louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00522236: Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to Elderly Subjects
Official title: A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008, When Administered to Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Adjuvanted Influenza Vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-08-29
Enrollment: 56
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 65 years and over


Eligibility criteria: Inclusion Criteria:

- 65 years of age or older

Exclusion Criteria:

* any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or insulin-dependent diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time
* hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or kanamycin or any other component of the vaccine
* history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
* known or suspected (or high risk of developing) impairment/alteration of immune function
* any acute disease or infections requiring systemic antibiotic or antiviral therapy within the past 7 days
* fever within the past 3 days

Primary outcomes:
measure: Antibody response to each influenza vaccine antigen as measured by Single Radial Hemolysis in elderly subjects (≥65y) in compliance with the requirements of the current EU recommendations for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96)
timeFrame: 21 days post-vaccination
Secondary outcomes:
measure: To evaluate the safety of the administration of a single intramuscular (IM) injection of FLUAD® vaccine (formulation 2007/2008) in elderly subjects (≥ 65 years).
timeFrame: 3 days, respectively 21 days post-vaccination
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Dipartimento di Medicina e Scienze dell'Invecchiamento
city: Lanciano
country: Italy
facility: Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto, Via S. Spaventa, 37
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
Clinical trial NCT02556736: RST-001 Phase I/II Trial for Advanced Retinitis Pigmentosa
Official title: Phase I/IIa, Open-Label, Dose-Escalation Study of Safety and Tolerability of Intravitreal RST-001 in Patients With Advanced Retinitis Pigmentosa (RP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced Retinitis Pigmentosa
Keywords: gene therapy
optogenetics
channelrhodopsin
retina
retinitis pigmentosa
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-09-22
Enrollment: 14
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: Currently enrolling a total of 12 patients for Phase 2a of the study: 6 patients must have VA of no-better-than hand motion in the study eye, and 6 patients must have VA in the study eye to range from no-worse-than count fingers to 20/200 vision.


Eligibility criteria: Inclusion criteria:

Participants must meet all of the following criteria.

1. Age \>= 18 years
2. Signed and dated written informed consent obtained from the patient.
3. Ability to comply with testing and all protocol tests.

Exclusion criteria:

Any one of the following will exclude patients from being enrolled into the study:

1. Unable or unwilling to meet requirements of the study;
2. Participation in a clinical study (ocular or non-ocular) with an investigational drug, agent or therapy in the past six months

Primary outcomes:
measure: Number of Participants With Any Grade 3 or Greater Adverse Event (AE) Considered Related to RST-001.
timeFrame: Baseline (Day 1) to 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco- Dept. of Ophthalmology
state: California
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
Study officials:
affiliation: Allergan
name: Hanh Badger, PharmD
role: STUDY_DIRECTOR
References:
citation: Simunovic MP, Shen W, Lin JY, Protti DA, Lisowski L, Gillies MC. Optogenetic approaches to vision restoration. Exp Eye Res. 2019 Jan;178:15-26. doi: 10.1016/j.exer.2018.09.003. Epub 2018 Sep 13.
Clinical trial NCT03711136: Comparison of stAndard and Hybrid Surgical Techniques in the Treatment of proximaL Aortic dissEctions
Official title: Comparison of Standard and Hybrid Techniques in Surgical Treatment of Proximal Aortic Dissection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: State of Non-operated Aortic Segments
Aorto-related Events
Lead sponsor: Novosibirsk Scientific Research Institute for Circulatory Pathology
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with proximal aortic dissection operated using one of the techniques

Brief summary: The study is devoted to the evaluation of the results of surgical treatment of patients with proximal aortic dissection. Two groups of patients with standard and hybrid surgery are compared. Early and long-term postoperative results are evaluated.


