bioihbjkbjnl/mcl2 huggingface dataset:
BiliCam Clinical Validation Study
Condition: Newborn Jaundice
MeSH terms: Jaundice, Neonatal; Jaundice
Study type: Interventional

Summary: 
      The goal of this study is to assess the accuracy of BiliCam, a non-invasive technology based
      on analysis of digital images obtained with an app installed on a commercial smartphone, in
      estimating total serum bilirubin levels in newborns. BiliCam estimated bilirubin levels will
      be compared to total serum bilirubin levels in up to 225 newborns.
    

Detailed description: 
      Jaundice, a yellowing of the skin and eyes caused by a build up of bilirubin in the blood, is
      a common problem in newborn infants. Measurement of total serum bilirubin (TSB) levels is
      used for clinical decision making. BiliCam is a non-invasive technology used to estimate TSB
      levels in newborns. With BiliCam, the user obtains digital images of a small portion of a
      newborn's skin using the BiliCam app installed on a commercial smartphone in a standardized
      manner. A color calibration card is placed on the baby's sternum to account for varying light
      conditions. Data on color levels in the photos are used to estimate a bilirubin level.

      For the study, paired BiliCam estimated bilirubin (BCB) and TSB levels will be compared on a
      racially and ethnically diverse sample of newborns. Recruitment will continue until 225
      newborns have completed the study.
    

Intervention name(s): BiliCam estimated bilirubin (BCB)
Intervention type(s): Device
Intervention description(s): Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care
Intervention MeSH terms: Bilirubin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Evaluation of the Efficacy of an Antioxidant Dressing in Chronic Wound Healing
Condition: Hard-to-heal Wounds
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The aim of this study is to compare the effect of antioxidant dressing (active product) on
      chronic wound healing with the use of non-active wound dressing for healing in a moist
      environment (standard clinical practice) in patients with hard-to-heal wounds
    


Intervention name(s): Antioxidant dressing (active product); Usual care dressing that create a moist environment (standard clinical practice)
Intervention type(s): Device; Device
Intervention description(s): Antioxidant dressing (active product), covered with secondary dressing. Compression bandage if necessary.
Device: Reoxcare®; Usual care dressing; moist environment dressing chosen from the study centres' formulary (hydrocolloid, alginate, polyurethane foam dressings, silver dressings). Compression bandage if necessary
Intervention MeSH terms: Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic wound; Wound healing; Hard-to-heal wounds; Antioxidant dressing; Oxidative stress
Application and Comparison of Fuzzy Scale for the Evaluation of Pain Skeletal Muscle With the Numerical Pain Scale
Condition: Pain
Study type: Interventional

Summary: 
      This study aimed to analyze the stratification of pain levels through a mathematical model
      built using the diffuse joint theory and to investigate the relationship between range of
      motion and pain related aspects.
    

Detailed description: 
      The incidence of pain is due to traumatic actions, surgical interventions, new habits of
      life, increased longevity of the individuals and the reduction of the tolerance of the
      suffering by the man. Musculoskeletal pain is more evident in adult individuals, being the
      main cause of chronic pain throughout society, generating an impact on the quality of life,
      interfering in the daily activity of 30 to 50% of the patients. Pain measurement can be
      divided into four levels, which include the nominal, the ordinal, the interval and the ratio,
      with both one-dimensional and multidimensional versions. In the health area, diagnosis and
      treatment of diseases involve various levels of imprecision and uncertainties. A single
      disease or symptom may manifest totally differently in different patients and with varying
      degrees of severity. These effects usually generate many uncertainties and inaccuracies
      affecting the interpretations of the exams and the diagnosis, as well as the treatment. Fuzzy
      Systems Theory, also known as nebulous logic, is used to interpret the approximate mode of
      human reasoning, to take it to a numerical format and to obtain answers in an environment of
      uncertainties that serve as a subsidy to decision-making . A Fuzzy system based on Fuzzy
      logic. It can also be considered as a kind of expert, knowledge-based system. The development
      of the proposed Fuzzy Scale for Skeletal Muscle Pain Evaluation used the Mamdani method that
      allowed the representation of specialist knowledge (s) to construct the rule base. The
      construction of this system was based on the numerical scale of pain adopted and spread
      worldwide, and on the range of motion represented by the action of the muscles and articular
      components of the human body. The diffuse model proposed by the Fuzzy Scale for Muscle
      Skeletal Pain Evaluation uses 25 rules using binary XOR logic. For the volunteer tests, the
      proposed model was a non-randomized single intervention transverse study to analyze and
      compare the model of diffuse pain evaluation with the numerical pain scale performed with 535
      volunteers.
    

Intervention name(s): Experimental Group
Intervention type(s): Diagnostic Test
Intervention description(s): All volunteers were evaluated by numerical pain scale and Fuzzy scale. This procedure was performed to compare the efficacy of the Fuzzy Scale demonstrating greater accuracy of quantification of skeletal muscle pain
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Evaluation of pain; Fuzzy systems theory
Evaluation of Technology-Based Stress Reduction Techniques Prior to Vascular Access
Condition: Stress, Emotional
Study type: Interventional

Summary: 
      Preprocedural, preoperative, and prevascular access anxiety in pediatric patients has been
      previously shown to increase the likelihood of family stressors, postoperative pain,
      agitation, sleep disturbances, and negative behavioral changes. The purpose of this study is
      to determine if a non-invasive distracting devices (Virtual Reality headset) is more
      effective than the standard of care (i.e., no technology based distraction) for preventing
      anxiety before vascular access among hospitalized children undergoing vascular access prior
      to anesthesia, procedures, surgery, blood draws, port access, or peripheral IV placement. The
      anticipated primary outcome will be reduction of child's anxiety during and after vascular
      access.
    

Detailed description: 
      Anxiety among children undergoing vascular access is common. Not only is high anxiety
      traumatic, but research indicates that high anxiety in children before surgery leads to
      adverse outcomes such as increased pain and analgesics requirements, delayed hospital
      discharge, and maladaptive behavioral changes. Treating anxiety may decrease any of these
      undesirable behaviors.

      In this study, investigators hope to determine if technology based distractions (VR headsets)
      are more effective than standard care for preventing high anxiety before vascular access. As
      a secondary aim of the study, we seek to determine if the use of technology based distraction
      will result in higher parent and patient satisfaction, decreased fear, and increased
      compliance, while monitoring for side-effects of the intervention.
    

Intervention name(s): Technology Based Distractions
Intervention type(s): Behavioral
Intervention description(s): Technology based distractions (VR headsets)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to find out if Exalgo (r) is beneficial for the patients with
      neuropathic pain.
    

Detailed description: 
      Neuropathic pain state is usually refractory to most analgesic regimens and requires
      polypharmacy for symptomatic relief. Current treatment options for neuropathic pain include
      both oral and topical medications. Most commonly prescribed oral treatments include
      antidepressants (eg, amitriptyline, desipramine, and duloxetine), antiepileptics (eg,
      gabapentin, pregabalin), and opiates such as tramadol and morphine. Current topical
      treatments include the lidocaine patch and the capsaicin patch. Many patients have inadequate
      pain relief in spite of these treatment options.

      Currently, there are no treatments available for treatment of neuropathy itself other than
      treating the underlying cause and addressing the symptomatic relief for pain. Current drug
      therapies for neuropathic pain provide inadequate pain relief and undesirable side effects
      including sedation and cognitive dysfunction. It is not uncommon to use a combination of
      agents for the treatment of neuropathic pain to minimize the side effects. Although treating
      the mild to moderate pain may be relatively easy, it is very challenging for severe
      neuropathic pain. Although the use of opiates for neuropathic pain is well accepted, it
      remains controversial because of the potential for abuse and diversion.
    

Intervention name(s): Hydromorphone
Intervention type(s): Drug
Intervention description(s): Oral hydromorphone extended release, once daily
Other intervention name(s): EXALGO (R)
Intervention MeSH terms: Hydromorphone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; Neuropathy; Neuropathic Pain; Hydromorphone
Effectiveness of Volume Spirometry and Deep Breathing Exercise for Dyspnea During Third Trimester of Pregnancy
Condition: Dyspnea; Pregnancy Related
MeSH terms: Dyspnea
Study type: Interventional

Summary: 
      During pregnancy women undergoes anatomical, mechanical and physiological changes to meet the
      demand of growing fetus. Dyspnea is a common complaint in pregnancy related to change in
      respiratory centre threshold and sensitivity. Pregnant women who engaged in regular exercise
      have less pregnancy induced discomforts like dyspnea and leg cramps than who did not engage
      in exercise. During pregnancy women undergoes anatomical, mechanical and physiological
      changes to meet the demand of growing fetus. Purpose of this study was to evaluate the
      efficacy of volume Spirometry and breathing exercise on dyspnea in third trimester of
      pregnancy. Rationale of the study was to find the effects of volume Spirometry and breathing
      exercise on dyspnea with focus on method of deep breathing exercise and volume Spirometry and
      outcomes. Significance of this study was to improve functional capacity and quality of life
      in pregnancy induced dyspnea. Subjects were randomly allocated to either two groups both
      groups received baseline treatment while interventional group received volume Spirometry and
      deep breathing exercise. Estimated sample size of 48 divided into 24 in either group by
      randomization. Modified Borg scale and visual analog scale were used to collect the findings.
      Non-parametric tests were used and analyzed by using spss22.
    


Intervention name(s): Conventional treatment; conventional treatment with volume Spirometry and deep breathing
Intervention type(s): Other; Other
Intervention description(s): Behavioral and life style modification and dyspnea prevention education i.e. Sitting: Sit upright with back against chair, feet wide apart, leaning forward with arms on bedside table or on knees. Standing: Lean back against wall with feet slightly apart with head and shoulder relaxed. In Bed: Elevate head of the bed, support and elevate arms with pillow. Stairs: Lean forward with on banister when climbing stairs.; Group B or interventional group was received conventional treatment along with volume Spirometry and deep breathing exercise, total 5 breaths with 3sec inhalational breath hold for each breath at one session per day for volume Spirometry and for deep breathing exercise 10 times with breath hold 2sec at every session for 5 minutes 3 times per week for total duration of two weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Assessment of Ability of 3D Fluorscopy in Aiding Accurate Syndesmotic Reduction Following Traumatic Ankle Injury
Condition: Displaced Ankle Fractures
MeSH terms: Ankle Fractures; Ankle Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to determine if use of new imaging technology termed "3D
      fluoroscopy" will lead the surgeon to change the position of the fractured bones to a more
      accurate position.
    


Intervention name(s): 2D Fluoroscopy; 3D Fluoroscopy
Intervention type(s): Device; Device
Intervention description(s): Patients with syndesmotic instability will undergo reduction of the syndesmosis followed by provisional fixation with a clamp or Kirshner wire. The reduction quality will be initially compared to the contralateral ankle mortise and talar-dome lateral radiographs using the technique of Summers et al i.e. 2D Fluoroscopy using device Ziehm Vision RFD 3D image-intensified fluoroscopic x-ray system.; After the attending surgeon is satisfied with the reduction quality from 2D Fluoroscopy, 3D fluoroscopy using device Ziehm Vision RFD 3D image-intensified fluoroscopic x-ray system will be used to generate additional images to assess syndesmotic and fibular reductions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 3D Fluoroscopy
Study in Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL
Condition: Postoperative Pain Management
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective: The primary objective of this study is to evaluate the pharmacokinetics
      (PK) of EXPAREL in pediatric subjects 12 to less than 17 years of age undergoing spinal
      surgery.

      Secondary objective: The secondary objective of this study is to evaluate the safety of
      EXPAREL in pediatric subjects 12 to less than 17 years of age undergoing spinal surgery.
    

Detailed description: 
      This is a Phase 1, single-center, open-label study designed to evaluate the safety and PK
      profile of EXAPREL when administered intraoperatively at the end of surgery via local
      infiltration. Fifteen pediatric subjects 12 to less than 17 years of age undergoing spinal
      surgeries are planned for enrollment.

      Subjects will be screened within 30 days prior to study drug administration. During the
      screening visit, subjects will be assessed for past or present neurologic, cardiac, and
      general medical conditions that, in the opinion of the investigator, would preclude them from
      study participation.

      Subjects will undergo their pre-planned spinal surgeries per the institution's standard of
      care. On Day 1, eligible subjects will receive a single dose of EXPAREL 4 mg/kg
      intraoperatively at the end of surgery via local infiltration into the surgical site. There
      is no required length of stay in the hospital; subjects may be discharged based on the
      medical judgment of the treating physician.

      A follow-up phone call will be scheduled for all subjects on Day 7. A final follow-up visit
      will be made on Day 30 to all subjects who received study drug.
    

Intervention name(s): Exparel
Intervention type(s): Drug
Intervention description(s): EXPAREL 4 mg/kg
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
LGBTQ-affirmative CBT for Youth
Condition: Anxiety Disorders; Depression; LGBTQ
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This study will adapt LGBTQ-affirmative cognitive behavior therapy (CBT) - previously only
      used with adults - for youth aged 12-17 years. This intervention addresses the pathways
      through which minority stress compromises lesbian, gay, bisexual, transgender, and queer
      (LGBTQ) young peoples' mental health. The purpose of this study is to determine if the
      intervention is acceptable and feasible for LGBTQ youth.
    

Detailed description: 
      Lesbian, gay, bisexual, transgender, and queer (LGBTQ) youth experience more mental health
      problems than their heterosexual and cisgender peers. The purpose of the proposed
      mixed-methods study is to assess the feasibility, acceptability, and need for refinement of
      LGBTQ-affirmative cognitive behavior therapy for youth aged 12-17 years in New York, New
      Jersey, and Connecticut. This study will be the first to adapt the randomized controlled
      trial tested LGBTQ-affirmative CBT intervention for youth, and the first to deliver it in a
      virtual group format. Qualitatively, investigators will conduct structured post-treatment
      interviews to assess the feasibility, acceptability, and refinement of the intervention in
      this population. Quantitatively, investigators will assess the feasibility and acceptability
      of the intervention through analysis of indices like number of sessions attended, number of
      homework assignments completed, weekly treatment satisfaction ratings, and a post-treatment
      feedback survey. Investigators will also examine changes from pre- to post-treatment in
      youth's mental health symptoms, minority stress reactions, and emotional regulation and
      coping difficulties. These pilot data will be used to estimate the sample sizes needed for a
      future, larger trial of this treatment, as well as areas in which the treatment could be
      refined.
    

Intervention name(s): LGBTQ-affirmative cognitive behavioral group therapy
Intervention type(s): Behavioral
Intervention description(s): 10 sessions of supportive, LGBTQ-affirmative psychotherapy
Intervention model: Single Group Assignment
Intervention model description: Open trial
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: minority stress; LGBTQ
A Pharmacokinetics Study to Evaluate Safety and Tolerability of JNJ-37822681 in Participants With Stable Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate safety, tolerability and pharmacokinetics (explores
      what the body does to the drug) of JNJ-37822681 in participants with stable schizophrenia
      (psychiatric disorder with symptoms of emotional instability, detachment from reality, often
      with delusions and hallucinations, and withdrawal into the self).
    

Detailed description: 
      This is a double-blind (neither physician nor participant knows the treatment that the
      participant receives), multi-center (conducted in more than one center), randomized
      (treatment group assigned by chance), and multiple-dose titration study of JNJ-37822681 in
      participants with stable schizophrenia. The total study duration will be approximately of 8
      weeks per participant, consists of 4 parts: Screening (that is, 21 days before study
      commences on Day 1); Double-blind treatment (14 days); Follow-up (7 to 14 days after last
      dose administration). Participants will be randomly assigned to treatment with ascending dose
      levels of JNJ-37822681 once daily and twice daily. Efficacy will primarily be evaluated by
      Positive and Negative Syndrome Scale and Clinical Global Impression-Severity scale. Safety
      will be Barnes Akathisia Rating Scale, Abnormal Involuntary Movement Scale and Simpson Angus
      Rating Scale. Participants' safety will be monitored throughout the study.
    

Intervention name(s): JNJ-37822681; Placebo
Intervention type(s): Drug; Other
Intervention description(s): JNJ-37822681 oral capsule will be administered at a starting dose of either 20 mg (once daily) or 10 milligram (twice daily) for 14 days.; Matching Placebo will be administered orally, once daily in the evening (12 hour after JNJ-37822681 20 mg administration) for 14 days.
Intervention MeSH terms: N-(1-(3,4-difluorobenzyl)piperidin-4-yl)-6-(trifluoromethyl)pyridazin-3-amine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; JNJ-37822681; Placebo
the Prevalence of "Wearing-off" in Patients With Parkinson's Disease in Shanghai
Condition: Wearing Off Effect; Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The study would be designed as a multi-center cross-sectional investigation on the prevalence
      of Wearing-off in Parkinson's patients in Shanghai as well as related influencing factors.
    

Detailed description: 
      PD patients would be randomly recruited into this investigation from around thirty hospital
      covering the 16 districts of Shanghai. The wearing off would be defined by two methods: the
      doctors' judgement or the WOQ-9 questionnaire which was a patient-determining tool. The
      investigation also includes the medicine, the severity of PD symptoms, the demographic
      factors. The study would be designed with the purpose of clarifying the prevalence of the
      "wearing-off" and its related influencing factors.
    

Intervention name(s): Wearing-off 9 questionnaire
Intervention type(s): Diagnostic Test
Intervention description(s): The participants would receive appropriate anti-PD medical treatments according to the patients' need during the investigation.The anti -PD treatment would not be changed in the population of the participants.
Other intervention name(s): No other intervention
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        clinical diagnosed PD patients
      
Keywords: wearing off; wearing-off 9 questionnaire; prevalence; sensitivity; specificity
Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis
Condition: Adolescent Idiopathic Scoliosis; Posterior Spinal Fusion
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      The primary purpose of this randomized trial is to compare the efficacy of an ultrasonic bone
      scalpel (or osteotome device) with standard of care surgical instruments during posterior
      spine fusion with instrumentation.
    


Intervention name(s): Posterior Spinal Fusion; Ultrasonic Bone Scalpel
Intervention type(s): Procedure; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ultrasonic Bone Scalpel; Adolescent Idiopathic Scoliosis; Posterior Spinal Fusion; Estimated Blood Loss