louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01088854: Acute Effect of Continuous Positive Airway Pressure in Heart Failure
Official title: Acute Effect of Continuous Positive Airway Pressure on Left Ventricular Diastolic Function and Exercise Tolerance in Compensated Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2010-03-17
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Acute effects of CPAP on diastolic function in patients with compensated heart failure (CHF) are unknown. The investigators hypothesized that acutely CPAP improves diastolic function, which is associated with increases exercise tolerance.

Objective: To evaluate the acute effects of CPAP on functional capacity and diastolic indices of patients with CHF. This is a randomized trial including 44 patients with compensated heart failure (functional classes II or III, NYHA). Patients will be allocated in CPAP(CPAP with 10cmH2O) or simulated CPAP (null pressure) after computed randomization, in a 1:1 ratio. All subjects shall complete a 6-minute walk test (6MWT) before and after CPAP (30 minutes; 10 cm H2O pressure). Doppler-echocardiogram will be performed before and at the end of CPAP. Wilcoxon or paired t tests were used to compare results, with significance level at p \< 0.05.


Eligibility criteria: Inclusion Criteria:

* functional class II or III (NYHA)heart failure
* agreement to participate in the study
* absence of acute exacerbation of dyspnea
* intact upper airway

Exclusion Criteria:

* valvular heart disease
* chest pain or unstable angina
* acute myocardial infarction in the prior month
* uncontrolled hypertension
* atrial fibrillation or other arrhythmias
* acute infection
* orthopedic limitations
* intolerance to CPAP mask

Primary outcomes:
measure: improvement of isovolumetric relaxation time
timeFrame: 30 minutes
Secondary outcomes:
measure: walk distance in the walk-test-six-minute (WT6M)
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: UPECLIN - Botucatu Medical School
state: Sao Paulo
Study officials:
affiliation: Full Professor Botucatu Medical School; UNESP
name: Beatriz B Matsubara, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bradley TD, Logan AG, Kimoff RJ, Series F, Morrison D, Ferguson K, Belenkie I, Pfeifer M, Fleetham J, Hanly P, Smilovitch M, Tomlinson G, Floras JS; CANPAP Investigators. Continuous positive airway pressure for central sleep apnea and heart failure. N Engl J Med. 2005 Nov 10;353(19):2025-33. doi: 10.1056/NEJMoa051001.
citation: Bussoni MF, Guirado GN, Matsubara LS, Roscani MG, Polegato BF, Minamoto ST, Bazan SG, Matsubara BB. Diastolic function and functional capacity after a single session of continuous positive airway pressure in patients with compensated heart failure. Clinics (Sao Paulo). 2014;69(5):354-9. doi: 10.6061/clinics/2014(05)010.
Clinical trial NCT04775654: The Effects of Blackcurrant Supplementation on Eye Health
Official title: The Effects of Blackcurrant Supplementation on Eye Health: a Randomized, Double Blind, Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eye Strain
Eye Fatigue
Keywords: black currant
blackcurrant
Ribes nigrum
digital eye fatigue
eye health
computer vision syndrome
dietary supplement
Lead sponsor: Nutraceuticals Research Institute
Sponsor class: OTHER
Collaborators: name: Artemis International
First posted: 2021-03-01
Enrollment: 57
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the potential for supplementation with black currant to support eye health among otherwise healthy adult women who spend 6+ hours per day using digital screens.

Detailed description: Women who are informed about the study and provide informed consent will be randomized to one of two groups: supplement and placebo. Group assignment will be a 1:1 ratio to supplement (455mg of blackcurrant standardized to 50mg anthocyanins in 2 capsules/day) or placebo (2 capsules/day). Outcomes will be assessed at baseline and again on day 70.

Eligibility criteria: Inclusion Criteria:

* Female
* Age 30-60
* Lives in the United States
* Employed full time in an online work environment OR enrolled full time in an online learning environment (average of 6+ hours per day)
* Ability to understand study instructions
* Ability to provide informed consent
* Residence within 100 miles of the study center

Exclusion Criteria:

* Low blood pressure
* Uncontrolled hypertension (i.e. systolic/diastolic blood pressure \> 140/90)
* Uncontrolled diabetes (i.e. fasting blood glucose \>180mg/dl)
* Any blood clotting disorder
* Ocular disease
* Best corrected visual acuity \<20/30
* Cataracts
* Renal disease
* Active hepatitis or cirrhosis
* Acute or chronic infectious disease
* Pregnant
* Breastfeeding
* Currently trying to conceive
* Surgical or other invasive procedure planned within the intervention period

Primary outcomes:
measure: Change from baseline in ocular discomfort on day 70.
timeFrame: Baseline and day 70
measure: Change from baseline in visual fatigue on day 70.
timeFrame: Baseline and day 70
measure: Change from baseline in computer vision symptoms on day 70.
timeFrame: Baseline and day 70
measure: Change from baseline in symptoms of computer vision syndrome on day 70.
timeFrame: Baseline and day 70
Secondary outcomes:
Other outcomes:
Locations:
city: Franklin
country: United States
facility: Franklin Health Research Center
state: Tennessee
Study officials:
affiliation: Franklin Health Research & Education Center
name: Jessie R Hawkins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04844554: Protocol of Assistance to Patients With Covid-19 Submitted to Treatment With HD-tDCS
Official title: Protocol of Assistance to Patients With Covid-19 Submitted to Treatment With HD-tDCS: Open Label, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronavirus
COVID-19 Respiratory Infection
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
Collaborators: name: City University of New York
name: University of Michigan
name: Rio de Janeiro State University
First posted: 2021-04-14
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: COVID-19 has a variety of symptoms from asymptomatic respiratory dysfunction to death. Considering the pathophysiology of SARS-CoV-2 and its relationship with the neuroimmune system, response, autonomic balance, musculoskeletal and respiratory and neuropsychiatric symptoms presented by patients, the investigators highlight the potential use of non-invasive neuromodulation methods to assess the effectiveness of treating patients with COVID-19, as these techniques can be useful in the management of important clinical aspects in the functional recovery of individuals affected by the disease.

The investigators intend to evaluate the effects of HD- tDCS to promote ventilatory weaning in patients admitted to the Intensive Care Unit (ICU) and to improve the respiratory performance of those hospitalized in nursing beds for treatment of COVID - 19.


Eligibility criteria: Intensive Care Unit's Inclusion Criteria:

Patients of at least 18 years-old with a PCR-confirmed SARS-CoV-2 diagnosis and receiving mechanical ventilation at least 48 hours of meeting criteria for moderate to severe acute respiratory distress syndrome (ARDS), under weaning, were enrolled in this study. An ARDS diagnosis was made according to the Berlin Definition criteria.

Intensive Care Unit's Exclusion Criteria:

Patients were excluded if they had a condition that could prevent adequate performance of inspiratory muscle training (e.g., neuropathy or myopathy), pregnancy or active lactation, Richmond Agitation and Sedation Scale (RASS) scores between -2 and + 1, Glasgow Coma Scale (GCS) ≤ 8, consent refusal, and contraindications to brain stimulation (e.g., aneurysm clips).

Primary outcomes:
measure: ICU's primary outcome - number of days alive and free from mechanical ventilation
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Federal University of Paraíba,Department of Psychology
state: Paraíba
Study officials:
References:
Clinical trial NCT05517733: ASSESSMENT OF SOFT TISSUE HEALING OVER IMMEDIATELY PLACED IMPLANT SEALED WITH PLATELETS RICH FIBRIN (PRF) VERSUS DIODE LASER
Official title: ASSESSMENT OF SOFT TISSUE HEALING OVER IMMEDIATELY PLACED IMPLANT SEALED WITH PLATELETS RICH FIBRIN (PRF) VERSUS DIODE LASER (A RANDOMIZED CONTROLLED CLINICAL TRIAL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immediate Implant Soft Tissue Healing
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the current study was to assess the efficacy of PRF in comparison to diode laser to promote tissue healing and soft tissue quality after placement of immediate implants.


Eligibility criteria: Inclusion Criteria:

* Any non-restorable hopeless tooth: a badly decayed tooth that cannot be restored, tooth with failed endodontic treatment, and teeth with longitudinal fracture.
* Post-extraction sockets type 1 with all bony walls intact; Type I extraction sockets according to Elian classification in 2007 have an intact labial plate of the bone and no soft tissue recession. Therefore, it does not require a mucoperiosteal flap elevation, only bone graft particles are packed into the socket after atraumatic extraction and socket debridement, then sealed with barrier membranes or soft tissue grafts.
* No signs of active periodontal disease in the selected tooth.
* Good oral hygiene

Exclusion Criteria:

* The presence of any systemic disease could complicate bone or soft tissue healing after immediate implant placement.
* The presence of Acute periapical infection.
* The presence of any local factor that may interfere with extraction as tooth ankyloses
* Subjects who had undergone therapeutical radiation. (187)
* Patients who had been subjected to or who were under bisphosphonate therapy

Primary outcomes:
measure: Soft tissue healing
timeFrame: up to 4 weeks
measure: Mid-buccal soft tissue thickness
timeFrame: up to 8 weeks
measure: Mid-crestal soft tissue height
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Post-operative pain level
timeFrame: 24 hours
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT02990533: Muscle Anabolic Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients
Official title: Translating Muscle Anabolic Strategies Into Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Aging
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this pilot study is to collect preliminary data on the feasibility and effect size of interventions to modify the physiological recovery trajectory from hospitalization in community dwelling older adults.

Detailed description: The purpose of this pilot study is to test the feasibility and effect size of interventions to modify the physiological recovery trajectory from hospitalization in community dwelling older adults.

Eligibility criteria: Inclusion Criteria:

* Admitted to the UTMB hospital
* Aged 65 years or older
* Self-reported ability (with or without the aid of an assistive device) to walk across a small room two weeks prior to hospitalization
* Alert and oriented x3 by a physician on H\&P.
* Discharged "to home" at hospital discharge. Participation in the study will be terminated in those subjects not discharged to home after hospital stay.

Exclusion Criteria:

* A Nursing home resident or hospice care patient
* Uncontrolled blood pressure (systolic \>170, or diastolic \> 100)
* New onset motor disability that prevents walking at the time of baseline testing (stroke with motor disability, lower limb orthopedic dx)
* End stage renal disease
* AST/ALT 2.5 times above the normal limit
* Recent (within 3 months) or current treatment with anabolic steroids.
* History of breast or prostate cancer
* Palpable prostate nodule or induration or prostate specific antigen (PSA) ≥ 4 ng/ml (PSA ≥ 3 ng/ml in men at high risk of prostate cancer)
* Hematocrit ≥ 50%
* Any other condition or event considered exclusionary by the PI and faculty physician

Primary outcomes:
measure: Physical Performance
timeFrame: Change from Baseline to 30-day Followup
Secondary outcomes:
measure: Handgrip Strength
timeFrame: Change from Baseline to 30-day Followup
measure: Physical Activity Level
timeFrame: Change from Baseline to 30-day Followup
measure: 30 day re-admission
timeFrame: 30 days post-discharge
Other outcomes:
Locations:
city: Galveston
country: United States
facility: Jennie Sealy Hospital
state: Texas
Study officials:
affiliation: UTMB
name: Elena Volpi, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01071733: Fracture Evaluated in Emergency Room by Ultra Sound
Official title: Fracture Evaluated in Emergency Room by Ultra Sound
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Fracture
Ultrasonography
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2010-02-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients in emergency room

Brief summary: The purpose of this study is to compare fracture diagnostic, conventional x-ray versus ultrasound.

Detailed description: to compare fracture diagnostic, conventional x-ray versus ultrasound in an emergency room department.

Eligibility criteria: Inclusion Criteria:

* Recent trauma to the wrist, ankle or fingers
* clinical exam by ER staff and x-ray indication.
* informed concent

Exclusion Criteria:

* open fracture
* wounds
* unstable fractures requiring cast immobilisation before x-ray
* multi traumatised patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital Emergency Dep.
Study officials:
affiliation: Dep. of Reumatology, Aarhus University Hospital, Denmark
name: Mogens P Jensen, phd, md
role: STUDY_DIRECTOR
References:
Clinical trial NCT05251233: Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy
Official title: Evaluation of the Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pancreatic Cancer
Pancreas Cancer
Ampullary Cancer
Pancreas Neuroendocrine Tumor
Pancreatitis
Distal Extrahepatic Cholangiocarcinoma
Duodenal Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to prospectively determine the effects of administering proton pump inhibitors (PPIs) following pancreaticoduodenectomy on postoperative outcomes. The findings of this study will help in avoiding the widespread use of PPIs during the immediate postoperative period following pancreatic surgery.


Eligibility criteria: Inclusion Criteria:

* All consecutive patients who will undergo pancreaticoduodenectomy with gastric/biliary reconstruction performed as definitive management for a benign or malignant disease at Washington University/Barnes-Jewish Hospital.
* At least 18 years of age.
* Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria:

* \<18 years of age

Primary outcomes:
measure: Number of Participants With Delayed Gastric Emptying as Measured by the International Study Group of Pancreatic Surgery (ISGPS) Criteria
timeFrame: Through 90 days after surgery
measure: Number of Participants With Delayed Gastric Emptying as Measured by Modified Accordion Grading System (MAGS)
timeFrame: Through 90 days after surgery
Secondary outcomes:
measure: Number of Participants With Surgical Complication(s) Defined by the Modified Accordion Grading System (MAGS)
timeFrame: Through 90 days after surgery
measure: Kaplan-Meier Estimated 90-days Marginal Ulcer-free Survival (MUFS) Probability
timeFrame: Through 90 days after surgery
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Natasha Leigh-Matijakovich, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03355833: Comparing Prognostic Performance of SEPSIS 2 and SEPSIS 3 Strategies at the Emergency Service
Official title: Comparing Prognostic Performance of SEPSIS 2 and SEPSIS 3 Strategies at the Emergency Service
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Retrospective study in patients admitted to the emergency department in the CHR Metz-Thionville

Brief summary: In 2016, the Third International Consensus proposed a new strategy to screen aggravating risk in patients with septic shock. This strategy is based on quick-SOFA and the SOFA score. The main objective is to compare the prognostic performance of SEPSIS 3 against the previous strategy SEPSIS 2 to predict the admission in intensive care unit or the intra-hospital death.

Detailed description: This study compare the prognostic performance of two strategies. It's a monocentric, retrospective study in patients admitted to the emergency department.

Eligibility criteria: Inclusion Criteria:

* Aged of 18 years or more
* Initiation of one or more antibiotics in the Accident and Emergency Department in the Metz-Thionville hospital (CHR) site Mercy, for curative purpose, regardless of the infectious aetiology
* Hospitalized in the CHR Metz-Thionville thereafter

Exclusion Criteria:

* Minors patients
* Absence of antibiotic treatment initiated in the Emergency department
* Prescription of antibiotic treatment in the emergency department for preventive purpose
* Transferred by hospitalisation service of CHR Metz-Thionville in the emergency department
* Absence of hospitalisation following their passage through the emergency department
* Transferred to hospitalisation in an other establishment
* Presence, at the admission, of an antibiotic treatment
* Patients deceased in the emergency department

Primary outcomes:
measure: Intrinsic and Extrinsic properties of SEPSIS 3 strategy
timeFrame: Day 1
Secondary outcomes:
measure: Correlation between lactate levels and mortality
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02881333: Various Type of Genetic Events in Patients With Intellectual Disability
Official title: Evaluation of Tools for the Simultaneous Detection of Point and Structural Mutations in Patients With Intellectual Disability
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intellectual Disability
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with intellectual deficit without diagnosis

Brief summary: Currently, for a patient with intellectual disability without a recognizable syndrome (most cases), the way to diagnosis is often long, tedious and expensive because different approaches are used one after the other to identify structural variants (duplications, deletions and other) and point mutations (sequencing of one or more candidate genes). The development of high-throughput sequencing techniques (next generation sequencing: NGS) has drastically increased the detection of point mutations offering the possibility to test a large number of genes simultaneously. NGS also shows a huge potential in detecting structural variants. The objective of this research is to assess the sensitivity of a simultaneous detection of point mutations and structural variants by NGS approaches. This would bring together in a single step the equivalent of performing an array-Comparative genomic hybridization (CGH) analysis plus performing a targeted sequencing of candidate genes. Investigators will compare two approaches for this simultaneous detection: a targeted enrichment of candidate genes coding regions using probes covering these regions associated with a backbone of genomic probes, an approach that could be implemented immediately in diagnostic at the hospital, and a whole genome sequencing (WGS), that is currently a too expensive tool for routine diagnosis but that should be the approach used in the future. Investigators will compare these two approaches to the traditional one: CGH array + WGS. The implementation of a "one step" strategy to detect both types of mutations (punctual and structural) would accelerate and improve the access of patients to a molecular diagnosis.


Eligibility criteria: Inclusion Criteria:

* Patients with developmental disabilities
* No etiologic diagnosis but suspected genetic cause
* Fragile X syndrome research negative

Exclusion Criteria:

* Children born to consanguineous couples
* Diagnosis already established or suspected
* Identification of an independent etiology

Primary outcomes:
measure: Detection of mutation from the CGH-array technology on 475 genes
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: