bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability & Pharmacokinetics of LEVI-04 in Healthy Volunteers and Patients With Osteoarthritis Knee Pain
Condition: Healthy Volunteers; Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human, phase 1, single centre, placebo-controlled, double-blind, single
      ascending dose study of LEVI-04 in heathy volunteers and osteoarthritis patients (with pain
      attributed to osteoarthritis of the knee)
    

Detailed description: 
      There will be 8 cohorts of 7 subjects each. Cohorts 1-3 and 8 will be composed of healthy
      volunteers. Cohorts 4-7 will be composed of osteoarthritis patients. Cohort 4 will be a
      bridging cohort; osteoarthritis patients in Cohort 4 will receive the same dose as the
      healthy volunteers in Cohort 3, if deemed safe.

      Each subject will be assigned to receive a single dose of LEVI-04 or matching placebo. Each
      dose will be administered as an intravenous infusion over 30 minutes. Planned doses will
      start at 0.003 mg/kg in Cohort 1, and may be increased to 3.0 mg/kg in Cohort 8. The planned
      doses may be changed, depending on the safety, tolerability and pharmacokinetic results after
      previous doses. The dose selected for each cohort will be determined by the Safety Review
      Team, following review of all available pharmacokinetic and safety data. For each escalating
      dose, there will be at least 2 weeks between the start of each cohort (at least 14 days
      between Day 0 for the last subject in the previous cohort and Day 0 for the first subject in
      the subsequent cohort), to allow for review of safety, tolerability and pharmacokinetic data.
      In each cohort, 5 subjects will receive LEVI-04 and 2 subjects will receive matching placebo.
    

Intervention name(s): LEVI-04; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LEVI-04 intravenous infusion; Placebo intravenous infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: First-in-human, phase 1, placebo-controlled, double-blind, single ascending dose study in heathy volunteers and osteoarthritis patients
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: osteoarthritis; knee; healthy; volunteer; LEVI-04
A Long-Term Safety Study of ALKS 5461
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.
    


Intervention name(s): ALKS 5461
Intervention type(s): Drug
Intervention description(s): Sublingual tablet, taken daily
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study To Assess The Safety And Tolerability Of GW642444 In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The compound GW642444 has previously been found to be well tolerated with no significant side
      effects in subjects with asthma and healthy volunteers. This study will assess the safety and
      tolerability of GW642444 in subjects with COPD in order to obtain information to support
      dosing in a broader population of subjects with COPD
    

Detailed description: 
      A multicentre, randomised, placebo-controlled, double-blind, 4-arm parallel-group, 2-week
      study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of
      GW642444H (100 administered once daily in the morning via DISKUS™ dry-powder inhaler)
      compared with SEREVENT (salmeterol) (50mcg administered twice daily via DISKUS dry-powder
      inhaler) and placebo in subjects with moderate COPD.
    

Intervention name(s): GW642444; Placebo
Intervention type(s): Drug; Other
Intervention description(s): GW642444H; Placebo administered twice daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Obstructive Pulmonary Disease (COPD); COPD
Absorption of Phenolic Acids From Coffee in Humans
Condition: Bioavailability; Cardiovascular Health Status
Study type: Interventional

Summary: 
      Phenolic acids are naturally-occurring constituents of plant-derived foods and beverages and
      are characterised by a phenol ring in their structure. The phenolic compounds we are going to
      focus on in this study are the Chlorogenic acids (CGAs), a family of esters conjugates formed
      between a Hydroxycinnamic acid and quinic acid (1) and that show a strong antioxidant
      activity (2).

      HCAs represent about 50% of the total polyphenolic coumpounds intake in a typical UK diet (3)
      and for people who drink it, coffee is a/the major dietary source of/for HCAs (4). A few
      studies suggest protective effects for cardiovascular diseases (5), neurodegenerative
      diseases, type 2 diabetis and liver and kidneys cancer risk. However, many data in the field
      are obtained from in vitro and/or in animal, and it is difficult and dangerous to extrapolate
      between these and risk in humans of development or progression of particular health
      conditions, more human studies are therefore needed.

      We aim to compare people that metabolise the best CGAs from coffee to those that metabolise
      them the least well. This will be achieved by measuring the metabolites in urine. The effect
      of CGAs on the human body does not only depend on the amount ingested, but also on the
      quality of the metabolism, we therefore also want to determine which mechanisms are
      responsible for inter-individual variations in order to identify any link with health
      biomarkers, these including non-cellular inflammation and cardiovascular risk indicators.

      For this cohort study funded by the University of Leeds, approximately 60 healthy volunteers
      will be recruited at the School of Food Science & Nutrition. If they meet the selection
      criteria, participants will be asked to undergo a 36-hour wash-out period. During those 36
      hours, participants won't be allowed to drink coffee, they will be asked to follow a diet low
      in phenolic acids and keep a record of their meals. On the first day of the study, a single
      dose of coffee rich in antioxidants will be given to the participant and urine will be
      collected from that time until 36 hours after coffee consumption. Participants will be
      followed again after 5 to 6 weeks.
    


Intervention name(s): Coffee
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Clinical Performance of Incremental and Bulk Fill Composites in Class II Restorations
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This study will examine the clinical performance of Class II restorations over a three year
      period with 3 composite resins - a conventional composite resin, a flowable composite resin
      and a bulk placed and cured composite resin.
    

Detailed description: 
      Specific Aim: To place three commercially available resin composites in Class II cavity
      preparations of adult patients, evaluate the resin composite restorations at baseline, 6
      months, 1 year, 2 and 3 years using specific criteria defined by International Dental
      Federation (FDI).
    

Intervention name(s): Supreme Universal Restorative; Supreme Flowable Restorative; Bulk Fill Flowable Restorative
Intervention type(s): Device; Device; Device
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Single group with a split mouth design in which each subject received all three treatments. Of the 53 total subjects, 3 study subjects actually received duplicate treatment, i.e., they received 6 dental restorations.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Class II; molar and premolar; resin composite; adult; restoration
Peer Education Program for HIV/AIDS Related Sexual Behaviors of Secondary School Students
Condition: HIV
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      Worldwide, about 50% of all new cases of HIV occur in youth between age 15 and 24 years.
      Studies in various countries show that both out of school and in school adolescents and youth
      are engaged in risky sexual behaviors. Peer-based interventions have become a common method
      to effect important health-related behavior changes and address the HIV/AIDS pandemic. This
      study therefore aimed to evaluate the effectiveness of peer education in improving HIV
      knowledge, attitude, and preventive practices among in-school adolescents
    


Intervention name(s): Peer Education Program
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Olanzapine on Sleep Electroencephalogram (EEG) in Schizophrenia Patients
Condition: Schizophrenia; Sleep
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      Acute and sub-chronic administration of olanzapine has shown a favourable effect on the sleep
      disturbances in previously medicated schizophrenia patients with predominantly negative
      symptoms. The present study will be carried out to clarify the effect of olanzapine on
      polysomnographic profiles of schizophrenia patients in an acute phase of illness after
      controlling for the drug effects.
    

Detailed description: 
      Twenty schizophrenia patients (11 drug naïve and 9 drug free) will be studied over a period
      of six weeks of olanzapine treatment. Patients will be assessed at the baseline on BPRS,
      PANSS, CDSS and UKU side effect rating scales and a baseline 40 channels polysomnography will
      be done. After the initial assessment, patients will put on olanzapine treatment, in flexible
      dosages based on clinical response, for a period of six weeks when a final assessment on
      clinical rating scales and polysomnography will be done. The sleep data will be scored
      manually for staging based on Rechtschaffen and Kales criteria.
    

Intervention name(s): Olanzapine
Intervention type(s): Drug
Intervention description(s): 06 weeks treatment with Olanzapine in a flexible dosage schedule.
Intervention MeSH terms: Olanzapine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Olanzapine; Schizophrenia; Polysomnography; Slow wave sleep
A Study of a Potential Mechanisms of Spinal Manipulation in the Treatment of Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to determine the immediate effect of 3 common physical therapy
      interventions for people experiencing low back pain on the perception of thermal pain.
      Additionally, the investigators wished to determine the influence of psychological factors
      related to fear and anxiety on their findings and to determine whether the effects of the
      individual interventions were local (specific to the area of application) or global
      (influenced regions away from the area of application).
    


Intervention name(s): stationary bike; lumbar extension exercise; spinal manipulative therapy
Intervention type(s): Other; Other; Other
Intervention description(s): Participants rode a stationary bike for five minutes; Participants performed four sets of fifteen lumbar extension exercises over fifteen minutes; participants received spinal manipulative therapy to the low back
Other intervention name(s): press up; spinal manipulation; manual therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: low back pain; spinal manipulation; central sensitization; manual therapy
STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation
Condition: Atrial Fibrillation; Atrial Fibrillation New Onset
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      To provide data demonstrating the safety and effectiveness of the Arctic Front Advance™
      Cardiac CryoAblation Catheter for the treatment of recurrent symptomatic paroxysmal atrial
      fibrillation, without the requirement that the subjects be drug refractory.
    

Detailed description: 
      Subjects with paroxysmal atrial fibrillation with no history of treatment with
      anti-arrhythmic drugs are randomized 1:1 to either an anti-arrhythmic drug or pulmonary vein
      isolation using the cryoballoon catheter.
    

Intervention name(s): Cryoablation; Antiarrhythmic drug
Intervention type(s): Device; Drug
Intervention description(s): Pulmonary vein isolation via ablation with cryoballoon catheter; Antiarrhythmic drug initiation
Other intervention name(s): ArcticFront Advance Cardiac CryoAblation Catheter
Intervention MeSH terms: Anti-Arrhythmia Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Total Sleep Deprivation on Vascular Function
Condition: Sleep Deprivation
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      Insufficient sleep is associated with an increased risk for cardiovascular disease. The
      causal mechanisms are currently unknown, but may include endothelial dysfunction. The purpose
      of this study is to examine the influence of sex and aging on the effects of total sleep
      deprivation on vascular function and whether exercise training attenuates these effects.
    


Intervention name(s): Exercise; Supervised Total Sleep Deprivation
Intervention type(s): Other; Other
Intervention description(s): 60 minutes of moderate-intensity treadmill exercise (70% of maximal heart rate determined from the maximal graded exercise test); Laboratory-monitored total sleep deprivation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Lubricating Eye Drops After Routine Cataract Surgery
Condition: Dry Eye; Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      Patient satisfaction and dry symptoms in patients undergoing routine uncomplicated cataract
      surgery in NHS patients treated with prophylactic phosphate-free, preservative-free lubricant
      eye drops (0.3% cross linked sodium hyaluronate, AEONTM Protect Plus and0.15% Sodium
      Hyalu-ronate with vitamins A and E, AEONTM Repair): A randomized, prospective, controlled
      study.
    

Detailed description: 
      The aim of this study is to investigate the routine use of such lubricating drops in a
      randomized, prospective methodology in patients undergoing uncomplicated cataract surgery in
      the NHS setting. As these drops are provided with the intraocular lens, if found to be of
      benefit in reducing dry eye problems such a study might provide evidence for the universal
      implementa-tion of post-operative ocular lubricant drops
    

Intervention name(s): AEONTM Repair and AEONTM Protect Plus lubricating eye drops
Intervention type(s): Drug
Intervention description(s): AEONTM Repair and AEONTM Protect Plus lubricating eye drops
Intervention MeSH terms: Ophthalmic Solutions; Lubricant Eye Drops
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: To assess the use of additional lubricant eye-drops for 6 weeks following uncomplicated, routine cataract sur-gery to improve patient satisfaction and symptoms of dry eye in an NHS (public health care) setting, compared to no additional lubricating eye drops
Masking: None (Open Label)
Primary purpose: Supportive Care
Human Leukocyte Antigen (HLA) - A*2402 Restricted Peptide Vaccine Therapy in Patients With Advanced Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study it to evaluate the safety and immune response of peptides (URLC10)
      emulsified with Montanide ISA51 in treating patients with unresectable, advanced or recurrent
      esophageal cancer.
    

Detailed description: 
      URLC10 have been identified as cancer specific molecules especially in non small cell lung
      cancer using genome-wide expression profile analysis by cDNA microarray technique. In a prior
      study, it has been shown that URLC10 are upregulated in human esophageal tumors. The
      investigators identified that peptides derived from these proteins significantly induce the
      effective tumor specific CTL response in vitro. According to these findings, in this trial,
      we evaluate the safety, immunological and clinical response of URLC10 peptide. Patients will
      be vaccinated once in one week to the eighth vaccine and will be vaccinated once in two weeks
      from the ninth vaccine. On each vaccination day, the URLC10 peptide (1mg) mixed with
      Montanide ISA 51 will be administered by endodermic injection
    

Intervention name(s): URLC10
Intervention type(s): Biological
Intervention description(s): Biological: URC10 Patients will be vaccinated once in one week to the eighth vaccine and will be vaccinated once in two weeks from the ninth vaccine. On each vaccination day, the URLC10 peptide (1mg) mixed with Montanide ISA 51 will be administered by endodermic injection.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: peptide vaccine; URLC10
This Study Will Investigate the Safety, Tolerability and Pharmacokinetic Profile of Repeat Oral Doses of GSK2140944 in Healthy Adult Subjects
Condition: Infections, Respiratory Tract
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a randomized, placebo-controlled, single blind study to investigate the safety,
      tolerability and pharmacokinetic (PK) profile of GSK2140944 following repeat oral doses in
      healthy adult subjects. The study will include a Screening period (40 days), Treatment period
      (16 days) and a Follow-up period (26 to 30 days). A single dose will be administered on Day 1
      for characterization of single dose PK, followed by twice-daily (BID) or thrice-daily (TID)
      dosing on Days 3 to 16. Subjects may only be randomized to one cohort per the randomization
      schedule. Up to 6 cohorts will be enrolled using a sequential panel. Subjects in Cohort 1
      will receive GSK2140944 (6) and placebo (2). Subsequent cohorts will enroll 16 subjects such
      that 12 subjects will receive GSK2140944 and 4 subjects will receive placebo, per dose level
      according to the randomization schedule. Dose escalations are planned to run in successive
      weeks. Cohort 2 may begin dosing once subjects in Cohort 1 have completed 7 days of BID
      dosing, PK data is reviewed and safety data from at least 6 subjects is available. Each
      subsequent dose escalation will commence only when GSK2140944 safety data and available PK
      data of at least 12 subjects dosed at the previous dose level have been reviewed. The number
      of cohorts may be reduced or expanded if needed. The first planned dose is 400 milligram (mg)
      BID but may be modified based upon emergent PK, safety and tolerability data from ongoing
      clinical study BTZ115198 evaluating single and repeat intravenous (IV) doses of GSK2140944.
      The projected dose for Cohort 2 is 800 mg BID, Cohort 3 is 1500 mg BID, Cohort 4 is 2300 mg
      BID or 1500 mg TID and Cohort 5 and cohort 6 will be decided later. The planned maximum dose
      is 2500 mg TID but may be modified based upon emergent safety, tolerability and PK data.
      Doses of GSK2140944 or placebo will be administered following a moderate fat meal.
    


Intervention name(s): GSK2140944; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK2140944 will be available as immediate release capsules of dose strength 100 mg and 500 mg; Matching placebo will be available
Intervention MeSH terms: Gepotidacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Breathing Training for Asthma
Condition: ASTHMA
MeSH terms: Asthma
Study type: Interventional

Summary: 
      For the proposed randomized controlled treatment study, the investigators plan to compare the
      effects of this hypoventilation-based breathing training with a control intervention that
      will focus on breathing regularity and awareness. The two therapeutic procedures are closely
      matched on important variables such as duration and the nature of patient-therapist
      interaction, monitoring asthma related status and the medication intake, use of scientific
      equipment and monitoring devices to increase adherence, and initial plausibility. Asthma
      patients who will be evaluated before, during, directly after, and at 2 months and 6 months
      after training.
    

Detailed description: 
      For this randomized controlled treatment study, the investigators plan to compare the effects
      of hypoventilation-based breathing training with a control intervention that will focus on
      breathing regularity and awareness. The two therapeutic procedures are closely matched on
      important variables such as duration and the nature of patient-therapist interaction,
      monitoring asthma related status and the medication intake, use of scientific equipment and
      monitoring devices to increase adherence, and initial plausibility. Asthma patients will be
      evaluated before, during, directly after, and at 1 month and 6 months after training. The
      primary goal of this training is to determine if a capnometry-assisted breathing training to
      raise end-tidal CO2 will produce more improvement in asthma control than a control training
      of breathing awareness. The second goal is to determine if capnometry-assisted breathing
      training for raising pCO2 will lead to higher pCO2 levels after training than before training
      on all three measures of pCO2 (the 2-hour monitoring, the standardized training sessions, and
      the homework assignments). The last objective is to determine if the clinical improvement in
      asthma outcomes for the raise-pCO2 breathing group will be greater in patients with more
      improvement in their pCO2.
    

Intervention name(s): Capnometry Assisted Respiration Training; Breathing Awareness
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients learn to alter their breathing pattern by breathing abdominally, slowly, regularly, and shallowly in order to raise their PCO2 levels with the assistance of a biofeedback device.; Patients learn to alter their breathing pattern by breathing abdominally, slowly, regularly using a biofeedback device.
Other intervention name(s): CART
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Dyspnea; Paroxysmal; Pulmonary; Respiratory hypersensitivity; Airway inflammation; Airway obstruction; Wheezing