louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00200434: A Study of the Efficacy and Safety of Nebivolol Added to Existing Antihypertensive Treatment in Patients With Hypertension
Official title: A Double-Blind, Multi-Center, Randomized, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Nebivolol Added to Existing Antihypertensive Treatment in Patients With Mild to Moderate Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Nebivolol
Beta-Blocker
Hypertension
Lead sponsor: Mylan Bertek Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to contrast the efficacy and safety of 3 dose levels of nebivolol vs. placebo, when added to a patient's existing antihypertensive medication(s) for 3 months, in patients with mild to moderate hypertension

Detailed description: Following a washout of any previous beta-blocker medication, if applicable, supine, sitting, and standing cuff blood pressure and pulse rate, 24-hour ambulatory blood pressure monitoring (ABPM), ECG, laboratory assessments and genomics testing were performed before randomization. Patients were randomized to receive placebo or nebivolol once daily in the morning together with their curently prescribed antihypertensive therapy. Patients had four scheduled clinical visits during the study, following the screening visit.

Eligibility criteria: Inclusion Criteria:

* Average sitting diastolic blood pressure (DBP) greater then or equal to 90 mmHg and less then or equal to 109 mmHg at screening and baseline, in patients on background antihypertensive therapy taking at least one and no more than two of either ACE inhibitor, ARB, or diuretic.

Exclusion Criteria:

* Recent myocardial infarction or stroke
* Contraindications to beta-blocker therapy

Primary outcomes:
measure: The change from baseline to week 12 in the average sitting DBP at trough.
Secondary outcomes:
measure: Change from baseline to week 2, 6, and 12 in the average sitting, supine, standing systolic and diastolic blood pressure and sitting HR.
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Mylan Pharmaceuticals Inc.
state: West Virginia
Study officials:
affiliation: Mylan Pharmaceuticals Inc
name: Betty S. Riggs, MD, MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT00297817: Study of the Safety and Immune Response of Two Serogroup B Meningococcal Vaccines Administered to Healthy Adolescents
Official title: A Phase 2, Single-Blind, Controlled, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine ± OMV When Administered at an 0-2-6-Month Schedule in Healthy Adolescents 11-18 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningococcal Disease
Keywords: Meningococcal Disease; Meningococcal Meningitis; Vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-03-01
Enrollment: 203
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety and immunogenicity of two serogroup B meningococcal vaccines in comparison to placebo administered to healthy adolescents ages 11 to 18 years.


Eligibility criteria: Inclusion Criteria:

* Healthy Adolescents between and including 11-18 years of age, who provide written informed consent.

Exclusion Criteria:

* Previous or suspected disease caused by N. meningitidis; or previous immunization with a serogroup B meningococcal vaccine; Any acute, chronic or progressive disease.

Primary outcomes:
measure: Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents
timeFrame: 1 month after completion of immunization schedule
Secondary outcomes:
measure: Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents
timeFrame: 6 months after completion of immunization schedule
Other outcomes:
Locations:
city: Encinitas
country: United States
state: California
city: Atlanta
country: United States
state: Georgia
city: St. Louis
country: United States
state: Missouri
city: Cleveland
country: United States
state: Ohio
city: Galveston
country: United States
state: Texas
city: Layton
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Novartis
name: Novartis Vaccines - Drug Information Services
role: STUDY_CHAIR
References:
Clinical trial NCT01515917: Citicoline and Omega-3 Fatty Acid Effects in Veterans With Traumatic Brain Injury (TBI)
Official title: Citicoline and Omega-3 Fatty Acid Effects in Veterans With TBI
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Traumatic Brain Injury
Substance Abuse
Substance Dependence
Keywords: Veterans
Traumatic Brain Injury
TBI
Substance Abuse
Substance Dependence
Veterans with traumatic brain injury (TBI)
Veterans with substance abuse or dependence
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2012-01-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a placebo-controlled study intended to examine the effects of the neutraceutical citicholine, together with omega-3 fatty acids, on a range of measures in individuals with concussive head injury, often referred to as traumatic brain injury, or TBI. The study will consist of three visits, during which participants will complete brain scans, a thorough testing battery and a clinical interview to assess mood and other diagnostic information relevant to the study.


Eligibility criteria: Inclusion Criteria:

* Veteran status
* Age 18 to 55
* History of TBI
* DSM-IV-TR diagnosis of abuse or dependence disorder for either alcohol or drugs of abuse
* Multiple concussive head injuries that meet the following criteria for TBI: 1) normal structural imaging, 2) loss of consciousness (LOC) between 0-30 minutes, 3) alteration of consciousness or mental status for a moment up to 2 hours or 4) post-traumatic amnesia of 0-1 day
* Stable on current psychotropic medication regimen for ≥ 3 months

Exclusion Criteria:

* Non Veteran
* Significant medical or neurological illness with the exception of TBI, which might affect cognitive function
* Significant medical illness which has the potential to be exacerbated by ingestion of citicoline/omega-3 fatty acids, including diabetes, congestive heart disorder, hyperlipidemia and severe coronary artery disease
* Age other than 18 to 55 years old
* History of ECT treatment
* Estimated IQ \< 70
* Past or present history of bipolar disorder, schizophrenia, delusional disorder or any other psychotic disorder
* Currently taking a prescribed blood thinner (i.e., Coumadin)
* Claustrophobia
* Metal implanted within the body
* Pregnancy or lactation
* Left-handedness
* Poor vision, as subjects must have normal or corrected-to-normal vision for viewing of cognitive challenge paradigms during fMRI protocols
* Non-native English speakers (for neurocognitive tasks)

Primary outcomes:
measure: Neurocognitive performance
timeFrame: 28 days
Secondary outcomes:
measure: Brain changes
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05833217: Obesity, Insulin Resistance, and PASC: Persistent SARS-CoV-2
Official title: Obesity, Insulin Resistance, and PASC: Persistent SARS-CoV-2 Infection and Inflammation in Human Adipose Tissue
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Long COVID
Insulin Resistance
Insulin Sensitivity
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators are studying the pathophysiologic links between obesity, insulin resistance (IR), adipose tissue infection, and post-acute sequelae of COVID-19 (PASC). This study looks at whether adipose (fat) tissue contributes to PASC by driving chronic inflammation or by serving as a reservoir for SARS-CoV-2 persistence. The results will not only determine whether obesity and IR are risk factors for PASC, but will also define fundamental biology that sets the stage for the investigation of novel or existing therapies that target the causal pathways identified.


Eligibility criteria: Inclusion Criteria:

* Ages 18 to 80
* BMI ≥ 25 kg/m2
* not currently pregnant

Exclusion Criteria:

Arm 2 (Adipose Tissue Biopsy) exclusions include

* pregnancy
* prior liposuction
* recent change in weight (\> 2 kg in one month)
* bleeding disorders
* anticoagulant use

Arm 3 (healthy controls only) exclusions include patients with

* major organ disease
* diabetes
* history of liposuction
* bariatric surgery
* eating disorders
* psychiatric disorders
* pregnancy or lactation
* recent change in weight (over the past 12 weeks),
* use of weight loss medication or oral steroids
* hematocrit \< 33%
* fasting glucose \>= 126 mg/dL
* blood pressure \>160/100 mmHg

Primary outcomes:
measure: Triglyceride/HDL-cholesterol ratio
timeFrame: 2 years
measure: Concentration of Viral RNA in Adipose Tissue
timeFrame: 2 years
measure: Rate of Inflammatory Response
timeFrame: 2 years
measure: Rate of Inflammatory Gene Expression in Adipose Tissue
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Clinical and Translational Research Unit
state: California
city: Palo Alto
country: United States
facility: Stanford Health
state: California
Study officials:
affiliation: Stanford School of Medicine
name: Tracey McLaughlin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00407017: Therapeutic Variables in Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract Surgery
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2006-12-04
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to compare patient outcomes in following cataract surgery in patients randomized to one of two surgical kits.


Eligibility criteria: Inclusion Criteria:

* Males or females scheduled to undergo cataract surgery
* Patients can be receiving monofocal IOLs only
* Likely to complete all study visits and able to provide informed consent
* Visual potential of 20/25 or better

Exclusion Criteria:

* Known contraindications to any study medication or ingredients
* Active ocular diseases or uncontrolled systemic disease
* Active ocular allergies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: The Center for Excellence in Eye Care
state: Florida
Study officials:
affiliation: The Center For Excellence in Eye Care
name: William Trattler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06687317: Reliabılıty,Validity Of The Turkish Version Of The KNAP
Official title: Reliabılıty,Validity Of The Turkish Version Of The KNAP
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Other
Keywords: Validity
Reliability
Version
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Physiotherapy and rehabilitation department students and physiotherapists who speak Turkish

Brief summary: This study, we performed the Turkish version validity and reliability of the KNAP

Detailed description: Chronic musculoskeletal pain is significantly affected by the attitudes and beliefs of healthcare professionals and affects patient management outcomes . Adopting a biopsychosocial approach rather than a solely biomedical approach is of great importance in order to comply with current pain management guidelines and reduce both pain levels and disability . Therefore, it is important to recognize healthcare professionals' knowledge, attitudes, and beliefs regarding pain . Pain science education is a powerful strategy to manage chronic musculoskeletal pain by addressing biopsychosocial factors . It improves the understanding of pain by integrating psychological and social aspects beyond anatomical factors and provides better rehabilitation outcomes. Healthcare professionals are crucial to providing effective treatment and patient pain education and require a solid understanding of pain science principles . Many validated surveys assess health care professionals' knowledge and attitudes regarding chronic pain, but they often lack elements of modern pain science and biopsychosocial treatment orientations . To address these limitations, the Knowledge and Attitudes to Pain (KNAP) questionnaire was developed to assess modern pain science and biopsychosocial attitudes toward pain. The KNAP questionnaire consists of 30 items divided into two domains. It is scored using a 6-point Likert scale and has been validated in Brazilian Portuguese, French, Spanish, and Japanese .Therefore, the aim of this study was to adapt the KNAP questionnaire for Turkish physiotherapists and to rigorously examine its psychometric properties among physiotherapy graduates and students in Turkey. The study aims to validate the questionnaire to accurately assess pain knowledge, attitudes, and beliefs by analyzing internal consistency, structural and construct validity, reliability, sensitivity, and interpretability.

Eligibility criteria: Inclusion Criteria: Physiotherapy and rehabilitation department students and physiotherapists who speak Turkish -

Exclusion Criteria: Physiotherapy and rehabilitation students and physiotherapists who do not speak Turkish.

-

Primary outcomes:
measure: KNAP
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gokhan MARAS
city: Ankara
country: Turkey
facility: Gökhan maraş
Study officials:
References:
Clinical trial NCT01294917: Comparison of a New Abbott Medical Optics (AMO) Multi-Purpose Solution (MPS) to Existing Contact Lens Regimens
Official title: Comparison of a New AMO MPS to Existing Contact Lens Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Normal Contact Lens Wearers
Lead sponsor: Abbott Medical Optics
Sponsor class: INDUSTRY
First posted: 2011-02-14
Enrollment: 40
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Crossover clinical evaluation three contact lens care regimens used for one month with Acuvue Oasys lenses.

Detailed description: This is a three-arm crossover clinical evaluation of 40 subjects who will use each of three contact lens care regimens for one month with Acuvue Oasys lenses. The subjects will be randomized on the order of solutions used: Investigational MPS, ClearCare, and Opti-Free RepleniSH MPS.

Eligibility criteria: Inclusion Criteria:

* Is at least 17 years of age and has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Has had an ocular examination in the last two years;
* Is a current soft lens wearer using either two-week or monthly replacement lenses;
* Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction (either spectacles or contact lenses);
* Has normal binocular vision (no strabismus, no amblyopia);
* Has clear corneas and no active ocular disease;
* Has a distance contact lens prescription between +8.00 diopters (D) to -12.00 D and a successful fit with the study lenses;
* Has astigmatism less than or equal to -1.00 D;
* Agrees to wear the study lenses on a daily wear basis.

Exclusion Criteria:

* Has any active ocular disease;
* Has any clinically significant lid, conjunctival, or corneal abnormalities that may affect a study outcome variable;
* Has undergone corneal refractive surgery;
* Has a systemic condition that may affect a study outcome variable;
* Is using any systemic or topical medications that may affect ocular health;
* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
* Is pregnant or lactating;
* Is participating in any other clinical or research study that may affect a study outcome variable;
* Currently wears daily disposable lenses or extended wear lenses.

Primary outcomes:
measure: Corneal Staining
timeFrame: 4 weeks
Secondary outcomes:
measure: Subjective Lens Wearing Comfort
timeFrame: 4 weeks
measure: Dryness
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Contact Lens Research
state: Ontario
Study officials:
affiliation: University of Waterloo
name: Craig Woods, MOptom
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01508117: Phase II Axitinib (AG-013736) in Elderly Glioblastoma Multiforme (GBM) Patients
Official title: A Phase II Window Study of Front-line Axitinib Followed by Axitinib and Radiation for Elderly Patients With Glioblastoma Multiforme (GBM)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Glioblastoma Multiforme
Keywords: GBM
brain tumor
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2012-01-11
Enrollment: 1
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the addition of an investigational medication, axitinib, to radiation therapy will improve the outcome of treatment in patients, above the age of 70.

Detailed description: The addition of axitinib to standard treatment is experimental and has not been approved by the United States Food and Drug Administration (FDA). Axitinib works by preventing new blood vessels from forming, and tumors need to make new blood vessels in order to grow. The study will find out what effects, good or bad, axitinib has on the tumor. In addition, this study will try to determine whether the response to axitinib and the overall outcome depends on certain characteristics of your tumor.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed patients with histologically proven glioblastoma multiforme
* Age above 70 years
* Karnofsky score of 50-80
* Adequate organ function as defined by laboratory values
* Life expectancy of \>12 weeks
* No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be 140 mm Hg, and the baseline diastolic blood pressure readings must be 90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are eligible.

Exclusion Criteria:

* Prior treatment with chemotherapy or radiation for glioblastoma multiforme
* Patients with extensive tumor hemorrhage
* Any of the following within the 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism

Primary outcomes:
measure: Overall Survival
timeFrame: average 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Rekha Chaudhury, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00449917: "Visiobiane Anti-age" Effects on Vision Parameters
Official title: Study of the Effects of "Visiobiane Anti-age" Dietary Supplement on Macular Pigment Optical Density, Contrast Sensibility and Visual Acuity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Macular Pigment Optical Density
Keywords: visual caracteristics
macular pigment optical density
visual acuity
contrast sensibility
lutein
docosahexaenoic acid (DHA)
Lead sponsor: PiLeJe
Sponsor class: INDUSTRY
First posted: 2007-03-21
Enrollment: 30
Sex: MALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the benefits of "Visiobiane Anti-age" dietary supplement on macular pigment optical density, contrast sensibility and visual acuity. Additionally, the study would like to evaluate seric variations of carotenoids and the total antioxydant capacity.

Detailed description: Visiobiane study is a randomized trial of 30 participants designed to assess the effects of oral supplementation of macular xanthophylls (lutein and zeaxanthin) and omega-3 LCPUFAs for the eyes protection. The study will enroll healthy participants aged 45 to 55 years. 15 subjects will be assigned in placebo group and 15 in experimetal group (Visiobiane anti-age). They will be supplemented for 24 weeks

Eligibility criteria: Inclusion Criteria:

* healthy caucasian men
* age : 45-55
* BMI \< 25

Exclusion Criteria:

* non healthy
* retinian and/or visual anomaly
* Ocular media not clear enough to allow good fundus photography

Primary outcomes:
measure: macular pigment optical density
Secondary outcomes:
measure: contrast sensibility
measure: visual acuity
measure: seric carotenoids concentrations
measure: total antioxidant capacity
measure: influence of SR-B1 genetic polimorphism
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CRNH Clermont-Ferrand
state: Auvergne
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Franck Bacin, MD
role: PRINCIPAL_INVESTIGATOR
References: