louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04079127: Avenir Müller Hip Stem Post Market Surveillance Study
Official title: A Multi-centre, Non-comparative, Retrospective Post-market Surveillance Study to Obtain Clinical Outcomes Data on the Zimmer Avenir Müller Hip Stem
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Hip
Rheumatoid Arthritis
Fracture of Hip
Dislocated Hip
Osteonecrosis
Post-traumatic; Arthrosis
Subluxation Hip
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2019-09-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from severe hip pain and disability requiring a total hip arthroplasty.

Brief summary: This study is a Post Market Clinical Follow up study to fulfil the post market surveillance obligations according to Medical Device Directive and European Medical Device Vigilance System (MEDDEV) 2.12-2. The data collected from this study will serve the purpose of confirming safety and performance of the Avenir Müller Hip Stem.

Detailed description: The objective of this post market surveillance study is to obtain outcome data on the Avenir Müller Hip Stem by analysis of standard scoring systems, radiographs and adverse event records, and thus to assess the long-term performance and safety of this implant.

This is a multi-centre, retrospective post-market surveillance study involving orthopaedic surgeons skilled in hip surgery. Each case enrolled has received the Avenir Müller Hip Stem for a primary hip arthroplasty. The Avenir Müller Hip Stem is CE marked (European Conformity) and commercially available.

Eligibility criteria: Inclusion Criteria:

* Patients able to participate in a follow-up program based upon physical examination and medical history.
* Patients or patient's legal representatives who have given written consent to take part in the study by signing the 'Patient Consent Form'.
* 18 years minimum.
* Male and female.
* Baseline data exist (pre-, peri- and immediate postoperative)

Exclusion Criteria:

* Patients who are unwilling or unable to comply with the follow-up program.
* Known pregnancy.
* Patients who are skeletally immature.

Primary outcomes:
measure: Evaluation of Pain and Functional Performance Determined by the Harris Hip Score
timeFrame: 10 years
Secondary outcomes:
measure: Confirmation of Safety Based on Complications
timeFrame: up to 10 years
measure: Survivorship of the Implant
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
affiliation: Zimmer Biomet
name: Paola Vivoda
role: STUDY_DIRECTOR
References:
citation: Erivan R, Villatte G, Brientini JM, Kreider D, Descamps S, Boisgard S. 7-year results of primary total hip arthroplasty with the uncemented Avenir stem. Hip Int. 2019 Jul;29(4):418-423. doi: 10.1177/1120700018810211. Epub 2018 Nov 11.
Clinical trial NCT00361127: Influence of Angiotensin Converting Enzyme (ACE) Genotype on Lung Diffusion in Heart Failure
Official title: Influence of ACE Genotype on Lung Diffusion at Rest and After Fluid Overload in Heart Failure Patients Treated With ACE-inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Congestive
Keywords: Heart failure
pulmonary edema
ACE-inhibitors
lung diffusion
exercise capacity
Chronic heart failure
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
First posted: 2006-08-07
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In patients with chronic heart failure ACE-inhibitor treatment improves lung diffusion and prevents pulmonary edema after fluid overload. In the western country, 3 population types of ACE genotypes exist (DD, ID, II). It is unknown whether the ACE genotype influences the response to fluid overload in ACE-inhibitor treated chronic heart failure patients.

Detailed description: Patients with chronic heart failure in stable clinical condition treated with ACE-inhibitors, but not aspirin, will be evaluated by means of maximal cardiopulmonary exercise test and lung function including lung diffusion measurements. These tests will be done before and after rapid 500 ml isotonic saline infusion. Patients will be grouped according to their ACE genotype.

Eligibility criteria: Inclusion Criteria:

* New York Heart Association (NYHA) class I and II heart failure
* Chronic ACE-inhibitor treatment

Exclusion Criteria:

* Aspirin treatment in the previous 2 months

Primary outcomes:
measure: Possible identification of a genetic pattern responsible for different responses to ACE-inhibition during fluid overload in heart failure
timeFrame: Third day
Secondary outcomes:
measure: Influence of ACE-genotype on exercise capacity
timeFrame: Third day
measure: Influence of ACE-genotype on lung function
timeFrame: Third day
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Centro Cardiologico Monzino
Study officials:
affiliation: Centro Cardiologico Monzino
name: Piergiuseppe Agostoni, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Agostoni P, Cattadori G, Bianchi M, Wasserman K. Exercise-induced pulmonary edema in heart failure. Circulation. 2003 Nov 25;108(21):2666-71. doi: 10.1161/01.CIR.0000097115.61309.59. Epub 2003 Oct 27.
citation: Guazzi M, Marenzi G, Alimento M, Contini M, Agostoni P. Improvement of alveolar-capillary membrane diffusing capacity with enalapril in chronic heart failure and counteracting effect of aspirin. Circulation. 1997 Apr 1;95(7):1930-6. doi: 10.1161/01.cir.95.7.1930.
Clinical trial NCT00189527: Assist Control Versus Pressure Support Modes for Domiciliary Noninvasive Ventilation in Chronic Respiratory Failure
Official title: Assist Control Versus Pressure Support Modes for Domiciliary Noninvasive Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Respiratory Failure
Lead sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 100
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: Noninvasive ventilation is a therapeutic option in some patients with chronic respiratory failure. Patients usually ventilate during nightime with a domiciliary ventilator either in assist control or in pressure support mode.

The aim of this study is to compare the clinical efficacy and the tolerance of assist control and pressure support modes during domiciliary noninvasive ventilation in patients with chronic respiratory failure.

Detailed description: The aim of this study is to compare the clinical efficacy and the tolerance of assist control and pressure support modes during domiciliary noninvasive ventilation in patients with chronic respiratory failure.

Eligibility criteria: Inclusion Criteria:

* Chronic respiratory failure
* Clinical symptoms of chronic alveolar hypoventilation
* PaCO2 ≥ 45 mmHg in case of restrictive pulmonary disorder or PaCO2 ≥ 55 mmHg in case or obstructive pulmonary disorder

Exclusion Criteria:

* Clinical exacerbation during the three previous weeks
* Previous treatment by domiciliary non invasive ventilation
* Previous treatment by non invasive ventilation for acute respiratory failure during the 3 previous months
* Bronchiectasis
* Duchenne muscular dystrophy
* Amyotrophic lateral sclerosis

Primary outcomes:
measure: PaO2
timeFrame: months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Rouen
name: Antoine CUVELIER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00160927: Microvascular Response in Diabetes Mellitus
Official title: Microcirculation cutanée et Vasodilatation Induite Par la Pression Non-Nociceptive Chez Les diabètiques
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Keywords: microcirculation
Laser doppler flowmetry
neuropathy
endothelial function
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Alfediam
name: UNIVALOIRE
First posted: 2005-09-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: Vascular and neurological mechanisms are both likely to be involved in foot ulcer. We recently reported on the hand an original transient pressure-induced vasodilation (PIV) during a 5 mmHg/min increase of pressure strain using laser Doppler flowmetry. This physiological response to non noxious external local pressure strain is a widely protective cutaneous mechanism. The impairment of PIV in diabetic subjects may be relevant to the high prevalence of foot ulcer that occurs in these individuals. The aim of the project is to analyse the different physiopathological processes involved in PIV impairment in diabetic subjects as compared to matched controls.

Detailed description: The whole study is a prospective observational study of diabetic type 1 and type 2 subjects focusing on the various physical, physiopathological or pharmacological mechanisms that may interfere with the normal response of the cutaneous microcirculation.The study is currently conducted under various parallel groups of patients and control subjects matched on age and sexe. Techniques used for the study are only non-invasive investigations such as iontophoresis with laser doppler flowmetry, clinical and paraclinical non-invasive investigation of peripheral neuropathy, ultrasound imaging of peripheral arteries.

Eligibility criteria: Inclusion Criteria:

* Diabetes

Exclusion Criteria:

* Non diabetic neuropathy
* Peripheral arterial disease
* pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre hospitalier universitaire
Study officials:
affiliation: Centre Hospitalier Universitaire Angers
name: Jean Louis Saumet, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koitka A, Legrand-Fernandez MS, Abraham P, Fizanne L, Fromy B, Sigaudo-Roussel D, Saumet JL. Low skin temperature impairs the cutaneous vasodilator response to local progressive pressure strain. Microvasc Res. 2004 Mar;67(2):203-6. doi: 10.1016/j.mvr.2003.12.001.
citation: Koitka A, Abraham P, Bouhanick B, Sigaudo-Roussel D, Demiot C, Saumet JL. Impaired pressure-induced vasodilation at the foot in young adults with type 1 diabetes. Diabetes. 2004 Mar;53(3):721-5. doi: 10.2337/diabetes.53.3.721.
Clinical trial NCT01011127: Different Metabolic Effects of Statins
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Keywords: Statins
Insulin resistance
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2009-11-11
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hypercholesterolemia

Brief summary: The investigators hypothesize that pravastatin and rosuvastatin may have different metabolic effects in hypercholesterolemic patients.


Eligibility criteria: Inclusion Criteria:

* Low-density lipoprotein cholesterol levels\>130

Exclusion Criteria:

* Overt liver disease Chronic renal failure Hypothyroidism Myopathy Uncontrolled diabetes Severe hypertension

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gil Medical Center
Study officials:
References:
citation: Yada T, Nakata M, Shiraishi T, Kakei M. Inhibition by simvastatin, but not pravastatin, of glucose-induced cytosolic Ca2+ signalling and insulin secretion due to blockade of L-type Ca2+ channels in rat islet beta-cells. Br J Pharmacol. 1999 Mar;126(5):1205-13. doi: 10.1038/sj.bjp.0702397.
Clinical trial NCT01883427: Nasal Spray With Glucose Oxidase Preventing Common Cold in Pre-school Children
Official title: Placebo Controlled Study Among Children Below Four Years of Age, Investigating Whether a Glucose Oxidase Nasal Spray Can Reduce Days With Upper Respiratory Tract Infection Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Upper Respiratory Tract Infections
Keywords: Days with URTI symptoms
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 40
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate if use of glucosoxidas nasal spray can reduce the number of days with upper respiratory tract infections in children beyond 4 years.

Detailed description: Children below 4 years of age and in public day care were invited to participate in this prospective study. The children started with a visit to an ENT doctor and after inclusion the children started to spray twice daily with glucose oxidase+glucose or only saline+glucose for 3 months. During this period the parents were asked to fill in a home protocol recording upper respiratory tract symptoms as: rhinitis, cough, fever, ear ache. After 6 weeks and 12 weeks the children had scheduled visits to the ENT department, where an ENT doctor examined the throat, nasal cavity and the ear drums for otitis media. After 12 weeks of treatment a nasopharyngeal swab was taken for bacterial culture.

Eligibility criteria: Inclusion Criteria:

* Children below 4 years of age

Exclusion Criteria:

* None

Primary outcomes:
measure: Respiratory Infectious Symptoms
timeFrame: 3 months of recording
Secondary outcomes:
Other outcomes:
Locations:
city: Piteå
country: Sweden
facility: Öronmottagningen
city: Sunderbyn
country: Sweden
facility: Öronmottagningen
city: Sundsvall
country: Sweden
facility: Öronmottagningen
city: Östersund
country: Sweden
facility: Öronmottagningen
Study officials:
affiliation: Västernorrlands Landsting
name: Eva Westman, MD, PhD
role: STUDY_CHAIR
affiliation: Jämtlands Landsting
name: Marie Ryding, MD, PhD
role: STUDY_CHAIR
affiliation: Norrbottens Landsting
name: Anders Niklasson, MD
role: STUDY_CHAIR
affiliation: Norrbottens Landsting
name: Helena Toolanen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01564927: Physiological Changes Associated With Deqi During Electroacupuncture to Right LI4 and LI11
Official title: Physiological Changes Associated With Deqi During Electroacupuncture to Right LI4 and LI11
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: deqi electroacupuncture
BP HR HRV
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2012-03-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aims of the study are to investigate the physiological responses associated with deqi during stimulation of the LI11 and LI4 acupuncture points and the correlation between the intensity of the deqi sensation to such responses.


Eligibility criteria: Inclusion Criteria:

1. Normal healthy subjects who were naïve to acupuncture
2. Able to read Chinese and no communication barrier

Exclusion Criteria:

1. Subjects with medical disorders, including neurological and psychologic disorder
2. Use of medications that may affect the cardiovascular system within one week
3. Subjects with painful or uncomfortable sensations of upper and lower limbs

Primary outcomes:
measure: Physiological Changes Associated with Deqi during Electroacupuncture to Right LI4 and LI11
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Elizabeth Hospital
state: Hong Kong
Study officials:
affiliation: Hong Kong Polytechnic University
name: David TW YU, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03521427: Effects of Intensive Upper and Lower Limbs Motor Control Therapy in Cerebral Palsy Children
Official title: Effects of Intensive Upper and Lower Limbs Motor Control Therapy in Cerebral Palsy Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Intensive Therapy
Cerebral Palsy
Lead sponsor: University of Alcala
Sponsor class: OTHER
Collaborators: name: European University Spain
First posted: 2018-05-11
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to determine the effetiveness of the intensive upper and lower limbs therapy to improve the funtional outcomes and to minimize ther energetic spendings during funtional activities in Cerebral Palsy patients.

Detailed description: The aim of the study is to determine the effetiveness of the intensive upper and lower limbs therapy to improve the funtional outcomes and to minimize ther energetic spendings during funtional activities in Cerebral Palsy patients. Also to know paretns and caregivers perceptions.

Eligibility criteria: Inclusion Criteria:

* Cerebral Palsy

Exclusion Criteria:

-

Primary outcomes:
measure: Arm Funtion
timeFrame: 6 months
Secondary outcomes:
measure: Funtional Activity
timeFrame: 6 months
measure: Perception of performance in everyday living
timeFrame: 6 months
Other outcomes:
Locations:
city: Alcalá de Henares
country: Spain
facility: University
state: Madrid
Study officials:
affiliation: Columbia Universuty
name: Andrew Gordon, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00060827: Measuring Head Impacts in Sports
Official title: Head Impact Recording Technology for Field Applications
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Brain Injuries
Brain Concussion
Keywords: Mild traumatic brain injury
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2003-05-15
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes

Brief summary: Head impacts in sports can lead to brain injury even when the participant is wearing a helmet. The forces that contribute to brain injury from sports-related head impacts are not well understood. This study will test a new device to measure the speed of head impacts among football players.

Detailed description: Each year, 50 to 70 million people in the United States participate in helmeted and unhelmeted sports with the potential for head impacts. Such sports include football, soccer, hockey, basketball, and boxing. Participating in these sports carries the risk of mild traumatic brain injury (MTBI). The biomechanics of head impacts that result in concussions or other MTBIs are not well understood; however, it is thought that such impacts correlate with head accelerations. Currently, there is no system that allows researchers to measure head acceleration in a large number of individuals during actual play. This is a major obstacle in understanding the mechanism of MTBI and its prevention. This study will evaluate a newly designed miniature device that uses Head Impact Recording Technology (HIRT) to quantify head acceleration during impact in actual sports play.

One hundred college football players will be enrolled in the study. Data from HIRT-instrumented helmets will be collected during normal team practice and games throughout a 5-month football season. Data collected will be assessed to determine the incidence, magnitude, and duration of head acceleration during impacts on the sports field.

Eligibility criteria: Inclusion Criteria

* College football players

Primary outcomes:
measure: Impact Severity
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: State College
country: United States
facility: Penn State University
state: Pennsylvania
Study officials:
name: Rick Greenwald, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004827: Study of Docosahexaenoic Acid (DHA) Supplementation in Patients With X-Linked Retinitis Pigmentosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinitis Pigmentosa
Keywords: ophthalmologic disorders
rare disease
retinitis pigmentosa
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 2000-02-25
Enrollment: 46
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Evaluate the potential of nutritional docosahexaenoic acid (DHA) supplementation to normalize the level of DHA in red blood cells, and to retard the progression of visual function loss in patients with early stage X-linked retinitis pigmentosa.

Detailed description: PROTOCOL OUTLINE: This is a randomized, parallel, double blind study. Patients receive 2 gel capsules per day of either docosahexaenoic acid (DHA) enriched oil or a placebo oil. Oral DHA supplementation continues daily for 3 years.

All patients are followed every 6 months for the 3 year duration of the study.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of X-linked retinitis pigmentosa

Early stage disease Sufficient cone function determined by recordable ERG (30 Hz amplitude; greater than 0.32 microvolts) Visual fields greater than 20 degrees Sufficient rod function (greater than 3.0 microvolts amplitude)

Media clarity sufficient for fundus photography

--Prior/Concurrent Therapy--

No concurrent use of anticoagulant medication

--Patient Characteristics--

* No chronic metabolic disease that may interfere with fatty acid metabolism
* No bleeding of clinical significance

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Retina Foundation of the Southwest
name: Dennis R. Hoffman
role: STUDY_CHAIR
References:
citation: Schwartz SG, Wang X, Chavis P, Kuriyan AE, Abariga SA. Vitamin A and fish oils for preventing the progression of retinitis pigmentosa. Cochrane Database Syst Rev. 2020 Jun 18;6(6):CD008428. doi: 10.1002/14651858.CD008428.pub3.