louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01683500: Calcinosis Cutis: Therapeutic Effects of Extracorporeal Shock Wave Therapy (ESWT)
Official title: Calcinosis Cutis: Therapeutic Effects of Extracorporeal Shock Wave Therapy (ESWT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Calcinosis Cutis in Connective Tissue Disease
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2012-09-11
Enrollment: 4
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: Patients with calcinosis cutis due to connective tissue disease get a shock wave therapy. The shock wave therapy will be done in 3 sessions with one week interval. The outcome parameters are: change in pain, size of the calcinosis, of possible ulcers and intake of painkillers.

* Trial with medical device

Detailed description: Patients with calcinosis cutis due to connective tissue disease get a shock wave therapy (medical device). The shock wave therapy will be done in 3 sessions with one week interval. The outcome parameters are: change in pain (questionnaire), size of the calcinosis (ultrasound and CT), new ulcers and intake of painkillers.

Eligibility criteria: Inclusion criteria:

* Age of 18
* Calcinosis cutis due to connective tissue disease
* information about ESWT given
* Patient understands the study and signs the informed consent

Exclusion criteria:

* No ESWT done
* cuagulopathy
* sepsis
* pregnancy
* pace maker
* severe disease in the opinion of the investigator
* cardiac risk with NYHA III-IV
* Ehlers-Danlos-Syndrome

Primary outcomes:
measure: change in pain
timeFrame: after 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Rheumatology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Rheumatology
name: Sandra Blumhardt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03627000: Microbiological Epidemiology in Patients Experiencing Microbiological or Clinical Failure Following Reimplantation After a 2-stage Exchange Strategy for Hip or Knee Prosthetic Joint Infection
Official title: Microbiological Epidemiology in Patients Experiencing Microbiological or Clinical Failure Following Reimplantation After a 2-stage Exchange Strategy for Hip or Knee Prosthetic Joint Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone and Joint Infection
Bacterial Infections
EPIDEMIOLOGY
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with prosthetic joint infection having had a 2-step exchange managed at the Croix Rousse Hospital from the reimplantation, between 2013 and 2015.

Brief summary: This study concerns patients having had an infection on their prosthesis (hip, knee,..) and for whom a 2-step exchange of prosthesis has been done.

A 2-step exchange consists in explantation of the prosthesis and implementation of a spacer at the first stage, and reimplantation of a new prosthesis in a second stage. Patients with late prosthetic joint infection are at risk for superinfection at the time of reimplantation.

The aim is to determine the microbiological epidemiology in patients experiencing failure following reimplantation to establish, based on the drug susceptibilities, which cement could be the most active.


Eligibility criteria: Inclusion Criteria:

* patients with prosthetic joint infection having had a 2-step exchange at least from the reimplantation, between 2013 and 2015.

Exclusion Criteria:

-

Primary outcomes:
measure: rate of treatment failure
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Secondary outcomes:
measure: rate of bacteria involved in microbiological failure
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
measure: rate of clinical failure
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Other outcomes:
Locations:
Study officials:
affiliation: Hospices Civils de Lyon Hôpital de la Croix-Rousse
name: Tristan FERRY, Md,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02719600: Motor Learning Through Virtual Reality Task in Individuals With Down Syndrome
Official title: Motor Learning Through Virtual Reality Task in Individuals With Down Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Keywords: Virtual Reality
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 40
Sex: ALL
Minimum age (years): 11
Maximum age (years): 28
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background: Down syndrome (DS) has unique physical, motor and cognitive characteristics. Despite cognitive and motor difficulties, there is a possibility of intervention based on the knowledge of motor learning. However, it is important to study the motor learning process in individuals with DS during a virtual reality task to justify the use of virtual reality to organize intervention programs. The aim of this study was to analyze the motor learning process in individuals with DS during a virtual reality task. Methods: A total of 40 individuals participated in this study, 20 of which were with DS (24 males and 8 females, ranging between 11-28 yrs.) and 20 typically developing individuals matched by age and gender to the individuals with DS. To examine this issue, we used software that uses 3D images and reproduced a coincidence timing task.


Eligibility criteria: Inclusion Criteria:

* medical diagnosis of DS and the ability to understand the task.

Exclusion Criteria:

* disorders in cognitive function that would prevent comprehension of the experimental instruction

Primary outcomes:
measure: Motor Learning test by using a timing coincident task in virtual reality
timeFrame: four months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Carlos B Monteiro, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Mello Monteiro CB, da Silva TD, de Abreu LC, Fregni F, de Araujo LV, Ferreira FHIB, Leone C. Short-term motor learning through non-immersive virtual reality task in individuals with down syndrome. BMC Neurol. 2017 Apr 14;17(1):71. doi: 10.1186/s12883-017-0852-z.
Clinical trial NCT01775800: Treatment Modification to Reduce Symptom Burden in Hemodialysis
Official title: Treatment Modification and Symptom Burden in High-Risk Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Lead sponsor: The Rogosin Institute
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
First posted: 2013-01-25
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many patients on hemodialysis experience high rates of symptom burden, such as pain, depression, anxiety and difficulty breathing. This study seeks to reduce these symptoms by modifying the usual guidelines used to manage patients on hemodialysis. For example, rather than trying to keep serum phosphorus below 5.5, patients enrolled in this study may have treatment goals of less than 6.5, in order to reduce the number of pills they need to take and potentially reduce harmful side effects. Blood pressure and serum parathyroid hormone goals will also be modified, to see if these modifications help hemodialysis patients feel better.


Eligibility criteria: Inclusion Criteria:

* hemodialysis patient
* transplant ineligible

Exclusion Criteria:

* dementia
* unable to answer questionnaires for any reason

Primary outcomes:
measure: Number of Participants Recruited, Consented, Randomized and Completed
timeFrame: Each participant was assessed for 6 weeks; total recruitment period was 15 months
Secondary outcomes:
measure: Symptom Burden
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: The Rogosin Institute
state: New York
Study officials:
affiliation: The Rogosin Institute
name: Nathaniel Berman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berman N, Reid MC, Teresi J, Eimicke JP, Adelman R. More with Less: A Trial of Reduced-Intensity Treatment in Transplant-Ineligible Hemodialysis Patients. J Palliat Med. 2016 May;19(5):503-8. doi: 10.1089/jpm.2015.0338.
Clinical trial NCT01998100: Maximizing Treatment Outcome in Post-Traumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-Traumatic Stress Disorder
Keywords: PTSD
Anxiety
Behavior Therapy
Prolonged Exposure
Exercise
Wellness
Post-traumatic
Stress
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 examine the efficacy of exercise + therapy to therapy alone to determine if they can improve the effects of prolonged exposure therapy (PE) in reducing symptoms of anxiety associated with Post-traumatic Stress Disorder (PTSD). In addition the two strategies (i.e., exercise + therapy and therapy alone condition) will be compared in terms of levels of brain-derived neurotrophic factor (BDNF). BDNF is a protein that helps to support the survival of existing neurons and stimulate the growth of new neurons and synapses. BDNF is important to learning and memory in general and therefore may be associated with the learning and memory as it relates to PE and corresponding symptoms PTSD improvement.


Eligibility criteria: Inclusion Criteria:

* You have PTSD.
* You are between the ages of 18 and 65.
* You have written physician approval/medical clearance to participate in an exercise protocol.
* You are currently taking no psychotropic medications or are able and willing to discontinue these medications prior to the first PE session.

Exclusion Criteria:

* You are currently participating in a structured exercise program.
* You have severe depression.
* You have any history of bipolar disorder, psychotic disorder, or obsessive compulsive disorder.
* You have a diagnosis of eating disorder, or substance abuse or dependence (excluding nicotine) within the past six months.
* You have any history of a suicide attempt, or are at a significant risk or self-harm or harm to others.
* You have ever been diagnosed with organic brain syndrome, mental retardation, or other cognitive dysfunction.

Primary outcomes:
measure: PTSD Symptoms
timeFrame: 3 months
Secondary outcomes:
measure: BDNF (by blood sample)
timeFrame: 3 months
measure: General Mood and Anxiety Symptoms
timeFrame: 3 months
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
city: Dallas
country: United States
facility: Southern Methodist University
state: Texas
Study officials:
References:
citation: Powers MB, Medina JL, Burns S, Kauffman BY, Monfils M, Asmundson GJ, Diamond A, McIntyre C, Smits JA. Exercise Augmentation of Exposure Therapy for PTSD: Rationale and Pilot Efficacy Data. Cogn Behav Ther. 2015;44(4):314-27. doi: 10.1080/16506073.2015.1012740. Epub 2015 Feb 23.
Clinical trial NCT04954352: Human Epidemiology of Newly Identified Arboviruses
Official title: Epidemiology in Humans of New Arbovirusus Sorted Out From Metagenomic Screen in Local Vectors and Animal Hosts.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arbovirus Infections
SARS-CoV Infection
Keywords: Patients with arboviral infection compatible signs
Unexplained isolated fever
Neurological infection conditions without any identified etiology
Arbovirus
Arboviral like infectious disease
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: UMR ASTRE (CIRAD)
name: Institut Pasteur
name: UMR PCCEI
First posted: 2021-07-08
Enrollment: 400
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patients admitted at the Monpellier University Hospital for any infectious syndrome compatible with an arboviral infection
* Healthy volunteers for seroprevalence investigation

Brief summary: A local network is being set up to study the impact of arboviruses in our region. It is committed to a one-health approach, in particular with research without a priori for new viruses hosted among vectors and wildlife. The candidates identified by high throughput sequencing approaches will serve as a basis for the development of serological and molecular tools for their detections. These tools will be used to assess the possible circulation of these new viruses in humans in biological collections created within the framework of this project Arbodocc

.


Eligibility criteria: Inclusion criteria:

- Patients admitted at the Monpellier University Hospital for any infectious syndrome compatible with an arboviral infection with samples available

Exclusion criteria:

- Informed consent non obtain for samples used

Primary outcomes:
measure: Seroprevalence
timeFrame: 1 day
Secondary outcomes:
measure: Molecular detection
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: UH MONTPELLIER
name: Vincent Foulongne, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05717452: Effects of a Single Dose of Wild Blueberries on Mood and Executive Function in Healthy Emerging Adults
Official title: Effects of a Single Dose of Wild Blueberries on Mood and Executive Function in Healthy Emerging Adults: a Single-Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mood
Affect
Executive Function
Keywords: Blueberry
Anthocyanins
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: Wild Blueberry Association of North America
First posted: 2023-02-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Standard two-arm trial with a placebo arm and active intervention arm
Primary purpose: PREVENTION

Brief summary: This study aims to investigate whether consuming a drink containing powdered blueberries (equivalent to 150 g of fresh fruit) can improve mood and executive function in healthy emerging adults.

Detailed description: The present study will examine the psychological effects of a single dose of freeze-dried wild blueberries using a randomized, single-blind, placebo-controlled design. A total of 80 participants will be randomly allocated to consume either a drink prepared with 22 g blueberry powder or a drink prepared with 22 g placebo powder matched for macronutrients, flavour and colour.

Eligibility criteria: Inclusion Criteria:

* 18 to 25 years of age

Exclusion Criteria:

* Any medically significant condition or mental health disorder (e.g. diabetes, endocrine or gastrointestinal disorders)
* Taking medication (excluding hormonal contraception or medication for asthma/seasonal allergies)
* Allergy to blueberries or any other Vaccinium species

Primary outcomes:
measure: Positive affect as measured by PANAS-X
timeFrame: 1.5 hours post-ingestion
Secondary outcomes:
measure: Negative affect as measured by PANAS-X
timeFrame: 1.5 hours post-ingestion
measure: Executive function (accuracy)
timeFrame: 1.5 hours post-ingestion
measure: Reaction time
timeFrame: 1.5 hours post-ingestion
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: School of Psychology and Clinical Languages, University of Reading
state: Berkshire
Study officials:
References:
Clinical trial NCT02854852: Photoplethysmography Detects Changes in Vascular Tone
Official title: Accuracy of Photoplethysmography to Detect Changes in Vascular Tone: a Doppler Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Diseases
Lead sponsor: Hospital Privado de Comunidad de Mar del Plata
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing general anesthesia

Brief summary: Changes in the vascular tone of anesthetized patients is common and cause hemodynamic problems. The monitoring of such changes in vascular resistance using simple and non-invasive tools is lacking. The present study was designed to determine if photoplethysmography can detect changes in the systemic vascular resistance using Doppler as the reference method.

Detailed description: This is a prospective and observational study designed to test the reliability of photoplethysmography to diagnose changes in the vascular resistance during anesthesia. The investigators will studied 50 mechanically ventilated patients undergoing general anesthesia. Photoplethysmography will be continuously recorded in the right thumb during anesthesia. Duplex color and power Doppler will measure flow in the radial artery of the right hand.The contour analysis of both, photoplethysmogram and radial artery flow will be analyzed, correlated and compared using the Bland-Altman plot.

Eligibility criteria: Inclusion Criteria:

* Written Inform Consent
* Programmed surgery
* Supine position

Exclusion Criteria:

* Emergency surgery
* Peripheral vascular diseases

Primary outcomes:
measure: Accuracy of photoplethysmography for the assessment of systemic vascular tone
timeFrame: 5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mar del Plata
country: Argentina
facility: Hospital Privado de Comunidad
state: Buenos Aires
Study officials:
affiliation: Study Principal Investigato
name: Gerardo Tusman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00180752: HDAC Activity in Peripheral Skeletal Muscle in COPD
Official title: The Investigation of HDAC and NF Kappa B Activity in Peripheral Skeletal Muscle in COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 31
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: COPD patients and healthy age-and sex-matched controls

Brief summary: We wish to study the effect of Chronic Obstructive Pulmonary Disease on the activity of the nuclear transcription pathway in peripheral skeletal muscle to determine whether altered activity of this pathway may be responsible for the muscle dysfunction observed in these patients.

Detailed description: Peripheral muscle dysfunction is well recognised in COPD. We wish to study patients who we have found to have weak quadriceps muscles and study the molecular mechanisms underlying this problem. Patients will be well characterised with regard to their physiologic parameters and quadriceps muscle biopsies will be taken. These biopsy samples will be analysed with respect to NFkappaB activity and HDAC activity by nuclear extraction and for muscle inflammatory cytokines. We know that in the lung tissue of COPD patients there is evidence of a reduction in HDAC activity which might be responsible for the higher levels of pronflammatory cytokines in the lung. We will also study a healthy control group and a small selection of patients who are in respiratory failure due to idiopathic scoliosis in the same way.

Eligibility criteria: Inclusion Criteria:

COPD

-

Exclusion Criteria:

Aspirin therapy Bleeding diasthesis Neuromuscular disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Michael I Polkey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Agusti A, Morla M, Sauleda J, Saus C, Busquets X. NF-kappaB activation and iNOS upregulation in skeletal muscle of patients with COPD and low body weight. Thorax. 2004 Jun;59(6):483-7. doi: 10.1136/thx.2003.017640.
citation: Ito K, Ito M, Elliott WM, Cosio B, Caramori G, Kon OM, Barczyk A, Hayashi S, Adcock IM, Hogg JC, Barnes PJ. Decreased histone deacetylase activity in chronic obstructive pulmonary disease. N Engl J Med. 2005 May 12;352(19):1967-76. doi: 10.1056/NEJMoa041892.
Clinical trial NCT00276952: Gonyautoxin in the Treatment of Chronic Tension-Type Headache
Official title: Phase 2 Study of Treatment of Chronic Tension-Type Headache Using Gonyautoxins
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Tension-Type Headache
Keywords: Gonyautoxins
Tension-type Headache
Human Treatment
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2006-01-13
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical efficacy of Gonyautoxin 2/3 epimers in the treatment of patients diagnosed with chronic tensional-type headache in accordance with International Headache Society guidelines

Detailed description: Gonyautoxin are phycotoxins, whose molecular mechanism of action is a reversible block of the voltage-gated sodium channels at neuronal level. They are axonal conduction blockers impeding nerve impulse propagation. In order to evaluate the clinical efficacy of Gonyautoxin 2/3 epimers in the treatment of patients diagnosed with chronic tensional-type headache, the patients were locally injected with placebo versus Gonyautoxin following a painful spots injection standarized protocol

Eligibility criteria: Inclusion Criteria:

* Chronic tensional-type headache patients according to the International Headache Society criteria: patients with headache of a pressing or tightening quality with episodic frequency above 15 days a month
* Refractory to conventional treatments such as, orally administered analgesics, systemic muscular relaxant, corticoids and antidepressant like Amytriptiline
* Treated and controlled in the University Hospital Neurology Clinic over 2 years with duration of symptoms over 3 years

Exclusion Criteria:

* Pregnancy
* Use of headache prophylactic treatment a month prior to infiltration
* Myasthenic syndromes
* Muscular dystrophies
* Inflammatory myopathies
* Acute and chronic polineuropathies
* Use of psychotropic substances 24-hour before infiltration
* Anticoagulant treatment
* terminal illnesses (AIDS, cancer)
* drugs or alcohol abuse

Primary outcomes:
measure: a) Drop off in the patient acute headache pain (2 minutes, weekly for 20 weeks)
measure: b) Number of days without headache pain following infiltration
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Departament of Neurology and Neurosurgery, Hospital Clínico Universidad de Chile.
Study officials:
affiliation: Faculty of Medicine University of Chile
name: Nestor Lagos, PhD
role: PRINCIPAL_INVESTIGATOR
References: