bioihbjkbjnl/mcl2 huggingface dataset:
Phase III Study to Evaluate the Efficacy and Safety of HOB-048 CR Tab. in Comparison With HOB-048 Syrup in Patients With Cough Due to Acute or Chronic Bronchitis
Condition: Evaluate the Efficacy and Safety of Levotuss CR Tab. in Comparison With Levotuss Syrup in Patients With Cough Due to Acute or Chronic Bronchitis
MeSH terms: Bronchitis; Bronchitis, Chronic; Cough; Acute Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized, double-blind, multicenter, active-controlled phase III study to evaluate the
      efficacy and safety of Levotuss CR tab. in comparison with Levotuss syrup in patients with
      cough due to acute or chronic bronchitis
    


Intervention name(s): Levotuss
Intervention type(s): Drug
Intervention description(s): oral taken
Intervention MeSH terms: Dipropizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Support for Cardiovascular Health in African American Primary Care Patients
Condition: Cardiovascular Diseases; Blood Pressure
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Project Overview:

      Poor hypertension control has dire consequences for the African-American population who
      suffer greater death and disability from heart disease, stroke, and renal failure than
      whites. To reduce these health disparities it is critical to promote of a healthy lifestyle
      in regard to diet, exercise, adherence to medications, as well as other behaviors. However,
      physicians usually fail to address lifestyle behaviors in the context of the harried patient
      visit. Therefore, the investigators hypothesized that the investigators could reduce
      cardiovascular risk by providing additional support to persons with poorly controlled
      hypertension through phone calls from trained peer patients and visits to an office support
      staff member.

      Study Design:

      A single-blind, randomized, controlled trial in 280 African-American primary care patients
      aged 40-75 with poorly controlled hypertension (HTN). The intervention group receives a
      practice-based team intervention that combines peer coach with office staff (i.e., medical
      assistant or licensed practice nurse) visits to address lifestyle challenges. Both
      intervention and control groups receive informational materials and healthy soul food recipes
      from the American Heart Association. The 6 month intervention alternates monthly phone calls
      from peer coaches about lifestyle behavioral changes with office-based visits with the
      support staff member during which patients review and discuss low literacy slide shows about
      healthy behaviors as well as examine their personal cardiovascular risk profile.
    


Intervention name(s): Peer Coach Phone Calls; Health Educator Visits; written materials
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): Subjects will receive 3 phone calls from a trained peer coach over 6 months.; Subjects will meet 2 times with a trained health educator in the practice; Subjects will receive written material and brochures and a cookbook from the American Heart Association addressing healthy lifestyle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Effect of GSK1160724 In Healthy Volunteers
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK1160724 is a potent mAChR antagonist, which is being developed for treatment of chronic
      obstructive pulmonary disease (COPD)
    


Intervention name(s): GSK1160724; Tiotropium bromide; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK1160724 will be available with dosing strengths of 10, 50 and 125 micrograms/blister for inhalation using the DISKUS inhaler.; Tiotropium bromide capsules will be supplied with a dose of 18 micrograms administered via a HandiHaler device.; Subjects will receive placebo.
Intervention MeSH terms: Bromides; Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: Anticholinergic,; FTIH,; Muscarinic Receptor Antagonist,; Plethysmography; COPD,
Safety Study Evaluating the Adrenal Suppression Potential of Product 0405 in Pediatric Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the trial is to assess Adrenal Suppression potential when pediatric subjects are
      administered Product 0405 for the treatment of Atopic Dermatitis
    

Detailed description: 
      Treatment medication will be administered topically, twice a day for 4 weeks.
    

Intervention name(s): Product 0405
Intervention type(s): Drug
Intervention description(s): Product 0405 will be administered topically, twice daily for 28 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atopic Dermatitis
A Study to Evaluate the Safety, Tolerability, and Activity of Intravenous MLDL1278A in Patients on Standard-of-Care Therapy for Stable Atherosclerotic Cardiovascular Disease (GLACIER)
Condition: Atherosclerosis
MeSH terms: Cardiovascular Diseases; Atherosclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II (proof-of-activity), double-blind, placebo-controlled, randomized,
      multicenter study of MLDL1278A (also known as BI-204) involving patients on standard-of-care
      therapy for atherosclerotic cardiovascular disease with evidence of vascular inflammation, as
      quantified by FDG-PET/CT.
    


Intervention name(s): MLDL1278A; MLDL1278A; placebo; statin, stable dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single intravenous dose; Repeating intravenous dose; Repeating intravenous dose; Repeating oral dose
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: BI-204
Effect of Mask Use on Hemodynamic Responses During Exertion
Condition: COVID-19; Heart Rate; Blood Pressure; Exercise Test; Mask
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The use of masks is a necessity due to the current pandemic conditions. The aim of the study
      is to examine the effects of the use of masks during effort on dyspnea and fatigue with
      hemodynamic parameters.
    

Detailed description: 
      The use of masks is a necessity due to the current pandemic conditions.There are studies on
      many parameters such as the effect of mask use on saturation (sp02), heart rate (HR) and
      blood pressure (BP). To determine whether there is a change in the performance of individuals
      in the masked and unmasked exercise test during exertion due to the scarcity of masked and
      unmasked maximal exercise tests and the insufficient measurement of the degree of fatigue
      felt, and to determine whether there is a change in the performance of individuals with and
      without mask, and to determine the hemodynamic responses in the body together with dyspnea
      and felt fatigue. This study will be conducted in order to examine the effect on
    

Intervention name(s): Treadmilll; mask
Intervention type(s): Device; Other
Intervention description(s): Hemodynamic changes before and after treadmill use; mask
Other intervention name(s): Saturation device; Sphygmomanometer
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Dyspnea; Mask; Oxygen Saturation; Blood Pressure; Heart Rate; Exercise Test; COVİD-19
A Study of Apalutamide Administered Orally as Whole Tablets and as a Mixture in Applesauce in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the bioavailability of apalutamide tablets
      administered orally as dispersed tablets mixed in applesauce relative to whole tablets under
      fasting conditions in healthy male participants.
    


Intervention name(s): Apalutamide
Intervention type(s): Drug
Intervention description(s): Participants will receive apalutamide 240 mg as a whole tablets administered orally (Treatment A) or as a dispersed mixture in applesauce (Treatment B) under fasted condition.
Other intervention name(s): JNJ-56021927 and ARN-509
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors
Condition: Glioblastoma Multiforme; Glioma; Gliosarcoma; Malignant Brain Tumor; Ependymoma; Medulloblastoma; Diffuse Intrinsic Pontine Glioma; Primary CNS Tumor
MeSH terms: Neoplasms; Glioblastoma; Glioma; Brain Neoplasms; Ependymoma; Gliosarcoma; Medulloblastoma; Diffuse Intrinsic Pontine Glioma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-children phase 1 trial using indoximod, an inhibitor of the immune
      "checkpoint" pathway indoleamine 2,3-dioxygenase (IDO), in combination with
      temozolomide-based therapy to treat pediatric brain tumors. Using a preclinical glioblastoma
      model, it was recently shown that adding IDO-blocking drugs to temozolomide plus radiation
      significantly enhanced survival by driving a vigorous, tumordirected inflammatory response.
      This data provided the rationale for the companion adult phase 1 trial using indoximod
      (IND#120813) plus temozolomide to treat adults with glioblastoma, which is currently open
      (NCT02052648). The goal of this pediatric study is to bring IDO-based immunotherapy into the
      clinic for children with brain tumors. This study will provide a foundation for future
      pediatric trials testing indoximod combined with radiation and temozolomide in the up-front
      setting for patients with newly diagnosed central nervous system tumors.
    


Intervention name(s): Indoximod; Temozolomide; Conformal Radiation; Cyclophosphamide; Etoposide
Intervention type(s): Drug; Drug; Radiation; Drug; Drug
Intervention description(s): Indoximod will be administered orally twice daily.; Temozolomide will be administered on days 1-5 of every 28 day cycle.; Conformal radiation will be administered on days 3-7 of induction cycle.; Cyclophosphamide will be administered orally daily.; Etoposide will be administered orally daily.
Other intervention name(s): 1-methyl-D-tryptophan; D-1MT; Temodar; Methazolastone
Intervention MeSH terms: Cyclophosphamide; Temozolomide; Etoposide; Tryptophan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glioblastoma multiforme; glioma; gliosarcoma; malignant brain tumor; ependymoma; medulloblastoma
Drug-Drug Interaction Study Between AT1001 (Migalastat Hydrochloride) and Agalsidase in Participants With Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective was to determine the effects of a single dose of migalastat hydrochloride (HCl)
      (migalastat) 150 and 450 milligrams (mg) on the safety and plasma pharmacokinetics (PK) of
      agalsidase and the effects of agalsidase on the safety and PK of migalastat 150 mg.
    

Detailed description: 
      This open-label study was conducted in 2 stages (Stage 1, Stage 2). Stage 1 included
      migalastat 150 mg; Stage 2 included migalastat 450 mg. Each dose of migalastat was selected
      to evaluate interaction with each of 3 doses of recombinant agalsidase: 0.5 mg/kilogram (kg)
      agalsidase beta; 1.0 mg/kg agalsidase beta; 0.2 mg/kg agalsidase alfa.

      Migalastat was administered orally. Agalsidase alfa was administered as a 40-minute
      intravenous (IV) infusion and agalsidase beta was administered as a 2-hour (hr) IV infusion.

      Stage 1 consisted of 3 treatment periods with 14 days intervening between each period.

      Period 1, Day 1: agalsidase was administered alone.

      Period 2, Day 1: migalastat was administered, followed 2 hrs later by agalsidase.

      Period 3, Day 7: migalastat was administered alone.

      Stage 2 consisted of two 14-day treatment periods in which the plasma exposure of migalastat
      was characterized when migalastat was administered with agalsidase solely to confirm the
      attainment of adequate migalastat plasma concentrations.

      Period 1, Day 1: agalsidase was administered as an IV infusion using a calibrated infusion
      pump.

      Period 2, Day 1: migalastat was administered, followed 2 hrs later by agalsidase.
    

Intervention name(s): Migalastat HCl; Agalsidase Beta; Agalsidase Alfa
Intervention type(s): Drug; Biological; Biological
Intervention description(s): Oral capsules, single dose; IV infusion, single dose; IV infusion, single dose
Other intervention name(s): AT1001; Galafold; migalastat; Fabrazyme; Replagal
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: A 2-stage design was used to study the effects of 2 dose levels of migalastat, while a 2- or 3-period design within each stage enabled study of the effects of one drug on the PK, pharmacodynamics, and safety of the other drug.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amicus Therapeutics; AT1001; Galafold; Migalastat; Pharmacokinetics
Fluoride Intake From Toothbrushig With Children's or Regular Toothpastes
Condition: Healthy Individuals
Study type: Interventional

Summary: 
      There are controversial data about fluoride intake by children when tooth brushing with
      children's or regular toothpastes. However, a study have showed that children were exposed to
      a dose of 0.051 mg F/Kg/day and 0.046 mg F/kg/day by tooth brushing with children's and and
      regular toothpaste, respectively. Fluorides doses were too close and is questioned if there
      is a real clinical relevance in terms of risk of dental fluorosis. It is important to
      evaluate if children's toothpastes does really represent a risk of fluoride intake when
      compared to the regular toothpastes in terms of risk of dental fluorosis. The hypothesis is
      that both children's and regular toothpastes can represente risks of development of dental
      fluorosis and can represent similar fluoride exposure by children.
    

Detailed description: 
      Subjects: Children at age of development of dental fluorosis (up to 4 years) enrolled at day
      care centres from the city of Montes Claros (0.7 ppm F), Brazil.

      The study design has two phases:

        1. In the first phase, children are required to bring at the day care centres the tooth
           brush and the toothpaste used at home. There is no randomization, since the inclusion in
           either children's or regular toothpaste groups will be done based on each child's
           preference. The children are requested to tooth brush as the usual manner that the
           parent and the child do at home. Saliva expectorates are collected as the protocol
           described by Guha-Chowdhury et al. (1996). No instructions are provided in this phase or
           interventions by the researcher. Saliva expectorates are collected for further
           laboratory analysis. Toothpastes are collected for laboratory analysis.

        2. In the second phase, children are required to toothbrush with other type of toothbrush
           following the same tooth brushing protocol. For example, children that previously used
           children's toothpaste will be provided a regular toothpaste, and vice-versa.

      Parents are requested to answer a questionnaire regarding their children's tooth brushing
      habits and socioeconomic factors.

      Laboratory analysis provides estimation of fluoride intake from tooth brushing with both
      toothpastes.

      Analysis will base on dose of fluoride intake (mg F/Kg body weight/day) considering
      children's and regular toothpastes.
    

Intervention name(s): Regular toothpastes; Children's toothpastes
Intervention type(s): Drug; Drug
Intervention description(s): One tooth brushing; One tooth brushing
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: children; dentifrice; fluoride; dental fluorosis
Shedding, Immunogenicity and Safety of Quadrivalent Live Intranasal Influenza Vaccine (QLAIV) in HIV-infected Children and Young Adults
Condition: Human Immunodeficiency Virus (HIV)
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to determine if there is a difference in shedding (primary
      objective) and in immunogenicity and safety (secondary objectives) between HIV-positive and
      HIV-negative children and young adults who are receiving the quadrivalent live-attenuated
      influenza vaccine (QLAIV).
    

Detailed description: 
      QLAIV is an intranasal vaccine that works by using 4 different attenuated strains of
      influenza virus that will replicate in the nose and stimulate an immune response in
      recipients that should protect them if they are infected with one of those strains of
      influenza in the future. A couple of studies have shown an increase in duration that the
      viruses remain in the nose in immunocompromised people. Those studies were done using the
      trivalent vaccine, so the investigators would like to evaluate the quadrivalent vaccine, and
      there is still a need for additional data to help understand the duration of shedding. If
      shedding is prolonged in HIV-infected children and young adults, it would be important to
      know for contacts of those individuals who are very immunocompromised. Shedding will be
      measured by looking for influenza RNA in nasopharyngeal swabs taken at baseline, 2-5 days,
      7-10 days and 14-21 days after the intranasal immunization.

      The live-attenuated influenza vaccines have been shown to have increased effectiveness in
      children and they stimulate the immune system in a different way than the inactivated
      influenza vaccines (TIV or QIV). In this study, the investigators will have the opportunity
      to compare the immunogenicity of QLAIV, measured at baseline and 14-21 days post-vaccination,
      in HIV-infected and uninfected children, adolescents and young adults. Although prior studies
      of LAIV in HIV-infected and other immunocompromised children and adults have not shown any
      increase in serious adverse events, safety will be actively monitored for the first 30-45
      days through a study-specific questionnaire administered at each clinic or phone visit and by
      asking the subjects to keep a diary of side effects. Safety will be monitored passively
      throughout the course of the study.
    

Intervention name(s): Quadrivalent Live Attenuated Influenza Vaccine
Intervention type(s): Biological
Other intervention name(s): FluMist Quadrivalent; QLAIV
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Shedding; Immunogenicity; Safety; HIV infected; Children; Young adults
A Study of the Efficacy and Safety of Semaglutide Injection in the Treatment of Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Semaglutide injection is a new drug developed according to Ozempic® biosimilars.This trial is
      conducted in China. The purpose of this study is to investigate the similarities in the
      efficacy and safety of semaglutide injection and Ozempic® in the treatment of type 2
      diabetes, respectively.
    

Detailed description: 
      This study is a multicenter, randomized, open-label, parallel assignment, which plans to
      enroll 476 patients with type 2 diabetes And Stable daily dose for 4 weeks prior to the day
      of screening of the metformin formulations (greater than or equal to 1500 mg to less than or
      equal to 2000 mg or maximum tolerated dose documented greater than or equal to 1000 mg. The
      study was divided into three phases: screening, baseline and treatment.
    

Intervention name(s): semaglutide injection
Intervention type(s): Biological
Intervention description(s): The subject will receive either a dose semaglutide once weekly (subcutaneous (s.c.) injection). The initial dose of 0.25 mg is s.c. once weekly, and the dose is increased to 0.5 mg after 4 weeks of administration, and the dose is increased to 1 mg after 4 weeks of 0.5 mg administration, and the dose is continued at a stable dose of 1 mg for 24 weeks.Treatment duration 32 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Product Use and Adaptation, Safety and Tolerability of P3P in Adult Healthy Smokers Switching to it
Condition: Pharmacokinetics
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the product use and adaptation in adult, current
      cigarette smoking subjects between baseline and after one month of use of one of two P3P
      variants. The effect of P3P use behavior on nicotine pharmacokinetic (PK) profile,
      acceptability, as well as the safety and tolerability of P3P over a period of 1 month will be
      investigated.
    

Detailed description: 
      This is a study of daily use of up to 15 P3P products over one month, including 2 confinement
      periods (2 overnight stays at the beginning of the study and 1 overnight stay at the end of
      the exposure period). During the confinement visits, nicotine PK from P3P exposure will be
      assessed as well as pharmacodynamic effects related to craving, sensory parameters, product
      experience, and product acceptance.

      Between the two confinement periods, subjects will return to the investigational site for
      weekly ambulatory visits during which P3P will be resupplied and selected safety and other
      study assessments will be performed.

      From the start of the exposure period onwards, subjects will be instructed not to smoke or
      use other tobacco or nicotine containing products and to use P3P exclusively.
    

Intervention name(s): P3P-1mg; P3P-2mg
Intervention type(s): Other; Other
Intervention description(s): P3P-1mg (P3P product containing 1mg of nicotine.); P3P-2mg (P3P product containing 2mg of nicotine.)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, double-blinded, 2-arm parallel groups, single center study
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Nicotine