bioihbjkbjnl/mcl2 huggingface dataset:
Physiological Response of Cortisol to Cardiac Catheterization
Condition: Adrenal Insufficiency
MeSH terms: Adrenal Insufficiency
Study type: Observational

Summary: 
      Cortisol is essential for survival. The importance of cortisol response is most apparent in
      patients with partial or complete deficiency of glucocorticoids during stressful events such
      as illness or surgery.
    

Detailed description: 
      It is known that cortisol and other stress hormones increase during acute myocardial
      infarction as well (9-11). Cardiac catheterization is an essential tool for the management of
      acute coronary syndrome, and for the evaluation of the burden of coronary artery disease in
      cardiac patients.
    

Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        30 males and females, age 20-90 years who are scheduled for elective cardiac
        catheterization procedure.
      
Keywords: adrenal; steroids; cortisol; stress
Memantine-enhanced Buprenorphine Treatment for Opioid-dependent Young Adults
Condition: Opioid Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to examine the effect of memantine and buprenorphine on opioid
      abusing behavior, to determine the effect of memantine and buprenorphine on early relapse and
      to evaluate the tolerability of memantine co-administrated with buprenorphine. The study
      seeks to determine if combined treatment of memantine and buprenorphine may provide
      shorter-term treatment for opioid dependence.
    

Detailed description: 
      Opiate dependence is an increasing problem among young adults (18-25 years old) whose rates
      of current use of illicit drugs are generally high (19.7 %)according to data from the 2007
      National Survey on Drug Use & Health (Substance Abuse and Mental Health Services
      Administration 2008). Young adults start using heroin around this age range, and more
      recently have had increasing rates of prescription-type drug use. Given that young adults
      with opiate dependence who are seeking treatment are relatively treatment naïve, have a
      shorter period of addiction, and are more likely to choose buprenorphine over methadone,
      developing short-term buprenorphine treatment alternatives to long-term methadone agonist
      treatment is needed.
    

Intervention name(s): Memantine; Memantine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 30mg/day Memantine orally everyday for 12 weeks; 15 mg/day Memantine orally everyday for 12 weeks; Placebo orally everyday for 12 weeks
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug Abuse
Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules
Condition: Meningococcal Infections
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary :1.To demonstrate a sufficient immune response of rMenB+OMV NZ, when given
      concomitantly with routine infant vaccines to healthy infants at 2, 4 and 6 and 2, 3 and 4
      months of age, as measured by percentage of subjects with serum bactericidal activity (SBA)
      titer ≥1:5, at 1 month after the third vaccination Secondary :To demonstrate that
      immunogenicity of routine infant vaccines, when given concomitantly with rMenB+OMV NZ to
      healthy infants at 2, 3 and 4 months of age, was non-inferior to that of routine infant
      vaccines given without rMenB+OMV NZ. 2. To demonstrate that the immunogenicity of rMenB+OMV
      NZ when given concomitantly with routine infant vaccines was non-inferior to that of
      rMenB+OMV NZ given without routine infant vaccines at 2, 4 and 6 months of age. 3. To assess
      prevalence of meningococcal B antibodies over the study period by evaluation of SBA, at
      baseline and at 1 month after third vaccination, in subjects- received routine infant vaccine
      without rMenB+OMV NZ.
    


Intervention name(s): rMenB+OMV NZ; combined diphtheria,tetanus,pertussis+polio+Hepatitis B+Haemophilus influenzae B vaccine; Pneumococcal vaccine
Intervention type(s): Biological; Biological; Biological
Other intervention name(s): Infanrix Hexa; Prevenar
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal disease,; Neisseria meningitidis serogroup B,; Prevention,; Vaccination,; Infants
Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat
Condition: Tophaceous Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the serum uric acid lowering effects, clinical benefits, and safety
      of lesinurad in combination with febuxostat to febuxostat alone in patients with tophaceaous
      gout.
    

Detailed description: 
      Febuxostat is an XO (Xanthine Oxidase) Inhibitor approved Urate Lowering Therapy (ULT) for
      patients with gout. Although febuxostat has been demonstrated to be superior to allopurinol
      in lowering serum urate (sUA) to < 6mg/dL in 3 randomized, controlled clinical trials,
      proportions of subjects experiencing a reduction in tophus area and gout flares were not
      significantly different compared to allopurinol. Although this study will allow subjects who
      are naïve to ULT to enroll, it is anticipated that the majority of subjects will currently be
      taking or have previously experienced XO Inhibitor therapy. This trial will enroll a
      population of subjects with high uric acid body burden, as all must demonstrate the presence
      of tophi.
    

Intervention name(s): Lesinurad; Lesinurad; Placebo; Febuxostat
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets, 400 mg once daily (QD); Tablets, 200 mg QD; Tablets, Placebo QD; 80 mg
Intervention MeSH terms: Febuxostat; Lesinurad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Safety and Efficacy Study of Oral XIGO Tablets to Treat The Common Cold
Condition: Common Cold
MeSH terms: Common Cold
Study type: Interventional

Summary: 
      The purpose of the study will be to assess the efficacy and safety of XIGO administered
      orally, three times a day, compared with placebo in patients with the common cold.
    

Detailed description: 
      The common cold is one of the most frequent human illnesses and has been shown to result in
      significant morbidity and economic loss. At the present time no truly effective therapy is
      available. Therapeutic interventions with compounds such as zinc have been found to be
      helpful however well reported side-effects have prevented its extensive use.

      Based on several years of anecdotal clinical evidence which has shown that XIGO is effective
      in alleviating the symptoms of the common cold-the findings of which are supported by
      competent and reliable evidence from in vivo and in vitro and clinical trials studies on each
      of the individual active ingredients of the formulation, it has been proposed that XIGO, when
      administered orally, has a direct stimulatory effect on multiple components of the immune
      system. It is proposed that this stimulation increases both the immune cell population as
      well as its functionality and this will be observed in cells and molecules from both the
      innate and adaptive responses.
    

Intervention name(s): lactoferrin, L-Glutamine and beta-glucans; Placebo Comparator
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subject will be given XIGO pills or placebo. two tablets to be taken by mouth 3 times per day.; Subject will be given placebo comparator of two tablets to be taken by mouth 3 times per day.
Intervention MeSH terms: Lactoferrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Common Cold; Cold Virus; Feeling sick; Influenza
A Study Evaluating the Safety, Tolerability, and Pharmacodynamic Effects of GLY-200 in Type 2 Diabetic Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a Phase 2, randomized, double-blind, placebo-controlled, single-center study in
      adult patients with type 2 diabetes. It will evaluate the safety and tolerability of oral
      GLY-200. Subjects will participate in a ≤ 18-day screening period followed by a metformin
      washout period of approximately 14 days, and an inpatient period of 16 days. Approximately 48
      subjects will be randomized to 1 of 3 active treatment groups or 1 of 3 placebo groups.
      Dosing will occur for 14 days. A follow-up clinic visit will occur on Day 21 [End of Study
      (EOS)] or Early Termination (ET).
    


Intervention name(s): GLY-200; GLY-200; GLY-200; Placebo; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 0.5 g GLY-200 (1 x 0.5 g capsule) BID for 14 days (n=12); 1.0 g GLY-200 (2 x 0.5 g capsules) BID for 14 days (n=12); 2.0 g GLY-200 (4 x 0.5 g capsules) BID for 14 days (n=12); 1 placebo capsule BID for 14 days (n=4); 2 placebo capsules BID for 14 days (n=4); 4 placebo capsules BID for 14 days (n=4)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 Diabetes; Diabetes Mellitus, Type 2; GLY-200; Glyscend, Inc.
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream With Phototherapy in Participants With Vitiligo
Condition: Vitiligo
MeSH terms: Vitiligo
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream with or
      without phototherapy in adolescent and adult participants with non-segmental vitiligo for
      whom vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).
    


Intervention name(s): Ruxolitinib 1.5% cream; NB-UVB phototherapy
Intervention type(s): Drug; Device
Intervention description(s): Ruxolitinib cream 1.5% applied twice a day (BID).; NB-UVB (311-312 nm) phototherapy is an established treatment modality for vitiligo. Starting dose will be 200 mJ/cm2 and dose may be increased by 10% at each visit
Other intervention name(s): Narrow-Band Ultraviolet B Phototherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-segmental; Vitiligo; hypopigmentation; Pigment Disorders; Skin Diseases; JAK inhibitor
Study of the ENTact Septal Staple System for Tissue Approximation During Septoplasty
Condition: Nasal Septum
Study type: Observational

Summary: 
      The purpose of this research study is to learn more about the ENTact™ Septal Staple System
      device performance and to collect information to support its premarket application.
    

Detailed description: 
      The ENTact™ Staple System is a device that inserts a small staple or tack to hold mucosa
      (moist tissues) in place instead of using stitches. The staple gradually dissolves and does
      not need to be removed. This clinical study will evaluate:

        -  surgical performance of the ENTact Septal Staple System

        -  one week post op clinical evaluation of gross tissue appearance at implantation site(s)

        -  ENTact™ Septal Staple functionality based on maintained coaptation
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients (ages 18-65) with clinically significant nasal septum deviation.
      
Keywords: Evaluation; ENTact™; Septal; Staple; System; tissue; approximation; during; septoplasties
Muscle Glycogen Synthesis When Caffeine and Protein is Co-Ingested With Carbohydrates
Condition: Exercise Recovery
Study type: Interventional

Summary: 
      The aim of the present study is to investigate the effect of added protein+leucine or
      caffeine to 1.2 g/kg/h CHO on the rate of post-exercise muscle glycogen re-synthesis in
      healthy, recreational athletes.

      The investigators hypothesize that both interventions (the addition of caffeine or
      protein+leucine) will lead to higher glycogen re-synthesis compared to the ingestion of CHO
      only, and that the co-ingestion of protein and leucine will result in the highest muscle
      glycogen synthesis rates.
    


Intervention name(s): Carbohydrate; Carbohydrate and protein ingestion; Carbohydrate and caffeine ingestion
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 1.2 g/kg/h; 1.2 g/kg/h carbohydrate plus 0.4 g/kg/h protein; 1.2 g/kg/h carbohydrate and 1.67 g/kg/h caffeine
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Glycogen; Carbohydrate; Protein; Caffeine; Post exercise muscle glycogen synthesis; Sports nutrition
Estimation of Pentraxin3 and PGingivalis Levels in Patients With Knee Joint and Gum Diseases
Condition: Rheumatoid Arthritis; Chronic Periodontitis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Periodontitis; Chronic Periodontitis
Study type: Observational

Summary: 
      Periodontitis and Rhematoid arthritis are chronic inflammatory diseases which share common
      risk factors The purpose of this study is to determine if Pentraxin 3 and Porphyromonas
      Gingivalis levels play an important role in the progression of both the diseases.
    

Detailed description: 
      Periodontal disease progression might play a significant role in the severity and outcome of
      systemic diseases like rheumatoid arthritis. Pentraxin3 is a newly discovered inflammatory
      biomarker. It is a member of acute phase proteins and it has been observed from previous
      studies that plasma pentraxin3 levels have increased with increasing severity of cardiac and
      renal problems.

      Porphyromonas gingivalis proteinase is responsible for the epitope development in RF-Fc
      region These proteinases are important virulence factors which lead to degradation of host
      tissue. Porphyromonas gingivalis is also a key periodonto pathogen. Thus the aim of this
      study is to compare the plasma pentraxin3 and p.gingivalis levels in patients with
      periodontitis and rheumatoid arthritis.
    

Intervention name(s): Estimation of Pentraxin3; Estimation of P.Gingivalis levels
Intervention type(s): Other; Genetic
Intervention description(s): 5ml of blood to be collected from each subject, centrifuged, to separate the plasma for estimation of Pentraxin3 (Quantikine ELISA); Pooled plaque sample will be collected and sent for DNA Extraction by PCR for assessment of levels of PGingivalis
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Total 90 Subjects of whom 30 subjects belong to the Arthritis and Periodontitis group,30
        subjects belong to the Periodontitis group and 30 subjects from the healthy group
      
Biospecimen description: 
      Pooled plaque sample will be collected and sent for DNA Extraction by PCR for asseessment of
      levels of PGingivalis.

      5ml of blood to be collected from each subject, centrifuged, to separate the plasma for
      estimation of Pentraxin3 (Quantikine ELISA)
Improving Mobility in Residential Aged Care
Condition: Geriatric Disorder
Study type: Interventional

Summary: 
      This study aims to test which of three exercise programs, previously demonstrated valuable
      for residential aged care adults, has the greatest benefit for walking speed and the
      spatiotemporal parameters that define it. The programs to be included are:

        1. The GrACE program and

        2. The GrACE plus Gait specific training.
    

Detailed description: 
      This study will employ a non-randomised controlled design in which three different 24-week
      exercise programs and a non-exercising control group will be compared in the residential aged
      care (RAC) setting. The three programs are the GrACE and the GrACE plus a gait specific
      training program.

      Data Collection

      ~40 participants from two RAC facilities will be recruited into the study. This number of
      participants will provide 80% statistical power to identify moderate effect size between
      group differences on the primary outcome measures. The control group will be drawn from each
      of the RAC facility approached receiving exercise treatment. Participation will be informed
      by a discussion with the facilities Service Manager about the eligibility of participants and
      a medical history screen undertaken. All participants will provide informed written consent
      prior to participation.

      Participants in the exercise group will perform twice weekly training for 24 weeks. Data will
      be collected at 0 weeks, 12 weeks and 24 weeks in the control and exercise groups.
    

Intervention name(s): GrACE program; GrACE + gait
Intervention type(s): Other; Other
Intervention description(s): to compare with the GrACE + gait programme in RAC, as well as the secondary objective of measuring the programme benefits on gait speed, sit to stand and handgrip strength against the intervention and control group; to compare with the GrACE programme in RAC, as well as the secondary objective of measuring the programme benefits on gait speed, sit to stand and handgrip strength against the intervention and control group
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: residential aged care; mobility; social participation; functional capability
Effect of Transcranial Direct Current Stimulation (tDCS) on the Excitability of the Diaphragmatic Primary Motor Cortex
Condition: Excitability of Diaphragmatic Primary Motor Cortex
Study type: Interventional

Summary: 
      Transcranial direct current stimulation (tDCS) is a non invasive, painless, harmless way to
      modulate cerebral cortex excitability. It was shown that anodal stimulation increases
      cortical excitability and the cathodal one decreases it (Nitsche and Paulus, 2000; Lang et
      al. 2004). To date, there is no data in the literature regarding the effect of tDCS on the
      corticodiaphragmatic pathways. This preliminary study aims to test and validate the
      modulating effect of tDCS on the excitability of the primary motor cortex dedicated to the
      hemi-diaphragms in a sample of healthy subjects, as a prelude to further large studies in
      patients with paretic hemi-diaphragms. Diaphragmatic motor evoked potentials will be assessed
      before and after applications of three different modalities of tDCS (anodal, cathodal and
      placebo).
    

Detailed description: 
      We therefore expect to observe a significant increase of the mean values of the right
      hemidiaphragm's MEP's amplitudes after application of anodal tDCS compared to the baseline
      MEP obtained before this treatment.
    

Intervention name(s): Eldith DC stimulator ( Magstim Company Ltd. UK)
Intervention type(s): Device
Intervention description(s): Anodal tDCS: Intensity of 2 mA , during 10 min Cathodal tDCS: Intensity of 2 mA , during 10 min Placebo type tDCS: Intensity of 0 mA during 10 min
Other intervention name(s): Magstim 200 TMS(Magstim Company Ltd.UK)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: tDCS; Diaphragm; Cortical Excitability; MEPs; TMS
Can Diet- and Exercise-Induced Weight Loss Improve Asthma Control in Adults?
Condition: Asthma; Obesity
MeSH terms: Asthma; Weight Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of the study is to investigate the efficacy of an evidence-based weight loss
      intervention, on a background of quality health care, on asthma control among obese adults.
      The intervention will employ a combination of recommended dietary and physical activity
      changes, and behavioral modification techniques.
    


Intervention name(s): Lifestyle intervention
Intervention type(s): Behavioral
Intervention description(s): Participants will attend a 15 weekly class sessions during the first 4 months. Classes will be co-lead by a dietician and exercise specialist and will involve a private weigh-in, a group discussion, a presentation of a lifestyle topic, 30 minutes of supervised moderate physical activity, followed by action-planning and goal-setting. During the next 2 months, participants will meet with a dietician on an individual basis for a private weigh-in, personal discussion and problem solving, review of self-monitoring records, and action-planning. The last 6 months will consist of applying and maintaining what has been learned in previous class sessions. Self-monitoring records, questions and problems will be discussed with interventions at least once every 2 months or more frequently if needed.
Other intervention name(s): In-person sessions and self-monitoring
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
A Low-osmolaric Glucose Polymer Drink for Gastric Distress and Running Performance
Condition: Gastric Distress; Running Performance
Study type: Interventional

Summary: 
      The objective of this study is to investigate whether two newly developed sports drink will
      affect gastric distress (GD) and running performance (RP) compared to an iso-caloric control
      drink both in a short and longer distance run. Furthermore, the effect of the newly developed
      sports drinks on gastric emptying will be investigated.

      The study will consist of 3 parts. Firstly, a randomized cross-over design is used for the
      short distance run and the effects on GD and RP. Secondly, a parallel design is used to study
      the effects of the drinks on GD and RP during a longer distance run. Thirdly, the gastric
      emptying tests will be performed in a randomized cross-over design. Participants will be
      asked to fill in questionnaire on the gastric distress they experience. 40 participants will
      be enrolled to participate in part 1 and part 2. 10 out of 40 will participate in part 3 of
      the study.
    


Intervention name(s): Sports drink 1; Sports drink 2; Placebo
Intervention type(s): Other; Other; Other
Intervention description(s): Sports drink with a specific source of CHO.; Sports drink with a specific source of CHO; iso-caloric sports drink with maltodextrin as CHO source
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)