bioihbjkbjnl/mcl2 huggingface dataset:
A Study of CNTO 3157 in Healthy Normal and Asthmatic Participants Inoculated With Human Rhinovirus Type 16
Condition: Healthy Volunteers and Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purposes of this study are to evaluate the safety (Parts 1 and 2) and efficacy (Part
      2) of pretreatment with CNTO 3157 in healthy adult and asthmatic adult participants before
      and after intranasal (into the nose) inoculation with human rhinovirus type 16 (HRV-16).
    

Detailed description: 
      This is a two-part, randomized (participants are assigned to treatment by chance),
      double-blind (participants and investigators do not know what study agent is being
      administered), placebo-controlled study. A placebo appears identical to a study agent, has no
      active ingredients, and helps investigators evaluate the effect of a study agent. In Part 1,
      following administration of CNTO 3157 or placebo, the severity of an upper respiratory tract
      infection, due to inoculation with HRV 16, will be assessed in healthy participants for
      safety reasons. In Part 2, following administration of CNTO 3157 or placebo and inoculation
      with HRV-16, efficacy and safety will be assessed in asthmatic participants using standard
      assessments to evaluate asthma treatments. The study (Parts 1 and 2) will be completed when
      the last participant completes the last visit (Week 11) in Part 2.
    

Intervention name(s): CNTO 3157 (healthy participants); Placebo (healthy participants); CNTO 3157 (asthmatic patients); Placebo (asthmatic patients); HRV-16
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): CNTO 3157 10 mg/kg, as a single intravenous infusion, on Day 1, 24 to 72 hours prior to inoculation with human rhinovirus type 16 (HRV-16).; Placebo, as a single intravenous infusion, on Day 1, 24 to 72 hours prior to inoculation with HRV-16.; CNTO 3157 10 mg/kg, as a single intravenous infusion, at Week 1 (Day 1), followed by 3 infusions of 3 mg/kg of CNTO 3157 at Week 2 (Day 8), Week 3 (Day 15), and Week 4 (Day 22). The final infusion (Week 4) will occur 24 to 72 hours prior to inoculation with HRV-16.; Placebo, as 4 intravenous infusions, at Week 1 (Day 1), Week 2 (Day 8), Week 3 (Day 15), and Week 4 (Day 22). The final infusion (Week 4) will occur 24 to 72 hours prior to inoculation with HRV-16.; Single inoculation of HRV-16 in a total volume of approximately 1.0 mL, administered as 2 instillations per naris.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy volunteers and asthma; CNTO 3157; Rhinovirus
A Phase II, 5-way Cross-over Study to Evaluate the Pharmacodynamics of "Nexthaler" Dry Powder Inhaler in COPD Patients
Condition: COPD
Study type: Interventional
Phase: Phase 2

Summary: 
      The study aim is to compare the pharmacodynamic effects (cardiovascular effects- primary
      variable: Heart rate over 4 hours post dosing- ) after administration of BDP and formoterol
      administered as CHF 1535 100/6 NEXThaler DPI or CHF1535 pMDI at two different dose levels.
    

Detailed description: 
      The effects of both formulations on serum potassium and serum glucose and the general safety
      and tolerability of study treatments will be also evaluated
    

Intervention name(s): CHF 1535 NEXThaler 800/48; CHF 1535 NEXThaler 200/12; CHF 1535 NEXThaler PLACEBO; CHF 1535 pMDI 200/12; CHF1535 pMDI 800/48
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pharmacodynamics COPD
PGC-1 and Mitochondrial Dysfunction in Diabetes
Condition: Diabetes; Obese
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is determine if you have too much fat in your body that it will
      decrease the conversion of food energy into energy that your body can use.
    

Detailed description: 
      The investigators' prior research has focused on defining the changes in expression of
      nuclear encoded mitochondrial genes that predict changes in insulin sensitivity in skeletal
      muscle, with the goal of defining the molecular mechanisms underlying the connection between
      mitochondrial dysfunction and insulin resistance in skeletal muscle.

      The purpose of this study is to determine whether experimental lipid oversupply decreases
      mitochondrial respiratory function. We will use mitochondrial respiration studies in vitro
      and mass spectrometry and proteomics analysis to test the hypothesis that experimental lipid
      oversupply:

        1. Decreases mitochondrial respiration in response to lipid fuels.

        2. Reduces abundance of mitochondrial proteins.

        3. Alters phosphorylation of proteins in the electron transport chain.

      Three groups of subjects will be studied: lean, healthy control subjects (n=12), obese
      non-diabetic subjects (n=12) and patients with type 2 Diabetes Mellitus (n=12) for a total of
      36 subjects. Twenty subjects have completed the study at Arizona State University; the
      remaining 16 subjects will be accrued at the Mayo Clinic in Arizona.

      Subjects will come to the Mayo Clinic 2 times. On study Day 1 subjects will be screened with
      a medical history and physical exam, and a 75 g oral glucose tolerance test, measure body fat
      percentage, and an electrocardiogram (EKG). On Study Day 2, subjects will report to the
      clinic after an overnight fast. Female subjects will take a urine pregnancy test. A muscle
      biopsy will be performed to take a small sample from one thigh. A lipid infusion will be
      performed for 5 hours (60 ml/hr), with blood samples taken at 8 intervals during the
      infusion. At the end of the 5 hour period, a second muscle biopsy will be taken from the
      other thigh. The fat infusion will stop, subjects will be given lunch and allowed to leave
      the clinic.
    

Intervention name(s): Lipid infusion and muscle biopsies
Intervention type(s): Other
Intervention description(s): Subjects will undergo a baseline muscle biopsy, a lipid infusion for 5 hours (60 ml/hr), and a muscle biopsy after the lipid infusion.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: insulin resistance
A Survey of Complementary and Conventional Medicine Use Patterns in the Veteran Population
Condition: Alternative Medicine; Attitudes; Beliefs; Veterans
Study type: Observational

Summary: 
      In this protocol, the investigators proposed to assess the Complementary Alternative Medicine
      (CAM) usage patterns in a Veteran population using a CAM survey developed by Dr. Hernandez
      and colleagues. This survey, the Complementary, Alternative and Conventional Medicines
      Attitudes Scale (CACMAS), is a brief, self-report questionnaire that assesses medical use
      patterns, as well as attitudes about medical treatment and the relationship among these. The
      CACMAS will assess the potential role of individual beliefs and attitudes towards
      complementary and conventional medicine usage patterns, and possibly indicate how this scale
      might be used to predict optimal treatment offerings for a particular population given
      attitudes about medical treatments.
    

Detailed description: 
      The use of complementary and alternative medicine (CAM) in the United States has seen a
      steady and steep rise over the past two decades. A national survey of over 31,000 adults
      found that 36% of respondents had used CAM therapies in the last month, and this estimate
      increased to 62% when prayer for health reasons was included. Second, this same survey showed
      that CAM is often used to treat symptoms and illnesses associated with stress such as
      depression, anxiety, back and neck pain, and gastrointestinal disorders. Finally, many
      individuals experiencing high levels of stress lack access to conventional medicine due to
      lack of medical insurance, possibly increasing the attractiveness of CAM for these
      individuals. This ongoing systematic characterization of CAM usage patterns in civilian
      populations has not been mirrored in active military and military Veteran populations across
      the United States. Data from the less than handful of studies that have been conducted thus
      far, suggest that CAM usage patterns in military and military Veteran populations are
      influenced by demographics and certain medical conditions, as well as dissatisfaction with
      certain aspects of conventional care. While there appears to be some similarity between
      civilian and non-civilians populations, there remains much to be known in the latter
      population.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A range of Veterans eligible to, or seeking care, from a Veterans Affairs healthcare
        setting.
      
Keywords: Complementary Alternative Medicine; Veteran; Attitudes; Beliefs
DSP-3025 A Phase 1 Study of Healthy Male Volunteers
Condition: Healthy
Study type: Observational

Summary: 
      Investigate safety/tolerability after repeated weekly doses intranasal administration of
      DSP-3025 comparator placebo to healthy male volunteers
    


Intervention name(s): DSP-3025; Placebo
Intervention type(s): Drug; Drug
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Brief Bactericidal Activity of Anti-Tuberculosis Drugs
Condition: Tuberculosis; Drug-resistant Tuberculosis; Isoniazid Resistant Tuberculosis (Disorder)
MeSH terms: Tuberculosis; Tuberculosis, Multidrug-Resistant
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators will determine the bactericidal activity of high-dose isoniazid against M.
      tuberculosis isolates that are (1) susceptible to isoniazid at 2.0 mcg/ml but resistant at
      0.1 and 0.4 mcg/ml or (2) susceptible at 0.4 mcg/ml but resistant at 0.1 mcg/ml when tested
      in the BD MGIT 960 system. Further, the investigators will investigate the molecular genetic
      determinants of these differences in susceptibility.

      To achieve these objectives the investigators will carry out an innovative variation on early
      bactericidal activity (EBA) study methodology. Patients at risk for drug-resistant TB will be
      screened for INH resistance using approved molecular assays. In those with INH-resistant TB,
      the investigators will quickly perform phenotypic DSTs using the direct method in the Bactec
      Mycobacterium Growth Indicator Tube (MGIT) 960 system, so results will be available within 7
      days. If the DST results show the susceptibility patterns noted above, patients will receive
      900 mg/d INH (600 mg if <45kg), and assess its effect with serial quantitative sputum
      cultures for 6 days. If the concentration of viable bacteria decreases significantly, the
      investigators will interpret this to mean the drug is having an effect. If not, the drug is
      ineffective. After 6 days, the patients will resume treatment according to national
      guidelines.

      In case the investigators identify drugs that are effective under these conditions, the
      investigators will sequence known and putative genes associated with the action of these
      drugs for the mycobacterial isolates from these patients.
    


Intervention name(s): High dose isoniazid
Intervention type(s): Drug
Intervention description(s): See arm description
Other intervention name(s): High dose INH
Intervention MeSH terms: Isoniazid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of AggreGuide A-100 (ADP) Assay
Condition: Risk Factor, Cardiovascular; Platelet Dysfunction Due to Drugs
MeSH terms: Blood Platelet Disorders
Study type: Interventional

Summary: 
      Study to evaluate the performance of the AggreGuide A-100 ADP assay for detection of platelet
      dysfunction caused by P2Y12 inhibitor antiplatelet therapy.
    

Detailed description: 
      Study subjects will have A-100 ADP measurements performed at baseline and after initiation of
      P2Y12 inhibitor antiplatelet therapy, following loading and maintenance doses.
    

Intervention name(s): P2Y12 inhibitor; Platelet function test
Intervention type(s): Drug; Device
Intervention description(s): Administration of P2Y12 inhibitor antiplatelet therapy; Blood is drawn for testing of platelet aggregation activity
Other intervention name(s): clopidogrel; prasugrel; ticagrelor; AggreGuide A-100 ADP assay
Intervention MeSH terms: Clopidogrel; Ticagrelor; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Diagnostic
Study of E3810 for Healthy Japanese Male (Under Fasting Condition)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics of rabeprazole under fasting
      condition.
    

Detailed description: 
      The purpose of this study is to assess bioequivalence after single administration of the
      following 4 types of formulation: normal 10 mg rabeprazole tablet rabeprazole, and Type 1,
      Type 2, and Type 3 granule formulation containing rabeprazole 10 mg.
    

Intervention name(s): rabeprazole; rabeprazole; rabeprazole; rabeprazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10 mg normal tablet; Type 1 granule containing rabeprazole 10 mg; Type 2 granule containing rabeprazole 10 mg; Type 3 granule containing rabeprazole 10 mg
Intervention MeSH terms: Rabeprazole
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rabeprazole; Japan; healthy Japanese male
Evaluation of Fe Absorption From Iron Salt in Milk
Condition: Healthy
Study type: Interventional

Summary: 
      The primary objective was:

        -  to compare iron absorption in apparently healthy children aged 3-6y from an instant full
           cream milk drink fortified with ferric pyrophosphate or ferric ammonium phosphate
           relative to ferrous sulfate as the reference fortificant.

        -  To compare iron absorption from ferric pyrophosphate to ferric ammonium phosphate from
           the milk drink
    


Intervention name(s): Iron fortified milk with iron salt labelled with 58Fe and 57Fe; Iron fortified milk with iron salt labelled with 58Fe and 57Fe
Intervention type(s): Other; Other
Intervention description(s): Oral administration of a serving of iron labelled with stable isotope (2 mg Fe per serving) in 200ml of reconstituted milk once after a overnight fast. The alternate test drink was fed on the following day in the same fashion. The administration was repeated on day 3 and 4.; Oral administration of a serving of iron labelled with stable isotope (2 mg Fe per serving) in 200ml of reconstituted milk once after a overnight fast. The alternate test drink was fed on the following day in the same fashion. The administration was repeated on day 3 and 4.
Other intervention name(s): Iron fortified milk with ferrous ammonium posphate labelled with 57Fe; Iron fortified milk with ferrous sulfate labelled with 58Fe; Iron fortified milk with ferrous sulfate labelled with 58Fe; Iron fortified milk with ferric pyrophosphate labelled with 57Fe
Intervention MeSH terms: Iron
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind randomized crossover study with two parallel arms
Masking: Double (Participant, Investigator)
Primary purpose: Other
Describing the Effects of Insoles in Children With Increased Femoral Anteversion and Pes Planovalgus
Condition: Femoral Anteversion; Pes Planovalgus; Flat Foot
MeSH terms: Flatfoot
Study type: Interventional

Summary: 
      Increased Femoral Anteversion is a transverse plan problem that affects lower body alignment,
      walking and standing characteristics and also pes planovalgus mostly accompanies with IFA. It
      is shown that children with IFA and PPV have back and leg pain, fatigue, muscle cramps and
      they are under the risk for chronic disorders such as osteoarthritis, scoliosis and muscle
      injuries.

      Insoles, which reduce pronation of foot (flat foot), provide apparently a static correction
      by supporting proper alignment in children with IFA and PPV. However, the dynamic effects of
      insoles to lower extremity biomechanics while walking is not known.

      The aims of this study are to determine the effects of the insoles on walking biomechanics in
      children with IFA and PPV by comparing with their healthy peers.
    


Intervention name(s): Insole
Intervention type(s): Device
Intervention description(s): Custom-made insoles which support the foot at subtalar neutral position
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Femoral anteversion, flat foot, insole, gait
The Use of Ketamine as an Anaesthetic During Electroconvulsive Therapy
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The main aim of this research is to ascertain whether Ketamine would be a more effective
      anaesthetic for Electroconvulsive Therapy (ECT) than the standard anaesthetic. In doing so
      the investigators aim to examine the effect of ketamine on ratings of depressive symptoms,
      the number of required ECT treatments, and the effect of this anaesthetic on memory.
    

Detailed description: 
      According to WHO statistics, depression is amongst the leading causes of disability
      worldwide. In its more severe forms, it can be life threatening. The most severe forms of
      depression, or those that fail to respond to chemical treatment are treated with
      electroconvulsive therapy (ECT). The treatment is highly effective, and undoubtedly saves
      lives, but a range of factors, including side effect profile, the necessity for extended
      hospital care, and stigma, restricts its use.

      A recent study has shown that patients who receive ketamine as the anaesthetic for ECT
      experience an earlier reduction in depressive symptoms and have a greater reduction in
      depressive symptoms than those receiving propofol (Okamoto et al., 2009). However, in this
      study eight ECT treatments were given to all participants so it is unknown whether ketamine
      could have reduced the number of treatments required. Overall, these studies suggest that as
      well as being a neuroprotective agent; ketamine may also have an antidepressant effect. Given
      these findings it is hypothesized that the use of ketamine in ECT treatment may reduce the
      number of ECT sessions required due to this drug's effects on depression ratings.

      Our main research question is whether the use of ketamine as the anaesthetic for ECT
      treatment for depression improves the treatment outcome with respect to speed of response and
      reduction in side effects when compared to conventional anaesthesia.
    

Intervention name(s): Ketamine; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Ketamine used as the anaesthetic during ECT.; The standard anaesthetic used for ECT.
Other intervention name(s): Ketalar; Diprivan 1%
Intervention MeSH terms: Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; electroconvulsive therapy; ketamine
Phase 2 Study of Indomethacin Capsules to Treat Dental Pain
Condition: Dental Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether Indomethacin Test Formulation Capsules are
      safe and effective for the treatment of dental pain.
    


Intervention name(s): Celecoxib 400 mg; Placebo; Indomethacin Test (lower dose); Indomethacin Test (upper dose)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Capsules 2 x 200 mg Single-Dose; Capsules 2 Single-Dose; 20-mg single dose; 40-mg single dose
Intervention MeSH terms: Celecoxib; Indomethacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effectiveness of Estradiol Valerate Pretreatment in Antagonist Protocol for Poor Ovarian Response Patient
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The purpose of study is to assess the efficacy of add-on estrogen pretreatment in GnRH
      antagonist protocol on oocyte retrieval as compared with GnRH antagonist protocol for
      patients with poor ovarian response Add-on estrogen pretreatment protocol is superior to none
      pretreatment GnRH antagonist protocol for the number of oocytes retrieval
    

Detailed description: 
      Women of advanced maternal age seeking ART treatment are characterized as poor ovarian
      responders in the process of ovarian simulation. Poor response to ovarian stimulation causes
      high cycle cancellation rate and extremely low pregnancy rate.

      More attention has been paid to the potential interest of steroid pretreatments in GnRH
      antagonist cycles; not only for scheduling the GnRH antagonist cycles, but also for
      synchronizing the follicular growth which may result in more oocytes retrieved. But available
      clinical results are controversial.

      Previous studies have shown that utilizing the natural negative feedback of the
      hypothalamus-pituitary-ovary axis induced by estradiol valerate pretreatment effectively
      prevented inter-cycle increases in follicle-stimulating hormone, improved follicle
      synchronization, and resulted in a more coordinated follicular development, leading to the
      recovery of more mature oocytes. However none of the randomized controlled studies compared
      estradiol valerate pretreatment or not on treatment outcomes, ongoing pregnancy rate,
      directly on poor response patients using estradiol valerate pretreatment in GnRH antagonist
      protocol.
    

Intervention name(s): Follitropin Beta;MSD; Ganirelix; hCG; estradiol valerate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Patients will start stimulation with a daily s.c. injection of follitropin beta( 300IU Puregonon;MSD) menstrual cycle day 2 or 3.; A daily administration of ganirelix (0.25 mg Orgalutran; MSD) was introduced when the leading follicle is near 13mm, and was repeated up to the time of hCG administration.; Ovulation was triggered when the leading follicles reach 18-20mm and at least two follicles 17-18mm , HCG 10000 IU is used to trigger; Estradiol valerate (progynova,Schering) daily dose of 4 mg (2 mg twice a day) was given orally, started 7 days before the presumed onset of menses and administered up to 2 days of the next menstrual cycle
Other intervention name(s): Puregon; Orgalutran; Ovidrel; progynova
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate; Follicle Stimulating Hormone; Ganirelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GnRH antagonist; Estrogen pretreatment; Poor response patient