louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04155073: E-Visit for COPD and Smoking Cessation
Official title: Development and Testing of an Electronic Visit for COPD Early Detection and Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Cigarette Smoking
Telemedicine
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2019-11-07
Enrollment: 125
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this work is to develop, refine, and pilot test an electronic visit (e-visit) to: 1) deliver smoking cessation treatment to adults at risk for COPD and 2) to improve rates of COPD early detection and accurate diagnosis. The investigators will conduct a pilot RCT of the COPD/smoking cessation e-visit as compared to treatment as usual (TAU), with primary objective to provide effect size estimates for a larger RCT.


Eligibility criteria: Inclusion Criteria:

* current cigarette smoker,
* enrolled in MUSC's Epic MyChart program or willing to sign up for MyChart,
* possess a valid e-mail address that is checked daily,
* English fluency, and
* owner of an iOS or Android-compatible smartphone and a webcam-enabled device

Exclusion Criteria:

* COPD on a patient's problem list within Epic.

Primary outcomes:
measure: Evidence-based Cessation Treatment Utilization
timeFrame: Baseline through Month 3
measure: Number of Participants at Month 1 and Month 3 With At Least 1 Quit Attempt
timeFrame: Baseline through Month 3
Secondary outcomes:
measure: E-visit Acceptability and Feasibility
timeFrame: Baseline through Month 3
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
citation: Dahne J, Player MS, Strange C, Carpenter MJ, Ford DW, King K, Miller S, Kruis R, Hawes E, Hidalgo JE, Diaz VA. Proactive Electronic Visits for Smoking Cessation and Chronic Obstructive Pulmonary Disease Screening in Primary Care: Randomized Controlled Trial of Feasibility, Acceptability, and Efficacy. J Med Internet Res. 2022 Aug 30;24(8):e38663. doi: 10.2196/38663.
Clinical trial NCT06606873: Complicated Rhinosinusitis
Official title: Anatomical Risk Factors for Orbital Complications in Patients With Acute Rhinosinusitis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Orbital Complications of Rhinosinusitis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: OBSERVATIONAL Split-half case-comparison study.

Brief summary: Rhinosinusitis is among the most common conditions encountered in the primary care clinic.

Detailed description: serious sequelae of ARS, including orbital and intracranial complications as Like Periorbital oedema and Displaced globe and Double vision and Ophthalmoplegia Reduced visual acuity

Eligibility criteria: Inclusion Criteria:

* Patients with orbital complications of rhinosinusitis

Exclusion Criteria:

* 1- Previous maxillofacial trauma history. 2- Previous nasal or paranasal surgery. 3- Invasive fungal rhinosinusitis. 4- Cases with odontogenic rhinosinusitis. 5- Immotile cilia syndrome, cystic fibrosis

Primary outcomes:
measure: Orbital complications of rhinosinusitis
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
Study officials:
affiliation: Assiut University
name: Mohamed Abdelaziz, MD
role: STUDY_CHAIR
References:
citation: Lucas JW, Schiller JS, Benson V. Summary health statistics for U.S. adults: National Health Interview Survey, 2001. Vital Health Stat 10. 2004 Jan;(218):1-134.
citation: Mekhitarian Neto L, Pignatari S, Mitsuda S, Fava AS, Stamm A. Acute sinusitis in children: a retrospective study of orbital complications. Braz J Otorhinolaryngol. 2007 Jan-Feb;73(1):75-9. doi: 10.1016/s1808-8694(15)31126-5.
citation: Sedaghat AR, Wilke CO, Cunningham MJ, Ishman SL. Socioeconomic disparities in the presentation of acute bacterial sinusitis complications in children. Laryngoscope. 2014 Jul;124(7):1700-6. doi: 10.1002/lary.24492. Epub 2013 Dec 11.
Clinical trial NCT03313973: Impact of Myotensives Techniques, With and Without Auto-reeducation, on the Vital Capacity Forced by the Patient Affected by a Honeymoon Parkinson's Disease
Official title: Impact of Myotensives Techniques, With and Without Auto-reeducation, on the Vital Capacity Forced by the Patient Affected by a Honeymoon Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-10-19
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Lower respiratory tract infections are one of the main hospitalization or mortality cause in idiopathic Parkinson's disease. Because of akinesia and articular rigidity these patient develop restrictive syndrome by reduction in the thoraco-lung compliance.The consequence is a progressive loss of the aerobic physical abilities and infection.

The myotensive technique of active muscular stretching seem to increase the range of motion in healthy subject but also in patient with chronic bronchiotisis . These technics also increase the vital respiratory capacity and re enforce the muscles.So adding these technics during the period when the Parkinson's disease patient is stable would be a way of improvement .

Detailed description: To validate if these techniques really improve the the vital respiratory capacity, investigators randomize patient in 2 groups; one will have the standard protocol of stretching + self stretching of the same muscles (experimental group) and the other one (control group) will have the standard protocol and self stretching of forearm . Self stretching of forearm is selected to avoid bias .

Eligibility criteria: Inclusion Criteria:

* Age \>18
* with Parkinson's disease
* stable stade of pathology
* without any treatment modification.

Exclusion Criteria:

* rehabilitation support or osteopathic support
* active smoking
* respiratory disease
* cognitives trouble
* any other neurologic pathology

Primary outcomes:
measure: Percentage vital respiratory capacity
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
References:
Clinical trial NCT01571973: Evaluation of Pharmaceutical Care in Depressed Outpatients
Official title: EVALUATION OF THE EFFECTIVENESS OF PHARMACEUTICAL CARE (DÁDER PROGRAM) IN DEPRESSED OUTPATIENTS TREATED WITH PSYCHOTROPIC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: pharmaceutical care
depression
compliance
pharmacist's intervention
Dáder
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2012-04-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study examines whether pharmacotherapeutic follow-up improves outcomes of treatment of depressed outpatients.


Eligibility criteria: Inclusion Criteria:

* women between 18 and 65 years, with diagnostic hypothesis of depression at the beginning of treatment or change in treatment unless 2 months (dosage or substance)

Exclusion Criteria:

* record of dependence on psychoactive substances, diagnosed schizophrenia,
* low education (illiterate) or cognitive impairment evident that compromise the completion of research instruments

Primary outcomes:
measure: depression level
timeFrame: six months
Secondary outcomes:
measure: anxiety level
timeFrame: 6 months
measure: compliance
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02905773: Postoperative Pain After the Removal of Root Canal Filling Material
Official title: Postoperative Pain After the Removal of Root Canal Filling Material Using Different Techniques in Teeth With Failed Root Canal Therapy: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Postoperative Pain
Keywords: Intensity
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 135
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this study was to evaluate the intensity and duration of postoperative pain after the removal of root canal filling material in retreatment procedures of upper incisor teeth with chronic apical periodontitis, using different techniques.

The patients were assigned to three groups of 45 patients, according to the method used to remove old canal filling material. The presence of postoperative pain was assessed after 6, 12, 24, 48, and 72 hours, 7 days, and finally after 10 days.

The hypothesis of this study: there would be no difference in postoperative pain intensity among the groups.


Eligibility criteria: Inclusion Criteria:

* asymptomatic incisor teeth with chronic apical periodontitis
* patients between 18-55 years of age

Exclusion Criteria:

* patients with systemic disease

Primary outcomes:
measure: postoperative pain after non-surgical endodontic retreatment using modified visual analog scale
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02150473: The Effect of Adalimumab Plus Methotrexate (MTX) Versus Placebo Plus MTX on Cartilage in (RA) Patients
Official title: Delayed Gadolinium-enhanced Magnetic Resonance (MR) Imaging of Cartilage - A Pilot Study to Measure the Effect of Adalimumab Plus MTX Versus Placebo Plus MTX on Cartilage in Early RA Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid Arthritis
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2014-05-29
Enrollment: 21
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: This study aims to compare longitudinally the effect of adalimumab plus methotrexate (MTX) versus MTX monotherapy on cartilage GAG content, reflected by Delayed Gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) index, in patients with early progressive rheumatoid arthritis (RA), who had not previously received any Disease modifying antirheumatic drug (DMARD) or biologic treatment.

Detailed description: Patients will be randomly assigned to either adalimumab q2w plus oral MTX qw combination therapy or oral MTX qw monotherapy plus placebo subcutaneous (SC) q2w in a ration 2:1. To maintain blinding, matching placebo SC injections will be dispensed q2w to the MTX monotherapy group. All subjects will receive open-label MTX 15 mg qw as oral tablets. All subjects will take approximately 5 mg weekly dietary supplement of oral folate throughout the study on any day beginning 48 hours after ingestion of their oral study medication. Defined as standard therapy oral folate supplementation will be taken in a single dose 24-48 h after MTX therapy.

Eligibility criteria: Inclusion Criteria:

* Subject has a diagnosis of early RA (ERA) fulfilling the 2010 American college of rheumatology (ACR) criteria for classification of RA
* Disease duration less than 12 months from symptoms onset.

Exclusion Criteria:

* Subject has previous exposure to any systemic biologic therapy (e.g. abatacept, tocilizumab) including anti-Tumor necrosis factor (TNF therapy) (e.g., infliximab, golimumab, certolizumab pegol, etanercept) including adalimumab.

Primary outcomes:
measure: Joint space narrowing of the metacarpophalangeal (MCP II) and MCP III joints in the clinically dominant hand measured by variable flip-angle imaging 3 time (3T) MRI
timeFrame: 104 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
state: NRW
Study officials:
affiliation: Poliklinik für Rheumatologie
name: Benedikt Ostendorf, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03515473: Subjective and Objective Results With CI Electrode Types
Official title: Subjective and Objective Results With CI Electrode Types
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cochlear Implant
Keywords: cochlear implant
CI532
CI512
CI522
electrode array
perimodiolar
electrophysiology
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2018-05-03
Enrollment: 139
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects implanted with CI532 or CI512 or CI522 in Szeged and St. Pölten between the indicated time frames

Brief summary: Background The authors' aim was to compare the influence of various electrode designs on selected objective and subjective clinical outcomes for cochlear implant recipients using the same model of receiver-stimulator, Cochlear™ Nucleus® Profile Series and sound processor.

Methods A multicenter study with subjects with profound sensorineural hearing loss, who were implanted and followed up in two tertiary centers. A total of 54 ears were implanted with Cochlear™ Nucleus® CI532, 51 with Cochlear™ Nucleus® CI522 and 54 with the Cochlear™ Nucleus® CI512. Implant loss and intraoperative electrophysiological tests (electrically evoked stapedial reflex threshold \[ESRT\], neural response telemetry threshold \[T-NRT\] and impedance), postoperative data (C-level, T-level, dynamic range, T-NRT and power consumption) and intracochlear position of the active electrode were analyzed with Nucleus Custom Sound 4.4 software.


Eligibility criteria: Inclusion Criteria:

* successful cochlear implantation with CI532 or CI512 or CI522
* gave informed consent

Exclusion Criteria:

* unsuccessful cochlear implantation

Primary outcomes:
measure: Intraoperative measurements
timeFrame: 1 day
measure: Intraoperative measurements
timeFrame: 1 day
measure: Intraoperative measurements
timeFrame: 1 day
Secondary outcomes:
measure: Postoperative measurements
timeFrame: 3 months
measure: Postoperative measurements
timeFrame: 3 months
measure: Postoperative measurements
timeFrame: 3 months
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: Universitiy of Szeged, Department of Otorhinolaryngology, Head and Neck Surgery
Study officials:
References:
Clinical trial NCT02834273: Patient Education Following a Stroke
Official title: Impact of Patient Education Following a Stroke on Knowledge of Risk Factors, Stroke Warning Signs and What to do in Cases of Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2016-07-15
Enrollment: 199
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 rapid diagnosis and treatment of acute ischemic stroke are critical in the reduction of morbidity, disability and stroke associated mortality Under-education about stroke may prevent people from recognizing symptoms early enough to seek immediate care.

The studies reported on stroke patients managed in stroke center have shown that 39-42% of patients could not name any symptoms of stroke and 36% to 43% no risk factor of stroke.

The stroke patients are therefore a population at high risk for neurological events and cardiac vascular recurrence. However, no studies have evaluated the interest of the development of therapeutic workshops in stroke unit to educate patients about symptoms suggestive of stroke, risk factors and what to do in cases of stroke.

Investigators assume that the setting up of a therapeutic education workshop in the stroke unit may allow a better understanding of the symptoms, risk factors and what to do following stroke. So there is a direct benefit to the patient represented by a better knowledge of stroke (warning signs, risk factors, what to do), improved treatment compliance and reduced risk of recurrence.

More generally, there is a real benefit to promote these messages to the public through the patient and his relatives


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years.
* Diagnosis of ischemic stroke;
* Patients with back home or shorter rehabilitation;
* Patients affiliated to a social security scheme;
* Patients who consented to participate in writing.

Exclusion Criteria:

* Patients with cognitive disorders, vigilance, aphasia.
* Patients institutionalized.

Primary outcomes:
measure: Questionnaire EPIC score
timeFrame: 3 months
Secondary outcomes:
measure: Blood pressure
timeFrame: 12 months
measure: LDL-C
timeFrame: 12 months
measure: Body Mass Index
timeFrame: 12 months
measure: Smoking intoxication
timeFrame: 12 months
measure: Recurrent stroke
timeFrame: 12 months
measure: Compliance to treatments
timeFrame: 12 months
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Bertrand Lapergue, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
Clinical trial NCT00663273: Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Tina Gel Sweet Flower
Official title: Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Tina Gel Sweet Flower
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-04-22
Enrollment: 30
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Tina Gel Sweet Flower.


Eligibility criteria: Inclusion Criteria:

* Integral skin test in the region;

Exclusion Criteria:

* Lactation or gestational risk or gestation;
* Use of Anti-inflammatory or immunosuppression drugs 1 month before the study;
* Topical medication use at the region to be treated;
* Cutaneous disease or active gynecological disease which may interfere in study results;
* Personal history of allergic disease at the area to be treated;
* Allergic or atopic history;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Adverse events and their intensity and their association with the treatment.
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sanofi-aventis
Study officials:
affiliation: Sanofi-aventis administrative office Brazil
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT04530773: Developing and Validating VR-Enabled Ophthalmic Clinics: A New Paradigm for Visual Function Testing
Official title: Developing and Validating VR-Enabled Ophthalmic Clinics: A New Paradigm for Visual Function Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Health of Virtual Reality
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aimed to design and validate a VR-based ophthalmic clinic that replicates traditional tests of visual acuity, stereopsis, and contrast sensitivity within an immersive digital environment. Using a rigorously developed system based onprogrammable interfaces, and standardized testing paradigms, we compared VR assessments against gold-standard clinical tools in a cohort of healthy adult participants. Key outcomes included test consistency, correlation, user acceptability, visual fatigue, and time efficiency. Our findings offer evidence for the viability of VR as a platform for remote ophthalmic testing and pave the way for scalable digital eye care delivery.


Eligibility criteria: Inclusion Criteria:

* The study included healthy individuals older than 18 years of age with a best-corrected visual acuity (BCVA) of \<0.1 logarithm of minimum angle of resolution (logMAR) and no ongoing or prior history of ocular or systemic disease.

Exclusion Criteria:

* The study excluded healthy individuals younger than 18 years of age with a best-corrected visual acuity (BCVA) of \>0.1 logarithm of minimum angle of resolution (logMAR) with ongoing or prior history of ocular or systemic disease.

Primary outcomes:
measure: Accommodative Response
timeFrame: 60 min
measure: AC/A Ratio
timeFrame: 60 min
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Opthalmic Center
state: Guangdong
Study officials:
References: