louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06940726: Exploring the Links Between Hearing, Cognition and Brain Activity in People With Tinnitus
Official title: Exploration Des Liens Entre Audition, Cognition et activité cérébrale Chez Des Personnes présentant un acouphène
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tinnitus
Keywords: tinnitus
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
Collaborators: name: IHU reConnect
First posted: 2025-04-23
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this observational study is to understand the mechanisms underlying tinnitus, and improve the clinical assessment strategies needed to develop targeted therapeutic interventions by comparing endogenous attention capacities in healthy subjects and subjects with tinnitus


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Good written and oral comprehension of the French language
* Normal or corrected vision

Group of people with tinnitus :

- Chronic tinnitus \> 3 months, uni or bilateral, stable (no period of remission)

Control group :

- No tinnitus

Exclusion Criteria:

* Presence of a known neurological disorder
* Presence of a known degenerative pathology
* Presence of a known hearing impairment
* Presence of a motor disability of the upper limbs
* Severe or profound deafness on one or both sides
* Person under legal protection (guardianship, curatorship, etc.)
* Use of hearing aids

Primary outcomes:
measure: Contingent negative variation (CNV) in EEG
timeFrame: 2 hours
Secondary outcomes:
measure: Response reaction time (in ms)
timeFrame: 2 hours
measure: Answer accuracy (% correct answers)
timeFrame: 2 hours
measure: Cerebral oscillations (alpha bands) obtained by EEG during behavioural tasks
timeFrame: 2 hours
measure: Skin conductance (μS)
timeFrame: 2 hours
measure: Heart rate variability (in ms)
timeFrame: 2 hours
measure: Pupillometry (pupillary dilation in mm)
timeFrame: 2 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03868826: Pain, Function and Quality of Life Before and After Treatment of Hamstring Avulsion
Official title: Pain, Function and Quality of Life Before and After Treatment of Hamstring Avulsion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hamstring Injury
Lead sponsor: Horsens Hospital
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 24
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 diagnosed with hamstring avulsion

Brief summary: The aim of the study is to investigate pain, function and quality of life before and 10-12 months after surgical repair and/or rehabilitation of hamstrings avulsion


Eligibility criteria: Inclusion Criteria:

* Patients eligible for treatment of hamstring avulsion

Exclusion Criteria:

* Conditions that contraindicate muscle strength testing e.g. cancer and neurological conditions
* Patients that do not speak or understand Danish

Primary outcomes:
measure: Perth Hamstring Assessment Tool (PHAT) (0-100 scale)
timeFrame: Change from before surgery to 10-12 months after surgery on the 0-100 scale.
measure: Knee flexion strength of affected leg (Newton meters per kilogram)
timeFrame: Change from before surgery to 10-12 months after surgery
measure: Hip extension strength of affected leg (Newton meters per kilogram)
timeFrame: Change from before surgery to 10-12 months after surgery
measure: Overall health
timeFrame: Change from before surgery to 10-12 months after surgery on the 0-100 scale
Secondary outcomes:
measure: Knee flexion strength of contralateral leg (Newton meters per kilogram)
timeFrame: Change from before surgery to 10-12 months after surgery
measure: Hip extension strength of contralateral leg (Newton meters per kilogram)
timeFrame: Change from before surgery to 10-12 months after surgery
measure: Hip Sports Activity Scale (0-8 scale)
timeFrame: Change from before surgery to 10-12 months after surgery on the 0-8 scale
Other outcomes:
Locations:
city: Horsens
country: Denmark
facility: Signe Kierkegaard
state: Danmark
Study officials:
References:
citation: Spoorendonk K, Bohn MB, Storm JO, Lund B, Kierkegaard-Brochner S. Proximal Hamstring Avulsions: Surgical Versus Conservative Treatment Using a Shared Decision-Making Strategy. Orthop J Sports Med. 2024 Oct 21;12(10):23259671241275656. doi: 10.1177/23259671241275656. eCollection 2024 Oct.
Clinical trial NCT00837226: Effects of Weight Loss From Bariatric Surgery on Intraocular Pressure (IOP)
Official title: The Effects of Weight Loss From Bariatric Surgery on Intraocular Pressure
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Intraocular Pressure
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2009-02-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are included in this study will have been evaluated for bariatric surgery and will meet the current eligibility requirements for bariatric surgery. These requirements include that the patient must have failed dietary therapy and have a BMI(body mass index) greater than 40 kg/m2 without associated comorbidities or have a BMI greater than 35 kg/m2 with associated comorbidities. Eleven subjects who will be evaluated for bariatric surgery but choose not to undergo the surgery will be recruited to serve as controls and to verify the changes in intraocular pressure (IOP) are due to the weight loss. It is expected that the IOP of the control patients will be relatively stable, assuming the patients will not have any other surgery or intervention which could affect the IOP.

Brief summary: The purpose of this study is to determine if there is an effect on the eye pressure from extreme weight loss by bariatric procedures. The hypothesis is that excess fat in the orbit of the eye compresses on the outflow system, which causes an elevated eye pressure. This can have many consequences, including the risk for glaucoma. We hope to establish if there is an effect between eye pressure and weight.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Written informed consent obtained
* BMI \> 40 kg/m2 without associated comorbidities or \> 35 kg/m2 with associated comorbidities. In the normal indication for routine bariatric surgery, comorbidities include hypertension, type II diabetes, venous stasis, sleep apnea, polycystic ovary syndrome, pseudotumor cerebri, nonalcoholic steatohepatitis, gastroesophageal reflux disease, coronary artery disease, degenerative joint disease, cancer, and hypercholesterolemia.

Exclusion Criteria:

* Current use of systemic steroids
* Any systemic medication which is unstable and can affect IOP
* History or evidence of glaucoma
* Any ocular trauma or ocular surgery
* Outside normal range of corneal thickness (500-600 microns)
* Unable to follow-up for 3 years
* Participating in any investigational device or medication study within 30 days of baseline

Primary outcomes:
measure: Intraocular pressure
timeFrame: Data will be recorded the same day when a patient comes to the clinic.
Secondary outcomes:
Other outcomes:
Locations:
city: Bellaire
country: United States
facility: Minimally Invasive Surgeons of Texas
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Robert Feldman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01591226: Caffeine and Sodium Citrate Ingestion
Official title: Effects of Caffeine and Sodium Citrate Ingestion in 1500m Wheelchair Racing Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Supplements
Heart Rate/Drug Effects
Lactic Acid/Metabolism
Physical Education and Training/Methods
Wheelchairs
Keywords: caffeine
sodium citrate
exercise performance
wheelchair athletes
1500m
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2012-05-03
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: A positive ergogenic effect of sodium citrate and caffeine ingestion in a short-term, high-intensity exercise task was shown by several studies. These studies were conducted with healthy, able-bodied subjects.

The aim of the study is to investigate whether caffeine or sodium citrate ingestion could enhance performance in spinal cord injured wheelchair athletes. It is a double blind, placebo controlled and randomized study.

Detailed description: The athletes have to complete four 1500m tests on a training roller. Before each treatment they get different supplementations. Once they get sodium citrate and a placebo, once caffeine and a placebo, once sodium citrate and caffeine and for the fourth treatment they get twice a placebo. Two hours after starting with the supplementation they have to complete the 1500m as fast as possible. Time to complete 1500m, blood pH, plasma bicarbonate, sodium concentration, heart rate, oxygen consumption, blood lactate concentration and rate of perceived exertion (RPE) were measured.

Eligibility criteria: Inclusion Criteria:

* wheelchair athletes
* national team
* category T53 and T54

Exclusion Criteria:

* medicated
* pregnant (for women)
* cardiovascular and respiratory diseases

Primary outcomes:
measure: Time
timeFrame: 3 weeks
Secondary outcomes:
measure: Heart Rate
timeFrame: during study phase of 3 week (4 tests)
measure: Lactate Concentration
timeFrame: during the 3 weeks study phase
measure: blood pH, sodium concentration and plasma bicarbonate
timeFrame: during the 3 weeks of study phase
measure: Oxygen Consumption
timeFrame: during 3 weeks of study phase
measure: rating of gastrointestinal stress
timeFrame: during the 3 weeks of study phase
measure: Rating of Perceived Exertion (RPE)
timeFrame: during the 3 weeks of study phase
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: Lucerne
Study officials:
affiliation: Swiss Paraplegic Research, Nottwil
name: Claudio Perret, Dr. sc. nat.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00119626: Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
Official title: SAINT I (Stroke - Acute Ischemic - NXY Treatment) A Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter, Phase IIb/III Study to Assess the Efficacy and Safety of Intravenous NXY-059 in Acute Ischemic Stroke.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cerebral Stroke
Ischemic Attack, Transient
Keywords: Stroke, Acute
Cerebrovascular Stroke
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-07-14
Enrollment: 1700
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: This study will determine if NXY-059 will reduce functional disability from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strength and coordination.


Eligibility criteria: Inclusion Criteria:

* Males and females
* Acute ischemic stroke with limb weakness, onset of symptoms within 6 hours
* Full functional independence prior to the present stroke

Exclusion Criteria:

* Unconsciousness
* Subjects who are unlikely to complete the infusion of investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition
* Severe illness with life expectancy less than 6 months
* Known severe kidney disorder
* Current known alcohol or illicit drug abuse or dependence
* Pregnant or breast-feeding
* Treatment with acetazolamide and methotrexate is not permitted during the infusion
* Participation in a previous clinical study within 30 days

Primary outcomes:
measure: Global disability on modified Rankin scale at 90 days.
Secondary outcomes:
measure: NIH stroke scale (termed "co-primary" in study protocol), Barthel Index, Stroke Impact Scale, EQ-5D all at 90 days, Safety outcomes.
Other outcomes:
Locations:
city: Södertälje
country: Sweden
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca NXY-059 Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: Lees KR, Zivin JA, Ashwood T, Davalos A, Davis SM, Diener HC, Grotta J, Lyden P, Shuaib A, Hardemark HG, Wasiewski WW; Stroke-Acute Ischemic NXY Treatment (SAINT I) Trial Investigators. NXY-059 for acute ischemic stroke. N Engl J Med. 2006 Feb 9;354(6):588-600. doi: 10.1056/NEJMoa052980.
Clinical trial NCT01297257: DELIVER Study: DELiverability of the Resolute Integrity Stent in All-Comer Vessels and Cross-OvER Stenting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
Collaborators: name: Medtronic Cardiac Rhythm and Heart Failure
First posted: 2011-02-16
Enrollment: 7845
Sex: ALL
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: The study population will consist of patients with symptomatic ischemic heart disease due to stenotic lesions in coronary arteries or bypass graft that are amenable to percutaneous treatment.

Brief summary: The primary objective of the DELIVER Study is to assess the deliverability of the Resolute Integrity Stent as primary stent or as a secondary cross-over stent following delivery failure of another stent type in real world patients.


Eligibility criteria: Inclusion Criteria:

* Minimum legal age (18)
* Acceptable candidate for treatment with a drug-eluting stent in accordance with applicable guidelines
* Patient has consented to participate and authorized in writing the collection and release of medical information

Exclusion Criteria:

* Pregnancy
* Participating in another study that interferes with study endpoints
* Untreatable hypersensitivity or allergies to aspirin, heparin, clopidogrel, zotarolimus or similar drugs or contrast media
* Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated

Primary outcomes:
measure: Delivery Success
timeFrame: stent implantation until hospital discharge (average 1-3 days)
Secondary outcomes:
measure: In-hospital MACE (Major Adverse Cardiac Event)
timeFrame: stent implantation until hospital discharge (average 1-3 days)
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis Ziekenhuis
Study officials:
References:
Clinical trial NCT00465257: Efficacy of Artesunate + Amodiaquine Four Years After Its Introduction in Zanzibar
Official title: Efficacy of Artesunate + Amodiaquine Four Years After Its Introduction as New Treatment Policy for Uncomplicated Plasmodium Falciparum Malaria in Zanzibar
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Malaria
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2007-04-24
Enrollment: 110
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to assess the efficacy of artesuante + amodiaquine four years after its introduction as first line treatment for uncomplicated childhood malaria in Zanzibar. The hypothesis is that the treatment has a polymerase chain reaction (PCR)adjusted parasitological cure rate of at least 85% 42 days after treatment.


Eligibility criteria: Inclusion Criteria:

* Age below 60 months
* Weight ≥5kg
* No general danger signs or severe malaria present (see 4.4.2.1 \& 4.4.2.2)
* History of fever within 24 hours OR axillary temperature ≥ 37.5Cº
* No other cause of fever is detectable
* No severe malnutrition
* Presence of P. falciparum asexual parasite density between 2000- 200,000/ul
* Guardian/Patient has understood the procedures of the study and is willing to participate
* Patient able to come for stipulated follow up visits and has easy access to the Study Site

Exclusion Criteria:

* Not able to drink or breastfeed
* Persistent Vomiting
* Recent history of convulsions
* Lethargic or unconscious
* Unable to sit or stand (as appropriate for age)
* History of allergy to test drugs
* History of intake of any drugs other than paracetamol and aspirin within 3 days

Primary outcomes:
measure: PCR adjusted parasitological cure rate by day 42.
Secondary outcomes:
Other outcomes:
Locations:
city: Kivunge
country: Tanzania
facility: Kivunge Cottage Hospital
state: North A District, Zanzibar
Study officials:
affiliation: Karolinska UH
name: Anders Björkman, Professor
role: STUDY_DIRECTOR
affiliation: Karolinska UH
name: Guida Rotlland, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03803657: Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates
Official title: Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Calorie Overload
Calorie Deficiency
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mechanically ventilated children.

Brief summary: The investigators have created and validated a device that allows us to accurately measure how many calories a baby consumes every day. The purpose of this study is to compare how many calories a baby consumes with how many calories are provided in a population of newborn infants and children. This may help clinicians to better understand how to feed babies during times of critical illness.


Eligibility criteria: Inclusion Criteria:

1. Mechanically ventilated neonates, infants and children, regardless of age, up to 10 kg
2. Inpatients in the cardiac (8S), medical-surgical (7S) or neonatal (7N) intensive care unit
3. Assent of patient's intensive care attending physician
4. Written parental informed consent.
5. Patient on conventional mechanical ventilation on a Servo I or Servo U ventilator with fraction of inspired oxygen \<80%.

Exclusion Criteria:

1. Clinically significant tracheo-esophageal fistula
2. Measured ETT leak \>20% (i.e. difference between inspiratory and expiratory tidal volumes)
3. Patient on high frequency oscillatory ventilation or high frequency jet ventilation.

Primary outcomes:
measure: Average caloric expenditure
timeFrame: through study completion, an average of 3 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Nachman E, Clemensen P, Santos K, Cole AR, Polizzotti BD, Hofmann G, Leeman KT, van den Bosch SJ, Kheir JN. A Device for the Quantification of Oxygen Consumption and Caloric Expenditure in the Neonatal Range. Anesth Analg. 2018 Jul;127(1):95-104. doi: 10.1213/ANE.0000000000003308.
Clinical trial NCT05663957: eVusheld Assessment reaL wORld Effectiveness in the VA Health System
Official title: An Observational Study to Assess the Real-World Effectiveness of EVUSHELD™ (Tixagevimab/Cilgavimab) as Pre-exposure Prophylaxis Against COVID-19 Among EVUSHELD-eligible Populations Receiving Care in VA Health System in the United States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2, COVID-19
Keywords: EVUSHELD
tixagevimab and cilgavimab
Pre-exposure prophylaxis
COVID-19
SARS-CoV-2
Effectiveness
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: VA Informatics and Computing Infrastructure (VINCI)
First posted: 2022-12-23
Enrollment: 5814
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All EUA-eligible immunocompromised patient population in the Department of Veterans Affairs Health System.

Brief summary: An AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population in the Department of Veterans Affairs (VA) Health System.

Detailed description: This a Phase IV observational, secondary data study to assess the effectiveness of Evusheld in preventing COVID-19 infection and severe outcomes using the electronic medical records from the nationwide integrated health system.

The study is designed as an AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population in the VA Health System.

Eligibility criteria: Inclusion Criteria:

1. Receipt of EVUSHELD under the FDA EUA for EVUSHELD
2. Eligibility to access EVUSHELD use under the EUA.

Exclusion Criteria:

* None

Primary outcomes:
measure: Hospitalization due to COVID-19
timeFrame: up to 6 months
measure: All-cause mortality
timeFrame: Up to 6 months
Secondary outcomes:
measure: Documented SARS-COV-2 infection
timeFrame: up to 6 and 12 months
measure: Medically attended COVID-19
timeFrame: up to 6 and 12 months
measure: COVID-19 hospitalisation
timeFrame: up to 12 months
measure: COVID-19 Intensive Care Unit (ICU) admisssion
timeFrame: up to 6 and 12 months
measure: COVID-19-related mortality
timeFrame: up to 6 and 12 months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
Study officials:
affiliation: VA Informatics and Computing Infrastructure (VINCI)
name: Scott L DuVall, PhD
role: PRINCIPAL_INVESTIGATOR
References: