bioihbjkbjnl/mcl2 huggingface dataset:
Impacts of a Physician-targeted Price Transparency Tool on Medication Out-of-pocket Costs
Condition: Prescriptions; Costs and Cost Analysis
Study type: Observational

Summary: 
      The goal of this study is to evaluate whether presenting patient out-of-pocket cost
      information to the provider at the time of prescribing leads to orders for medications with
      lower out-of-pocket costs. The Real-Time Prescription Benefits (RTPB) tool has been
      implemented to randomly selected providers across NYU Langone Health's outpatient physician
      practices. The RTPB tool provides physicians with information about patient out-of-pocket
      (OOP) cost for medications at the point of outpatient prescribing. OOP is inclusive of any
      copay, coinsurance, and deductible that the patient owes given their prescription drug
      benefit plan. If the physician is submitting a prescription order and a
      clinically-appropriate alternative with a lower OOP cost is available, an alert with OOP cost
      information for the drug being initially ordered as well as up to three lower-cost
      alternatives will be displayed. Implementation of this tool will be analyzed to see if it
      will lead to reduced out-of-pocket costs on ordered medications when alternatives were
      available. Because effects could vary along many dimensions (e.g., specialty, drug class,
      insurance type), secondary analyses will be conducted and stratified along such dimensions.
      Analyses will be conducted at the prescription order level.
    


Intervention name(s): Real-time benefits check
Intervention type(s): Other
Intervention description(s): Prescribers practicing in outpatient departments assigned to the intervention arm will be shown popup alerts with their patient's insurance benefit design-specific out-of-pocket cost for the drug being ordered as well as out-of-pocket costs for up to 3 lower-cost alternatives if available. Alternatives will only be shown when available and when the patient and his or her benefit design information can be matched by the electronic health record system to accurately query out-of-pocket cost information.
Other intervention name(s): Physician-focused medication price transparency
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The intervention group refers to medication orders placed by prescribers when practicing in
        an outpatient department randomly assigned to receive the intervention, which is
        implementation of the RTPB tool. The control group refers to medication orders placed by
        prescribers when practicing in an outpatient department randomly selected to not receive
        the intervention.
MsFLASH-04: Pilot Trial: Telephone Behavioral Therapy for Menopause-related Sleep Disturbance
Condition: Hot Flashes; Menopause; Vasomotor Disturbance; Sleep
MeSH terms: Dyssomnias; Parasomnias; Hot Flashes
Study type: Interventional

Summary: 
      Self-reported sleep complaints are common in peri- and postmenopausal women and have been
      identified as a key symptom of the menopausal transition. The MsFLASH study, A Pilot Trial of
      Telephone-Based Cognitive-Behavioral Therapy for Midlife Women with Menopause-related Sleep
      Disturbance, is a randomized, single-blind, placebo-controlled, two arm clinical trial. The
      target population will include women in general good health, aged 40-65 years, who report
      symptoms of insomnia (trouble sleeping) and who are bothered by hot flashes. We plan to
      enroll 100 women from Seattle, Washington and surrounding areas into the trial. Half of the
      women will be randomly assigned to receive the behavioral intervention and half to receive
      the behavioral control.

      The intervention arm participants will receive 6 sessions of a telephone-based,
      cognitive-behavioral therapy intervention for insomnia (CBT-I), based on state-of-the-art
      methods and specifically targeted to women with menopause-related sleep disturbance (CBT-I).
      The control arm participants will receive telephone-based Menopause Education Control (MEC)
      that includes elements of sleep hygiene. Assessments for both groups will be collected at
      baseline (pre-randomization), 8-week post-randomization, and 6-month post-randomization.

      The inclusion/exclusion criteria are designed to target broadly those midlife women who have
      menopause-related sleep disturbance and also report being bothered by vasomotor symptoms.
      This target population defines the clinical population seeking treatment for relief of
      menopause-related sleep problems. Exclusion criteria are kept minimal and intended only to
      exclude women with significant medical problems likely to account for their sleep problems
      (instead of menopause), or likely to interfere with their ability to participate in the
      intervention. We include women taking hormone therapy or other medication who meet these
      criteria because they are part of the population seeking clinical care for relief of sleep
      disturbances.

      Our primary objective is to develop an intervention that is generalizable to the greatest
      number of women and maximally translatable into real-world primary care practice.
    


Intervention name(s): Cognitive Behavioral Therapy-Insomnia (CBT-I); Menopause Education Control (MEC)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): See Experimental Arm Description; See Experimental Arm Description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Menopause; Vasomotor; Symptoms; Sleep; Cognitive Behavioral Therapy
Reconstruction of Interdental Papilla Using Hyaluronic Acid
Condition: Defected Interdental Papilla
Study type: Observational

Summary: 
      Objective and background: The aim of this study is to evaluate the clinical outcome of using
      the hyaluronic acid gel in reconstructing inter-dental papillae at the aesthetic zones in a
      follow-up period of six months.

      Materials and Methods: 30 interdental papilla deficiencies which would meet the the inclusion
      criteria will be evaluated. After applying local anesthesia, 0.2 ml hyaluronic acid gel will
      be injected at the affected areas. This procedure will be repeated 3 times for the evaluated
      areas. Photographs will be taken before injection this material, and at 3 and 6 months
      following the intervention.
    

Detailed description: 
      The presence or absence of the interproximal papilla is essential concern to periodontists,
      restorative dentists, and to the patients. The loss of papilla can cause cosmetic deformities
      (black triangles), phonetic problems, and food debris accumulation. Often the loss of papilla
      is a consequence of periodontal disease because of gingival inflammation, attachment loss and
      interproximal bone height resorption.

      Several reasons also lead to absence of interdental papillae including:

      1) Plaque associated lesions, 2) Traumatic oral hygiene procedures, 3) Abnormal tooth shape,
      4) Improper contours of the restoration, 5) Spacing between teeth, 6) Loss of teeth.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients will be recruited from the database of Periodontics Department at University of
        Damascus. A random sample of 30 patients will be included in this evaluation study from
        those who have been identified with defected interdental papillae.
      
Keywords: Interdental papilla; hyaluronic acid; esthetic zone; black triangles
The Effects of Red Wine Polyphenols on Microvascular Dysfunction
Condition: Obesity
Study type: Interventional

Summary: 
      Rationale:

      Epidemiological studies have shown that consumption of alcoholic beverages, red wine in
      particular, is associated with less cardiovascular mortality. In addition, there are reported
      beneficial effects of red wine on components of the metabolic syndrome, arguably the most
      menacing cardiometabolic condition facing us due to the unfolding obesity epidemic.
      Beneficial effects have also been reported with other polyphenol-rich food stuff, such as
      cocoa and green tea and points to a beneficial effect which does not seem to be dependent on
      the alcohol content of red wine. Experimental studies with mixed or separate Red Wine
      Polyphenols (RWPs) (i.e. without alcohol) have shown beneficial effects on cardiometabolic
      parameters associated with obesity. Most research has focused on resveratrol, a specific
      polyphenol components which is quite specific to red wine and has, at least in animal
      studies, beneficial effects on insulin sensitivity, insulin secretion, and endothelial
      function. Moreover, RWPs have shown to improve endothelial NO-mediated relaxation using the
      same PI3-kinase/Akt pathway as does insulin. However, data in humans are remarkably scarce

      Objective:

      To study effects of RWPs on insulin sensitivity, beta-cell function, microvascular function
      (skin, muscle and cardiac), blood pressure, insulin-mediated microvascular responsiveness.

      Study design:

      Randomized controlled trial (double blind).

      Study population:

      Obese (BMI >30); n=30, men or women, aged 18-60 years.

      Intervention:

      Mixed RWP 600mg/day or matching placebo for a total duration of 8 weeks.
    


Intervention name(s): Red Wine Polyphenols 600mg/day; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): Provinols™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pilates, Postural Global Reeducation and Ball Exercises
Condition: Strength, Muscle; Endurance , Physical; Flexibility
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate and compare the effects of three Exercise Movement
      Techniques Global Postural Reeducation(RPG), Pilates method and Segmented Dynamic Exercises
      (SDE) regarding muscular strength and endurance of the trunk, spine mobility and flexibility
      of the posterior muscle chain.
    


Intervention name(s): Pilates Group; Segmented Dynamic Exercises Group; Global Postural Reeducation
Intervention type(s): Other; Other; Other
Intervention description(s): The exercises were applied once a week during eight weeks.; The exercises were applied once a week during eight weeks. once a week for eight weeks.; The exercises were applied once a week during eight weeks.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise Movement Techniques; Exercise Therapy; Physical Therapy Modalities.
14-day Quadruple Therapy Versus Triple Therapy in HP Eradication
Condition: Gastritis H Pylori
MeSH terms: Gastritis
Study type: Interventional
Phase: Phase 4

Summary: 
      In this prospective randomized-controlled study, treatment-naive H. pylori-infected patients
      are randomized to receive either standard triple therapy or sequential therapy. The aim is to
      compare the efficacy of concomitant quadruple therapy with standard triple therapy as a first
      line treatment for H. pylori infection in Tunisian patients.
    

Detailed description: 
      This study includes male and female patients aged between 18 and 65, with documented Hp
      infection and who have had no previous eradication treatment.The diagnosis of Hp infection
      was made through an anatomopathological study. Gastric biopsies were taken according to the
      Sydney protocol: two fundics in one pot, two antrals and one at the angle of the lesser curve
      in a second pot. The biopsies were studied by an experienced anatomopathologist.

      The included patients were randomly divided into two treatment groups according to a 1: 1
      ratio: the first group received concomitant quadruple therapy (QC) combining a double dose
      PPI (esomeprazole: 40 mg x 2 per day) with the amoxicillin (1 g x 2 per day), metronidazole
      (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days. The second group
      received triple therapy (TT) combining a double dose PPI (esomeprazole: 40 mg x 2 per day)
      with amoxicillin (1 g x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days.

      H. pylori eradication was assessed by the 13C-urea breath test 8 weeks after treatment.
    

Intervention name(s): metronidazole based quadriple therapy; placebo based quadriple therapy
Intervention type(s): Drug; Drug
Intervention description(s): patient randomized in QC will be treated by a double dose PPI (esomeprazole: 40 mg x 2 per day) in combination with amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day); patient randomized in TT will be treated by double dose PPI (esomeprazole: 40 mg x 2 per day) in combination with amoxicillin (1 g x 2 per day), clarithromycin (500 mg x 2 per day) and a placebo of metronidazole.
Other intervention name(s): concomitant quadruple therapy (QC); Triple therapy (TT)
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Breath Tests; Helicobacter pylori
Effects of a Psycho-corporal Training on Postural and Cognitive Dual-task Performances in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Beside these well-known symptoms (positive symptoms (such as delirium and delusions),
      negative symptoms (such as affective flattening and impoverishment of speech), disorganized
      behavior, patients with schizophrenia show different kinds of cognitive alterations and motor
      abnormalities. In schizophrenia, postural impairment could increase the attentional cost of
      daily motor tasks, leading to a lack of attentional resources, essential to achieve complex
      cognitive tasks. The intrication of cognitive and postural processings (both impaired in
      schizophrenia) can be explored by using of a dual-task paradigm.
    

Detailed description: 
      This study assesses a psycho-corporal training (8 weeks psycho-corporal training) benefits on
      both postural (increased automation of balance control) and cognitive processings (smaller
      impact of the dual-task condition on attentional performances) in population of patients
      suffering from schizophrenia.
    

Intervention name(s): Movement group
Intervention type(s): Other
Intervention description(s): Experimental group : patients with schizophrenia who realise psycho-corporal training once a week, during 1 hour and a half for a period of two months
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Schizophrenia; Postural; Cognitive; task
Urokinase Versus Primary Video-Assisted Thorascopic Surgery for Empyema
Condition: Empyema
MeSH terms: Empyema
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare VATS versus chest drain insertion and urokinase in the treatment of
      childhood empema by a randomised prospective study.
    


Intervention name(s): insertion of a chest drain with urokinase instillation; primary video-assisted thorascopic surgery
Intervention type(s): Drug; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Marathon, Genetics, Inflammation and the Cardiovascular System: MAGIC-Trial
Condition: Heart Failure; Sudden Cardiac Death
MeSH terms: Death, Sudden, Cardiac; Death
Study type: Interventional

Summary: 
      The purpose of the study is to determine the myocardial function and vascular adaptation
      after strenuous exercise in association with genotype/polymorphisms. We aim to investigate
      the effects of extreme endurance exercise on the cardiovascular system. Furthermore, the role
      of the inflammatory response and adaptive mechanisms of the vasculature are examined.
      Subclinical injuries to the myocardium and vascular wall are being investigated.
    

Detailed description: 
      Regular exercise leads to an improvement of cardiovascular risc factors in patients with
      coronary heart disease, atherosclerosis and metabolic disorders. Aerobic exercise has
      anti-inflammatory effects. In contrast, the exertional exercise of marathon running causes an
      acute pro-inflammatory impulse. This may lead to myocardial injury and, in case of
      preexisting plaques, may result in plaque rupture and acute myocardial infarction.

      We aim to define the critical role of inflammatory markers and cardiovascular risc factors as
      a predictor of an increased risk for myocardial and endothelial dysfunction in marathon
      runners.

      Diagnostic tools include measurements of augmentation index (AIx), arteriolar-venular ratio
      (AVR) and, for the first time, 2D and 3D echocardiographic measurements such as TDI-imaging
      and speckle tracking. Inflammatory markers include c-reactive protein (CRP), interleukins and
      tumor necrosis factor. Additionally, cardiovascular markers are measured. All variations are
      analysed on the basis of genotype characteristics/polymorphisms.
    

Intervention name(s): Munich Marathon
Intervention type(s): Behavioral
Intervention description(s): 42,195 km marathon run
Other intervention name(s): MAGIC
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: exercise, myocardial dysfunction, endothelial dysfunction,; polymorphism
Comparison of New Contact Lens With Current Marketed Lens
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study is to validate the clinical performance of a new contact lens
      design.
    

Detailed description: 
      Evaluate the clinical performance of its Phoebe contact lenses (Test) compared to the
      commercially available MyDay contact lenses (Control).
    

Intervention name(s): Phoebe test lens; stenfilcon A lens (control)
Intervention type(s): Device; Device
Intervention description(s): Daily disposable contact lens; Daily disposable contact lens
Other intervention name(s): Test Lens; Phoebe Contact Lens; MyDay daily disposable contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Impact of Active Thermoregulation on the Microcirculation of Free Flaps
Condition: Microcirculation; Thermoregulation; Free Flap
Study type: Interventional

Summary: 
      This study evaluates the impact of active thermoregulation on free flap microcirculation
      following free flap transfer. Thermoregulation is performed by passive warming, active
      warming (water circulation based device) and active cooling. Changes in microcirculation are
      assessed using combined laser Doppler flowmetry and remission spectroscopy.
    

Detailed description: 
      Measurements are conducted at the day of the operation as well as the first three days
      following the operation. Tissue temperature is assessed by a temperature measurement probe
      that is placed 8 mm underneath the skin. The microcirculation parameters of free perforator
      flaps are assessed using combined laser Doppler flowmetry and remission spectroscopy (O2C®).
      This allows non-invasive measurement of blood flow, capillary venous oxygen saturation and
      relative postcapillary filling pressure using a fiber optic probe that is placed on the flap
      surface. Controlled Thermoregulation (between 10 and 38°C) is enabled using a water
      circulation based system (Hilotherm Clinic®).
    

Intervention name(s): Hilotherm Clinic®
Intervention type(s): Device
Intervention description(s): Controlled Thermoregulation using a water circulation based system (Hilotherm Clinic®). Controlled Thermoregulation with Hilotherm Clinic® - Flap Temperature is altered by passive warming (dressing), active warming (38 C) and active cooling (10 C) each for 60 minutes following free flap transfer in every subject at the day of surgery and the following three days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Pegylated Interferon-alpha-2a in Patients With Malignant Melanoma Stage IIA-IIIB
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of adjuvant treatment with
      pegylated interferon-α-2a (PEG-IFN) vs. 'low dose' interferon-α-2a in patients with malignant
      melanoma in stage IIA (T3a) - IIIB.

      A total of 880 will be randomized up to three months after first surgical management of their
      melanoma to either: PEG-IFN-α-2a or low-dose interferon-α-2a.
    


Intervention name(s): pegylated interferon-alpha-2a; interferon-alpha-2a
Intervention type(s): Drug; Drug
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: malignant melanoma; adjuvant therapy; Adjuvants, Immunologic
Study to Evaluate the Immunogenicity and Safety of an Ebola Virus (EBOV) Glycoprotein (GP) Vaccine in Healthy Subjects
Condition: Ebola
MeSH terms: Hemorrhagic Fever, Ebola
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, observer-blind, placebo-controlled trial in male and female subjects
      ≥18 to <50 years of age. Subjects will be healthy adults based on history, physical
      examination, and baseline clinical laboratory testing.

      Approximately 230 eligible subjects will be enrolled into 1 of 13 treatment groups.

      Treatments will comprise two IM doses at a 21-day interval (Day 0 and Day 21), in alternate
      deltoids with the test article assigned (i.e., saline placebo, dose of EBOV GP vaccine with
      or without Matrix-M adjuvant), in a 0.5mL injection volume.
    


Intervention name(s): Base Dose EBOV GP Vaccine; 2x Base Dose EBOV GP Vaccine; 4x Base Dose EBOV GP Vaccine; 8x Base Dose EBOV GP Vaccine; Placebo; Matrix-M Adjuvant
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Ebola