bioihbjkbjnl/mcl2 huggingface dataset:
Tiotropium Bromide Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2, Randomized, Partially-blinded, Parallel Group, Dose-ranging Study to Assess the
      Pharmacodynamics, Relative Bioavailability, and Safety of Three Doses of Tiotropium Bromide
      Inhalation Solution in Subjects with Chronic Obstructive Pulmonary Disease
    

Detailed description: 
      Objectives:

      Primary:

      • To determine the effect of once daily dosing with tiotropium bromide inhalation solution
      for 22 consecutive days on trough forced expiratory volume in 1 second (FEV1) change from
      baseline compared with that of placebo inhalation solution in subjects with chronic
      obstructive pulmonary disease (COPD).

      Secondary:

        -  To determine the effect of once daily dosing with tiotropium bromide inhalation solution
           for 22 consecutive days on trough FEV1 change from baseline compared with that of
           Spiriva Respimat; area under the curve (AUC) FEV10-6 change from baseline compared with
           that of placebo and Spiriva Respimat; and trough forced vital capacity (FVC) change from
           baseline compared with that of placebo and Spiriva Respimat

        -  To assess the safety and tolerability of tiotropium bromide inhalation solution in
           subjects with COPD

        -  To assess the relative bioavailability of tiotrop
    

Intervention name(s): Tiotropium bromide inhalation solution; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tiotropium bromide inhalation solution; Placebo comparator
Intervention MeSH terms: Bromides; Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-004)
Condition: Streptococcus Pneumoniae Infection; Pneumococcal Infections
MeSH terms: Infections; Communicable Diseases; Pneumonia, Pneumococcal; Pneumococcal Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to assess the safety, tolerability, and immunogenicity of 5 different
      formulations of V114 in healthy adults and infants. Adults only will be enrolled in Period 1
      and infants only will be enrolled in Period 2; Period 1 will complete prior to the start of
      Period 2.
    


Intervention name(s): Prevnar 13®; V114 1x:1x:1x; V114 2x:2x:2x; V114 2x:1x:2x; V114 1x:1x:2x; V114 0.5x:0.5x:2x
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 µg each), and 6B (4.4 µg) in each 0.5 mL dose.; V114 1x:1x:1x contains 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of Aluminum Phosphate Adjuvant (APA).; V114 2x:2x:2x contains 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA.; V114 2x:1x:2x contains 4.0 μg of polysaccharide serotypes 6A, 18C, 19A, 19F, and 23F; 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 7F, 9V, 14, 22F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA.; V114 1x:1x:2x contains 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA.; V114 0.5x:0.5x:2x contains 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
MOMENTUM 3 IDE Clinical Study Protocol
Condition: Advanced Refractory Left Ventricular Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by
      demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of
      advanced, refractory, left ventricular heart failure.
    

Detailed description: 
      The HM3 LVAS is intended to provide hemodynamic support in patients with advanced, refractory
      left ventricular heart failure; either for short term support, such as a bridge to cardiac
      transplantation (BTT) or myocardial recovery, or as long term support, such as destination
      therapy (DT). The HM3 is intended for use inside or outside the hospital.
    

Intervention name(s): HeartMate 3 LVAS; HeartMate II LVAS
Intervention type(s): Device; Device
Intervention description(s): Implantation of HeartMate 3 LVAD to evaluate the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure; Implantation of the commercially approved HeartMate II LVAD which is the standard treatment for advanced heart failure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heart Failure; Left Ventricular Assist Device; Ventricular Dysfunction; Cardiomyopathy; Heart Disease; Cardiovascular Disease; Heart-assist devices; Thoratec Corporation
p28 in Treating Younger Patients With Recurrent or Progressive Central Nervous System Tumors
Condition: Teratoid Tumor, Atypical; Choroid Plexus Neoplasms; Anaplastic Astrocytoma; Anaplastic Oligodendroglioma; Brainstem Tumors; Giant Cell Glioblastoma; Glioblastoma; Gliosarcoma; Medulloblastoma; Neuroectodermal Tumor, Primitive
MeSH terms: Neoplasms; Glioblastoma; Astrocytoma; Gliosarcoma; Medulloblastoma; Oligodendroglioma; Neuroectodermal Tumors; Neuroectodermal Tumors, Primitive; Brain Stem Neoplasms; Choroid Plexus Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I trial studies the side effects and best dose of azurin-derived cell-penetrating
      peptide p28 (p28) in treating patients with recurrent or progressive central nervous system
      tumors. Drugs used in chemotherapy, such as azurin-derived cell-penetrating peptide p28, work
      in different ways to stop the growth of tumor cells, either by killing the cells or by
      stopping them from dividing.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To establish whether the adult recommended phase II dose of 3x/week bolus infusions of
      p28is safe for pediatric patients with recurrent/refractory central nervous system (CNS)
      tumors.

      II. To describe dose-limiting toxicities of 3x/week bolus infusions of p28 in pediatric
      patients with recurrent/refractory CNS tumors.

      III. To evaluate and characterize the plasma pharmacokinetics of p28 in children with
      recurrent/ refractory CNS tumors.

      SECONDARY OBJECTIVES:

      I. To describe in the context of a phase I trial any observed antitumor activity of p28.

      II. To investigate levels of p53 in clinical tumor specimens of patients with pediatric
      gliomas and other pediatric CNS tumors treated with p28.

      III. To document the type/site(s) of p53 mutation in tumor tissue specimens. IV. To evaluate
      and characterize the intratumoral pharmacokinetics of p28 in children with recurrent/
      refractory CNS tumors, if available.

      OUTLINE: This is a dose-escalation study.

      Patients receive azurin-derived cell-penetrating peptide p28 intravenously (IV) over 15
      minutes thrice weekly for 4 weeks. Treatment repeats every 6 weeks for up to 10 courses in
      the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up for at least 30 days.
    

Intervention name(s): azurin-derived cell-penetrating peptide p28
Intervention type(s): Drug
Intervention description(s): Given IV
Other intervention name(s): azurin-derived CPP p28
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Open, Single Center, Three Periods, Fixed Sequence Design Study on the Effects of Clopidogrel Co-administration on the Pharmacokinetics of Neramexane
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary:

      To assess the effects of CYP2B6 inhibition by repeated dose Clopidogrel (75 mg/day)
      co-administration on the single-dose pharmacokinetics of Neramexane

      Secondary:

      To assess safety and tolerability of Neramexane single dose treatment alone and
      co-administration of a Neramexane single-dose with a Clopidogrel repeated dose treatment
    


Intervention name(s): Neramexane
Intervention type(s): Drug
Intervention description(s): Drug-Drug Interaction Study
Masking: None (Open Label)
A Drug-Drug Interaction Study Between Sotagliflozin and Ramipril
Condition: Diabetes Mellitus; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To evaluate the effects of multiple-dose ramipril on the steady state pharmacokinetic (PK)
      parameters of sotagliflozin and its main metabolite (sotagliflozin-3-O-glucuronide) in
      healthy male and female subjects.

      Secondary Objectives:

        -  To assess the effects of multiple-dose sotagliflozin on the PK of ramipril and its
           active metabolite (ramiprilat).

        -  To assess the safety and tolerability of multiple-dose sotagliflozin with and without
           multiple-dose of ramipril.
    

Detailed description: 
      The expected duration of subject participation, including Screening of up to 29 days,
      Treatment Periods of 6 days and 11 days each with a Washout period of minimum of 7 days in
      between periods, Follow-up period of 6 days, and end-of-study-period of 10-14 days after last
      sotagliflozin dose, is approximately 66 days.
    

Intervention name(s): Sotagliflozin (SAR439954); Ramipril
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: tablets
Route of administration: oral; Pharmaceutical form: tablets
Route of administration: oral
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol; Ramipril
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Computerized Anger-Reduction Treatment for Smoking Cessation
Condition: Anger; Smoking Cessation
Study type: Interventional

Summary: 
      Problematic anger is a strong predictor of failed attempts at smoking cessation. The
      investigators proposed study seeks to evaluate whether a novel 8-session computerized
      anger-reduction treatment improves quit rates among smokers. Smokers with elevated trait
      anger will be administered transdermal nicotine patch therapy and either anger-reduction
      treatment or a control intervention. They will be assessed throughout treatment and up until
      three months after a scheduled mid- treatment quit date. The investigators propose to test
      whether, compared to the control condition, the anger-reduction treatment will lead to: 1)
      greater reductions in anger and 2) greater abstinence rates at post-cessation and at
      follow-up assessments. The investigators will also test whether changes in anger-related
      symptoms account for group differences in abstinence rates.
    

Detailed description: 
      The current proposal seeks to evaluate an eight-session, computerized, anger-focused
      intervention for smokers (Anger Reduction Treatment or ART). The investigators will
      administer this intervention to smokers (N = 114) who are interested in quitting and have
      elevated levels of trait anger. Participants will be randomly assigned to receive either: (1)
      computerized ART, consisting of interpretation bias modification, or (2) a computerized
      control condition, which consists of health education and relaxing video clips. The
      computerized sessions (eight total) will take place twice a week for four weeks. All
      participants will have a scheduled quit date for the beginning of the third week of treatment
      (i.e., at mid-treatment). All participants will also receive nicotine patch therapy to use at
      their scheduled quit date. Anger symptoms, smoking cravings, and smoking frequency will be
      assessed throughout treatment. Smoking status, anger, and other measures of negative affect
      will also be assessed at baseline and regularly for 12-weeks following the scheduled quit
      date.

      The investigators will test whether, compared to the control condition, the anger-reduction
      treatment will lead to: 1) greater reductions in anger and 2) greater abstinence rates at
      post-cessation and at follow-up assessments. The investigators will also test whether changes
      in anger-related symptoms account for group differences in abstinence rates.
    

Intervention name(s): Anger Reduction Treatment; Control Condition
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Eight 30-minute sessions of interpretation modification to reduce angry interpretation biases.; Eight 30-minute sessions of informative videos on healthy living and relaxation videos.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Tolerability of the Ophthalmic Solution PRO-156 in Ophthalmologically Healthy Volunteers.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety and tolerability of the ophthalmic solution
      PRO-156 over the ocular surface of ophthalmologically healthy volunteers
    

Detailed description: 
      A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability
      of the ophthalmic solution PRO-143 over the ocular surface of ophthalmologically healthy
      volunteers.
    

Intervention name(s): PRO-156
Intervention type(s): Drug
Intervention description(s): Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.
Other intervention name(s): Ketorolac
Intervention MeSH terms: Ketorolac
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to evaluate, in patients with Type 2 Diabetes Mellitus, whether
      Canakinumab can lower Glycosylated hemoglobin / hemoglobin A1c (HbA1c) and/or peak glucose
      levels in response to an oral glucose tolerance test (OGTT).
    


Intervention name(s): Canakinumab; Placebo; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Canakinumab given as single dose IV injection of 0.03 mg/kg, or single dose IV infusion at doses of 0.1 mg/kg 0.3 mg/kg, 1.5 mg/kg or 10 mg/kg.; Placebo to Canakinumab given as single dose IV injection of 0.03 mg/kg, or single dose IV infusion at doses of 0.1 mg/kg 0.3 mg/kg, 1.5 mg/kg or 10 mg/kg.; Participants continued on their stable daily dose of metformin throughout the study
Other intervention name(s): ACZ885; Glucophage; Glumetza
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; Canakinumab; ACZ885; IL-1B antagonist; metformin; glycemic control; insulin sensitivity
Bioavailability of Maqui Berry Extract (MBE) in Healthy Subjects
Condition: Bioavailability
Study type: Observational

Summary: 
      The aim of the present study is to describe the bioavailability for the proprietary
      standardized maqui berry extracts Delphinol® and MaquiBright® enriched in anthocyanins and in
      particular delphinidins. The analyses are based on two selected key substances namely
      delphinidin-3-glucoside and cyanidin-3-sambubioside and their metabolism to phenolic acids.

      The bioavailability of anthocyanins specific for Delphinol®/MaquiBright® was analyzed in
      plasma sample kinetics (at 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h and 8h after intake of 1000mg
      standardized maqui berry extract in capsules) in 12 healthy subjects.
    


Intervention name(s): Standardized maqui berry extract enriched in anthocyanins
Intervention type(s): Dietary Supplement
Intervention description(s): Single oral intake of 1000mg standardized maqui berry extract (in 4 capsules - 250mg each) with 200ml still water
Other intervention name(s): Delphinol® / MaquiBright®
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        normal population
      
Biospecimen description: 
      plasma samples
    
Keywords: anthocyanins, maqui berries, bioavailability
Appetite Regulation and Mycoprotein
Condition: Appetite; Energy Intake
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of eating various levels of
      mycoprotein (Quorn) on feelings of appetite, energy intake and levels of gut hormones in
      overweight volunteers.
    