Eligibility criteria: Inclusion Criteria:

* aortic dissection type A

Exclusion Criteria:

* age limits

Primary outcomes:
measure: Aorto-related events
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: NRICP
Study officials:
References:
Clinical trial NCT01402336: GnRH Antagonist Versus GnRH Agonist in Polycystic Ovary Syndrome During in Vitro Fertilization - Embryo Transfer
Official title: 'A Multicentre, Prospective Randomized Study to Assess the Effect When GnRH Antagonist is Started Either on Stimulation Day 1 and Day 6 vs. Conventional GnRH Agonist Long Protocol in Patients With Polycystic Ovary Syndrome Undergoing IVF-ET
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Polycystic Ovary Syndrome
Keywords: Polycystic ovary syndrome
ovulation induction
In vitro fertilization-embryo transfer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-07-26
Enrollment: 43
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: GnRH (Gonadotropin-releasing hormone) antagonists in IVF (in vitro fertilization) has been accomplished by several randomized controlled trials compared with conventional GnRH agonist long protocol in polycystic ovary syndrome (PCOS) patients. Moreover, there are debating issues that refer to the timing of GnRH antagonist initiation. The purpose of this study is to investigate the laboratory and clinical priority during ovarian stimulation for IVF in patients with PCOS treated with three different protocols.

Detailed description: GnRH Antagonist is Started on Stimulation Day 1 GnRH Antagonist is Started on Stimulation Day 6 Conventional GnRH Agonist Long Protocol

Eligibility criteria: Inclusion Criteria:

* PCOS patients (diagnosed as 2003 ASRM(The American Society for Reproductive Medicine)/ESHRE(The European Society of Human Reproduction and Embryology) consensus meeting guideline)
* age 20-40 years
* patients who have normal uterus
* Korean ethnicity

Exclusion Criteria:

* patients who have abnormal thyroid function
* patients who have abnormal prolactin test
* patients who have diabetes, or Cushing's syndrome, or congenital adrenal hyperplasia, or androgen-producing tumor.
* Patients who reject informed consent
* patients who have experience of adverse events for GnRH agonist, antagonist, recombinant FSH(follicle-stimulating hormone).

Primary outcomes:
measure: number of oocyte retrieved
timeFrame: ovum pick up day, At the point of ovum pick-up, we can count how many oocyte was retrieved. So, almost just after ovum pick-up, outcome measure will be possible.
Secondary outcomes:
measure: pregnancy rate
timeFrame: after confirming fetal heart beat via transvaginal ultrasound. Usually 2~4 weeks after ovum pick-up day.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Young Min Choi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04173936: Community-based Tai Chi, Balance, and Fall Risk
Official title: Effects of a Community-based Tai Chi Program on Balance, Functional Outcomes, and Sensorimotor Function in Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postural Balance
Fall
Proprioceptive Disorders
Lead sponsor: University of North Carolina at Asheville
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 405
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older adult volunteers willing to participate in a 12-week community-based tai chi program

Brief summary: Aims: Examine the effects of a community Tai Chi program on measures of balance and sensorimotor function.

Methods: In a pre-test and post-test design, balance was measured in older adults (N=344; 73.4±7.4 years) with 30-second chair stand, timed-up and go, and 4-stage balance test following a 12-week community-based tai chi intervention. Balance measures and additional sensorimotor measures, including hip abductor electromechanical delay and hip proprioception, were measured in a smaller sample of older adults (n=11; 67.3±3.7 years).


Eligibility criteria: Inclusion Criteria:

* age 60 years or older
* ability to independently ambulate
* self-described concern with stability and/or mobility.

Exclusion Criteria:

* Neurological diagnosis
* Participants body weight exceeds \>450 pounds).

Primary outcomes:
measure: 30-second chair number
timeFrame: 12 weeks
measure: Timed Up and Go
timeFrame: 12 weeks
measure: 4 stage balance test
timeFrame: 12 weeks
measure: Hip abductor muscle contraction time
timeFrame: 12 weeks
measure: Brief-Balance Evaluation System Test
timeFrame: 12 weeks
measure: Activities-Specific Balance Confidence Scale (ABC) scale
timeFrame: 12 weeks
measure: Hip joint proprioception error
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Asheville
country: United States
facility: UNC Asheville
state: North Carolina
Study officials:
affiliation: UNC Asheville
name: Jason R Wingert, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06926036: Micromanaging Human Sleep Physiology to Treat Sleep Apnea and Other Disorders
Official title: Micromanaging Human Sleep Physiology to Treat Sleep Apnea and Other Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Apnea Obstructive (OSA)
Keywords: sleep
sleep apnea obstructive (OSA)
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will examine whether a combination of breathing training during wake and targeted reactivation of the training during sleep can induce breathing changes during sleep and subsequent cognitive benefits during wake.

Participants with obstructive sleep apnea (who have not yet been treated for sleep apnea) will be recruited. Participants will engage in breath training for one week in their own homes and to record their sleep at home using commercially available mobile devices and subsequently have their sleep monitored for one night of polysomnography recordings plus targeted reactivation in a laboratory setting.


Eligibility criteria: Inclusion Criteria:

1. Right-handed, English-speaking adults, 18-60 years old who report normal hearing during sleep
2. Participants with suspected obstructive sleep apnea (OSA) (including those who have been diagnosed by a physician and those whose self-reported symptoms of OSA on the STOP-BANG questionnaire classify them as being "individuals with intermediate to high risk".
3. No report of any other sleep disorder besides OSA.
4. No report of any neurological or cardiometabolic diseases or disorders.
5. Not currently under active treatment for sleep apnea.
6. BMI ≤ 40.

Primary outcomes:
measure: Apnea-Hypopnea Index (AHI)
timeFrame: Day 1
measure: Respiratory event duration
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Ken A Paller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05337436: Ionized Magnesium Balance During Hemodialysis Session
Official title: Ionized Magnesium Balance During Hemodialysis Session
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Diseases
Keywords: Chronic Kidney Disease patient on dialysis (stage 5D)
Extracorporeal purification
Ionized magnesium
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients issued from dialysis units (non profit dialysis centers)

Brief summary: Aim of this study is to evaluate in a population of chronic kidney disease patients on dialysis (Stage 5D) the balance of total and ionized magnesium according to different types of dialysate used in clinical practice (acetate + Mg 0.50 or 0.75 mM vs citrate + Mg 0.50 ou 0.75 mM)


Eligibility criteria: Inclusion criteria:

* Chronic Kidney Disease patient on dialysis (stage 5D) for more than 1 month
* Anuric patient

Exclusion criteria:

* Patient protected by law
* Patient under guardianship ou curatorship
* Patient deprived of liberty

Primary outcomes:
measure: Comparison of ionized magnesium levels before and after dialysis session
timeFrame: day 1
Secondary outcomes:
measure: Comparison of total magnesium levels before and after dialysis session
timeFrame: day 1
measure: Comparison of ionized calcium levels before and after dialysis session
timeFrame: day 1
measure: Comparison of total calcium levels before and after dialysis session
timeFrame: day 1
measure: Per-dialytic balance of ionized magnesium according to predialysis level
timeFrame: day 1
measure: Per-dialytic balance of total magnesium according to predialysis level
timeFrame: day 1
measure: Per-dialytic balance of ionized calcium according to predialysis level
timeFrame: day 1
measure: Per-dialytic balance of total calcium according to predialysis level
timeFrame: day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
name: Jean-Paul CRISTOL, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT00218036: Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals - 8
Official title: Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cocaine Abuse
Opiate Dependence
Keywords: Cocaine Abuse
Opiate Abuse
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: University of Texas
First posted: 2005-09-22
Enrollment: 54
Sex: ALL
Minimum age (years): 22
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine two medications, modafinil and citalopram, in the treatment of cocaine dependent individuals who are maintained on methadone.

Detailed description: This is a 24-week, randomized, double-blind, placebo-controlled study examining two doses of modafinil (200 and 400 mg) and citalopram (20 and 40 mg) in the treatment of methadone maintained cocaine dependent individuals.

Participants will first be given methadone to determine its tolerated and effective doses. Most participants will be able to reach a stable dose of methadone within 7 to 10 days of methadone initiation. When 80% of the projected dose of methadone has been achieved, participants will begin the medication regimen of modafinil or citalopram. Modafinil will be given over a 7-day period. Dosing of modafinil will begin at 200 mg and, depending on the individual, may increase to 400 mg. Citalopram will be given in increasing doses, starting at 20 mg and increasing to 40mg.

Eligibility criteria: Inclusion Criteria:

* Meets cocaine abuse and dependence criteria (as determined by the SCID)
* Meets opiate dependence criteria (as determined by the SCID)
* In good general physical and psychiatric health (except for possible acute drug use related problems)

Exclusion Criteria:

* Meets diagnostic criteria for other psychiatric disorders, including other forms of drug dependence (other than nicotine)
* Current cardiovascular disease (as determined by an electrocardiogram)
* Circumstances will not allow for completion of study (on probation or parole)
* Ethical constraints of supervision do not allow confidentiality (on probation or parole)

Primary outcomes:
measure: Confirmed Abstinence From Cocaine
timeFrame: 12 weeks of treatment
Secondary outcomes:
measure: Retention
timeFrame: 12 weeks of treatment
measure: Medication Compliance
timeFrame: 12 weeks of treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
affiliation: University of Texas
name: Joy M Schmitz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Medical School at Houston
name: F. Gerard Moeller, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00420836: Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study
Official title: Crossover Pharmacokinetic Study of Tobramycin Administered for Inhalation by PARI eFlow® Rapid Electronic Nebulizer (no Compressor) vs. PARI LC PLUSTM Jet Nebulizer (With Compressor) in Cystic Fibrosis Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Keywords: Cystic fibrosis, tobramycin, PARI eFlow, PARI LC Plus, nebulizer, pharmacokinetic
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-11
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study assesses the aerosol delivery characteristics (measured by nebulization time, serum and sputum tobramycin pharmacokinetic parameters) and safety of tobramycin administered for inhalation by PARI eFlow rapid electronic nebulizer (no compressor) vs. PARI LC PLUS Jet Nebulizer (with compressor) in subjects with cystic fibrosis.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects aged 6 years or over at the time of screening,
* Chronically colonized with Pseudomonas aeruginosa.
* Diagnosis of cystic fibrosis (CF)
* Ability to expectorate sputum samples on command.
* Ability to tolerate a 1-week washout interval with no inhaled tobramycin or other aminoglycoside treatment.
* Clinically stable in the opinion of the investigator.

Exclusion Criteria:

* Inhaled or intravenous aminoglycosides within 7 days before study drug administration.
* Any investigational drug within 2 weeks before screening.
* Loop diuretics within 7 days before study drug administration.
* Current use of inhaled tobramycin delivered by the PARI LC PLUS jet nebulizer without washout period of at least 1 week before entering the study.
* Women who are, or plan to become, pregnant during the course of the study.
* Serum creatinine or blood urea (BU) above the upper limit of normal for sex and age, or an abnormal urine analysis
* Known local or systemic hypersensitivity to aminoglycosides.

Other protocol defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Aerosol delivery characteristics of tobramycin when inhaled using either PARI LC PLUS jet nebulizer or PARI eFlow rapid Electronic Nebulizer evaluated by serum concentrations
Secondary outcomes:
measure: Potential accumulation of tobramycin in serum measured as the change in tobramycin levels from the first day of treatment to the last day of treatment.
measure: Pharmacokinetics
measure: Safety assessed by adverse events, serious adverse events
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Basel
role: STUDY_DIRECTOR
References: