bioihbjkbjnl/mcl2 huggingface dataset:
A Pilot Study of Efficacy of Lactobacillus CD2 Lozenges in Preventing High-dose Chemotherapy Induced Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation
Condition: Oral Mucositis
MeSH terms: Mucositis; Stomatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with various malignancies who are taken up for high dose chemotherapy followed by
      stem cell transplant (blood and marrow transplant) have very high chances of developing
      severe oral mucositis (between 95-100%). This mucositis not only causes significant morbidity
      but also hampers quality of life so much so that patients at times feel difficult to continue
      treatment.

      No definite treatment exists for prevention or treatment of oral mucositis in this group of
      patients. Though one study has suggested that use of IV palifermin (a keratinocyte growth
      factor) will reduce duration and severity. Palifermin is very expensive and not available in
      country. Recently the investigators have shown effectiveness of a probiotic Lactobacillus CD
      2 in reducing incidence and severity of chemo-radiotherapy induced mucositis in head and neck
      squamous cell cancer patients. (Published online in European Journal of Cancer:
      http://dx.doi.org/10.1016/j.ejca.2011.06.010). No significant toxicity has been reported with
      its use.

      Now, the investigators want to study the efficacy of this drug to reduce severity of
      mucositis in patients undergoing hematopoietic stem cell transplantation. The drug will be
      supplied by CD Pharma India Private Limited.

      The investigators further give undertaking that study will be carried as per good clinical
      practices (GCP) and declaration of Helsinki.
    


Intervention name(s): lactobacillus CD2 lozenges
Intervention type(s): Drug
Intervention description(s): The study drug contains not less than 2x109 (2 billion) viable cells of Lactobacillus CD2 as active ingredient
Other intervention name(s): CD#2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Lactobacillus CD2 lozenges; high-dose chemotherapy induced; hematopoietic stem cell transplantation
Efficacy of Splinting, Exercise and Electrotherapy on Hallux Valgus
Condition: Hallux Valgus
MeSH terms: Hallux Valgus; Bunion
Study type: Interventional

Summary: 
      The aim of this study was to investigate the effects of splinting, exercise and
      electrotherapy on the hallux valgus (HV) angle, and foot-specific health-related quality of
      life. Sixty women (120 feet) with bilateral HV deformity were randomly assigned to one of
      three groups - an HV night splint (SP) group, an exercise (EX) group, and a high-voltage
      galvanic stimulation (EL) group. Angular degrees (hallux interphalangeal, HV, and
      intermetatarsal angles expressed as angles A, B and C, respectively) were determined before
      enrollment (t0) and three months after treatment (t2). Foot-specific quality of life was
      assessed using the Manchester-Oxford Foot Questionnaire (MOFQ) at t0, after one month (t1),
      and at t2. All groups exhibited significant changes in the A, B, and C angles and outcome
      measures (p ≤0.001). Decreases in the A and C angles, and MOFQ-Pain subscale scores, were
      higher in the SP group than in the other two groups (p<0.05). C angle at t2, MOFQ-Walking
      score at t1 and t2 and MOFQ-Pain subscale score at t1 were lower in the SP group (p<0.05).
    


Intervention name(s): hallux valgus night splint; exercise; Electrotherapy
Intervention type(s): Device; Other; Other
Intervention description(s): The HV night splint holds the hallux in abduction in order to provide a correct position. The SP group was given splints consisting of a rigid polyethylene bar along the medial of the hallux, and soft polyform and Velcro fastener parts.; The exercises involved strengthening the AbdH (abductor hallucis) and plantar fascia muscles, and stretching the hallux; Two self-adhesive electrodes were used. One was placed over the medial distal end of the first metatarsal and the other was attached to the motor point of the AbdH (inferior and posterior to the navicular tuberosity).21 The stimulation intensity was increased until a contraction was observed without causing discomfort and pain. Twenty-minute HVPGS was applied in total over three weekly sessions for four weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hallux valgus; Night splint; Exercise; High voltage galvanic stimulation; Radiographic angular degree; Foot-specific health-related quality of life
EDG004 Treatment of Adult Patients With Generalized Anxiety Disorder (GAD)
Condition: Generalized Anxiety Disorder (GAD)
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy of EDG004 compared to placebo for the treatment of adult patients
      with GAD, diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. (DSM-5)
      and confirmed by the Mini International Neuropsychiatric Interview (MINI 7.0). Efficacy will
      be measured by a statistically significant greater mean reduction from baseline compared to
      endpoint in anxiety symptoms as measured by the total score of the clinician-rated Hamilton
      Rating Scale for Anxiety (HAM-A) for the EDG004 treatment group compared to placebo.
    


Intervention name(s): Extended-release lorazepam; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Extended-release lorazepam capsules; Placebo capsules
Other intervention name(s): EDG004
Intervention MeSH terms: Lorazepam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Web-based Insulin Titration - An Efficacy Study
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The main objective of the study is to determine whether an intensive web-based titration
      system, called PANDIT (Patient Assisting Net-based Diabetes Insulin Titration), is effective
      in improving glycaemic control in patients with diabetes mellitus type 2 using a basal
      insulin, compared to standard care.
    


Intervention name(s): Web-based insulin titration
Intervention type(s): Device
Other intervention name(s): PANDIT
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dysport® Injection in the Treatment of Chronic Lateral Epicondylitis
Condition: Tennis Elbow
MeSH terms: Tennis Elbow
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether a single injection of Dysport with a new
      protocol at forearm is effective in the management of chronic lateral epicondylitis.
    

Detailed description: 
      Some studies valued the effectiveness of botulinum toxin. There is a great amount of
      controversy on the amount of botulinum toxin injected and the location of the injection. The
      purpose of the study is to compare the effectiveness of botulinum toxin injection with
      placebo at a new injection site at the forearm in the treatment of chronic tennis elbow
      unrelieved by corticosteroid injection and physiotherapy. It is a double blind randomized
      controlled trial.
    

Intervention name(s): NaCl 0.9%; Botulinum Toxin A
Intervention type(s): Drug; Drug
Other intervention name(s): Dysport
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Tennis Elbow; Botulinum Toxin
A Study to Evaluate the Effects of SB-751689 or rhPTH(1-34) on Excretion of Calcium and Phosphate in Women
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      SB-751689 may alter calcium and phosphate handling at the kidney level. This study will
      examine what happens to calcium and phosphate, and other electrolytes, at the kidney after
      treatment with SB-751689 for 1 month. Another group of subjects will get another drug called
      Forteo for 1 month to compare the response of the kidney for calcium and phosphate.
    


Intervention name(s): rhPTH(1-34); SB-751689 100 mg; SB-751689 400 mg
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): rhPTH(1-34); SB-751689 100 mg
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: renal,; pharmacology,; Osteoporosis
Evaluation of Intubation Conditions Following BX1000 or Rocuronium in Subjects Undergoing Surgery
Condition: Neuromuscular Blockade; Anesthesia; Surgery
Study type: Interventional
Phase: Phase 2

Summary: 
      Assessment of Intubation conditions following administration of neuromuscular blocking
      agents; BX1000 (investigational) or rocuronium (active control).
    

Detailed description: 
      Intubation conditions will be assessed in anesthetized subjects undergoing an elective
      surgical procedure utilizing general anesthesia. Following administration of IV anesthesia,
      subjects will have electromyography (EMG) neuromuscular monitoring device applied prior to
      administration of neuromuscular blocking agent (NMBA). NMBA will be administered and
      assessment of intubation conditions will begin 60 seconds after administration according to
      the methods defined in Viby-Mogensen 1996; assessment will be repeated at 90 and 120 seconds
      after administration when intubation has not already been completed.

      After intubation is completed, subjects will progress to have their elective surgery
      completed and will be maintained under general anesthesia until neuromuscular function is
      recovered. Once recovered from anesthesia and extubation, subjects will be monitored in a
      recovery area until they are suitable to be discharged to the inpatient floor, after which
      time they may be discharged at the clinical discretion of the investigator.
    

Intervention name(s): BX1000; Rocuronium Bromide
Intervention type(s): Drug; Drug
Intervention description(s): IV BX1000; IV Rocuronium
Intervention MeSH terms: Bromides; Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intubation
Psychosocial Determinants of Nutrient Intake in Girls
Condition: Cardiovascular Diseases; Heart Diseases; Obesity
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      To better understand the determinants of nutrient intake in black and white adolescent girls
      and to examine the effects of nutrient intake and eating behaviors on obesity, a significant
      risk factor for CVD.
    

Detailed description: 
      BACKGROUND:

      Studies have documented the importance of eating behavior as a modifiable risk factor for the
      development of obesity and cardiovascular disease (CVD). The burden of obesity and CVD is not
      equally distributed in the population; women from ethnic minority populations are
      particularly likely to be obese and to have higher rates of CVD and stroke than white women.

      DESIGN NARRATIVE:

      The study determines the extent to which psychological and familial factors contribute to
      nutrient intake in black and white girls, beyond the well-established effects of ethnicity
      and socioeconomic factors. Specifically, the aims of the project are the following: 1) to
      provide a detailed developmental description of eating behaviors and nutrient intake in black
      and white girls and to examine the "clustering" of certain eating behaviors (e.g., skipping
      meals and snacking) into eating patterns; 2) to determine the clinical significance of eating
      behaviors and eating patterns by examining their contribution to nutrient intake and the
      development of obesity; 3) to examine the role of psychological and familial factors as
      determinants of eating behaviors, eating patterns, nutrient intake, and obesity in black and
      white girls. Capitalizing upon the availability of extensive data collected prospectively
      among an exceptionally well-maintained cohort of 2,379 black and white females over a 12-year
      period (from ages 9-10 to ages 21-23), the study applies innovative analytic procedures to
      further the scientific understanding of the determinants of nutrient intake and eating
      behaviors in adolescent girls. Participants were assessed annually for ten years as part of
      the National Heart, Lung and Blood Institute Growth and Health Study (NGHS) with measurements
      of anthropometry, food intake, eating and weight related attitudes and behaviors and family
      cohesion. Parents also provided information about weight, eating, and family environment at
      two assessments. In a subsequent study with the same sample, structured clinical interviews
      were conducted to determine history of psychiatric disorders and risk factors for eating
      disorders. Adult weight was also measured.
Effectiveness of Bobath/Halliwick on Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      Investigation of the effectiveness of water based therapy on children with Cerebral Palsy
      (CP)
    

Detailed description: 
      The purpose of this randomized controlled trial was:

      To examine the effectiveness of the Halliwick concept intervention in water approach for
      people with motor deficiency and, more specifically, for children with diagnosed cerebral
      palsy.

      In a second phase, to compare the contribution of water intervention to the child's motor
      development against just Bobath physiotherapeutic intervention, in terms of the milestones of
      gross motor skills of the children over time.

      The aim of the research is to determine the contribution of the Halliwick Concept-
      Hydrotherapeutic Intervention approach in the psychomotor development in children with
      cerebral palsy and to explore its contribution to a comprehensive therapeutic approach for
      these children. It is a fact that, in recent years, parallel therapeutic approaches have
      gained ground, which, in combination with the physiotherapeutic treatment, contributes to the
      enhancement of therapeutic effects in early and follow-up intervention for children with
      cerebral palsy.

      The study resulted from the fact that there is not such a large-scale study in Greece. Also,
      there are few published studies in the world, trying to evaluate the therapeutic benefit of
      the Halliwick Concept as an hydro-therapeutic approach.
    

Intervention name(s): Halliwick Concept
Intervention type(s): Other
Intervention description(s): Halliwick Concept: Water intervention Bobath Concept: Neurodevelopmental Treatment
Other intervention name(s): Bobath Concept
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3 groups, 80 children with CP
group: Intervention in water- halliwick, 40 children
group: On land therapy- bobath, 40 children
group: No intervention
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: aquatic therapy; pediatrics; cerebral palsy; Bobath; Halliwick
Neurophysiological and Immunological Effects of the Transition From Combustible to Electronic Cigarettes
Condition: Tobacco Smoking; Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The objective of this study is to examine the cognitive, immunological, and
      neurophysiological effects of transitioning from tobacco cigarettes to electronic cigarettes.
      The central hypothesis of this study is that this transition will be accompanied by a
      decrease in peripheral inflammation, which will lead to significant changes in the
      neurocircuitry underlying interoception and appetite.
    

Detailed description: 
      Participants who are current cigarette smokers will be randomly assigned to either the
      experimental or control groups. Following a baseline psychiatric assessment session, subjects
      will return to the study center for two to three additional follow-up visits.

      During the second visit, all subjects will undergo a functional magnetic resonance imaging
      (fMRI) scanning session, during which they will perform a series of functional neuroimaging
      tasks designed to examine the neural substrates involved in visceral interoception and eating
      behavior. Prior to the start of the scan session, blood samples will be collected from each
      subject, for the measurement of bio-markers related to nicotine use and peripheral
      inflammation. After the end of the second visit, subjects within the experimental group will
      be asked to switch from combustible to electronic cigarettes. Subjects within the control
      group will continue to smoke combustible cigarettes as previously.

      During the third visit, which will follow two to eight weeks after the second visit, all
      subjects will provide a second blood sample and complete a second fMRI scan session. Both
      groups of participants will complete the same fMRI tasks as they did during the second visit.
    

Intervention name(s): Electronic Cigarette; Tobacco Cigarette
Intervention type(s): Other; Other
Intervention description(s): eGo-type electronic cigarette with a supply of 18mg/ml nicotine solution; Smoke own brand of cigarette as previously
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Electronic Cigarette
Childhood Obesity Treatment Targeting Specific Behaviors
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The US is in the midst of an obesity epidemic, affecting young children. The pediatric
      primary care setting is an ideal place to address this problem since most families have
      frequent contact with their pediatrician and a child's health status is regularly assessed in
      this setting. Recommendations for treating children with a body mass index (BMI) over the
      85th percentile in the primary care setting have been developed by an Expert Committee on
      childhood. Programs are needed that meet the recommendations from the Committee, which
      include: 1) beginning treatment as young as possible; 2) focusing on the family, with the
      parent being the primary change agent for treatment; 3) using behavior modification
      techniques to change eating and activity behaviors; and 4) making 2 or 3 very specific
      changes in diet and activity at one time. Thus, the aim of this R21 application is to
      develop, implement, and evaluate a 6-month behavioral childhood obesity intervention that
      meets the Committee's recommendations and can be implemented in a primary care setting. A
      second aim of this project is to determine which eating and activity behaviors should be
      targeted in the intervention. One hundred thirty-five children, aged 4 to 9 years with a BMI
      > 85th percentile, assessed and referred by their pediatricians, will be randomized to one of
      three conditions: 1) a newsletter condition; 2) a Behavioral Parenting Program that increases
      physical activity (60 min/day) and decreases sweetened drink consumption (< 3 servings/week)
      (Traditional); or 3) a Behavioral Parenting Program that reduces TV watching (< 2 hours/day)
      and increases low-fat milk consumption (2 servings/day) (Substitutes). Follow-up assessments
      on weight, height, and standardized BMI (z-BMI), the primary dependent variable, will be
      conducted at 3, 6, 9, and 12 months. Pediatricians will provide follow-up letters to
      families, regarding weight and height status, following the assessments. This pilot study
      allows us to determine the feasibility and efficacy of a pediatric obesity intervention that
      optimizes the role of the pediatrician and meets the Committee's recommendations for
      treatment in a primary care setting. Moreover, by comparing the effects of targeting the
      traditional or substitute behaviors, data will be obtained for a power analysis for a
      full-scale trial of the effects of these two approaches on long-term weight loss.
    


Intervention name(s): Diet and Activity
Intervention type(s): Behavioral
Intervention description(s): Diet and Activity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Randomized Controlled Trial Comparing the Efficacy and Safety of FMT in Hepatitis B Reactivation Leads to Acute on Chronic Liver Failure.
Condition: Acute on Chronic Liver Failure
MeSH terms: Hepatitis B; Liver Failure; Hepatic Insufficiency; End Stage Liver Disease; Acute-On-Chronic Liver Failure
Study type: Interventional

Summary: 
      Data for stool microbiome will be collected for all the chronic hepatitis B subjects (pre
      cirrhotic,compensated,decompensated and reactivation). All the in and out patient with
      Hepatitis B reactivation will be recruited and randomized into two arms.

      Group 1 Tenofovir Group 2 Tenofovir with FMT (Fecal Microbiota Transplant).

      Tenofovir would be given 300 mg once daily FMT through NJ (Naso-Jejunal) tube for 7 days.
    


Intervention name(s): Tenofovir; Fecal Microbiota Transplantation (FMT)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Breast Feeding Analgesia in Preterm Infants
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the effects of mothers' breastfeeding with the
      effects of pacifier sucking on preterm infant biobehavioural responses during and immediately
      after a painful procedure

      Hypothesis:

        1. When breast fed by their mothers during blood collection, preterm infants will show less
           pain reaction than when sucking on a pacifier.

        2. Following breast feeding during the blood collection, mothers will find no differences
           in their infants' breast feeding ability.
    

Detailed description: 
      Research Method:

      In a within subjects, randomized, cross-over design, 50 stable preterm infants born between
      30-36 weeks gestational age will be studied. Infants will be randomized to two interventions
      which will take place during two separate blood collections that are required for clinical
      management. For the standard care condition, infants will remain in their isolettes and will
      be positioned in prone and given a pacifier to suck on throughout the blood collection. For
      the feeding condition, infants will be held and then breast fed by their mother during the
      blood collection.
    

Intervention name(s): Blood collection; Blood collection
Intervention type(s): Procedure; Procedure
Intervention description(s): For the standard care condition, infants will remain in their isolettes and will be positioned in prone and given a pacifier to suck on throughout the blood collection.; For the feeding condition, infants will be held and then breast fed by their mother during the blood collection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pain Response