bioihbjkbjnl/mcl2 huggingface dataset:
Two Cycles of PAD Combination by AHCT in MM
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Based the proven efficacy and the ability to induce rapid response of various combinations of
      bortezomib including PAD combination in refractory and newly diagnosed patients with Multiple
      Myeloma, the investigators intend to investigate the efficacy of 2 cycles of PAD combination
      (Ps-341/Bortezomib, Adriamycin, and Dexamethasone) and to examine the feasibility of
      harvesting G-CSF mobilized PBSC and performing early AHCT after 2 cycles of PAD.
    

Detailed description: 
      1.PAD combination chemotherapy

        -  Bortezomib 1.3 mg/m2 will be given by intravenous bolus injection on days 1, 4, 8, 11 of
           each cycle. Oral or intravenous dexamethasone 40 mg will be administered on days 1-4 and
           8-11 with doxorubicin 9 mg/m2 by intravenous bolus on days 1-4 of each cycle. The cycle
           will be repeated every 3 weeks. A total of 2 cycles is planed before AHCT.

        -  For mobilization, G-CSF 10ug/kg/d alone will be given by subcutaneous injection from day
           12 of the second PAD cycle until completion of harvesting.

      Melphalan 100 mg/m2/day will be administered on day -3 and day -2 for high-dose chemotherapy.

      -Maintenance :Thalidomide 100 - 200 mg/d for 2 years
    

Intervention name(s): PAD combination
Intervention type(s): Drug
Intervention description(s): Bortezomib 1.3 mg/m2/d iv on D 1, 4, 8, 11
Doxorubicin 9 mg/m2/d iv on D 1-4
Dexamethasone 40mg/d po or iv on D1-4, 8-11
Other intervention name(s): -vincristine; -doxorubicin; -dexamethasone
Intervention MeSH terms: Dexamethasone; Doxorubicin; Vincristine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MM
Study to Evaluate the Effect of Erenumab on Blood Pressure When Given Concomitantly With Subcutaneous Sumatriptan
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study was to assess the effects of subcutaneous sumatriptan
      alone and the effects of a single dose of erenumab (AMG 334) intravenous (IV) and sumatriptan
      concomitant therapy on resting blood pressure in healthy adults.
    


Intervention name(s): Placebo; Sumatriptan; Erenumab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered by intravenous infusion; Administered by two 6 mg subcutaneous injections 1 hour apart on day 2 and day 5; Administered by intravenous infusion
Other intervention name(s): Imitrex™; AMG 334; Aimovig™
Intervention MeSH terms: Sumatriptan; Erenumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Treatment of ADHD With Atomoxetine in Children & Adolescents With ADHD & Comorbid Dyslexia
Condition: Attention Deficit Hyperactivity Disorder; Dyslexia
MeSH terms: Dyslexia; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the effect of atomoxetine in treating
      Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in children and adolescents with
      ADHD and comorbid reading disability (dyslexia)
    


Intervention name(s): Atomoxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Atomoxetine will be administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 to 32 weeks; oral, daily, for 16 weeks
Other intervention name(s): LY139603
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of the Safety and Effectiveness of JNJ-39758979 in the Treatment of Adults With Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of once daily oral
      administration of JNJ-39758979 in the treatment of adults (18 to 65 years of age) with
      persistent asthma.
    

Detailed description: 
      This is a multicenter, double-blind (neither physician nor participants knows the treatment
      that the participant receives), randomized (study medication is assigned by chance),
      placebo-controlled (an inactive substance is compared with a medication to test whether the
      medication has a real effect in a clinical study), parallel group (each group of participants
      will be treated at the same time), exploratory study (JNJ-39758979 is introduced in
      participants with asthma for the first time). This study consists of 4 phases: screening
      phase (4 weeks prior to the start of the run-in period), placebo run-in phase (2 weeks prior
      to the start of treatment phase), double-blind treatment phase (12 weeks), and posttreatment
      phase (5 weeks). Approximately 100 participants will be randomly allocated to 1 of 2
      treatment groups: Treatment A (participants will receive JNJ-39758979 once daily) and
      treatment B (participants will receive placebo once daily). Safety will be evaluated by
      assessment of adverse events, clinical laboratory tests, vital signs, physical examination,
      and 12-lead electrocardiogram. Total study duration for each participant will be
      approximately 23 weeks.
    

Intervention name(s): JNJ39758979; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive capsule-shaped tablet of JNJ39758979 300mg once daily orally for 12 weeks.; Participants will receive matching placebo once daily orally for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Persistent asthma; Adults with persistent asthma; Chronic asthma; JNJ-39758979; Placebo
Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr.Reddy's Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to

        1. Compare and evaluate the single dose, crossover, bioequivalence study of Fexofenadine
           HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets and Allegra-D 24 hr tablets.

        2. Monitor the adverse events and ensure the safety of subjects.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,
      crossover bioequivalence study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER
      Tablets of Dr. Reddy's and Allegra-D 24 hour ER Tablets of Aventis Pharmaceuticals Inc., USA
      in healthy, adult, human subjects under fed conditions.
    

Intervention name(s): Fexofenadine HCl + Pseudoephedrine HCl
Intervention type(s): Drug
Intervention description(s): Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's Laboratories Limited
Other intervention name(s): Allegra-D 24 hour ER Tablets
Intervention MeSH terms: Fexofenadine; Pseudoephedrine; Ephedrine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Fexofenadine Hydrochloride + Pseudoephedrine Hydrochloride
Physiological Data in the Menstrual Cycle
Condition: Fertility
Study type: Observational

Summary: 
      Research results suggest changes of physiological parameters such as heart rate, respiration,
      skin conductance response, sleep duration, sleep quality and skin perfusion during the
      menstrual cycle. Latest fitness trackers allow to conveniently and non-invasively record
      these parameters. The present study aims to evaluate whether there is a correlation between
      physiological parameters and the menstrual cycle i.e. ovulation as measured by a urine
      ovulation test and the onset of menses. To collect data women will wear two smartwatches and
      a smartshirt at night. All three devices are CE-approved for sports and fitness.
    


Intervention name(s): Participants wear a sensor bracelet for collecting physiological data and conducted urine tests to estimate the day of ovulation
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A maximum of 50 healthy, 20-40 years old, non-pregnant women will be included in the study.
Randomized Trial of Accelerated Partial Breast Irradiation
Condition: Breast Neoplasms; Neoplasm Recurrence, Local
MeSH terms: Neoplasms; Breast Neoplasms; Neoplasm Recurrence, Local; Recurrence
Study type: Interventional

Summary: 
      This study is to compare radiation toxicity of accelerated partial breast irradiation (ABPI)
      with whole breast irradiation (WBI) in low-risk breast cancer.
    

Detailed description: 
      This study is a single-center phase II randomized clinical trial to enroll low-risk breast
      cancer treat with breast-conserving surgery. All eligible patients are randomized to receive
      either ABPI (40Gy/10fx/2wks) or WBI(43.5Gy/15fx/3wks). Intensity modulated radiation therapy
      (IMRT) technique is used. Grade 2 or more acute and late toxicities are prospectively
      evaluated and compared.
    

Intervention name(s): APBI; WBI
Intervention type(s): Radiation; Radiation
Intervention description(s): Patients receive radiation to the breast tumor bed to a total dose of 40Gy/10fx/2wks, using intensity-modulated radiation therapy technique.; Patients receive radiation to the whole breast to a total dose of 43.5Gy/15fx/3wks, using intensity-modulated radiation therapy technique.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Oral Care to Prevent Ventilator-associated Pneumonia
Condition: Oral Hygiene, Oral Health; Ventilators, Mechanical
MeSH terms: Pneumonia
Study type: Interventional

Summary: 
      This study was conducted to investigate the effect of oral care given by two different
      methods on the development of ventilator-associated pneumonia in patients connected to
      mechanical ventilators.
    

Detailed description: 
      The universe of this research, which was designed as a semi-experimental study, is composed
      of patients connected to the mechanical ventilator lying in Atatürk University Training and
      Research Hospital Anesthesia and Reanimation Intensive Care Unit between September 2019 and
      February 2020. A total of 57 patients, 29 method-1, 28 method-2 groups, met the inclusion
      criteria of the study. In the data collection phase, 'Patient Identifier Information Form',
      'Patient Monitoring Form', 'Oral Assessment Scale' and 'Tracheal Aspirate Culture Result
      Form' were used. In the evaluation of the data, number and percentage distributions, Kruskal
      Wallis, Mann Withney-U, Wilcoxon Analysis, Chi-Square test were used.
    

Intervention name(s): One group received standard oral care.; It was applied to the other group by aspiration.
Intervention type(s): Combination Product; Combination Product
Intervention description(s): the effect of oral care given by two different methods on the development of ventilator-associated pneumonia in patients connected to mechanical ventilators.; the effect of oral care given by two different methods on the development of ventilator-associated pneumonia in patients connected to mechanical ventilators.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Mechanical ventilation; nursing; oral care; pneumonia
A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of GK
      Activator (2) in combination with metformin, compared to that of placebo (metformin
      monotherapy), in patients with type 2 diabetes mellitus. Patients will continue on their
      stable dose of metformin and will be randomized to receive either GK Activator (2) or
      placebo. The anticipated time on study treatment is less than 3 months, and the target sample
      size is 100-500 individuals.
    


Intervention name(s): GK Activator (2); Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Escalating doses, po bid or qd for 12 weeks.; As prescribed, for 12 weeks
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bellomic PCA in Laparoscopic Gynecologic Surgery
Condition: Laparoscopic Gynecological Surgery
Study type: Interventional

Summary: 
      In laparoscopic gynecological surgery, when intravenous patient-controlled analgesia (IV-PCA)
      device is used after surgery, the degree of postoperative side effects and pain control is
      compared when a combination of fentanyl and ketorolac is administered compared to when
      fentanyl alone is used.
    


Intervention name(s): Fentanyl selector; Fentanyl continuous; Ketorolac continuous
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Selector (1 ml; Lock out 10 min): Fentanyl 200 mcg + N/S 16 ml = total 20 ml; Continuous (2 ml/hr): fentanyl 700 mcg + N/S 86 ml = total 100 ml; Continuous (2 ml/hr): Ketorolac 180 mg + N/S 94 ml = total 100 ml
Intervention MeSH terms: Ketorolac; Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Shifting Salty Taste Preferences in Children
Condition: Development
Study type: Interventional

Summary: 
      The goals of the proposed research are to determine whether repeated exposure to a low sodium
      food will result in reduced preference for salt in that food among children; and to determine
      whether such reductions in preference are related to dietary intake of salt, taste receptor
      genotype, and anthropometric and physiological measures.
    

Detailed description: 
      This is a within- and between-subjects randomized controlled trial on children consuming
      either a low sodium or a higher sodium cereal over a 2-month period to determine if repeated
      exposure to the low sodium cereal is effective for reducing preference for salt in that food.
      Children will be genotyped for markers related to taste, dietary intake will be recorded, and
      anthropometric and physiological measures will be collected at baseline.
    

Intervention name(s): Low Sodium Group
Intervention type(s): Other
Intervention description(s): Breakfast Cereal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Salty taste; Psychophysics; Genetics; Diet; Age
A Study of Japanese Encephalitis Chimeric Virus Vaccine Compared With SA14-14-2 Vaccine in Infants and Toddlers
Condition: Encephalitis; Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare a single dose of Japanese encephalitis (JE) chimeric
      virus vaccine (JE-CV) with a single dose of SA14-14-2 live vaccine as primary vaccination in
      infants and toddlers.

      Primary Objective:

        -  To demonstrate the non-inferiority of the antibody response 28 days after vaccine
           administration of one dose of JE CV (administered on Day 0) compared to the antibody
           response after one dose of the SA14-14-2 control vaccine (administered on Day 0).

      Secondary Objectives:

        -  To describe the immune response to JE in both vaccine groups in JE-CV virus and
           SA14-14-2 virus before and after a single dose of JE CV or a single dose of SA14-14-2
           vaccine

        -  To describe the safety profile in all vaccinated subjects up to 28 days and all serious
           adverse events (SAEs) up to 6 months after vaccination.

        -  To describe only related SAEs and all death from 6 month to 12-month follow-up.
    

Detailed description: 
      All participants will receive one injection of their randomized vaccine on Day 0. Follow-up
      will continue for 12 months after vaccination.
    

Intervention name(s): Japanese encephalitis chimeric virus vaccine (JE-CV); Japanese encephalitis live vaccine (SA14-14-2 vaccine) (CD.JEVAX®)
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Encephalitis; Japanese Encephalitis; Japanese Encephalitis Vaccines; Infant
25gr. Glucomedics vs 25gr. Zusto
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      Objective: to compare blood glucose and insulin responses after consumption of 100ml water,
      sweetened with 25gr Zusto® and 100ml water sweetened with 25gr Glucomedics® (standard drink)
    

Detailed description: 
      This is an experimental study enrolling 10 healthy female subjects. The study compares the
      blood glucose and insulin responses after consumption of 100ml water, sweetened with 25gr
      Zusto® and 100ml water sweetened with 25gr Glucomedics® (standard drink). Subjects need to be
      fasted for at least 8 hours before all visits. At visit 1, five women will consume the
      solution with 25gr Zusto®, the other five will have the solution with 25gr Glucomedics®. On
      visit 2, groups will be switched. Visit 1 and 2 will be performed within approximately one
      week interval.

      Both drinks will be identical in amount of water and only be different by the use of 25gr
      Glucomedics® and 25gr Zusto®.

      Before intake of the drink, vital signs, weight and bedside blood glucose and baseline blood
      samples - 15' and 0' for glucose, insulin and C-peptide will be taken at visit 1 and 2. Both
      drinks will be consumed within 5 minutes and time of start and end of intake of Zusto® /
      Glucomedics® will be documented.

      Blood samples for glucose, insulin and C-peptide will be taken at 15', 30', 60', 90', 120'
      and 180' after start of intake 25gr Zusto® and 25gr Glucomedics®.
    

Intervention name(s): Zusto; Glucomedics®
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 25gr; 25gr
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Patient Satisfaction With Different Numbers of Implants
Condition: Patient Satisfaction
Study type: Interventional

Summary: 
      the goal of this randomized controlled trial aimed to assess patient satisfaction for
      completely edentulous patients with implant overdenture retained by ball attachment over a
      single symphyseal , or four interforaminal implants when compared to two interforaminal ones
    

Detailed description: 
      48 edentulous patients were recruited and randomized to receive either 1,2 or 4 implants for
      a mandibular overdenture,3 months later implants were uncovered, and ball attachments were
      torqued, and all overdentures were picked up ,patient satisfaction questionnaires were
      recorded for all patients 2 weeks after pickup 3 months ,6 months, 9 months and 1year.
    

Intervention name(s): implants supported overdentures
Intervention type(s): Other
Intervention description(s): implant supported and retained with different number of implants retained by ball attachments
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: three parallel arms one comparator and two interventions
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Secondary Lymphedema Due to Human Adjuvant Disease
Condition: Lymphedema, Secondary; Lymphedema of Leg; Granuloma, Foreign-Body
MeSH terms: Neoplasm Metastasis; Lymphedema; Granuloma; Granuloma, Foreign-Body; Foreign Bodies
Study type: Observational

Summary: 
      This observational, descriptive, retrospective study the clinical and imaging findings of 10
      lower legs of 5 patients with previous history of injection of modeling substances for
      cosmetic purposes at buttocks and hips ande developed lower limb edema. Lower limb lymphedema
      index and lymphoscintigraphy findings were evaluated and reported.
    

Detailed description: 
      Lymphoscintigraphy findings were reported with the Transport index (TI), were any value over
      5 will represent abnormalities in lymphatic function.
    

Intervention name(s): Lower extremity Lymphoscintigraphy
Intervention type(s): Diagnostic Test
Intervention description(s): Study of lymphoscintigraphy (LCG) abnormalities in a group of patients with history of infiltration of modeling substances in buttocks and hips and complain about lower extremities edema. LCG was performed and evaluated by a single nuclear medicine specialist through injection of the sulfur nanocolloid Technetium 99m, injected intradermal and interdigital in bilateral toes. Dynamic studies were requested for all patients. Standardized acquisition times at 15, 30, 60 and 120 minutes after injection were taken. The following parameters were considered to obtain the transport index in each pelvic limb: transport kinematics, distribution pattern, index time for the appearance of regional lymph nodes, number and collection of colloids in lymph nodes and presence and quality of the colloid uptake by the lymphatic vessels. Summation of these five components resulted in the transport index, which could range from 0 to 45 points
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with history of injection of modeling substances for cosmetic purposes (non
        Federal Drug Administration-approved substances) in buttocks and presenting lower limb
        edema
      
Keywords: human adjuvant disease
A Clinical Study to Assess the Effects of KB295 in Patients With Ulcerative Colitis (UC) on Gut Microbiota Structure and Function
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional

Summary: 
      This exploratory, open-label clinical study aims to explore the effects of KB295, a novel
      glycan, on adult patients with ulcerative colitis (UC) presenting with mild-to-moderate UC
      symptoms
    


Intervention name(s): KB295
Intervention type(s): Other
Intervention description(s): KB295 is a novel glycan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Microbiome; Ulcerative Colitis; Kaleido; Kaleido Biosciences; KB295; Oligosaccharide; Glycan; Pathogens; Microbiome metabolic therapy; MMT; Mild-to-moderate UC