bioihbjkbjnl/mcl2 huggingface dataset:
UTMB Research on Severe Asthma (UROSA) Study
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      To identify and understand biologic aspects of severe asthma compared to subjects with mild
      to moderate asthma and subjects without asthma (normal or healthy volunteers).
    

Detailed description: 
      It has been shown that severe asthma differs from milder asthma in its pathophysiology; in
      particular we are interested in examining why patients with severe asthma have disease that
      is resistant to corticosteroids. While we will be studying patients with severe asthma, we
      also need to study subjects to act as controls. To this end we will recruit subjects into the
      following groups: Normal volunteers; Mild asthmatics not taking inhaled corticosteroids; Mild
      to moderate asthmatics requiring and using inhaled corticosteroids and Severe asthmatics.

      Subjects between the ages of 18 and 65 will be enrolled in this study. We aim to recruit
      enough subjects such that 120 male and female participants (30 in each of the above groups)
      will complete the bronchoscopy.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Normal volunteers; Mild asthmatics not taking inhaled corticosteroids; Mild to moderate
        asthmatics requiring and using inhaled corticosteroids and Severe asthmatics
High-Dose Therapy Treatment in Patients With Follicular Lymphoma
Condition: Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Study type: Interventional
Phase: Phase 3

Summary: 
      Follicular lymphomas are a subgroup of B-cell non-Hodgkin lymphomas, accounting for 15% to
      30% of newly diagnosed lymphomas.1-3 Median survival varies from 5 to 10 years depending on
      the prognostic factors at diagnosis and response to first-line therapy.4-6 Whatever the
      treatment, no plateau appears on survival curves, and virtually all patients relapse;
      follicular lymphomas are ultimately progressive, and fatal.2,3,5 No reference first-line
      treatment is clearly defined. One of the most active therapies is still doxorubicin-based
      chemotherapy with or without interferon.7-9 New therapeutic approaches including purine
      analogs and anti-CD20 monoclonal antibody are promising and are progressively included in the
      management of these lymphomas.2,3,10-13 The role of high-dose therapy (HDT) as a salvage
      treatment for patients with relapsing follicular lymphoma is demonstrated by some authors;
      several reports have shown the superiority of HDT followed by autologous stem-cell
      transplantation, purged or unpurged, compared with conventional chemotherapy in terms of no
      relapse and overall survival.14-18 Only a few reports have been published showing HDT results
      as a first-line treatment for poor-risk patients with follicular lymphoma, and the results
      remain controversial.19-26 These data prompted the French Groupe Ouest-Est des Leucémies et
      Autres Maladies du Sang (GOELAMS) to conduct a prospective randomized trial using patients
      with newly diagnosed follicular lymphoma with a high tumor burden. A combined
      doxorubicin-based chemotherapy associated with interferon was compared to front-line HDT
      followed by purged autologous stem-cell transplantation.
    

Detailed description: 
      Age 8-60 years old follicular lymphoma Not previously treated Stage II bulky, III or IV An
      Arbor classification high tumor burden
    

Intervention name(s): chemotherapy; high dose therapy and autologous stem cell transplantation
Intervention type(s): Procedure; Procedure
Intervention description(s): injection cyclophosphamide doxorubicin (25 mg/m2), and teniposide (60 mg/m2)(600 mg/m2)on day 1 and prednisone (40 mg/m2), administered orally on days 1 to 5.4,12 Treatment consisted of a 6-course induction phase administered monthly, followed, for responders and patients presenting a stable disease, by a maintenance phase that consisted of 1 cycle every 2 months for 1 year. Concomitant subcutaneous interferon alfa-2b was administered at 5 x 106 3 times a week for 18 months.; VCAP regimen 3 cycles , less than PR: 2-3 DHAP, stem cell collection, in vitro purging autologous stem cell transplantation with TBI and cyclophosphamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phase III study patients with follicular lymphoma
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Nebulized Ensifentrine in Healthy Chinese Subjects
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, open-label, parallel cohort study to evaluate the PK, safety and
      tolerability of nebulized ensifentrine following administration of single and multiple doses
      in healthy Chinese male subjects.
    

Detailed description: 
      This study consists of two cohorts, and approximately a total of up to 28 healthy male
      subjects, 14 subjects in Cohort 1, and 14 subjects in Cohort 2, will be enrolled. Cohort 2
      will be randomly assigned to Sequence 1 and Sequence 2 according to the ratio of 1:1.

      Treatment Group

        1. Cohort 1: subjects will receive a 3 mg ensifentrine single dose, followed by 3 mg
           repeated dose (twice daily, BID).

        2. Cohort 2: subjects will receive two single doses of 1.5 mg and 6 mg ensifentrine,
           separated by at least a 7-day washout period using crossover design.
    

Intervention name(s): Ensifentrine; Ensifentrine
Intervention type(s): Drug; Drug
Intervention description(s): 14 Subjects enrolled will use one 3 mg/2.5 mL ampule for the 3 mg dose, subjects will receive a 3 mg ensifentrine single dose, followed by 3 mg repeated dose (twice daily, BID). On the dosing day (Day 1), subjects will receive a single dose of 3 mg ensifentrine. On Day 4, subjects will receive multiple doses of 3 mg ensifentrine BID for 3 days (Day 4 to Day 6), and a morning dose will be administered on Day 7.; 14 subjects will be enrolled in this cohort, then randomly assigned to one of 2 treatment sequences (6mg and 1.5mg single dose). Subjects will 2 different dose levels of study drug. Two 3 mg/2.5 mL ampules will be needed for the 6 mg dose (5 mL total volume) and the 1.5 mg dose will be achieved using an appropriate dilution protocol described in the pharmacy manual.
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug Interaction Study - Effect of AZD5672 on the Pharmacokinetics of Digoxin
Condition: Healthy Volunteers; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to examine the effect of AZD5672 (dosed to steady state) on the
      pharmacokinetics of digoxin (single dose administration).
    


Intervention name(s): AZD5672; Digoxin
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg, for 13 days; 0.5mg dose
Other intervention name(s): Lanoxin
Intervention MeSH terms: N-(1-(3-(3,5-difluorophenyl)-3-(4-methanesulfonylphenyl)propyl)piperidin-4-yl)-N-ethyl-2-(4-methanesulfonylphenyl)acetamide; Digoxin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: AZD5672; digoxin
Biologic Assessment of Satiety
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      Subjective measures of satiety are correlated with biologic mechanisms of appetite control.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy men and women
      
Biospecimen description: 
      blood samples
    
Keywords: obesity; satiety; body weight management
Transcranial Magnetic Stimulation (TMS) for Upper Limb Dysfunction in Spinal Cord Injury: a Feasibility Study
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      This study will investigate how repetitive transcranial magnetic stimulation (TMS) using
      intermittent theta-burst stimulation (iTBS) paradigm affects sensorimotor dysfunction such as
      pain, spasticity, motor weakness and sensory loss. TMS is technique which allows non-invasive
      stimulation of the cortex, and can modulate activity of neurons. The purpose of this study
      will be to assess the feasibility of using TMS with iTBS paradigm to treat sensorimotor
      dysfunction in people with incomplete spinal cord injury affecting the upper limbs.
    


Intervention name(s): Transcranial Magnetic Stimulation using iTBS Paradigm
Intervention type(s): Device
Intervention description(s): TMS is a non-invasive, painless method of stimulating the central and peripheral nervous system. ITBS is a form of TMS which is delivered for ~200sec and can promote changes in neural activity.
Other intervention name(s): repetitive Transcranial Magnetic Stimulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: transcranial magnetic stimulation; Spinal Cord Injuries; Muscle Spasticity; Pain; Spinal Cord; Spinal Cord Diseases
Child and Adolescent Anxiety Disorders (CAMS)
Condition: Anxiety Disorders; Social Phobia; Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized, controlled trial compared the efficacy of the medication sertraline
      (Zoloft®), cognitive-behavioral therapy, the combination of these treatments, and placebo for
      youth with anxiety disorders.
    

Detailed description: 
      Anxiety disorders are among the most common conditions affecting children and adolescents.
      These disorders impair school, social, and family functioning. When left untreated, they also
      put children at risk for major depression and substance abuse in late adolescence and
      adulthood. Previous studies demonstrated the efficacy of cognitive behavioral therapy and
      selective serotonin-reuptake inhibitors for the treatment of child anxiety disorders. This
      study is testing the relative and combined efficacy of cognitive behavioral therapy and
      selective serotonin reuptake inhibitors as compared to each other and pill placebo.

      During Phase I of this two-phase study, 488 participants were randomly assigned to receive
      sertraline (Zoloft), cognitive behavioral therapy, a combination of these treatments, or a
      placebo for 12 weeks. Phase II involved a 6-month maintenance period for participants.
    

Intervention name(s): Sertraline (SRT); Cognitive Behavioral Therapy (CBT); Placebo
Intervention type(s): Drug; Behavioral; Drug
Intervention description(s): Participants were treated with sertraline.; Participants received CBT.; Participants were treated with a placebo pill.
Other intervention name(s): Zoloft
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phobic Disorders; Anxiety, Separation
A Sedation/Cognition/Electroencephalogram (EEG) Study Using AZD7325 and Comparator.
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine the effects of the compound AZD7325 as compared to
      lorazepam on sleepiness, concentration and brain activity.
    


Intervention name(s): AZD7325; AZD7325; AZD7325; Lorazepam; Lorazepam
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): AZD7325 10 mg oral 2 capsules; AZD7325 1 mg oral 2 capsules; AZD7325 Placebo oral 2 capsules; Lorazepam 1 mg oral 2 tablets; Lorazepam Placebo oral 2 tablets
Intervention MeSH terms: Lorazepam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Phase I; pharmacodynamic study
Pirfenidone in Treating Young Patients With Neurofibromatosis Type 1 and Plexiform Neurofibromas
Condition: Neurofibromatosis Type 1; Precancerous Condition
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma; Precancerous Conditions; Neurofibroma, Plexiform
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
      development or recurrence of cancer. Pirfenidone may slow the growth or prevent further
      development of plexiform neurofibromas.

      PURPOSE: Phase I trial to study the effectiveness of pirfenidone in treating young patients
      who have neurofibromatosis type 1 and plexiform neurofibroma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose or "comparable dose" of pirfenidone in pediatric
           patients with neurofibromatosis type 1 and inoperable, symptomatic plexiform
           neurofibromas.

        -  Determine the toxic effects of this drug in these patients.

        -  Determine the plasma pharmacokinetics of this drug in these patients.

        -  Determine, preliminarily, if this drug could be beneficial for pediatric patients with
           refractory solid tumors.

        -  Assess the quality of life of patients treated with this drug.

      OUTLINE: This is an open-label, multicenter, dose-escalation study.

      Patients receive oral pirfenidone three times daily on days 1-28. Courses repeat every 28
      days for up to 2 years in the absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of pirfenidone until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
      of 6 patients experience dose-limiting toxicity.

      Quality of life is assessed at baseline, before course 4, and then after every 6 courses.

      PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study within 18 months.
    

Intervention name(s): pirfenidone
Intervention type(s): Drug
Intervention MeSH terms: Pirfenidone
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: plexiform neurofibroma; neurofibromatosis type 1
Gabapentin for the Treatment of Hot Flashes in Menopausal Women
Condition: Hot Flashes; Menopause
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of gabapentin compared
      to placebo in the treatment of hot flashes in postmenopausal women using a phase III
      randomized controlled trial.
    

Detailed description: 
      For women who fear developing breast cancer, those who have contraindications to hormone
      replacement therapy and those who prefer an alternative treatment, there is presently no
      standard treatment for hot flashes. Women and health care providers have few options other
      than hormone replacement therapy as evidenced-based trials of alternatives have not shown
      many effective options. Many non-hormonal agents have been studied including antidepressants,
      antihypertensives, vitamin E, soy products, black cohosh, acupuncture, and belladonna and
      ergotamine combinations. Preliminary studies using the antiseizure medication, gabapentin
      (Neurontin), has demonstrated a substantial reduction in hot flashes. This agent may provide
      an effective treatment for hot flashes in postmenopausal women.
    

Intervention name(s): gabapentin
Intervention type(s): Drug
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: gabapentin; hot flashes or flushes; menopause
A Study to Determine the Safety and Tolerability of Dupilumab (REGN668/SAR231893) in Patients Aged ≥6 to <18 Years With Atopic Dermatitis (Eczema)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to characterize the safety and pharmacokinetics (PK) of
      dupilumab in pediatric patients with moderate-to-severe atopic dermatitis (AD) (for
      adolescents ≥12 to <18 years of age) or severe AD (for children ≥6 to <12 years of age).

      The secondary objective of the study is to explore the immunogenicity and efficacy of
      dupilumab in pediatric patients with moderate-to-severe AD (for adolescents ≥12 to <18 years
      of age) or severe AD (for children ≥6 to <12 years of age).
    


Intervention name(s): Dupilumab
Intervention type(s): Drug
Other intervention name(s): REGN668(SAR231893)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eczema
Normative Values for Cognitive Testing and Alzheimer's Imaging Biomarkers in Young Adults
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Biomarkers of Alzheimer's disease (AD) occupy an essential place in recently formulated
      diagnostic criteria for AD where their role is to identify the pathophysiological processes
      underlying cognitive impairment or to predict time to dementia. Three of these biomarkers are
      brain imaging tests (amyloid PET, fludeoxyglucose (FDG) PET, and structural MRI). In order to
      effectively use AD biomarkers for diagnostic and prognostic purposes, continuous values much
      be divided into normal and abnormal ranges. This requires that a cut point(s) be established
      in the continuous distribution of values for each biomarker.

      The investigators objective in this proposal is to obtain imaging biomarker data in a group
      of individuals who are appropriate for establishing normative values for AD biomarkers. The
      investigators believe the most valid approach to establishing biomarker cut points is to base
      them on the upper bound of the range observed in young to early-middle-age subjects in whom
      the presence of occult AD pathology is extremely unlikely. Based on a large volume of
      community-based autopsy data, that upper age limit would be about 50 years old. The lower age
      bound for a group of subjects used to establish normative AD biomarker values would have to
      be based on considerations of brain maturation, which may continue into the middle- to
      late-20s. Thus, taking the above into consideration, the ideal age range for establishing
      normative AD imaging biomarker data (amyloid PET, FDG PET, and structural MRI) may be ages
      30-49 years old.
    


Intervention name(s): F-18 FDG; C-11 PiB
Intervention type(s): Drug; Drug
Intervention description(s): One time intravenous administration of 17 millicurie (mCi) +/- 10%; One time intravenous administration of 10-20 mCi
Intervention MeSH terms: Fluorodeoxyglucose F18
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study of Copanlisib in Hepatic or Renal Impairment
Condition: Hepatic Insufficiency, Renal Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetics and safety of copanlisib in subjects with impaired hepatic
      or renal function in comparison to healthy subjects
    


Intervention name(s): Copanlisib (ALIQOPA, BAY80-6946)
Intervention type(s): Drug
Intervention description(s): 12mg single dose, intravenous on Day 0
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Renal Impairment; Pharmacokinetics; Hepatic impairment; Envisaged indication: Treatment of cancer
mRNA Expression in Lymphocytes of Glaucoma Patients
Condition: Glaucoma; Healthy Subjects
MeSH terms: Glaucoma
Study type: Observational

Summary: 
      The aim of the study is to compare messenger ribonucleic acid (mRNA) expression of various
      genes in lymphocytes between glaucoma patients and sex and age-matched healthy subjects. A
      secondary objective is to analyze the impact of different forms of glaucoma or of a
      vasospastic propensity on the findings.
    

Detailed description: 
      Glaucoma is a leading cause of blindness world-wide. Chronic primary open-angle glaucoma is
      the most common form among Caucasian patients. The glaucoma patients will be divided into
      four groups: (1) high tension glaucoma, (2) normal tension glaucoma, (3) pseudoexfoliation
      glaucoma, and (4) juvenile glaucoma. Healthy subjects are separated into two age groups.
      Vasospastic propensity will be assessed with a questionnaire: patients and subjects answering
      yes to the questions: "do you have always cold hands, even during summer time?" and "do other
      people tell you that you have cold hands?" will be classified as vasospastic, and as normals
      if they deny a history of cold hands. Blood will be drawn from an arm vein, lymphocytes will
      be isolated and mRNA of following genes will be assessed in these lymphocytes:

      Nuclear proteins: NF-kappa B, XPGC, P53, XIAP; Multi-drug resistance proteins: ABC 1, ABC 8,
      MDR 3; Adhesion protein: ICAM 1; Blood brain barrier breakdown protein: P2Y; Energy
      metabolism proteins: Adrenodoxin, Adrenodoxin-reductase, Cytochrome p450,
      Cytochrome-reductase, Alcohol-dehydrogenase; Tissue remodeling proteins: MMP 9, MMP 8, MMP
      14, TIMP 1, TIMP 2, TIMP 3, TIMP 4.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        glaucoma patients, healthy subjects
      
Biospecimen description: 
      white cells
    
Keywords: mRNA; glaucoma