louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01715870: Life Style and Food Habits Questionnaire in the Portuguese Population Aged 55 or More
Official title: Life Style and Food Habits Questionnaire in the Portuguese Population Aged 55 or More.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age Related Macular Degeneration
Keywords: Age related macular degeneration
Food habits
Life style
Risk factors
questionnaire
Lead sponsor: Association for Innovation and Biomedical Research on Light and Image
Sponsor class: OTHER
First posted: 2012-10-29
Enrollment: 2000
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects that participated in the "Epidemiological study on the prevalence of Age related Macular Degeneration in Portugal" (Protocol N. CC-01-2009) will be invited to answer a validated life style and food habits questionnaire.

Brief summary: The study population will be selected from the "Epidemiological study on the prevalence of Age related Macular Degeneration in Portugal" (Protocol N. CC-01-2009) where retinal photographic grading (current gold standard for AMD assessment) was performed to confirm AMD diagnostic. This study provides a population-based sample in which precise and contemporary information on the frequency of nutritional and lifestyle risk factors will be collected, enabling to evaluate whether the separate and/or joint effects of these factors, if found significant, are likely to have a major public health impact in terms of AMD.


Eligibility criteria: Inclusion Criteria:

* Subjects included in the Epidemiologic Study (Protocol N. CC-01-2009). (Subjects aged over 55 years-old included in health care units of Mira or Lousã).
* Written Informed Consent Form signed.

Exclusion Criteria:

- None

Primary outcomes:
measure: Life style and food habits questionnaire.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: AIBILI
Study officials:
affiliation: Association for Innovation and Biomedical Research on Light and Image
name: Rufino M Silva, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04525170: Clinical Evaluation of HPT Treated Rigid Contact Lenses Made From Hexafocon A
Official title: Clinical Evaluation of Hydra-PEG (Polyethylene Glycol) Treatment (HPT) Treated Rigid Contact Lenses Made From Hexafocon A
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ametropia
Lead sponsor: Contamac Ltd
Sponsor class: INDUSTRY
First posted: 2020-08-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be an up to six months, subject-masked, contralateral, parallel-group, randomised, daily wear study. All subjects will wear the Test lens in one eye and the Control lens in the other eye. Data from the first four weeks of Test and Control lens exposure will be used for the FDA 510 (k) submission.


Eligibility criteria: Inclusion Criteria:

* Willing and able to sign the informed consent form
* Aged ≥18 years old
* Experienced wearer of rigid gas permeable contact lenses
* Subject's habitual contact lenses must be made of Boston XO (hexafocon A) material
* Subjects must have owned spectacles or contact lenses prior to enrolment for this trial
* Spherical power between -10.00 D and +10.00 D (at vertex distance 0 mm)
* Corneal astigmatism ≤2.00 D

Exclusion Criteria:

* Eye injury or surgery within 3 months immediately prior to enrolment for this trial
* Pre-existing ocular irritation that would preclude contact lens fitting
* Currently enrolled in an ophthalmic clinical trial
* Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of the accessory solutions, as determined by the investigator
* Any use of medications for which contact lens wear could be contradicted, as determined by the investigator
* Current extended-wear users (sleep-in overnight)
* Current monovision lens wearers
* Current wearers of multifocal contact lenses
* Current wearers of toric contact lenses (front surface design)
* Current wearers of astigmatic contact lenses (posterior surface design)
* Has a reported "Strong" comfort or vision preference between each eye with their habitual RGP lenses
* Unacceptable fit of habitual lenses
* Pregnant women and nursing mothers
* Best-corrected visual acuity worse than 6/9 (LogMAR: +0.20; Snellen decimal: 0.63)

Primary outcomes:
measure: questionnaire addressing subjective comfort and wear time
timeFrame: subjects will be followed-up for one month
measure: limbal redness - ocular biomicroscopy
timeFrame: subjects will be followed-up for one month
measure: corneal staining - ocular biomicroscopy
timeFrame: subjects will be followed-up for one month
Secondary outcomes:
Other outcomes:
Locations:
city: Heikendorf
country: Germany
facility: Hartwig Research Center
state: S-H
city: Kassel
country: Germany
facility: Siehste
Study officials:
affiliation: Hartwig Research Center
name: Andreas Hartwig, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01812070: Innovative Smartphone Application of a New Behavioral Method to Quit Smoking: Pilot Trial (Smart Quit)
Official title: Innovative Smartphone Application of a New Behavioral Method to Quit Smoking: Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: smoking cessation
quit smoking
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2013-03-15
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This innovative study will compare a newly developed smartphone application for Acceptance and Commitment Therapy (ACT) to a smartphone application for traditional cognitive behavioral therapy (CBT).

Detailed description: The study matches these National Cancer Institute (NCI) research funding priorities: (1) increasing the dissemination of smoking cessation treatments and (2) new treatment approaches to boost the effectiveness of cessation interventions.

Eligibility criteria: Inclusion Criteria:

* age 18 or older
* smokes at least five cigarettes daily for at least past 12 months
* wants to quit in the next 30 days
* interested in learning skills to quit smoking
* willing to be randomly assigned to either smartphone application
* resides in US
* has at least daily access to their own personal Apple iPhone 4, 4s, or 5
* knows how to login and download a smartphone application from Apple's "App Store" Store
* willing and able to read in English
* not participating in other smoking cessation interventions (including our other intervention studies)
* has never used the NCI's Quit Guide smartphone application.\]
* willing to complete one follow-up survey
* provide email, phone, and mailing address.

Exclusion Criteria:

* The exclusion criteria are the opposite of the inclusion criteria above.

Primary outcomes:
measure: 7-day and 24-hour point prevalence quit rates
timeFrame: 2 months post randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
References:
Clinical trial NCT01428570: Comparison of the Pentax AWS® With the Macintosh Laryngoscopic Intubation in Obstructive Sleep Apnea Syndrome Patients
Official title: Comparison of the Pentax AWS® With the Macintosh Laryngoscope for Tracheal Intubation in Patients With Obstructive Sleep Apnea Syndrome: a Randomized Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sleep Apnea, Obstructive
Keywords: sleep apnea, obstructive
intubation
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
First posted: 2011-09-05
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The Pentax-AWS_ system (AWS; Pentax Corporation, Tokyo, Japan) is a new rigid indirect laryngoscope which has an integrated tube passage function. Pentax-AWS improved the laryngeal view and facilitated tracheal intubation in patients with restricted neck motion. The purpose of this clinical trial was to evaluate the relative efficacy of the AWS laryngoscopes when used by experienced anesthetists in Obstructive Sleep Apnea Syndrome (OSAS) patients and to compare its performance with the Macintosh laryngoscope.

Detailed description: The occurrence of difficult intubation in OSAS patients is higher than in age and sex matched control patients. The Pentax-AWS_ system (AWS; Pentax Corporation, Tokyo, Japan) is a new rigid indirect laryngoscope which has an integrated tube passage function. Several studies reported that Pentax-AWS improved the laryngeal view and guide also facilitated rapid, easy and reliable tracheal intubation in patients undergoing elective surgery. The purpose of this clinical trial was to evaluate the relative efficacy of the AWS laryngoscopes when used by experienced anesthetists in OSAS patients and to compare its performance with the Macintosh laryngoscope. The investigators hypothesized that, in comparison with the Macintosh, AWS would reduce intubation difficulty, as measured by the intubation difficulty scale (IDS) score.

Eligibility criteria: Inclusion Criteria:

* ASA physical status 1-3 patients,
* aged 20years or older,
* undergoing uvulopalatopharyngoplasty(UPPP) surgery under general anesthesia for a polysomnography-confirmed diagnosis of OSAS.

Exclusion Criteria:

* unstable teeth or mouth opening of \< 18mm
* Patients with any pathology of the neck,
* upper respiratory tract or upper alimentary tracts,
* risk of pulmonary aspiration of gastric contents,
* a history of relevant drug allergy.

Primary outcomes:
measure: Intubation Difficulty Scale(IDS) score
timeFrame: After the end of intubation (within 10 minute after the end of intubation.)
Secondary outcomes:
measure: Cormack and Lehane grade
timeFrame: After the end of intubation (within 10 minute after the end of intubation.)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee university hospital
Study officials:
affiliation: Kyung Hee University Hospital
name: Mi Kyeong Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04328870: Fluid Absorption in Patients Undergoing Operative Hysteroscopy; Results From a Prospective Controlled Study
Official title: The Impact of Spinal Anesthesia and Use of Oxytocin on Fluid Absorption in Patients Undergoing Operative Hysteroscopy; Results From a Prospective Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Overload
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: To determine if combining intravenous oxytocin infusion and spinal anesthesia will reduce the amount of glycine absorption in patients undergoing operative hysteroscopy

Detailed description: Prospective controlled study in premenopausal patients who had hysteroscopic surgery including endometrial resection, endometrial polypectomy, myomectomy resection and uterine septal resection. The effect of combined spinal anesthetic with oxytocin infusion on fluid deficit was studied.

Eligibility criteria: Inclusion Criteria:

* premenopausal with no cardiovascular comorbidities

Exclusion Criteria:

* endometrial cancer cases, patients who received pre-operative hormonal preparations, previously resected cases and cases done using bipolar diathermy.

Primary outcomes:
measure: fluid overload
timeFrame: 16 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: University of Jordan
Study officials:
affiliation: jordan university
name: Abdelkarim ALoweidi, consultant
role: STUDY_DIRECTOR
References:
Clinical trial NCT05077670: Hybrid Characterization of Driver Sites During Atrial Fibrillation and Sinus Rhythm
Official title: Hybrid Characterization of Driver Sites During Atrial Fibrillation and Sinus Rhythm With CARTOFINDER and COHERENT Mapping
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Persistent Atrial Fibrillation
Keywords: Atrial fibrillation
Catheter ablation
Rotors
Lead sponsor: Fundacion para la Innovacion en Biomedicina (FIBMED)
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2021-10-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include 50 patients. No statistical considerations were made to determine the sample size of this study.

Brief summary: The primary objective of this study is twofold, first we aim to identify rotors in atrial fibrillation (AF) and analyze their relationship with the left atrium-left atrial appendage (LA-LAA) connections. Secondly, we will analyze the areas harboring rotors in SR to define the characteristics that describe the presence of rotors.

Detailed description: The primary objective of this study is the identification of LA and LAA areas driving atrial fibrillation to study their relationship with LAA-LA connections and sinus rhythm (SR) analysis using the CartoFinder and COHERENT algorithms that CARTO V7 offers.

The CartoFinder tool will be able to determine the activation patterns of reentrant drivers (rotors) in the LA and LAA in AF. The characterization of areas harboring rotors could be performed with the COHERENT tool provided by CARTO V7 to determine the activation patterns during reentrant rhythms, and after sinus rhythm restoration it could be used to assess the conduction patterns at LA-LAA connections and driver sites identified with CartoFinder.

Eligibility criteria: Inclusion Criteria:

* Persistent atrial fibrillation
* The patient has signed the informed consent form
* No LAA previous ablation procedure
* No valvular disease
* LVEF ≥ 35% prior to recruitment
* Age ≥ 18 years

Exclusion Criteria:

* LVEF \< 35 %
* Hyperthyroidism or hypothyroidism
* Mental or physical illness incapacitation
* Planned cardiac procedure
* Non-controlled hypertension
* Terminal renal failure or dialysis
* Class IV of the NYHA
* Age ≥ 75 years
* Life expectancy \< 2 years
* Atrioventricular block
* Pregnancy

Primary outcomes:
measure: CartoFinder and COHERENT tools utility assessment
timeFrame: 2 years
Secondary outcomes:
measure: Atrial fibrillation driver location analysis
timeFrame: 2 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
Study officials:
affiliation: Hospital General Universitario Gregorio Marañón
name: Ángel Arenal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General Universitario Gregorio Marañón
name: Gonzalo R Ríos-Muñoz, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05575570: Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During EVAR
Official title: Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During Endovascular Abdominal Aortic Repair for Infrarenal Abdominal Aortic Aneurysm - Randomized Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Abdominal Aortic Aneurysm Without Rupture
Keywords: AAA
Embolization
Endoleak
sac regression
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pre-emptive abdominal aortic aneurysm sac embolization during endovascular abdominal aortic repair for infrarenal abdominal aortic aneurysm - Randomized study

Detailed description: In all 124 patients will be included, 62 in each group.

The first group (62 patients) with pre-emptive AAA sac embolization during EVAR and the control group consisted of 62 patients without pre-emptive AAA sac embolization.

The primary goal is to investigate AAA shrinkage/diameter changes in the pre-emptive embolization group compared with the non-embolization group. Further, to investigate all endoleaks and secondary interventions during the follow-up and any difference between groups and correlation if any with pre-emptive embolization.

Demographic, comorbidities, antiplatelet and anticoagulation drugs, AAA characteristics, patent lumbal and inferior mesenteric artery, intervention characteristics and follow-up data will be recorded and analysed.

Eligibility criteria: Inclusion Criteria:

* Patient with 55mm (male) or 50 mm (female) AAA, available for EVAR
* \> 18 year old

Exclusion Criteria:

* Not accept to participate
* Ruptured AAA
* Outside for instruction for the use EVAR

Primary outcomes:
measure: AAA diameter and volume changes/sac regression during follow-up, measurement on control CT and/or ultrasound after EVAR.
timeFrame: 5 years
measure: AAA diameter and volume changes/sac regression during follow-up, measurement on control CT with automatic volume software program
timeFrame: 3 years
Secondary outcomes:
measure: Secondary interventions, endovascular secondary interventions( additional embolization, a new stent graft deployment etc)
timeFrame: 5 years
measure: Endoleak type 2 incidence, on control CT and ultrasound scanning
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05965570: A Study to Investigate Effect of Clarithromycin, a Strong CYP3A4 Inhibitor, on Brensocatib Pharmacokinetics in Healthy Participants
Official title: A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effect of Clarithromycin, a Strong CYP3A4 Inhibitor, on Brensocatib Pharmacokinetics in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Insmed Incorporated
Sponsor class: INDUSTRY
First posted: 2023-07-28
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to determine the effect of clarithromycin on the single-dose pharmacokinetics (PK) of brensocatib in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Females of nonchildbearing potential and males, of any race, between 18 and 65 years of age, inclusive, without current disease.
* Body mass index between 18.0 and 32.0 kilograms per square meter (kg/m\^2), inclusive, and a total body weight ≥50 kilograms (kg).

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed; cholecystectomy will not be allowed).
* Positive serology test results for hepatitis B panel or hepatitis C antibody and/or reactive human immunodeficiency virus 1/2 test.
* Participants whose results are compatible with prior immunization for hepatitis B or natural immunity may be included at the discretion of the investigator.
* Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test at screening or check-in.
* Poor peripheral venous access. Note: Other inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Area Under the Plasma Concentration-time Curve (AUC) of Brensocatib
timeFrame: Pre-dose and at multiple timepoints post-dose on Days 1 to 8, and Days 13 to 20
Secondary outcomes:
measure: Number of Participants who Experienced at Least one Adverse Event (AE)
timeFrame: Up to Day 27
Other outcomes:
Locations:
city: Dallas
country: United States
facility: USA001
state: Texas
Study officials:
References:
Clinical trial NCT03850470: The Diagnostic Accuracy of the Clinical Examination
Official title: The Diagnostic Accuracy of the Clinical Examination in Common Musculoskeletal Pathologies
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Musculoskeletal Pain
Musculoskeletal Injury
Keywords: Diagnostic accuracy
Clinical examination
neck
back
shoulder
hip
knee
foot
ankle
stress fracture
Lead sponsor: High Point University
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: These will be patients with musculoskeletal pain or dysfunction that report to one of our several clinics as a normal part of procedure

Brief summary: This study examines the diagnostic accuracy of the clinical examination as compared to MRI findings

Detailed description: When patients get musculoskeletal pain and seek care, the healthcare professional performs a detailed clinical examination to determine a diagnosis and determine a plan of care which often includes imaging. There are only a few studies that have looked at the accuracy of the clinical examination in a primary care setting, most studies having been performed in a specialty practice treating Orthopedic or Sports injuries. In these practices, surgery has become and remains the gold standard. However, in primary care, often imaging like Magnetic Resonance Imaging (MRI) has become the the criterion standard. This double blind study will compare the diagnosis reached by clinical exam to the results found on MRI. In addition, the examining clinician will report their recommended plan of care after the examination.

Eligibility criteria: Inclusion Criteria:

* Subjects 18-80 years old with musculoskeletal pain/dysfunction

Exclusion Criteria:

* Outside the inclusion age range, pain/dysfunction of other than musculoskeletal origin, those in whom MRI is contraindicated for example, with shrapnel in the body

Primary outcomes:
measure: likelihood ratios
timeFrame: 5 years
measure: Area under the curve
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: High Point
country: United States
facility: High Point University
state: North Carolina
Study officials:
affiliation: Professor
name: Eric J Hegedus, PhD
role: PRINCIPAL_INVESTIGATOR
References: