louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04506515: Psychological Impact of COVID-19 Pandemic in Healthcare Workers
Official title: Psychological Impact of COVID-19 Pandemic in Healthcare Workers in Spain: A Cross-sectional Study. PSIMCOV Group
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Stress, Psychological
Work Related Stress
Epidemic Disease
SARS-CoV Infection
Lead sponsor: Hospital General Universitario de Valencia
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Respondents are healthcare workers in any center/hospital treating patients and are involved directly or indirectily with patients who suffer from COVID-19.

Respondents might be physicians, nurses, ancillary staff, etc or be involved in other type of jobs like administration, techinical support, kitchen and cleaning servicies, etc.

Brief summary: Background. The current coronavirus disease (COVID-19) has a great impact worldwide. Healthcare workers play an essential role and are one of the most exposed groups.Information about the psychosocial impact on healthcare workers is limited.

Methods. 3109 healthcare workers completed a national, internet-based, cross-sectional 45-item survey between 9 and 19 April 2020. The objective is to assess the psychological impact of the COVID-19 pandemic in Spanish healthcare workers. A Psychological Stress and Adaptation at work Score (PSAS) was defined combining four modified versions of validated psychological assessment tests (A) Healthcare Stressful Test, (B) Coping Strategies Inventory,(C) Font-Roja Questionnaire and (D) Trait Meta-Mood Scale.

Detailed description: PSAS (Psychological Stress and Adaptation at work Score) is a self conducted questionnaire designed to assess psychological impact in healthcare workers to match times of crisis and when the time is scarce. PSAS has a range between 0 and 105, and higher scores represent higher stress detected.

Eligibility criteria: Inclusion Criteria:

* Active healthcare workers in any private/public hospital \> 18 years old

Exclusion Criteria:

* Refusal to participate

Primary outcomes:
measure: PSAS (Psychological Stress and Adaptation at work Score) during the crisis
timeFrame: during the pandemic (April 9, 2020 to April 19, 2020)
Secondary outcomes:
measure: PSAS (Psychological Stress and Adaptation at work Score) in basal conditions
timeFrame: After the pandemic (back to regular activity to be considered in the future as we do not know it yet. It expected to be in less than one year.
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: CHGUV
Study officials:
References:
citation: Romero CS, Delgado C, Catala J, Ferrer C, Errando C, Iftimi A, Benito A, de Andres J, Otero M; PSIMCOV group*. COVID-19 psychological impact in 3109 healthcare workers in Spain: The PSIMCOV group. Psychol Med. 2022 Jan;52(1):188-194. doi: 10.1017/S0033291720001671. Epub 2020 May 14.
Clinical trial NCT00692315: Treating Oxidative Stress in Children With Autism
Official title: Efficacy of Methylcobalamin and Folinic Acid Treatment on Glutathione Redox Status and Core Behavior in Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autistic Disorder
Keywords: glutathione
methionine
folinic acid
redox
oxidative stress
behavior
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2008-06-06
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open label trial was undertaken in 40 autistic children to determine whether treatment with metabolic precursors methylcobalamin and folinic acid would improve plasma biomarkers of oxidative stress and measures of core behavior using the Vineland Adaptive Behavior Scales (VABS). Metabolites involved in methionine and glutathione synthesis and VABS behavior scores were measured before and after a three month intervention period.

The results indicated that pre-treatment metabolites in autistic children were significantly different from values in age-matched control children. The three month intervention resulted in significant increases in cysteine, cysteinylglycine, and glutathione (GSH, p \< 0.001). The oxidized disulfide form of glutathione (GSSG) was decreased (p \< 0.008) and the glutathione redox ratio (GSH/GSSG) was increased after treatment (p \< 0.001). Although significantly improved, these metabolites remained below control levels after intervention (p \> 0.01). Similarly, increases in VABS composite score and sub-scores for Socialization, Communication, and Daily Living Skills increased after treatment (p \< 0.007) but also remained below standard scores.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Autistic Disorder by DSM-IV 299.0 or CARS score \>30

Exclusion Criteria:

* Primary genetic disease with co-morbid autism
* frequent seizures
* recent surgery
* active infection with fever
* high dose vitamin/mineral supplements
* severe gastrointestinal symptoms

Primary outcomes:
measure: Glutathione redox status (GSH/GSSG)
timeFrame: 3 months
Secondary outcomes:
measure: Vineland Adaptive Behavior Scales
timeFrame: 3 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital Research Institute
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: S. Jill James, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: James SJ, Melnyk S, Fuchs G, Reid T, Jernigan S, Pavliv O, Hubanks A, Gaylor DW. Efficacy of methylcobalamin and folinic acid treatment on glutathione redox status in children with autism. Am J Clin Nutr. 2009 Jan;89(1):425-30. doi: 10.3945/ajcn.2008.26615. Epub 2008 Dec 3.
Clinical trial NCT04223115: A Randomized Controlled Study of Digitalized Cognitive Behavioral Intervention for Antenatal Depression
Official title: Randomized Controlled Trial of Digitalized Cognitive Behavioral Therapy With Telephone Coaching for Mothers Suffering From Depression During Pregnancy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Antenatal Depression
Keywords: digital intervention
cognitive behavioral therapy
antenatal depression
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 634
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of the current research project is to evaluate the effectiveness of the digitalized cognitive behavioral therapy program including telephone coaching for antenatal depressive symptoms. The participants are screened from the general population of pregnant women, as a part of the routine maternity health care check-ups. Mothers with depressive symptoms will be randomized into intervention group receiving guided digitalized treatment program or control group receiving education material about depression in digital form.


Eligibility criteria: Inclusion Criteria:

* fluent in written and spoken Finnish or Swedish
* access to computer or mobile phone with internet
* between 12 and 22 weeks pregnant
* screening and baseline score on the EPDS ≥10 points

Exclusion Criteria:

* lifetime history of psychotic disorder (e.g. schizophrenia, schizoaffective disorder, bipolar disorder, psychotic depression)
* active suicidal ideation
* severe substance abuse or dependence
* actively ongoing psychotherapy
* participates in another intervention study aiming at treating the symptoms of antenatal depression
* multiple pregnancy

Primary outcomes:
measure: Change in the Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Baseline and 11 weeks after randomization
Secondary outcomes:
measure: Change in the General Anxiety Disorder 7-item scale (GAD-7)
timeFrame: Baseline and 11 weeks after randomization
measure: Change in the Beck Depression Inventory II (BDI-II)
timeFrame: Baseline and 11 weeks after randomization
measure: Social Phobia Inventory (SPIN)
timeFrame: Baseline and 11 weeks after randomization
measure: Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ)
timeFrame: Baseline and 11 weeks after randomization
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline and 11 weeks after randomization
Other outcomes:
Locations:
city: Turku
country: Finland
facility: University of Turku
Study officials:
affiliation: University of Turku, Research Center for Child Psychiatry
name: Andre Sourander, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00165815: The Efficacy, Tolerability and Safety of Donepezil (Aricept) in Parkinson's Disease Patients With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dementia With Parkinson's Disease
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-14
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomised, double-blind, 3-arm parallel group study comparing Aricept® with placebo.


Eligibility criteria: Patients with an established diagnosis of PD and dementia, who fulfill all of the inclusion criteria and none of the exclusion criteria listed below, will be eligible for enrolment into this study.

Best efforts must be made on clinical grounds to exclude patients with DLB and AD. The key inclusion criteria in this respect is the onset of dementia documented to have occurred at least 1 year after the diagnosis of PD.

Primary outcomes:
measure: PD patients with dementia will be screened up to 4 weeks prior to initiating dose administration. Baseline measurement on efficacy measures will be conducted at baseline, after which the first dose of study medication will be administered.
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Allgemeines Krankenhaus Barmbeck
state: Hambug
city: Wolfach
country: Germany
facility: Parkinson Klinik Wolfach
city: Belfast
country: Ireland
facility: Belfast City Hospital
city: Blackpool
country: Ireland
facility: Unit 20 Black Poo Technology Centerl
Study officials:
affiliation: Eisai Limited
name: Jina Schwartz
role: STUDY_DIRECTOR
References:
Clinical trial NCT05993715: Nitrate Supplementation on Motor Unit Activity
Official title: Influence of Nitrate Supplementation on Motor Unit Activity During Recovery Following a Sustained Ischemic Contraction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Supplements
Healthy
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: Manchester Metropolitan University
First posted: 2023-08-15
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study aimed to assess if nitrate supplementation influence motor unit (MU) activity following a sustained ischemic contraction and whether this is affected by blood flow restriction (BFR) during the recovery period. Fourteen male participants (mean ± SD, 25 ± 6 years) completed two experimental trials following 5-days of supplementation with either nitrate-rich (NIT) or nitrate-depleted (PLA) beetroot juice in a randomized, double-blinded, cross-over design. Intramuscular electromyography was used to assess MU potential (MUP) size and firing rates (MUFR) during a submaximal (25% MVC) sustained isometric contraction with BFR. These variables were also assessed during a 90 s recovery period with the first half completed with, and the second half completed without, BFR. Nitrate supplementation can expedite the recovery of MUP duration following a sustained ischemic contraction in healthy adults. These novel observations improve understanding of the effects of nitrate on the recovery of neuromuscular function post-exercise and might have implications for recovery of muscle contractile function.


Eligibility criteria: Inclusion Criteria:

* Male between 18 - 30 years
* free from known respiratory insufficiency, cardiovascular disease and neuro-musculo-skeletal problems at present or in the preceding 6 months.
* having at least 5 years competitively (team) sport experience.

Exclusion Criteria:

* having cardiovascular disease, neuromuscular disease and any lower limb injury and treatment for chronic respiratory complaints.

Primary outcomes:
measure: Plasma Nitrite Level
timeFrame: Pre-exercise
measure: Motor Unit Activity
timeFrame: Pre-exercise, post-exercise, recovery (45 s)
Secondary outcomes:
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Northumbria University
Study officials:
References:
Clinical trial NCT04511715: Intravitreal Bevacizumab for Nonproliferative Diabetic Retinopathy
Official title: Efficacy and Safety of Intravitreal Bevacizumab for the Improvement of Severe Non-proliferative Diabetic Retinopathy Without DME: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Non-proliferative Diabetic Retinopathy
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this randomized clinical trial, 100 eyes with nonproliferative diabetic retinopathy will be included and divided randomly into 2 groups: Intravitreal Bevacizumab group (50 eyes) that receive 6 bimonthly intravitreal bevacizumab, and control group (50 eyes) that undergo regular follow-up for Diabetic Retinopathy. Diabetic macular edema (DME) will be treated independently in all groups by intravitreal bevacizumab. Primary outcome will be the percentage of patients with progression of 2 or more stages through international diabetic retinopathy staging. The secondary measures will be changes in best corrected visual acuity (BCVA) and central macular thickness (CMT), and number of examinations and injection.


Eligibility criteria: Inclusion Criteria:

* Presence of severe NPDR with DRSS score more than 53 with or without diabetic macular edema
* Diagnosis of DM (type 1 or 2) with age more than 18 years' old
* Visual acuity from 20/25 to 20/40 according to Snellen chart examination or more than 69 letters according to ETDRS chart

Exclusion Criteria:

* Presence of proliferative diabetic retinopathy features including vitreous hemorrhage or optic disc or retinal neovascularization
* History of retinal laser photocoagulation
* Tractional retinal detachment involving the macula
* Evidence of neovascularization of angle on examination
* Macular edema due to a cause other than DME
* Any ocular condition which may change visual acuity during the study
* History of intravitreal injection of anti-vascular endothelial growth factor agent in past 3 months
* History of any use of intravitreal corticosteroid
* History of major intra-ocular surgery except cataract surgery in the past 6 months
* History of thromboembolic every in the past 3 months

Primary outcomes:
measure: Percentage of patients with equal or more than 2 stages of progression in diabetic retinopathy staging
timeFrame: 12 months
Secondary outcomes:
measure: Best corrected visual acuity
timeFrame: 12 months
measure: Central retinal thickness
timeFrame: 12 months
measure: Number of visits
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02214615: Carbamazapine for Inherited Erythromelalgia Patients With NaV1.7 Mutations
Official title: Pilot Study on the Response of Inherited Erythromelalgia Patients With NaV1.7 Mutations to Carbamazepine: Clinical Imaging Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erythromelalgia
Lead sponsor: VA Connecticut Healthcare System
Sponsor class: FED
First posted: 2014-08-12
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This research study is designed to investigate brain response using fMRI scan, and behavioral responses, to treatment with the drug carbamazepine (CBZ) in patients with the painful sodium channelopathy inherited Erythromelalgia (IEM). This study is designed to identify the central nervous system (CNS) regions that are activated during ongoing or evoked pain attacks, and the altered CNS response to CBZ treatment. This will advance our understanding of how IEM affects the brain. We also hope to validate a pharmacogenic approach to the study of IEM by use of an FDA approved drug. We hope, but cannot be sure, that subjects will directly benefit from this study.


Eligibility criteria: Inclusion Criteria:

* diagnosis/symptoms of EM
* specific NaV1.7 sodium channel mutations (including S241T)

Exclusion Criteria:

* patients with no identified NaV1.7 mutation

Primary outcomes:
measure: Carbamazepine Affects Pain in Patients With S241T NaV1.7 IEM Mutation
timeFrame: 15 days
Secondary outcomes:
measure: Carbamazepine Affects Mean Duration of Pain Episode
timeFrame: 15 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: VAMC West Haven and Yale University
name: Stephen Waxman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03063515: AchE Inhibitor and Insulin
Official title: Using Acetylcholinesterase Inhibitors to Promote Insulin Secretion in Human Beings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Keywords: Insulin secretion
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2017-02-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The investigator will examine the effect of a single dose of pyridostigmine, AchE inhibitor on insulin secretion in healthy subjects. Each subject will undergo an intravenous glucose tolerance test (IVGTT) where IV glucose will be administered and the glucose excursion and insulin secretion response will be evaluated by measuring insulin and glucose at different time points. The test will be carried out twice, once without and once with the administration of a single dose of Pyridostigmine on two separate days. The investigator hypothesizes that inhibiting AChE will potentiate insulin secretion.


Eligibility criteria: Inclusion Criteria:

* 18 years and older

Exclusion Criteria:

* BMI \>30 Kg/m2
* fasting glucose \>100
* Glycohemoglobin (Hemoglobin A1C) 5.7% or more
* History of asthma
* Use of medications that may interfere with glucose metabolism

Primary outcomes:
measure: First phase insulin response to IV glucose infusion
timeFrame: -10, -4, 1, 2, 3, 4, 5, 6, 8, and 10 minutes
Secondary outcomes:
measure: Glucose excursion after IV glucose infusion
timeFrame: -10, -4, 1, 2, 3, 4, 5, 6, 8, and 10 minutes
Other outcomes:
Locations:
city: Miami
country: United States
facility: Diabetes Research Institute
state: Florida
Study officials:
affiliation: University of Miami
name: Maria del Pilar Solano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03213015: Correlation Between the Amplitude of Ankle Dorsiflexion and Occurrence of Patellofemoral Pain Syndrome
Official title: Correlation Between the Amplitude of Ankle Dorsiflexion and Occurrence of Patellofemoral Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Keywords: confiability
ankle
patellofemoral pain syndrome
Lead sponsor: Universidade Anhanguera
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study was to verify the clinical reliability of ankle dorsiflexion range of motion (ADROM) measurement with weight bearing (WB) using an app on the smartphone (iHand) and to verify if there is correlation between the limitation of the ADROM and the PFP.

Detailed description: The change in lower extremity movement pattern has been previously associated with severe knee disorders, including anterior cruciate ligament rupture, patellar tendinopathy, iliotibial band syndrome, and patellofemoral pain (PFP). The aim of this study was to verify the clinical reliability of ankle dorsiflexion range of motion (ADROM) measurement with weight bearing (WB) using an app on the smartphone (iHand) and to verify if there is correlation between the limitation of the ADROM and the PFP.

Eligibility criteria: Inclusion Criteria:

* volunteers with a history of patelofemoral pain
* presence of image (lesion) in cartilage tissue in Nuclear Magnetic Resonance
* knee dynamic valgus during the single leg squat test and step down test (clinical tests)

Exclusion Criteria:

* acute knee lesion
* acute ankle lesion
* surgical procedures before six months ago

Primary outcomes:
measure: Ankle Dorsiflexion Degrees
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Campo Grande
country: Brazil
facility: Filipe Abdalla
state: Mato Grosso do Sul
Study officials:
References:
citation: Dill KE, Begalle RL, Frank BS, Zinder SM, Padua DA. Altered knee and ankle kinematics during squatting in those with limited weight-bearing-lunge ankle-dorsiflexion range of motion. J Athl Train. 2014 Nov-Dec;49(6):723-32. doi: 10.4085/1062-6050-49.3.29.