louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03825484: Expanded Access Program (EAP) for Participants With Advanced Cancers and Fibroblast Growth Factor Receptor (FGFR) Genetic Alterations Who Have Exhausted All Treatment Options
Official title: Expanded Access Program (EAP) for Patients With Advanced Cancers and FGFR Genetic Alterations Who Have Exhausted All Treatment Options
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Advanced Cancers and FGFR Genetic Alterations
Lead sponsor: Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
First posted: 2019-01-31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of this program is to provide participants an early access to erdafitinib prior to market authorization (that is, Food and Drug Administration \[FDA\] approval in the United States). The program is limited to participants with advanced cancers and fibroblast growth factor receptor (FGFR) genetic alterations who have exhausted at least 2 lines of standard of care therapy and who are not eligible for an erdafitinib clinical trial.


Eligibility criteria: Inclusion Criteria:

* Participant has a documented fibroblast growth factor receptor (FGFR) alteration
* Participant does not have co-morbidities that would alter risk-benefit of providing erdafitinib (determined by treating physician's assessment)
* Life expectancy is greater than (\>) 3 months (determined by treating physician's assessment)
* Participant has exhausted treatment options for their disease (review of prior treatments)
* Participant is not eligible for other erdafitinib clinical trials including but not limited to BLC3001/NCT03390504 and BLC2002/NCT03473743

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Scientific Affairs, LLC
name: Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT04699084: The Evaluation of Mozart Music on Pain and Respiratory Rate After Thyroidectomy
Official title: The Evaluation of Mozart Music on Pain and Respiratory Rate After Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Prolepsis Institute for Preventive, Environmental and Occupational Medicine
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were assigned to two groups. One group underwent a music intervention postoperatively, while the other received only usual postoperative care (control group).
Primary purpose: TREATMENT

Brief summary: To investigate the effect of Mozart music on postoperative pain and physiological parameters in patients after total thyroidectomy.

Detailed description: Postoperative pain is a major concern in postsurgical patients. Meanwhile, there is a general consensus on minimizing the use of analgesic drugs in patients undergoing total thyroidectomy. Therefore, alternative methods need to be investigated in order to reduce postoperative pain. Although the clinical importance of music has been recognised in other pathological situations, further research is needed to investigate the effect of music on postoperative pain.

Eligibility criteria: Inclusion Criteria:

* Adults scheduled for total thyroidectomy under general anesthesia

Exclusion Criteria:

* Visual impairments
* Hearing impairments
* Severe anxiety or other psychiatric disorders
* History of chronic pain
* Past complications during anesthesia or surgery
* American Society of Anesthesiologists (ASA) physical status beyond II

Primary outcomes:
measure: Postoperative Pain
timeFrame: Change of VAS was evaluated; from the beginning (time of arrival at the PACU, baseline), to the middle (10 minutes after surgery), to the end of the music intervention (20 minutes after surgery) at the PACU and to 2 hours after surgery in the ward.
Secondary outcomes:
measure: Systolic and diastolic blood pressure
timeFrame: Change of blood pressure was evaluated during the first postoperative day.
measure: Heart rate
timeFrame: Change of heart rate was evaluated during the first postoperative day.
measure: Respiratory rate
timeFrame: Change of respiratory rate was evaluated during the first postoperative day.
measure: Oxygen saturation
timeFrame: Change of oxygen saturation was evaluated during the first postoperative day.
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hygeia Hospital
Study officials:
affiliation: Hygeia Hospital, National and Kapodistrian University of Athens
name: Dimitrios Linos, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05100784: The Human Sperm Survival Assay (HSSA) as an Internal Quality Control for the IVF Consumables (REPROTOX 2)
Official title: The Human Sperm Survival Assay (HSSA) as an Internal Quality Control for the IVF Consumables
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Human Sperm Survival Assay
Embryotoxicity
in Vitro Fertilization
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
name: Private hospital Parly II
First posted: 2021-10-29
Enrollment: 1800
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male between 18 and 65 years-old with normal spermogram

Brief summary: The main embryotoxicity quality controls are the mouse embryo test (MEA = Mouse Embryo Assay) and the human sperm survival test (HSSA = Human Sperm Survival Assay). The HSSA test measures the survival (or mobility) of human sperm after exposure to the tested consumable for a predetermined period of time and compares it to that of unexposed sperm. It would appear that the HSSA is comparable in terms of sensitivity to the MEA test for the detection of toxicity.

Detailed description: The main objective is to assess the embryotoxicity of the main IVF consumables using the HSSA test before their introduction to the IVF laboratory.

Eligibility criteria: Inclusion Criteria:

* Male over 18 years-old
* Normal spermogram (concentration ≥15 million / ml or total count\> 39 million, progressive mobility ≥32% or total mobility ≥40%)
* Progressive mobility ≥70% after selection
* Total number of progressive motile spermatozoa recovered after TMS\> 10 million
* Patient affiliated or beneficiary of a social security scheme
* Patient having been informed and not opposing to this research.

Exclusion Criteria:

* Male over 65 years-old
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

Primary outcomes:
measure: Presence of embryotoxicity
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: Private Hospital of Parly II-Le Chesnay
Study officials:
References:
Clinical trial NCT05224284: BPA Levels Relationship With IVF/ICSI Outcomes in Patients With Male Factor
Official title: Impact of Blood and Ejaculate Bisphenol A Concentrations on ICSI Cycles Outcome in Patients With Male Factor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Male
IVF
Lead sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 75
Sex: MALE
Minimum age (years): 23
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Association between blood and semen BPA levels and ICSI outcomes in patients with male factor


Eligibility criteria: Inclusion Criteria:

* female patients aged 23-40 years who underwent IVF due to male factor
* men with semen sample obtained from ejaculate
* male patients provided blood, and ejaculate samples on the oocyte retrieval day
* patients who did not smoke or use alcohol
* patients did not work in the plastic industry

Exclusion Criteria:

* men with a diagnosis of azoospermia
* patients who underwent IVF due to low ovarian reserve or unexplained infertility indications
* patients diagnosed with endometriosis
* patients with freeze-all cycles
* women with metabolic disease (such as hypertension or diabetes mellitus)
* patients (male or females) with a known genetic problem (male or female)

Primary outcomes:
measure: Exposure to BPA
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Nefise Nazlı YENIGUL
Study officials:
References:
Clinical trial NCT04145284: Quantitative Magnetic Resonance Imaging (MRI) Sub-Study of MS PATHS
Official title: Performance and Feasibility of Quantitative MRI Metrics in Routine Radiology Practice: A Sub-Study of MS PATHS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2019-10-30
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is the cohort of radiologists.

Brief summary: The primary objective is to assess the performance of a new magnetic resonance imaging (MRI) metrics software prototype when used in radiological practice in multiple sclerosis (MS).


Eligibility criteria: Key Inclusion Criteria:

* Board-certified neuroradiologists or experienced neuroradiology fellows.
* Employed at a participating MS PATHS institution.
* At least 3 years of experience in interpreting brain MRI scans of MS participants.

Key Exclusion Criteria:

* Inability to comply with sub-study procedures.
* Other unspecified reasons that, in the opinion of Biogen or the MS PATHS Radiology Lead at the institution, make the radiologist unsuitable for participation.

Primary outcomes:
measure: Radiologist Assessment of the Performance of the MS MRI Metrics Software Prototype by the Number of Approve or Reject Decision
timeFrame: Baseline up to 6 weeks
measure: Radiologist Assessment of the Performance of the MS MRI Metrics Software Prototype by the Number of False-Positive and False-Negative Lesions
timeFrame: Baseline up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Dresden
country: Germany
facility: Research Site
state: Saxony
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02776384: Prognostic and Diagnostic Value of Biomarkers and Cardiac Functional Parameters in Patients With Chronic Heart Failure
Official title: Prognostic and Diagnostic Value of Serial Biomarker Measurements, Echocardiographic Techniques and Cardiopulmonary Function Tests in Patients With Chronic Heart Failure.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Heart Failure
Keywords: Heart Failure
Biomarkers
Echocardiography
Cardiopulmonary Function Tests
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-05-18
Enrollment: 1000
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 who are diagnosed with chronic heart failure with either preserved or reduced ejection fraction in NYHA Ⅱ\~Ⅳ

Brief summary: The study aims to investigate whether disease progression in patients with chronic heart failure (CHF) can be assessed by new biomarkers, and determine their diagnostic value. The study also intends to describe comparison of echocardiography with cardiopulmonary function test in CHF patients, and relating these cardiac functional parameters to clinical outcome.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* with symptoms and signs in NYHA Ⅱ\~Ⅳ
* with cardiac structural changes confirmed by echocardiography

Exclusion Criteria:

* with other severe diseases combined and will be alive for less than 12 months
* hard to participate in the investigation or accept the follow-up visits
* pregnant or lactating women
* during the acute phase of ST-elevation acute myocardial infarction, stroke, severe infection and other critical conditions

Primary outcomes:
measure: main adverse cardiovascular and cerebrovascular events, MACCE
timeFrame: 10 years
measure: cardiovascular mortality
timeFrame: 10 years
Secondary outcomes:
measure: all-cause mortality
timeFrame: 10 years
measure: new myocardial infarction
timeFrame: 10 years
measure: new stroke
timeFrame: 10 years
measure: heart failure rehospitalization
timeFrame: 10 years
measure: quality of life
timeFrame: 10 years
measure: worsening of renal function
timeFrame: 10 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT06587984: Influenza Reminder Text-Messaging
Official title: Influenza Reminder Text-Messaging: A Randomized Quality Improvement Effort to Promote Influenza Vaccine in Pediatric Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 228361
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Through a large, population-level quality improvement effort within the Children's Hospital of Philadelphia Care Network, we will evaluate text message reminders on flu vaccination rates for both patients with and without a scheduled well child care visit during flu season.

Detailed description: This is a randomized control trial with two patient cohorts: patients with and without a scheduled well child care visit during the upcoming 2024 flu season. Patients with a scheduled well child visit will be randomized into one of three groups (control, intervention message #1, or intervention message #2). Patients within the intervention groups will receive a one-time text message reminder to get their flu shot for their child at their child's upcoming well visit. Intervention groups will be texted at the same time, the same month as their child's well visit. The text message language will differ between groups. Patients without a scheduled upcoming well child visit during the 2024 flu season will also be randomized into one of three groups (control, intervention message #1, or intervention message #2). Intervention groups will be texted at the same time, at the start of flu season. The text message language will differ between groups.

Flu vaccine uptake will be measured within each patient cohort.

Eligibility criteria: Inclusion Criteria:

* All patients between ages 6 months-18 years old who have an upcoming well visit during the Fall of 2024 (September through December 2024) or had a completed well visit from January 2023 through August 2024
* Patients have a mobile phone number within their medical record
* Patients have opted-in to text communications from CHOP
* English-speaking

Exclusion Criteria:

* Subjects who do not meet the above inclusion criteria will be excluded

Primary outcomes:
measure: The effectiveness of a text message reminder on influenza vaccine uptake
timeFrame: Baseline to approximately 30 days post-text message
Secondary outcomes:
measure: The effectiveness of text message language within Cohort 1
timeFrame: Baseline to approximately 30 days post-text message
measure: The effectiveness of text message language within Cohort 2
timeFrame: Baseline to approximately 30 days post-text message
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Brian P. Jenssen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01202084: A Study Comparative of Formoterol/Fluticasone Foraseq® and Fluticasone in Asthma Patients
Official title: A Phase III, Randomized, Open-label, Non-inferiority Study Comparative of Formoterol/Fluticasone Eurofarma 12/250 µg, Foraseq® 12/400 µg and Fluticasone 500 µg in Asthma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Eurofarma Laboratorios S.A.
Sponsor class: INDUSTRY
First posted: 2010-09-15
Enrollment: 222
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective will be to compare the impact of the study formulations on pulmonary function in persistent asthma carriers.


Eligibility criteria: Inclusion Criteria:

* Sign the ICF
* Age ≥ 12 years
* Persistent asthma diagnosis, as per the GINA classification (www.ginasthma.com),18 with symptoms for at least 6 months and clinically stable for at least 1 month, with the ACQ-745 test (see Appendix C) ≤ 3.0
* Current use of inhaled corticosteroid (beclomethasone dipropionate dose of up to 1000 µg), associated or not with long-term β2-adrenergic agents and breakthrough medication (salbutamol or equivalent)
* Initial FEV1 of at least 40% of the predicted normal value
* Serum cortisol assessment within normal values.

Exclusion Criteria:

* Use of oral or parenteral corticosteroid within the 3 months prior to study beginning
* Requirement of admission due to asthma within the 3 months prior to study beginning
* Presence of active smoking, defined as the use of cigarette, pipe, cigar or any form of smoking at any amount within the last 3 months
* Presence of severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatological, neurological, psychiatric or chronic respiratory disease other than asthma
* Recent (\< 6 months) or predicted participation during this study in other clinical studies involving drugs of any nature or in studies of any form of intervention for treating asthma
* Intolerance or allergy to any of the components of the drugs assessed in the study
* Pregnancy or lactation
* Chronic use of β-blocker medications, per routine oral or intravenous route, or also as ophthalmic solutions

Primary outcomes:
measure: Forced expiratory volume in 1 second (FEV1) at final visit.
timeFrame: 12 weeks
Secondary outcomes:
measure: Peak expiratory flow (PEF)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
Study officials:
References:
Clinical trial NCT04771884: Population Pharmacokinetics of Commonly Used Antimicrobial Agents in Children of Bacterial Meningitis With Augmented Renal Clearance
Official title: Population Pharmacokinetics of Commonly Used Antimicrobial Agents in Children of Bacterial Meningitis With Augmented Renal Clearance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bacterial Meningitis
Augmented Renal Clearance
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Chongqing Medical University
First posted: 2021-02-25
Enrollment: 300
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children (2 months-18 years) of bacterial meningitis with augmented renal clearance

Brief summary: The investigator's purpose is to study the population pharmacokinetics of commonly used antimicrobial agents in children of bacterial meningitis with augmented renal clearance and assess dosage individualization feasibility.

Detailed description: The investigator's purpose is to study the population pharmacokinetics of meropenem, vancomycin, ceftazidime, ceftriaxone, ceftizoxime and linezolid in children of bacterial meningitis with augmented renal clearance and assess dosage individualization feasibility. In this study, the investigator will detect drug concentration in both plasma and cerebrospinal fluid to construct population pharmacokinetics.

Eligibility criteria: Inclusion Criteria:

* Children have been diagnosed with bacterial meningitis with augmented renal clearance (eGFR ≥ 160 mL/(min\*1.73m2));
* Age: 2 months-18 years;
* Meropenem, vancomycin, ceftazidime, ceftriaxone, ceftizoxime and/ or linezolid used as part of regular treatment;
* Meropenem, vancomycin, ceftazidime, ceftriaxone, ceftizoxime and linezolid was administered intravenously.

Exclusion Criteria:

* Patients who die within the treatment cycle;
* Severe congenital malformation;
* Receive other systemic experimental drug therapy;
* Other factors that the researchers consider unsuitable for inclusion.

Primary outcomes:
measure: The peak plasma and cerebrospinal fluid drug concentration of meropenem，vancomycin，ceftazidime，ceftriaxone，ceftizoxime，linezolid.
timeFrame: at (5-10) minutes after intravenous administration
measure: The random plasma and cerebrospinal fluid drug concentration of meropenem，vancomycin，ceftazidime，ceftriaxone，ceftizoxime，linezolid.
timeFrame: at (0.5-10) hours after intravenous administration
measure: The trough plasma and cerebrospinal fluid drug concentration of meropenem，vancomycin，ceftazidime，ceftriaxone，ceftizoxime，linezolid.
timeFrame: at 1-2 hours before the next administration
Secondary outcomes:
measure: clinical response
timeFrame: Through study completion, an average of 14 days
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Children's Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References: