louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05546983: How to Report Postoperative Outcomes After a Paediatric Cardiac Surgery ?
Official title: How to Report Postoperative Outcomes After a Paediatric Cardiac Surgery ?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease in Children
Keywords: Congenital Heart Disease
Abnormality in newborns
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 189
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Minor patients, under the age of 18 operated at the HUS between 01/01/2010 and 03/31/2022 for transposition surgery of the great vessels (arterial switch) with or without CIV; or isolated ventricular septal closure

Brief summary: Congenital heart disease is a common abnormality in newborns. The marked improvement in the surgical management of congenital heart disease has led to a reduction in postoperative mortality, historically a quality criterion for surgical and resuscitation management. With the improvement of medical knowledge and surgical techniques, mortality is no longer a single quality criterion for a center and the search for other quality criteria is essential.


Eligibility criteria: Inclusion criteria:

* Minor patients, under the age of 18
* operated at the HUS between 01/01/2010 and 03/31/2022 for transposition surgery of the great vessels (arterial switch) with or without CIV; or isolated ventricular septal closure
* Child or holders of parental authority who do not object to the reuse of their data for scientific research purposes.

Exclusion criteria:

* Transposition surgery of the great vessels associated with coarctation of the aorta, pulmonary stenosis or any other complex malformation
* Surgical technique different from the arterial switch for the transpositions of the great vessels
* Closure of interventricular communication associated with another complex heart malformation (tetralogy of Fallot, atrioventricular canal, right ventricle with double outlet, etc.)
* Child or holders of parental authority who have expressed their opposition to the reuse of their data for scientific research purposes.

Primary outcomes:
measure: Retrospective analysis of the quality criteria described in the literature after pediatric cardiac surgery by studying their behavior within a local cohort within the University Hospitals of Strasbourg
timeFrame: Files analysed retrospectively from January 01, 2010 to March 31, 2022 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Pédiatrie 1 - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT05695183: IV SafeLock Device Functionality in Emergency Department
Official title: Functionality of the IV SafeLock Device in Emergency Department Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intravenous Access
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this research study is to evaluate the functionality of the IV SafeLock in the clinical emergency department setting.


Eligibility criteria: Inclusion Criteria:

* Emergency Department nurses who are consenting and willing to perform tasks.
* Their patient population will include stable patients 18 or over, who present through triage, are medically stable, are able to verbally consent and require intravenous access.

Exclusion Criteria:

* Emergency Department nurses who are unwilling to consent to use IV SafeLock on their patient population.
* The patient population will exclude pregnant patients, children, prisoners, patients with dementia, or any member of protected class as specified by IRB.
* The patients must be medically stable and not include patients presenting with acute stroke, acute myocardial infarction, severe sepsis or shock.

Primary outcomes:
measure: Functionality of the IV SafeLock
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Kara Bragg, APRN, DNP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05858983: Gene Therapy in Subjects With Biallelic RPE65 Mutation-associated Retinal Dystrophy
Official title: A Multi-center, Open-label, Dose-escalation Phase I/II Clinical Study to Evaluate the Safety, Tolerability and Efficacy of FT-001 Administered Via Subretinal Injection in Subjects With Biallelic RPE65 Mutation-associated Retinal Dystrophy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Biallelic RPE65 Mutation-associated Retinal Dystrophy
Keywords: FT-001
Biallelic RPE65 Mutation-associated Retinal Dystrophy
Lead sponsor: Frontera Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-05-15
Enrollment: 9
Sex: ALL
Minimum age (years): 8
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of subretinal administration of FT-001 in subjects with biallelic RPE65 mutation-associated retinal dystrophy.

Detailed description: This study is a multi-center, open-label, phase I/II clinical study to evaluate the safety, tolerability, efficacy, immunogenicity, and in vivo biodistribution characteristics of FT-001 in subjects with biallelic RPE65 mutation-associated retinal dystrophy. Assessments will include visual acuity, vector shedding, immunogenicity and adverse events. Participants will be monitored for 5 years after treatment.

Eligibility criteria: Inclusion Criteria:

1. Subjects who are able to understand and sign the ICF
2. Female or male aged 8-45 years old when signing the ICF
3. Clinically diagnosed with biallelic RPE65 mutation-associated retinal dystrophy

Exclusion Criteria:

1. Other interfering eye diseases
2. Presence of any systemic or ocular disease that can cause or likely to cause vision loss
3. There is evidence of obviously uncontrolled concomitant diseases
4. Known to have active or suspected autoimmune diseases
5. With active systemic infection under treatment
6. Pregnant or lactating women
7. Other conditions unsuitable for the study as determined by the investigator

Primary outcomes:
measure: Safety of FT-001(incidence of ocular and non-ocular AEs and SAEs)
timeFrame: 52 weeks
Secondary outcomes:
measure: Changes in visual function from baseline
timeFrame: 52 weeks
measure: Changes in visual function from baseline
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Ruifang Sui
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01506583: Clinical Evaluation of QFlu Combo Test
Official title: Clinical Evaluation of QFlu Combo Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cough
Myalgia
Nasal Obstruction
Sore Throat
Headache
Fatigue
Fever
Keywords: cough
myalgia
nasal obstruction
sore throat
headache
fatigue
feverishness
Patients who exhibit flu-like symptoms during a flu season, including cough, myalgia, nasal obstruction, sore throat, headache, fatigue, and/or feverishness.
Lead sponsor: Cellex, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2012-01-10
Enrollment: 506
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There are three population of participants: pediatric (in patient or out patient), in-patient (any age) and out-patient (any age).

Brief summary: Currently effective antivials for influenza treatment are two influenza viral neuraminidase inhibitors, oseltamivir (Tamiflu) and zanamivir (Relenza). Resistance to these drugs is reflected by reduced susceptibility of viral neuraminidase to these drugs. The hypothesis is that the signal ratio of two reagents (with or without a single concentration of the drug) correlates the IC50 value, an accurate measurement of drug resistance but impractical for clinical use.

Detailed description: The study design is to collect samples from participants. A portion of the sample is used for drug resistance detection using the test (QFlu Combo Test) under investigation. The remaining portion of the sample is used for culture. The culture positive samples are used for determination of IC50 values, which is used as a gold standard for defining whether a virus isolate is resistant to a drug or not. The sensitivity and specificity of the QFlu test will be calculated by comparing to the gold standard test.

Eligibility criteria: Inclusion Criteria:

* Those who exhibit flu-like symptom(s) during a flu season and who (or whose guardians) are willing to participate in the study.

Primary outcomes:
measure: Sensitivity and specificity for drug resistance detection
timeFrame: approximately 12 months after the study is completed.
Secondary outcomes:
measure: Sensitivity and Specificity of the Test for Influenza Diagnosis
timeFrame: 12 months after the study is completed.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
Study officials:
References:
Clinical trial NCT04749797: Cranial Blocks for Postoperative Anesthesia
Official title: Randomized Study Of Cranial Blocks For Postoperative Anesthesia To Reduce Pain And Postoperative Opioid Usage
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Craniotomy Surgery
Keywords: craniotomy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to one of three groups: saline, bupivacaine, liposomal bupivacaine
Primary purpose: TREATMENT

Brief summary: This study compares the standard of care to the standard of care plus the administration of bupivacaine or liposomal bupivacaine in patients receiving craniotomies.

Detailed description: Objective: To assess the effectiveness of analgesia by scalp nerve block with various agents in the first 72 hours following elective craniotomy.

The investigators will employ a randomized, single-blinded, prospective study design. Participants will be randomized 1:1:1 into one of three treatment groups: Bupivacaine, Liposomal Bupivacaine, and Saline.

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* Need for elective supratentorial craniotomy
* Preoperative GCS \> 13

Exclusion Criteria:

* Preoperative GCS ≤ 13
* Child (\<18 years of age)
* Inability to understand or use the visual analog scale (VAS)
* Proven or suspected allergy to local anesthetics
* Craniotomy incision extending beyond the field of the block
* Patients chronically (more than 2 wk) treated with narcotic medications
* Previous scalp incision
* Bilateral craniotomies
* Allergies to local anesthetics
* GCS verbal score \< 4 after extubation
* Patients whose surgeries extend past 6 hours (will be placed on standard of care and removed from study)
* Patients currently on ergot-type oxytoxic drugs, MAOIs, or certain antidepressants
* Lactating Mothers

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 10 months (study terminated prior to completion)
Secondary outcomes:
measure: Length of Stay (ICU and
timeFrame: 10 months (study terminated)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Timothy H Lucas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01456897: A Long-term Trial of OPC-34712 in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-10-21
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the safety and efficacy of long-term administration of OPC-34712 in patients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Patients age 18 years or older (at time of informed consent) diagnosed with schizophrenia based on DSM-IV-TR diagnostic criteria
* Outpatients who are receiving an oral antipsychotic treatment (other than clozapine), who are considered to require maintenance therapy using antipsychotics, and for whom monotherapy with OPC-34712 is considered feasible

Exclusion Criteria:

* Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product
* Patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current DSM-IV-TR Axis Ι criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)

Primary outcomes:
measure: Percentage of Participants With Adverse Events
timeFrame: From Baseline up to 52 Weeks
Secondary outcomes:
measure: Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF)
measure: Mean Change From Baseline in PANSS Positive Subscale Score
timeFrame: From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF)
measure: Mean Change From Baseline in PANSS Negative Subscale Score
timeFrame: From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF)
measure: Mean Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S)
timeFrame: From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF)
measure: Mean Clinical Global Impression - Global Improvement(CGI-I)
timeFrame: From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF)
Other outcomes:
Locations:
city: Kanto Region
country: Japan
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Kyoji Imaoka, Operating Officer
role: STUDY_DIRECTOR
References:
citation: Ishigooka J, Usami T, Iwashita S, Kojima Y, Matsuo S. Post-hoc analysis investigating the safety and efficacy of brexpiprazole in Japanese patients with schizophrenia who were switched from other antipsychotics in a long-term study (Secondary Publication). Neuropsychopharmacol Rep. 2020 Jun;40(2):122-129. doi: 10.1002/npr2.12107. Epub 2020 Apr 15.
Clinical trial NCT01190397: Warming Efficiency of Warm Compresses Versus BLEPHASTEAM® in Eyelid Therapy
Official title: Phase I, Prospective, Comparative Study, Investigator Masked , Monocentric Measuring Warming Efficiency and Safety of Blephasteam® Versus Warm Compresses in Eyelid Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Eyelid Diseases
Keywords: Warming goggles
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2010-08-27
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The eyelid warming device is designed to relieve the symptoms of dysfunction of the glands in the eyelids

Phase I, prospective, comparative study, investigator masked , monocentric

Objectives are To assess and compare the warming and moisture of Blephasteam® device versus the warming and moisture of warm and moist compresses.

To assess and compare safety on the ocular surface after 10 minutes of Blephasteam® application versus after 10 minutes of warm and moist compresses application


Eligibility criteria: Inclusion Criteria:

* Male or female aged from 18 to 80 years old.
* Healthy volunteers.
* For any contact lens wearers, they must be wearing hydrogel contact lenses (worn at least 3 times per week)
* Normal ocular examination in both eyes.

Primary outcomes:
measure: Temperature measurements
Secondary outcomes:
measure: Humidity measurements
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: School of Optometry & Vision Sciences
Study officials:
affiliation: Cardiff University
name: Heiko PULT, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03735797: Cancer Stem Cells in Acute Leukemia
Official title: Cancer Stem Cells in Acute Leukemia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Leukemia
Lead sponsor: Sanford Health
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study team will enroll approximately 50 subjects (age 1 month to 30 years) with newly diagnosed or relapsed acute leukemia.

Brief summary: Descriptive study of acute leukemia patients. Bone marrow aspirate or peripheral blood samples will be analyzed by next-generation sequencing for novel gene signatures and variations in transcriptional and epigenetic regulatory elements such as ARID5B and SALL4 variants.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed or relapsed acute leukemia (AML or ALL)
* Plan to undergo diagnostic bone marrow aspirate or peripheral blood if clinically indicated (i.e. WBC\>50,000 and bone marrow contraindicated)
* Age 1 month to 30 years
* Understand and provide informed consent (subject if\>18, legal guardian if\<18)

Exclusion Criteria:

* Age 0 to 4 weeks
* Treatment related leukemia or leukemia secondary to MDS
* Situations that would limit compliance with study requirements or ability to willingly give consent

Primary outcomes:
measure: ARID5B polymorphism/mutation status
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Sanford Health
state: North Dakota
city: Sioux Falls
country: United States
facility: Sanford Health
state: South Dakota
Study officials:
affiliation: Sanford Health
name: Samuel Milanovich, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01324297: The Topical Niacin Skin Flush Test in First Episode Psychosis
Official title: The Topical Niacin Skin Flush Test: A Means for Longitudinal Monitoring of Two Different Biological Subgroups of Patients With First Episode Psychosis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Psychotic Disorders
Schizophrenia
Keywords: Diagnostic Techniques and Procedures
Sensitivity and Specificity
Skin Tests
Biological Markers
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2011-03-29
Enrollment: 107
Sex: ALL
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy young adults

Brief summary: The purpose of this study is to gather normative data from healthy adults and to determine a sensitive and specific cut-off value for responders and non-responders to the Niacin Skin Flush Test in a sample of first episode psychosis patients.


Eligibility criteria: Inclusion Criteria:

* caucasian
* within twelve months of initial DSM IV TR diagnosis of schizophreniform psychosis, schizophrenia, schizoaffective disorder or psychotic disorder NOS
* outpatient

Exclusion Criteria:

* known allergy to study compound (methyl nicotinate, vitamin B3, niacin)
* skin conditions (e.g., dermatitis, psoriasis, eczema)
* diagnosis or treatment for medical conditions that may affect normal vascular tone (e.g., diabetes, vasculitis, chronic hypertension, etc.)
* Use of anti-inflammatory, antibiotic, or antihistamine medications within one month prior to study entry
* Use of supplements like Omega 3 fatty acids within 3 months prior to study entry
* Use of vitamin or nutritional supplement containing a dose of niacin/nicotinic acid above 50 mg/day at study entry

Primary outcomes:
measure: change in visual rating of skin response (redness and oedema)
timeFrame: ratings made at 3, 6, 9 and 12 minutes after application of methyl nicotinate
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia First Episode Psychosis Program; QEII health Sciences Centre; Capital District Health Authority
state: Nova Scotia
Study officials:
affiliation: Capital District Health Authority, Nova Scotia, Canada
name: Phillip G Tibbo, MD, FRCPC
role: STUDY_CHAIR
References:
citation: Kerr M, Cotton S, Proffitt T, McConchie M, Markulev C, Smesny S, McGorry P, Berger G. The topical niacin sensitivity test: an inter- and intra-rater reliability study in healthy controls. Prostaglandins Leukot Essent Fatty Acids. 2008 Jul-Aug;79(1-2):15-9. doi: 10.1016/j.plefa.2008.06.001. Epub 2008 Jul 24.
citation: Nadalin S, Buretic-Tomljanovic A, Rubesa G, Tomljanovic D, Gudelj L. Niacin skin flush test: a research tool for studying schizophrenia. Psychiatr Danub. 2010 Mar;22(1):14-27.