louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01031355: Bioequivalence Study: 3 mg Estradiol Valerate (EV) With and Without Levomefolate Calcium
Official title: Open-label, Randomized, Cross-over Study to Investigate the Bioequivalence of Estradiol Valerate (EV) and Levomefolate Calcium After Single Oral Administration of a Tablet Formulation Containing 3 mg EV Without and With 0.451 mg Levomefolate Calcium and a Tablet Formulation Containing 0.451 mg Levomefolate Calcium in 42 Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Contraception
Ovulation Inhibition
Keywords: Female Contraception
Contraceptives, Oral
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-12-14
Enrollment: 42
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Investigation of the bioequivalence (BE) of Estradiol Valerate (EV) after administration of one film-coated tablet containing 3 mg Estradiol Valerate and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 3 mg Estradiol Valerate Investigation of the bioequivalence of levomefolate calcium after administration of one film-coated tablet containing 3 mg Estradiol Valerate and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 0.451 mg levomefolate calcium


Eligibility criteria: Inclusion Criteria:

* BMI:\>18 \<30 kg/m²
* Healthy female volunteers
* Age 45-75 years
* Postmenopausal state

Exclusion Criteria:

* Contraindications for use of combined (Estradiol Valerate/dienogest) contraceptive (e.g.history of venous/arterial thromboembolic disease)
* Regular intake of medication
* Clinically relevant findings (ECG, blood pressure, physical and gynaecological examination, laboratory examination)
* Smoking

Primary outcomes:
measure: Uncorrected Cmax and AUC(0-tlast) and baseline corrected Cmax and AUC (if possible) for E1, E2, E1S, and L-5- methyl-THF
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Neu-Ulm
country: Germany
state: Bayern
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06460155: CompuFlo CathCheck
Official title: CompuFlo CathCheck; Using Pulse Wave Analysis Versus the Epidurogram for Determining Epidural Catheter Location, A Crossover Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Epidural Placement
Keywords: Epidural
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a prospective diagnostic accuracy study. All participants will undergo all three methods being studied: epidurogram (gold standard), CompuFlo CathCheck, and physical exam in PACU following epidural placement.
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if the Compuflo CathCheck system is equivalent to an epidurogram in determining epidural catheter location (in or outside the epidural space), using the epidurogram as the gold standard. In short, this will be completed by performing an epidurogram (as is standard of practice and the gold standard of determining epidural placement) and compare it to the results of the Compuflo CathCheck system. Equivalency will be summarized through agreement and concordance. Additionally, secondary outcomes will look at how classical physical exam findings to confirm epidural placement correlate and compare to epidurogram and Compuflo CathCheck findings.


Eligibility criteria: Inclusion Criteria:

* Any adult patients (age 18-99 years old) undergoing epidural placement for an operative procedure will be eligible for participation in this study.

Exclusion Criteria:

* All patients unable to receive or who refuse placement of epidural will be excluded
* patients who are unable to consent
* non-English speakers, pregnant individuals)
* Individuals with known or who have an allergic reaction to bupivacaine

Primary outcomes:
measure: CompuFlo's Success
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Aaron Berg
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03665155: First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody
Official title: First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Keywords: 89Zr-DFO-daratumumab
CD38-targeting monoclonal antibody
CT
MR
FDG PET/CT
18-267
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 11
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a phase I/II study with the goal to assess the feasibility of using the anti-CD38 monoclonal antibody daratumumab, labeled with Zirconium-89 (89Zr ) through deferoxamine (DFO), known as 89Zr-DFO-daratumumab, for PET imaging of multiple myeloma.
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to test 89Zr-DFO-daratumumab, a new imaging agent, to demonstrate its safety and ability to take pictures of the myeloma.


Eligibility criteria: Inclusion Criteria:

* Age 21 years or greater
* Histologically/Immunohistochemistry confirmed CD38-positive multiple myeloma
* At least one tumor lesion on CT, MRI, or FDG PET/CT within 60 days of protocol enrollment
* ECOG performance status 0 to 2
* For Phase II patients only: plan for initiation of standard-of-care daratumumab/lenalidomide therapy.

Exclusion Criteria:

* Life expectancy \< 3 months
* Pregnancy or lactation
* Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.
* History of anaphylactic reaction to humanized or human antibodies or a Grade 3 or 4 administration reaction during a daratumumab administration.

Primary outcomes:
measure: Average Absorbed Radiation Dose Estimates for Normal Tissues for Phase I Participants
timeFrame: up to 19 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Slaon-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Gary Ulaner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03576950: Uterine Rupture International Data Acquisition
Official title: Uterine Rupture in Pregnancy: the URIDA (Uterine Rupture International Data Acquisition) Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Uterine Rupture Gravid
Keywords: Uterine rupture
Cesarean section
Labour
Myomectomy
Delivery
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with uterine rupture occurred during pregnancy.

Brief summary: Uterine rupture represents an uncommon event: it is is a life-threatening obstetric complication with high maternal and perinatal morbidity and mortality. Indeed, uterine rupture may cause catastrophic maternal and fetal complications (uterine hemorrhage, hysterectomy with consequent fertility loss, maternal and fetal death or cerebral palsy) which are hardly acceptable within the context of a natural event such as birth.

