bioihbjkbjnl/mcl2 huggingface dataset:
Paraorbital-Occipital Alternating Current Stimulation Therapy of Patients With Post-Chiasmatic Lesions
Condition: Complete Hemianopia; Incomplete Hemianopia; Scotoma; Quadrantanopia; Stroke; Hemorrhage; Brain Trauma
MeSH terms: Hemianopsia; Brain Injuries, Traumatic; Scotoma; Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      Visual field areas, which are not absolutely blind, are hypothesized to have some residual
      capacities that constitute their potential for vision restoration. Vision restoration can be
      achieved by varies methods including behavioral training and electrical brain stimulation
      such as transcranial direct current stimulation (tDCS) and repetitive transorbital
      alternating current stimulation (rtACS) which are able to influence the excitability and
      activity of cortical areas.

      It is hypothesized that transorbital alternating current stimulation (tACS) can improve the
      residual field of vision in patients with post-chiasmatic lesions.
    


Intervention name(s): Verum stimulation; Placebo stimulation
Intervention type(s): Device; Device
Intervention description(s): 10 days (2x 5 working days), daily transorbital alternating current stimulation (rtACS) is applied with a device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse is below 1000 µA. Current intensity is individually adjusted according to how well patients perceived phosphenes, e.g. any sensation of flickering light in response to the rtACS stimulation. Stimulation frequencies were between the individual alpha frequency peak and below flicker fusion.; 10 days (2x 5 working days), daily sham-stimulation with the same electrode montage set-up that is used for verum transorbital alternating current stimulation (rtACS). Minimal sham-stimulation was performed with single bursts (approx. one per min) of electrical currents at a given frequency of 5Hz and individually adjusted current amplitude.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hemianopia; visual field defect; stroke; non-invasive brain stimulation; alternating current stimulation
Study of the Diaphragmatic Function by Transient Elastography (ELASTODIAPH)
Condition: Healthy
Study type: Interventional

Summary: 
      The study of diaphragmatic function is usually measured by the pressures and volumes
      generated by contraction of the diaphragm, which is often difficult (cumbersome technique,
      difficulty to obtain a perfect cooperation of the subjects, and difficulty to specifically
      analyze the diaphragm compared to other accessory respiratory muscle groups). In this study,
      the investigators aimed at analysing diaphragmatic function by measuring the shortening,
      stiffness, strain and thickening of the diaphragm by ultrasound.
    


Intervention name(s): Ultrasound
Intervention type(s): Diagnostic Test
Intervention description(s): Volitional and non volitional respiratory tasks
Other intervention name(s): Magnetic and electrical phrenic nerve stimulation
Intervention model: Single Group Assignment
Intervention model description: To compare diaphragm elastrography provided by ultrasound to diaphragm function indices provided by magnetic/electrical phrenic nerves stimulation
Masking: None (Open Label)
Primary purpose: Basic Science
Vestibular Stimulation to Treat Hemispatial Neglect
Condition: Hemispatial Neglect; Stroke
MeSH terms: Perceptual Disorders
Study type: Interventional

Summary: 
      The purpose of the current proposal is to pilot a new and potentially improved treatment for
      neglect. The procedure involves the delivery of transcutaneous small-amplitude current to the
      vestibular nerves that lie directly below the mastoid bones.
    

Detailed description: 
      The purpose of the current proposal is to pilot a new and potentially improved treatment for
      neglect. The procedure involves the delivery of transcutaneous small-amplitude current to the
      vestibular nerves that lie directly below the mastoid bones. With the intention of boosting
      activity in the damaged left hemisphere, positive and negative current is delivered to the
      left and right mastoids respectively. While successfully used to rehabilitate gait and
      balance disorders, the procedure has only once been applied to neglect.

      In the present investigation, we will first confirm and then optimize the conditions under
      which galvanic vestibular stimulation (GVS) ameliorates neglect. This in turn will justify
      subsequent work (in a later funding cycle) that will demonstrate the safety and efficacy of
      the treatment on a much larger clinical scale, and merit the construction of a miniaturized
      portable device.
    

Intervention name(s): Transcutaneous current to the vestibular nerve
Intervention type(s): Device
Intervention description(s): Delivery of randomly oscillating low level current
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Device Feasibility
Keywords: Galvanic Vestibular Stimulation; Hemispatial Neglect; Stroke
Trial to Assess Response to Oral Vitamin D3 Supplementation in Obese Individuals
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study is an extension of an earlier study of vitamin D supplementation conducted on
      normal weight individuals by Dr. John Aloia of the Bone Mineral Research Division at Winthrop
      University Hospital. The investigators plan to compare the response to vitamin D
      supplementation in obese individuals with the response already measured in normal weight
      individuals. The same dosing schedule of vitamin supplementation will be used as in the past.
      The doses used in the past have demonstrated safety in a number of trials, here at Winthrop
      as well as outside of Winthrop Hospital. Sixty study volunteers are planned for enrollment in
      the study. The study participants will mainly be recruited from a group of patients who have
      in the past been enrolled in the weight loss program at Winthrop Hospital. Each participant
      will be on vitamin D supplementation for a total of 8 weeks. Vitamin D blood levels will be
      measured before and at the end of the supplementation period. They will then be compared to
      see the change over time as a result of supplementation.
    


Intervention name(s): Oral vitamin D3; Placebo equivalent
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Vitamin D3 50-100 mcg capsule(depending on baseline serum 25(OH)D concentration) daily for 8 weeks.; One capsule daily for 8 weeks
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Vitamin D3; obesity; cholecalciferol
Topical Composition Therapy (2013-MCN-333) for the Treatment of Melasma
Condition: Melasma
MeSH terms: Melanosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to gather information on the effectiveness and
      tolerability of a novel composition of existing U.S. Food and Drug Administration (FDA)
      approved topical medications for the treatment of moderate to severe melasma.
    

Detailed description: 
      Subjects with moderate to severe melasma will apply 0.5 grams (pea-sized) amount of
      Illuminate Cream topically to affected areas for 20 weeks. The change in Melasma Area and
      Severity Index (MASI) score will be evaluated a baseline and Weeks 4, 12, and 20.

      The MASI score is a validated test, calculated by subjective assessment of 3 factors: Area
      (A) of involvement, Darkness (D), and Homogeneity (H), with the forehead, right malar region,
      left malar region, and chin, corresponding to 30%, 30%, 30% and 10% of the total face,
      respectively. The area of involvement in each of these 4 areas is given a numeric value of 0
      to 6 (0 = no involvement; 1 = <10%; 2 = 10%-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; and 6 =
      90-100%).

      Darkness and homogeneity are rated on a scale from 0 to 4 (0 = absent; 1 = slight; 2 = mild;
      3 = marked; and 4 = maximum). The score is calculated by adding the sum of the severity
      ratings for darkness and homogeneity, multiplied by the value of the area of involvement, for
      each of the 4 facial areas.
    

Intervention name(s): Illuminate Cream
Intervention type(s): Drug
Intervention description(s): Topical compound applied daily
Other intervention name(s): 2013-MCN-333
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Open Label, Multicentre Trial to Assess Safety and Efficacy of ITF2357 in Active Systemic Juvenile Idiopathic Arthritis
Condition: Active Systemic; Onset Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 2

Summary: 
      This study has the following objectives:

      Primary objective:

      - To determine the safety and tolerability of oral ITF2357 in patients with active SOJIA with
      inadequate response or intolerance to standard therapy with oral steroids and methotrexate,
      with or without previously used biologic agents.

      Secondary objectives:

        -  to evaluate the effect of ITF2357 on disease activity in patients with active SOJIA

        -  to investigate the possibility of steroid dose tapering in patients with active SOJIA
           during ITF2357 treatment

        -  to assess the effect of ITF2357 on levels of circulating cytokines

        -  to assess the pharmacokinetic properties of ITF2357
    

Detailed description: 
      The present study has been designed in order to evaluate safety and tolerability of ITF2357
      in patients with active SOJIA with inadequate response or intolerance to standard therapy
      with oral steroids and methotrexate, with or without previously used biologic agents, and to
      have a preliminary evaluation of efficacy of ITF2357 in the treatment of SOJIA.

      ITF2357 will be administered orally at the daily cumulative dose of 1.5 mg/kg: this dose in
      children/young adults is considered roughly equivalent to the dose of 1 mg/kg/day in adults,
      which so far has been proven to be free of any relevant safety concerns both in healthy
      volunteers and in patients.
    

Intervention name(s): ITF2357
Intervention type(s): Drug
Intervention description(s): ITF2357 orally administered at the cumulative daily dose of 1.5 mg/kg, achieved by administration of different dose strengths identifiable by different colours.
Other intervention name(s): Givinostat, histone deacetylase inhibitor
Intervention MeSH terms: Givinostat hydrochloride; Histone Deacetylase Inhibitors
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Activity Levels and Rehabilitation Outcomes of Patients Post-stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      Patients admitted to the in-patient rehabilitation center with a diagnosis of stroke will be
      recruited into the study. The participants will wear two activity monitors (one commercial
      grade and one research grade) for the duration of their rehab stay. Data from the monitors
      will be correlated with rehab outcomes, therapy units billed, and length of stay.
    


Intervention name(s): activity monitors
Intervention type(s): Other
Intervention description(s): activity monitors are worn on the wrist, much like a watch. Data from the activity monitors will be downloaded once a week and at discharge. Normal hospital and therapy activities will not be altered.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will include only people with a diagnosis of stroke who have been admitted to
        the in-patient rehabilitation facility "Brookdale Center for Healthy Aging &
        Rehabilitation" in Naples, FL. The side of the stroke, the type of the stroke, or a history
        of prior stroke are not considerations. The study is intended to be very clinically focused
        to better understand the activity level of the population seen at the facility. This study
        is purposely not controlling the population to a very narrow presentation so that the
        results will speak directly to the facility and their outcomes
      
Keywords: rehabilitation outcomes; activity level
What Makes People Better at Retrieving Difficult Words?
Condition: Healthy Aging
Study type: Interventional

Summary: 
      This study is being conducted to learn more about how various personal and situational
      characteristics are related to the ability to produce words in response to definitions.
      Participants will watch a video, then see definitions and try to come up with a word that
      fits each one. Participants will also complete some surveys and other measures. Collected
      data will give researchers a better understanding of how individuals' personality and
      cognitive traits and setting in which word retrieval occurs relate to the ability to produce
      individual words.
    

Detailed description: 
      This study is being conducted to learn more about how various personal and situational
      characteristics are related to the ability to produce words in response to definitions. Adult
      participants ages 18-30 and 65-80 will participate in videoconference calls during which a
      video is shown and definitions are presented. Participants will try to come up with a word
      that fits each definition, and then complete some surveys, including some about anxiety,
      mindfulness, attention, vocabulary, and demographics. Participation will take approximately
      1.25 hours. Collected data will be de-identified, and the aggregate data will give
      researchers a better understanding of how individuals' personality and cognitive traits and
      setting in which word retrieval occurs relate to peoples' ability to produce individual
      words.
    

Intervention name(s): Mindful breathing; Control video
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants watch a 10 minute mindful breathing video; Participants watch a 10 minute control video
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomly assigned to one of two behavioral intervention conditions before performing a word retrieval task
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: mindful breathing; anxiety; word retrieval
Lifting and Tightening of the Face in Subjects With Skin of Darker Color
Condition: Facial Skin Laxity
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      This prospective, multi-center, single treatment clinical trial evaluates the clinical
      outcomes associated with non-invasive treatment to obtain lift and tightening of facial
      tissue and improve jawline definition in subjects with darker skin color utilizing the
      Ulthera® System to deliver focused ultrasound energy below the skin surface.
    

Detailed description: 
      The primary objective of this clinical trial is to demonstrate the effectiveness of the
      Ulthera® System for the non-invasive treatment to obtain overall lift and tightening of
      facial tissue and jawline definition improvement.
    

Intervention name(s): Ulthera® System treatment
Intervention type(s): Device
Intervention description(s): Ulthera® System treatment delivering focused ultrasound energy
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Motivational Interviewing to Acutely Admitted Psychiatric Patients With Comorbid Substance Use
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The purpose for this study is to determine whether 2x45 minutes Motivational Interviewing
      given during hospital stay to acutely admitted psychiatric patients with substance use
      problems, can reduce substance use after discharge.
    

Detailed description: 
      The aims of the study are in a randomized controlled trial to compare the effects of 2 x 45
      minutes Motivational Interviewing and standard treatment with standard treatment alone.All
      patients acutely admitted to Østmarka Psychiatric Hospital are evaluated for substance use,
      and all patients with substance use that give their consent to participate are randomized to
      Motivational Interviewing and standard treatment or standard treatment alone.

      Substance use and function will be followed for two years.Admittances to hospital and
      contacts with primary health care for five years.
    

Intervention name(s): Motivational Interviewing; Treatment as usual
Intervention type(s): Behavioral; Other
Intervention description(s): 2 sessions of 45 minutes each with manual guided motivational interviewing delivered individually by a trained therapist.; Treatment as usual is individualized according to the clinical condition of the patients during the stay and in accordance with general national and international medical standards. It includes detoxification, pharmacotherapy, and general psychotherapy. Also, treatment is given for any coexisting non-substance-related disorder, including psychiatric disorders.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Motivational Interviewing; Substance abuse; Acuteley admitted psychiatric patients; Emergency Services, Psychiatric
Effects of Atypical Antipsychotics on Appetite and Eating Behavior of Schizophrenia Patients
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Observational

Summary: 
      In this study, we are going to investigate quantitative and qualitative natures of appetite
      and eating-behavior changes induced by atypical antipsychotics, i.e., risperidone, olanzapine
      and aripiprazole, in schizophrenia patients.
    

Detailed description: 
      This is an observational study. 2 Self-report questionnaires assessing changes of appetite
      and eating behaviors after medication are applied to patients who have been receiving one of
      the three atypical antipsychotics. We are going to compare changes of appetite and eating
      behaviors after medication between three atypical antipsychotics and investigate the
      association between changes of appetite and eating behaviors and changes of weight after
      medication.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        outpatients clinic for schizophrenia
      
Keywords: schizophrenia; atypical antipsychotics; appetite; eating behavior
Use of Baxter Animated Retching Faces (BARF) Scale to Measure Nausea in Children Who Speak Spanish
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Observational

Summary: 
      Pediatric research in the management of nausea has been limited by the absence of a reliable
      method to quantify the intensity of this subjective symptom. In adults, the visual analog
      scale (VAS) is an accurate tool, but this has not been shown to be reliable in young
      children. A scale is a series of points made on a line that will be used for measurement; a
      mark on the far left of the line shows little pain and the mark on the far right means alot
      of pain.
    

Detailed description: 
      By default the most common objective outcome measure used in pediatric studies has been the
      incidence and number of emetic episodes. This measure, however, correlates poorly with the
      somatic subjective symptom of nausea. Apfel et al have shown that 30-40% of adult patients
      undergoing surgery have post discharge nausea and / or vomiting while 12% have vomiting.
      These data on nausea in adults were based on a visual analog scale for nausea. There are no
      data on the incidence of postoperative nausea in children since the severity of symptoms are
      difficult to measure as younger children are known to be unable to use the VAS reliably.
      Recently a pictorial scale for measuring nausea, the Baxter Animated Retching Faces (BARF)
      scale, has been developed and shown to have construct, content and convergent validity as an
      instrument to measure nausea in children. This was a two center study that was limited to
      children who could speak English. The clinical usefulness of this scale in determining the
      incidence of postoperative and post-discharge nausea in children has yet to be determined
      including the lowest age where it can be used reliably, the score associated with a patient's
      perception of a need for treatment, the minimum change in the scores of clinical relevance
      and the test-retest reliability when nausea is rated as not having changed. The score has
      also not been validated in children who speak Spanish. This study is designed to provide the
      missing information and will specifically look at the Spanish speaking population.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Spanish Speaking patients undergoing surgery
Pharmacokinetics of Insulin Detemir in Healthy Chinese Male Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Asia. The aim of this trial is to investigate the pharmacokinetics
      after a single dose of insulin detemir in healthy Chinese male subjects.
    


Intervention name(s): insulin detemir
Intervention type(s): Drug
Intervention description(s): Each subject will be randomly allocated to an insulin detemir dosing sequence. Three doses of insulin detemir (0.2, 0.4 or 0.8 U/kg) will be administered on three inconsecutive days with a wash-out period between each dosing. Injected subcutaneously (s.c., under the skin)
Intervention MeSH terms: Insulin Detemir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Overnight Post-Exercise Recovery After Protein Ingestion Prior to Sleep
Condition: Exercise; Resistance Training
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of post-exercise protein ingestion prior
      to sleep on overnight protein kinetics and muscle recovery.
    


Intervention name(s): protein; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): protein; placebo control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: resistance; exercise; protein; recovery