bioihbjkbjnl/mcl2 huggingface dataset:
Investigating the Role of EN in NTIS Among Fistula Patients
Condition: Gastrointestinal Fistula
MeSH terms: Digestive System Fistula; Fistula
Study type: Observational

Summary: 
      The purpose of this study is to investigate whether enteral nutrition are effective in the
      treatment of nonthyroidal illness syndrome among fistula patients.
    

Detailed description: 
      Nonthyroidal illness syndrome (NTIS) is a common alterations in thyroid function observed in
      about 70% of hospitalized patients, with or without acute systemic illnesses. Mechanisms in
      the pathogenesis of NTIS are not yet well understood. Our previous study demonstrated that
      NTIS occurred frequently with a prevalence of 57.5% in gastrointestinal fistulas patients. In
      recent study, it has been shown that early enteral nutrition decreases the duration of
      hospitalization and mortality in the burn population, indicating a potential role of enteral
      nutrition in NTIS.In addition, the management of fistula patients requires bundle therapy
      including Nutrition therapy, especially enteral nutrition.The purpose of this study is to
      investigate whether enteral nutrition are effective in the treatment of nonthyroidal illness
      syndrome among fistula patients.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Department of general surgery in Jinling hospital
      
Biospecimen description: 
      whole blood
    
Keywords: gastrointestinal fistula; enteral nutrition; thyroid function
Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary outcome of the study is to evaluate the cumulative area under the concentration
      time curve (AUC) over 2 weeks, as measured by AUC from time 0 to 336 hours post dose
      (AUC0-336h), for serum concentrations of BIIB017 and Rebif.

      The secondary outcomes are to evaluate the maximum observed serum concentrations (Cmax) of
      BIIB017 and Rebif and to evaluate the safety and tolerability of BIIB017 and Rebif over 2
      weeks in healthy volunteers.
    


Intervention name(s): peginterferon beta-1a; Rebif
Intervention type(s): Drug; Drug
Intervention description(s): Administered as subcutaneous injection; Administered as subcutaneous injection
Other intervention name(s): BIIB017; Plegridy
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Paroxetine on Smokers' Cardiovascular Response to Stress - 1
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      Smokers report that they often smoke cigarettes during stressful times. The combined effect
      of smoking and exposure to stress leads to exaggerated increases in blood pressure, heart
      rate and other measures of stress response. This combination may result in greater
      cardiovascular harm than either smoking or stress alone. The purpose of this study is to
      determine the effects of paroxetine on the response to stress after smoking.
    

Detailed description: 
      Smokers report that they often smoke cigarettes during stressful times. Smoking and stress
      produce similar physiological responses such as increases in heart rate, blood pressure, and
      adrenaline levels. The combination of smoking and stress results in greater increases in
      these physiological responses compared to smoking or stress alone. Such increases are thought
      to be harmful to cardiovascular health. Additionally, smokers with exaggerated responses to
      stress may be more likely to relapse following a smoking cessation attempt. The purpose of
      this study is to assess the effects of paroxetine, a selective serotonin reuptake inhibitor
      (SSRI), on the cardiovascular response to stress after smoking.

      Participants in this double-blind, placebo-controlled study will receive 1 month of
      paroxetine and 1 month of placebo with the order of which is taken during the first month
      randomly assigned. Paroxetine will be administered at a daily dose of 10 mg for the first
      week and increased to a daily dose of 20 mg for the remainder of the study. After one month
      of medication, participants will abstain from smoking for one night and then undergo mental
      stress testing the following day. Immediately prior to the mental stress testing,
      participants will smoke a cigarette. Mental stressors will include speaking and math tasks.
      Physiological measures of stress (e.g., blood pressure, heart rate, and plasma catecholamine
      concentrations) and subjective measures of stress will be evaluated. Following the second
      month of medication, participants will again undergo the procedure for mental stress testing
      and evaluation.
    

Intervention name(s): Paroxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg for 1 week followed by 20 mg for 3 weeks
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Smoking
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the efficacy and safety of AR101 through
      reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.
    

Detailed description: 
      This is an international, multicenter, randomized, double-blind, placebo-controlled study of
      the efficacy and safety of AR101 in a characterized desensitization oral immunotherapy
      regimen in peanut-allergic individuals.
    

Intervention name(s): AR101 powder provided in capsules & sachets; Placebo powder provided in capsules & sachets
Intervention type(s): Biological; Biological
Intervention description(s): Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol; Study product formulated to contain only inactive ingredients for use as defined in the protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: AR101 (Characterized Peanut Allergen); Characterized Peanut Allergen; CPNA (Characterized Peanut Allergen); OIT (oral immunotherapy); Oral Immunotherapy; Peanut Allergy; Allergy; Peanut-Allergic Children; Peanut-Allergic Adults; Desensitization
Periodontal Therapy in Thalassemia Major Patients
Condition: Thalassemia Major; Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis; Thalassemia; beta-Thalassemia
Study type: Interventional

Summary: 
      The study aims to evaluate the effect of local non surgical periodontal therapy on the
      systemic pro-inflammatory markers in the β-thalassemia (TM-β) patients with chronic
      periodontitis and systemically healthy demographically matched controls with chronic
      periodontitis. Both groups will receive non surgical periodontal therapy.
    

Detailed description: 
      Treatment modalities in patients with thalassemia include long-term transfusion therapy, iron
      chelation, splenectomy, allogeneic hematopoietic transplantation and supportive measures.
      Attempts to downgrade the systemic proinflammation and thereby reducing the morbidity of the
      disease warrants investigation in patients with β-thalassemia (TM-β). In blood disorders, as
      with most other diseases, achieving and maintaining inflammatory homeostasis is essential and
      necessary for survival. Both TM and gingival diseases cause increased levels of
      pro-inflammatory cytokines in the body fluids. Moreover, higher prevalence of gingival
      diseases is reported in children with TM. With oral hygiene maintenance and care,
      down-regulation of the systemic burden of the disease might be attained which will
      subsequently aid in achieving reduced morbidity in children with TM.

      Both the groups will receive non surgical periodontal therapy (scaling and root planing) with
      the chlorhexidine containing adjunct in the form of a mouthrinse. Additionally, they will be
      taught standard tooth brushing technique (Fones technique). Participants will receive both
      verbal instructions and practical demonstrations.
    

Intervention name(s): Non surgical periodontal therapy; Chemical plaque control
Intervention type(s): Procedure; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cytokines; scaling root planing; oral hygiene; systemic inflammation
Sensorimotor Training and Constraint Induced Movement Therapy on Upper Extremity Function in Children With Hemiplegic CP
Condition: Hemiplegic Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The aim of the work was to find out the effects of sensorimotor training and constraint
      induced movement therapy on upper extremity function in children with hemiplegic cerebral
      palsy.
    

Detailed description: 
      The significance of this study is that there was paucity of literature in finding the
      comparative effects of sensorimotor training and constraint induced movement therapy on upper
      extremity function in children with hemiplegic cerebral palsy. The aim is to find out the
      effects of sensorimotor training on motor functioning of the upper extremity in comparison of
      constraint induced movement therapy.
    

Intervention name(s): sensorimotor training; constraint induced movement therapy
Intervention type(s): Other; Other
Intervention description(s): sensorimotor training include activities like play with dough, peg games, puzzles for 5 days a week for 4 week.; constraint induced movement therapy in which arm was constraint for 6 hours a day for 5 days a week for 4 week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: sensorimotor training; motor function; constraint induced movement therapy
Premedication and Haemodynamics After Spinal Anesthesia
Condition: Hemodynamics After Spinal Anesthesia
Study type: Interventional

Summary: 
      Blood pressure drop following spinal anesthesia is connected with sympathetic/parasympathetic
      activity which may be determinated by Heart Rate Variability (HRV) assessment. Sympathetic
      predomination expressed as LF/HF ratio above 2.5 is strongly connected with deeper blood
      pressure fall. As drugs given for premedication may have impact on HRV variables, the
      investigators would like to determine if pharmacological premedication may modify hemodynamic
      changes following spinal blockade. Two drugs will be compared - midazolam which is known to
      lead to increase in LF/HF ratio and morphine - opioid which provokes opposite effect.
    


Intervention name(s): Morphine hydrochloride; Midazolam; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): intramuscular morphine 10 mg given 30 minutes before spinal blockade performing; intramuscular midazolam 15 mg given 30 minutes before spinal blockade performing
Intervention MeSH terms: Midazolam; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: spinal anesthesia; heart rate variability; premedication; heart rate; blood pressure
Intestinal Permeability in Response to Treatment in Eosinophilic Esophagitis Patients
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Do patient's with eosinophilic esophagitis have increased small intestinal permeability and
      if this changes in response to topically administered esophageal steroids?
    

Detailed description: 
      Eosinophilic esophagitis is an allergy mediated disease in which antigens exposed to the
      gastrointestinal tract trigger a combined immediate hypersensitivity.

      The investigators anticipate that patients with active eosinophilic esophagitis will have
      increased intestinal permeability on urine collection of sugars. The investigators are not
      sure whether these findings will be found in patients who have been successfully treated with
      topical esophageal steroids. Improvement in intestinal permeability would be perceived as
      indicating that esophageal disease drives the intestinal permeability. Lack of improvement
      would indicate that eosinophilic esophagitis is a more systemic disease in which increased
      small bowel permeability is a marker or perhaps important driver of the disease.
    

Intervention name(s): Absorbable sugars
Intervention type(s): Other
Intervention description(s): Lactulose (1,000 mg) and mannitol (200 mg). For the liquid formulation, these sugars will be administered in 250 ml of water. After oral ingestion of the sugars in liquid form, urine will be collected every 30 minutes for the first 2 hours.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eosinophilic Esophagitis
Osteoporosis Choice Decision Aid for Use of Bisphosphonates in Postmenopausal Women
Condition: Osteoporosis; Bone Loss, Age Related; Postmenopausal Bone Loss; Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional

Summary: 
      To develop a decision aid to support the decision to use (or not use) bisphosphonates in
      postmenopausal women at risk for osteoporotic fractures, and to assess the impact of the
      decision aid on start and six month adherence to bisphosphonates.
    

Detailed description: 
      Bisphosphonates can reduce fracture risk in patients with osteoporosis. However, many
      patients may not start and adhere to bisphosphonates, consequently losing independence,
      quality, and length of life. We hypothesize that a decision aid that efficiently improves
      patient education and communication with their provider about fracture risk, and about using
      bisphosphonates to reduce that risk, will improve the quality of treatment decisions. We
      anticipate that patients will become more involved in the decision-making process and
      decisions will be more consistent with patients' values and health care goals. We expect this
      will lead to increased bisphosphonate start and adherence and improved patient outcomes.
    

Intervention name(s): Osteoporosis Choice Decision Aid
Intervention type(s): Behavioral
Intervention description(s): The provider will introduce the patient to the choice of bisphosphonates using the decision aid.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Keywords: Osteoporosis, age-related; Osteoporosis, Postmenopausal; Bone Loss; Low Bone Density
Study Evaluating Effexor XR for Major Depression.
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      Study Evaluating Effexor XR for Major Depression.
    


Intervention name(s): Effexor XR; Milnacipran
Intervention type(s): Drug; Drug
Intervention MeSH terms: Milnacipran; Venlafaxine Hydrochloride; Levomilnacipran
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Depression
Acupoint Application in Patients With Stable Angina Pectoris (AASAP)
Condition: Stable Angina Pectoris
MeSH terms: Angina Pectoris; Angina, Stable
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Hypothesis: acupoint application is effective for managing chronic stable angina pectoris.
      Aim: to evaluate the efficacy and safety of acupoint application on the specific acupoints
      for chronic stable angina pectoris. Design: A Randomized, Controlled,Double Blind trial. 200
      participants will be included. Four arms: herbal medicine application on acupoint group ,
      placebo application on acupoint group , herbal medicine application on non-acupoint group and
      placebo application on non-acupoint group.
    

Detailed description: 
      Acupoint application with herbal medicine is a kind of external treatment of traditional
      Chinese medicine and has a long history in China, which is use herbal medicine made of
      plaster and stick to specific acupoints, using the double effects of acupoints and herb to
      treat disease. In China, acupoint application with herbal medicine has been used in clinical
      treatment of angina pectoris, but there is no convincing evidence for the efficacy of
      acupoint application for angina pectoris, due to low methodologic quality and small sample
      size. The investigators designed the Randomized, Controlled, Double Blind clinical trial to
      investigates the efficacy of acupoint application in treating angina pectoris, the purpose of
      this study is to provide the convincing evidence for acupoint application treatment of angina
      pectoris.
    

Intervention name(s): Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech); acupoint; Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.
Intervention type(s): Drug; Device; Drug
Intervention description(s): Application containing herbal medicine that mainly include styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech and other herbal medicine.; select acupoint according to traditional Chinese medicine; foundation treatment
Other intervention name(s): Herbal medicine application; acupuncture point; basic treatment
Intervention MeSH terms: Aspirin; Metoprolol; Ramipril; Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acupoint Application,Stable Angina Pectoris,herbal medicine
Use of Sugammadex Administered at 5 Minutes After Administration of 1.2 mg/kg Esmeron® (19.4.205)(P05942)
Condition: Anesthesia, General
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the optimal dose of sugammadex when this compound
      is administered during deep neuromuscular block. Sugammadex is administered shortly (5
      minutes) after administration of a high dose (1.2 mg/kg) of the neuromuscular blocking agent
      rocuronium . Under these circumstance the neuromuscular block is deep. The safety and
      pharmacokinetics of sugammadex are also studied.
    


Intervention name(s): sugammadex; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6)
At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered; After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6)
At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered
Other intervention name(s): Org 25969
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Warfarin Dosing Using Decision Model Versus Pharmacogenetic Algorithm
Condition: Atrial Fibrillation; Pulmonary Embolism; Deep Vein Thrombosis
MeSH terms: Pulmonary Embolism; Atrial Fibrillation; Thrombosis; Embolism; Venous Thrombosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective comparison of clinician dosing and a pharmacogenetic algorithm in
      diagnosed patients requiring warfarin therapy.
    

Detailed description: 
      Diagnosed patients with atrial fibrillation, pulmonary embolism, or deep venous thrombosis
      requiring warfarin therapy will be consented and a tube of blood for DNA analysis will be
      drawn. The clinician dosing group will not be eligible to obtain the pharmacogenetic results
      and the algorithm group will have their warfarin pharmacogenetic SNPs performed and
      integrated into the algorithm and the warfarin dose will be calculated. Outcomes of patients
      receiving both methods will be gathered and statistically analyzed.
    

Intervention name(s): Warfarin Dose based on pharmacogenetics
Intervention type(s): Genetic
Intervention description(s): Warfarin dose adjustment will be based on the standard clinician dosing compared to the use of the pharmacogenetic base algorithm
Intervention MeSH terms: Warfarin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: mechanical valve