louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06860711: Safety of Short-course of NSAIDs in Pediatric Patients With CKD
Official title: Safety of Short-term NSAID Use in the Postoperative Setting in Pediatric Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Chronic Kidney Disease
Pediatric Urology
Keywords: NSAIDs
CKD
Pediatrics
Urology
post-surgical
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if non-steroidal anti-inflammatory (NSAID) use in the postoperative setting increases the risk of acute kidney injury (AKI) in pediatric patients with mild-to-moderate chronic kidney disease (CKD). The investigators hypothesize that there is no increased risk. This will be a limited pilot study within a Pediatric Urology population, intended to inform future work in a larger patient population.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 months of age
* diagnosis of CKD stages 2-3a, confirmed by cystatin C laboratory testing within 6 months of surgery

Exclusion Criteria:

* diagnosis of CKD stage 1 or 4-5
* home medications of angiotensin converting enzyme inhibitors (ACEi, such as lisinopril or captopril) or angiotensin receptor blocker (ARB, such as losartan, valsartan) diuretics, or trimethoprim
* IV contrast in last 30 days
* PMH of renal transplant, diabetes, hypertension, nephrotic syndrome or heart failure, asthma, or hyperthyroidism
* history of hyperkalemia
* recent glucocorticoid exposure
* procedure for oncologic indications
* ongoing viral or fungal infection, or chemotherapy
* allergy to NSAIDs

Primary outcomes:
measure: Frequency of Acute Kidney Injury
timeFrame: From start of intervention, through 7 days later
Secondary outcomes:
measure: Opiates received while inpatient
timeFrame: From start of intervention, through 7 days later
measure: Days with elevated pain score
timeFrame: From start of intervention, through 7 days later
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Kyle Rove, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ha D, Halstead NV, Blanchette ED, Wilcox DT, Vemulakonda VM, Wood DN, Rove KO. Risk of acute kidney injury after lower urinary tract reconstruction with early NSAID therapy: A propensity matched retrospective analysis. J Pediatr Urol. 2024 Oct;20(5):911-920. doi: 10.1016/j.jpurol.2024.07.005. Epub 2024 Jul 16.
Clinical trial NCT01842711: Cumulative Irritation Patch Test
Official title: Exclusive Cumulative Irritation Patch Test (21 Day) With Challenge Patch Application
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergy
Irritation
Sensitization
Lead sponsor: Chattem, Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-30
Enrollment: 224
Sex: ALL
Minimum age (years): 16
Maximum age (years): 79
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 240 subjects will be enrolled in the trial so that at least 200 subjects will complete the trial. Subjects who meet all of the inclusion criteria and none of the exclusion criteria will be eligible to enroll into the trial.

Brief summary: A Cumulative Patch Test with a Challenge Phase is a test devised to ascertain if a chemical agent or agents have the potential to cause contact irritation or contact allergy in the skin. Allergy is only elicited in immunologically competent individuals who have become sensitized through exposure to the chemical agent at a sufficient concentration and for a sufficient duration of time.


Eligibility criteria: Inclusion Criteria:

* Subjects must not have any visible skin disease that might be confused with a skin reaction to the test trial;
* Subjects must not be participating in another clinical trial at this facility or any other facility;
* Subjects must be willing to avoid using topical or systemic steroids or antihistamines for at least 7 days prior to trial initiation and during the duration of the trial;
* Subjects must understand and execute and Informed Consent Form;
* Subjects must be capable of understanding and following directions;
* Subjects must be considered reliable;
* Subjects must be aged 16 to 79 years, inclusive;
* Subjects aged less than 18 years must have a parent or legal guardian execute the Informed Consent Form.

Exclusion Criteria:

* Subjects in ill health or taking medications, other than birth control, which could influence the purpose, integrity or outcome of the trial;
* Female subjects who report orally they are pregnant, planning to become pregnant or nursing during the course of the trial;
* Subjects who have a history of adverse reactions to adhesive tape, cosmetics, Over-The-Counter drugs or other personal care products;
* Subjects judged by the PI to be inappropriate for the trial.

Primary outcomes:
measure: Primary or Cumulative Irritation Potential of the skin
timeFrame: 21 days
Secondary outcomes:
measure: Allergic Contact Sensitization Potential
timeFrame: 21 days
Other outcomes:
Locations:
city: Fairfield
country: United States
facility: Consumer Product Testing Company, Inc.
state: New Jersey
Study officials:
affiliation: Consumer Product Testing Company
name: Michael Caswell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00139711: Three Combinations Of Docetaxel And Irinotecan For Recurrent Or Metastatic Non Small Cell Lung Cancer
Official title: A Multicenter Randomized Phase II Study Evaluating The Activity And Tolerability Of Three Different Combinations Of Docetaxel (Taxotere) And Irinotecan (Campto) As Second Line Therapy For Recurrent Or Metastatic Non Small Cell Lung Cancer (NSCLS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-31
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter randomized phase II study evaluating the activity and tolerability of three different combinations of docetaxel (taxotere) and irinotecan (campto) as second line therapy for recurrent or metastatic non small cell lung cancer (NSCLC)


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically proven NSCLC
* Recurrent or metastatic NCSLC

Exclusion Criteria:

* Prior malignancies; except for cured non melanoma skin cancer, curatively treated in situ carcinoma of the cervix or other cancer adequately treated an with non evidence of disease for at least 5 years
* History or presence of brain or meningeal metastases

Primary outcomes:
measure: Evaluate the activity and tolerability of the association of irinotecan and docetaxel according to three different schedules as second line treatment for recurrent or metastatic NSCLC.
Secondary outcomes:
measure: Evaluate, in each arm, the time to progression, the duration of response and the survival
Other outcomes:
Locations:
city: Alzano Lombardo
country: Italy
facility: Pfizer Investigational Site
state: BG
city: Gravedona
country: Italy
facility: Pfizer Investigational Site
state: CO
city: Crema
country: Italy
facility: Pfizer Investigational Site
state: CR
city: Gorgonzola
country: Italy
facility: Pfizer Investigational Site
state: MI
city: Melegnano
country: Italy
facility: Pfizer Investigational Site
state: MI
city: Vimercate
country: Italy
facility: Pfizer Investigational Site
state: MI
city: Bari
country: Italy
facility: Pfizer Investigational Site
city: Benevento
country: Italy
facility: Pfizer Investigational Site
city: Borgomanero
country: Italy
facility: Pfizer Investigational Site
city: Brescia
country: Italy
facility: Pfizer Investigational Site
city: Mantova
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Monza
country: Italy
facility: Pfizer Investigational Site
city: Napoli
country: Italy
facility: Pfizer Investigational Site
city: Varses
country: Italy
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02442011: Hematology Biobank : Invitro Study of Blood Disorders
Official title: Hematology Biobank : Invitro Study of Blood Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematological Disorders
Keywords: Hematology Biobank
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
First posted: 2015-05-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects \>18 years of age and able to consent

Brief summary: This is a bio repository of blood specimens from subjects with different Hematological disorders.

Detailed description: There has been a marked increase in our knowledge of Blood Disorders in the last decade. Much of this knowledge comes from examining blood specimens from patients and subjecting these samples to red cell, plasma, serum or DNA analyses. We propose to set up a Hematology biobank, which will include patient histories, their medical progress and a linked but de-identified bank of blood samples. This will enable us to have a large database, which can be used to learn more about these diseases.

The Hematology biobank will use whole blood, red blood cells, plasma, serum and/or DNA.

Eligibility criteria: Inclusion Criteria:

Above 18 years of age and able to consent

Exclusion Criteria:

None

Primary outcomes:
measure: Biobank
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Henny Billett
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02943811: Effect of Uterine Manipulator on Recurrence and Mortality of Endometrial Cancer
Official title: Effect of Uterine Manipulator on Recurrence and Mortality of Endometrial Cancer: a Multi-centric Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Cancer
Keywords: endometrial cancer
survival
uterine manipulator
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2016-10-25
Enrollment: 951
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women affected by early endometrial cancer

Brief summary: The investigators sought to retrospectively assess whether the use of a intrauterine device to manipulate the uterus does affect the long-term oncologic outcomes of patients operated by laparoscopy for endometrial cancer

Detailed description: The investigators retrospectively collected data regarding patients who received operation by laparoscopy for presumed clinical stage I endometrial cancer. The subjects were then stratified according to the use or not of the uterine manipulator. The investigators also considered the actual type of manipulator used. Then disease-free, disease-specific and overall survival were evaluated, as well as all the possible factors associated with prognosis.

Data were retrieved from specifically designed research quality internal surgical databases, prospectively updated by trained residents on a regular basis, in order to capture all the possible surgical and follow-up data.

