louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01294098: Efficacy Study of Femoral Nerve Block in Children With a Femur Fracture
Official title: Examining the Efficacy of Femoral Nerve Block in Children With a Femoral Shaft Fracture
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Femoral Fractures
Pain, Postoperative
Keywords: Femoral Fractures
Pediatrics
Pain, Postoperative
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2011-02-11
Enrollment: 2
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the efficacy of the use of Marcaine in femoral nerve blocks and hematoma blocks for post operative pain relief for femoral shaft fractures in a pediatric population.

Detailed description: Children with femur fractures can have severe pain after elastic nail fixation. The current national standard for post operative pain control would be intravenous narcotics. In addition to the use of intravenous narcotics, there are two alternative methods used during the surgery in order to potentially decrease the pain post-operatively. These methods are hematoma block or a femoral nerve block. Both are proven safe and effective in children, however little research has been done to look at the effectiveness of these various methods compared to one another.

Eligibility criteria: Inclusion Criteria:

* A child with a femoral shaft fracture requiring surgical treatment and the placement of intramedullary nails
* Weight of 30-100 Kg
* Child must be older than 6 years old

Exclusion Criteria:

* Any child that had an open fracture
* A child that has a pain abnormality
* Any child with an allergy to local anesthetic
* Any child with a neurological injury
* Any child with the inability to report pain
* Any child that is unable to use a PCA post-operatively

Primary outcomes:
measure: Post-operative Pain Scores
timeFrame: with in the first 24 hours
measure: Post-operative Narcotic Use
timeFrame: within first 24 horus
Secondary outcomes:
measure: Femur Fracture Healing
timeFrame: first year
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St. Louis Childrens Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: J. Eric Gordon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04936698: The Prevalence and Risk Factors for Thyroid Dysfunction in Pregnant Women in Taiwan
Official title: The Prevalence and Risk Factors for Thyroid Dysfunction in Pregnant Women in Taiwan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Disease Pregnancy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women at their first trimester of pregnancy may be enrolled.

Brief summary: The investigators' aim is to enroll around 2000 patients from Taipei, Keelung, Linkou, Chiayi and Kaohsiung CGMH. All participants will receive universal thyroid function screening at 1st trimester, and those who was found to have hyperthyroidism or hypothyroidism will be referred to Endocrine department for further treatment. All participants will be followed at outpatient clinic, and their obstetric visit finding will be recorded. The maternal and neonatal outcomes will be analyzed.


Eligibility criteria: Inclusion Criteria:

* Pregnant women at first trimester (\< 14 weeks of gestational age)

Exclusion Criteria:

* None

Primary outcomes:
measure: The prevalence thyroid dysfunction
timeFrame: 40 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Chang Gung Memorial hospital
Study officials:
References:
Clinical trial NCT00575198: Drainage Amount for Removal of Thoracostomy Tube
Official title: Non-inferiority Randomized Trial Evaluating Removal of Thoracostomy Tubes Independent of the Drainage Amount Versus Removal When the Drainage Amount Is Low
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumothorax
Pleural Effusion
Keywords: Chest tubes
Trauma
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2007-12-18
Enrollment: 280
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether chest tubes can be safely removed without considering how much fluid is draining through the tube.

Detailed description: Thoracostomy tubes are routinely used to drain the pleural space of fluid and gas to optimize pulmonary mechanics. Clinicians frequently postpone removal of thoracostomy tubes if the drainage from the tube exceeds a specific volume threshold for the prior 24 hours. However, there is substantial variability in the drainage volume threshold that different clinicians use, and no threshold has been established as clearly superior to any other. Removing tubes independently of the drainage volume may result in a greater risk of pleural effusion or pneumothorax requiring an invasive drainage procedure. However, removing tubes independently of the drainage volume might also expedite recovery by allowing earlier removal of the tube, thus diminishing pain and increasing patient mobility.

Thoracostomy tube management practices, including the drainage volume threshold used, may be dissimilar for different types of disease processes, so this study will be restricted to patients who required a thoracostomy tube for treatment of traumatic injury.

Eligibility criteria: Inclusion Criteria:

* Thoracostomy tube in place for \<72 hours
* Age at least 14 years
* Hospitalized for traumatic injury or elective operation

Exclusion Criteria:

* Thoracostomy tube already removed from the pleural cavity of interest
* Mediastinal tubes
* Death expected within 48 hours
* Prisoner status
* Severe congestive heart failure
* End-stage liver disease
* End-stage renal disease
* History of or suspected empyema involving the pleural cavity of interest
* History of or anticipated need for pleurodesis of the pleural cavity of interest
* Malignant pleural effusion
* Pregnancy
* Previous participation in this study
* Thoracostomy tube drainage already \<2 mL/kg

Primary outcomes:
measure: Invasive drainage procedure
timeFrame: Within 60 days
Secondary outcomes:
measure: Time to thoracostomy tube removal
timeFrame: Within 60 days
measure: Pulmonary symptoms
timeFrame: 60 days
measure: Mortality
timeFrame: 60 days
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis, Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Garth H Utter, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01086098: PACE30: 30 Years in Cardiac Pacing
Official title: Trends in Cardiac Pacing - 30 Years of Implants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pacemakers
Keywords: Pacemakers
Survival
Lead sponsor: University of Dundee
Sponsor class: OTHER
First posted: 2010-03-12
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with pacemakers

Brief summary: Limited data exist regarding temporal trends in permanent pacemaker (PPM) implantation. To describe trends in incidence and comorbidities of PPM recipients, the investigators aim to conduct a retrospective population-based cohort study using record linkage, over a 32 year period.


Eligibility criteria: Inclusion Criteria:

* All patients with pacemakers

Primary outcomes:
measure: Cardiovascular Mortality
timeFrame: 30 years
Secondary outcomes:
measure: Hospitalisation for heart failure
timeFrame: 30 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05781698: Repurposing Fenofibrate in Modulating mTOR/NLRP3 Inflammasome in Patients With Ulcerative Colitis
Official title: Repurposing Fenofibrate in Modulating mTOR/NLRP3 Inflammasome in Patients With Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Manal Ali Mahrous Hamouda Faculty of Pharmacy, Menufia University
First posted: 2023-03-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fibrates, specific pharmacological agonists of PPARα, have been widely used to treat hypercholesterolemia and hypertriglyceridemia. Apart from their metabolic action, anti-inflammatory properties of fibrates have been described, including inhibition of NF-kappa B signaling and pro-inflammatory cytokine production. 4 Fenofibrate, an important peroxisome proliferator-activated receptor-a (PPAR- α) agonist, is widely used in clinical as a triglyceride (TG)-lowering agent


Eligibility criteria: Inclusion Criteria:

Age ≥ 18 years Both male and female will be included Negative pregnancy test and effective contraception. Mild and moderate UC patients diagnosed and confirmed by endoscope

Exclusion Criteria:

Breast feeding Significant liver and kidney function abnormalities Colorectal cancer patients Other inflammatory bowel diseases (CD). Patients with severe UC Patients taking rectal or systemic steroids Patients taking immunosuppressives or biological therapies Addiction to alcohol and/or drugs Known allergy to the Fenofibrate

Primary outcomes:
measure: • The primary endpoint is the change in disease activity index and the improvement in health-related quality of life (HRQL).
timeFrame: 6 months
Secondary outcomes:
measure: The secondary endpoint is estimated by changes in serum biomarkers.
timeFrame: 6 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Medicine, Menoufia University
state: Shebeen El-Kom
Study officials:
References:
Clinical trial NCT04502745: A Study to Evaluate Endoscope-assisted, Minimally-invasive Cortical Access System for Chronic Subdural Evacuation
Official title: A Pilot Study of Endoscope-assisted, Minimally-invasive Cortical Access System (MICAS) for Chronic Subdural Evacuation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Subdural Hematoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 6
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to evaluate a less-invasive alternative to the currently available method of removing aging blood in the subdural space.


Eligibility criteria: Inclusion Criteria:

* Must be 55 years of age or greater.
* Have a clinically symptomatic chronic subdural hematoma greater than 1 cm in maximal thickness and be judged clinically to need subdural evacuation.

Exclusion Criteria:

* Failure to obtain consent.
* Vulnerable study population.
* Any need for chronic anticoagulation.
* Pregnancy (verified by pregnancy testing at screening or medical history of a hysterectomy, oophorectomy, or post-menopausal).Prior surgery for subdural hematoma.
* Glasgow Coma Scale (GCS) less than 8.

Primary outcomes:
measure: Incidence of all serious adverse events
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jamie Van Gompel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02862145: Pharmacodynamics Study of MRX34, MicroRNA Liposomal Injection in Melanoma Patients With Biopsy Accessible Lesions
Official title: A Multicenter Phase 1B Pharmacodynamics Study of MRX34, MicroRNA miR-Rx34 Liposomal Injection, in Patients With Advanced Melanoma and Biopsy Accessible Lesions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Melanoma
Keywords: Biosy accessible melanoma
Lead sponsor: Mirna Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to investigate the biomarkers, pharmacodynamics and pharmacokinetics of the liposomal micro-ribonucleic acid-34 (microRNA-34, miR-34). Melanoma patients with easily accessible lesions will undergo serial biopsies and serial blood samples will be collected.

Detailed description: MRX34 Induction Therapy consists of 3 cycles of MRX34 treatment given over an approximately 8 week period. Dexamethasone 10 mg PO (or IV) will be given as premedication. On Days 1-5 of each treatment cycle, MRX34 will be given as a daily infusion followed by 16 days of rest. At screening a tumor biopsy sample will be required from all patients. Additional biopsies will be collected at Cycle 1 Day 3 and the end of Cycles 1 and 3 (Day 18 +/- 1 day)

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* Advanced or metastatic cutaneous, acral or mucosal melanoma
* Tumor lesions accessible to serial biopsies
* ECOG ≤ 1
* ANC ≥, Plts ≥100,000 /mm3

Exclusion Criteria:

* Serious active non-malignant disease
* Central Nervous System metastasis

Primary outcomes:
measure: Peak blood concentration and Area Under the Curve (AUC) of MRX34 after IV dosing and drug concentration in tissue biopsies
timeFrame: 3 months
Secondary outcomes:
measure: Frequency and severity of adverse events associated with MRX34 treatment
timeFrame: 6 months
Other outcomes:
measure: Change in tumor measurements over time using RECIST criteria.
timeFrame: 6 months
measure: RNA sequencing analysis of PBMCs to evaluate gene expression through TLR signaling, RIG-I Pathway and PD1/PD-L1 Blockade.
timeFrame: During 3 months of treatment
measure: Assessment of MRX34 accumulation in tumor tissue measured by qPCR and CISH.
timeFrame: During 3 months of treatment
Locations:
Study officials:
affiliation: Mirna Therapeutics
name: Susan Smith, MSN
role: STUDY_DIRECTOR
References:
Clinical trial NCT00172445: Clinical Studies of Kikuchi's Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Lymphadenitis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Kikuchi-Fujimoto disease is a distinctive syndrome of necrotizing lymphadenitis which was formally described in 1972 by two Japanese pathologists, Kikuchi and Fujimoto. It is a benign, self-limited disease that predominantly occurs in young women. It was more common in Asian people, especially in Japanese. The most frequent clinical presentations are fever (30\~50%) and cervical lymphadenopathy, often tender in palpable. Other lymph node regions can be affected, and hepatosplenomegaly may be present. The laboratory findings include leucopenia with atypical lymphocytosis. ESR, transaminases and lactate dehydrogenase are often raised. The clinical features are easily confused with other conditions, particularly lymphoma. Therefore the diagnosis depends on the pathological findings. The typical findings are paracortical lesions consisting of patchy zones of eosinophilic fibrinoid necrosis and abundant karyorrhexis. In general, spontaneous resolution of symptoms and signs within a few months can be expected without treatment.For decades, the etiology of Kikuchi's disease has been speculated. Although the perforin and Fas pathways of cytotoxic T cells induce an abundance of apoptosis and thus induce necrotizing lesions, the trigger factor is unknown. Since the disease can precede or occur in association with a connective tissue disorder, especially SLE, the autoimmune contribution to the etiology has also been speculated. However, the clinical course of Kikuchi's disease, often sudden onset and spontaneous resolution, the frequent flu-like or upper respiratory prodrome, and the prominence of cervical lymphadenopathy, support a viral cause. Evidence for a viral cause also includes peripheral blood atypical lymphocytosis and elevated serum IFN-a or 2'-5' oligoadenylate synthetase levels. Several infectious agents have been suggested, including bacteria (e.g. Brucella, Yersinia), parasites (e.g. toxoplasmosis) and viruses (e.g. EBV, CMV, HHV6, HHV8, parvovirus B19, HTLV, HIV).The aim of this study is to collect cases of Kikuchi' disease in bureau of NHI and NTUH. We will analyze the incidence rate, age of onset, sex, season of onset and clinical course to see if there is any clustered cases, or nosocomial infection. Then we will study the etiology of Kikuchi's disease especially the infection causes by analyzing pathologic specimen and serology. We hope to find out the etiology of Kikuchi's disease and the new treatment.


Eligibility criteria: Inclusion Criteria:

* Kikuchi's disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: LI-Chieh Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06179498: Partner Navigation Intervention for Hepatitis C Treatment Among Young People Who Inject Drugs
Official title: A Randomized Trial to Test the Efficacy of a Partner Navigation Intervention for HCV Treatment Among Young Adult People Who Inject Drugs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatitis C
Keywords: Young people who inject drugs
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-12-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Behavioral intervention: two counseling based sessions
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Partner Navigation Intervention Study is a randomized controlled study (RCT) to assess the efficacy and mechanism of action of the first behavioral intervention to increase hepatitis C (HCV) treatment initiation among adult people who inject drugs (PWID).

Detailed description: After an initial ramp-up phase to ensure intervention materials and protocols meet the needs of the target population and organizational setting, we will apply a stratified randomized design to enroll 250 adult PWID with recently diagnosed HCV infection ("index") and their primary injecting partner("partner") into a randomized control efficacy trial of a two-session partner navigation intervention, compared to standard of care. The primary endpoint is starting HCV treatment. Recruitment will over sample PWID between 18-30 years of age.

Eligibility criteria: Inclusion Criteria:

* Self report injecting drugs in the past month
* Self report a primary injecting partner (currently inject drugs together)
* HCV infection identified at partnering community-based clinical site

Primary outcomes:
measure: Intervention efficacy
timeFrame: 6 months, 12 months, and 24 months after HCV infection disclosure visit.
Secondary outcomes:
measure: Change in Partner Support (Intervention mechanism)
timeFrame: 1 week, 1 month, 3 months and 6-months after HCV infection disclosure visit
measure: HCV Treatment Completion
timeFrame: Point of HCV treatment initiation up to 3 years
measure: Sustained Virologic Response at 12 weeks post treatment completion (SVR12)
timeFrame: Point of HCV treatment initiation up to 3 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Meghan D Morris, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01564745: Cough Determinants in Mechanically Ventilated Patients
Official title: Cough Determinants in Mechanically Ventilated Patients: a Physiological Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Centre d'Investigation Clinique et Technologique 805
First posted: 2012-03-28
Enrollment: 180
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: In our knowledge there is only few data about the cough determinants in mechanically ventilated patients. However some failure of extubation is due to inefficiency cough. In order to determine some determinants of cough, the investigators propose to evaluate systematically different physiological parameters before and after extubation.

Detailed description: In order to evaluate, and identify the cough determinants, the investigators propose a physiological evaluation for each patients who were intubated and mechanically ventilated during at least 72 hours. Indeed inefficacy of cough after extubation is one of the main reason of extubation failure. However there is no any mean to evaluate it simply now.

Eligibility criteria: Inclusion Criteria:

* Patients mechanically ventilated since 72h
* Age \> 18 years
* Hospitalized in Intensive care Unit
* In weaning phase - with the classically criteria to be extubated
* Patients who passed the weaning test (T tube test or other)

Exclusion Criteria:

* Hemodynamic instability
* Absence of consent
* No cooperation of the patient
* Hemodynamic instability
* pH \< 7,30
* Severe hypoxemia

Primary outcomes:
measure: Interest of systematically cough evaluation before extubation
timeFrame: 2 days after extubation
Secondary outcomes:
measure: Correlation between success of extubation and respiratory parameters
timeFrame: 2 days after extubation
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital, Caen
city: Garches
country: France
facility: University Hospital, Garches
Study officials:
affiliation: University Hospital, Caen
name: Nicolas TERZI, MD - PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Garches
name: Frédéric Lofaso, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Garches
name: David Orlikowski, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Terzi N, Lofaso F, Masson R, Beuret P, Normand H, Dumanowski E, Falaize L, Sauneuf B, Daubin C, Brunet J, Annane D, Parienti JJ, Orlikowski D. Physiological predictors of respiratory and cough assistance needs after extubation. Ann Intensive Care. 2018 Feb 5;8(1):18. doi: 10.1186/s13613-018-0360-3.