bioihbjkbjnl/mcl2 huggingface dataset:
Single Treatment With FT1050 of an Ex-vivo Modulated Umbilical Cord Blood Unit
Condition: Non-Hodgkin's Lymphoma (NHL); Hodgkin's Disease; Chronic Lymphocytic Leukemia (CLL); Acute Myelogenous Leukemia (AML); Acute Lymphoblastic Leukemia (ALL)
MeSH terms: Leukemia; Lymphoma, Non-Hodgkin; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Hodgkin Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is a prospective, open-label, single-arm trial of the safety of a single
      FT1050-treated CB unit for hematopoietic reconstitution after a reduced-intensity
      conditioning regimen for hematologic malignancies. A maximum of 40 eligible adult subjects
      will be enrolled and treated in the trial at approximately 2-4 centers within the U.S.
    

Detailed description: 
      The trial will be conducted in three sequential cohorts of 6-12 evaluable subjects each.

      Cohort 1 will enroll eligible subjects for whom a single CB unit has been identified that
      meets the minimum HLA-matching criteria and has a minimum pre-cryopreservation total
      nucleated cell (TNC) dose of at least 2.5 x 10^7 cells/kg. Cohort 2 is identical to Cohort 1,
      except that the TNC dose of the CB unit must be between 2.0 - <2.5 x 10^7 cells/kg. Finally,
      Cohort 3 is identical to Cohort 2, except that the TNC dose of the CB unit must be between
      1.5 - <2.0 x 10^7 cells/kg. If no safety rules are triggered, the study will proceed to the
      next dosing cohort. Within a dosing cohort, no more than three subjects may be before Day 42
      at any one time, unless they have already engrafted neutrophils. The final dosing cohort is
      defined as the last cohort where 12 evaluable subjects are treated and no stopping rules are
      triggered. The corresponding TNC dose level will be considered the minimally acceptable TNC
      dose level.
    

Intervention name(s): Single FT1050 treated UCB unit
Intervention type(s): Biological
Intervention description(s): Ex-vivo CXCR4 upregulated hematopoietic progenitor cells, cord blood
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hematologic malignancies
Transdermal Fentanyl Patch for Postoperative Analgesia After Abdominal Surgery: a Randomized Placebo-controlled Trial
Condition: Postoperative Pain Relief
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Abdominal surgery causes severe postoperative pain. Multi-modal pain therapy is usually
      applied but there is no perfect choice. It depends on physician's skill and situation. The
      best regimen is patient-controlled analgesia, but it requires an expensive equipment.
      Transdermal fentanyl patch, usually used in chronic pain relief, can steadily release
      fentanyl into blood stream for 72 hours, but it has slow onset of 12 hours.

      Hypothesis: If Transdermal fentanyl patch is applied 10-12 hours before surgery, it may
      provide good analgesia for 72 hours.
    


Intervention name(s): transdermal fentanyl patch (50 mcg/hour); Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Duragesic
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transdermal fentanyl patch, postoperative pain,
Multicenter, Open-label, Safety and Tolerability Study
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a multicenter, 52 week, open label study to assess the safety and tolerability
      of oral OPC-34712 (1 to 6 mg) as monotherapy in adult patients with schizophrenia. The study
      will be conducted on an outpatient basis. Enrollment into the study will be drawn from
      eligible subjects who have completed participation in Study 331-07- 203 and who, in the
      investigator's judgment, would benefit from continued treatment with oral OPC-34712.
    


Intervention name(s): OPC-34712
Intervention type(s): Drug
Intervention description(s): oral administered once daily
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia
Study of Nitazoxanide in the Treatment of Amebiasis in Children
Condition: Amebiasis
MeSH terms: Amebiasis; Dysentery, Amebic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effect of nitazoxanide suspension in treating
      diarrhea caused by Entamoeba histolytica in children.
    


Intervention name(s): Nitazoxanide
Intervention type(s): Drug
Intervention MeSH terms: Nitazoxanide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Amebiasis; Entamoeba histolytica
Adjuvant Cetuximab and Chemoradiation in Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This multicenter, open-label, uncontrolled phase II trial evaluates safety and efficacy of
      post-operative chemoradiation in combination with cetuximab in squamous cell carcinoma of the
      head and neck.
    

Detailed description: 
      Advanced squamous cell carcinoma of the head and neck still has a poor prognosis and
      loco-regional recurrence frequently occurs. Efforts have been made to improve response rates
      and survival and different therapeutic regimens including concurrent chemo-radiotherapy or
      sequential chemo-radiotherapy have been developed.

      To further increase the outcome of patients with locally advanced SCCHN effective new
      treatments with minimal toxicities are needed. Molecular targeted agents, which do not
      demonstrate overlapping toxicities with commonly used chemotherapy agents, have therefore
      been investigated. The EGFR is widely expressed at high levels in SSCHN and is associated
      with poor prognosis.

      Cetuximab has already been investigated in combination with radiotherapy or chemotherapy in
      patients with head and neck cancer. The immunoradiotherapy was well tolerated with most of
      the side effects related to the high dose irradiation. The most common side effects are
      mucositis and dysphagia. Additionally, skin reactions appear sometimes more frequently in
      cetuximab administration. Grade 3 to 4 infusion reactions were observed in 3% of the patients
      treated with cetuximab. Based on the current promising results with RCT in patients with
      locally advanced head and neck cancer and clinical results with EGFR-antibodies plus RT, the
      present study was primarily designed to define the acute grade 3/4 toxicity.

      We expect to show effective results in reducing the risk of distant metastasis, with
      administration of an additional six month adjuvant cetuximab treatment, in patient with
      recurrent SCCHN.
    

Intervention name(s): Cetuximab
Intervention type(s): Drug
Intervention description(s): Loading dose prior to chemoradiotherapy 400 mg/m², followed by every week infusion of 250 mg/m² during chemoradiotherapy. After chemoradiotherapy every 2 week infusions of 500 mg/m² over 6 months.
Other intervention name(s): Erbitux
Intervention MeSH terms: Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Head and Neck Cancer; Radiation therapy; Chemotherapy; Chemoradiotherapy; adjuvant cetuximab administration
Weekly Paclitaxel and Cyclophosphamide in Metronomic Administration : Dose Escalation Study of Weekly Paclitaxel
Condition: Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to determine the MTD of Paclitaxel in association with metronomic
      Cyclophosphamide.
    

Detailed description: 
      The aim of the study is to determine the MTD of Paclitaxel in association with metronomic
      Cyclophosphamide for cancer which present no therapeutic solution
    

Intervention name(s): Paclitaxel dose escalation; Paclitaxel; Cyclophosphamide; Blood collection
Intervention type(s): Drug; Drug; Drug; Biological
Intervention description(s): Paclitaxel will be administered intravenously over 60 minutes, at D1, D8 and D15, at a given dose.
The Paclitaxel dose (mg/infusion) levels are as follows:
40
60
70
75
80
85
90; Patients will be treated at the recommended dose in order to confirm the recommended paclitaxel dose in association with metronomic cyclophosphamide; D1 to D28: 50 mg x 2/day/cycle
1 cycle = 28 days; At D1, D8, D15 and D21 of cycle 1 and cycle 2:2 blood samples for the correlation between clinical response and biological parameters
Other intervention name(s): Taxol; Taxol; Endoxan
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Cyclophosphamide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer
Needle Guidance in Ultrasound Guided Nerve Blocks
Condition: Elective Knee Surgery
Study type: Interventional

Summary: 
      An FDA-approved product, InfinitiPlus (TM), is a needle guidance system that has been
      recently developed to guide clinicians in performing ultrasound guided nerve blocks. This
      system helps the clinician to align the needle with ultrasound beam while performing an
      ultrasound guided nerve block. InfinitiPlus (TM) has a unique open channel design allowing
      efficient needle movement while having improved needle shaft and tip visualization. This is a
      disposable system specifically designed for improving success rate of ultrasound guided block
      and patient safety.

      This study will be done with patients having elective knee surgery and a femoral nerve block
      with a catheter. The nerve block procedure will be performed under ultrasound guidance to
      help improve safety and efficacy of the injection. InfinitiPlus (TM) has been recently
      developed to try to improve needle guidance in the ultrasound guided nerve block procedure.
      This study will determine whether femoral nerve block procedures performed under ultrasound
      guidance with InfinitiPlus (TM) take less time than procedures performed with ultrasound
      guidance and a conventional block needle. The study will also determine whether the
      InfinitiPlus (TM) needle reduces the number of times the clinician attempts the procedure,
      reduces the cost of the procedure, increases the procedure success rate, and improves
      ultrasound visibility of the needle.

      Participants will be randomly assigned to either ultrasound guidance with the InfinitiPlus
      (TM) needle guidance system or ultrasound guidance with a conventional block needle. After
      surgery, pain will be rated every 30 minutes for the first 2 hours, then every 4 hours while
      awake for 24 hours. 24 hours after surgery, participants will be given a survey about pain
      treatment satisfaction and a questionnaire about recovery.
    


Intervention name(s): Infiniti Plus needle guidance system; Conventional block needle
Intervention type(s): Device; Device
Intervention description(s): The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks.; conventional block needle used for insertion of femoral nerve catheters.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single Dose, Pharmacokinetic, Safety, Tolerability and QTc Study of GSK1278863 in Healthy Volunteers
Condition: Anaemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being performed to comply with regulatory requirements that all new
      non-antiarrhythmic drugs must be assessed for potential effects on cardiac repolarization
      through electrocardiographic evaluation in a 'Thorough QT/ Corrected QT interval (TQT)'
      study. This will be a two part study, Part A will be an open-label, single oral dose study
      design in order to evaluate the pharmacokinetics, safety and tolerability of a 500 milligram
      (mg) dose of GSK1278863 and Part B will be a single-blind, randomized, placebo-controlled,
      single, oral dose, four-way crossover study design. Parts A and B will be conducted in
      healthy adult subjects with 12-lead electrocardiograms (ECGs), clinical laboratory safety
      tests, vital sign measurements, physical examinations, adverse event reports, and
      pharmacokinetic samples collected throughout the study.
    


Intervention name(s): GSK1278863 75 mg; GSK1278863 500 mg; Moxifloxacin 400 mg; Placebo matching GSK1278863; Placebo matching Moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): A round, biconvex, white film coated tablet available in two doses (25 and 100 mg); A round, biconvex, white film coated tablet available in two doses (25 and 100 mg); Oblong, dull red, film-coated, convex tablets with M400 on one side; A round, biconvex, white film coated tablet as matching placebo for GSK1278863; Capsule shaped white film coated tablet as matching placebo for Moxifloxacin
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Glycine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Prolyl hydroxylase inhibitor; GSK1278863; Anemia; QTc; erythropoiesis stimulating agent
The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the effectiveness and safety of neoadjuvant intravesical
      mitomycin-C instillation in non-muscle invasive bladder cancer patients
    

Detailed description: 
      Study Design: Intervention Model: Single Group Assignment Masking: Open Label

      Primary Outcome Measures:

      Recurrence-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group
      and control group.

      Secondary Outcome Measures:

      Progression-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation
      group and control group.

      Time to recurrence in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and
      control group.

      Change of tumor size after neoadjuvant intravesical mitomycin-C 40mg/20ml instillation.

      Safety of neoadjuvant intravesical mitomycin-C 40mg/20ml instillation.
    

Intervention name(s): intravesical mitomycin-C 40mg/20ml instillation
Intervention type(s): Drug
Intervention description(s): neoadjuvant Intravesical mitomycin-C 40mg/20ml instillation
one day before surgery
four hours before surgery
Other intervention name(s): Mitomycin_C Kyowa
Intervention MeSH terms: Mitomycins; Mitomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Lactoferrin Supplementation on Urinary Tract Infections in Infants.
Condition: Urinary Tract Infections in Children
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study was to evaluate the efficacy of orally administered bovine lactoferrin
      (bLF) on Urinary Tract Infections in neonates and infants. Fifty-five patients with urinary
      tract infection were randomized to receive either bLF (n = 27) or an identical placebo (n =
      28) for 4 weeks. The patients were assessed clinically and laboratory.
    

Detailed description: 
      This study was a prospective randomized controlled trial at a single university medical
      center. Participants were neonates or infants with Urinary Tract Infection (UTI) admitted to
      the Neonatal and Infant Pathology Department of Children's University Hospital in the period
      from July 2015 to December 2017. The intervention was bovine lactoferrin at a dosage of 100
      mg/day for a period of 4 weeks compared with placebo in a control group.

      During hospital treatment, laboratory tests were performed to evaluate the activity of
      inflammatory markers (C-reactive protein, procalcitonin, Interleukin-6 and Interleukin-8
      levels and white blood cell count).

      Fifty-five patients heve been included in the study.
    

Intervention name(s): Bovine Lactoferrin; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Orally intake 1 sachet per day for 4 weeks. Lactoferrin will be dissolved in human milk or infant formula or in a 5% glucose solution.; Orally intake 1 sachet per day for 4 weeks. Maltodextrin will be dissolved in human milk or infant formula or in a 5% glucose solution.
Other intervention name(s): Lactoferrin 100 mg; Maltodextrin
Intervention MeSH terms: Lactoferrin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: patients with Urinary Tract Infections were recruited subjects were randomized into two groups:
the experimental group received bLF
the control group received placebo without bLF
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: urinary tract infections; infants; lactoferrin
InPen User Experience
Condition: Diabetes Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the user experience of InPen™ with InPen™ Diabetes
      Management App and Guardian 4 system in adult patients with type 1 diabetes for the design of
      a future pivotal study.
    

Detailed description: 
      This study is a multi-center, single arm study in insulin-requiring adult subjects with type
      1 diabetes treated with MDI (basal and bolus) therapy.

      The total study duration will be approximately 10 weeks long for each participant.

      The study consists of a run-in (phase 1) and study phases 2, 3 and 4.

      Phase 1:

      The purpose of the run-in phase is to collect baseline HbA1c and blinded Continuous Glucose
      Monitoring (CGM) data while subjects are on their current MDI therapy.

      Phase 2:

      All subjects will utilize a smart bolus insulin pen injector (InPen™) and app with dose
      calculator (InPen™ Diabetes Management App), and will continue their own SMBG, iscCGM or
      RT-CGM for two weeks.

      Phase 3:

      Subjects will continue on the InPen and InPen App for another two weeks utilizing the HCP
      insights gained during the titration follow-up visit.

      Phase 4:

      All subjects will utilize the InPen™ system consisting of:

        -  InPen™ and InPen™ Diabetes Management App

        -  Guardian™ 4 system (RT-CGM)

        -  Guardian™ 4 sensor

        -  Guardian™ 4 transmitter

        -  Guardian™ 4 app
    

Intervention name(s): InPen with Guardian 4 System
Intervention type(s): Device
Intervention description(s): Subjects will receive the InPen™ and InPen™ Diabetes Management App combined with the Guardian™ 4 system.
Intervention model: Single Group Assignment
Intervention model description: Single Arm exploratory and descriptive study.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Multiple Daily injections; Continuous Glucose Monitoring
Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Seladelpar in Subjects With Hepatic Impairment and Healthy Subjects
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic
      (PK) profiles of seladelpar following administration of a single oral dose in subjects with
      varying degrees of hepatic impairment (HI) compared to healthy matched control subjects with
      normal hepatic function.
    


Intervention name(s): seladelpar
Intervention type(s): Drug
Intervention description(s): Oral single dose 10 mg
Other intervention name(s): MBX-8025
Intervention MeSH terms: Seladelpar
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic Impairment
Effectiveness and Cost-Efficiency of Aquatic Exercise for Management of Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study was to estimate the cost and outcomes of the Arthritis Foundation
      aquatic exercise classes.

        -  DESIGN. Randomized trial of 20-week aquatic classes.

        -  SUBJECTS AND METHODS. Recruited 249 adults from Washington State aged 55 to 75 with a
           doctor-confirmed diagnosis of osteoarthritis

        -  MEAURES. The Quality of Well-Being Scale (QWB), Current Health Desirability Rating
           (CHDR), Health Assessment Questionnaire(HAQ), Center for Epidemiologic
           Studies-Depression Scale (CES-D), Perceived Quality of Life Scale (PQOL)
    


Intervention name(s): Aquatic exercise
Intervention type(s): Behavioral
Intervention description(s): Arthritis Foundation Aquatics Program
community-based aquatic exercise program
participants asked to attend 2 classes per week for 20 weeks
each class 45-60 minutes in duration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Osteoarthritis
Assessment, Feedback, Incentive, Exchange (AFIX OB) A Customizable Quality Improvement Intervention to Increase Maternal Vaccine Uptake
Condition: Influenza; Whooping Cough
MeSH terms: Whooping Cough
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the AFIX-OB model to determine its impact on the
      change in flu and pertussis (Tdap) uptake, provider knowledge, attitudes and beliefs, and
      patient knowledge, attitudes and beliefs regarding maternal vaccination. The structure of the
      model and quality improvement interventions are guided by theory including the elaboration
      likelihood model and P3 model. These quality improvement measures will be implemented in OB
      clinics within the Yale New Haven Health System.
    


Intervention name(s): AFIX-OB Quality Improvement Package
Intervention type(s): Behavioral
Intervention description(s): Practices randomized to the intervention arm will be provided with a package of core and supplemental quality improvement interventions to choose from so that the most effective combination for their practice is implemented. Each practice will be required to implement a tablet-based educational app for patients, and evidence based online educational module for providers, standing order protocol, and a reminder/recall protocol. They can then choose to also use flyers and posters in their waiting rooms, standardized talking points for maternal immunization for the providers, educational content for the practice website, and laminated and highlighted CDC Vaccine Information Sheets. The recruited patients and providers at the practice will be given a baseline and follow-up survey to assess their knowledge, attitudes, and beliefs towards maternal immunization.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pregnancy; Vaccination; Vaccine Acceptance; Influenza; Pertussis; Tdap