bioihbjkbjnl/mcl2 huggingface dataset:
In Situ Simulation Training in Transferring Critically Ill COVID-19 Patients
Condition: Simulation of Physical Illness; COVID-19 Respiratory Infection
MeSH terms: COVID-19; Respiratory Tract Infections
Study type: Interventional

Summary: 
      This study aimed to determine the role of in situ simulation training during a pandemic by
      using standard and high-fidelity mannequins to improve interprofessional communication,
      skills, and teamwork in transferring critically ill COVID-19 patients.
    

Detailed description: 
      Fourty subjects were randomly allocated into two large groups, the High Fidelity Simulator
      group and the Low Fidelity Simulator group. Each group was divided into small groups, consist
      of 2 doctors and 3 nurses. All subjects underwent the same interactive lectures, and two
      sessions of in-situ simulation according to their assign group. In-situ simulation and
      debriefing were performed by implementing appropriate personal protective equipment and
      social distancing. At the end of each simulation session, each group would underwent a
      debriefing session, which was performed by an experience instructor. The first simulation was
      aimed to teach participants skills and steps in transporting critically-ill COVID-19 patients
      according to the hospital check-list. While the second simulation was aimed to assess skills,
      team work and communication that participants had learned from the previous simulation, by
      using assessment tools that had been developed before. In addition to comparing each point in
      the assessment tool between the two groups, the points that had been earned were also added
      up to get the overall points for total skills, cooperation and communication score. At the
      end of the session, learner immediate feedback were also collected using an online feedback
      form, which provided accountability for attendance, content learning, and course evaluation
      feedback.
    

Intervention name(s): Simulation Training
Intervention type(s): Procedure
Intervention description(s): Simulation Training using High and Low Fidelity Simulator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: In Situ Simulation; Intreprofessional Training; High Fidelity Mannequin
Fitness Training Using WBEMS Among Individuals With SCI
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      Up to 15 individuals living with chronic SCI will be recruited for this study. Each
      participant will complete an initial clinical assessment before starting a 10-week training
      program. The training program will consist of three 45-minute Whole-Body Electrical Muscle
      Stimulation (WBEMS)-augmented exercise training sessions for 10 weeks. At each training
      session, all adverse events (pain, redness, injury, etc.) will be recorded along with
      participants' comments concerning comfort (i.e. Objective 1). The investigators hypothesize
      that the use of a WBEMS will result in no serious adverse effect during and following the
      training sessions and that it will take less than 10 minutes to don and doff the suit.

      At the fifth session, after participants have had the opportunity to become familiar with the
      WBEMS intervention, the immediate effects of the intervention on physiological responses will
      be assessed (i.e. Objective 2). It is hypothesized that during a single training session
      consisting of WBEMS and exercise, physiological responses and energy expenditure (EE) will be
      significantly improved in participants with SCI compared to a training session consisting
      solely of exercises without WBEMS.

      At the end of the training program, participants will complete the final clinical assessment
      to evaluate the therapeutic benefit of the WBEMS-augmented exercise intervention (i.e.
      Objective 3). Three months after the end of the training program, the participants will be
      asked to complete a semi-structured interview and questionnaire to evaluate the perceived
      benefits of the training program (i.e. Objective 3).It is also hypothesized that participants
      will perceive benefits of the 10-week training program such as decreased spasticity,
      increased energy and improved mood.
    


Intervention name(s): StimaWell®EMS
Intervention type(s): Other
Intervention description(s): The StimaWell®EMS device is a 12-channel medium-frequency device with modulated low frequency using a high-tech stimulation suit for the trunk and strap electrodes for the arms and legs allowing whole-body stimulation. The device has 70 preprogramed training programs based on goals (e.g., strengthening, endurance training, aerobic training).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Physical Fitness; Whole body electrical muscle stimulation
Prevention and Treatment of Chronic Low Back Pain Through an Adapted Exercise Program
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Objective: The purpose of this study is to investigate the effects of a adapted exercise
      program and general exercise recommendations compared with only general exercise
      recommendations for the management of chronic back pain among the workers of BSH (Bosch
      Siemens Hausgeräte), a manufacturing company.
    

Detailed description: 
      Design: Randomized controlled trial. Participants: Subjects (N_40 volunteers) experimental
      group (n_20) control group (n_20). All of the participants needs to be diagnosed with chronic
      back pain by a physician. Participants are going to be randomly assigned to two groups: a
      control group (CG), and experimental group (EG).

      Intervention: The experimental group is going to follow a home-exercise program designed
      specifically to compensate the overloads and strength necessities of the workplace, the
      patient enter the description of the workplace in a mobile application (APP) and the APP
      shows specific exercises that the patient needs to practice. The exercise program includes
      muscle strengthening, flexibility, and endurance training, during 2 months, 3 times/week and
      generla recommendations. The control group is going to receive only general recommendation
      (ACSM recommendations) with the same kind of mobile application to control the amount of
      exercise that each patient performs during the week.

      Data on pain intensity (BPI short form, Brief Pain Inventory), disability (Oswestry Low Back
      Pain Disability Questionnaire), functional assessment of the lumbar spine (EMG
      Flexion-relaxation test), amount of weekly physical activity (IPAQ), and number of sick
      leaves are going to be measured immediately before and after intervention and 3 months after
      the end of the intervention period.
    

Intervention name(s): Adapted exercise; General exercise recommendations
Intervention type(s): Other; Other
Intervention description(s): 2 months, 3 times/week; 2 months, 3 times/week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Non-Inferiority Study Comparing 3 Weekly Injections of SUPARTZ® vs 3 Weekly Injections of Euflexxa® for Knee OA
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate non-inferiority of three weekly intra-articular
      injections of SUPARTZ to three weekly intra-articular injections of Euflexxa for the relief
      of knee OA.
    

Detailed description: 
      The purpose of this study is to demonstrate non-inferiority of three weekly intra-articular
      injections of SUPARTZ to three weekly intra-articular injections of Euflexxa for the relief
      of knee joint pain in subjects with osteoarthritis (OA) of the knee as measured by the VAS
      (0-100 mm) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain
      subscale score Change from Baseline (CFB) over Weeks 3, 6, 12.

      Safety will be accessed by recording adverse events, concomitant medications, physical
      examinations, and vital signs.
    

Intervention name(s): Supartz; Euflexxa
Intervention type(s): Device; Device
Intervention description(s): Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.; Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: osteoarthritis; knee pain; Supartz; Euflexxa; HA; hyaluronic acid
Safety and Reactogenicity of a H1N1 Influenza Challenge Virus in Healthy Volunteers
Condition: Influenza A
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to determine the dose level of live, wild-type A/California/ H1N1
      2009 virus that has an appropriate safety and illness/infectivity profile to be used as an
      influenza virus, challenge strain in future intervention studies.

      Illness parameters were collected by subject symptom scores as well as by physical
      examination. Virus parameters were measured by PCR and cell culture assay (performed by
      VisMederi srl).
    


Intervention name(s): 1:1000 Live wild-type A/California/H1N1 2009; 1:100 Live wild-type A/California/H1N1 2009; 1:10 Live wild-type A/California/H1N1 2009
Intervention type(s): Other; Other; Other
Intervention description(s): 1:1000 dilution of neat virus; 1:100 dilution of neat virus; 1:10 dilution of neat virus
Other intervention name(s): virus; Virus; Virus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Influenza; Vaccine; Virus; H1N1; Challenge; Vismederi
COgnitive REhabilitation in Pediatric Patients With sABI From Vegetative State to Functional Recovery
Condition: Acquired Brain Injury; Development, Child
MeSH terms: Brain Injuries; Persistent Vegetative State
Study type: Interventional

Summary: 
      Acquired brain lesions (GCLA) represent one of the most important cause of disability and
      mortality during the pediatric age, also in the western Countries. The important medical
      progresses of the last decade in the medical field have increased the percentages of
      survival, also in the most severe clinical pictures. On the other hand, a brain lesion
      reported in the first years of life presents with a more dramatic impact on the cognitive and
      neurological development of the patients and it can significantly interfere with the same
      quality of their life. Recent studies suggest that a brain damage in this stage of the life
      is related to more persistent sequelae in comparison of the same lesion reported by an adult
      patient, because of the neurological immaturity at the moment of the insult. Furthermore, in
      most cases, the brain lesion is related not only to motor and sensorial deficits but also to
      very important behavioral and cognitive problems, that can arise immediately after the acute
      phase, or also several years after the pathological event.
    

Detailed description: 
      The aims of the present study are:

        1. To contribute to the adaptation of the Italian version of the Coma Recovery Scale
           (CRS-R) for the pediatric age, with specific differentiation and taking into account the
           age of the patients and the specific learning that characterize each developmental
           stage;

        2. As regards the patients with an adequate cognitive profile, to compare the effectiveness
           of a traditional multifunction neuropsychological treatment (cognitive functions are
           stimulated at the same time) vs a sequential treatment (cognitive functions are
           stimulated step by step).
    

Intervention name(s): Neuropsychological treatment
Intervention type(s): Behavioral
Intervention description(s): Neuropsychological treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Validation of assessement scale; study of the effectivness of two models of neuropsychological intervention
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Rehabilitation
PulseHaler Drug Deposition Study in Chronic Obstructive Pulmonary Disease Patients
Condition: COPD
Study type: Interventional

Summary: 
      This study is aimed at finding the effect of PulseHaler™ with Albuterol on Lung Deposition of
      Aerosol and on Pulmonary Functions in COPD Patients
    


Intervention name(s): Pulsehaler; Nebulizer & Albuterol 0.5ml
Intervention type(s): Device; Drug
Intervention description(s): Albuterol aerosolized by a nebulizer
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Stress Response Pathways in Vitiligo
Condition: Vitiligo
MeSH terms: Vitiligo
Study type: Interventional

Summary: 
      The purpose of this study is to investigate stress response pathways in tissues and
      melanocytes from patients with vitiligo. Investigators are collecting evidence of UPR and
      stress response activation in tissues and melanocytes from patients with vitiligo.
      Individuals with vitiligo will have punch biopsies to study stress response UPR activation
      and NF-κB signaling to test our hypothesis. In order to characterize differences between
      disease and normal states, a second arm of control individuals (Arm 2) will be recruited.
    

Detailed description: 
      Identifying a role for NF-κB signaling in vitiligo may improve therapies for this disfiguring
      disorder. Current treatments vary in effectiveness and may not always be long lasting cases.
      The NF-κB pathway and IL-6 itself are the target of several FDA approved drugs, thus opening
      new therapeutic avenues.
    

Intervention name(s): Punch Biopsy at a Lesional Site; Punch Biopsy at a Non- Lesional site
Intervention type(s): Procedure; Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Telehealth Initiative on Lupus Patients
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional

Summary: 
      SLE is mostly seen in young women and causes significant deformity in patients. In SLE,
      disease activity, body damage due to disease or treatment, comorbidities, and drugs affect
      body image negatively. SLE causes changes in the body such as skin rashes, uneven
      pigmentation, vitiligo, scars, tooth loss, alopecia, increased facial hair, stretch marks,
      weight gain, fatigue, pain, depression, the unpredictability of exacerbations or lack of
      independence, which worsens the subjective well-being of patients. can affect in that
      direction. Subjective well-being (SBL) is the scientific term for happiness, and SLE is
      thought to have a significant negative impact on SWB.
    

Detailed description: 
      Telehealth has been proposed as a component of patient education for disease management.
      Telehealth, which is defined as the remote delivery of health services via telecommunication
      tools including telephone and internet, enables accessible and appropriate health care
      service and provides communication, support, and monitoring opportunities with patients.
      Researchers think that a telehealth education initiative can be effective on the pain and
      life activities of SLE patients and this effect will improve their happiness in a good way.
      Based on these findings, this study aimed to examine the effects of a specific telephone
      educational intervention on pain, happiness, and activities of living in patients with SLE.
      The hypothesis of this study is; is that adapted telehealth education intervention can
      increase the happiness and life activities of patients with SLE and reduce pain.
    

Intervention name(s): Structured training using telehealth
Intervention type(s): Behavioral
Intervention description(s): The intervention is based on self-care activities. Self-care states that people have an innate ability to take care of themselves.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Life activities; Pain; Happiness
Effects of Colesevelam HCl On Bile Acid Kinetics
Condition: Type 2 Diabetes Mellitus; Impaired Glucose Tolerance
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Intolerance
Study type: Observational

Summary: 
      This project will compare the amount of bile acids and their kinetics in overweight and obese
      people with normal glucose metabolism, impaired glucose tolerance and frank type 2 diabetes.
      We hypothesize that bile acids will behave differently in these groups. We will also explore
      the effects of Colesevelam HCl, a medicine that lowers LDL cholesterol by binding bile acids,
      on bile acids in those groups. We hypothesize the drug may have different actions on bile
      acids in subjects with different degrees of abnormal glucose metabolism.
    

Detailed description: 
      Bile acids, which are synthesized from cholesterol in the liver, play a key role in digestion
      as they solubilize dietary lipids and aid their absorption in the digestive tract. While for
      many years bile acids have been characterized by this digestive role, recent research
      indicates that bile acids play other important roles. Because bile acids have been shown to
      act in signaling pathways that affect metabolism, there has been renewed interest in
      investigations of their effects. This study explores potential differences in bile acid
      kinetics based on insulin resistance or type 2 diabetes at baseline.

      Colesevelam HCl is a bile acid sequestrant, which in addition to its primary role in lowering
      serum LDL-C levels, has secondarily been implicated in lowering blood glucose levels. This
      study explores the relationship between insulin resistance and type 2 diabetes and changes in
      bile acid pool sizes and kinetics with colesevelam treatment. Isotopically labeled bile acids
      will be administered to subjects before and after treatment with colesevelam and comparisons
      will be made in bile acid pool size, fractional turnover rate, and synthesis rate in the
      three study groups.
    

Intervention name(s): Colesevelam HCl
Intervention type(s): Drug
Intervention MeSH terms: Colesevelam Hydrochloride
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        overweight and obese people with normal glucose metabolism, impaired glucose tolerance and
        frank type 2 diabetes
      
Keywords: Type 2 diabetes mellitus; Bile acid; Stable isotope; Colesevelam HCl; Impaired Glucose Tolerance
Single Fraction Intraoperative Radiotherapy
Condition: Invasive Ductal and Invasive Lobular Breast Carcinoma; Stage 0 Breast Carcinoma; Stage I Breast Carcinoma; Stage II Breast Carcinoma
MeSH terms: Carcinoma; Breast Neoplasms; Carcinoma, Lobular; Breast Carcinoma In Situ
Study type: Interventional

Summary: 
      This clinical trial is being conducted to find out the effects (good and bad) of giving the
      full radiation treatment for breast cancer as a single dose of radiation during surgery for
      breast cancer. This single fraction intraoperative radiotherapy with electrons will study the
      toxicity, local control and cosmetic outcome.
    

Detailed description: 
      For patients with certain types of breast cancer, one standard treatment is breast conserving
      surgery or lumpectomy (surgery to remove abnormal tissue or cancer from the breast and a
      small amount of normal tissue around it) followed by breast radiation. The radiation
      treatment in this situation usually lasts 3 to 5 1/2 weeks followed by 5-8 daily localized
      irradiation (or boost) treatments at the site where the lump was removed. During this study,
      the single dose of electron irradiation given at the surgical site during the operation will
      replace the radiation given after surgery.
    

Intervention name(s): Intraoperative Radiotherapy
Intervention type(s): Procedure
Intervention description(s): Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure. IORT is performed on mobile or fixed linacs with variable electron energies in the range of 6-12 MeV prescribed to a dose of 21 Gy, with the prescription dose covering at least 90% of the Planning Target Volume (PTV). PTV is defined as a 3D volume of 1-2 cm beyond the former macroscopic tumor edge (excluding skin, limit to anterior rib surface: 5 Gy). The choice of electron energy as well as the cone applicator size has to account for minimum PTV requirements. Tissue depth measurement will be documented by intraoperative sonography.
Other intervention name(s): IORT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer; Carcinoma; Radiotherapy; Intraoperative Radiotherapy; IORT
A Study of Acetaminophen for Post Surgical Dental Pain
Condition: Pain, Postoperative; Dental Pain
MeSH terms: Toothache; Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the safety, tolerability, analgesic, efficacy and pharmacokinetics of high dose
      acetaminophen relative to placebo and low dose acetaminophen relative to placebo over a 24
      hour period in patient experiencing moderate to severe pain following the surgical removal of
      third molar.
    

Detailed description: 
      This will be a randomized, double-blind, single-site, placebo-controlled, parallel-group
      study to assess similarities in safety, tolerability, efficacy, and pharmacokinetics of high
      dose acetaminophen given relative to placebo, and low dose acetaminophen given relative to
      placebo over a 24-hour period in patients experiencing moderate to severe postsurgical pain
      within 7 hours following surgical removal of 2 or more molars
    

Intervention name(s): Acetaminophen; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Acetaminophen is an analgesic and antipyretic; Saline
Other intervention name(s): APAP
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: High Dose Acetaminophen (APAP) versus Placebo, Low Dose APAP versus Placebo
Masking: Double (Participant, Investigator)
Primary purpose: Treatment