bioihbjkbjnl/mcl2 huggingface dataset:
Immunological Mechanisms of Oralair® in Patients With Seasonal Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 4

Summary: 
      Allergic diseases represent a major health issue worldwide and epidemiological studies in
      Melbourne, Australia, have reported a high prevalence of rhinitis (hayfever) and atopy
      (genetic tendency to make allergy antibody) in Asian and Caucasian subjects. Mainstay
      treatment of allergic rhinitis is allergen avoidance and pharmacotherapy for symptom relief.
      Allergen immunotherapy offers the advantages of specific treatment with long lasting
      efficacy, and can modify the course of disease. However, use of this treatment is restricted
      by the high risk of adverse events especially in asthmatics. Other, better tolerated, routes
      of allergen administration than the current conventional subcutaneous route (SCIT) have been
      investigated including the sublingual route (SLIT) and recently sublingual tablets for pollen
      allergy immunotherapy became available. The tablets are safe and easy to use and contain
      pollen extracts from 5 of the most common allergy-causing European grasses but include
      ryegrass (Lolium perenne), the major seasonal pollen for allergy in Melbourne and
      south-eastern Australia. The immunological mechanisms of sublingual immunotherapy are not
      fully understood. The investigators propose conducting a longitudinal open label study to
      investigate the immunological changes that occur with the 5 grass pollen sublingual
      immunotherapy tablet (Oralair®) in a cohort of Chinese and non-Chinese background subjects.
      The investigators will investigate the induction of relevant T cell regulatory immune
      mechanisms and changes in serum allergen-specific immunoglobulin (Ig) E and IgG4.
      Immunoregulatory cytokine synthesis and T cell phenotype (Bio-plex and flow cytometry) will
      be examined. This project will provide important fundamental knowledge on which to inform
      decisions for the greater application of this treatment for subjects with moderate and severe
      allergic rhinitis.
    


Intervention name(s): Grass pollen sublingual immunotherapy tablet; Control
Intervention type(s): Other; Drug
Other intervention name(s): Oral anthistamines AND/OR Nasal steroids AND/OR Nasal antihistamines
Intervention MeSH terms: Immunomodulating Agents; Histamine Antagonists
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allergic rhinitis; Asthma; Regulatory T cells; IgE; IgG4
AMG 404 in Patients With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of AMG 404, a monoclonal antibody that binds to PD-1
      and inhibits its engagement with ligands, in patients with advanced solid tumors.
    


Intervention name(s): AMG 404
Intervention type(s): Drug
Intervention description(s): AMG 404 will be examined for safety, tolerability, PK, and PD of AMG 404 in subjects with advanced solid tumors.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
OFC rTMS in Emotionally Unstable and Depressed Patients
Condition: Personality Disorder, Borderline; Personality Disorder; Unstable; Depression
MeSH terms: Depression; Personality Disorders; Borderline Personality Disorder
Study type: Interventional

Summary: 
      Treatment of depression with conventional transcranial magnetic stimulation (rTMS) has shown
      high evidence using high-frequency left dorsolateral prefrontal cortex (DLPFC) stimulation.
      Recently, it could be demonstrated that treatment of the right orbitofrontal cortex may be
      effective in patients who did not respond to conventional DLPFC rTMS. Orbitofrontal cortex
      (OFC) seem to be involved in the etiopathology of emotionally instable personality disorders.
      Thus, the present one-arm trial is a pilot study investigating if OFC rTMS is feasable,
      tolerable and effective.
    


Intervention name(s): OFC rTMS
Intervention type(s): Device
Intervention description(s): repetitive transcranial magnetic stimulation over right orbito-frontal cortex with 1Hz (360 pulses in 6 trains á 60 pulses with 30s intertrain-interval)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rTMS
Tulsi Consumption and Its Effects on Cognition, Stress and Anxiety
Condition: Cognitive Change
Study type: Interventional

Summary: 
      Tulsi and its effects on facilitative cognitive enhancement through lowering levels of stress
      and anxiety. A randomised placebo-controlled clinical trial.
    

Detailed description: 
      Ocimum Sanctum or Holy Basil, commonly called Tulsi is a traditional Indian herb. It is
      believed to bring about a facilitative enhancement of cognitive ability and lower stress
      levels in individuals. Stress and an inability to perform at a required level of cognition
      can induce anxiety. This study is looking at the effects of daily consuming Tulsi among a
      group of individuals who work in an environment that demands memory, attention and executive
      functioning.
    

Intervention name(s): Ocimum Sanctum; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active capsules containing leaves of organically prepared ocimum sanctum; Placebo capsules of look alike inert substance for control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Free Venlafaxine Treatment for Marijuana Addiction and Depression - 1
Condition: Depression; Marijuana Abuse
MeSH terms: Marijuana Abuse; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if Venlafaxine Extended Release (Ven-XR) is
      effective in treating individuals with marijuana addiction and depression.
    

Detailed description: 
      Given that depression and marijuana addiction often occur together, medications to treat
      individuals diagnosed with both conditions may be effective. The purpose of this study is to
      determine the effectiveness of Ven-XR in treating individuals diagnosed with depression and
      marijuana addiction.

      During this twelve-week, double-blind, placebo-controlled study, study visits will occur
      twice each week. During study visits, participants will receive either placebo or medication
      and provide a urine sample for drug screening. Blood tests will be collected each month and
      women must take pregnancy tests each month. Throughout the study, all participants will
      receive individualized psychotherapy sessions. At each study visit, participants will be
      given $5 to cover transportation costs.
    

Intervention name(s): Venlafaxine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 375mg/day; Placebo
Other intervention name(s): Effexor
Intervention MeSH terms: Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cannabis dependence; depression; treatment; venlafaxine
The Effect of Colchicine on the Pharmacokinetic Profile of LC350189 in Healthy Aldults.
Condition: Gout; Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, fixed-sequence, 3-period, 2-way drug interaction study
      designed to assess the PK, PD, safety, and tolerability of LC350189 and colchicine when
      administered alone and in combination in healthy subjects.
    


Intervention name(s): Xanthine Oxidase Inhibitor
Intervention type(s): Drug
Intervention description(s): LC350189 200mg qd
Other intervention name(s): LC350189
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and safety of GW815SF HFA MDI 25/50µg 1 inhalation bid in comparison
      with concomitant treatment with salmeterol xinafoate DPI 25µg 1 inhalation bid plus
      fluticasone propionate DPI 50µg 1 inhalation bid in paediatric patients with asthma.

      To evaluate the safety of long-term treatment of GW815SF HFA MDI 25/50µg 1 inhalation bid in
      paediatric patients with asthma.
    


Intervention name(s): GW815SF HFA MDI; salmeterol and fluticasone propionate
Intervention type(s): Drug; Drug
Intervention description(s): salmeterol and fluticasone propionate combination; salmeterol + fluticasone propionate
Other intervention name(s): salmeterol/fluticasone propionate combination
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Salmeterol; Fluticasone propionate; Salmeterol/Fluticasone propionate combination; Pediatric bronchial asthma
Minoxidil 2% for Eyebrow Enhancement
Condition: Hypotrichosis of Eyebrows; Thinning Eyebrows
MeSH terms: Hypotrichosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to compare minoxidil 2% versus placebo in enhancement of
      eyebrows.
    


Intervention name(s): Minoxidil lotion 2%; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Minoxidil lotion 2% is applied twice daily to one eyebrow.; Placebo is applied twice daily to the other eyebrow.
Intervention MeSH terms: Minoxidil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hypotrichosis of eyebrows; thinning eyebrows; minoxidil; placebo; randomized
Preoperative Oral Pregabalin Effect on Inhalational Anesthetic Requirements ln Hysterectomy Under General Anesthesia
Condition: Hysterectomy
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study the investigators hypothesized that preoperative pregabalin tablet (150 mg
      orally ) may be effective in reducing intraoperative isoflurane requirements needed to
      maintain intraoperative hemodynamics within ± 20% of baseline measurement and/or attenuates
      hemodynamic response to endotracheal intubation in female patients ASA I or II , aged 18-60
      years, schedule for elective abdominal hysterectomy surgery under general anesthesia.
    

Detailed description: 
      In this study the investigators hypothesized that preoperative pregabalin tablet (150 mg
      orally ) would be effective in reducing intraoperative isoflurane requirement needed to
      maintain intraoperative hemodynamics within ± 20% of baseline measurement and/or attenuates
      hemodynamic response to endotracheal intubation in female patients ASA I or II schedule for
      elective abdominal hysterectomy surgery under general anaesthesia.

      The investigators aim to compare the efficacy of preoperative oral pregabalin versus placebo
      in reducing intraoperative isoflurane requirements needed to maintain intraoperative
      hemodynamic stability (Blood pressure and heart rate within ± 20% of baseline measurements)
      in female patients ASA I/II undergoing elective abdominal hysterectomy surgery under general
      anaesthesia.
    

Intervention name(s): Pregabalin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pregabalin capsule 150 mg oral; Placebo
Other intervention name(s): laryca
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: General Anesthesia
hsCRP in Japan Statin Treatment Against Recurrent Stroke (J-STARS hsCRP)
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      Inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can play a role in
      preventing recurrent vascular events from ischemic heart disease patients, whose mechanism
      consists in not only the reduction of serum lipid level but also anti-inflammatory effects.
      Serum high sensitive CRP is known to be a predictor of cardiovascular events independent of
      other conventional risk factors. The present substudy examine whether such pleiotrophic
      effect of HMG-CoA reductase inhibitor (statin) which decreases high sensitive CRP would be
      observed in the post-ischemic stroke patients who have already been registered in the
      J-STARS, and the relationship the values of high sensitive CRP and recurrence of stroke.
    


Intervention name(s): Statin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: stroke; brain ischemia; cerebrovascular accident; statin; hydroxymethylglutaryl-CoA reductase inhibitors; cholesterol; hypercholesterolemia; hyperlipidemia; multicenter studies; prospective studies; endpoint determination; randomized controlled trials; recurrence; pravastatin; c-reactive Protein
Paricalcitol in Fabry Disease
Condition: Fabry Disease; Proteinuria
MeSH terms: Fabry Disease; Proteinuria
Study type: Interventional

Summary: 
      Proteinuria is the predominant risk factor for renal disease progression in Fabry disease
      (FD). When urine protein excretion is controlled to <0.50 g/24 hr, the rate loss of
      glomerular filtration rate (GFR) is not significantly different from 0. However, enzyme
      replacement therapy (ERT) alone does not decrease proteinuria and it has been recommended
      that patients receiving ERT also receive anti Renin-Angiotensin-System (RAS) therapy.
      Emerging evidences show that paricalcitol (PCT) reduces proteinuria in presence of
      intensified inhibition of RAS; however, there is no evidence in FD. The aim of this study is
      to evaluate the antiproteinuric effect of PCT in FD patients with proteinuria >0.50 g/24 hr
      persisting despite the ERT and anti-RAS therapy titrated to maximum tolerated dosage.
    


Intervention name(s): Paricalcitol
Intervention type(s): Drug
Intervention description(s): Paricalcitol was administered at the dose of 1 mcg/die
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Validation of Lower Body Negative Pressure (LBNP) Model of Human Hemorrhage in Trauma Patients
Condition: Physical Trauma
MeSH terms: Hemorrhage; Wounds and Injuries
Study type: Observational

Summary: 
      Lower body negative pressure (LBNP) is a laboratory model used to study hemorrhage in humans.
      The investigators hypothesize that the physiologic changes that occur with application of
      LBNP mimic those observed in bleeding and hemodynamically unstable trauma patients, and that
      LBNP is a truly valid model of human hemorrhage.
    

Detailed description: 
      Specific aims:

        1. Compare physiologic waveform data obtained from bleeding and hemodynamically unstable
           trauma patients to existing data collected from LBNP subjects.

        2. Determine the accuracy of LBNP in approximating the physiologic changes that occur in
           bleeding and hemodynamically unstable trauma patients.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Trauma patients
      
Keywords: Physical trauma
A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase III, double-blind, placebo and active-comparator controlled, multicenter study
      will investigate the efficacy and safety of etrolizumab in induction of remission in
      participants with moderately to severely active ulcerative colitis (UC) who are naÏve to
      tumor necrosis factor (TNF) inhibitors and refractory to or intolerant of prior
      immunosuppressant and/or corticosteroid treatment. In addition to this study, a second Phase
      III trial with identical study design (GA28949; NCT02171429) was independently conducted.
    


Intervention name(s): Adalimumab; Adalimumab Placebo; Etrolizumab; Etrolizumab Placebo
Intervention type(s): Drug; Other; Drug; Other
Intervention description(s): Adalimumab 160 milligrams (mg) will be administered subcutaneously (SC) at Week 0; 80 mg SC at Week 2; 40 mg SC at Weeks 4, 6, and 8.; Placebo matching to adalimumab will be administered SC at Weeks 0, 2, 4, 6, and 8.; Etrolizumab 105 mg will be administered SC every 4 weeks (Q4W) up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]).; Placebo matching to etrolizumab will be administered SC once every 4 weeks (Q4W) up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]).
Other intervention name(s): Humira; PRO145223; RO5490261; RG7413
Intervention MeSH terms: Adalimumab; Etrolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bupropion for the Treatment of Apathy in Alzheimer's Dementia
Condition: Apathy in Dementia
MeSH terms: Dementia; Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Apathy in dementia prevents successful application of non-pharmacological treatments,
      accelerates cognitive and functional decline and increases disease-related costs by earlier
      need for full-time care. Apathy is a distinct entity and occurs independently of other
      neuropsychiatric syndromes, like depression.

      Today, there is no high-level evidence for any effective treatment of apathy in AD. In
      contrast to other neuropsychiatric syndromes in AD, like psychosis and depression, and
      despite its high prevalence and clinical relevance, apathy has never been the primary outcome
      in a clinical trial. Basic and clinical research has provided a distinct model of the
      pathophysiology of apathy with dopamine and norepinephrine as the key neurotransmitter
      systems involved. The antidepressant Bupropion is a dopamine and norepinephrine reuptake
      inhibitor. There is evidence from case-series, that Bupropion reduces apathy in patients with
      organic brain disorders. This study will test the efficacy and safety of Bupropion in the
      treatment of apathy in AD in a 12-week multicenter doubleblind placebo controlled trial.
      Secondary endpoints will be quality of life of patients, caregivers' distress, ability of
      patients to perform activities of daily living,utilization of healthcare resources by
      patients and by caregivers, and cognitive functions.
    


Intervention name(s): Elontril; placebo
Intervention type(s): Drug; Drug
Intervention description(s): flexible dose of Bupropion 150-300 mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Emergence Times and Airway Reactions in General Laryngeal Mask Airway Anesthesia
Condition: Anesthesia With Use of LMA (Laryngeal Mask Airway)
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is first to assess if desflurane is superior in order to achieve a
      faster emergence from anesthesia.
    

Detailed description: 
      The aim of this study is first to assess if desflurane is superior in order to achieve a
      faster emergence from anesthesia (stating the date of birth) and second if desflurane is
      non-inferior in the occurrence of airway complications compared to sevoflurane or total
      intravenous anesthesia with propofol in the setting of laryngeal mask airway.
    

Intervention name(s): Desflurane; Sevoflurane; propofol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): inhalation with laryngeal mask to maintain anaesthesia; inhalation with laryngeal mask to maintain anaesthesia; intravenous injection to maintain anaesthesia
Other intervention name(s): Suprane; Sevorane; Anesia
Intervention MeSH terms: Propofol; Sevoflurane; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: laryngeal mask airway; desflurane; sevoflurane; propofol