bioihbjkbjnl/mcl2 huggingface dataset:
Single Cohort 4-period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of steady-state ranolazine on the steady
      state PK of metformin in subjects with type 2 diabetes mellitus (T2DM).
    

Detailed description: 
      The primary objective of this study is as follows:

      • To evaluate the effect of steady-state ranolazine on the steady state PK of metformin in
      subjects with T2DM.

      The secondary objectives of this study are as follows:

        -  To examine the safety and tolerability of metformin when co administered with ranolazine
           at steady-state in subjects with T2DM.

        -  To determine the steady-state PK of ranolazine in subjects with T2DM receiving
           metformin.
    

Intervention name(s): Metformin; Ranolazine
Intervention type(s): Drug; Drug
Intervention description(s): Metformin 500 mg bid on Days 1-5
Metformin 850 mg bid on Days 6-10
Metformin 500 mg bid on Days 11-15
Metformin 850 mg bid on Days 16-20; Ranolazine 1000 mg bid on Days 11-15
Ranolazine 1000 mg bid on Days 16-20
Other intervention name(s): Glucophase; Ranexa
Intervention MeSH terms: Metformin; Ranolazine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Metformin; Ranolazine; Type 2 Diabetes Mellitus
A Roll-over Study to Provide Continued Treatment With Lyophilized Pegaspargase (S95014) in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL)
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to provide treatment with lyophilized S95014 in pediatric
      patients with ALL who completed the CL2-95014-002 study during the induction phase and who
      are clinically benefitting from S95014 without major toxicity.
    


Intervention name(s): Lyophilized S95014
Intervention type(s): Drug
Intervention description(s): Each patient was administrated, over 1 to 2 hours, every 2 weeks Lyophilized S95014 intravenously at the dose of 1000, 2000 or 2500U/m2, as per investigator's judgement.
In total, 9 infusions of lyophilized S95014 were administrated (at week 7, 9, 11, 15, 17, 19, 23, 25 and 27).Patients received other backbone chemotherapy agents as per ALL-MB 2015.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Lymphoblastic Leukemia; Phase II; Oncology / Haematology; Continued treatment; Pegaspargase; Lyophilized pegaspargase; Roll-over study / extension study
Achilles Tendon Rupture, Conservative vs. Operative Treatment: Prospective Randomized Controlled Trial
Condition: Achilles Tendon Rupture
MeSH terms: Rupture
Study type: Interventional

Summary: 
      The intention is to compare prospectively operative and conservative early functional
      rehabilitation protocol in treatment of total achilles tendon rupture. To compare these
      treatments, the investigators use 1998 published Leppilahti-score, Rand-36 quality of
      life-questionnaire and MRI. The Leppilahti-score includes both subjective and objective items
      (pain, stiffness, subjective calf muscle weakness, footwear restrictions, active range of
      motion between ankles, subjective result, isokinetic calf muscle strength). The investigators
      also study MRI-imaging for both legs and compare including achilles tendon elongation and
      muscle volume correlations to Leppilahti-score results between these two treatments.
      Follow-up time is 18 months.

      Hypothesis is that operative treatment offers no benefit in comparison conservative
      treatment, with identical rehabilitation protocol.
    


Intervention name(s): End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture; Conservative treatment of achilles tendon rupture
Intervention type(s): Procedure; Other
Intervention description(s): Operative treatment of achilles tendon rupture; End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture and after operation identical protocol as conservative treatment.; Conservative treatment of achilles tendon rupture; 1 week equinus-cast without bearing, and then 6 week Vacoped orthosis with different equinus degrees and full weight bearing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Achilles tendon rupture; treatment, elongation; operative treatment of achilles tendon rupture; conservative treatment of achilles tendon rupture
Decitabine and Vorinostat Conditioning Followed by CD3-/CD19- NK Cells Infusion for High Risk Myelodysplastic Syndromes
Condition: Myelodysplastic Syndrome
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II therapeutic trial combining Decitabine days 1-5 with oral Vorinostat twice
      daily days 6-15 followed by a single infusion of CD3-/CD19- enriched donor natural killer
      (NK) cells on day 17 and a short course of Interleukin-2 (IL-2) to facilitate NK cell
      survival and expansion. Two courses of treatment will be given separated by 6-8 weeks. The
      intent is to administer all treatment in the outpatient setting.
    

Detailed description: 
      A single donor apheresis will be collected on day 15 of cycle 1, enriched for NK cells with
      the large scale CliniMacs device (Miltenyi) and activated by overnight incubation with IL-2.
      After washing, the final NK cell product will be divided in two, with half given fresh on day
      17 of course #1 and half stored frozen until day 17 of course #2.

      Clinical response will be formally assessed 4-6 weeks after the start of 2nd course based on
      International Working Group (IWG) criteria; however, bone marrow evaluations will be
      completed to assess for any sign of significant disease progression between cycle 1 and 2.
    

Intervention name(s): Decitabine; Vorinostat; Interleukin-2; Natural killer (NK) cells
Intervention type(s): Drug; Drug; Biological; Other
Intervention description(s): administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.; 200 mg by mouth (PO) twice a day on days 6-15; 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17; infusion intravenously (IV) over 15 to 60 minutes day 17
Other intervention name(s): Dacogen; Zolinza; IL-2
Intervention MeSH terms: Decitabine; Interleukin-2; Vorinostat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: high risk myelodysplastic syndrome; natural killer cells
Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
Condition: Chronic Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate and compare the side effects and anti-leukemic
      benefits of imatinib with those of interferon and Ara-C for patients who have chronic myeloid
      leukemia (CML) in the chronic phase. Patients in this study will be randomized (1:1) to
      receive either interferon plus Ara-C or imatinib as initial treatment.
    


Intervention name(s): imatinib mesilate; interferon-alpha (INF-a); cytarabine (ARA-C)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): imatinib supplied as 100 mg and 400 mg tablets or 100 mg capsules.; interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day.; cytarabine 20 mg/m^2/day (max 40 mg) SC for 10 days every month.
Other intervention name(s): Glivec®; Gleevec®; STI571; Roferon®-A; Intron®-A
Intervention MeSH terms: Interferons; Cytarabine; Interferon-alpha; Interferon alpha-2; Imatinib Mesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CML; STI571; imatinib; interferon; interferon alpha; cytosine arabinoside; chronic myeloid leukemia; Philadelphia chromosome positive
A Study of RO6807952 in Patients With Diabetes Mellitus Type 2
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, placebo-controlled, multiple ascending dose study will evaluate the safety,
      tolerability, pharmacokinetics and pharmacodynamics of RO6807952. Patients will receive
      multiple weekly subcutaneous doses of RO6870952. The anticipated time on study treatment is 8
      weeks.
    


Intervention name(s): Placebo; RO6807952
Intervention type(s): Drug; Drug
Intervention description(s): Placebo to RO6807952; Escalating subcutaneous dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
PROcalcitonin Impact on Antibiotic Reduction, adverSe Events and AVoidable healthcarE Costs (ProSAVE): A RCT
Condition: Pneumonia, Bacterial
MeSH terms: Pneumonia, Bacterial
Study type: Interventional

Summary: 
      Trials comparing PCT-guided antibiotic algorithms to standard management show a significant
      reduction in antibiotic exposure without an increase in mortality or treatment failure.
      Despite this strong evidence from multiple studies a recent prospective multicentric
      interventional trial in the US fell short of demonstrating antibiotic reductions by
      PCT-guided antibiotic management. Amongst other limitations the authors of that study
      concluded that successful implementation of PCT may require closer educational oversight. As
      such, this study will compare effectiveness and safety of antibiotic prescription guided by a
      PCT-algorithm via a Stewardship Team over standard guidelines in hospitalized adult patients
      with suspected or confirmed LRTI (including sepsis with respiratory focus).
    


Intervention name(s): procalcitonin
Intervention type(s): Diagnostic Test
Intervention description(s): accuracy of procalcitonin as a diagnostic marker in guiding antibiotic therapy in patients with a lower respiratory tract infection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
GnRH Antagonist for Treatment of Early Ovarian Hyperstimulation Syndrome
Condition: Ovarian Hyperstimulation Syndrome; Effects of Gonadotropin; Oocyte Maturation
MeSH terms: Ovarian Hyperstimulation Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to analyze the effectiveness of GnRh antagonist in the treatment of
      early ovarian hyperstimulation syndrome.
    

Detailed description: 
      Ovarian hyperstimulation syndrome (OHSS) is a serious complication of ovarian stimulation
      protocols. Gonadotrophin-releasing hormone (GnRH) antagonist administration in the luteal
      phase was recently proposed as a new approach for the management of patients with established
      severe OHSS We analyze the response of egg donors with moderate- severe early ovarian
      hyperstimulation syndrome after a GnRH antagonist stimulation protocol to the administration
      of a daily doses of GnRH antagonist (Cetrorelix 0.25) during 7 days after the second day of
      oocyte retrieval compared with placebo (saline solution).
    

Intervention name(s): GnRH antagonist (Cetrorelix); Placebo (saline solution)
Intervention type(s): Drug; Drug
Intervention description(s): •GnRH antagonist (Cetrorelix 0.25) during 7 days beginning administration the second day of oocyte retrieval; • Placebo (saline solution) 1 ampoule every 24 hours during 7 days beginning administration the second day of oocyte retrieval
Intervention MeSH terms: Cetrorelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Ovarian hyperstimulation syndrome (OHSS); GnRH antagonist; Ascitis.
Child-centered Communication and Anesthesia Use for MRI
Condition: Behavioral Problem of Child; Anxiety
MeSH terms: Problem Behavior
Study type: Interventional

Summary: 
      The goal of this project is to study the influence of child-centered communication on
      children's anxiety, satisfaction and the use of anesthesia for MRI
    

Detailed description: 
      This study seeks to inspect the influence of a child-centered communication (CCC) on
      anesthesia use in magnetic resonance imaging (MRI) exams among four- to 10-year-old children.
      Children's levels of anxiety and satisfaction with the interaction also are assessed.
      Children are divided into three groups by order of arrival. Group 1 receives routine
      information about the MRI and simulates it with an MRI toy (EG1). Group 2 simulates the exam
      with the toy and receives the CCC. These two groups are compared with a third group of
      children who had received only the routine information about the exam and who served as a
      comparison group (CG).
    

Intervention name(s): Child-centered communication
Intervention type(s): Behavioral
Intervention description(s): The child is asked for ideas, fears and concerns regarding the magnetic resonance imaging exam and responses are tailored to these individual needs
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: patient-centered communication; children; MRI; anesthesia; toy simulation
Correlation of Nasopharyngeal (NP) and Lower Oesophageal (LO) Temperatures in Ventilated Children
Condition: Child
Study type: Interventional

Summary: 
      Children lose heat under general anaesthesia, thus temperature is routinely monitored during
      anaesthesia for all but the shortest cases, and active warming can be used to prevent
      hypothermia and its resulting complications. Temperature can be measured at several sites
      dependent on the type of surgery and patient factors. Previously a temperature probe has been
      sited in the lower third of the oesophagus (swallowing tube) but it is difficult to
      accurately place this without an X-Ray. Consequently it is more common to use a temperature
      probe placed in the nasopharynx (where the nose and throat meet), when the child is
      anaesthetised.

      However the investigators do not know if the temperature in the nasopharynx correlates well
      with the real core temperature or not.This prospective, unblinded, agreement study will seek
      to find an agreement of 2 methods to measure temperature in children undergoing general
      anaesthesia with a breathing tube that has a leak.
    

Detailed description: 
      It is known that temperature in the lower third of the oesophagus correlates well with the
      gold standard of core temperature measurement, namely the temperature of blood in the heart.
      It is not known if oesophageal and nasopharyngeal temperatures correlate in children on a
      breathing machine via a tube with leak. If this study were to find a good correlation between
      oesophageal and nasopharyngeal temperature, this would allow clinicians to confidently use
      the more feasible nasopharyngeal temperature probes.

      For this study 100 children will have both nasopharyngeal and oesophageal temperatures
      measured during general anaesthesia, both in the presence and absence of a leak around the
      endotracheal tube.

      It is hypothesised that even in the presence of a leak, the temperature difference between
      the two methods will be less than 0.5 degrees centigrade.
    

Intervention name(s): Nasopharyngeal and oesophageal temperature probes
Intervention type(s): Device
Other intervention name(s): Covidien; Mon-a-therm™ General Purpose Temperature Probe 400TM; 90050
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Oesophageal; Nasopharyngeal; temperature; Intubation, endotracheal; Pediatric; Anesthesia; Hypothermia
Safety Study of SD-101 (a Novel C Type Toll-like Receptor 9 (TLR9) Agonist) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine safety, tolerability, and preliminary efficacy of escalating doses of SD-101
      alone and SD-101 plus ribavirin in subjects with chronic hepatitis C and no prior therapy.
    


Intervention name(s): SD-101; ribavirin
Intervention type(s): Drug; Drug
Intervention description(s): Intramuscular (IM); oral, 2 times per day, for 2 months
Other intervention name(s): CpG Class C Immunostimulatory Sequence (ISS); TLR9 Agonist
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: HCV; Immunostimulatory sequence (ISS); TLR9 (toll-like receptor 9); interferon (IFN); ribavirin
Vortex - Temporary Percutaneous, Transvalvular Circulatory Support System Feasibility Study
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      Vortex - First in Human study to evaluate the feasibility, safety, clinical and technical
      success of the Vortex temporary percutaneous, transvalvular circulatory support system
      (Vortex System)
    


Intervention name(s): Temporary Percutaneous Transvalvular Circulatory Support System (Vortex System)
Intervention type(s): Device
Intervention description(s): The Vortex System is indicated to provide temporary circulatory support in subjects undergoing elective high-risk percutaneous coronary intervention (HR-PCI).
Intervention model: Single Group Assignment
Intervention model description: Prospective, open-label, single-arm feasibility study
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Mechanical circulatory support; High risk percutaneous coronary intervention (HR PCI)
Short-term Sugary Beverage Consumption on Glucose Control and Cardiovascular Disease Risk Factors
Condition: Metabolic Syndrome
MeSH terms: Cardiovascular Diseases; Metabolic Syndrome
Study type: Interventional

Summary: 
      Our goal is to determine how the addition of sugar-sweetened beverages to the diet affects
      glucose control, cardiovascular disease risk factors, and pulmonary function in healthy,
      young adults.
    

Detailed description: 
      In a 3-arm randomized controlled trial, 36 participants consumed one of three beverages for
      three weeks: water (W), caffeine-free soda (S), or 100% fruit juice (FJ). Participants
      consumed two servings/day (~710mL) of their randomized beverage for three weeks, along with
      their habitual diets. At baseline and following the 3-week intervention, participants
      completed glucose control, cardiovascular disease risk factor, and pulmonary function
      assessments.
    

Intervention name(s): Sugary beverage: Fruit juice; Sugary beverage: Soda; Control: Water
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Participants consumed 100% fruit juice (~710mL) daily for three weeks, along with their habitual diets.; Participants consumed soda (~710mL) daily for three weeks, along with their habitual diets.; Participants consumed water (~710mL) daily for three weeks, along with their habitual diets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Glucose control; Cardiovascular disease risk factors; Sugary beverages; Pulmonary function
Dose Escalation Of Icotinib In Previously Treated Patients With Routine Dose
Condition: Non-small Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine whether dose escalation can provide a better survival to patients who failed
      with icotinib at routine dose.
    

Detailed description: 
      Lung cancer is a major cause of morbidity and mortality, which is the rapidest increased type
      of cancer in China with over 5 times incidence rate increase during the past 30 years.
      Tyrosine kinase inhibitors (TKIs) of the epidermal growth factor receptor (EGFR) have been
      widely used for the treatment of patients with non-small cell lung cancer(NSCLC). Icotinib is
      a novel EGFR-TKI developed by a group of Chinese scientists and clinician. Icotinib appears
      to be non-inferior to Gefitinib in terms of efficacy, better in terms of safety, and larger
      of therapeutic window in phase I-III trials. In this study, an open , single-center, single
      arm phase IV trial was designed to evaluate the safety and efficacy of dose escalation of
      icotinib in the treatment of advanced NSCLC patients after failure with routine dose. PFS
      (progress free survival) is the primary end-point with OS (overall survival), ORR (objective
      response), TTP (time to progress), HRQOL and safety as the secondary end-point.
    

Intervention name(s): Icotinib
Intervention type(s): Drug
Intervention description(s): 125 mg Tid (375 mg per day) 250 mg Tid (750 mg per day)
Other intervention name(s): BPI-2009, Conmana
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Efficacy; Safety; EGFR-TKI; phase IV; NSCLC; Dose escalation
Dietary Education Intervention Impact on Dietary Protein Intake in PD
Condition: Dietary Modification
Study type: Interventional

Summary: 
      This study is a prospective randomized controlled pilot trial/(a combined prospective and
      retrospective study). The investigators will use wechat intervening dietary protein intake in
      patients treated with peritoneal dialysis.
    

Detailed description: 
      Malnutrition is highly prevalent in peritoneal dialysis (PD) patients, and protein
      malnutrition will adversely affect outcomes. The investigators develop a dietary education
      intervention for PD patients to improve fundamental food knowledge that will increase protein
      intake to target level of 1.2 g/kg of protein intake per day. In additional the dietary
      intervention will provide information about sodium, phosphorus, calcium intake. To more
      effectively deliver the intervention, the investigators explored a technology using social
      media in China called wechat. The purpose of this study is to test whether a dietary
      intervention can be more effective when delivered using wechat compared to a traditional
      patient education intervention delivered during routing clinical visits.
    

Intervention name(s): wechat
Intervention type(s): Behavioral
Intervention description(s): The wechat model of dietary education every 1 month by cellphone
Other intervention name(s): wechat model
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention