louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05749094: Optic Nerve Sheath Ultrasound in Giant Cell Arteritis
Official title: The Sonographic Assessment of the Optic Nerve Sheath in Giant Cell Arteritis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Giant Cell Arteritis
Anterior Ischemic Optic Neuropathy
Optic Neuropathy, Ischemic
Lead sponsor: Hopital du Sacre-Coeur de Montreal
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 260
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive participants referred for suspected GCA.

Brief summary: The Sonographic Assessment of the Optic Nerve Sheath in GCA (SONIC-GCA) study will: 1) assess the performance, in terms of sensitivity and specificity, of the optic nerve sheath diameter (ONSD) to detect new-onset, active GCA; 2) evaluate the intra- and interobserver reliability of ONSD measures; 3) establish if an association exists between the ONSD and the presence of GCA retinal findings; and 4) evaluate if the ONSD is a dynamic biomarker of GCA remission and relapse.

Detailed description: SONIC-GCA is a prospective cohort and validation study conducted in centers of the Canadian Vasculitis Research Network (CanVasc).

Eligibility criteria: Inclusion criteria are:

1. adult patient aged \> 50 years;
2. referred for suspected, new-onset cranial GCA;
3. ability to understand and provide a written informed consent.

Exclusion criteria:

1. referral for a suspected GCA relapse;
2. current use of systemic glucocorticoids for ≥ 14 consecutive days in the previous 30 days;
3. known previous medical history of conditions which may affect the ONSD, such as optic nerve diseases, demyelinating diseases, or any conditions associated with intracranial hypertension;
4. known underlying condition that impairs the ability to perform optic nerve sheath ultrasound or fundoscopy.

Primary outcomes:
measure: Mean difference in ONSD on ultrasound between participants with and without GCA
timeFrame: Baseline
Secondary outcomes:
measure: Performance of the ONSD on ultrasound to identify GCA, in terms of sensitivity, specificity, positive and negative predictive values, and accuracy.
timeFrame: Baseline
measure: The Paired mean difference in ONSD during the follow-up period, based on changes in disease activity in GCA patients-from new-onset disease to clinical remission and from clinical remission to the first relapse (if any).
timeFrame: Months 3 - 24
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal
state: Quebec
Study officials:
affiliation: Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal, University of Montreal
name: Jean-Paul Makhzoum, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02660294: Intrauterine Autologous PRP Infusion Compared to HRT for Enhancing Endometrial Thickness in Patients Undergoing ICSI
Official title: Intrauterine Autologous Platelet -Enriched Plasma Infusion Compared to Hormonal Replacement Therapy for Enhancing Endometrial Thickness in Patients Undergoing ICSI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Infertility
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-01-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Successful embryo implantation needs an optimum embryonic development with a receptive endometrium. Endometrial thickness is an independant factor for endometrial receiptivity. The aim of that trial is to assess the benefecial effect of platelt rich plasma in copmarison with standard hormonal therapy.

Detailed description: This is a single blinded randomized trial comparing the effect of of platlet rich plasma versus hormonal therapy on endometrial thickness and consequently endometrial receptivity. The primary endpoint of this trial is clinical pregnancy rate.

Eligibility criteria: Inclusion Criteria:

* patients undergoing ICSI
* endometrial thickness less than 7 mm on early follicular phase

Exclusion Criteria:

-

Primary outcomes:
measure: endometrial thickness in mm
timeFrame: 72 hours
Secondary outcomes:
measure: clinical pregnancy rate
timeFrame: 4 weeks after embryo transfer
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Rasha
state: Al Qahirah
Study officials:
affiliation: Ain Shams University
name: RASHA DR MEDHAT, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03969394: The Prognostic Role of the Right Ventricle in Patients With Heart Failure or Congenital Heart Disease
Official title: The Prognostic Role of the Right Ventricle in Patients With Heart Failure or Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: strain
MRI
echocardiography
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Fonds National de la Recherche Scientifique
First posted: 2019-05-31
Enrollment: 100
Sex: ALL
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 objectives are

1. to validate quantification of 2D and 3D right ventricular strian measurements of right ventricular performance in cross comparison to cardiac MRI and to evaluate its relation to right ventricular fibrosis.
2. to evaluate their prognostic value in patients with heart failure with either depressed or preserved ejection fraction.


Eligibility criteria: Inclusion Criteria:

* Adult Patients with heart failure

Exclusion Criteria:

* Renal failure
* Contraindications to Cardiac MRI

Primary outcomes:
measure: overall survival
timeFrame: 3 years
Secondary outcomes:
measure: Heart Failure
timeFrame: 3 years
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Bernhard Gerber, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Houard L, Amzulescu MS, Colin G, Langet H, Militaru S, Rousseau MF, Ahn SA, Vanoverschelde JJ, Pouleur AC, Gerber BL. Prognostic Value of Pulmonary Transit Time by Cardiac Magnetic Resonance on Mortality and Heart Failure Hospitalization in Patients With Advanced Heart Failure and Reduced Ejection Fraction. Circ Cardiovasc Imaging. 2021 Jan;14(1):e011680. doi: 10.1161/CIRCIMAGING.120.011680. Epub 2021 Jan 13.
Clinical trial NCT02853994: Safety and Efficacy of the DEVOIR Sirolimus-Coated Coronary Balloon in the Real-world Clinical Practice
Official title: Assessment of Safety and Efficacy of the DEVOIR Sirolimus-Coated Balloon for the Treatment of Native Coronary Artery Lesions in the Real-world Clinical Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: CAD
Keywords: DCB
DEB
Sirolimus
PCI
ISR
SVD
Restenosis
Bifurcation
CAD
Coronary artery
Lead sponsor: MINVASYS
Sponsor class: INDUSTRY
First posted: 2016-08-03
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: Patients with coronary artery diseases (in-stent restenosis, small vessel diseases, bifurcation lesions, de novo lesions)

Brief summary: The study is a prospective, non-randomized, multicenter, post-marketing surveillance study evaluating the CE-marked DEVOIR Sirolimus-Coated Coronary Balloon in 4 subgroups regarding device approved indications:

* In-stent restenosis lesions: either bare metal or drug eluting stent restenosis
* Bifurcation lesions (with drug-eluting stent in main branch and drug-coated balloon in side branch): treatment of lesion of all Medina types except (0,0,1) in native coronary arteries
* Small vessels: treatment of lesions ≤2.75 mm
* BMS implantation followed by DCB inflation


Eligibility criteria: Patient's inclusion and exclusion criteria are per device instructions for use's indications and contraindications.

Inclusion criteria:

1. Patient is at least 18 years old
2. Lesion lengths ranging from 8 to 38 mm and diameters ranging from 1.50 mm to 4.00 mm.

Exclusion criteria:

1. Patients with a hypersensitivity to Sirolimus drug or its structural activity related compounds.
2. Patients with a known hypersensitivity to excipients with phospholipid or related origins.
3. Patients whose diseased segment cannot be pre-dilated or prepared before drug coated balloon treatment.
4. Severely calcified lesions requiring treatment of other type for e.g. Rotational Atherectomy (Rotablator)
5. Patients judged to have lesion that prevents complete inflation of angioplasty balloon or proper placement of delivery catheter
6. Patients who cannot receive recommended antiplatelet or anticoagulation therapy.

Primary outcomes:
measure: Rate of Major Adverse Cardiac Events (MACE)
timeFrame: 12 months
Secondary outcomes:
measure: Rate of Target Lesion Revascularization (TLR)
timeFrame: 12 months
measure: Rate of Target Vessel Failure (TVF)
timeFrame: 12 months
measure: Rate of Target Vessel Revascularization (TVR)
timeFrame: 12 months
measure: Angiographic success
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00721994: Post-PMA Approval Study: 10 Year Follow-Up IDE Subjects
Official title: Cormet Resurfacing Hip System Post PMA Approval Study (PMA #P050016)Pre-market (IDE) Study Group 10 Year Follow-Up With Metal Ion and Renal Function Data Collection Clinical Investigation Plan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Avascular Necrosis
Rheumatoid Arthritis
Keywords: hip resurfacing
osteoarthritis
avascular necrosis
rheumatoid arthritis
Lead sponsor: Corin
Sponsor class: INDUSTRY
First posted: 2008-07-25
Enrollment: 231
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IDE study subjects at 5 IDE study sites

Brief summary: primary endpoint of this Study is maintenance of "at least good clinical status" for a period of 10 years following initial implantation among Cormet procedures enrolled inthe pre-market IDE.

Detailed description: Maintaining "at least good clinical status" will be determined based upon the composite clinical success (CCS) criterion which includes no revision, removal, or replacement of any device component and a Harris Hip Total score of greater or equal to 80 points.

Eligibility criteria: Inclusion Criteria:

* subjects enrolled in the Cormet IDE study at the 5 identified clinical sites
* Individuals who agree to participate in the study by signing the informed patient consent form

Exclusion Criteria:

* none

Primary outcomes:
measure: to monitor the clinical performance of the Cormet implant system for a period of up to 10 years postoperative in order to confirm that there are no unexpected reductions in device performance following PMA approval
timeFrame: 10 years
Secondary outcomes:
measure: Harris Hip Score components including total score, pain, function and range of motion
timeFrame: 10 years
measure: device survival
timeFrame: 10 years
measure: device related adverse events
timeFrame: 10 years
measure: radiographic evaluation including radiolucencies, component migration, and femoral subsidence and tilt
timeFrame: 10 years
measure: whole blood trace metals and renal function
timeFrame: 10 years
Other outcomes:
Locations:
city: Merritt Island
country: United States
facility: Space Coast Orthopaedics Ctr.
state: Florida
city: Sarasota
country: United States
facility: Kennedy White Orthopedics
state: Florida
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Baltimore
country: United States
facility: Good Samaritan Hospital
state: Maryland
city: Cleveland
country: United States
facility: Cleveland Center for Joint Reconstruction
state: Ohio
Study officials:
affiliation: Corin
name: Kathy Trier, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00140894: A Study of Rofecoxib in Familial Adenomatous Polyposis (FAP) (0966-205)(TERMINATED)
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Rofecoxib in Familial Adenomatous Polyposis (FAP)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Adenomatous Polyposis Coli
Keywords: Osteoarthritis
Cancer Pain
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 62
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: A study to evaluate rofecoxib in the treatment of rectal, colon, or duodenal adenomas in patients with Familial Adenomatous Polyposis.


Eligibility criteria: Inclusion Criteria:

* Males or females at least 18 years of age with familial adenomatous polyposis.

Primary outcomes:
measure: Number and average size of rectal polyps
measure: Safety and tolerability
Secondary outcomes:
measure: Number and average size of duodenal polyps
measure: Proportions of patients with improved overall colon rating
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT07016594: Acute Cardiovascular Responses to Two Types of Exercise
Official title: The Effect of Aerobic Exercise With and Without Neuromuscular Electrical Stimulation on Acute Cardiovascular Responses Between Biological Sexes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aerobic Exercise
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research was to explore potential differences in acute cardiovascular responses between two conditions: 1) moderate-intensity cycle ergometer exercise; and 2) moderate-intensity cycle ergometer exercise with NMES. Young, healthy, physically active participants were recruited for this study.


Eligibility criteria: Inclusion Criteria:

* healthy
* performing aerobic activity greater than or equal to three times per week at any intensity

Exclusion Criteria:

* had lower body musculoskeletal injuries recently (within the past 6 months)
* health conditions that may place risk to the individual such as those with respiratory issues, hypertension, chronic atrial fibrillation, valvular diseases, heart disease; or obstructive cardiomyopathy
* if taking pharmacological drugs, performance-enhancing drugs, recreational drugs, nutritional supplements, or smoked nicotine

Primary outcomes:
measure: Oxygen consumption
timeFrame: 20 minutes
Secondary outcomes:
measure: Carbon dioxide production
timeFrame: 20 minutes
measure: Heart rate
timeFrame: 20 minutes
measure: Respiratory exchange ratio
timeFrame: 20 minutes
measure: Rating of perceived exertion
timeFrame: 20 minutes
measure: Kilocalories utilized
timeFrame: 20 minutes
measure: Carbohydrate utilized
timeFrame: 20 minutes
measure: Fats utilized
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Active Living Centre/Applied Research Centre
state: Manitoba
Study officials:
References:
Clinical trial NCT04928794: Thermal-Imaging Comparison of Nerve Blocks for Bilateral Mastectomy
Official title: Dermatomal Spread of Paravertebral and Erector Spinae Plane Nerve Blocks as Compared by Thermal Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Conduction
Keywords: Paravertebral nerve block
Erector Spinae Plane block
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a one-armed trial of two regional anesthesia (peripheral nerve block) techniques to provide postoperative analgesia after bilateral mastectomy. The two techniques are paravertebral block and erector spinae plane (ESP) block. Patients will serve as their own controls, with one block technique applied on one side of the body and the other technique contralaterally. Anatomical distribution of block effectiveness will be assessed with thermal imaging, and this distribution will be visually compared between the two techniques.


Eligibility criteria: Inclusion Criteria:

* Adult female patients having bilateral mastectomy surgery at University of New Mexico Outpatient Surgical and Imaging Services (OSIS) facility
* Age \>18 years
* Consenting to regional anesthesia for postoperative pain control

Exclusion Criteria:

* Age \<18 years
* Unable to consent
* Using anticoagulant medication or have a bleeding disorder
* Pregnancy
* Inability to speak English for consent process

Primary outcomes:
measure: Skin Temperature Increase From Baseline
timeFrame: 30 minutes
Secondary outcomes:
measure: Average Skin Temperature
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Outpatient Surgical and Imaging Services
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Mary Billstrand, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00347594: A Clinical Evaluation of the Next Generation Diagnostic Instrument (NGDI)
Official title: A Clinical Evaluation of the Next Generation Diagnostic Instrument (NGDI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Corneal surface topography
Ocular aberrations
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 76
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to measure the aberrations, corneal surface topography and pachymetry of normal human eyes with the NGDI.


Eligibility criteria: Inclusion Criteria:

* +10.00D to -20.00D of absolute spherical ametropia
* Must be part of the Bausch \& Lomb research clinic
* Snellen visual acuity must be correctable to 20/25

Exclusion Criteria:

* No more than -6.00D of refractive astigmatism

Primary outcomes:
measure: Measurement of aberrations with the NGDI and the Zywave II.
timeFrame: Single visit
Secondary outcomes:
measure: Measurement of corneal topography and pachymetry with the NGDI and the Orbscan IIz.
timeFrame: Single visit
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Michele Lagana
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01852994: Exercise Training and Testosterone Replacement in Heart Failure Patients
Official title: Exercise Training and Testosterone Replacement in Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2013-05-14
Enrollment: 39
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if exercise training with or without testosterone replacement can improve cardiopathy in heart failure patients

Detailed description: In this study, we are evaluating:

* hospital length of stay and readmission
* muscle sympathetic nerve activity
* functional capacity
* body composition

Eligibility criteria: Inclusion Criteria:

* heart failure
* hypogonadism
* left ventricular fraction ejection \< 45%

Exclusion Criteria:

* chronic renal failure
* normal testosterone
* pace maker

Primary outcomes:
measure: Microneurography
timeFrame: 4 months of exercise training/testosterone replacement
measure: Forearm blood flow
timeFrame: 4 months of exercise training/testosterone replacement
Secondary outcomes:
measure: Cardiopulmonary exercise
timeFrame: 4 months of exercise training/testosterone replacement
measure: Body composition
timeFrame: 4 months of exercise training/testosterone replacement
measure: Muscle biopsy
timeFrame: 4 months of exercise training/testosterone replacement
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Coração do Hospital da Clínicas da Universidade de Sao Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Maria Janieire N Alves, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References: