louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05032911: Sensorimotor Control in People With and Without Neck Pain
Official title: Analysis of Sensorimotor Control in People With and Without Neck Pain Using Inertial Sensor Technology: Study Protocol for a Longitudinal Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Movement Disorders
Neck Pain
Lead sponsor: CEU San Pablo University
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from a community sample in Madrid, Spain

Brief summary: This is a descriptive, observational, longitudinal, prospective study consecutively enrolling patients with non-specific neck pain and age-matched asymptomatic participants.

The investigators will register sensorimotor control variables, including active range of motion, movement speed, acceleration, smoothness of motion, head repositioning accuracy and motion coupling patterns. These variables will be recorded by means of Inertial Measurement Unit (IMU) sensors during the following tests consecutively performed in two measuring sessions separated by 12 months: (a) kinematics of planar movements, (b) kinematics of the craniocervical flexion movement, (c) kinematics during functional tasks and (d) kinematics of task-oriented neck movements in response to visual targets.


Eligibility criteria: Inclusion Criteria:

* Population aged between 18 and 65 years old

Exclusion Criteria:

* Visual impairment not corrected by the use of glasses/contact lenses
* Migraine headache
* Complex regional syndrome
* Previous surgeries in the neck and/or head region
* Sensory and/or vestibular alterations, (f) Otogenic or idiopathic vertigo/dizziness
* Presence of tumors in the craniocervical region
* Previous fracture in the head or neck region
* Osseous deformities in the thoracic, cervical or cranial region

Primary outcomes:
measure: Active range of motion
timeFrame: 1 year
measure: Movement speed
timeFrame: 1 year
measure: Smoothness of motion
timeFrame: 1 year
measure: Head repositioning accuracy
timeFrame: 1 year
measure: Motion coupling patterns
timeFrame: 1 year
Secondary outcomes:
measure: Physical activity level
timeFrame: 1 year
measure: Fear of movement and injury
timeFrame: 1 year
measure: Pain-related fear-avoidance
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: Moggioli F, Perez-Fernandez T, Liebana S, Corredor EB, Armijo-Olivo S, Fernandez-Carnero J, Raya R, Conde P, Rodriguez-Lopez O, Sanchez C, Martin-Pintado-Zugasti A. Analysis of sensorimotor control in people with and without neck pain using inertial sensor technology: study protocol for a 1-year longitudinal prospective observational study. BMJ Open. 2022 Feb 15;12(2):e058190. doi: 10.1136/bmjopen-2021-058190.
Clinical trial NCT05282511: A Multi-Omics Study of Vasospastic Angina
Official title: Identification of the Key Factors Increasing the Risk of Vasospastic Angina Based on Multi-omics.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vasospastic Angina
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese patients with vasospastic angina

Brief summary: This is a observational study to identify the key factor associated with vasospastic angina and to explore the prognosis of the participants. The study will recruit 400 patients with vasospastic angina, 400 healthy controls and 400 patients with acute myocardial infarction. Next generation sequencing, metabolome and proteomics will be performed in these participants.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* diagnosed as vasospastic angina

Exclusion Criteria:

* participate in any drug clinical trials within 3 months
* patients with life-threatening complications, or the researchers determined that the survival time of patients with no more than 1 years
* serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients)
* previous history of cancer or tumor, or pathological examination confirmed precancerous lesions (such as breast ductal carcinoma in situ, or atypical hyperplasia of the cervix)

Primary outcomes:
measure: Cardiovascular Death
timeFrame: up to 48 months
measure: Stroke
timeFrame: up to 48 months
measure: Myocardial Infarction
timeFrame: up to 48 months
Secondary outcomes:
measure: Recurrent angina
timeFrame: up to 48 months
measure: Rehospitalization due to cardiovascular causes
timeFrame: up to 48 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT04354493: Myoelectric Game Training and Outcomes
Official title: Myoelectric Game Training and Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Prosthesis User
Prosthesis
Keywords: myoelectric
training
upper limb
prosthetics
video games
Lead sponsor: Liberating Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2020-04-21
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-group study with same baseline and intervention. One group ceases intervention and returns to control condition.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to evaluate the effects of myo-electric training tools on prosthesis functional outcomes.

Detailed description: Participants will undergo informed consent and schedule an initial site visit. A logging device will be used to track activity of prosthetic arm usage while in everyday use at home. After a baseline period, participants will schedule a second visit to be introduced to the training technology.

The study will span up to 7 months with participants training at home for 15-60 minutes, 3-5 times a day. Every 3-6 weeks, investigators will schedule a study event and sit visit to conduct functional outcome tasks and measurements.

Eligibility criteria: Inclusion Criteria:

* User of upper-limb myo-prosthesis or able to wear prosthesis simulator
* The subjects must be able to read, write, and speak English in order to be properly consented and to express their thoughts to the study personnel, and they must be willing and able to complete the activities outlined in the study.

Exclusion Criteria:

* The risks to pregnant people and fetuses are unknown and therefore pregnant individuals should not participate in the study.

Primary outcomes:
measure: South Hampton Hand Assesment
timeFrame: 6 week periods
Secondary outcomes:
measure: Static Tracking Test
timeFrame: 6 week periods
measure: Dynamic Tracking Test
timeFrame: 6 week periods
Other outcomes:
Locations:
city: Holliston
country: United States
facility: Liberating Technologies Inc.
state: Massachusetts
Study officials:
References:
Clinical trial NCT01776593: The Best Parameter of Bladder Diary Correlates With the Volume at Strong Desire to Void of Filling Cystometry
Official title: The Best Parameter of Bladder Diary Correlates With the Volume at Strong Desire to Void of Filling Cystometry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Diary
Urodynamic Studies
Keywords: bladder capacity; bladder diary; bladder oversensitivity; lower urinary tract symptoms
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 900
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients with lower urinary tract symptoms

Brief summary: To identify the bladder diary parameters that are best correlated to VSD.

Detailed description: To identify the bladder diary parameters that are best correlated to VSD.

Eligibility criteria: Inclusion Criteria:

* Female patients with lower urinary tract symptoms who had underwent urodynamic studies

Exclusion Criteria:

* Patients without data of bladder diary

Primary outcomes:
measure: To identify the bladder diary parameter that is best correlated to the volume at strong desire to void of filling cystometry.
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Obstetrics & Gynecology, National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT03145493: Effect of Suction Drains in Total Knee Arthroplasty With Tranexamic Acid
Official title: (L'Effet Des Drains Aspiratifs en Arthroplastie du Genou Avec l'Utilisation de l'Acide Tranexamique)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Keywords: Drainage, Suction
tranexamic acid
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 140
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: Problem Suction drains during TKA present certain costs to the health system and requires additional nursing care. There is no clear evidence that supports their use, and no studies so far have compared blood loss in patients with or without drains when TA is administered during TKA.

Hypothesis During total knee arthroplasty, the postoperative blood loss, measured by hemoglobin level, will be lower when no drains are used.

Method

* Randomized controlled trial
* Monocentric, 3 surgeons
* Randomisation by sealed envelopes

Detailed description: During total knee arthroplasty, the postoperative blood loss, measured by hemoglobin level, will be lower when no drains are used.

Eligibility criteria: Inclusion Criteria:

* Unilateral primary total knee arthroplasty

Exclusion Criteria:

* TKA revision
* Bilateral TKA
* Patients that refuse transfusions
* Contraindication to tranexamic acid use: allergy, thromboembolic history
* Coagulopathy
* Kidney failure

Primary outcomes:
measure: Hb variation
timeFrame: 3 days after surgey
Secondary outcomes:
measure: Number of blood transfusions
timeFrame: from admission till 2 months after surgery
measure: Cost of blood transfusions
timeFrame: from admission till 2 months after surgery
measure: Cost of suction drains
timeFrame: from admission till 2 months after surgery
measure: Range of motion of knee
timeFrame: preoperative visit , at the end of surgery, and on post-op day 3
measure: Length of hospital stay
timeFrame: from admission till 2 months after surgery
measure: additional surgery
timeFrame: from admission till 2 months after surgery
measure: Clinical results
timeFrame: from admission till 2 months after surgery
measure: KOOS score
timeFrame: At preoperative visit and post-operative visit of six weeks after surgery
measure: SF-12 score
timeFrame: At preoperative visit and post-operative visit of six weeks after surgery
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: CHUM
name: Frédéric Lavoie, MD MSc FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05060393: Efficacy of Mindfulness-based Mobile Application Use in Patients With Depressive Disorder
Official title: Efficacy of Mindfulness-based Mobile Application Use in Patients With Depressive Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The presented randomized-controled study aim to assess the use of internet-based mindfulness intervention via mobile application for 30 days in patients with Major Depressive Disorder (MDD)

Detailed description: Mindfulness-based interventions (MBI) proved to be effective in relapse prevention in MDD. Next, MBI in form of free mobile applications can be an effective augmentation of the treatment as usual (TAU) and can fill a gap in the ambulatory care. Given this background, the aim of this randomized controlled study is to assess the effectiveness of additional MBI via mobile app on the symptom severity and stress levels, compared to TAU.

Eligibility criteria: Inclusion Criteria:

* Depression, current ill

Exclusion Criteria:

* acute alcohol- and drug dependency, schizophrenia or psychotic disorder, severe somatic illnes, not having smartphone or not willing to use mobile application

Primary outcomes:
measure: Change from baseline self reported Depression Severity
timeFrame: 30 days
measure: Change from Baseline Depression Severity
timeFrame: 30 days
Secondary outcomes:
measure: Change from baseline heart rate
timeFrame: 30 days
measure: Change from baseline blood pressure
timeFrame: 30 days
measure: Change from baseline respiratory rate
timeFrame: 30 days
measure: Change from baseline tobacco consumption
timeFrame: 30 days
measure: Change from baseline alcohol consumption
timeFrame: 30 days
measure: Change in consumption of anxiolytics
timeFrame: 30 days
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Jan Sarlon
Study officials:
affiliation: University of Basel
name: Jan Sarlon
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sarlon J, Doll JPK, Schmassmann A, Brand S, Ferreira N, Muehlhauser M, Urech-Meyer S, Schweinfurth N, Lang UE, Bruehl AB. Effectiveness of a Mindfulness-Based Mobile Application for the Treatment of Depression in Ambulatory Care: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Mar 31;11(3):e33423. doi: 10.2196/33423.
Clinical trial NCT01723293: Fetal Cardiovascular Response to Maternal Exercise During Third Trimester
Official title: Effect of a Specific Exercise Program During Whole Pregnancy on Fetal Heart Rate Response to Maternal Effort in Third Trimester. A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Keywords: Fetal heart rate, pregnancy, fetus, cardiovascular system
Lead sponsor: Technical University of Madrid
Sponsor class: OTHER
First posted: 2012-11-07
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study was to examine the behavior of the fetal heart rate in response to different intensities of acute maternal exercise in training and non-training pregnant women

Detailed description: Fetal heart rate is considered an important index of fetal well-being, especially during the third trimester of pregnancy (Rodney JR, Huntley BJ, Rodney WM, 2012). An increase in the FHR of 5-25 beats per min (bpm) in response to maternal exercise has been established as a normal reaction(Riemann,Kanstrup Hansen, 2000)however the normal FHR response to maternal exercise has remained unclear for several reasons

Most of the studies are focused on obtain data in order to examine the fetal heart rate response to maternal exercise using cardiotocography measurements prior to and following maternal exercise

Eligibility criteria: Inclusion Criteria:

* Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
* Being able to communicate in spanish
* Giving birth at Hospital Universitario de Fuenlabrada

Exclusion Criteria:

* Multiparity
* Obstetrician complications
* Being interested in the study after 18 weeks
* Not being regular in physical exercise program
* Younger than 18 years old

Primary outcomes:
measure: Fetal heart rate
timeFrame: Up to 34 weeks
Secondary outcomes:
measure: Fetal outcomes
timeFrame: After labor
measure: Maternal outcomes
timeFrame: During labor
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Politecnica de Madrid
Study officials:
affiliation: Universidad Politecnica de Madrid
name: Rubén Barakat, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02959593: The Effects of Visior on Ocular Hemodynamics
Official title: The Effects of Visior on Ocular Hemodynamics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open Angle Glaucoma
Keywords: Primary open-angle glaucoma
retinal capillary blood flow
visual stimulation
Lead sponsor: Visior Technologies Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Indiana University School of Medicine
First posted: 2016-11-09
Enrollment: 35
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To determine the relationship between the affects of viewing commercially available content through the VISIOR video goggles and ocular blood flow in glaucoma patients and healthy subjects.

Detailed description: To determine if glaucoma patients and healthy subject experience any alteration in localized retinal blood flow after retinal stimulation by viewing commercially available content through the VISIOR video goggles.

Both groups will undergo measurements of arterial blood pressure, cardiac pulse (heart rate), intraocular pressure, and retinal blood flow using Heidelberg retinal flowmetry (Heidelberg Engineering, Heidelberg, Germany) at baseline and then ten minutes, thirty minutes, and sixty minutes after viewing commercially available content through the VISIOR video goggles for thirty minutes.

Eligibility criteria: Inclusion Criteria:

* Patients with open-angle glaucoma 30 years or older, free from other ophthalmic disease, free from diabetes, beta agonists and uncontrolled blood pressure.

Exclusion Criteria:

* Women who are pregnant or lactating or who plan to become pregnant (self reporting); smoker during last ten years (self reporting); systemic diseases that may interfere with blood flow measurements or wearing the goggles.
* In addition, 10 healthy subjects, age 18 or older, free from eye disease will be enrolled. Identical exclusion criteria apply to this healthy group. Identical procedures apply to this group, which only differs by ocular health status.

Primary outcomes:
measure: retinal capillary blood flow
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eugene and Marilyn Glick Eye Institute, Department of Ophthalmology, Indiana School of Medicine
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Alon Harris, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siesky B, Harris A, Gross J, Sechrist E, Camp D, Cardenas A, Patel P, Hasnain F, Kawiecki R, Shah A, Verticchio Vercellin AC. Effects of image brightness and contrast dynamic altering stimuli (DAS) when viewing video content on ocular blood flow. Br J Ophthalmol. 2019 Oct;103(10):1511-1517. doi: 10.1136/bjophthalmol-2018-312561. Epub 2019 Jan 2.
Clinical trial NCT00796393: Study of the Effects of Probiotics Upon Infectious Episodes in Subject Aged More Than 60, During Winter.
Official title: Effects of Daily Consumption of a Probiotic on the Evolution of Infectious Episodes (ENT, Gastro-intestinal and Pulmonary), in Subject Aged 60 Years or Over, During Winter.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infectious Episodes (ENT, Gastro-intestinal and Pulmonary)
Lead sponsor: Institut Rosell Lallemand
Sponsor class: INDUSTRY
Collaborators: name: BioFortis
First posted: 2008-11-24
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: We put forward that probiotics have an effect on infectious episodes evolution in subjects aged 60 years or over. The main objective of this research is to observe the effect of consumption of the probiotic on the average number of days with infectious episodes.


Eligibility criteria: Inclusion Criteria:

* Subjects who accept not to alter their food habits

Exclusion Criteria:

* Food allergy
* Regular consumption of probiotics
* Diabetes
* Respiratory deficiency
* Cardiac deficiency
* Cancer or chronicle disease not stabilized
* Splenectomy, sickle-cell anemia
* Immuno depression or immunodeficiency acquired or congenital
* Immuno depressor or corticoid treatments

Primary outcomes:
measure: Number of infectious episodes
timeFrame: During the study
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Biofortis
Study officials:
affiliation: BioFortis
name: Jean Marc Cazaubiel, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02886793: Cell Proliferation in Pulmonary Hypertension. FDG-PET Comparison Between Patients and Healthy Subjects
Official title: Cell Proliferation in Pulmonary Hypertension. FDG-PET Comparison Between Patients and Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pulmonary Hypertension
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) are serious diseases with poor prognosis despite recent advances. Currently, pulmonary hypertension (PH) is considered a cell proliferative disorder, which has not been adequately characterized due to the lack of markers. A better understanding of the mechanisms that regulate this proliferative disorder will allow the identification of new therapeutic targets for HP.

The objective of the project is to identify cell proliferative processes in severe forms of PH. Patients with PAH (n=20), CTEPH (n=20) and healthy controls (n=20) will undergo characterization of microRNAs (miRNAs) contained within circulating microparticles (MPs) analysis and mitochondrial functionality and FDG-PET to compare cell metabolism in the lungs and the right ventricle between patients and controls.


Eligibility criteria: Inclusion Criteria:

1. Patients with PAH:

   * Hemodynamic diagnosis of precapillary pulmonary hypertension: PAPm ≥25 mmHg, PCWP ≤15 mmHg
   * Exclusion of group 2,3,4 or 5
2. Patients with CTEPH:

   * Hemodynamic diagnosis of precapillary pulmonary hypertension: PAPm ≥25 mmHg, PCWP ≤15 mmHg
   * Persistence of thrombotic perfusion defects on pulmonary scintigraphy or angioCT, after 3 months or more of correct anticoagulant therapy
3. Healthy subjects

   * No known disease or condition
   * Normal lung function, chest x-ray, EKG and blood chemistry and haematology

Exclusion Criteria:

* Severe comorbidity.
* Pulmonary, pleural or rib cage disease interfering with FDG-PET acquisition
* Malignancy with exception of basocellular carcinoma
* Current smoker or former smoker (last 10 years or more than 10-year-pack).
* Pregnant or lactating women Hyperglycemia (fasting above 200 mg/dL)
* Hypersensitivity to the product or its excipients

Primary outcomes:
measure: FDG uptake in lung parenchyma
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: