louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03889041: Caregivers of Children With Repaired Esophageal Atresia-tracheoesophageal Fistula
Official title: Concerns of Caregivers of Children With Repaired Esophageal Atresia-tracheoesophageal Fistula
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysphagia
Quality of Life
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Caregivers of children with EA-TEF

Brief summary: Children with esophageal atresia and tracheoesophageal fistula (EA-TEF) may experience feeding and swallowing difficulties, which result in stressful interactions between children and caregivers, and potentially impact the concerns of caregivers. The aim of this study was to assess concerns of caregivers of children with EA-TEF related to feeding-swallowing difficulties.

Detailed description: Children with repaired esophageal atresia-tracheoesophageal fistula (EA-TEF) experience some degrees of feeding and swallowing difficulties Feeding and swallowing difficulties cause aspiration-induced recurrent pneumonia, malnutrition, dehydration and stressful interactions with their caregivers. There is lack of knowledge regarding the concerns of caregivers of children with EA-TEF related to feeding and swallowing disorders.Therefore, the aim of this study was to assess concerns of caregivers of children with EA-TEF related to feeding-swallowing difficulties.

Eligibility criteria: Inclusion Criteria:

* Having a child with EA-TEF
* Having a child with swallowing disorders aged between 6 months-18 years

Exclusion Criteria:

* Having a child without swallowing disorders

Primary outcomes:
measure: The Turkish Feeding/Swallowing Impact Survey
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacetttepe University
Study officials:
affiliation: Hacettepe University
name: SELEN S ARSLAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02139241: The Efficacy and Safety of Ramosetron in Patients Undergoing Off Pump Coronary Artery Bypass Surgery
Official title: The Efficacy and Safety of Ramosetron in Patients Undergoing Off Pump Coronary Artery Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Bypass Graft Triple Vessel
Hypotension
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-05-15
Enrollment: 114
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the effects of ramosetron on corrected QT interval in patients undergoing off pump coronary artery bypass surgery.


Eligibility criteria: Inclusion Criteria:

* Elective off-pump coronary artery bypass graft surgery

Exclusion Criteria:

* Emergency operation
* preoperative use of any inotropics or mechanical assist device
* severe liver disease (\>Child class II)
* dialysis dependent renal failure
* Left ventricular ejection fraction \<30 %
* Combined major surgery like carotid endarterectomy
* Previous allergy history to any 5-hydroxytryptamine type 3 (5-HT3) antagonist
* Preoperative QT prolongation ( 500 \>msec) or arrhythmia

Primary outcomes:
measure: corrected QT interval (QTc interval)
timeFrame: up to 240 minutes after induction of general anesthesia
Secondary outcomes:
measure: hypotension or bradycardia during the peri-induction period and the coronary anastomosis period
timeFrame: up to 240 minutes after induction of general anesthesia
measure: incidence of postoperative atrial fibrillation
timeFrame: during the hospital stay (from ICU admission to hospital discharge, average of 1 week)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Havrilla PL, Kane-Gill SL, Verrico MM, Seybert AL, Reis SE. Coronary vasospasm and atrial fibrillation associated with ondansetron therapy. Ann Pharmacother. 2009 Mar;43(3):532-6. doi: 10.1345/aph.1L544. Epub 2009 Mar 3.
citation: Sahoo T, SenDasgupta C, Goswami A, Hazra A. Reduction in spinal-induced hypotension with ondansetron in parturients undergoing caesarean section: a double-blind randomised, placebo-controlled study. Int J Obstet Anesth. 2012 Jan;21(1):24-8. doi: 10.1016/j.ijoa.2011.08.002. Epub 2011 Nov 18.
citation: Kim TK, Cho YJ, Lim CW, Min JJ, Choi EK, Hong DM, Jeon Y. Effect of ramosetron on QTc interval: a randomised controlled trial in patients undergoing off-pump coronary artery bypass surgery. BMC Anesthesiol. 2016 Aug 3;16(1):56. doi: 10.1186/s12871-016-0222-1.
Clinical trial NCT03456141: Multimodal Analgesic Protocol to Moderate Acute Pain
Official title: Prospective, Observational Study With a Multimodal Analgesic Protocol to Moderate Acute Pain After Third Molar Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Post-operative
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for surgery at UNC oral and maxillofacial surgery clinic

Brief summary: With a prospective, observational study assess post-surgery pain levels and patient's use of opioids and other analgesic drugs to moderate pain following third molar surgery.

Detailed description: SPECIFIC AIMS Using the UNC surgery clinic multi-modal protocol of drugs/dosages to control acute pain after third molar surgery assess each post-surgery day(PSD) the patient reported

1. pain levels post-surgery as recorded by Likert-type and Gracely scales
2. quality of life(QOL) outcomes for lifestyle and oral function
3. number of opioid doses taken by subject-patients
4. number of NSAID and acetaminophen doses taken by subject-patients.

Eligibility criteria: Inclusion Criteria:

* ASA I,II At least two lower 3rd molars scheduled for removal

Exclusion Criteria:

* Patient being treated for opioid addiction/abuse including having Rx for suboxone, methadone

Primary outcomes:
measure: The impact of the surgery on the patient's post-surgery pain.
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina School of Dentistry
state: North Carolina
Study officials:
affiliation: UNC oral and maxillofacial surgery
name: Glenn Reside, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02386241: Identification of Genomic Changes in Families Having Multiple Members With Tumors
Official title: Identification of Genomic Changes in Families Having Multiple Members With Tumors
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Glioma
Keywords: brain tumor
Lead sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Sponsor class: OTHER
Collaborators: name: Translational Genomics Research Institute
First posted: 2015-03-11
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Families having multiple members (1st degree) with tumors.

Brief summary: This study will compare genomic alterations between the parents and the patients with high-grade glioma.

Detailed description: Genomic changes leading to the formation of brain tumors are slowly being discovered. Despite advances in genomic technology, much analysis is hindered by the lack of control samples that could better delineate genomic alterations leading to disease. The ideal genomic control would be the genetic material of the parents of afflicted individuals. The researchers propose to then compare the genomic material from parents of siblings, both of whom have a diagnosis of a high-grade glioma. Additionally, the researchers will then compare the genomic alterations between the parents and the patients. This analysis will provide an unprecedented insight into genomic level changes that take place between parents and patients that resulted in the formation of a high-grade glioma.

Eligibility criteria: Inclusion Criteria:

* 18 years or older.
* Family history of brain tumor in first degree relative

Exclusion Criteria:

* less than 18 years

Primary outcomes:
measure: Total genomic sequencing
timeFrame: within 30 days of blood or saliva collection
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute at St. Joseph's Hospital Medical Center
state: Arizona
Study officials:
affiliation: Saint Joseph's Hospital and Medical Center/Barrow Neurological Institute
name: Peter Nakaji, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06400719: Pilot Study of AVT16 in Healthy Adult Subjects
Official title: An Open Label, Single Arm Pilot Study to Investigate the Safety and Tolerability of a Single 300mg Intravenous Dose of AVT16 in Healthy Adult Subjects Aged 18 to 55 Years Inclusive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Alvotech Swiss AG
Sponsor class: INDUSTRY
First posted: 2024-05-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study in healthy adult subjects to evaluate the safety and tolerability of AVT16 after administration of a single intravenous administration. Pharmacokinetics and immunogenicity of AVT16 will also be evaluated.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects aged between 18 and 55 years old inclusive
* Medical history without evidence of clinically significant disorder, condition or disease that would pose a risk to subject safety
* Haematology and biochemistry tests within normal range

Exclusion Criteria:

* History of relevant drug and/or food allergies
* History of hypersensitivity to vedolizumab, AVT16 of their constituents
* Past or concurrent medical conditions that could potentially increase subject's risks or interfere with study evaluations

Primary outcomes:
measure: Incidence, nature and severity of Treatment Emergent Adverse Events
timeFrame: 18 weeks
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax) of AVT16
timeFrame: 18 weeks
measure: Frequency of anti-drug antibodies
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
facility: CCST
Study officials:
References:
Clinical trial NCT03906019: Indications of Erector Spinae Plane Block in Pediatric Patients
Official title: Defining the Indications and Levels of Erector Spinae Plane Block in Pediatric Patients: A Retrospective Study About Our Current Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Keywords: erector spinae plane block
postoperative pain
pediatric patients
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 141
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were operated by Department of Pediatric Surgery between the 1 September 2017 and 28 February 2019 and who received erector spinae plane blocks as a part of postoperative analgesia management.

Brief summary: Patients who were operated by Department of Pediatric Surgery between the 1 September 2017 and 28 February 2019 and who received erector spinae plane blocks as a part of postoperative analgesia management will be scanned.

Detailed description: There are a few randomized prospective studies of ESPB for its clinical effectiveness and all of them are in adults, except one. Also pediatric case reports are limited when compared to adults. We have been applying ESPB to our patients almost since from its first definition. But ESPB applications for pediatric patients, in our clinic, have started after a learning curve. Patients who were operated by Department of Pediatric Surgery between the 1 September 2017 and 28 February 2019 and who received erector spinae plane blocks as a part of postoperative analgesia management will be scanned.

Demographical data of the patient, patient position for the block, indication/surgery type, level of ESPB, unilateral or bilateral application, total volume applied, additional analgesic use, type of the analgesic if used will be investigated.

Eligibility criteria: Inclusion Criteria:

* Patients who were operated by Department of Pediatric Surgery

Exclusion Criteria:

* Incomplete patient forms

Primary outcomes:
measure: Numeric Rating Scale
timeFrame: preoperative 24th hour
measure: Face, Legs, Activity, Cry and Consolability Score
timeFrame: postoperative 24th hour
Secondary outcomes:
Other outcomes:
Locations:
city: İzmit
country: Turkey
facility: Kocaeli University Hospital
state: Kocaeli
Study officials:
affiliation: Kocaeli University
name: Can Aksu, Assistant Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04860219: Lactoferrin Use in (SARS-CoV-2) Management
Official title: The Prospect of Lactoferrin Use as Adjunctive Agent in Management of SARS COV-2 Patients: A Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2021-04-26
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Preventive, adjunctive and curative properties of lactoferrin have been evaluated since the first wave of severe acute respiratory syndrome coronavirus (SARS-CoV), viral respiratory disease, emerged 18 years ago. Despite the discovery of new vaccine candidates, there is currently no widely approved treatment for SARS-CoV-2 (COVID-19). Strict adherence to infection prevention and control procedures, as well as vaccines, can, however, prevent the spread of SARS-CoV-2. Objective: Hence, this study evaluated the efficacy of lactoferrin treatment in improving clinical symptoms and laboratory indices among individuals with mild to moderate coronavirus disease-19 (COVID-19). Design and Participants: A randomized, prospective, interventional pilot study conducted between July 8 and September 18, 2020 used a hospital-based sample of 54 laboratory confirmed participants with mild to moderate symptoms of COVID-19. Randomization into a control and two treatment groups ensured all groups received the approved Egyptian COVID-19 management protocol; only treatment group participants received lactoferrin at different doses for seven days. Clinical symptoms and laboratory indices were assessed on Days 0, 2 and 7 after starting treatments. Mean values with standard deviation and one-way analysis of variance with least significant difference post hoc of demographic and laboratory data between control and treatment groups were calculated. Key Results: Our study showed no stastically significant difference among studied groups regarding recovery of symptoms or laboratory improvement. Conclusion: Further research into therapeutic properties particularly related to dosage, duration and follow-up after treatment with lactoferrin in individuals with COVID-19 is required.


Eligibility criteria: Inclusion Criteria:

1. participants over 20 years of age
2. positive for nasopharyngeal swab reverse transcriptase polymerase chain reaction (RT-PCR) for COVID-19
3. blood oxygen saturation (SpO2) \> 93%.

Exclusion criteria:

1. pregnant and breastfeeding women
2. individuals confirmed to be allergic to milk protein
3. those with a medical history of bronchial hyperactivity or pre-existing respiratory diseases
4. ICU inpatients with COVID-19.

Primary outcomes:
measure: time to be symptoms free and normal laboratory results
timeFrame: 7 days after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine -Zagazig University
Study officials:
References:
Clinical trial NCT00848419: A Prospective Randomized Comparison of Fentanyl, Methadone and Morphine for Epidural Analgesia in an Experimental Pain Model
Official title: A Prospective Randomized Comparison of Fentanyl, Methadone and Morphine for Epidural Analgesia in an Experimental Pain Model
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Pain
Keywords: Epidural
Analgesia
Methadone
Morphine
Pharmacokinetic-pharmacodynamic
Experimental pain - analgesic response
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-02-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aims of this study are to provide pharmacokinetic-pharmacodynamic data to quantify the analgesic and side effect profiles of epidural methadone, fentanyl and morphine. The investigators will compare the analgesic effect at three dermatomes to assess the rostral spread of drug, the investigators will assess plasma levels to assess the systemic redistribution of drug and the investigators will assess surrogate markers of central opiate effects (nasal capnography and pupilometry). The investigators hypothesize that due to the long-duration of action of methadone, and its intermediate lipophilicity, that methadone will provide a predominantly segmental analgesia of long duration of action, with low rostral spread and low direct central depressant effects (including respiratory depression).


Eligibility criteria: Inclusion Criteria:

* Patients (men and women) scheduled for extracorporeal shock wave lithotrypsy (for nephrolithiasis) under regional anesthesia.

Exclusion Criteria:

* Inability to understand consent form; poor communication Refusal to sign consent form Contraindication to regional anesthesia Chronic opioid administration ASA classification 3 or greater Age \< 18 or \> 70

Primary outcomes:
measure: Change in heat pain tolerance from baseline (using QST Medoc)
timeFrame: At intervals: 30, 60, 90, 120, 180, 240, 300, 360, 410 min following drug and 24 hours following drug.
Secondary outcomes:
measure: Change in electrical pain tolerance from baseline
timeFrame: At same time intervals as primary outcome
measure: Plasma concentration of methadone, fentanyl, morphine (and metabolites)
timeFrame: At each of the time intervals as for primary endpoint
measure: Pupilometry
timeFrame: At each of the time intervals as primary endpoint
measure: Respiratory rate and arterial CO2 tension
timeFrame: At each of the time intervals as primary endpoint
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03744819: Biomarkers for Prediction of Tumor Response to Radiotherapy
Official title: Exploration of Potential Biomarkers to Predict Tumor Response to Radiotherapy in Patients With Solid Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Solid Tumors
Lead sponsor: Shantou University Medical College
Sponsor class: OTHER
Collaborators: name: University of Oxford
First posted: 2018-11-16
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients proven diagnosis of solid tumors and will have radiotherapy as part of their therapeutic regimens or will undergo surgery in Cancer Hospital of Shantou University Medical College.

Brief summary: This study aims to explore potential biomarkers for prediction of therapeutic outcomes in patients with solid tumors after radiotherapy

Detailed description: Patients pathologically confirmed with solid tumors that requires radiotherapy or surgery will be recruited to this study. Tumor samples were obtained from patients underwent surgery to establish the baseline status of biomarker assessed. Peripheral and microbiota will also be collected before and after surgery. For patients undergoing radiotherapy, tumor biopsy as well as collection of blood samples and microbiota will be performed during the course of treatment. These biological specimens will be used for assessment of tumor phenotypes and for exploration of potential biomarkers that could predict the tumor response to therapeutics and prognsis in patients with solid tumors.

Eligibility criteria: Inclusion Criteria:

* Pathological proven diagnosis of solid tumors
* Tumor accessible for biopsy during the course of radiotherapy or tumor samples could be obtained via surgery
* Patient must provide study-specific informed consent prior to study entry

Exclusion Criteria:

* History of autoimmune diseases
* History of immunotherapy
* Prior radiation therapy that would result in overlap of planned radiation therapy fields
* Will receive immunotherapy during the course of radiotherapy
* Contraindications for biopsy, such as high bleeding risk

Primary outcomes:
measure: Expression status of biomarkers and their dynamic changes during treatment and follow-up
timeFrame: From the date of enrollment until the date of disease progression, assessed up to 3 years
measure: Tumor short-term response to therapeutics
timeFrame: Within 1 month after the completion of radiotherapy
measure: Tumor long-term response to therapeutics
timeFrame: up to 3 years of follow-up
Secondary outcomes:
measure: Disease-specific survival
timeFrame: up to 3 years of follow-up
Other outcomes:
measure: Overall survival
timeFrame: up to 3 years of follow-up
Locations:
city: Shantou
country: China
facility: Cancer Hospital, Shantou University Medical College
state: Guangdong
Study officials:
affiliation: Affiliated Cancer Hospital of Shantou University Medical College
name: Chuangzhen Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: