louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00247468: Strict Glucose Control of Pediatric Intensive Care Unit (ICU) Patients
Official title: Strict Glucose Control of Pediatric ICU Patients to Reduce Mortality and Morbidity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Respiratory Failure
Cardiovascular Failure
Sepsis
Trauma
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2005-11-02
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study objective is to improve morbidity and mortality of high-risk critically ill children. Our hypothesis is that a strict ICU glucose control protocol will decrease morbidity and mortality associated with hyperglycemia in a population of high-risk critically ill pediatric patients.


Eligibility criteria: Inclusion Criteria:

* Vasoactive infusion (e.g. dopamine, epinephrine, norepinephrine) and/or
* Invasive mechanical ventilation
* Age between 1 mo and 21 yrs

Exclusion Criteria:

* Type I diabetes mellitus
* Have an illness that requires insulin daily
* Recipients of solid organ transplants
* Participation in an experimental trial that might affect outcome
* Post-operative patients with planned extubation upon recovery
* Patients on a dopamine infusion of less than 3 mcg/kg/minute

Primary outcomes:
measure: 30-day mortality rate from the time of enrollment
Secondary outcomes:
measure: Pediatric Overall Performance Category scores at ICU discharge and 6 months post-discharge
measure: rates of nosocomial bloodstream infections
measure: time to resolution of organ failure (mechanical ventilator days and days of vasopressor support)
measure: change in Pediatric Logistic Organ Dysfunction scores
measure: requirement of dialysis or hemofiltration for patients with acute renal failure
measure: volume of blood product transfusions per kilogram body weight (vol/kg).
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Vinay Nadkarni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02181868: Comparison of Biodegradable and Titanium Fixation Systems in Mandibular Symphysis or Parasymphysis Solitary Fractures
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Mandible Fracture
Rigid Internal Fixation
Three-dimensional Finite Element
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
First posted: 2014-07-04
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT

Brief summary: The mandible bears a wide range of mechanical load from the contraction of masticatory muscles, and has a significant function in normal chewing movements. Mandibular fractures are the most common maxillofacial fractures, accounting for 40%-71% of all maxillofacial fracture cases with an average of 62%. The etiology of mandibular fractures mainly includes assaults, road traffic accidents (RTAs), falls, and sports injuries. Although a wide variance exists in the reported percentage of anterior mandible fractures, aggregate analysis approximates these fractures at 17% of all mandibular fractures. The rigid internal fixation (RIF) technique has become a common treatment for mandibular fractures, in which titanium plates are used in the operation. Some patients have to remove the titanium plates in a second operation following bone healing because of sequelae, such as stress shielding. Biodegradable plates and screws have been developed to eliminate the problems associated with titanium fixtures. In this study, we aim to compare the clinical performance between biodegradable and titanium fixation systems after 12 months of follow-up in fixation of mandibular symphysis and parasymphysis solitary fractures. We also investigate the stress distributions of biodegradable and titanium fixation systems at mandibular symphysis solitary fracture on the conditions of intercuspal position, labial teeth occlusion, and premolar and molar occlusion using finite element analysis.


Eligibility criteria: Inclusion Criteria:

* Undisplaced and displaced mandibular symphysis and parasymphysis solitary fractures conducted at the department of Oral and Maxillofacial (OMF) Surgery, Tianjin Medical University General Hospital

Exclusion Criteria:

* The exclusion criteria were comminuted fractures
* Diabetes
* Connective tissue diseases
* Patients under the age of 18 and over the age of 60

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT06012968: Study on the Protective Effect of Gastrodin on Myocardial Injury in Patients Undergoing Cardiac Surgery
Official title: Study on the Protective Effect of Gastrodin on Myocardial Injury in Patients Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Surgical Procedures
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients included in this study were preoperatively diagnosed as hypertrophic cardiomyopathy.

Diagnosis of hypertrophic cardiomyopathy: according to the medical history and physical examination, echocardiography showed diastolic ventricular septal thickness of 15 mm.

Brief summary: This study intends to include hypertrophic cardiomyopathy patients over 18 years old who underwent cardiac surgery in our hospital. Patients were divided into medication group and control group according to the use of gastrodin during operation. The patients ' myocardial tissue samples were collected, the postoperative prognosis data were observed and recorded, and the data were analyzed. The degree of myocardial tissue cell damage and postoperative clinical outcomes were compared between the two groups.


Eligibility criteria: Inclusion Criteria:

* Patients with hypertrophic cardiomyopathy aged≥18 years, regardless of gender;
* Patients undergoing elective hypertrophic cardiomyopathy outflow tract surgery;
* Signed informed consent, good compliance.

Exclusion Criteria:

* suffering from more serious genetic diseases (such as immunodeficiency, thalassemia, etc.);
* moderate to severe malnutrition, moderate to severe anemia;
* persistent infection;
* severe preoperative underlying diseases (such as severe liver and kidney dysfunction)

Primary outcomes:
measure: Degree of myocardial cell injury
timeFrame: During postoperative hospitalization stay, an average of about two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT00477568: Back Pain Prevalence in Wheelchair Users and Associated Risk Factors
Official title: Back Pain Prevalence in Wheelchair Users and Associated Risk Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Back Pain
Keywords: Wheelchair users
Back pain
Prevalence
Risk factors
Lead sponsor: Kovacs Foundation
Sponsor class: OTHER
Collaborators: name: Mallorca Institute of Social Affairs
First posted: 2007-05-23
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Wheelchair users who do so on a constant basis (not occasional).

Brief summary: The primary purpose of this study is to determine the prevalence of back pain in permanent wheelchair users (excludes transitory users) in different regions of Spain. Another study objective is the identification of risk factors for back pain in this population. Data collection will be by means of a structured questionnaire which will be validated in a previous pilot study.


Eligibility criteria: Inclusion Criteria:

* Adults with established disability;
* Permanent wheelchair users;
* Having physical and intellectual ability to answer questionnaire.

Exclusion Criteria:

* Transitory wheelchair users;
* Diagnosis of inflammatory rheumatic disease, cancer, systemic infection;
* Red flags for systemic disease.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: Fundación Kovacs
state: Balearic Islands
city: Palma de Mallorca
country: Spain
facility: Instituto de Asuntos Sociales y Deportes de Mallorca
state: Balearic Island
Study officials:
affiliation: Unidad de la Espalda Kovacs, Hospital Universitario HLA-Moncloa
name: Francisco M Kovacs, MD, PhD
role: STUDY_DIRECTOR
affiliation: Instituto de Asuntos Sociales y Deportes de Mallorca, Palma de Mallorca, Spain
name: Juan Noguera, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004468: Study of Topical Calcitriol or Oral Calcitriol in Patients With Psoriasis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Psoriasis
Keywords: dermatologic disorders
psoriasis
rare disease
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: Boston University
First posted: 1999-10-19
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Evaluate the long term safety and efficacy of orally administered calcitriol in patients with at least 5% of their body covered with psoriasis.

II. Evaluate the long term safety and efficacy of topically administered calcitriol in patients with at least 5% of their body covered with psoriasis.

III. Compare the topical calcitriol treatment to the oral calcitriol treatment in these patients.

Detailed description: PROTOCOL OUTLINE: This is a part placebo-controlled (arm I) study. Patients either apply topical petrolatum (Vaseline) with calcitriol (vitamin D3) on a psoriatic lesion daily and petrolatum only on an other similar lesion daily to serve as a control (arm I) or receive oral calcitriol nightly (arm II).

Arm I patients continue treatment for at least 2 months. At the end of 2 months of topical treatment, one biopsy is taken of the lesion treated with calcitriol, one biopsy of the lesion treated with petrolatum alone, and one biopsy of skin unaffected by psoriasis. Lesions are also photographed prior to therapy, 2-4 weeks during therapy for the first two months, then once every 1-3 months, and then once at end of treatment.

Arm II patients increase dosage of oral calcitriol every 2 weeks up to a maximum dosage daily in the absence of adverse effects (high urinary calcium or serum calcium levels). Patients continue treatment for at least 1 month. Lesions are photographed prior to therapy, 2-4 weeks during therapy, and then once at end of treatment.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Psoriasis covering at least 5% of body

--Prior/Concurrent Therapy--

At least 30 days since prior systemic therapy for psoriasis

At least 14 days since prior topical therapy for psoriasis

No other concurrent treatment for psoriasis for the first 2-4 months of study

No calcium supplement greater than 1,000 mg per day

--Patient Characteristics--

No hypercalcemia

No hypercalciuria

Not pregnant

Effective contraception required of all fertile patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Boston University
name: Michael F. Holick
role: STUDY_CHAIR
References:
Clinical trial NCT05851768: Efficacy of Dexmedetomidine VS Magnesium Sulphate With Bupivacaine in Erector Spinae Block for Thoracotomy Pain
Official title: Analgesic Efficacy of Adding Dexmedetomidine VS Magnesium Sulphate as Adjuvants With Bupivacaine in Ultrasound-guided Erector Spinae Plane Block for Post Thoracotomy Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Analgesia
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative pain management is considered an integral part of perioperative care in patients undergoing thoracotomy. In order to reduce these complications, multiple regional techniques have been developed for thoracotomy including Intercostal nerve block, Erectospinae plane block and serratus block. Multiple adjuvants have been used in regional analgesia including adrenaline,clonidine,magnesium sulphate,dexmedatomidine and opoids.


Eligibility criteria: Inclusion Criteria:

* Age from 18 to 65 years.
* Male and female sexes.
* ASA I-II.,III
* Cancer patients undergoing thoracotomy incisions
* Body mass index (BMI) from 18.5 to 30 kg/m2

Exclusion Criteria:

* Patient refusal
* Known allergy to any of the used drugs
* Low platelet count, any coagulation defect

Primary outcomes:
measure: Total postoperative morphine consumption
timeFrame: First 24 hours postoperatively
Secondary outcomes:
measure: Time to first postoperative rescue analgesia.
timeFrame: First 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Walaa Y Elsabeeny
Study officials:
affiliation: Assistant professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University
name: Walaa Y Elsabeeny, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Anesthesia,Surgical intensive care and Pain management,Faculty of medicine
name: Ahmed A Mohamed, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00948168: Effect of Exenatide on Glucose Homeostasis Determinants in Type 2 Diabetes
Official title: 6-Months Exenatide and Glucose Homeostasis Determinants in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: T2DM
exenatide
HbA1c
weight
waist circumference
insulin sensitivity
beta-cell function
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2009-07-29
Enrollment: 34
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine in type 2 diabetic patients in secondary failure to combined oral therapy whether, besides improvement in glycemic control, addition of exenatide, a new drug introduced to treat diabetes before addition of insulin to current therapy, over 6 months is associated with improvement in beta-cell function, insulin sensitivity following 24-hours discontinuation of the drug.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes subjects
* 40 to 80 years
* body mass index (BMI) between 25 and 40 kg/m²
* baseline glycated haemoglobin (HbA1c) \> 7.0 %, despite a maximally-tolerated combined oral therapy with a BCF stimulant (sulfonylurea or repaglinide) plus metformin

Exclusion Criteria:

* previous or current use of glitazone
* previous use of systemic glucocorticoids, weight-reducing drug(s) such as sibutramine
* previous exposure to GLP-1 receptor agonist or DPP-4 inhibitors

Primary outcomes:
measure: Improvement in HbA1c
timeFrame: 6 months
Secondary outcomes:
measure: Non-invasive modeling of glucose homeostasis determinants, including insulin sensitivity
timeFrame: 6 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires St-Luc
state: Brabant
Study officials:
References:
Clinical trial NCT04878068: Study to Evaluate the Performance of the Therma COVID-19 Rapid Antigen Test for Detection of SARS-CoV-2
Official title: POC Study to Evaluate the Performance of the Therma COVID-19 Rapid Antigen Test for Detection of SARS-CoV-2 Virus in Human Saliva
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: Saliva Antigen
Rapid Saliva Test
Lead sponsor: Cannabis Research Associates
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential participants attending a COVID-19 testing centre for a PCR test will be approached to determine eligibility and obtain consent after they have had their PCR test completed. Three hundred participants will be recruited into the study.

Brief summary: The Therma COVID-19 Rapid Antigen Test is an in vitro rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in human saliva specimens. This test is intended for near-patient use at the point-of-care or lay person, self-use in a non-laboratory or home setting using saliva samples from individuals with or without symptoms of COVID-19.

The Therma COVID-19 Rapid Antigen Test will be compared to a Health Canada approved RT-PCR COVID-19 test. Nasopharyngeal (for RT-PCR) samples will be collected at a COVID-19 Testing centre and saliva (for the rapid antigen test) samples will be collected and compared.

The prospective, observational, feasibility study will test 300 participants to establish the performance characteristics of the test on saliva specimens.


Eligibility criteria: Inclusion Criteria:

1. Participant is willing to sign verbal informed consent form
2. Age 12 or older and parents or legal guardians must consent for children as required by law.
3. Participant is attending COVID-19 testing centre for a nasopharyngeal swab sample
4. Participant is willing to provide a self-collected saliva sample

Exclusion Criteria:

1. Participant has previously tested positive for COVID-19 within the past 90 days

Primary outcomes:
measure: Establish Performance of Therma COVID-19 Rapid Antigen Test
timeFrame: 1 day
Secondary outcomes:
measure: Participant Feedback
timeFrame: 1 day
measure: User Feedback
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: McMaster University
name: Ira Price, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05773768: EHRA-PATHS: Clinical and Health Economic Evaluation of New Care Pathways
Official title: EHRA-PATHS: Addressing Multimorbidity in Elderly Atrial Fibrillation Patients Through Interdisciplinary, Patient-centred Systematic Care Pathways - Clinical and Health Economic Evaluation of New Care Pathways
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 1300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In elderly atrial fibrillation (AF) patients, AF is usually a manifestation of risk factors and comorbidities not only limited to cardiovascular diseases. Especially in elderly often more than two comorbidities are present. The presence of comorbidities also affects outcomes in AF patients. Current healthcare systems are single-disease focused, which increases the risk of underdiagnosing, replicating diagnostic tests and adverse drug-drug interactions, placing a high burden on healthcare costs. Healthcare systems and hospitals are in need of new care pathways to address the complexity of multimorbid AF patients and to reduce costs. The EHRA-PATHS consortium set out to address this need for change in management for multimorbid, elderly AF patients in Europe through the development of new care pathways. The aim of this study is to evaluate the current management of risk factors and comorbidities, and subsequently implement the newly developed care pathways and evaluate if these pathways lead to better management of risk factors and comorbidities in multimorbid, elderly AF patients, compared to current standard care.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed atrial fibrillation (paroxysmal, persistent or permanent)
* ≥65 years of age
* Willing and able to participate and to attend the scheduled follow-up visits.

Exclusion Criteria:

* Atrial fibrillation episode was due to a trigger (i.e. postoperative, infection, hyperthyroidism etc.)
* Life expectancy of less than 1 year
* Participation in another clinical study (registry studies not included)
* Severe cognitive impairment / dementia (defined based on MMSE and CDR scoring systems)

Primary outcomes:
measure: Identification and management of risk factors and comorbidities
timeFrame: 6 months
Secondary outcomes:
measure: AF symptom burden
timeFrame: 6 months
measure: Quality of life (QoL)
timeFrame: 6 months
measure: Referrals to other disciplines
timeFrame: 6 months
measure: Patient and health care provider satisfaction
timeFrame: 6 months
measure: Healthcare resource use/costs
timeFrame: 6 months
measure: HRQoL/utility
timeFrame: 6 months
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References:
Clinical trial NCT02778672: Thermal Imaging of the Lung on a Smartphone to Differentiate Bacterial From Non Bacterial Causes of Pneumonia
Official title: Thermal Imaging of the Lung on a Smartphone to Differentiate Bacterial From Non Bacterial Causes of Pneumonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia, Bacterial
Infections, Bacterial
Keywords: bacterial pneumonia
children
diagnosing pneumonia
thermal imaging
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2016-05-20
Enrollment: 273
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 275 Infants at Queen Elizabeth Central Hospital in Blantyre, Malawi having a chest x-ray done to rule out pneumonia

Brief summary: This is a study of up to 275 participants from birth to 12 months who are having a chest x-ray while a patient at the Queen Elizabeth Central Hospital in Blantyre, Malawi. Participants will have thermal pictures of their chest taken by trained study staff using a Smartphone and a FLIR ONE attachment. Thermal images will be read by trained study staff to determine if bacterial pneumonia is present. Results of the thermal images will then be compared to the results of the chest X-ray. If additional images of the chest are available, additional thermal images will be taken of the same location within 24 hours of the other image.


Eligibility criteria: Inclusion Criteria:

* patient at Queen Elizabeth Central Hospital in Blantyre, Malawi
* having chest x-ray done to rule out pneumonia
* thermal image can be taken within 24 hours of chest x-ray
* parent/guardian provides written informed consent

Exclusion Criteria:

* none

Primary outcomes:
measure: Rate of concordance between thermal image and the concurrent chest x-ray regarding the diagnosis of bacterial pneumonia
timeFrame: Within 24 hours of the chest x-ray
Secondary outcomes:
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Queen Elizabeth Central Hospital
Study officials:
affiliation: Boston University
name: Patricia L Hibberd, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: