bioihbjkbjnl/mcl2 huggingface dataset:
Interleukin-1 Trap to Treat Vascular Dysfunction in Chronic Kidney Disease (CKD)
Condition: Renal Insufficiency, Chronic
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      Risk of cardiovascular diseases (CVD) is significantly elevated in patients with chronic
      kidney disease (CKD); however, this increased risk is only partially explained by traditional
      cardiovascular risk factors. Patients with CKD exhibit chronic inflammation, a key mechanism
      contributing to vascular dysfunction (i.e., large elastic artery stiffening and endothelial
      dysfunction). Inhibiting inflammation improves vascular dysfunction in other populations
      characterized by chronic inflammation. However, it is currently unknown if reducing
      inflammation with an interleukin-1 (IL-1) blocker enhances vascular function in CKD patients.
      Aim 1 will assess the efficacy of IL-1 blocking with rilonacept for treating vascular
      dysfunction in patients with stage III or IV CKD (estimated glomerular filtration rate 15-60
      mL/min/1.73 m2). Aim 2 will determine if blocking IL-1 with rilonacept also reduces
      inflammation and oxidative stress. These studies could shift clinical practice guidelines by
      establishing a novel therapy for reducing CVD risk in CKD patients not requiring chronic
      hemodialysis.
    


Intervention name(s): Rilonacept; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk); Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)
Other intervention name(s): Arcalyst; normal saline
Intervention MeSH terms: Rilonacept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Interleukin-1; Endothelium, Vascular; Vascular Stiffness; Oxidative Stress; Inflammation; Endothelial cells
A Pivotal Study to Evaluate Guardian™ Connect CGM System Performance in China
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate the performance and safety of the Guardian™
      Sensor (3) over 170 hours (7 days) when inserted in the abdomen used in subjects age 14 - 75
      years with the Guardian™ Connect System.
    

Detailed description: 
      This study is a multi-center, prospective single-arm design without controls. Up to 72
      subjects will be enrolled in order to have approximately 60 subjects complete the study.
      Three investigational centers in China will be used during this study.

      During the study, each subject will be randomly assigned to one day of the Yellow Springs
      Instrument (YSI™*) frequent sample testing (FST) (Day 1, 3-5, or 7).Subjects will wear two
      Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7
      days (one which will be paired to the Guardian Connect app and the other will function as a
      glucose recorder.).

      The Guardian Sensor (3)s will be worn in the abdomen area and self-inserted by the subject on
      same side or opposite sides.

      On the evening prior to FST, subjects will be asked to fast for approximately 12 hours and
      adjust their insulin and medications according to routine care (for example as they would do
      for fasting lipid panel). Subjects may fast for shorter period of time based on investigator
      discretion.

      The subject should be in fasting status upon arrival hospital to start FST process. The
      feeding protocol may be modified based on investigator discretion. The duration of FST will
      be approximately 7 hours.

      During the study, subjects will continue with their current diabetes regimen independent of
      the study devices. Subjects will be instructed by the investigational center that they are
      not to use the study devices (except for the CONTOUR™* study meter) for the management of
      their diabetes. The CONTOUR™* study meter may be used for treatment decisions and calibration
      of Guardian™ Sensor (3).
    

Intervention name(s): Guardian™ Sensor (3)
Intervention type(s): Device
Intervention description(s): Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Type I Type II
A Study to Evaluate the Safety of FluMist in Healthy Children and Healthy Adults
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study was to expand the data describing the safety profile of FluMist in
      the indicated populations (5-8, 9-17, and 18-49 years of age) and to assess the safety of
      annual revaccination in those who received FluMist in 2 or more consecutive years.
    

Detailed description: 
      The primary objective of this study was to assess the safety of FluMist vaccination by
      comparing the rates of medically attended events (MAEs) (including serious adverse events
      [SAEs], anaphylaxis, urticaria, asthma, wheezing, pre-specified grouped diagnoses, and rare
      events potentially related to wild-type influenza) in FluMist recipients to rates in multiple
      non-randomized control groups.
    

Intervention name(s): FluMist; FluMist; FluMist
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Nasal Sprayer dose of FluMist with annual follow up; Nasal Sprayer dose of FluMist with annual follow up; Nasal Sprayer dose of FluMist with annual follow up
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This is an observational study conducted over multiple years with multiple non-randomized
        control groups.
Low Energy Availability, Menstrual Irregularity, and Low Bone Mass
Condition: Bone Density; Energy Availability
MeSH terms: Menstruation Disturbances
Study type: Observational

Summary: 
      This study examines the role of energy availability on menstrual function and bone mass in
      female adolescent endurance athletes. Specific evaluations include dietary intake, exercise
      energy expenditure, training schedules, menstrual function and bone density.
    

Detailed description: 
      The purpose of this project is to examine the relationships among low energy availability,
      H-P-A axis, menstrual function and bone density and bone turnover in high school female cross
      country runners. Our objectives are to: 1)determine energy intake, exercise energy
      expenditure, and fat-free mass to examine energy availability; 2)in a subset of runners,
      using double labelled water, estimate total energy expenditure and indirect calorimetry to
      estimate resting metabolic rate; 3)assess the relationship between energy availability,
      hormones that regulate bone turnover, markers of bone formation and resorption and bone
      mineral content and density; 4)identify the relationship between energy availability,
      hormones that regulate menstrual function and current menstrual status; and 5)determine the
      energy intake and energy expenditure variables exhibiting the strongest associations with
      energy availability.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        adolescent female cross country runners
      
Keywords: bone density; energy availability; menstrual status; female; adolescent
Effect of Montmorillonite Power or Loperamide on the Pharmacokinetics of Pyrotinib in Healthy Subjects
Condition: HER2-positive Recurrent / Metastatic Breast Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will assess the effect of anti-diarrhea drug Montmorillonite Power or Loperamide on
      the single dose pharmacokinetic parameters of pyrotinib in healthy Chinese subjects. The
      safety of pyrotinib alone and when co-administered with each drug will also be assessed.
    


Intervention name(s): pyrotinib tablet; Montmorillonite Power; Loperamide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single oral dose of pyrotinib or co-administered with Montmorillonite Power or Loperamide; 3 g or one pouch of montmorillonite power 2 hours after pyrotinib administration; 4 mg of loperamide with pyrotinib followed by 2mg every 2 hours for 2 times for a total of 8mg/day
Intervention MeSH terms: Loperamide; Antidiarrheals; Bentonite
Intervention model: Single Group Assignment
Intervention model description: Pyrotinib alone and then combined with Montmorillonite Power or Loperamide
Masking: None (Open Label)
Primary purpose: Treatment
Comparative Clinical Evaluation Between a Novel Self Adhesive and Conventional Bulk-fill Composites
Condition: Class II Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This study aimed to evaluate the clinical performance of a novel, tooth-colored,
      self-adhesive bulk-fill restorative, and a conventional bulk-fill composite, for restoring
      class II cavities.
    


Intervention name(s): Surefil one®; Filtek One
Intervention type(s): Other; Other
Intervention description(s): For Surefil one® restorations, the capsule will be activated by pressing it against a stable surface, then mixed in a capsule mixer for 10 s. The capsule tip will be inserted into the proximal box, and the material is extruded as the tip is gradually moved in a coronal direction, ensuring that the material adapts to the cavity bottom and walls.; Scotchbond™ Universal (SBU) will be used as an adhesive system in self-etch mode for FiltekTM One restoration. SBU will be applied actively for 20 seconds with a disposable brush tip, air-dried gently for 5 seconds to create a consistent bond thickness, then light-cured for 10 seconds. The FiltekTM One will be packed in increments up to 4 mm thick. A second layer of FiltekTM One will be applied on top of the first 4-mm layer if 4 mm is not adequate to properly restore the tooth. Each increment will be light cured for 20 seconds.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: a randomized controlled split-mouth study.
Masking: Single (Participant)
Primary purpose: Treatment
Comparison of Peripheral Blood Stem Cell Transplantation With Bone Marrow Transplantation for the Treatment of Serious Hematological Malignancies
Condition: Blood Stem Cell Transplant
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the outcomes of study participants who have had peripheral blood stem
      cell transplantation or with those who have had bone marrow transplantation from an unrelated
      donor for the treatment of serious hematological malignancies.
    

Detailed description: 
      This study is a randomized, open-label, multicenter, prospective, comparative trial of
      granulocyte colony stimulating factor (G-CSF) mobilized peripheral blood stem cells verses
      marrow from unrelated donors for transplantation in patients with hematologic malignancies.
      The study will be comparing two-year survival probabilities between process has many steps
      after a matched donor is found. The donor also needs to give permission to join this study.
      Participants will be randomized to either peripheral blood stem cells (PBSC) or bone marrow.
      The kind of transplant the participant receives is random. Neither the participant nor the
      doctor may choose the type of transplant.

      Participants will receive vaccinations for diphtheria, tetanus, hepatitis B and pneumococcus.
      Blood samples will be drawn as part of a participant's normal care. Blood samples will also
      be collected to see if infection fighting cells are working. These samples will be collected
      at 12 weeks, one year and then yearly until three years post transplant. Information will be
      collected from the participant's medical history. Participants will also have phone
      interviews conducted and questions will be asked about their physical and emotional health.
      Participants taking part in this study may be followed for up to 5 years.
    

Intervention name(s): Blood stem cell versus bone marrow transplant
Intervention type(s): Procedure
Intervention description(s): Cyclophosphamide and Total Body Irradiation (CY-TBI)-based regimens that include at least 120 mg/kg cyclophosphamide and at least 1200 cGy of fractionated TBI.
Busulfan and cyclophosphamide (BU-CY)-based regimens that include at least 14 mg/kg busulfan orally or 11.2 mg/kg busulfan intravenously (14 x 0.8 correction factor) or a targeted busulfan dosing strategy aimed at a serum concentration greater than 600 ng/mL at steady state and at least 120 mg/kg cyclophosphamide.
Fludarabine and melphalan (Flu-Mel)-based regimens that include a fludarabine dose of least 120 mg per m2 and a melphalan dose of at least 140 mg per m2.
Fludarabine, busulfan, and ATG (Flu-Bu-ATG)-based regimens that include a fludarabine dose of at least 120 mg/m2, at least 8 mg/kg busulfan orally or 250 mg/m2 busulfan intravenously, and at least 40 mg/kg equine ATG or 4 mg/kg rabbit ATG. Institutional standards should be followed for targeting plasma levels.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Statin Association With Standard Treatment in Prevention of Recurrent Hemorrhage in Patient With Cirrhosis and Variceal Bleeding
Condition: Cirrhosis; Hypertension, Portal; Bleeding Esophageal Varices; Portal Vein Thrombosis
MeSH terms: Liver Cirrhosis; Esophageal and Gastric Varices; Hypertension, Portal; Thrombosis; Hemorrhage; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a prospective, double blind controlled trial in which patients with esophagic
      variceal bleeding treated with standard therapy (endoscopic variceal ligation(EVL) +
      B-blockers), will be randomized to receive statins or placebo. They will be followed up
      during 12 months to determinate whether statins are effective in prevention of variceal
      bleeding recurrence and evaluate patient survival.

      Randomization will be stratified according to the degree of hepatic insufficiency, assessed
      by the Child-Pugh classifications (A,B or C).
    

Detailed description: 
      A mayor cause of cirrhosis-related morbility and mortality is the development of variceal
      hemorrhage, a direct consequence of portal hypertension. In addition, survivors of an episode
      of active bleeding have a 70 % risk of recurrent hemorrhage within two years of the bleeding
      episode and the highest risk it is situated in the first six weeks after the hemorrhage
      episode.

      The recommended treatment in AASLD guidelines is the combination of non selective
      Betablockers with endoscopic treatment with EVL, with high recurrence (30% in 2 years).

      The hypothesis of this study is that statins are candidates for improving portal hypertension
      treatment in patients with cirrhosis, improving vascular function as well as preventing
      venous thrombotic events.

      Patients with liver cirrhosis and variceal bleeding with standard treatment will be
      stratified and after randomized to undergo either statins (20 mg for 15 days, and after 40
      mg/day) or placebo. They will be followed up for 12 months.
    

Intervention name(s): Simvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Simvastatin 20 mg for 15 days, then 40 mg until the end of the study.; Simvastatin placebo
Other intervention name(s): Simvastatina; Simvastatina Ratiopharm
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Testing the Efficacy of REThink Main Game-based ER Strategies on the Stress Reactivity
Condition: Emotion Regulation
Study type: Interventional

Summary: 
      This activity will aim to test the comparative efficacy of the main game-based
      emotion-regulation abilities training of the REThink online game: cognitive change,
      biofeedback and problem-solving in reducing stress reactivity of the children and adolescents
    

Detailed description: 
      Children included in this study (aged 8-16 years, G*Power estimated N=98) will be allocated
      to one of the three experimental conditions (cognitive change, biofeedback and
      problem-solving game based training based on the REThink online game levels), or no
      intervention Control condition. All children will be exposed afterwards to psychosocial
      stress in the form of peer rejection "ball toss" task. It will be measure both game-based
      skills outcomes, and EMA stress reactivity outcomes.
    

Intervention name(s): REThink Game
Intervention type(s): Other
Intervention description(s): REThink is a online therapeutic game developed by David and collaborators (2018), proved to be an efficient intervention to reduce emotional symptoms of children and adolescents.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Patients With Chronic Obstructive Pulmonary Disease At Altitude
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of a stay at moderate altitude on
      exercise performance of patients with chronic obstructive lung disease.
    

Detailed description: 
      Patients with moderate to severe COPD living below 800 m, will be recruited to participate in
      a randomized cross-over field trial evaluating the hypothesis that exercise capacity during a
      4 day sojourn at moderate altitude is reduced in comparison to low altitude. Outcomes will be
      assessed during 2 days in Zurich (490 m, low altitude baseline), 2 days at Davos Clavadel
      (1650 m), and 2 days at Davos Jakobshorn (2590 m). The main outcome is the 6 minute walk
      distance.
    

Intervention name(s): altitude exposure
Intervention type(s): Other
Intervention description(s): stay at different altitudes: 490, 1630, 2590 m
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: airway disease; bronchitis; emphysema; lung
Biomarkers in Obese Patients With Knee Osteoarthritis; Weight Maintenance
Condition: Osteoarthritis; Obesity
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a substudy to a randomized trial investigating the effect of liraglutide on body
      weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In
      the parent trial, patients will be subjected to an 8-week diet intervention phase including a
      low-calorie diet and dietetic counseling, after which they will be randomized to receive
      either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on
      re-introducing regular foods and a focus on continued motivation to engage in a healthy
      lifestyle.

      This substudy aims to investigate the impact of, and subsequent change of biomarkers in obese
      patients with knee osteoarthritis following a randomization to Liraglutide 3 mg or
      Liraglutide 3 mg placebo treatment between weeks 0-52.
    


Intervention name(s): Liraglutide 3 mg (Saxenda); Liraglutide 3 mg placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis; Obesity; Liraglutide 3 mg; Liraglutide; Biomarkers
Sleep Quality in Mechanically Ventilated Patients
Condition: Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      Patients requiring mechanical ventilation in the ICU will undergo three consecutive nights of
      polysomnography to record sleep patterns while receiving three modes of mechanical
      ventilation; Proportional assist ventilation (PAV), Pressure support ventilation (PSV),
      Assist control ventilation (ACV), applied in random order. The purpose is to determine the
      effect of mode of mechanical ventilation on patient-ventilator asynchrony and sleep quality.
    


Intervention name(s): PAV; PSV; ACV
Intervention type(s): Other; Other; Other
Intervention description(s): Proportional Assist Ventilation will be used to ventilate the patient for a 24 hour period; Pressure Support Ventilation will be used to ventilate the patient for a 24 hour period; Assist Control Ventilation will be used to ventilate the patient for a 24 hour period
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: PAV (proportional assist ventilation); sleep; polysomnography; mechanical ventilation
Self-Hypnotic Relaxation Therapy During Invasive Procedures
Condition: Uterine Neoplasms; Leiomyoma
MeSH terms: Leiomyoma; Uterine Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effectiveness of self-hypnotic relaxation on
      mental and physical distress during and after tumor treatment procedures.
    

Detailed description: 
      Pain relievers and sedatives may have limited effectiveness and serious side effects when
      given to alleviate distress during minimally invasive surgical procedures. Unabated distress
      may interfere with the ongoing procedure and may negatively impact future interventions.

      Studies have shown that nonpharmacologic analgesia in the form of self-hypnotic relaxation
      during invasive medical procedures significantly reduces patients' pain, anxiety, drug use,
      and number of complications. The long-term goal of this study is to determine whether
      self-hypnotic relaxation therapy can be a safe and practical method for reducing cognitive
      and physiologic distress associated with invasive procedures.

      Participants in this study will be randomly assigned to one of three groups: a standard care
      group, an empathic control group, and a self-hypnotic relaxation group. The emphatic control
      group will meet with a clinician who will offer encouragement and support. The group assigned
      to self-hypnotic relaxation will read a standardized script prior to procedure. Self-report
      questionnaires will be used to assess pain and anxiety.
    

Intervention name(s): Self-hypnotic relaxation
Intervention type(s): Behavioral
Intervention MeSH terms: Hypnotics and Sedatives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypnosis; Analgesia; Embolization, Therapeutic; Chemoembolization, Therapeutic