bioihbjkbjnl/mcl2 huggingface dataset:
Nebulized Hypertonic Saline (3%) Versus Nebulized Adrenaline for Treatment of Bronchiolitis
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional

Summary: 
      The primary objective of this study was to compare the effectiveness of nebulized hypertonic
      saline (3%) and nebulized adrenaline in bronchiolitis. The secondary objective was to assess
      whether non-responders to initial therapy benefit from continuation of the same therapy.

      This trial was conducted at a tertiary care teaching hospital over a period of one year in
      children with bronchiolitis presenting to the out-patient department and emergency. After
      obtaining a signed informed consent from the parents, all eligible children were assessed for
      baseline characteristics. A complete hemogram, chest X-ray were done in all and arterial
      blood gas analysis where ever required.

      Computer generated random numbers were used for enrolment in consecutive manner and patients
      were randomly assigned into two groups. The first group received one dose (4ml) of nebulized
      hypertonic saline (3%).The second group received one dose (0.1 mg/kg) of nebulized adrenaline
      diluted in normal saline to make it a 4ml solution. Supportive care (nasal clearing,
      antipyretics, oxygenation, intravenous fluids) was done in both groups as necessary.

      All children were reassessed 20 minutes after one dose of nebulization using the clinical
      score and a child was labelled as a "responder" if he showed an improvement in the clinical
      severity score by atleast 3 points after 20 minutes of nebulization. Both responders and
      non-responders were given a repeat dose of nebulization according to the group to which the
      child had been randomized, if: a) Severe audible wheeze with severe respiratory distress
      (severity score ≥9) b) Inability to maintain saturation >92% even on an O2 flow of 4 L/min.
      Non responders were given a maximum of three continuous doses of nebulization.

      Child was considered fit for discharge if he/she was feeding well orally, there was no need
      for intravenous fluids, clinical severity score ≤3 and maintaining oxygen saturation >92% on
      room air for a period of more than 12 hours.
    


Intervention name(s): Hypertonic saline; Adrenaline
Intervention type(s): Drug; Drug
Intervention description(s): The nebulizations were administered via an oxygen run jet nebulizer, with a flow of 6-7 litres/min.; The nebulizations were administered via an oxygen run jet nebulizer, with a flow of 6-7 litres/min.
Other intervention name(s): Epinephrine
Intervention MeSH terms: Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: nebulization; adrenaline; hypertonic saline; bronchiolitis
Role of Psychoanalysis in Prevention of Girl Child Maltreatment and Neglect
Condition: Abuse Neglect; Social; Deprivation, Maltreatment Syndrome (Infant or Child)
Study type: Interventional

Summary: 
      In India, precisely northern states, skewed sex ratios, female feticide and higher child
      mortality rates for girls have become serious concern. The female child mortality as a result
      of son preference have increased during the last several decades .Since families cannot know
      the sex of the fetus due to Indian government policies, maltreatment and serious neglect has
      been tools to ensure there are few survivors.
    


Intervention name(s): Psychoanalytic therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Gender discrimination; Psychoanalysis; Randomized controlled trial
Docosaexahenoic Acid and Gross Motor Milestones in Infants
Condition: Healthy
Study type: Interventional

Summary: 
      To examine whether daily supplement of docosahexaenoic acid throughout the first year of life
      may speed up the achievement of gross motor development milestones in healthy infants, a
      total of 1160 healthy infants randomly allocated to receive throughout the first year of life
      daily oral supplement of vitamin D3 (400 IU) plus docosahexaenoic acid (20 mg) or vitamin D3
      (400 IU) alone. Primary outcome measure: time of achieving gross motor development
      milestones. Secondary outcome measure: time of achieving early fine motor development
      milestones and language.
    


Intervention name(s): Docosahexaenoic acid (DHA)
Intervention type(s): Dietary Supplement
Intervention description(s): DHA 20 mg per day through 12 months of life
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Performance of motor skills
4-point vs 4-roll Canne as Walking Aids After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Stroke patients frequently necessitate walking aids such as 4-point canne. However, the
      4-point canne has to be lifted by the patient which limited gait speed. The adjunction of
      small wheel below the 4 point of the canne (4-roll) gives the possibility to the patient to
      walk without having to lift the canne as it will roll over the ground.

      The aim of our study is to compare gait parameters (gait speed and energy cost) with a
      classical 4-point canne and with 4-roll canne.
    

Detailed description: 
      Stroke patients frequently need walking aids such as 4-point canne. However, the 4-point
      canne has to be lifted by the patient which limited gait speed. The adjunction of small wheel
      below the 4 point of the canne (4-roll) gives the possibility to the patient to walk without
      having to lift the canne as it will roll over the ground.

      OBJECTIVE To compare the gait parameters with a 4-point canne and with a 4-roll canne METHODS
      The investigators will recruited stroke patients who necessitate 4 point-canne as walking
      aids. A 10 meters walking test, a 6 minutes walking test, an estimated energy cost and a
      patient's satisfaction will be monitored with a 4-point canne (day 1) and with a 4-roll canne
      (day 2) in a cross-over study. The first tested device will be randomized.

      PERSPECTIVE The investigators hope to demonstrate that a 4-roll canne makes possible to walk
      faster in a safe way after stroke
    

Intervention name(s): 4-roll canne
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stroke; walking; rehabilitation
Clinical Study to Evaluate Effectiveness of Digital Refraction
Condition: Myopia; Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      Prospective, comparative, randomized, non-masked clinical study to compare the a digital
      refraction with LogMAR VA testing utilizing trial lenses, to standard manual refraction using
      a Phoropter, and LogMAR VA testing, in accuracy of visual acuity measurement.
    

Detailed description: 
      A digital refraction tool is a device meant to measure visual acuity and to subjectively
      measure refractive value for a patient's eye for the conditions of myopia and astigmatism. It
      is intended for adults aged 22 to 55 years that have no prior correction with up to 3.00
      diopters (D) of myopia and up to 2.00 D of astigmatism, or those with prior correction up to
      10.00 D of myopia and require an over-refraction of no more than 2.75 D.

      LogMAR (ETDRS) chart to measure visual acuity.

      The manual manifest refraction is performed by an eyecare specialist using a phoropter.

      The LogMAR Visual Acuity chart is used to measure visual acuity. The manual refraction will
      be used in this study for obtaining the refractive error of each eye.
    

Intervention name(s): Digital refraction; Manual Refraction
Intervention type(s): Device; Other
Intervention description(s): A web-based application for obtaining the refractive error and visual acuity of each eye, using a computer and a smart phone.; Manual refraction and ETDRS chart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Metformin for Treatment of Antipsychotic-induced Dyslipidemia
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      Almost all antipsychotics can induce dyslipidemia, but no treatment has been established.
      Metformin can improve lipid levels in obese patients. The investigators conducted a
      randomized, placebo-controlled study to test the efficacy of metformin for
      antipsychotic-induced dyslipidemia.
    

Detailed description: 
      The study was designed as a double-blind randomized controlled trial, with research assessors
      and patients intended to be blind to the intervention status. The staff members performing
      the assessment were not involved in implementing any aspect of the intervention.162 patients
      were randomized to one of two 24-week individual treatments: metformin (1000mg/day)or
      placebo. Medications were provided in double-blind fashion.The assessments include lipid
      levels, body weight, body mass index, fasting glucose, fasting insulin and insulin resistance
      index.
    

Intervention name(s): metformin
Intervention type(s): Drug
Intervention description(s): 1000mg/day for 24 weeks
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; dyslipidemia
A Study to Assess Food Effect on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess food effect on the pharmacokinetics of fimasartan in healthy male volunteers.
    


Intervention name(s): Fimasartan; Fimasartan
Intervention type(s): Drug; Drug
Intervention description(s): Period 1: administration of fimasartan 240mg at 9:00am, 30 minutes after the breakfast Period 2: administration of fimasartan 240mg at 9:00am, without the breakfast; Period 1: administration of fimasartan 240mg at 9:00am, without the breakfast Period 2: administration of fimasartan 240mg at 9:00am, 30 minutes after the breakfast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: To assess food effect on the pharmacokinetics of fimasartan in healthy male volunteers
Pregnancy Subsequent to Ventral Hernia Repair
Condition: Hernia, Ventral; Pregnancy
MeSH terms: Hernia; Hernia, Ventral
Study type: Observational

Summary: 
      We will examine the outcome of ventral hernia repair with subsequent pregnancy
    


Intervention name(s): No intervention
Intervention type(s): Other
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Nationwide study population of patients registered with a ventral hernia repair in The
        Danish Hernia Database between January 1 2007 and December 31 2014
Sexual Health of Spinal Cord Injured Females
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to assess the impact on sexuality in women with a spinal cord
      injury, twelve months after their first return to home, of a program including structured
      information and education on sexuality, delivered 6 months after their first return to home.
    

Detailed description: 
      Multicentre, prospective study, aiming to assess the effect on sexuality of an information
      and education program in women with spinal cord injury.

      Included patients will be women hospitalized for initial rehabilitation, and will be included
      two weeks before their first return to home.

      Socio-demographic data, diagnosis and etiology, secondary conditions, treatment,
      comorbidities and expectations towards rehabilitation care will be assessed at inclusion.

      At M3 Patients will be randomized in either the intervention arm or the control arm.

      Patients enrolled in the intervention arm will benefit from a standardised information and
      education consultation on physiology of sexual response 6 months after their return home.

      Patients enrolled in the control arm will undergo the same follow-up but will only have the
      usual unstructured and unformalized information provided by the clinical team.

      At M3, M6, M12 secondary conditions , sexual function index (FSFI), social integration (LHS),
      treatment and expectations towards rehabilitation care will be assessed
    

Intervention name(s): Standardised information and education on sexuality in women with spinal cord injury
Intervention type(s): Other
Intervention description(s): Program of information and education on the physiology of sexual response in women with spinal cord injury 6 months after their first return to home:
Educational footage
Clinical neurological examination with educational aim
Structured consultation providing information on the physiology of sexual response in women with spinal cord injury
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Spinal cord injuries; Sexual function; Sexual response; Sexuality; Women
Implementing a Low FODMAP Diet in Irritable Bowel Syndrome Patients
Condition: IBS - Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Researchers are trying to determine the best course of action regarding the dietary
      management with a diet low in fermentable oligosaccharides, disaccharides, monosaccharides
      and polyols (FODMAP diet) for irritable bowel syndrome.
    

Detailed description: 
      An analysis of different educational programs providing information on the low FODMAP diet
      will be performed.
    

Intervention name(s): Registered dietitian; On-line video program; Printed handout; Dietitian-led group
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Education on low FODMAP diet is provided in person by a registered dietitian who is an expert on the low FODMAP diet; Education on low FODMAP diet is provided by an on-line program via a link sent through email; Education on low FODMAP diet is provided through printed handout material at the initial visit.; Education on low FODMAP diet is provided in a dietitian-led group setting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Study of JNJ-77474462 (Bermekimab) in Healthy Participants of Japanese Descent Following Administration of Single Ascending Subcutaneous Doses
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the safety and tolerability of JNJ-77474462 following
      single subcutaneous (SC) administration to healthy participants of Japanese descent.
    


Intervention name(s): JNJ-77474462; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): JNJ-77474462 will be administered as SC injection.; Matching placebo to JNJ-77474462 will be administered as SC injection.
Other intervention name(s): Bermekimab
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Effects of Virtual Reality and Cyclic Training on Balance
Condition: Stroke, Acute
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Stroke is the third leading cause of functional disability and death in the world. It leads
      to many problems that affect gait, upper extremity function and balance. In stroke patients
      balance dysfunction leads to impaired postural control and walking. Because of poor balance
      fall rate increases in stroke patients. Balance is an important predictor of outcome in
      stroke rehabilitation. After stroke difficulties in balance control may be caused by multiple
      factors such as muscle weakness, impaired proprioception, and asymmetry in weight wearing,
      spasticity and impaired motor control. Different means are used to treat stroke, some
      conventional treatments along with new adjunct therapies are usual practice for the
      rehabilitation of the stroke.

      Virtual Reality is choice of adjunct therapy now a days and can be used in different ways for
      the rehabilitation. Virtual Reality or active video gaming proved their role as vital part of
      the treatment program in pediatric rehabilitation as well as adult rehabilitation program.
      These programs help the patient to achieve goals for functional and activities of daily
      living skills.
    

Detailed description: 
      This study will be a randomized control trial, used to compare the effectiveness of virtual
      reality and cyclic training on balance in sub-acute stroke patients. Subjects with sub-acute
      stroke meeting the predetermined inclusion and exclusion criteria will be divided into two
      groups using simple random sampling technique. Assessment will be done by using berg balance
      scale (BBS) and time up and go test. Subjects in one group will be treated with Virtual
      reality and Conventional therapy and in other group Cyclic training and Conventional therapy.
    

Intervention name(s): Virtual reality group; Cyclic training group
Intervention type(s): Other; Other
Intervention description(s): This will receive Virtual reality sessions and both group will receive conventional physical therapy as base line treatment; This will receive cyclic training session. both group will receive conventional physical therapy as base line treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Its a randomized control trial, used to compare the effects of virtual reality and cyclic training on balance in sub-acute stroke patients. Subjects with sub-acute stroke meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling technique
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Stroke; Virtual Reality; Cyclic Training; Active Video gaming
Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS)
Condition: Relapsing Multiple Sclerorsis; Multiple Sclerosis, Primary Progressive
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label, multicenter, biomarker study designed to be hypothesis-generating in
      order to better understand the mechanism of action of ocrelizumab and B-cell biology in RMS
      or PPMS. The study will be conducted in two cohorts i.e. RMS cohort (4 arm group) and PPMS
      cohort (one arm group). RMS cohort: Ocrelizumab will be administered as two intravenous (IV)
      infusions of 300 milligrams (mg) on Days 1 and 15. Subsequent doses will be given as single
      600-mg infusions at Weeks 24 and 48. Participants will be randomized in 1:1:1 ratio to
      receive lumbar puncture (LP) post-treatment at Week 12, 24, or 52 following the first dose of
      ocrelizumab in three arm groups. A fourth RMS arm with delayed treatment start (Arm 4
      [control group]) will not be a part of the randomization and will be recruited separately,
      wherein treatment with ocrelizumab will be delayed for 12 weeks from pre-treatment baseline.
      PPMS cohort: Ocrelizumab 600 mg will be administered as two 300-mg IV infusions separated by
      14 days at a scheduled interval of every 24 weeks. Participants will receive a LP at the
      start of the study before dosing with ocrelizumab and second LP at Week 52 following the
      first dose of ocrelizumab. A long-term extension will be conducted for participants that
      complete the study and continue to receive ocrelizumab. Treatment with ocrelizumab in the
      entire study will continue for approximately 4.5 years after the first infusion.
    


Intervention name(s): Ocrelizumab; Lumbar Puncture; Methyloprednisolone; Antihistamine
Intervention type(s): Drug; Procedure; Drug; Drug
Intervention description(s): Ocrelizumab will be administered as IV infusion.; Participants will receive LP as specified in individual arms. Lumbar puncture is optional at week 52, except for RMS Cohort Arm 3 and PPMS Cohort. In addition, the lumbar punctures in the Long Term Extension phase is every other year.; Participants will receive 100 mg of IV methylprenisolone (or an equivalent) prior to ocrelizumab infusion.; Participants will receive an antihistamine, such as diphenhydramine, prior to ocrelizumab infusion.
Other intervention name(s): RO4964913
Intervention MeSH terms: Ocrelizumab; Histamine Antagonists; Histamine H1 Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Investigate VX-787 Given to Adult Volunteers Inoculated With Live Influenza Virus
Condition: Influenza Virus
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the antiviral activity and safety of VX-787 given
      to healthy adult volunteers that have been inoculated with the influenza virus.
    


Intervention name(s): VX-787; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study of E6007 in Healthy Subjects
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of single oral ascending
      doses of E6007 in healthy subjects.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, ascending single dose study to
      evaluate the safety and tolerability of E6007 in healthy subjects. Six dose groups will be
      evaluated. Subjects will receive either 25 mg, 50 mg, 100 mg, 200 mg, 400 mg, or 600 mg E6007
      or matching placebo tablets. Subjects will undergo screening evaluations, baseline
      evaluations, Day 1 (dosing day), and Days 2-5 evaluations. They will also have a follow-up
      visit on Day 90 and a Day 180 follow-up phone call.
    

Intervention name(s): E6007; E6007; E6007; E6007; E6007; E6007
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): E6007 25mg single dose or matching placebo; E6007 50mg single dose or matching placebo; E6007 100mg single dose or matching placebo; E6007 200mg single dose or matching placebo; E6007 400mg single dose or matching placebo; E6007 600 mg single dose or matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Inflammatory Bowel Disease