bioihbjkbjnl/mcl2 huggingface dataset:
A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of Azithromycin SR Versus Amoxicillin For The Treatment Of Strep Throat In Children
Condition: Tonsillitis
MeSH terms: Tonsillitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective was to determine if a single 60 mg/kg dose of azithromycin SR was as safe and
      effective as a 10-day regimen of amoxicillin (45 mg/kg/day, given in divided doses every 12
      hours) when used to treat children with strep throat.
    


Intervention name(s): amoxicillin; azithromycin SR
Intervention type(s): Drug; Drug
Intervention description(s): 10 day regimen, 45 mg/kg/day, given in divided doses every 12 hours; 60 mg/kg dose of azithromycin SR was as safe and effective as a 10-day regimen of amoxicillin when used to treat children with strep throat
Intervention MeSH terms: Amoxicillin; Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Open Label Study of Tolerability, Pharmacokinetics and Pharmacodynamics of BCD-054 (Pegylated Interferon Beta-1a), IM and SC, Compared to Rebif® and Avonex® in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an international multicenter study of tolerability, pharmacokinetics and
      pharmacodynamics of drug product BCD-054 (CJSC BIOCAD, Russia), administrated intramuscular
      and subcutaneous, compared to Rebif® (Merck Serono S.p.A., Italy) and Avonex® (Biogen Idec
      Ltd, UK) in healthy volunteers. The study involves 2 stages - single ascending dose
      administration and multiple estimated therapeutic dose administration of BCD-054.
    


Intervention name(s): BCD-054; Rebif; Avonex
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): pegylated interferon beta 1a; interferon beta 1a; interferon beta 1a
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pegylated interferon beta; Volunteers
Improving Lower Limb Blood Flow in Healthy Adult Volunteers
Condition: Deep Vein Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The THRIVE-1 study will examine novel methods for enhancing blood flow in the lower limb
      using electrical stimulation. Increases in lower limb blood flow improve venous return and
      thereby reduce venous stasis. Since stasis is one of the compounding factors in the
      development of deep vein thrombosis, the risk of developing thrombosis should theoretically
      be proportionally reduced. This technique may prove to be a useful tool in preventing and
      reducing the incidence of deep vein thrombosis in both medical and surgical patients together
      with passengers undertaking significant duration travel (as travel - related deep vein
      thrombosis is not exclusively related to flying).
    


Intervention name(s): geko
Intervention type(s): Device
Intervention description(s): The geko is a neuromuscular stimulator device, which when applied stimulates the common peroneal nerve
Other intervention name(s): geko TM
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Deep Vein Thrombosis
The Clinical Performance of Inlay Zirconia Bridges
Condition: Dental Crowns
Study type: Interventional

Summary: 
      When missing tooth structure or teeth are replaced, minimal biologic risk should be involved
      to re-establish function and esthetics. The increased use of the adhesive technique and
      preservation of dental tissues have greatly impacted conservative tooth preparation design.
      The development use of zirconia technology and all-ceramic systems has opened the potential
      for fabrication inlays zirconia bridges with durability and good aesthetics.

      The purpose of this study is to clinically evaluate the placement of inlay bridge made of a
      Y-TZP framework veneered with a pressed ceramic and bonded with a completely adhesive
      approach in the replacement of a single missing tooth.
    

Detailed description: 
      This study evaluates the use of inlay bridge made of Zirconia and all ceramic systems with
      three designs in the replacement process of one single tooth (i.e. a missing premolar or
      molar.) The first design is going to be fabricated with CAD/CAM Zirconia and the occlusal
      surface from e-max press.

      The second design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface
      from e-max press and the internal surface coated with glaze layer to improve the adhesion.

      The third design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface
      from e-max press and the internal surface coated with a layer of e-max ceramic press to
      improve the adhesion.
    

Intervention name(s): Glaze layer; E-max Press layer
Intervention type(s): Procedure; Procedure
Intervention description(s): A coating of a glaze layer will be used at the inner surface of the bridge to improve adhesion; A coating of E-max Press layer will be used at the inner surface of the bridge to improve adhesion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Efficacy, Tolerance and Satisfaction With CLOBEX® Spray When Used as Monotherapy or Add-on Therapy in Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Observational

Summary: 
      Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on
      therapy to existing systemic or topical anti-psoriatic agents.
    

Detailed description: 
      Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on
      therapy to existing systemic or topical anti-psoriatic agents, as determined by the change in
      the target plaque severity (TPS) rating between Weeks 0 and 4.
    

Intervention name(s): Clobetasol Propionate, 0.05%; Clobetasol propionate, 0.05% Spray
Intervention type(s): Drug; Drug
Intervention description(s): Apply twice daily for 2 or 4 weeks as monotherapy; Apply twice daily for 2 or 4 weeks as add-on therapy
Other intervention name(s): Clobex® Spray, 0.05%; Clobex® Spray, 0.05%
Intervention MeSH terms: Clobetasol
Observational model: Case-Only
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Community Sample
Validation of Medication Non-adherence Model (UK)
Condition: Diabetes Mellitus; Chronic Obstructive Pulmonary Disease; Chronic Illness; Primary Care; Medication Management at Home
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Chronic Disease
Study type: Observational

Summary: 
      Research has shown that nearly 50% of patients with chronic conditions around the globe do
      not adhere to their prescribed medicine, leading to enormous cost to the healthcare
      providers. Non-adherence can be due to various forms and have multiple causes.

      To address this need, Philips Research has developed Medication Non-adherence model. This
      tool will help in developing a systemic way of assessing medication non-adherence and
      providing decision support for targeted intervention to healthcare professionals. The aim of
      this study is to validate this model with 750 chronically ill patients in UK.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        patients with chronic illness taking more than 3 medications. These patients will be
        between the age of 18 - 89
Combined Training on Body Composition of Postmenopausal Women Undergoing Treatment for Breast Cancer
Condition: Breast Cancer; Aromatase Inhibitors; Postmenopausal
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Breast cancer is a multifactorial disease affecting women, and one of the treatments for its
      healing and survival is hormone therapy. Aromatase inhibitors are third-generation drugs that
      promote lower chance of metastasis, but their side effects include the loss of bone mineral
      density and increased fat percentage. In this way, the Combined Training (combined resistance
      and endurance training) may be an interesting strategy to minimize the side effects of
      aromatase inhibitors, providing better quality of life, survival and changes in body
      composition.
    


Intervention name(s): Combined Training
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Combined Training; Breast Cancer; Body Composition; Postmenopausal Women; Aromatase Inhibitors; Quality of life
Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A
Condition: Congenital Bleeding Disorder; Haemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted globally. The aim of this clinical trial is to investigate the safety
      and pharmacokinetics (the determination of the concentration of the administered medication
      in blood over time) of NNC 0129-0000-1003 in previously treated subjects with severe
      haemophilia A.
    


Intervention name(s): turoctocog alfa pegol; turoctocog alfa pegol; turoctocog alfa pegol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose (low) administered intravenously (into the vein); Single dose (medium) administered intravenously (into the vein); Single dose (high) administered intravenously (into the vein)
Other intervention name(s): NNC 0129-0000-1003; NNC 0129-0000-1003; NNC 0129-0000-1003
Intervention MeSH terms: Factor VIII
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial of DB289 for the Treatment of Stage I African Trypanosomiasis
Condition: African Trypanosomiasis
MeSH terms: Trypanosomiasis; Trypanosomiasis, African
Study type: Interventional
Phase: Phase 2

Summary: 
      Human African Trypanosomiasis or sleeping sickness has made a spectacular return during the
      last decade, and in many places the demand largely surpasses the capacities of the treatment
      centers. Treatment of the disease remains unsatisfactory. All currently used drugs must be
      administered parenterally, treatment is lengthy, and adverse drug reactions frequent. There
      are currently no drugs that are easily administered and have low toxicity, and might thus be
      used as tools to support disease control.

      This study aims to compare the safety and efficacy of DB289, a new, orally administered
      dication prodrug to pentamidine i.m. injection for the treatment of first stage sleeping
      sickness. The project will be executed in the framework of an international consortium
      consisting of several partners from academia, industry and from the Democratic Republic of
      Congo Ministries of Health.
    


Intervention name(s): DB289; Pentamidine
Intervention type(s): Drug; Drug
Intervention description(s): Pafuramidine maleate (DB289), 100 mg BID orally; Pentamidine isethionate (Aventis) for injection (200 mg/vial), 4 mg/kg QD IM
Other intervention name(s): pafuramidine maleate
Intervention MeSH terms: Pentamidine; Pafuramidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: first stage; Trypanosoma brucei gambiense; T. b. gambiense; sleeping sickness; First stage T. b. gambiense sleeping sickness
Treating Pre-School Children at Risk for Overweight in the Primary Care Setting
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The goal of this study is to test, in the primary care setting, the efficacy of an innovative
      intervention program for children aged 2-5 years with a BMI over the 85th percentile and one
      overweight parent (BMI >27 kg/m2.
    


Intervention name(s): family based lifestyle and behavioral counseling; counseling focused on the child
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 16 group meetings; 16 meetings
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: BMI >85%for age and gender
Multiple Dose Study in Heart Failure of BAY 1067197
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to investigate the safety, tolerability and early effects on cardiac function
      of the partial A1 agonist BAY1067197 in patients with chronic heart failure. BAY1067197 will
      be applied once daily over 7 days in addition to standard therapy including a beta-blocker.
      The aim of the study is to assess if a 7 day treatment with BAY1067197 is well tolerated when
      given on top of standard therapy for heart failure. Furthermore, the study aims to assess if
      cardiac function improves in the early course of therapy.
    


Intervention name(s): BAY1067197 (10 mg); BAY1067197; Placebo (10 mg); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10 mg BAY1067197 for 7 d treatment once daily as oral application; The dose escalation to the second dose step will proceed only if the previous dose step has shown acceptable safety and tolerability 5 mg / or 10 mg / or 20 mg BAY1067197 for 7 d treatment as oral application.; 10 mg Placebo for 7 d treatment once daily as oral application; 5 mg / or 10 mg / or 20 mg Placebo for 7 d treatment once daily as oral application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Methodological Validation of Ibuprofen Verses Placebo for Post Operative Pain After Third Molar Extraction Surgery
Condition: Dental Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a single center placebo controlled, prospective, randomized study on healthy adults
      undergoing third molar surgery.
    


Intervention name(s): Placebo; Ibuprofen
Intervention type(s): Drug; Drug
Intervention description(s): 400 mg PO
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Third Molar Extraction
Study Where Pharmaco Magnetic Resonance Imaging (MRI) Effects of AZD6765 Will be Compared to Placebo in Depressive Male and Female Subjects
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of a single dose infusion of AZD 6765
      compared with placebo and ketamine on the blood oxygen level dependent signal using fMRI
      (functional Magnetic Resonance Imaging) in depressed subjects.
    


Intervention name(s): AZD6765; Ketamine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single infusion; single infusion; single infusion
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase I; BOLD signal; fMRI; AZD6765; BOLD signal measured by fMRI
Pharmacokinetics/Pharmacodynamics (PK/PD) of Cangrelor
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to:

        -  Evaluate the tolerability of two cangrelor regimens.

        -  Compare the PD of cangrelor regimens with oral clopidogrel.
    

Detailed description: 
      The purposes of this study are:

        -  To evaluate the tolerability of two cangrelor regimens of bolus plus infusion (A and B).

        -  To characterize the pharmacokinetics of Cangrelor (A and B).

        -  To compare the pharmacodynamics of cangrelor regimens with that of an oral 600 mg dose
           of clopidogrel (A, B, C and D).

        -  To determine the effect of prior cangrelor treatment on the pharmacodynamics of
           clopidogrel (C and D).

        -  To determine the effect of prior clopidogrel treatment on the pharmacodynamics of
           cangrelor (Group D).

        -  To determine the effects of concomitant clopidogrel and cangrelor exposure on the
           pharmacodynamics of clopidogrel (Group D).
    

Intervention name(s): cangrelor
Intervention type(s): Drug
Intervention MeSH terms: Cangrelor
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cangrelor; clopidogrel
Effect of the Angiotensin II Receptor Antagonist Irbesartan on Biochemical and Functional Markers of Endothelial Dysfunction in Patients With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary:

        -  To evaluate the impact of irbesartan on endothelial function in hypertensive patients
           with metabolic syndrome.

      Secondary:

        -  To evaluate the oxidative stress status in patients with hypertension with metabolic
           syndrome.

        -  To correlate the oxidative stress status with endothelial function in these patients.

        -  To evaluate the effect of irbesartan on the oxidative stress stage in patients with
           metabolic syndrome and to correlate it with the effect on endothelial function .

        -  To correlate the change in endothelial function and oxidative stress stage with the
           change of arterial pressure levels.
    


Intervention name(s): IRBESARTAN; Atenolol
Intervention type(s): Drug; Drug
Intervention description(s): Tablets; Tablets
Intervention MeSH terms: Atenolol; Irbesartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Contrast Agents on the Anticoagulant Properties of Oral Factor Xa Inhibitors
Condition: Contrast Agents and Oral Factor Xa Inhibitor
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study is to evaluate the effect of iohexol as a contrast agent on the
      anticoagulant activity of oral factor Xa inhibitors.
    

Detailed description: 
      The study included 65 people who underwent contrast computerized tomography (CT). The study
      patients were divided into 4 groups. Patients in group 1 were using rivaroxaban (20
      patients), patients in group 2 were using apixaban (20 patients), patients in group 3 were
      using edoxaban (20 patients), and group 4 was the control group (5 volunteers). Iohexol (60
      ml) was used as a contrast agent. Two tubes were used to collect 2 ml of blood from the
      patients at 4 hours after the drug dose (rivaroxaban, apixaban, or edoxaban) and 1 hour after
      the contrast CT (CT was performed 3 hours after the drug was taken). In the control group, at
      any time and 1 hour after contrast CT, 2 tubes of 2 ml of blood were collected. The
      anticoagulant properties of rivaroxaban, apixaban, and edoxaban were evaluated using
      anti-factor Xa levels.
    

Intervention name(s): computerized tomography
Intervention type(s): Drug
Intervention description(s): Anti Factor Xa level
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study prospectively included 65 people who underwent contrast computerized tomography
        (CT). The CT indications were thoracic aortic dilatation, chronic obstructive pulmonary
        disease, abdominal aortic dilatation, chronic abdominal pain.
Bioequivalence Bewteen DopaSnap® (Cabidopa/Levopdoap 25/100 mg Tablet) and Carbidopa/Levodopa 25/100 mg Tablet (Actavis)
Condition: Other
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a single center, bioequivalence and food-effect, open-label study designed to be
      conducted in three sequential parts:
    

Detailed description: 
      This will be a single center, bioequivalence and food-effect, open-label study designed to be
      conducted in three sequential parts:

        -  Part I: bioequivalence, food-effect, randomized, open-label, single dose, 3-period,
           6-sequence, crossover design.

        -  Part II: multiple-dose (every 4 hours), open-label, 1-period design.

        -  Part III: multiple-dose (every 2 hours), open-label, 1-period design.
    

Intervention name(s): DopaSnap®; RDL of CD-LD
Intervention type(s): Drug; Drug
Intervention description(s): immediate release CD/LD 25/100mg; Riverside Pharmaceuticals Corporation, USA; (immediate release CD/LD 25/100mg; Merck Sharp & Dohme Corp., USA),
Other intervention name(s): test product; Reference
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Part I: bioequivalence, food-effect, randomized, open-label, single-dose, 3-period, 6-sequence, crossover design.
Part II: multiple-dose (every 4 hours), open-label, 1-period design.
Part III: multiple-dose (every 2 hours), open-label, 1-period design. Subjects enrolled in Part II and Part III will be a subset of those who completed Part I.
Masking: None (Open Label)
Primary purpose: Basic Science
Study of SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan
Condition: Poliomyelitis; Polio
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to assess the immunogenicity and safety of SP059 as a three-dose
      primary and booster vaccination in Japanese infants aged 3 through 68 months.

      Primary objective:

        -  To assess that the seroprotection rates against polio types 1, 2 and 3 are over 90%
           approximately one month following the three dose primary vaccination series with
           inactivated polio vaccine (IPV).

      Secondary objective:

        -  To describe the immunogenicity (in terms of seroprotection / seroconversion vaccine
           response rates and Geometric Mean Titers) of IPV before and after the primary
           vaccination and before and after the booster vaccination.

        -  To describe the safety after each dose of IPV.
    

Detailed description: 
      Study participants will receive three doses of inactivated polio vaccine (IPV) (at each visit
      and given 3-8 weeks apart) as a three-dose primary vaccination starting at 3-68 months of age
      and followed by a single dose of IPV as a booster vaccination 6-18 months after completion of
      the three-dose primary vaccination.

      Subjects will be observed by the Investigator or sub-Investigator for 30 minutes following
      the vaccine injection.

      The duration of each participant's participation in the trial will be approximately 1 year.
    

Intervention name(s): Inactive Poliovirus Vaccine
Intervention type(s): Biological
Intervention description(s): 0.5 mL, Subcutaneous
Other intervention name(s): SP059
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Poliomyelitis; Inactivated polio vaccine; Polio; Poliovirus