louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00972439: Oral Contraceptive (OC) Progestin Dose and Breast Proliferation
Official title: Evaluating the Effect of Oral Contraceptive Progestin Dose on Breast Epithelial Cell Proliferation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Contraceptive
Keywords: Oral Contraceptives
Breast Tissue
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2009-09-07
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research study is to gain a better understanding of the changes that may occur in the breast when a woman uses an oral contraceptive (birth control pill). Some research indicates that women who use birth control pills with lower amounts of progestin (a hormone in the birth control pill) may have lower breast cell growth than women who use birth control pills with a higher amount of progestin; this research will examine that in detail.


Eligibility criteria: Inclusion Criteria:

1. Age 18-34.
2. Premenopausal.
3. Currently taking or want to start oral contraceptives for contraception
4. Non-smoker.
5. Competent to give informed consent (as judged by the investigator).
6. Provided written informed consent.
7. Willingness to refrain from smoking and consumption of grapefruit or grapefruit juice during the study (grapefruit interferes with metabolism of exogenously administered OCs).

Exclusion Criteria:1.

1. Abnormal breast examination.
2. History or current therapeutic or prophylactic use of anticoagulants.
3. Known bleeding disorder or history of unexplained bleeding or bruising.
4. History of breast cancer or previous diagnostic breast biopsy.
5. Known allergy to local anesthetic.
6. Currently pregnant or pregnant within the previous 6 months.
7. Having any standard contra-indication to being prescribed OCs.

Primary outcomes:
measure: Breast Cell Proliferation Levels Between the Two Oral Contraceptive Dose Groups
timeFrame: 32 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County Hospital
state: California
Study officials:
affiliation: University of Southern California
name: DeShawn Taylor, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hovanessian-Larsen L, Taylor D, Hawes D, Spicer DV, Press MF, Wu AH, Pike MC, Pearce CL. Lowering oral contraceptive norethindrone dose increases estrogen and progesterone receptor levels with no reduction in proliferation of breast epithelium: a randomized trial. Contraception. 2012 Sep;86(3):238-43. doi: 10.1016/j.contraception.2011.12.015. Epub 2012 Feb 9.
Clinical trial NCT04208139: A Random Selection of Patients From the SENTRY Study Who Have a Bioconverted Sentry IVC Filter in Situ With a Minimum Dwell Time of 24 Months From a Single Center Follow up
Official title: A Random Selection of Patients From the SENTRY Study Who Have a Bioconverted Sentry IVC Filter in Situ With a Minimum Dwell Time of 24 Months From a Single Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Pulmonary Embolism (Disorder)
Lead sponsor: NC Heart and Vascular Research, LLC
Sponsor class: OTHER
Collaborators: name: Novate Medical Limited, a BTG Group Company
First posted: 2019-12-23
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with at least 24 months dwell time will undergo IVUS assessment of the inferior vena cava

Brief summary: IVUS Evaluation of the Bioabsorbable Sentry IVC Filter 3-5 Years Post Deployment Follow up

Detailed description: IVUS Evaluation of the Bioabsorbable Sentry IVC Filter 3-5 Years Post Deployment Follow up

Eligibility criteria: Inclusion Criteria:

* 18 years of age
* Signed the informed consent document
* Participants from the SENTRY clinical trial willing to undergo one time IVUS evaluation ( outpatient )

Exclusion Criteria:

* Any filter that remained non converted.

Primary outcomes:
measure: Patency of the inferior vena cava
timeFrame: 3-5 years
measure: Cylindrical frame integrity
timeFrame: 3-5 years
measure: Impact of the Sentry cylindrical frame on the vessel wall evaluation for endothelialization and neointimal hyperplasia and wall dynamics
timeFrame: 3-5 years
measure: Presence and characterization of adherent thrombus
timeFrame: 3-5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: NC Heart and Vascular Research, LLC
state: North Carolina
Study officials:
References:
Clinical trial NCT02602639: Functional Electrical Stimulation With Rowing as Exercise After Spinal Cord Injury
Official title: Development of a Spinal Cord Injury-specific Exercise-based Capacity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injury
Paraplegia
Tetraplegia
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2015-11-11
Enrollment: 6
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
Primary purpose: PREVENTION

Brief summary: Currently, those with spinal cord injury (SCI) demonstrate increased prevalence of obesity (75%) cardiovascular disease (30 - 50%), type II diabetes (21%) and osteoporosis in the legs (100%) when compared to the general population. It is important to identify the modes and intensities of exercise most likely to generate a reduction in these inactivity-related diseases in this population.

Therefore, the main purpose of this pilot research project is to implement and test a form of a spinal cord injury-specific exercise, known as FES rowing (FES: functional electrical stimulation).


Eligibility criteria: Inclusion Criteria:

* Have a spinal cord injury, C5-T12 (level), AIS A-D (severity)
* Be aged 18-75 for duration of study
* Medically stable and healthy enough to complete exercise requirements
* Willing and able to complete the at-home training requirements as prescribed
* Willing and able to complete the exercise sessions as prescribed
* Willing and able to complete the VO2 testing throughout the study
* Willing and able to complete the DEXA (Dual-energy X-ray absorptiometry) scans during the study
* Able to understand and follow written or verbal instructions from study staff

Exclusion Criteria:

* Current pressure ulcer(s) at sites of electrical stimulation
* Previous spontaneous or low-impact leg fracture
* Previous diagnosis of cardiovascular disease (ie enlarged heart, heart murmur)
* Unsatisfactory results of EKG (electrocardiogram) screening test
* Known thyroid dysfunction
* Kidney disease
* Cancer
* Blood pressure \> 140/90 mmHg
* Currently taking blood pressure medication
* History of epilepsy
* Current hand, arm or shoulder injury
* Current deep vein thrombosis
* Implanted electronic cardiac device (pace maker, defibrillator, etc)
* Ventilator-dependent
* Unable to follow written and verbal instructions

Primary outcomes:
measure: Peak VO2 (volume oxygen) output during exercise
timeFrame: 24 weeks compared to baseline
Secondary outcomes:
measure: Body composition
timeFrame: 24 weeks compared to baseline
measure: Leg EMG (electromyogram) while rowing
timeFrame: Throughout study (up to 36 weeks)
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Kristine Cowley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06370039: Study of INV-102 Ophthalmic Solution in Adults With Moderate to Severe Dry Eye Disease
Official title: Phase 2, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study of INV-102 Ophthalmic Solution in Adult Subjects With Moderate to Severe Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Disease
Keywords: Dry Eye
Keratoconjunctivitis sicca
Lead sponsor: Invirsa, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-17
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase 2 study to assess the efficacy of topically administered eyedrops of INV-102 during 4-week repeat dosing in subjects with moderate to severe dry eye disease.


Eligibility criteria: Key Inclusion Criteria:

* Subjects ≥18 and \<75 years of age
* Presence of moderate to severe dry eye disease (DED) in at least one eye

Key Exclusion Criteria:

* Presently using prescription eyedrops, except those used for dry eye disease, which must be discontinued 4 weeks prior
* Use of over-the-counter (OTC) eyedrops except for lubricant eyedrops or artificial tears, within 1 week prior to initiation of study drug dosing
* History or evidence of ocular infection within the previous 30 days
* Blepharitis or meibomian gland disease requiring the use of either topical or systemic antibiotics within 2 months
* Allergic conjunctivitis requiring treatment within 30 days
* Unable to discontinue contact lens wear for 2 weeks prior and for the duration of the study

Primary outcomes:
measure: Change from Baseline in corneal fluorescein staining total score on the National Eye Institute (NEI)/Industry scale
timeFrame: Baseline to Day 29
Secondary outcomes:
measure: Percentage of eyes with complete clearing of central corneal fluorescein staining
timeFrame: Baseline to Day 29
Other outcomes:
Locations:
city: Rush
country: United States
facility: iuvo BioScience
state: New York
Study officials:
affiliation: Invirsa, Inc.
name: Robert Shalwitz, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00101439: A Study to Evaluate the Effects of Ezetimibe (MK-0653) on the Postprandial (Following a Meal) Lipoprotein Response in Participants With Primary Hypercholesterolemia (High Cholesterol) (MK-0653-072)(COMPLETED)
Official title: A Randomized, Double-Blind, Placebo-Controlled, 2-Period, Crossover Study to Evaluate the Effects of Ezetimibe on the Postprandial Lipoprotein Response in Patients With Primary Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Keywords: Primary Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-01-11
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A study to evaluate the cholesterol-lowering effects of ezetimibe in participants with primary hypercholesterolemia (high cholesterol) after eating a meal that is high in cholesterol. The primary hypothesis is that treatment with ezetimibe 10 mg/day reduces the cholesterol concentration of the chylomicron-containing Sf≥400 fraction following a cholesterol-enriched test meal.


Eligibility criteria: Inclusion Criteria:

* Eligible patients will be otherwise healthy men and women (if not on oral contraceptives or hormone replacement therapy) 18 through 70 years of age with moderately high cholesterol.

Exclusion Criteria:

* Individuals on other lipid-lowering therapy (medicines that lower cholesterol) including statins (within 6 weeks) and fibrates (within 8 weeks) prior to administration of the study drug.

Primary outcomes:
measure: Total Cholesterol Concentration of Chylomicron (Sf≥400) Fractions After a Cholesterol-Rich Test Meal
timeFrame: Immediately prior to consumption of the test meal (baseline) and at 2, 3, 4, and 6 hours after test meal on Day 28 of each treatment period.
Secondary outcomes:
measure: Total Cholesterol Concentration of Chylomicron-remnant (Sf 60-400) Subfractions After a Cholesterol-Rich Test Meal
timeFrame: Immediately prior to consumption of the test meal (baseline) and at 2, 3, 4, and 6 hours after test meal on Day 28 of each treatment period.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05385939: Gastric Bacterial Colonization of Preterm Neonates
Official title: Impact of Transition to a New Single Patient Room NICU on Gastric Bacterial Colonization of Preterm Neonates Compared to a Traditional Open Bay NICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microbial Colonization
Preterm Birth
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
Collaborators: name: University of Delaware
First posted: 2022-05-23
Enrollment: 122
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of infants born at less than 32 weeks born and admitted to the CCHS NICU. Infants in Time period 2 that were admitted to the traditional, open bay NICU will be excluded.

Brief summary: This prospective cohort study was conducted in the Christiana Care Health System Neonatal Intensive Care Unit. It occurred at two time periods: Time period 1 included infants admitted to the traditional, open bay NICU. Time period 2 included infants admitted to the new private, single family room NICU. There was a 3 month period between Time period 1 and Time period 2 to ensure that there was no patient overlap. Stool samples and environmental samples were collected at 1 and 4 weeks after birth in both time periods. The objective of this study was to establish the gastrointestinal microbiome of infants born at less than 32 weeks gestation admitted to the exiting open bay NICU and compare it to the gastrointestinal microbiome of infants born at less than 32 weeks admitted to the new private, single family room NICU.


Eligibility criteria: Inclusion Criteria:

* Less than 32 weeks gestation at birth

Exclusion Criteria:

* Infants in Time period 2 that were admitted to the traditional, open bay NICU

Primary outcomes:
measure: Microorganisms identified in stool samples
timeFrame: 4 weeks
Secondary outcomes:
measure: Microorganisms identified in environmental samples
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health Services, Inc.
state: Delaware
Study officials:
References:
Clinical trial NCT00188539: Cervix:Hypoxia, Interstitial Fluid Pressure and GSH Levels
Official title: Predictive Assays in Cervix Cancer: Assessment of Hypoxia, Interstitial Fluid Pressure, and GSH Levels
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Cervix Neoplasms
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Trials Group
name: Princess Margaret Hospital, Canada
First posted: 2005-09-16
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to measure the oxygen content and interstitial fluid pressure in cervix cancer patients. Tumour oxygen content and internal pressure of tumours may be an important factor that influences the effectiveness of radiotherapy and other treatments.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed patients with carcinoma of the cervix ( 3 cm in size or larger) where an examination under anesthesia is to be performed for staging purposes
* Informed consent

Exclusion Criteria:

* Patients with clinically occult cervix carcinoma

Primary outcomes:
measure: To determine if tumour oxygen tension prior to and during radiation therapy is an independent prognostic factor for primary tumour response and control in patients with cervix cancer.
timeFrame: tumour measurement will be done 2-3 months following completion of treatment; follow-up every 3 months for 2 years; every 4-6 months during year 3 to 5; and annually thereafter
measure: To correlate tumour IFP measured before and during radiation therapy with oxygen tension as measured by the Eppendorf probe and to assess IFP as a prognostic factor for pelvic control.
timeFrame: tumour measurement will be done 2-3 months following completion of treatment; follow-up every 3 months for 2 years; every 4-6 months during year 3 to 5; and annually thereafter
Secondary outcomes:
measure: To determine if whole cell or nuclear GSH levels are correlated with tumour oxygen tension and with tumour response and control.
timeFrame: follow-up every 3 months for 2 years; every 4-6 months during year 3 to 5; and annually thereafter
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Anthony Fyles, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06921239: HLA Antibodies in Systemic Lupus Erythematosus
Official title: HLA Antibodies in Systemic Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HLA Antibodies
Systemic Lupus Erythematosus
Keywords: HLA antibodies
systemic lupus erythematosus
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients Adults - Followed in the internal medicine department of Amiens University Hospital - With systemic lupus erythematosus - Without HLA immunization risk factors (no history of pregnancy, transfusions or transplants) - With sera stored in the biobank

Brief summary: Patients suffering from autoimmune diseases show false-positive results when anti-HLA antibodies are identified. This false positivity makes it difficult to obtain an organ transplant based on immunological compatibility (absence of anti-HLA antibodies directed against graft antigens). The objectives of this project are to study the prevalence of these false positivities in a population of lupus patients, and to evaluate biological tests that can negate these false positivities.


Eligibility criteria: Inclusion Criteria:

* Patients Adults
* Followed in the internal medicine department of Amiens University Hospital - With systemic lupus erythematosus
* Without HLA immunization risk factors (no history of pregnancy, transfusions or transplants)
* With sera stored in the biobank

Exclusion Criteria:

* minor Patients
* Opposing the re-use of their personal data for research purposes

Primary outcomes:
measure: prevalence of unexplained antibody positivity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHRU Amiens
Study officials:
References:
Clinical trial NCT02893839: Evaluation of Allergy to Potato in a Large Cohort
Official title: Study of Sensitization to Potato in Patients Consulting at the Allergy Unit in Montpellier
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergy
Keywords: Allergy
cross-reactivity
oral allergy syndrome
potato
sensitization
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 2000
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patients consulting in the Allergy Unit of the Arnaud de Villeneuve Hospital for whatever suspicion of allergy were asked to participate in the study. Besides a standard battery of respiratory allergens, native raw and cooked potato were tested by means of the prick to prick method, using a metal lancet.


Eligibility criteria: Inclusion criteria:

* patients aged 2 years or older
* consent obtained from patients or their parents/legal representative

Exclusion criteria:

* refusal to participate in the study
* antihistamine drugs taken before testing
* pregnant women
* vulnerable patients according to French regulation

Primary outcomes:
measure: Rate of sensitization and allergy to potato
timeFrame: 35 months after the first inclusion
Secondary outcomes:
measure: Rate of risk factors of sensitization to raw potato
timeFrame: 35 months after the first inclusion
measure: Rate of risk factors of sensitization to cooked potato
timeFrame: 35 months after the first inclusion
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital of Montpellier
Study officials:
References:
Clinical trial NCT04283539: Identification of Pathways to Mitigate Immune-Related Adverse Events With Cancer Immunotherapy
Official title: Identification of Pathways to Mitigate Immune-Related Adverse Events With Cancer Immunotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: checkpoint inhibitor
immuno-oncology
cutaneous adverse events
Lead sponsor: National Jewish Health
Sponsor class: OTHER
Collaborators: name: Memorial Sloan Kettering Cancer Center
First posted: 2020-02-25
Enrollment: 238
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: Adult male or female with diagnosis of solid tumor

Brief summary: This protocol is a prospective, observational study of participants receiving immunotherapy (checkpoint inhibitors, CPI) for cancer therapy, testing the hypothesis that patients with immune related cutaneous adverse events (ircAEs) have unique immunologic endotypes associated with polarized immune responses.


Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, \>18 yo
4. Diagnosis of solid tumor including, but not limited to, genitourinary/gynecologic, lung, gastrointestinal and melanoma
5. Receiving, or prior to starting on, a checkpoint inhibitor
6. Grade ≥ 2 ircAE (CTCAE v 5.0) (for cohort 1 only)
7. An indication for system corticosteroids or biologic therapies as determined by the treating physician (for cohort 1 only)
8. Life expectancy ≥ 12 weeks

Exclusion Criteria:

1. Daily use of systemic steroid treatment in the past 4 weeks (prednisone \>10mg a day or equivalent) except for indications other than the cutaneous adverse event, and/or as an anti-emetic pre- or post-chemotherapy infusions.
2. Enrollment in any investigational drug trial with a drug that has not been approved
3. Taking other checkpoint inhibitors beyond anti-PD-(L)-1 or anti-CTLA-4 not yet indicated/approved for use
4. Pregnancy
5. Known blood borne infectious disease
6. Current or pervious diagnosis of a leukemia or lymphoma
7. Unable to give consent for study participation
8. Life expectancy \< 12 weeks
9. Any other condition or diagnosis in the opinion of the investigator that would interfere with the study results

Primary outcomes:
measure: Immune Biomarkers
timeFrame: 30 days
Secondary outcomes:
measure: Presence of skin and circulating lipid biomarkers which occur during and after ircAEs
timeFrame: 30 days
measure: Mechanisms associated with corticosteroid unresponsiveness in patients with ircAE
timeFrame: 12 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Denver
country: United States
facility: The Melanoma and Skin Cancer Institute
state: Colorado
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
References: