louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01832129: Vitamin B12 Acceptance and Biomarker Response Study
Official title: Acceptance and Biomarker Response With Oral vs. Intramuscular Supplementation of Vitamin B12 in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vitamin B 12 Deficiency
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University of Basel
name: Aarelab AG
First posted: 2013-04-15
Enrollment: 37
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 this study, biomarker response after supplementation with oral and intramuscular vitamin B12 will be compared in a randomized clinical trial. Electronic compliance monitoring will be used to control for non compliance as a possible confounder in oral treatment. Additionally subjective acceptance in terms of presumed preferences will be compared with oral vs. intramuscular supplementation of vitamin B12 in the view of the patient.


Eligibility criteria: Inclusion Criteria:

* General practitioner's prescription for Vitamin B12 deficiency testing
* Age\> 18 years
* Ability to give written informed consent
* Vitamin B12 serum concentrations \< 200pmol/l
* indication for vitamin B12 supplementation according to the General practitioners estimation

Exclusion Criteria:

* Patients with incorrect intake of vitamin preparations containing vitamin B12
* Patients with previously diagnosed dementia
* Patients with known hereditary transcobalamin transportation defects
* lack of written and/or oral understanding in German, French, Italian or English languages

Primary outcomes:
measure: Biochemical response to vitamin B12 substitution
timeFrame: Day 28
Secondary outcomes:
measure: taking and timing adherence with oral vitamin B12
timeFrame: day 28
measure: Comparison of patient acceptance of oral vs. i.m. vitamin B12 supplementation
timeFrame: day 0, day 28
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Pharmaceutical Care Research Group
Study officials:
affiliation: Pharmaceutical Care Research Group
name: Kurt E Hersberger, Professor
role: STUDY_CHAIR
name: Cyrill Jeger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pharmaceutical Care Research Group
name: Philipp N Walter, MSc
role: STUDY_DIRECTOR
References:
citation: Metaxas C, Mathis D, Jeger C, Hersberger KE, Arnet I, Walter P. Early biomarker response and patient preferences to oral and intramuscular vitamin B12 substitution in primary care: a randomised parallel-group trial. Swiss Med Wkly. 2017 Apr 7;147:w14421. doi: 10.4414/smw.2017.14421. eCollection 2017.
Clinical trial NCT06503029: Evaluate Cytotoxicity, Leaching, and Structural Conformation of Clear Aligners
Official title: Cytotoxicity, Leaching, and Structural Conformation of Invisalign Clear Aligners Subjected to Different Cleaning Methods: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Malocclusion
Cytotoxicity
Keywords: Cytotoxicity
Leaching
Clear aligner
Orthodontics
Lead sponsor: Riyadh Elm University
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 84
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim is to evaluate clear aligners' cytotoxicity, leaching, and structural properties and compare them with four cleaning tools. The null hypothesis is the cleansers have no impact on the properties tested.

Detailed description: Orthodontic Invisalign clear aligners patients will be randomly distributed into four groups using four cleaning methods. Participants will be instructed to clean their trays as instructed by the production company.

Leaching, Cytotoxicity, and Structural Confirmation will be evaluated of the Invisalign clear aligners after being used.

Eligibility criteria: Inclusion Criteria:

* Participants who are on Invisalign Clear aligner treatment.
* Participants who are 21 years and older and committed to their treatment.
* Participants with caries-free dentition
* Participants with no smoking habits
* Participants are not pregnant females

Exclusion Criteria:

* Participants who are on Orthognathic treatment.
* Participants with Hypodontia.

Primary outcomes:
measure: Cytotoxicity
timeFrame: 1-2month
measure: Leaching
timeFrame: 1-2months
measure: Structural Conformation
timeFrame: 1-2months
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Riyadh Elm University
Study officials:
affiliation: Associated Professor, Riyadh Elm University.
name: Omar AlKadhi, BDS,MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahrari F, Tavakkol Afshari J, Poosti M, Brook A. Cytotoxicity of orthodontic bonding adhesive resins on human oral fibroblasts. Eur J Orthod. 2010 Dec;32(6):688-92. doi: 10.1093/ejo/cjq019. Epub 2010 Jun 21.
citation: Alhendi A, Khounganian R, Almudhi A. Cytotoxicity assessment of different clear aligner systems: An in vitro study. Angle Orthod. 2022 Sep 1;92(5):655-660. doi: 10.2319/121621-919.1. Epub 2022 Jun 7.
citation: Alhendi A, Khounganian R, Almudhi A, Ahamad SR. Leaching of Different Clear Aligner Systems: An In Vitro Study. Dent J (Basel). 2022 Feb 14;10(2):27. doi: 10.3390/dj10020027.
citation: Eliades T, Pratsinis H, Athanasiou AE, Eliades G, Kletsas D. Cytotoxicity and estrogenicity of Invisalign appliances. Am J Orthod Dentofacial Orthop. 2009 Jul;136(1):100-3. doi: 10.1016/j.ajodo.2009.03.006.
Clinical trial NCT00134329: Erectile Dysfunction and Diabetes Mellitus
Official title: Erectile Dysfunction and Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Erectile Dysfunction
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2005-08-24
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: This study consists of filling out a questionnaire on possible erectile dysfunction.

Detailed description: Male diabetic patients who attend a diabetic routine year program visit will be asked to give their voluntary permission to fill out a questionnaire on possible erectile dysfunction.

The questionnaire consists of two parts: Part 1 is the IIEF (International Index of Erectile Function) questionnaire and Part 2 is an additional questionnaire. The included patients have to fill out these questionnaires two times; once at the beginning at a diabetic year program visit and a second time one year later at the next diabetic year program consultation.

The patients will also be asked to give their permission for using their results of the routine diabetic year program for scientific research.

Eligibility criteria: Inclusion Criteria:

* Male diabetic patients
* Age older than 18 years

Exclusion Criteria:

Primary outcomes:
measure: Documentation of the prevalence of erectile dysfunction in the diabetic convention
measure: Increase the awareness of diabetologist for erectile dysfunction
measure: Relation of erectile dysfunction with metabolic parameters
measure: Relation of erectile dysfunction with sex steroids
Secondary outcomes:
measure: Adjustment of the systematic follow-up of diabetic complications.
measure: Optimalisation of the healthcare for diabetic patients, so that the quality of life for male diabetic patients can be improved
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Guy T'Sjoen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02473029: Interest of Medical Imaging in the Diagnostic Strategy Vis a Vis a Suspected Horton Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Horton Disease
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2015-06-16
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the Fondation Ophtalmologique Adolphe de Rothschild with a suspected Horton disease

Brief summary: The study aims at measuring the sensitivity and specificity of a series of imaging signs (recorded by magnetic resonance angiography, vascular tomodensitometry, vascular ultrasonography, retina angiography and retina optic coherence tomography) for the diagnosis of Horton disease, the gold standard being the result of temporal artery biopsy.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to the Fondation Ophtalmologique Adolphe de Rothschild and suspected to suffer from Horton disease, based on the presence of 3 or more major criteria, or 2 major criteria and at least one minor criteria.

Major criteria : Age \> 50 ans ; headache ; intermittent jaw or tongue pain ; visual impairment ; ESR \> 50 mm at 1h and/or CRP \> 8mg/l.

Minor criteria: temporal artery or scalp tenderness ; facial pain or tenderness ; fever \>38°C, weight loss \>10%, anorexia, fatigue.

Exclusion Criteria:

* Autoimmune disease
* Active infectious condition
* Malignant disease
* Condition counterindicating one or several of the protocol's imaging procedures : allergy to iodine and/or renal insufficiency and/or claustrophobia and/or metallic foreign body...

Primary outcomes:
measure: MRI angiography mural inflammation
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rotchschild
Study officials:
References:
Clinical trial NCT03987529: Effects of Volatile and Intravenous Anesthetics on Pupillary Function
Official title: Comparison of Effects of Volatile and Intravenous Anesthetics on Pupillary Function During General Anesthesia in Children; a Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pupillary Functions, Abnormal
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 22
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: From other study results, average NPi for Sevoflurane and propofol were 3.6, 4.2, and standard deviation was 0.1, 0.4 respectively. Using Gpower program, total of 18 patients were required. Considering 20% of drop-out rate, total of 22 patients(18+3.6 patients) were to be recruited.

Brief summary: To compare of effects of volatile and intravenous anesthetics on pupillary function during general anesthesia in children

Detailed description: The investigator will measure the pupillary function with pupillometry during general anesthesia with volatile or intravenous anesthetics in children.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients undergoing general anesthesia

Exclusion Criteria:

* If injection of any agents that can change pupil size or index
* Any severe side effects, adverse drug reaction

Primary outcomes:
measure: NPi
timeFrame: 1hour afer skin incision
Secondary outcomes:
measure: %CH
timeFrame: 1. Stage of loss of consciousness after induction with bolus propofol 2. Before and after tracheal intubation 3. Skin incision 4. 1hour afer skin incision 5. Just before extubation
measure: CV
timeFrame: 1. Stage of loss of consciousness after induction with bolus propofol 2. Before and after tracheal intubation 3. Skin incision 4. 1hour afer skin incision 5. Just before extubation
measure: DV
timeFrame: 1. Stage of loss of consciousness after induction with bolus propofol 2. Before and after tracheal intubation 3. Skin incision 4. 1hour afer skin incision 5. Just before extubation
measure: NPi
timeFrame: 1. Stage of loss of consciousness after induction with bolus propofol 2. Before and after tracheal intubation 3. Skin incision 4. 1hour afer skin incision 5. Just before extubation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hee-Soo Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06092229: Palpation Versus TACA- Ultrasonography for Identifying the Cricothyroid Membrane in Case of a Laterally Deviated Larynx
Official title: Palpation Versus TACA ("Thyroid-Airline-Cricoid-Airline") Ultrasonography for Identifying the Cricothyroid Membrane in Case of a Laterally Deviated Larynx
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Airway Management
Keywords: Airway Management, cricothyrotomy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised to either "palpation" or "ultrasonography"

The participants are thus randomised to use either "palpation" or to use "ultrasonography" to DIAGNOSE the position of the cricothyroid membrane
Primary purpose: DIAGNOSTIC

Brief summary: test persons, anaesthesiologists will identify the cricothyroid membrane on a silicone model of the neck with either palpation or ultrasonography.

The ultrasonographic method to be used is the Thyroid-Airline-Cricoid-Airline (TACA) approach.

The larynx-model is deviated to one of the sides to simulate a patient with neck pathology

Detailed description: test persons, anaesthesiologists will identify the cricothyroid membrane on a silicone model of the neck with either palpation or ultrasonography.

The ultrasonographic method to be used is the Thyroid-Airline-Cricoid-Airline (TACA) approach.

The larynx-model is deviated to one of the sides to simulate a patient with neck pathology.

The test persons are randomised to use other palpation or ultrasonography. Al attempts are video-taped

Eligibility criteria: Inclusion Criteria: Participants in a course of airway management -

Exclusion Criteria: Exclusion Criteria: unwillingness to participate

-

Primary outcomes:
measure: Correct identification of the cricothyroid membrane within a minute
timeFrame: 1 minute
Secondary outcomes:
measure: Correct identification of the sagittal plane within the airway
timeFrame: 1 minute
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, department of anaesthesia
Study officials:
affiliation: Rigshospitalet, Denmark
name: Michael Kristensen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00192829: Hypercoagulable Parameters as Predictors of Thrombotic Events and Prognosis in Patients With Advanced Non-Small Cell Lung Carcinoma
Official title: Hypercoagulable Parameters as Predictors of Thrombotic Events and Prognosis in Patients With Advanced Non-Small Cell Lung Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-Small Cell Lung Carcinoma
Venous Thromboembolism
Keywords: Lung cancer
Thrombosis
Hypercoagulable
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The association between cancer and thrombosis is well known and the occurrence of thrombotic complications is commonly associated with poor prognosis. The aim os this study is to determine the possible value of hypercoagulable parameters as prognostic parameters in advanced non-small cell lung carcinoma (NSCLC).


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of NSCLC.
* normal serum bilirubin
* informed concent to participate in the study

Exclusion Criteria:

* anticoagulant therapy
* infectious disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Hematology Laboratory
city: Haifa
country: Israel
facility: Oncology Institution, Rambam Health Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Galit Sarig, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haim N, Lanir N, Hoffman R, Haim A, Tsalik M, Brenner B. Acquired activated protein C resistance is common in cancer patients and is associated with venous thromboembolism. Am J Med. 2001 Feb 1;110(2):91-6. doi: 10.1016/s0002-9343(00)00691-4.
citation: Blom JW, Osanto S, Rosendaal FR. The risk of a venous thrombotic event in lung cancer patients: higher risk for adenocarcinoma than squamous cell carcinoma. J Thromb Haemost. 2004 Oct;2(10):1760-5. doi: 10.1111/j.1538-7836.2004.00928.x.
citation: Ferrigno D, Buccheri G, Ricca I. Prognostic significance of blood coagulation tests in lung cancer. Eur Respir J. 2001 Apr;17(4):667-73. doi: 10.1183/09031936.01.17406670.
Clinical trial NCT05483829: Digital Health Intervention Based on Artificial Intelligence to Support the Personalized Recovery of Long COVID Patients Affected by Fatigue (AIDA)
Official title: AIDA - A Digital Health Intervention Based on Artificial Intelligence to Support the Personalized Recovery of Long COVID Patients: Feasibility Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Acute COVID-19 Syndrome
Keywords: Long COVID
mhealth
digital health
emotional health
behavioral intervention
mental wellbeing
mood disturbance
emotional adjustment
Lead sponsor: Adhera Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol)
First posted: 2022-08-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The AIDA feasibility study builds upon mental health and technology acceptance theoretical frameworks. It examines the feasibility of a mobile-based digital program to support patients with long covid affected by fatigue. The program Adhera ® Fatigue Self-management is adapted for long covid patients.

Detailed description: The study will explore the usability and engagement of a digital program designed for long covid patients affected by fatigue. The digital program relies on the Adhera® personalized digital health solution that includes personalized patient education and support, monitoring using psychometrics and wearables, and mental wellbeing exercises. The patients access the mobile solution via a mobile app. A total of 15 patients will be recruited and use the mobile solution for one month.

Eligibility criteria: Inclusion Criteria:

* Legal adults (older than 18)
* Long COVID diagnosis within the last year
* In possession of a compatible smartphone (Android OS v4.4 or higher)
* Reporting any of these symptoms:

  * Fatigue
  * Dyspnea
  * Anxiety
  * Stress
  * Depression
  * Sleep disorder

Exclusion Criteria:

* Hospital admission during follow-up due to pathology not related to COVID-19
* Patients without digital literacy or who cannot use the mobile application.
* Known severe psychiatric illness or cognitive impairment
* Being pregnant (or suspected to be pregnant)

Primary outcomes:
measure: Behavioral outcome: Usability
timeFrame: At week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Sant Fruitós De Bages
country: Spain
facility: Gerencia Territorial de la Catalunya Central - Institut Catala de la Salut
state: Catalonia
Study officials:
affiliation: Institut Universitari per a la recerca a l'Atencio Primaria de Salut Jordi Gol i Gurina (IDIAPJGol)
name: Josep Vidal-Alaball, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04716829: LUNA-EMG to Enhance Motor Functions in Neurological Disorders
Official title: Study of the Efficacy of the LUNA-EMG System on Motor Function in the Management of Neurological Disorders.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: stroke
EMG
rehabilitation
physiotherapy
occupational therapy
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: Jean-François Kaux, MD PhD
name: Jordan Roncin
First posted: 2021-01-20
Enrollment: 60
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: The aim of the present study is to evaluate the effects of training performed with the LUNA-EMG system to enhance motor functions of the upper limb in stroke This is a randomized open-label trial. Patients will be randomized into the intervention group (LUNA-EMG) or in the control group (standard care).

The effect of the training will be measured with the EMG, the upper limb motor function and the quality of life.


Eligibility criteria: Inclusion Criteria:

* Adult
* Having signed the informed consent

Exclusion Criteria:

* Acute pain syndrome
* Severe cognitive deficits
* Risk of fracture or unconsolidated fracture
* Rigid joints (spasticity, severe osteoarthritis and arthritis) or unstable joints
* Severe ataxia and apraxia
* Epilepsy
* Pacemakers and similar implants
* Insufficient skin conditions

Primary outcomes:
measure: muscular strength in mV
timeFrame: 12 weeks
Secondary outcomes:
measure: Fugl-Meyer
timeFrame: 12 weeks
measure: Modified Ashworth Scale
timeFrame: 12 weeks
measure: Lovett
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tinlot
country: Belgium
facility: CNRF
state: Liege
Study officials:
References:
Clinical trial NCT04177329: Impact of Cardiac Complications on Outcomes of Patients After Subarachnoid Hemorrhage
Official title: Impact of Cardiac Complications on Outcomes of Patients After Subarachnoid Hemorrhage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Subarachnoid Hemorrhage
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presented with spontaneous subarachnoid hemorrhage admitted to our department included in this study

Brief summary: Patients with subarachnoid haemorrhage frequently develop cardiac complications affecting their outcome


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed as spontaneous subarachnoid hemorrhage.
* SSAH patients aged (18-70 years) of both sexes

Exclusion Criteria:

* History or current evidence of any CNS disease other than SAH which may cause cardiac complications.
* History or current evidence of medical illness as endocrinal and metabolic disorders which may cause cardiac complications

Primary outcomes:
measure: Electrocadriogram
timeFrame: 1 miute
measure: Echocardiogarphy
timeFrame: 30 minute
Secondary outcomes:
measure: serum treponin level
timeFrame: 30 minute
Other outcomes:
Locations:
Study officials:
References: