bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Study Using a Wireless Motility Capsule
Condition: Food Selection
Study type: Interventional

Summary: 
      Research suggests dietary fiber may decrease transit time through the gastrointestinal tract.
      Research studies traditionally use radio-opaque markers to determine gastric emptying,
      colonic transit, and whole gut transit time. The SmartPill is a single use pill that can be
      used to determine gastric emptying, colonic transit, and whole gut transit time without
      requiring X-rays or fecal collections. Previous studies have found radio-opaque markers and
      the SmartPill detect the similar transit times.

      The purpose of this pilot study is to determine if the SmartPill can detect a change in
      transit time using a significant dose of dietary fiber.
    

Detailed description: 
      The ability of a device to track gastrointestinal transit time, including gastric emptying
      time, was measured in healthy people consuming low and high fiber diets.
    

Intervention name(s): SmartPill
Intervention type(s): Device
Intervention description(s): SmartPill
Intervention model: Single Group Assignment
Masking: Single (Participant)
Screening in Myocardial Perfusion Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      To expand the understanding of the uptake and distribution of Tc-99m sestamibi in the breast
      in a normal female population undergoing myocardial perfusion imaging using Molecular Breast
      Imaging (MBI).
    

Detailed description: 
      You are being asked to take part in this research study because you have been scheduled to
      have a scan of your heart. The radioactive dye used to image your heart is also taken up by
      many types of breast cancer. The investigators have developed a new method for detecting
      breast cancer, called Molecular Breast Imaging that uses this dye.

      The purpose of this study is to see how well this new method works in normal subjects with no
      known breast cancer and to see if we can detect breast cancer at an earlier stage than
      mammography. As you read this form describing the study, ask any questions you have. Take
      your time to decide. Feel free to discuss the study with your family, friends, and healthcare
      provider before you decide. You may stop participating at any time during the study. You may
      decide not to participate. If so, none of your current benefits or normal health care will be
      affected in any way. When you feel comfortable that all your questions have been answered,
      and you wish to take part in this study, sign this form in order to begin your participation.
      Your signature means you have been told about the study and what the risks are. Your
      signature on this form also means that you want to take part in this study.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Female subjects who are undergoing Myocardial Perfusion imaging in the Nuclear Cardiology
        laboratory at the Mayo Clinic in Rochester, MN.
      
Keywords: Breast; Breast Cancer; MBI; Molecular Breast Imaging; Molecular Imaging
Pharmacokinetics of Eleclazine in Adults With Normal and Impaired Hepatic Function
Condition: Long QT Syndrome
MeSH terms: Long QT Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of oral
      eleclazine and its metabolite, GS-623134, in participants with normal and impaired hepatic
      function. Participants in the healthy control group will be matched to participants with
      impaired hepatic function by age (± 5 years), gender, and body mass index (± 10%).
    


Intervention name(s): Eleclazine
Intervention type(s): Drug
Intervention description(s): Eleclazine tablets administered orally
Other intervention name(s): GS-6615
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic Impairment
Glufast On Insulin Glargine Trial in Type 2 DM
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      We will evaluate the efficacy and safety of combination therapy of 10 mg mitiglinide or 0.2mg
      voglibose with insulin glargine for 16 weeks after single administration of insulin glargine
      for 4 weeks in type 2 diabetic patients whose glycemic control were not enough despite
      administration of oral antidiabetic drug or insulin glargine.
    


Intervention name(s): Mitiglinide; Voglibose
Intervention type(s): Drug; Drug
Intervention description(s): mitiglinide 10mg three times a day before a meal; voglibose 0.2mg three times a day before a meal
Other intervention name(s): Glufast; Basen
Intervention MeSH terms: Voglibose; Mitiglinide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes mellitus, Type 2; mitiglinide
Post-marketing Safety Study to Assess the Risk of Spontaneous Abortions in Women Exposed to Cervarix Residing in UK
Condition: Infections, Papillomavirus
MeSH terms: Abortion, Spontaneous
Study type: Observational

Summary: 
      This study will assess the risk of spontaneous abortion during weeks 1-23 and weeks 1-19 of
      gestation, respectively, and other pregnancy outcomes, in an exposed cohort, i.e. women with
      last menstrual period (LMP) between 30 days before and 45 days after, or 30 days before and
      90 days after any dose of Cervarix, when compared to a non-exposed cohort, i.e. women with
      LMP between 120 days and 18 months after the last Cervarix dose. The data collected in the
      Clinical Practice Research Datalink General Practitioner OnLine Database (CPRD GOLD) in the
      UK, will be analysed in this study.
    

Detailed description: 
      Convenience sampling will be used in this study. It is planned to include all eligible
      pregnant women (included in CPRD GOLD and who fulfil to the inclusion/exclusion criteria) in
      each of the two cohorts.
    

Intervention name(s): Data Collection; Cervarix
Intervention type(s): Other; Biological
Intervention description(s): Analyses of data collected within the CPRD GOLD database.; Women with last menstrual period (LMP) between 30 days before and 45 days after, or 30 days before and 90 days after any dose of Cervarix and women with LMP between 120 days and 18 months after the last Cervarix dose.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women aged 15 to 25 years, residing in UK, exposed to Cervarix and whose data is
        recorded in the CPRD GOLD.
      
Keywords: Cervarix; Spontaneous abortion; Vaccine; Human Papillomavirus
Postoperative Pain After Endodontic Irrigation Using 1.3% Versus 5.25% Sodium Hypochlorite
Condition: Dental Pulp Necrosis
MeSH terms: Dental Pulp Necrosis; Pain, Postoperative; Necrosis
Study type: Interventional

Summary: 
      The aim of this prospective, randomized, clinical trial was to evaluate the effect of 1.3%
      sodium hypochlorite (NaOCl) concentration versus 5.25% NaOCl concentration on post-operative
      pain and medication intake in adult patients with pulp necrosis in mandibular molars.
    

Detailed description: 
      The aim of this prospective, randomized, clinical trial was to evaluate the effect of 1.3%
      sodium hypochlorite (NaOCl) concentration versus 5.25% NaOCl concentration on post-operative
      pain and medication intake in adult patients with pulp necrosis in mandibular molars. Medical
      and dental history was obtained from all participants in this trial and clinical and
      radiographic evaluation for teeth was recorded. Participants with pulp necrosis with or
      without apical periodontitis were included. After access cavity preparation, participants
      were randomly assigned to one of the following groups: experimental group (irrigation using
      1.3% NaOCl) or control group (irrigation using 5.25% NaOCl ). Two-visit root canal treatment
      was performed with a week interval in between visits. Each patient received a 7-day diary to
      record postoperative pain and rescue medication intake. Post-operative pain was measured at
      the following time points: immediately , 3, 24, 48 hours and 7 days after the first visit and
      postobturation.
    

Intervention name(s): 1.3% NaOCl; 5.25% NaOCl
Intervention type(s): Other; Other
Intervention description(s): Endodontic irrigant; Endodontic irrigant
Other intervention name(s): 1.3% sodium hypochlorite; 5.25% sodium hypochlorite
Intervention MeSH terms: Sodium Hypochlorite; Eusol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
The Impact of Dosimeter on Measurement of Airway Responsiveness to Methacholine
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      To determine whether there is a difference in two different breathing tests used to detect
      asthma. Hypothesis: The Digidoser delivers less methacholine to the airways and will result
      in a higher PC20 than the value determined by the Rosenthal Dosimeter.
    

Detailed description: 
      Bronchoprovocation with methacholine is used to confirm the diagnosis of asthma. The
      procedure involves inhaling methacholine through a nebulizer attached to a dosimeter that
      delivers a precise volume of methacholine. The endpoint of the test is the provocational
      concentration that produces a 20% decrease in FEV1 (PC20). To standardize the procedure, the
      American Thoracic Society (ATS) recommends that the nebulizer output be calibrated to deliver
      an output of 0.9 ± 0.09 mL/min.

      The Rosenthal Dosimeter and the KoKo Digidoser are two commonly used dosimeters. In an
      attempt to follow the ATS guideline we discovered that the nebulizer output was lower with
      the KoKo Digidoser and could not be calibrated. However, it is unclear whether the apparent
      lower output is a result of the Digidoser delivering less solution or that the ATS method of
      determining output is not applicable to this dosimeter. To answer this question, we propose
      to determine the methacholine PC20 in subjects with asthma using the two dosimeters. It is
      our hypothesis that the Digidoser delivers less methacholine and thus will produce a higher
      PC20 than the Rosenthal Dosimeter.

      Twelve nonsmoking subjects with mild asthma will be selected on the basis of > 18 years of
      age, a baseline FEV1 of > 60% predicted and a screening PC20 of < 8mg/ml. Subjects will be
      randomized to perform a methacholine challenge with the Digidoser and the Rosenthal Dosimeter
      on two different days in an unblinded, crossover manner. The geometric mean PC20 with each
      dosimeter will be compared with a paired t test. The results of this study will indicate
      whether the Digidoser has the potential of causing false negative test results or whether the
      ATS method of determining output should not be used with this dosimeter.
    

Intervention name(s): methacholine; KoKo Digidoser; Rosethal Dosimeter
Intervention type(s): Drug; Device; Device
Intervention MeSH terms: Methacholine Chloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: methacholine PC20; dosimeter; asthma
Neuromotor Control During Walking in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      One out of every three children with cerebral palsy (CP) falls daily, with more than half of
      the falls occurring while walking. To avoid falling, the nervous system must continuously
      monitor how the body moves and, when an imbalance is detected, activate muscles for an
      appropriate correction. In this project, we will use small electrical stimulation of muscles
      and tendons that enhances the sense of body positioning, to allow children with CP to
      generate more accurate balance corrections.
    


Intervention name(s): Stochastic Resonance (SR)
Intervention type(s): Device
Intervention description(s): The system consists of six linear isolated stimulators (STMISOLA, Biopac Systems, Inc., Goleta, USA). The SR signal (Gaussian White Noise, zero mean) will be generated through a 16 bit PCI 6733 National Instruments multifunction data acquisition card by a custom LabView program. The stimulation sites include the ankle, lateral soleus, peroneus longus, and tibialis anterior muscles and the hip.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Cross sectional study of responses to visual perturbations in two groups, children with CP and age-and sex- matched TD (typical development). Each group will undergo two stimulation conditions, stochastic resonance (SR) stimulation and a control / no stochastic resonance (noSR) condition while walking with and without visual perturbations.
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: locomotor control; balance
Understanding the Role of Gut Microbiota in Hyperphagia in Prader-Willi Syndrome
Condition: Prader-Willi Syndrome; Obesity
MeSH terms: Prader-Willi Syndrome; Syndrome; Hyperphagia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to use a high-fiber supplementation, an intervention known to create shifts
      in the gut microbiota towards a healthier structure, to explore the relationship between gut
      microbiota, appetite control and feeding behavior in PWS patients.
    

Detailed description: 
      This study is recruiting PWS patients aged 18-35 years who have not received growth hormone
      treatment in the previous 6 months. Study candidates will be recruited from Robert Wood
      Johnson. Participants will attend a baseline visit at the Center for Advanced Human Brain
      Imaging Research (CAHBIR) at Rutgers University, during which functional magnetic resonance
      imaging (fMRI) coupled with a meal test will be performed to assess peripheral and central
      feeding pathways (7, 8). fMRI scans will be performed during resting state to assess
      functional connectivity of feeding related networks, with a specific focus on connectivity
      between the hypothalamus, insula, anterior cingulate, ventromedial/orbitofrontal prefrontal
      cortex and amygdala (9, 10). Activation to food (vs non-food) images will be assessed to
      index responsivity to appetitive feeding networks including the above regions and the ventral
      striatum using paradigms that have previously been found to be sensitive to trait and state
      in multiple studies (11-13). Thereafter participants will consume a liquid meal (525 kcal;
      Ensure Plus, Abbott). fMRI will be repeated immediately after the meal. Participants will
      obtain laboratory work coupled with a meal test to assess satiety hormones and inflammatory
      markers. Fasting blood draw will be taken, and the participants will consume a liquid meal
      (525 kcal; Ensure Plus, Abbot) followed by blood draws at 30, 60, 120, 180 and 240 min
      post-meal. Upon completion of baseline testing and providing a fecal sample, participants
      will consume NBT-NM108 (a mixture of inulin, Fibersol-2, and brans of oat, wheat, corn and
      sorghum; Notitia Biotechnologies) daily for 4 weeks. At the completion of the 4-week
      intervention, all sampling and testing will be repeated as per baseline. At baseline and end
      of intervention, participants will be interviewed with appetite and physical activity
      questionnaires (Appendix C and G) and requested to complete a 24-h food recall using
      MyFitnessPal, a mobile health app on their phone.
    

Intervention name(s): NBT-NM108
Intervention type(s): Drug
Intervention description(s): All patients will consume NBT-NM108 in the form of 2 muffins daily.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Strides for Life I: Increasing Physical Activity in Stage 1 Lung Cancer Patients
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      This randomized controlled trial will evaluate, among 54 stage early stage lung cancer
      patients, whether a behavioral intervention versus an educational Control group results in
      improved function at 6-months.
    

Detailed description: 
      This is a two arm randomized controlled trial that will evaluate, among 54 stage 1 non-small
      cell lung cancer patients, whether induction of positive affect vs. an educational Control
      group, results in improved function as assessed by the 6-minute Walk Test. Our primary
      outcome will be a within-patient change in the 6-Minute Walk Test at 6 months.
    

Intervention name(s): Physical activity plus positive affect; Physical activity plus education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects will be randomized to a physical activity goal and will receive the positive affect component.; Subjects will be randomized to a physical activity goal and will receive the educational component.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Physical activity; non-small lung cancer; positive affect
A Study to Compare Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% to Acanya® Topical Gel in the Treatment of Acne Vulgaris
Condition: Acne
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study was to evaluate the efficacy and safety of Perrigo's test
      formulation of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% compared to
      the already marketed formulation, Acanya gel in patients with acne vulgaris.
    


Intervention name(s): Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5%; Acanya Gel; Placebo of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% product
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Test product; Reference product; Placebo product
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Identification of Markers (Klotho-FGF23 Axis) as Determinant in the Evolution of Arterial Stiffness During the First Year of Renal Transplant
Condition: Renal Transplant
Study type: Interventional

Summary: 
      The primary objective is to show that the contribution of Klotho by the renal graft is an
      independent determinant of the evolution of the recipient's central arterial stiffness during
      the first year of renal transplant. The contribution of Klotho by the graft will be estimated
      by: its circulating concentrations assay, its urinary excretion assay, and, indirectly, by
      the circulating concentrations of FGF23. The recipient's central arterial stiffness will be
      estimated by the measure of the carotid-femoral pulse wave velocity, noninvasive reference
      method for measuring aortic stiffness in human.
    


Intervention name(s): Biological sample; Non invasive Arterial investigations; Abdominal tomodensitometry
Intervention type(s): Biological; Procedure; Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Arterial stiffness; Klotho-FGF23
A Study to Investigate the Effect of RO7049389 on the Pharmacokinetics of Pitavastatin in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of the study is to characterize the interaction between RO7049389 and the
      cholesterol-lowering drug, pitavastatin, in healthy volunteers. There is no intended clinical
      benefit to this study. The total duration of the study for each participant is approximately
      12 weeks.
    


Intervention name(s): RO7049389; Pitavastatin
Intervention type(s): Drug; Drug
Intervention description(s): RO7049389 will be taken orally, in tablet form, BID on Days 1-6 of Period 2.; Pitavastatin will be taken orally, in tablet form, once on Day 1 of Period 1, and once on Day 4 of Period 2.
Intervention MeSH terms: Pitavastatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function
Condition: Hypogonadism, Male
MeSH terms: Hypogonadism; Eunuchism
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates anastrazole and clomiphene in the improvement in hypogonadal symptoms
      and erectile function. Each subject will receive Anastrazole 1 mg/day, clomiphene 25 mg/day
      and placebo in randomized schedule of 8 week intervals.
    

Detailed description: 
      Aromatase inhibitors (AI) (Anastrazole) and selective estrogen receptor modifiers
      (SERMS)(clomiphene) increase testosterone production through stimulation of the hypothalamic
      pituitary axis. While these drugs both reduce the feedback inhibition of estrogen on the
      pituitary, SERMs cause an increase in serum estradiol, whereas AIs reduce estradiol levels.
      Using these medications, we can obtain therapeutic testosterone levels with either an
      increase or decrease in estradiol levels.
    

Intervention name(s): Anastrozole 1mg; Clomiphene Citrate 25mg; Placebo - Cap
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Anastrozole; Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Drug Interaction Study Between AZD3480 and Cytochrome P450
Condition: Metabolism; Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate if AZD3480 inhibits Cytochrome P450 1A2, 2C19, 3A4,
      2C8, 2B6 and UGT1A1 activity.
    


Intervention name(s): AZD3480; Placebo; Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Capsule, oral, dose once daily, 7 days; Capsule, oral, dose once daily, 7 days; Cocktail mix which contains the following:
CYP1A2 (Caffeine), CYP2B6 (Bupropion), CYP2C8 (Rosiglitazone), CYP2C19 (Omeprazole), CYP3A4 (Midazolam), UGT1A1 (Bilirubin)
single dose of mix
Intervention MeSH terms: Rosiglitazone; Midazolam; Caffeine; Bupropion; Omeprazole; Bilirubin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: AZD3480; Cocktail; caffeine; bupropion; omeprazole; midazolam; rosiglitazone; metabolism; Drug Drug Interaction