bioihbjkbjnl/mcl2 huggingface dataset:
Plerixafor and Filgrastim Following Cyclophosphamide for Stem Cell Mobilization in Patients With Multiple Myeloma
Condition: Refractory Multiple Myeloma; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: There are different methods of stem cell mobilization, such as using
      colony-stimulating factors alone or following chemotherapy priming. More recently, the
      combination of plerixafor and colony-stimulating factors has been shown to enhance stem cell
      mobilization. This study will assess whether the combination of plerixafor and Granulocyte
      Colony-Stimulating Factor (G-CSF) is effective following chemotherapy mobilization with
      cyclophosphamide.

      PURPOSE: To assess the safety, tolerability, and best dose of intravenous plerixafor
      following cyclophosphamide priming.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To assess the safety and tolerability of intravenous(IV) PLERIXAFOR when given in
      combination with cyclophosphamide and G-CSF as a mobilization regimen in patients with
      Multiple Myeloma.

      SECONDARY OBJECTIVES:

      I. To determine if intravenous PLERIXAFOR, given with a cyclophosphamide and G-CSF mobilizing
      regimen, will allow collection of greater than or equal to 5 x 10^6 CD34+ cells/kg in 2 or
      less apheresis days.

      II. To review the timing of intravenous plerixafor administration prior to apheresis and
      describe our experience.

      OUTLINE:

      MOBILIZATION: Patients receive cyclophosphamide intravenously (IV). Patients also receive
      filgrastim subcutaneously (SC) daily beginning approximately 24 hours later.

      TREATMENT/APHERESIS: Beginning 10 days after cyclophosphamide, patients receive plerixafor IV
      over 30 minutes followed by filgrastim SC on each day of apheresis.

      Following the collection of an adequate number of stem cells, patients undergo high-dose
      chemotherapy and autologous stem cell rescue. Patients are followed post-autologous stem cell
      transplant for engraftment.

      After completion of study treatment, patients are followed periodically.
    

Intervention name(s): plerixafor; filgrastim; cyclophosphamide; autologous hematopoietic stem cell transplantation; laboratory biomarker analysis
Intervention type(s): Drug; Biological; Drug; Procedure; Other
Intervention description(s): Given IV; Given SC; Given IV; autologous hematopoietic stem cell transplantation; Correlative studies
Other intervention name(s): AMD 3100; LM-3100; Mozobil; G-CSF; granulocyte colony-stimulating factor; Neupogen; r-metHuG-CSF; Recombinant Methionyl Human Granulocyte Colony Stimulating Factor; CPM; CTX; Cytoxan; Endoxan; Endoxana; Enduxan
Intervention MeSH terms: Plerixafor; Cyclophosphamide; Lenograstim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Moxifloxacin vs. Polytrim for Conjunctivitis
Condition: Conjunctivitis
MeSH terms: Conjunctivitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to compare the effect of Polytrim Ophthalmic Solution and
      Moxifloxacin Ophthalmic Solution in treating your child's pink eye. Both these medications
      are approved by the Food and Drug Administration, for treatment of conjunctivitis. This study
      will investigate if both of the medications are equally good.
    


Intervention name(s): moxifloxacin; polytrim
Intervention type(s): Drug; Drug
Intervention description(s): 1-2 drops three times a day for 8-10 days.; 1-2 drops four times a day for 8-10 days.
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Effect of Oral Ketone and Sodium Bicarbonate Administration During Endurance Exercise in Hypoxia
Condition: Exercise; Hypoxia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      This study is investigating the effects of oral ketone and sodium bicarbonate administration
      on physiological and metabolic parameters during cycling endurance exercise in hypoxia.
      Ketone body supplementation is commonly used among elite endurance athletes that also compete
      in the hypoxia (at altitude). To-date effects of ketones have only been investigated in
      normoxia and the data in hypoxia is lacking. Hence, we want to investigate the effect of oral
      ketone ester intake with and without additional sodium bicarbonate (NaHCO3) ingestion on i)
      blood-acid base balance and ii) exercise performance during prolonged exercise under hypoxic
      conditions. Information obtained via this study should provide valuable information with
      regard to optimisation of exercise training and athletic performance, and more importantly,
      provide pioneering insight on the metabolic and physiological responses to ketosis under
      hypoxic conditions.
    


Intervention name(s): Ketone ester; Sodium bicarbonate; Placebo
Intervention type(s): Dietary Supplement; Other; Other
Intervention description(s): 75g ketone ester in the form of a drink [96% (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, Oxfordshire, UK)] will be provided.; Sodium bicarbonate - widely accessible food ingredient will be provided.; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: exercise; hypoxia; ketone
A Study to Assess the Effects of Repeat Doses of Fluticasone Furoate and GW642444M Combination in Healthy Subjects and in Subjects With Severe Impairment.
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the saftey of giving fluticasone furoate 200mcg/GW642444M 25mcg once
      daily for 7 days to patients with severe renal imparement. The results of this study will aid
      in deciding whether a FF/GW642444M doseadjustment is justified in subjects with severe renal
      impairment and in estimating any such adjustments.
    

Detailed description: 
      This is an open-label, non-randomized study which will assess the pharmacokinetics and safety
      following 7 days once daily dose of inhaled FF/ GW642444M (200/25mcg) in subjects with renal
      impairment. Nine subjects with severe renal impairment (as defined by a Clcr<30mL/min) will
      be recruited along with healthy control subjects (as defined by a Clcr>80mL/min matched to
      the severe subjects based on gender, ethnicity, body mass index (±15%) and age (±5 years)).
      All subjects will receive fluticasone furoate 200mcg/GW642444M 25mcg once daily for 7 days.
      The results of this study will aid in deciding whether a FF/GW642444M dose adjustment is
      justified in subjects with severe renal impairment and in estimating any such adjustments.
    

Intervention name(s): Inhaled FF/ GW642444M (200/25mcg)
Intervention type(s): Drug
Intervention description(s): All subjects will be assigned to take FF/ GW642444M (200/25mcg) combination once daily for 7 days.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: cortisol; renal impairment; serum potassium; pharmacokinetics; Fluticasone furoate; heart rate
Adalimumab PK Bioequivalence Study to EU and US Sourced Humira
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Double-Blind, 3-Way Parallel Study to Compare the Pharmacokinetics, Safety and Tolerability
      of BMO-2 to EU and US Sourced Humira® Administered as a Single Dose (40 mg) Subcutaneous
      Injection in Healthy Adults.
    

Detailed description: 
      This is a single-center, randomized, double-blind, 3-way parallel study in 270 healthy adult
      male and female subjects. During this study, the PK bioequivalence of BMO-2, containing 40 mg
      adalimumab, will be compared to EU licensed Humira® (EU-Humira® ) (40 mg) and US licensed
      Humira® (US-Humira® ) (40 mg).

      Randomization will be stratified by body weight (weight categories of 60.0-79.9 kg and
      80.0-95.0 kg). After randomization, subjects will receive one of the following treatments: a
      single sc injection of 40 mg BMO-2, an equivalent sc injection of EU-Humira® (40 mg), or an
      equivalent sc injection of US-Humira® (40 mg).

      Volunteers participation in the study is expected to finish with the follow-up visit,
      scheduled 70 days after the injection of study drug.
    

Intervention name(s): BMO-2; EU-Humira; US-Humira
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Volunteers randomized in Treatment A will receive a single subcutaneous injection of BMO-2 (40mg / 0.8mL).; Volunteers randomized in Treatment B will receive a single subcutaneous injection of EU-Sourced Humira (40 mg / 0/8 mL); Volunteers randomized in Treatment C, will receive a single subcutaneous injection of US-sourced Humira (40 mg / 0.8 mL).
Other intervention name(s): Adalimumab; Adalimumab; Adalimumab
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Pharmacokinetics; Adalimumab; Biosimilar Pharmaceuticals
Evaluation and Validation of Endogenous Markers for the Assessment of CYP3A Activity in Korean Healthy Subjects Using Metabolomics
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study objective is to evaluate and validate of endogenous markers for the assessment of
      CYP3A activity in Korean healthy subjects using metabolomics.

      In part 1, total 75 healthy subjects (males and females) will be enrolled. In part 2, total
      25 healthy female subject aged 20-45 years will be enrolled. In both part A and B, subjects
      will be administered midazolam I.V. 1 mg.
    


Intervention name(s): Midazolam I.V.
Intervention type(s): Drug
Intervention description(s): Midazolam I.V. 1mg/ml
Intervention MeSH terms: Midazolam
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: CYP3A
Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study
Condition: Urinary Incontinence; Quality of Life
MeSH terms: Urinary Incontinence; Enuresis
Study type: Observational

Summary: 
      To assess pelvic floor symptoms and quality of life in elderly women.
    

Detailed description: 
      The aim is to assess pelvic floor symptoms and quality of life in elderly women. The study is
      conducted as population-based in 100-130 women at the age of 64-66 years. All study objects
      are examined gynecologically and with vaginal ultrasound. Subjective symptoms are evaluated
      with validated questionnaires concerning pelvic floor symptoms, sexual symptoms and quality
      of life. This is a pilot study before a larger scale population-based study.
    

Intervention name(s): Gynecological examination
Intervention type(s): Other
Intervention description(s): Comparison of questionnaires and gynecological examination
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        100-130 women aged 64-66 years in one single municipality
      
Keywords: urinary incontinence; pelvic floor; quality of life; elderly women
A Web-Based Intervention to Prevent Drug Abuse Among Adolescent Girls
Condition: Drug Abuse Prevention
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      This study is designed to develop and test a gender-specific, web-based drug abuse prevention
      program. Study participants will be adolescent girls aged 13 and 14 years who will complete
      all measures online. Randomly assigned girls will also interact online with a skills-based
      program and subsequent annual booster sessions.

      The study's primary hypothesis is that rates of 30-day alcohol and drug use will be lower
      among girls assigned to receive the intervention.
    


Intervention name(s): RealTeen
Intervention type(s): Behavioral
Intervention description(s): A web-based, gender-specific program intended improve girls' cognitive and behavioral skills. Each of the 9 sessions requires approximately 20 minutes. After initial intervention, girls will receive two annual booster sessions (i.e., a 20-minute review of previously learned material indexed to new age).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: gender-specific; web-based; drug abuse; prevention
MT2014-25: Haplo NK With SQ IL-15 in Adult Relapsed or Refractory AML Patients
Condition: Acute Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      A phase II trial of CD3/CD19 depleted, IL-15 activated, donor natural killer (NK) cells in
      adults and subcutaneous IL-15 given after a preparative regimen for the treatment of relapsed
      or refractory acute myelogenous leukemia (AML). The primary objective is to study the
      potential efficacy of NK cells and IL-15 to achieve complete remission while maintaining
      safety.
    


Intervention name(s): IL-15
Intervention type(s): Biological
Intervention description(s): Preparative Regimen:
Fludarabine 25 mg/m2 x 5 days start day -6 Cyclophosphamide 60 mg/kg x 2 days on day -5 and -4 (if < 4 months from prior transplant, omit day -4 dose)
IL-15 Activated Donor NK Cells:
The apheresis product (collected day -1) will be enriched for NK cells with the large-scale CliniMacs® device (Miltenyi) by depletion of CD3+ cells to remove T-lymphocytes and depletion of CD19+ cells to remove B-lymphocytes. The NK cell enriched product will be activated by overnight incubation with10 ng/ml IL-15 under GMP conditions and infused on day 0.
IL-15 to Facilitate NK Cell Survival and Expansion:
IL-15 at 2 mcg/kg subcutaneously (SC) beginning day +1, once a day for 5 days followed by a 2 day rest, and then once a day for 5 days for 10 doses total
Other intervention name(s): Interleukin-15
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AML; Relapsed; Refractory
Pharmacokinetics and Safety Study of BI 695502 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial will investigate the pharmacokinetics and safety of BI 695502 and to establish
      pharmacokinetic biosimilarity of BI 695502 compared to bevacizumab.
    


Intervention name(s): BI 695502; bevacizumab; bevacizumab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BI 695502 single i.v. infusion; bevacizumab single i.v. infusion; bevacizumab single i.v. infusion
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Safety of a Single Intravenous Dose of Recombinant Factor XIII in Children With Congenital FXIII A-subunit Deficiency
Condition: Congenital Bleeding Disorder; Congenital FXIII Deficiency
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Europe and United States of America (USA). The aim of this
      clinical trial is to investigate the pharmacokinetics (at which rate the substance is
      distributed and eliminated from the body) and the safety profile of catridecacog (recombinant
      factor XIII (rFXIII)) in children with congenital FXIII A-subunit deficiency. Young children
      (1 to less than 6 years old) with congenital FXIII deficiency are evaluated.
    


Intervention name(s): catridecacog
Intervention type(s): Drug
Intervention description(s): Intravenous injection of a single dose of recombinant factor XIII, 35 IU/kg bodyweight
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Gait Analyses After Resurfacing Hip Arthroplasty Versus Metal on Metal Total Hip Arthroplasty, an Exploratory Study
Condition: Difficulty Walking; Gait, Stumbling
MeSH terms: Gait Disorders, Neurologic; Mobility Limitation
Study type: Interventional

Summary: 
      Total hip replacement surgery is a very successful operation with good long-term results. Hip
      resurfacing arthroplasty is offered as a treatment option for young and active patients with
      osteoarthritis of the hip. It has been proposed as a treatment option for younger patients
      because of claims that it preserves femoral bone stock and has better functional outcomes.
      The assessment of gait after hip replacement surgery may be able to determine functional
      differences between patients who have undergone total hip replacement / arthroplasty (THA)
      versus hip resurfacing.
    

Detailed description: 
      A group of 58 patients, part of a ungoing randomized trial comparing resurfacing hip
      arthroplasty to metal-on-metal total hip arthroplasty, will be invited to a single gait
      analysis on a trendmill. All patients have reached a follow up of five years. Patient 's gait
      will be assessed during two walking sessions, in both sessions spatio-temporal, kinetic and
      kinematic parameters will be recorded.

        -  At first when flat walking with increasing speeds to their top walking speed.

        -  Secondly: when walking at a fixed speed with an increasing incline to their top walking
           incline.
    

Intervention name(s): Gait analysis on a trendmill
Intervention type(s): Other
Intervention description(s): Gait analysis on a trendmill "GRAIL" to analyse spatio-temporal kinetics and kinematics when flat walking and inclining
Other intervention name(s): Gait realtime analysis interactive lab: MOTEK Medical
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Gait disorder; Resurfacing Hip Arthroplasty; Total Hip Arthroplasty
A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids
Condition: Fibroid Uterus; Leiomyoma; Menorrhagia; Metrorrhagia; Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma; Menorrhagia; Metrorrhagia
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to determine the safety and efficacy effects of two doses of
      asoprisnil (10 mg and 25 mg) compared with placebo when administered daily for 6 months to
      premenopausal subjects with symptomatic uterine leiomyomata.
    

Detailed description: 
      No medical therapy is currently available for the long-term treatment of abnormal uterine
      bleeding associated with uterine fibroids. Asoprisnil (10 mg and 25mg) is being evaluated in
      a Phase 3 program to establish long term safety and effectiveness and therefore provide women
      with a medical alternative to surgery.
    

Intervention name(s): Asoprisnil; Asoprisnil; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Asoprisnil 10 mg Tablet, oral Daily for 6 months; Asoprisnil 25mg Tablet, oral Daily for 6 months; Placebo Tablet, oral Daily for 6 months
Other intervention name(s): J867; J867
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Symptomatic Uterine Fibroids; Excessive Uterine Bleeding; Uterine Hemorrhage
Progesterone for Perimenopausal Night Sweats
Condition: Hot Flushes; Night Sweats
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test whether a oral micronized progesterone reduces the
      Vasomotor Symptom Score comprised of the number and severity of hot flushes and night sweats
      in perimenopausal women. Oral micronized progesterone is molecularly identical to human
      progesterone, a steroid hormone. It is sold by prescription for use to prevent endometrial
      cancer in women taking estrogen in menopause. This research study will test whether
      progesterone reduces perimenopausal hot flushes and night sweats. It will also test whether
      progesterone improves sleep disturbances and anxiety.
    

Detailed description: 
      This is a randomized, double-blind placebo-controlled trial of oral micronized progesterone
      (300 mg daily at bedtime) for perimenopausal women living anywhere in Canada. Using the
      self-reported maximum menstrual cycle length in the previous year, women will be stratified
      as in Early Perimenopause (<60 days) or Late Perimenopause (>=60 days). The design includes a
      28-day baseline run-in followed by 12 weeks of randomized therapy.
    

Intervention name(s): Oral micronized progesterone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 300 mg as 3-100 mg capsules taken orally at bedtime daily for 12 weeks; placebo comparator, taken as 3 round capsules at bedtime daily for 12 weeks
Other intervention name(s): Prometrium; Utrogestan
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hot flushes/hot flashes; night sweats; sleep problems; negative mood; anxiety; perimenopause; progesterone; vasomotor symptoms; depression; women's perceived change; perimenopause interference questionnaire
Golimumab for Adherence in Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      The purpose of this study is to determine if non-adherence to Rheumatoid Arthritis (RA) drugs
      in participants treated with biologic disease modifying anti-rheumatic drugs (DMARDs) is
      associated with a greater incidence of disease in clinical practice.
    


Intervention name(s): Golimumab
Intervention type(s): Biological
Intervention description(s): Participants will receive golimumab as a part of clinical practice.
Other intervention name(s): SIMPONI ™
Intervention MeSH terms: Golimumab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All Rheumatoid Arthritis (RA) participants treated with golimumab in a clinical practice
        setting will be observed.