louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01327222: Intravitreal Bevacizumab for Low Vision in Neovascular Age-related Macular Degeneration (AMD)
Official title: Intravitreal Bevacizumab for the Treatment of Patients With Low Vision Due to Neovascular Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Age Related Macular Degeneration
Keywords: age-related macular degeneration
bevacizumab
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2011-04-01
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of intravitreal bevacizumab injection (IVBI) with respect to simple observation in patients with subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD) presenting at baseline with best corrected visual acuity (BCVA) less than 20/200.

Detailed description: There is no clear indication regarding the treatment of patients with subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD) presenting at baseline with best corrected visual acuity (BCVA) less than 20/200.

Treatment of eyes with low visual acuity could lead to a waste of resources, without any functional and social improvements.

Aim of the present study is to compare the effectiveness of intravitreal bevacizumab injection (IVBI) with respect to simple observation in

Eligibility criteria: Inclusion Criteria:

* age-related macular degeneration
* naïve subfoveal choroidal neovascularization
* best-corrected visual acuity less then 20/200

Exclusion Criteria:

* previous treatments
* any other condition able to limit the visual improvement

Primary outcomes:
measure: change in best-corrected visual acuity
timeFrame: 6 months
Secondary outcomes:
measure: change in central macular thickness
timeFrame: 6 months
measure: NEI VFQ-25 scores
timeFrame: 6 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS San Raffaele
state: MI
Study officials:
affiliation: Department of Ophthalmology
name: Francesco Bandello, MD
role: STUDY_CHAIR
References:
citation: Arevalo JF, Sanchez JG, Wu L, Berrocal MH, Alezzandrini AA, Restrepo N, Maia M, Farah ME, Brito M, Diaz-Llopis M, Rodriguez FJ, Reategui G, Iturralde-Iraola J, Udaondo-Mirete P; Pan-American Collaborative Retina Study Group. Intravitreal bevacizumab for subfoveal choroidal neovascularization in age-related macular degeneration at twenty-four months: the Pan-American Collaborative Retina Study. Ophthalmology. 2010 Oct;117(10):1974-81, 1981.e1. doi: 10.1016/j.ophtha.2010.01.056. Epub 2010 May 31.
citation: Parodi MB, Cascavilla M, Papayannis A, Kontadakis DS, Bandello F, Iacono P. Intravitreal bevacizumab in advanced-stage neovascular age-related macular degeneration with visual acuity lower than 20/200. Arch Ophthalmol. 2012 Jul;130(7):934-5. doi: 10.1001/archophthalmol.2011.2617. No abstract available.
Clinical trial NCT02096822: Efficacy of Facilitated Tucking During Pain Procedure in Preterm Infants
Official title: Efficacy of Facilited Tucking and Non-nutritive Sucking of Sterile Water to Relieve Preterm Infants From Pain During Heel-stick Procedures.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facilitated Tucking
Non Nutritive Sucking
Preterm
Pain Relief
Keywords: Facilitated tucking
Non nutritive sucking
Preterm
Pain relief
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 60
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Preterm infants undergo very frequent painful procedures during neonatal care particularly during the first few days. The support for the pain of the preterm is a priority for nurses and neonatologists. Previous studies showed that non-nutritive sucking combined with sucrose ensures effective pain-relief for preterm (28-32 weeks GA). Unfortunately, the use of sucrose is limited to 4 administrations per day which is insufficient compared to the average of daily painful procedures. So, validation of an effective non-pharmacological intervention to relieve or avoid pain is essential. Facilitated tucking alone has been validated for preterm less than 37 GA during heel stick procedure with the PIPP score but no study looks for the benefit for pain relief of the association of non-nutritive sucking and facilitated tucking during heel stick procedure.

Detailed description: After randomization, baby will receive heel stick procedure with either non-nutritive sucking and sterile water or non-nutritive sucking and sterile water combined with facilited tucking. The sequence will be filmed. Evaluation of PIPP and DAN will be done after viewing by 3 independent experts. Each child will receive only one procedure.

Eligibility criteria: Inclusion Criteria:

* Newborn from 28 weeks to 31 weeks +6 days GA.
* Age from 0 to 48 hours of life.
* Admission in intensive care unit or neonatal unit.
* Need for more than 4 heel stick procedures per 24 hours.
* One parents's consent

Exclusion Criteria:

* Hemodynamic instability with initropic drug need.
* Therapeutic Hypothermia in context of neonatal asphyxia.
* Curarized child.
* Neurologic anomaly of contact/tonus.
* Lidocaine application during the 4 hours before the procedure

Primary outcomes:
measure: PIPP (Premature Infant Pain Profile)
timeFrame: 15 sec before to 30 sec after heel-lance procedure
Secondary outcomes:
measure: DAN (Douleur Aigue Nouveau-né)
timeFrame: 15 sec before to 3 min after heel-lance procedure
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital A.Trousseau La roche Guyon
Study officials:
affiliation: Assistance Publique
name: Anne Perroteau, Nurse
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06362122: Anatomo-clinico-biological Profiles in Severe Nasal Polyps
Official title: Anatomo-clinico-biological Profiles in Severe Nasal Polyps
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: NASAL POLYPS
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Nasal sinus polyposis is a chronic inflammatory pathology of the nasal cavity and sinus cavities that causes bilateral and multifocal polyp development and has a prevalence of 2 to 4% in the general population.

Therapeutic management consists of first-line medical treatment for anti-inflammatory purposes. Local corticosteroid therapy, using nasal sprays, is the background treatment. Surgical management is offered to patients in case of failure of medical treatment. Although effective, surgery does not protect patients from recurrence of symptoms related to regrowth of polyps. Recently, biologics have appeared, which despite its effectiveness, about 20% of patients have a partial or no response to these treatments. There is currently no possibility of determining the probability of response to treatments in patients.

It is therefore essential to determine an anatomo-clinico-biological correlation associating the anatomopathological profile, the clinical characteristics and the cytokine signature in order to best guide the patient's management, including the initiation of biotherapy. Indeed, patients, according to their clinical, biological characteristics and the cytokine signature of their polyps will react differently to different treatments, including surgery and biotherapy. This correlation will serve as a predictor of treatment response.


Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 year-old
* Patient with nasal sinus polyposis resistant to medical treatment and requiring surgical treatment with ethmoidectomy type is considered for the first time
* Having signed the consent form
* Having an health insurance

Exclusion Criteria:

* Current or past biotherapy treatment
* Taking general corticosteroid therapy within 4 weeks of surgery
* Protected person
* Pregnant women or lactating women

Primary outcomes:
measure: Identify anatomical profiles present in nasal sinus polyposis resistant to medical treatment.
timeFrame: 1 day
measure: Evaluation of symptoms related to nasal sinus polyposis by visual analogue scale
timeFrame: 1 day
measure: Evaluation to quality of life by Sino-Nasal Outcome Test
timeFrame: 1 day
measure: Identify biological profiles for patients with nasal sinus polyposis
timeFrame: 1 day
measure: Evaluation to cytokine concentration in serum for patients with nasal sinus polyposis
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Chu Poitiers
Study officials:
References:
Clinical trial NCT06306222: Thulium Fiber Laser vs. Holmium:YAG Laser for the Ureteroscopic Treatment of Patients With Urinary Stone Disease
Official title: Comparing the Efficacy of Thulium Fiber Laser vs. Holmium:YAG Laser for the Ureteroscopic Treatment of Patients With Urinary Stone Disease: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Stone
Ureteral Stone
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial which aims to compare the efficacy and safety of Thulium fiber laser (TFL) and holmium:yttrium-aluminum-garnet (Ho:YAG) laser ablation during the treatment of upper urinary tract stone disease with flexible ureteroscopy, demonstrating clinical superiority of TFL.


Eligibility criteria: Inclusion Criteria:

* Renal/ureteral stones \> 4 mm

Exclusion Criteria:

* Anatomical abnormalities

Primary outcomes:
measure: Lithotripsy speed
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Stone free rate
timeFrame: 3 months after the procedure
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References:
Clinical trial NCT03600922: Clinical Study of Patellar Resurfacing and Non-resurfacing in Total Knee Arthroplasty
Official title: A Prospective Randomized Clinical Study of Patellar Resurfacing and Non-resurfacing in One-stage Bilateral Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: Osteoarthritis
Patellar resurfacing
Anterior knee pain
Lead sponsor: Liaocheng People's Hospital
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 66
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The literature regarding resurfacing of the patella in total knee arthroplasty has conflicting conclusions. This study assesses medium-term clinical results of total knee arthroplasties performed with and without the patellar resurfacing in patients undergoing single-staged bilateral total knee arthroplasty in a randomized controlled, clinical study at a minimum of 5 years follow-up.

Detailed description: Sixty-six patients (132 knees) underwent primary single-staged bilateral total knee arthroplasty for osteoarthritis. Patients were randomized to receive resurfacing or retention of the patella. All patients received the Scorpio NRG knee prosthesis. Evaluations were done preoperatively and yearly, up to a minimum of 5 years postoperatively. Knee Society Score and Feller Score outcomes were measured. Anterior knee pain, the clunk of patella, and patient satisfaction questionnaires were completed.

Eligibility criteria: Inclusion Criteria:

* degenerative OA
* 50-75 years
* All patients with OA were bilateral knee OA

Exclusion Criteria:

* previous patellectomy
* inflammatory arthritis
* patellar fracture
* patellar instability
* previous extensor mechanism procedures
* high tibial osteotomy,
* severe valgus or varus deformity (\> 20°), severe flexion contracture (\> 30°)
* previous unicondylar knee replacement
* a history of septic arthritis or osteomyelitis.

Primary outcomes:
measure: Change From Baseline in the Feller score
timeFrame: Baseline,1,2,3,4 and 5 years
measure: Change From Baseline in visual analogue scale (VAS)
timeFrame: Baseline,1,2,3,4 and 5 years
measure: Change From Baseline in knee society score ( KSS)
timeFrame: Baseline,1,2,3,4 and 5 years
measure: Change From Baseline in anteroposterior long weight-bearing X-ray
timeFrame: Baseline,1,2,3,4 and 5 years
measure: Change From Baseline in MOS item short from health survey(SF-36)
timeFrame: Baseline,1,2,3,4 and 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ha C, Wang B, Li W, Sun K, Wang D, Li Q. Resurfacing versus not-resurfacing the patella in one-stage bilateral total knee arthroplasty: a prospective randomized clinical trial. Int Orthop. 2019 Nov;43(11):2519-2527. doi: 10.1007/s00264-019-04361-7. Epub 2019 Jun 21.
Clinical trial NCT00405522: Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children
Official title: Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children: Evaluation of Two Dose Combinations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spinal Puncture
Keywords: Lumbar Puncture
Pediatrics
Propofol
Remifentanil
sedation
Oncology
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2006-11-30
Enrollment: 34
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare intraoperative and recovery parameters in patients who receive two different dose combinations of propofol and remifentanil in patients undergoing a lumbar puncture.

Detailed description: Lumbar punctures (LP) are performed in approximately one thousand oncology patients per year at the Hospital for Sick Children. In a previous study, we determined the optimal dose of remifentanil which provides effective anesthesia with little or no movement during LP in children. The present study will determine the optimal dose combination of propofol and remifentanil to keep patients comfortable and still during the procedure while decreasing the incidence of side effects and allows for shorter recovery times and earlier discharge from the recovery room.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of a hemato-oncological disorder
* Scheduled to undergo a lumbar puncture
* Aged 3-12 years
* Unpremedicated

Exclusion Criteria:

* children who are known or suspected to be difficult to ventilate by face mask
* children who are deemed medically unfit to receive either of the two study medications
* children who are obese (weight for height \> 95th percentile)
* children who do not have an indwelling intravenous line

Primary outcomes:
measure: Duration of Apnea
timeFrame: This outcome was measured for the duration of the procedure (lumbar puncture).
measure: Duration of Postoperative Recovery (Time to Spontaneous Eye Opening, Verbalization, Purposeful Movement).
timeFrame: This outcome was measured for the duration of the recovery phase.
Secondary outcomes:
measure: Incidence of Adverse Events and Clinically Significant Changes in Routine Vital Signs as Measured by Electrocardiogram, Non-invasive Blood Pressure, and Pulse Oximeter.
timeFrame: This outcome was measured for the duration of the procedure (lumbar puncture).
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Jason Hayes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01454622: A Study to Assess the Bioequivalence of 2 Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) (50 mg/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin IR Tablets (2 x 1,000 mg) in Healthy Volunteers
Official title: A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 FDC Tablets of Canagliflozin and Metformin IR (50 mg/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin IR Tablets (2 x 1,000 mg) in Healthy Fed Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteers
Bioequivalence
Canagliflozin (JNJ-28431754)
Metformin IR
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2011-10-19
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and metformin IR.

Detailed description: This is an open-label (identity of study drug will be known to volunteer and study staff), single-center study to evaluate the bioequivalence of canagliflozin and metformin IR when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin IR) (Treatment A) and when administered as fixed-dose combination (FDC) tablets (ie, canagliflozin and metformin IR contained in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive Treatment A followed by Treatment B or Treatment B followed by Treatment A with a washout period of approximately 15 days between treatments.

Eligibility criteria: Inclusion Criteria:

- Body mass index (BMI) between 18.5 and 30 kg/m² (inclusive) and a body weight of not less than 50 kg

Exclusion Criteria:

* History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) deemed to be clinically significant by the Investigator

Primary outcomes:
measure: Canagliflozin plasma concentrations
timeFrame: Up to 72 hours
measure: Metformin plasma concentrations
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Adverse Events
timeFrame: Up to approxmately 23 days
measure: Clinical laboratory tests
timeFrame: Up to approximately 23 days
measure: Vital signs
timeFrame: Up to approximately 23 days
Other outcomes:
Locations:
city: Tempe
country: United States
state: Arizona
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research and Development, L.L.C Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT04695522: ADR-002K for Patients With Ischemic Cardiomyopathy Who Undergo Coronary Artery Bypass Surgery
Official title: Phase I Trial of ADR-002K for Patients With Ischemic Cardiomyopathy Who Undergo Coronary Artery Bypass Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: D017202
Keywords: Coronary artery bypass
Ischemic cardiomyopathy
Adipose-derived mesenchymal stem cells
Regenerative medicine
Spray method
Lead sponsor: Osaka University
Sponsor class: OTHER
Collaborators: name: Rohto Pharmaceutical Co., Ltd.
First posted: 2021-01-05
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ischemic cardiomyopathy undergoing coronary artery bypass surgery


Eligibility criteria: Inclusion Criteria:

1. Patients who are clinically diagnosed with ischemic cardiomyopathy and receive CABG
2. Patients with a left ventricular ejection fraction of 40% or less by cardiac ultrasonography within 4 weeks before obtaining consent
3. Others

Exclusion Criteria:

1. Patients who have a combination of cardiovascular disease such as severe organic valvular disease or aortic aneurysm determined by investigator or co-investigator to affect clinical trial procedure
2. Patients whose participation in a clinical trial is considered inappropriate at the discretion of the investigator or co-investigator
3. Others

Primary outcomes:
measure: Number of participants with Adverse event
timeFrame: 26 weeks
measure: Amount of change in late gadolinium contrast-enhanced area at the time of screening and 6 months after surgery
timeFrame: 26 weeks
measure: Number of complication associated with drug administration method
timeFrame: 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
Study officials:
affiliation: Osaka University Hospital
name: Daisuke Mori, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: