bioihbjkbjnl/mcl2 huggingface dataset:
A Phase I Study of LX-039 Tablets
Condition: Advanced Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I dose escalation and expansion study in patients with ER+, HER2- advanced
      breast cancer to explore the tolerance, PK/PD(pharmacokinetics/pharmacodynamics) profiles and
      preliminary anti-tumor activity of different doses of LX-039 tablets. The trial consists of
      two parts, dose escalation and dose expansion. Part 1 is the dose escalation phase with
      initial 6 dose groups, and "3 + 3" design is used to explore MTD of the drug; Part 2 is the
      dose expansion phase with 2 ~ 3 doses selected for expansion according to the escalation
      results of Part 1, and more subjects are enrolled to further observe the tolerance and
      preliminary anti-tumor activity of the drug. After the completion of dose expansion, the
      recommended phase II dose (RP2D) will be determined after discussion based on the obtained
      tolerance and PK/PD data.
    


Intervention name(s): LX-039 tablets
Intervention type(s): Drug
Intervention description(s): orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, or study termination
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Retinal Effects After Combined Photodynamic Therapy (PDT) With Intravitreal Triamcinolone
Condition: Neovascular Age Related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional
Phase: Phase 3

Summary: 
      Background: To identify characteristic morphological changes of the retina, their change over
      time and the association with visual function after combined photodynamic therapy (PDT) and
      intravitreal triamcinolone (IVTA).

      Methods: In this retrospective study, 40 patients (40 eyes) were treated with PDT and same
      day IVTA. Optical coherence tomography (OCT), fluorescein angiography (FA) and evaluation of
      distance visual acuity (VA) were performed. Main outcome measures were the anatomical changes
      within intra- and subretinal compartments and their detailed analysis and grading.
    


Intervention name(s): PDT plus intravitreal triamcinolone
Intervention type(s): Other
Intervention description(s): PDT plus intravitreal triamcinolone
Intervention MeSH terms: Triamcinolone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IVTA; CNV; age-related macular degeneration; PDT
Assessment of the Safety of Adalimumab in Rheumatoid Arthritis Patients Showing Rapid Progression of Structural Damage of the Joints, Who Have no Prior History of Treatment With Disease-modifying Anti-rheumatic Drugs or Biological Agents
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      This study was conducted to examine the safety profile and the effectiveness in daily
      clinical practice of adalimumab in rheumatoid arthritis participants showing rapid
      progression of structural damage of the joints, who had no prior history of treatment with
      disease-modifying anti-rheumatic drugs or biological agents.
    

Detailed description: 
      This was a multicenter, prospective, observational study of adalimumab. Each participant
      enrolled when initiating adalimumab treatment and was to be followed up for 24 weeks or until
      discontinuation of the drug.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Rheumatoid Arthritis participants showing rapid progression of structural damage of the
        joints, who have no prior history of treatment with disease-modifying anti-rheumatic drugs
        or biological agents.
      
Keywords: Rheumatoid arthritis
Study to Evaluate the Safety and Clinical Outcome of Using Navigation System in Pedicle Screw Placement in Spine Surgery
Condition: Spinal Tumor; Traumatic Injury of Spine; Degenerative Spine Disease
MeSH terms: Spinal Cord Neoplasms; Spinal Neoplasms; Spinal Diseases; Wounds and Injuries; Spinal Injuries
Study type: Interventional

Summary: 
      The research project is testing whether in screw insertion of spine surgery using "Anatase"
      Spine Surgery Navigation System is at least as safe and accurate as using O-arm assisted
      spine surgery- Medtronic Stealthstation S7 Treatment Guidance System.
    

Detailed description: 
      Pedicle screw insertion is performed to treat the patients with spine conditions, including
      degenerative, traumatogenic, and neoplastic lesions. Accurate insertion of pedicle screw is a
      crucial step which directly affects the surgical outcomes. In order to place the screws
      safely and accurately, various conventional techniques have been used, focusing on marking
      anatomical locations, entry points and insertion angles. Since the early 1990, the methods
      using computer systems that allow real-time image processing have been explored in order to
      improve the accuracy of pedicle screw placement.

      The Medtronic StealthStation® S7® System is a hardware platform that enables real-time
      surgical navigation using radiological patient images. The application software reformats
      patient-specific CT or MR images acquired before surgery, or fluoroscopic images acquired
      during surgery, and displays them on-screen from a variety of perspectives. The "Anatase"
      Spine Surgery Navigation System is indicated for precisely positioning of surgical
      instruments and/or implants during general spinal surgery, such as pedicle screw placement.

      This study will be a two-arms, single center, evaluator blind, controlled, parallel,
      randomised study in patients with pedicle screw placement in spine surgery. This trial will
      include patients need to undergo pedicle screw placement surgery with indication of spinal
      tumor, traumatic injury or degenerative spine disease (Pedicle screws placed from 10th
      thoracic vertebra to first sacrum), who are ≥20 years and ≤80 years of age with Body Mass
      Index (BMI) < 40 kg/m2 and Spine T-Score ≥ -2.5.
    

Intervention name(s): "Anatase" Spine Surgery Navigation System; Medtronic Stealthstation S7 Treatment Guidance System
Intervention type(s): Device; Device
Intervention description(s): using navigation system in pedicle screw placement in spine surgery; using navigation system in pedicle screw placement in spine surgery
Intervention MeSH terms: Titanium dioxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pedicle screw placement surgery; 10th thoracic vertebra to 1st sacrum
Study of Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of the Alzheimer's Type
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to learn if aripiprazole is safe and effective in the treatment
      of psychosis associated with dementia of the Alzheimer's type.
    


Intervention name(s): aripiprazole
Intervention type(s): Drug
Intervention MeSH terms: Aripiprazole
Primary purpose: Treatment
Keywords: Psychosis Associated with Dementia of the Alzheimer's Type
Cryotherapy in Treating Patients With Primary Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery
Condition: Lung Cancer; Metastatic Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Cryotherapy kills tumor cells by freezing them. This may be an effective treatment
      for primary lung cancer or lung metastases that cannot be removed by surgery.

      PURPOSE: This clinical trial is studying how well cryotherapy works in treating patients with
      primary lung cancer or lung metastases that cannot be removed by surgery.
    

Detailed description: 
      OBJECTIVES:

        -  Estimate the local and distant failure rates after percutaneous thoracic cryotherapy
           (PTC) in patients with unresectable primary lung cancer or lung metastases.

        -  Estimate rates of PTC complications and adverse reactions.

        -  Determine the correlations between procedural parameters and follow-up imaging
           parameters, with the latter being used as surrogates of local and/or distant treatment
           failure.

      OUTLINE: Patients undergo CT-guided percutaneous thoracic cryotherapy over 2 hours under
      local or general anesthesia. Grouped cryoprobes are inserted into the tumor, utilizing a
      freeze-thaw-freeze cycle, creating cytotoxic temperatures (less than -20°C to -40°C) that
      encompass the entire anticipated tumor volume.

      Patients undergo positron emission tomography at baseline and after cryotherapy to assess
      tumor standard uptake variable.

      After completion of study treatment, patients are followed at 1, 3, 6 and 12 months.

      PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
    

Intervention name(s): cryosurgery; positron emission tomography
Intervention type(s): Procedure; Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lung metastases; recurrent non-small cell lung cancer; recurrent small cell lung cancer; stage I non-small cell lung cancer; stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; extensive stage small cell lung cancer; limited stage small cell lung cancer; pulmonary carcinoid tumor
Cerebral Embolic Load in Patients Undergoing Surgical Aortic Valve Replacement: A Comparison of the Conventional With the Minimized Extracorporeal Circulation Technique Using Transcranial Doppler Ultrasound
Condition: Aortic Valve Stenosis; Extracorporeal Circulation
MeSH terms: Aortic Valve Stenosis
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, the investigators aim to compare cerebral embolic load in patients undergoing
      surgical aortic valve replacement using either the minimized extracorporeal circulation or
      the conventional extracorporeal circulation technique. The detection of cerebral emboli is
      performed not-invasively by transcranial Doppler detection of high-intensity transient
      signals representing solid or gaseous microembolism in the middle cerebral arteries. The
      investigators hope to get more insight in the mechanism (incl. quantity) of cerebral embolism
      during aortic valve surgery using extracorporeal circulation.
    

Detailed description: 
      Background

      The gold standard to treat severe aortic valve stenosis is currently the surgical aortic
      valve replacement (SAVR) using conventional extracorporeal circulation (CECC). SAVR, however,
      can be performed also on minimized extracorporeal circulation (MECC), which is characterized
      by reduced priming volume and interfaces between blood and artificial surfaces and blood-air
      interface, respectively. Further technical developments of the MECC system together with
      reports on less induction of the coagulation cascade and activation of inflammatory systemic
      response may account for a reduced incidence of microbubble generation with MECC system.

      Objective

      The aim of the is to investigate the procedural-related incidence of high-intensity transient
      signals (HITS) representing solid or gaseous microembolism reaching the cerebral vessels.

      Methods

      Patients undergoing SAVR are included in the study and randomised to either MECC or CECC
      technique. HITS are continuously bilaterally detected during the entire intraoperative period
      by transcranial Doppler ultrasound.
    

Intervention name(s): Minimized Extracorporeal Circulation (MECC); Conventional Extracorporeal Circulation (CECC)
Intervention type(s): Procedure; Procedure
Intervention description(s): This group of patients receives surgical aortic valve replacement using MECC.; This group of patients receives surgical aortic valve replacement using CECC.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intracranial Embolism; Ultrasonography, Doppler, Transcranial
Glycemic Relapse Prevention: Maintenance Dose Assessment
Condition: Type 2 Diabetes
MeSH terms: Recurrence
Study type: Interventional
Phase: Phase 4

Summary: 
      This purpose of this study is to determine the optimal frequency of maintenance intervention
      needed to prevent glycemic relapse.
    

Detailed description: 
      Recent large randomized controlled trials have proven that tight glycemic control reduces the
      microvascular and macrovascular complications of diabetes. Reduction of these complications
      also leads to a great cost savings to healthcare and society. However, it has been difficult
      to translate the success of these large randomized control trials to everyday practice. A
      recent cross-sectional analysis of 95 clinicians revealed only 40.5% of type 2 diabetes
      patients had a glycated hemoglobin (HbA1c) less than 7%. The disparity of care between the
      large trials and a primary care office is largely due to the difference in resources
      available in the typical medical office. Practical, sustainable ways of maintaining tight
      glycemic control are needed in everyday practice.

      While diabetes improvement programs are successful in acutely lowering HbA1c the long-term
      effectiveness of these programs is disappointing. Approximately 40% of those who return to
      routine care after completing an intensive diabetes improvement program experience a relapse
      in their glycemic control within one year. Some proportion of the relapse is likely due to a
      patient's inability to maintain adherence to key self-care behaviors - diet, exercise,
      self-monitoring of blood glucose and medication regimen.

      The purpose of this study is to better understand prevention of glycemic relapse. The primary
      aim of this study is to assess the relative effectiveness of three management approaches,
      varying in frequency, for preventing glycemic relapse after glycemic control has been
      achieved through participation in an intensive diabetes improvement program. This study will
      determine the optimal frequency of intervention needed to prevent glycemic relapse in
      patients with type 2 diabetes. The authors hypothesize that high intensity intervention will
      lead to a decrease in glycemic relapse in a dose dependent fashion.
    

Intervention name(s): Telephonic diabetes care
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diabetes; Chronic disease management; Relapse
Iron-Biofortified Rice Intervention in the Philippines
Condition: Iron-deficiency; Anemia
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      The objective of this randomized efficacy feeding trial was to determine the effects of
      consuming iron-biofortified rice on iron status in women, compared to non-biofortified rice.
      A randomized trial of biofortified rice (IR68144-2B-2-2-3), bred to enhance iron content, was
      conducted among women living in convents in the greater area of Manila, Philippines for 9
      months.
    

Detailed description: 
      Iron deficiency is the most prevalent nutritional deficiency globally, with the highest
      burden in women of reproductive age and children. In this randomized controlled trial, 317
      women aged 18-45 years living in convents in the greater Manila area, Philippines, were fed
      meals using either biofortified or commercially available rice for all meals, 7 days a week,
      for 9 months. Women living in convents in the greater Manila area were recruited for this
      study. These women represent a segment of the population at high risk for iron deficiency,
      consume large quantities of rice, and all of their meals are prepared and consumed in common
      kitchen and dining areas, respectively.

      The investigators hypothesized that daily consumption of iron-biofortified rice
      (IR68144-2B-2-2-3) would improve hemoglobin, serum ferritin, and total body iron in 9 months,
      compared to control rice. In order to examine this hypothesis, the investigators conducted a
      randomized efficacy trial of iron-biofortified rice and iron status in among women living in
      convents in the greater area of Manila, Philippines for 9 months.

      The objective of this randomized efficacy feeding trial was to determine the effects of
      consuming iron-biofortified rice on iron status in women, compared to non-biofortified rice.

      The long-term goal of this study is to determine if iron bio-fortification of rice is an
      efficacious and potentially effective strategy to improve iron status of at-risk populations
      in resource-limited settings.
    

Intervention name(s): Iron-biofortified rice; Control rice
Intervention type(s): Other; Other
Intervention description(s): Iron-biofortified rice (IR68144-2B-2-2-3); Control rice (C4), identical in appearance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Anemia; Iron; Biofortification; Philippines; Iron deficiency; Women of reproductive age
Acupuncture and Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Although traditional Chinese medicine advocates the use of acupuncture not only to induce
      analgesia but also to treat essential hypertension, acupuncture's postulated antihypertensive
      efficacy in humans has not been subjected to rigorous Western scientific testing. Before
      advocating acupuncture as an effective complementary/alternative medicine strategy for
      essential hypertension, it is necessary to demonstrate that the beneficial effects of
      acupuncture are scientifically robust, long-lasting, and explicable in terms of modern
      scientific mechanisms. In spontaneously hypertensive rats, acupuncture-like electrical
      stimulation of thinly myelinated (Group III) somatic afferents activates central endorphin
      (naloxone-sensitive) pathways that elicit long-lasting decreases in sympathetic nerve
      activity (SNA) and blood pressure. The ability to record SNA with microelectrodes in
      conscious humans provides a new opportunity to test this novel mechanistic hypothesis in
      patients undergoing electroacupuncture, a modification of the ancient technique that provides
      a quantifiable and reproducible stimulus to human skeletal muscle afferents. Using a
      randomized, double-blind placebo-controlled design, we will test the following major
      hypotheses: Electroacupuncture produces a long-lasting reduction in SNA, thereby providing a
      safe and effective complementary treatment of human hypertension. Given the enormous interest
      in acupuncture by our lay public, but the paucity of Western scientific data about its
      efficacy in cardiovascular disorders, our studies in normotensive and hypertensive humans
      should provide a conceptual framework for deciding whether to accept or reject the large body
      of Chinese (and Russian) literature advocating acupuncture as a safe and effective treatment
      of essential hypertension and other cardiovascular disorders (such as heart failure, and
      myocardial ischemia).
    


Intervention name(s): Acupuncture
Intervention type(s): Procedure
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Evaluation of Prototype Lenses With Experimental UV/HEV Blocker
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a bilateral, 2-week dispensing, randomized, controlled, subject-masked, 2×2 crossover
      study to evaluate the clinical performance of prototype contact lenses with experimental
      UV/HEV-blocker.
    


Intervention name(s): TRP-200; JJVC Marketed Contact Lens
Intervention type(s): Device; Device
Intervention description(s): JJVC Investigational Contact Lens; ACUVUE Oasys 1-Day
Other intervention name(s): TEST Lens; CONTROL Lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effects of Interleukin-1 Beta on Low Testosterone Levels in Men With Obesity and Metabolic Syndrome
Condition: Hypogonadism; Metabolic Syndrome X; Obesity
MeSH terms: Microvascular Angina; Obesity; Metabolic Syndrome; Hypogonadism; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Obesity and the metabolic syndrome in men are associated with a high prevalence of
      hypogonadism of up to 50%. Increased fat mass leads to augmented release of adipocytokines
      and pro-inflammatory cytokines such as IL-1-beta, IL-6 and tumor necrosis factor-alpha which
      in turn suppress the hypothalamic-pituitary-gonadal (HPG) axis, leading to hypogonadism. This
      pathophysiological interplay is termed hypogonadal-obesity-adipocytokine hypothesis. TestIL
      is a prospective, multicenter, randomized, double-blinded, placebo-controlled trial to test
      the hypothesis that inhibition of IL-1-activity diminishes the inhibitory effects on HPG axis
      and increases testosterone levels in men with metabolic syndrome.
    

Detailed description: 
      Obesity and the metabolic syndrome are considered as chronic low-grade inflammatory states.
      Elevated pro-inflammatory mediators in obesity and metabolic syndrome have an inhibitory
      effect on the hypothalamic-pituitary-gonadal axis (HPG axis) leading to hypogonadism.
      Decreased testosterone production in obese men in turn promotes additional fat deposition,
      contributing to a vicious cycle of fat accumulation. This complex pathophysiological
      interplay is termed hypogonadal-obesity-adipocytokine hypothesis, describing a bidirectional
      relationship between low levels of testosterone and the metabolic syndrome.

      TestIL is a prospective, multicenter, randomized, double-blinded, placebo-controlled trial to
      test the hypothesis that inhibition of IL-1-activity diminishes the inhibitory effects on HPG
      axis and increases testosterone levels in men with metabolic syndrome.
    

Intervention name(s): Anakinra; Sodium Chloride 0.9%
Intervention type(s): Drug; Drug
Intervention description(s): Anakinra 100mg s.c. bid; Sodium Chloride 0.9% s.c. bid
Other intervention name(s): KINERET; NaCl 0.9%
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Metabolic syndrome X; Hypogonadism; Testosterone; Inflammation; Obesity