bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess the Pharmacokinetics and Safety of AZD9977 in Participants With Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single dose, non-randomized, open-label, parallel group study. The study will be
      conducted in participants with severe renal impairment and compared with matched participants
      with normal renal function. The duration of the study for an individual participant from
      Screening to Follow-up will be approximately 5 weeks.
    

Detailed description: 
      The study will have 4 cohorts, consisting of participants with severe renal impairment who
      are not on dialysis (Cohort 1), moderate renal impairment (Cohort 2), mild renal impairment
      (Cohort 3) and participants with normal renal function (Cohort 4). Following completion of
      Cohort 1 and Cohort 4, pharmacokinetics (PK) and safety data will be reviewed and a decision
      will be made whether to study unmatched participants with moderate and mild renal impairment
      (Cohorts 2 and 3, respectively).

      Participants will be screened up to 21 days before administration of study drug. Eligible
      participants will be admitted to the clinical unit either on the evening of Day -2 or on the
      morning of Day -1. Each participant will receive a single oral dose of the study drug under
      fasted conditions on Day 1. Participants will be required to remain resident in the clinical
      unit until the morning of Day 3 but, if participants prefer, may also remain resident until
      all PK and other study procedures are completed on Day 7. This decision to extend residency
      will be made at the discretion of the principal investigator. If participants do check out on
      Day 3, participants will then return to the unit, as scheduled, for collection of PK samples
      and safety assessments, with a final Follow-up Visit on Day 14.
    

Intervention name(s): AZD9977
Intervention type(s): Drug
Intervention description(s): Participants will receive a single oral dose of AZD9977 under fasted conditions.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fosamax Bone Loss Study: Alendronate to Prevent Bone Loss
Condition: Perimenopausal Bone Loss
MeSH terms: Bone Diseases, Metabolic; Osteoporosis, Postmenopausal
Study type: Observational

Summary: 
      This is a study to determine if Fosamax (alendronate), a medication approved by the Food and
      Drug Administration (FDA) for the prevention and treatment of osteoporosis in postmenopausal
      women, is effective in decreasing the rate of bone loss which often begins to increase in the
      three to five years preceding the menopause (perimenopausal transition).

      During the three to five years prior to the menopause, the rate of bone loss increases. One
      way that physicians treat this is with oral contraceptive medication. However, the incidence
      of complications from oral contraceptives after the age of 40 increases. Therefore, a
      non-hormonal means of preventing bone loss should be useful. Fosamax (alendronate) is in a
      class of compounds called bisphosphonates. This study is being done to determine whether
      Fosamax can be used to prevent the increased rate of bone loss during the perimenopausal
      transition.
    


Intervention name(s): Fosamax
Intervention type(s): Drug
Intervention MeSH terms: Alendronate
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Perimenopausal women
      
Keywords: Perimenopausal bone loss
Attentional Focus and Prefrontal Cortical Activation
Condition: Healthy
Study type: Interventional

Summary: 
      Attention may influence the motor performance and frontal activity. This study will examine
      the effect of different attentional focus : internal, external and divided attention (dual
      task) on prefrontal cortical activation (fNIRS) and on gait performance. Thirty young healthy
      voluntary adults will participate in this study.
    

Detailed description: 
      The subjects will be guided to walk at a normal pace while maintaining the required
      attentional focus. They will walk on 30 m five times in each of the four different focus
      conditions :1) no instructions about the attentional focus 2) internal focus on their feet
      movements, 3) external focus on two lines drawn on the floor, 4) divided attention (walking
      while performing an arithmetic task). A fNIRS system will be used for the prefrontal cortex
      activation evaluation and FeetMe soles for gait analyses.
    

Intervention name(s): Functional Near-Infrared Spectroscopy (fNIRS)
Intervention type(s): Device
Intervention description(s): The hemodynamic response in prefrontal cortex will be measured using an Octamon+ system (Artinis). Eight emission and two detector probes will be arranged on the participant's forehead.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: near infrared spectroscopy; prefrontal cortex; attention; gait
A Comparison: High Intense Periodic vs. Every Week Therapy in Children With Cerebral Palsy (ACHIEVE)
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      The ACHIEVE study is a comparison of the effectiveness of 2 intensities of physical therapy
      treatment for children with Cerebral Palsy in an outpatient physical therapy setting. High
      intensity periodic is 2 hours of focused and high intense treatment per weekday for 4 weeks.
      In comparison, usual weekly is considered standard of care; although both dosing models are
      used clinically for children with CP. Participants are assign to the treatment group at
      random. Participant who are unable to consent to randomization are allowed to chose a
      treatment group.
    

Detailed description: 
      The overall goal of this project is to compare the effectiveness of high intense periodic and
      usual weekly therapy in treating Cerebral Palsy (CP) in children 2-8 years of age for motor
      rehabilitation. In this prospective randomized controlled trial (RCT), 108 children ages 2 to
      8 years of age with CP will be enrolled and assigned to one of 2 service delivery models: 1
      hour per day, 1 x per week for 40 weeks (usual weekly); and 2 hours every weekday for two
      10-consecutive-weekdays (total 4 weeks), for a repeated "periodic" bout (high intense
      periodic). Participants unable to consent to randomization are allowed to chose a treatment
      group. All patients enrolled in ACHIEVE will also have 1 hour per month of Physical Therapy
      Consultation (PTC) during the treatment period of 40 weeks (9 months). PTCs provide monthly
      motor skill monitoring, consultation, and home therapy program progression. Outcome
      evaluations will be performed by blinded evaluators at baseline (month 0, before treatment),
      month 9 for all patients to assess short term effects, and at months 12 and 18 for patients
      to assess long term effects. Parent surveys will be collected at 0, 4.5, and 9 months only
      (PC-2). Short-term and long-term effects will be analyzed to determine individual differences
      in children's response to intensity. A subset will be analyzed at 12 and 18 month.
    

Intervention name(s): Physical Therapy
Intervention type(s): Other
Intervention description(s): One-on-one physical therapy sessions (one therapist and one patient). Principles of motor learning used include repetition, task-specificity, active practice, generalization of skills, errors, structured practice, and developmentally appropriate feedback with sufficient time to practice.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral Palsy; Motor Impairments
Supervised Asthma Medication in Schools (SAMS)
Condition: Childhood Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesize that school-based, direct supervision of daily controller
      therapy will result in more effective asthma control, as assessed by the Asthma Control
      Questionnaire than usual care. Additionally, as the result of enhanced asthma control and
      resulting decrease in health care utilization, school-based, direct supervision of daily
      controller therapy will result in lower cost per quality-adjusted life year (QALY) gained
      than usual care.
    

Detailed description: 
      This research is being done to test if children with asthma will have fewer asthma symptoms
      if they are monitored at school to make sure they take their inhaled steroid medication (ICS)
      every day and take the medication the right way. All of the children with asthma in the
      school will be asked to participate. In the first year in one-half of the schools, children
      and school staff will participate in a standardized asthma education program presented by the
      American Lung Association (ALA). Children will have daily monitoring of their inhaled asthma
      medication. The other half of schools will continue with the usual treatment of children with
      asthma. In the second year of the study, all schools and children will have the asthma
      education program and monitoring. Parents will be queried quarterly for information about
      their child's asthma.
    

Intervention name(s): Supervised asthma therapy in schools
Intervention type(s): Drug
Intervention description(s): Therapy observed daily in school. Asthma education by American Lung Association
Other intervention name(s): Inhaled Corticosteroid; Ventolin
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Supervised Training Program on Mobility and Balance Confidence in Individual With Lower Limb Amputation
Condition: Amputation
Study type: Interventional

Summary: 
      It was quasi experimental study where the researchers assess the effectiveness of supervised
      training program on mobility and balance confidence in individual with lower limb amputation.
    


Intervention name(s): Gait Training
Intervention type(s): Other
Intervention description(s): the physical therapist will provide different protocol at different weeks in the following way.
first week: first fitting and initial Gait training second week: Specific Gait Training third week: Advance Gait Training fourth week: Functional Training
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were non randomly allocated to two groups and and were analyzed in the end of the study.
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: Lower limb Amputation; Balance; Mobility
An Adaptive Physical Activity Intervention for Overweight Adults
Condition: Physical Activity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to develop and evaluate an adaptive shaping intervention based
      on Behavioral Economics and Operant principles to promote physical activity behaviors
      (adaptive group) and compare to a static physical activity intervention (static group) using
      a two-group randomized controlled trial design. Participants will include 20 overweight men
      and women (BMI 25-35 kg/m2) between 18 to 55 years. Both groups will receive the following
      components: 1) a pedometer, 2) self-monitoring of physical activity, 3) brief educational
      materials, 4) motivational prompts, 5) physical activity goals, and 6) small financial
      incentives. The Adaptive Intervention (AI) group will receive adaptive goals and feedback
      based on percentiles and a "moving" window of their recent physical activity, with incentives
      linked to goal attainment. Comparison intervention participants will receive the static
      10,000 steps per day goal, with matching incentive amounts but without incentives linked to
      goal attainment. The study will compare differences in goal setting and shaping procedures
      that aim to increase physical activity behavior.

      Primary aims include:

        1. To determine whether physical activity (pedometer-measured steps/day) in both the
           Adaptive and Static interventions increased compared to their respective baselines.
           Hypothesis: Both the adaptive and static interventions will result in increased physical
           activity over 6 months.

        2. To evaluate whether the Adaptive Intervention results in greater change in physical
           activity (pedometer-measured steps/day) compared to the Static Intervention. Hypothesis:
           The adaptive intervention will result in significantly greater physical activity,
           measured by pedometer, compared to the static intervention over 6 months.

        3. To assess participants' satisfaction with the overall program. Hypothesis: Adaptive
           Intervention participants will report greater overall satisfaction with the intervention
           than the Static Intervention participants.
    


Intervention name(s): Adaptive Intervention (AI); Static Intervention (SI)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Adaptive Intervention Group (AI) receives adaptive step goals and feedback/incentives based on personal physical activity performance.; Static Intervention group (SI) receives a static "usual care" goal of 10,000 steps/day and feedback/incentives for uploading their pedometer to the study website.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Pedometer,; adaptive,; exercise,; reinforcement,; goal setting,; technology,; email,; weight loss; mHealth; eHealth
Adjustment of Mask Pressure, for Bilevel Positive Airways Pressure Therapy, by Automated Algorithm
Condition: Respiratory Insufficiency; Sleep Disordered Breathing
MeSH terms: Respiratory Aspiration; Sleep Apnea Syndromes; Respiratory Insufficiency
Study type: Interventional

Summary: 
      The aim of the study is to test the hypothesis that an automated algorithm for desired mask
      pressure improves breathing pattern and sleep quality in patients with hypercapnic
      ventilatory failure. For this purpose, The investigators will study different groups of
      patients, including those with obstructive and restrictive ventilatory defect, and
      obstructive sleep apnoea, non-naive to conventional bi-level positive airways pressure
      therapy.
    

Detailed description: 
      Persisting ventilatory failure associated with chronic obstructive pulmonary disease (COPD),
      obesity-hypoventilation-syndrome, sleep apnoea or neuromuscular disease is increasingly
      managed with domiciliary non-invasive positive pressure ventilation (NIPPV).

      Optimal settings of non-invasive ventilation are usually titrated manually and require time
      and expertise. The development of systems lead to automated analysis and development of
      algorithms to adjust ventilators. However, there is a paucity of optimal algorithms,
      particularly the problem of upper airway obstruction. Therefore, the central aim of this
      study is to develop the automated setting of an end-expiratory positive airway pressure
      (EPAP), because upper airway obstruction is relatively common in this group of patients. We
      hypothesise that an automated end-expiratory airway pressure (AutoEEP) adjusting algorithm
      could overcome these problems and further optimise and adjust ventilator settings. Using
      non-invasive ventilation in patients with hypercapnic ventilatory failure, awake and asleep,
      we will measure physiological outcome parameters and apply an AutoEEP algorithm, comparing it
      against usual care.
    

Intervention name(s): AutoVPAP with addition of AutoEPAP; AutoVPAP with EPAP manually selected
Intervention type(s): Device; Device
Intervention description(s): Implementation of automated algorithm for adjustment of conventional device parameter (EPAP0.; Conventionally applied Expiratory Positive Airway Pressure (EPAP)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Breathing pattern; Gas exchange; Sleep quality
Safety and Tolerability of Odanacatib (0822-059)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test the weighted average inhibition of u-NTx/Cre (aminoterminal crosslinked
      telopeptide of Type 1 collagen) and AUC (0-168 hours) of Odanacatib
    


Intervention name(s): Odanacatib; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral doses of Odanacatib 50 mg administered once weekly for 4 consecutive weeks; Oral Placebo tablet administered once weekly for 4 consecutive weeks
Other intervention name(s): MK0822
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Phase I Study of IBI325 in Patients With Advanced Solid Tumor
Condition: Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this phase I study is to evaluate the safety and potential efficacy
      and to determine the recommended phase 2 dose (RP2D) of IBI325 in patients with advanced
      solid tumors
    


Intervention name(s): IBI325 + sintilimab; IBI325
Intervention type(s): Drug; Drug
Intervention description(s): IBI325 + sintilimab combination does-escalation Patients will receive IBI325 and sintilimab until progressive disease, intolerability, or other reasons leading to treatment discontinuation; IBI325 monotherapy does-escalation Patients will receive IBI325 until progressive disease, intolerability, or other reasons leading to treatment discontinuation
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Double-blind, Placebo-controlled Comparative Study and Open-label Extension Study to Confirm the Efficacy and Safety of E2020 in Subjects With Down Syndrome Having Regression Symptoms and Disabled Activities of Daily Living.
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this double-blind, placebo-controlled, comparative study and open-label
      extension study is to confirm the efficacy and safety of E2020 in subjects with Down syndrome
      having regression symptoms and disabled activities of daily living.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, multiple-dose (two doses),
      placebo-controlled, parallel-group comparative study followed by an open-label extension
      study of E2020 in subjects with Down syndrome having regression and disabled ADL. A total of
      60 subjects will be randomized to one of three dosing groups (at 1:1:1) to receive 3 mg of
      E2020, 5 mg of E2020, or placebo for 24 weeks based on their total scores of Body
      Functionality Checklist, sex, and study site as the allocation factors. This study consists
      of Pre-randomization Phase (4 weeks), Double-blind Phase (28 weeks), and Extension Phase (24
      weeks). The Double-blind Phase includes a 24-week treatment period plus a 4-week transition
      period.
    

Intervention name(s): E2020-Donepezil hydrochloride; E2020-Donepezil hydrochloride; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3 mg of E2020 (oral) once daily, for 24 weeks; 5 mg of E2020 (oral) once daily, for 24 weeks; placebo (oral) once daily, for 24 weeks
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Down syndrome; regression symptoms; disabled activities of daily living
Evaluation of the Long Term Efficacy of Endovascular Treatment of Type 2 Endoleaks
Condition: Abdominal Aortic Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Endoleak
Study type: Observational

Summary: 
      Endovascular treatment has become the first choice to repair abdominal aortic aneurym, but
      exposes patients to a risk of endoleaks. Although treatment of type 1 and 3 endoleaks has
      proven to prevent aneurysms from rupture, controversies remain about type 2 endoleaks. The
      investigators described the different techniques of type 2 endovascular repair, and their
      efficacy at short and long term..
    


Intervention name(s): Type II endoleak treatment
Intervention type(s): Procedure
Intervention description(s): Type II endoleak endovascular treatment
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients treated for type II endoleaks by endovascular therapy between the 01 January
        2008 and the 31 December 2018
To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria
Condition: Chronic Spontaneous Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 3

Summary: 
      A Double-blind, Randomized, Active-controlled, Parallel Group, Phase 3 Study to Compare
      Efficacy and Safety of CT-P39 and Xolair in Patients with Chronic Spontaneous Urticaria Who
      Remain Symptomatic despite H1 antihistamine Treatment
    

Detailed description: 
      CT-P39, containing the active ingredient omalizumab, is a recombinant humanized monoclonal
      antibody that is being developed and manufactured as a proposed biosimilar to Xolair
      (omalizumab) by the Sponsor. CT-P39 is identical to Xolair with respect to concentration and
      presentation. The 150 mg of drug product (CT-P39) will have the same pharmaceutical form and
      strength as 150 mg Xolair (in a prefilled syringe [PFS] for subcutaneous injection) and is
      intended to have a similar quality profile compared with Xolair.
    

Intervention name(s): CT-P39; EU-approved Xolair
Intervention type(s): Biological; Biological
Intervention description(s): Prefilled syringe (PFS) of 1 mL solution; Prefilled syringe (PFS) of 1 mL solution
Other intervention name(s): Omalizumab; Omalizumab
Intervention MeSH terms: Omalizumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Spontaneous Urticaria