bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Musical Training in Hong Kong Chinese Childhood Brain Tumor Survivors
Condition: Brain Neoplasms; Child
MeSH terms: Brain Neoplasms
Study type: Interventional

Summary: 
      This study aims to work out the effectiveness (effect size) of the musical training
      intervention in reducing depressive symptoms, improving self-esteem and quality of life among
      childhood brain tumour survivors and to examine the feasibility, appropriateness, and
      acceptability of implementing musical training intervention in clinical practice. Subjects in
      the experimental group will receive weekly 45-minute lessons on musical training for one year
      (52 weeks), while those in the control group will receive usual care.
    

Detailed description: 
      Musical training has been increasingly implemented to promote one's psychological well-being
      and cognitive functioning. For instance, to reduce depression, anxiety in psychiatric
      patients, to improve self-esteem and mood recognition in hospitalized adolescent patients
      diagnosed with "adjustment reaction to adolescence", to improve social skills of children
      with autism, to enhance reading skills and academic achievement in young poor readers, and to
      facilitate children's cognitive development. Nevertheless, the effectiveness of musical
      training in promoting psychological well-being, particularly to reduce their depressive
      symptoms and enhance self-esteem, and enhancing quality of life among the childhood brain
      tumour survivors is remain underexplored. It is of paramount importance to examine the
      effectiveness of musical training so as to ameliorate adverse disease- and treatment-related
      late effects, such as depression and low self-esteem, hence enhancing childhood brain tumour
      survivors' quality of life.
    

Intervention name(s): musical training; usual care
Intervention type(s): Behavioral; Other
Intervention description(s): The subjects in the experimental group will receive weekly 45-minute lessons on musical training for 52 weeks.; The subjects in the control group will receive usual care, such as medical follow-up according to the schedule of the oncology units.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Effectiveness of Kinesio Taping On Balance In Patients With Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The aim of this study is to investigate the long term effects of Kinesio taping applied on
      ankle and peroneal muscle in patients with stroke.
    

Detailed description: 
      Stroke is a common neurological problem and is one of the major causes of disability and
      death (1,2). In stroke patients, the mortality rate is approximately 30%, and there is an
      increase in the morbidity rate after stroke occurrence. In addition, stroke is one of the
      main factors in increases in the burden of health care expenses during adulthood (3).

      There is a constant requirement for specific data about stroke rehabilitation methods for
      achieving evidence-based rehabilitation guidelines.To investigate the effects of repeated
      correction taping applied on the ankle and peroneus longus and peroneus brevis muscles on
      balance and gait in patients with stroke. Therefore, the aim of this study is to assess the
      long term effect of KT applied on ankle and peroneal muscle on both dynamic and static
      balance in patients with stroke.
    

Intervention name(s): Intervention; Control
Intervention type(s): Other; Other
Intervention description(s): Kinesio Tape apply to peroneal muscles in supine position starting from the peroneal muscle origin with using muscle activation technique by a certified KT1 and KT2 practitioner. Then ligament technique which will go through around ankle starting from medial and lateral metatarsophalangeal joints in order to improve ankle stability. Taping will be applied one week later and two weeks later prior to first application.; Any sham taping was not applied to the control group in order to prevent the sensory stimulant effect of taping. In order to achieve patients' blinding both groups participant will sign a same consent but control group will be called for taping a month later after study data collection completed.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients' information and contact will be obtained from neurologist and willing participant's gender, age and stroke onset data will be processed with a random number generator in order to form groups. Patients will divide into two groups as intervention and control with a normal distribution of gender, age and stroke onset.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Athletic Tape; Proprioception; Hemiplegia; Gait
Efficacy and Safety of Lacidipine in Chronic Stable Angina
Condition: Angina Pectoris
MeSH terms: Angina Pectoris; Angina, Stable
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study was to explore whether lacidipine at doses of 2 mg, 4 mg and 6 mg
      decreased the symptoms of angina, compared to placebo in patients with chronic stable angina
    


Intervention name(s): Lacidipine, low dose; Lacidipine, medium dose; Lacidipine, high dose; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Lacidipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Validation Study Using a Time-lapse Morphometry MIRI Imaging Incubator
Condition: Fertility
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the MIRI-TL time-lapse
      incubator and CultureCoin dish compared to standard big-box incubators and standard culture
      dishes used for embryo culture.
    

Detailed description: 
      Following randomization and standard ovarian stimulation protocols to obtain a sufficient
      number of mature (MII) oocytes, these oocytes will be fertilized by Intra-Cytoplasmic Sperm
      Injection (ICSI). If a patient has been randomized to the study group, all inseminated
      oocytes and subsequently all fertilized diploid (2PN) zygotes will be placed in the
      CultureCoin and then into the MIRI-TL Time-lapse incubator and cultured as per normal
      protocol to the blastocyst stage (Day 5/6 or 7). Top quality blastocyst(s) will be
      transferred and monitored for implantation, pregnancy and ongoing birth. Embryo transfers
      will either occur in a fresh or frozen embryo transfer cycle.
    

Intervention name(s): MIRI-TL Incubator
Intervention type(s): Device
Intervention description(s): MIRI-TL Timelapse incubator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Neurophysiologic Correlates of Hypersomnia
Condition: Major Depressive Disorder; Primary Hypersomnia; Bipolar Disorder; Narcolepsy; Primary Insomnia
MeSH terms: Narcolepsy; Sleep Initiation and Maintenance Disorders; Disorders of Excessive Somnolence; Idiopathic Hypersomnia; Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder
Study type: Observational

Summary: 
      The goal of this project is to examine the neurophysiology of hypersomnia during sleep and
      wakefulness, to identify biomarkers for excessive sleepiness in neuropsychiatric disorders,
      and pilot acoustical slow wave induction during sleep in patients with hypersomnolence, to
      determine if this decreases daytime sleepiness in these patients. The primary study
      hypotheses are that individuals with hypersomnolence will have reduced slow wave activity
      (SWA) during sleep and increased waking theta/alpha activity during wake in specific brain
      regions. A secondary hypothesis is that acoustical slow wave induction in hypersomnolent
      patients will increase SWA during sleep, reduce theta/alpha activity during wake, and improve
      subjective sleepiness.
    


Intervention name(s): Acoustical slow wave induction
Intervention type(s): Other
Intervention description(s): Brief tones (50 millisecond duration) at a frequency of 0.8 and 2 Hz, a rate that approximates the natural cellular oscillations of cortical neurons during sleep, will be played in blocks of 15-20 during non-rapid eye movement (NREM) sleep. Blocks of active acoustic slow wave induction will be followed by blocks of equal duration without induction, in order to make comparisons between stimulation periods (ON) and no stimulation periods (OFF). Tone intensity will be manually adjusted so as to be above an individual participant's auditory threshold during waking, but still quiet enough as not to awaken the subject from sleep. Sham slow wave induction will consist of auditory tones played prior to sleep, and during sleep of insufficient timing and intensity to alter slow wave activity.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited from the greater Madison, WI area. Hypersomnolent subject groups
        (n=30 in each group) may include unipolar MDD with hypersomnolence, primary hypersomnia
        (idiopathic hypersomnia), bipolar disorder with hypersomnolence, and narcolepsy.
        Non-hypersomnolent comparison groups (n=30 in each group) will include: MDD without
        hypersomnolence, bipolar disorder without hypersomnolence, primary insomnia, and healthy
        controls.
A Study of LY3502970 in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to measure how much of the study drug gets into the
      bloodstream and how long it takes the body to eliminate it. This study will involve a single
      dose of ¹⁴C radiolabelled LY3502970. This means that a radioactive substance will be
      incorporated into the study drug. The purposes are to investigate the study drug and its
      breakdown products and to find out how much of these pass from blood into urine and feces.
      The study will last up to 8 weeks (maximum).
    


Intervention name(s): LY3502970; [¹⁴C]-LY3502970
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Intrathecal vs Intraarticular Dexmedetomidine on Postoperative Pain Following Arthroscopy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Comparison between intrathecal Dexmedetomidine versus Intraarticular Dexmedetomidine on
      postoperative pain after knee arthroscopy.
    


Intervention name(s): Intrathecal Dexmedetomidine; Intraarticular Dexmedetomidine; Bupivacaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Addition of Intathecal Dexmedetomidine plus Intrathecal Bupivacaine; Addition of Intraarticular Dexmedetomidine plus Intrathecal Bupivacaine; Intrathecal Bupivacaine
Intervention MeSH terms: Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Pilot Evaluation of FAMCOPE-ICU (Family Coping and Emotion Regulation Tool in the ICU)
Condition: Emotion Regulation; Coping Skills
Study type: Interventional

Summary: 
      Having a family member or loved one in the ICU can be a very stressful experience. The
      investigators have created a tablet-based tool (FAMCOPE-ICU) that is designed to help people
      in this position cope with this experience.
    


Intervention name(s): FAMCOPE-ICU
Intervention type(s): Behavioral
Intervention description(s): (1) FAMCOPE-ICU is a digital eHealth emotion regulation and coping intervention. FAMCOPE-ICU contains three digital modules representing the three interventional doses. Corresponding with Gross's Extended Process Model of Emotion Regulation, the three respective doses entail assessments, adaptive feedback, and interactive activities pertaining to understanding their affective experiences, learning strategies to regulate emotions and stress, and practicing these skills in a virtual decision-making task. Each dose of the intervention is expected to last 10-15 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Critical Care; Informal Caregiving; Surrogate Decision-Making; Self-Regulation
A Study on Analgesia and Related Outcomes for Patients With Tabacco Smoking
Condition: Current Smokers; Past Smokers; Never Smokers
Study type: Interventional

Summary: 
      Numbers of postoperative PCA(Patient-Controlled Analgesia) related side effects among
      current, past and non smokers are determined by comparing and analyzing frequency
      distributions. To determine whether smokers require more post operative opiate analgesics
      than others. Multivariate analysis will be performed to identify the major and the minor
      factors predicting the use of postoperative pain therapy. Our previous related study showed
      that the smoker male patients consumed more analgesics than those without smoking, but the
      female group showed the similar findings. However, the case number, especially the female
      cases, is underpowered. Investigators hope to increase the case number to have a better
      statistical and clinical significance.
    


Intervention name(s): 5 ml arterial blood
Intervention type(s): Procedure
Intervention description(s): A sample of 5 ml arterial blood will be withdraw to test the arterial blood oxygen saturation, CO2 content, carbon monoxide (CO) content and carboxyhemoglobin (COHg).
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Gluten-Casein-free Diet in Children With Autism: A Clinical Results of the Ophthalmic and Behavioral Manifestations
Condition: Autism Spectrum Disorder; Ophthalmic Abnormalities
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      To evaluate the efficacy of eight weeks of GFCF in children with ASD on autistic symptoms and
      ophthalmic findings such as corneal reflex, interpupillary distance (IPD) and pupil size.
    

Detailed description: 
      Autism spectrum disorder (ASD) is a common condition. ASD is a heritable illness
      characterized by early-onset differences in interaction, communication, sensory atypicality,
      and stereotyped behaviors. Recent studies suggest a link between elimination diets and
      severity of autistic behaviors. The etiology of ASD has been still uncertain. Therefore,
      elucidating the underlying pathology may assist in risk assessment and facilitate process
      management. Non-harmful and existing evidence for the diet's benefits in ASD must be
      elucidated.

      Primary Study Objective:

      To assess the effect of a GFCF diet on variables autism index, stereotyped behaviors,
      communication, social interaction associated with ASD.

      The pupillary response can be utilized to anticipate neurological and physiological
      activities under the surface. Changes in light trigger the pupil response, which adjusts the
      amount of brightness falling on the retina by instinctively constricting or dilating the
      pupil. Atypical pupil size has been linked to abnormal autonomic function in people with ASD.
      Disturbances in autonomic functions may also lead to differences in the corneal reflex. This
      study aimed to obtain more data on the behavioral symptoms and ophthalmic measurements of
      gluten-free casein-free (GFCF) on ASD. In addition, normal development children and children
      with autism may differ in facial morphology. This study also evaluates the effect of GFCF
      diet on IPD distance.

      Secondary Objectives:

      To assess the role of GFCF diet in the manifestation of opthalmic measurements such as pupil
      size, corneal reflex and IPD.

      30 children with ASD were enrolled in a 8-weeks prospective GFCF diet treatment study. In the
      study, a single group was evaluated with measurements before and after dietary intervention.
    

Intervention name(s): Gluten Free Casein Free Diet
Intervention type(s): Behavioral
Intervention description(s): Thirty children with autism were evaluated before the diet (Pre-Test) and after 8 weeks of dietary intervention (Post-Test).
Intervention MeSH terms: Caseins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gluten free casein free diet
A Study of Infacort® Versus Cortef® in Healthy Adult Male and Female Subjects
Condition: Adrenal Insufficiency
MeSH terms: Adrenal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a two-part, single centre, open-label, randomised, single dose, two-period,
      crossover study to evaluate the bioavailability of Infacort® versus Cortef® immediate release
      hydrocortisone tablets in dexamethasone-suppressed healthy adult male and female subjects in
      the fasted and fed states.
    

Detailed description: 
      The study was conducted in two parts (Part 1 and 2) which were not performed sequentially. In
      Part 1, 26 subjects were dosed in a fasted condition and in Part 2, 25 subjects were dosed in
      a fed condition. Each part comprised of a pre-study screen, followed by 2 treatment periods
      (1 and 2) and a post-study follow-up.

      Screening assessments (for Parts 1 and 2) were conducted within the 28 days before the first
      administration of a study intervention. Eligible participants were asked to return for the 2
      treatment periods. Continued eligibility was confirmed pre-dose for each treatment period.

      Part 1 (fasted state): Treatment Periods: Eligible participants received a single dose of
      each study intervention over 2 treatment periods (1 per treatment period). Each treatment
      period was approximately 1.5 days in duration. Participants arrived at the Clinical Unit on
      Day -1 and dexamethasone 1 mg was administrated at approximately 22:00 hours and then again
      at approximately 06:00 and 12:00 of Day 0 of each treatment period to suppress endogenous
      cortisol production. The study intervention was administered at approximately 08:00 on Day 0
      in the fasted state (after an overnight fast of at least 10 hours). Participants were
      discharged following the 12-hour post-dose blood sampling and consumption of a snack (Day 0).

      Part 2 (fed state): The same procedures were followed as for Part 1 except that study
      interventions were administered in a fed condition (30 minutes after the start of a
      standardised high-fat breakfast). PK samples in both study parts were collected pre-dose and
      up to 12 hours post-dose (19 samples for each treatment period) for measurement of cortisol
      levels. Safety was evaluated throughout the study. There was at least a 7-day washout period
      (up to a maximum of 14 days) between dose administrations. After completion of both study
      periods, participants were to return 7±2 days later for a final follow-up visit.
    

Intervention name(s): Infacort®; Cortef®
Intervention type(s): Drug; Drug
Intervention description(s): Immediate release multiparticulate formulation (granules) of hydrocortisone; Immediate release hydrocortisone tablets
Intervention MeSH terms: Hydrocortisone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ActiPatch Plantar Fasciitis Clinical Trial
Condition: Plantar Fasciitis; Plantar Fasciopathy
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional
Phase: Phase 3

Summary: 
      Plantar fasciopathy is a chronic condition affecting both sedentary populations, individuals
      in the workplace who must stand for prolonged periods of time, and athletes. It can be
      disabling. There is no single accepted treatment course that is recommended in the
      literature.

      The use of pulsed radio-frequency electromagnetic (PRFE) devices has been proposed as a
      treatment option in chronic soft-tissue injury due to its ability to reduce pain and
      inflammation.

      The proposed study will investigate the efficacy of the use of a PRFE device for the
      treatment of chronic heel pain using a double blind randomized placebo controlled design
      study.
    


Intervention name(s): Sham pulsed radio-frequency electromagnetic device; ActiPatch PRFE Device
Intervention type(s): Device; Device
Intervention description(s): Disabled PRFE device; Actipatch PRFE device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Culture Media for in Vitro Embryo Development
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The purpose of this study is to collect development and outcome data on human embryos which
      are cultured in a 2nd generation continuous single culture medium (CSCM2) with the objective
      to demonstrate its performance efficacy in comparison to existing commercially available
      single culture or continuous embryo culture media.
    

Detailed description: 
      A multi-center (3 sites and 2 investigators), prospective trial with up to 300 patients.
      Patients will be enrolled from participating sites from the United States. Study sites will
      conduct this study under the oversight of Sterling IRB. Each study site should enroll enough
      patients to achieve at least 50 evaluable patients that have undergone a treatment cycle
      using split case sibling embryos in which half of the embryos are cultured in CSCM2 and the
      other half in current CSCM (as control).

      The methods will consist of standard ovarian stimulation protocols at each facility to obtain
      a sufficient number of mature (MII) oocytes for fertilization by ICSI. Following
      fertilization, identified diploid (2PN) zygotes will be evenly divided and randomly allocated
      to the embryo culture treatment conditions of CSCM2 or CSCM and cultured according to
      standard laboratory procedure (incubated in 5-6% CO2 in air or low O2 concentrations of 5-6%)
      to the blastocyst stage (Day 5/6 or 7). Top quality blastocyst(s) will be transferred and
      monitored for implantation, pregnancy and ongoing birth. Embryo transfers will either occur
      in a fresh or frozen cycle.

      The procedures in this study are designed to follow the standard medical care at each study
      site for women having IVF treatment (the participant will sign a separate consent at your
      clinic for your IVF procedures). The participants study doctor will explain in detail the
      procedures participants will undergo at the clinic; this form is only meant to explain the
      details of the research study. This study does not involve randomization of patient
      participation or any sham procedures.
    

Intervention name(s): CSCM2
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science