Detailed description: 
      Owing to its relatively high protein and fibre content, mycoprotein presents an attractive
      food product to improve appetite regulation and postprandial glycaemic and insulin responses
      in overweight and obese individuals at risk of developing T2DM
    

Intervention name(s): mycoprotein; control protein
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: appetite; overweight; energy intake; obesity; gut hormones
A Randomized, Open-label, Three-arm Study of MZRW on Tolerability, Exposure and Pharmacokinetics
Condition: Functional Constipation; Gastrointestinal Disorders
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Constipation
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized open-label, three-arm, phase 1 clinical study. The investigators aim to
      investigate a Chinese Proprietary Medicine, MZRW on its tolerability, system exposure and
      pharmacokinetics profile.
    

Detailed description: 
      This is a randomized, open-label, three-arm study. The participants will be enrolled and
      randomized in a ratio of 1:1:1 to receive 5.0g, 7.5g, 10g b.i.d. of MZRW at 9 am
      respectively. The study drug, MZRW will be administrated to the participants by site
      personnel after participants have fasted overnight for more than 8 hours and 6 hours after
      administration. Each participant will consume a standardized meal. In addition, the
      participants refrain from Semen Cannabis Sativae, Semen Pruni Armeniacae, Radix Paeoniae,
      Fructus Immaturus Citri Aurantii, Cortex Magnoliae and Radix et Rhizoma Rhei foods for 3 days
      before the study until completion of the study.

      Blood samples (5 ml each) will be collected from the medial cubital vein into evacuated tubes
      containing heparin just before and at 0.25, 0.5, 1, 2, 4, 8, 12h after administration and
      were immediately centrifuged (1700g, 10 min). Plasma fractions were stored at -20°C until
      analysis. All study procedures conduct in accordance with the ethical principles of the
      Declaration of Helsinki, consistent with Good Clinical Practice guidelines, and approved by
      Hong Kong Baptist University Ethics Committee on the Use of Human Subjects for Teaching and
      Research. Subjects will be given their written informed consent before participating in the
      study. Urine samples (50 ml each) will be collected the day before the administration and at
      0 to 3h, 3 to 6h, 6 to 9h and 9 to 12h after administration. Plasma and urine fractions will
      be stored at -80°C until analysis.
    

Intervention name(s): MZRW
Intervention type(s): Drug
Intervention description(s): MZRWs is composed of Fructus Cannabis (HuoMaRen), Radix et Rhizoma Rhei (DaHuang), Radix Paeoniae Alba (BaiShao), Semen Armeniacae Amarum (KuXingRen), Fructus Aurantii Immaturus (ZhiShi) and Cortex Magnoliae Officinalis (HouPo). All MZRW granules will be prepared by PuraPharm International (H.K.) Limited. The entire manufacturing process, from authenticating the raw materials to the final products, is in strict compliance with the standards of Good Manufactory Practice (GMP) and Chinese Pharmacopoeia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Randomized open-label study; Chinese Herbal; Constipation/drug therapy
Interactive Effects of IV Ethanol and IV Nicotine
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      There are mixed reports on nicotine's effects on ethanol-induced impairment in cognitive
      performance and behavior in humans. The main objective of this study is to characterize the
      interactive effects of acute intravenous (IV) ethanol and nicotine administration on
      cognition and behavior in healthy smokers. The general hypothesis is that nicotine will
      attenuate the negative effects of ethanol on cognition and subjective stimulant/sedative
      effects of ethanol.
    


Intervention name(s): Intravenous ethanol placebo plus nicotine infusions; intravenous ethanol 40mg% plus nicotine infusions; intravenous ethanol 100mg% plus nicotine infusions
Intervention type(s): Drug; Drug; Drug
Intervention description(s): nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg; nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg; nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg
Intervention MeSH terms: Ethanol; Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Intravenous Ethanol; Intravenous Nicotine; Interactive effects; cognition; subjective effects; healthy subjects