bioihbjkbjnl/mcl2 huggingface dataset:
Molecular and Cellular Mechanism in Rhinitis Allergic Patients Treated With GRAZAX®
Condition: Allergic Rhinoconjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      The specific clinical trial is a part in which ALK- Abelló will directly work to explore
      human immunological mechanisms of SIT (observed after GRAZAX treatment).
    

Detailed description: 
      The main idea of the project was to address the study of some of the most important
      inflammatory diseases (psoriasis, rheumatoid arthritis, lupus, rhinitis/asthma… ) with the
      aim of identifying novel inflammatory markers.
    

Intervention name(s): GRAZAX
Intervention type(s): Drug
Intervention description(s): GRAZAX
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Proof of Concept Study to Evaluate the Dose Response for the Systemic Benefit Risk Ratio of Inhaled Fluticasone Propionate in Chronic Obstructive Pulmonary Disease
Condition: COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      Chronic Obstructive Pulmonary Disease (COPD) is a major worldwide problem.Steroids inhalers
      are now an established treatment for COPD. Inhaled steroids can have a number of bad effects
      including suppression of the adrenal glands because of absorption. A previous study in
      patients with COPD.

      C-reactive Protein (CRP) is a peptide produced in the liver in response to inflammation.
      Elevated circulating levels of CRP are associated with heart conditions. High levels of CRP
      have also been found in patients with COPD. In some studies, steroid inhalers have reduced
      CRP levels, and that of other inflammatory mediators, in patients with COPD. It is unknown
      whether this reflects a reduction in lung inflammation or an effect of systemically absorbed
      corticosteroid.

      It is proposed to investigate the link between inhaled corticosteroid and serum CRP, lung
      inflammation (measured by exhaled nitric oxide) and systemic absorption of steroids.
    


Intervention name(s): Fluticasone propionate; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of a Motor-cognitive Rehabilitation on Attention in Parkinsonian Patients
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      In this study the Investigators explore two questions: if the attentive reaction times
      differs in parkinsonian patients from health controls and if an intensive, focused and
      aerobic rehabilitation program (Multidisciplinary Intensive Rehabilitation Treatment - MIRT)
      tailored mainly for motor problems, could have a specific positive effect on multiple choices
      Reaction Times (RTs) as an indirect marker for an effect on attentional-executive frontal
      circuits. The hypothesis is that the MIRT could have a positive effect on the top-down
      control mechanisms, since the continuous feedback given by physiotherapist during exercises
      and the use of cues and devices (such as treadmill plus and stabilometric platform),
      stimulate the selective attention processes that enable goal-directed, internally-driven
      decision, helping the patients to overcome externally-driven decision based on stimulus
      salience and novelty
    

Detailed description: 
      Objective: To evaluate the attentive performances in Parkinsonians in comparison with healthy
      controls and the effect of motor-cognitive rehabilitation program on attention.

      Methods: 103 Parkinsonians (stage 2,5-3 H&Y) hospitalized for a 4-week Multidisciplinary
      Intensive Rehabilitation Treatment and 34 healthy controls were enrolled. All subjects
      underwent three different attentive tasks: visual reaction times, auditory reaction times and
      multiple choices reaction times tasks. To evaluate the effect of rehabilitation on attention,
      patients performed the same battery at discharge. To investigate the effects of MIRT on motor
      functions and quality of life we also assessed UPDRS III, Timed Up and Go test and
      Parkinson's Disease Questionnaire.
    

Intervention name(s): MIRT
Intervention type(s): Procedure
Intervention description(s): MIRT consists of a 4-week physical therapy that entails four daily sessions, five days a week, in a hospital setting. The duration of each session, including recovery periods, is about one hour. The first session comprise cardiovascular warm-up activities, relaxation, muscle-stretching, exercises to improve the range of motion of spinal, pelvic and scapular joints, exercises to improve the functionality of the abdominal muscles, and postural changes in the supine position. The second session includes aerobic exercises to improve balance and gait using a stabilometric platform, treadmill plus, crossover and cycloergometer. The third is a session of occupational therapy to improve autonomy in day living activities. The last session includes one hour of speech therapy.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's disease; rehabilitation; attention; executive functions
Pharmacokinetic Study of Lansoprazole Capsules in Healthy Chinese Volunteer
Condition: Effect of Drugs; Safety Issues
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to compare pharmacokinetic of Lansoprazole Capsules 30 mg
      with Lansoprazole Capsules of Takeda 30 mg in healthy adult human subjects.
    

Detailed description: 
      i. randomized, open label, single-dose, two-treatment, three-period,partial replicate
      pharmacokinetic study of Lansoprazole 30 mg Capsules of Beijing Sihuan Pharm, comparing with
      that of Lansoprazole enteric-coated Capsules 30 mg of Takeda Pharmaceutical Company Limited
      in healthy, adult, human subjects under fasting conditions.

      ii. randomized, open label, single dose, two-period, pharmacokinetic study of Lansoprazole 30
      mg Capsules of Beijing Sihuan Pharm in healthy, adult, human subjects under fasting/fed
      conditions.
    

Intervention name(s): Lansoprazole capsules
Intervention type(s): Drug
Intervention description(s): Test 1: 30 healthy volunteers will be included and randomized into 3 groups (10 for each). During the study session, subjects will receive a single dose of Lansoprazole capsules 30 mg in sequence of T-R-R in group A; R-T-R in group B; and R-R-T in group C.
Test 2: 12 healthy volunteers will be recruited and randomized to 2 groups (6 for each). Subjects in group A will receive a single dose of experimental drug in sequence of fast-fed condition; while in group B, subjects will receive the same dose and drug but in fed-fast order.
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Drug-Drug Interaction Study of Warfarin and PA21
Condition: Drug Interaction Potentiation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if Warfarin is affected by PA21.
    


Intervention name(s): PA21; Warfarin
Intervention type(s): Drug; Drug
Intervention description(s): The maximum dose of PA21 will be 15.0 g/day.; The maximum dosage of Warfarin will be 10 mg/day
Intervention MeSH terms: Warfarin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug-drug interaction; Pharmacokinetics; PA21
Immunogenicity, Safety & Reactogenicity of GSK Vaccine Tritanrix™-HepB/Hib2.5 Compared to GSK Vaccine Tritanrix™-HepB/Hiberix™
Condition: Haemophilus Influenzae Type b
Study type: Interventional
Phase: Phase 2

Summary: 
      In order to reduce the amount of thiomersal in its vaccines, GSK Biologicals has developed a
      DTPw-HBV vaccine with low thiomersal content (Tritanrix™- HepB low thio). This vaccine is to
      be used in combination with a Hib low dose vaccine containing 2.5µg of PRP antigen (Hib 2.5).
      The purpose of this study is to generate clinical data with Tritanrix™-HepB low thio vaccine
      when extemporaneously mixed with Hib 2.5 vaccine. The control group will receive
      Tritanrix™-HepB/Hiberix™.

      Subjects received primary vaccination in study 208108/091 (double blind). Of these subjects
      50% were randomised to participate in the PRP challenge study (208108/092) (open), and all
      subjects will be invited to participate in a booster study DTPWHBV=HIB2.5-093 (101477).
    


Intervention name(s): Tritanrix™-HepB low thio /; Hib 2.5; Tritanrix™-HepB; Hiberix™; Unconjugated Hib vaccine (plain PRP)
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): One dose as intramuscular injection at 6, 10 and 14 weeks of age.; One dose as intramuscular injection at 6, 10 and 14 weeks of age.; One dose as intramuscular injection at 6, 10 and 14 weeks of age.; One dose as intramuscular injection at 6, 10 and 14 weeks of age.; One dose as intramuscular injection at 10 months of age
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Pertussis; Tetanus; Hiberix™; Hepatitis B; DTPw-HBV vaccine; Tritanrix™-HepB; Haemophilus influenzae type b; Diphtheria; Hib vaccine
Dose-finding Study of LFB-R593, A Monoclonal Anti-RhD Antibody, in Healthy RhD Negative Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II study is designed to demonstrate the ability of LFB-R593 to effectively
      eliminate exogenously-administered RhD-positive red blood cells from the circulation of an
      RhD-negative individual, thereby preventing RhD-alloimmunisation.
    


Intervention name(s): polyclonal anti-D immunoglobulin; monoclonal anti-D immunoglobulin
Intervention type(s): Drug; Drug
Intervention description(s): single injection of 300 µg; Comparison of different dosages of LFB-R593
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; Rho(D) Immune Globulin; gamma-Globulins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Prevention of foeto-maternal allo-immunisation
Endothelium Dependent and Non-dependent Vasodilatation in Human Gingiva
Condition: Vasodilatation; Oral Soft Tissue Conditions
Study type: Interventional

Summary: 
      The aim of this study is to compare the endothelim-dependent and non-dependent vasodilatation
      between genders in the human gingiva.
    

Detailed description: 
      Gender differences were observed in studies according to gingival microcirculation between
      physiological circumstances and during wound healing as well.

      For blood flow measurement Laser Spackle Contrast Imaging is a reliable tool. It has good
      reproducibility, it doesn't get in touch with the measured surface, it's easy to use and it
      can measure on a bigger surface in same time.

      Two wells were fabricated on the labial surface of the right lateral incisor (test tooth) and
      on the labial surface of the left central incisor (control tooth). These wells are opened
      towards the high-prermeability gingival sulcus, so the dropped solutions nitroglycerine vs
      physiological saline or nitroglycerine vs physiological saline can esasily penetrate to the
      gingival tissues. After applying the solutions, the blood flow was monitored fot 15 minutes.
    

Intervention name(s): Nitroglycerin; Acetylcholine
Intervention type(s): Drug; Drug
Intervention description(s): Vasodilatator solution is dropped on the labial surface on the lateral incisor, so it can penetrate through the sulcus.; Vasodilatator solution is dropped on the labial surface on the lateral incisor, so it can penetrate through the sulcus.
Other intervention name(s): Ach
Intervention MeSH terms: Nitroglycerin; Acetylcholine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: spreading vasodilatation; gingial microcirculation; LSCI
Relative Bioavailability of Two Different Batches of a Linagliptin / Metformin Combination Tablet in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the current study is to investigate the relative bioavailability of two
      different batches of a 2.5 mg linagliptin / 1000 mg metformin fixed dose combination tablet
      (FDC).
    


Intervention name(s): Linagliptin/Metformin (standard batch); Linagliptin/Metformin (side batch)
Intervention type(s): Drug; Drug
Intervention description(s): Fixed dose combination tablet; Fixed dose combination tablet
Intervention MeSH terms: Metformin; Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial to Assess the Safety, Tolerability and Pharmacokinetics of MDT-637 in Healthy Volunteers
Condition: Drug Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the tolerability and safety of a range of repeated
      inhaled doses of MDT-637. This includes monitoring effects on pulmonary function and
      determination of blood levels of MDT-637 following inhalation.
    


Intervention name(s): MDT-637; MDT-637
Intervention type(s): Drug; Drug
Intervention description(s): Inhaled doses of MDT-637 over a 10 day period; Inhaled doses of MDT-637 over a 10 day period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Respiratory Syncytial Virus Infection; RSV
Study of rBet v1 Tablets
Condition: Birch Pollen-related Rhinoconjunctivitis; Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy and safety of three doses of r Bet v1
      administered as sublingual tablets in birch pollen allergic subjects.
    


Intervention name(s): Placebo; rBet v 1; rBet v 1; rBet v 1
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): One sublingual tablet of matching placebo daily during approximately 5.5 months; One sublingual tablet containing rBet v 1 at a dosage of 12.5 µg daily during approximately 5.5 months; One sublingual tablet containing rBet v 1 at a dosage of 25 µg daily during approximately 5.5 months; One sublingual tablet containing rBet v 1 at a dosage of 50 µg daily during approximately 5.5 months
Other intervention name(s): Placebo control; rBet v 1.0101; rBet v 1.0101; rBet v 1.0101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypersensitivity; Allergy; Birch, allergy, Sublingual Immunotherapy
Family Experience of Home Opioid Use After Pediatric Surgery
Condition: Pain Management
Study type: Observational

Summary: 
      A systematic review examining outpatient opioid use identified only three pediatric studies
      published between 2015 and 2016. Of these three, two studies had a short-term follow up with
      patients at three days after discharge; moreover, these three studies were limited by
      focusing on one surgical population, restriction of data to 0-12 yr old participants, and the
      other being a brief report. As a result, there are no pediatric studies that have examined
      opioid use amongst 0-18 yr olds, across multiple surgery types, and beyond 3 days after
      discharge.
    

Detailed description: 
      This study is being done to learn how long children (0-18 yrs) needed to use the prescribed
      opioid medication for and how families can be better prepared to provide adequate and safe
      pain management at home. Follow up will take place 28 days after discharge from the hospital.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Any child (0-18 years) who has undergone a surgical procedure at The Hospital for Sick
        Children within 7 days of discharge.
Cortical Pharyngeal Area: Excitability, Facilitation and Plasticity in Healthy Subjects
Condition: Healthy
Study type: Observational

Summary: 
      The aims of this study are in four experimental sessions. The aims are:

        -  to characterize the excitability of the cortical pharyngeal area with pharyngeal
           pressure and electromyograms (EMGs), at rest, in awake healthy subjects;

        -  to study its facilitation by inspiration and deglutition; and

        -  to study its plasticity by respiration and swallowing.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy subjects
      
Keywords: swallowing; ventilation; pressure; EMG; cortical magnetic stimulation; Brain Mapping
TMC278-TiDP6-C121: Drug-drug Interaction Trial to Investigate the Potential Interaction Between TMC278 25 mg Daily and Methadone, at Steady State.
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this Phase I, open-label, single-sequence drug-drug interaction trial in
      patients on stable methadone maintenance therapy is to investigate the potential interaction
      between TMC278 25 mg daily and methadone, at steady-state.
    

Detailed description: 
      This is a Phase I, open-label, single-sequence drug-drug interaction trial in patients on
      stable methadone maintenance therapy, to investigate the potential interaction between TMC278
      25 mg daily and methadone, at steady-state. TMC278 is under development for the treatment of
      HIV-1 infected patients. The trial population will consist of 16 HIV-negative patients on
      stable methadone maintenance therapy. Patients will receive TMC278 25 mg daily for 11 days,
      added to their current methadone therapy. The current methadone dosage for each patient is
      not to be changed from screening until Day 11 inclusive. Methadone dose will be
      individualized for each patient and should be between 60 and 150 mg daily. Full 24 hour
      pharmacokinetic profiles of R- and S-methadone will be determined on Day -1 (methadone alone)
      and on Day 11 (methadone + TMC278). A full 24 hour pharmacokinetic profile of TMC278 will be
      determined on Day 11 (methadone + TMC278). Pharmacodynamic assessments of the symptoms of
      methadone withdrawal (Short Opiate Withdrawal Scale (SOWS), Desires for Drugs Questionnaire
      (DDQ), pupillometry) will be performed on Day -7 and daily from Day -3 until Day 11, within 2
      hours before the intake of methadone. Safety and tolerability will be evaluated continuously
      throughout the trial. Patients will receive TMC278 added to their current methadone therapy
      in the following way: methadone individualized maintenance therapy, 60 to 150 mg daily from
      Day -14 to 11 and TMC278 25 mg tablet by mouth daily from Day 1 to 11. TMC278 and methadone
      will both be taken within 10 minutes after completion of a breakfast.
    

Intervention name(s): TMC278
Intervention type(s): Drug
Intervention MeSH terms: Rilpivirine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TMC278-TiDP6-C121; TMC278-C121; open-label; drug-drug interaction; methadone; TMC278
Assessment of Conventional and Patient-specific Instrumentation in Total Knee Arthroplasty
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      This study will use a special type of x-ray called radiostereometric analysis (RSA) imaging
      to determine whether patient-specific instrumentation for total knee arthroplasty
      (replacement) has an effect on implant loosening compared to conventional instrumentation.
      Secondary objectives will include assessment of post-operative implant alignment, patient
      satisfaction, operative time and surgical instrument use, cost, and environmental impact.
    

Detailed description: 
      This is a prospective randomized controlled trial which will enroll 50 patients undergoing
      total knee replacement surgery. All study patients will undergo an MRI prior to surgery. Half
      (25)of these patients will be randomized to have their MRI used to develop a patient-specific
      instrument to be used during their surgery. The other half (25) will have conventional
      instrumentation (CI) used for their knee replacement surgery.

      All patients will have the same type of knee implant used for their total knee replacement
      (Genesis II posterior stabilized (Smith & Nephew).

      Patients will not know which group they have been randomized to. For patients randomized into
      the patient-specific randomization group, If the surgeon is not happy with the
      patient-specific instrumentation, they have the option to switch to conventional
      instrumentation at any time during the surgery.

      • Length of operation, number of instruments used, amount of OR room waste and number and
      type of adjustments to the patient specific instrumentation will be tracked.

      During the surgery, all patients in the study will have tantalum marker beads placed in the
      bone surrounding their knee replacement. These beads will be used as markers to measure
      implant fixation over the next two years. All patients will undergo a special type of x-ray
      imaging called RSA imaging to quantify implant fixation over time.

      RSA examinations will occur at 6 weeks, 3 months, 6 months, 1 year, and 2 years at the
      Robart's Research Institute after their standard of care visit with orthopaedic surgeon.

      Model based RSA software used to measure motion of implant components relative to bone
      markers.

      All patients will complete our standard outcome measures in the form of surveys completed at
      their follow-up visits after surgery. •
    

Intervention name(s): Total Knee Arthroplasty with use of Visionaire Patient-Specific Instrumentation
Intervention type(s): Device
Intervention description(s): The manufacturing of a patient-specific instrument to be used by the orthopaedic surgeon during the knee replacement surgery.
Other intervention name(s): Visionaire Patient Specific Instrumentation
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Total Knee Replacement; Visionaire