louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01333345: Post-Implant Performance of the EC-3 IOL
Official title: Post-Implant Performance of the EC-3 IOL ADDENDUM TO THE PROTOCOL: Clinical Evaluation of the EC-3 Hydrophobic Acrylic Posterior Chamber Aphakic Intraocular Lens
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract
Keywords: Cataract replacement surgery
implantation
EC-3 IOL
Lead sponsor: Aaren Scientific Inc.
Sponsor class: INDUSTRY
First posted: 2011-04-12
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were enrolled in the EC-3 study and implanted with the EC-3 IOL.

Brief summary: The purpose of this study is to obtain data on the performance of the EC-3 lens at an interval of two years (and beyond) from subjects who were implanted. The primary aim of the study will be to evaluate the presence, if any, of PCO, lens glistening, and other anomalies in the subjects.

Detailed description: Anomalies include, but are not limited to:

Posterior Capsule Opacification (PCO) (pathological condition) - delayed clouding of the lens capsule after cataract surgery.

Glistenings - fluid-filled micro-vacuoles that form within the intraocular lens (IOL) optic when the IOL is in an aqueous environment. They may appear to be on the lens surface.

Artifacts - glares, halos, starbursts and/or shadows caused by IOLs.

Fibrosis - the formation of fibrous connective tissue, as in a scar.

Glare - undesirable sensation produced by brightness that is much greater than that to which the eyes are adapted. Causes annoyance, discomfort, or loss in visual performance.

Halos (symptom) - the appearance of hazy ring(s) around light.

Eligibility criteria: Inclusion Criteria:

* Enrollment in the EC-3 clinical trial
* Subjects who were implanted with EC-3 IOL

Exclusion Criteria:

* Removal of the EC-3 IOL at any time

Primary outcomes:
measure: To evaluate the presence, if any, of PCO (Posterior Capsule Opacification) in the EC-3 lens.
timeFrame: 2-3 years post-implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Venice
country: United States
facility: Stephenson Eye Associates
state: Florida
city: Dover
country: United States
facility: Eyesight Ophthalmic Services
state: New Hampshire
city: Le Puy en Velay
country: France
facility: Cabinet d'Ophtalmologie du Dr. Pey
Study officials:
affiliation: Stephenson Eye Associates
name: P. Dee G. Stephenson, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Eyesight Ophthalmic Services PA
name: N. Timothy Peters, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cabinet d'Ophtalmologie du Dr. Pey
name: Christophe Pey, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04545645: The Effect of Auditory and Motor Cognitive Distractions on the Neural Provocation Test in Subjects With Neck Pain
Official title: The Effect of Auditory and Motor Cognitive Distractions on the Neural Provocation Test in Subjects With Neck Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
Collaborators: name: Centro Universitario La Salle
First posted: 2020-09-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The main objective of this research is to evaluate the influence of different distraction stimuli on neural mechano-sensitivity tests.


Eligibility criteria: Inclusion Criteria:

* Men and women aged between 18 and 65 years
* Medical diagnosis of non specific chronic neck pain with more than 6 months of evolution of neck pain

Exclusion Criteria:

* Patients with rheumatic diseases, cervical hernia, cervical whiplash syndrome, neck surgeries o a history of arthrodesis
* Systemic diseases
* Vision, hearing or vestibular problems
* Severe trauma or a traffic accident that had an impact on the cervical area.

Primary outcomes:
measure: Mechanosensitivity based on range of motion
timeFrame: Change in pressure pain threshold immediately at the end of the intervention
measure: Pain intensity
timeFrame: Change in pain intensity immediately at the end of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CSEU La Salle
Study officials:
References:
Clinical trial NCT01881945: Validation of Study in Respiratory Physiology and it Interactions
Official title: Validation of Tools Studying Respiratory Physiology and it Interaction With Swallowing and Cardiac Physiology.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Life Experiences
Respiratory Function
Cardiac Function
Keywords: Swallowing
Hyperventilation
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2013-06-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study was to validate tools of physiological signal processing and interpretation on healthy human volunteers in order to improve the understanding in respiratory physiology and its interactions with heart function, and swallowing.


Eligibility criteria: Inclusion Criteria:

* healthy subject
* between 18 and 60 years old

Exclusion Criteria:

* patient
* person protected by the law

Primary outcomes:
measure: Heart rate
timeFrame: one measure within two weeks of inclusion
measure: end tidal CO2
timeFrame: one measure within two weeks of inclusion
measure: Non invasive arterial pressure
timeFrame: one measure within two weeks of inclusion
measure: Non invasive stroke volume
timeFrame: one measure within two weeks of inclusion
measure: Inspiratory and expiratory times
timeFrame: one measure within two weeks of inclusion
measure: Tidal volume
timeFrame: one measure within two weeks of inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: La Tronche
country: France
facility: Laboratoire TIMC-IMAG
Study officials:
affiliation: University Hospital, Grenoble
name: BRIOT Raphael, MCU-PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Besleaga T, Blum M, Briot R, Vovc V, Moldovanu I, Calabrese P. Individuality of breathing during volitional moderate hyperventilation. Eur J Appl Physiol. 2016 Jan;116(1):217-25. doi: 10.1007/s00421-015-3260-3. Epub 2015 Sep 23.
Clinical trial NCT06348745: Trans Thoracic Ultrasound to Assess Diaphragmatic Function in Stable COPD Versus Bronchial Asthma.
Official title: Trans Thoracic Ultrasound to Assess Diaphragmatic Function in Stable COPD Versus Bronchial Asthma.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diaphragm
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: * Assessment of diaphragmatic function (excursion, thickness variation, thickness ratio) in COPD and bronchial asthma patients.
* Assessment of presence of correlation between diaphragmatic dysfunction and pulmonary function.
* Assessment of possible association between diaphragmatic dysfunction and presence of reversibility in pulmonary function post bronchodilator.

Detailed description: * Assessment of diaphragmatic function (excursion, thickness variation, thickness ratio) in COPD and bronchial asthma patients.
* Assessment of presence of correlation between diaphragmatic dysfunction and pulmonary function (FEV1/FVC).
* Assessment of possible association between diaphragmatic dysfunction and presence of reversibility in pulmonary function post bronchodilator (short acting B2 agonist)

Eligibility criteria: Inclusion Criteria:

Stable patients (not in exacerbation).

Exclusion Criteria:

* Patients with comorbidities as cardiac, renal or hepatic diseases.
* Patients who have combined COPD and bronchial asthma.

Primary outcomes:
measure: diaphragmatic function
timeFrame: 2 years
Secondary outcomes:
measure: pulmonary function .
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04396145: The Effects of Chronic Otitis Surgery on SVV
Official title: The Effects of Chronic Otitis Surgery on Virtual Subjective Vertical
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Otitis Media
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic otitis media

Brief summary: Inner ear trauma during chronic otitis surgery is one of the major concerns of Otolaryngology. Hearing thresholds or semicircular canals were investigated with this purpose. The investigator's aim is to test the utricle for surgical trauma.

Detailed description: All patients who will have surgery for ear will be tested before the operation and after the first day and the first week. Virtual SVV(Interacoustics) will be used for testing. The deviation angle from the vertical line will be measured when 15, 30, and 45-degree head tilt to the left and right side while they were standing.

Eligibility criteria: Inclusion Criteria:

* Chronic Otitis Media
* Who had surgical treatment

Exclusion Criteria:

* A patient who had the vestibular disease before
* Neurologic disease
* Patients who had ear, brain and musculoskeletal surgery before

Primary outcomes:
measure: SVV angle
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Fazıl N Ardıç
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03503747: Investigating Genetic Risk for Type 1 Diabetes
Official title: Investigating Genetic Risk for Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Disease
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Keywords: type 1 diabetes
Infants
INGR1D
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 15640
Sex: ALL
Minimum age (years): 0
Maximum age (years): 4
Standard ages: CHILD
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include all infants where the mother has consented to the additional screening test being performed.

Brief summary: The objective of this study is to determine the percentage of children with genetic markers putting them at increased risk of developing type 1 diabetes, and to offer the opportunity for these children to be enrolled into a phase II b primary prevention trial.

Detailed description: This is a population screening study to undertake (with prospective consent) additional testing of the newborn screening blood to identify children at increased genetic risk of type 1 diabetes. This study will enrol newborn babies whose mothers have given consent to additional testing for the newborn blood screening (routinely performed when the baby is approximately 5 days old).

Women will be approached by research staff in the second or third trimester of pregnancy (≥18 weeks gestation) when attending for antenatal care. At this point, the study will be discussed with the woman and if interested a patient information sheet will be provided as well as the opportunity to ask questions. If they agree to participate, a qualified member of the research team will take written informed consent. This consent will allow a) completion of a questionnaire and b) prospective consent to use the surplus neonatal screening blood sample for genetic testing.

The punch from the blood sample will analysed for the child's risk of type 1 diabetes. If found to be at high risk (\>10%) they will be contacted by a member of the clinical study team to discuss the results and invite them to participate in a phase II prevention trial.

Eligibility criteria: Inclusion Criteria:

* Parent/guardian of participant is willing and able to give informed consent for participation in the study.
* Participant has provided blood for the newborn screening blood test, with sufficient sample remaining after routine testing.

Exclusion Criteria:

* Parent/legal guardian unwilling or unable to give written informed consent to participate in the study
* Unable to understand written or verbal English which would preclude them from understanding the study

Primary outcomes:
measure: Quantification of the number of participants with high-risk genetic markers for the development of type 1 diabetes.
timeFrame: February 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust
Study officials:
References:
Clinical trial NCT05579847: Feasibility of a Smart-Phone App for Patients With Advanced Renal Cell Carcinoma Undergoing Combination Immunotherapy
Official title: The Feasibility of an Educational and Monitoring Smart-Phone Application for Patients With Advanced Renal Cell Carcinoma Undergoing Combination Immunotherapy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Renal Cell Carcinoma Stage IV
Keywords: Kidney cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2022-10-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at the genitourinary medical oncology clinic at Moffitt Cancer Center with Stage IV Renal Cell Carcinoma.

Brief summary: The purpose of the study is to test and understand acceptability and preliminary effectiveness of a mobile educational app specifically customized to patients with advanced Renal Cell Carcinoma (RCC) receiving therapy with combination immunotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients with Stage IV Renal Cell Carcinoma
* Within 3 weeks from starting combination immune checkpoint blockade with tyrosine kinase inhibitor or multikinase inhibitor
* Estimated survival of 6 months or more
* Able to read and speak English

Exclusion Criteria:

* Unable to read or speak English
* Enrolled in another clinical trial

Primary outcomes:
measure: Acceptability of Smart Phone Application
timeFrame: at 6 months
Secondary outcomes:
measure: Efficacy of Smart Phone Application -Quality of Life
timeFrame: at 6 months
measure: Efficacy of Smart Phone Application - Patient Knowledge
timeFrame: Weekly, beginning at baseline to month 6
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Jad Chahoud, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06088147: Methotrexate Versus Triamcinilone Acetonide in Treatment of Recalcitrant Alopecia Areata
Official title: Methotrexate With Microneedling Versus Triamcinilone Acetonide With Microneedling in Treatment of Recalcitrant Alopecia Areata
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alopecia Areata
Keywords: Alopecia areata
Methotrexate
Triamcinolone
microneedling
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 34
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Alopecia areata is the second most common cause of hair loss following androgenic alopecia.

It is affecting 2% of global population with an increasing prevalence. Briefly, it is a chronic, immunomediated disease characterized by acute onset of non-scarring hair loss ranging from small circumscribed patchy areas on the scalp to complete scalp and body hair loss. Until recently our understanding of the pathophysiology of alopecia areata is scarce, despite being so common.

Methotrexate is an immunosuppressant drug that has been widely used for a range of inflammatory and immune-mediated skin disorders.

Methotrexate has been recently proven to inhibit Jak/STAT Pathway. Triamcinolone acetonide as another type of treatment of alopecia areata either intralesionally or topically remains the first line of treatment.


Eligibility criteria: Inclusion Criteria:

* Age groups: \> 12 years old.
* Sex: both sexes.
* Co-operative Patients.
* Recalcitrant or resistant cases to treatment (meaning that all patients had received various modalities of treatment in the past with poor/partial response or relapse after discontinuing therapy.

Exclusion Criteria:

* Patients \<12 years.
* Pregnant and lactating women.
* Patients with any underlying Systemic disorders.
* Patients with HBV or HCV.
* Patient with active infection of T.B.
* Patients with bone marrow suppression (leukopenia, thrombocytopenia)
* Patients who had received any other modalities of treatment in last 3-6 months.

Primary outcomes:
measure: To evaluate the efficacy of methotrexate with microneedling versus triamcinolone with microneedling in treatment of recalcitrant alopecia areata.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Al-Azhar University
Study officials:
References:
Clinical trial NCT00240747: Open-label, Multiple-dose, Phase III Study of the Population Pharmacokinetics of I.V. Synercid in 75 Pediatric Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Gram-Positive Bacterial Infections
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Aventis Pharmaceuticals
First posted: 2005-10-18
Sex: ALL
Minimum age (years): 27
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open-label, multicenter, multiple-dose, study of population pharmacokinetics of I.V. Synercid (7.5 mg/kg every 8 hours) in 75 pediatric patients. The purpose is to assess the population pharmacokinetics of Synercid in pediatric patients and to collect additional safety and efficacy data in pediatric patients.


Eligibility criteria: Inclusion Criteria:

* Serious, suspected or documented gram-positive infection

Exclusion Criteria:

-

Primary outcomes:
measure: Population pharmacokinetics
Secondary outcomes:
measure: Safety
measure: Efficacy
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Children's Hospital
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Children's Hospital
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Tulsa
country: United States
facility: Children's Hospital at Saint Francis
state: Oklahoma
Study officials:
affiliation: Yale University
name: George Talbot, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01024647: Optimizing Cimzia in Crohn's Patients
Official title: Optimizing Response in Crohn's Disease Patients Who Have Insufficient Initial Response or Who Have Loss of Successful Response to Certolizumab Pegol (Cimzia) Induction Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Crohn's Disease
Lead sponsor: Atlanta Gastroenterology Associates
Sponsor class: OTHER
Collaborators: name: UCB Pharma
First posted: 2009-12-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if increasing the dose and/or dosing frequency of certolizumab pegol (Cimzia) is effective in regaining and optimizing response in patients with moderate to severe Crohn's disease.

Detailed description: This open label study for patients with moderate to severe Crohn's disease will evaluate treatment options to improve capture of initial response and to regain loss of response to certolizumab pegol (Cimzia). It is a 26 week open label clinical trial that may be extended to 52 weeks in patients who respond to treatment during the initial 26 week study. The following dosing options will be tested: 1) Re-induction (one supplemental dose of 400mg) 2) Dose splitting (200mgQ2W) and 3) Dose Escalation (400mg Q2W. The highest dose in the study, 400mg Q2W, has been used in a large phase III trial (WELCOME) without any new safety signals. Efficacy and safety measures will be monitored.

Eligibility criteria: Inclusion Criteria:

* ileal and/or colonic Crohn's disease
* moderate to severe Crohn's disease

Exclusion Criteria:

* short bowel syndrome
* ostomy
* anti-TNF therapy within 4 weeks
* prior certolizumab therapy

Primary outcomes:
measure: Crohn's Disease Activity Index
timeFrame: 26 Weeks, if responder up to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
Study officials:
affiliation: Atlanta Gastroenterology Associates
name: Douglas C Wolf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02731547: Education Against Tobacco Randomized Trial in Bosnia and Herzegovina
Official title: Education Against Tobacco: Medical-student-delivered Smoking Prevention Programme for Secondary Schools in Bosnia and Herzegovina - Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tobacco Prevention
Tobacco
Schools
Lead sponsor: University of Giessen
Sponsor class: OTHER
Collaborators: name: University of Dhaka
First posted: 2016-04-07
Enrollment: 1500
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A two armed randomized trial is evaluating the effect of the medical-student-delivered school-based intervention Education Against Tobacco on the smoking behavior of adolescents in 7-11th grade of secondary schools in Bosnia and Herzegovina. The primary endpoint is the change in smoking prevalence between the two groups.


Eligibility criteria: Inclusion Criteria:

Visiting grades 7-9 of regular secondary schools in Bosnia and Herzegovina.

Exclusion Criteria:

Not fulfilling inclusion criteria.

Primary outcomes:
measure: Smoking prevalence measured via questionnaire.
timeFrame: 12 months follow-up
Secondary outcomes:
measure: Smoking onset: Difference in the number of new smokers at 12 months of follow-up who were not present at baseline
timeFrame: Baseline and 12 months
measure: Difference in the number of new non-smokers at 12 months of follow-up who were smoking at baseline
timeFrame: Baseline and 12 months
measure: Relevant differences due to the theory of planned behaviour between the two groups measured via questionnaire.
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
Study officials:
References: