bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Effect of Fluticasone Furoate Nasal Spray on Spring Allergy Eye Symptoms
Condition: Allergic Conjunctivitis to Tree Pollen or Grass Pollen
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      Rationale and objectives:

      Fluticasone furoate nasal spray (Veramyst) has been shown to improve ocular symptoms when
      used for the treatment of seasonal allergic rhinitis during the ragweed pollen season.
      Although this is the only published report of an intranasal corticosteroid shown to
      effectively treat ocular symptoms, the mechanism has not been delineated. Furthermore, the
      tears of patients with allergic conjunctivitis are known to have increased concentrations of
      cytokines and allergic mediators.

      The objective of this study is to determine if the positive effects of Veramyst nasal spray
      on ocular symptoms is via the inhibition of allergic mediators in the eyes. The investigators
      will conduct a double blind placebo controlled trial to determine if Veramyst nasal spray
      decreases the amount of allergic mediators in the tears of subjects randomized to Veramyst
      nasal spray versus placebo. The investigators will also compare the subjects' symptoms to the
      amount of allergic mediators detected in their tears.
    


Intervention name(s): Fluticasone furoate nasal spray; Placebo nasal spray
Intervention type(s): Drug; Drug
Intervention description(s): 2 sprays each nostril every morning for 2 weeks; 2 sprays each nostril every morning for 2 weeks
Other intervention name(s): Veramyst
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Compression and Cold Therapy on the Post-Operative Shoulder
Condition: Postoperative Pain; Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate and compare clinical post-operative outcomes for
      patients using active cooling and compression device and those using ice bags and elastic
      wrap after acromioplasty or arthroscopic rotator cuff repair.
    


Intervention name(s): Cold Compression (CC); Ice Wrap (IW)
Intervention type(s): Device; Other
Intervention description(s): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours.; The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Effect of Fasting on the Non-invasive Measurement of the Body's Water Compartments
Condition: Dehydration; Perioperative Complication
MeSH terms: Dehydration
Study type: Interventional

Summary: 
      Preoperative fasting is defined as refraining from food for at least 6 hours and clear fluids
      for at least 2 hours prior to anaesthesia. On the one hand, it is a procedure that reduces
      the risk of aspiration of food content and the occurrence of Mendelson's syndrome, and on the
      other hand, it was considered to be the cause of disturbances in water management in patients
      undergoing general anaesthesia. However, reports from recent years have found that moderate
      preoperative fasting does not influence the risk of hypovolemia in anesthetized patients. It
      is also known that in fasting people the total body water is reduced. Thus, it can be assumed
      that there are mechanisms causing the movement of extravascular water into the lumen of blood
      vessels. For several years, the Body Composition Monitor (BCM) device for non-invasive
      measurement of the volume of individual water compartments of the human body has been
      available on the market. It allows to determine the volume of total body water, intracellular
      body water and extracellular body water. It is mainly used during dialysis, but it can also
      be used in other circumstances that require the determination of the body's hydration status.
      The principle of this method is based on non-invasive bioimpedance measurement with the use
      of 4 electrodes placed on two extremities.

      The aim of the study is to determine whether there is a fluid shift between the intracellular
      and extracellular compartments in people undergoing preoperative fasting. Examination of this
      issue would allow for the development of hypothesis regarding the optimal perioperative fluid
      therapy. If there was a shift of fluid from the intracellular space, it seems more rational
      to supplement fluid deficiencies resulting from starvation with a 5% glucose solution. If, on
      the other hand, no fluid shift from the intracellular space was detected, which would suggest
      shifts within the extracellular space, it would be advisable to hydrate the patient with
      crystalloid solutions.
    


Intervention name(s): Nutricia Pre-op, 400 milliliters, per os
Intervention type(s): Dietary Supplement
Intervention description(s): After 10 hours of fasting participants will receive per os 400 milliliters of Nutricia Pre-op
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy and Safety of Navarixin (SCH 527123) in Participants With Allergen-Induced Asthma (P05363)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluation of treatment in participants with mild asthma.
    

Detailed description: 
      To evaluate the effect of navarixin (MK-527123, SCH 527123) treatment on allergen-induced
      late asthmatic response (LAR) in participants with mild asthma.
    

Intervention name(s): Navarixin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 30 mg capsule to be taken once daily in the morning for 10 days during Treatment Period 1 or Treatment Period 2; Matching capsule to be taken once daily in the morning for 10 days during Treatment Period 1 or Treatment Period 2
Other intervention name(s): SCH 527123
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Neutrophilic Asthma
Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy
Condition: Abnormal Uterine Bleeding; Chronic Pelvic Pain; Infertility, Female
MeSH terms: Infertility; Infertility, Female; Uterine Hemorrhage; Pelvic Pain
Study type: Interventional

Summary: 
      Research objective To compare effectiveness of oral Misoprostal for cervical priming in
      premenopausal women underwent to diagnostic hysteroscopy Research hypothesis: Null hypothesis
      Effectiveness of oral misoprostal for cervical priming in premenopausal women underwent to
      diagnostic hysteroscopy is not different from placebo Alternative hypothesis: : Oral
      Misoprostal for cervical priming in Premenopausal women underwent to diagnostic hysteroscopy
      is better than placebo
    

Detailed description: 
      Research design Randomized double-blinded placebo-controlled trial. The investigators who
      assess the outcomes and the participants do not know Misoprostal group or control group. The
      patients are given the random concealed envelop which contains Misoprostal or placebo to take
      before hysteroscopy. Surgeon and the investigator whom assess patients do not know group
      allocation.
    

Intervention name(s): Misoprostol 200Mcg Tab
Intervention type(s): Drug
Intervention description(s): patient takes 2 tab of 200 mcg of Misoprostal 3 hr before hysteroscopy
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cervical priming; Diagnosis hysteroscopy; Oral Misoprostal; Premenopause
Lipid-lowering Effect of Phytosterols, Red Yeast Rice and Their Combination
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      A large body of evidence confirm the cholesterol lowering effect of phytosterols and red
      yeast rice. Because their mechanisms of action mime the ones of chemical statins and
      cholesterol absorption inhibitors, it is plausible that their association will provide a more
      relevant (and safe) LDL cholesterolemia reduction.
    

Detailed description: 
      A large body of literature suggest that the patients are strongly interested in
      self-medicating them with "natural" products aimed at reducing their plasma level of
      LDL-cholesterol. Plant sterols and red yeast rice are among the most widely marketed product
      with these properties in Western countries. However plant sterols per se have a limited
      effect on cholesterolemia, while full dosed red yeast rice can induce myalgias and myopathies
      as statins do. In this context, the aim of the investigators' study was to evaluate if the
      association of both products at low dosage could induce an additive or synergistic effect in
      term of LDL-reduction in humans.
    

Intervention name(s): Plant sterols; Red Yeast Rice; Red Yeast Rice plus Plant sterols
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Plant sterols 800 mg/dose, 1 liquid stick per day, for 8 weeks; Red Yeast Rice titrated in 5 mg monacolin K per daily dose, 1 liquid stick per day, for 8 weeks; Red Yeast Rice titrated in 5 mg monacolin K per daily dose plus Plant sterols 800 mg/dose, together in 1 liquid stick per day, for 8 weeks
Intervention MeSH terms: Red yeast rice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hypercholesterolemia; dietary supplements; red yeast rice; plant sterols
Methods Study to Characterize Early Indicators of Weight Loss in People
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Methods study to characterize early indicators of weight loss in people.
    


Intervention name(s): caloric restriction - 10%; caloric restriction - 25%; caloric restriction - 50%; caloric restriction - Control
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Subjects maintained on 10% caloric restriction (caloric intake = 90% of baseline); Subjects maintained on 25% caloric restriction (caloric intake = 75% of baseline); Subjects maintained on 50% caloric restriction (caloric intake = 50% of baseline); Subjects maintained on their baseline caloric intake (caloric restriction = none)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients
Condition: Psychomotor Agitation
MeSH terms: Delirium; Psychomotor Agitation
Study type: Interventional
Phase: Phase 4

Summary: 
      Scheduled, low-dose quetiapine is effective in preventing delirium in high-risk critically
      ill, trauma/surgical patients. Prophylaxis also reduced ventilator duration and ICU length of
      stay.
    

Detailed description: 
      Objective: To evaluate the efficacy of scheduled quetiapine for delirium prophylaxis in
      critically ill, trauma/surgical patients identified as high-risk for delirium utilizing a
      validated prediction model.

      Design: Prospective, open-label, single-center study. Setting: Trauma/surgical intensive care
      unit at an academic medical center. Patients: Eighty two adult trauma/surgical patients who
      were admitted to the intensive care unit and were at high-risk for the development of
      delirium (PRE-DELIRIC Score ≥50%, past medical history of dementia, past medical history of
      alcohol misuse, or past medical history of drug abuse).

      Interventions: Patients were randomized by unit location to receive pharmacologic prophylaxis
      for delirium (quetiapine 12.5 mg every 12 hours) or no pharmacologic prophylaxis for delirium
      within forty-eight hours of admission to the intensive care unit.

      Measurements: The primary end point was the incidence of delirium during admission to the
      intensive care unit (ICU). Secondary end points included time to onset of delirium, ICU and
      hospital lengths of stay, ICU and hospital mortality, duration of mechanical ventilation, and
      adverse events. Delirium was assessed using the confusion assessment method for the intensive
      care unit.
    

Intervention name(s): Quetiapine
Intervention type(s): Drug
Intervention description(s): escalating dose to prevent delerium.
Other intervention name(s): Seroquel
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Long-term Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06333AM1)
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      Mometasone furoate nasal spray (MFNS) is a once-a-day product. This is a multi-center,
      open-label study of MFNS in children with perennial allergic rhinitis. MFNS will be
      administered to pediatric subjects (3-15 years old) with perennial allergic rhinitis at a
      dose of 100 to 200 μg/day (once daily) for 12 weeks. Subjects (subject's legal
      representatives) provided consent to continue treatment beyond 12 weeks will receive
      treatment for up to 24 weeks. At each clinic visit, observation of adverse events, nasal
      symptom scores, and nasal findings will be evaluated. The presence/absence of serious adverse
      events and trial procedure-related AEs will be reviewed 30 days after the end of the
      follow-up.
    


Intervention name(s): mometasone furoate
Intervention type(s): Drug
Intervention description(s): MFNS 50 μg spray device
3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning.
12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning.
Other intervention name(s): Nasonex
Intervention MeSH terms: Mometasone Furoate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Traditional African Healing Ceremony in a U.S. Population
Condition: Chronic Fatigue Syndrome; Anxiety; Depression; Cancer
MeSH terms: Fatigue Syndrome, Chronic
Study type: Interventional

Summary: 
      Pre-agricultural societies almost universally used healing ceremonies that involved
      reverence, rhythm and dance in the presence of a healer. It is believed that we are "wired"
      for such experiences and they foster an integrative mode of consciousness similar to that of
      mindfulness based stress reduction, which has been shown to have therapeutic effects in a
      variety of conditions. Collaborator Ava Lavonne Vinesett of the Duke Dance Program has
      developed a healing ceremony based in sub-Saharan African traditions. The investigators plan
      is to have 25 subjects with a variety of clinical conditions participate in this ceremony.
      Subjects will then be asked to write a commentary about their experience and to participate
      in a focus group discussion. It is anticipated that the study will give us some idea of how
      promising this approach would be and what kinds of patients might benefit. Safety issues are
      minimal and include the possibility of injury (though the dancing is not strenuous) and
      psychological distress.
    


Intervention name(s): Movement to rhythm
Intervention type(s): Behavioral
Intervention description(s): Movement to rhythm
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Open-label Study of Inhaled RVT-1601 in Preterm Infants
Condition: Respiratory Morbidities of Prematurity (RMP)
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 1

Summary: 
      Preterm birth predisposes infants to greater risk for respiratory morbidities and the need
      for pulmonary care compared to term infants both in the short-term and long-term. In the
      short-term, preterm birth is a high risk factor for development of bronchopulmonary dysplasia
      (BPD), the second most common chronic pediatric respiratory disease after asthma. In the
      long-term, following discharge from the neonatal intensive care unit (NICU) and the hospital,
      preterm birth carries a high risk for respiratory morbidities (e.g., wheezing, cough, doctor
      visits, and hospitalizations for respiratory infections) and resource use, which in turn
      predisposes infants to the development of lung diseases in childhood and adulthood, including
      airway hyperresponsiveness, asthma, and chronic obstructive pulmonary disease (COPD). There
      is a significant unmet need for safe and efficacious approaches in the prevention and
      treatment of respiratory morbidities of prematurity.

      The study will be conducted in the neonatal intensive care unit (NICU) in preterm infants to
      determine safety, tolerability and lung delivery performance of RVT-1601, a new inhalation
      formulation of cromolyn sodium delivered via the eFlow® Closed System (CS) nebulizer/face
      mask.
    


Intervention name(s): RVT-1601
Intervention type(s): Drug
Intervention description(s): Inhaled RVT-1601 administered once daily over two days
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Diet and Exercise in Breast Cancer Survivors
Condition: Breast Cancer; Obesity
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This study seeks to see if a 12-week diet and exercise program improves exercise ability,
      energy level, and quality of life.
    


Intervention name(s): aerobic exercise
Intervention type(s): Behavioral
Intervention description(s): 3 times per week for 12-weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      Elective percutaneous coronary intervention (PCI) is associated with troponin release in
      approximately one third of cases. Myocardial necrosis may result from downstream embolization
      of atheromatous material, coronary side-branch occlusion and may involve ischemia/reperfusion
      injury. The investigators hypothesized that a single remote ischemic preconditioning cycle
      would reduce peri-procedural troponin release.
    

Detailed description: 
      Elective percutaneous coronary intervention (PCI) is associated with troponin release in
      approximately one third of cases, which is a sensitive and specific marker of myocyte
      necrosis. Myocardial necrosis may result from downstream embolization of atheromatous
      material, coronary side-branch occlusion and may involve ischemia/reperfusion injury. A
      number of studies have demonstrated that procedure-related troponin release is associated
      with subsequent cardiovascular events and a worst prognosis, especially in those patients
      with the most marked elevation in troponin concentration.

      Recently, 3 cycles of 5-minute ischemia followed by 5-minute reperfusion of the upper
      extremities were shown to reduce troponin release in elective PCI. However, this ischemic
      preconditioning (IPC) protocol requires 30 minutes and is of limited use in the context of
      PCI at the time of initial cardiac catheterization (ad hoc coronary intervention).

      Since experimental evidence suggests that IPC is a graded than an "all-or-nothing"
      phenomenon, and even a short, single IPC cycle may have protective effects in the myocardium,
      the investigators hypothesized that patients undergoing ad hoc coronary intervention would
      have reduced peri-procedural troponin release if subjected to a single, remote IPC cycle,
      between diagnostic catheterization and coronary intervention.
    

Intervention name(s): Remote Ischemic Preconditioning
Intervention type(s): Other
Intervention description(s): Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: percutaneous coronary intervention; remote ischemic preconditioning
Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients
Condition: Liver Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial evaluated the efficacy and safety of Everolimus in combination with tacrolimus
      versus a standard immunosuppressive regimen concerning kidney function in liver transplant
      recipients.
    


Intervention name(s): Everolimus; Tacrolimus; Corticosteroids
Intervention type(s): Drug; Drug; Drug
Intervention description(s): tablet containing 0.25mg, 0.5mg, 0.75mg or 1.0mg; capsule containing 0.5, 1.0, or 5.0mg; For patients in all groups, corticosteroids were initiated at or prior to the time of transplantation according to local practice. Corticosteroids may have been used for the duration of the study according to the investigator's discretion, but may not have been eliminated sooner than 6 months post-transplantation.
Other intervention name(s): RAD001 / Certican; Tacrolimus Hexal
Intervention MeSH terms: Everolimus; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liver transplantation; Everolimus; Tacrolimus; Renal function