bioihbjkbjnl/mcl2 huggingface dataset:
PREventing CHemotherapy Induced Neuropathy (PreChIN)
Condition: Chemotherapy-induced Peripheral Neuropathy (CIPN)
MeSH terms: Peripheral Nervous System Diseases
Study type: Interventional

Summary: 
      The project is designed to study the use of localized hypothermia alone, or with compression
      to the limbs during chemotherapy infusion for the prevention of chemotherapy induced
      peripheral neuropathy (CIPN). As a pilot study, safety, tolerability and early clinical
      activity will be studied. The study will be conducted on healthy volunteers and cancer
      patients receiving taxane chemotherapy.
    

Detailed description: 
      Localized limb hypothermia during chemotherapeutic infusion may prevent a common side effect
      of chemotherapy: chemotherapy-induced peripheral neuropathy (CIPN). There are no reliable
      methods for the prevention or the treatment of CIPN. On the basis of the dose-related
      pathophysiology of CIPN, the investigators hypothesize that reducing the delivery of the
      toxic chemotherapeutic agents to the peripheral nerves by reducing blood flow through
      hypothermia may reduce the occurrence of CIPN. The proposed potential treatment method would
      aim to reduce the development of CIPN. This project comprises of a healthy subject trial to
      investigate the best tolerated temperature which will be used in cancer subject trial to
      investigate the safety and tolerability of hypothermia or cryocompression (hypothermia with
      pressure) in the prevention of CIPN in cancer subjects undergoing taxane-based chemotherapy.
    

Intervention name(s): Hypothermia; Cryocompression
Intervention type(s): Device; Device
Intervention description(s): Healthy subjects will undergo 3 hours of hypothermia at various temperature levels.Cancer subjects will undergo 4 hours of hypothermia during every cycle of chemotherapy.; Healthy subjects will undergo 3 hours of cryocompression. Cancer subjects will undergo a minimum duration of 2 hours and a maximum duration of up to 4 hours of cryocompression during every cycle of chemotherapy.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: The first part of this study is in healthy subjects, followed by breast cancer patients receiving paclitaxel to study the effect of limb hypothermia in the prevention of chemotherapy-induced neuropathy.
The second part of this study is to study the effect of cryocompression in the prevention of chemotherapy-induced neuropathy.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: paclitaxel; neuropathy; hypothermia; cryocompression
Early Independent Adaptive Arm and Hand Rehab
Condition: Post-stroke Hemiparesis
MeSH terms: Paresis
Study type: Interventional

Summary: 
      The purpose of this study is to test the hypothesis that early independent adaptive
      bimanual-to-unimanual training of arm and hand movements, assisted with specially designed
      mechanical devices: the mirrored motion bimanual arm trainer (m2 BAT), will improve motor
      control and function in patients with post-stroke hemiparesis.
    

Detailed description: 
      This study will randomly assign individuals admitted to the inpatient stroke rehabilitation
      unit to receive either conventional occupational therapy (OT) or conventional OT plus 1 hour
      additional bimanual-to-unimanual device-assisted therapy.
    

Intervention name(s): Conventional Occupational Therapy (OT); m2 BAT
Intervention type(s): Other; Device
Intervention description(s): Standard of care occupational therapy for stroke recovery; Conventional OT plus 1 hour additional bimanual-to-unimanual device-assisted therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Motor control
CBT for Spanish Speakers
Condition: Substance Use
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The investigators are conducting a randomized clinical trial of our new web-based version of
      the CBT4CBT (Computer Based Training for Cognitive Behavioral Therapy) in Spanish. This
      program specifically designed for Spanish-speaking substance users to evaluate its
      effectiveness relative to standard outpatient counseling at the Hispanic Clinic. The
      computer-based training program (CBT4CBT) focuses on teaching basic coping skills, presenting
      examples of effective use of coping skills in a number of realistic situations in video form,
      and providing opportunities for patients to practice and review new skills while receiving
      substance use treatment.
    

Detailed description: 
      100 Spanish-speaking substance using individuals seeking treatment at the Hispanic Clinic of
      the Connecticut Mental Health Center will be randomized to (1) standard outpatient counseling
      at the Hispanic Clinic (typically consisting of weekly group counseling), OR (2) CBT4CBT plus
      standard outpatient counseling. Treatments will be delivered over an 8-week period with a
      six-month follow-up after termination of the study treatments. The primary outcome measures
      will be reduction in substance use (frequency of substance use by time, confirmed by urine
      toxicology screens and breathalyzers). Secondary outcomes will include treatment utilization
      and cost, several measures intended to detect whether web-based CBT4CBT retains key
      characteristics of traditional clinician-administered CBT (e.g., acquisition of coping
      skills, use of change strategies), participant characteristics which will be evaluated as
      potential moderators of outcome, as well as participant satisfaction and treatment
      credibility.
    

Intervention name(s): Standard Treatment as Usual; CBT4CBT plus Standard treatment as usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Treatment normally offered at this clinic which could include individual or group substance use counseling sessions one time per week lasting one hour each time.; Subjects work with a computerized program in Spanish that teaches skills for stopping substance use and increasing coping skills. Computerized sessions are one time per week and last about one hour per session. Plus Standard treatment as usual
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: substance use, Spanish speaking, CBT4CBT
Effects of Microfluidic Noodle on Blood Glucose Levels of Healthy Volunteers.
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      In this study, microfluidics was applied in the creation of low-GI food gel made from
      non-traditional ingredients like alginate and soy protein isolate. This method is previously
      tested to produce lower glycaemic response than normal noodle and pasta.
    

Detailed description: 
      Research has confirmed that a food's glycemic effect cannot be accurately predicted from the
      type and amount of carbohydrates it contains, as the rate at which the carbohydrates is
      digested and released into the bloodstream is influenced by many factors such as the food's
      physical form, its fat, protein and fibre content, and the chemical structure of its
      carbohydrates. For these reasons, it is possible to produce food from the same group with
      different effects on blood glucose. Consumption of low GI food has shown to improve glycemic
      control, lipid profile and reduce systemic inflammation. However, there are few dietary
      intervention studies attempting to change the GI of food by changing the staple
      carbohydrates. In this study, microfluidics was applied in the creation of low-GI food gel
      made from non-traditional ingredients like alginate and soy protein isolate. This method is
      previously tested to produce lower glycaemic response than normal noodle and pasta. With
      noodles being one of the staples to many Singaporeans, food gels formed using functional
      ingredients derived from food sources offer a lower GI alternative to the conventional noodle
      and pasta without affecting the people dietary preference.
    

Intervention name(s): Microfludic noodle; Control noodle
Intervention type(s): Other; Other
Intervention description(s): In this intervention arm, subjects will be served with noodles made using microfludic technology.; In this intervention arm, subjects will be served with normal noodle.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study is a within-subject cross-over trial design to assess the glycemic response of microfluidic noodle consumption by human subjects as compared to mee sua (control noodle).
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: microfludic
Effect of Sugammadex for Muscle Motor Response and Awareness in Intraoperative Wakeup
Condition: Spinal Curvatures
MeSH terms: Spinal Curvatures
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will be performed to evaluate motor response and awareness with using sugammadex
      during wakeup procedure in spine surgery. The investigator's goal is to investigate the
      effect of sugammadex on the state of consciousness and motor-somatosensorial evoked
      potentials.
    

Detailed description: 
      Between 10-25 age, American Society of Anesthesiologist clinical status(ASA) I-II, 60 patient
      which will be performed spine surgery in orthopedics clinic will be enrolled in this study.
      Patient will be randomized into two group that include 20 patient. General anesthesia will be
      administered by Totally intravenous anesthesia (TIVA) with propofol and remifentanyl for all
      patients. Two groups will be monitored with BIS (bispectral index), TOF (train-of-for) MEP
      (motor evoked potential) and SSEP (somatosensorial potential). During wakeup procedure, in
      group S, TIVA will be stopped and 2 mg/kg of sugammadex will be given intravenously. BIS,
      TOF, MEP, SSEP will be measured. In group N, TIVA will be stopped and 0.04 mg/kg of
      neostigmine will be given. Also BIS, TOF, MEP, SSEP will be measured. Sugammadex will be
      given group S and Neostigmine will be given group N at the end of the operation. At
      postoperative sixth hour, the investigators will visit all the patients and ask standard
      questions about intraoperative wakeup procedure.
    

Intervention name(s): Sugammadex; Neostigmine
Intervention type(s): Drug; Drug
Intervention description(s): Administration of Sugammadex; Administration of Neostigmine
Other intervention name(s): group I; group II
Intervention MeSH terms: Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
De Novo Metabolic Syndrome in Liver Transplant Patients After Immunosuppression Withdrawal
Condition: Single Transplant; 5 Years of Follow-up After Transplant, in Which an Attempt Was Made to Suspend IS
MeSH terms: Metabolic Syndrome
Study type: Observational

Summary: 
      Evaluate de novo onset of metabolic syndrome, NAFLD and NASH in liver transplant recipients
      who have discontinued immunosuppressive therapy ("tolerant") and in those taking
      immunosuppressive therapy ("non-tolerant").
    

Detailed description: 
      A retrospective single-center study was conducted aiming to define the incidence of de novo
      Metabolic Syndrome (MS) in patients who withdraw Immunosoppression (IS) drugs after Liver
      Transplant (Tolerant-group) compared to these who couldn't wean IS drugs(non-TOL-group).
    

Intervention name(s): Immunosuppressive
Intervention type(s): Drug
Intervention description(s): compare MS development in patients who achieve to suspend IS drugs after LT and in those who could not suspend.
Intervention MeSH terms: Immunosuppressive Agents
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        92 patients with liver transplantation who attempted to suspend/ achieve suspension of
        immunosuppressive therapy, in follow-up in Tor Vergata transplant center.
      
Keywords: Metabolic Syndrome, Liver transplantation, Immunosoppression, Tolerance
Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease (AD)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and tolerability and Aß-specific antibody response of
      CAD106 in patients with mild to moderate Alzheimer's Disease.

      Patients also had a 2 year follow-up to assess disease progression where no drug was
      administered.
    


Intervention name(s): CAD106; Placebo
Intervention type(s): Biological; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mild, moderate Alzheimer's Disease (AD), Aß-specific antibody, CAD106
The Effect of Creative Drama on Postmortem Care in Nursing Students
Condition: Healthy
Study type: Interventional

Summary: 
      The goal of this randomized controlled including pretest, posttest and persistence test study
      is to examine the effect of creative drama method on student nurses' knowledge and skill
      levels related to postmortem care, learning permanence and satisfaction with the training
      method.

      The main question it aims to answer are:

      •Is the postmortem care training given to nursing students with the creative drama method
      effective on the level of knowledge and skills, the permanence of knowledge and skills and
      satisfaction with the training method? Participants will participate in an educational
      activity related to postmortem care. Researchers will compare it with the classical education
      method to see if postmortem care training given to nursing students with the creative drama
      method is effective.
    

Detailed description: 
      The research will be carried out in the form of determining the preliminary knowledge of
      nursing third year students about postmortem care, providing education with classical
      education and creative drama methods, evaluating the educational outcomes and permanence in
      education for knowledge and skills, and determining their satisfaction with the educational
      methods.

      Hypotheses of the research are as follows. H1: There is a difference between the knowledge
      scores of the experimental and control groups on postmortem care. Is there a difference
      between the creative drama method and classical education method and the satisfaction of
      postmortem care students with the training method? H2: There is a difference between the
      skill scores of the experimental and control groups for postmortem care. H

      : There is a difference between the information persistence scores of the experimental and
      control groups related to postmortem care.

      H4: There is a difference between the skill persistence scores of the experimental and
      control groups for postmortem care.

      H5: There is a difference between the satisfaction of the experimental and control groups
      with the training method
    

Intervention name(s): Creative Darama Group; Classical Education Group
Intervention type(s): Other; Other
Intervention description(s): Postmortem care training given by creative drama method; Postmortem care training given by classical education method
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a randomized controlled trial with experimental and control groups including pretest, posttest and persistence test.
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Postmortem care; Creative drama; Nursing Students; Nursing Education
Short and Mid-term Repeatability of Active Anterior Rhinomanometry (AAR) Measurements in Paediatric Age
Condition: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Rhinitis, Allergic, Perennial
Study type: Observational

Summary: 
      Longitudinal, observational study to assess the short-term (test re-test) and mid-term
      (within the span of 28 days) repeatability of active anterior rhinomanometry (AAR) measures
      on 4 parallel groups of children with different rhinitis phenotypes, and 1 group of control
      (healthy) children.

      Secondary objectives are: i) assessing of association between AAR, exhaled FeNO (eFeNO) and
      nasal FeNO (nFeNO); ii) assessing association between objective measurements (AAR, eFeNO and
      nFeNO) and subjective measurements (Total 5 Symptom score, T5SS).

      The study is intended to obtain useful information for improving rhinitis management.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A study population of 40 rhinitis children (10 for each of 4 different rhinitis phenotypes)

        attending the outpatient clinic of Pediatric Allergology & Pulmonology (PAP) within the
        Institute

        of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of
        Palermo (IBIM CNR), and a control group of 10 healthy volunteers.
Effectiveness of Foam Rolling on Selected Muscle Groups on Jumping
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      An experiment elucidating the immediate effect of foam rolling of the posterior chain on
      reactive force performance that will represent multiple jumps over low obstacles. The
      measurements will be performed using the Optojump device, which will provide data on the time
      of foot contact with the ground and the jump height. The angles of the torso inclination to
      the vertical will also be measured during jumping.
    

Detailed description: 
      Fifteen women were selected for this experiment in the form of a randomized crossover study.
      Measurements were taken by leg jumps over 5 obstacles 125 cm apart. The pre-test was
      performed twice with a two-minute rest between each trial. Immediately after finishing the
      second trial, a randomly selected half of the probands performed posterior chain facilitation
      using a foam roller, facilitating first the left leg, then the right leg and finally spinal
      erectors. Rolling was performed with a sense of maximal intensity and at a high rolling speed
      across the full length and width of the muscle with both cranial and caudal rolling
      directions. Facilitation was performed on each muscle group in the distoproximal direction.
      Immediately following the intervention, a post-test was performed a total of 3 times, 1
      minute after the intervention, 3 minutes after the intervention and 5 minutes after the
      intervention. The control measurement was performed the same way as the intervention, but the
      control group of probands rested in a resting sitting position for 4 minutes instead of foam
      rolling. After one week, a second measurement followed, where the original control group
      underwent the intervention measurement and vice versa.

      The Optojump instrument (Microgate, Bolzano, Italy) was used to obtain the resistance and
      flight phase data. A video recording (GoPro HERO 9) was taken of the skipping procedure, from
      which photographs were taken over each obstacle at the moment of the greatest trunk tilt (the
      junction of the trochanter major and the external auditory canal exit) from the vertical
      axis.
    

Intervention name(s): Foam Rolling
Intervention type(s): Other
Intervention description(s): Foam rolling was performed for 4 minutes with the goal of affecting the entire myofascial posterior chain.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: SMR; plyometrics; jumps over hurdles; posterior myofascial chain
Study of Electrical Impedance Myography (EIM) in ALS
Condition: Amyotrophic Lateral Sclerosis; Motor Neuron Disease; Charcot-Marie-Tooth Disease; Multiple Sclerosis
MeSH terms: Tooth Diseases; Multiple Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Charcot-Marie-Tooth Disease; Nerve Compression Syndromes; Hereditary Sensory and Motor Neuropathy; Sclerosis
Study type: Observational

Summary: 
      This trial is studying Electrical Impedance Myography (EIM) for measuring muscle health. The
      trial is studying people with Amyotrophic Lateral Sclerosis (ALS), other neuromuscular
      diseases, and healthy volunteers to see if the EIM device can measure disease in muscle
      tissue.
    

Detailed description: 
      This is a multicenter, 9-month study evaluating the effectiveness of electrical impedance
      myography (EIM) as a diagnostic and disease-tracking tool. In addition, the following will be
      studied:

        1. Determine EIM device's ability to discriminate between ALS and "look-alike" non-fatal,
           motor-predominant syndromes;

        2. Track EIM progression over time and determine the best summary EIM measure that could
           serve as an endpoint in future clinical trials and individual patient care; and,

        3. Determine whether EIM progression is predictive of a combined outcome of survival and
           progression as measured by ALS Functional Rating Scale, Revised (ALSFRS-R), Hand-held
           Dynamometry (HHD) and Vital Capacity (VC) measures.
    

Intervention name(s): Electrical impedance myography (EIM)
Intervention type(s): Device
Intervention description(s): In EIM, high-frequency alternating electrical current is applied to localized areas of muscle via surface electrodes and the consequent surface voltage patterns analyzed.
EIM is very sensitive to the compositional and structural elements of muscle. Data from both human subjects and animal disease models, including ALS, spinal muscular atrophy (SMA), and Duchenne muscular dystrophy (DMD), show that EIM may be sensitive to a variety of pathological states. It is anticipated that EIM will thus likely be able to assist in quantifying the severity of the disease affecting various muscle groups as well as in measuring changes in the disease over time.
Other intervention name(s): EIM1102 device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        People with ALS People diagnosed with early ALS (possible, probable, probable- laboratory
        supported or definite ALS according to El Escorial criteria)

        Other Neurological Diseases People with a diagnosis of a disease that mimics ALS

        Healthy Controls Healthy Volunteers that do not have ALS or another neurological disease
        that mimics ALS.