louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06338605: Evaluating the Incidence of Pseudo-Acute Kidney Injuries in Patients With Metastatic Breast Cancer on CDK4/6 Inhibitors Trough Cystatin C Analysis
Official title: Evaluating the Incidence of Pseudo-Acute Kidney Injuries in Patients With Metastatic Breast Cancer on CDK4/6 Inhibitors Trough Cystatin C Analysis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Advanced Breast Cancer
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with metastatic breast cancer that are treated with a CDK4/6 inhibitor (i.e. palbociclib, ribociclib, abemaciclib).

Brief summary: CDK4/6 inhibitors have led to an improvement of both progression free survival (PFS) and overall survival (OS) in patients with advanced estrogen positive (ER+)/HER2- breast cancer when applied in the first or second line of treatment. Despite the advantages of CDK4/6 inhibitors, these medications can lead to adverse effects. One of the adverse events observed across all types of CDK4/6 inhibitors is an elevation in creatinine levels. An elevation in plasma creatinine during treatment with abemaciclib is not always indicative of a reduction in renal function; it can also be attributed to the inhibition of active tubular secretion of creatinine. This phenomenon is known as pseudo acute kidney injury (pseudo-AKI).

The incidence of pseudo-AKI in patients using CDK4/6 inhibitors is currently unknown. A method to distinguish pseudo-AKI from AKI is measuring the level of an alternative filtration marker in blood, for example cystatin C. Cystatin C is also filtered at the glomerulus but not secreted intro the renal tubulus or reabsorbed into the bloodstream. Also, there is no affection by muscle mass or diet. In this study the investigators will explore the incidence of both AKI and pseudo-AKI in patients who are treated with CDK4/6 inhibitor treatment by assessing both creatinine and cystatin C in plasma.


Eligibility criteria: Inclusion Criteria:

* Adult patients who are receiving CDK4/6 inhibitors for metastatic breast cancer
* Patients must have used the CDK4/6 inhibitor for a minimum duration of one month
* Patients must have undergone at least one measurement of creatinine after the initiation of CDK4/6 inhibitor treatment

Exclusion Criteria:

- Patients who are undergoing dialysis therapy for kidney failure.

Primary outcomes:
measure: Pseudo-AKI in patients on CDK4/6 inhibitors
timeFrame: jan-april 2024
Secondary outcomes:
measure: Pseudo-AKI in patients on CDK4/6 inhibitors per drug
timeFrame: jan-april 2024
measure: AKI in patients
timeFrame: jan-april 2024
measure: Influencing factors cystatin C levels
timeFrame: jan-april 2024
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
References:
Clinical trial NCT01306305: A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2010/2011 Influenza Virus Strains for the Northern Hemisphere
Official title: Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2010/2011-season Influenza Vaccine in Elderly and Young Subjects According to European Medicines Agency (EMEA) Regulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Influenza
Virus
Vaccination
Immunisation
Lead sponsor: Crucell Holland BV
Sponsor class: INDUSTRY
First posted: 2011-03-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to assess whether the Northern Hemisphere 2010/2011 season influenza vaccine Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines


Eligibility criteria: Inclusion Criteria:

* Healthy female and male adults
* Aged ≥18 to ≤60 years or \>60 years on Day 1
* Written informed consent

Exclusion Criteria:

* Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
* Acute febrile illness (≥38.0 °C)
* Prior vaccination with an influenza vaccine in the past 330 days
* Known hypersensitivity to any vaccine component
* Previous history of a serious adverse reaction to influenza vaccine
* History of egg protein allergy or severe atopy
* Known blood coagulation disorder
* Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
* Known immunodeficiency (incl. leukemia, cancer, HIV seropositivity)
* Investigational medicinal product received in the past 3 months (90 days)
* Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
* Pregnancy or lactation
* Participation in another clinical trial
* Employee at the investigational site, or relative or spouse of the investigator
* Suspected non-compliance

Primary outcomes:
measure: Seroconversion
timeFrame: Day 22 ± 2 days
measure: Seroprotection
timeFrame: Day 22 ± 2 days
measure: Fold Increase in Geometric Mean Titer (GMT)
timeFrame: Day 22/Day 1
Secondary outcomes:
measure: Safety: Numbers of Subjects Reporting Solicited Local Adverse Events
timeFrame: Days 1 to 4 inclusive, and Days 8, 15 and 22
measure: Numbers of Subjects Reporting Solicited Systemic Adverse Events
timeFrame: Days 1 to 4 inclusive, and Days 8, 15 and 22
Other outcomes:
Locations:
city: Allschwil
country: Switzerland
facility: Covance Clinical Research Unit AG
Study officials:
affiliation: Covance Clinical Research Unit AG
name: Michael Seiberling, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04339205: Diffusion Imaging in Acute Auto-immune Encephalitis
Official title: Diffusion Imaging in Acute Auto-immune Encephalitis : a Cohort of 80 Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Auto-immune Encephalitis
Keywords: MRI
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with auto-immune encephalitis

Brief summary: The aim of this non randomised retrospective study is to investigate the imaging (MRI) of auto-immune encephalitis at presentation, especially in diffusion-weighted sequences.

Indeed, few series describe the MRI aspect of auto-immune at their beginning. Recognize early MRI abnormalities seen in auto-immune encephalitis could help reduce the time to positive diagnosis and improve the therapeutic management.


Eligibility criteria: Inclusion Criteria:

* Auto-immune encephalitis proved by biological results (blood and/or CSF sample)

Exclusion Criteria:

* No MRI available

Primary outcomes:
measure: MRI characterization, especially in Diffusion-weighted magnetic resonance imaging (DWI-MRI), of auto-immune encephalitis at presentation.
timeFrame: at following-up until 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT05804305: Misoprostol for NASH
Official title: Misoprostol for Non-alcoholic Steatohepatitis- a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: NASH
Lead sponsor: Ziauddin University
Sponsor class: OTHER
Collaborators: name: Nabiqasim Industries (Pvt) Ltd
First posted: 2023-04-07
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a double blind randomised control trial to see the effect of Misoprostol in treating patients with NASH
Primary purpose: TREATMENT

Brief summary: The aim of this randomised control trial is to evaluate the effect of Misoprostol in treating patients with NASH.


Eligibility criteria: Inclusion Criteria:

1. Patients between age 25 and 64 years
2. Patients having NAFLD as evident by a radiologic test like ultrasound/fibroscan/CT scan etc.
3. ALT level of 1.5 times ULN
4. If already known case of NAFLD, then patient should be on stable doses of Vitamin E, oral hypoglycemics or anti-lipidemic drugs, with no change in medication during 6 months prior to recruitment.

Exclusion Criteria:

1. Patients with age less than 18 yrs or more than 80 yrs,
2. Women of childbearing age
3. Clinically significant acute or chronic liver disease unrelated to NAFLD
4. Evidence of hepatitis B and C
5. Evidence of primary biliary cirrhosis, primary sclerosing cholangitis, or biliary obstruction
6. Autoimmune hepatitis
7. Drug-induced steatohepatitis (ingestion of drugs known to produce hepatic steatosis including corticosteroids, high-dose estrogens, methotrexate, tetracycline or amiodarone in the previous 6 months)
8. Any cardiovascular event or evidence of active CVS disease
9. Type 1 Diabetes
10. Those consuming alcohol of over 20 grams/day for males and 10 grams/day for females
11. Severe end-organ damage
12. Human immunodeficiency virus (HIV) infection
13. Compensated and decompensated cirrhosis
14. Patients with uncontrolled diabetes
15. Mental instability or incompetence

Primary outcomes:
measure: Change From Baseline in liver function tests
timeFrame: Baseline to 2 Months
measure: Change From Baseline in Interleukin-6 (IL-6)
timeFrame: Baseline to 2 Months
measure: Change From Baseline in endotoxin levels
timeFrame: Baseline to 2 Months
Secondary outcomes:
measure: Change From Baseline in hepatic steatosis
timeFrame: Baseline to 2 Months
measure: Change From Baseline in hepatic fibrosis
timeFrame: Baseline to 2 Months
measure: Change From Baseline in dyslipidemia
timeFrame: Baseline to 2 Months
measure: Change From Baseline in Insulin resistance
timeFrame: Baseline to 2 Months
measure: Incidence of Adverse Events
timeFrame: Baseline to 2 Months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dr. Ziauddin Hospital Clifton
state: Sindh
Study officials:
affiliation: Dr. Ziauddin Hospital Clifton
name: Mehreen Siyal, MBBS, FCPS-1
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01068405: Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo
Official title: Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo - Assessment of Structural and Clinical Action of Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Polyarthritis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2010-02-15
Enrollment: 64
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Interest of methotrexate in inflammatory rheumatisms was demonstrated since several years.

At present time,there is no effective treatment against digital arthritis. The investigators purpose to measure the efficacy of methotrexate on digital arthritis.

In this aim, two groups were compared. The first group receive 10mg/week of methotrexate administered in one shot (every Monday for example)during 12 months. The second group receive 10mg/week of placebo according to the same procedure


Eligibility criteria: Inclusion Criteria:

* hand arthritis
* pain over 40/100
* stable treatment since 4 weeks at least with non-steroid analgesic
* between 45 et 85 years

Exclusion Criteria:

* pregnancy or breast feeding women
* hyaluronic acid injection within the past 6 months
* cortisonic derivated injection within the past 3 months

Primary outcomes:
measure: pain assessed with EVA
timeFrame: at screening visit, inclusion visit, first month, and every month during one year
Secondary outcomes:
measure: Quality of life survey : SF-36
timeFrame: at inclusion visit, first month, and every month during one year
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital, Rheumatology Department
Study officials:
affiliation: Nice University Hospital
name: Christian H ROUX, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferrero S, Wittoek R, Allado E, Cruzel C, Fontas E, Breuil V, Ziegler L, Kremer J, Loeuille D, Roux CH. Methotrexate treatment in hand osteoarthritis refractory to usual treatments: A randomised, double-blind, placebo-controlled trial. Semin Arthritis Rheum. 2021 Aug;51(4):831-838. doi: 10.1016/j.semarthrit.2021.04.016. Epub 2021 May 6.
citation: Allado E, Wittoek R, Albuisson E, Ferrero S, Chenuel B, Chary-Valckenaere I, Roux C, Loeuille D. Topographical analysis of structural lesions between dominant and non-dominant hands in erosive osteoarthritis. Rheumatol Int. 2021 Mar;41(3):617-623. doi: 10.1007/s00296-020-04784-1. Epub 2021 Jan 27.
Clinical trial NCT04908605: Emergence Agitation After Nasal Surgery: a Randomized Controlled Comparison Between Melatonin and Mirtazapine
Official title: Emergence Agitation After Nasal Surgery: a Randomized Controlled Comparison Between Melatonin and Mirtazapine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Agitation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 165
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Emergence agitation (EA) is common after nasal surgery under general anesthesia, which can lead to several problems, such as increased risk of injury to the patient or medical staff, pain, decreased patient satisfaction, hemorrhage, re-bleeding at the operation site and unplanned self-extubation.

Melatonin is an oral or sublingual medication, most commonly used for insomnia and improving sleep in different conditions for example shift-work disorder and for helping people to establish a day and night cycle especially blind children or adults.

Mirtazapine is an antidepressant used in medicine in a pill form, most commonly used for major depressive disorder and other mood disorders, relief of anxiety, panic disorders, insomnia, headache and migraine.


Eligibility criteria: Inclusion Criteria:

1. Patients according to American Society of Anesthesiologists physical status classification (ASA) I or II.
2. Patients according to Mallampati classification I or II.
3. Patients accepting the study and consenting.
4. Undergoing general anesthesia for elective nasal surgery in which nasal packing on each side was used until 24 h after surgery.
5. Body mass index(BMI)\<30

Exclusion Criteria:

1. Patient's refusal.
2. Known allergy to any of the study medications.
3. History of obstructive sleep apnea.
4. History of psychiatric illness or intake of antipsychotics.
5. History of liver impairment.
6. Pregnancy.
7. History of uncontrolled hypertension.
8. History of renal disease.
9. Body mass index (BMI) ≥30 kg/m2.
10. Contraceptive drugs.

Primary outcomes:
measure: Total number of patients with the Riker sedation-agitation score ≥5
timeFrame: 24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain-Shams University Hospitals
Study officials:
References:
Clinical trial NCT01112605: Standard Deviation of the Distance Between the Sural Nerve and Achilles Tendon by Ultrasound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: achilles tendon
sural nerve
distance
US
ultrasound
Distance between Sural nerve and the Achilles tendon
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-04-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: otherwise healthy persones, age 18-60, community sample.

Brief summary: The purpose of this study is to define the standardization of the distance between the Sural nerve \& Achilles tendon, in otherwise healthy persons and athletes.

Detailed description: The distance between the two anatomic structures is measured by US and data is analyzed to define the standardized distance in the population in order to avoid damage to the sural nerve while repairing an Achilles tendon rupture using the percutaneous methode.

Eligibility criteria: Inclusion Criteria:

* healthy
* age 18-60

Exclusion Criteria:

* known bone or muscle disease
* major trauma to the leg or ankle in present or past
* surgery of leg or ankle in the past
* mental disabilities

Primary outcomes:
measure: distance between the Sural nerve & the Achilles tendon
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Omer Mei-Dan, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04761705: Safety and Efficacy Study of JV-GL1 in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official title: A Phase 1/2 Safety and Efficacy Study of JV-GL1 Applied to the Periorbital Skin in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
PHASE2
Conditions: Ocular Hypertension
Open Angle Glaucoma
Keywords: open angle glaucoma
Ocular Hypertension
Lead sponsor: JeniVision, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-21
Enrollment: 70
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: The aim of this research study is to assess the safety and feasibility of lowering intraocular pressure (IOP) using an experimental study drug, JV-GL1.

Detailed description: This is an open-label, dose escalation and dose expansion, study in adult participants with open-angle glaucoma or ocular hypertension. The study is divided into 2 parts:

Part 1 of the study is a dose escalation, sequentially testing escalating doses of JV-GL1.

Part 2 of the study will be randomized 2:2:1 (Experimental Dose A: Experimental Dose B: Active Control), treating additional subjects at the selected JV-GL1 doses or Latanoprost for 28 days.

Eligibility criteria: Inclusion Criteria:

* bilateral open-angle glaucoma or ocular hypertension

Exclusion Criteria:

-

Primary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: From Baseline to Day 28 of Treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
Study officials:
affiliation: Eye Research Foundation, Inc.
name: David Wirta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00564005: Mechanism and Efficacy of Rehabilitation Approaches
Official title: Mechanisms and Long-term Effects of Separate vs. Coupled Rehabilitation Approaches After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accidents
Keywords: stroke rehabilitation
cortical reorganization
kinematic analysis
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
name: National Health Research Institutes, Taiwan
First posted: 2007-11-27
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Identify the possible mechanisms and the relative effectiveness of existing rehabilitation approaches that target upper extremity deficits of stroke patients on the ground that these approaches are based on neuroplasticity principles and sound motor control theories.

Detailed description: Comparisons of constraint-induced therapy (CIT) vs. bilateral arm training (BIT)vs. combined therapy were made. Stroke patients will receive one of these three approaches and be evaluated pre- and post-treatment. the treatment will last 3 weeks and 5 days per week. The evaluation will include clinical measures of motor function, ADL, and quality of life, kinematic performance, and activation patterns of cortex.

Eligibility criteria: Inclusion Criteria:

* a first-ever clinical cerebrovascular accident patients
* at least 6 months post-stroke onset
* premorbid right-hand dominance
* demonstration of Brunnstrom stage III of the affected upper extremity
* no excessive spasticity in the joints of the affected upper extremity

Exclusion Criteria:

* a score of less than 24 on the Mini Mental State Exam
* poor physical conditions that would interfere with participation
* excessive pain in any joint that might limit participation

Primary outcomes:
measure: Cortical reorganization and kinematic analysis
timeFrame: 2008-2010
Secondary outcomes:
measure: clinical measures at the impairment, activity, participation levels
timeFrame: 2008-2010
Other outcomes:
Locations:
city: Kwei-shan
country: Taiwan
facility: Chang Gung Memorial Hospital
state: Toayuan county
Study officials:
affiliation: Department of Occupational Therapy, Chang Gung Univ.
name: Ching-yi Wu, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu CY, Chen YA, Lin KC, Chao CP, Chen YT. Constraint-induced therapy with trunk restraint for improving functional outcomes and trunk-arm control after stroke: a randomized controlled trial. Phys Ther. 2012 Apr;92(4):483-92. doi: 10.2522/ptj.20110213. Epub 2012 Jan 6.