bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Dynamine Ingestion on Various Indices of Sustained Energy
Condition: Energy
Study type: Interventional

Summary: 
      This study is a randomized, placebo-controlled, double-blind, within-subject crossover trial
      of 25 men and women. The objective of this study is to assess the effects of Dynamine
      (methylliberine) supplementation on overall well-being including energy, sustained energy,
      mental stamina, focus, concentration, motivation to accomplish difficult tasks, drive, vigor,
      positive outlook, maintaining a healthy mood, feelings of well-being, and resilience to
      stress.
    

Detailed description: 
      This study is a randomized, placebo-controlled, double-blind, within-subject crossover trial
      of 25 men and women. Dynamine (methylliberine) is a caffeine metabolite and purine alkaloid
      found in the kucha tea leaf. Dynamine has become a popular dietary supplement with consumers
      due to its neuro-energetic effects. Previous research has shown Dynamine can improve energy,
      mood and focus without the cardiovascular effects of elevating heart rate or blood pressure.

      In this study, participants will attend 5 study visits. During Visit 1, participants will be
      screened for participation (i.e., medical history, routine blood work, background baseline
      diet). During Visits 2 and 4, participants will complete baseline testing including
      subjective questionnaires that assess energy, sustained energy, mental stamina, focus,
      concentration, motivation to accomplish difficult tasks, drive, vigor, positive outlook,
      maintaining a healthy mood, feelings of well-being, resilience to stress in addition to
      completion of a series of an objective neuropsychological test (Stroop test) to assess mental
      processing, cognitive flexibility, and attention. After three-4- days of supplementation,
      participants will return for Visit 3 and 5 where they will take a 4th dose of Dynamine or
      placebo and repeat the testing outlined at previous baseline visits.
    

Intervention name(s): Dynamine (methylliberine)
Intervention type(s): Dietary Supplement
Intervention description(s): Dynamine (methylliberine) is a purine alkaloid found in the kucha leaf, and available to consumers as a dietary supplement.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
ReStOre@Home: Feasibility Study of a 12-week Multidisciplinary Telehealth Rehabilitation Programme for Survivors of Upper Gastrointestinal (UGI) Cancer
Condition: Oesophageal Cancer; Gastric Cancer
Study type: Interventional

Summary: 
      Feasibility study of a 12-week multidisciplinary telehealth rehabilitation programme for
      survivors of upper gastrointestinal (UGI) cancer
    

Detailed description: 
      A single arm feasibility study will be conducted to examine the feasibility of delivering the
      12-week ReStOre programme (aerobic and resistance physiotherapy led-exercise, 1:1 dietary
      counselling and group education sessions) via telehealth to a cohort of upper
      gastrointestinal cancer survivors.
    

Intervention name(s): Multidisciplinary rehabilitation programme delivered via telehealth
Intervention type(s): Other
Intervention description(s): 12 week programme of;
1) Physiotherapy led aerobic and resistance exercise 2)1:1 Dietetics Counselling 3) Group Multidisciplinary Education Sessions
Intervention model: Single Group Assignment
Intervention model description: Single arm feasibility study
Masking: None (Open Label)
Primary purpose: Treatment
Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients with diabetes are susceptible to dementia, but regular therapy fails to reduce the
      risk of dementia. In previous observational study, the investigators found that liraglutide
      can improve cognitive function in patients with T2DM through a metabolism-independent
      pathway. Here the investigators aim to further verify such effects through a randomized,
      controlled study.
    


Intervention name(s): Liraglutide; Oral antidiabetic drugs: Metformin, Sulfonylureas (2nd generation), Thiazolidinediones, α-Glucosidase inhibitors, and Glinides
Intervention type(s): Drug; Drug
Intervention description(s): Liraglutide is a glucagon-like peptide type 1 (GLP-1) analogue. We had fond its cognitive improvement effects in an observational study. In order to confirm the effects, the investigators conduct a randomized, controlled study.; oral antidiabetic drugs (OADs) or insulin, except for glucagon-like peptide type 1 (GLP-1) analogues
Intervention MeSH terms: Metformin; Liraglutide; Hypoglycemic Agents; 2,4-thiazolidinedione
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; Cognitive function; Liraglutide; Functional near-infrared spectroscopy; Metabolic changes
Safety, Pharmacokinetics (PK), and Efficacy of Buprenorphine Transdermal System (BTDS) in Children
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to characterize the safety, PK, and efficacy of BTDS in patients
      of ages 7 to 16 years.
    

Detailed description: 
      A study of safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years, inclusive, who
      require continuous opioid analgesia for moderate to severe pain.
    

Intervention name(s): Buprenorphine transdermal system
Intervention type(s): Drug
Intervention description(s): Buprenorphine transdermal system 2.5 mcg/h, 5 mcg/h, 10 mcg/h or 20 mcg/h applied transdermally for 7-day wear.
Other intervention name(s): Butrans
Intervention MeSH terms: Buprenorphine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; Opioid; Analgesia; Moderate to severe pain
Clinical Efficacy and Safety of Loxacon Dietary Supplement Capsules at Patients With Knee Arthrosis
Condition: Osteo Arthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will be a multicenter, randomized, double-blind, follow-up clinical trial.

      Neither the examining doctor nor the patient knows which capsule they will receive. Just the
      test unlock the codes after completion. T
    

Detailed description: 
      The study will be a multicenter, randomized, double-blind, follow-up clinical trial.

      Neither the examining doctor nor the patient knows which capsule they will receive. Just the
      test unlock the codes after completion. The randomization was performed externally, not
      included in the study performed by a person. Number of patients: a total of 105 patients /
      25-25 per clinic (with 8 patients each in three treatment groups) Three treatment groups

        -  35 people physical therapy + Loxacon

        -  35 main physical therapy + Placebo

        -  35 people only for physical therapy Physiotherapy(exercise) takes place according to a
           uniform protocol. Physiotherapy 2x30 minutes per week for 5 weeks (10 times in total).
           The course of the investigation

             1. st visit: selection, filling in questionnaires

             2. nd visit: after the 10th exercise session, while taking Loxacon/placebo, filling in
                questionnaires

             3. rd visit: Uniformly after another 2 months of taking Loxacon, in all three groups,
                completing questionnaires After the first 5 weeks, all three branches will receive
                enough Loxacon capsules for 2 months! The parameters to be tested

                  -  WOMAC test

                  -  VAS

                  -  EQ-5D-5L quality of life test

                  -  Goniometer angle measurement The test is completed by patients who
                     participated in more than 70% of the treatment! Monitoring of side effects It
                     is the duty of the doctor of the given center - who reports to the
                     investigator.
    

Intervention name(s): • harpagozid • boswellin = LOXACON
Intervention type(s): Drug
Intervention description(s): Exercise therapy
Other intervention name(s): Physiotherapy(exercise)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Boswellia serrata,; Harpagophytum procumbens,; knee OA
Effect of Spacer in Extrafine Formoterol-Beclomethasone Treatment to Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Combined inhaled treatment with long acting adrenergics and steroids in an unique inhaler
      plays an important role in the management of non-mild asthma. Some studies have demonstrated
      that the use of spacers achieve better lung deposition and decrease the number of side
      effects. Recently a new combined treatment for asthma has been developed (extrafine
      formoterol plus beclomethasone dipropionate). The small size of the extrafine particles of
      this new combination get the small airway and theorically improve their positive effect. Some
      authors have stated that the use of a spacer with extrafine particle could decrease the
      effectiveness of this treatment due to the adhesion of particles on the walls of the spacer
      because of the electrostatic characteristics of plastic spacers. However, there are no
      clinical or functional studies demonstrating the role of this phenomena in the control of
      asthmatic patients. The investigators' hypothesis is that the benefit of using spacers with
      this new treatment is at least equal in magnitude than the loss of efficacy because of the
      adhesion of particles on the wall of the spacer and then the investigators hypothesized that
      the use of spacer with extrafine formoterol-beclomethasone do not suppose a decrease in
      clinical or functional control in stable moderate-severe asthma patients.
    


Intervention name(s): Volumatic spacer
Intervention type(s): Device
Intervention description(s): A spacer is a plastic device to inhaler medication
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Asthma; Formoterol; Beclomethasone; Extrafine formulation; Spacer; Moderate; Severe; Stable
Thorough QT (TQT) Study to Evaluate the Effect of LC350189 on Cardiac Repolarization in Healthy Male and Female Subjects
Condition: Hyperuricemia; Gout; Qt Interval, Variation in
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a Phase 1, single-center, randomized, partially double-blind, placebo- and positive
      controlled, 4-way crossover study to evaluate the effect of a therapeutic and a
      supratherapeutic dose of LC350189 on the QTcF in healthy male and female subjects.
    


Intervention name(s): LC350189 200mg; Placebo; Moxifloxacin 400mg; LC350189 600mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subject will receive an LC350189 200mg as single-dose on Day 1(Period 1) or Day 5(Period 2) or Day 9(Period 3) or Day 13(Period 4); Subject will receive a Placebo as single-dose on Day 1(Period 1) or Day 5(Period 2) or Day 9(Period 3) or Day 13(Period 4); Subject will receive a Moxifloxacin 400mg as single-dose on Day 1(Period 1) or Day 5(Period 2) or Day 9(Period 3) or Day 13(Period 4); Subject will receive an LC350189 600mg as single-dose on Day 1(Period 1) or Day 5(Period 2) or Day 9(Period 3) or Day 13(Period 4)
Other intervention name(s): LC350189 (therapeutic dose); Placebo control; Positive control; LC350189 (supratherapeutic dose)
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 4-way cross over
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Combination of Intravitreal Ranibizumab With or Without Macular Laser Photocoagulation for ME Secondary to BRVO
Condition: Branch Retinal Vein Occlusion; Ranibizumab; Laser Photocoagulation
MeSH terms: Retinal Vein Occlusion
Study type: Interventional

Summary: 
      To investigate the efficacy of laser photocoagulation combined with ranibizumab intravitreal
      injection in macular edema (ME) secondary to branch retinal vein occlusion (BRVO) in long
      term.
    

Detailed description: 
      To investigate the efficacy of ranibizumab intravitreal injections-driven by achieving vision
      acuity stabilization compared to combination with laser photocoagulation in Chinese patients
      with visual impairment in ME due to BRVO.

      The result of the trial will be used to support new therapy in the BRVO in China.
    

Intervention name(s): Ranibizumab combined macular laser; Ranibizumab
Intervention type(s): Procedure; Drug
Intervention description(s): subjects in one group receive both macular laser photocoagulation and ranibizumab injections but ones in the other group just received ranibizumab injection.; all subjections received 3+PRN ranibizumab injections by BCVA stabilization
Other intervention name(s): Lucentis
Intervention MeSH terms: Ranibizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Laser Photocoagulation; Ranibizumab; Branch Retinal Vein Occlusion; Vascular Endothecial Growth Factor
A Pharmacokinetic Study to Evaluate TREXIMET in Adolescents With Migraine and Healthy Subjects Administered at Three Doses.
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pharmacokinetic (PK) study designed to investigate a combination product containing
      sumatriptan succinate and naproxen sodium administered at 3 single doses (10mg
      sumatriptan/60mg naproxen sodium, 30mg sumatriptan/180mg naproxen sodium, 85mg
      sumatriptan/500mg naproxen sodium) in adolescent migraine patients. The same doses will be
      also administered to a group of healthy volunteer (HV) adult subjects and the PK parameters
      will be compared between these two groups and between doses.
    

Detailed description: 
      This will be an open label, single dose, randomised, parallel group study. Approximately 27
      adolescent patients with migraine and 27 healthy volunteer (HV) adult subjects will be
      enrolled so that a total of 24 evaluable subjects complete in each group. The treatment
      procedures for these two groups are almost identical but some flexibility has been allowed
      for the timing of some of the PK samples in adolescents. All subjects will be required to
      attend a screening visit within 28 days prior to the first dose of study medication. Each
      subject will participate in one dosing session with one of the 3 doses of sumatriptan/
      naproxen sodium. Sequential PK samples will be collected through 48 hours after dosing and
      the PK parameters will be compared between these two groups and between doses.
    

Intervention name(s): This is a pharmacokinetic study (Treximet); This is a pharmacokinetic study (Treximet); This is a pharmacokinetic study (Treximet)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): This is a pharmacokinetic study to collect PK samples from subject after single dose.; This is a pharmacokinetic study to collect PK samples from subject after single dose.; This is a pharmacokinetic study to collect PK samples from subject after single dose.
Intervention MeSH terms: Naproxen; Sumatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: migraine; single dose; healthy volunteer; adolescence; pharmacokinetics
Rosiglitazone on Microalbuminuria in Type 2 Diabetics
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Following a 4-week single-blind placebo run-in period, eligible subjects were randomized in a
      1:1 ratio to receive 32 weeks of double-blind study medication: Rosiglitazone (starting dose
      4mg od) or Glyburide (starting dose 5mg od), both in combination with open-label Metformin >
      or = (1g/day). Subjects were stratified for use of ACEI, nondihydropyridine calcium channel
      blockers (NDP CCB), or angiotensin II receptor blockers (ARB) to provide equal representation
      of these subjects in each treatment group.
    


Intervention name(s): Rosiglitazone
Intervention type(s): Drug
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: microalbuminuria,; Type 2 Diabetes; rosiglitazone,
Tailored Antiplatelet Therapy During Percutaneous Coronary Intervention in Patients With Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      The researchers aimed to investigate the effect of point-of-care platelet function assay on
      the periprocedural cardiac enzyme elevation in patients with diabetes mellitus.

      All patients who are supposed to undergo coronary angiography were loaded with clopidogrel
      (300mg) and aspirin (300mg) at D-1. If patients were determined to implant coronary stent
      after diagnostic coronary angiography, their platelet function is assayed with Verifynow-ADP
      (Accumetrics). If patients have >270 unit in the assay, they are randomized to abciximab or
      control group. After successful stent implantation, cardiac enzymes (CK-MB, Troponin-I) are
      followed at 8hr, 16hr and 24hr. Clinical outcomes including bleeding complications are
      assessed at 1 month.
    


Intervention name(s): Abciximab; control
Intervention type(s): Drug; Drug
Intervention description(s): Patients, who showed PRU >270 unit and were randomized to abciximab group,were treated with abciximab in addition to conventional antiplatelet treatment (aspirin+clopidogrel).; Patients,who showed PRU >270 unit and were randomized to control group,were treated with conventional antiplatelet therapy (aspirin+clopidogrel) during PCI and follow up periods.
Aspirin : D-1 300mg, D0-30 100mg qd Clopidogrel : D-1 300mg, D0-30 75mg qd
Other intervention name(s): *Reopro, Lily Korea; Dose: 0.25mg/kg intravenous bolus injection and 0.125ug/kg/min continuous infusion for 12hrs; Aspirin; Clopidogrel (Plavix)
Intervention MeSH terms: Abciximab; Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: platelet reactivity; platelet function assay; abciximab; tailored therapy
Efficacy and Safety Study of Benralizumab to Reduce OCS Use in Patients With Uncontrolled Asthma on High Dose Inhaled Corticosteroid Plus LABA and Chronic OCS Therapy
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to confirm if benralizumab can reduce the use of maintenance OCS
      in systemic corticosteroid dependent patients with severe refractory asthma with elevated
      eosinophils.
    


Intervention name(s): Benralizumab; Placebo; Benralizumab
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Benralizumab administered subcutaneously every 4 weeks; Placebo subcutaneously on study week 0 until study week 24 inclusive.; Benralizumab administered subcutaneously every 4 weeks for the first 3 dose and then every 8 weeks; matching placebo subcutaneously at the 4 week interim to maintain the blind.
Intervention MeSH terms: Benralizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases, OCS, Oral Corticosteroids
Consumption of Dairy Yogurt Enhanced Immune Function
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To investigate the impact of consumption of dairy yogurt with rhamnogalacturonan (RG) in
      Korean citrus Hallabong peel polysaccharide on Natural Killer (NK) cell activity and
      circulating cytokine levels.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled study was conducted on 120 nondiabetic and
      nonobese subjects. Over an 8 week period, the test group consumed one pack (150ml) of dairy
      yogurt with 50mg probiotics and 100mg Korean citrus Hallabong peel polysaccharide (60% RG,
      20% mono- and di-saccharide, 5% polyphenol) each day, whereas the placebo group consumed the
      same product without Korean citrus Hallabong peel polysaccharide. NK cell activities (%) were
      measured based on the ratios of effector cells (E) (peripheral blood mononuclear cell, PBMC)
      from each participant to Target cell (T) (K562 cells) as 10:1, 5:1, 2.5:1 or 1.25:1.
    

Intervention name(s): RG; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The 100mg Korean citrus Hallabong peel polysaccharide contained 60mg rhamnogalacturonan (RG), 20mg mono- and di-saccharide, 5mg polyphenol, 5mg ash and 10mg moisture; Same product without RG
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: rhamnogalacturonan; Natural killer cell activity; interleukin-12; interferon-gamma; immune function; inflammatory
Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach
Condition: Femoral Neck Fractures; Hemiarthroplasty; Heterotopic Ossification
MeSH terms: Ossification, Heterotopic; Femoral Neck Fractures
Study type: Interventional

Summary: 
      Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral
      Approach. Comparing leg length discrepancy, femoral offset, valgus/varus position of the
      stem. Also is there a difference in heterotopic ossification at 12 months.
    

Detailed description: 
      Between January 2014 and July 2017 a RCT was conducted at Sorlandet Hospital Kristiansand,
      Norway. The trial was approved by the regional ethics committee (2013/1853/REK) and
      registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier NCT02028468). This study is a
      follow-up on the same study population.

      150 patients (70 to 90 years) with a displaced femoral neck fracture was randomized to be
      operated With either anterolateral og Direct lateral surgical approach. Investigators want to
      compare the radiological features of the femoral stem between the two Groups.
    

Intervention name(s): Hemiarthroplasty
Intervention type(s): Procedure
Intervention description(s): Radiological features comparing the femoral stem position is measured on the postoperative x-ray. Presence of heterotopic ossification is assessed on the 12 months follow up.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: femoral offset; leg length discrepancy; valgus/varus position; Lateral approach; Anterolateral approach