louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06373510: Longitudinal Evaluation of Antibody Kinetics of Vaccinated Patients With Non-mandatory Vaccine Following Administration of a Non-public Marketed Vaccine in the General Population, Real-life Study
Official title: Longitudinal Evaluation of Antibody Kinetics Following Administration of a Non-mandatory Marketed Vaccine in the General Population, Real-life Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vaccination Reaction
Lead sponsor: CerbaXpert
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study would make it possible to document more explicitly the evolution of antibody titers at following a non-public vaccination over a large post-vaccination period in the French population .

Analysis of real-life data would enhance knowledge of vaccine response kinetics It would be useful to identify possible early declines requiring doses Similarly, by analyzing antibody kinetics by age, sex, and vaccination status, the would be possible to determine whether there are differences in the immune response between these different sub-groups. In addition, it would provide additional information to assess the real impact of these non-public vaccines in public health and guide vaccine policies.


Eligibility criteria: Inclusion Criteria:

* Subject over 18 years of age
* Subject presenting to the investigation centre as part of its usual management (prevention, screening, tracking)
* Subject who has been vaccinated and/or wishes to be vaccinated
* Subject able to understand the purpose of research that has given free and informed express consent
* Member or beneficiary of a social security scheme

Exclusion Criteria:

* Protected subject: major under guardianship, curatorship or other legal protection, deprived of liberty by decision judicial or administrative

Primary outcomes:
measure: Quantification of specific serum antibodies (IgM, IgG) at different times before and/or after vaccination by a reference technique such as ELISA.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04638010: Increasing Breast, Cervical, and Colorectal Cancer Screening and HPV Vaccination Among Underserved Texans
Official title: Increasing Breast, Cervical, and Colorectal Cancer Screening and HPV Vaccination Among Underserved Texans: A Collaboration With the United Way's 2-1-1 Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Prevention
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Cancer Prevention Research Institute of Texas
First posted: 2020-11-20
Enrollment: 1554
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study involves a partnership between UTHealth School of Public Health and the Texas 2-1-1 service, which is a helpline connecting low-income and minority callers with a number of needed services. The purpose of this study is to evaluate the effectiveness of a prevention program in which a phone navigator intervention designed to connect 2-1-1 helpline callers to evidence-based screening and prevention services including mammography, Pap test screening, colorectal cancer screening, and HPV vaccination.


Eligibility criteria: Inclusion Criteria:

* callers to 2-1-1
* consents to participate,
* English or Spanish speaking
* not in a crisis (e.g., disaster-related 2-1-1 call or personal crisis)

Exclusion Criteria:

* not English or Spanish speaking
* in crisis (e.g., disaster-related call or personal crisis)
* calling on behalf of another client and not for self

Primary outcomes:
measure: Number of participants who complete needed cancer screening and prevention services
timeFrame: one month after referral
measure: Number of participants who complete needed cancer screening and prevention services
timeFrame: three months after referral
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Maria E Fernandez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00377481: COMFORT Study: A Crossover Study of NeoRecormon (Epoetin Beta) and Darbepoetin Alfa in Patients With Renal Anemia.
Official title: A Randomised, Cross-Over Study to Investigate the Comfort of Injection of Renal Anaemia Patients Receiving Subcutaneous NeoRecormon® Compared to Darbepoetin Alfa.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-09-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will assess the comfort of subcutaneous injections of NeoRecormon and darbepoetin alfa (Aranesp) in patients with renal anemia. Eligible patients will be randomized to receive comparable subcutaneous injections of either darbepoetin alfa (30 micrograms) or NeoRecormon (6000IU). They will then be crossed over to the alternative treatment arm for further treatment. After each injection pain will be assessed using the visual analogue scale (VAS) and 6-point verbal rating scale (VRS), and patient preference will be assessed. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>18 years of age;
* patients with renal anemia or post-transplant anemia.

Exclusion Criteria:

* poorly controlled hypertension;
* known hypersensitivity to NeoRecormon or darbepoetin alfa.

Primary outcomes:
measure: Local pain due to s.c. injection (by VAS).
timeFrame: After each injection
Secondary outcomes:
measure: Patient preference.
timeFrame: At end of study
measure: AEs, vital signs.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Adelaide
country: Australia
city: Gosford
country: Australia
city: Liverpool
country: Australia
city: Melbourne
country: Australia
city: Parkville
country: Australia
city: St. Leonards
country: Australia
city: Sydney
country: Australia
city: Woolloongabba
country: Australia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Roger SD, Suranyi MG, Walker RG, Disney A, Isbel NM, Kairaitis L, Pollock CA, Brown FG, Chow J, Truman MI, Ulyate KA; COMFORT study group. A randomised, cross-over study comparing injection site pain with subcutaneous epoetin beta and subcutaneous darbepoetin alfa in patients with chronic kidney disease. Curr Med Res Opin. 2008 Aug;24(8):2181-7. doi: 10.1185/03007990802240552. Epub 2008 Jun 18.
Clinical trial NCT05388981: Study of Single Doses of SBT115301 in Healthy Participants
Official title: A Randomized, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of SBT115301 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety
Keywords: healthy volunteers
safety
Lead sponsor: Sonoma Biotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Placebo-controlled, sequential escalating dose cohorts
Primary purpose: TREATMENT

Brief summary: This study will test the safety and effects of SBT115301 when given as a single dose to healthy adult volunteers. It is the first study being done in humans. Increasing dose levels will be given after the safety at lower dose levels is shown. Some participants will receive placebo, and neither the participants or the study staff will know what drug (SBT115301 or placebo) is being given.


Eligibility criteria: Inclusion Criteria:

* Males or females not of childbearing potential
* Healthy participants based on medical history, physical examination, vital signs, electrocardiogram, and clinical laboratory tests
* Use of highly effective methods of contraception (sexually active males with partners of childbearing potential)
* Up-to-date vaccinations for coronavirus disease (COVID-19) and influenza

Exclusion Criteria:

* Chronic or acute illness
* History of drug or alcohol abuse or positive drug or alcohol screening results
* Clinically significant ECG abnormality
* Received attenuated live vaccine within 1 month or COVID-19 vaccine within 2 weeks prior to study, or anticipated vaccination during study period

Primary outcomes:
measure: Adverse events
timeFrame: Day of treatment to end of follow-up period (71 days for Cohorts 1-4; 140 days for Cohort 5)
measure: Serious adverse events
timeFrame: Baseline to end of follow-up period (71 days for Cohorts 1-4; 140 days for Cohort 5)
Secondary outcomes:
measure: SBT115301 Serum Concentration
timeFrame: Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
measure: Pharmacokinetic Parameters: Cmax
timeFrame: Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
measure: Pharmacokinetic Parameters: Tmax
timeFrame: Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
measure: Pharmacokinetic Parameters: AUC(0-last)
timeFrame: Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
measure: Pharmacokinetic Parameters: AUC(0-inf)
timeFrame: Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
measure: Pharmacokinetic Parameters: t1/2
timeFrame: Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
measure: Anti-Drug Antibodies
timeFrame: Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Celerion
name: Michelle Valentine, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01003210: Homeopathic Ear Drops for Otitis Media Study
Official title: Homeopathic Ear Drops for Children With Otitis Media Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Otitis Media
Keywords: otitis media
children
homeopathy
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2009-10-28
Enrollment: 210
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if a commercially available homeopathic ear drop preparation is effective in reducing symptoms in children 6 months - 11 years old with acute otitis media in whom the health care provider has recommended that antibiotics not be immediately administered. A total of 150 study patients with otitis media will be randomized to receive homeopathic ear drops, or no ear drops, in addition to receiving standard care. It is postulated that children using the ear drops will have more rapid resolution of symptoms and need fewer antibiotics than those randomized to not receive the ear drops.


Eligibility criteria: Inclusion Criteria:

* Age 6 months - 11 years old
* Diagnosed with otitis media by clinician at participating clinic
* Clinician determines that a "watch and wait" antibiotic prescription treatment plan is optimal management

Exclusion Criteria:

* Antibiotic treatment during past 7 days
* Homeopathic treatment within past 30 days
* History of serious chronic illness (e.g. diabetes, autoimmune disease, cystic fibrosis
* Perforated tympanic membrane
* Immediate antibiotic treatment plan decided by examining clinician

Primary outcomes:
measure: Severity of Symptoms of Otitis Media
timeFrame: 15 days
measure: Administration of Antibiotics
timeFrame: 15 days
Secondary outcomes:
measure: Side Effects From Study Remedy
timeFrame: 15 days
Other outcomes:
Locations:
city: Mercer Island
country: United States
facility: Mercer Island Pediatric Associates
state: Washington
city: Renton
country: United States
facility: Valley Children's Clinic
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center-Roosevelt Pediatric Care Center
state: Washington
Study officials:
affiliation: University of Washington
name: James A Taylor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01898910: Ganglionated Plexi Ablation vs Renal Denervation in Patients Undergoing Pulmonary Vein Isolation
Official title: Ganglionated Plexi Ablation vs Renal Denervation in Patients Undergoing Pulmonary Vein Isolation. A Randomized Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation
Hypertension
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2013-07-15
Enrollment: 80
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: The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different strategies, PVI plus Renal Denervation (RD) versus PVI plus GP ablation, in patients with atrial fibrillation. Results were assessed after follow-up of at least 1 year with the use of an implanted monitoring device (IMD).


Eligibility criteria: Inclusion Criteria:

* Symptomatic drug-refractory AF (with history of failure of ≥ 2 class I or III antiarrhythmic drugs) in patients referred for catheter ablation of AF
* PAF with ≥1 monthly episodes or PersAF in patients who had already undergone ≥3 electrical cardioversions. PAF was defined as episodes lasting less than 7 days with spontaneous termination. PersAF was defined as lasting more than 7 days before being terminated pharmacologically or by electrical cardioversion.
* History of significant hypertension (defined as SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg), receiving treatment with at least one antihypertensive medication
* A glomerular filtration rate ≥45 mL/min/1⋅73 m2, with modification of diet using a renal disease formula

Exclusion Criteria:

* Previous atrial fibrillation ablation
* Type 1 of diabetes mellitus
* Structural heart disease
* Secondary cause of atrial hypertension
* Severe renal artery stenosis or renal arteries abnormalities
* Previous operations on renal arteries
* Pregnancy
* Previous heart, kidney, liver, or lung transplantation
* Unwillingness of participant

Primary outcomes:
measure: Freedom of AF or other atrial arrhythmias
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Pathology
Study officials:
References:
Clinical trial NCT03280810: Effects of a Psycho-corporal Training on Postural and Cognitive Dual-task Performances in Patients With Schizophrenia
Official title: Effects of a Psycho-corporal Training on Postural and Cognitive Dual-task Performances in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
Postural
Cognitive
task
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Beside these well-known symptoms (positive symptoms (such as delirium and delusions), negative symptoms (such as affective flattening and impoverishment of speech), disorganized behavior, patients with schizophrenia show different kinds of cognitive alterations and motor abnormalities. In schizophrenia, postural impairment could increase the attentional cost of daily motor tasks, leading to a lack of attentional resources, essential to achieve complex cognitive tasks. The intrication of cognitive and postural processings (both impaired in schizophrenia) can be explored by using of a dual-task paradigm.

Detailed description: This study assesses a psycho-corporal training (8 weeks psycho-corporal training) benefits on both postural (increased automation of balance control) and cognitive processings (smaller impact of the dual-task condition on attentional performances) in population of patients suffering from schizophrenia.

Eligibility criteria: Inclusion Criteria:

* a DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) diagnosis of schizophrenia (men or women)
* Men or woman aged 18-55
* Patients with no change in antipsychotic medication and clinical status within four weeks prior to the study
* Affiliates or entitled to a social security scheme
* Have given their informed consent before participating in the study.

Exclusion Criteria:

* Intelligence Quotient below 70 (score PM38)
* History of head trauma, neurological disease or not stabilized serious physical illness
* Disorders related to the use of a psychoactive substance, as defined by the DSM-IV (abuse, dependence or withdrawal) within 6 months.

Primary outcomes:
measure: the losses of postural and attentional control
timeFrame: At 8 weeks
Secondary outcomes:
measure: cognitive decrement
timeFrame: At 8 weeks
measure: postural decrement
timeFrame: At 8 weeks
Other outcomes:
Locations:
city: St Etienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Catherine MASSOUBRE, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06048510: New Markers of Glycation to Predict Gestational Diabetes Mellitus and Macrosomia.
Official title: New Markers of Glycation to Predict Gestational Diabetes Mellitus and Macrosomia.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Macrosomia, Fetal
Gestational Diabetes Mellitus in Pregnancy
Keywords: skin autofluorescence
glycated albumin,
HbA1c
glycation biomarkers
macrosomia
gestational diabetes mellitus
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Société Francophone du Diabète
First posted: 2023-09-21
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Gestational diabetes mellitus (GDM) increases the risk of macrosomia and other adverse pregnancy outcomes. Screening strategies are debated: universal vs. selective, and macrosomia may begin before the time of screening, suggesting that glycation markers may have an interest. The objective of this trail is to compare novel markers: skin autofluorescence and glycated albumin, to HbA1c (reference) as predictors of GDM, macrosomia and other adverse outcomes, in pregnant women.


Eligibility criteria: Inclusion criteria:

1. Age ≥ 18 years
2. Singleton pregnancy (or twin pregnancy reduced spontaneously or medically before 14 weeks of amenorrhea)
3. Gestational age at inclusion \<28 weeks of amenorrhea
4. Participant affiliated with or beneficiary of a social security scheme
5. Collection of patient consent.

Exclusion criteria:

1. Gestational age at inclusion ≥ 28 weeks of amenorrhea
2. Multiple pregnancy
3. Known diabetes prior to pregnancy
4. History of bariatric surgery
5. Expected delivery in another maternity unit not participating in the study
6. Person deprived of liberty by judicial or administrative decision
7. Guardianship or curatorship
8. Participant not affiliated or not benefiting from a social security scheme.

Primary outcomes:
measure: Incidence of GDM diagnosed during pregnancy.
timeFrame: At trimester 1
Secondary outcomes:
measure: Fetal morbidity
timeFrame: Between the day of delivery and the following day
measure: Obstetrical outcome
timeFrame: Between the day of delivery and the following day
measure: Maternal morbidity
timeFrame: Between the day of delivery and the following day
measure: Neonatal morbidity 1
timeFrame: Between the day of delivery and the following day
measure: Neonatal morbidity 2
timeFrame: Between the day of delivery and the following day
measure: Neonatal morbidity 3
timeFrame: Between the day of delivery and the following day
measure: Neonatal morbidity 4
timeFrame: Between the day of delivery and the following day
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hopital Pellegrin
Study officials:
References:
Clinical trial NCT04058210: VX-445/TEZ/IVA Expanded Access Program for Cystic Fibrosis (CF) Patients Heterozygous for F508del Mutation and a Minimal Function Mutation (F/MF Genotypes)
Official title: VX-445/TEZ/IVA Triple Combination Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function CFTR Mutation
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Cystic Fibrosis
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2019-08-15
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of this program is to provide elexacaftor(ELX, VX-445)/tezacaftor(TEZ)/ivacaftor(IVA) combination therapy to CF patients in critical need who are 12 years of age and older, heterozygous for F508del and a minimal function (MF) mutation in response to unsolicited physician requests.


Eligibility criteria: Inclusion Criteria:

1. Patients who have F/MF genotypes AND who meet at least 1 of the following criteria:

* The percent predicted forced expiratory volume in 1 second (ppFEV1) is \<40 for a minimum of 2 months before the date of the request, OR
* Documentation of being active on a lung transplant waiting list or documentation of being evaluated for lung transplantation, but deemed unsuitable because of contraindications

Exclusion Criteria:

1. Patients with severe hepatic impairment (Child-Pugh Class C)
2. History of any other comorbidity that, in the opinion of the treating physician, might pose undue risk in administering ELX/TEZ/IVA to the patient
3. Pregnancy

Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: