louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01707953: Efficacy of Midodrine for the Prevention of Orthostatic Hypotension During Early Mobilization After Fast-track Hip Arthroplasty
Official title: Efficacy of Midodrine for the Prevention of Orthostatic Hypotension During Early Mobilization After Fast-track Hip Arthroplasty - a Randomized, Placebo Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Orthostatic Hypotension
Postoperative Orthostatic Intolerance
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2012-10-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to examine the efficacy of 5 mg Midodrine (Gutron) vs. placebo on reducing the incidence of orthostatic hypotension during mobilization 6 h after a total hip arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Scheduled for primary unilateral hip arthroplasty
* Age \>= 18 years
* Able to give informed consent

Exclusion Criteria:

* General anaesthesia for the current procedure
* Digoxin treatment.
* history of renal or hepatic failure
* history of glaucoma
* history chronic urinary retention requiring treatment
* history of orthostatic intolerance / hypotension
* other autonomous nervous system disease
* alcohol or drug abuse
* current malignant disease
* females in the fertile age (possible pregnancy or breast feeding)
* Treatment with anticoagulants
* BMI \> 40 kg/m2
* Dementia or cognitive dysfunction (investigators evaluation)

Primary outcomes:
measure: Orthostatic hypotension
timeFrame: 6 hours after surgery
Secondary outcomes:
measure: Orthostatic hypotension 24 hours after surgery
timeFrame: 24 hours after end of surgery.
measure: Orthostatic Intolerance
timeFrame: 6 and 24 hours after end of surgery
measure: Treatment side effects
timeFrame: 6 and 24 hours after end of surgery
Other outcomes:
measure: Haemodynamic response to mobilization 6 and 24 hours after surgery
timeFrame: 6 and 24 hours after end of surgery
measure: Heart rate variability
timeFrame: before surgery, 6- and 24 hours after surgery
Locations:
city: Hellerup
country: Denmark
facility: Gentofte Hospital, Department of orthopaedic surgery
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital, Department of orthopaedic surgery
city: Vejle
country: Denmark
facility: Vejle Sygehus, Department of orthopedic surgery
Study officials:
affiliation: Rigshospitalet, Section for Surgical Pathophysiology
name: Henrik Kehlet, Proffessor
role: STUDY_CHAIR
affiliation: Rigshospitalet, Section for Surgical Pathophysiology
name: Oeivind Jans, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06438653: Reinterventions of Thoracic Endovascular Aortic Repair: a Retrospective Multicenter Cohort Study
Official title: Reinterventions of Thoracic Endovascular Aortic Repair: a Retrospective Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thoracic Endovascular Aortic Repair
Keywords: Thoracic endovascular aortic repair
Reinterventions
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent thoracic endovascular aortic repair (TEVAR) in multiple centers across Taiwan.

Brief summary: We aimed to investigate the incidence of reinterventions in patients who underwent thoracic endovascular aortic repair (TEVAR) in multiple centers across Taiwan

Detailed description: This study analyzed the multicenter data set for TEVAR procedures performed between 2012 and 2017. Each patient's survival was verified with a query to the national data set. Student's t-test and χ2 analysis were used to compare continuous and categorical variables between the groups that required reintervention and those that did not, respectively. Kaplan-Meier methods were applied to analyze freedom from reintervention and survival rates.We aimed to investigate the incidence of reinterventions in patients who underwent thoracic endovascular aortic repair (TEVAR) in multiple centers across Taiwan

Eligibility criteria: Inclusion Criteria:

* Patients who underwent thoracic endovascular aortic repair (TEVAR)

Exclusion Criteria:

* No thoracic endovascular aortic repair (TEVAR)

Primary outcomes:
measure: Reintervention
timeFrame: 7 years
Secondary outcomes:
measure: Mortality
timeFrame: 7 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chih-Yang Chan, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02244853: Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease
Official title: Association of Heart Rate With Cardiovascular Disease Prognosis of Patients With Stable Coronary Artery Disease: A CALIBER Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stable Angina
Myocardial Infarction
Coronary Heart Disease
Heart Failure
Stroke
Death, Sudden, Cardiac
Peripheral Arterial Disease
Atrial Fibrillation
Bleeding
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
name: National Institute for Health Research, United Kingdom
First posted: 2014-09-19
Enrollment: 51703
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: An open cohort of 2,23 million people covering approximately 5% of the UK population was drawn from registrants to 225 GP practices who consented to data linkage.

Brief summary: The Cardiovascular disease research using Linked Bespoke studies and Electronic Records (CALIBER) e-health database was the data resource for this study. CALIBER links patient records from four different data sources: Clinical Practice Research Database (CPRD), MINAP (Myocardial Ischaemia National Audit Project registry) Hospital Episodes Statistics (HES), the Office for National Statistics (ONS).

Detailed description: This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the NIHR and Wellcome Trust. The central theme of the CALIBER research is linkage of the Myocardial Ischaemia National Audit Project (MINAP) with primary care (GPRD) and other resources. The overarching aim of CALIBER is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).

Eligibility criteria: Inclusion Criteria:

* Aged \>=30 years at study entry -\>=1 year registration prior to the 'index date'

Exclusion Criteria:

* Free from previous atherosclerotic events
* No heart rate measurement after their 'index date' of eligibility to entry the study

Primary outcomes:
measure: Risk of cardiovascular diseases in patients with low and high heart rate and stable coronary artery disease
timeFrame: expected average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Farr Institute, University College London
Study officials:
affiliation: Farr Institute
name: Harry Hemingway, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03139253: Antimicrobial Susceptibility Testing Guided Triple Therapy in Salvage Helicobacter Pylori Treatment
Official title: Antimicrobial Susceptibility Testing Guided Triple Therapy in Salvage Helicobacter Pylori Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Antimicrobial Susceptibility Testing
Triple Therapy
Keywords: Helicobacter Pylori Infection
Antimicrobial susceptibility testing (AST)
Triple Therapy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Helicobacter pylori (H. pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H. pylori eradication is an effective approach to reduce the incidence of those pathologies.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients who are 18-70 years old with persistent H. pylori infection after first or second line treatment attempts.

Exclusion Criteria:

* Enable to undergo upper endoscopy;
* Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
* Known or suspected allergy to study medications;
* Taking bismuth and antibiotics in the previous four weeks, or taking proton pump inhibitor and H2-receptor blockers in the previous two weeks;
* Currently pregnant or lactating
* Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Primary outcomes:
measure: Eradication rate of AST guided triple therapy
timeFrame: 3 months
Secondary outcomes:
measure: the rate of improving dyspepsia symptoms after H. pylori eradication
timeFrame: 3 months
measure: the rate of adverse events happening
timeFrame: 3 months
measure: the rate of good compliance (take pills more than 90%)
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Li Yanqing, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06706453: Sleep Survey for Medical Trainees
Official title: Sleep Survey for Medical Trainees: a Collaboration Between the World Sleep Society and National Sleep Centre / Sleep Societies
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Sleep
Shift Work
Circadian Rhythm
Sleep Apnea
Insomnia
Keywords: Medical training
on call
working time
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical staff that undertakes on call work (medical student, intern, fellow, resident, consultant)

Brief summary: Background

This is a survey to understand sleep in the context of medical trainees (on call) and the participants knowledge about the relevance of sleep, shiftwork, and the impact that sleep may have on their working performance. The survey has been developed by sleep experts from America, Europe, and Africa, in collaboration with the World Sleep Society. It should take about 30-40 minutes to complete.

The survey will focus on three different aspects, complemented by two standard questionnaires:

1. Demographics and Place of Work
2. Basic Knowledge and Perception of Sleep
3. Sleep Routine
4. Epworth Sleepiness Scale, Insomnia Sleep Inventory


Eligibility criteria: Inclusion Criteria:

* medical staff
* student / intern / fellow / resident / consultant
* delivering on call work
* any gender

Exclusion Criteria:

* non-medical staff working in hospitals from the wider multidisciplinary team
* underage (less than 18 years)

Primary outcomes:
measure: Impact of being ON CALL in the hospital on sleep
timeFrame: cross-sectional survey (while filling in the questionnaire); experience within 3 months of completion
Secondary outcomes:
measure: Demographics
timeFrame: within 3 months of completion of survey
measure: Sleep routine
timeFrame: within 3 months of completion of survey
measure: Epworth Sleepiness Scale
timeFrame: within 3 months of completion
measure: Insomnia Severity Index
timeFrame: within 3 months of completion
measure: Basic knowledge and perception of sleep
timeFrame: within 3 months of completion of survey
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Kings College London
Study officials:
References:
citation: Lim DC, Najafi A, Afifi L, Bassetti C, Buysse DJ, Han F, Hogl B, Melaku YA, Morin CM, Pack AI, Poyares D, Somers VK, Eastwood PR, Zee PC, Jackson CL; World Sleep Society Global Sleep Health Taskforce. The need to promote sleep health in public health agendas across the globe. Lancet Public Health. 2023 Oct;8(10):e820-e826. doi: 10.1016/S2468-2667(23)00182-2.
Clinical trial NCT02565953: Primary Patency in Post-angioplasty Dysfunctional Arteriovenous Fistula in Renal Dialysis: Paclitaxel-releasing PTA Balloon Catheter vs PTA Balloon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arteriovenous Fistula Renal Dialysis Devices Obstruction
Keywords: Vascular access devices obstruction
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
First posted: 2015-10-01
Enrollment: 134
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: In recent years the use of paclitaxel releasing percutaneous transluminal angioplastic (PTA) balloon catheter is spreading in vascular pathology, mainly in stenosis infrainguinal arteries. This device combined the mechanical action of PTA balloon with the antiproliferative effects of paclitaxel. The use of these devices in venous pathology is limited. This devices could improve the treatment of renal dialysis arteriovenous fistula stenosis.


Eligibility criteria: Inclusion Criteria:

* Patient with renal dialysis with arteriovenous fistula (AVF) at least 3 months before.
* Patient diagnosed with AVF stenosis by clinical and radiological criteria
* Sign informed consent

Exclusion Criteria:

* Pregnant or breastfeeding
* Patients with AVF stenosis not could be treated with PTA catheter
* Paclitaxel allergy
* Iodinated contrast allergy
* Local or systemic active infection
* Life expectancy less than 12 moths

Primary outcomes:
measure: Freedom from target lesion revascularization
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Puerto Real
country: Spain
facility: Hospital Universitario Puerto Real
state: Cádiz
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramón Jiménez
Study officials:
References:
Clinical trial NCT03674853: The Study of Wuling Capsule in Treatment Chronic Tinnitus
Official title: Clinical Study of Wuling Capsule in the Treatment of Chronic Tinnitus With Emotional Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus, Subjective
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of psychological/mental factors on the severity of subjective tinnitus, to observe the efficacy and safety of Wuling capsule in the treatment of chronic subjective tinnitus with emotional disorders, and to evaluate the control rate of tinnitus complications, such as depression, anxiety and insomnia, and the improvement of patients'quality of life.

Detailed description: To evaluate the effect of psychological/mental factors on the severity of subjective tinnitus, to observe the efficacy and safety of Wuling capsule in the treatment of chronic subjective tinnitus with emotional disorders, and to evaluate the control rate of tinnitus complications, such as depression, anxiety and insomnia, and the improvement of patients'quality of life. Patients with chronic tinnitus complicated with mild to moderate anxiety or depression were randomly divided into two groups. The experimental group was given oral treatment with Wuling capsule, and the control group was given gurusu treatment. The improvement of tinnitus, sleep, anxiety and depression in patients was evaluated at 2,4 and 8 weeks after treatment, respectively, and the efficacy of Wuling capsule in improving tinnitus combined with anxiety, depression and tinnitus was analyzed。

Eligibility criteria: Inclusion Criteria:

* Tinnitus with a history longer than 6 months;
* 7 \< HAMD score \< 24 and / or 7 \< HAMA score \< 21;
* No antianxiety, depression or antipsychotic treatment within 2 weeks.

Exclusion Criteria:

* objective tinnitus;
* tinnitus with defined causes;
* accompanied with acute infection, acute trauma, perioperative, chronic disease in the acute stage;
* with mental illness family history;
* HAMD score greater than 24 points or HAMA score greater than 21 points;

Primary outcomes:
measure: the change of severity of tinnitus
timeFrame: 8 weeks
Secondary outcomes:
measure: the change of anxiety level
timeFrame: 8 weeks
measure: the change of depression level
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital of Fourth Military Medical University
name: Zha Dingjun, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT05284253: Is There an Allergy to Pure Metallic Gold Microparticles?
Official title: Is There an Allergy to Pure Metallic Gold Microparticles?: A Epicutaneous Test of Gold Microparticles, Gold Thiosulphate and Placebo.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Allergic Reaction
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
Collaborators: name: Aalborg University
First posted: 2022-03-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators hypothesize gold is inert and thereby there is no pure-gold allergy. The primary aim of this study is to measure the prevalence of allergy to metallic pure gold microparticles and allergy to GSTS.

Detailed description: TRUE test panel which includes gold sodium thiosulphate (GSTS), 1 % w/v in petrolatum, and gold microparticles, 20-micron diameter, 1 % w/v in petrolatum, will be added added to the baseline series. It will be applied to the upper back of healthy adults in aluminum Finn Chamber for 48 hours. Clinical evaluation will be performed 24 hours after removal the test according to standard procedures for evaluation of epi-cutaneous challenging (Johansen 2015).

Eligibility criteria: Inclusion Criteria:

* Patients with chronic dermatitis

Exclusion Criteria:

* age \< 18

Primary outcomes:
measure: Patch test
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Clinical Medicine, Aalborg Unviversity
name: Sten Rasmussen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03849053: Mézières Therapy in the UCAM's Athletes With Low Back Pain
Official title: The Effectiveness of Mézières Therapy in the UCAM's Athletes With Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Postural; Strain
Keywords: Low back pain
Mézières method
Postural treatment
Athletes
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 139
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study focuses on the re-harmonization of the kinetic chains and posture based on spinal muscular atrophy and global stretching while trying to test the effectiveness of Mézières therapy on sports subjects with low back pain.

Detailed description: The experimental study was conducted on 139 young athletes of National Rhythmic Gymnastics of Murcia, UCAM Murcia CF and UCAM Murcia CB/EBA during a six months period in the city of Murcia. Precisely, the Mézières therapy was conducted in an experimental group of 69 athletes and in a control group with other 70 athletes with Low Back Pain. This study is developed through a cycle of global stretching decompensate interventions on the athletes with postural alterations and vertebral pain at 95% confidence level. The statistical analysis was handled by using the univariate general linear model with the support of SPSS statistics.

Eligibility criteria: Inclusion Criteria:

* between 15 - 39 years
* athletes with low back pain lasting more than 1 month
* scoliosis
* kyphosis

Exclusion Criteria:

* presence of tumors or spinal metastases
* vertebral fractures
* osteoporosis
* infection or inflammation in acute diseases with involvement of the central nervous system
* herniated discs

Primary outcomes:
measure: VAS (Visual Analogic Scale)
timeFrame: 6 months
measure: Sit and Reach flexibility test
timeFrame: 6 months
measure: Runtastic Performance Pedometer
timeFrame: 6 months
Secondary outcomes:
measure: Roland-Morris Questionnaire (CRM)
timeFrame: 6 months
measure: Health status questionnaire (SF-12)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: