louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05489224: A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis
Official title: A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of Two Intravenous Infusion Formulations of Tocilizumab (CT-P47 and RoActemra) When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2022-08-05
Enrollment: 471
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: TREATMENT

Brief summary: This is a phase 3 study to compare efficacy and safety of CT-P47 and RoActemra in patients with moderate to severe active rheumatoid arthritis.

Detailed description: CT-P47, containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to RoActemra/Actemra. The purpose of this study is to demonstrate similar efficacy and safety of CT-P47 and RoActemra in patients with moderate to severe rheumatoid arthritis when co-administered with methotrexate.

Eligibility criteria: Inclusion Criteria:

1. Patient is male or female aged 18 to 75 years old, both inclusive.
2. Patient has had a diagnosis of RA according to the 2010 ACR/EULAR classification criteria for at least 24 weeks prior to the first administration of the study drug.

Exclusion Criteria:

1. Patient who has previously received investigational or licensed product; targeted synthetic DMARD(s) (e.g., tofacitinib, baricitinib) for the treatment of RA and/or an interleukin-6 (IL-6) inhibitor for any purposes.
2. Patient who has previously received more than 1 biologic agents approved for the treatment of RA.
3. Patient who has allergies to any of the excipients of study drug or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.

Primary outcomes:
measure: Mean Change From Baseline in Disease Activity Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Mean Change From Baseline in DAS28 (ESR) at Week 32
timeFrame: Week 32
measure: ACR20, ACR50, and ACR70 Response Rate at Week 24
timeFrame: Week 24
measure: ACR20, ACR50, and ACR70 Response Rate at Week 32
timeFrame: Week 32
Other outcomes:
Locations:
city: Bialystok
country: Poland
facility: INTER CLINIC Piotr Adrian Klimiuk
Study officials:
affiliation: INTER CLINIC Piotr Adrian Klimiuk
name: Klimiuk Piotr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04648124: VIsual Cerebral ConnecTivity On Functional Magnetic Resonance Imaging in Patients With Hereditary REtinal Dystrophies
Official title: VIsual Cerebral ConnecTivity On Functional Magnetic Resonance Imaging in Patients With Hereditary REtinal Dystrophies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vision Functional Brain Networks in Patients With Hereditary Retinal Dystrophies
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2020-12-01
Enrollment: 200
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 hereditary retinal dystrophies whether or not to undergo implantation surgery

Brief summary: The Rothschild Foundation A Hospital follows a cohort of approximately 300 patients with hereditary retinal dystrophy. These patients are followed in ophthalmology consultation every year. In order to plan the MRI on the day of the annual consultation and to avoid additional travel for patients, patients will be informed of the study before the consultation (transmission of an information letter and the information note from study). If patients agree to participate in the study, rMRI will be scheduled. During the follow-up ophthalmologic consultation, after checking the inclusion and non-inclusion criteria, the study information will be repeated, and patients who still agree to participate will sign the study consent.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years old
* Diagnostic clinique de dystrophie rétinienne héréditaire ou maculopathie héréditaire, syndromique ou non syndromique
* Artificial vision treatment such as a retinal implant, or optogenetics scheduled in the next 6 months
* Express consent to participate in the study
* Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

* Patient benefiting from a legal protection measure
* Pregnant or breastfeeding woman
* Contraindication to MRI (claustrophobia, implanted equipment such as pacemaker).
* Other additional ocular pathology that can significantly affect vision
* Recent eye surgery less than 3 months old

Primary outcomes:
measure: Localization and characterization of neural networks
timeFrame: baseline
measure: Evolution of neuronal networks after retinal implantation
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Adolphe de Rothschild
Study officials:
affiliation: Fondation Ophtalmologique A. de Rothschild
name: Augustin LECLER
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00147524: Non-Comparative Study To Evaluate Changes In FMD After Quinapril Therapy In Hypertensive Women
Official title: Multicenter, Open-Label (Non-Comparative) Study To Evaluate Changes In Flow Mediated Dilatation During And After A 6 Months Treatment Period With Step By Step Increased Doses With Quinapril Therapy In Post-Menopausal Women With Mild Or Moderate Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Menopause
Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-07
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: ACE inhibitors are thought to modify the endothelium in a number of ways. Quinapril is an effective and well-tolerated ACE-I for the treatment of patients with hypertension and congestive heart failure. Quinapril produces favourable haemodynamic changes and improves ventricular and endothelial function in patients with various cardiovascular disorders. These effects are mediated through the binding of quinaprilat to both tissue and plasma-ACE.

Quinapril 10 to 40 mg once daily improved endothelial function (as measured by improved FMD or reduced vasoconstrictive/increased vasodilative response to Ach) in patients with CAD and hypertension over 2 to 6 months of therapy; improved endothelial function was also observed in patients with CHF receiving a single infusion of quinaprilat. In general, quinapril showed neutral or beneficial effects on lipid profiles, glycaemia and renal haemodynamics. (3) There are no data available considering effects of quinapril on endothelial dysfunction in post- menopausal woman with mild to moderate hypertension and with pathological endothelial function.


Eligibility criteria: Inclusion Criteria:

* pathological baseline FMD (\< 5%) at screening
* women in post-menopause at least for 2 years (post-menopausal defined as having amenorrhea for Å' 2 years)
* mild or moderate hypertension (BP \> 140/90 mmHg)

Exclusion Criteria:

* uncontrolled severe hypertension (BP \> 180/110 mmHg)

Primary outcomes:
measure: To evaluate the effect of 10, 20 and 40 mg daily sequential quinapril doses in a 3 x 8 weeks treatment period as changes to baseline pathological FMD.
Secondary outcomes:
measure: 1.In a subgroup of about 30 patients to assess microvascular vasomotor function by laser Doppler (LD) techniques. For all patients: 2.Evaluation of changes of BP parameters. 3.Changes in PAI-1 level. 4.Collect safety data.
Other outcomes:
Locations:
city: Hodmezovasarhely
country: Hungary
facility: Pfizer Investigational Site
state: Csongrad
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Mateszalka
country: Hungary
facility: Pfizer Investigational Site
city: Szeged
country: Hungary
facility: Pfizer Investigational Site
city: Szombathely
country: Hungary
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05602324: Nutritional Supplement for Patients With Severe Infection
Official title: Nutritional Supplement for Patients With Severe Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Infection
Keywords: dyslipidemia
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized trial testing a supplement that has been approved by Health Canada to support healthy cholesterol levels (i.e. high density lipoprotein (HDL) cholesterol). This trial is proposing to use this approved supplement to determine whether it is able to raise HDL cholesterol in patients treated in the intensive care unit (ICU) with severe infection who have detrimentally low levels of HDL cholesterol. Patients who present to the ICU with severe infection will be approached for consent. If they choose to participate, patients will be given usual care or a 150mL daily nutritional supplement containing lauric acid (15 ml) and Berberine (1000 mg) daily for 14 days. Participants will be followed during their stay in the ICU and will receive follow up phone calls at Day 28 and 90.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Sepsis
* plasma high density lipoprotein levels less than 1 mM
* receiving enteral nutrition

Exclusion Criteria:

• known pregnancy/intending to get pregnant within 28 days of enrollment in study

Primary outcomes:
measure: Plasma HDL
timeFrame: 14 days
Secondary outcomes:
measure: WBC
timeFrame: 14 days
measure: Cytokines
timeFrame: 14 days
measure: 28-day survival
timeFrame: 28 days
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St Paul's Hospital
state: British Columbia
Study officials:
References:
Clinical trial NCT04623424: Intestinal Microbiota in Stem Cell Transplant Transplant Admission
Official title: Intestinal Microbiota Alteration by Antibiotics Used During Stem Cell Transplant Admission
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stem Cell Transplant Complications
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: stem cell transplant patients

Brief summary: In this prospective study, the primary objective will be to investigate the association between the use of antibiotics administered during the admission period of Stem cell transplant (SCT) and the rate of overall change in microbiota composition across adjacent samples in time.

Detailed description: Early preclinical studies suggested that intestinal microflora contribute to aGVHD and may be relapse. There is increasing evidence that use of antibiotics may have a detrimental impact on intestinal microbiota composition and, consequently, the outcome of SCT.However, effect on different antibiotic prophylaxis regimens and broad-spectrum antibiotics used during transplant and the intestinal microbiota composition and hence adverse outcomes are not known. Stool samples will be collected from patients who are undergoing SCT at:

1. preconditioning
2. at day 0 (stem cell infusion)
3. once in the period of day + 7-10 post SCT
4. once first day or second day of BMT OPD clinic visit
5. once if they develop \>=grade I GVHD
6. once at time of recovery from GVHD

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-80 years
* patients undergoing allogenic or autologous SCT for malignant hematological conditions or bone marrow failure

Primary outcomes:
measure: Changes in microbiome
timeFrame: Up to 6 months post stem cell transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
affiliation: Henry Ford
name: shatha farhan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05207124: Sarcopenia and Osteopenia in Individuals With Cerebral Palsy and Influences After Botulinum Neurotoxin Type A Injection
Official title: Survey of Sarcopenia and Osteopenia in Individuals With Cerebral Palsy and Examination of Influences After Botulinum Neurotoxin Type A Injection
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cerebral Palsy
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cerebral palsy is vulnerable for osteopenia and sarcopenia

Brief summary: Botulinum neurotoxin type A (BoNT-A) intervention to control the hypertonia of muscles is one of the evidence-based managements for children with spastic cerebral palsy. However, BoNT-A injection in animal models to induce weakness had revealed some detrimental effects on muscular and skeletal systems. There are some objectives of this research. The first aim is to establish the baseline data of deficiencies in bone condition and muscle mass for individuals with cerebral palsy. To confirm the influences of intramuscular administration of Botox on muscular and bony health in this population is the other aim.

Detailed description: Individuals with cerebral palsy is vulnerable to osteopenia and sarcopenia. Botulinum neurotoxin type A (BoNT-A) intervention to control the hypertonia of muscles is one of the evidence-based managements for children with spastic cerebral palsy. However, BoNT-A injection in animal models to induce weakness had revealed some detrimental effects on muscular and skeletal systems. There are some objectives of this research. The first aim is to establish the baseline data of deficiencies in bone condition and muscle mass for individuals with cerebral palsy. To confirm the influences of intramuscular administration of Botox on muscular and bony health in this population is the other aim.

Eligibility criteria: Inclusion Criteria:

1. diagnosis of spastic CP (cerebral palsy)
2. moderate to severe spasticity over the limbs, Modified Ashworth Scale score≧2

Exclusion Criteria:

1. fixed contractures of the limbs
2. previous musculoskeletal surgery on the limbs
3. contraindications to botulinum toxin intervention

Primary outcomes:
measure: DXA (dual-energy x-ray absorptiometry)
timeFrame: change from baseline at 24 weeks after botulinum neurotoxin type A injection
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital
Study officials:
References:
Clinical trial NCT01665924: Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy Subjects
Official title: Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2012-08-16
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the amount of compound present in the blood (pharmacokinetics) after single and of multiple doses of GLPG0634 in elderly healthy subjects.

During the course of the study, the effect of aging on the pharmacokinetics as well as the effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) will be assessed and the safety of multiple oral doses of GLPG0634 in elderly healthy subjects will be characterized.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female, age 40 years and older
* BMI between 18-30 kg/m2

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking

Primary outcomes:
measure: The amount of GLPG0634 in plasma over time after single and multiple doses of GLPG0634
timeFrame: From predose (before first study drug administration) up to 72 hours post last study drug administration
Secondary outcomes:
measure: The amount of GLPG0634 mechanism-of-action-related biomarkers in blood after multiple doses of GLPG0634
timeFrame: From predose (before first study drug administration) up to 24 hours post last study drug administration
measure: Number of adverse events
timeFrame: From screening up to 10 days after the last study drug administration
measure: Changes in vital signs as measured by heart rate, blood pressure and body temperature
timeFrame: From screening up to 10 days after the last study drug administration
measure: Changes in 12-lead ECG measures
timeFrame: From screening up to 10 days after the last study drug administration
measure: Changes in physical exam measures
timeFrame: From screening up to 10 days after the last study drug administration
measure: Changes in blood safety lab parameters
timeFrame: From screening up to 10 days after the last study drug administration
measure: Changes in urine safety lab parameters
timeFrame: From screening up to 10 days after the last study drug administration
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SGS LSS Clinical Pharmacology Unit Antwerp
Study officials:
affiliation: Galapagos NV
name: Frédéric Vanhoutte, MD
role: STUDY_DIRECTOR
affiliation: SGS LSS Clinical Pharmacology Unit Antwerp
name: Magdalena Petkova, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06360224: Collect Flow and Ultrasound Images of Coronary Bypass Grafts
Official title: Collect Flow and Ultrasound Images of Coronary Bypass Grafts
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiac Bypass Surgery (CABG)
Lead sponsor: Medistim ASA
Sponsor class: INDUSTRY
First posted: 2024-04-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for cardiac bypass surgery (CABG) that have signed an informed consent form for this study

Brief summary: This is a post-market observational, non-interventional, multicenter clinical investigation with the purpose of harvesting high quality data from regular cardiac bypass surgery (CABG).


Eligibility criteria: Inclusion Criteria:

* Patient older than 18 years
* Scheduled for CABG
* Understand the nature of the procedure and willingness to comply with the CIP
* Provide written informed consent

Exclusion Criteria:

* Patient younger than 18 years
* Any condition that the investigator believes should exclude participation

Primary outcomes:
measure: Wide and high-quality dataset uploaded to CaseCloud from CABG-procedures.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01498224: ReSure Sealant Pivotal Study
Official title: ReSure Sealant Pivotal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract Surgery Incision Leak
Keywords: Cataract surgery
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-23
Enrollment: 488
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized multicenter study to evaluate the safety and effectiveness of ReSure Sealant compared to sutures for preventing incision leakage within the first 7 days of cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Subject has a cataract and is expected to undergo clear cornea cataract surgery with phacoemulsification and implantation of posterior chamber intraocular lens
* Subject must be 22 years of age or older

Exclusion Criteria:

* Any intraocular inflammation in study eye or presence of ocular pain in operative eye at preoperative assessment
* Previous corneal or retinal surgery or planned multiple procedures during cataract surgery.

Primary outcomes:
measure: Proportion of eyes with any clear corneal incision/suture leakage as determined by positive Seidel test indicating fluid egress within first 7 days after surgery.
timeFrame: Days 1-28
Secondary outcomes:
measure: Foreign Body Sensation
timeFrame: Days 1-28
measure: Best corrected visual acuity
timeFrame: Day 1
measure: Best corrected visual acuity
timeFrame: Day 28
Other outcomes:
measure: Presence of ReSure Sealant or suture(s)
timeFrame: Day 28
measure: Presence of blue colorant in ReSure Sealant
timeFrame: Day 28
measure: Device ease of use
timeFrame: Day 0
measure: Corneal edema at 1 day
timeFrame: Day 1
measure: Anterior chamber inflammation
timeFrame: Day 1
Locations:
city: Jacksonville
country: United States
facility: Levenson Eye Associates
state: Florida
Study officials:
References: