bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Intranasal Corticosteroids on Systemic Allergen Specific IgE
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional

Summary: 
      Evaluation of the effect of fluticasone propionate vs placebo applied as nasal spray on the
      increase of allergen-specific serum IgE levels following nasal exposure to recombinant
      allergens. Nasal sprays will be applied for four weeks starting two weeks before nasal
      provocation and serum IgE levels will be followed during eight weeks after nasal provocation.
    


Intervention name(s): Fluticasone propionate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 200 µg intranasal, 4 weeks, od.; Placebo intranasal spray
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Dietary Macronutrient Manipulation and Substrate Oxidation During Exercise
Condition: Dietary Manipulation
Study type: Interventional

Summary: 
      This study will investigate the effect of dietary macronutrient manipulation on glycogen
      (stored carbohydrate) levels in the muscle and substrate oxidation during exercise. The
      investigators will investigate the hypothesis that manipulating the macronutrient content of
      the diet will alter the levels of glycogen in the muscle and, in turn, substrate oxidation
      during exercise.
    

Detailed description: 
      One way to help reduce body fat is to expend more energy from the oxidation of fat as a fuel.
      Exercise is one way to increase fat oxidation. The extent to which exercise facilitates the
      use of fat as a fuel may be influenced by an individual's dietary intake.

      This study aims to establish the effect of dietary macronutrient manipulation on muscle
      glycogen levels and substrate oxidation during exercise. Participants will undertake three
      separate trial periods. During each trial period participants will consume a diet containing
      different macronutrient compositions. For each of the trials the investigators will assess
      how the macronutrient composition of the diet affects muscle glycogen level and substrate
      oxidation during exercise.
    

Intervention name(s): Diet with a different macronutrient content A; Diet with a different macronutrient content B; Diet with a different macronutrient content C; Interval treadmill running exercise; Steady state treadmill running exercise
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): A diet with altered macronutrient content will be provided to participants on days 4-6 of experimental arm 1.; A diet with a different macronutrient content compared to arm 1 will be provided to participants on days 4-6 of experimental arm 2.; A diet with a different macronutrient content compared to arms 1 and 2 will be provided to participants on days 4-6 of experimental arm 3.; Participants will perform interval treadmill running exercise on days 4 and 5 of all experimental arms.; Participants will perform steady state treadmill running exercise on day 7 of all experimental arms.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
A Long-term Extension Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs)
Condition: Refractory Partial Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to investigate the safety and tolerability of perampanel in
      long- term treatment in the patients with refractory partial epilepsy (uncontrolled with
      other anti-epileptic drugs) who completed Week 10 of Phase II Study E2007-J081-231 study.
    


Intervention name(s): perampanel
Intervention type(s): Drug
Intervention description(s): Patients will receive the same oral dosage (2 mg up to 12 mg once daily before bedtime) as used in the maintenance period of Study 231.
Other intervention name(s): E2007; Fycompa
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Seizure; epilepsy
Deep Brain Stimulation for Refractory Major Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      Despite many available treatments, there are patients with major depression who remain
      treatment refractory and chronically disabled. For these severely ill patients, several
      neurosurgical procedures are available where brain lesions are made that interrupt white
      matter tracts linking orbital frontal cortex to the striatum, resulting in significant
      therapeutic benefit for many patients. In this study, we will test the safety and efficacy of
      Deep Brain Stimulation (DBS)--a reversible method used to modulate brain activity--as an
      alternative to the standard subcaudate tractotomy (SCT). The physiological consequences of
      this procedure will be mapped longitudinally using positron emission tomography (PET)
      measures of brain glucose metabolism. Patients will be clinically monitored for 1 year with
      longitudinal psychiatric, neurological, neurosurgical, neuropsychological and PET imaging
      examinations to assess treatment efficacy and side effects.
    

Detailed description: 
      Study Design Subjects: Ten patients will be enrolled in this pilot study. Eligibility
      criteria: (i) age 30-70 years old, (ii) diagnosis of refractory unipolar major depression,
      (iii) recurrent illness with a minimum four major depressive episodes, (iv) current episode
      duration of no less than twelve months; (v) current episode treatment failure to a minimum of
      four treatment classes-including serotonin-reuptake inhibitors (SSRI), other novel agents,
      monoamine oxidase inhibitors (MAOI), tricyclics; somatic treatments such as ECT or vagus
      nerve stimulation (VNS); some form of psychotherapy. Exclusion criteria (i) previous brain
      surgery (ii) neurological disorder of any type, (iii) significant psychiatric comorbidity as
      defined by DSM IV diagnostic criteria (such as schizophrenia, panic disorder) (iv) serious
      medical conditions or contraindication for surgery such as cardiac pacemaker/defibrillator or
      other implanted devices. Full medical records from a treating psychiatrist will first be
      reviewed by Dr. Kennedy. Eligible patients will then undergo a full psychiatric, neurological
      and neuropsychological evaluation (Appendix 1 and 2). Final selection will be made by
      consensus of the investigative team in collaboration with a senior independent psychiatrist
      Robert Cooke, MD with expertise in intractable mood disorders. Informed consent will be
      obtained prior to entering the study.
    

Intervention name(s): Deep Brain Stimulation
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Deep Brain Stimulation; Treatment failure
Medium-term Venous Access in Congenital Heart Surgery
Condition: Congenital Heart Surgery
Study type: Interventional

Summary: 
      This study is designed to evaluate medium-term central venous catheter placement in infants
      undergoing complex cardiac surgery using a new technique. This technique involves placement
      of the catheter into the inferior vena cava through a subcutaneous tunnel and through a
      tunnel between pericardium and diaphragm.
    


Intervention name(s): Placement of transthoracic catheter
Intervention type(s): Procedure
Intervention description(s): Placement of transthoracic catheter into the inferior vena cava
Other intervention name(s): Bard; transthoracic catheter
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetics of XW10508 Immediate and Modified Release Formulations in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of
      XW10508 in healthy volunteers.
    

Detailed description: 
      This is a first-in-human single and multiple ascending oral dose pharmacokinetic and safety
      study where participants will receive either XW10508 or placebo. Both immediate release and
      modified release formulations will be assessed. Timed blood samples will be collected to
      assess the pharmacokinetics after the study drug is ingested by the participants.
    

Intervention name(s): XW10508; Placebo
Intervention type(s): Drug; Other
Intervention description(s): XW10508 capsules or tablets; Placebo capsules or tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In this double-blind study, participants will be randomized to XW10508 or placebo.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Biomarkers for Intestinal Permeability
Condition: Focus: Simplified Method to Assess Intestinal Permeability
Study type: Observational

Summary: 
      This study aims to find easy-to-measure biomarkers of intestinal permeability as surrogate
      markers for effortful "gold standard" methods.
    

Detailed description: 
      This study aims to find easy-to-measure biomarkers of intestinal permeability as surrogate
      markers for effortful "gold standard" methods. In healthy volunteers potential biomarkers for
      intestinal permeability as well as an established "gold standard" method for intestinal
      permeability (urinary lactulose/mannitol excretion) will be measured at one time point. Using
      correlation analyses, potential associations will be assessed and potential biomarkers will
      be addressed and discussed.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers
      
Biospecimen description: 
      Plasma, serum and fecal samples will be stored at -80°C.
    
Keywords: Gastroenterology; Gut barrier; Intestinal permeability
Probiotics in Adults: do They Improve Atopic Dermatitis?
Condition: Adult Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      Probiotics are suggested to have beneficial effects in atopic dermatitis (AD) treatment and
      prevention but their precise role is not yet clear.

      The aim of this randomized double blinded active treatment vs placebo study was to evaluate
      clinical efficacy of intake of a combination of two probiotics (Lactobacillus salivarius LS01
      and Bifidobacterium breve BR03) for the treatment of adult AD patients.

      The rationale for the use of probiotics in the treatment of atopic dermatitis would be due to
      some experimental hypotheses:

        1. The use of these microbial agents at an early age seems to play an important role in
           inducing immunity T type 1 (Th1) and inhibit the development of a Th2 response IgE
           mediated

        2. the normal intestinal flora (including probiotics) would play an important role in
           inducing immunological tolerance

        3. the hygiene hypothesis that the reduced bacterial environment would favour a type 2
           response T and the development of allergic diseases
    


Intervention name(s): probiotics; maltodextrin
Intervention type(s): Dietary Supplement; Other
Intervention description(s): a mixture of Lactobacillus LS01 DSM 2275 and Bifidobacterium BR03 DSM 16604 at a dose of 1 x 109 colony forming units (CFU)/g each in maltodextrin; sachets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Taste Assessment Study of SHP429 in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the palatability of SHP429 capsule contents delivered
      via 3 means of administration (sprinkled on yogurt, sprinkled on applesauce, and emptied into
      a cup and administered with water).
    


Intervention name(s): Mesalamine
Intervention type(s): Drug
Other intervention name(s): Pentasa, SHP429
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Comparative Pharmacokinetics and Safety of TNX-102 SL Tablets and Cyclobenzaprine Oral Tablet in Healthy Adults
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for
      fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for
      bedtime use. The present trial is designed to assess the safety and tolerability of TNX-102
      2.4 mg SL Tablets (a new formulation of cyclobenzaprine designed to result in increased
      dosage precision and decreased potential for morning grogginess) at 2.4 mg and 4.8 mg and to
      compare the bio-availability of TNX-102 2.4 mg SL Tablets at 2.4 mg and 4.8 mg to that of
      TNX-102-A 2.4 mg SL Tablets (without phosphate) at 2.4 mg and cyclobenzaprine (5 mg tablets).
    


Intervention name(s): SL TNX-102 at 2.4 mg; SL TNX-102 at 4.8 mg; SL TNX-102-A at 2.4 mg; Cyclobenzaprine tablets
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 TNX-102 SL Tablet at 2.4 mg held under the tongue until dissolution, without swallowing or chewing it.; 2 TNX-102 SL Tablet at 2.4 mg held under the tongue until dissolution, without swallowing or chewing them.; 1 TNX-102-A SL Tablet at 2.4 mg held under the tongue until dissolution, without swallowing or chewing it.; 1 x 5 mg cyclobenzaprine tablet, swallowed with 240 mL of room-temperature water
Intervention MeSH terms: Cyclobenzaprine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Epidural Oxycodone and Epidural Morphine
Condition: Pruritus
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objectives of this study are to compare the efficacy of pain relief between
      epidural oxycodone and epidural morphine for postoperative analgesia after elective caesarean
      section and to compare the incidence and severity of pruritus. Secondary objectives are to
      compare other side effects of epidural administered oxycodone and morphine (nausea and
      vomiting, sedation, respiratory depression) and to investigate the safety and efficacy of
      epidural oxycodone and epidural morphine after use for postoperative analgesia in caesarean
      sections.
    

Detailed description: 
      Undesirable side effects such as pruritus and nausea are common with epidural morphine and
      are thought to be due to mu-opioid receptor stimulation at the supra-spinal level. Recent
      studies of epidural oxycodone for abdominal and gynaecological surgery have shown that it is
      as effective as morphine with fewer side effects by this route. This has not been established
      in patients undergoing caesarean section. Oxycodone is a semi-synthetic opioid derivative
      that resembles morphine structurally and has similar lipid solubility. It has been reported
      that the analgesic action of oxycodone is more rapid in onset when compared with morphine and
      is mediated by kappa-opioid receptors in the spinal cord. The significance of our study would
      be to establish that epidural oxycodone reduces the side effects of pruritus of epidural
      morphine whilst still maintaining similar analgesia.
    

Intervention name(s): Opioid administration oxycodone; Opioid administration morphine
Intervention type(s): Drug; Drug
Intervention description(s): Epidural administration single dose through epidural catheter
Other intervention name(s): Epidural Opioid
Intervention MeSH terms: Morphine; Oxycodone; Analgesics, Opioid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pruritus
Radiotherapy Combined With S-1/DDP for Elderly Esophageal Squamous Cell Cancer.
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This Prospective, single-arm Phase Ⅱ study is to determine the efficacy and safety of
      Once-daily Simultaneous Modulated Accelerated Radiotherapy combined with S-1/DDP for geratic
      esophageal squamous cell carcinoma patients.
    


Intervention name(s): SMART; DDP; S-1
Intervention type(s): Radiation; Drug; Drug
Intervention description(s): Once-daily simultaneous modulated accelerated radiotherapy(64Gy/30f ); DDP(25 mg/m2.qw) for six weeks.; S-1(40 mg/m2.Bid .po) on D1-14，D22-35 during radiotherapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Once-daily Simultaneous Modulated Accelerated Radiotherapy; S-1; DDP; elderly patients
A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate oncological outcome of patients for T3 and T4
      colorectal cancer undergoing laparoscopic versus open surgery.
    

Detailed description: 
      The benefits of laparoscopic surgery (LAP) in comparison to open surgery (OPEN) have been
      suggested with respect to decreased morbidity, decreased pain, faster recovery, and shorter
      hospital stay.1-4 However, the long-term survival of LAP for colorectal cancer is still
      unclear, especially for advanced colorectal cancer requiring extended lymphadenectomy. Thus,
      the investigators designed a study which investigates whether LAP is suitable for advanced
      colorectal cancer with respect to survival and post-operative morbidity.
    

Intervention name(s): open colectomy; laparoscopic colectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Procedure/Surgery: open colectomy; Procedure/Surgery: laparoscopic colectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: colorectal cancer; laparoscopic surgery; randomized controlled trial; oncological outcome
The Effects of Physical Training on Physiological and Psychological Stress-reactions and Cognitive Function.
Condition: Healthy Volunteers; Sedentary Lifestyle
MeSH terms: Fractures, Stress; Stress, Psychological
Study type: Interventional

Summary: 
      One of the biggest challenges of today is the high stress levels among employees in companies
      and organizations. Physical exercise may be an effective preventive measure for
      stress-related problems. This relatively simple and inexpensive action is believed to be
      important for increasing and maintaining work ability and reduce the cost of stress-related
      ill health in the workplace.

      The aim is to investigate how regular physical exercise affects the individual's ability to
      mentally and physiologically cope with stress. Acute stress physiological responses are
      measured before and after a 6 -month intervention, where 100 untrained individuals are
      randomized to either regular physical exercise or a control group.

      The hypothesis is that exercise leads to lesser activation of the individual's stress
      physiological systems and to an efficient physiological protection system. Mental ability to
      handle stress is also studied as well as possible effects on the brain's cognitive functions.
      From a work perspective, cognitive impairment due to high exposure to stress is a major
      problem leading to substantial costs in businesses and organizations as a result of reduced
      performance and production.

      We believe that physical activity can alter and mitigate individual stress reactions. This
      study brings new knowledge that can contribute to increased motivation to prioritize physical
      activity in everyday life. The study could also provide evidence for businesses and
      organizations of the benefits of engaging in interventions and fitness initiatives to
      facilitate/enable increased physical activity in daily life for its employees. With an aging
      population, we are expected to work longer, which poses a challenge as the ability to manage
      stress and maintain cognitive abilities decline with age. For older employees, regular
      physical activity could be an important factor directly affecting the prospects for a
      sustainable working life.
    


Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Physical training Duration: 45-60 minutes Frequency: 3 times per week Intensity: mean heart rate > 75% of maximum heart rate determined by exercise test before start of the intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Exercise; Physical Fitness; Stress, Psychological; Cognition; Psychophysiology; Ergometry; Exercise Test; Sedentary Lifestyle