cyrilzakka/clinical-trials huggingface dataset:
HYPOCHLOROUS ACID SUBSTANTIVITY AS ANTIPLAQUE AGENT (HOCl-SAP)

Hypochlorous acid (HOCl) in a non-antibiotic antimicrobial agent used in clinical medicine. Nevertheless, its antiplaque oral effect has not been evaluated. Chlorhexidine (CHX) is the gold standard as an antiplaque agent for its high substantivity in plaque and saliva. There are no published studies evaluating the substantivity of hypochlorous acid compared to CHX. Objective: To evaluate the efficacy of mouthwashes of HOCl in substantivity evaluated by reduction of bacterial viability in saliva during 7 hours compared to CHX rinses and a placebo.

Materials and Methods: A randomized, double-blind clinical trial with 75 participants was conducted. Participants were randomly assigned using block randomization in five groups: HOCl 0.025% and 0.05%, CHX 0.12 and 0.2% and sterile water as placebo. Participants were instructed to use each rinse with 10 ml of each solution for 30 seconds after dental prophylaxis. Samples of saliva were taken at baseline and after 30 seconds, 1, 3.5 and 7 hours to assess substantivity establishing the bacterial viability by the fluorescence method with the SYTO 9/propidium iodide dual staining. All participants were assessed with the Turesky visible plaque index at baseline and at 7 hours and adverse events were assessed. For the comparisons of the viability of the different rinses between times, the statistical test of generalized linear mixed model \[GT1\] adjusted to treatment, time and treatment-time interaction was used.

Eligibility Criteria:
Inclusion Criteria:

* Dentate young men with minimum 22 teeth were considered eligible for the study. Participants should have good dental and gingival status (DMFT index ≤ 3, median of Lobene gingival index ≤ 1) and detectable levels of dental plaque at 7 hours of brushing during the selection process.

Exclusion Criteria:

* Exclusion criteria included smoking, orthodontic, orthopedic or rehabilitation treatment, cavitated carious lesions and consumption of systemic antimicrobials or anti-inflammatory drugs in the last 6 months.
Rapid Breath-hold Quantitative Macromolecular Proton Fraction Imaging for Liver Fibrosis

Chronic liver disease is a major health problem worldwide. Liver fibrosis is a key feature in most chronic liver diseases. When identified early, liver fibrosis may be reversible. Currently, liver biopsy is the gold standard for the diagnosis of liver fibrosis. Liver biopsy; however, is invasive. Non-invasive diagnostic tools are increasingly used in clinical practice. However, the existing noninvasive methods still have significant limitations to detect early-stage liver fibrosis.

Liver fibrosis is characterized by excessive deposition of collagen-rich connective tissues in the liver. The macromolecular proton fraction (MPF) is an MRI parameter which characterizes the magnetization transfer (MT) effect in tissues. Quantitative MPF imaging is non-invasive and can be used to measure collagen deposition in the liver due to the strong MT effect of collagen. It has been reported MPF quantification can be used for diagnosis of early-stage liver fibrosis. However, the existing approaches require B1, B0, and T1 map in addition to the imaging data for MPF quantification, which makes it challenging to adopt them for routine clinical use.

The investigators propose a fast and robust MPF quantification approach. In contrast to the existing methods which rely on saturation radiofrequency pulses for MPF quantification, our approach is based on spin-lock radiofrequency pulses which have minimum Rabi oscillations. The whole imaging data can be acquired within a breath-hold less than 8 seconds. Our approach only needs a B1 map in addition to the imaging data for MPF quantification. The preliminary clinical studies on 3.0T MRI show the measurement using our approach is specific to collagen content and can be used to detect early-stage liver fibrosis. To further confirm the clinical value of the proposed approach, the investigators will investigate the relationship of the collagen content measured using the proposed non-invasive imaging approach and those measured based on morphometry analysis of histology, and determine the diagnostic value of the proposed method for detection of early stage liver fibrosis in a large cohort. The investigators will also perform comparative studies of the proposed method and the state-of-the-art quantitative MPF imaging technique.

This project will provide a diagnostic technology for early detection of liver fibrosis. The proposed MRI technology also has potential to be used for other clinical purposes.


Eligibility Criteria:
Inclusion Criteria:

1. Patient group

   * patients with histology-proven liver fibrosis, including those with liver fibrosis stage F0, early-stage liver fibrosis (F1-2), and late stage.

   liver fibrosis(F3-4).
   * patient aged 18 years old and above.
2. Healthy control group

   * controls aged 18 years old and above.

Exclusion Criteria:

* Contraindications to MRI, such as cardiac pacemaker, claustrophobia, pregnancy, metallic implants not suitable for MRI scan.
Antibodies Response to mRNA Vaccine Against Covid-19

Vaccine rollout has started in many countries. In Italy, the Covid-19 vaccine used at the moment is the mRNA-based BNT162b2 and is given to Hospital employers. The investigators undertake this study to monitor IgG evolution after vaccination in the participant hospital settings, which includes 500 subjects.

Vaccine rollout has started in many countries. In Italy, the Covid-19 vaccine used at the moment is the mRNA-based BNT162b2 and is given to Hospital employers.

The investigators undertake this observational study to monitor antibody evolution after vaccination in a hospital setting. The primary endpoint is serum IgG at the first month of 2nd jab, and at 3, 6, and 12 months afterward.

As secondary measures, nasopharyngeal swabs are included, at fortnight intervals to detects the spike protein antigen, in the event that putative vaccine inefficacy would expose the health personnel to Covid-19 disease with potential spreading to inpatients.

Further, clinical signs and symptoms are monitored at the weekly interval in the context of adverse reactions/events.

Eligibility Criteria:
Inclusion Criteria:

* Hospital employers vaccinated against Sars-Cov2

Exclusion Criteria:

* none
Hyaluronic Acid and Adelmidrol (Hyadrol®) in Patients With Degenerative Joint Disease

Osteoarthritis is a major cause of chronic musculoskeletal pain. Behind this disorder there is a process of chronic neuroinflammation due to the overactivation of mast cells at the tissue level. The mast cells present in the synovial membranes act as first sensors in pathological situations, degranulating in an uncontrolled manner.

Furthermore, in degenerative joint pathologies, there is a marked reduction in the viscoelastic capacity of the synovial fluid associated with a reduction in both the concentration and the average molecular weight of endogenous hyaluronic acid. The association of hyaluronic acid and Adelmidrol (Hyadrol®) could represent an effective treatment for controlling the neuroinflammation process that supports degenerative joint diseases.

The objective of the present clinical investigation is to evaluate its safety and efficacy in patients with arthritis of the hip (coxarthrosis) and trapezium-metacarpal joints (rhizoarthrosis).


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 40 years;
* both genders;
* diagnosis of stage II-III coxarthrosis or rhizoarthrosis according to radiological classification (Kellgren and Lawrence or modified Eaton-Littler criteria respectively)
* pain intensity ≥ 5 on NRS;
* wash-out for at least two weeks from anti-inflammatory drugs before enrollment;
* compliant patients;
* signed informed consent.

Exclusion Criteria:

* age \< 40 years;
* presence of concomitant inflammatory systemic pathologies (e.g.: rheumatoid arthritis, etc.);
* severe and progressive clinical conditions,
* NSAIDs therapy in the 2 weeks prior to enrollment;
* corticosteroid therapy in the 3 months prior to enrollment;
* chondroprotectors intake in the 6 months prior to enrollment;
* arthroscopic procedures or intra-articular visco-supplementation in the 6 months prior to enrollment;
* presence of cognitive impairment;
* ongoing rehabilitation and/or physiotherapy;
* allergy or hypersensitivity to the study treatment;
* pregnant and/or lactating female subjects;
* not compliant patients;
* denied informed consent.
Amino Acid Nutrition in the Critically-ill

Enhancing the anabolic effect of nutrition in critically ill patients by administering exogenous amino acids.

Critically-ill patients admitted to the intensive care unit are invariably catabolic and are commonly undernourished. Previous observational studies indicate that increased dietary administration of protein or essential amino acids might be associated with improved clinical outcomes. The investigators propose that the parenteral supplementation of intravenous amino acids in critically-ill patients will restore anabolic processes and that anabolism is associated with molecular markers of amino acid sensing and protein synthesis. The results from this study will establish biomarkers of anabolism (i.e., nutritional success) that can be used in future clinical trials on the use of amino acid supplementation in the critically-ill.

Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated adult patients (\>18 years old) admitted to ICU with an expected ICU dependency (alive and need for mechanical ventilation
* Vasopressor therapy, or mechanical circulatory support) at the point of screening of an additional 3 days, as estimated by the treating physician.

Exclusion Criteria:

* Patients who are moribund (expected death within 48 hours)
* Expected to have life-sustaining treatments withdrawn in the next 3 days
* Those with a contraindication to enteral nutrition (EN)
* Already on parenteral nutrition (PN)
* Those with acute fulminant hepatitis or severe chronic liver disease (Child's class C)
* Patients on extracorporeal membrane oxygenation or carbon dioxide removal\* Patients with organ transplantation
* Those with a broncho-pleural fistula
* Patients with documented allergies to any of the study nutrients or its excipients will be excluded.
* Patients requiring continuous renal replacement therapy or extracorporeal membrane oxygenation are excluded due to inability to accurately measure protein turnover.
Transcutaneous Supraorbital Nerve Stimulator Versus Topiramate in Prevention of Recurrent Migraine

Migraine has been ranked as the second most disabling neurological disorder in the worldwide. Medication or nonpharmacological treatments are all reasonable options for the prevention. Oral topiramate treatment is a typical effective method, while transcutaneous supraorbital nerve stimulation (SNS) was reported to be valuable for migraine acute treatment and even the prevention. As a new nonpharmacological therapeutic method, whether SNS is equivalent to topiramate is still unknown. The aim of the present study was to compare their effects in a cohort of migraine patients. After diagnosed with recurrent or chronic migraine and consented to this research, patients received randomly treatments by either SNS or topiramate, and were followed up prospectively. After a 1-month period of baseline observation, patients were followed by a 1-month treatment, and next 2-month period of followup. At least the following assessments will be performed: (1) Change from baseline in the number of migraine days during the 3 observing months; (2) Change from baseline in the number of moderate/ severe headache days over the 3 observing months; (3) 50% responder rate for the reduction of migraine days (percentage of patients having at least 50% reduction of migraine days) during the first treating month. Comparison of outcome measures between the 2 treatment groups will be performed to show the equivalence of SNS versus topiramate.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-60 years old;
* Diagnosed with definite migraine (ICHD-3 code 1.1 or 1.2);
* At least 2 migraine attacks per month during the past 3 months;
* Consent to participate in the study;
* No contraindications to associated treatments.

Exclusion Criteria:

* Received preventive treatments during the previous 3 months;
* Definite other kinds of headache, especially tension-type, medication overuse and secondary headache (ICHD-3 code 8.2);
* Severe neurological or psychiatric disorders;
* Severe primary systemic disorders including heart, brain, liver, kidney, and hematopoietic system;
* Women with pregnancy or lactation.
Stretching With And Without Pressure Biofeeback In Patients With Postural Syndrome

Postural syndrome describes a variety of conditions in which repetitive or continued bad posture over a long period of time causes pain and reduced function in the muscles and joints.

Improper posture can cause pain throughout the length of the spine from the neck to the pelvis. Modern sedentary style of living is one of the main reasons for postural abnormalities evident in modern society. The prolonged sitting hours required in most of the jobs, and educational setups can affect flexibility of soft tissues, especially two joint muscles. Bad posture while standing or walking, if left uncorrected, can worsen over time and lead to pain and dysfunction. Hamstring is a key component of flexibility in the human body and it is more prone to get tightened. Many reasons can lead to the development of hamstring tightness such as genetic predisposition, injury to muscle, and adaptive shortening due to some chronic condition. Short hamstring muscles, because of their attachments to the posterior leg and to the ischial tuberosity, may limit hip flexion ROM and induces posterior pelvic tilt and decreased lumbar lordosis, which can result in LBP The purpose of this study will be to find out the effects of stretching with and without pressure biofeedback unit (PBU) on hamstring muscle flexibility in patients with postural syndrome. The active knee extension (AKE) test will be used to determine the length of the hamstring muscles using a goniometer. A PBU will be used to maintain the anterior pelvic tilt position during active knee extension (AKE) test or stretching, by monitoring the pressure of airbag. Patients will be recruited into study by convenient sampling technique after that will be allocated to groups by simple random assignment. All participants will actively stretch three days per week for four weeks. After collecting data from defined study setting, data will be entered and analyzed by using Statistical Package for the Social Sciences (SPSS) for Windows software, version 25.


Eligibility Criteria:
Inclusion Criteria:

* Males and females of aged 18 to 25 years with hamstrings shortening less than 70 degrees are included in the study

Exclusion Criteria:

* Subjects with any past hamstring injury within last 2 years

  * Low back pain since past 3 months
  * Current or recent (last 3 months) participation in a specific program designed to lengthen the hamstrings are excluded
External Fixation Versus Splinting of Acute Calcaneus Fractures

Aim:

* Determine if external fixation decreases soft tissue complications compared to splinting.
* Determine if external fixation decreases time to definitive surgical stabilization and improves final fixation compared to splinting.
* Determine if external fixation improves functional outcomes as evaluated by validated functional scoring systems.

Hypothesis:

* External fixation improves definitive fixation and functional outcomes of acute calcaneal fractures with decreased complication rates compared to splinting


Eligibility Criteria:
Inclusion Criteria:

* Voluntary consent
* Age 18 to 69
* Clinical and/or advanced imaging confirming an acute calcaneal fracture that has occurred within 2 days of which, eventually definitive surgery is recommended/accepted.
* Unable to consent

Exclusion Criteria:

* Age \<18
* Prior surgery of the affected extremity
* Prisoners
* Pregnant women
* Inflammatory arthritis
* Non-English-speaking patients
A Volunteer Study to Collect Imaging Data for the Development of the ntelligentUltrasound Anatomy Guide

The aim of this study is to determine if machine learning can be used to automatically highlight key anatomy on the ultrasound image to help anaesthetists perform ultrasound-guided regional anaesthesia.

The study will involve adult volunteers who are willing to be scanned by a trained sonographer to collect ultrasound video data for the following categories:

* Adductor canal
* Popliteal fossa
* Fascia Iliaca
* Rectus sheath
* Axillary
* ESP
* PECS
* Interscalene

Each volunteer will be scanned to collect data for every category in the list. Where applicable, both sides of the body will be scanned.

The videos will be segmented by hand to identify the relevant anatomical regions for each category.

The primary objective for this study is to provide the range of data required to develop robust models in conjunction with additional data from patients undergoing a Peripheral Nerve Block procedure that are able to produce the desired segmentation on the unseen validation images. The models will be scored using the standard "Mean intersection over Union" pixel-level metric for semantic segmentation.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, at least 18 years of age;
2. Willing to undergo ultrasound scanning and provide ultrasound video data for the following categories:

   * Adductor canal
   * Popliteal fossa
   * Fascia Iliaca
   * Rectus sheath
   * Axillary
   * ESP
   * PECS
   * Interscalene
3. Able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion Criteria:

1. Aged \<18 years of age;
2. Unwilling or unable to provide informed consent.
The Effects of Integrative Neuromuscular Training on Physical Function in Overweight Children

Childhood obesity is an ongoing and increasing issue, resulting in changes in body mass which cause biomechanical alterations in the lower limbs. Exercise interventions have been effectiveness at causing positive changes to the lower limbs gait, strength and functioning but children often report lack of enjoyment from the sessions which inhibits long term changes. This intervention takes a neuromuscular exercise approach whilst considering the psychological needs of children to motivate them to participate in the intervention and physical activity.


Eligibility Criteria:
Inclusion Criteria:

* children aged 8-11 years old
* overweight/obese children

Exclusion Criteria:

* children who have not given consent or had parental consent to participate
* children who fall outside of the selected age range
* children who have a physical or mental impairment that will affect their ability to participate in the procedures in the laboratory and intervention settings
A Workflow and Satisfaction Study Evaluating the Implementation of a New "Smart" Ambulatory Infusion System

The purpose of this study is to describe the home healthcare organization ambulatory infusion pump programming workflow and the process that was followed to introduce the new CADD®-Solis VIP System to each home healthcare organization or facility. In addition, this study will characterize the overall clinician (Phase 1) and patient (Phase 2) ease of use and satisfaction with the CADD®-Solis VIP System.

This is a prospective, multi-center, non-randomized, post-market study conducted within the United States. There will be two independent components (Phases) to this study. Phase 1 will involve data collection to describe the home infusion pump programming workflow and the process that was used to introduce the new CADD®-Solis VIP System to each home healthcare organization. This phase is further broken down into data collection consisting of four parts: drug protocol library creation and development within the CADD™ Solis Medication Safety Software Administrator, pump programming, home care implementation, and overall workflow and new smart pump implementation. Phase 2 will involve data collection from patients that receive a prescription requiring use of the CADD®-Solis VIP pump.

Eligibility Criteria:
Phase 1

Inclusion Criteria:

* Part 1: Licensed clinicians that would be responsible for protocol library creation at the center
* Part 2: Individuals that are responsible for ambulatory infusion pump programming per the organization's standard operating procedure
* Part 3: Licensed clinicians that are responsible for performing the pump set-up and implementation activities within the home setting
* Part 4: Center personnel that are involved in the CADD®-Solis VIP System implementation process

Exclusion Criteria:

* Individuals that are unwilling or unable to answer questions as required by the protocol

Phase 2

Inclusion Criteria:

* Patients 18 years of age or older
* Patients prescribed a home infusion requiring use of the CADD®-Solis VIP pump
* Patients with infusions prescribed for a minimum duration of five (5) days
* Patient or patient's personal caregiver on behalf of the patient is willing and able to comply with the data collection requirements
* Patient is willing and able to provide informed consent for study participation

Exclusion Criteria:

* Patient is currently enrolled or plans to enroll in a concurrent study that may confound the results of this study
* Based upon a clinician's opinion, the patient has health conditions or a psychological/cognitive status that would preclude proper participation in the study and does not have a personal caregiver available to perform study activities on behalf of the patient
* Previous use or experience with the CADD®-Solis VIP pump
Inflammatory Response In Schizophrenia

Schizophrenia affects a significant proportion of the population and current levels of understanding of the illness is inadequate to treat it effectively. Converging lines of evidence suggest that neuroinflammation occurs in schizophrenia, and specifically over-activity of brain-resident immune cells called microglia. It is however unclear whether activated microglia play a primary role in schizophrenia, or whether this is a secondary phenomenon of no pathophysiological significance. The investigators therefore plan to test the effect of a monoclonal antibody (natalizumab) on psychotic symptoms in a cohort of first episode psychosis patients.

One of the key aims of the study is to determine if there is a relationship between change in imaging inflammation markers from baseline to follow-up and changes in other markers of inflammation over the same period. In September 2021, an open label arm for natalizumab was added to the study. The relationship between changes in imaging inflammation markers and changes in other markers of inflammation will be analysed within subjects including all patients who received natalizumab.

Eligibility Criteria:
Inclusion criteria:

1. Aged 18-50 years
2. Diagnosis of schizophrenia or other psychotic disorder (Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5);
3. Symptomatic, defined as one or more positive symptom \>3 AND one or more negative symptom \>3 on the Positive and Negative Syndrome Scale (PANSS);
4. No acute relapse and psychiatrically stable for \>1 month before screening;

Exclusion criteria:

1. History of significant co-morbid CNS disorder (including significant head trauma or significant loss of consciousness, Parkinson's Disease, Epilepsy, Alzheimer's Dementia, Huntington's Disease).
2. Any absolute contraindications to natalizumab, as per natalizumab SPC
3. Current or recent (last 3 months) infection, or history of significant infection, or an immunocompromised state
4. Previous use of natalizumab or previous use of other monoclonal antibody.
5. Ongoing long-standing use of oral steroids or non-steroidal anti-inflammatory drugs.
6. Pregnancy and/or breast-feeding.
7. Substance dependence/abuse other than to cigarettes.