Uterine rupture can occur during pregnancy, early in labor or following a prolonged labor, most frequently near or at term and, rarely, during early to mid-pregnancy. Its prevalence ranges between 0.006% for women without previous cesarean section (CS) in the western countries, to 25% for women with obstructed labor in African countries.

Pregnancy after myomectomy or CS, vaginal delivery after cesarean sections (VBACs) and vaginal delivery after myomectomy are potentially "at risk" of uterine rupture.

Despite uterine rupture is widely considered a life-threatening condition, so far most of published data refer to case reports or very small case series. In this scenario, the "Uterine Rupture International Data Acquisition" study group would like to collect a large number of events, in order to identify the potential risk factors among different populations through a multivariate analysis.


Eligibility criteria: Inclusion Criteria:

* Women with uterine rupture occurred during pregnancy.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Uterine rupture
timeFrame: A retrospective analysis of 10 years.
Secondary outcomes:
measure: Gestational age at uterine rupture
timeFrame: A retrospective analysis of 10 years.
measure: Parity
timeFrame: A retrospective analysis of 10 years.
measure: Body Mass Index
timeFrame: A retrospective analysis of 10 years.
measure: Presence of myomas
timeFrame: A retrospective analysis of 10 years.
measure: Hysterectomy
timeFrame: A retrospective analysis of 10 years.
measure: Hospital stay
timeFrame: A retrospective analysis of 10 years.
measure: Neonatal complications
timeFrame: A retrospective analysis of 10 years.
Other outcomes:
Locations:
Study officials:
affiliation: U.O. Ginecologia e Ostetricia, Ospedale Vito Fazzi, 73100 Lecce, Italy
name: Andrea Tinelli, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00219050: A Clinical Study to Compare the Safety and Efficacy of an Aliskiren-based Regimen With a Lisinopril Based Regimen in Patients With Severe Hypertension
Official title: An Eight-week, Randomized, Double-blind, Multi-center, Active-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of an Aliskiren-based Regimen Compared to a Lisinopril-based Regimen in Patients With Uncomplicated Severe Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the safety and efficacy of an aliskiren-based regimen to a lisinopril-based regimen in the treatment of severe hypertension


Eligibility criteria: Inclusion Criteria

* Patients with essential severe hypertension Exclusion Criteria
* History or evidence of a secondary form of hypertension
* History of hypertensive encephalopathy or cerebrovascular accident.
* Diabetic patients requiring insulin Other protocol-defined inclusion/exclusion criteria also apply

Primary outcomes:
measure: Evaluate safety through adverse events and laboratory abnormalities after 8 weeks
Secondary outcomes:
measure: Change from baseline in diastolic blood pressure after 8 weeks
measure: Change from baseline in systolic blood pressure after 8 weeks
measure: Change from baseline in standing systolic blood and diastolic pressure after 8 weeks
measure: Diastolic blood pressure is less than 90 mmHg or reduction of 10 mmHg or greater from baseline after 8 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Investigative Site
city: Budapest
country: Hungary
facility: Investigative Site
city: Madrid
country: Spain
facility: Investigative Site
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2.
Clinical trial NCT04791150: Rheumatologic Adverse Events and Cancer Immunotherapy
Official title: Rheumatologic Adverse Events and Immunotherapy in Oncology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oncology
Autoimmunity
Arthritis
Adverse Drug Event
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: In this study, every patient with cancer who is going to be treated by immunotherapy will fill in a form. In this form, we try to determine if he presents rheumatologic complications of his immunotherapy. If the patient answers yes to one question on the form, the patient will be see in rheumatologic consultation to explore his clinical signs.

The number of patients referred in consultation thanks to this questionnaire will be compared to the number of patients who would have been spontaneously referred by the oncologist.

The aim of this questionnaire is to optimise the management of rheumatological effects secondary to immunotherapy.


Eligibility criteria: Inclusion Criteria:

* Patient with cancer needed to be treated by immunotherapy

Exclusion Criteria:

* Patient already treated by immunotherapy

Primary outcomes:
measure: to determine whether a self-questionnaire completed by a patient treated with immunotherapy can identify more patients with rheumatological side effects related to this treatment, compared to the complaint reported by the patient to the oncologist
timeFrame: ONE YEAR
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: C.H.U de Poitiers
Study officials:
References:
Clinical trial NCT02769650: Stress-MRI Assessment After Right Coronary Artery CTO Recanalization
Official title: Clinical Significance of Stress-MRI Evaluation of Right Coronary Artery Chronic Total Occlusion Recanalization Efficacy in Patients With Coronary Artery Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease
Coronary Atherosclerosis
Coronary Artery Disease
Coronary Artery Stenosis
Keywords: Coronary stenosis
Drug-eluting stent
Coronary angioplasty with stenting
Ischemic Heart Disease
Chronic total occlusion
Right coronary artery
Stress-MRI
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2016-05-11
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The hypothesis of this study is that Stress-MRI is a clinically significant method of myocardial perfusion assessment after coronary angioplasty with stenting of right coronary artery (RCA) chronic total occlusion (CTO) is performed.


Eligibility criteria: Inclusion Criteria:

* Stable angina, CCS FC II-IV
* "Right-dominance" coronary circulation according to coronary angiography
* Absence of other significant atherosclerotic coronary lesions (more than 65%)
* High risk of myocardium ischemia according to stress-MRI data (perfusion defect in 2 or more segments in the area of interest)
* Signed, documented informed consent prior to admission to the study

Exclusion Criteria:

* Acute coronary syndrome
* Contraindications for adenosine stress test
* Low and moderate risk of myocardium ischemia according to stress-MRI data (perfusion defect in less than 2 segments in the area of interest)

Primary outcomes:
measure: Stress-MRI evaluation
timeFrame: Within 2 and 12 month after hospitalization
Secondary outcomes:
measure: Clinical assessment
timeFrame: Within 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 moths after hospitalization
measure: Stress-MRI evaluation (2)
timeFrame: Within 2 and 12 month after hospitalization
measure: Major adverse cardiac and cerebrovascular events (MACCE)
timeFrame: During 1 year after first stress-MRI assessment
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of CIrculation Pathology
Study officials:
References:
Clinical trial NCT02005250: Bone Structure and Strength Evaluated by Extreme-CT Scan Before and After Treatment of Hyper- and Hypothyroidism
Official title: Bone Structure and Strength Evaluated by Extreme-CT Scan Before and After Treatment of Hyper- and Hypothyroidism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperthyroidism
Hypothyroidism
Keywords: osteoporosis
hyperthyroidism
hypothyroidism
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 93
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with untreated hyper- or hypothyroidism

Brief summary: The aim to evaluate the bone structure by Dexa-scan, extreme CT and bone markers before and one year after treatment for a thyroid functional disorder

Detailed description: The aim to evaluate the bone structure by Dexa-scan, extreme CT and bone markers before and one year after treatment for a thyroid functional disorder. Women with hyper- og hypothyroidism are included and undergo usual treatment. Patients are stratified into 10 different groups.

Eligibility criteria: Inclusion Criteria:

informed consent, female sex, age 20-85 years, indication for treatment of the thyroid disorder,

Exclusion Criteria:

pregnancy, renal insufficiency, known osteoporosis, other disease that may affect bone metabolism, medication which affects bone metabolism, T-score below -3.5, thyroidea ophthalmopathy with indication for steroids,

Primary outcomes:
measure: Thyroid Extreme CT
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Steen Bonnema, phd, DMsci
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vinther CJ, Poulsen LH, Nicolaisen P, Obling ML, Brix TH, Hermann AP, Hegedus L, Jorgensen NR, Hansen S, Bonnema SJ. Do bone turnover markers reflect changes in bone microarchitecture during treatment of patients with thyroid dysfunction? J Endocrinol Invest. 2023 Feb;46(2):345-358. doi: 10.1007/s40618-022-01907-2. Epub 2022 Sep 5.
citation: Larsen CB, Riis KR, Winther KH, Larsen EL, Ellervik C, Hegedus L, Brix TH, Poulsen HE, Bonnema SJ. Treatment of Hyperthyroidism Reduces Systemic Oxidative Stress, as Measured by Markers of RNA and DNA Damage. J Clin Endocrinol Metab. 2021 Jun 16;106(7):e2512-e2520. doi: 10.1210/clinem/dgab273.
Clinical trial NCT06183450: Hearing and Cognition in Aging Adults
Official title: Hearing and Cognition in Aging Adults
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Presbycusis
Keywords: presbycusis
aging
cognitive decline
speech in noise
sound localisation
hearing loss
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 262
Sex: ALL
Minimum age (years): 45
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult normal hearing subjects aged between 45 and 50 years old.

Brief summary: This cohort study is expected to provide valuable insights into the complex interplay between auditory and cognitive functions and how they change over time. The results of this study will have important implications for the prevention, diagnosis, and treatment of age-related hearing and cognitive disorders

Detailed description: The aim of the study is to identify the early perceptual and cognitive alterations related to age-related hearing loss or presbycusis, establish a correlation between the degree of hearing loss and the deterioration of cognitive functions, and examine the effectiveness of hearing loss management in reversing observed cognitive impairments. This project has the potential to shed light on the importance of early detection of hearing impairments in preventing cognitive decline. The data collected from this cohort, rigorously assessed for both auditory and cognitive functions, could serve as the basis for several high-level scientific investigations.

Eligibility criteria: Inclusion Criteria:

* Normal hearing (Pure Tone Audiometry \< or = 20 dB)
* Residency in one of the three neighborhoods :
* Affiliation with a social security system

Exclusion Criteria:

* Individuals under guardianship, trusteeship or curators
* History of neurological pathologies
* Taking of psychotropic medication.

Primary outcomes:
measure: Pure-ton audiometry
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cahors
country: France
facility: Ecole d'audioprothèse
Study officials:
affiliation: CHU Toulouse
name: Mathieu Marx, Pr
role: PRINCIPAL_INVESTIGATOR
References: