louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03274505: Sleep Disorders in Transient Ischemic Attack and Stroke: SOMN'AIC Study
Official title: Comparison of the Prevalence of Sleep Disorders in Transient Ischemic Attack and Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disorder
Stroke
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-09-07
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke and transient ischemic attack patients

Brief summary: Sleep disorders in the setting of stroke are numerous, including sleep-related breathing disorders, insomnia, excessive daytime sleepiness and restless legs syndrome. Consequences of theses sleep disturbances include impaired functional outcome and quality of life, anxious and depressive troubles and increased cardio-vascular morbi-mortality. Mechanisms underlying sleep disorders in the setting of stroke are complex and still partly elucidated. They probably involve the consequences of the ischemic lesion and of the handicap, but also of associated vascular risk factors and more generally pre-existent medical history, or they could represent themselves a risk factor for stroke. Transient ischemic attack (TIA) is a particular condition in which risk factors and background of patients are similar to that observed in stroke, without any cerebral lesion and no persistent neurological deficit. The main objective of the SOMN'AIC study is to compare the prevalence of sleep disorders in stroke and in transient ischemic attack (TIA). The study hypothesis is that the prevalence of sleep disorders may be higher in stroke than in TIA patients, reflecting the consequences of the lesion and the associated handicap.


Eligibility criteria: Inclusion Criteria:

* Stroke group: patients with a diagnosis of stoke and seen at the routine post-stroke 3 month' rehabilitation examination
* TIA group: diagnosis of a TIA by a stroke specialist at the "SOS TIA" examination
* \> 18 years

Exclusion Criteria:

* Refusal to participate
* Severe cognitive impairment leading to inability to fulfil questionnaires
* For the TIA group: presence of an ischemic lesion on CT scan or MRI

Primary outcomes:
measure: Comparison of stroke and transient ischemic attack population regarding the prevalence of the presence of at least one sleep disorder
timeFrame: Maximum 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Neurologie Vasculaire Groupement Hospitalier Est
city: Lyon
country: France
facility: Sleep Medicine Center, Croix-Rousse Hospital, Hospices Civils de Lyon
city: Saint-Genis-Laval
country: France
facility: Service de MPR- Hôpital Henry Gabrielle - Groupement Sud
Study officials:
affiliation: Centre de Médecine du Sommeil et des Maladies respiratoires, CH de la Croix Rousse - HCL
name: Laure PETER-DEREX, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03109405: Assess Veinplicity Venous Access Device Safety and Effectiveness
Official title: A Prospective, Single Center, Randomized, Cross-over Clinical Trial to Assess the Safety and Effectiveness of the Veinplicity Venous Access Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phlebotomy
Lead sponsor: Physeon GmbH
Sponsor class: INDUSTRY
First posted: 2017-04-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study was to examine the Veinplicity Device as an adjunctive IV cannulation tool in subjects with a history of difficult to access veins. The Veinplicity Device is intended to improve venous access rates in compromised patients by taking advantage of the increased circulation that results from provoked muscle stimulation. The study collected information about the device, intravenous access, user and patient perceptions for IV access, and any device or procedural complications or other adverse events. Device use was examined with patients in both a prone and upright position.


Eligibility criteria: Inclusion Criteria:

* Subject ≥ 18 years of age
* Subject with history of failed venous access, venipuncture, or IV cannula placement
* Subject agreed to required follow-up
* Subject provided written, informed consent

Exclusion Criteria:

* Subject currently had compromised skin on either forearm or hand
* Subject currently on any blood thinning medication other than 81mg of aspirin
* Subject had been diagnosed with peripheral neuropathy, has had a complex fracture or surgery in the forearm, or has other condition that diminishes sensation in one or both arms, hands or fingers
* Subject had a demand type pacemaker or defibrillator
* Subject is female of child-bearing potential and had a positive urine pregnancy test
* Subject had a history of seizure, convulsions or epilepsy
* Subject had a known allergy to Epsom salts
* Subject had any other condition that may affect the ability to complete study requirements

Primary outcomes:
measure: Rate of successful venous access on the first attempt.
timeFrame: 7 days
measure: Rate of adverse events associated with either the treatment or the venous access site.
timeFrame: 7 days
Secondary outcomes:
measure: User Perception of IV cannulation difficulty,
timeFrame: 7 days
measure: Subject Preception of IV cannulation pain
timeFrame: 7 days
measure: Subject Perception of Device stimulation
timeFrame: 7 days
measure: Time required to achieve successful IV cannula placement
timeFrame: time from initial puncture to successful IV cannulation
measure: Number of attempts required to achieve successful IV cannula placement
timeFrame: over a 24 hour period
Other outcomes:
Locations:
Study officials:
affiliation: Medpace Medical Device
name: Leela Vrishabhendra, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04382105: Evaluation of Saliva IL-6 Levels and Periodontitis
Official title: Association Between Salivary IL-6 and Extent of Periodontitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2020-05-11
Enrollment: 287
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Forty-nine patients with periodontitis and 47 healthy subjects (HS) were enrolled in the present study. Enrolled patients were examined and characterized for clinical and blood samples analysis, and salivary P.Gingivalis antibodies were expressed and evaluated enzyme-linked immunosorbent assay (ELISA) units (EU).

Brief summary: The aim of this study was to analyze the association between salivary IL-6 levels in patients with periodontitis. Furthermore, the objective was to determine if the periodontitis influenced salivary IL-6 levels

Detailed description: Forty-nine patients with periodontitis and 47 healthy subjects (HS) were enrolled in the present study. Enrolled patients were examined and characterized for clinical and blood samples analysis, and salivary IL-6 levels. The Spearman Correlation Test and Jonckheere-Terpstra Test were applied in order to assess the interdependence between salivary IL-6 levels and clinical periodontal parameters.

Eligibility criteria: Inclusion Criteria:

* Presence of at least 16 teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL)

  ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives
* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
* Status of pregnancy or lactation
* Previous history of excessive drinking
* Allergy to local anaesthetic
* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.

Primary outcomes:
measure: Clinical Attachment Level
timeFrame: 1-year
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: University of Messina
Study officials:
affiliation: University of Messina
name: Giovanni Matarese
role: STUDY_CHAIR
References:
Clinical trial NCT06901505: To Evaluate the Efficacy of Three Times Weekly (TIW) Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis
Official title: A Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy of Three Times Weekly Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Anemia of Chronic Kidney Disease
Keywords: Chronic Kidney Disease
Hemodialysis
Erythropoiesis-Stimulating Agent
Open-label
Vadadustat
Lead sponsor: Akebia Therapeutics
Sponsor class: INDUSTRY
First posted: 2025-03-30
Enrollment: 500
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: This is a multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the efficacy of vadadustat administered three times a week compared to standard of care erythropoiesis-stimulating agent for the treatment of anemia in in-center hemodialysis participants with end-stage kidney disease (ESKD). The total duration of the study is approximately 33 Weeks including screening and follow-up.


Eligibility criteria: Inclusion Criteria:

* Adult participants ≥18 years of age.
* Receiving outpatient in-center hemodialysis for ESKD at least three times a week.
* Currently prescribed or meets criteria for ESA based on approved facility policy.
* Hb \> 8 grams per deciliter (g/dl).
* Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20%.
* Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.

Exclusion Criteria:

* Contraindication to receive vadadustat per United States prescribing information (USPI) as determined by the treating health care provider.
* Concomitant use of any hypoxia-inducible factor prolyl hydroxylase inhibitor(HIF-PHI).
* Known cirrhosis or active, acute liver disease.
* Unable to comply with study requirements or compliance with attending dialysis treatments as prescribed, or in the opinion of the treating physician or Investigator, not clinically stable to participate in the study.
* Pregnant at the time of consent (per participant self-report).
* Any other reason, which in the opinion of the Investigator, would make the participants unsuitable for participation in the study.

Primary outcomes:
measure: Change in hemoglobin (Hb)
timeFrame: Baseline and from Week 20 to Week 24
Secondary outcomes:
measure: Number of participants reporting treatment-emergent serious adverse events (TESAEs)
timeFrame: Up to 29 Weeks
measure: Proportion of participants with mean Hb levels within target range
timeFrame: Week 16 to Week 24
measure: Proportion of participants receiving red blood cell (RBC) transfusions
timeFrame: Up to 29 Weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04425005: Home-based Exercise Training During Covid-19 Pandemic in Post-bariatric
Official title: Effect of Home-based Exercise Training Program During the Covid-19 Pandemic in Post-bariatric Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery
Obesity
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the effect of a home-based exercise training during social isolation due to covid-19 pandemic in patients who undertook bariatric surgery.

Detailed description: Eligible patients will be invited to participate in the study by phone call. The research team will visit the included patients. All patients giving the written consent will perform the following tests before being randomly allocated into exercise training or control: 1) blood pressure; 2) anthropometric measures; 3) blood sampling; 4) handgrip test; 5) sit and stand test; 6) exercise capacity; 7) nutritional recalls and 8) health-related questionnaires. Patients will be randomized in a 1:1 ratio to control group (will receive information to keep active and eating healthy) or exercise training group (will receive a telemonitored exercise program through video conference, three times a week, during 3 months). Following 3 months of intervention, the outocomes will be re-assessed.

Eligibility criteria: Inclusion Criteria:

* Men and women submitted to bariatric surgery in the last 12 months.
* Not engaged in regular exercise training programs.

Exclusion Criteria:

* Patients with \>12 months of post-operatory period.
* Patients with diagnosed mental disorders.
* Patients with physical limitations or not allowed by the physician to exercise.
* Patients infected with Covid-19 at the time of data collection.

Primary outcomes:
measure: Change from baseline on waist circumference at 3 months of follow-up.
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change from baseline on cardiometabolic risk factor at 3 months of follow-up.
timeFrame: Baseline and 3 months
measure: Change from baseline on cardiopulmonary fitness at 3 months of follow-up.
timeFrame: Baseline and 3 months
measure: Change from baseline on quality of life at 3 months of follow up.
timeFrame: Baseline and 3 months
measure: Change from baseline on Physical activity levels at 3 months of follow up.
timeFrame: Baseline and 3 months follow-up.
measure: Change from baseline on dietary intake at 3 months of follow up.
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Univsersity of Sao Paulo
Study officials:
affiliation: HC FMUSP
name: Bruno Gualano
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02859805: Validation of a Diagnostic Self-assessment Scale Non-motor Fluctuations at the Parkinson's Patient
Official title: Validation of a Diagnostic Self-assessment Scale Non-motor Fluctuations at the Parkinson's Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 255
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient suffering from Parkinson's disease

Brief summary: The objective of this study is to validate a diagnostic tool severity of these common non-motor manifestations, disturbing and little recognized as a self-questionnaire. This assessment tool used on different subgroups of patients (free from any treatment at an early stage of the disease and the stage of motor complications) will better understand the natural history of the non-motor fluctuations (FNM)


Eligibility criteria: Inclusion Criteria:

Patient aged 30 or over Patient having an Parkinson's disease Patient hospitalized in one of the clinical sites participating in the project Patient have agreed to participate in the study subject that masters the French language and able to fulfill the self-questionnaire.

Exclusion Criteria:

Patient aged under 30 Patient can not answer the self-administered questionnaire Patient has not agreed to participate in the study.

Primary outcomes:
measure: Quality of life
timeFrame: 2 years
measure: Quality of life
timeFrame: 2 years
Secondary outcomes:
measure: Socio-demographic data
timeFrame: 2 years
measure: clinical evaluation
timeFrame: 2 years
measure: clinical evaluation
timeFrame: 2 years
measure: clinical evaluation
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique des Hôpitaux de Marseille
name: Urielle DESALBRES
role: STUDY_DIRECTOR
References:
Clinical trial NCT05615805: The Effect of Ocular Rinse Volume on Surface Irritation After Intravitreal Injections
Official title: The Effect of Ocular Rinse Volume on Surface Irritation After Povidone-iodine Preparation for Intravitreal Injections: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intravitreal Injection
Ocular Rinse
Age-Related Macular Degeneration
Diabetic Macular Edema
Cystoid Macular Edema
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is the first randomized controlled trial looking into post-injection rinse volume of standard ophthalmic eyewash and its affect on patient comfort up to 72 hours after injections.

Detailed description: Purpose To evaluate whether the volume of wash out rinse after povidone iodine (PI) application for intravitreal injections (IVI) affects patients' ocular surface irritation.

Methods This was a prospective, single-masked, randomized-controlled trial consisting of 142 subjects . A total of 51, 45, and 46 patients received 3-mL, 10-mL, and 15-mL of ocular rinse respectively. Reductions in the Ocular Surface Disease Index (OSDI) and the Standardized Patient Evaluation of Eye Dryness II (SPEED II) surveys, conducted before and at 24-72 hours post-injection, were analyzed.

Eligibility criteria: Inclusion Criteria:

choroidal neovascular membrane or cystoid macular edema requiring intravitreal injections for treatment.

Exclusion Criteria:

active ocular infection, eyelid trauma, graft versus host disease, thyroid eye disease, pregnancy.

Primary outcomes:
measure: Ocular Surface Disease Index
timeFrame: 24-72 hours after injection
Secondary outcomes:
measure: Standardized Patient Evaluation of Eye Dryness II
timeFrame: 24-72 hours after injection
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Dean McGee Eye Institute
state: Oklahoma
Study officials:
References:
Clinical trial NCT06651905: Nerve Block Vs Sedation Infusion for Awake Fiberoptic Intubation.
Official title: Superior Laryngeal Nerve Block Versus Sedation with Intravenous Dexmedetomidine Infusion for Awake Fiberoptic Intubation of Hemimandibulectomy Patients with an Anticipated Difficult Airway: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Superior Laryngeal Nerve Block
Sedation
Dexmedetomidine
Awake Fiberoptic Intubation
Hemimandibulectomy
Anticipated Difficult Airway
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 80
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: This study compares the efficacy and safety of dexmedetomidine infusion versus superior laryngeal nerve block during awake fiberoptic intubation in hemimandibulectomy patients.


Eligibility criteria: Inclusion Criteria:

* Age range ≥ 18 or ≤60.
* Both sexes.
* American Society of Anesthesiologists (ASA) II-III.
* Body mass index:18.5 to 30 kg/m2.
* Hemimandibulectomy patients with an anticipated difficult airway \[El-Ganzouri Risk Index (EGRI)\>3\].

Exclusion Criteria:

* Patient's refusal.
* Known allergy to drugs used in the study.
* Neurological disorders.
* Advanced liver or kidney disease.
* Patient with psychiatric disorders.
* Patient who needs postoperative ICU.
* Airway distortion and cervical spine movement.

Primary outcomes:
measure: The intubation score
timeFrame: time from introduction of scope of fibroptic device in the mouth of the patient to the insertion of the endotracheal tube between the vocal cords.Time range of 10 minutes
Secondary outcomes:
measure: The degree of comfort
timeFrame: time from introduction of scope of fibroptic device in the mouth of the patient to the insertion of the endotracheal tube between the vocal cords. Time range of 10 minutes
measure: Degree of airway obstruction
timeFrame: time from introduction of scope of fibroptic device in the mouth of the patient to the insertion of the endotracheal tube between the vocal cords Time range of 10 minutes
measure: Heart rate
timeFrame: From one minute before intubation to 10 minutes after intubation
measure: Mean arterial pressure
timeFrame: From one minute before intubation till10 minutes after intubation
measure: Ramsay sedation score
timeFrame: From time of injection of Drugs (Dexetodomidine , Lidocaine) to the patient to 10 minutes after intubation
measure: Patient satisfaction score
timeFrame: From the end of the operation to 24 hours postoperative
measure: Incidence of complications
timeFrame: From the end of the operation to 24 hours postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Professor
name: Tarek Abd EL Halim Kaddah, MD
role: STUDY_DIRECTOR
affiliation: Lecturer
name: Mai M EL Rawas, MD
role: PRINCIPAL_INVESTIGATOR
References: