louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06757439: Frailty and Spinal Anesthesia-Induced Hypotension in Elderly
Official title: Effect of Frailty on Spinal Anesthesia-induced Hypotension in Geriatric Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Frailty
Spinal Anesthesia
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female patients aged 65 and over

Brief summary: 60 patients aged 65 and older with ASA I-III physical status undergoing elective surgery under spinal anesthesia will be included in the study.

Patients with cardiac arrhythmia, severe heart failure, cerebrovascular disease, or contraindications to neuraxial anesthesia will be excluded. Frailty assessments will be performed using the Clinical Frailty Scale (CFS) version 2.0 by anesthesiologists in preoperative clinics or wards. Participants will be categorized into frail (CFS Level ≥4, Group I) and non-frail (CFS Level ≤3, Group II) groups.

Prior to spinal anesthesia, 8 mL/kg of crystalloids will be administered. Baseline preoperative mean arterial blood pressure (MABP) and heart rate (HR) will be recorded as the average of three measurements in the supine position.

During the study, MABP and HR will be monitored every 2 minutes for the first 20 minutes post-spinal anesthesia, then every 5 minutes until surgery ends. Hypotension (MABP \<80% of baseline) will be treated with 5 mg intravenous ephedrine, while bradycardia (HR \<50 beats/min) will be treated with 0.5 mg intravenous atropine.


Eligibility criteria: Inclusion Criteria:

* 65 and older
* ASA I-III physical status
* Undergoing elective surgery under spinal anesthesia

Exclusion Criteria:

* Patients with cardiac arrhythmia
* Patients with severe heart failure
* Patients with cerebrovascular disease
* Contraindications to neuraxial anesthesia

Primary outcomes:
measure: Rate of Hypotension
timeFrame: Preoperative baseline, every 2 minutes for the first 20 minutes, and then at 5-minute intervals until the completion of the surgery.
Secondary outcomes:
measure: Rate of Bradycardia
timeFrame: Preoperative baseline, every 2 minutes for the first 20 minutes, and then at 5-minute intervals until the completion of the surgery.
measure: Ephedrine usage
timeFrame: During the procedure
measure: Rate of Nausea and vomiting
timeFrame: up to 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01881139: Impact of Exercise Training on Cardiac Function in Man
Official title: Effects of Exercise Training on Cardiac Function and Lipid Metabolism in Mem 18-22 Year Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cardiovascular Disease
Keywords: Exercise
Lipid
Left ventricular
heart function
Lead sponsor: No. 150 Central Hospital of the Chinese People Liberation Army
Sponsor class: OTHER_GOV
First posted: 2013-06-19
Enrollment: 46
Sex: MALE
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to monitor the impact of exercise training on cardiac functions and lipoprotein lipids.

Detailed description: Exercise can increase the mass of left ventricle, which is also called athletic heart. Athletic heart is most frequently encountered as a pathological manifestation of cardiovascular disease, and the early determinants of athelitic remodeling in the general population are largely unknown. We will recruit 45 men aged 18-25 years who will run 5000 meters 2/day for 3 months. caridac function is examined by ECG and echocardiogram, blood pressure, lipoprotein, heart rate, body weight, cardiac troponin will be examined prior to exercise program and 3 months after exercise.

Eligibility criteria: Inclusion Criteria:

* men
* age 18-25 years
* body mass index (BMI) 18-25 kg/m2
* no regular exercise
* no tobacco use
* no current use of prescribed medications
* no self-report of acute of chronic diseases

Exclusion Criteria:

* conditions that do not meet the inclusion criteria listed.

Primary outcomes:
measure: change of cardiac function at baseline to exercise training for 3 months
timeFrame: baseline to 3 months
Secondary outcomes:
measure: change of lipoprotein at baseline to exercise training for 3 months
timeFrame: baseline to 3 months
measure: change of heart rate at baseline to exercise training for 3 months
timeFrame: baseline to 3 months
measure: Change of body weight at baseline to exercise training for 3 months
timeFrame: baseline to 3 months
measure: change of cardiac troponin frome baseline to exercise training for 3 months
timeFrame: baselin to 3 months
measure: Change of blood pressure from baseline to exercise training for 3 months
timeFrame: baseline to 3 months
Other outcomes:
Locations:
city: Luoyang
country: China
facility: No. 150 Central hospital of Chinese People's Liberation Army
state: Henan
Study officials:
affiliation: No. 150 Central Hospital of PLA
name: Shenxu Wang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05818839: Biomechanical Properties and Their Association With Balance and Functional Mobility in Children With Cerebral Palsy
Official title: Biomechanical Properties and Their Association With Balance and Functional Mobility in Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: postural balance
muscle properties
mobility
paralysis
children
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children diagnosed with unilateral spastic cerebral palsy (GMFCS level I-II, spasticity level MAS ≤ 2) and their age-matched typically developing peers.

Brief summary: This study aimed to investigate the differences in the biomechanical properties of the dorsal trunk and lower extremity muscles of children with unilateral spastic cerebral palsy compared with their typically developing peers, and the effect of these biomechanical properties on balance and functional mobility performance.


Eligibility criteria: Inclusion criteria for unilateral spastic cerebral palsy were:

* aged between 4 and 12 years,
* spasticity level MAS≤2,
* mental level sufficient to understand commands given,
* and ambulation without the use of an orthosis or other device. In addition, children had to be GMFCS level I or II.

Exclusion criteria were:

* a history of spinal surgery or spinal orthosis use,
* uncorrected vision or hearing problems,
* severe epileptic seizures,
* lower extremity contractures,
* botulinum toxin A injection in the previous six months,
* lower extremity surgery in less than one year,
* use of pharmacological agents that affect muscle tone,
* and poor cooperation.

Inclusion criteria for controls were:

* aged between 4 and 12 years,
* no neurological or orthopaedic diagnosis,
* no known systemic problems,
* normal vision and hearing,
* and a mental level sufficient to understand the commands given.

Primary outcomes:
measure: The Pediatric Balance Scale
timeFrame: Baseline
measure: Trunk Control Measurement Scale
timeFrame: Baseline
measure: 2-Minute Walk Test
timeFrame: Baseline
measure: Timed Up and Go Test
timeFrame: Baseline
measure: Muscle tone (Hz)
timeFrame: Baseline
measure: Stiffness (N/m)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Okan University
Study officials:
References:
Clinical trial NCT02853539: Denosumab in Metabolic Bone Disease in Chronic Intestinal Failure Patients
Official title: Denosumab Counteracts Metabolic Bone Disease in Chronic Intestinal Failure Patients: A Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metabolic Bone Disease
Lead sponsor: Stanley Dudrick's Memorial Hospital
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low bone mineral density (BMD) is commonly reported in patients receiving home parenteral nutrition (HPN). Denosumab represent a new drug, which helped to prevent osteoclast. The aim of the study was to assess its value in chronic intestinal failure patients.

Detailed description: Low bone mineral density (BMD) is commonly reported in patients receiving home parenteral nutrition (HPN). Oral and intravenous calcium, vitamin D and bisphosphonates have been commonly used to treat BMD, but their efficiency is may be inadequate due to limited absorption and compliance. Denosumab represent a new drug, which helped to prevent osteoclast development and activation, hence decreased bone resorption in some studies. The aim of the study was to assess its value in chronic intestinal failure patients receiving HPN.

Between November 2011 and March 2013 denosumab was administered to 16 HPN patients (9 F, 7 M mean age 55.4) with intestinal failure. Regional dual-energy x-ray absorptiometry of spine and hip were performed before the therapy was initiated, and after 12 months. BMD, T-score and Z-score were measured.

Eligibility criteria: Inclusion Criteria:

* intestinal failure requiring home parental nutrition
* bone disease measurement

Exclusion Criteria:

* intestinal failure not requiring HPN
* diagnostic modalities impossible

Primary outcomes:
measure: Improvement of bone structure: Spine
timeFrame: 36 months
measure: Improvement of bone structure: Femur
timeFrame: 36 months
Secondary outcomes:
measure: Treatment tolerance: gastrointestinal
timeFrame: 36 months
measure: Treatment tolerance: bone pain
timeFrame: 36 months
Other outcomes:
Locations:
city: Skawina
country: Poland
facility: Stanley Dudrick's Memorial Hospital
Study officials:
References:
Clinical trial NCT05402839: Screening of Malignant Hyperthermia Susceptible Individuals
Official title: Molecular Genetics Study on Screening of Malignant Hyperthermia Susceptible Individuals
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Hyperthermia
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Since the incidence of malignant hyperthermia is low (1/50,000 in adults, 1/15,000 in children), it is a rare disease, so this study will continue for 10-20 years. This study is an observational study, so the sample is estimated based on the past incidence of this rare disease. The amount is about 50 patients.

Brief summary: This study intends to target patients who underwent surgery under general anesthesia during the study period and developed malignant hyperthermia during or after surgery. Therefore, the total sample size was estimated to be about 50 people based on the past incidence of this rare disease. Every year, about 20 patients and their families who developed malignant hyperthermia during or after surgery will participate in this nationwide study (estimated by the current incidence of malignant hyperthermia), and about 1-5 patients will be admitted to Peking University Third Hospital participate in this research. Relevant specimens were collected from malignant hyperthermia (MH) patients and their family members for genetic analysis to determine the mutation of MH-related pathogenic gene loci.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgery under general anesthesia during the study period developed malignant hyperthermia during or after surgery.

Exclusion Criteria:

* Malignant hyperthermia was ruled out by later treatment and diagnosis;
* The patient or family member refuses to be recruited.

Primary outcomes:
measure: Whole exome sequencing
timeFrame: immediately after MH was diagnosed
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04893122: Impact of Pandemic of Presentation to Emergency Department and Admissions
Official title: Impact of the COVID-19 Pandemic on Emergency Department Attendances and Admissions in Southampton for Children and Young Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergencies
Keywords: emergencies
children
adolescents
young adult
Lead sponsor: University of Southampton
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 166459
Sex: ALL
Minimum age (years): 0
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and young adults aged 0 to 24 years who have presented +/- admitted to the emergency department at University Hospital Southampton NHS Foundation Trust between the 1st of April 2016 and 31st of March 2021. Some children presented to paediatric assessment unit prior to September 2019; after that the patient pathway was merged with the emergency department.

Brief summary: Observational study assessing the impact of the COVID-19 pandemic on presentations and admission to hospital in children and young adults.

Detailed description: The COVID-19 pandemic has had a major impact on healthcare utilisation and delivery for children and young adults. This is despite these groups experiencing minimal morbidity and almost no mortality as a direct result of the pandemic. The immediate impact of the first lockdown in April 2020 has been well documented. A number of studies show a marked reduction in presentations of children and young adults to the emergency department.

The question is now, are these trends continuing and are they particularly impacting on specific groups and on specific presentations? With these data, services can be modified to minimise any potential for deleterious effects. It may also be possible to target groups who are not utilising health services as the investigators would expect.

The investigators will use fully anonymised routine data on presentations and admission of 0 to 24 years olds to University Hospital Southampton NHS Foundation Trust. Data will be graphed to show trends in activity before and after the start of the pandemic. An interrupted time series regression analysis will be used to assess the significance of any changes in trends.

Eligibility criteria: Inclusion Criteria:

* Children and young adults aged 0 to 24 years
* Presented +/- admitted to the emergency department at University Hospital Southampton NHS Foundation Trust between the 1st of April 2016 and 31st of March 2021

Exclusion Criteria: None

Primary outcomes:
measure: Attendance in emergency department or paediatric assessment unit
timeFrame: 5 years from April 2016
Secondary outcomes:
measure: Emergency admission to hospital
timeFrame: 5 years from April 2016
Other outcomes:
Locations:
Study officials:
References:
citation: Solanke F, Easton S, Selby A, James D, Roberts G. Impact of COVID-19 pandemic on emergency department attendances for young people. Arch Dis Child. 2023 May 3;107(10):e1-e7. doi: 10.1136/archdischild-2021-323389.
Clinical trial NCT04789122: Assessment of Poles' Attitudes Towards Living Kidney Donation
Official title: Assessment of Poles' Attitudes Towards Living Kidney Donation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease
Lead sponsor: Andrzej Frycz Modrzewski Krakow University
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Poles randomly chosen from all voivodships,

Brief summary: The main goal of the project is to examine the public opinion on living kidney donation and to assess the knowledge of Poles in this field.

Detailed description: Researchers also want to estimate how large percentage of the respondents will declare their willingness to donate a kidney to a stranger and what percentage of respondents would support a possible extension of the existing law on the collection, storage and transplantation of cells, tissues and organs of July 1, 2005 to include donation to a stranger.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Polish citizenship

Exclusion Criteria:

* below 18 yers of age
* not Polish citizen

Primary outcomes:
measure: Questionnaire answers under statistical processing
timeFrame: 15.03.2021
Secondary outcomes:
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Andrzej Frycz Modrzewski Krakow University
state: Małopolska
Study officials:
References:
citation: Kurleto P, Tomaszek L, Milaniak I, Bramstedt KA. Polish attitudes towards unspecified kidney donation: a cross-sectional study. BMC Nephrol. 2022 Apr 13;23(1):142. doi: 10.1186/s12882-022-02767-x.
citation: Kurleto P, Tomaszek L, Milaniak I, Medrzycka-Dabrowska W. Factors Associated with the Willingness to Become a Living Kidney Donor: A National Cross-Sectional Study. Int J Environ Res Public Health. 2022 Jan 25;19(3):1313. doi: 10.3390/ijerph19031313.
Clinical trial NCT04869839: Oral Functions and Malocclusions
Official title: Oral Functions and Malocclusions: a Comprehensive Epidemiological Study on 358 Schoolchildren in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malocclusion
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 359
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Comprehensive study involving all six-grade schoolchildren in Cagnes sur mer, Alpes Maritimes, France

Brief summary: The aim of our research is to establish a link between malocclusions and oral dysfunctions. The clinical examination includes: caries screening (DMFT and dft scores), a quantification of dental plaque (Silness and Loë's plaque index) and orthodontic treatment need (Haute Autorité de Santé HAS). The functional examination includes improper mouth breathing, abnormal deglutition and incorrect position of tongue at rest.


Eligibility criteria: Inclusion Criteria:

* All the pupils benefit from the clinical examination

Exclusion Criteria:

* NONE

Primary outcomes:
measure: Dental malocclusion - extraoral examination
timeFrame: 1 day
measure: Dental malocclusion - intraoral examination
timeFrame: 1 day
measure: Dental malocclusion - intraoral examination
timeFrame: 1 day
measure: Dental malocclusion - intraoral examination
timeFrame: 1 day
measure: Dental malocclusion - intraoral examination
timeFrame: 1 day
Secondary outcomes:
measure: Functional oral examination - ventilation
timeFrame: 1 day
measure: Functional oral examination - ventilation
timeFrame: 1 day
measure: Functional oral examination - ventilation
timeFrame: 1 day
measure: Functional oral examination - deglutition
timeFrame: 1 day
measure: Functional oral examination - position of tongue
timeFrame: 1 day
measure: Oral health
timeFrame: 1 day
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
Study officials:
References:
Clinical trial NCT05404139: Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)
Official title: Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Metastatic Prostate Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
First posted: 2022-06-03
Enrollment: 132
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-centre, investigator-initiated, two-arm, randomized trial to investigate the addition on androgen receptor pathway inhibitor to standard of care radiation and hormone therapy improve quality of life.

Participants will either receive standard of care radiation and hormone (ADT) therapy (Arm 1) or standard of care radiation and hormone (ADT) therapy plus oral abiraterone for 8-9 months (Arm 3). Participants will be routinely follow-up in clinic or remotely for up to 5 years.


Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years
2. Able to provide informed consent
3. Histologic diagnosis of prostate adenocarcinoma
4. ECOG performance status 0-2
5. Stage IV castrate sensitive metachronous metastatic prostate cancer. diagnosed within 6 months of study enrollment with 1-10 metastases

   1. Maximum one metastatic deposit on conventional imaging (CT or bone scan or MR)
   2. Additional metastases can be detectable by PSMA PET only
6. All sites of disease are amenable to and can be safely treated with radiotherapy
7. Patients decline continuous use of ADT

Exclusion Criteria:

1. Significant comorbidities rendering patient not suitable for ADT, enzalutamide and SBRT
2. History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer, managed non-curatively
3. Prior use of salvage systemic therapy
4. Evidence of spinal cord compression

Primary outcomes:
measure: Progression free survival
timeFrame: 5 years
Secondary outcomes:
measure: Patient-reported quality of life
timeFrame: 5 years
measure: Patient-reported quality of life
timeFrame: 5 years
measure: Patient-reported quality of life
timeFrame: 5 years
measure: Physician-reported toxicity
timeFrame: 5 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontartio
Study officials:
References: