bioihbjkbjnl/mcl2 huggingface dataset:
Navigator Guided e-Psychoeducational Intervention
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the impact of providing newly diagnosed prostate
      cancer patients and their caregivers with an interactive mobile tablet technology-based
      application delivered by a community navigator versus providing National Cancer Institute
      (NCI) information booklets delivered by a Community Navigator (CN) on patient outcomes
      (decisional satisfaction, quality of life, knowledge, decisional conflict) and shared
      decision making practices (decision making involvement).
    


Intervention name(s): Personalized Health Information Navigator (PHIN); NCI Information Booklets (IB)
Intervention type(s): Other; Other
Intervention description(s): The application (or "app") titled Personalized Health Information Navigator (PHIN) is an interactive psycho-educational intervention that will be delivered via mobile tablet technology. The PHIN provides patient-centered education. At the first meeting, the community navigator will provide a visual demonstration of PHIN on the Apple iPad. The community navigator will leave the iPad with the participant for 6-weeks and will stress the importance of using the PHIN app to address any educational or psychosocial needs.; Participants will receive a packet of information booklets ("What You Need to Know About Prostate Cancer"; "Taking Time: Support for People with Cancer"; and "Facing Forward, Life After Cancer Treatment") that address prostate cancer treatment options, the late and long term effects, follow-up care, and sources of support. At the first meeting, the community navigator will provide a review of the print materials and stress the importance of reading the booklets carefully to help prepare for the discussion with your healthcare provider. The community navigator will leave the print materials with the participant for 6-weeks.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients from Moffitt Cancer Center Genitourinary Clinic, University of South Florida
        Genitourinary Clinic, or community-based urologists and primary care providers.
      
Keywords: newly diagnosed prostate cancer; prostate
Cockroach Immunotherapy in Children and Adolescents
Condition: Persistent Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Scientific evidence has shown that, over the past two decades, the combination of cockroach
      allergy and cockroach exposure is one of the most important factors contributing to the
      dramatic increase in asthma morbidity seen in inner city children with asthma. Therefore, a
      major goal of the Inner City Asthma Consortium (ICAC) is to evaluate the efficacy of
      cockroach immunotherapy in inner city asthma.

      The primary objective of the study is to determine if the response to nasal allergen
      challenge (NAC) will be changed with treatment with cockroach subcutaneous immunotherapy
      (SCIT) treatment.
    

Detailed description: 
      This is a 1:1 randomized, double-masked (blind), placebo-controlled, multicenter trial with 2
      treatment arms:

        -  German Cockroach Subcutaneous Immunotherapy (SCIT) + guideline-based standard asthma
           care, OR

        -  Placebo (for German Cockroach Subcutaneous Immunotherapy [SCIT]) + guideline-based
           standard asthma care

      Eighty participants 8 to 17 years of age who are sensitized to cockroach, have asthma, and a
      positive cockroach Nasal Allergen Challenge (NAC) before treatment randomization will be
      enrolled.
    

Intervention name(s): German cockroach allergenic extract; Placebo for German cockroach allergenic extract
Intervention type(s): Biological; Biological
Intervention description(s): Active ingredient: a non-standardized allergen derived from the extraction and purification of proteins from German cockroach (Blattella germanica). Non-standardized glycerinated German cockroach allergenic extract is approved in the United States for diagnostic skin testing and immunotherapy by subcutaneous injection (U.S. License 467).; Commercially- labeled licensed product, sterile diluent for allergenic extract (50% glycerinated), sodium bicarbonate (0.091%) sodium chloride (0.166%).
Other intervention name(s): Blattella germanica allergenic extract; Placebo for Blattella germanica allergenic extract
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: cockroach; immunotherapy; inner city asthma; subcutaneous immunotherapy (SCIT); Nasal Allergen Challenge (NAC)
Evaluating the Effect of an Evidence-Based One Page With Supplemental Visual Aids on the Knowledge and Perceptions of Blood Pressure Management Among Adults With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate changes in patient knowledge of blood pressure
      management and perceptions of making lifestyle changes to manage their blood pressure after
      implementation of an evidence-based one-page teaching protocol with supplemental handouts and
      optional use of suggested apps and web sites.
    


Intervention name(s): Blood pressure education
Intervention type(s): Behavioral
Intervention description(s): One page teaching protocol performed by pharmacy students; phone follow-up
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Vitamin D Intervention in Infants - 6 Years Follow-up (VIDI2)
Condition: Bone Strength; Growth; Body Composition; Infection; Allergic Diseases; Dental Health
Study type: Observational

Summary: 
      Exposure to vitamin D intervention in early life may have permanent effects on physiology and
      metabolism. Bone growth and mineralization, development of immunity, body composition and
      brain structure and functioning may be affected. The importance of a long-term surveillance
      includes follow-up of both beneficial but also harmful effects of vitamin D.

      Vitamin D intervention in infants (VIDI) study was conducted in 2013-2016. VIDI study was a
      large randomized trial that aimed to evaluate effects of two vitamin D supplemental doses of
      daily 10 ug and 30 ug from the age 2 weeks until 2 years on bone strength, infections,
      immunity, allergy, atopy and asthma, neurologic and cognitive development, and genetic
      regulation of mineral homeostasis. Current study is a 6 Years Follow-up (VIDI2) study of the
      original VIDI trial.

      Our focuses of interest in the follow-up are: bone strength, growth pattern, body
      composition, and morbidity due to infections and allergic diseases, and the development of
      immunity. Further, in addition to more classical associates of vitamin D, our aim is to
      continue to follow-up children's neurocognitive development and mental health. We will also
      focus on the effect of vitamin D supplementation on occurrence of molar-incisor
      hypomineralization, dental caries, and oral immunity.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        In the original VIDI study the eligible infants were born at term (37 weeks and 0 days' to
        42 weeks and 0 days' gestation), with a birth weight within 2 SDs of the mean for
        gestational age. Infants excluded were those requiring intravenous glucose, antibiotics,
        nasal continuous positive airway pressure treatment for more than 1 day, phototherapy for
        more than 3 days, or nasogastric tube feeding for more than 1 day and infants with
        seizures.
      
Biospecimen description: 
      blood samples, saliva
Down Syndrome and Effects of Foot Muscle Exercise
Condition: Pes Planus Down Syndrome Patients
MeSH terms: Flatfoot; Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      Down syndrome (DS) is a common chromosomal pediatric disorder and accounts for approximately
      8 % of all congenital anomalies. Children with DS experience delays in Cognitive, Physical,
      Speech and Language development. Hypotonity and laxity that is part of its features causes
      delay on motor acquisition. Furthermore it causes musculoskeletal issues and lower extremity
      malalignment resulting in inefficient and abnormal pattern of movement compromising
      locomotion and day to day functions therefore, problems for the population further
      aggravates. Combined effects of these factors causes a high level of stress on foot as it
      provides the foundation for whole body therefore, individuals with Down syndrome are at risk
      for foot alignment problems. Pes planus being the most common amongst them and accounts for
      91% of the total DS patients diagnosed. Pes planus causes alteration in foot kinetics and
      kinematics that not only interferes significantly with normal daily life activities as
      balance and gait but also increases the risk of musculoskeletal injuries. Hence researchers
      have shown interest in addressing this condition for the effective management of DS
      population. Conventional treatment approach are the use of insoles, foot orthosis and arch
      taping however, they fail to produce residual effect. Hence the present study is to determine
      the role of foot muscles exercises in Down Syndrome having pes planus since its effects are
      positively recorded in normal population.
    


Intervention name(s): Foot Muscle Exercise Protocol; Arch Support Insole and One Leg Balance Activities
Intervention type(s): Other; Combination Product
Intervention description(s): Foot Muscle Exercise was given for 3 days per week for 40 minutes for the period of 6 months including home program; Arch Support Insoles were provided that the child had to wear for 5 hours per day thrice weekly for 6 months plus performed one leg balance activities
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Down syndrome; foot deformities; muscle hypotonia; pes planus; joint laxity; exercise training
Trial Comparing Two Protocols of re Irradiation in an Irradiated Area for Carcinoma of the Upper Aerodigestive Tract
Condition: Squamous Cell Carcinoma
MeSH terms: Carcinoma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Patients will be randomised after surgery, provided surgery is macroscopically adequate, that
      there is a flap of tissue protecting the vascular axis and that wound healing allows
      reirradiation to begin less than 8 weeks after surgery.Reirradiation will begin in the two
      arms less than 8 weeks after surgery in the irradiated area. The reirradiated volume : tumour
      bed + a safety margin of < 2 cm with immediate protection of bone marrow. This volume should
      be jointly defined by the radiotherapist and the surgeon. During reirradiation, 60 Gy will be
      delivered in the two arms but will last 11 weeks in the reference arm and 5 weeks in the
      investigational arm.Acute toxicity (NCI-CTCAE) will be evaluated at the end of reirradiation
      and at 6 months from randomization (first follow-up consultation)
    


Intervention name(s): single-fraction radiotherapy with concomitant 5FU and Hydrea; hyperfractionated radiotherapy with concomitant Cetuximab
Intervention type(s): Radiation; Radiation
Intervention description(s): single-fraction radiotherapy with concomitant 5FU and Hydrea; hyperfractionated radiotherapy with concomitant Cetuximab
Intervention MeSH terms: Cetuximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: phase II/III; upper aerodigestive tract carcinoma; re irradiation; Recurrent or second upper aerodigestive tract carcinoma
The Safety, Tolerability, and Pharmacokinetics Study of HEC113995 PA•H2O Tablets in Healthy Subjects
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The Safety, Tolerability and Pharmacokinetics Study of HEC113995 PA•H2O Tablets in Healthy
      Male and Female Subjects
    


Intervention name(s): HEC113995 PA•H2O tablets; Placebo tablets
Intervention type(s): Drug; Drug
Intervention description(s): Each dose of HEC113995 PA•H2O tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.; Placebo tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Safety, Tolerability and Pharmacokinetics of Medical Grade Cannabis (MGC) Orally Disintegrating Tablets With Buccal Sativex®, in Healthy Adult Volunteers
Condition: Healthy Subjects
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a preliminary study designed to assess the safety and properties of a new oral
      formulation containing the two most common cannabinoids used for medicinal purposes -
      Tetrahydrocannabinol (THC) and Cannabidiol (CBD). The formulation is designed to disintegrate
      sublingually in order to enhance absorption of these ingredients by circumventing first-pass
      metabolism by the liver (and probably also by the intestinal mucosal cells) as well as
      gastric acid degradation, thus allowing a rapid onset and more intensive pharmacological
      effect.
    

Detailed description: 
      This is a single-center, open-label, single-dose, crossover, randomized, pharmacokinetic
      study in healthy male adults.

      Sixsteen (16) subjects will participate in the study. Each subject will undergo screening
      procedures within 28 days prior to dosing, to assess his eligibility to participate in the
      study.

      Eligible subjects will participate in two dosing periods. They will be randomized to one of
      two administration sequences - AB or BA. In each period subjects will be admitted to the
      clinic on the evening before dosing. On the next morning, under fasting conditions they will
      receive one of the following administrations, according to a randomization list:

        -  Administration A: A single tablet of Medical Grade Cannabis - Orally Disintegrating
           Tablet (MGC-ODT) containing 5mg THC and 5 mg CBD (Test Formulation)

        -  Administration B: Sativex® spray X 2 actuations (1 under the tongue and 1 inside the
           cheek administered within 2 min) - Reference Product [Each 100 μL spray contains 2.7 mg
           THC and 2.5 mg CBD, total per administration: 5.4 mg THC and 5.0 mg CBD] A taste
           assessment questionnaire will be filled in by the subjects 2 minutes after drug
           administration (immediately following water administration).

      Dosing will be followed by Pharmacokinetic (PK ) blood sampling for 24 hours and Adverse
      Events (AE) monitoring for the next 24 hours, at time points specified below.

      A washout period of at least 2 weeks is required between the dosings.

      An End-of Study (EOS)/Safety Follow-up visit will take place 7-10 days after the last dose of
      study treatment.
    

Intervention name(s): OWCP Orally Disintegrating Tablet; Sativex
Intervention type(s): Drug; Drug
Intervention description(s): Medical Grade Cannabis - Orally Disintegrating Tablet (MGC-ODT) containing 5 mg THC and 5 mg CBD; Sativex® Oromucosal Spray
Intervention MeSH terms: Nabiximols
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Sequence ABBA
Masking: None (Open Label)
Primary purpose: Treatment
The Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study are: to confirm the superiority of TAU-284 over placebo after
      two weeks of administration to pediatric patients with perennial allergic rhinitis and to
      investigate safety of TAU-284.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, 2-arm parallel-group comparative
      study to confirm the superiority of TAU-284 over placebo after two weeks of administration of
      TAU-284 (20 mg/day) or placebo to pediatric patients with perennial allergic rhinitis, with
      "the change from baseline in total nasal symptom score (total score for the three major nasal
      symptoms [sneezing, rhinorrhea, and nasal congestion])" as the primary endpoint; and to
      investigate safety of TAU-284.
    

Intervention name(s): Bepotastine besilate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Two TAU-284 5mg tablets will be taken orally twice a day; Two Placebo tablets will be taken orally twice a day
Other intervention name(s): TALION 5mg tablets
Intervention MeSH terms: Bepotastine besilate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: TAU-284; Bepotastine besilate; Histamine H1 receptor antagonists; children
Exposure-Focused Family-Based CBT for Youth With ASD and Comorbid Anxiety
Condition: Autism; Asperger's Syndrome; Pervasive Developmental Disorder Not Otherwise Specified; Generalized Anxiety Disorder; Social Phobia; Separation Anxiety Disorder; Obsessive-compulsive Disorder; Specific Phobia
MeSH terms: Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Phobic Disorders; Phobia, Social; Developmental Disabilities; Autism Spectrum Disorder; Asperger Syndrome; Anxiety, Separation
Study type: Interventional

Summary: 
      Autism spectrum disorders affect as many as 1 out of 88 children and are related to
      significant impairment in social, adaptive, and school functioning. Co-occurring conditions,
      such as anxiety, are common and may cause substantial distress and impairment beyond that
      caused by the autism diagnosis. Accordingly, we are proposing a randomized controlled trial
      to examine the effectiveness of a form of cognitive-behavioral therapy relative to treatment
      as usual (TAU) in 50 youth ages 6-12 with autism spectrum disorders and comorbid anxiety.
    

Detailed description: 
      Autism spectrum disorders affect as many as 1 out of 88 children and are related to
      significant impairment in social, adaptive, and school functioning. Co-occurring conditions,
      such as anxiety, are common and may cause substantial distress and impairment beyond that
      caused by the autism diagnosis. Many children with anxiety disorders, especially those on the
      autism spectrum, do not receive evidence based treatment, which has fueled the development
      and evaluation of cognitive-behavioral therapy (CBT). Accordingly, we are proposing a
      randomized controlled trial to examine the efficacy of exposure based CBT that heavily
      incorporates parents (EF-CBT) relative to a TAU condition (TAU) in 50 youth ages 6-12 years
      with ASD and comorbid anxiety disorder(s).
    

Intervention name(s): Cognitive Behavioral Therapy; Treatment as usual
Intervention type(s): Other; Other
Intervention description(s): This condition involves 12 weekly CBT sessions.; This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism; Asperger's Syndrome; Pervasive Developmental Disorder Not Otherwise Specified; Treatment; Cognitive-behavioral therapy; Anxiety; Children; Therapy; Generalized Anxiety Disorder; Social Phobia; Separation Anxiety Disorder; Obsessive-compulsive Disorder; Specific Phobia
NeoFent-I Study; Fentanyl Treatment in Newborn Infants; a Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Study
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will assess the efficacy of fentanyl using a pharmacokinetic/pharmacodynamic
      (PK/PD) model where the concentration of the drug is related to effect curve (pain score
      change in response to standardized procedural pain). Further cortical, physiological and
      biochemical responses to fentanyl will be assessed, elucidating the feasibility before the
      main study project (NeoOpioid) start.
    


Intervention name(s): Fentanyl (5 microgram/ml) prediluted ampoules
Intervention type(s): Drug
Intervention description(s): Bolus; Fentanyl (5 microgram/ml) 0,5 microgram/kg (0.1 ml/kg) is administered over 1 min starting 3-5 min before the lighter skin breaking procedure.
Fentanyl (5 microgram/ml) 2 microgram/kg is administered over 10 min before the start of the more painful procedur ( pleura drainage or tracheal intubation).
Intervention MeSH terms: Fentanyl
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: analgesia; neonates; procedural pain; pain assessment; physiological response; pharmacogenetics
Does the Natural Medicinal Plant St John's Wort Affect the Glucose Tolerance in Healthy Individuals
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of the study is to examine if healthy individuals that ingest St John's wort will
      have a significantly difference in glucose tolerance.
    


Intervention name(s): St John's wort
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Glucose tolerance