louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02433964: Evaluation of Therapeutic Effects of LED (627 +/- 10nm) The Initial Phase of the Ankle Sprains Treatment
Official title: EVALUATION OF THERAPEUTIC EFFECTS OF LED (627 +/- 10nm) THE INITIAL PHASE OF THE ANKLE SPRAINS TREATMENT - A RANDOMIZED PLACEBO-CONTROLLED CLINICAL TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Sprain
Keywords: laser
LED
PRICE
pain
edema
Lead sponsor: Universidade do Vale do Paraíba
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the therapeutic effects of the LED (627 +/- 10 nm) with respect to the localized pain and local swelling of ankle sprains in the initial phase.

Detailed description: A variety of therapies for the treatment of sprains has emerged as they occur advances in technological applications. Therapy with coherent and non-coherent light is a treatment modality for a variety of musculoskeletal injuries. The main benefits certificates for phototherapy are the reduction of nociceptive processes, tissue remodeling, among others. The aim of the present paper is to analyze the changes caused by the use of LED (627 +/- 10 nm) with an energy density of 10 J / cm2 in 40 subjects divided into two groups (placebo and LED). All volunteers participating in this study had ankle inversion sprain grade II treated with the price technique. The study was performed in six days. And the results were verified by review of all individuals, through the Visual Analogue Scale (VAS) of pain, McGill Pain Questionnaire and Titrimetry. Measurements were performed at first, third and sixth day's of treatment.

Eligibility criteria: Inclusion Criteria:

* Active individuals
* With medical referral
* With clinical diagnosis of inversion sprain grade II
* The day he suffered the injury
* Without prescriptions

Exclusion Criteria:

* Individuals who had previous trauma and orthopedic disorders such as fractures, tendinopathy, previous surgical procedure
* Other systemic diseases.

Primary outcomes:
measure: edema, measured by volumetry
timeFrame: the development of edema in 6 days
Secondary outcomes:
measure: pain, measured by the Visual Analogue Pain Scale (VAS) and McGill Pain Questionnaire
timeFrame: the evolution of the pain in 6 days
Other outcomes:
Locations:
city: São José dos Campos
country: Brazil
facility: Lasertherapy and Photobiology Center
state: São Paulo
Study officials:
affiliation: Universidade do Vale do Paraíba
name: Bruno de Moraes Prianti
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04456764: The Sleep and Teamwork in EMS Study
Official title: Real-time Intervention to Reduce Fatigue Among Emergency Medical Services Workers: A Cluster-randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fatigue
Sleep
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute for Occupational Safety and Health (NIOSH/CDC)
First posted: 2020-07-02
Enrollment: 708
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: More than half of Emergency Medical Services (EMS) workers report work-related mental and physical fatigue. Odds of injury among fatigued EMS workers are nearly double that of non-fatigued workers. There is a compelling need to reduce fatigue among EMS workers, yet few EMS organizations have a formal fatigue management program and many may not be cost-effective or evidence-based. This trial addresses national goals of the National Occupational Research Agenda (NORA) and tests a novel approach to fatigue risk management that is easily scalable to large workforces and low-cost for employers of shift workers.

Detailed description: The investigators will test an enhanced version of our SleepTrackTXT pilot intervention - Sleep and Fatigue Treatment in EMS (SaFTiE) - in a two-arm parallel cluster-randomized design of EMS agencies. Our unit of randomization will be the EMS agency, with the intervention deployed as a Fatigue Risk Management Program that can be integrated into an agency's existing program. During the active intervention phase, the investigators will use SaFTiE and an attention placebo control (APC) group to test the specific effect of our multi-component intervention on EMS worker fatigue and sleep health.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Live in United States (including Hawaii and Alaska)
* Licensed / certified EMS clinician
* Currently work in shifts
* Do at least one clinical shift per week
* Own a smartphone
* Willing to answer monthly surveys and daily text-messages,

Exclusion Criteria:

* Exclude EMS personnel who are primarily administrative with non-clinical duties
* Are restricted from using personal smartphone during periods of work
* Do not own a smartphone capable of running the study mobile app

Primary outcomes:
measure: Fatigue
timeFrame: At baseline, 3 months, and 6 months
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, 3 months, and 6 months
measure: Poor Sleep Quality
timeFrame: At 6 months
measure: Inter-Shift Recovery Measure
timeFrame: At baseline, 3 months, and 6 months
measure: Acute Fatigue Measure
timeFrame: Baseline, 3 months, and 6 months
measure: Chronic Fatigue Measure
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: P. Daniel Patterson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02489864: The Effect of Terlipressin in the Prevention of Type 2 Hepatorenal Syndrome by Improving Mean Arterial Pressure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatorenal Syndrome
Keywords: Terlipressin
mean arterial pressure
type 2 HRS
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-07-03
Enrollment: 30
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: PREVENTION

Brief summary: Appreciation of the central role for arterial vasodilatation in the pathogenesis of hepatorenal syndrome (HRS) has led to routine use of vasoconstrictors in combination with albumin as a medical therapy for HRS. Terlipressin have been explored but the optimal approach for such therapies has not yet been established. As compared with albumin, treatment with terlipressin and albumin is effective in improving renal function in patients with cirrhosis and hepatorenal syndrome. Our previous study showed that mean arterial pressure (MAP) is a predictor of hepatorenal syndrome occurrence in cirrhotic patients with ascites. The purpose of this study was to examine the role of targeting an early and substantial increase in mean arterial pressure in the prevention of type 2 HRS.


Eligibility criteria: Inclusion Criteria:

1. cirrhosis as diagnosedby liver biopsy or clinical, biochemical, ultrasound,and/or endoscopic findings;
2. type 2 HRS with a MAP decrees for at least 10mmHg compared to basal blood pressure ;
3. age 18 to65 years;
4. absence of severe bacterial infection associated with findings of systemic inflammatory response as diagnosedby the presence of at least 2 of the following criteria: body temperature \<36°C or \>38°C, heart rate \>90 beats/min, respiration rate\>20/min, and white-cell count \<4 or \>12 X106/L or \>6% of band forms; patients with bacterial infections, however, could be included in the study if renal failure persisted after infection resolution;
5. the absence of cardiovascular diseases and any extra hepatic disease that could affect the short-term prognosis;
6. the absence of findings suggestive of organic nephropathy;
7. the absence of advanced hepatocellularcarcinoma.

Exclusion Criteria:

1. Patients with history of coronary artery disease
2. Cardiomyopathy
3. Ventricular arrhythmia
4. Obstructive arterial disease of limbs -

Primary outcomes:
measure: HRS incidence rate
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT02710864: A Cross-sectional Study of Congenital Cytomegalovirus Infection in Newborns in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Cytomegalovirus Infection
Keywords: Cytomegalovirus
Lead sponsor: Xiamen University
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 1510
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Neonates aged 0 to 14 days in MCHHs of Xinmi City, Jiaxian County, Zhongmu County and Huli District Xiamen City, in China ,were recruited, after written informed consents provided by the parents.

Brief summary: The primary objectives of this study were to evaluate the incidence of congenital CMV infection in neonates, and assess the concordance of detecting congenital cytomegalovirus (CMV) infection in neonatal saliva and urine samples.

Detailed description: This Cross-sectional study was conducted to recruit neonates less than 14 days old delivered in Maternal and Child Health Hospitals (MCHHs) of Xinmi City, Jiaxian County, Zhongmu County and Huli District Xiamen City, in China, from June 2015 to June 2016. The aim of this study is to enroll \~1800 neonates, and collect their saliva and urine samples which will be tested the CMV DNA by using real-time PCR.

Eligibility criteria: Inclusion Criteria:

* Neonates aged 0 to 14 days
* Neonates delivered in MCHHs of Xinmi City, Jiaxian County, Zhongmu County and Huli District Xiamen City

Exclusion Criteria:

* the parents of neonates not comply with our study

Primary outcomes:
measure: Number of cCMV infection in newborns
timeFrame: up to 5 months
Secondary outcomes:
measure: the Kappa value of CMV prevalence between saliva and urine samples
timeFrame: up to 5 months
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Maternity and Child care of Huli District
state: Fujian
city: Pingdingshan
country: China
facility: Maternity and Child care of Jiaxian County
state: Henan
city: Zhengzhou
country: China
facility: Maternity and Child care of Xinmi City
state: Henan
city: Zhengzhou
country: China
facility: Maternity and Child care of Zhongmu County
state: Henan
Study officials:
affiliation: Xiamen University
name: Jun Zhang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03540264: Tooth Wear:m Tooth Wear : Diagnosis- Treatment Decision
Official title: Tooth Wear : Diagnosis- Treatment Decision- Management- Monitoring- Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Wear
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 52
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: Tooth wear is a physiological process occurring from normal functioning of the dentition throughout lifetime.

Detailed description: The studies in the current literature indicated that both techniques of tooth preparation and the materials used are appropriate for the treatment of this condition, but the tendency is to reduce tooth preparation as reasonably possible. In this clinical trial, the investigators will compare the outcomes of direct resin composite and indirect polymer-infiltrated-ceramic-network.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older, in good general health, willing to participate in the study and accepting to come to regular controls in the future.
* Patients representing any type of significant tooth wear (≥ 1 mm depth) with dentine exposure in at least 4 teeth: localized tooth wear anterior or posterior teeth and generalized tooth wear anterio and posterior teeth.
* Patients having posterior support with at least 4 molars in occlusion, 1 pair per side, excluding third molar.

Exclusion Criteria:

* Patients wearing removable partial prosthesis
* Patients presenting skeletal Cl III occlusal Relationship
* Patients with remaining clinical crown of ≤ 3 mm in height and presenting tooth anomaly in shape and number in addition to anterior diastemas.
* Patients with symptomatic temporomandibular joint disorders.

Primary outcomes:
measure: Restoration
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: De Carvalho Joana, Dentist, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05629364: A Multi-Centre, Randomised, Controlled, Masked Phase 2 Study of the Safety and Efficacy of KIO-101 Ophthalmic Solution, Versus Vehicle Control in the Treatment of Dry Eye Disease in Patients With Autoimmune Disease
Official title: A Multi-Centre, Randomised, Controlled, Masked Phase 2 Study of the Safety and Efficacy of KIO-101 Ophthalmic Solution, Versus Vehicle Control in the Treatment of Dry Eye Disease in Patients With Autoimmune Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Dry Eye Disease
Lead sponsor: Kiora Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-29
Enrollment: 4
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Multi-Centre, Randomised, Controlled, Masked Phase 2 Study of the Safety and Efficacy of KIO-101 Ophthalmic Solution, versus Vehicle Control in the treatment of Dry Eye Disease in Patients with Autoimmune Disease


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of autoimmune disease (psoriatic arthritis, Systemic Lupus Erythematosus (SLE), or fibromyalgia) ≤ 10 years
* Have an Ocular Discomfort Score (ODS) score of ≥3 at Screening
* Have an average VAS score ≥ 50 at Screening; and ≥ 40 at Baseline, Visit 2/Day 1
* Schirmer's 1 test \>1 but \< 10 mm at Screening.
* National Eye Institute (NEI) corneal fluorescein staining score of ≥ 4 at Screening (Day 14) provided that the total NEI score did not change \> ± 2 grades from Screening (Day -14) to Baseline (Day 1) visits, as confirmed by the investigator
* Have a Best Spectacle Corrected Visual Accuity (BSCVA) score of 20/200 (+1.0 LogMAR) or better in both eyes at both the Screening and Baseline visits
* Have a conjunctival hyperaemia score of Grade 2 or more on the Efron Scale in both eyes

Exclusion Criteria:

* Have a history or presence of any ocular disorder or condition (other than dry eye disease (DED)) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety
* Have an autoimmune based vasculitis
* Have a history of RA \> 10 years.
* Have a Schirmer's 1 test score of 0 to 1mm at Screening
* Have had a corneal transplant in either or both eyes
* Have had puncta or intracanalicular plug present in either eyelid within 1 year prior to the Screening Visit or anticipated plug insertion or occlusion at any time during the study

Primary outcomes:
measure: Change in Schirmer's 1 test
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Teneriffe
country: Australia
facility: Ophthalmic Trials Australia
state: Queensland
Study officials:
affiliation: Ophthalmic Trials Australia
name: Mark Hinds
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04065464: TRACY - Track My Cycle
Official title: TRACY - Track My Cycle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fertility Monitor
Cycle Tracking
Lead sponsor: Center for Epidemiology and Health Research, Germany
Sponsor class: OTHER
Collaborators: name: Ava AG
First posted: 2019-08-22
Enrollment: 303
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All women aged 18 to 40 years matching the eligibility criteria can be enrolled in the pilot study.

Brief summary: The primary aim of the pilot study is to collect data for the fine-tuning and evaluation of the Ava algorithm. Secondary outcomes are the estimation of the accuracy in detecting the fertility status of each cycle day.


Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 40 at the time of admission
* Not pregnant and no pregnancy wish during the pilot study period
* Have a regular sleep pattern (sleep at least four hours per night and not working nightshift)
* Have regular menstrual cycles

Exclusion Criteria:

* Pregnant at study admission
* Currently breastfeeding or have breastfed in the past 6 months before study admission
* Currently using hormonal contraception or hormonal medication
* Health-related conditions that may affect menstrual cycle length and variability (e.g. PCOS, menopause, thyroid dysfunction)
* Unable to understand study instructions and/or not able to understand English or German
* More than one international overseas travel per month
* Unwilling to sign the ICF.

Primary outcomes:
measure: Fine-tuning Ava algorithm
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin-Mitte
country: Germany
facility: ZEG Berlin
state: Berlin
Study officials:
References:
Clinical trial NCT00610064: Brain Effects of Sacral Neuromodulation
Official title: Brain Effects of Sacral Neuromodulation in Patients With Refractory Lower Urinary Tract Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Disease
Keywords: Refractory lower urinary tract dysfunction
Sacral neuromodulation
Brain effects
Neuroimaging
Neuromodulation
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2008-02-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Sacral neuromodulation (SNM) has become an accepted treatment for patients with refractory lower urinary tract dysfunction such as urgency frequency syndrome, urgency incontinence, non-obstructive chronic urinary retention and chronic pelvic pain syndrome. Modulation of central afferent activity is considered critical to this therapeutic effect but the neural mechanisms are poorly understood.

We hypothesize that SNM has a significant effect on brain activity detectable by positron emission tomography (PET).


Eligibility criteria: Inclusion Criteria:

* Patients with refractory lower urinary tract dysfunction scheduled for sacral neuromodulation

Exclusion Criteria:

* Pregnancy
* Age \<18 years
* Claustrophobia

Primary outcomes:
measure: Effect of sacral neuromodulation on brain activity
timeFrame: 2-8 weeks
Secondary outcomes:
measure: Differences in brain activity effects of sacral neuromodulation (SNM) in patients with successful compared to failed SNM testing
timeFrame: immediately and 2-8 weeks after study inclusion
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Urology, University of Bern
Study officials:
affiliation: Department of Urology, University of Bern, 3010 Switzerland
name: Thomas M Kessler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04125264: Intense Therapeutic Ultrasound (ITU) to Treat Plantar Fasciitis
Official title: The Application of Intense Therapeutic Ultrasound in Plantar Fasciitis. A Randomized, Non-probabilistic and Superiority Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plantar Fasciitis
Plantar Fasciitis, Chronic
Ultrasound Therapy
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2019-10-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Non-probabilistic and Superiority Controlled Clinical Trial.
Primary purpose: TREATMENT

Brief summary: It was previously hypothesized that patients receiving Intense Therapeutic Ultrasound (ITU) in addition to the standard of care would have a more rapid resolution of pain, faster return to activities, and a decrease in intra- and perifascial lesions.

Detailed description: Intense Therapeutic Ultrasound (ITU) is an established ultrasound-based therapy in which sound waves are concentrated and focused into a well-defined specific area of musculoskeletal tissue. Previous researches hipothesize that the application of ITU improve and accelerate healing in patients with chronic plantar fasciitis.

Eligibility criteria: Inclusion Criteria:

* Both sex patients.
* Plantar fasciitis diagnosis: pain during walking during the first steps in the morning; pain due to palpation of plantar fasciia insertion.
* Chronic pain of at least 6 month.
* Longitudinal thickness of the plantar fasciia more than 4 millimeters.
* No previous surgery in the plantar fasciia.
* No previous application of alternative treatments such us shock waves or injections (last ninety days)

Exclusion Criteria:

* Platelet count disorder or anticoagulation therapy.
* Anti-inflammatories usual treatment for the treatment of plantar fasciitis.
* Diabetic foot syndrome.
* Presence of metabolic disease such us: hypertension, hiper or hipothyroidism.
* Pregnancy or breastfeeding.
* Previous treatment with fluoroquinolones antibiotic.
* Bilateral plantar fasciitis.
* Diagnosed Autoimmune disesase.
* Morphofunctional disorders in the foot and ankle.
* Diagnosed fibromyalgia.
* Heel disestesy.

Primary outcomes:
measure: Pain reduction
timeFrame: 24 weeks
measure: Plantar fasciia thickness reduction
timeFrame: 24 weeks
Secondary outcomes:
measure: Hypoechoic volume area reduction
timeFrame: 24 weeks
measure: Ankle range of motion reduction
timeFrame: 24 weeks
measure: Time to incorporation to daily live activities
timeFrame: 24 weeks
measure: Autonomous gait without pain in the heel
timeFrame: 24 weeks
measure: Improvement of patients satisfaction
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Diabetic foot Unit Complutense University
Study officials:
affiliation: Universidad Complutense Madrid
name: José Luis Lázaro Martínez, Phd
role: PRINCIPAL_INVESTIGATOR
References: