louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02477423: A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome
Official title: A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth of Newborn
Enterocolitis, Necrotizing
Keywords: Microbiome
Antibiotics
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2015-06-22
Enrollment: 27
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether antibiotics given immediately after birth alter the development of the developing preterm infant's microbiome, which may further alter overall clinical outcomes.


Eligibility criteria: Inclusion Criteria for antibiotic randomization:

1. Infant must be born between the gestational ages of 28 0/7 weeks and 34 6/7 weeks

   -AND-
2. Infant must be born at investigator's home institution.

   -AND-
3. Infant must be considered to have a low risk of infection by one of the following criteria:

   1. Delivered for maternal indications (Cesarean section or induction of labor for maternal health, including pre-eclampsia, placental abruption, history of intrauterine fetal demise (IUFD)/abruption, multiple gestation requiring preterm delivery, etc) -OR-
   2. Delivered due to preterm labor to a mother without the diagnosis of chorioamnionitis/maternal fever or prolonged rupture of membranes \>18 hours

Exclusion Criteria for antibiotic randomization:

1. Signs of clinical illness within the first 3 hours of life:

   1. 5-minute Apgar \<5
   2. Requiring vasoactive drugs
   3. Seizures
   4. Significant respiratory distress requiring supplemental oxygen \>40%
2. Immature:Total (I:T) Ratio of \>0.2 on initial complete blood count (CBC)
3. Congenital anomalies, including renal anomalies requiring serum antibiotic level monitoring

ANY infant born between the gestational ages of 28 0/7 weeks and 34 6/7 weeks who do not meet inclusion criteria, with parental consent, can participate in the stool analysis only arm of the study.

Primary outcomes:
measure: Richness of the Preterm Infant Microbiome
timeFrame: 2 weeks
measure: Shannon Diversity of the Preterm Infant Microbiome
timeFrame: 2 weeks
Secondary outcomes:
measure: Chronic Lung Disease of Infancy (CLD)
timeFrame: 4-12 weeks
measure: Necrotizing Enterocolitis (NEC)
timeFrame: 4-12 weeks
measure: Retinopathy of Prematurity (ROP)
timeFrame: 4-12 weeks
measure: Intraventricular Hemorrhage (IVH)
timeFrame: 4-12 weeks
measure: Death
timeFrame: 18 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center - Comer Children's Hospital
state: Illinois
Study officials:
References:
Clinical trial NCT03945123: Effects of Red Ginseng on Liver Function
Official title: Effect of Korea Red Ginseng on Non-alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Dysfunction
Keywords: ginseng
Liver
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 94
Sex: ALL
Minimum age (years): 37
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Korea Red Ginseng (KRG) has effect on liver function

Detailed description: Korea Red Ginseng (KRG) has been known as a natural product with anti-inflammatory effect in liver disease. Gut microbiota plays an important roles in the pathophysiology of nonalcoholic statohepatitis (NASH). We evaluated the effect of KRG on the pathophysiology of NASH

Eligibility criteria: Inclusion Criteria:

* AST or ALT level \> 50 IU/L

Exclusion Criteria:

* Viral hepatitis
* Alcoholic hepatitis
* Autoimmune hepatitis
* Pancreatitis
* Hemochromatosis
* Wilson's disease
* Drug induced liver injury
* Cancer

Primary outcomes:
measure: Liver enzyme
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: ChuncheonSHH
state: Kangwon
Study officials:
affiliation: Chuncheon Sacred Heart Hospital
name: Ki Tae Suk, PhD.Md.
role: STUDY_CHAIR
affiliation: Chuncheon Sacred Heart Hospital
name: Jun Seok, MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hong JT, Lee MJ, Yoon SJ, Shin SP, Bang CS, Baik GH, Kim DJ, Youn GS, Shin MJ, Ham YL, Suk KT, Kim BS. Effect of Korea red ginseng on nonalcoholic fatty liver disease: an association of gut microbiota with liver function. J Ginseng Res. 2021 Mar;45(2):316-324. doi: 10.1016/j.jgr.2020.07.004. Epub 2020 Jul 16.
Clinical trial NCT02307123: One-year Outcome After Prehospital Intubation
Official title: One-year Outcome After Prehospital Intubation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: One-year Outcome After Prehospital Intubation
Keywords: Prehospital emergency care (MeSH)
Emergency medical services (MeSH)
Helicopter emergency medical service, Critical care (MeSH)
Airway management (MeSH)
Endotracheal intubation (MeSH)
Patient outcome
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2014-12-04
Enrollment: 483
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All non-cardiac arrest patients, whose airway was secured by the HEMS physician.

Brief summary: The primary aim of this study was to describe the long-term outcome of critically ill or severely injured patients not in cardiac arrest treated by an EMS physician.

Detailed description: The aim of helicopter emergency medical services (HEMS) is to supplement ground EMS units in the care of prehospital patients. The need for advanced airway management in critical out-of-hospital patients can be considered as one indicator of the severity of the patient's condition.

A recent European initiative suggested advanced airway management to be included in the top five research priorities for physician-provided prehospital care.To our knowledge, no previous studies describe the long-term outcome of critical prehospital patients treated by an EMS physician.

The primary aim of this study was to describe the long-term outcome of critically ill or severely injured patients not in cardiac arrest treated by an EMS physician. Our secondary aims were to determine the indications and causes for EMS physician performed prehospital endotracheal intubation.

Eligibility criteria: Inclusion Criteria:

* All non-cardiac arrest patients.

Exclusion Criteria:

* Patients with a known need for personal assistance in activities of daily life prior to the incident leading to prehospital intubation (outcome evaluation).
* Patients intubated by EMS before HEMS arrival.
* Death on scene or during transportation.

Primary outcomes:
measure: Mortality
timeFrame: 1 year
Secondary outcomes:
measure: Glasgow Outcome Score (GOS)
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Tampere University Hospital
name: Arvi Yli-Hankala, professor
role: STUDY_DIRECTOR
affiliation: Tampere University Hospital
name: Toni VS Pakkanen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University Hospital
name: Ilkka Virkkunen, MD, PhD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Tom Silfvast, MD, PhD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Tarja Randell, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05785923: Low-Risk Chest Pain Echo Study
Official title: The Impact of Point-of-Care Ultrasound Echocardiography on the Disposition of Low-Risk Chest Pain Patients in the Emergency Department
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chest Pain
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Pilot study to assess if a bedside point-of-care echocardiogram performed on emergency department patients identified as low-risk chest pain prior to discharge significantly changes patient disposition or follow up instructions.


Eligibility criteria: Inclusion Criteria:

* Adults presenting to the emergency department with an isolated chief complaint of chest pain with a HEART score of 3 or less
* Emergency physician of record has decided to discharge this patient from the Emergency Department

Exclusion Criteria:

* Patients who are unable to consent for themselves
* History of cardiac transplant or LVAD
* Pediatric patients
* Patients presenting with multiple complaints in addition to chest pain
* Echocardiogram already performed on patient during usual care
* Patients with another non-cardiac admittable diagnosis
* HEART score greater than or equal to 4

Primary outcomes:
measure: Disposition
timeFrame: Day of enrollment
Secondary outcomes:
measure: Follow up instructions
timeFrame: day of enrollment
Other outcomes:
Locations:
Study officials:
References:
citation: Laureano-Phillips J, Robinson RD, Aryal S, Blair S, Wilson D, Boyd K, Schrader CD, Zenarosa NR, Wang H. HEART Score Risk Stratification of Low-Risk Chest Pain Patients in the Emergency Department: A Systematic Review and Meta-Analysis. Ann Emerg Med. 2019 Aug;74(2):187-203. doi: 10.1016/j.annemergmed.2018.12.010. Epub 2019 Feb 2.
citation: Rainer TH, Leung YK, Lee A, Chan PY, Cheng NM, Wong JK, Yan BP, Ahuja AT, Graham CA. Add-on tests for improving risk-stratification in emergency department patients with chest pain who are at low to moderate risk of 30-day major adverse cardiac events. Int J Cardiol. 2016 Oct 1;220:299-306. doi: 10.1016/j.ijcard.2016.05.057. Epub 2016 May 14.
citation: Guner NG, Yurumez Y, Yucel M, Alacam M, Guner ST, Ercan B. Effects of Point-of-care Ultrasonography on the Diagnostic Process of Patients Admitted to the Emergency Department with Chest Pain: A Randomised Controlled Trial. J Coll Physicians Surg Pak. 2020 Dec;30(12):1262-1268. doi: 10.29271/jcpsp.2020.12.1262.
citation: Buhumaid RE, St-Cyr Bourque J, Shokoohi H, Ma IWY, Longacre M, Liteplo AS. Integrating point-of-care ultrasound in the ED evaluation of patients presenting with chest pain and shortness of breath. Am J Emerg Med. 2019 Feb;37(2):298-303. doi: 10.1016/j.ajem.2018.10.059. Epub 2018 Oct 30.
Clinical trial NCT05882123: Gender Heterogeneity in the Influencing Factors for Cerebral Microbleeds in Acute Ischemic Stroke Patients
Official title: Gender Heterogeneity in the Influencing Factors for Cerebral Microbleeds in Acute Ischemic Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Keywords: Acute ischemic stroke
Cerebral microbleeds
Influencing factors
Gender heterogeneity
Lead sponsor: The First Hospital of Hebei Medical University
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 482
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study, the data of patients with AIS who were admitted to the Department of Neurology of Hebei Provincial People's Hospital from January 2014 to December 2015 were continuously collected.

Brief summary: The investigators continuously collected data from 482 AIS inpatients at the Neurology Department of Hebei General Hospital. Both demographic and clinical data were collected from the study subjects. Different head magnetic resonance imaging sequences were used to assess the subjects' CMBs, white matter lesions, and old lacunar infarcts (LI). Various statistical methods, including the t-test, χ2 test, and logistic regression, were used to analyze the gender heterogeneity of the influencing factors for CMBs in AIS patients.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years and older
* Must meet the diagnostic criteria for AIS as presented in the Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2014
* Must be in good physical condition and have the ability to cooperate with MRI examinations
* Must have underwent SWI

Exclusion Criteria:

* MRI contraindications present, such as cardiac pacemaker, cardiac stents, or metal implants
* Head MRI or carotid artery ultrasound suggests the presence of severe stenosis or occlusion in the intracranial or extracranial segments of the cerebral arteries
* Severe comorbid diseases, such as cardiac, pulmonary, hepatic, and renal insufficiencies

Primary outcomes:
measure: Comparison of clinical data between AIS patients in CMB and non-CMB groups
timeFrame: from January 2014 to December 2015
measure: Comparison of clinical data between male and female AIS patients
timeFrame: from January 2014 to December 2015
measure: Comparison of CMB-related characteristics between the male and female AIS patients
timeFrame: from January 2014 to December 2015
measure: Predictive factor analysis for CMBs in male AIS patients
timeFrame: from January 2014 to December 2015
measure: Predictive factor analysis for CMBs in female AIS patients
timeFrame: from January 2014 to December 2015
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05979623: Clinicopathological Characteristics and Prognosis Analysis of Stage IB Non-small Cell Lung Cancer
Official title: Clinicopathological Characteristics and Prognosis Analysis of Stage IB Non-small Cell Lung Cancer：A Retrospective Real World Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stage IB Non-Small Cell Lung Carcinoma
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 971
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NSCLC patients with pathological stage IB resected by surgery (R0)

Brief summary: The goal of this observation study is to learn about clinicopathological characteristics and prognostic factors of stage IB NSCLC. The main question it aims to answer is wheather there is relationship between newly proposed clinicopathological features and the prognosis of stage IB NSCLC .The postoperative pathological and follow-up information of participants will be used for subsequent analysis.

Detailed description: A total of 971 NSCLC patients with pathological stage IB resected by surgery (R0) from January 2016 to December 2020 at Zhongshan Hospital of Fudan University were reviewed. The primary endpoint is RFS (recurrence-free survival) and OS (overall survival) is the secondary endpoint. The baseline characteristics of the patients were obtained statistically, and factors affecting the prognosis of patients with stage IB NSCLC were analyzed using survival analysis and Cox proportional hazard models. The characteristics of the patients include pathological type, STAS, GGO, gene mutation, and postoperative adjuvant chemotherapy.

Eligibility criteria: Inclusion Criteria:

* It was confirmed by histopathology as primary non-small cell lung cancer, and the pathological type was LUSC or LUAD;
* According to the 8th edition of TNM clinical staging standards, it is determined as IB stage
* No treatment was performed for the primary lesion of lung cancer before surgery;
* No history of other malignant tumors before surgery;
* Detailed clinical and pathological information, complete survival data, and no missing follow-up data.

Exclusion Criteria:

* The postoperative histopathological types include non-scale and non adenocarcinoma, such as lung adenosquamous cell carcinoma, large cell lung cancer, or lung sarcomatoid carcinoma;
* Multiple lesion staging surgery;
* History of merging with other malignant tumors
* Having preoperative treatment;
* Missing follow-up information.

Primary outcomes:
measure: RFS
timeFrame: 5 years
Secondary outcomes:
measure: OS
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
Study officials:
affiliation: Zhongshan Hospital, Fudan University, Shanghai, China
name: Di Ge, Ph.D;M.D
role: STUDY_CHAIR
References:
Clinical trial NCT04063423: Non- Clinical Coagulation Activation During Hemodialysis
Official title: Non- Clinical Coagulation Activation During Hemodialysis: a Cross-sectional Study Evaluating Agreement and Correlation Between Hemodialysis Session Parameters, Biological Markers and Objective Measurements of Hemodialyzers: "NC-coact"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Diseases
End Stage Renal Disease
Hemodialysis Complication
Keywords: clotting
coagulation
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with end stage renal disease treated with hemodialysis

Brief summary: Every patient included in the study will undergo 1 conventional hemodialysis treatment, ie 1 study visit. During the conventional hemodialysis treatment lasting 4 hours, 2 blood samples will be taken at different time points (5 minutes after dialysis start and 240 minutes after dialysis = at the end of the dialysis session) to evaluate coagulation activation (TAT, PF1+2). Hemodialysis session parameters (arterial and venous pressure, TMP, OCM, BVM and prefilter pressure) will be noted at different time points (T5, T30, T60, T120, T180, T240). After discontinuation of the dialysis session, total cell volume will be measured using the Renatron II system® and the number of open fibers will be determined using micro-CT scanning.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age.
* Patients able and agree to provide signed informed consent.

Exclusion Criteria:

* Known allergy for polysulphone dialysis membrane.
* Use of vitamin K antagonists or novel oral anticoagulant therapy.
* Use of chronic heparin treatment, UFH or LMWH.

Primary outcomes:
measure: TAT
timeFrame: From first hemodialysis study session until interpretation of biological results, up to 6 months
measure: open fibers
timeFrame: From first hemodialysis study session until interpretation of scan results, up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
Study officials:
References:
Clinical trial NCT05997823: Dorsovolar Kinesiotape in Carpal Tunnel Syndrome
Official title: Is Dorso-Volar Kinesiotape Added to the Home Exercise Program Effective in the Treatment of Carpal Tunnel Syndrome?-Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome Treatment
Keywords: carpal tunnel syndromes
kinesiotape
electromyography
median neuropathy
muscle strength
pain
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 120
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to compare the short- and medium-term efficacy of dorso-volar kinesiotape (KT) added to home exercises (HE) with sham-KT and HE alone in the treatment of mild or moderate carpal tunnel syndrome (CTS) in terms of pain, symptom severity, function, grip strength, and electrophysiological parameters.


Eligibility criteria: Inclusion Criteria:

* pain or numbness radiating to the palm for at least 6 weeks,
* at least one positive Tinel's, Phalen's, or carpal compression test on physical examination, and
* mild/moderate CTS on EMG examination.

Exclusion Criteria:

* Metabolic disease (diabetes, rheumatoid arthritis, thyroid disease),
* systemic or malignant disease, history of trauma, fracture or surgery to the wrist,
* physical therapy programs, surgical procedures, injections or KT applications to the wrist for CTS treatment in the past year,
* severe thenar atrophy,
* C6-C7 radiculopathy among CTS differential diagnoses,
* cervical spondylosis, thoracic outlet syndrome, entrapment of the median nerve above the wrist,
* polyneuropathy or traumatic injury to the median nerve,
* rashes or open wounds on the skin of the wrist and forearm that could prevent treatment with kinesiology taping

Primary outcomes:
measure: Electrodiagnostic Evaluation
timeFrame: 30 minutes
measure: Hand Strength
timeFrame: 10 minutes
measure: Pain Evaluation
timeFrame: 5 minutes
measure: Finger Strength
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Health Sciences University, Kocaeli Derince Training and Research Hospital
state: Deince
Study officials:
References:
Clinical trial NCT00368823: A Trial of Point of Care Information in Ambulatory Pediatrics
Official title: A Randomized Clinical Trial to Improve Prescribing Patterns in Ambulatory Pediatrics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Otitis Media
Allergic Rhinitis
Sinusitis
Constipation
Pharyngitis
Croup
Urticaria
Bronchiolitis
Keywords: point of care
evidence based medicine
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2006-08-29
Enrollment: 44
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Does presentation of clinical evidence for decision making at point-of-care improve prescribing patterns in ambulatory pediatrics?

Detailed description: We showed previously that an electronic prescription writer and decision support system improved pediatric prescribing behavior for otitis media in an academic clinic setting. This study assessed whether point-of-care evidence delivery could demonstrate similar effects for a wide range of other common pediatric conditions. We performed a randomized controlled trial in a teaching clinic/clinical practice site and a primary care pediatric clinic serving a rural and semi-urban patient mix. There were 36 providers at the teaching clinic/practice site, and 8 providers at the private primary pediatric clinic, and an evidence-based message system presented real time evidence to providers based on prescribing practices for acute otitis media, allergic rhinitis, sinusitis, constipation, pharyngitis, croup, urticaria, and bronchiolitis. We measured the proportion of prescriptions dispensed in accordance with evidence.

Eligibility criteria: Inclusion Criteria: The 44 clinical providers at the two participating clinics. -

Exclusion Criteria: Study investigators

-

Primary outcomes:
measure: prescribing practices for acute otitis media,
measure: allergic rhinitis,
measure: sinusitis,
measure: constipation,
measure: pharyngitis,
measure: croup,
measure: urticaria,
measure: bronchiolitis
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Roosevelt Pediatric Clinic
state: Washington
city: Skagit Valley
country: United States
facility: Skagit Valley Pediatrics
state: Washington
Study officials:
affiliation: University of Washington
name: Robert L Davis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: