bioihbjkbjnl/mcl2 huggingface dataset:
Autologous Transplantation for Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      The present study was designed in an attempt to prospectively evaluate in a randomized
      fashion whether further cytotoxic dose intensification, as delivered with two sequential
      autologous stem-cell transplantations, improved the outcome of younger patients with newly
      diagnosed multiple myeloma in comparison with a single autologous transplantation.
    

Detailed description: 
      Following demonstration that single autologous transplantation for the treatment of younger
      patients with newly diagnosed multiple myeloma prolonged overall survival in comparison with
      conventional chemotherapy, double autologous transplantation was tested, initially in
      refractory myeloma and subsequently to include also patients with newly diagnosed disease. To
      explore the role of double autologous stem-cell transplantation as part of up-front therapy
      for multiple myeloma, in 1996 we launched a prospective, randomized trial comparing a single
      course of stem-cell-supported melphalan with the same regimen followed, after three to six
      months, by a second autologous transplantation in support of melphalan and busulfan. The
      study was designed to detect a 15 percent increase in complete or near complete response rate
      with double transplants compared to a single transplantation. With a 2-sided significance
      level α = 0.05 and a power 1-β = 0.80, 162 patients were required in each treatment arm of
      the study to detect a statistically significant increase in complete or near complete
      response rate from 30% in the single-transplant arm to 45% in the double-transplant arm.
      Primary study endpoint was the complete or near complete response rate. Secondary study
      endpoints were relapse-free survival, event-free survival and overall survival. The
      recruitment target was 324 patients.
    

Intervention name(s): Autologous Stem Cell Transplantation
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myeloma previously untreated; Single autologous transplantation; Double autologous transplantation; Complete response
Virtual Care In Pediatric Asthma
Condition: Asthma in Children
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study was to determine the impact of virtual care for children with
      asthma on the disease management and quality of life of children with asthma.
    

Detailed description: 
      After children were randomized by protocol number, they completed the child information form,
      the quality of life scale of the child with asthma, and the asthma control test at the first
      interview. PEF meter and asthma diary were given at the first interview. Children in the
      virtual care group received online training in four modules within the first month.The
      virtual group provided counseling services by phone and video conference for six months. The
      control group received the standard care provided in the clinic. Asthma diary data were
      collected from both groups at the end of each month
    

Intervention name(s): Virtual Care
Intervention type(s): Other
Intervention description(s): Children in the virtual care group had distance asthma education, case management and virtual care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Virtual Care
Impact of Folates in the Care of the Male Infertility
Condition: Male Infertility
MeSH terms: Infertility; Infertility, Male
Study type: Interventional
Phase: Phase 3

Summary: 
      Unexplained male infertility is increasing, and, nowadays, the investigators only can propose
      palliative treatment, as In VITRO Fertilization (IVF). The folate metabolism is a key for the
      maintenance of genome integrity. A dysfunction in this pathway can be responsible of
      spermatogenesis defects, and further, of infertility. Few assays have shown that folate
      treatment can improve sperm parameters and fertility, till 30% in some of theses studies. The
      purpose of the investigators study is to demonstrate the impact of folates treatment on
      improvement of sperm parameters and on the rate of success of in VITRO fertilization
      procedures.
    

Detailed description: 
      The folate impact in the treatment of male infertility will be reviewed by this large
      multicentric randomized controlled double-blind study comparing 2 parallel groups of 184
      patients. In each group: folic acid 15mg/day versus placebo, orally for at least 3 months
      (duration of a cycle of spermatogenesis). This assay will evaluate the effectiveness of
      treatment with folic acid compared to its placebo in infertile men with the outcome of
      IVF+/-ICSI techniques (pregnancy rate). It will also assess the impact of folate therapy on
      sperm parameters, and further, the impact on abnormal sperm DNA methylation profiles.
    

Intervention name(s): Folic acid; placebo of folic acid
Intervention type(s): Drug; Drug
Intervention description(s): Taking of folic acid 15 mg per day by hanging oral route during 3 at 4 months; Taking of placebo of folic acid by hanging oral route during 3 at 4 months
Intervention MeSH terms: Folic Acid; Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Male infertility; folic acid; in VITRO fertilization; sperm parameters; MTHFR genotype
Prevention of Mucositis in Patients With Head and Neck Cancer Treated With Radiotherapy
Condition: Radiation- Induced Mucositis; Adverse Effect of Radiation Therapy; Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms; Mucositis
Study type: Interventional

Summary: 
      Prevention of radiation-induced mucositis in patients with head and neck cancer treated with
      radiotherapy : A Double-blind Randomized Controlled Trial
    

Detailed description: 
      To compare the effect of each herb extracts in form of mouth wash to protect or delay the
      onset of the radiation-induced mucositis from the adverse effects of radiation therapy in
      patients with head and neck cancer.
    

Intervention name(s): Normal saline with salt/Soda; Clinacanthus nutans; Boesenbergia rotunda
Intervention type(s): Other; Other; Other
Intervention description(s): Head and Neck cancer Patients have to rinse 4 times a day/everyday for 15 ml. each time during and after completed the radiation treatment; Head and Neck cancer Patients have to rinse 4 times a day/everyday for 15 ml. each time during and after completed the radiation treatment; Head and Neck cancer Patients have to rinse 4 times a day/everyday for 15 ml. each time during and after completed the radiation treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental design in 3 groups
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Radiation- induced mucositis; Head and Neck Cancer; Radiation therapy side effect
AdCh63 ME-TRAP and MVA ME-TRAP Malaria Vaccines Evaluation in Healthy Adults and Children in a Malaria Endemic Area
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to assess the safety and immunogenicity of MVA ME-TRAP and
      AdCH63 ME-TRAP candidate vaccines in healthy children and adult volunteers in a malaria
      endemic region. The regimen proposed here has protected non-immune volunteers in Oxford
      against sporozoite challenge, and so may be protective against naturally acquired infection
      in The Gambia.
    


Intervention name(s): AdCh63 ME-TRAP, MVA ME-TRAP; AdCh63 ME-TRAP, MVA ME-TRAP; AdCh63 ME-TRAP, MVA ME-TRAP; AdCh63 ME-TRAP, MVA ME-TRAP; HDCRV; AdCh63 ME-TRAP, MVA ME-TRAP; AdCh63 ME-TRAP, MVA ME-TRAP; HDCRV
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): AdCh63 ME-TRAP 1 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later; AdCh63 ME-TRAP 5 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later; AdCh63 ME-TRAP 1 x 10^10vp IM followed by MVA ME-TRAP 1 x 10^8 pfu IM 8 weeks later; AdCh63 ME-TRAP 1 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later; HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later; AdCh63 ME-TRAP 5 x 10^10vp IM followed by MVA ME-TRAP 1 x 10^8 pfu IM 8 weeks later; AdCh63 ME-TRAP 5 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later; HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Vaccine; Immune response
Study to Determine the Effect of Food on the Blood Levels of AZD9291 Following Oral Dosing of a Tablet Formulation in Patients With Non-Small Cell Lung Cancer
Condition: Advanced Non Small Cell Lung Cancer; Advanced (Inoperable) Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2-part study in patients with epidermal growth factor receptor mutation positive
      (EGFRm+) non-small cell lung cancer (NSCLC) whose disease has progressed on treatment with an
      epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI): Part A will
      determine the effect of food on the pharmacokinetics (PK) of AZD9291; Part B will allow
      patients further access to AZD9291 and will provide for additional safety data collection.

      Part A is a randomised, open-label, 2 treatment period crossover study in which patients will
      each receive a single oral dose of AZD9291 (1 x 80 mg tablet) at breakfast time
      (approximately 0800) in each of 2 treatment periods (once immediately following a high fat
      meal [fed], and once in the fasted state [fasted]), with a washout period of 9 days between
      doses.

      Approximately 38 patients are planned to be enrolled and dosed; at least 30 evaluable
      patients will be required to complete Part A (ie, the last PK sample in Treatment Period 2
      [TP 2] has been collected). Additional patients may be enrolled to allow for at least 30
      evaluable patients
    


Intervention name(s): AZD9291 tablets; Pharmacokinetic sampling - AZD9291; Dietary Fasted; Dietary High Fat; Pharmacokinetic sampling - AZ5140 and AZ7550
Intervention type(s): Drug; Procedure; Other; Other; Procedure
Intervention description(s): AZD9291 tablets: Part A 80mg od, days 1 and 10 only. Part B 80mg od for 12 months.; Blood samples taken pre and post dosing of AZD9291 following either a period of fasting or consumption of a meal.; Fasted from 10 hours prior to dosing with 80mg AZD9291 tablet and 4 hours after dosing; Allocated breakfast prior to dosing with 80mg AZD9291 tablet; Blood samples taken pre and post dosing of AZD9291 following either a period of fasting or consumption of a meal.
Intervention MeSH terms: Osimertinib
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Other
Keywords: oncology, cancer, non small cell lung cancer, anticancer drug, pharmacokinetics, AZD9291, EGFR sensitivity mutation, food effect
Ex Vivo High-Throughput Assay for Vaginal Community Post-menopausal Women
Condition: Postmenopausal Syndrome
Study type: Observational

Summary: 
      This purpose of this study is to collect vaginal microbial samples of postmenopausal women to
      assess the optimal conditions for cultivation and storage of the vaginal microbiota. These
      samples will subsequently be used to develop a high-throughput assay that mimicks the vaginal
      microbial community of postmenopausal women. This assay will be used to select and screen
      compounds that can affect the vaginal microbiota and subsequently affect related symptoms
      such as vaginal dryness.
    

Detailed description: 
      Vaginal swabs will be collected from post-menopausal women (5 women vaginal pH ≤4.5 and 5
      women with vaginal pH≥5.5), aged 45 - 75, with at least 12 months of amenorrhea. Enough women
      will be screened to ensure five women for each pH range.

      Using a speculum, the mid lateral vaginal wall is made visible, samples will be collected by
      the physician or nurse using a flocked swab. After collection, vaginal swabs will be stored
      immediately in adequate liquid medium at 4ºC and will be transported to the lab within 7
      hours after sampling for further storage and culture of the material.

      The vaginal microbiota of post-menopausal women with a vaginal pH of ≤ 4.5 and ≥ 5.5 will be
      characterized and compared using 16S ribosomal ribonucleic acid (rRNA) sequencing. In
      additional, optimal conditions for cultivation and storage of the vaginal microbiota will be
      examined for use in assays mimicking the vaginal microbial community of postmenopausal women.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Post-menopausal women
      
Biospecimen description: 
      Microbiota from Vaginal Swab
    
Keywords: Vaginal Microbiota
Night Myopia and Dark Focus of Accommodation
Condition: Dark Focus of Accommodation
Study type: Interventional

Summary: 
      Shifts in accommodation at decreasing luminance levels are considered as principle cause for
      night myopia. Previous studies with laser optometers quantified the dark focus of
      accommodation up to 3 D. In addition to the measurement of dark focus, the aim of this study
      was to investigate the influence of an imaginary target at finite distances on the state of
      accommodation at scotopic luminance.
    

Detailed description: 
      Accommodation was measured by using an open-field autorefractor (WAM 5500, GRAND SEIKO). Full
      corrected right eyes of 39 subjects aged from 18 to 40 years were investigated in this
      randomized, cross-sectional study. Accommodation measurements in photopic luminance were
      taken for 6 m of empty field and for optotype fixation at 2 m, 1 m and 0.5 m. At scotopic
      luminance, dark focus of accommodation was examined directly after darkening and after 10 min
      of dark adaptation. After adaptation, subjects had to visualize imaginary targets in the four
      distances while accommodation was measured.
    

Intervention name(s): Accommodation Measurement
Intervention type(s): Diagnostic Test
Intervention description(s): Accommodation was measured for different distances and light conditions.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: accommodation; dark focus; night myopia
Neuroimaging and Neuromonitoring in Critically Ill Children With Sepsis
Condition: Septic Shock
MeSH terms: Shock, Septic; Critical Illness
Study type: Observational

Summary: 
      In critically ill children with severe sepsis, neurophysiologic derangements often proceed
      undetected and can lead to irreversible brain injury causing neurocognitive and behavioral
      deficits. The etiology of these impairments is unclear, however, it is likely that some of
      this neural injury is preventable. The overarching goal for this study is to show that acute
      acquired structural and microstructural brain injury occurs in critically ill children with
      severe sepsis, and that this injury is related to neuropsychological deficits and impaired
      cerebral autoregulation (CAR). Subjects will complete Magnetic resonance (MR) imaging within
      2-10 days of recognition of their severe sepsis. Subjects will undergo serial interrogation
      of CAR for up to 10 days. CAR will be determined by the correlation of arterial blood
      pressure with middle cerebral artery flow velocity measured by transcranial doppler
      ultrasonography and cerebral oximetry derived from near-infrared spectroscopy. Subjects will
      also participate in a neuropsychological evaluation 6 months after enrollment to evaluate
      multiple domains of behavior and cognition.
    


Intervention name(s): MR imaging
Intervention type(s): Diagnostic Test
Intervention description(s): Conventional structural imaging will be combined with advanced neuroimaging modalities to evaluate integrity of white matter tracts, regional brain perfusion, and the 3-dimensional volume of specific brain structures.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children admitted to the pediatric intensive care unit (PICU) at the Children's Hospital of
        Philadelphia (CHOP) with severe sepsis from an extracranial source and have no history of a
        preexisting underlying a neurologic disorder.
Variability in the Measurement of WBCT Between Blood Drawn From Indwelling Catheters and Direct Venipuncture
Condition: Healthy
Study type: Interventional

Summary: 
      1. Determine if there is any difference between the whole blood clotting time results
           obtained from blood drawn from indwelling catheters and direct venipuncture

        2. Determine the intra-subject variability in both procedures
    

Detailed description: 
      No investigational products were administered to any subjects.
    

Intervention name(s): Blood drawn from indwelling catheters versus direct venipuncture
Intervention type(s): Drug
Intervention description(s): Evaluation of the source of blood samples on whole blood clotting time
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Aspirin on Mammogram Density in Healthy Postmenopausal Women With a Moderate or High Level of Breast Density
Condition: Mammographic Breast Density
Study type: Interventional

Summary: 
      RATIONALE: Aspirin may be effective in reducing breast density in healthy postmenopausal
      women with a moderate or high level of breast density.

      PURPOSE: This randomized clinical trial is studying the effect of aspirin on mammogram
      density compared with a placebo in healthy postmenopausal women with a moderate or high level
      of breast density.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the effect of acetylsalicylic acid (aspirin) vs placebo on mammographic density
           in healthy postmenopausal women with a moderate or high level of breast density.

      Secondary

        -  Determine whether there is a differential response in mammogram density to aspirin
           treatments in individual homozygous wild-type, heterozygous, and homozygous variant for
           several UGT gene polymorphisms.

        -  Determine the effect of aspirin therapy on potential adverse events, including
           gastrointestinal symptoms and signs, bleeding events, blood pressure, and other major
           comorbidities and hospitalizations, as well as generalized symptoms, in these
           participants.

        -  Determine the effects of aspirin therapy on putative biomarkers of breast and ovarian
           cancer that are currently being validated as part of ongoing Fred Hutchinson Cancer
           Research Center Ovarian SPORE activities.

        -  Determine the effects of aspirin therapy on levels of serum estradiol, estrone and sex
           hormone binding globulin (SHBG) as measured by radioimmunoassay at baseline and 6 month
           timepoints

      OUTLINE: This is a randomized, placebo-controlled, double-blind study. Participants are
      randomized to 1 of 2 treatment arms.

        -  Arm I: Participants receive oral acetylsalicylic acid (aspirin) daily for 6 months.

        -  Arm II: Participants receive oral placebo daily for 6 months. In both arms, participants
           undergo a repeat mammogram at 6 months.

      Blood and urine samples are collected at baseline and at 6 months. Single-nucleotide
      polymorphisms in the UGT genes and variable number of tandem repeat-type polymorphisms are
      genotyped.

      PROJECTED ACCRUAL: A total of 144 participants will be accrued for this study.
    

Intervention name(s): Aspirin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Two 325 mg doses of aspirin per day for 6 months; Two placebo pills per day for 6 months
Other intervention name(s): Acetylsalicylic acid; Placebo, sugar pill
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: mammographic breast density aspirin
Pilot Study in Patients With Symptomatic Steroid-Naive Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate an investigational medication to treat chronic
      asthma. The research is being conducted at 20 clinical research sites in the US and is open
      to both men and women ages 18 to 70 years. Participants in the study will have a number of
      visits to a research site over an 8-month period. All study-related care and medication is
      provided to qualified participants at no cost. This includes all visits, examinations and
      laboratory work.
    


Intervention name(s): anti-IL-4 monoclonal antibody (pascolizumab)
Intervention type(s): Drug
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: asthma; anti-IL-4 monoclonal antibody; pascolizumab
The Influence of Meibomian Gland Expression on Corneal Aberrations in MGD Patients
Condition: Meibomian Gland Dysfunction
MeSH terms: Meibomian Gland Dysfunction
Study type: Observational

Summary: 
      To evaluate the influence of corneal-aberrations before and after the meibomian gland thermal
      massage treatment.
    

Detailed description: 
      62 MGD patients treated with meibomian gland thermal massage once a week for 3 to 4 weeks
      were recruited.The Ocular Surface Disease Index questionnaire; tear film assessment
      encompassing tear meniscus height and non-invasive keratograph breakup time ; meibography
      score,corneal fluorescein staining; the Schirmer I test ; expressible meibomian gland, and
      quality ,anterior and total corneal aberrations were evaluated before and after treatment.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Diagnosed as meibomian glands dysfunction in our hospital; treatment with thermal massage
        and expression
      
Keywords: thermal massage; corneal aberrations; physical therapy