louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01829230: Myopia Progression After Ceasing Myopia Control Contact Lens Wear
Official title: Myopia Progression After Ceasing Myopia Control Contact Lens Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-11
Enrollment: 82
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a continuation study for subjects who were previously fit with test or control lenses; all will stop wearing their study lenses assigned in the previous study and will start to wear an FDA-approved marketed spherical soft contact lens.


Eligibility criteria: Inclusion Criteria:

1. The subject must be enrolled in the parent protocol for at least one year.
2. The subject's parent or legal guardian must read and sign the STATEMENT OF INFORMED CONSENT and the subject must read and sign the Child's Assent Form and be provided a copy of each form.
3. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

1. Ocular or systemic allergies that may interfere with contact lens wear.
2. Systemic disease or autoimmune disease or use of medication (e.g. antihistamine), which may interfere with contact lens wear.
3. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
4. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear.
5. Any ocular infection.
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
7. Any infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV)
8. Diabetes
9. Previous refractive surgery, orthokeratology, keratoconus, or other corneal irregularity in either eye. Rigid contact lens wearers cannot be enrolled in the study.
10. Strabismus.
11. Pupil or lid abnormality or infection in either eye
12. Central corneal scar in either eye
13. Aphakia in either eye
14. Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear.
15. History of participation in prior clinical trials aimed to control myopia progression, except for the parent trial
16. Surgically altered eyes, ocular infection of any type, ocular inflammation.
17. Anterior chamber angle grade 2 or narrower by Van Herrick method.

Primary outcomes:
measure: Axial Length of the Eye
timeFrame: Baseline and every 6 months post-baseline up to 18 months
measure: Spherical Equivalent Refractive Error
timeFrame: Baseline and every 6 months up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
state: Massachusetts
Study officials:
References:
Clinical trial NCT03207230: Multicenter Exploratory Study of Accelerometry in Dilated Cardiomyopathy
Official title: A Multicenter Exploratory Study of Accelerometry Measurements in Dilated Cardiomyopathy Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dilated Cardiomyopathy
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants enrolled in the study will receive the wearables and will be evaluated for the relationship between daily physical activity levels and functional capacity (VO2 peak).
Primary purpose: OTHER

Brief summary: Study evaluates the relationships between daily physical activity levels (PAL) and functional capacity (VO2peak) in patients with dilated cardiomyopathy (DCM)

Detailed description: The study will evaluate the daily physical activity with the use of activity monitor, heart rate monitor and event monitor in patients with dilated cardiomyopathy (DCM). These wearables track the heart rate, heart rhythm, tracks activity and step count. The VO2 peak will be measured via the exercise test.

Eligibility criteria: Inclusion Criteria:

1. Males and females, 18-75 years of age
2. Diagnosis of dilated cardiomyopathy

   * (Unexplained left ventricular enlargement (left ventricular end diastolic dimension (LVEDD) \>95th percentile for gender and height by echo or MRI)
   * (Left ventricular ejection fraction (LVEF) less than 50%)
3. CPET within 14 days prior to baseline visit with no intervening change in therapy
4. Echocardiogram or cardiac MRI within 1 year prior to baseline
5. Able to walk \>100ft without limitation
6. More than 30 minutes of exercise per week for at least 3 months prior to study enrollment, and plan to continue exercising for the next two weeks (duration of study).
7. Ability to provide informed consent and willingness to complete the study (including weekly phone follow-up)

Exclusion Criteria:

1. Heart failure hospitalization within four weeks prior to enrollment
2. Non-cardiac limitation of activity

4. Prior exercise-induced syncope or exercise-induced sudden death 5. Primary exercise mode is swimming or stationary biking 6. Participation in competitive or high intensity exercise against medical advice 7. Implantable Cardiverter Defibrillator (ICD) placement in the 2 months prior to enrollment 8. Plan for surgery, device implantation, or significant change in clinical management during the two weeks of the study

Primary outcomes:
measure: VO2max correlation with daily physical activity
timeFrame: 2 weeks
Secondary outcomes:
measure: NYHA correlation with daily step count
timeFrame: 2 weeks
measure: KCCQ correlation with daily step count
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Matthew T Wheeler, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000230: Buprenorphine Detoxification With Two Types of Treatment. BBD III - 12
Official title: Buprenorphine Detoxification With Two Types of Treatment. BBD III
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate buprenorphine and behavioral treatment with and without contingent payment on compliance with naltrexone.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Drug use
measure: Retention
measure: Weeks abstinent
measure: Weeks continuous abstinence
measure: Overall treatment outcome
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Treatment Research Center
state: Vermont
Study officials:
affiliation: University of Vermont
name: Warren Bickel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03092830: Molecular Characterization of Cutaneous Tumors
Official title: Molecular Characterization of Cutaneous Tumors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Squamous Cell Carcinoma
Basal Cell Carcinoma
Keywords: SCC
BCC
DNA
RNA
HEDGE HOG
epidermal growth factor receptor
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2017-03-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: above 18 years old with Scc and BCC skin tumors not pregnant women and no children or any person without judgment ability

Brief summary: The objective is to find genes which are responsible for the appearance of skin tumors (sCC, BCC) and it will be the basis for prediction of the disease and response to the treatment

Detailed description: Prospective, 1-arm, 500 participates above 18 age with skin tumor affliction sCC and BCC type.

Eligibility criteria: Inclusion Criteria:

* patient that have sCC and BCC tumors
* above 18 years old

Exclusion Criteria:

* below 18 years old
* pregnant women
* children or person without judgment ability

Primary outcomes:
measure: Molecular Characterization of cutaneous tumors
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: RabinMC
Study officials:
affiliation: Rabin Medical Center
name: DR Dean Ad EL, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winder M, Viros A. Mechanisms of Drug Resistance in Melanoma. Handb Exp Pharmacol. 2018;249:91-108. doi: 10.1007/164_2017_17.
Clinical trial NCT04339530: Vitamin D and Type 2 Diabetes Risk in UK Adults
Official title: Association Between Vitamin D Status and Risk of Type 2 Diabetes in a Population of UK Adults: A Cross-sectional Study.
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Overweight
Obesity
Keywords: Vitamin D
Type 2 diabetes
Insulin resistance
Glucose
Lead sponsor: Liverpool Hope University
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Overweight and obese adults , aged 18-50 (premenopausal women), males and females with no known chronic conditions.

Brief summary: This study is exploring the association between vitamin D and Type 2 diabetes risk in normal weight and overweight UK adults.

Detailed description: The aim of this study is to assess the link between vitamin D status and glucose homeostasis in a population of normal weight and overweight individuals (BMI\> 18.5 Kg/m2).

Eligibility criteria: Inclusion Criteria:

* Normal weight and overweight and obese adults (BMI\>= 18.5 Kg/m2) with no restriction to ethnicity, occupation or socioeconomic status.
* Males and females
* 18-50 years

Exclusion Criteria:

* Patients diagnosed with diabetes type 2, myocardial infarction or coronary heart disease.
* HbA1c \> 6.4%
* Pregnancy
* Diagnosis of liver disease (including liver enzymes \> 3 times above normal values)
* Diagnosis of renal disease (creatinine of \> 150 mmol/l)
* Post-menopausal women

Primary outcomes:
measure: HOMA-IR (Homeostasis modelling assessment-Insulin resistance)
timeFrame: One venous sample collected after 8 hours of fasting
Secondary outcomes:
measure: Fasting bood glucose levels
timeFrame: One venous sample collected after 8 hours of fasting
measure: HbA1C
timeFrame: Sample collected at one single time point with no follow-up
measure: Body fat percentage
timeFrame: Measurement conducted in the morning after 8 hours of fasting
measure: Central and brachial Systolic and Diastolic Blood pressure
timeFrame: Measurement taken 3 times after a-10 minute rest
measure: Augmentation index
timeFrame: Measurement taken 3 times after a-10 minute rest
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: School of Health sciences
Study officials:
References:
Clinical trial NCT00725530: Evaluation of Deposits on Contact Lenses Worn Extended Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: Lens deposits
Soft contact lens wearers
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-07-30
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study was to measure lipid deposits on commercially marketed contact lenses when worn on an extended wear (overnight) basis for 7 days.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older.
* Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses.
* Successfully wearing hydrogel or silicone hydrogel contact lenses.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Evidence or history of ocular conditions as prescribed in the protocol.
* One functional eye or a monofit lens.
* Any slit-lamp finding score of (1) at the Screening Visit as defined by the protocol.
* Use of concomitant topical ocular prescription or over-the-counter ocular medications.
* History of seasonal allergies with significant ocular side effects.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Front Surface Lens Deposits
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT02258230: Laparoscopic Three-dimensional Versus Two-dimensional Sacral Colpopexy and Paravaginal Repair
Official title: Laparoscopic 3D Versus 2D Sacral Colpopexy and Paravaginal Repair for Pelvic Organ Prolapse: a Comparison of Operative Times and Complications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Cystocele
Lead sponsor: Olympus Corporation of the Americas
Sponsor class: INDUSTRY
Collaborators: name: International Urogynecology Associates
First posted: 2014-10-07
Enrollment: 194
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare operative times and complications of sacral colpopexy and paravaginal repair between two-dimensional and three-dimensional laparoscopic systems.

Detailed description: The purpose of this study is to compare operative times of laparoscopic sacral colpopexy (LSC) for the treatment of symptomatic vaginal vault prolapse as well as paravaginal repair (PVR) for symptomatic cystocele between two-dimensional and three-dimensional laparoscopic systems. Additionally this study will evaluate postoperative complications from surgeries performed using two-dimensional versus three-dimensional laparoscopic systems.

Eligibility criteria: Inclusion Criteria:

* Symptomatic vaginal vault prolapse (stage 2 or greater point C-1 pelvic organ prolapse quantification \[POP-Q\] or grade 2 or greater Baden-Walker half way system) undergoing laparoscopic sacral colpopexy

And/Or

* Symptomatic cystocele (stage 2 or greater, point Aa or Ba \> -1 POP-Q or grade 2 or greater Baden-Walker half way system) undergoing laparoscopic paravaginal repair

Exclusion Criteria:

* Age less than 18 years
* Inability to comprehend questionnaires
* Inability to give informed consent or to return for review
* Vaginal vault prolapse \< stage 2
* Unable to undergo general anesthesia
* More than 5 previous laparotomies
* Prior sacral colpopexy or vaginal mesh prolapse procedure
* Prior surgery involving the retropubic space
* Vaginal length less than 6 cm

Primary outcomes:
measure: Operative Times
timeFrame: Intraoperative
Secondary outcomes:
measure: Complications
timeFrame: Intraoperative up to 6 weeks post procedure
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Beverly Hills Sunset Surgery Center
state: California
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
Study officials:
affiliation: International Urogynecology Associates
name: Robert D Moore, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04516330: Can MicroRNA's Predict Multicentricity in Breast Cancer?
Official title: Can MicroRNA's Predict Multicentricity in Breast Cancer?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multicentric Breast Cancer
Keywords: multicentric
breast
cancer
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to determine if microRNA's have role in predicting multicentricity in breast cancer. If a specific microRNA will be found to be related with multicentricity, it will help us to make appropriate decisions on the treatment of patients with multicentric breast cancer.

Detailed description: In the study that will be held at Bezmialem Vakif University Medical Faculty, General Surgery Department, 20 unifocal and 20 multifocal breast cancer patients will be included. Tissues will be taken from both tumoral and normal breast tissues and they will be saved in microRNA later solution under -80°C. Then, 84 microRNA's will be studied in these tissues to see if they express any of these microRNA's.

Eligibility criteria: Inclusion Criteria:

1. Having breast cancer
2. Having no other malignancy
3. Female patient

Exclusion Criteria:

1. Having other malignancy
2. Under 18 years old
3. Male patient

Primary outcomes:
measure: MicroRNA's in multicentric breast cancer
timeFrame: April 2014
Secondary outcomes:
measure: Treatment plan according to the detected microRNA in patients with multicentric breast cancer
timeFrame: April 2014
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
References:
Clinical trial NCT06957730: A Comparison of Hearing Aid Noise Programs on Speech Intelligibility
Official title: A Comparison of Hearing Aid Noise Programs on Speech Intelligibility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Bilateral or Unilateral
Keywords: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2025-05-04
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will be tested with the same three hearing aid programs, but the order of the programs will be randomized for each participant.
Primary purpose: TREATMENT

Brief summary: Hearing impaired participants will be fit with study devices which will have three different hearing aid programs. Speech intelligibility will be measured using validated tests for each of the three hearing aid programs. The order of the hearing aid programs will be randomized across participants and each participant will be blinded as to the programs being tested.

Detailed description: Program 1 is the current default in the commercially available devices. Programs 2 and 3 are being tested against the current default.

Eligibility criteria: Inclusion Criteria:

* Bilateral moderate to severe hearing loss (N3-N4)
* Experienced hearing aid user
* Fluent in English
* Cognitively able to complete complex listening tasks

Exclusion Criteria:

* Unilateral hearing loss
* New hearing aid user
* Unable or unwilling to complete complex listening tasks

Primary outcomes:
measure: AZBio Speech in noise testing
timeFrame: Day 1 of 1 day study
Secondary outcomes:
measure: Subjective ratings of sound quality
timeFrame: Day 1 of 1 day study
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Phonak Audiology Research Center
state: Illinois
Study officials:
References:
Clinical trial NCT00000330: Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-2 - 5
Official title: Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-2
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Heroin Dependence
Opioid-Related Disorders
Keywords: Heroin Dependence
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the abuse liability and reinforcing effects of intravenous buprenorphine and buprenorphine/naloxone combinations in heroin-dependent volunteers

Detailed description: not available at this time

Eligibility criteria: Inclusion Criteria:

Individuals must be at least 18 yrs of age, currently opioid dependent and must not be seeking treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency and have a history of IV opioid use.

Exclusion Criteria:

Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.

Primary outcomes:
measure: Subjective dose estimate
measure: Observed withdrawal rating
measure: Opioid antagonist rating
measure: Pupil diameter
measure: Analog rating scale for drug effects
measure: Drug effect characteristics
measure: Drug/Money Preferences
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Leslie Amass, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: