bioihbjkbjnl/mcl2 huggingface dataset:
Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer
      cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may
      stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. A
      peripheral stem cell transplant may be able to replace blood-forming cells that were
      destroyed by chemotherapy. When the healthy stem cells are infused into the patient they may
      help the patient's bone marrow make stem cells, red blood cells, white blood cells, and
      platelets. Giving combination chemotherapy together with imatinib mesylate and peripheral
      stem cell transplant may be an effective treatment for acute lymphoblastic leukemia.

      Nevertheless, in the last few years GIMEMA has pubblished a paper in which 100% of Ph+ ALL
      patients reach HCR only with Imatinib, without any chemiotherapy. Thus, this treatment will
      be implemented in patients pertaining to this category.
    


Intervention name(s): asparaginase; daunorubicin hydrochloride; etoposide; idarubicin; imatinib mesylate; mercaptopurine; methotrexate; methylprednisolone; mitoxantrone hydrochloride; prednisone; vincristine sulfate; allogeneic hematopoietic stem cell transplantation; autologous hematopoietic stem cell transplantation; peripheral blood stem cell transplantation; radiation therapy
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Procedure; Procedure; Procedure; Radiation
Intervention MeSH terms: Prednisone; Methylprednisolone; Methotrexate; Etoposide; Vincristine; Imatinib Mesylate; Daunorubicin; Asparaginase; Mitoxantrone; Mercaptopurine; Idarubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: B-cell adult acute lymphoblastic leukemia; T-cell adult acute lymphoblastic leukemia; untreated adult acute lymphoblastic leukemia; L1 adult acute lymphoblastic leukemia; L2 adult acute lymphoblastic leukemia; TdT positive adult acute lymphoblastic leukemia
Safety and Efficacy of Ohhmed Treatments for the Improvement of Erectile Dysfunction - A Feasibility Study
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional

Summary: 
      Erectile dysfunction, the persistent inability to achieve or maintain an erection sufficient
      for satisfactory sexual performance, is estimated to affect up to 30 million men in the
      United States. The disorder is age-associated. The available treatments include oral therapy,
      vacuum-constriction devices; shockwave therapy, intracavernosal injections of vasoactive
      agents, including alprostadil (prostaglandin E1, transurethral delivery of alprostadil,
      Implantation of penile prostheses.

      The OhhMed Company has developed the Vertica device that provides treatments for improvement
      of erectile function in patients with erectile dysfunction. This study assess the safety,
      efficacy, ease of use, and satisfaction of the Vertica device by men with mild to moderate
      erectile dysfunction.
    


Intervention name(s): Vertica RF device
Intervention type(s): Device
Intervention description(s): The treatment provided by the Vertica device is indicated for improving the erectile function in men with erectile dysfunction
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Erectile dysfunction
Exercise Dose and Nonalcoholic Fatty Liver Disease
Condition: Non-alcoholic Fatty Liver Disease (NAFLD)
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      The purpose of this research is to provide a better understanding of how exercise (walking)
      affects non-alcoholic fatty liver disease (NAFLD) in overweight people. NAFLD, which is
      common in obese people, occurs when the liver has too much fat.
    

Detailed description: 
      Non-alcoholic fatty liver disease (NAFLD) affects about 33% of adults in the United States.
      The prevalence of NAFLD is four to five times higher in obese than lean persons and is
      associated with insulin resistance and the metabolic syndrome. Decreasing calorie intake and
      increasing physical activity has been recommended as primary therapy for NAFLD, but the
      independent effect of aerobic exercise is unknown. The current exercise guidelines for
      disease prevention and weight management range from 150 min/wk, recommended by the Centers
      for Disease Control and the American College of Sports Medicine, to 300 min/wk, recommended
      by the Institute of Medicine. However, it is not known whether aerobic exercise alone can
      improve NAFLD, and which recommended dose of exercise might have the most beneficial effects.
      The purpose of this proposal is to determine the effect of moderate intensity endurance
      exercise on: 1) hepatic fat content; 2) hepatic lipoprotein kinetics; and 3) plasma
      inflammatory markers. We hypothesize that aerobic exercise will decrease hepatic fat content,
      improve VLDL kinetics, and decrease inflammation in a dose-dependent fashion. The results
      from this study will help determine exercise guidelines for obese patients with NAFLD, and
      lay the groundwork for future studies evaluating the effects of exercise on metabolic
      diseases associated with obesity.

      This proposal involves conducting a randomized controlled trial that will randomize obese
      subjects with NAFLD (> 10% hepatic fat content) to one of two groups: Group 1 (Control, no
      exercise) and Group 2 (Moderate Intensity Aerobic Exercise- 150 min/wk to 300 min/wk of
      supervised exercise performed at 45-55% of O2 max).
    

Intervention name(s): exercise
Intervention type(s): Behavioral
Intervention description(s): For 16 weeks subjects will exercise from 30-60 minutes five times a week.
Other intervention name(s): walking
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: NAFLD; Obesity; Metabolic Syndrome; Nonalcoholic Fatty Liver Disease
Safety and Efficacy of Lansoprazole in Patients With Reflux Disease
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to measure the safety, efficacy and quality of life of
      lansoprazole in patients with reflux disease over a five year period.
    

Detailed description: 
      Lansoprazole is currently approved in Germany for the treatment of erosive reflux esophagitis
      and active duodenal and gastric ulcer disease, and for long-term treatment including
      maintenance of healed reflux esophagitis and duodenal ulcer disease and treatment of
      pathological hypersecretory conditions such as Zollinger-Ellison syndrome.

      This study was conducted to evaluate the safety, efficacy and quality of life of patients
      receiving up to five years of treatment with lansoprazole.
    

Intervention name(s): Lansoprazole
Intervention type(s): Drug
Intervention description(s): Lansoprazole capsules
Other intervention name(s): Prevacid; Helicid; Zoton; Inhibitol; Agopton; AG-1749
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GERD; Gastroesophageal Reflux Disease; Drug Therapy
Effect of Red Grape Cells (RGC) Powder Consumption on Measures of Aerobic Fitness and Mood
Condition: Healthy
Study type: Interventional

Summary: 
      This is a 3-arm double blind placebo controlled study to investigate the effect of Red Grape
      Cell (RGC) powder containing all the matrix of polyphenols that can be found in red grapes.
      polyphenols have several beneficial effects on various body systems, are present in many
      edible foods, and are considered safe for human consumption by regulatory authorities. Animal
      and human studies suggest a potential for polyphenol-rich compounds in enhancing
      mitochondrial activity and exercise capacity. However, the effect of RGC on exercise
      performance in humans had not yet been tested. A special population where increasing
      performance is highly sought are competitive athletes. The aim of the current study is to
      investigate the effect of RGC on measures of aerobic fitness, body composition and mood in
      trained male cyclists
    


Intervention name(s): RGC; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): Red Grape Cell powder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Red Grapes; polyphenols; cyclists; resveratrol; aerobic fitness; trained
Shigella Flexneri 2a Invaplex 50 Vaccine Dose Finding and Assessment of Protection
Condition: Shigellosis
MeSH terms: Dysentery, Bacillary
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to select a safe and immunogenic dose of Invaplex 50 intranasal
      vaccine, and to assess protection of Invaplex 50 intranasal vaccine against diarrhea,
      dysentery, and fever following challenge with the Shigella flexneri 2a 2457T strain.
    


Intervention name(s): 240 µg Shigella flexneri 2a Invaplex 50 vaccine; 480 µg Shigella flexneri 2a Invaplex 50 vaccine; 690 Shigella flexneri 2a Invaplex 50 vaccine; Shigella challenge strain
Intervention type(s): Biological; Biological; Biological; Other
Intervention description(s): Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.; Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.; Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.; 300 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T
Other intervention name(s): Shigella challenge material
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis
Condition: Nasal Polyposis
MeSH terms: Colorectal Neoplasms; Nasopharyngeal Neoplasms; Nasal Polyps
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this present study is to investigate the use of benralizumab as treatment for
      severe nasal polyposis. The effect of benralizumab on nasal polyps will be assessed over a 56
      weeks of treatment period in patients with severe bilateral nasal polyposis who are still
      symptomatic despite standard of care therapy, i.e current use of intranasal corticosteroids
      (INCS) and prior surgery and/or use of systemic corticosteroids. The first 200 patients that
      complete the 56-week treatment will have a 6 month follow-up (FU) period without dosing.
    


Intervention name(s): Benralizumab 30 mg SC + Mometasone Furoate; Matching placebo SC + Mometasone Furoate
Intervention type(s): Biological; Biological
Intervention description(s): Benralizumab injection is 30mg/ml SC clear to opalescent, colourless to yellow solution in accessorized pre-filled syringe.
Benralizumab 30 mg SC will be injected every 4 weeks for the first 3 doses - Weeks 0 , 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48. Total of 8 doses.
Mometasone Furoate Nasal Spray (MFNS) - intranasal corticosteroid - 2 doses (1 dose = 50 micrograms/actuation) in each nostril twice daily. Total daily dose of 400mcg. MFNS will be used for a minimum of 4 weeks prior to randomization and will be continued throughout the study.; Matching placebo injection is SC clear to opalescent, colourless to yellow solution in accessorized pre-filled syringe.
Matching placebo SC will be injected every 4 weeks for the first 3 doses - Weeks 0 , 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48. Total of 8 doses.
Mometasone Furoate Nasal Spray (MFNS) - intranasal corticosteroid - 2 doses (1 dose = 50 micrograms/actuation) in each nostril twice daily. Total daily dose of 400mcg. MFNS will be used for a minimum of 4 weeks prior to randomization and will be continued throughout the study.
Intervention MeSH terms: Mometasone Furoate; Benralizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Polyps; Nasal polyps; Nasal polyposis; Nose diseases; Respiratory tract diseases; Otorhinolaryngologic diseases; Benralizumab; Mometasone furoate
Assessment of Vertical Root Fracture Resistance of Endodontically Treated Teeth Instrumented by Single Endodontic Files
Condition: Vertical Fracture of Root of Tooth (Disorder)
MeSH terms: Tooth, Nonvital; Fractures, Bone
Study type: Interventional

Summary: 
      The purpose of this study is the assessment of vertical root fracture resistance of roots
      prepared with three different single endodontic rotary files in extracted human mandibular
      premolar roots.
    

Detailed description: 
      88 human extracted mandibular premolars will be selected. Teeth will be sectioned below
      cementoenamel junction to get 13mm from the apex of root. Roots will then be standardized
      according to buccolingual and mesiodistal widths and will be examined for fracture and craze
      lines. The roots will then be randomly divided into 3 experimental groups and 1 control group
      (n=22). Group 1 will be instrumented with Hyflex EDM. Group 2 will be instrumented with F6
      Sky Taper. Group 3 will be instrumented with One Shape and Group 4 will be negative control
      group in which no instrumentation will be done. After performing rotary instrumentation,
      roots will then be obturated with respective GP and sealer. Samples will then be exposed to
      vertical load utilizing Universal Testing Machine till fracture occur which will be recorded
      in Newton(N).
    

Intervention name(s): Endodontic Root Canal Treatment
Intervention type(s): Procedure
Intervention description(s): Root canal shaping procedures were performed. Irrigation was done after each three pecks of endodontic file. After instrumentation (Groups 1-3), the canals were dried with sterile paper points. The dentinal walls were then coated with Sealapex. For vertical root fracture resistance testing, sample preparation was done in acrylic blocks. Then roots were coated with polyvinylsiloxane impression material. After that roots were inserted again into acrylic resin blocks. The acrylic blocks with the vertically aligned roots were mounted in the Instron testing machine. 0.5 mm diameter round tip stainless-steel rod was fixed to the universal testing machine. The universal testing machine was adjusted and vertical compressive force was applied at a crosshead speed of 1mm/min. The Instron tester applied a slowly increasing force, until the root fractured. The maximum amount of force necessary to fracture every sample was recorded in Newton (N).
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Samples were randomly divided in 4 groups. Random sampling was done with computer generated method. There were 3 working groups comprising of 22 canals and 1 negative control group having 22 canals.
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Hyflex EDM,F6 Sky Taper,One Shape
Serum Folic Acid Status, Genotyping MTHFR 677C-->T, Plasma Homocysteine, DNA Methylation of IGF2 Gene and Microbiota of the Children: Mother-Children Cohort Study
Condition: Folic Acid Deficiency
MeSH terms: Folic Acid Deficiency
Study type: Observational

Summary: 
      This study is part of the East Jakarta Cohort Study to assess the current micronutrient
      status of the mothers and their children. The study also includes the assessment of
      genotyping of MTHFR 677C-->T of the mother and DNA methylation of IGF2 gene of the children.
    

Detailed description: 
      The initial study recruited 315 mothers in the public health centre and one district hospital
      in East Jakarta. The follow-up study is able to re-visit the 127 of them. This also includes
      127 peers of the subject that lives in the same neighbourhood. The design of the study is
      case-cohort design, part study of the existing cohort. The assessment of the follow-up study
      includes the mother and the children born in the initial study. Anthropometric measurement,
      socioeconomic data from a structured questionnaire, biomarker assessment, blood pressure were
      obtained from the subjects.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        In 2014, the pregnant mothers in 10 public health centre and one sub-district hospital in
        East Jakarta were recruited in the study. They were in the third trimester gestation
        period, receive iron-folic acid supplementation and ANC. In 2018, the repeated collection
        was conducted to collect follow-up data. We also include peer of the subjects that lived in
        the same neighbourhood since the first cohort study and have children in the same age with
        cohort participant
      
Biospecimen description: 
      DNA isolated from the whole blood using standardized equipment and procedure of blood taking.

      DNA obtained from mother-children of the participant in the study
    
Keywords: serum folic acid; genotyping; dna methylation of IGF2; East Jakarta Cohort Study; mother-children
A Study of Dasatinib to See How Liver Impaired and Healthy Subjects Process and React to the Study Drug
Condition: Liver Diseases
MeSH terms: Liver Diseases
Study type: Observational

Summary: 
      The primary purpose of this study is to evaluate how a person with liver impairment processes
      and reacts to the study drug. Information about any side effects that may occur will also be
      collected.
    


Intervention name(s): Dasatinib; Dasatinib; Dasatinib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 50 mg, once daily, for one day; Tablets, Oral, 20 mg, once daily for one day; Tablets, Oral, 70 mg, once daily for one day
Other intervention name(s): Sprycel; Sprycel; Sprycel
Intervention MeSH terms: Dasatinib
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Male and Female Subjects with hepatic insufficiency conforming to Child-Pugh classification
        B

        Male and Female Subjects with hepatic insufficiency conforming to Child-Pugh classification
        C

        Healthy Control subjects in good health
      
Biospecimen description: 
      Whole Blood
    
Keywords: hepatically impaired
Enhancing Influenza Vaccination in Seniors With TLR (Toll Like Receptor) Agonists
Condition: Influenza Vaccination in Seniors
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The application of the TLR7/8 (Toll Like Receptor) agonist gel (immune response helper)
      resiquimod will enhance the immune response to the intradermal influenza vaccine in seniors
      65-75 years of age.
    


Intervention name(s): resiquimod; placebo gel
Intervention type(s): Drug; Drug
Other intervention name(s): R-848
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: influenza, human; influenza vaccines; older adults; immune response
Anti-VEGFR Vaccine Therapy in Treating Patients With Neovascular Maculopathy
Condition: Neovascular Maculopathy; Age Related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and time to progression of HLA-A*2402 or
      A*0201 restricted epitope peptides VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in
      patients with Neovascular Maculopathy, including Age Related Macular Degeneration
    

Detailed description: 
      VEGF receptor 1 and 2 are essential targets to pathogenic angiogenesis, and we identified
      that peptides derived from these receptors significantly induce the effective tumor specific
      CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the
      safety, immunological and clinical response of those peptides. Patients will be vaccinated
      once a week for 12 weeks. On each vaccination day, VEGFR1 peptide (1mg) and VEGFR2 peptide
      (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. In the
      study, our primary aim is to evaluate the safety and tolerability of these peptide vaccine.
      The second aim is evaluate the immunological and clinical response of this vaccine therapy.
    

Intervention name(s): VEGFR1 and VEGFR2
Intervention type(s): Biological
Intervention description(s): Biological: VEGFR1 and VEGFR2 Patients will be vaccinated once a week for 12 weeks. On each vaccination day, VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
Other intervention name(s): VEGFR1; VEGFR2; AMD
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment