louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03077035: Using ICDAS II and KaVo DIAGNOdent Pen Detecting Tooth Pit and Fissure Level Incipent Caries Progression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries on Pit and Fissure Surface
Keywords: ICDAS
DIAGNOdent
glass ionomer sealant
resin-based sealant
pit and fissure sealants
effectiveness of preventing caries
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2017-03-10
Enrollment: 300
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study was to monitor effectiveness of glass ionomer sealant and resin-based sealant in ICDAS, and to evaluat the correlation between ICDAS and DIAGNOdent over 24 months. Over 200 8-year-old children with at least 2 permanent molar with the International Caries Detection and Assessment System (ICDAS) scores 0-4 were placed glass ionomer sealant and resin-based sealant split-mouthed randomly, and examined with ICDAS and DIAGNOdent before sealents placement and 6, 12 and 24 months after.


Eligibility criteria: Inclusion Criteria:

* Subjects provided written informed consent;
* They were 7 to 9 years old;
* They have at least 2 permanent molar with the International Caries Detection and Assessment System (ICDAS) scores 0-4;
* They were generally heallthy

Exclusion Criteria:

* They were allergic to the constituents in pit and fissure sealants

Primary outcomes:
measure: Change in Decayed Surfaces (DS) of Different Fissure Sealants
timeFrame: Baseline, 6 months, 12 months and 24 months
measure: Change in Repaired Sealants by the baseline ICDAS
timeFrame: 6 months, 12 months and 24 months
measure: Change in DIAGNOdent Score
timeFrame: Baseline, 6 months, 12 months and 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: School of Stomatology The Fourth Military Medical University
state: Shaanxi
Study officials:
References:
Clinical trial NCT02375035: Developing a Safer and More Accurate Device for Biopsies of Suspected Prostate Cancer
Official title: Developing a Safer and More Accurate Device for Biopsies of Suspected Prostate Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Prostate Biopsy
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2015-03-02
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who have had a standard biopsy and now require a transrectal biopsy as part of their management

Brief summary: To evaluate the use of the CAMbridge PROstate Biopsy devicE (CAMPROBE) as a method of undertaking prostate biopsy as part of their clinical management.

Detailed description: To assess patient's experience and complications of the CAMPROBE and compare the results with known published outcomes from standard transrectal biopsies .

To use data from the pilot study to determine the feasibility of a randomised trial comparing CAMPROBE with the current standard method of prostate biopsies.

Eligibility criteria: Inclusion Criteria:

* Fit and well enough to undergo a repeat prostate biopsy
* Men who have previously had a transrectal ultrasound biopsy of the prostate and due to have a repeat biopsy as part of normal care
* Men on active surveillance
* Men on PSA monitoring

Exclusion Criteria:

* Contraindication for a repeat prostate biopsy
* Contraindication for a transperineal prostate biopsies
* Previous perineal or anal surgery
* MRI suggesting anterior lesion or extra capsular disease
* MRI suggesting lesion that needs fusion image targeting
* Unable to lie down and with legs in a stirrup for at least 45 minutes

Primary outcomes:
measure: Pain score assessment of CAMPROBE biopsy procedure
timeFrame: 3 weeks
measure: Patient reported adverse events related to CAMPROBE biopsy
timeFrame: 3 weeks
measure: Patient perception and acceptance of CAMPROBE biopsy
timeFrame: 3 weeks
Secondary outcomes:
measure: Deterioration in urinary function after CAMPROBE biopsy
timeFrame: 3 weeks
measure: Deterioration in sexual function after CAMPROBE biopsy
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
Study officials:
affiliation: University of Cambridge
name: Vincent Gnanapragasam
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01263535: Use of an Ocular Telemetry Sensor in Tafluprost Treated Patients
Official title: Circadian Continuous Intraocular Pressure Monitoring With SENSIMED Triggerfish® Ocular Telemetry Sensor in Patients on Tafluprost Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Glaucoma
Lead sponsor: Sensimed AG
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Geneva
First posted: 2010-12-20
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: DIAGNOSTIC

Brief summary: This clinical trial is designed to investigate the performance of SENSIMED Triggerfish® during 24-hour continuous IOP fluctuation monitoring, defined as the number of valid recording intervals over the 24-hour period.

The investigation will recruit male and female patients older than 18 years and diagnosed with glaucoma and treated with tafluprost in both eyes. 20 subjects will be enrolled in the study. Patients will be considered enrolled in the study upon signature of informed consent. A screening visit and one 24-hour IOP fluctuation monitoring session during a 36-hour hospitalisation, are planned for each patient.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years.
* Untreated IOP of ≥22 mmHg in both eyes.
* Documented, typical glaucomatous visual field (VF) loss (nasal step, or arcuate, paracentral or Seidel's scotoma) determined by automated static threshold perimetry (Octopus 100), and glaucomatous optic nerve head cupping (neural rim notching or saucerization) in both eyes.
* Patients under tafluprost treatment since at least 4 weeks in both eyes.
* Patients who accept signing an informed consent approved by the Ethics Committee.

Exclusion Criteria:

* Patients not able to understand the nature of the research
* Patients under tutorship
* Corneal abnormalities in both eyes
* Subjects with contraindications for wearing contact lenses
* History of ocular surgery within the last 3 months
* Known hypersensitivity to tafluprost or to any of its excipients
* Full-frame metal glasses during monitoring with SENSIMED Triggerfish®
* Pregnancy and lactation
* Simultaneous participation in other clinical research
* Patients with evidence of ocular infection or inflammation

Primary outcomes:
measure: Acquisition of 24-hour Sensor output signal
timeFrame: After 24-hour continuous recording
Secondary outcomes:
measure: Possible IOP fluctuation
timeFrame: After 24-hour recording with study device
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospital Geneva
Study officials:
References:
Clinical trial NCT00848835: Long Term Integrity Follow-up Evaluation
Official title: Long Term Integrity Follow-up Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sudden Cardiac Death
Keywords: defibrillator
Lead sponsor: Guidant Corporation
Sponsor class: INDUSTRY
First posted: 2009-02-20
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients who are indicated for a market released ICD

Brief summary: To document the performance of the Guidant ENDOTAK EZ and the RELIANCE defibrillation leads over 5 years.

Detailed description: There are few prospective long term follow-up studies on implanted cardiac device (pacemaker/implantable cardioverter defibrillator (ICD)) survivability. This study will evaluate the long term performance (5 years) of the transvenous defibrillation leads (ENDOTAK ENDURANCE EZ and teh ENDOTAK RELIANCE. Data will be collected at implant, 1 and 6 months, 1,3 and 5 years.

Eligibility criteria: Inclusion Criteria:

* Patients selected for Guidant ICD system implant, available for follow-up at the defined intervals

Exclusion Criteria:

* Patients enrolled in other studies, not available for follow-up, \< 18 yrs, unable to sign consent, life expectancy \< 1 year due to a medical condition

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Victoria Cardiac Arrythmia trials
name: Lawrence Sterns, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02991235: Efficacy and Safety of PRJ212 to Improve the Memory of Patients With Mild Severity Alzheimer's Disease
Official title: Evaluation of the Efficacy and Safety of PRJ212 on Improving the Memory of Patients With Mild Severity Alzheimer's Disease: A 6-month Randomized, Double-blind and Placebo-controlled, Followed by a 6-month Open Label Extension Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: Bioiberica
Sponsor class: INDUSTRY
First posted: 2016-12-13
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A 6-month randomized, double-blind and placebo-controlled, followed by a 6-month open label extension study.

Detailed description: Men and women from 60 to 85 years old with diagnosis of mild severity Alzheimer's disease, according to the diagnostic criteria established by the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease and Related Disorders Associations (NINCDS-ADRDA).

Eligibility criteria: Inclusion Criteria:

* Patients aged from 60 to 85 years.
* Patients with a diagnosis of probable or possible Alzheimer's disease according to the NINCDS-ADRDA.
* Patients with mild Alzheimer's disease according to MMSE.
* Patients with ability to ingest oral medication.
* Patients able to undergo a MRI.

Exclusion Criteria:

* Pregnant or breastfeeding women or planning a pregnancy during the study.
* Patients and caregivers unwilling or unable to perform cognitive testing.
* Patients taking part in an interventional clinical trial.
* Patients who have a risk of non-compliance to the study procedures.
* Patients with clinical or significant laboratory abnormalities.
* Patients treated with concomitant treatment or food supplements which could interfere with evaluation criteria.

Primary outcomes:
measure: Efficacy of PRJ212 versus placebo on the memory measured by Repeatable Battery for the Assessment of Neuropsychological Status (R-BANS).
timeFrame: Comparison of the R-BANS score, from baseline to 6 months.
measure: Efficacy of PRJ212 versus placebo on the memory measured by Wechsler Memory Scale (WMS).
timeFrame: Comparison of the WMS score, from baseline to 6 months.
measure: Efficacy of PRJ212 versus placebo on the memory measured by memory composite (R-BANS+WMS).
timeFrame: Comparison of the total memory composite score, from baseline to 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Fundació ACE
Study officials:
affiliation: Bioiberica, S.A.
name: Martinez
role: STUDY_DIRECTOR
References:
Clinical trial NCT03598335: Characterizing Malignant Tumors Using Ultrasound Doppler Imaging
Official title: Characterizing Malignant Tumors Using Ultrasound Doppler Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malignant Tumor of Women's Reproductive System
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-07-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women presenting at the Hillel Yaffe Medical Center gynecological ultrasound clinic.

Brief summary: The aim of this study is to determine whether Ultrasound Doppler imaging can identify malignant tumors at a very early stage.


Eligibility criteria: Inclusion Criteria:

* Women presenting for routine abdominal/vaginal ultrasound

Exclusion Criteria:

* Pregnant women

Primary outcomes:
measure: Early characterization of malignant tumors
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hille Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Alon Shrim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01699035: Survey on Return to Work After Stroke
Official title: Survivor Perspective on Critical Factors to Return to Work After Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: stroke
work
vocational rehabilitation
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2012-10-03
Enrollment: 715
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: stroke survivors

Brief summary: Survey of survivor perspective on critical elements that either facilitate or inhibit return to work after a stroke. Critical elements are queried in areas of finances, stroke impairments, interpersonal support, therapeutic support, organization influences, work or job specific issues and psychological issues.

Detailed description: The objective of this project is to more accurately describe the stroke survivor's perspective on return to work. The survey development included qualitative analysis of a set of interviews with stroke survivors to arrive at the critical elements described above, followed by item development with an expert panel and preliminary testing of the wording and format for legibility. The survey is being administered both on-line and by paper through the mail to a wide range of survivors with the objective of obtaining a large, diverse sample. The ultimate goal of the project is to arrive at a refined set of recommendations to inform stroke survivors, health care professionals and employers to increase their sensitivity to the needs and desires of individual attempting to return to work after stroke.

Eligibility criteria: Inclusion Criteria:

* have returned to work, have thought about returning to work, or have tried to return to work

Exclusion Criteria:

* non-stroke disability
* retired or no plan to return to work

Primary outcomes:
measure: critical factors that facilitate or inhibit return to work after stroke
timeFrame: after collection of data on all surveys
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Robert J Hartke, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hartke RJ, Trierweiler R, Bode R. Critical factors related to return to work after stroke: a qualitative study. Top Stroke Rehabil. 2011 Jul-Aug;18(4):341-51. doi: 10.1310/tsr1804-341.
Clinical trial NCT03320135: EMD for Treatment of Proximal Class-II Furcation Involvements
Official title: Enamel Matriz Derivate for Treatment of Proximal Class II Furcation Defects: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Aggressive Periodontitis
Keywords: enamel matrix derivative
proximal furcation
randomized clinical trial
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to evaluate the clinical response of proximal furcations treated with enamel matrix derivative proteins (EMD).

Detailed description: Proximal class-II furcation represents a challeng to periodontal therapy. Studies show that the ultrasonic non-surgical therapy doesn't work in these defects and the guided tissue regeneration therapy with membranes also demonstrates an unpredictable improvement. Therefore, enamel matrix derivative proteins (EMD) have been proposed as a periodontal regenerative procedure due to their fundamental role in cementum development.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of generalized aggressive periodontitis (Armitage, 1999; American Academy of Periodontology, 2015);
* Have undergone a first approach for periodontal treatment (full-mouth ultrasonic debridement);
* Presence of one proximal class-II furcation presenting probing depth \> 4 mm and bleeding on probing ;
* Good general health;
* Agree to participate in the study and sign the informed consent form (TCLE) after explaining the risks and benefits;

Exclusion Criteria:

* Systemic problems (cardiovascular alterations, blood dyscrasias, immunodeficiency - ASA III / IV / V) that contraindicate the periodontal procedure;
* Have used antibiotics and anti-inflammatories in the last six months;
* Smoke ≥ 10 cigarettes/day;
* Pregnant or lactating;
* Chronic use of medications that may alter the response of periodontal tissues;
* Indication of antibiotic prophylaxis for dental procedures;

Primary outcomes:
measure: Horizontal clinical attachment level
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: São José dos Campos
country: Brazil
facility: Naira Andere
state: SP
Study officials:
affiliation: Universidade Estadual Paulista "Julio de Mesquita Filho", ICT/UNESP
name: Mauro M Santamaria, DDS, PhD
role: STUDY_DIRECTOR
References:
citation: Casarin RC, Del Peloso Ribeiro E, Nociti FH Jr, Sallum AW, Sallum EA, Ambrosano GM, Casati MZ. A double-blind randomized clinical evaluation of enamel matrix derivative proteins for the treatment of proximal class-II furcation involvements. J Clin Periodontol. 2008 May;35(5):429-37. doi: 10.1111/j.1600-051X.2008.01202.x. Epub 2008 Mar 12.
Clinical trial NCT05781035: Dexmedetomidine Versus General Anesthesia on the Diagnosis of Endobronchial US-Guided Transbronchial Needle Aspiration
Official title: Moderate Sedation by Dexmedetomidine Versus General Anesthesia on the Diagnostic Yield of Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedation
Dexmedetomidine
EBUS Guided Transbronchial Needle Aspiration
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 compare dexmedetomidine as moderate sedation versus general anathesia on the diagnostic yield of Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration

Detailed description: Endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (EBUS-TBNA) has emerged as a highly effective, minimally invasive technique for sampling peribronchial, mediastinal, and lung masses for pathologic examination with low rate of complications, and costs.

Dexmedetomidine, is a high-affinity adrenergic agonist of the alpha 2 receptor, is a potential alternative sedative.

The use of dexmedetomidine does not lead to respiratory depression, or to a decline in cognitive skills or patient cooperation. This is because dexmedetomidine acts on the alpha-2 receptors in the locus coeruleus, in contrast to other sedatives (midazolam and propofol) which act on GABA receptors/cerebral cortex.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status classification II or III a requiring EBUS-TBNA based on suspicion of either benign or malignant disease in mediastinal or hilar lymph nodes (LNs) or masses or requiring EBUS-TBNA for mediastinal staging of lung cancer.

Exclusion Criteria:

* Suspected need for additional procedures other than EBUS-TBNA during planned bronchoscopy (e.g., need for navigational bronchoscopy, endobronchial biopsies, and therapeutic bronchoscopy)
* body mass index \> 35 kg/m2
* allergies to any of the involved sedatives or anesthetic agents
* comorbidities contraindicating the EBUS procedure
* pregnancy

Primary outcomes:
measure: Diagnostic yield of Endobronchial ultrasound -guided transbronchial needle aspiration
timeFrame: During procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Mohammad Fouad Algyar
state: ElGharbiaa
Study officials:
affiliation: Lecturer of Chest Department , Faculty of Medicine, Tanta University
name: Mohamed S Torky
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01734135: Provider Notification for High B-type Natriuretic Peptide Values
Official title: Trial of Provider Notification for Patients With High B-type Natriuretic Peptide and no Imaging to Identify Unsuspected Heart Failure.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: B type natriuretic peptide
heart failure
cardiac imaging
quality of care
Lead sponsor: VA Palo Alto Health Care System
Sponsor class: FED
First posted: 2012-11-27
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This proposal examines use of a clinical reminder to the primary provider of patient with a high B type natriuretic peptide but no prior imaging.

Electrical Medical Record-based Intervention to Determine whether Clinical Reminders Improve Heart Failure Management in Patients with High BNP Values and Unknown LVEF.

Detailed description: Rationale: B type natriuretic peptide is known to be elevated (\> 100 pg/ml) in patients with heart failure. Furthermore, treatments are available to improve survival and reduce hospitalization if the left ventricular ejection fraction (LVEF) is \< 40%. Accordingly, guidelines recommend an LVEF measure for patients with suspected heart failure. Prior work has demonstrated that patients with high BNP values do not always have a measure of left ventricular ejection.

Hypothesis: A reminder to patients with BNP and no imaging may prompt providers to order appropriate imaging potentially leading to 1) identification of unsuspected depressed ejection fraction and 2) more appropriate treatment.

Eligibility criteria: Inclusion Criteria:

* BNP \>= 200 pg/ml in last 2 months

Exclusion Criteria:

* Measure of LVEF in the last 12 months
* Last measure of LVEF \< 40%

Primary outcomes:
measure: Measurement of left ventricular ejection fraction
timeFrame: 6 months after randomization
Secondary outcomes:
measure: Identification of LVEF < 40%
timeFrame: 6 months following randomizaiton
measure: Treatment of Low LVEF
timeFrame: 6 months following randomization
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
affiliation: VA Palo Alto HCS
name: Paul A Heidenreich, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: