bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 4, Open-label Study of KRYSTEXXA® (Pegloticase) Co-administered With Methotrexate (MTX) in Patients With Uncontrolled Gout (FORWARD OL)
Condition: Uncontrolled Gout; Chronic Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is to assess efficacy, safety, blood levels and bodily effects of up to 2 dose
      levels of intravenous (IV) pegloticase (KRYSTEXXA) infusions at every 4 week intervals (Q4
      Weeks) for up to 6 months (Day 1 to 24 weeks with an optional 24 - 48 weeks treatment
      duration) when given in combination with weekly oral doses of methotrexate (MTX). The goal is
      to identify an appropriate dose to be administered every 4 weeks to be used for future
      clinical trials for patients with chronic gout that does not adequately respond to
      conventional therapy.
    

Detailed description: 
      The primary objective is to choose a dose for further investigation by assessing the effect
      of up to 2 dose levels of pegloticase administered IV Q4 weeks, co-administered with weekly
      doses of oral MTX, as measured by the sustained normalization of serum uric acid (sUA) to < 6
      mg/dL for at least 80% of the time during Month 6 and the duration of sUA to < 6 mg/dL over
      24 week treatment period in adult participants with chronic gout refractory to conventional
      therapy.
    

Intervention name(s): Pegloticase and Methotrexate (MTX); Pegloticase and Methotrexate (MTX)
Intervention type(s): Biological; Biological
Intervention description(s): 16 mg IV dose of pegloticase q4 weeks co-administered with 15 mg oral dose methotrexate weekly; Potential higher IV dose of pegloticase (between 24-32 mg) q4 weeks co-administered with 15 mg oral dose methotrexate weekly and/or potential reduction of infusion duration
Intervention MeSH terms: Methotrexate
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Screening period up to 35 days, followed by 4-week methotrexate (MTX) tolerability run-in. Treatment consists of pegloticase IV Q4 Wks dose for a total of 6 infusions (24 Weeks) with co-administered weekly oral MTX. Optional extension treatment (24-48 weeks) will be available for 6 more infusions (total of 12). Study will consist of Cohort 1: 16 mg pegloticase, co-administered with weekly doses of oral MTX; and, potential Cohort 2: 24 to 32 mg pegloticase, co-administered with weekly doses of oral MTX and/or potential infusion duration reduction to 60 min.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gout; KRYSTEXXA; Pegloticase; Methotrexate; Uncontrolled gout
Evaluation of the Safety and the Ability of a DNA Vaccine to Protect Against Dengue Disease
Condition: Dengue Disease; Dengue Fever
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether a new investigational dengue vaccine is
      safe, well-tolerated, and to see if an immune response against dengue disease will be
      generated.
    

Detailed description: 
      Arguably the need for a tetravalent dengue vaccine that will effectively induce immunity
      against all four dengue serotypes has never been greater. Currently, several different
      approaches are being taken to develop a protective tetravalent dengue vaccine. These include
      live-attenuated vaccines derived by serial passage in tissue culture, live chimeric vaccines,
      recombinant protein vaccines and DNA vaccines. While live attenuated and live chimeric
      vaccines have shown promise in clinical trials, viral competition with suspected immune
      interference resulting in imbalanced immune responses and reactogenicity with the occurrence
      of dengue like symptoms remains a concern. It is imperative that any candidate vaccine
      produce solid immunity against each of the four dengue virus serotypes. Failure to do so may
      place the recipient of the vaccine at risk for developing severe dengue disease (dengue
      hemorrhagic fever/dengue shock syndrome) following exposure to the virus serotype to which
      there was incomplete protective immunity, resulting in antibody dependent enhancement due to
      the presence of non-neutralizing anti-dengue antibodies.
    

Intervention name(s): Tetravalent Dengue Vaccine (TVDV); Tetravalent Dengue Vaccine (TVDV) with Vaxfectin® (low-dose); Tetravalent Dengue Vaccine TVDV with Vaxfectin® (High Dose)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Low dose delivered intramuscularly on Study Days 0, 30 and 90; Low dose: TVDV formulated with Vaxfectin®; 1.0 mL volume delivered intramuscularly on Study Days 0, 30 and 90; High dose: TVDV formulated with Vaxfectin®; 1.0 mL volume delivered intramuscularly on Study Days 0, 30 and 90
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: dengue; dengue fever; dengue disease; tetravalent dengue vaccine; Vaxfectin®
Ultrasound Diagnosis of Cleft Lip and Palate
Condition: Cleft Lip and Palate
MeSH terms: Cleft Lip
Study type: Observational

Summary: 
      Cleft lips and palate are one of the most frequent congenital malformation. From 2005 to
      2009, a French study, conducted by Dr Bäumler et al. evaluated the accuracy of prenatal
      ultrasound in the diagnosis of cleft palate when cleft lip is present.

      The aim of this study is to continue this study from 2009 till 2016. The hypothesis is that
      the diagnosis rate is constant since 2005.
    


Intervention name(s): Study of medical records
Intervention type(s): Other
Intervention description(s): Study of medical records
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Fœtus with cleft lip diagnosed at mid-trimester ultrasound screening in Montpellier
        hospital (Arnaud de Villeneuve) between February 2009 and December 2016.
      
Keywords: Ultrasound; Pregnancy; Diagnosis
Early Levothyroxine Post Radioactive Iodine
Condition: Graves' Disease
MeSH terms: Graves Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study will try to answer the question of whether early treatment with levothyroxine at 4
      weeks after radioactive iodine for Graves'disease will prevent overt hypothyroidism (low
      thyroid hormone levels).
    


Intervention name(s): Levothyroxine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Early initiation of levothyroxine after radioactive iodine (to start at 4 weeks).; Placebo to start at 4 weeks after RAI
Other intervention name(s): Thyroid hormone
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Graves' disease; Radioactive iodine; Hypothyroidism
Postprandial Effects of Walnut Components Versus Whole Walnuts on Cardiovascular Disease (CVD) Risk Reduction
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the acute, postprandial effects and mechanism of
      action of various walnut components (separated nut skins, de-fatted nut meat, nut oil) versus
      whole walnuts on oxidative stress, inflammation and measures of platelet and endothelial
      function in healthy adults with moderately elevated cholesterol levels.
    

Detailed description: 
      Walnuts contain high contents of polyunsaturated fatty acids (PUFA), particularly linoleic
      acid and linolenic acid. The high PUFA content has been suggested to reduce CVD risk through
      decreasing total and LDL-cholesterol concentrations, and increasing HDL-C concentrations. In
      addition, walnuts are rich in substances such as ellagic acid (a polyphenol), antioxidants,
      vitamin E, fiber, essential fatty acids, flavanoids, and phenolic acids. Polyphenolic
      compounds are believed to have multiple biological effects influencing oxidative stress,
      platelet function, inflammation, and cancer initiation and propagation. There is interest in
      identifying foods with these and other favorable compounds to test their efficacy in real
      world settings to further understand their role in the human diet. Despite positive benefits
      found in consumption of the walnuts, it is not known which specific component of the walnut
      (i.e., whole walnut, walnut skin, defatted walnut, or walnut oil) is most beneficial to
      health. The investigators hypothesize that maximum improvements in oxidative stress,
      inflammatory markers, platelet and endothelial function will be observed following
      consumption of the whole nut versus isolated walnut components, thereby leading to a
      recommendation to consume walnuts. In addition, results from the research proposed will
      provide new information about the antioxidant, inflammatory, platelet activity and
      endothelial effects of the different walnut components and the synergistic effects these
      components have in the postprandial state.
    

Intervention name(s): Walnut "meat"; Walnut Oil; Walnut Skins; Whole walnut
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Separated, ground walnut de-fatted nut meat incorporated into inert food carrier; Walnut oil extracted from nut meat and incorporated into inert food carrier; Separated, ground walnut skins incorporated into inert food carrier; 85g whole walnuts, ground, incorporated into inert food carrier
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cardiovascular Disease
Pain Education to Improve Cancer Pain Management Patients
Condition: Pain; Inpatient; Cancer
MeSH terms: Cancer Pain
Study type: Interventional

Summary: 
      Cancer pain is one of the problems of treating cancer pain. Although, there is a WHO
      analgesic ladder to improve this problem, it is still inadequate pain control. Pain does not
      affect only physical but also emotional and quality of life.

      From review literatures we found that patients' knowledge about cancer pain management is
      inaccurate; for example, fear to use opioid, try to patience of pain, concerning only cancer
      treatments, which can cause of unfavorable pain management outcome.

      Therefore, we will conduct the RCT of using pain education by video comparing to conventional
      face to face pain education by nurse in hospitalized cancer pain patients.We will use 25 MCQs
      examination for testing pre-post intervention to test level of understanding of patients. The
      measurements are NRS, ThaiHADs and FACT-G at the first and last day of study. We expect that
      NRS should improve more than 50% at the seven day of study.
    

Detailed description: 
      protocol Randomized controlled trial study Sample size is 70 patients divided to 2 groups (35
      for video group and 35 for conventional face to face group) Inclusion criteria

        1. patients' age 18-70 years old

        2. moderate to severe cancer pain

        3. ECOG(Eastern cooperative Oncology Group) performance status <= 3

        4. Patients can write and read Thai language Exclusion criteria

      1.Clinical unstability 2.Confusion and delirium 3.Bed ridden 4.Psychotic problem We will
      randomly allocate patients by using computer program nQuery advice 6.0. After patients sign
      inform consent we will record baseline characteristics, assess baseline Numerical rating
      scale (NRS), emotional status (ThaiHADs), Quality of life status (FACT-G). All patients will
      do the 25 MCQs test within 30 minutes before intervention. Video group will watch video 10
      minutes and conventional group will receive pain education from trained nurse in the same
      period. The knowledge includes cancer pain definition, cancer pain management, pain
      assessment and role of patients in cancer pain management. After finishing intervention
      patients will the same 25 MCQs test (30 minutes) and patients can ask questions to the
      trained nurse.

      All patients will be educated to record pain diary everyday for seven days. All patients will
      receive standard pain management from the physicians. At the day seven we will assess NRS,
      ThaiHADs and FACT-G and finish the study.
    

Intervention name(s): Video group; conventional group
Intervention type(s): Other; Other
Intervention description(s): Using video for educate cancer pain patients; Face to face cancer pain education by trained nurse
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Effect of Nanotechnology Structured Water Magnalife for the Prevention of Recurrent Urinary Tract Infections.
Condition: Recurrent Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Recurrence
Study type: Interventional

Summary: 
      This study investigates nanotechnology structured water magnalife in urology and to test its
      effects against lower urinary tract infections (UTI) in females.
    

Detailed description: 
      This study represents the first time to use nanotechnology structured water magnalife in
      urology and to test its effects against lower urinary tract infections (UTI) in females.
      Urinary tract infection (UTI ) is the second most common bacterial infection, affecting women
      at a much higher frequency than men. There is a higher rate of recurrence of UTI, and a
      recurrent infection will follow 25-35% of initial UTI episodes within 3-6 months.

      Intermittent or prolonged low dose antibiotic therapy has been used to treat and prevent
      recurrent UTI. Emerging of resistance to antimicrobial agents, enormous economic burden, and
      the side effects of antibiotics have led to the search for an alternative non-antibiotic
      prophylaxis of recurrent UTI. Nanotechnology structured water is a new type of drinking water
      that has been prepared using different types of energy fields and electromagnetic fields to
      produce this structured water, which has new and different characteristics from the ordinary
      water.

      In the current study, the efficacy of nanotechnology structured water magnalife was compared
      with low-dose Trimethoprim and bottled drinking water for the prevention of recurrent UTI.
    

Intervention name(s): Nanotechnology Structured water Magnalife; Trimethoprim; Ordinary bottled drinking water
Intervention type(s): Dietary Supplement; Drug; Dietary Supplement
Intervention description(s): Nanotechnology Structured water Magnalife is drinking water that has been modified using nanotechnology to change the structuring of water molecules; Antibiotic; Placebo
Other intervention name(s): Magnalife; 5200250040466; Proloprim
Intervention MeSH terms: Trimethoprim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: nanotechnology water, antibiotic prophylaxis, recurrent UTI.
Do Taping and Orthosis Affect Pain, Gait, or Functionality in Mild Knee Osteoarthritis?
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Objective: The aim of this study was to compare the effects of elastic taping, rigid taping,
      and braces applied to women with mild knee Osteoartritis(OA) on pain, gait, and knee
      functionality.

      Methods: This randomised study included 21 female patients (mean age of 53.81±6.20 years)
      with bilateral grade 2 knee OA according to the Kellgren & Lawrence Classification. Pain was
      evaluated with the visual analog scale, functionality was evaluated with the Western Ontario
      McMaster Osteoarthritis Index, and the kinetic, kinematic, and spatiotemporal parameters were
      evaluated using a three-dimensional gait analysis system at baseline (no application) and
      immediately after the application of elastic taping, rigid taping, and orthoses. The
      dependent variables were measured after 45 minute the application of four different
      conditions neutral, elastic taping, rigid taping, and knee brace on each participant with
      1-day intervals.
    

Detailed description: 
      Objective: The aim of this study was to compare the effects of elastic taping, rigid taping,
      and braces applied to women with mild knee OA on pain, gait, and knee functionality.

      Methods: This randomised study included 21 female patients (mean age of 53.81±6.20 years)
      with bilateral grade 2 knee OA according to the Kellgren & Lawrence Classification. Pain was
      evaluated with the visual analog scale, functionality was evaluated with the Western Ontario
      McMaster Osteoarthritis Index, and the kinetic, kinematic, and spatiotemporal parameters were
      evaluated using a three-dimensional gait analysis system at baseline (no application) and
      immediately after the application of elastic taping, rigid taping, and orthoses. The
      dependent variables were measured after 45 minute the application of four different
      conditions neutral, elastic taping, rigid taping, and knee brace on each participant with
      1-day intervals.
    

Intervention name(s): Taping
Intervention type(s): Behavioral
Intervention description(s): Taping types and brace acute effects for knee osteoartritis
Other intervention name(s): Brace
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: knee osteoarthritis; athletic tape; brace; kinesiotape; gait
CLAGE Sequential With Flu-Bu Conditioning for Refractory Acute Leukemia
Condition: Refractory Hematologic Cancer; Allogeneic Stem Cell Transplantation
MeSH terms: Hematologic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      For patients with refractory acute leukemia, allogeneic stem cell transplantation is the only
      curative therapy. Only 20% of patients may achieve long-term survival mostly due to relapse
      or nor-relapse mortality (NRM). In previous study, we demonstrated that intensive leukemia
      debulking chemotherapy FLAG-IDA sequential with Flu-BU conditioning is feasible with ~40%
      long-term survival. In the study, we further modified the chemotherapy with cladribine
      replacing fludarabine aiming a more potent anti-leukemia effect. Meanwhile, we reduce the
      dose of busulfan for patients with poor performance status and age over 45 aim to reduce the
      NRM. All patients will also receive post-transplantation maintenance therapy with low-dose
      decitabine to prevent relapse.
    

Detailed description: 
      For patients with refractory acute leukemia, allogeneic stem cell transplantation is the only
      curative therapy. Only 20% of patients may achieve long-term survival mostly due to relapse
      or nor-relapse mortality (NRM). In previous study, we demonstrated that intensive leukemia
      debulking chemotherapy FLAG-IDA sequential with Flu-BU conditioning is feasible with ~40%
      long-term survival. The most important cause of treatment failures were relapse and
      non-relpase mortality. The further analysis demonstrated that patients with higher bone
      marrow blast before allo-HSCT was associated with treatment failure and patients with poor
      perforce status or age over 45 had increased rate of NRM. To further optimization the
      protocol, we modified the chemotherapy with cladribine replacing fludarabine aiming a more
      potent anti-leukemia effect and replace idarubicin with VP-16. All patients will also receive
      post-transplantation maintenance therapy with low-dose decitabine (5mg/m2 daily for 5 days)
      to prevent the further reduce the relapse incidence. We anticipate LFS at 1 year should be
      above 50% and 1-year LFS of 20% is considered unacceptable.
    

Intervention name(s): CLAGE-FluBu
Intervention type(s): Drug
Intervention description(s): Cladribine combined with cytarabine and VP16 sequential with Fludarabine combined with busulifan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Explore the Effect of Diet Intervention on Lipid Metabolism and Body Mass Index Among the Patients With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The prevalence of metabolic syndrome (MetS) is increasing all over the world, which is
      largely related to the increasing obesity population and the current inactive lifestyle of
      human beings. It is a common problem facing public health and clinical practice.Metabolic
      syndrome is an accumulation of biologically metabolic risk factors related to cardiovascular
      disease and diabetes, including glucose metabolism disorders, hypertension, dyslipidemia, and
      obesity (especially central obesity).Researchers believe that the common pathological basis
      of these manifestations is insulin resistance, which is generally considered to be a
      reduction in the biological effects of insulin compared with the normal biological effects of
      expected biological phenomena.Nowadays, there are more and more studies on insulin resistance
      in the world. We have known that age, poor living and eating habits, high blood fat, high
      blood sugar and stress all lead to insulin resistance.

      The researchers hope to reduce weight, reduce body fat rate, improve body fat distribution
      and insulin resistance, reverse abnormal metabolic indicators, and ultimately reduce the
      incidence of chronic diseases in patients with metabolic syndrome through the intervention of
      lifestyle and diet habits in the early stage of the disease.
    


Intervention name(s): Intermittent fasting; Low carb diet; Low carbon diet and intermittent fasting group
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Intermittent fasting group:During the three-month intervention period, participants were allowed to eat for eight consecutive hours and fast for 16 hours a day.The eating time can be freely chosen in the following two periods: 8:00 -- 16:00;12:00 -- 20:00.No specific restriction shall be made on the type and quantity of food.; Low carb diet:The daily carbohydrate intake of participants in this group was limited to 130g/ D, and the recommended diet was formulated according to the standard and combined with the local eating habits in Xi 'an, and dietary habit education was conducted. Participants could eat according to the recommended diet.; Low carbon diet and intermittent fasting group:Participants fasted for 16 hours a day and ate for eight consecutive hours on the same diet as the low-carb group.
Other intervention name(s): Low carb diet; Low carbon diet and intermittent fasting group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment