bioihbjkbjnl/mcl2 huggingface dataset:
An Attempt to Reduce Community-Acquired Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection in Soldiers
Condition: Community-Acquired MRSA Infections; Abscesses; Cellulitis; Folliculitis
MeSH terms: Infections; Communicable Diseases; Staphylococcal Infections; Cellulitis; Folliculitis
Study type: Interventional

Summary: 
      The main purpose of this study is to determine if applying mupirocin into soldiers noses who
      are colonized with methicillin-resistant Staphylococcus aureus (MRSA) will reduce infections
      in them and their cohort of fellow soldiers.
    

Detailed description: 
      Community-acquired MRSA infections are increasingly common in the community and in particular
      among certain groups of which soldiers are one. Many researchers and clinicians have
      postulated that one method to prevent infections is to selectively eradicate CA-MRSA in those
      who are colonized with the pathogen. The two main purposes of the study are: to determine if
      selective CA-MRSA eradication in subjects reduces infections in the CA-MRSA colonized
      individual; and to determine if selective CA-MRSA eradication in subjects reduces infections
      in the study cohort. Other information concerning CA-MRSA includes: prevalence, risk factors,
      and virulence data. The population will be soldiers enrolled in the combat medic training
      class at Ft. Sam Houston. We will enroll approximately 3000 soldiers over a two year period.
      After informed written consent, we will culture their anterior nares nares and administer
      questionnaires at the beginning and at the end of the study, following them prospectively for
      infections. The follow-up period will be 16 weeks. For those with CA-MRSA in their nares,
      they will be randomized (by cohort) to receive either 5 days of mupirocin or placebo.
    

Intervention name(s): Mupirocin (drug)
Intervention type(s): Drug
Intervention MeSH terms: Mupirocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Methicillin-resistant Staphylococcus aureus; Staphylococcus aureus; MRSA; CA-MRSA
Dose Response Study of Dexamethasone in Combination With Bupivacaine 0.25%
Condition: Post Surgical Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      When used in conjunction with a local anesthetic, dexamethasone may prolong both the sensory
      and motor effects of high supraclavicular brachial plexus nerve block (SBP) in arthroscopic
      shoulder surgery. This study seeks to determine if there is a relationship between the
      duration of sensory and motor blockade in supraclavicular brachial plexus nerve blocks (SBP)
      when combined with increasing doses of dexamethasone.
    

Detailed description: 
      The exact mechanism of dexamethasone on peripheral nerve block is unclear. The current theory
      is that the effect is not dose related, while only 4mg and 8mg doses were studied. Our
      hypothesis is that the dose differences at 1mg, 2mg, or 4mg, does not have significant effect
      on the duration of analgesia. Therefore, we are not considering any patients to receive
      suboptimal dosing of preservative free dexamethasone in this study.
    

Intervention name(s): Bupivacaine 0.25%; Dexamethasone; normal saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): placebo
Intervention MeSH terms: Dexamethasone; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Exploratory Study to Evaluate the Effect of SYN111 (Rufinamide) in Patients With Generalized Anxiety Disorder (GAD)
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      A Multi-Centered Randomized, Double-Blind, Placebo-Controlled, Phase 2, Exploratory Study to
      Evaluate the Effect of Rufinamide on Anxiety in Patients with Moderate to Severe Generalized
      Anxiety Disorder.
    

Detailed description: 
      This was an exploratory study to evaluate the effect of 500 or 1000 mg per day for 8 weeks of
      Rufinamide compared to placebo on measures of anxiety in patients with Generalized Anxiety
      Disorder, and to determine tolerability of Rufinamide in this population.
    

Intervention name(s): SYN111; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg for 1 week followed by 1000 mg for 7 weeks; 0 mg tablets
Other intervention name(s): Rufinamide
Intervention MeSH terms: Rufinamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GAD
Induction Chemotherapy Prior to Radio-immunotherapy in Head and Neck Cancer Stage III/IV - a Methodical Trial
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional

Summary: 
      The purpose of the trial is to determine the feasibility of an induction chemotherapy with
      radio-immunotherapy in patients with head and neck cancer stage III/IV
    

Detailed description: 
      3 Cycles of: Docetaxel 75 mg/m2 on d1, Cisplatin 75 mg/m2 on d1, 5-FU 750 mg/m2 on days 1-5
      as continuous i.v. infusion, Duration of 1 cycle: 21 days;

      Followed by Cetuximab 400 mg/m2, Start of radiotherapy: 1 week after the first application of
      Cetuximab, During radiotherapy (35 x 2 Gy): Cetuximab 250 mg/m2 weekly, Up to 8 applications
      of Cetuximab.
    

Intervention name(s): Docetaxel; Cisplatin; 5-FU; Radiotherapy; Cetuximab
Intervention type(s): Drug; Drug; Drug; Radiation; Drug
Intervention description(s): 75mg/m² day 1; 75mg/m² day 1; 750mg/m²/day day 1-5; standard fraction up to a total dose of 70Gy/35 fractions/7weeks or accelerated regimen, up to a total dose of 72Gy/42 fractions over 6 weeks; 250mg/m²/week after an initial loading dose of 400mg/m²
Intervention MeSH terms: Docetaxel; Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: head and neck cancer, stage III/IV; no prior radiotherapy of head and neck region
Pharmacokinetic Non-interaction Study With a Fixed-dose Combination Tablet With Tramadol and Diclofenac
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study was to evaluate whether or not there is a substantial
      pharmacokinetic interaction between diclofenac and tramadol in a new formulation of a
      fixed-dose combination of diclofenac 25 milligrams (mg) and tramadol 25 mg for oral
      administration. The study was conducted in healthy participants of both genders.
    

Detailed description: 
      After a screening period of about 2 weeks, 36 eligible healthy men and women were randomly
      allocated to receive 3 sequential treatments in the following order:

        -  a single dose of diclofenac followed by a single dose of the fixed-dose combination of
           diclofenac/tramadol followed by a single dose of tramadol

        -  a single dose of tramadol followed by a single dose of the fixed-dose combination of
           diclofenac/tramadol followed by a single dose of diclofenac.

      There were washout periods of 7 days between treatments.

      Sixteen blood samples were collected per participant: at pre-dose and 0.16, 0.33, 0.5, 0.75,
      1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 36 hours after administration of each of the study
      drugs.

      The pharmacokinetic parameters and relative bioavailabilities of diclofenac and tramadol (and
      of the tramadol metabolite M1) were determined for the new fixed-dose combination product and
      were compared to the single compound reference products.

      Furthermore, the safety (frequency of adverse events) and tolerability of the new fixed-dose
      combination of diclofenac 25 mg and 25 mg tramadol in healthy men and women was assessed.
    

Intervention name(s): Diclofenac sodium 25 mg; Tramadol hydrochloride 25 mg; Diclofenac sodium 25 mg/Tramadol hydrochloride 25 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Diclofenac sodium 25 mg Tablets (Laboratorios Tecnandina S.A., Ecuador); Tramadol hydrochloride 25 mg Tablets (Laboratorios Tecnandina S.A., Ecuador); Fixed-dose combination tablet containing diclofenac sodium 25 mg and tramadol hydrochloride 25 mg (Laboratorios Tecnandina S.A., Ecuador)
Other intervention name(s): Adorlan (Trade Mark)
Intervention MeSH terms: Diclofenac; Tramadol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Longitudinal, prospective, crossover, open, randomized, single-dose study with 3 periods, 2 sequences (ACB and BCA), and 3 treatments (A, B, and C) in healthy participants and under fasting conditions.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: fixed-dose combination; diclofenac; tramadol; interaction
MRI Study of Brain Activity in Healthy Adults and Individuals With Parkinsonism and Rapid Eye Movement Disorder.
Condition: Movement Disorders (Incl Parkinsonism); Tremor Familial Essential, 1; REM Sleep Behavior Disorder
MeSH terms: Tremor; Movement Disorders; Parkinsonian Disorders; REM Sleep Behavior Disorder; Mental Disorders
Study type: Observational

Summary: 
      This proposal is focused on developing a reliable, valid, and reproducible imaging techniques
      and statistical methodology for segregation of various forms of Parkinsonism from healthy
      adults without Parkinsonism.
    

Detailed description: 
      This proposal is focused on developing a reliable, valid, and reproducible imaging techniques
      and statistical methodology for segregation of various forms of Parkinsonism from healthy
      adults without Parkinsonism. We focus on early diagnosis of Parkinsonism, other tremor
      disorders, and determine how imaging might be used to improve diagnosis. The purpose of this
      protocol is to gather a multi-modal dataset to explore and validate the investigator's
      previous research findings in prior studies.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with PD, MSA-P, ET, or PSP will be recruited based on clinical criteria from the
        UAB Comprehensive Parkinson Disease and Movement Disorder Clinic located at The Kirklin
        Clinic at UAB. This center sees over 3,500 patients annually. Individuals with RBD will be
        recruited from the UAB University Hospital and UAB Highlands Sleep Disorders Center and
        will be identified through patient contact with a UAB Department of Neurology physician.
PRKAA2 Genetic Polymorphisms and Its Susceptibility to Chinese Type 2 Diabetes Mellitus and Diabetic Nephropathy
Condition: T2DM (Type 2 Diabetes Mellitus)
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Metformin is a classical oral antidiabetic drug, often recommended to be the first-choice
      treatment of type 2 diabetes mellitus (T2DM). Based on the previous research on PRKAA2, STK11
      and diabetes, this study aimed to investigate the distributive characteristic of PRKAA2 and
      STK11 polymorphisms and the potential influence of STK11polymorphisms on metformin efficacy
      among Chinese T2DM patients, discuss the association of PRKAA2 polymorphisms between T2DM
      patients and healthy subjects.
    


Intervention name(s): Metformin
Intervention type(s): Drug
Intervention MeSH terms: Metformin
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        the study recruited 500 T2DM patients and 250 healthy subjects who meet the enrollment
        cirterion from Zhengzhou Central Hospital during the period of July 2013 to December 2015
        randomly.
      
Keywords: T2DM; genetic polymorphism; diabetic nephropathy
Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to evaluate the efficacy and safety of risperidone versus
      placebo in subjects with Major Depressive Disorder with sub-optimal response to
      antidepressant therapy.
    

Detailed description: 
      Many patients who suffer from Major Depressive Disorder (MDD) do not benefit or show only
      partial benefit from current psychotropic therapy. This clinical trial seeks to study the
      efficacy and safety of adjunctive treatment with risperidone in patients with MDD who failed
      to adequately respond to standard antidepressant treatment prior to this trial and who
      prospectively do not respond to adequate treatment with standard antidepressant therapy
      (SAD).

      Patients entering the open label phase of the study will have already taken a commercially
      available SAD for a minimum of 4 weeks, and provided the dose was optimal, will continue on
      this dose of SAD throughout the four-week open-label and six-week double-blind phases of the
      trial.

      If the dose in the four weeks prior to entering the study was not optimal (as per standard
      clinical practice), the dose will be increased to be within the optimal range and continued
      at that dose through the entire open-label SAD and double-blind phases.

      During the double-blind phase, subjects receive an adjunctive dose of risperidone or placebo,
      once daily, added to their stable dose of SAD. The starting dose of risperidone or placebo is
      0.25 mg for the first three days of the double-blind phase, and is increased to 0.5 mg for
      days 4 through 14. On the 15th day of this phase, the dose is increased to the target dose of
      1.0 mg/day. If response to this dose is not optimal by day 29, it is increased to 2.0 mg/day
      and is maintained for the duration of the 6-week double-blind phase. This dose may be reduced
      once to 1.0 mg/day, but then must be maintained at that dose for the remainder of the study.
    

Intervention name(s): risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Stress-physiology Coherence, Interoception, and Well-being Following Mindfulness Training or Tracking Time Spent on Mobile Device
Condition: Not Seeking to Treat Any Conditions
Study type: Interventional

Summary: 
      Chronic stress has been shown to impact long-term emotional and physical health. When nearly
      three-quarters of Americans report stress at levels that exceed what they consider healthy,
      there is a desperate need to understand factors that contribute to effective stress
      regulation. This work seeks to develop a measure tied to awareness and acceptance of stress
      that has shown promise as a predictor of multiple markers of mental and physical well-being,
      understand how it relates to awareness of the body, and explore whether it can be trained to
      alleviate suffering and promote well-being. This study aims to 1) Conceptually replicate and
      extend previous findings linking greater stress-physiology coherence to higher well-being. 2)
      Assess whether awareness of physiology is associated with stress-physiology coherence. 3)
      Explore whether stress-physiology coherence can be trained through a brief mindfulness
      training intervention.
    


Intervention name(s): Mindfulness training; Tracking time spent on mobile device
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Brief audio recordings discussing mindfulness or guided mindfulness practices.; Participants will record each day how much time they estimate they spent on their smart phone in the past 24 hours.
Other intervention name(s): Mindfulness, contemplative, meditation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomly assigned after a baseline testing to either a mindfulness intervention or control group.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Electromagnetic Field Effects of Mobile Communication (LTE) on Sleep in the Context of Genetic Variation
Condition: Sleep
Study type: Interventional

Summary: 
      The effect of electromagnetic fields of the latest standard in mobile communication (long
      term evolution, LTE) on sleep is studied in healthy, young individuals.
    


Intervention name(s): LTE field; sham field
Intervention type(s): Other; Other
Intervention description(s): electromagnetic field of the latest standard in mobile communication (long term evolution, LTE); no electromagnetic field
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Culturally Specific Interventions: African American Smokers
Condition: Smoking; Smoking Cessation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators expect that a culturally specific group intervention targeting African
      American smokers will result in greater smoking cessation rates compared to a standard
      intervention.
    


Intervention name(s): Culturally Specific CBT; Standard CBT
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Culturally Specific Cognitive Behavioral Therapy; Standard Cognitive Behavioral Therapy
MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-centre, randomised, double-blind, placebo controlled, parallel group, Phase
      II study to evaluate efficacy and safety of 3 doses of MEDI7183, in Japanese subjects with
      moderate to severe UC
    


Intervention name(s): MEDI7183 low dose; MEDI7183 medium dose; MEDI7183 high dose; Matching Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8; MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8; MEDI7183 will be administered by SC on Day 1, and placebo for MEDI7183 at Week 2, 4, and 8; Placebo will be administered by SC on Day 1, Week 2,4, and 8
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ulcerative Colitis, Japanese, subcutaneously
RSV Observational Study 2
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Observational

Summary: 
      Respiratory Syncytial Virus (RSV) is a virus that causes chest infections. It is the single
      most important cause of severe respiratory illness in infants and young children, and severe
      RSV infection early in life is associated with an increased risk of later developing asthma.
      RSV also causes severe disease in elderly and immune-compromised adults, and the amount of
      RSV disease in the elderly is similar to that from seasonal flu. The virus is transmitted in
      the secretions of the upper respiratory tract of infected individuals and by contact with
      contaminated surfaces (such as toys). Hospital outbreaks, especially on paediatric and
      neonatal wards, are not uncommon.

      Infection by RSV does not develop a natural long-lasting protection against re-infection
      (like, for example, measles does). In the USA nearly all children by 24 months of age have
      been infected at least once with RSV, and about half will have experienced two infections.
      There is no effective anti-viral drug to treat an infection and the only way of managing
      cases of severe infection is through supporting organs, such as the lungs, to withstand and
      recover from the illness.

      There remains a real need to develop an effective vaccine to prevent severe infections caused
      by RSV. A better understanding of the way the immune system responds to RSV in children would
      aid the development of such a vaccine.

      The purpose of this study is to increase our understanding of how the immune system responds
      to RSV. Only limited data is available on some important components of the immune response
      and this study is designed to measure these in more detail. This is done using a single blood
      sample.

      A total of 35 children are anticipated to be recruited to this study, at ages when we expect
      to see differences in the immune response to RSV;

        -  5 infants aged between 2 and 4 months (Group 1), who have not yet been exposed to RSV

        -  20 infants aged between 6 and 12 months (Group 2), who will have had exposure to one
           single RSV season in the winter of 2011/12

        -  10 children aged between 3 and 6 years (Group 3), who have been exposed to RSV over
           several winter seasons
    


Intervention name(s): Blood sample
Intervention type(s): Procedure
Intervention description(s): An extra volume of blood is obtained, with prior consent, when phlebotomy is required for another unrelated clinical reason.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants aged 2-4 months inclusive Infants aged 6-12 months inclusive Children aged 3-6
        years inclusive
      
Biospecimen description: 
      serum
    
Keywords: RSV; Immune response; Paediatric