketamine is used as intervention before surgery, vital signs data, serum IL-6, CRP and other inflammatory indicators are collected during surgery, and the incidence and degree of anxiety and depression are evaluated after surgery. To determine the effect of esketamine on reducing anxiety and depression in adolescents after surgery, and to provide an effective clinical basis for accelerating the rehabilitation of adolescents after surgery.


Eligibility criteria: Inclusion Criteria:

1. 8 years ≤ age ≤17 years;
2. Patients who plan to undergo elective surgery under general anesthesia, and the operation time is ≥2h;
3. ASA grade I-II

Exclusion Criteria:

1. Patients expected to be admitted to ICU after surgery;
2. Patients who need to return to the ward with tracheal intubation after surgery;
3. Allergic to the active ingredients or excipients of isketamine hydrochloride injection;
4. Patients with severe consciousness disorder or mental system disease (schizophrenia, mania, bipolar disorder, psychosis, etc.) or cognitive dysfunction;
5. Patients with congenital heart disease and severe developmental delay;
6. Patients with one of the following contraindications to esketamine :(a) patients at risk of a significant increase in blood pressure or intracranial pressure; (b) Patients with ocular hypertension (glaucoma) or penetrating ocular trauma; (c) Patients with poorly controlled or untreated hypertension (resting systolic blood pressure greater than 180 mmHg or resting diastolic blood pressure greater than 100 mmHg); (d) Untreated or undertreated hyperthyroidism;
7. Previous history of ketamine abuse or dependence, drug or alcohol dependence for more than 6 months, previous ketamine ineffective tests or adverse reactions.

Primary outcomes:
measure: Anxiety and depression scale scores 1 month after surgery
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03749915: Ametop Compared to Ametop With Pain Ease Spray
Official title: A Single Blinded Observational Study of the Effectiveness of a Pain Ease Local Anesthetic Spray, Combined With Ametop Gel, to Reduce the Discomfort of Intravenous Insertion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Analgesia
Topical Anesthetic
Keywords: Pain Ease
Ametop Gel
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 240
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators propose to examine if Pain Ease spray, used as an adjunct to the topical anesthetic Ametop Gel, can improve the percentage of pain-free IV starts.

Detailed description: Purpose:

The aim of this study is to assess the effectiveness of Pain Ease® spray, used as an adjunct to Ametop Gel™.

Hypothesis:

The investigators hypothesize that using Pain Ease® spray as an adjunct to the standard use of Ametop Gel™ will increase the number of pain free venipunctures from 30% to 50% or more.

Objectives:

Primary Objective

1. To determine if using Pain Ease® spray as an adjunct to Ametop Gel™ will increase the number of pain free venipunctures Secondary Objectives
2. To document the side effects of Pain Ease® spray and Ametop Gel™
3. To document the number of attempts for a successful IV insertion

Research Design:

The investigators propose a patient-blinded randomized control trial of Ametop Gel™ with and without Pain Ease® spray as an adjunct.

Statistical Analysis:

An interim analysis will be performed at the study's halfway point after recruitment of 120 participants. A score on the Faces Pain Scale - Revised (FPS-R) of either 0 or 2 will be considered a pain-free IV start, while a score of 4-10 will be considered a painful IV cannula insertion. Fischer's Exact test will be used to determine statistical significance; a critical alpha of 0.05 will be considered for significance.

Eligibility criteria: Inclusion Criteria:

* ASA I \& II
* Elective day case procedure requiring an IV

Exclusion Criteria:

* Planned IV insertion after inhalation induction
* Developmental delay or inability to interpret the Revised Faces Pain Scale (FPS-R)10
* Ametop Gel™ application \< 30 minutes before estimated IV start at time of screening
* Allergies to any of the components in Ametop Gel™, Pain Ease® spray, or adhesives
* Patients receiving sedative pre-medication
* Severe Needle phobia

Primary outcomes:
measure: Pain-free IV insertion
timeFrame: intraoperative
Secondary outcomes:
measure: Insertion attempts
timeFrame: intraoperative
measure: FPS-R pain score
timeFrame: intraoperative
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital - Department of Anesthesia
state: British Columbia
Study officials:
affiliation: BC Children's Hospital, Department of Anesthesia
name: Stephan Malherbe, FRCA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03954015: Comparison of Three Methods for Early Detection of Breast Cancer
Official title: Contrast Enhanced Ultrasound (CEUS) With US Microvessel Imaging, Contrast Enhanced Dual Energy Mammography (CEDM) and Contrast Enhanced Breast MR (CEMR): Comparison of Three Methods for Early Detection of Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Proliferative Breast Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-05-17
Enrollment: 3
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Subjects with suspicious breast lesion (BIRADS category 4/5) who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with Contrast Enhanced Dual Energy Mammography (CEDM), Contrast Enhanced Breast MR (CEMR) and Contrast Enhanced Ultrasound (CEUS).

Detailed description: The co-primary endpoints are to estimate the sensitivity and specificity of CEUS relative to pathology determined diagnosis.

1. Positive predictive value of CEDM in detecting lesions seen on MR
2. Estimate the negative predictive value (TN/(TN+FN)) of CEUS as an adjunct.
3. Compare the frequency of recommendation of biopsy of MG±US vs MG±US plus CEUS as an adjunct based on BIRADS scores.
4. Comparison of background enhancement seen on CEUS with that seen on CEDM and CEMR.

Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Patients, greater than 30 years of age
* In good general health as evidenced by medical history
* BIRADS 4 or 5 suspicious breast lesions who are scheduled for breast biopsy.

Exclusion Criteria:

* Patients who are less than 30 years of age
* Have known or suspected cardiac shunts
* Have history of hypersensitive allergic reactions to any imaging contrast agents
* Pregnant (a urine pregnancy test will be given at no cost to the patient)
* Are nursing babies
* Poor renal function
* Are unwilling or unable (such as having a pacemaker) to undergo a CEMR

Primary outcomes:
measure: CEUS true positive diagnosis
timeFrame: 1 year
measure: CEUS false positive diagnosis
timeFrame: 1 year
measure: CEUS true negative diagnosis
timeFrame: 1 year
measure: CEUS false negative diagnosis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Katrina N. Glazebrook, M.B., Ch.B.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04272515: Molecular Characterization for Understanding Biliary Atresia
Official title: Molecular Characterization for Understanding Biliary Atresia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Biliary Atresia
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2020-02-17
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: BA patients and their parents will be enrolled in this study.
Primary purpose: BASIC_SCIENCE

Brief summary: Although considered a rare disease, Biliary Atresia (BA) is the leading cause of neonatal cholestasis and liver transplantation in children. Little is known about the molecular mechanisms that drive BA. The purpose of this study is to collect the fluid samples, explanted liver tissue samples and dermal biopsy samples to enable investigators to perform the genetic and molecular analyses that might point to the gene(s) and cellular pathway involved in etiology of BA disease.

Detailed description: Biliary atresia (BA) is a disease characterized by intra- and extra-hepatic bile duct obstruction diagnosed in the neonatal period. If left untreated, this obstruction leads to biliary cirrhosis and early death. Although considered a rare disease (between 1/15,000 and 1/20000 births), it is the leading cause of neonatal cholestasis and liver transplantation in children. The reasons for this obstruction are still poorly known and might involve several factors (immune, infectious and possible toxin effect). The accumulating evidence point to genetic factors involved, yet they are not of the classic monogenic or Mendelian types. The purpose of this study is to collect the fluid samples, explanted liver tissue samples and dermal biopsy samples to enable investigators to perform the genetic and molecular analyses that might point to the gene(s) and cellular pathway involved in etiology of BA disease.

Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of biliary atresia in patients
* parents of BA patients

Exclusion Criteria:

* no

Primary outcomes:
measure: To identify the molecular mechanisms implicated in the etiology of BA
timeFrame: 10 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Necker enfants malades
state: De
city: Paris
country: France
facility: PRC Inserm
Study officials:
References:
Clinical trial NCT01230515: Opioid Titration in the Hospice Setting: Barriers Assessment and Modification of the Model Order Sheet and Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Pain
Keywords: Oncology Pain Management in outpatient hospice setting
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-10-29
Enrollment: 65
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospice Staff Caregiver Patient Referring Physician

Brief summary: The purpose of this study is to modify the opioid titration order sheet to meet the needs of the outpatient hospice population and to conduct a pilot trial to assess feasibility, utility, and derive preliminary efficacy data.


Eligibility criteria: Inclusion Criteria:

* Patient eligibility includes:

  * Alive Hospice outpatient
  * Diagnosis of carcinoma
  * Pain requiring fixed dose opioids
  * Age \> 21 years
  * Not pregnant or lactating
  * Willing and able to sign informed consent
  * Able to speak/comprehend English

Caregiver eligibility will include:

* Caregiver for an Alive Hospice patient
* Willing and able to sign informed consent
* Able to speak/comprehend English

Hospice Staff eligibility will include:

* Currently on staff at Alive Hospice
* Willing and able to sign informed consent
* Able to read/speak English.

Referring Physician eligibility will include:

* Having recently referred patients to Alive Hospice
* Willing and able to sign informed consent and able to read/speak English.

Exclusion Criteria:

* patients \< 21 years of age
* pregnant or lactating
* patients, caregiver and or Hospice staff that does not speak/comprehend English

Primary outcomes:
measure: Adequate pain control
timeFrame: Until death.
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingam Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Barbara Murphy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04892615: he Safety Research of Timing of the Removal of Abdominal Drains After Pancreatic Surgery
Official title: The Safety Research of Timing of the Removal of Abdominal Drains After Pancreatic Surgery ： Results of a Prospective Randomized Clinical Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Safety Issues
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prepare for elective pancreatic surgery, including laparoscopic or open pancreaticoduodenectomy and distal pancreaticocaudal body resection;

Brief summary: Randomized, open, single-center, controlled prospective studies were designed to obtain reliable level I evidence in evidence-based medicine.Based on the premise of at least a 6-fold reduction in pancreatic fistula, as observed by Kawai et al after early drainage.Considering the overall incidence of pancreatic fistula after standard pancreatectomy at our center (approximately 20%), we would expect this complication to occur in approximately 3.4% of cases in Group A.α was set as 0.05 and β was set as 0.2 (efficacy was 80%), indicating that the total number of study subjects was at least 114 patients (at least 57 patients in the experimental group and 57 patients in the control group).


Eligibility criteria: Inclusion Criteria:

* ECOG 0-2;
* The amylase value in the drainage tube of patients receiving pancreaticoduodenectomy or distal pancreatectomy was lower than 5000 IU/L on the first day after surgery;
* postoperative drainage tube placement;
* Patients with no obvious contraindication to surgery;
* Expected postoperative survival ≥3 months;

Exclusion Criteria:

* Pancreaticoduodenectomy and pancreaticogastric anastomosis were performed;
* Suspicion or abdominal bleeding within 5 days after surgery;
* suspected biliary and intestinal fistula within 5 days after operation;
* On the fifth day after the operation, abdominal CT reexamination showed local effusion with a depth greater than 3cm.

Primary outcomes:
measure: The incidence of postoperative pancreatic fistula and abdominal infection;
timeFrame: 3month
measure: Severity of complications (duration of postoperative hospital stay) was assessed by Dindo Clavien classification.
timeFrame: 3month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xianjun Fudan Yu
state: Sahnghai
Study officials:
affiliation: Fudan University
name: Xianjun F Yu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03287115: Biomarkers of Broccoli Intake: A Pilot Study
Official title: Biomarkers of Broccoli Intake: A Pilot Study to Characterize Novel Metabolites by Targeted Metabolic Profiling and Non-Targeted Metabolomics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
First posted: 2017-09-19
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objectives of the study are 1) to characterize plasma and urinary metabolites that originate from glucobrassicin, 1-methoxyglucobrassicin, 4-methoxyglucobrassicin, and 4-hydroxyglucobrassicin, which are the major indole glucosinolates found in broccoli, and 2) to identify novel plasma and urinary metabolites following broccoli consumption that may have roles in reducing the risk of cancer.

Detailed description: Consumption of Brassica vegetables is inversely associated with incidence of several cancers, including cancer of the lung, stomach, liver, colon, rectum, breast, endometrium, and ovaries. Brassicas are a good source of many nutrients, but the unique characteristic of Brassicas is their rich content of glucosinolates. Breakdown products of indole glucosinolates in Brassica vegetables show promise for reducing the risk of cancer, but have received comparatively less research attention than those of aliphatic glucosinolates. The aim of this study is to investigate plasma and urinary metabolites of indole glucosinolates from broccoli and to identify novel metabolites that may have roles in reducing cancer risk.

Eligibility criteria: Inclusion Criteria:

* Non tobacco user
* Cancer Free
* Not currently taking glucosinolate/isothiocyanate containing supplements

Exclusion Criteria:

* Type 2 diabetes requiring the use of diabetes pills, insulin, or non-insulin shots
* Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol, or Miradon (anisindione)
* History of bariatric surgery or nutrient malabsorption disease (such as celiac disease) or other metabolic disorders requiring special diet recommendations
* Pregnant, lactating, or intending to become pregnant during the study period
* Crohn's disease or diverticulitis
* Suspected or known strictures, fistulas or physiological/mechanical GI obstruction
* Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)

Primary outcomes:
measure: The change in glucosinolate metabolites will be measured in blood plasma and urine.
timeFrame: On Day 11
Secondary outcomes:
Other outcomes:
Locations:
city: Beltsville
country: United States
facility: USDA-ARS, Beltsville Human Nutrition Research Center
state: Maryland
Study officials:
References:
Clinical trial NCT05068115: Characteristics and Treatment Trends of Young Breast Cancer in China
Official title: An Study on the Trend of Change and Influencing Factors of Clinicopathologic Characteristics, Diagnosis and Treatment Pattern, and Survival Status of Young Breast Cancer in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2021-10-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young Breast cancer patients (≤35 years old) in China

Brief summary: To describe the clinical characteristics, the diagnosis and treatment, the survival status and change trend of young breast cancer patients in China from 2000 to 2015, and to explore and discuss the main influencing factors.

Detailed description: In this study, medical records and follow-up information of young breast cancer patients (age ≤35 years at first diagnosis) who were first diagnosed and treated in the years (2000, 2003, 2006, 2009, 2012 and 2015) were collected from multiple hospitals in China from 2000 to 2015, to establish a retrospective cohort of young breast cancer patients. Clinical characteristics, diagnosis and treatment, and survival rates of young breast cancer patients from 2000 to 2015 were analyzed. To explore the main factors affecting the clinical diagnosis and treatment and the survival of patients.

Eligibility criteria: Inclusion Criteria:

* Young Breast cancer patients (≤35 years old) in China

Exclusion Criteria:

* Breast cancer patients (\>35 years old) in China

Primary outcomes:
measure: Clinical features and trend
timeFrame: Between 2000 and 2015
measure: Diagnosis and treatment and trend
timeFrame: Between 2000 and 2015
measure: Survival situation and change trend
timeFrame: Between 2000 and 2015
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02825615: Better Arterial Cannulation Technique With Different Hemodynamics
Official title: Comparison of Conventional and Ultrasound Guided Techniques of Radial Artery Cannulation in Different Hemodynamic Subsets: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Failure
Shock
Keywords: radial artery cannulation
ultrasound guided
first success rate
systolic blood pressure
shock
Lead sponsor: Sultan Qaboos University
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Purpose Two techniques of radial artery cannulation, ultrasound guided (USG) and conventional method (CM) were compared to find the better technique in general and in different hemodynamic subsets of patients.

Method This is a prospective randomized, single center study of 100 patients. The details of the primary cannulation technique, number of attempts, time taken, failure and cross-over technique were recorded for three different hemodynamic subsets with Systolic blood pressure \<80 mm hg, 80-100 mm hg and \> 100 mm hg.


Eligibility criteria: Inclusion Criteria:

* All adult Patients worthy of radial artery cannulation, who consented

Exclusion Criteria:

* No consent

Primary outcomes:
measure: First pass success rate
timeFrame: 1 year
measure: Final/ultimate success rate of an intervention
timeFrame: 1 year
Secondary outcomes:
measure: Time taken for the respective technique
timeFrame: 1 year
measure: Attempts of cannulation
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.