louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04353856: Quality of Life During a Twin Pregnancy
Official title: Evolution of the Quality of Life During a Twin Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Twin Pregnancy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 50
Sex: FEMALE
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: women over 18 years old, followed for a twin pregnancy

Brief summary: Quality of life has recently appeared as a component of health. Pregnancy has an impact on the quality of life of the parturient, whether through physical or psychological changes.

It is common to think that quality of life is altered in the context of a twin pregnancy, but this has never been scientifically demonstrated.

The hypothesis is to observe a decrease in the quality of life of pregnant women with twins at the end of pregnancy, in particular in case of a pregnancy-related pathology.


Eligibility criteria: Inclusion Criteria:

* woman over 18
* ongoing twin pregnancy (2 live fetuses)
* pregnancy \<15 weeks (weeks of gestation) completed
* patient with follow-up at the Hôpital Femme Mère Enfant
* person having expressed her non-opposition

Exclusion Criteria:

* inability to understand the information given and the questionnaire
* person deprived of liberty, under guardianship

Primary outcomes:
measure: Quality of life EQ5D questionnaire
timeFrame: Month 3
measure: Quality of life EQ5D questionnaire
timeFrame: Month 4
measure: Quality of life EQ5D questionnaire
timeFrame: Month 5
measure: Quality of life EQ5D questionnaire
timeFrame: Month 6
measure: Quality of life EQ5D questionnaire
timeFrame: Month 7
measure: Quality of life EQ5D questionnaire
timeFrame: Month 8
measure: Quality of life EQ5D questionnaire
timeFrame: Month 9
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
Study officials:
References:
Clinical trial NCT00626756: Lithium Dilution Method in Guiding Fluid Therapy in Critically Ill Patients
Official title: LIGA Trial-Lithium Dilution Method in Guiding Fluid Therapy in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Illness
Keywords: fluid
Lidco technology
guided therapy
fluid management guided by Lidco technology
Lead sponsor: ASQA a.s.
Sponsor class: INDUSTRY
First posted: 2008-02-29
Enrollment: 15
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: HEALTH_SERVICES_RESEARCH

Brief summary: Hypothesis: Fluid management guided by LiDCO doesn´t increase cumulative fluid balance and shorten organ dysfunction compared to fluid management based on CVP and clinical judgment.


Eligibility criteria: Inclusion Criteria:

* Age
* Needs for fluid chalange
* Invasive ventilatory supportinvasive blood pressure monitoring
* Lidco monitoring
* Central venous catheter

Exclusion Criteria:

* DNR
* Need for CRRT
* Head injury

Primary outcomes:
measure: positive or negative fluid balance
timeFrame: one year
Secondary outcomes:
measure: effect of LiDCO monitoring on cumulative fluid balance
timeFrame: one year
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: ASQA a.s.
Study officials:
affiliation: University Hospital Hradec Kralove
name: Vladimir Cerny, MD, PhD, FCCM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sinclair S, James S, Singer M. Intraoperative intravascular volume optimisation and length of hospital stay after repair of proximal femoral fracture: randomised controlled trial. BMJ. 1997 Oct 11;315(7113):909-12. doi: 10.1136/bmj.315.7113.909.
citation: Wakeling HG, McFall MR, Jenkins CS, Woods WG, Miles WF, Barclay GR, Fleming SC. Intraoperative oesophageal Doppler guided fluid management shortens postoperative hospital stay after major bowel surgery. Br J Anaesth. 2005 Nov;95(5):634-42. doi: 10.1093/bja/aei223. Epub 2005 Sep 9.
citation: Price J, Sear J, Venn R. Perioperative fluid volume optimization following proximal femoral fracture. Cochrane Database Syst Rev. 2002;(1):CD003004. doi: 10.1002/14651858.CD003004.
citation: Price JD, Sear JW, Venn RM. Perioperative fluid volume optimization following proximal femoral fracture. Cochrane Database Syst Rev. 2004;(1):CD003004. doi: 10.1002/14651858.CD003004.pub2.
citation: Conway DH, Mayall R, Abdul-Latif MS, Gilligan S, Tackaberry C. Randomised controlled trial investigating the influence of intravenous fluid titration using oesophageal Doppler monitoring during bowel surgery. Anaesthesia. 2002 Sep;57(9):845-9. doi: 10.1046/j.1365-2044.2002.02708.x.
Clinical trial NCT06829056: Presence of Pain Shows Greater Effect Than Tendon Structural Alignment During Landing Dynamics
Official title: Presence of Pain Shows Greater Effect Than Tendon Structural Alignment During Landing Dynamics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patellar Tendon
Athletes
Keywords: jump performance
patellar tendon
tendon structure
UTC
Lead sponsor: Escola Superior de Tecnologia da Saúde do Porto
Sponsor class: OTHER
Collaborators: name: Universitat Internacional de Catalunya
First posted: 2025-02-17
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population for this study consisted of volleyball athletes aged 18 to 35, of both sexes.

Brief summary: The goal of this observational study is to investigate the relationship between temporal, kinetic, and kinematic jump variables and patellar tendons' structure in athletes. The main research questions are:

Does the structure of the patellar tendon relate to the temporal, kinetic, and kinematic variables of different jumps?

To answer these questions, participants will undergo a UTC (Ultrasound Tissue Characterization) scan of the patellar tendon and perform two vertical jump: a countermovement jump and tuck jump test.


Eligibility criteria: Inclusion Criteria:

* aged between 18-30 years;
* competing in the highest-level Portuguese volleyball league with a minimum of 10 years of volleyball practice.

Exclusion Criteria:

* presence of injuries or discomfort that impeded maximal jumping tests;
* history of surgery within the last 12 months;
* illness during data collection

Primary outcomes:
measure: Tendon Structure
timeFrame: Baseline
measure: Jump Variables
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Escola Superior de Saúde do Instituto Politécnico do Porto
Study officials:
References:
Clinical trial NCT04859556: Performance, Safety and Efficiency Comparison Between 10,000 and 5,000 Cuts Per Minute Vitrectomy Using a 25G Cutter - A Prospective Randomized Controlled Study
Official title: Performance, Safety and Efficiency Comparison Between 10,000 and 5,000 Cuts Per Minute Vitrectomy Using a 25G Cutter - A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitreous Hemorrhage
Macula Hole
Epiretinal Membrane
Retinal Detachment
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2021-04-26
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: As technology advances, vitrectomy cutters are smaller and cut rates have become faster. In this prospective study, the vitrectomy efficiency and safety between 5,000 cuts per minute with 10,000 cuts per minute are compared

Detailed description: Purpose:

This study aims to compare the performance of the Alcon 25+® UltraVit® 5000 cpm vitrectomy probe versus the 25+® Ultravit 10,000 cpm® beveled tip, dual drive vitrectomy probe. The safety profile and efficiency were compared.

Method:

Prospective, randomised study. Consecutive patients from January 2019 to August 2019 requiring vitrectomy for retinal detachment, epiretinal membrane, vitreous haemorrhage, and macula hole were randomized into either the 10K or 5K vitrectomy group. Both groups underwent vitrectomy using the proportional vacuum mode with the cut rate set at the fastest rate. Patients with previous vitrectomy, other ocular diseases (glaucoma, corneal disease, or significant corneal opacities), or trauma were excluded from the study. The primary endpoint was vitrectomy time, while secondary endpoints included posterior vitreous detachment time, intraoperative complications, and number of instruments used. The preoperative, postoperative 1 month and 3 month best corrected visual acuity (BCVA), and complications were recorded.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients over the age of 18 requiring vitrectomy for vitreous haemorrhage (VH), epiretinal membrane (ERM), macular hole (MH), dislocated lens, rhegmatogenous retinal detachment and diabetic tractional retinal detachment were randomized into the study from January 2019 till August 2019

Exclusion Criteria:

* Patients with ocular comorbidities affecting surgical view including corneal opacities or scar, previous vitrectomy, history of trauma or requiring silicone oil were excluded from the study

Primary outcomes:
measure: Vitrectomy time
timeFrame: 1 day
Secondary outcomes:
measure: Safety and complications
timeFrame: up to 6 months
measure: Number of instruments used
timeFrame: 1 Day
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
Study officials:
References:
Clinical trial NCT04882709: Compression Headphone Study
Official title: Using Headphone Presentation to Investigate Compression Strategy Modifications in Hearing Aids for Moderate-to-severe Hearing Loss
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
Collaborators: name: Sonova Canada Inc.
First posted: 2021-05-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The stimuli consist of speech in quiet, speech in noise, reverberant speech, and music recorded with different hearing aid settings, post-processed for headphone presentation and incorporated in an online sound survey. Participants will receive tablets and headphones to conduct a sound quality rating at home. The survey will involve a training session and within-subject repeated measures. Stimuli will be randomized.


Eligibility criteria: Inclusion Criteria:

* Adults (18-99 years) with ≥3 months hearing aid experience
* binaural, symmetric, sensorineural N3 to N4 hearing loss
* able to use Android interface and receive a video call on phone/computer
* fluent in English

Exclusion Criteria:

* children/teenagers
* normal hearing or hearing loss exceeding N4 by 10dB
* cannot wear over-ear headphones

Primary outcomes:
measure: Sound quality rating
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Sonova Innovation Centre Toronto
state: Ontario
Study officials:
affiliation: Sonova Canada Inc.
name: Jinyu Qian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02554409: Sanofi Pasteur Quadrivalent Intradermal Influenza Vaccine Pregnancy Registry
Official title: Sanofi Pasteur Quadrivalent Intradermal Influenza Vaccine Pregnancy Registry Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Influenza
Keywords: Fluzone Quadrivalent Intradermal Influenza Vaccine
Pregnancy Registry
Influenza
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2015-09-18
Enrollment: 87
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women exposed to Sanofi Pasteur's Quadrivalent Intradermal Influenza Vaccine (QIV ID)

Brief summary: The Sanofi Pasteur Fluzone Intradermal Quadrivalent vaccine (Fluzone QIV-ID) Pregnancy Registry will be a prospectively recruited pregnancy surveillance program designed to collect to collect and analyze information on vaccine exposures, pregnancy outcomes, and fetal and offspring outcomes on pregnant women exposed to Fluzone QIV-ID vaccine.

Detailed description: Sanofi Pasteur will encourage registration of pregnant women exposed to Fluzone QIV-ID in the Sanofi Pasteur Pregnancy Registry by providing the registry's toll-free number, 1-800-VACCINE (1-800-822-2463), in the USPI. The toll-free number will also be available through the Sanofi Pasteur-sponsored Website for the Pregnancy Registry. Both the United States product insert (USPI) and Website will advise health care providers to register women who are pregnant or became aware they were pregnant at the time of Fluzone QIV-ID immunization.

Descriptive statistical methods will be the primary approach for summarizing data from the Fluzone QIV-ID Pregnancy Registry. No vaccine products will be provided or administered as part of this registry protocol.

Eligibility criteria: Inclusion Criteria:

Pregnant women will be enrolled in the registry prospectively (after exposure to a product but before the conduct of any prenatal tests that could provide knowledge of the outcome of pregnancy). If the condition of the fetus has already been assessed through prenatal testing (e.g., targeted ultrasound, amniocentesis, etc.), such reports will be considered retrospective reports. Retrospective reports are also eligible for the registry, but they will be analyzed separately from prospective reports.

Exclusion Criteria:

N/A

Primary outcomes:
measure: Number of cases and outcomes of pregnancies following exposure to QIV ID vaccine.
timeFrame: Up to six years
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Albany
country: United States
state: New York
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Product Safety Officer
role: STUDY_DIRECTOR
References:
Clinical trial NCT03049709: Non-invasive Validation of Non-invasive Central Blood Pressure Measurements Using Oscillometric Pulse Wave Analysis
Official title: Non-invasive Automated Central Blood Pressure Measurements Using Oscillometric Pulse Wave Analysis - Comparison With Non-Invasive Reference Values
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Hypertension
Healthy Control
Coronary Heart Disease
Diabetes Mellitus
Keywords: central blood pressure
measurement
oscillometric radial pulse wave analysis
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2017-02-10
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: in-patients and healthy controls (students, hospital staff)

Brief summary: There is growing evidence that central blood pressure is a better predictor of hypertensive end-organ damage and cardiovascular outcome than routine brachial readings.

The investigators aimed to evaluate the accuracy of a novel device for the non-invasive determination of central blood pressure based on automated oscillometric radial pulse wave analysis.


Eligibility criteria: Inclusion Criteria:

* cardiovascular disease, diabetes mellitus or healthy control

Exclusion Criteria:

* inability to give informed consent
* hemodynamic instability

Primary outcomes:
measure: agreement of systolic central blood pressure measurements
timeFrame: 15 minutes
measure: agreement of diastolic central blood pressure measurements
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim
Study officials:
affiliation: Universitätsmedizin Mannheim
name: Jens J Kaden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsmedizin Mannheim
name: Joachim Saur, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsmedizin Mannheim
name: Urs Benck, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00681109: Topical IL-1-Ra for Treatment of Posterior Blepharitis
Official title: Safety and Efficacy of Topical Interleukin-1-Receptor Antagonist in the Treatment of Signs and Symptoms of Posterior Blepharitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Posterior Blepharitis
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2008-05-21
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: 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 the effectiveness and safety of Topical Interleukin-1-Receptor Antagonist in treatment of signs and symptoms of posterior blepharitis.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of posterior blepharitis
* A negative urine pregnancy test result for women of childbearing potential
* Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation
* Normal lid position and closure
* Ability to understand and provide informed consent to participate in this study
* Willingness to follow study instructions and likely to complete all required visits.

Exclusion Criteria:

* History of Stevens-Johnson syndrome or ocular pemphigoid
* History of eyelid surgery
* Intra-ocular surgery or ocular laser surgery within 3 months
* History of microbial keratitis, including herpes
* Active ocular allergies
* Corneal epithelial defect \> 1mm2
* Use of topical steroids or Restasis within the past 2 weeks
* Use of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the last month
* Use of isotretinoin (Accutane) within the past 6 months
* Have had any previous treatment with Anakinra (Kineret®) or any therapeutic agent targeted at IL-1 blockade
* Pregnant or lactating women
* Signs of current infection, including fever and current treatment with antibiotics
* Liver, renal, or hematologic disease
* The use of any other investigational drug

Primary outcomes:
measure: Meibomian Gland Secretion Quality
timeFrame: 12 Week Time Point
measure: Tear Breakup Time (TBUT)
timeFrame: 12 Week Time Point
measure: Corneal Fluorescein Staining Score
timeFrame: 12 Week Time Point
measure: Ocular Surface Disease Index (OSDI)
timeFrame: Baseline and 12 Week Time Point data
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts Eye and Ear Infirmary
name: Reza Dana, MD, MPH, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amparo F, Dastjerdi MH, Okanobo A, Ferrari G, Smaga L, Hamrah P, Jurkunas U, Schaumberg DA, Dana R. Topical interleukin 1 receptor antagonist for treatment of dry eye disease: a randomized clinical trial. JAMA Ophthalmol. 2013 Jun;131(6):715-723. doi: 10.1001/jamaophthalmol.2013.195.
Clinical trial NCT06834009: A Study of Suzetrigine (SUZ) Spray-dried Dispersion (SSD) in Healthy Adult Panelists
Official title: A Phase 1, Open-label, Taste Assessment Study of Suzetrigine Spray-dried Dispersion in Healthy Adult Panelists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2025-02-19
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the sensory attributes (basic tastes, aroma, texture, mouthfeel) of SUZ SDD and assess the impact of the dose on the sensory attributes.

Detailed description: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility criteria: Key Inclusion Criteria:

- Panelists are qualified based on training and experience. They will be required to detect, identify, recognize, and accurately describe different taste elements and flavor combinations.

Key Exclusion Criteria:

* History of any illness or clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the participant
* Sensitivity to SUZ
* Pregnant, nursing, or planning to become pregnant during the study

Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Flavor Assessment Based on Flavor Profile Method of Descriptive Sensory Analysis per American Society for Testing and Material (ASTM) Approved Sensory Evaluation Method
timeFrame: Periodic Intervals up to 30 minutes post oral administration
Secondary outcomes:
Other outcomes:
Locations:
city: Woburn
country: United States
facility: Senopsys, LLC
state: Massachusetts
Study officials:
References: