louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04709029: Effect of Intravenous Versus Intrathecal Dexamethazone on Postdural Puncture Headache
Official title: Effect of Intravenous Versus Intrathecal Dexamethazone in Bupivacaine Spinal Anesthesia on Postdural Puncture Headache
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postdural Puncture Headache
Keywords: intravenous dexamethazone
intrathecal dexamethazzone
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: PREVENTION

Brief summary: This study will be conducted at Ain Shams University Hospital in Operating Theatre after ethical committe approval number (MS 32/ 2020). It is a prospective randomized controlled study will be done on patients undergoing lower abdominal and lower limb surgeries under spinal anethesia,Eligible patients will be randomized by computer system to one of two groups, either intravenous dexamethazzoe 8 mg with intrathecal heavy bupivacaine 0.5% or intrathecal 4mg dexamethazone with intrathecal heavy bupivacaine 0.5%. .

Detailed description: Patients will be randomly divided into two equal groups: Group 1: patients receive intrathecal 3 ml bupivacaine 0. 5% +1 ml normal saline + intravenous 8 mg dexamethazone in 10 ml saline. Group 2: patients receive intrathecal 3 ml bupivacaine 0. 5% + 4 mg (1 ml) dexamethazone + intravenous 10 ml normal saline. Upon patients' arrival into the operating room, peripheral oxygen saturation (SPO2), ECG, pulse rate (PR), and systolic and diastolic blood pressures will be monitored one of the researchers and recorded every 5 minutes till the end of surgery. In a sitting position and with antiseptic techniques, 25 G Quincke needle was inserted intrathecally at L3-L4 or L4-L5 interspace through midline approach. The study drugs were given by an anesthesiologist not not aware of the type of medications injected. Subsequently, the patients were put in the supine position, and given oxygen 3 L/minutes by nasal prongs.

Eligibility criteria: Inclusion Criteria:

* Patients ASA I or II undergoing lower limb surgeries under spinal anesthesia
* Patients ASAI or II undergoing lower abdominal surgeries under spinal anesthesia.

Exclusion Criteria:

* Emergency surgeries.
* Patients with uncompensated heart diseases.
* Patients with coagulopathy.
* Presence of infection at site of injection of spinal anesthesia.

Primary outcomes:
measure: Prevention of postdural puncture headache
timeFrame: 48 hours after spinal anesthesia
Secondary outcomes:
measure: Duration of sensory block
timeFrame: 4 hours from injection of drug in subarachnoid space.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT01338129: The Effect of Vitamin c on Preventing Complex Regional Pain Syndrome (CRPS Type I) Following Ankle Fracture
Official title: The Effect of Vitamin c on Preventing Complex Regional Pain Syndrome (CRPS Type I) Following Ankle Fracture, Prospective Double Blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ankle Fracture
Keywords: vitamin c
ascorbic acid
ankle fracture
crps
rds
crps prevention
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2011-04-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The use of prophylactic treatment with vitamin c may prevent complex regional pain syndrome (CRPS)

Detailed description: There are several studies similar in wrist fracture.

Eligibility criteria: Inclusion Criteria:

* ankle fracture within 3 weeks after the fracture

Exclusion Criteria:

* pregnant or lactating woman
* open fracture
* already treated with vitamin c
* chronic renal failure

Primary outcomes:
measure: CRPS incidence
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Petah Tikva,
country: Israel
facility: Beilinson, Rabin Medical Center,
Study officials:
References:
Clinical trial NCT03429829: Fluoride Varnish Community Trial
Official title: Fluoride Varnish for Caries Prevention in South African Children: A Cluster-randomized Controlled Community Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Oral Disease
Costs
Keywords: Caries
Fluoride Varnish
Dental Health
Costs
Lead sponsor: DMG Dental Material Gesellschaft mbH
Sponsor class: INDUSTRY
Collaborators: name: Dental Wellness Trust (DWT)
name: University of Western Cape (UWC)
First posted: 2018-02-12
Enrollment: 513
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children in the reception grade and grade 1 of two schools in a township in South Africa are class-wise cluster-randomized to the fluoride varnish or control groups.
Primary purpose: PREVENTION

Brief summary: This cluster-randomized controlled community trial aimed to assess the efficacy and costs of fluoride varnish application for caries prevention in a high-risk population in South Africa.

Detailed description: Despite advances in oral health, dental caries remains a significant problem - particularly in disadvantaged communities in low- and middle-income countries. A study in the Western Cape Region, which was conducted between 2001 and 2015, reported for example a caries prevalence of 84% for 6-years-old (Smit 2017), highlighting the need for oral health programs and cost-effective interventions. Fluoride varnish offers hereby a feasible possibility to supplement toothbrushing programs in order to improve fluoride delivery and consequently caries prevention. However, many studies failed to confirm the benefits of fluoride varnish for caries prevention, which may partially be explained by the fact that many of these studies were conducted in high-income countries, in which the caries increment is low due to a wide access to fluoride.

This study, thus aimed to further validate the benefits of fluoride varnish application specifically in a primary school setting within a peri-urban, low socio-economic, high-caries risk community in South Africa.

Eligibility criteria: Inclusion Criteria:

* Reception grad or grade 1 (age 4-8)
* Signed consent form
* Good general health

Exclusion Criteria:

* Any allergies (especially sticking plaster)
* History of asthma
* Chronic Ulcerated gums
* Chronic Stomatis
* Participation in other study (except LifeSmart)

Primary outcomes:
measure: Increment of teeth with cavitated lesions, restorations or extraction.
timeFrame: 2 years
Secondary outcomes:
measure: Increment of teeth with cavitated lesions or restorations.
timeFrame: 2 years
measure: Increment of extracted teeth.
timeFrame: 2 years
measure: Cost
timeFrame: 2 years
Other outcomes:
Locations:
city: Mfuleni
country: South Africa
facility: Itsitsa Primary School
state: Western Cape
city: Mfuleni
country: South Africa
facility: Nyameko Primary School
state: Western Cape
Study officials:
References:
Clinical trial NCT00519129: Improving Quality of Colonoscopy Using a 3D-imager
Official title: Magnetic Endoscopic Imaging Versus Standard Colonoscopy in a Routine Colonoscopy Setting: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain During Colonoscopy
Keywords: Pain
Patient satisfaction
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
First posted: 2007-08-22
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Coloscopy may be a painful procedure for the patient. This is due to a loop-formation of the coloscope. A 3D-real time imager produced by Olympus creates a real-time image of the scope while a traditional fluoroscopy device will only show instant pictures. We want to investigate whether the 3D-imager causes the patient less pain and is more time consuming than ordinary fluoroscopy

Detailed description: Results published in Holme et.al. Gastrointestinal Endoscopy 2011;73:1215-1222.

Eligibility criteria: Inclusion Criteria:

* All patients referred for coloscopy on an out-patient basis

Exclusion Criteria:

* Pregnancy
* Pacemaker
* Lack of ability to understand information given
* Prior resection of the colon/rectum
* Demanding analgetics prior to start of procedure

Primary outcomes:
measure: pain during coloscopy
timeFrame: instant
measure: Time used to reach the coecum
timeFrame: instant
Secondary outcomes:
measure: coecum-intubation rate
timeFrame: instant
measure: level achieved when the coecum can not be reached
timeFrame: instant
measure: Need for assistance by a colleague
timeFrame: instant
measure: Need for analgetics
timeFrame: instant
measure: Pain during the first 24 hours after coloscopy
timeFrame: 24 hours
measure: Polyp detection rate
timeFrame: instant
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Sorlandet Sykehus HF
Study officials:
name: Geir S Hoff, PhD
role: STUDY_DIRECTOR
References:
citation: Holme O, Hoie O, Matre J, Stallemo A, Garborg K, Hasund A, Wiig H, Hoff G, Bretthauer M. Magnetic endoscopic imaging versus standard colonoscopy in a routine colonoscopy setting: a randomized, controlled trial. Gastrointest Endosc. 2011 Jun;73(6):1215-22. doi: 10.1016/j.gie.2011.01.054. Epub 2011 Apr 8.
Clinical trial NCT05505929: eUltra 10k - Biofreedom Ultra
Official title: A Post-Market Registry of the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post Market Clinical Follow up (PMCF)
Keywords: PMCF
Registry
Biofreedom Ultra
eUltra
Lead sponsor: Biosensors Europe SA
Sponsor class: INDUSTRY
Collaborators: name: European Cardiovascular Research Center
First posted: 2022-08-18
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This observational registry is open to all patients with coronary artery disease treated by percutaneous coronary intervention (PCI) with one or more BioFreedom™ Ultra CoCr DCS within the products indications of the Instructions for Use (IFU).

Brief summary: This registry captures data on BioFreedomTM Ultra CoCr DCS in standard clinical practice (real world population) and serves as Post Market Clinical Follow up (PMCF) as part of the Post-Market Surveillance.

Detailed description: Prospective, observational multi-center registry to be conducted at up to 150 interventional cardiology centers in up to 15 countries. Patients will be followed by telephone for 1 year after PCI for data collection. This registry captures data on BioFreedomTM Ultra CoCr DCS in standard clinical practice (real world population) and serves as Post-Market Surveillance.

This registry will enroll up to 10000 patients in up to 150 investigative centers in Europe, South America, Middle East, Asia over a period of 5 years. Each patient be followed with phone (or clinic) visit at 12 months.

Eligibility criteria: Inclusion Criteria:

* According to the current version of Instructions of Use (IFU)
* Patient is at least 18 years old
* Patient provides a signed informed consent

Exclusion Criteria:

* According to current version of IFU
* Patients will be excluded as per Medical Device Regulation (MDR) (Article 65: "Clinical investigations on minors" and article 66: "Clinical investigations on pregnant or breastfeeding women"
* Patients will be excluded if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 12 months
Secondary outcomes:
measure: Clinically driven Target Lesion Revascularization (TLR)
timeFrame: 12 months
measure: Cardiovascular death (CD)
timeFrame: 12 months
measure: Target Vessel MI
timeFrame: 12 months
measure: Target Vessel Revascularization (TVR)
timeFrame: 12 months
measure: Stent thrombosis
timeFrame: 12 months
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth hospital
Study officials:
References:
Clinical trial NCT04289129: The Viscoelastic Properties of Lower Extremity's Muscles
Official title: The Mechanical Characteristics of Lower Extremity Muscles in Healthy Individuals Using Myotonometric Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Loss
Keywords: Muscle tone
viscoelastic properties
aging
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 389
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SCREENING

Brief summary: This study aims to create normative values for stiffness, tonus and elasticity in the lower extremity muscles and to determine age and gender differences.


Eligibility criteria: Inclusion Criteria:

* Individuals without any systemic or metabolic diseases, psychological illnesses, or drug abuse; those without any diseases that could cause muscle disease or muscle atrophy; and those who had not undergone any surgery in the musculoskeletal system during the past 3 months were included

Exclusion Criteria:

-

Primary outcomes:
measure: Myotonometric evaluation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu Üniversity
Study officials:
References:
citation: Correa-de-Araujo R, Harris-Love MO, Miljkovic I, Fragala MS, Anthony BW, Manini TM. The Need for Standardized Assessment of Muscle Quality in Skeletal Muscle Function Deficit and Other Aging-Related Muscle Dysfunctions: A Symposium Report. Front Physiol. 2017 Feb 15;8:87. doi: 10.3389/fphys.2017.00087. eCollection 2017.
citation: Perkisas, S., et al., Physiological and architectural changes in the ageing muscle and their relation to strength and function in sarcopenia. European Geriatric Medicine, 2016. 7(3): p. 201-206
Clinical trial NCT00086229: Absorption and Distribution of Glucosamine and Chondroitin
Official title: A Pharmacokinetic Study of Glucosamine and Chondroitin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Complementary Therapies
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2004-06-29
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the way the dietary supplements glucosamine and chondroitin are absorbed and distributed throughout the body.

Detailed description: Osteoarthritis is the most common musculoskeletal disease in the world. While predisposing conditions have been identified, the actual cause of osteoarthritis remains unknown. Traditional treatments, most often anti-inflammatory drugs and pain relievers, produce variable results and may cause significant toxicity. The use of complementary and alternative therapies in the treatment of osteoarthritis has become more common, and particular interest has focused on glucosamine and chondroitin treatments. This study will examine the pharmacokinetics of glucosamine and chondroitin.

This study consists of two phases. In Phase I, participants will have two study visits, during which multiple blood samples will be taken to determine levels of glucosamine and chondroitin found naturally in the body. During Phase II, participants will be randomly assigned to receive glucosamine, chondroitin, or a combination of the two for 3 months. Blood samples will be taken at each of the three Phase II study visits to examine the pharmacokinetics of glucosamaine and chondroitin.

Eligibility criteria: Inclusion Criteria:

* Able to walk

Exclusion Criteria:

* Allergy to glucosamine, chondroitin, or shellfish
* Liver or kidney disease
* Diabetes mellitus
* Concurrent use of other complementary or alternative therapies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
Study officials:
affiliation: University of Utah
name: Christopher G. Jackson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02686229: Registry Study on Epidemiological and Biological Disease Profile as Well as Clinical Outcome in Patients With Low Grade Gliomas
Official title: Registry Study on Epidemiological and Biological Disease Profile as Well as Clinical Outcome in Patients With Low Grade Gliomas: The LOG-Glio-Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glioma
Keywords: Low grade glioma, registry, neurosurgery, brain tumor
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
First posted: 2016-02-19
Enrollment: 300
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: All adult patients with radiological suspected diagnosis of a low grade glioma

Brief summary: The LoG-Glio-Registry is based on a network of german hospitals gathering radiological, clinical, epidemiological and molecular data on all patients diagnosed with a low grade glioma.


Eligibility criteria: Inclusion Criteria:

* Patients with radiological suspected diagnosis of a low grade glioma
* Age ≥ 18 years. There is no upper age limit.

Exclusion Criteria:

* Severe neurological or psychiatric disorder interfering with ability to give an informed consent
* No consent for registration, storage and processing of the individual disease characteristics and course as well as information of the family physician about study participation
* No consent for bio-banking of patient's biological specimens and performance of analyses on stored material.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 5yrs
measure: Overall survival (OS)
timeFrame: 15yrs
Secondary outcomes:
measure: Extent of tumor resection
timeFrame: 3yrs
measure: Quality of life (QoL) assessed by the EORTC QLQ C-30/BN-20. (European Organisation for Research and Treatment of Cancer Quality of Life Questionaire C-30
timeFrame: 5yrs
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University of Ulm
Study officials:
References:
citation: Pala A, Nadji-Ohl M, Faust K, Ruckriegel S, Roder C, von der Brelie C, Forster MT, Lobel F, Schommer S, Lohr M, Renovanz M, Grubel N, Rothenbacher D, Konig R, Engelke J, Schmitz B, Wirtz CR, Ringel F, Senft C, Rohde V, Tatagiba M, Ernestus RI, Vajkoczy P, Ganslandt O, Nagel G, Coburger J. Multicentric Registry Study on Epidemiological and Biological Disease Profile as Well as Clinical Outcome in Patients with Low-Grade Gliomas: The LoG-Glio Project. J Neurol Surg A Cent Eur Neurosurg. 2020 Jan;81(1):48-57. doi: 10.1055/s-0039-1693650. Epub 2019 Sep 24.
Clinical trial NCT06885229: Reusable Face Masks to Reduce Risk of Viral Respiratory Infections and Asthma Exacerbations
Official title: Reuseable Face Masks to Reduce Risk of Viral Respiratory Infections and Exacerbations in Adults With Asthma: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Acute Respiratory Infection
Asthma Exacerbations
Keywords: Upper Respiratory Infection
Acute Respiratory Infection
Asthma Exacerbation
Lower Respiratory Infection
Reusable Face Mask
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: REMASK trial is a Trial within Cohort study (TwiCs), nested within the COVIDENCE UK longitudinal study. It has been designed to determine whether the offer of a free reusable, elastomeric face mask to adults with asthma and other members of their household reduces risk of RT-PCR confirmed viral respiratory infections and asthma exacerbations.


Eligibility criteria: Eligibility criteria, participants with asthma ('index participants'):

Inclusion Criteria:

* Aged 16 or more years
* Doctor diagnosis of asthma
* Current prescription for treatment of asthma
* Participant in COVIDENCE UK nasal swab study

Exclusion Criteria:

* Regularly using any FFP-rated face mask when in an indoor public place
* Currently sharing household with one or more children
* Currently sharing household with one or more other COVIDENCE UK participants who have asthma
* Unable to tolerate wearing face mask

Eligibility criteria, household members of index participants:

Inclusion criteria

* Age 16 or more
* Living in same household as index participant who has consented to take part in trial

Exclusion criteria

- Unable to tolerate wearing face mask

Primary outcomes:
measure: Time to first RT-PCR-proven viral respiratory infection
timeFrame: 12 months
Secondary outcomes:
measure: Time to first severe acute exacerbation of asthma (i.e. exacerbation requiring treatment with systemic corticosteroids and/or hospitalisation or emergency department visit)
timeFrame: 12 months
measure: Time to first hospitalisation for treatment of acute respiratory infection or asthma exacerbation
timeFrame: 12 months
measure: Time to first antibiotic prescription for treatment of acute respiratory infection
timeFrame: 12 months
measure: Rate of RT-PCR-proven / symptom defined acute respiratory infections
timeFrame: 12 months
measure: Cost per viral respiratory infection averted
timeFrame: 12 months
measure: Cost per severe asthma exacerbation averted
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Queen Mary University of London
state: Greater London
Study officials:
References: