louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03161392: Correlation of Solitary Dilated Duct at Mammography With Ultrasonography and Anatomopathological Findings
Official title: Evaluation of Solitary Dilated Duct Visualized by Mammography in Correlation With Ultrasonography and Anatomopathological Findings.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mammary Duct Ectasia of Unspecified Breast
Mammographic Findings
Female
Keywords: mammography
ductal ectasia
breast neoplasm/diagnostic imaging
mammary Glands, Human/pathology
female
Lead sponsor: Faculdade de Medicina do ABC
Sponsor class: OTHER
Collaborators: name: Instituto Brasileiro de Controle do Cancer
First posted: 2017-05-19
Enrollment: 135
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women submitted to mammography for breast cancer screening or for diagnosis purposes

Brief summary: Mammograms performed at the Diagnostic Imaging Department of the "Instituto Brasileiro de Controle do Câncer" (IBCC - Brazilian Cancer Control Institute) will be prospectively evaluated. Patients who present a solitary dilated duct visualized by mammography will be submitted to breast ultrasonography. In case of detection of lesion, a percutaneous biopsy will be performed.

Detailed description: Purpose: To determinate the incidence, pathological significance and risk factors associated with the presence of solitary dilated duct visualized at mammography exam.

Methods: Mammograms performed at the Diagnostic Imaging Department of the "Instituto Brasileiro de Controle do Câncer" (IBCC - Brazilian Cancer Control Institute) will be prospectively evaluated. Patients who present a solitary dilated duct visualized by mammography will be included in the study. These patients will be recalled in order to be submitted to an ultrasonography directed to the mammographic finding. Patients who present lesions on ultrasonography will undergo method-guided percutaneous biopsy.

Patients with ductal ectasia, without evident lesions, will be followed for 2 years to evaluate stability by means of mammography or ultrasonography every 6-month intervals.

Eligibility criteria: Inclusion Criteria:

* Identification of a solitary dilated breast duct at mammography

Exclusion Criteria:

* Previous breast surgery at same side of detection of dilated duct

Primary outcomes:
measure: Abnormal histological finding at breast biopsy
timeFrame: At guided-percutaneous biopsy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: ABC Medicine School
name: Luciano M Pompei, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05340192: Effect of Octreotide on Saliva
Official title: Effect of Octreotide on Saliva
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a healthy volunteer pilot study. Subjects will be asked to provide a saliva sample after a 2 hour fast and 5 minutes after rinsing their mouth with tap water. The sample will be collected in an Eppendorf vial. After providing the saliva sample, each subject will be injected subcutaneously with 100 mcg (1 ml) of Octreotide by either a physician or registered nurse. A second sample of saliva will be collected using the same protocol 45-55 minutes after administering the drug.
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the effect of Octreotide on saliva enzymes. The study team hypothesizes that Octreotide will decrease the levels of certain proteins, specifically the metalloproteinase family.

Detailed description: This is a healthy volunteer pilot study. The purpose of this study is to determine the effect of a drug, Octreotide, on saliva enzymes in order to see if this drug can help prevent pharyngo-cutaneous fistulas (an abnormal tissue connection in the pharynx) in patients undergoing laryngectomy.

Eligibility criteria: Inclusion Criteria:

* Healthy adults between the ages of 18-40 years old
* Healthy volunteer who is willing to undergo research activities
* Healthy volunteer with no self-report of disease, oral symptoms or lesions, or cold or flu like symptoms that would affect the reflective measurements in the oral cavity
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Pregnant or nursing women
* Children under the age of 18 or adults over 40
* Complaint of oral symptoms (self-reported)
* Medical condition affecting saliva (e.g. Sjogren's)
* History of head/neck radiation
* Medication that might affect saliva (e.g. Proton Pump Inhibitors)
* Known allergy to Octreotide
* Non-English speaking
* Diabetes, gallbladder disease, heart disease, high blood pressure, a heart rhythm disorder, thyroid problems, pancreatitis, kidney disease, or liver disease (self-reported)

Primary outcomes:
measure: To quantify the change of saliva proteomes of subjects pre-octreotide treatment
timeFrame: Day 1 pre-treatment
measure: To quantify the change of saliva proteomes of subjects post-octreotide treatment
timeFrame: Day 1 post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke Health
name: Walter Lee, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03750292: Residential Cleaning of Indoor Air to Protect COPD Patients
Official title: Residential Cleaning of Indoor Air to Reduce Acute Exacerbations of COPD (CARE): A Pilot Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study looks at whether air cleaning devices put in the bedroom and living room of your home could reduce the irritation of your lungs and body that is caused by indoor air pollution. While participating in this study there will be two, 2 month long study segments (Study Period 1 and Study Period 2) where the air filter units, placed in your living room and bedroom windows, will be turned on at your home.


Eligibility criteria: Inclusion Criteria:

* severe COPD (FEV1 \< 50%)
* live in Monroe County
* referred for pulmonary rehabilitation
* suffered from an AECOPD in the past year
* have standard sized windows in their bedroom and living room amenable to installation of the HEPAirX® device
* expect to sleep each night of the 4 months (2 months of Period 1, and 2 months of period 2) in either their bedroom or living room for at least 6 hours/night, and not use other air filtering devices during the study

Exclusion Criteria:

* under age 18
* smoking at the time of their prior COPD exacerbation
* current smokers
* those who live with an active smoker
* those with an occupation that has a high pollutant exposure (e.g. professional drivers)
* those who already have a home air filtration device (other than basic furnace filter)

Primary outcomes:
measure: Mean Change in St. George Respiratory Questionnaire
timeFrame: baseline to 8 weeks
measure: Mean Change in St. George Respiratory Questionnaire
timeFrame: 11 weeks to 19 weeks
measure: Mean Change in St. George Respiratory Questionnaire
timeFrame: week 19 to week 31
measure: Mean Change in Daily Steps
timeFrame: week 0 to week 8
measure: Mean Change in Daily Step
timeFrame: 11 weeks to 19 weeks
Secondary outcomes:
measure: Mean Plasma C-reactive Protein Level
timeFrame: week 0 to week 19
measure: Mean Number of Outpatient and Inpatient Visits for Chronic Obstructive Pulmonary Disorder Exacerbations
timeFrame: baseline to week 31
measure: Mean Number of Outpatient and Inpatient Visit for Chronic Obstructive Pulmonary Disorder Exacerbations
timeFrame: baseline to week 31
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT04688892: Immediate Effects of Dynamic Cupping on Median Nerve's Mechanosensitivity
Official title: Immediate Effects of Dynamic Cupping on Median Nerve's Mechanosensitivity, Measured by the Upper Limb Neurodynamic Test 1 (ULNT1) in Healthy Participants: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University Fernando Pessoa
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose oh this study is to verify the immediate effects of dynamic cupping on median nerve's mechanosensitivity, measured by the upper limb neurodynamic test 1 (ULNT1) in healthy participants.

Detailed description: After completing the socio-demographic and clinical questionnaire, the participants will be randomly assigned into two designated groups, the Intervention Group (IG; n = 30) (dynamic cupping therapy throughout the median nerve course) and the Control Group (CG; n = 30) (remained at rest for 5 minutes), using the software www.graphpad.com/quickcals.

Eligibility criteria: Inclusion Criteria:

• Healthy university students of both genders with normal mobility of the joints of the upper quadrant of the body.

Exclusion Criteria:

* Deformities in the upper quadrant region of the body;
* Complaints in this region in the last 6 months;
* Surgical procedures or musculoskeletal, cardiac, renal, metabolic, neurological and or oncological pathologies of the upper quadrant that may disturb nerve function;
* Not present any mechanosensitive response to ULNT1;
* Pregnant women;
* Ingestion of non-steroidal anti-inflammatory drugs or consumption of any type of narcotic drugs and participants who have drunk alcohol in the last 12 hours.

Primary outcomes:
measure: change in elbow extension range of motion
timeFrame: Baseline (M0), Immediately after intervention or control (M1).
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Ricardo Cardoso
Study officials:
affiliation: Fernando Pessoa University
name: Ricardo Cardoso, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06629792: A Clinical Study Evaluating the Efficacy and Tolerability of a Topical Facial Treatment For Facial Rejuvenation
Official title: A Clinical Study To Evaluate the Efficacy and Tolerance of a Topical Facial Treatment on Women With Mild to Moderate Fine Lines, Wrinkles, and Laxity on the Global Face
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fine Lines
Wrinkles
Laxity; Skin
Keywords: topical treatment
skin rejuvenation
anti-aging
Lead sponsor: Revision Skincare
Sponsor class: INDUSTRY
Collaborators: name: SGS Stephens, Inc
First posted: 2024-10-08
Enrollment: 32
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single-center clinical trial was conducted to evaluate the efficacy and tolerability of a topical facial treatment when applied by a license esthetician in clinic in a series of 3 sessions with 1 month intervals, in combination with a cleanser, moisturizer, and sunscreen over the course of 12 weeks in healthy women aged 35 to 60 with mild to moderate global facial fine lines, wrinkles, and laxity. Thirty-two (32) healthy female subjects completed the clinical study.

Detailed description: This single-center clinical trial was conducted to evaluate the efficacy and tolerability of a topical facial treatment when applied by a license esthetician in clinic in a series of 3 sessions with 1 month intervals, in combination with a cleanser, moisturizer, and sunscreen over the course of 12 weeks in healthy women aged 35 to 60 with mild to moderate global facial fine lines, wrinkles, and laxity.

The efficacy and tolerability of the topical facial treatment in improving mild to moderate global facial fine lines, wrinkles, and laxity. was evaluated by Investigator clinical efficacy grading and tolerability grading by a board-certified dermatologist, subject tolerability grading, and clinical photography.

Eligibility criteria: Inclusion Criteria:

* Having Fitzpatrick Skin Type I - VI
* Having mid to moderate global face fine lines, wrinkles, and laxtiy (tactile) (score of 3 to 6 according to a modified Griffiths scale).

Exclusion Criteria:

* Breastfeeding, pregnant, or planning to become pregnant during the study.
* Currently having or having a history of cold sores (Herpes simplex) on the face.

Primary outcomes:
measure: Change Investigator Clinical Efficacy Grading versus Baseline
timeFrame: 12 weeks
measure: Lack of significant change in Investigator Tolerability Parameters versus Baseline
timeFrame: 12 weeks
measure: Lack of significant change in Subjective Tolerability versus Baseline
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Facial Parameters in a Self-Assessment Questionnaire versus Baseline and Percent Agreement
timeFrame: 12 weeks
measure: Clinical Photography: VISIA-CR and Antera 3D
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Richardson
country: United States
facility: SGS Stephens, inc.
state: Texas
Study officials:
References:
Clinical trial NCT00479492: Study To Determine The Effects And Safety Of A Weight Loss Compound On Overweight, Otherwise Healthy, Volunteers
Official title: A 12-Week, Randomized, Subject And Investigator Blind, Placebo-Controlled Trial To Evaluate The Effect Of CP-866,087 On Weight Loss In Obese, Otherwise Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: Obesity, weight loss
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-28
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether CP-866,087 is effective in the weight loss of overweight patients.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) 30 to 40 kg/m2 and total body weight of \>110 lbs.
* Otherwise healthy

Exclusion Criteria:

* Women must be of non-childbearing potential.
* Significant current or history of medical illness.

Primary outcomes:
measure: Measure the effect of weight loss over 12 weeks in overweight otherwise healthy patients. Measurements will include body weight and waist circumference. Measurements will occur at Day 1, 7, 14, 28, 42, 56, 70, 84 and 94.
timeFrame: 94 days
Secondary outcomes:
measure: To characterize the effect of 4 weeks of dosing of 3 different doses of CP-866,087 on 24-hour urinary cortisol levels. Measured at Day 1 and Day 29
timeFrame: 29 days
measure: Exploratory biomarkers measured at Day 1, 14, 28, 56, and 84.
timeFrame: 84 days
measure: Waist circumference measured at Day 1, 7, 14, 28, 42, 56, 70, 84, 94.
timeFrame: 94 days
measure: To explore changes in pharmacodynamics (PD) markers of efficacy resulting from multiple PO doses of CP-866,087, including waist circumference, and serum lipids and exploratory biomarkers.
timeFrame: 94 days
measure: Serum Lipids measured at Day 1, 7, 14, 28, 56, 84 and 94.
timeFrame: 94 days
measure: To explore the effects of chronic, 12-week dosing with CP-866,087 on neuroendocrine endpoints, including testosterone, TSH, T4, and IGF1. Measured at Day 1, 28, 84 and 94.
timeFrame: 94 days
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00311792: Transfer of Skills From VR-Trainer to Operation Room
Official title: Transfer of Skills From LapSimGyn VR-Simulator to a Laparoscopic Salpingectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Clinical Competence
Keywords: training
teaching
curriculum
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2006-04-06
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose is to determine if skills obtained by training in the laparoscopic virtual reality simulator LapSimGyn can be transferred to a real laparoscopic operation measured as improved score in a technical skills assessment.

Detailed description: The purpose is to determine if skills obtained by training in the laparoscopic virtual reality simulator LapSimGyn can be transferred to a real laparoscopic operation measured as improved score in a technical skills assessment. Design: prospective randomized double blinded intervention study.

Subjects:Younger gynaecologists (Postgraduate year 2-8) Half are having conventional training the other half is undergoing virtual reality simulator training before performing their first laparoscopic salpingectomy.

Outcome is measured by blinded video evaluation with criteria. The criteria is defined in the previous validated scoring system Objective Structured Assessment of Technical Skills (OSATS)

Eligibility criteria: Inclusion Criteria:

* Gyn/obs trainee 1.-2. year, with no experience from advanced laparoscopy

Exclusion Criteria:

* Advanced laparoscopic experience
* Previous training in simulator

Primary outcomes:
measure: Rating Scale Score
timeFrame: 1 day
Secondary outcomes:
measure: Time used to perform operation
timeFrame: 1 day
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Bent Ottesen, MD Dr.Sci
role: STUDY_DIRECTOR
References:
citation: Issenberg SB, McGaghie WC, Petrusa ER, Lee Gordon D, Scalese RJ. Features and uses of high-fidelity medical simulations that lead to effective learning: a BEME systematic review. Med Teach. 2005 Jan;27(1):10-28. doi: 10.1080/01421590500046924.
citation: Larsen CR, Soerensen JL, Grantcharov TP, Dalsgaard T, Schouenborg L, Ottosen C, Schroeder TV, Ottesen BS. Effect of virtual reality training on laparoscopic surgery: randomised controlled trial. BMJ. 2009 May 14;338:b1802. doi: 10.1136/bmj.b1802.
Clinical trial NCT03677492: Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD)
Official title: Cytochalasin D Supplementation to ICSI Handling Medium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Ibn Sina Hospital
Sponsor class: OTHER_GOV
First posted: 2018-09-19
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Vienna Consensus has identified 10% damage rate after ICSI as a competency value. Despite the highest quality embryologists doing ICSI, degeneration sometimes occurs due to oocyte factors such as the fragile membrane, etc. Cytochalasin D serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported. Using Cytochalasin D during ICSI could serve to rescue some oocytes from the degeneration allowing for more chances of viable zygotes.


Eligibility criteria: Inclusion Criteria:

* ICSI indicated participants

Exclusion Criteria:

-

Primary outcomes:
measure: Oocyte survival rate
timeFrame: 6 days of culture
Secondary outcomes:
measure: Fertilization rate
timeFrame: 6 days of culture
measure: Blastocyst formation rate
timeFrame: 6 days of culture
measure: Embryo utilization rate
timeFrame: 6 days of culture
measure: Clinical pregnancy rate
timeFrame: three months
measure: Implantation rate
timeFrame: 7 weeks
measure: Ongoing pregnancy rate
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Banon Assiut
city: Sohag
country: Egypt
facility: IbnSina IVF Center, IbnSina Hospital
Study officials:
References:
Clinical trial NCT06597292: The VIS Opti-K Low Vision Aid Device Provides Vision Improvement.
Official title: Vision Improvement for Patients With Presbyopia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hyperopia
Presbyopia
Keywords: Vision improvement
Lead sponsor: VIS, Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The VIS Opti-K Low Vision Aid device will be used to provide vision improvement to patients with refractive disorders (hyperopia and presbyopia).


Eligibility criteria: Inclusion Criteria

Subjects who meet all of the following criteria are candidates for this study:

1. Male or Female
2. Any race
3. Patient is at least 40 years old.
4. Patient is pseudophakic or is phakic with no clinically significant cataract in eye(s) to be treated.
5. Patient has manifest refraction, spherical equivalent (MRSE) between -0.50 D to 2.50 D, with no more than 1.0 D of refractive cylinder, in eye(s) to be treated.
6. Patient has uncorrected distance visual acuity (UDVA) of 20/100 or better (i.e., LogMAR ≤ 0.70) in both eyes.
7. Patient has best corrected distance visual acuity (CDVA) of 20/20 or better (i.e., LogMAR ≤ 0.00) in both eyes.
8. Patient has uncorrected near visual acuity (UNVA) between 20/50 (LogMAR 0.40) and better than 20/100 (LogMAR \&lt; 0.70) in eye(s) to be treated.
9. Patient has best corrected near visual acuity (CNVA) of at least 20/20 (LogMAR ≤ 0.00) in eye(s) to be treated.
10. Patient requires reading adds of +1.0 to +3.0 D in eye(s) to be treated.
11. Patient is not a contact lens (CL) wearer.
12. Patient has normal corneal topography.
13. Patient is willing and able to comply with all examinations.
14. Patient must be competent to sign an informed consent form before study entry.

Exclusion Criteria

Subjects who meet any of the following criteria are to be excluded from this study:

1. Corneal disease or corneal disorder in either eye.
2. Any active ocular surface disease of any severity.
3. Increased IOP (above 20 mm Hg), glaucoma or history of glaucoma.
4. Previous corneal surgery in the eye to be treated.
5. Conjunctivochalasis
6. Nystagnus
7. Diabetes
8. Pregnancy
9. Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable as a candidate for study participation or that may confound the outcome of the study.

nclusion Criteria: -

Exclusion Criteria:

-

Primary outcomes:
measure: Uncorrected Distance Visual Acuity (UDVA)
timeFrame: Up to 24 months post-treatment
measure: Uncorrected Near Visual Acuity (UNVA)
timeFrame: Up to 24 months post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: VIS, Inc.
state: Texas
city: Toronto
country: Canada
facility: Clarity Eye Institute
state: Ontario
Study officials:
affiliation: VIS, Inc.
name: Michael Berry, PhD
role: STUDY_DIRECTOR
References: