bioihbjkbjnl/mcl2 huggingface dataset:
Epidemiological Features and Clinical Course of COVID -19 Infection in Cancer Patients: The Rovid Study
Condition: Solid Tumor, Adult
MeSH terms: Disease Progression
Study type: Observational

Summary: 
      The study aims to retrospectively collect epidemiological and clinical data in patients with
      solid tumors and SARS Covid2 infections belonging to oncology centers within the Veneto
      Oncology Network
    

Detailed description: 
      The aim of this study is to create a Veneto Oncology Network with the aim of collecting
      clinical and epidemiological data of cancer Patients affected by SAR- Covid-2 infection over
      a period of 1 year. Descriptive statistical approaches will be used to process the data.

      The aim is to evaluate the development rate of severe clinical forms of infection in patients
      with SARS-Cov-2 and the possible association with tumour characteristics and treatment.

      In addition, the results of serological tests can be compared with the outcome of the
      diagnostic swabs and the clinical evolution of the infection in order to obtain more
      information regarding the significance of specific antibody development.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cancer patients with SAR COV-2 infection within the Veneto Oncology Network
An Investigation of Trainees' Performance in Augmented Reality Simulation for Invasive Procedure Training
Condition: Healthy
Study type: Interventional

Summary: 
      The primary aim of this study is to measure the efficacy of augmented reality technology in
      ultrasound-guided medical intervention.
    

Detailed description: 
      BACKGROUND: A significant challenge facing novice physicians is mastering
      ultrasound(US)-guided procedures, such as central venous catheter (CVC) placement. CVC
      placements are typically performed on critically ill patients and demand precision and speed.
      Physicians are often required to switch focus between the ultrasound screen and the patient,
      memorize multiple images, coordinate hand-eye movements, and interpret 2D images in a 3D
      context simultaneously. These complexities pose challenges in spatial orientation and impose
      a considerable cognitive load, affecting both learning and performance. Within the
      pedagogical landscape, medical educators are exploring the potential merits of Augmented
      Reality (AR) via head-mounted displays to enhance immersive learning experiences in clinical
      settings. This study aimed to determine whether AR could ease challenges related to spatial
      orientation and cognitive overload during this procedure and ultimately enhance skill
      acquisition for trainees.

      Intervention:

      Prior to the commencement of the trial, all participants verified their previous training in
      ultrasound-guided CVC placement. They also provided their written informed consent. The
      participants are set to be split into two groups as part of a crossover design: the first
      group will initially be subjected to the traditional ultrasound-guided CVC placement, whereas
      the second group will begin with the AR-assisted CVC placement

      STUDY IMPLICATIONS:

      Leveraging AR technology in skill acquisition may reduce trainees' cognitive burden and
      improve trainee efficiency during ultrasound-guided CVC placement procedures..
    

Intervention name(s): AR-US
Intervention type(s): Device
Intervention description(s): The ultrasound imagery is projected onto the glasses, and participants use the AR-US throughout the entire CVC placement procedure
Other intervention name(s): augmented reality smart glasses
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cognitive load; Clinical competence; Augmented reality
Evaluation of Continuity of Care of Children With Special Health Needs
Condition: Children With Special Health Needs
Study type: Observational

Summary: 
      Children and adolescents with special health care needs represent a small but relevant subset
      of the pediatric population due to high costs for the health care system, risk of lower
      quality of care, unmet health care needs, and negative health outcomes. Coordination of care
      and continuity of care are essential issues of appropriate care for these patients, as showed
      also by the "Special Needs Kids" project, carried out in Emilia Romagna. This project showed
      the potential for family pediatricians (FP) in Italy to serve as care coordinators and
      facilitate the implementation of integrated care pathways for children with special health
      care needs. In Friuli-Venezia Giulia (FVG), a system of "continuity of care" for patients
      with special needs was developed and implemented. This system integrate hospital and
      community care in a network involving also FPs, General Practitioner and different actors of
      social and health services. The aim of this study is to prospectively evaluate the continuity
      of care provided to children and adolescents with special health needs residing in the FVG
      region.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study involves pediatric patients with special health care needs recruited at IRCCS
        Burlo Garofolo over a 12-month period and followed prospectively for the next 12 months
        (follow-up)
      
Keywords: Special health needs; Continuity of care; Care coordination; Children
Pharmacokinetics and Safety Study of Tapentadol for Postsurgical Pain in Children and Adolescents
Condition: Pain, Postoperative; Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic (PK) profile; and safety and
      tolerability of a single dose of tapentadol oral solution (OS) 1 mg/kg in children and
      adolescents aged from 6 to less than 18 years with acute, moderate to severe postsurgical
      pain.
    

Detailed description: 
      This is a multicenter, single-arm, open-label (all people involved know the identity of the
      intervention), single-dose study to evaluate the pharmacokinetic (PK) profile (how drugs are
      absorbed in the body, how they are distributed within the body and how they are removed from
      the body over time), safety and tolerability of tapentadol 1 mg/kg oral solution (OS) in
      children aged from 6 to less than 18 years after scheduled surgical procedures that routinely
      produce acute, moderate to severe postsurgical pain. A screening phase, as per standard of
      care but not exceeding 30 days, will include the preoperative evaluation, the surgical
      procedure and its immediate post recovery, and will be followed by the open-label treatment
      phase and end-of-study assessments. Study drug administration will take place after the
      surgery has been completed, when the patient is alert, orientated, able to follow commands
      and complete the required postoperative procedures, and able to tolerate fluid and medication
      orally. Confinement to the study center for a patient will be as per standard of care, and
      will include the surgery, the entire 15-hour postdose evaluation period and the end-of-study
      evaluations. Children with a body weight less than 20 kg will be dosed with a single dose of
      tapentadol 4 mg/mL OS and children with a body weight of 20 kg or greater will be dosed with
      a single dose of tapentadol 20 mg/mL OS.
    

Intervention name(s): Tapentadol (OS) Oral Solution
Intervention type(s): Drug
Intervention description(s): Tapentadol OS Bodyweight <20 kg: Type=4 unit=mg/mL form=oral solution route=oral use or Tapentadol OS Bodyweight >=20 kg: Type=20 unit=mg/mL form=oral solution route=oral use. Single oral dose administered once.
Intervention MeSH terms: Tapentadol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain, Postoperative; Postoperative Pain; Tapentadol; NUCYNTA; CG5503; R331333; Pharmacokinetics; Postsurgical pain; Children; Adolescents
A Multiple Ascending Dose Phase I Study of SB 9200 in Treatment Naïve Adults With Chronic Hepatitis C Infection
Condition: Hepatitis C Infection
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety and tolerability of ascending doses of SB
      9200 given for up to 14 days to subjects with chronic Hepatitis C infection.
    

Detailed description: 
      This is a First-in-human, Two-stage, Multi-centre study. Part A is an open-label, single
      ascending dose study in fed or fasted subjects and Part B is a randomized, placebo-controlled
      multiple ascending dose study. The study is designed to evaluate the safety and tolerability
      of ascending doses of SB 9200 given as monotherapy for up to 14 days to subjects with chronic
      Hepatitis C infection, and to determine the pharmacokinetic and pharmacodynamic relationship
      over this dose range.
    

Intervention name(s): SB9200; SB9200; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Part A open-label, single ascending doses of SB9200 from 100mg - 1500mg.; Part B randomised 6:2 (active:placebo) using recommended Part B starting dose, and ascending to up to 1500mg for 7-14 days of dosing.; Part B randomised 6:2 (active:placebo) using anhydrous lactose capsules identical to active comparator, minus active ingredient.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hepatitis C Infection; Treatment Naïve, Chronic; First In Human; Single Ascending Dose; Multiple Ascending Dose
Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib Vaccine Followed by the Same Vaccine and Oral Polio Vaccine
Condition: Hepatitis B; Acellular Pertussis; Haemophilus Influenzae Type b; Diphtheria; Tetanus; Poliomyelitis
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the immunogenicity and safety of the GlaxoSmithKline (GSK)
      Biologicals' (formerly SmithKline Beecham Biologicals') combined DTPa-HBV-IPV/Hib (Infanrix
      hexa™) vaccine administered in the 3rd, 5th, 11th month of life. The last dose of
      DTPa-HBV-IPV/Hib will be given simultaneously with one dose of OPV vaccine.
    


Intervention name(s): DTPa-HBV-IPV/Hib (Infanrix hexa™); OPV
Intervention type(s): Biological; Biological
Intervention description(s): Three doses administered intramuscularly; One dose administered orally
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Oral polio vaccine (OPV); DTPa-HBV-IPV/Hib vaccine
The Use of Serratus Block for Cardiac Surgery
Condition: Cardiac Surgery
Study type: Interventional

Summary: 
      The purpose of this randomized, un-blinded study is to determine if serratus blocks or
      Patient Controlled Analgesia (PCA)-alone (no block) offer patients adequate pain relief. This
      study will compare two standard of care pain management options and the patients narcotic
      requirements in the immediate postoperative period.
    


Intervention name(s): Anesthetic regimen including SB; Anesthetic regimen including SB or no block
Intervention type(s): Procedure; Procedure
Intervention description(s): Group receiving general anesthesia with the serratus block; Group receiving general anesthesia alone
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Robotic Cardiac Surgery
Micronutrient Supplementation in Patients With Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      There is some evidence to suggest that patients with heart failure may have a reduced dietary
      intake of vitamins and essential minerals (micronutrients) and that this may worsen the
      function of the heart. This study is designed to investigate if supplementation with
      micronutrients (including high-dose vitamin D) will improve the function of the heart in
      patients with heart failure.
    


Intervention name(s): Placebo; Forceval plus 50 micrograms Vitamin D3
Intervention type(s): Drug; Drug
Intervention description(s): 1 Tablet Daily; Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Heart Failure; Micronutrients; Vitamin D; Inflammation; Oxidative Stress; Quality of Life; Physical Functioning
A Clinical Trial to Study the Effects of Revamilast in Patients With Chronic Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Asthma is a common, chronic inflammatory disease of the bronchial airways, with a reported
      prevalence in most industrialized countries of between 5 to 10 % of the adult population.
      Asthma is clinically characterized by repeated episodes of wheezing, breathlessness, chest
      tightness, and coughing; usually in the presence of variable airflow obstruction that is
      often reversible either spontaneously or with treatment (The Global Initiative for Asthma
      (GINA), 2009).

      Drug treatment of asthma has focused on anti-inflammatory therapy in all but the mildest,
      intermittent cases. Inhaled corticosteroids have been shown to be anti-inflammatory in
      asthma, but chronic use of these agents may be associated with a range of side effects,
      especially at high doses. In asthma, there remains a need for the development of novel
      anti-inflammatory therapies that are at least equally effective and possess a superior safety
      profile in comparison to corticosteroids.

      This is a randomized, double-blind, triple dummy, placebo controlled, parallel group, dose
      ranging study. The study will be conducted in adult patients with a diagnosis of chronic
      persistent asthma with an Forced Expiratory Volume in one second(FEV1) of 50% to 80% of the
      predicted value. Study will enroll 448 patients globally (278 from India) across different
      centers.

      Patients will be recruited after providing written informed consent. After screening and run
      in period, patient will be randomized (patient meeting randomization criteria) in 1:1:1:1
      ratio to receive either one of the three dose regimens of revamilast or placebo.

      The primary objective of the study is to evaluate the effect of revamilast on lung function
      as assessed by Forced Expiratory Volume in one second (FEV1) after the therapy (12 weeks).
      Secondary objective includes area under curve for FEV1, Change in asthma symptoms, patient /
      investigator's global assessments and safety. Patients will be followed for safety and
      efficacy assessment at week 1, 4, 8 12 and 14 after start of therapy.
    


Intervention name(s): Revamilast; Revamilast; Revamilast; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet. Low dose, Once daily for 12 weeks; Medium dose, Once daily for 12 weeks; High dose, Once daily for 12 weeks; Placebo tablet in triple dummy format, Once daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Persistent Asthma
Evaluation of Meal Gesture Dosing in Adults With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this feasibility study is to evaluate subject safety of using the Klue Health
      app utilizing meal gesture micro insulin dosing (meal gesture dosing) within the AHCL system
      in adult subjects with type 1 diabetes in a clinic setting.
    

Detailed description: 
      This study is a single-center, single arm study in adult subjects with type 1 diabetes
      utilizing AHCL System with meal gesture detection and micro dosing (meal gesture dosing).
      Meal gesture dosing is a mode whereby meal announcements are not entered manually by the
      user. Instead, when meal gesture dosing is active, meal announcements are generated
      automatically by the system based on the detection of eating gestures and micro doses of
      insulin are given.

      Overall subject participation will be approximately 3 weeks to 6 months.

      A total of up to 40 subjects (aged 18-75) may be enrolled at one investigational center in
      Israel to have at least 16 subjects complete the study.

      The study consists of a run-in period and a study period. The run-in period is intended to
      allow subjects to become familiar with using the study pump system with the SmartGuard
      feature active and wearing the watch. Subjects should use the same insulin they will be using
      during the study period.

      During the first week of the study period, subjects will undergo a 5-day at-home baseline
      meal challenge at specific meals on each day. The Klue app will be set to monitoring-mode.
      After run-in period and completion of the 5-day at-home study period with baseline meal
      challenges, study subjects will check into the clinic for a 5-day (4 nights) intervention.
      Study subjects will wear the system with Klue meal gesture dosing activated for the entire
      duration of the 5-day intervention.
    

Intervention name(s): MiniMed™ 780G insulin pump with Klue Health app utilizing meal gesture micro insulin dosing (meal gesture dosing)
Intervention type(s): Device
Intervention description(s): The AHCL system with Meal Gesture Dosing evaluated in this study includes a commercial/CE-Marked insulin pump with investigational software, and the Klue Health mobile app with investigational software (installed on Apple Watch) for meal gesture detection and micro dosing.
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced Hybrid Closed Loop; Meal Gesture Dosing; Klue™ Health App
EARLY IFNB-1a and Simvastatin Combination Therapy in Clinically Isolated Syndrome Suggestive of Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the safety, tolerability and efficacy of a
      combination therapy interferon beta-1a(Avonex) plus simvastatin (Zocor) vs. interferon
      beta-1a plus placebo in patients with clinically isolated syndrome suggestive of Multiple
      Sclerosis.
    

Detailed description: 
      Interferon beta-1a (IFNB-1a), a FDA approved therapy for relapsing-remitting (RR) MS has
      several mechanisms of action. It lowers proinflammatory cytokine production and inhibits
      antigen presentation by class II major histocompatibility complex (MHC) molecule. It also
      reduces metalloproteinase activity, which all lead to decreased migration of T-lymphocytes
      into the central nervous system (CNS), and subsequent inhibition of inflammatory lesion
      formation. We propose that combination therapy during early stages of the disease with second
      immunomodulatory agent that targets different steps in the pathogenesis of the disease may
      add to the effectiveness of IFNB-1a. IFNB-1a administered intramuscularly at 30 mg per week
      is particularly suitable for combination therapy due to its proven efficacy in Clinically
      Isolated Syndrome (CIS),favorable safety profile and low frequency of neutralizing antibodies
      (NABs) against IFNB-1a in comparison to other forms of IFNB-1a. Recent studies have reported
      a significant anti-inflammatory and neuroprotective effects of statins, cholesterol-lowering
      agents. Statins disrupt cellular membrane lipid rafts, which inhibit the clustering of T-cell
      receptor (TCR), co-stimulatory, and adhesion molecules, required for optimal T-cell
      activation. Along with inhibiting T-cell activation, statins decrease IFNB inducible MHC
      class II expression, suppressing an effective antigen presentation. They block migration of
      activated mononuclear cells from peripheral circulation into the CNS by blocking LFA-1
      adhesion molecule and by reducing metalloproteinase type 9 secretion. While their
      anti-inflammatory effects at tolerable oral doses may not justify their use as monotherapy
      for RR MS, their pleiotropic mechanisms of action showed synergistic effects with IFNB-1a in
      studies in vitro. We propose that simvastatin may enhance the immunomodulatory effects of
      INFB-1a in patients with CIS suggestive of MS and that this combination may even more
      effectively prevent further disease activity if administered early in the course of the
      disease.
    

Intervention name(s): Avonex/Zocor
Intervention type(s): Drug
Intervention MeSH terms: Interferon beta-1a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Clinically Isolated Syndrome
Effect of Intraoperative Fluid Management on Morbidity
Condition: Epidural Anesthesia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether intraoperative fluid and sodium restriction
      decreases postoperative morbidity
    


Intervention name(s): fluid management; fluid management; fluid management
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): volume and sodium restriction; volume restriction; liberal fluid management
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Fluid therapy
Cost Efficacy Evaluation of Robot Assisted Radical Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      In this observational cost efficacy study, the investigator compare the Laparoscopic Radical
      Prostatectomy (LRP) versus Robotic-Assisted Laparoscopic Prostatectomy (RALP). Every cost of
      care that include hospitalization related or post operative medical consumption are obtained
      and recorded up to 5 years follow up. Functional results (continence, potency, quality of
      life) are obtained through standardised questionnaires. Carcinologic results are estimated by
      Prostate Specific Antigen (PSA) relapse and salvage treatments. Economic evaluation will be
      made to estimate direct costs of the four postoperative year along with the incremental
      cost-effectiveness ratio (ICER) per successful surgical treatment (preserved urinary
      continence and erectile function and PSA < 0.2).
    


Intervention name(s): Robotic-Assisted Radical Prostatectomy; Laparoscopic Radical Prostatectomy
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Clinically localized prostate cancer; Robotic-assisted prostatectomy; Laparoscopic prostatectomy; Erectile function ;; Cost efficacy study