Eligibility criteria: Inclusion Criteria:

* Clinical stage I endometrial cancer
* Laparoscopic operation

Exclusion Criteria:

* post-operative oncologic follow-up \< 12 months
* extra-uterine evidence of disease

Primary outcomes:
measure: Disease recurrence
timeFrame: 4 years
Secondary outcomes:
measure: disease specific survival
timeFrame: 4 years
measure: overall survival
timeFrame: 4 years
Other outcomes:
Locations:
Study officials:
affiliation: Università degli Studi dell'Insubria
name: Stefano Uccella
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marcos-Sanmartin J, Lopez Fernandez JA, Sanchez-Paya J, Pinero-Sanchez OC, Roman-Sanchez MJ, Quijada-Cazorla MA, Candela-Hidalgo MA, Martinez-Escoriza JC. Does the Type of Surgical Approach and the Use of Uterine Manipulators Influence the Disease-Free Survival and Recurrence Rates in Early-Stage Endometrial Cancer? Int J Gynecol Cancer. 2016 Nov;26(9):1722-1726. doi: 10.1097/IGC.0000000000000808.
citation: Tinelli R, Cicinelli E, Tinelli A, Bettocchi S, Angioni S, Litta P. Laparoscopic treatment of early-stage endometrial cancer with and without uterine manipulator: Our experience and review of literature. Surg Oncol. 2016 Jun;25(2):98-103. doi: 10.1016/j.suronc.2016.03.005. Epub 2016 Mar 23.
Clinical trial NCT02245711: Cell Therapy in Limb Girdle Muscular Dystrophy
Official title: Intrathecal Autologous Mononuclear Cell Therapy for Limb Girdle Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Limb Girdle Muscular Dystrophy
Keywords: Limb Girdle Muscular Dystrophy
Autologous Bone Marrow Mononuclear cell therapy
Stem Cell
Lead sponsor: Neurogen Brain and Spine Institute
Sponsor class: OTHER
First posted: 2014-09-22
Enrollment: 0
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to study the effect of stem cell therapy on Limb Girdle Muscular Dystrophy patients.


Eligibility criteria: Inclusion Criteria:

* age group of 15 years-60 years
* limb girdle muscular dystrophy diagnosed on the basis of clinical presentation
* Electromyographic and Nerve Conduction velocity findings

Exclusion Criteria:

* presence of respiratory distress
* presence of acute infections such as Human Immunodeficient Virus/Hepatitis B Virus/Hepatitis C Virus
* malignancies
* acute medical conditions such as respiratory infection, fever, hemoglobin less than 8, bleeding tendency, bone marrow disorder, left ventricular ejection fraction \< 30%
* pregnancy or breastfeeding

Primary outcomes:
measure: Change in Functional Independence Measure (FIM) scale
timeFrame: 1 year
Secondary outcomes:
measure: Change in Manual Muscle Testing (MMT)
timeFrame: 1 year
Other outcomes:
Locations:
city: Navi Mumbai
country: India
facility: Neurogen brain and spine institute
state: Maharashtra
Study officials:
References:
Clinical trial NCT04138511: Ecofisio, a Mobile Application for Assessment and Diagnosis Using Ultrasound Imaging for Undergraduate Health Science Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sport Injury
Educational Problems
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2019-10-24
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The new called "Generation Z" is starting to reach college age. They have adopted technology and create a deep dependence on it, becoming more drawn to the virtual world. M-learning has experienced a huge expansion in recent years in both, medical context and medical and health's sciences education. Ultrasound is an important diagnosis technique in physiotherapy, especially in sports pathology. m-Learning environments could be a useful tool for improve the comprehension of ultrasound concepts and the acquisition of professional competencies. The purpose of this study was to evaluate the efficacy and the use of an interactive platform accessible through mobile devices (ECOFISIO) using ultrasound imaging for the development of professional competencies in the evaluation and diagnosis of sports pathologies.

Participants were 110 undergraduate students enrolled in two groups of this randomized controlled multicentre study: a control group (traditional learning) and experimental group (ECOFISIO mobile application). All participants were assessed both theoretically and by means of the Objective Structured Clinical Examination (OSCE) exams.


Eligibility criteria: Inclusion criteria:

* To have anatomy and biomechanics previous knowledge.
* To be enrolled in any required subject.
* To have basic ability to use a mobile application.
* To have a smartphone with Internet Access (Android Operating System).

Exclusion criteria:

- To have received any previous training in ultrasound imaging and managing.

Primary outcomes:
measure: Objective Structured Clinical Examination (OSCE)
timeFrame: After the self-study periods in both study groups, up to two weeks.
Secondary outcomes:
measure: Multiple Choice Questionnaire (MCQ)
timeFrame: After the self-study periods in both study groups, up to two weeks.
Other outcomes:
measure: Satisfaction survey
timeFrame: After the self-study periods in both study groups, up to two weeks.
Locations:
Study officials:
References:
citation: Lozano-Lozano M, Galiano-Castillo N, Fernandez-Lao C, Postigo-Martin P, Alvarez-Salvago F, Arroyo-Morales M, Cantarero-Villanueva I. The Ecofisio Mobile App for Assessment and Diagnosis Using Ultrasound Imaging for Undergraduate Health Science Students: Multicenter Randomized Controlled Trial. J Med Internet Res. 2020 Mar 10;22(3):e16258. doi: 10.2196/16258.
Clinical trial NCT00111111: An Evaluation of Etanercept in the Treatment of Subjects With Psoriasis
Official title: A Multicenter, Open-Label, Prospective Study to Evaluate the Effectiveness and Safety of Etanercept in the Treatment of Subjects With Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Psoriasis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-05-18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this multicenter, open-label, prospective study is to evaluate the effectiveness and safety of etanercept in the treatment of subjects with psoriasis.


Eligibility criteria: Inclusion Criteria: - Stable, active plaque psoriasis involving greater than or equal to 10% of body surface area (BSA) at screening and baseline Exclusion Criteria: - Any grade 3 or 4 adverse event or infection within 28 days before screening, or between the screening visit and study drug initiation - Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis - Psoralen plus ultraviolet A radiation (PUVA), oral retinoids, cyclosporine, alefacept (Amevive®), efalizumab (Raptiva®), or any other systemic anti-psoriasis therapy within 28 days of study drug initiation - Ultraviolet light B (UVB) therapy, topical steroids, topical vitamin A or D analog preparations, or anthralin within 14 days of study drug initiation (exception: topical steroids, at no higher than moderate strength, are permitted on scalp, axillae, and groin but dose and formulation must remain stable throughout trial) - Prior exposure to any tumor necrosis factor (TNF)-inhibitor, including etanercept - Severe comorbidities - Known history of tuberculosis (TB), or previous positive purified protein derivative (PPD) test

Primary outcomes:
measure: Improvement in Physician's Global Assessment of Psoriasis
Secondary outcomes:
measure: Patient-reported outcomes including Dermatology Life Quality Index, SF-36, Euro-QoL 5D, and Beck Depression Index
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Moore A, Gordon KB, Kang S, Gottlieb A, Freundlich B, Xia HA, Stevens SR. A randomized, open-label trial of continuous versus interrupted etanercept therapy in the treatment of psoriasis. J Am Acad Dermatol. 2007 Apr;56(4):598-603. doi: 10.1016/j.jaad.2006.09.002. Epub 2006 Nov 17.
citation: Gelfand JM, Kimball AB, Mostow EN, Chiou CF, Patel V, Xia HA, Freundlich B, Stevens SR. Patient-reported outcomes and health-care resource utilization in patients with psoriasis treated with etanercept: continuous versus interrupted treatment. Value Health. 2008 May-Jun;11(3):400-7. doi: 10.1111/j.1524-4733.2007.00251.x.
Clinical trial NCT03224611: Usefulness of Light Wand-guided Insertion of Flexible Reinforced Laryngeal Mask Airway
Official title: Usefulness of Light Wand-guided Insertion of Flexible Reinforced Laryngeal Mask Airway: Comparison With Conventional Blind-insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngeal Mask Airway
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 54
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Flexible LMA (Laryngeal mask airway) is very useful for variable situation but it is hard to insert in correct position because of it's flexible structure. Especially in classical way of manual LMA insertion, when the index finger could not guide the flexible LMA to the optimal position, we could not guarantee the correct position of the LMA. Therefore several studies have been investigated to improve this.

The light wand is a kind of stylet which have a light on the tip. Recently some studies demonstrated the usefulness of the light wand which could be used for indicating correct position of the LMA. We hypothesised there will be two advantages if the light wand is used as a stylet of the flexible LMA. First the stylet could support the mildness of the flexible LMA, and second the lightness could confirm the correct position of the flexible LMA.


Eligibility criteria: Inclusion Criteria:

* The patient need general anesthesia using LMA and belonged to the ASA(American society of Anesthesiologist) class I or II

Exclusion Criteria:

* The patient who has URI(upper respiratory infection) symptom within 14 days or
* The patient's BMI(body mass index) exceeds 35 kg/m2
* The patient has severe GERD(gastroesophageal reflux disease) or hiatus hernia
* The patient who has any contraindication for LMA insertion

Primary outcomes:
measure: Oropharyngeal leak pressure
timeFrame: 5 minutes after LMA is inserted
Secondary outcomes:
measure: The grade of oropharyngeal view through the fiberoptic assessment
timeFrame: 5 minutes after LMA is inserted
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggido
Study officials:
affiliation: Clinical assistant professor
name: Ji Young Yoo
role: PRINCIPAL_INVESTIGATOR
References: