louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01042912: Frequency Analysis of Carotid Artery Disease
Official title: A Single-centered Investigation Into the Frequency Domain Patterns in the Carotid Vessel in Patients With Suspected Stenosis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Carotid Artery Disease
Keywords: diagnosis
carotid
artery
disease
auscultation
sound
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2010-01-06
Enrollment: 0
Sex: ALL
Minimum age (years): 40
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: Any inpatient or outpatient with inclusion criteria met and exclusion criteria not met presenting for aniography to the University of Minnesota Fairview Hospital or Clinic in Minneapolis or Redwing, Minnesota

Brief summary: The purpose of this study is to determine if carotid artery stenosis can be detected using an electronic stethoscope. This study will use a commercially available electronic stethoscope to record carotid sounds in patients with suspected carotid artery stenosis. The presence of absence of abnormal vessels will be confirmed by diagnostic ultrasound as part of normal patient care at this institution.


Eligibility criteria: Inclusion Criteria:

* Age 40-80
* Indicated for diagnostic ultrasound related to carotid artery stenosis

Exclusion Criteria:

* Pregnant women
* Prior carotid intervention

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center (UMMC) Fairview Clinics
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Marie A Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01617512: Study Accelerometer Signals to Measure Daily Activities (SASMDA)
Official title: Study Accelerometer Signals to Measure Daily Activities: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Disorders
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: TIMC-IMAG
name: Laboratory TIMA
name: Clinical Investigation Centre for Innovative Technology Network
First posted: 2012-06-12
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine if it is possible to identify activities in the daily accelerometer measures of a person with urinary disorders.


Eligibility criteria: Inclusion Criteria:

* man
* patients fitted with artificial urinary sphincter
* patients affiliated to social security or similar regime

Exclusion Criteria:

* patient do not speak french
* patient unable to express his consent
* patient hospitalize without consent
* patient under legal protection
* patient deprived of liberty

Primary outcomes:
measure: Number of patients with urinary disorders for which it is possible to identify automatically activities among all the daily accelerometer data.
timeFrame: 6 months
Secondary outcomes:
measure: Score of satisfaction with the use of the medical device, assessed by the patients
timeFrame: 6 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Grenoble
name: Alexandre Moreau-gaudry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02891512: Very Low Frequency Magnetic Fields Versus the Supplement "Xinepa" in the Treatment of the Carpal Tunnel Syndrome
Official title: Effectiveness of Very Low Frequency Magnetic Fields Versus the Supplement "Xinepa" in the Treatment of the Carpal Tunnel Syndrome: Randomized Double-blind Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Magnetic Fields
Pain
Paresthesia
Visual Analogue Scale
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the effectiveness of the treatment with very low frequency magnetic fields (ELF) on the reduction of pain and the relief of the associated signs such as sensitivity disorders that affect the first three fingers and half of the fourth finger of the hand in patients with carpal tunnel syndrome versus the supplement (= Xinepa).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of carpal tunnel syndrome

Exclusion Criteria:

* Pregnancy;
* Pacemaker or other metallic implants;
* Systemic infectious disorders;
* Neoplastic disorders;
* Epilepsy;
* Severe heart disease.
* Known hypersensitivity to the components of Xinepa

Primary outcomes:
measure: Change of Visual Analogue Scale (VAS) from baseline to 12 weeks
timeFrame: baseline, 4 weeks, 12 weeks
Secondary outcomes:
measure: Change of Semmes-Weinstein Monofilaments of light touch and pressure sensation test from baseline to 12 weeks
timeFrame: baseline, 4 weeks, 12 weeks
measure: Change of Boston Carpal Tunnel Questionnaire from baseline to 12 weeks
timeFrame: baseline, 4 weeks, 12 weeks
measure: Change of the measurement of the grip strength trough the Jamar dynamometer from baseline to 12 weeks
timeFrame: baseline, 4 weeks, 12 weeks
measure: Change of the measurement of the pinch strength trough the Pinch Gauges dynamometer from baseline to 12 weeks
timeFrame: baseline, 4 weeks, 12 weeks
measure: Change of electroneurography from baseline to 12 months
timeFrame: baseline, 4 weeks, 12 weeks
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Umberto I Hospital
Study officials:
affiliation: Umberto I hospital, Sapienza University of Rome
name: Vincenzo Maria Saraceni
role: STUDY_DIRECTOR
References:
Clinical trial NCT01518712: A Study to Assess the Bioequivalence of 2 Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) (150 mg/850 mg) With Respect to the Individual Components of Canagliflozin (1 x 300 mg) and Metformin IR Tablets (2 x 850 mg) in Healthy Volunteers
Official title: A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 Fixed Dose Combination Tablets of Canagliflozin and Metformin Immediate Release (IR) (150 mg/850 mg) With Respect to the Individual Components of Canagl
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteers
Bioequivalence
Canagliflozin (JNJ-28431754)
Metformin IR
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2012-01-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and metformin IR.

Detailed description: This is an open-label (identity of study drug will be known to volunteer and study staff), single-center study to evaluate the bioequivalence of canagliflozin and metformin IR when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin IR) (Treatment A) and when administered as fixed-dose combination (FDC) tablets (ie, canagliflozin and metformin IR contained in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive Treatment A followed by Treatment B or Treatment B followed by Treatment A with a period of approximately 15 days between treatments.

Eligibility criteria: Inclusion Criteria: - Body mass index (BMI) between 18.5 and 30 kg/m² (inclusive) and a body weight of not less than 50 kg. Exclusion Criteria: - History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) deemed to be clinically significant by the Investigator

Primary outcomes:
measure: Canagliflozin plasma concentrations
timeFrame: At 15 time points up to 72 hours
measure: Metformin plasma concentrations
timeFrame: At 13 time points up to 24 hours
Secondary outcomes:
measure: Adverse events
timeFrame: Up to approxmately 23 days
measure: Clinical laboratory tests
timeFrame: Up to approxmately 23 days
measure: Vital signs
timeFrame: Up to approximately 23 days
Other outcomes:
Locations:
city: Tempe
country: United States
state: Arizona
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research and Development, L.L.C Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT01495312: 24-hr Intraocular Pressure (IOP) Patterns of Glaucoma Patients After Selective Laser Trabeculoplasty (SLT)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Glaucoma
Keywords: IOP fluctuations
during two 24-hour periods
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2011-12-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the relationship between Intraocular Pressure (IOP) fluctuations of glaucoma patients as recorded with an IOP-sensing contact lens (SENSIMED Triggerfish®), during two 24-hour periods after selective laser trabeculoplasty (SLT) for routine treatment of glaucoma.


Eligibility criteria: Inclusion Criteria:

* Subjects must correspond to all other inclusion criteria in order to be eligible for the investigation.

  * Subject is able to comply with the study procedures
  * 18-80 years old
  * Subjects diagnosed with glaucoma, based on presence of repeatable visual field loss and/or glaucomatous optic neuropathy based on masked review of optic disc stereophotographs and under ocular hypotensive treatment, or diagnosed with ocular hypertension, with an IOP of \> 22 mmHg at the screening visit and under ocular hypotensive treatment.
  * Subject has consented to be in the trial
  * Visual acuity of 20/200 or better
  * Ability to understand the character and individual consequences of the study
  * For women of childbearing potential, adequate contraception

Exclusion Criteria:

* Subjects presenting with any of the following criteria will not be included in the trial:

  * Subjects with contraindications for wearing contact lenses
  * Severe dry eye syndrome
  * Keratoconus or other corneal abnormality
  * Conjunctival or intraocular inflammation
  * Eye surgery prior to and throughout the study.
  * Full frame metal glasses during SENSIMED Triggerfish® monitoring
  * Known hypersensitivity to silicone, plaster or ocular anesthesia (proparacaine)
  * Pregnancy and lactation
  * Simultaneous participation in other clinical studies

Primary outcomes:
measure: IOP
timeFrame: 2 months after SLT
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD
state: California
city: La Jolla
country: United States
facility: UCSD
state: California
Study officials:
References:
Clinical trial NCT03219112: Training Balance Control in Children With Cerebral Palsy Using Virtual Reality Games
Official title: Training Balance Control Using Virtual Reality Games in Children With Cerebral Palsy and Typically Developing Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy, Spastic
Keywords: balance
rehabilitation
exergaming
virtual reality
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2017-07-17
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study the clinical relevance of the use of commercially available virtual reality games in the rehabilitation of balance will be assessed in children with cerebral palsy. It will be investigated how different commercially available platforms (i.e. Xbox One + Kinect and Nintendo Wii + balance board) will affect the compensations of children with cerebral palsy to preserve their balance. The effect of 1 training session will be assessed as well as the effect of a long-term training of 8 weeks.


Eligibility criteria: Inclusion Criteria:

1. children diagnosed with cerebral palsy (spastic type)
2. age: 8-11 years and 11 months
3. bilateral CP (diplegia) \& unilateral CP (hemiplegia)
4. GMFCS level 1 \& 2
5. able to independently stand still for 2 minutes
6. sufficient cooperation to participate in the measurements and training

Exclusion Criteria:

1. No informed consent
2. surgery of the lower limbs that affects mobility
3. Botulinum-toxin A treatment within 6 months prior to inclusion in the study
4. vestibular deficits, benign vertigo, ADHD or instable epilepsia

For typically developing children:

Inclusion criteria;

1. age: 8-11 years and 11 months
2. no history of neurologic, musculoskeletal or other impairments that could affect mobility

Primary outcomes:
measure: Change in Pediatric Balance Scale compared to baseline
timeFrame: measured at baseline, after 40 minutes (of training), and after 8 weeks of training
Secondary outcomes:
measure: Change in Bruininks-Oseretsky test for motor proficiency - subscale 'balance' and 'speed & agility' compared to baseline
timeFrame: measured at baseline, after 40 minutes (of training), and after 8 weeks of training
measure: Change in Upper body kinematics compared to baseline
timeFrame: measured at baseline, after 40 minutes (of training), and after 8 weeks of training
measure: Change in Posturography compared to baseline
timeFrame: measured at baseline, after 40 minutes (of training), and after 8 weeks of training
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Vakgroep REVAKI (Ghent University - Ghent University hospital)
Study officials:
References:
Clinical trial NCT06812312: Impact of Basic Cardiopulmonary Resuscitation on the Knowledge and Attitude of Professional Football Players and Coaches
Official title: Impact of Basic Cardiopulmonary Resuscitation on the Knowledge and Attitude of Professional Football Players and Coaches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CPR Skills
CPR Quality Assessment
CPR
Football Players
Coaches
Keywords: cardiopulmonary resuscitation
knowledge
attitude
nursing
professional soccer
Spain
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
Collaborators: name: Villarreal CF
name: Cardenal Herrera University
First posted: 2025-02-06
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study was conducted in two phases:

The first phase consisted of an observational cross-sectional study with 206 participants who completed the questionnaires in person.

The second phase consisted of an educational intervention with pre-post intra-subject control over 70 participants, conducted online.
Primary purpose: OTHER

Brief summary: This study aims to evaluate the change in attitudes and knowledge about basic cardiopulmonary resuscitation (CPR-B) in football professionals following a training intervention and to examine its correlation with sociodemographic variables.

The study consists of two phases. The first phase involves an observational cross-sectional study to assess the level of attitude and knowledge in cardiopulmonary resuscitation. The second phase includes an educational intervention consisting of a training and practical session on CPR-B, with a pre-post intra-subject control. The questionnaire was completed by football professionals from the Spanish first division and their coaches, with N=206 in the first phase and N=70 30 days after the training intervention in the second phase.


Eligibility criteria: Inclusion Criteria:

* being professional football players or coaches in the Valencian Community
* accept voluntarily participating in the study. All participants gave their written consent after being informed.

Exclusion Criteria:

* Not completing the questionnaire correctly (missing data)

Primary outcomes:
measure: Evaluate the change in attitudes and knowledge about CPR-B
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Villarreal
country: Spain
facility: Héctor Uso Vicent
state: Castellón
Study officials:
References:
Clinical trial NCT01189812: Safety and Efficacy Study of Citalopram and Lithium for the Treatment of Depressive Mood Disorder Symptoms
Official title: A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study to Assess the Safety and Efficacy of Citalopram in Combination With Lithium or Placebo in the Treatment of Symptoms in Patients With Depressive Mood Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Dysthymia
Depression Not Otherwise Specified
Borderline Personality Disorder
Keywords: hopelessness
alone
sad
troubled
depression
Lead sponsor: Columbia Northwest Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-08-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that patients receiving citalopram in combination with lithium will have a greater reduction in depressive symptoms than patients receiving citalopram in combination with placebo.


Eligibility criteria: Inclusion Criteria:

* 18-75 years of age
* Meets criteria for Major Depressive Disorder, Dysthymia, Depression Not Otherwise Specified or Borderline Personality Disorder
* Ability to speak, read and understand the English Language and provide written informed consent

Exclusion Criteria:

* Current, unstable and significant medical condition or illness
* History of Thyroid disorder, seizure disorder, tumors or other CNS condition that predisposes the patient to risk of seizure
* Pregnant or lactating females
* Abnormal clinical laboratory test results
* Intolerance or hypersensitivity to SSRIs or lithium
* History or current diagnosis of bipolar mood disorder, psychosis, schizophrenia or dementia
* Certain mediations my not be used prior or during the study

Primary outcomes:
measure: Sheehan-Suicidality Tracking Scale (S-STS)
timeFrame: 4 weeks; from Baseline to Week 4
Secondary outcomes:
measure: Beck Hopelessness Scale (BHS)
timeFrame: 4 weeks
measure: Beck Scale for Suicide Ideation (BSS)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: Northwest Clinical Research Center
name: Arifulla Khan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aretmis Institute for Clinical Research
name: Vishaal Mehra, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02327312: Multicenter Investigation of Trabecular Micro-Bypass Stents vs. Laser Trabeculoplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Primary Open-Angle Glaucoma
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2014-12-30
Enrollment: 91
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and effectiveness of Trabecular Micro-Bypass stents (two stents per study eye) vs. laser trabeculoplasty, in subjects with open angle glaucoma


Eligibility criteria: Inclusion Criteria:

* Open angle Glaucoma

Exclusion Criteria:

* Active corneal inflammation or edema
* Choroidal detachment, effusion, choroiditis

Primary outcomes:
measure: IOP reduction
timeFrame: up to 24 months
Secondary outcomes:
measure: % IOP reduction
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Glendale
country: United States
state: Arizona
city: Fayetteville
country: United States
state: Arkansas
city: Hemet
country: United States
state: California
city: Cape Coral
country: United States
state: Florida
city: Elizabeth City
country: United States
state: North Carolina
city: Memphis
country: United States
state: Tennessee
city: Fort Worth
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Racine
country: United States
state: Wisconsin
Study officials:
affiliation: Glaukos Corporation
name: Kerry Stephens, OD
role: STUDY_CHAIR
References:
citation: Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.