bioihbjkbjnl/mcl2 huggingface dataset:
Relative Bioavailability of Single Oral Doses of Dabigatran Etexilate With or Without Oral Administration of Verapamil in Two Different Dosages in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate whether and to what extent the P-glycoprotein inhibitor (P-gp) verapamil
      affects the pharmacokinetic parameters of dabigatran with verapamil given at different
      dosages, in different formulations (immediate release (IR) and extended release (ER)), and in
      different intervals in relation to the dabigatran dose.
    


Intervention name(s): dabigatran; Verapamil; Verapamil ER
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Verapamil; Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess the Safety and Pharmacokinetics of ADASUVE® at Doses of 2.5, 5, or 10 mg in Children and Adolescents (10 Through 17 Years of Age) With Any Condition Warranting Chronic Use of an Antipsychotic Medication
Condition: BiPolar
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the pharmacokinetics of loxapine and will be using plasma
      concentration data obtained over 48 hours after administration of the study drug
    


Intervention name(s): ADASUVE®
Intervention type(s): Drug
Intervention description(s): ADASUVE® 2.5, 5, or 10 mg
Other intervention name(s): STACCATO® Loxapine for Inhalation
Intervention MeSH terms: Loxapine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of DA-8159 in Subjects With Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study will be to evaluate the clinical efficacy and safety of DA-8159, an
      orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment
      of subjects with erectile dysfunction (ED).
    

Detailed description: 
      This will be a multi-center, randomized, double-blind, placebo-controlled, parallel-group
      study in 300 erectile dysfunction patients. Patients will complete a screening visit (V1) to
      determine eligibility for the study based on the International Index of Erectile Function
      (IIEF) erectile function (EF) domain scores, patient history and safety measures. Patients
      that meet the entrance criteria for this study will enter a 4 week, drug-free run-in period
      to establish a baseline for the erectile function domain score and to meet the criteria for
      participation in the study.

      Patients successfully completing screen will be randomly assigned to one of four treatment
      groups at Visit 2 (V2): placebo or one of 3 active drug doses of DA-8159 tablets. Patients
      will be given medication for at-home use and will also be given diaries for recording
      information regarding sexual encounters, quality of erections and adverse events. At 4-week
      intervals for 3 months (V3, V4, V5), patients will return to the clinic to review and collect
      SEP diaries, safety data, 12-lead ECG and medication reconciliation. In addition, at each
      4-week interval patients will complete an IIEF, and at Visit 5 will have blood drawn for
      safety evaluation.

      The primary efficacy end points are: a) the change in score (baseline to Visit 5) for the
      Erectile Function domain score of the IIEF, b) change in response, relative to baseline, for
      sexual encounter profile (SEP) question 2, and c) change in response, relative to baseline,
      for SEP question 3. For DA-8159 tablets to be judged efficacious, the DA-8159 tablet groups
      must be shown superior to the placebo group on all three measures.
    

Intervention name(s): DA-8159
Intervention type(s): Drug
Intervention MeSH terms: Udenafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Erectile Dysfunction
Suitability of a Low Dose Lipopolysaccharide (LPS) Inhalation as a Challenge Model
Condition: Healthy
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      This pilot study is planned to assess the suitability of a low dose Lipopolysaccharide (LPS)
      inhalation as a challenge model. As LPS effects are based on a different mode of action, this
      challenge model will provide the possibility to test a wider spectrum of potential drugs in
      the future. Provided that the LPS response is reproducible, it is planned to test whether a
      single high dose of inhaled steroid can serve as a positive control in the LPS model. Another
      major aim of the study is to test a variety of novel tools for the non-invasive assessment of
      airway inflammation induced by LPS challenge.
    

Detailed description: 
      In this study, airway inflammation will be induced by LPS inhalation. In case a neutrophilic
      airway inflammation can be safely induced by inhaled LPS, the LPS challenge will be repeated.
      If neutrophil airway inflammation after LPS challenge is reproducible LPS challenge will be
      repeated after pre-treatment with a single high dose of inhaled fluticasone propionate.

      To determine airway inflammation, the subjects' exhaled breath will be analyzed by different
      techniques, and blood samples as well as induced sputum will be collected.
    

Intervention name(s): LPS challenge with nebulized LPS; fluticasone propionate (FP)
Intervention type(s): Drug; Drug
Intervention description(s): 20,000 EU of Clinical Center Reference Endotoxine (CCRE) will be applied by an AKITA® Jet Nebulizer under the constant supervision of the site staff.; The dosage of FP will be 2 mg. This dosage will be inhaled by 4 puffs of Flutide® forte 500 Diskus® 500 µg / dose according to the package insert.
Intervention MeSH terms: Fluticasone; Xhance
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety, Tolerability and PD Activity of Inhaled TPI 1020 Versus Inhaled Budesonide in COPD Patients
Condition: Copd Bronchitis
MeSH terms: Bronchitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess and compare the safety and tolerability of inhaled TPI 1020 (repeated
      nominal doses; 500 μg BID x 6 weeks) versus inhaled budesonide (repeated doses; 800 μg BID x
      6 weeks) and a matching placebo. Pharmacodynamic (PD) activity on FEV1, sputum and blood
      cells and cytokines will also be studied.
    

Detailed description: 
      A multi-centre, randomized, placebo and active-controlled, 6-week study of inhaled TPI 1020,
      inhaled budesonide or matching placebo (random allocation of eligible patients to the three
      treatments at a ratio of 3:3:1), to evaluate the safety, tolerability and pharmacodynamic
      activity of TPI 1020 in 42 evaluable COPD subjects.
    

Intervention name(s): TPI 1020; Budesonide; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 250 mcg/caps 2 caps BID x 42 days; 400mcg mcg capsules- 2 capsules BID; 2 caps BID x42 days
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Ascending Multiple Dose Study With VTP-43742 in Healthy Volunteers and Psoriatic Patients
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a two-part, randomized, double-blind, placebo-controlled study in which VTP-43742
      will be administered to normal healthy volunteers (NHV) and to moderate to severe psoriatic
      patients, both in sequential ascending dose panels.
    

Detailed description: 
      This is a prospective, randomized, double-blind, placebo-controlled, ascending multiple dose
      study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics effects of
      VTP-43742 in healthy volunteers conducted at a single, study center and in patients with
      moderate to severe chronic plaque-type psoriasis at approximately 8 study centers in the
      United States. A total of 108 participants will be enrolled in the study (48 healthy subjects
      and 60 psoriatic patients).
    

Intervention name(s): VTP-43742; Placebo 1; Placebo 2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): VTP-43742 administered as an oral capsule once daily; Placebo 1 matching VTP-43742 administered as an oral capsule once daily; Placebo 2 matching VTP-43742 administered as an oral capsule once daily
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Safety, Tolerability and Effects of MEDI-563 in Adults With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate the safety and tolerability of MEDI-563 in adults with asthma and the effects of
      MEDI-563 on eosinophil counts in airway mucosal biopsies
    

Detailed description: 
      Evaluate the safety and tolerability of MEDI-563 in adults with atopic asthma; and evaluate
      the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies 28 days after
      completion of dosing in adults with atopic asthma.
    

Intervention name(s): MEDI-563; MEDI-563; Placebo Comp.; Placebo
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): 1.0 mg/kg IV: MEDI-563; 100 mg, 200 mg SC; Placebo SC; Placebo as a single IV infusion (Certain number of subjects)
Intervention MeSH terms: Benralizumab
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Pharmacodynamics of SEL-212 (Pegsiticase + SEL-110) in Subjects With Elevated Blood Uric Acid Levels
Condition: Gout
Study type: Interventional
Phase: Phase 1

Summary: 
      This Study will first evaluate the safety and pharmacokinetics of a single intravenous dose
      of SEL-110, a nanoparticle containing rapamycin, in subjects with elevated blood uric acid
      levels. This will be followed, in separate subjects, by evaluation of the safety,
      pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous dose of
      SEL-212, SEL-037 (pegsiticase) plus SEL-110, in subjects with elevated blood uric acid
      levels. Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is
      then excreted and SEL-110 is designed to prevent unwanted anti-drug-antibodies (ADAs) from
      forming.
    

Detailed description: 
      This Study will first evaluate the safety and pharmacokinetics of a single intravenous dose
      of SEL-110, a nanoparticle containing rapamycin, in subjects with elevated blood uric acid
      levels. This will be followed, in separate subjects, by evaluation of the safety,
      pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous dose of
      SEL-212, SEL-037 (pegsiticase) plus SEL-110, in subjects with elevated blood uric acid
      levels. Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is
      then excreted and SEL-110 is designed to prevent unwanted anti-drug-antibodies (ADAs) from
      forming. Cohorts of subjects in the SEL-110 only arms of the study will be given a single,
      ascending intravenous dose of SEL-110 and then monitored for safety and rapamycin levels
      (pharmacokinetics) over 30 days. Cohorts of subjects in the SEL-212 arms of the study will be
      given a single, ascending intravenous dose of SEL-110 with a fixed dose of SEL-037 and then
      monitored for safety, rapamycin levels, SEL-037 levels, uric acid levels and
      anti-drug-antibodies (ADAs) to SEL-037 for 30 days. One additional control group with receive
      a single intravenous infusion of SEL-037 at a fixed dose and then monitored for safety,
      SEL-037 levels, uric acid levels and anti-drug-antibodies (ADAs) to SEL-037 for 30 days
    

Intervention name(s): SEL-110; SEL-212; SEL-037
Intervention type(s): Drug; Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Remineralization Effects of Hydroxyapatite Toothpaste
Condition: Caries, Dental
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The objective of this in situ clinical study is to determine whether a toothpaste containing
      hydroxyapatite microclusters is as effective as a fluoridated kid's toothpaste in promoting
      remineralization of early caries lesions and inhibiting the development of caries lesions.
    

Detailed description: 
      The investigators hypothesize that (1) both the hydroxyapatite and the fluoridated toothpaste
      promote caries remineralization that is significantly greater than zero, and (2) the two
      toothpaste formulations are equally effective with respect to post-treatment remineralization
      and inhibition of demineralization.

        -  Non-inferiority will be considered established if there is no statistically significant
           difference in percentage of remineralization between the hydroxyapatite-containing
           toothpaste and the fluoridated kid's toothpaste for any one measurement method.

        -  Superiority/inferiority will be considered established if at least 20% statistically
           significant difference is observed between the hydroxyapatite-containing toothpaste and
           the fluoridated kid's toothpaste for any one measurement method
    

Intervention name(s): Hydroxyapatite toothpaste; Fluoridated toothpaste
Intervention type(s): Other; Other
Intervention description(s): If in a subject a significant increase of carious lesions will be observed, her/his parents are informed about the necessity for further caries preventive measures (e.g. dietary changes, use of fluoride products, reduction of cariogenic microflora with chlorhexidine, xylitol chewing gum, etc.) and caries preventive treatment (removing caries and placing a restoration) by the study centers is offered.; If in a subject a significant increase of carious lesions will be observed, her/his parents are informed about the necessity for further caries preventive measures (e.g. dietary changes, use of fluoride products, reduction of cariogenic microflora with chlorhexidine, xylitol chewing gum, etc.) and caries preventive treatment (removing caries and placing a restoration) by the study centers is offered.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Low Dose Ticagrelor Versus Low Dose Prasugrel in Patients With Prior Myocardial Infarction
Condition: Myocardial Infarction; Diabetes Mellitus; Coronary Artery Disease; Renal Disease
MeSH terms: Coronary Artery Disease; Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      Taken together the results from DAPT and PEGASUS-TIMI54, it appears that physicians may
      consider extending beyond 1 year or reinitiating treatment with a thienopyridine or
      ticagrelor 60mg bid in patients with a prior MI and features of high ischemic and low
      bleeding risk. Comparative clinical or pharmacodynamic studies, however, between prasugrel 5
      mg od and ticagrelor 60 mg bid in the chronic phase of stable post MI patients have not been
      performed.

      In light of this, we believe that a dedicated pharmacodynamic study of ticagrelor 60 bid mg
      vs prasugrel 5 mg od in a PEGASUS-like population would be informative for the practicing
      clinician, thus setting the rationale for conducting this specifically designed
      investigation.
    

Detailed description: 
      This is a prospective, randomized, single blind, single center, crossover study. Eligible
      patients undergoing P2Y12 receptor antagonist therapy before screening will undergo a 14-day
      minimum washout period before randomization. Following screening/washout period (visit 1),
      patients will be randomized (visit 2, time 0) in 1:1 fashion to either prasugrel 5 mg od or
      ticagrelor 60 mg bid. Following 14±2 days (visit 3) patients will receive alternate treatment
      for additional 14 days (visit 4). Platelet reactivity assessment will be performed with the
      VerifyNow P2Y12 reaction assay at time 0, prior to first study drug dose. At visit 3 platelet
      function will be assessed at 2-4 hours post dose and prior to crossover. At visit 4 also
      platelet function will be assessed at 2-4 hours post study drug post dose. All patients will
      receive concomitant aspirin (100 mg/d) and standard secondary prevention medication.

      The primary endpoint is the platelet reactivity measured in P2Y12 reaction units (PRU) at the
      end of the 2 study periods (pre-crossover and post-crossover).
    

Intervention name(s): Ticagrelor 60 mg; Prasugrel 5mg
Intervention type(s): Drug; Drug
Intervention description(s): Ticagrelor 60 mg twice daily; Prasugrel 5 mg once daily
Intervention MeSH terms: Ticagrelor; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: ticagrelor; prasugrel
Effect of Allopregnanolone on Stress-induced Craving
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this study is to determine whether intravenous infusion of allopregnanolone
      (ALLO) attenuates stress-induced craving and stress-induced anxiety in a clinical laboratory
      setting. The secondary objective of this project is to characterize the behavioral effects of
      ALLO in heavy drinkers.
    

Detailed description: 
      This is a double-blind, placebo-controlled study that will randomize 60 heavy "at risk"
      drinkers to 2 groups: targeted dose of targeted dose of 100 nM of ALLO (N=30) or placebo
      (N=30). Participants will receive a continuous infusion of ALLO (or placebo) for 175 min.
      Sixty min. after the start of the infusion, when ALLO levels are relatively stable, the
      stress induction paradigm will be introduced. Participants will be presented with a stress
      cue and a neutral cue in random order. Stress and neutral cues will consist of personalized 5
      min. scripts created prior to testing. Measures of stress-induced craving and stress-induced
      anxiety will be presented before the cue (pre), immediately following the cue (post) and 10
      min after (recovery).The study outcomes will include measures of stress-induced craving and
      stress-induced anxiety as well as measures of subjective mood effects, cognitive performance,
      and motor coordination.
    

Intervention name(s): Allopregnanolone; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): neurosteroid; placebo
Intervention MeSH terms: Pregnanolone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double blind, placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Effectiveness of a Home-based Ergonomic Intervention Program in Caregivers of Chronic Post-stroke Patients
Condition: Stroke; Quality of Life
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The objective of the present study is to evaluate the effectiveness of two home-based
      ergonomic intervention programs compared to a control group on the quality of life of
      caregivers of post-stroke patients
    

Detailed description: 
      Stroke is a neurological pathology that can cause functional problems and an impairment to
      perform activities of daily living at home.

      For this reason, these patients need the support of a caregiver. Caregivers of post-stroke
      patients often have also problems with their quality of life because of the care that they
      must provide. These problems appear mainly during the support tasks in the activities
      performed at the patient's home.

      The objective of the present study is to evaluate the effectiveness of two home-based
      ergonomic intervention programs compared to a control group on the quality of life of
      caregivers of post-stroke patients
    

Intervention name(s): Ergonomic intervention; Postural plus kinesiotherapy intervention program; Control or conservative intervention
Intervention type(s): Other; Other; Other
Intervention description(s): An ergonomic intervention program focused to caregivers, including recommendation about how they should help themself and the patients activities at home.; An ergonomic intervention program focused to caregivers, including recommendation about how they should help themself and the patients activities at home.; A control or conservative intervention, including general information about stroke disease for the caregivers of these patients
Other intervention name(s): A postural plus kinesiotherapy intervention program, including excercises for caregivers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Frequency of Sexual Intercourse,Women With Fibromyalgia
Condition: Fibromyalgia; Pain; Depression
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Observational

Summary: 
      Does frequency of sexual intercourse affect symptom severity in female patients with
      fibromyalgia?
    


Intervention name(s): Fibromyalgia Impact Questionnaire
Intervention type(s): Diagnostic Test
Intervention description(s): diagnostic tests
Other intervention name(s): Visual Analog Scale; Beck Depression Inventory; Widespread Pain Index; Symptom Severity Scale; frequency of sexual intercourse
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        tertiary healthcare facility