bioihbjkbjnl/mcl2 huggingface dataset:
RBM-007 in Subjects witH ExudatIve Age-related Macular Degeneration
Condition: Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an open label, non-controlled, dose-escalating study assessing the safety,
      tolerability, and bioactivity of a single intravitreal (i.vt.) injection of RBM-007 in
      approximately nine subjects with exudative age-related macular degeneration.
    

Detailed description: 
      Nine subjects in three dose cohorts (3 subjects each cohort) will receive a single i.vt.
      injection of RBM-007 in the study eye. Subjects will be followed through Day 56.
    

Intervention name(s): RBM-007 Injectable Solution
Intervention type(s): Drug
Intervention description(s): (No additional description)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: This is an open label, non-controlled, sequential, dose-escalating study
Masking: None (Open Label)
Primary purpose: Treatment
Chronicity Dependence of a Balance Training in Adults Post-stroke
Condition: Stroke, Postural Balance, Virtual Rehabilitation
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The level of stroke chronicity has been proposed as an influential variable related to
      functional balance. However, little is known about the effect of this variable on the
      effectiveness and maintenance of gains of physical therapy interventions on balance. The
      objective of this study is to determine the influence of time since injury on the
      rehabilitation of balance after stroke. Participants will be assigned to a least (6-12
      months), a moderate (12-24 months), or a most chronic (> 24 months) group. All the
      participants will train for 20 one-hour sessions, administered three to five times a week,
      combining conventional physical therapy exercises and customized exercises interfaced on a
      balance board that promotes the training of the ankle and hip strategies. Participants will
      be assessed before, after the intervention, and one month later with a posturography test
      (sway speed and limits of stability) and clinical scales (Berg Balance Scale, Functional
      Reaches Test, 30-Second Sit-to-Stand Test, Timed Up and Down Stairs Test, Stepping Test,
      Timed Up-and-Go Test, and the 10-meter Walking Test).
    


Intervention name(s): balance virtual rehabilitation
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Home Based Exercise Program for Brain Injury Children
Condition: Brain Injury; Cerebral Palsy
MeSH terms: Brain Injuries; Cerebral Palsy
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether simple home-base aerobic exercise program
      have beneficial effect on walking abilities and balance performance in children with brain
      damage
    


Intervention name(s): home exercise
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study of ONO-8539 in Patients With Overactive Bladder
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to investigate efficacy, safety and tolerability of ONO-8539
      in patients with overactive bladder.
    


Intervention name(s): Placebo; Tolterodine; ONO-8539; ONO-8539; ONO-8539
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo / 12 weeks; 4mg / 12 weeks; low dose / 12 weeks; medium dose / 12 weeks; higher dose / 12 weeks
Intervention MeSH terms: Tolterodine Tartrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ONO-8539; Overactive bladder; OAB
Examining Validity and Reliability of the Shared Decision Making Process Survey in Adults With Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Observational

Summary: 
      The purpose of this study is to test two differently worded versions of the Shared Decision
      Making Process scale in a sample of adults who have recently made a decision about treatment
      of depression. The main goals are to gather evidence of reliability, to test whether the
      generic version has similar psychometric performance to the original, and to extend
      generalizability of the findings to younger adults.
    

Detailed description: 
      The purpose of this study is to test two differently worded versions of the Shared Decision
      Making Process scale in a sample of adults who have recently made a decision about treatment
      of depression. The main goals are to gather evidence of psychometric performance of the
      scale, compare performance of different wording for items, and to extend generalizability of
      the findings to younger adults.

      Subjects are randomly assigned to one of the two versions of the Shared Decision Making
      Process scale and complete a set of measures regarding their experiences with decision making
      for depression, demographics, and health status. A subset of respondents will complete the
      Shared Decision Making Process scale and selected other items again 1 week later to examine
      short term test-retest reliability.

      Staff will work with a national sampling firm to recruit subjects and obtain 500 responses to
      the baseline survey (n=250 for each version) and a subset will complete a retest survey
      (n=200; 50 from each age and survey type group). Eligible subjects are adults aged 18-75 who
      talked with a health care provider about treatment for depression in the preceding 12 months.
      The sample is not a national probability sample; however, the recruitment efforts will ensure
      about 50% of respondents aged 18-39 and 50% aged 40-75, and to ensure at least 25% of the
      sample is racial/ethnic minorities (Black or African American, Asian, Hispanic or Latino).

      The investigators will examine validity and reliability of the different versions. The sample
      size was determined to ensure sufficient power to detect differences in key subgroups,
      including age (younger adults vs. older adults) and version (A vs. B). To detect a difference
      of about 0.33 standard deviations at 0.05 significance with 80% power would require 125 per
      group.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Sample of adults in the United States who have made decision about treatment of depression
        in the past 12 months will be recruited from an online panel.
      
Keywords: shared decision making
Study of Genotype and Phenotype Expression in Congenital Nephrogenic Diabetes Insipidus
Condition: Diabetes Insipidus, Nephrogenic
MeSH terms: Diabetes Insipidus; Diabetes Insipidus, Nephrogenic
Study type: Observational

Summary: 
      OBJECTIVES:

      I. Determine the relationship between genotype variations and clinical phenotype in patients
      with congenital nephrogenic diabetes insipidus.
    

Detailed description: 
      PROTOCOL OUTLINE: A detailed family history is obtained from all participants. Whenever
      possible, standard growth curves of affected children are obtained.

      Participants then undergo clinical studies of antidiuretic function. A standard fluid
      deprivation-vasopressin challenge is performed with timed measurements of osmolality,
      electrolytes, creatinine, and vasopressin. The next day, blood pressure, plasma cyclic AMP,
      GMP, von Willebrand Factor, Factor VIII, and urine osmolality are measured during a water
      load desamino-D-arginine vasopressin (dDAVP) infusion test.

      Participants with a confirmed diagnosis of congenital diabetes insipidus are then treated
      with chlorothiazide. Daily urine volume and osmolality are determined before and after
      therapy. Sodium and fluid are not restricted.

      For each family, the entire vasopressin V2 gene of at least 1 affected male, and where
      possible at least 1 obligate carrier and 1 unaffected brother of a patient is sequenced. In
      addition, a detailed Xq28 haplotype analysis is done to identify the origin of de novo
      mutations. If no mutation is found and the disorder is not transmitted in an X-linked mode,
      both alleles of the gene that codes for aquaporin-II are also sequenced. DNA is collected by
      mail from as many kindred as possible who do not participate in the clinical studies.
    

Intervention name(s): chlorothiazide
Intervention type(s): Drug
Intervention MeSH terms: Chlorothiazide
Keywords: diabetes insipidus; endocrine disorders; rare disease
Treatment Development Targeting Severe and Persistent Negative Symptoms
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      People with schizophrenia often have problems with negative symptoms; expressing and
      identifying their emotions, their amount of speech, motivation and interests, feelings of
      purpose, social skills, and experiencing enjoyment. For this reason, new interventions are
      being developed to treat these problems. One new intervention is the Motivation and
      Engagement (MOVE) Program. The MOVE program is a new program which consists of weekly
      meetings for 9 months between a patient and a trainer. The weekly meetings will consist of
      goal setting and organization of the home to make daily tasks more manageable. During the
      weekly meetings the patient and trainer will discuss emotions and the trainer will help the
      patient identify their emotions.

      The researchers hope to learn whether MOVE will help improve the problems. If it works the
      researchers will do a larger study comparing MOVE to other treatments that have addressed
      some of the problems already.

      The therapist will ask you if the sessions can be audio taped to ensure that the therapist is
      doing a helpful job for you. They will also ask if the session can be video taped so that the
      tapes can be used to train other therapists learning about MOVE. The choice to do either of
      these is voluntary and you can continue to participate in the study if you choose not to have
      the session be audio and/or video taped.You will be provided a University Release document to
      provide that permission if you so choose.
    


Intervention name(s): MOVE
Intervention type(s): Behavioral
Intervention description(s): MOVE Program group: MOVE consists of medication follow-up at the CHCS or ATCMHMR and meeting once a week for 9 months with a MOVE trainer in your home. You and your trainer will work on interviews for the first three visits that will talk about negative symptoms, thoughts, attitudes, and social skills that will help each of you develop goals together. Activities will be developed around improving initiation, enjoyment, success and outcome. These activities will be customized to you and will change based on your needs weekly throughout the 9 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: negative symptoms
Safety and Efficacy of Pegylated IFN-alpha 2B Added to Dasatinib in Newly Diagnosed Chronic Phase Myeloid Leukemia
Condition: Leukemia, Myeloid, Chronic-Phase
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with newly diagnosed CML have excellent outcomes with tyrosine kinase inhibitors
      (TKI). However, a few patients will be cured with TKIs alone, and thus need continued
      life-long treatment. Some patients achieve complete molecular remission (CMR), and this rate
      is higher with second generation TKIs compared with imatinib. Some experience with drug
      discontinuation in CMR has been derived from a few small studies, most notably the French
      STIM study. Approximately 40 % of patients with a minimum of two years in MR4.5 (4.5 log
      reduction in molecular response) can stop imatinib without relapse, indicating possible cure.
      To increase the non-relapse rate is of major importance. To achieve a permanent "cure"
      without stem cell transplantation is presently the most relevant goal of clinical studies in
      CML.

      The investigators hypothesize that to significantly increase cure rates in CML, therapy
      should eradicate leukemic stem cells and/or induce or restore anti-CML immunity. Second
      generation TKIs may have a more profound effect on the stem cell pool as compared to
      imatinib. This is assessed in our current randomized study with a reduction in leukemic stem
      cell burden as the primary endpoint (NordCML006). Interferon-alpha (IFN) has a prominent
      immunomodulatory and antiproliferative mode of action, and has also activity in stem cells.
      Pegylated IFN in combination with imatinib results in improved therapy responses as compared
      to imatinib monotherapy. This advantage may translate into higher cure rates.

      Dasatinib has a unique dual mechanism of action: it is the most potent of available TKIs and
      induces immunological effects that are different from those of IFN. Both of these drugs may
      have immunological adverse-effects when used as a monotherapy. However, immunological
      adverse-effects may also be markers of anti-leukemia efficacy. A combination of dasatinib and
      pegylated IFN (PegIFN) may have additive or synergistic effects and should be tested in a
      clinical study.
    


Intervention name(s): Dasatinib + PegIFN
Intervention type(s): Drug
Intervention MeSH terms: Dasatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dasatinib; Protein Kinase Inhibitors; pegylated IFN-alpha 2B; Interferon-alpha
Pilot Study on the Effect of Oral Controlled-Release Alpha-Lipoic Acid on Oxidative Stress in Adolescents With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The long-term effects of high blood sugar include blindness, kidney failure, and nerve damage
      that can ultimately cause loss of limbs. Research has shown that high blood sugar increases
      the amount of reactive oxygen species (ROS) produced in diabetics, and that the increase in
      ROS causes damage to eyes, kidneys, and nerves by a process called "oxidative stress." We
      postulate that alpha-lipoic acid, a potent anti-oxidant, can stop ROS from forming, thereby
      preventing long-term complications in diabetes. In this pilot study, we will be giving 30
      teenagers with type 1 diabetes (T1D) controlled-release alpha-lipoic acid for 3 months, and
      comparing the amount of oxidative stress before and after treatment. Ten teenagers with T1D
      will receive placebo instead of alpha-lipoic acid and undergo the same research protocol to
      aid in validation of outcome measures.
    


Intervention name(s): controlled-release oral alpha-lipoic acid
Intervention type(s): Drug
Intervention MeSH terms: Thioctic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 1; lipoic acid; oxidative stress
Ozone and Rhinovirus-Induced Disease in Asthmatics
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      In the U.S., morbidity associated with human rhinovirus (RV) infection represents a major
      health problem. In asthmatics, up to 80% of asthma exacerbations are associated with upper
      respiratory infections. Despite evidence that environmental oxidant pollutants, such as
      ozone, may increase the severity of viral disease, the mechanisms underlying such an effect
      have not been identified. This study will test the hypothesis that exposure of allergic
      asthmatic subjects to ambient levels of ozone directly enhances viral disease by increasing
      infectivity and intensifying virus-induced inflammation.
    

Detailed description: 
      In mild asthmatics, the study will investigate: (1) if exposure to ozone will enhance the
      viral infective process in the nasal epithelium, (2) the effect of ozone exposure on
      RV-induced inflammatory gene expression, mediator release and inflammatory cell influx into
      the upper and lower airways, and (3) the interactive effects of ozone and RV on airway
      reactivity. This information will improve our understanding of the risk associated with
      oxidant pollutant exposure in this population of individuals in whom RV infection may
      represent a significant health concern.
    

Time perspective: Prospective
Keywords: Asthma; Rhinovirus; Ozone
Video Education About Nasogastric Tube Feeding
Condition: Nutrition, Healthy; Nurse's Role; Education; Pediatric
Study type: Interventional

Summary: 
      Summary Aim: This research was conducted to determine the effectiveness of education given to
      students using video in feeding with the nasogastric tube for pediatric patients.

      Method: It was a randomized controlled experimental study. The sample of the study consisted
      of 61 nursing students. The students included in the study were divided into two equal
      groups: the experimental and control groups. Video-supported education material of the
      experimental group and theoretical education was applied to the control group. Before and
      after the education, a post-knowledge test was made and evaluated.
    


Intervention name(s): Video-supported education group
Intervention type(s): Other
Intervention description(s): Providing training on nutrition with a nasogastric tube in pediatric patients with a video-supported education method
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The research was a randomized controlled, experimental study.
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Nursing students; Education; Pediatric patient; Nasogastric tube; Feeding
Study in Healthy Volunteers to Investigate the Effects of Ketoconazole on the Pharmacokinetics of NKTR-118
Condition: Bioavailability; Healthy Volunteers; Drug- Drug Interactions
Study type: Interventional
Phase: Phase 1

Summary: 
      Study in healthy volunteers to investigate the effects of Ketoconazole on the
      Pharmacokinetics of NKTR-118
    

Detailed description: 
      An Open-label, 1-sequence, 3-period, 3-treatment, Crossover Study to Assess the Effects of
      Ketoconazole on the Pharmacokinetics of NKTR-118 in Healthy Subjects
    

Intervention name(s): NKTR-118; Ketoconazole
Intervention type(s): Drug; Drug
Intervention description(s): Oral 25 mg; Oral 400 mg
Intervention MeSH terms: Ketoconazole; Naloxegol
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; Healthy male and female volunteers; Drug-drug interaction; Pharmacokinetics; NKTR-118
Calcium Kinetic Responses to Exercise
Condition: Nutritional Status; Bones
Study type: Interventional

Summary: 
      This randomized cross-over study will identify physiological factors that underlie changes in
      bone metabolism that could affect skeletal injury risk, to include increases in parathyroid
      hormone (PTH) in response to militarily relevant exercise in females. The primary objective
      is to determine the hormone and calcium (Ca) response to multiple bouts of load carriage
      exercise in females. The investigators hypothesize that PTH will increase after multiple
      bouts of load carriage exercise and this increase will be due to disruption in Ca kinetics,
      specifically either a decrease in fractional intestinal Ca absorption (FCA) or changes in
      bone formation and/or resorption.
    

Detailed description: 
      Initial military training (IMT) results in increased risk of stress fracture, particularly
      for females as up to 21% of females may sustain a stress fracture during IMT, an incidence
      that is approximately 4-fold higher than that for males. Young female adults will undergo two
      separate study periods in random order, one will include exercise and the other will not.
      Each study period will use dual stable Ca isotope methodology in order to determine Ca
      kinetic responses to a militarily relevant exercise, and dietary intake will be controlled.
      Kinetic analyses will include fractional intestinal Ca absorption (FCA), Ca flux into bone
      (Vo+) and out of bone (Vo-), as well as renal Ca handling. Serial blood samples collected
      during the study periods will also be used to determine hormonal responses to exercise. The
      treadmill exercise will consist of a 60 minute timed trial with load carriage (30% body
      weight) completed three times during the 6 day kinetic period. At the start of the study,
      blood will be collected for analysis of Ca and bone-related genetic markers, and habitual
      food intake and exercise will be assessed. The information gathered from this trial will be
      used to identify physiological responses that can be targeted by future interventions
      designed to improve bone responses to training and decrease injury risk in female Warriors.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Treadmill exercise for 60 minutes with load carriage (weighted vest, 30% body weight) completed three times during the 6 day kinetic period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine
Condition: Major Depressive Disorders
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective :

        -  To demonstrate the antidepressant efficacy on the Hamilton Depression Rating Scale of
           SR58611A 700mg/day compared with placebo in the treatment of patients with a recurrent
           major depressive episode.

      Secondary objectives:

        -  To assess the safety profile of SR58611A 700 mg/d in comparison to placebo and to assess
           plasma concentrations of the active metabolite.
    


Intervention name(s): amibegron (SR58611A); placebo; paroxetine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral administration 2 X 350mg/day at 12 hours intervals; oral administration 12 hours intervals; oral 20 mg/day
Intervention MeSH terms: Paroxetine; Amibegron; Amibegron hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Depression