louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06557057: Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk
Official title: Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HER2-Positive Breast Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 75
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-menopausal women with hormone receptor positive breast cancer who are planning to start or within 6 months of starting treatment with an aromatase inhibitor or tamoxifen and healthy post-menopausal women.

Brief summary: This study assesses the effect of hormone directed treatment for breast cancer on glucose metabolism.

Detailed description: PRIMARY OBJECTIVE:

I. Assess the impact of endocrine adjuvant therapy with aromatase inhibitors in women with hormone receptor positive breast cancer, on various indices of glucose homeostasis, utilizing oral minimal model assessment, in comparison to healthy post menopausal women and another cohort of women on tamoxifen.

OUTLINE: This is an observational study.

Patients undergo blood sample collection, glucose testing, DEXA scan to measure body composition, complete a questionnaire and have their medical records reviewed on study.

Eligibility criteria: Inclusion Criteria:

* Post-menopausal women with hormone receptor positive breast cancer. Post-menopause will be defined as women who experience 12 months of amenorrhea or have undergone bilateral salpingo-oophorectomy.

  * 25 women who are planning to start or are within 6 months of starting treatment with aromatase inhibitors, after consultation in breast clinic and cancer center.
  * 25 women who will be starting Tamoxifen (comparative group)
  * 25 healthy post menopausal women will also be recruited.

Exclusion Criteria:

* Established diagnosis of diabetes

  * Therapy with medications that could affect glucose metabolism
  * Screening fasting glucose ≥ 126 mg/dl, and/or HbA1c ≥ 6.5%
  * History of upper GI surgery that alters gastric emptying or causing malabsorption e.g., bariatric surgery, fundoplication

Primary outcomes:
measure: DI (disposition index)
timeFrame: Baseline; up to 1 year
measure: Glucose homeostasis - tamoxifen compared to no treatment
timeFrame: Baseline; up to 1 year
measure: Glucose homeostasis - aromatase inhibitor compared to tamoxifen
timeFrame: Baseline; up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Kalpana Muthusamy, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03006757: Measurement of the Biting Force of Rabid Heat Cured Acrylic Resin Versus Modified Conventional Acrylic
Official title: Measurement of the Biting Force of Rabid Heat Cured Acrylic Resin Versus Modified Conventional Acrylic Resin With Titanium Dioxide Nanoparticles in Maxillary Single Dentures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Anxiety
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-12-30
Enrollment: 2
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to compare the effect of rapid heat cured acrylic resin material with titanium dioxide nanoparticles added to conventional acrylic resin material on the biting force of the single maxillary complete denture .

Detailed description: Bite force is one indicator of the functional state of the masticatory system that results from the action of jaw elevator muscles modified by the craniomandibular biomechanics .Determination of individual bite force level has been widely used in dentistry, mainly to understand the mechanics of mastication for evaluation of the therapeutic effects of prosthetic devices and to provide reference values for studies on the biomechanics of prosthetic devices. In addition, bite force has been considered important in the diagnosis of the disturbances of the stomatognathic system .

Twenty (20) single maxillary completely edentulous patients were selected from the out-patient clinic of the Removable Prosthodontics Department, Faculty of Oral and Dental Medicine, Cairo University.

The primary outcome is to measure the biting force of single maxillary complete denture by I Load star sensor .

Eligibility criteria: Inclusion Criteria:

* completely edentulous maxillary arch and full or partial dentate mandibular arch with adequate inter arch space
* edentuluos arches should be covered by firm healthy mucosa angle class 1 maxillomandibular relationship

Exclusion Criteria:

* patients with bad habits
* previous history of radiotherapy or chemotherapy

Primary outcomes:
measure: measurement of the biting force of rabid heat cured acrylic resin versus modified conventional acrylic with titanium dioxide nanoparticles in maxillary single denture using i load star sensor
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Mahmoud Adly
Study officials:
References:
Clinical trial NCT01771757: Measurement of Retinal Venous Pressure Under Short-term Low-oxygen Environment
Official title: Measurement of Retinal Venous Pressure (Retinal Venous Pressure RVP) Under Conditions of Reduced Ambient Pressure and Oxygen Partial Pressure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: retinal venous pressure
reduced ambient pressure
oxygen partial pressure
short-term hypoxic changes
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteers

Brief summary: The hypothesis is that the pressure in the retinal veins increases under a short-term lack of oxygen and leads to a decreased blood circulation. On the basis of measurements in the hypobaric chamber this hypothesis should be verified.

Detailed description: Conduct a pilot study to describe and quantify the retinal venous pressure (RVP) in healthy volunteers under conditions of controlled, reduced ambient and oxygen partial pressure in the pressure chamber of the Aeromedical Institute FAI in Dübendorf, Switzerland. Obtaining evidence of the adaptation behavior of the retinal vascular system in controlled, short-term hypoxic changes.

Eligibility criteria: Inclusion Criteria:

* healthy

Exclusion Criteria:

* eye diseases
* systemic diseases
* term medication (except contraceptives)
* pregnancy
* allergies to the ingredients Alcain, Tropicamide and Phenylephrine
* blood pressure levels except standard (\<60 /\> 140 mmHg)
* oxygen saturation (SO2) \<90%

Primary outcomes:
measure: Retinal venous pressure
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel, Dept. of Ophthalmology
Study officials:
affiliation: University of Basel, Dept. of Ophthalmology
name: Josef Flammer, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01684657: A Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Tolerability of Asenapine With Flexible Dosing From 5mg to 20mg in Adults With Developmental Stuttering
Official title: A Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Tolerability of Asenapine With Flexible Dosing From 5mg to 20mg in Adults With Developmental Stuttering
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Stuttering
Keywords: Stuttering
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2012-09-13
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to find out the potential benefits and safety of asenapine (Saphris®) in adults who suffer from the developmental form of stuttering.

It is hypothesized that individuals who are randomly assigned to asenapine will have an improvement in speech as compared to a placebo.


Eligibility criteria: Inclusion Criteria:

Subjects can be enrolled in the study only if they meet all of the following criteria:

1. Subjects must satisfy DSM-IV criteria for stuttering.
2. The nature of stuttering must be developmental in origin with the onset prior to ten years of age.
3. Subjects must have a score of moderate or higher on the SSI-IV. 4) Women of child-bearing potential are eligible to participate as long as they are practicing a medically accepted form of contraception (i.e. condom with spermicide or diaphragm, oral or depot contraception, or an intrauterine device).

5)Subjects will be male or female from the ages of 18-70. 6)Subjects will be of only English speaking.

Exclusion Criteria:

Subjects will be excluded from the study for any of the following reasons:

1. Stuttering related to a known neurologic cause (e.g. head trauma, stroke).
2. Unstable medical or psychiatric illness.
3. Active substance abuse within three months prior to study inclusion.
4. Any illness that would require the concomitant use of a CNS active medication during the course of the study.
5. Subjects with Parkinson's dementia or other degenerative neurologic illness.
6. Subjects who are pregnant or nursing an infant.
7. No minors (under the age of 18) will not be enrolled in this study as the research with this compound in children and adolescents has not been fully performed.
8. Subjects who suffer from seizures, irregular heartbeat or an elevated blood sugar level (glucose).

Primary outcomes:
measure: Stuttering Severity Instrument
timeFrame: 10 minutes
Secondary outcomes:
measure: Clinical Global Impression
timeFrame: 2 minutes
measure: Barnes Akathisia Scale
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
Study officials:
affiliation: UCIMC
name: Gerald Maguire, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00345657: Efficacy Study of Extended-Release Niacin/Lovastatin Versus Usual Care
Official title: Extended-Release Niacin/Lovastatin Versus Usual Care for Treatment of Dyslipidemia in a Primary Care Setting (EXTEND Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperlipidemia
Mixed Hyperlipidemia
Dyslipidemia
Keywords: Hyperlipidemia
Dyslipidemia
Niacin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Combination lipid therapy
Lovastatin
Lead sponsor: In His Image
Sponsor class: OTHER
Collaborators: name: Kos Pharmaceuticals
First posted: 2006-06-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin in patients receiving standard care who are not at LDL goal per ATP III guidelines.

Detailed description: Both LDL and HDL are important contributors in the pathophysiology of atherosclerosis and coronary artery disease (CAD); however, HDL is often ignored in primary care. The combination of niacin extended-release (ER)/lovastatin in a single tablet formulation (Advicor®) may be the most effective therapeutic option for simultaneously correcting both of these lipoprotein abnormalities to reduce CAD risk. The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin in patients receiving standard care who are not at LDL goal per ATP III guidelines.

Eligibility criteria: Inclusion Criteria:

1. \>18 years old with CAD or risk factors for CAD
2. under standard care at Family Medical Care of Tulsa
3. not at LDL goal per ATP III guidelines

Exclusion Criteria:

1. pregnancy/lactating
2. liver disease
3. allergies to statin or niacin
4. active peptic ulcer disease
5. previous treatment with combination therapy for dyslipidemia

Primary outcomes:
measure: Lipid parameter change at 3 and 6 months
measure: Percent of patients achieving ATP III LDL goals at 3 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Family Medical Care of Tulsa
state: Oklahoma
Study officials:
affiliation: In His Image Family Medicine Residency
name: Jason A Logan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: In His Image Family Medicine Residency
name: Edward Rylander, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01908257: Lesinurad Interaction Study With Ranitidine
Official title: A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Potential Effects of Ranitidine on the Pharmacokinetics of Lesinurad in Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Ardea Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-25
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a drug-drug interaction study in healthy volunteers to evaluate the potential pharmacokinetic (PK) effects of ranitidine on lesinurad.

Detailed description: This study will evaluate the potential effect of ranitidine on the pharmacokinetics of lesinurad. An earlier study demonstrated an effect on lesinurad PK in the presence of both calcium-containing and magnesium- and aluminum-containing antacids. The current study will assess whether raising gastric pH, without the presence of these cations, affects lesinurad PK and PD under the fasted state. If an impact is seen, then the optional second cohort will be conducted under the fed state.

Eligibility criteria: Inclusion Criteria:

* body weight ≥ 50 kg (110 lbs) and body mass index ≥ 18 and ≤ 30 kg/m2.
* Screening sUA value ≤ 7.0 mg/dL.
* free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures.
* Subject has no clinically relevant abnormalties in vital signs, ECG, physical examination or safety laboratory values per the Investigator's judgment.

Exclusion Criteria:

* history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic renal,urological, or psychiatric disorders.
* history or suspicion of kidney stones.
* undergone major surgery within 3 months prior to Day 1.
* donated blood or experienced significant blood loss (\> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to the Screening visit.
* inadequate venous access or unsuitable veins for repeated venipuncture.

Primary outcomes:
measure: PK profile of lesinurad from plasma and urine
timeFrame: Days 1 and 6 (Sequence 1) or Days 2 and 7 (Sequence 2)
Secondary outcomes:
measure: Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters
timeFrame: 6 weeks
measure: PD profile of lesinurad from serum
timeFrame: Days 1 and 6 (Sequence 1) or Days 2 and 7 (Sequence 2)
Other outcomes:
Locations:
city: Cypress
country: United States
state: California
Study officials:
affiliation: Ardea Biosciences, Inc.
name: S. Bradley, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00817557: Use of Loteprednol for Contact Lens Intolerance and Dryness
Official title: Use of Loteprednol for Contact Lens Intolerance and Dryness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Contact Lenses Dryness
Keywords: Contact lenses
Loteprednol
Effect on CL dryness
Lead sponsor: Hom, Milton M., OD, FAAO
Sponsor class: INDIV
Collaborators: name: Bausch & Lomb Incorporated
First posted: 2009-01-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study of the effects of Loteprednol on CL dryness


Eligibility criteria: Inclusion Criteria:

1. Between the ages of 18 and over inclusive.
2. Males or females
3. Any race or ethnic background
4. CL history- experienced intolerance and either switched solutions or lenses without satisfactory relief.
5. Patient is in generally good \& stable overall health.
6. Patient likely to comply with study guidelines \& study visits.
7. Informed consent signed.
8. OSDI score 18 or higher while wearing lenses
9. Unsatisfactory wearing time with contact lenses

Exclusion Criteria:

1. Corneal refractive surgery within 6 months of this study.
2. Contact lens use on day of examination.
3. Corneal ectasia.
4. Current use of Restasis
5. Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
6. Pregnant or lactating women.
7. Ocular pathology (includes glaucoma and cataract) which could impact results and/or place patient at risk.

Primary outcomes:
measure: Wearing time
timeFrame: 28 days
Secondary outcomes:
measure: OSDI
timeFrame: 28 days
Other outcomes:
Locations:
city: Azusa
country: United States
facility: Milton M. Hom, OD, FAAO.
state: California
Study officials:
affiliation: Private Practice
name: Milton M Hom, OD FAAO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02086357: Investigation of Ultrasound Elastographic Techniques in Soft Tissue Pathology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tissue Pathology
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 500
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Musculoskeletal US department at Chapel Allerton Hospital

Brief summary: Ultrasound (US)tissue elastography has recently been found to have a number of clinical applications in the assessment of soft tissue disease for example, in breast and thyroid pathology. There are few current studies exploring its use in musculoskeletal pathology, particularly a new technique called sheer wave ultrasound elastography (SWUE).

Magnetic Resonance (MR) elastography has shown wide reaching applications in orthopaedics, sports medicine and rheumatology and SWUE may have the potential to also demonstrate clinical effectiveness in these areas.

Our aim is to explore the effectiveness of this technique in the assessment of musculoskeletal pathology.

Participants will be recruited through current referral protocols and would undergo an additional elastographic investigation in addition to their standard US examination. This investigation will be conducted within the musculoskeletal US department at Chapel Allerton Hospital by trained musculoskeletal specialists. The study will be conducted over a period of approximately 24 months with quarterly review during this time.


Eligibility criteria: Inclusion Criteria:

* Have clinical symptoms and signs of soft tissue pathology
* Be able to give consent
* Be over 16 years of age

Exclusion Criteria:

* Unable to give consent
* 16years of age or less
* Multifactorial soft tissue pathology

Primary outcomes:
measure: Clinical effectiveness of Sheer wave ultrasound elastography (SWUE) in the assessment of soft tissue pathology
timeFrame: Baseline to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospital NHS Trust
Study officials:
References:
Clinical trial NCT04578457: Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2020_09
Official title: Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2020_09
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2020-10-08
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Participants will perform two different listening tasks: (1) listening to, and repeating back, sentence lists presented in noise, and (2) Subjective rating of effort \& performance following each condition. During this study, continuous, non-invasive physiological measurements (skin conductance, changes in pupil dilation) will be recorded from participants. Using this paradigm we will be assessing the effect of different hearing aid processing algorithms on listening effort. The study takes the form of a one factor (algorithm), within-subjects design.

Each participant performs the Speech perception task with each algorithm (reference, noise reduction I, noise reduction II, noise reduction III), at two individualized signal-to-noise ratios (SRT90 and SRT50). Additionally subjective performance ratings in real-life will be collected.


Eligibility criteria: Inclusion Criteria:

* Healthy outer ear (without previous surgical procedures)
* Ability to fill in a questionnaire conscientiously
* Informed Consent as documented by signature
* Minimum 1 year hearing aid experience
* Moderate-Severe (N3-N5) hearing loss or Normal Hearing

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Known central hearing disorders

Primary outcomes:
measure: Differences in Event-related-skin-conductance
timeFrame: 6 weeks
measure: Differences in Event-related-pupil-dilation (ERPDs)
timeFrame: 6 weeks
Secondary outcomes:
measure: Oldenburg Sentence Test
timeFrame: 6 weeks
measure: Sound Quality Ratings
timeFrame: 6 weeks
measure: Spectro-temporal-modulation Detection Thresholds (STM)
timeFrame: 6 weeks
Other outcomes:
measure: Non-verbal Trail Making Test A & B
timeFrame: 2 weeks
measure: Digit-Span Test Forward (FW) & Backward (BW)
timeFrame: 2 weeks
measure: Go/No-go Task
timeFrame: 6 weeks
measure: Blood Volume Pulse
timeFrame: 6 weeks
measure: Respiration Data
timeFrame: 6 weeks
measure: Skin Temperature Data
timeFrame: 6 weeks
measure: Acoustic Reflex Thresholds
timeFrame: 3 weeks
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
Study officials:
References: