louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06681818: Novel Method to Assess Hepatic Regeneration and Predict Hepatic Related Morbidity After Partial Hepatectomy
Official title: Postoperative Heme Oxygenase Induction and Carbon Monoxide Production as a Novel Method to Assess Hepatic Regeneration and Predict Hepatic Related Morbidity After Partial Hepatectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Liver Cancer Adult
Liver Regeneration
Keywords: hepatectomy
Lead sponsor: Englewood Hospital and Medical Center
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: the investigators will pursue two specific aims: (1) to monitor the extent of heme oxygenase induction (by measuring endogenous CO production) in relationship to the extent of hepatic resection (2) to assess the production of CO in patients following liver resection and correlate these findings to the rate of liver regeneration and liver function.


Eligibility criteria: Inclusion Criteria:

* Patient plans to have partial liver resection for primary liver pathology or metastatic disease
* Patient is able to comprehend and willing to sign the written consent form

Exclusion Criteria:

* Patients \< 18 years
* Patients identified as members of a vulnerable population, except women of child bearing potential with negative pregnancy test

Primary outcomes:
measure: correlation of carbon monoxide levels in exhaled breath with quantity and quality of liver regeneration
timeFrame: measurements will be taken pre, then 4 hours and 24 hours post resection
Secondary outcomes:
measure: level of carbon monoxide in exhaled air of patients
timeFrame: measurements will be taken pre, then 4 hours and 24 hours post resection
measure: quantity of liver regeneration, liver volume (ml)
timeFrame: one and three months after resection
measure: quality of hepatic regeneration, normalized liver function
timeFrame: one and three months post resection
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Englewood Hospital
state: New Jersey
Study officials:
affiliation: Englewood Hospital
name: Cherif Boutros, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02018718: Development and Validation Phase of Diffusion Tensor Imaging and Arterial Spin Labelling at 3 Tesla Using a Long-term Effort Model Applicable to Skeletal Muscle Characterization.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Marathoners
Keywords: Skeletal muscle
Marathon
MRI
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 25
Sex: MALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to demonstrate and quantify the micro architecture and micro vascular changes within skeletal muscles after marathon using 3T MRI (diffusion tensor and arterial spin labeling). Apparent diffusion coefficient, fractional anisotropy and flow parameters will be registered before and after the long-distance run on the lower leg. Axial T1 and axial SPAIR sequences will also be applied at the same time.Stress ox and inflammatory markers will be collected in blood and urine samples and compare with both MRI and Near-infrared spectroscopy (NIRS).


Eligibility criteria: Inclusion Criteria:

* Realizing between 2:10 and 4:30 in the marathon.

Exclusion Criteria:

* Smoker
* Subject with medical treatment or with a treatment interrupted for less than 30 days.
* Subject with a osteo-articular, cardiovascular, infectious, lung pathology and/or a metabolic chronic pathology.
* MRI Contraindication : Claustrophobic subject ; subject with a intra-cranial vascular clip, with a pacemaker, with a neurostimulator or a cochlear implant ; subject with intraocular metallic foreign bodies.

Primary outcomes:
measure: Fractional Anisotropy (FA) measure
timeFrame: at 4 days
Secondary outcomes:
measure: Apparent Diffusion Coefficient (ADC) value
timeFrame: at 4 days
Other outcomes:
Locations:
city: Montpellier Cedex 5
country: France
facility: University Hospital of Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Sébastien BOMMART
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05270018: Bacterial Lysates on Respiratory Tract Microecology and Evaluation of the Efficacy of Prevention and Treatment of VAP
Official title: Effect of Bacterial Lysates on Respiratory Tract Microecology in Patients With Mechanical Ventilation and Evaluation of the Efficacy of Prevention and Treatment of Ventilator-associated Pneumonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventilators, Mechanical
Keywords: Ventilators; Bacterial Lysates; Microecology; pneumonia
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 assess the effect of bacterial lysates on respiratory tract microecology in patients with mechanical ventilation and the efficacy of prevention and treatment of ventilator associated pneumonia.

Detailed description: After being informed about the study and potential risks, all patients giving written informed consent will undergo a one-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner in a 1:1 ratio to Bacterial Lysates( 14mg, once a day) or placebo(once a day).

Eligibility criteria: Inclusion Criteria:

* Patients admitted to ICU for mechanical ventilation
* The expected mechanical ventilation time is more than 72h
* Sign the informed consent form when conscious and voluntary, and complete the questionnaire survey and follow-up as required; If it is unable to sign the informed consent form and complete the questionnaire survey and follow-up, the legal representative or guardian can act on behalf of it.

Exclusion Criteria:

* Ventilator associated pneumonia is known and confirmed
* Pregnant or lactating female
* Allergic to the active ingredients of bacterial lysates or any excipients listed in the ingredients
* Patients with autoimmune diseases
* Patients with acute intestinal infection
* Patients participating in other clinical studies at the same time
* Patients considered unsuitable by other researchers to participate in this study

Primary outcomes:
measure: VAP incidence
timeFrame: 2 weeks
Secondary outcomes:
measure: Assessment of human immune status
timeFrame: one week
measure: drug resistant bacteria Incidence
timeFrame: one week
measure: Composition of respiratory bacteria
timeFrame: one week
measure: survival rate
timeFrame: 28 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT00644618: Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy
Official title: Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy Versus Gemcitabine Alone in Patients With Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Locally Advanced Pancreatic Cancer
Keywords: pancreatic cancer
locally advanced
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2008-03-27
Enrollment: 120
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
Primary purpose: TREATMENT

Brief summary: For patients with unresectable locally advanced pancreatic cancer, the combined use of external-beam radiation therapy (EBRT) and systemic chemotherapy of 5-FU has been widely recognized as the most effective chemoradiotherapy approach.But most patients succumb to local recurrence and metastasis after treatment, and the prognosis remains poor On the basis of the development and superiority of the interstitial brachytherapy and the radiosensitizing effect of gemcitabine, we performed a clinical study to explore the interaction of improved I-125 brachytherapy and gemcitabine and compare the regimen to the standard gemcitabine treatment specifically in patients with non-metastatic, unresectable pancreatic cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically proven
* locally advanced pancreatic adenocarcinoma stage
* No systemic metastases
* Age between 18-75
* Karnofsky-Performance Status equal to, or greater than 70 %
* At least a 2-dimensionally measurable tumor lesion
* Adequate renal and liver function
* Written consent statement
* Patients' compliance and geographical proximity
* Life expectancy equal to or greater than 3 months

Exclusion Criteria:

* Serious psychological disease
* Pregnancy and inadequate or not secure contraception or breastfeeding women
* Other previous malignant disease in the past two years
* Serious systemic concomitant diseases, excluding participation in a trial
* Other experimental treatment during or within 6 weeks prior to this trial (including chemotherapeutic medicine or immune-therapies)
* Every other condition or therapy assessed by the physician as an eventual risk for the patient or restricting the aims of the trial
* Distant metastasis

Primary outcomes:
measure: Survival
timeFrame: 2 years after the inclusion of the last patient
Secondary outcomes:
measure: response rate, clinical benefit response, and safety
timeFrame: 2 month after the treatment finished
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05445518: Jump Start Plus COVID-19 Support
Official title: Jump Start Plus: Coronavirus Disease (COVID-19) Support to Improve Resiliency and Mitigate Risks in Childcare Centers Serving Children From Low-income Ethnic Minority Backgrounds.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Health Wellness 1
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-07-06
Enrollment: 1200
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to further develop and examine the Jump Start Plus COVID Support (JS+CS) program, which encourages improved psychosocial functioning by promoting resiliency in childcare centers.


Eligibility criteria: Center Inclusion Criteria:

1. Have greater than 30 children ages 2- to 5-years old
2. Serve low-income families
3. Reflect the ethnic diversity of Miami-Dade County (60%Hispanic, 20% Non-Hispanic Black, 20% Non-Hispanic White

Child Inclusion Criteria:

1. Child ages 2-5 years old
2. Child enrolled in a childcare center

Exclusion Criteria:

* Children with feeding tubes or those that bring their own meals.

Primary outcomes:
measure: Change in Health Environment Rating Scale Scores
timeFrame: Baseline, Up to 3 years
measure: Change in Strengths and Difficulties Questionnaire Scores
timeFrame: Baseline, Up to 3 years
measure: Change in Devereux Early Childhood Assessments Scores
timeFrame: Baseline, Up to 3 years
Secondary outcomes:
measure: Change in Brief Resilient Coping Scale Scores
timeFrame: Baseline, Up to 3 years
measure: Change in Childcare Worker Job Stress Index Scores
timeFrame: Baseline, Up to 3 years
measure: Change in Every Day Stressors Index Scores
timeFrame: Baseline, Up to 3 years
measure: Change in Healthy Caregivers-Healthy Children Survey
timeFrame: Baseline, Up to 3 years
measure: Change in Teacher Opinion Survey
timeFrame: Baseline, up to 3 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Ruby Natale
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02387918: Prevention of POV After Paediatric Tonsillectomy
Official title: Vomiting After Tonsillectomy in Children: A Comparison of Dexamethasone and Acupuncture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vomiting
Keywords: Tonsillectomy
postoperative vomiting (POV)
Dexamethasone
Acupuncture
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-03-13
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Tonsillectomy is one of the most frequently performed surgical procedures in children. It remains associated with a high morbidity related to postoperative vomiting (POV), pain, risk of bleeding, and dehydration due to impaired oral intake. Current medications for POV have limited efficacy and may even be associated with potential side-effects. Non-pharmacological techniques such as acupuncture has been investigated as alternatives to antiemetics and as additional treatment modalities for POV.

Detailed description: Postoperative vomiting (POV) is one of the most common complication in children undergoing tonsillectomy. Its incidence is between 62% and 73% when no prophylactic antiemetic is given. Because of Limited efficacy and side effects with antiemetics, many alternative treatment had been used. Acupuncture is simple, inexpensive, and noninvasive with minimal side effects. The objective of this study is to compare two prophylactic antiemetic treatments :

* Dexamethasone (0.15 mg/kg) immediately after induction of anaesthesia
* Acupuncture treatment (immediately after induction of anaesthesia and for approximately 20 minutes)

Eligibility criteria: Inclusion Criteria:

* children aged 2-8 y.
* children ASA 1-2
* tonsillectomy with or without adenoidectomy

Exclusion Criteria:

* American Society of Anesthesiologists grade greater than or equal to III (patient with severe systemic disease)
* intravenous induction
* contraindication to steroids
* Rash or local infection over an acupuncture point
* administration of steroids in the 24 hours before the surgery
* Use of medication with antiemetic effect within the 24 hours before surgery
* Gastric or intestinal diseases
* refusal of parents

Primary outcomes:
measure: Incidence of POV after tonsillectomy with or without adenoidectomy
timeFrame: 24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Egypt
country: Egypt
facility: Faculty of Medicine Assuit University
state: Assuit
Study officials:
affiliation: health,Higher education
name: Seham Ibrahim, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02724618: Nanocurcumin for Prostate Cancer Patients Undergoing Radiotherapy (RT)
Official title: Phase II Study of Nanocurcumin Versus Placebo for Patients Undergoing Radiotherapy for Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Curcumin
Protection, Radiation
Controlled Clinical Trials, Randomized
Radiation Therapy
Prostate Cancer
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Behnam Daheshpour Charity Organization, Tehran, Iran
First posted: 2016-03-31
Enrollment: 64
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: There is a growing body of evidence exploring the role of curcumin as a radioprotector against radiation-induced injury in normal tissues as well as a radiosensitizer in tumor cells. The aim of this study is to determine the efficacy of oral nanocurcumin in prostate cancer patients undergoing radiotherapy.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate
* Candidate for External Beam Radiotherapy
* ECOG performance status 0-2

Exclusion Criteria:

* Patients with Metastatic Prostate Cancer
* Patients with Kidney \& Liver dysfunction
* Gastrointestinal disorders such as IBD, reflux and peptic ulcers
* Any adverse reaction to curcumin

Primary outcomes:
measure: Proctitis [assessed using Common terminology criteria for adverse events (CTCAE)]
timeFrame: 90 days
Secondary outcomes:
measure: Cystitis [assessed using CTCAE Grading Criteria]
timeFrame: 90 days
measure: Hematologic Toxicity
timeFrame: 90 days
measure: Biochemical progression-free survival (b-PFS)
timeFrame: 5-years
measure: Treatment Response
timeFrame: 3 months after treatment termination
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shohada-e-Tajrish Medical Center
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Abolfazl Razzaghdoust
role: STUDY_DIRECTOR
References:
Clinical trial NCT03834818: Collecting Outcomes and Managing Pain After Surgery
Official title: COMPAS Trial. Collecting Outcomes and Managing Pain After Surgery: Predicting Patients at High Risk for Chronic Opioid Use and Creating Algorithms to Responsibly Tailor Opioid Prescribing and Weaning After Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgery
Keywords: opioid use
pain
surgery
orthopedic surgery
orthopedic
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients undergoing orthopedic surgery at Duke Health will be eligible for enrollment. Additionally, all potential participants must be an adult at least 18 years of age, speak and read English, own a smartphone they are willing to use for the study, and live in the United States of America. All study assessments will take place on the app and other than baseline screening all assessments will take place after surgery until the patient stops taking opioids. Patients will be approached in the orthopedic clinic up to the day of surgery and asked if they are willing to be screened for inclusion. If they accept the screening request a link will be emailed to them or a QR code supplied that permits them to download the study app on their phone. Screening, consent, and all study data collection will occur from the app launch. All data will be collected after enrollment and consent through the Medable Research Application.
Primary purpose: PREVENTION

Brief summary: The primary aim of this study is to measure pain and psychosocial patient reported outcomes, objective functionality, and actual daily at home opioid usage in orthopedic patients. The study's goal following the data collection is to predict which patients are at high risk for chronic opioid use.


Eligibility criteria: Inclusion Criteria:

* aged 18-90 years old who are undergoing elective orthopedic surgery at Duke Health.
* Patients must have their own smartphone IOS or Android device.
* Patients must be able to read English.

Exclusion Criteria:

* Lacking capacity to provide consent.
* Cannot read English
* Under 18 years of age
* Older than 90 years of age

Primary outcomes:
measure: Reported Pain of Participants measured via PROMIS-29
timeFrame: 6 Months
measure: Reported Pain of Participants measured via PROMIS-29
timeFrame: 6 Months
measure: Reported Pain of Participants measured via Pain Catastrophizing pain scale.
timeFrame: 6 Months
measure: Opioid Use of Participants
timeFrame: 6 months
measure: Practicality of Mobile Application
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Orthopaedics
state: North Carolina
Study officials:
affiliation: Duke University
name: Michael Bullock, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01089218: The Impact of Antibiotic Prophylaxis on Incidence of Post-bronchoscopy Fever and Change of Serum Cytokines
Official title: The Impact of Antibiotic Prophylaxis on Incidence of Post-bronchoscopy Fever and Change of Serum Cytokines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fever
Pneumonia
Keywords: bronchoscopy
post-bronchoscopy fever
pneumonia
cytokines
amoxicillin/clavulanate
prophylaxis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-03-18
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Fever can develop after fiberoptic bronchoscopy (FB) in about 2.5 - 16 % of adult patients. We evaluated the impact of oral amoxicillin/clavulanate (AC) on incidence of postbronchoscopic fever and pneumonia.

Detailed description: For the population being undergone with bronchoscopy, the clinical signs and procedural measures for complication of bronchoscopy and cytokines will be checked.

Eligibility criteria: Inclusion Criteria:

* adult patients (aged 18 years or older) who underwent FB

Exclusion Criteria:

* concurrent treatment with antibiotics or systemic corticosteroid

Primary outcomes:
measure: The incidence of fever
timeFrame: 24 hr after bronchoscopy
Secondary outcomes:
measure: change of serum cytokines level
timeFrame: before bronchoscopy and 24hr after bronchoscopy
Other outcomes:
Locations:
Study officials:
affiliation: Seoul Metropolitan Government, Seoul National University Boramae Medical Center, 39 Boramae-Gil, Dongjak-Gu, Seoul, Republic of Korea 156-707.
name: Deog Kyeom Kim, MD.
role: STUDY_DIRECTOR
References:
citation: Park JS, Lee CH, Yim JJ, Yang SC, Yoo CG, Chung HS, Kim YW, Han SK, Shim YS, Kim DK. Impact of antibiotic prophylaxis on postbronchoscopy fever: a randomised controlled study. Int J Tuberc Lung Dis. 2011 Apr;15(4):528-35. doi: 10.5588/ijtld.10.0386.